Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

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

For the quarterly period ended March 31, 2015

Commission File Number 1-6926

 

 

C. R. BARD, INC.

(Exact name of registrant as specified in its charter)

 

 

 

New Jersey

730 Central Avenue

Murray Hill, New Jersey 07974

22-1454160
(State of incorporation)

(Address of principal

executive offices)

(I.R.S. Employer

Identification No.)

Registrant’s telephone number, including area code: (908) 277-8000

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

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

 

Large accelerated filer  x Accelerated filer   ¨
Non-accelerated filer  ¨    (Do not check if smaller reporting  company) 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 at March 31, 2015

Common Stock - $0.25 par value 74,245,736

 

 

 


Table of Contents

C. R. BARD, INC. AND SUBSIDIARIES

INDEX

 

             Page    

PART I – FINANCIAL INFORMATION

  

Item 1.

 

Financial Statements (unaudited)

  
 

Condensed Consolidated Statements of Income for the Three Months Ended March 31, 2015 and 2014

       
 

Condensed Consolidated Statements of Comprehensive Income for the Three Months Ended March 31, 2015 and 2014

       
 

Condensed Consolidated Balance Sheets – March 31, 2015 and December 31, 2014

       
 

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2015 and 2014

       
 

Notes to Condensed Consolidated Financial Statements

       

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     18    

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

     26    

Item 4.

 

Controls and Procedures

     26    

PART II – OTHER INFORMATION

  

Item 1.

 

Legal Proceedings

     27    

Item 1A.

 

Risk Factors

     31    

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

     31    

Item 5.

 

Other Information

     31    

Item 6.

 

Exhibits

     31    

Signatures

     32    

 

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(dollars in thousands except per share amounts, unaudited)

 

  Three Months
Ended March 31,
 
  2015   2014  

Net sales

 $ 819,700       $      799,300     

Costs and expenses:

Cost of goods sold

  311,200        309,500     

Marketing, selling and administrative expense

  235,700        236,800     

Research and development expense

  60,600        64,300     

Interest expense

  11,300        11,100     

Other (income) expense, net

  16,300        (6,000)    
  

 

 

    

 

 

 

Total costs and expenses

  635,100        615,700     
  

 

 

    

 

 

 

Income from operations before income taxes

  184,600        183,600     

Income tax provision

  44,800        35,200     
  

 

 

    

 

 

 

Net income

 $      139,800       $ 148,400     
  

 

 

    

 

 

 

Basic earnings per share available to common shareholders

 $ 1.85       $ 1.89     
  

 

 

    

 

 

 

Diluted earnings per share available to common shareholders

 $ 1.82       $ 1.86     
  

 

 

    

 

 

 

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

 

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(dollars in thousands, unaudited)

 

  Three Months
Ended March 31,
 
  2015   2014  

Net income

$       139,800      $       148,400     

Other comprehensive income (loss):

Change in derivative instruments designated as cash flow hedges, net of tax

  100        400     

Foreign currency translation adjustments

  (53,700)       1,000     

Benefit plan adjustments, net of tax

  1,900        1,600     
  

 

 

    

 

 

 

Other comprehensive income (loss)

  (51,700)       3,000     
  

 

 

    

 

 

 

Comprehensive income

$ 88,100      $ 151,400     
  

 

 

    

 

 

 

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

 

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(dollars in thousands except share and per share amounts, unaudited)

 

  March 31,
2015
  December 31,
2014
 

ASSETS

Current assets

Cash and cash equivalents

 $ 1,004,200       $ 960,100     

Restricted cash

  23,100        47,500     

Accounts receivable, less allowances of $8,600 and $10,100, respectively

  436,500        455,200     

Inventories

  377,800        376,200     

Short-term deferred tax assets

  69,300        93,300     

Other current assets

  125,900        114,800     
  

 

 

    

 

 

 

Total current assets

  2,036,800        2,047,100     
  

 

 

    

 

 

 

Property, plant and equipment, at cost

  761,800        747,900     

Less accumulated depreciation and amortization

  309,200        301,500     
  

 

 

    

 

 

 

Net property, plant and equipment

  452,600        446,400     

Goodwill

  1,081,700        1,091,200     

Core and developed technologies, net

  725,100        749,100     

Other intangible assets, net

  296,600        304,800     

Deferred tax assets

  11,500        11,500     

Other assets

  452,400        442,500     
  

 

 

    

 

 

 

Total assets

 $ 5,056,700       $ 5,092,600     
  

 

 

    

 

 

 

LIABILITIES AND SHAREHOLDERS’ INVESTMENT

Current liabilities

Short-term borrowings and current maturities of long-term debt

 $ 484,600       $ 78,000     

Accounts payable

  78,800        81,900     

Accrued expenses

  229,000        287,700     

Accrued compensation and benefits

  104,700        162,600     

Income taxes payable

  5,900        4,400     
  

 

 

    

 

 

 

Total current liabilities

  903,000        614,600     
  

 

 

    

 

 

 

Long-term debt

  1,147,400        1,401,900     

Other long-term liabilities

  1,111,900        1,125,300     

Deferred income taxes

  145,600        145,900     

Commitments and contingencies

Shareholders’ investment:

Preferred stock, $1 par value, authorized 5,000,000 shares; none issued

  —        —     

Common stock, $0.25 par value, authorized 600,000,000 shares; issued and outstanding 74,245,736 shares at March 31, 2015 and 74,893,483 shares at December 31, 2014

  18,600        18,700     

Capital in excess of par value

  2,005,100        1,945,300     

Accumulated deficit

  (134,400)       (70,300)    

Accumulated other comprehensive loss

  (140,500)       (88,800)    
  

 

 

    

 

 

 

Total shareholders’ investment

  1,748,800        1,804,900     
  

 

 

    

 

 

 

Total liabilities and shareholders’ investment

 $    5,056,700       $    5,092,600     
  

 

 

    

 

 

 

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

 

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(dollars in thousands, unaudited)

  Three Months
Ended March 31,
 
  2015   2014  

Cash flows from operating activities:

Net income

 $ 139,800       $ 148,400     

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization

  46,100        42,500     

Litigation charges

  10,300        —     

Restructuring and productivity initiative costs, net of payments

  3,300        —     

Asset impairment

  —        600     

Gain on sale of investment

  —        (7,100)    

Deferred income taxes

  26,500        8,900     

Share-based compensation

  23,000        19,500     

Inventory reserves and provision for doubtful accounts

  5,200        5,200     

Other items

  1,300        500     

Changes in assets and liabilities:

Accounts receivable

  8,600        26,800     

Inventories

  (20,600)       (13,700)    

Current liabilities

  (104,100)       (42,100)    

Taxes

  (8,300)       (78,200)    

Other, net

  (17,100)       3,000     
  

 

 

    

 

 

 

Net cash provided by operating activities

  114,000        114,300     
  

 

 

    

 

 

 

Cash flows from investing activities:

Capital expenditures

  (29,200)       (22,700)    

Change in restricted cash

  26,100        1,200     

Payments made for intangibles

  (200)       (100)    

Proceeds from sale of investment

  —        7,100     
  

 

 

    

 

 

 

Net cash used in investing activities

  (3,300)       (14,500)    
  

 

 

    

 

 

 

Cash flows from financing activities:

Change in short-term borrowings, net

  153,000        —     

Proceeds from exercises under share-based compensation plans, net

  5,300        35,400     

Excess tax benefit relating to share-based compensation plans

  17,600        10,100     

Purchases of common stock

  (204,200)       (255,700)    

Dividends paid

  (16,800)       (16,600)    

Payment of contingent consideration

  (4,000)       —     
  

 

 

    

 

 

 

Net cash used in financing activities

  (49,100)       (226,800)    
  

 

 

    

 

 

 

Effect of exchange rate changes on cash and cash equivalents

  (17,500)       —     
  

 

 

    

 

 

 

Increase (decrease) in cash and cash equivalents during the period

  44,100        (127,000)    
  

 

 

    

 

 

 

Balance at January 1

  960,100           1,066,900     
  

 

 

    

 

 

 

Balance at March 31

 $    1,004,200       $ 939,900     
  

 

 

    

 

 

 

Supplemental cash flow information

Cash paid for:

Interest

 $ 16,000       $ 16,000     

Income taxes

  9,000        94,400     

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

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of C. R. Bard, Inc. and its subsidiaries (the “company” or “Bard”) should be read in conjunction with the audited consolidated financial statements and notes thereto included in Bard’s 2014 Annual Report on Form 10-K. These financial statements have been prepared on a basis that is substantially consistent with the accounting principles applied in the financial statements in Bard’s 2014 Annual Report on Form 10-K. The preparation of these financial statements requires the company to make estimates and judgments that affect reported amounts of assets, liabilities, revenues and expenses and the related disclosure of contingent assets and liabilities at the date of the financial statements. These financial statements include all normal and recurring adjustments necessary for a fair presentation. The accounts of most foreign subsidiaries are consolidated as of and for the quarters ended February 28, 2015 and February 28, 2014 and as of November 30, 2014. No events occurred related to these foreign subsidiaries during the months of March 2015, March 2014 or December 2014 that materially affected the financial position or results of operations of the company. The results for the interim periods presented are not necessarily indicative of the results expected for the year.

New Accounting Pronouncements Not Yet Adopted

In May 2014, the Financial Accounting Standards Board issued a new accounting standard that provides for a comprehensive model to use in the accounting for revenue arising from contracts with customers. Under this standard, revenue will be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. This standard will be effective as of the beginning of Bard’s 2017 fiscal year. The company is assessing the new standard and has not yet determined the impact to the consolidated financial statements.

2. Earnings per Common Share

Earnings per share (“EPS”) is computed under the two-class method using the following common share information:

 

  Three Months Ended
March 31,
 
  2015   2014  
(dollars and shares in millions)        

EPS Numerator:

Net income

 $ 139.8         $ 148.4       

Less: Income allocated to participating securities

  2.1          2.5       
  

 

 

    

 

 

 

Net income available to common shareholders

 $     137.7         $     145.9       
  

 

 

    

 

 

 

EPS Denominator:

Weighted average common shares outstanding

  74.4          77.0       

Dilutive common share equivalents from share-based compensation plans

  1.4          1.5       
  

 

 

    

 

 

 

Weighted average common and common equivalent shares outstanding, assuming dilution

  75.8          78.5       
  

 

 

    

 

 

 

3. Income Taxes

The company’s effective tax rate for the quarter ended March 31, 2015 was 24.3% compared to 19.2% for the same period in the prior year. The effective tax rate for the quarter ended March 31, 2014 reflected a tax benefit of $10.9 million as a result of the completion of U.S. Internal Revenue Service examinations for the tax years 2008 through 2010.

At March 31, 2015, the total amount of liability for unrecognized tax benefits related to federal, state and foreign taxes was $36.1 million (of which $30.8 million would impact the effective tax rate, if recognized) plus $3.2 million of accrued interest. At December 31, 2014, the liability for unrecognized tax benefits was $36.1 million plus $2.9 million of accrued interest. Depending upon the result of open tax examinations and/or the expiration of applicable statutes of limitation, the company believes it is reasonably possible that the total amount of unrecognized tax benefits may decrease by up to $11.8 million within the next 12 months.

4. Financial Instruments

For further discussion regarding the company’s use of derivative instruments, see Note 1 of the notes to consolidated financial statements in Bard’s 2014 Annual Report on Form 10-K.

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

Foreign Exchange Derivative Instruments

The company enters into readily marketable forward and option contracts with financial institutions to help reduce its exposure to foreign currency exchange rate fluctuations. These contracts limit volatility because gains and losses associated with foreign currency exchange rate movements are generally offset by movements in the underlying hedged item. The notional value of the company’s forward currency and option currency contracts was $194.6 million and $191.1 million at March 31, 2015 and December 31, 2014, respectively.

Interest Rate Derivative Instruments

The company’s outstanding interest rate swap contract effectively converts its 2.875% fixed-rate notes due 2016 to a floating-rate instrument. The notional value of the company’s interest rate swap contract is $250 million.

The company’s outstanding forward starting interest rate swap contract manages its exposure to interest rate volatility in anticipation of issuing fixed-rate debt. The forward swap contract has a notional value of $250 million and a mandatory termination date of May 2016.

The location and fair value of derivative instruments that are designated as hedging instruments recognized in the condensed consolidated balance sheets are as follows:

 

    Fair Value
of Derivatives
 
Derivatives Designated as Hedging Instruments

Balance Sheet

Location

March 31,
2015
  December 31,
2014
 
(dollars in millions)          

Forward currency contracts

Other current assets

 $ 2.7       $ 1.9     

Option currency contracts

Other current assets

  14.8        9.3     

Interest rate swap contract

Other current assets

  3.6        —       

Forward currency contracts

Other assets

  0.2        —       

Interest rate swap contracts

Other assets

  —          4.9     
     

 

 

   

 

 

 
 $         21.3       $         16.1     
     

 

 

   

 

 

 

Forward currency contracts

Accrued expenses

 $ 6.6       $ 6.6     

Forward currency contracts

Other long-term liabilities

  0.1        —       

Interest rate swap contract

Other long-term liabilities        

  7.6        —       
     

 

 

   

 

 

 
 $ 14.3       $ 6.6      
     

 

 

   

 

 

 

The location and amounts of gains and losses on derivative instruments designated as cash flow hedges and the impact on shareholders’ investment are as follows:

 

  Gain/(Loss)
Recognized in Other
Comprehensive
Income (Loss)
  Location of
Gain/(Loss) Reclassified
from Accumulated
    Other Comprehensive Loss into    
Income
Gain/(Loss) Reclassified
from Accumulated
Other Comprehensive Loss
into Income
 
  Three Months Ended
March 31,
  Three Months Ended
March 31,
 
  2015   2014   2015   2014  
(dollars in millions)                  

Forward currency contracts

$         0.1       $ 0.3       Cost of goods sold  $ 0.8         $         0.6      

Option currency contracts

  9.0         (0.6)      Cost of goods sold   1.1          (0.6)     

Interest rate swap contract

  (7.9)        —          Interest expense   —             —         
 

 

 

   

 

 

      

 

 

   

 

 

 
 $ 1.2       $         (0.3)       $         1.9         $ —         
 

 

 

   

 

 

      

 

 

   

 

 

 

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

The location and amounts of gains and losses on the derivative instrument designated as a fair value hedge for the three months ended March 31, are as follows:

 

      Income Statement    
Location
(Loss) Recognized on Swap   Gain Recognized on Debt  
  2015   2014   2015   2014  
(dollars in millions)                  

Interest rate swap contract

Interest expense  $           (1.0)      $           (1.0)      $           1.0       $           1.0      
     

 

 

    

 

 

    

 

 

    

 

 

 

Financial Instruments Measured at Fair Value on a Recurring Basis

Fair value is defined as the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that is determined using assumptions that market participants would use in pricing an asset or liability. The fair value guidance establishes a three-level hierarchy which maximizes the use of observable inputs and minimizes the use of unobservable inputs used in measuring fair value. The levels within the hierarchy range from Level 1 having observable inputs to Level 3 having unobservable inputs.

The following table summarizes certain financial instrument assets and (liabilities) measured at fair value on a recurring basis:

 

  March 31,
2015
  December 31,
2014
 
(dollars in millions)        

Forward currency contracts

 $           (3.8)      $         (4.7)    

Option currency contracts

  14.8        9.3     

Interest rate swap contracts

  (4.0)       4.9     

The fair values were measured using significant other observable inputs and valued by reference to similar financial instruments, adjusted for restrictions and other terms specific to each instrument. These financial instruments are categorized as Level 2 under the fair value hierarchy.

The fair value of the liability for contingent consideration related to acquisitions was $8.9 million and $23.1 million at March 31, 2015 and December 31, 2014, respectively. The decrease in the fair value of the liability for contingent consideration was due to a reduction in the probability of the achievement of a certain revenue-based milestone and payment in respect of the achievement of an unrelated milestone. The fair value was measured using significant unobservable inputs and is categorized as Level 3 under the fair value hierarchy.

Financial Instruments Not Measured at Fair Value

The company maintains a $750 million five-year committed syndicated bank credit facility that expires in November 2019. The credit facility supports the company’s commercial paper program and can be used for general corporate purposes. The facility includes pricing based on the company’s long-term credit ratings and includes a financial covenant that limits the amount of total debt to total capitalization. At March 31, 2015 the company was in compliance with this covenant. The fair value of commercial paper borrowings outstanding of $231.0 million and $78.0 million at March 31, 2015 and December 31, 2014, respectively, approximated the carrying value.

The estimated fair value of long-term debt including current maturities and the effect of the related interest rate swap contract was approximately $1,501.4 million and $1,481.7 million at March 31, 2015 and December 31, 2014, respectively. The fair value was estimated using dealer quotes for similarly-rated debt instruments over the remaining contractual term of the company’s obligation and is categorized as Level 2 under the fair value hierarchy.

Concentration Risk

Accounts receivable balances include sales to government-supported healthcare systems outside the United States. The company monitors economic conditions and evaluates accounts receivable in certain countries for potential collection risks. Economic conditions and other factors in certain countries, particularly in Spain, Italy, Greece and Portugal, have resulted in, and may continue to result in, an increase in the average length of time that it takes to collect these accounts receivable and may require the company to re-evaluate the collectability of these receivables in future periods. At March 31, 2015, the company’s accounts receivable, net of allowances, from the national healthcare systems in these four countries was $33.4 million, of which $8.5 million was greater than 365 days past due.

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

5. Inventories

Inventories consisted of:

 

  March 31,
2015
  December 31,
2014
 
(dollars in millions)        

Finished goods

 $ 214.5        $ 225.4      

Work in process

  27.4         23.5      

Raw materials

  135.9         127.3      
  

 

 

    

 

 

 
 $     377.8        $     376.2      
  

 

 

    

 

 

 

6. Contingencies

In the ordinary course of business, the company is subject to various legal proceedings, investigations and claims, including, for example, environmental matters, employment disputes, disputes on agreements and other commercial disputes. In addition, the company operates in an industry susceptible to significant product liability and patent legal claims. The company accounts for estimated losses with respect to legal proceedings and claims when such losses are probable and reasonably estimable. If the estimate of a probable loss is a range and no amount within the range is more likely, the company accrues the minimum amount of the range. Legal costs associated with these matters are expensed as incurred. At any given time, in the ordinary course of business, the company is involved as either a plaintiff or defendant in a number of patent infringement actions. If a third party’s patent infringement claim were to be determined against the company, the company might be required to make significant royalty or other payments or might be subject to an injunction or other limitation on its ability to manufacture or distribute one or more products. If a patent owned by or licensed to the company is found to be invalid or unenforceable, the company might be required to reduce the value of certain intangible assets on the company’s balance sheet and to record a corresponding charge, which could be significant in amount. Many of the company’s legal proceedings and claims could have a material adverse effect on its business, results of operations, financial condition and/or liquidity.

Product Liability Matters

Hernia Product Claims

As of April 15, 2015, approximately 55 federal and 40 state lawsuits involving individual claims by approximately 95 plaintiffs, as well as one putative class action in the United States, are currently pending against the company with respect to its Composix® Kugel® and certain other hernia repair implant products (collectively, the “Hernia Product Claims”). The company voluntarily recalled certain sizes and lots of the Composix® Kugel® products beginning in December 2005. As of April 15, 2015, all but one of the putative class actions pending against the company were dismissed. The remaining putative class action, which has not been certified, seeks: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2014, a settlement was reached with respect to the three putative Canadian class actions within amounts previously recorded by the company. Approximately 20 of the state lawsuits, involving individual claims by approximately 20 plaintiffs, are pending in the Superior Court of the State of Rhode Island, with the remainder in various other jurisdictions. The Hernia Product Claims also generally seek damages for personal injury resulting from use of the products.

In June 2007, the Composix® Kugel® lawsuits and, subsequently, other hernia repair product lawsuits, pending in federal courts nationwide were transferred into one Multidistrict Litigation (“MDL”) for coordinated pre-trial proceedings in the United States District Court for the District of Rhode Island.

In June 2011, the company announced that it had reached agreements in principle with various plaintiffs’ law firms to settle the majority of its existing Hernia Product Claims. Each agreement was subject to certain conditions, including requirements for participation in the proposed settlements by a certain minimum number of plaintiffs. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Hernia Product Claims, and intends to vigorously defend Hernia Product Claims that do not settle, including through litigation. There are three trials currently scheduled in the second half of 2015. The company cannot give any assurances that the resolution of the Hernia Product Claims that have not settled, including asserted and unasserted claims and the putative class action lawsuit, will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

 

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Women’s Health Product Claims

As of April 1, 2015, product liability lawsuits involving individual claims by approximately 14,500 plaintiffs have been filed against the company in various federal and state jurisdictions alleging personal injuries associated with the use of certain of the company’s surgical continence products for women. In addition, five putative class actions in the United States and five putative class actions in Canada have been filed against the company. In addition, a limited number of claims have been filed or asserted in various non-U.S. jurisdictions (all lawsuits, collectively, the “Women’s Health Product Claims”). The Women’s Health Product Claims generally seek damages for personal injury resulting from use of the products. The putative class actions, none of which has been certified, seek: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2015, the Ontario Superior Court of Justice dismissed the plaintiffs’ motion for class certification in one Canadian putative class action. The plaintiffs may appeal this decision or may file an alternatives motion with the Ontario Superior Court to redefine the class. With respect to approximately half of the filed and asserted Women’s Health Product Claims, the company believes that two subsidiaries of Medtronic plc (as successor in interest to Covidien plc) (“Medtronic”), each a supplier of the company, have an obligation to defend and indemnify the company with respect to any product defect liability.

In October 2010, the Women’s Health Product Claims involving solely Avaulta® products pending in federal courts nationwide were transferred into an MDL in the United States District Court for the Southern District of West Virginia (the “District Court”), the scope of which was later expanded to include lawsuits involving all women’s surgical continence products that are manufactured or distributed by the company. The first trial in a state court was completed in California in July 2012 and resulted in a judgment against the company of approximately $3.6 million. On appeal the decision was affirmed by the appellate court in November 2014. The company filed a petition for review to the California Supreme Court on December 24, 2014, which was denied on February 18, 2015. The judgment in this matter, including interest and costs, was paid on March 20, 2015 within amounts previously recorded by the company. The first trial in the MDL commenced in July 2013 and resulted in a judgment against the company of approximately $2 million. The company has appealed this decision. During the third quarter of 2013, the company settled one MDL case and one New Jersey state case. In addition, during the third quarter of 2013, one MDL case was voluntarily dismissed with prejudice. On January 16, 2014 and July 31, 2014, the District Court ordered that the company prepare 200 and then an additional 300 individual cases, respectively, for trial (the “WHP Pre-Trial Orders”) (the timing for which is currently unknown). These WHP Pre-Trial Orders resulted in significant additional litigation-related defense costs beginning in the second quarter of 2014 and are expected to result in material additional cost in 2015 in defending Women’s Health Product Claims. The District Court may also order that the company prepare additional cases for trial, which could result in material additional cost in future periods. During the second quarter of 2014, the company reached an agreement with two plaintiffs’ law firms to settle their inventory of cases, representing more than 500 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The company also settled one MDL case that was originally scheduled for trial in May 2014. In the third quarter of 2014, the company reached an agreement with a plaintiffs’ law firm to settle approximately 25 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The settlements reached in 2014 for Women’s Health Product Claims were within the amounts previously recorded by the company. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims, which may include additional inventory settlements. In February 2015, the District Court appointed a Special Master to assist with settlement resolution. A trial was scheduled to begin in the MDL in February 2015, however, the parties reached an agreement in principle to settle the case. A state court trial in Florida is scheduled for October 2015, and one in Missouri is scheduled for November 2015. The company anticipates that multiple additional trials, including a possible consolidated trial or trials, may occur in 2015.

In December 2014, Medtronic filed a motion for leave to amend its answer in the underlying MDL for Women’s Health Product Claims to assert cross-claims against the company challenging the indemnification provisions of certain of their supply agreements with the company. In March 2015, the court granted Medtronic’s motion. On January 22, 2015, the company initiated litigation and/or arbitration seeking, among other things, declaratory relief under these supply agreements with Medtronic in three separate jurisdictions - New Jersey state court, the English High Court of Justice in London and Atlanta, Georgia.

The company does not believe that any verdicts entered to date are representative of potential outcomes of all Women’s Health Product Claims. The case numbers set forth above do not include approximately 850 generic complaints involving women’s health products where the company cannot, based on the allegations in the complaints, determine whether any of those cases involves the company’s women’s health products. In addition, the case numbers set forth above do not include approximately 1,650 claims that have been threatened against the company but for which complaints have not yet been filed. While the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of

 

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unsettled Women’s Health Product Claims and intends to vigorously defend the Women’s Health Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims and the related litigation with Medtronic will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Filter Product Claims

As of April 15, 2015, product liability lawsuits involving individual claims by approximately 45 plaintiffs are currently pending against the company in various federal and state jurisdictions alleging personal injuries associated with the use of the company’s vena cava filter products (all lawsuits, collectively, the “Filter Product Claims”). The first Filter Product Claim trial was completed in June 2012 and resulted in a judgment for the company. During the second quarter of 2013, the company finalized settlement agreements with respect to more than 30 Filter Product Claims and made payments with respect to such claims within the amounts previously recorded. The case numbers set forth above do not include approximately 150 claims that have been threatened against the company but for which complaints have not yet been filed. The company expects additional trials of Filter Product Claims to take place over the next 12 months. While the company intends to vigorously defend Filter Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

General

In most product liability litigations (like those described above), plaintiffs allege a wide variety of claims, ranging from allegations of serious injury caused by the products to efforts to obtain compensation notwithstanding the absence of any injury. In many of these cases, the company has not yet received and reviewed complete information regarding the plaintiffs and their medical conditions and, consequently, is unable to fully evaluate the claims. The company expects that it will receive and review additional information regarding any remaining unsettled product liability matters.

The company believes that some settlements and judgments, as well as some legal defense costs, relating to product liability matters are or may be covered in whole or in part under its product liability insurance policies with a limited number of insurance carriers, or, in some circumstances, indemnification obligations to the company from other parties. In certain circumstances, insurance carriers reserve their rights with respect to coverage, or contest or deny coverage, as has occurred with respect to certain claims. In addition, other parties may dispute their indemnification obligations to the company, as has occurred with respect to certain claims. When either of these occur, the company intends to vigorously contest disputes with respect to its insurance coverage or indemnification and to enforce its rights, and accordingly, will record receivables with respect to amounts due under these policies or arrangements, when recovery is probable. Amounts recovered under the company’s product liability insurance policies or indemnification arrangements may be less than the stated coverage limits or less than otherwise expected and may not be adequate to cover damages and/or costs relating to claims. In addition, there is no guarantee that insurers or other parties will pay claims or that coverage or indemnity will be otherwise available.

The company’s insurance coverage with respect to the Hernia Product Claims has been exhausted. The company continues to evaluate its available insurance coverage as it relates to Women’s Health Product Claims and Filter Product Claims.

Other Legal Matters

Since early 2013, the company has received subpoenas or Civil Investigative Demands from a number of State Attorneys General seeking information related to the sales and marketing of certain of the company’s products that are the subject of the Hernia Product Claims and the Women’s Health Product Claims. The company is cooperating with these requests. Since it is not feasible to predict the outcome of these proceedings, the company cannot give any assurances that the resolution of these proceedings will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

In December 2007, a U.S. District Court jury in Arizona found that certain of W.L. Gore & Associates, Inc.’s (“Gore”) ePTFE vascular grafts and stent-grafts infringe the company’s patent number 6,436,135 (the “135 patent”). The jury upheld the validity of the company’s patent and awarded the company $185 million in past damages. The jury also found that Gore willfully infringed the patent. In a second phase of the trial, the District Court ruled that Gore failed to prove that the patent is unenforceable due to inequitable conduct. In March 2009, the District Court doubled the jury award to approximately $371 million for damages through June 2007. The District Court also awarded the company attorneys’ fees of $19 million and prejudgment interest of approximately $20 million. In addition, the District Court denied Gore’s remaining motions, including its motions for a new trial and to set aside the jury’s verdict. In July 2010, the District Court awarded the company approximately $109 million in additional damages for the period from July 2007 through March 2009. The District Court

 

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also assessed a royalty rate of between 12.5% and 20%, depending on the product, that will be used to calculate damages for Gore’s infringing sales from April 2009 through the expiration of the patent.

Gore appealed this matter to the Court of Appeals for the Federal Circuit (the “Court of Appeals”), which on February 10, 2012 affirmed the decision of the District Court. Gore filed a petition with the Court of Appeals for a rehearing of its appeal. On June 14, 2012, the Court of Appeals reaffirmed its February 10, 2012 decision, including the ongoing royalty rates as set by the District Court, with the exception of the issue of willfulness with respect to Gore’s infringement of the 135 patent, which was remanded to the District Court for further consideration. On October 12, 2012, Gore filed a petition for a writ of certiorari to the U.S. Supreme Court requesting a review of the portion of the decision that the Court of Appeals reaffirmed. The U.S. Supreme Court denied Gore’s petition on January 14, 2013.

On January 28, 2013, Gore filed with the U.S. District Court a Request for Judicial Notice that the U.S. Patent and Trademark Office (“USPTO”) granted Gore’s previously filed request for a re-examination of the 135 patent. On April 1, 2013, the USPTO issued a First Office Action initially rejecting all of the claims of the 135 patent that are the subject of the re-examination. On July 10, 2013, the USPTO issued a Notice of Intent to Issue an Ex Parte Reexamination Certificate upholding the patentability of all re-examined claims of the 135 patent. This action terminated the re-examination proceeding and upheld the claims involved in the re-examination.

On remand of the action from the Court of Appeals, the District Court heard oral argument on June 5, 2013 on three motions pending before it – Gore’s motion requesting a determination that Gore’s infringement was not willful, Gore’s motion for a new trial, and the company’s motion to execute on the judgment with respect to all amounts other than enhanced damages due to willfulness. On October 16, 2013, the District Court denied Gore’s motion for entry of a judgment holding that Gore’s infringement was not willful and Gore’s motion for a new trial. The District Court granted the company’s motion to execute on the judgment, holding that all aspects of the judgment relating to infringement were “final and non-appealable.” The District Court continued its stay on the execution of the judgment with respect to willfulness and the related enhanced damages.

On November 1, 2013, Gore paid to the company $894.3 million in cash (the “Gore Proceeds”), the total amount of the compensatory damages for infringement, including pre- and post-judgment interest, and the royalties accrued through September 30, 2013. Gore expressly reserved its right to appeal from the District Court’s rulings and notified the company that, if successful on appeal, it would seek to recover the amounts paid to the company. On December 5, 2013, Gore filed an appeal in the Court of Appeals on all of the District Court’s rulings, including the order denying Gore’s motion for a new trial. On August 8, 2014, the Court of Appeals heard oral argument on Gore’s appeal of the District Court’s rulings. On January 13, 2015, the Court of Appeals affirmed the decision of the District Court regarding its determination that the company established standing and that the 135 patent was willfully infringed. On February 12, 2015, Gore filed a petition for rehearing en banc at the Court of Appeals on the issue of willfulness. On April 8, 2015, the Court of Appeals denied Gore’s petition for rehearing en banc on the issue of willfulness. The Company filed a motion to execute on the judgment on the issue of willfulness, which was granted by the District Court on April 23, 2015. Gore may petition for review by the U.S. Supreme Court.

As of the third quarter of 2013, the company considered both the compensatory damages and the enhanced damages and the royalty awards to be contingent gains. In the fourth quarter of 2013, the company recorded a gain of $894.3 million ($557.4 million after tax) to other (income) expense, net, based on the District Court’s October 2013 rulings and the company’s receipt of the Gore Proceeds. In January 2015, the company received $38.4 million of royalty payments from Gore representing Gore’s calculation of royalties for its infringing sales for the quarter ended December 31, 2014. This royalty payment was recorded to revenue in the first quarter of 2015. The company has received cumulative proceeds from Gore of $1,084.5 million. The company has concluded that the chance of Gore establishing its right to recover this cash is remote. The company continues to account for the enhanced damages of approximately $209 million awarded by the District Court due to Gore’s willfulness as a contingent gain. The company anticipates receiving this amount in the second quarter of 2015.

The timing of final resolution of this litigation remains uncertain. The company cannot give any assurances that royalties for Gore’s future infringing sales will remain at or near historical levels.

In an unrelated matter, Gore filed suit in June 2011 in the U.S. District Court in Delaware alleging the company had infringed on several of Gore’s patents. Fact and expert discovery have been completed and in the fourth quarter of 2014, the parties both filed motions for summary judgment. Oral arguments on the motions occurred on January 30, 2015. The company intends to vigorously defend the allegations asserted by Gore. The company cannot give any assurances that an adverse resolution of this matter will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

The company is subject to numerous federal, state, local and foreign environmental protection laws governing, among other things, the generation, storage, use and transportation of hazardous materials and emissions or discharges into the

 

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ground, air or water. The company is or may become a party to proceedings brought under various federal laws including the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), commonly known as Superfund, the Resource Conservation and Recovery Act, the Clean Water Act, the Clean Air Act and similar state or foreign laws. These proceedings seek to require the owners or operators of contaminated sites, transporters of hazardous materials to the sites and generators of hazardous materials disposed of at the sites to clean up the sites or to reimburse the government for cleanup costs. In most cases, there are other potentially responsible parties that may be liable for remediation costs. In these cases, the government alleges that the defendants are jointly and severally liable for the cleanup costs; however, these proceedings are frequently resolved so that the allocation of cleanup costs among the parties more closely reflects the relative contributions of the parties to the site contamination. The company’s potential liability varies greatly from site to site. For some sites, the potential liability is de minimis and for others the costs of cleanup have not yet been determined. Accruals for estimated losses from environmental remediation obligations generally are recognized no later than completion of the remedial feasibility study and are adjusted as further information develops or circumstances change. Costs of future expenditures for environmental remediation obligations are not discounted to their present value. Recoveries of environmental remediation costs from other parties are recorded as assets when their receipt is deemed probable. The company believes that the proceedings and claims described above will likely be resolved over an extended period of time. While it is not feasible to predict the outcome of these proceedings, based upon the company’s experience, current information and applicable law, the company does not expect these proceedings to have a material adverse effect on its financial condition and/or liquidity. However, one or more of the proceedings could be material to the company’s business and/or results of operations.

Litigation Reserves

The company regularly monitors and evaluates the status of product liability and other legal matters, and may, from time-to-time, engage in settlement and mediation discussions taking into consideration developments in the matters and the risks and uncertainties surrounding litigation. These discussions could result in settlements of one or more of these claims at any time.

In the second quarter of 2013, the company recorded a charge, net of estimated recoveries to other (income) expense, net, of approximately $293.0 million ($276.0 million after tax) related to certain of the product liability matters discussed above under the heading “Product Liability Matters”. The company recorded this charge after evaluating these matters based on information then currently available, including but not limited to: the allegations and documentation supporting or refuting such allegations; publicly available information regarding similar medical device mass tort settlements; historical information regarding other product liability settlements involving the company; and the procedural posture and stage of litigation. In the fourth quarter of 2013, based on information then available regarding these and other factors, including but not limited to: the increase in the number of claims; the estimate of unasserted claims; the settlement of claims both by the company and by other manufacturers subject to product liability claims with respect to similar products; and settlements subject to negotiation during the quarter, the company recorded an additional charge, net of estimated recoveries, of approximately $108.0 million ($92.0 million after tax).

In the second quarter of 2014, the company recorded an additional charge related to these matters, net of estimated recoveries to other (income) expense, net, of approximately $259.0 million ($238.0 million after tax). The company recorded this charge based on additional information obtained during the quarter, including with respect to the factors noted above. Specifically, the company considered its discussions with plaintiffs’ counsel, the increase in the rate of claims being filed (which led the company to increase its estimate of unasserted claims), and the value, number of cases and nature of the inventory of cases with respect to the recent settlements of claims by the company and other manufacturers.

These charges recognized the estimated costs for the product liability matters discussed above, including (with respect to such matters) asserted and unasserted claims, and costs to administer the settlements related to such matters. These charges exclude any costs associated with the putative class action lawsuits.

The company cannot give any assurances that the actual costs incurred with respect to these product liability matters will not exceed the related amounts accrued. With respect to product liability claims that are not resolved through settlement, the company intends to vigorously defend against such claims, including through litigation. The company cannot give any assurances that the resolution of any of its product liability matters, including asserted and unasserted claims and the putative class action lawsuits, will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Accruals for product liability and other legal matters amounted to $1,014.4 million, of which $90.4 million was recorded to accrued expenses, and $1,041.5 million, of which $101.7 million was recorded to accrued expenses, at March 31, 2015 and December 31, 2014, respectively. The company has made total payments of $249.5 million to qualified settlement funds (“QSFs”), subject to certain settlement conditions, for certain product liability matters. No payments were made to

 

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QSFs during the three months ended March 31, 2015. Payments to QSFs are recorded as a component of restricted cash. Total payments of $228.8 million from these QSFs have been made to qualified claimants, of which $26.8 million were made during the three months ended March 31, 2015. In addition, other payments of $38.9 million have been made to qualified claimants, of which $3.0 million were made during the three months ended March 31, 2015.

The company recorded receivables related to product liability matters amounting to $377.8 million, of which $358.6 million was recorded to other assets, and $379.3 million, of which $358.9 million was recorded to other assets, at March 31, 2015 and December 31, 2014, respectively. A substantial amount of the receivable at March 31, 2015 and December 31, 2014 is the subject of a dispute with Medtronic, which has contested, at least in part, its obligation to defend and indemnify the company, which the company refutes. Approximately half of the filed and asserted Women’s Health Product Claims relate to certain products distributed by the company under agreements with Medtronic. These agreements include indemnification provisions pursuant to which the company is indemnified by Medtronic for any liabilities of the company arising from product liability claims relating to any alleged product defect, one of the theories on which the Women’s Health Product Claims are based. The company engaged outside counsel to evaluate the company’s rights with respect to the dispute, and outside counsel issued a legal opinion supporting the company’s belief regarding Medtronic’s obligation to defend and indemnify the company for product defect claims with respect to the products manufactured by Medtronic that are the subject of the Women’s Health Product Claims. As noted above, the company instituted litigation against Medtronic in three separate jurisdictions regarding the supply agreements at issue. After considering the following factors (as appropriate): the nature of the claims; relevant contracts; relevant factual and legal issues; the advice and judgment of outside legal counsel, including a legal opinion; the creditworthiness of Medtronic; and other pertinent factors, the company believes that collectability of these receivables is probable and therefore has been recorded as a receivable.

The company is unable to estimate the reasonably possible losses or range of losses, if any, arising from certain existing product liability matters and other legal matters. Under U.S. generally accepted accounting principles, an event is “reasonably possible” if “the chance of the future event or events occurring is more than remote but less than likely” and an event is “remote” if “the chance of the future event or events occurring is slight”. With respect to all putative class action lawsuits relating to product liability matters, the company is unable to estimate a range of reasonably possible losses for the following reasons: (i) all or certain of the proceedings are in early stages; (ii) the company has not received and reviewed complete information regarding all or certain of the plaintiffs and their medical conditions; and/or (iii) there are significant factual issues to be resolved. In addition, there is uncertainty as to the likelihood of a class being certified or the ultimate size of the class. In addition, with respect to the Civil Investigative Demands from a number of State Attorneys General, the company is unable to estimate a range of reasonably possible losses for the following reasons: (i) all or certain of the proceedings are in early stages; and/or (ii) there are significant factual issues to be resolved.

7. Share-Based Compensation Plans

The company may grant a variety of share-based payments under the 2012 Long Term Incentive Plan of C. R. Bard, Inc., as amended and restated (the “LTIP”) and the 2005 Directors’ Stock Award Plan of C. R. Bard, Inc., as amended and restated (the “Directors’ Plan”) to certain directors, officers and employees. The total number of remaining shares at March 31, 2015 that may be issued under the LTIP was 4,753,485 and under the Directors’ Plan was 31,462. At the company’s Annual Meeting of Shareholders on April 15, 2015, the shareholders authorized an additional 1,500,000 shares for issuance under the LTIP. Awards under the LTIP may be in the form of stock options, stock appreciation rights, limited stock appreciation rights, restricted stock, unrestricted stock and other stock-based awards. Awards under the Directors’ Plan may be in the form of stock awards, stock options or stock appreciation rights. The company also has two employee stock purchase programs.

For the quarters ended March 31, 2015 and 2014, amounts charged against income for share-based payment arrangements were $23.0 million and $19.5 million, respectively.

In the first quarter of each of 2015 and 2014, the company granted performance restricted stock units to certain officers. These units have requisite service periods of three years and have no dividend rights. The actual payout of these units varies based on the company’s performance over the three-year period based on pre-established targets over the period and a market condition modifier based on total shareholder return (“TSR”) compared to an industry peer group. The actual payout under these awards may exceed an officer’s target payout; however, compensation cost initially recognized assumes that the target payout level will be achieved and may be adjusted for subsequent changes in the expected outcome of the performance-related condition. The fair values of these units are based on the market price of the company’s stock on the date of the grant and use a Monte Carlo simulation model for the TSR component. The fair values of the TSR components of the

 

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2015 and 2014 grants were estimated based on the following assumptions: risk-free interest rate of 0.86% and 0.70%, respectively; dividend yield of 0.51% and 0.62%, respectively; and expected life of 2.78 and 2.88 years, respectively.

As of March 31, 2015, there were $115.9 million of unrecognized compensation expenses related to share-based payment arrangements. These costs are expected to be recognized over a weighted-average period of approximately three years. The company has sufficient shares to satisfy expected share-based payment arrangements in 2015.

8. Pension Plans

The company has both tax-qualified and nonqualified, noncontributory defined benefit pension plans, that together cover certain domestic and foreign employees. These plans provide benefits based upon a participant’s compensation and years of service.

The components of net periodic pension cost are as follows:

 

          Three Months Ended        
March 31,
 
  2015   2014  
(dollars in millions)              

Service cost, net of employee contributions

    $ 7.5             $         6.7        

Interest cost

     5.0              5.3        

Expected return on plan assets

     (7.8)             (6.8)       

Amortization

     2.9              2.4        
  

 

 

    

 

 

 

Net periodic pension cost

 $         7.6          $ 7.6        
  

 

 

    

 

 

 

9. Shareholders’ Investment

The company repurchased approximately 1.2 million shares of common stock for $204.2 million in the three months ended March 31, 2015 under its previously announced share repurchase authorization.

Other Comprehensive Income (Loss)

The changes in accumulated other comprehensive income (loss) by component are as follows:

 

  Derivative
Instruments
Designated as
  Cash Flow Hedges  
   Foreign Currency 
Translation
Adjustments
  Benefit
Plans
  Total  
(dollars in millions)                           

Balance at December 31, 2013

    $ —              $ 47.3         $ (68.2)       $ (20.9)     

Other comprehensive income (loss) before reclassifications

     0.3            1.0          —                      1.3      

Tax (provision) benefit related to other comprehensive income (loss) before reclassifications(a)

     0.3            —                         —            0.3      
  

 

 

    

 

 

    

 

 

   

 

 

 

Other comprehensive income (loss) before reclassifications, net of taxes

  0.6         1.0       —          1.6      
  

 

 

    

 

 

    

 

 

   

 

 

 

Amounts reclassified from accumulated other comprehensive income (loss)

  (b)          —          2.4( c)    2.4      

Tax provision (benefit) related to amounts reclassified from accumulated other comprehensive income (loss)

  (0.2)        —          (0.8)      (1.0)     
  

 

 

    

 

 

    

 

 

   

 

 

 

Reclassifications, net of tax

  (0.2)        —          1.6       1.4      
  

 

 

    

 

 

    

 

 

   

 

 

 

Other comprehensive income (loss)

  0.4         1.0       1.6       3.0      
  

 

 

    

 

 

    

 

 

   

 

 

 

Balance at March 31, 2014

 $                 0.4        $             48.3      $ (66.6)     $ (17.9)     
  

 

 

    

 

 

    

 

 

   

 

 

 

Balance at December 31, 2014

 $ 0.9        $ (3.1)     $ (86.6)     $ (88.8)     

Other comprehensive income (loss) before reclassifications

  0.2         (53.7)      —          (53.5)     

 

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  Derivative
Instruments
Designated as
  Cash Flow Hedges  
   Foreign Currency 
Translation
Adjustments
  Benefit
Plans
  Total  
(dollars in millions)                          

Tax (provision) benefit related to other comprehensive income (loss) before reclassifications(a)

     1.3            —             —            1.3      
  

 

 

   

 

 

    

 

 

   

 

 

 

Other comprehensive income (loss) before reclassifications, net of taxes

  1.5          (53.7)      —          (52.2)     
  

 

 

   

 

 

    

 

 

   

 

 

 

Amounts reclassified from accumulated other comprehensive income (loss)

  (1.9)(b )    —          2.9( c)    1.0      

Tax provision (benefit) related to amounts reclassified from accumulated other comprehensive income (loss)

  0.5          —          (1.0)      (0.5)     
  

 

 

   

 

 

    

 

 

   

 

 

 

Reclassifications, net of tax

  (1.4)         —          1.9       0.5      
  

 

 

   

 

 

    

 

 

   

 

 

 

Other comprehensive income (loss)

  0.1          (53.7)      1.9       (51.7)     
  

 

 

   

 

 

    

 

 

   

 

 

 

Balance at March 31, 2015

 $ 1.0         $ (56.8)    $         (84.7)    $     (140.5)     
  

 

 

   

 

 

    

 

 

   

 

 

 

 

  (a) Income taxes are not provided for foreign currency translation adjustment.
  (b) See Note 4 of the notes to condensed consolidated financial statements.
  (c) These components are included in the computation of net periodic pension cost. See Note 8 of the notes to condensed consolidated financial statements.

10. Segment Information

The company’s management considers its business to be a single segment entity – the manufacture and sale of medical devices. The company’s products generally share similar distribution channels and customers. The company designs, develops, manufactures, packages, distributes and sells medical, surgical, diagnostic and patient care devices. The company sells a broad range of products to hospitals, individual healthcare professionals, extended care health facilities and alternate site facilities on a global basis. In general, the company’s products are intended to be used once and then discarded or either temporarily or permanently implanted. The company’s chief operating decision makers evaluate their various global product portfolios on a net sales basis and generally evaluate profitability and associated investment on an enterprise-wide basis due to shared geographic infrastructures.

Net sales based on the location of external customers by geographic region are:

 

  Three Months Ended
March 31,
 
          2015                   2014          
(dollars in millions)              

United States

   $ 574.1           $ 551.4     

Europe

     106.4            120.1     

Japan

     41.0            38.9     

Other

     98.2            88.9     
  

 

 

    

 

 

 
$       819.7        $       799.3     
  

 

 

    

 

 

 

Total net sales by product group category are:

 

  Three Months Ended
March 31,
 
          2015                   2014          
(dollars in millions)              

Vascular

   $ 231.9           $ 219.2     

Urology

     205.6            201.4     

Oncology

     224.6            219.0     

Surgical Specialties

     135.9            135.2     

Other

     21.7            24.5     
  

 

 

    

 

 

 
$       819.7        $       799.3     
  

 

 

    

 

 

 

 

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

This management’s discussion and analysis provides a review of the results of operations, financial condition and the liquidity and capital resources of C. R. Bard, Inc. and its subsidiaries (the “company” or “Bard”). The following discussion should be read in conjunction with Bard’s 2014 Annual Report on Form 10-K, and the condensed consolidated financial statements and notes thereto included elsewhere in this Form 10-Q. Certain statements contained herein may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995; see “Risks and Uncertainties; Cautionary Statement Regarding Forward-Looking Information” below.

Overview

The company designs, develops, manufactures, packages, distributes and sells medical, surgical, diagnostic and patient care devices. The company sells a broad range of products to hospitals, individual healthcare professionals, extended care health facilities and alternate site facilities on a global basis. Outside the United States, Europe, Japan and China are the company’s largest markets, while certain emerging markets in Asia, Latin America, and Eastern Europe are the company’s fastest-growing markets. In general, the company’s products are intended to be used once and then discarded or either temporarily or permanently implanted. The company reports sales in four major product group categories: vascular; urology; oncology; and surgical specialties. The company also has a product group category of other products.

The company’s earnings are driven by its ability to continue to generate sales of its products and improve operating efficiency. Bard’s ability to increase sales over time depends upon its success in developing, acquiring and marketing differentiated products that meet the needs of clinicians and their patients. For the quarter ended March 31, 2015, the company’s research and development (“R&D”) expense as a percentage of net sales was 7.4%. The company also makes selective acquisitions of businesses, products and technologies, generally focusing on small-to-medium sized transactions to provide ongoing growth opportunities. In addition, the company may from time-to-time consider acquisitions of larger, established companies. The company may also periodically divest lines of business in which it is not able to reasonably attain or maintain a leadership position in the market or for other strategic reasons.

Results of Operations

Net Sales

Bard’s consolidated net sales for the quarter ended March 31, 2015 increased 3% on a reported basis (5% on a constant currency basis) compared to the same period in the prior year. Net sales “on a constant currency basis” is a non-GAAP measure and should not be viewed as a replacement of GAAP results. See “Management’s Use of Non-GAAP Measures” below. Price changes had the effect of decreasing consolidated net sales for the quarter ended March 31, 2015 by approximately 130 basis points as compared to the same period in the prior year. The strengthening of the U.S. dollar, a trend that may continue, had the effect of decreasing consolidated net sales by approximately two percentage points for the quarter ended March 31, 2015 as compared to the same period in the prior year. The primary exchange rate fluctuation that impacted net sales was the movement of the Euro compared to the U.S. dollar. The impact of exchange rate fluctuations on net sales is not indicative of the impact on net earnings due to the offsetting impact of exchange rate movements on operating costs and expenses, costs incurred in other currencies and the company’s hedging activities.

Bard’s United States net sales of $574.1 million for the quarter ended March 31, 2015 increased 4% compared to $551.4 million in the prior year quarter. International net sales of $245.6 million for the quarter ended March 31, 2015 decreased 1% on a reported basis (increased 8% on a constant currency basis) compared to $247.9 million in the prior year quarter.

A summary of net sales by product group category is as follows:

 

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Product Group Summary of Net Sales

 

  Three Months Ended March 31,  
  2015   2014       Change       Constant
    Currency    
 
(dollars in millions)                

Vascular

 $ 231.9      $ 219.2        6%          10%       

Urology

  205.6        201.4        2%          5%       

Oncology

  224.6        219.0        3%          5%       

Surgical Specialties

  135.9        135.2        1%          3%       

Other

  21.7        24.5        (11)%         (9)%      
  

 

 

    

 

 

       

Total net sales

$    819.7      $    799.3        3%          5%       
  

 

 

    

 

 

       

Vascular Products - Bard markets a wide range of products for the peripheral vascular market, including endovascular products and vascular graft products. Also included within vascular products are royalty payments from W.L. Gore & Associates, Inc. (“Gore”). Consolidated net sales of vascular products for the quarter ended March 31, 2015 increased 6% on a reported basis (10% on a constant currency basis) compared to the prior year quarter. United States net sales of vascular products for the quarter ended March 31, 2015 increased 8% compared to the prior year period. International net sales of vascular products for the quarter ended March 31, 2015 increased 1% on a reported basis (12% on a constant currency basis) compared to the prior year quarter. These increases were primarily due to growth in sales of endovascular products.

Consolidated net sales of endovascular products for the quarter ended March 31, 2015 increased 6% on a reported basis (10% on a constant currency basis) compared to the prior year quarter. Net sales in this product line for the quarter ended March 31, 2015 were favorably impacted by growth in sales of percutaneous transluminal angioplasty (“PTA”) balloon catheters, including drug-coated PTA balloon catheters, and biopsy products, and were partially offset by a decline in sales of stents, a trend that may continue.

Consolidated net sales of vascular graft products for the quarter ended March 31, 2015 decreased 10% on a reported basis (4% on a constant currency basis) compared to the prior year quarter. Declining sales of peripheral vascular grafts was the primary contributor to the decrease in sales for vascular graft products for the quarter ended March 31, 2015.

Urology Products - Bard markets a wide range of products for the urology market, including basic urology drainage products, fecal and urinary continence products and urological specialty products. Bard also markets StatLock® catheter stabilization products, which are used to secure many types of catheters sold by Bard and other companies, as well as Targeted Temperature Management products, which are used for therapeutic hypothermia. Consolidated net sales of urology products for the quarter ended March 31, 2015 increased 2% on a reported basis (5% on a constant currency basis) compared to the prior year quarter. This increase was primarily due to growth in sales of basic drainage products and Targeted Temperature Management products and was partially offset by a decline in sales of surgical continence products, a trend that may continue. United States net sales of urology products for the quarter ended March 31, 2015 increased 4% compared to the prior year quarter. International net sales of urology products for the quarter ended March 31, 2015 decreased 1% on a reported basis (increased 6% on a constant currency basis) compared to the prior year quarter.

Consolidated net sales of basic drainage products for the quarter ended March 31, 2015 increased 2% on a reported basis (4% on a constant currency basis) compared to the prior year quarter.

Consolidated net sales of urological specialty products for the quarter ended March 31, 2015 decreased 5% on a reported basis (1% on a constant currency basis) compared to the prior year quarter. The decrease was primarily due to a decline in sales of brachytherapy products. The brachytherapy market has been losing procedural share to alternative therapies, a trend that may continue.

Consolidated net sales of continence products for the quarter ended March 31, 2015 increased 2% on a reported basis (7% on a constant currency basis) compared to the prior year quarter. The increase was primarily due to sales of continence care products used to treat male urinary incontinence and was partially offset by a decline in sales of surgical continence products, a trend that may continue.

Consolidated net sales of the StatLock® catheter stabilization product line for the quarter ended March 31, 2015 increased 3% on a reported basis (5% on a constant currency basis) compared to the prior year quarter.

Oncology Products - Bard’s oncology business includes specialty vascular access products and enteral feeding devices. Specialty vascular access products include peripherally inserted central catheters (“PICCs”) used for intermediate to long-term central venous access, specialty access ports and accessories (“Ports”) used most commonly for chemotherapy,

 

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dialysis access catheters and vascular access ultrasound devices, which help facilitate the placement of PICCs. Consolidated net sales of oncology products for the quarter ended March 31, 2015 increased 3% on a reported basis (5% on a constant currency basis) compared to the prior year quarter. This increase was primarily due to growth in sales of PICCs and was partially offset by a decline in sales of Ports. United States net sales of oncology products for the quarter ended March 31, 2015 increased 1% compared to the prior year quarter. International net sales of oncology products for the quarter ended March 31, 2015 increased 6% on a reported basis (15% on a constant currency basis) compared to the prior year quarter. International net sales were favorably impacted by growth in sales of PICCs.

Consolidated net sales of PICCs for the quarter ended March 31, 2015 increased 7% on a reported basis (9% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of Ports for the quarter ended March 31, 2015 decreased 6% on a reported basis (3% on a constant currency basis) compared to the prior year quarter.

Consolidated net sales of dialysis access catheters for the quarter ended March 31, 2015 increased 5% on a reported basis (8% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of vascular access ultrasound devices for the quarter ended March 31, 2015 increased 10% on a reported basis (12% on a constant currency basis) compared to the prior year quarter.

Surgical Specialty Products - Surgical specialty products include soft tissue repair products, performance irrigation devices and biosurgery products, including hemostats and sealants. Consolidated net sales of surgical specialty products for the quarter ended March 31, 2015 increased 1% on a reported basis (3% on a constant currency basis) compared to the prior year quarter. This increase was primarily due to growth in sales of synthetic hernia repair products and biosurgery products and was partially offset by a decline in sales of performance irrigation products, a trend that may continue. United States net sales of surgical specialty products for the quarter ended March 31, 2015 increased 5% compared to the prior year quarter. International net sales of surgical specialty products for the quarter ended March 31, 2015 decreased 12% on a reported basis (4% on a constant currency basis) compared to the prior year quarter.

The soft tissue repair product line includes synthetic and natural tissue hernia repair implants, natural tissue breast reconstruction implants and hernia fixation products. Consolidated net sales of soft tissue repair products for the quarter ended March 31, 2015 increased 3% on a reported basis (5% on a constant currency basis) compared to the prior year quarter. Net sales in this product line were favorably impacted by growth in sales of synthetic hernia repair products and were partially offset by a decline in sales of hernia fixation products, a trend that may continue.

Consolidated net sales of biosurgery products for the quarter ended March 31, 2015 increased 10% on a reported basis (11% on a constant currency basis) compared to the prior year quarter. Net sales in the product line were favorably impacted by growth in sales of hemostats and surgical sealant products.

Other Products - The other product group includes irrigation, wound drainage and certain original equipment manufacturers’ products.

Costs and Expenses

A summary of costs and expenses as a percentage of net sales is as follows:

 

  Three Months Ended
March 31,
 
    2015(A)       2014(A)    

Cost of goods sold

  38.0%        38.7%     

Marketing, selling and administrative expense

  28.8%        29.6%     

Research and development expense

  7.4%        8.0%     

Interest expense

  1.4%        1.4%     

Other (income) expense, net

  2.0%        (0.8)%     
  

 

 

    

 

 

 

Total costs and expenses

      77.5%            77.0%     
  

 

 

    

 

 

 

 

(A) Amounts do not add due to rounding.

Cost of goods sold - Cost of goods sold consists principally of the manufacturing and distribution costs of the company’s products. The category also includes royalties paid by the company, amortization of intangible assets and the impact of certain hedging activities. Cost of goods sold as a percentage of net sales for the quarter ended March 31, 2015 decreased 70 basis points compared to the prior year period primarily due to a reversal of a liability with respect to a certain revenue-based milestone. Incremental amortization primarily attributable to amortization of intangible assets related to the

 

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Lutonix drug-coated PTA balloon increased cost of goods sold as a percentage of net sales by approximately 40 basis points over the prior year period.

Marketing, selling and administrative expense - Marketing, selling and administrative expense consists principally of the costs associated with the company’s sales and administrative organizations. These costs as a percentage of net sales for the quarter ended March 31, 2015 decreased 80 basis points compared to the prior year quarter.

Research and development expense - Research and development expense consists principally of costs related to internal research and development activities, milestone payments for third-party research and development activities, and acquired in-process R&D (“IPR&D”) costs arising from the company’s business development activities. IPR&D payments may impact the comparability of the company’s results of operations between periods. Research and development expense for the quarter ended March 31, 2015 was $60.6 million, a decrease of approximately 6% compared to the prior year quarter.

Interest expense - Interest expense was $11.3 million and $11.1 million for the quarters ended March 31, 2015 and 2014, respectively.

Other (income) expense, net - The components of other (income) expense, net, are as follows:

 

  Three Months Ended
March 31,
 
  2015   2014  
(dollars in millions)        

Interest income

 $ (0.3)       $ (0.3)     

Foreign exchange losses

  0.3         0.8      

Litigation charges

  10.3         —         

Restructuring and productivity initiative costs

  3.9         —         

Gain on sale of investment

  —            (7.1)     

Other, net

  2.1         0.6      
  

 

 

    

 

 

 

Total other (income) expense, net

 $     16.3        $     (6.0)     
  

 

 

    

 

 

 

Litigation charges – For the quarter ended March 31, 2015, the amount reflects litigation-related defense costs of $8.3 million in connection with the District Court’s pre-trial orders to prepare 500 individual cases for trial (the “WHP Pre-Trial Orders”) and other litigation-related matters. See Note 6 of the notes to condensed consolidated financial statements.

Restructuring and productivity initiative costs – For the quarter ended March 31, 2015, the amount primarily reflects costs incurred in connection with productivity initiatives to streamline certain general and administrative functions to better align resources to the company’s business strategies. Key activities under these initiatives may include systems enhancements, the implementation of shared services centers designed to standardize and centralize processes or the outsourcing of certain services. Productivity initiative costs include consulting costs, primarily related to program creation and management, employee separation costs under the company’s existing severance program, and other related costs.

Gain on sale of investment – For the quarter ended March 31, 2014, the amount reflects the sale of an equity investment in an e-commerce technology company.

Income Tax Provision

The company’s effective tax rate for the quarter ended March 31, 2015 was 24.3% compared to 19.2% for the same period in the prior year. The effective tax rate for the quarter ended March 31, 2014 reflected a tax benefit of $10.9 million as a result of the completion of U.S. Internal Revenue Service (“IRS”) examinations for the tax years 2008 through 2010.

Net Income and Earnings Per Share Available to Common Shareholders

The company reported net income and diluted earnings per share available to common shareholders for the quarter ended March 31, 2015 of $139.8 million and $1.82, respectively. Net income and diluted earnings per share available to common shareholders for the prior year quarter were $148.4 million and $1.86, respectively. The current year quarter reflects amortization of intangible assets of $19.2 million, or $0.25 per diluted share, litigation charges of $9.4 million, or $0.12 per diluted share, a net benefit from acquisition-related items (primarily consisting of purchase accounting adjustments) of $9.4 million, or $0.12 per diluted share, and restructuring and productivity initiative costs of $2.6 million, or $0.03 per diluted share. The prior year quarter reflects amortization of intangible assets of $17.7 million, or $0.22 per diluted share, charges from acquisition-related items (primarily consisting of integration costs, purchase accounting adjustments and transaction costs) of $2.3 million, or $0.03 per diluted share and a gain on sale of an equity investment of $4.9 million, or $0.06 per

 

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diluted share. The prior year quarter also reflects a $10.9 million, or $0.14 per diluted share, benefit to the income tax provision as a result of the completion of IRS examinations for the tax years 2008 through 2010.

Liquidity and Capital Resources

The company assesses its liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. Significant factors affecting the management of liquidity are cash flows generated from operating activities, capital expenditures, acquisitions of businesses and technologies, cash dividends and common stock repurchases. Cash provided from operations continues to be a primary source of funds. The company believes that it could borrow adequate funds at competitive terms should it be necessary. The company also believes that its overall financial strength gives it sufficient financial flexibility. A summary of certain liquidity measures for the company as of March 31, is as follows:

 

  2015   2014  
(dollars in millions)        

Working capital

 $     1,133.8       $     1,409.5     
  

 

 

    

 

 

 

Current ratio

  2.26/1        3.65/1     
  

 

 

    

 

 

 

Cash and cash equivalents held by the company’s foreign subsidiaries were $998.8 million and $950.9 million at March 31, 2015 and December 31, 2014, respectively. It is the company’s intention to permanently reinvest the majority of these funds outside the United States to finance foreign operations, and the company’s plans do not demonstrate a need to repatriate these funds. If these funds are needed for U.S. operations for currently unforeseen circumstances or can no longer be permanently reinvested outside the United States, the company would be required to accrue and pay U.S. taxes on the earnings associated with these funds. In the United States, ongoing operating cash flows and available borrowings under the company’s committed syndicated bank credit facility provide it with sufficient liquidity.

For the three months ended March 31, 2015 and 2014, net cash provided by operating activities was $114.0 million and $114.3 million, respectively. Net cash provided by operating activities primarily reflects higher payments to claimants for certain product liability matters in the current year period, a higher discretionary contribution to the U.S. pension plan in the current year period, improvements in accounts receivable collections in the prior year period, and lower tax payments in the current year period.

For the three months ended March 31, 2015 and 2014, net cash used by investing activities was $3.3 million and $14.5 million, respectively. Capital expenditures were approximately $29.2 million and $22.7 million for the three months ended March 31, 2015 and 2014, respectively. The current year reflects a decrease of $26.1 million in restricted cash primarily related to payments from qualified settlement funds for certain product liability matters. In addition, the company received proceeds from the sale of an investment of $7.1 million during the three months ended March 31, 2014.

For the three months ended March 31, 2015 and 2014, net cash used for financing activities was $49.1 million and $226.8 million, respectively. Total debt was $1.6 billion (including current maturities of $253.6 million) and $1.5 billion at March 31, 2015 and December 31, 2014, respectively. Total debt to total capitalization was 48.3% and 45.1% at March 31, 2015 and December 31, 2014, respectively. Net cash used in financing activities reflects $204.2 million used to repurchase 1,184,553 shares of common stock in the three months ended March 31, 2015 compared to $255.7 million to repurchase 1,833,447 shares of common stock in the prior year period. The company paid cash dividends of $0.22 per share and $0.21 per share for the three months ended March 31, 2015 and 2014, respectively.

The company maintains a $750 million five-year committed syndicated bank credit facility that expires in November 2019. The credit facility supports the company’s commercial paper program and can be used for general corporate purposes. The facility includes pricing based on the company’s long-term credit ratings and includes a financial covenant that limits the amount of total debt to total capitalization. At March 31, 2015, the company was in compliance with this covenant. The company had commercial paper borrowings outstanding of $231.0 million and $78.0 million at March 31, 2015 and December 31, 2014, respectively.

Contingencies

In the ordinary course of business, the company is subject to various legal proceedings and claims, including product liability matters, environmental matters, employment disputes, contractual disputes on agreements and other commercial disputes. In addition, the company operates in an industry susceptible to significant patent legal claims. At any given time in the ordinary course of business, the company is involved as either a plaintiff or defendant in a number of patent infringement actions. See Note 6 of the notes to condensed consolidated financial statements.

 

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Certain Regulatory Matters

In October 2014 and November 2014, the United States Food and Drug Administration (“FDA”) conducted directed inspections at two of the company’s facilities after which the FDA issued Form-483’s to the company in connection with these inspections. The company responded to the FDA, is in the process of addressing the observations in the Form-483’s and intends to fully implement corrective and preventive actions to address the FDA’s concerns. The company cannot give any assurances that the FDA will be satisfied with its responses to the Form-483 observations or as to the expected date of resolution of matters included in the Form-483 observations.

Management’s Use of Non-GAAP Measures

Net sales “on a constant currency basis” is a non-GAAP measure. The company analyzes net sales on a constant currency basis to better measure the comparability of results between periods. Because changes in foreign currency exchange rates have a non-operating impact on net sales, the company believes that evaluating growth in net sales on a constant currency basis provides an additional and meaningful assessment of net sales to both management and the company’s investors. Constant currency growth rates are calculated by translating the prior year’s local currency sales by the current period’s exchange rate. Constant currency growth rates are not indicative of changes in corresponding cash flows. The limitation of these non-GAAP measures is that they do not reflect results on a standardized reporting basis. Non-GAAP measures are intended to supplement the applicable GAAP disclosures and should not be viewed as replacements of GAAP results.

Critical Accounting Policies

The preparation of financial statements requires the company’s management to make estimates and assumptions that affect the reported amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical accounting policies are those that require application of management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. Such policies are summarized in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section in Bard’s 2014 Annual Report on Form 10-K. There have been no significant changes to the company’s critical accounting policies since December 31, 2014.

Risks and Uncertainties; Cautionary Statement Regarding Forward-Looking Information

Certain statements contained herein or in other company documents and certain statements that may be made by management of the company orally may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “forecast,” “plan,” “believe” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to product approvals, future performance of current and anticipated products, sales efforts, expenses, the outcome of contingencies, such as legal proceedings, and financial results. The company’s forward-looking statements speak only as of the date of this report or as of the date they are made, and the company undertakes no obligation to update its forward-looking statements.

In addition, there are substantial risks inherent in the medical device business. The company’s business involves the design, development, manufacture, packaging, distribution and sale of life-sustaining medical devices. These devices are often used on, or permanently or temporarily implanted in, patients in clinically demanding circumstances, such as operating rooms, emergency units, intensive care and critical care settings, among others. These circumstances, among other factors, can cause the products to become associated with adverse clinical events, including patient mortality and injury, and could lead to product liability claims (including lawsuits seeking class action status or seeking to establish multi-district litigation proceedings) and other litigation, product withdrawals, warning letters, recalls, field corrections or regulatory enforcement actions relating to one or more of the company’s products, any of which could have a material adverse effect on our business, results of operations, financial condition and/or liquidity. For further discussion of risks applicable to our business, see “Risk Factors” in Bard’s 2014 Annual Report on Form 10-K.

Because actual results are affected by these and other risks and uncertainties, the company cautions investors that actual results may differ materially from those expressed or implied. It is not possible to predict or identify all risks and uncertainties, but the most significant factors, in addition to those addressed above and those described under Item 1A. “Risk Factors” in Bard’s 2014 Annual Report on Form 10-K, that could adversely affect our business or cause the actual results to differ materially from those expressed or implied include, but are not limited to:

 

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Effective management of and reaction to risks involved in our business, including:

 

    the ability to achieve manufacturing or administrative efficiencies, including gross margin benefits from our manufacturing processes and supply chain programs or in connection with the integration of acquired businesses;

 

    the effects of negative publicity concerning our products, which could result in product withdrawals or decreased product demand and which could reduce market or governmental acceptance of our products;

 

    the ability to identify appropriate companies, businesses and technologies as potential acquisition candidates, to consummate and successfully integrate such transactions or to obtain agreements for such transactions on favorable terms;

 

    the reduction in the number of procedures using our devices caused by customers’ cost-containment pressures or preferences for alternate therapies;

 

    the ability to implement, and realize the benefits of, our prior and planned investments in our business, including research and development expenditures focused on new market categories, and our plan to grow in emerging and/or faster-growing markets outside the United States and acquire growth platforms designed to change the mix of our portfolio towards faster, sustainable long-term growth;

 

    the uncertainty of whether research and development expenditures and sales force expansion will result in increased sales;

 

    the ability to reduce exposure and uncertainty related to tax audits, appeals and litigation;

 

    the risk that the company may not successfully implement its expansion of its Enterprise Resource Planning (“ERP”) information system and other productivity initiatives;

 

    internal factors, such as retention of key employees, including sales force employees;

 

    the ability to achieve earnings forecasts, which are generated based, among other things, on projected volumes and sales of many product types, some of which are more profitable than others, and projected royalty revenue from Gore;

 

    changes in factors and assumptions or actual results that differ from our assumptions on stock valuation and employee stock option exercise patterns, which could cause compensation expense recorded in future periods to differ significantly from the compensation expense recorded in the current period;

 

    changes in factors and assumptions could cause pension cost recorded in future periods to differ from the pension cost recorded in the current period;

 

    the effect of market fluctuations on the value of assets in the company’s pension plans and the possibility that the company may need to make additional contributions to the plans as a result of any decline in the fair value of such assets;

 

    damage to a facility where our products are manufactured or from which they are distributed, which could render the company unable to manufacture or distribute one or more products and may require the company to reduce the output of products at the damaged facility thereby making it difficult to meet product shipping targets;

 

    the potential impairment of goodwill and intangible assets of the company resulting from insufficient cash flow generated from such assets specifically, or our business more broadly, so as to not allow the company to justify the carrying value of the assets;

 

    the ability to obtain appropriate levels of insurance on reasonable terms, or at all;

 

    the ability to recover for claims made to our insurance companies or under indemnification obligations to the company and that any amounts recovered under these arrangements may not be adequate to cover the company’s damages and/or costs; and

 

    the ability to realize the anticipated benefits of our restructuring activities to improve the company’s overall cost structure and improve efficiency.

Competitive factors, including:

 

    the trend of consolidation in the medical device industry as well as among our customers, resulting in potentially greater pricing pressures, competition and more significant and complex contracts than in the past, both in the United States and abroad;

 

    development of new products or technologies by competitors having superior performance compared to our current products or products under development which could negatively impact sales of our products or render one or more of our products obsolete;

 

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    technological advances, patents and registrations obtained by competitors that would have the effect of excluding the company from new market segments or preventing the company from selling a product or including key features in the company’s products;

 

    attempts by competitors to gain market share through aggressive marketing programs; and

 

    reprocessing by third-party reprocessors of our products designed and labeled for single use.

Difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, including:

 

    the ability to complete planned and/or ongoing clinical trials successfully, to develop and obtain regulatory approval for products on a timely basis and to launch products on a timely basis within cost estimates;

 

    lengthy and costly regulatory approval processes, which may result in lost market opportunities and/or delayed product launches;

 

    delays or denials of, or grants of low or reduced levels of reimbursement for, procedures using newly developed products;

 

    the suspension or revocation of authority to manufacture, market or distribute existing products;

 

    the imposition of additional or different regulatory requirements, such as those affecting manufacturing and labeling;

 

    performance, efficacy, quality or safety concerns for existing products, whether scientifically justified or not, that may lead to product discontinuations, product withdrawals, recalls, field corrections, regulatory enforcement actions, litigation or declining sales, including adverse events and/or concerns relating to the company’s vena cava filters, pelvic floor repair products and hernia repair products;

 

    FDA inspections resulting in Form-483 notices and/or warning letters identifying deficiencies in the company’s manufacturing practices and/or quality systems; warning letters identifying violations of FDA regulations that could result in product holds, recalls, restrictions on future clearances by the FDA and/or civil penalties;

 

    the failure to obtain, limitations on the use of, or the loss of, patent and other intellectual property rights, and the failure of efforts to protect our intellectual property rights against infringement and legal challenges that can increase our costs;

 

    difficulties obtaining necessary components or raw materials used in the company’s products and/or price increases from the company’s suppliers of critical components or raw materials, including oil-based resins, or other interruptions of the supply chain; and

 

    customers that may limit the number of manufacturers or vendors from which they will purchase products, which can result in the company’s inability to sell products to or contract with large hospital systems, integrated delivery networks or group purchasing organizations.

Governmental action, including:

 

    the impact of continued healthcare cost containment;

 

    new laws and judicial decisions related to healthcare availability, healthcare reform, payment for healthcare products and services or the marketing and distribution of products, including legislative or administrative reforms to the United States Medicare and Medicaid systems or other United States or international reimbursement systems in a manner that would significantly reduce or eliminate reimbursements for procedures that use the company’s products;

 

    changes in the FDA and/or foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity;

 

    the impact of compliance and enforcement activities affecting the healthcare industry in general or the company in particular (including sales and marketing practices);

 

    changes in tax laws affecting our business, such as proposed comprehensive tax reform in the United States and proposed legislation in multiple jurisdictions resulting from the adoption of Organisation for Economic Co-operation and Development (OECD) policies;

 

    changes in environmental laws or standards affecting our business including, among others, compliance with new labeling standards related to ozone-depleting substances;

 

    changes in laws that could require facility upgrades or process changes and could affect production rates and output; and

 

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    compliance costs and potential penalties and remediation obligations in connection with environmental laws, including regulations regarding air emissions, waste water discharges and solid waste.

Legal disputes, including:

 

    disputes over legal proceedings, the outcome of the Gore matters and the timing of final resolution of the Gore matters, including the patent infringement suit against Gore;

 

    product liability claims, which may involve lawsuits seeking class action status or seeking to establish multi-district litigation proceedings, including the Hernia Product Claims, the Women’s Health Product Claims and the Filter Product Claims;

 

    claims asserting securities law violations;

 

    claims asserting, and/or subpoenas seeking information regarding, violations of law in connection with federal and/or state healthcare programs such as Medicare or Medicaid;

 

    derivative shareholder actions;

 

    claims and subpoenas asserting antitrust violations;

 

    environmental claims, including risks relating to accidental contamination or injury from the use of hazardous materials in the company’s manufacturing, sterilization and research activities and the potential for the company to be held liable for any resulting damages; and

 

    commercial disputes, including disputes over distribution agreements, license agreements, manufacturing/supply agreements, development/research agreements (including indemnification provisions), acquisition or sale agreements, and insurance policies.

General economic conditions, including:

 

    international and domestic business conditions;

 

    political or economic instability in foreign countries;

 

    interest rates;

 

    foreign currency exchange rates;

 

    changes in the rate of inflation; and

 

    instability of global financial markets and economies including Greece, Italy, Spain, Portugal and certain other countries or places where we operate or do business.

Other factors beyond our control, including catastrophes, both natural and man-made, earthquakes, floods, fires, explosions, strikes, work stoppages or slowdowns, acts of terrorism or war.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

The quantitative and qualitative disclosures about market risk are discussed in “Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in Bard’s 2014 Annual Report on Form 10-K. There have been no material changes in the information reported since the year ended December 31, 2014.

Item 4. Controls and Procedures

The company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in the company’s reports under the Securities Exchange Act of 1934 (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosures. Any controls and procedures, no matter how well defined and operated, can provide only reasonable assurance of achieving the desired control objectives.

The company’s management, with the participation of the company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of the company’s disclosure controls and procedures as of March 31, 2015. Based upon that evaluation, the company’s Chief Executive Officer and Chief Financial Officer have concluded that, as of March 31, 2015, the design and operation of the company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were effective to accomplish their objectives at the reasonable assurance level. There have been no changes in internal control over financial reporting for the quarter ended March 31, 2015 that have materially affected, or are likely to materially affect, the company’s internal control over financial reporting.

 

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PART II – OTHER INFORMATION

Item 1. Legal Proceedings

In the ordinary course of business, the company is subject to various legal proceedings, investigations and claims, including, for example, environmental matters, employment disputes, disputes on agreements and other commercial disputes. In addition, the company operates in an industry susceptible to significant product liability and patent legal claims. At any given time, in the ordinary course of business, the company is involved as either a plaintiff or defendant in a number of patent infringement actions. If a third party’s patent infringement claim were to be determined against the company, the company might be required to make significant royalty or other payments or might be subject to an injunction or other limitation on its ability to manufacture or distribute one or more products. If a patent owned by or licensed to the company is found to be invalid or unenforceable, the company might be required to reduce the value of certain intangible assets on the company’s balance sheet and to record a corresponding charge, which could be significant in amount. Many of the company’s legal proceedings and claims could have a material adverse effect on its business, results of operations, financial condition and/or liquidity.

Product Liability Matters

Hernia Product Claims

As of April 15, 2015, approximately 55 federal and 40 state lawsuits involving individual claims by approximately 95 plaintiffs, as well as one putative class action in the United States, are currently pending against the company with respect to its Composix® Kugel® and certain other hernia repair implant products (collectively, the “Hernia Product Claims”). The company voluntarily recalled certain sizes and lots of the Composix® Kugel® products beginning in December 2005. As of April 15, 2015, all but one of the putative class actions pending against the company were dismissed. The remaining putative class action, which has not been certified, seeks: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2014, a settlement was reached with respect to the three putative Canadian class actions within amounts previously recorded by the company. Approximately 20 of the state lawsuits, involving individual claims by approximately 20 plaintiffs, are pending in the Superior Court of the State of Rhode Island, with the remainder in various other jurisdictions. The Hernia Product Claims also generally seek damages for personal injury resulting from use of the products.

In June 2007, the Composix® Kugel® lawsuits and, subsequently, other hernia repair product lawsuits, pending in federal courts nationwide were transferred into one Multidistrict Litigation (“MDL”) for coordinated pre-trial proceedings in the United States District Court for the District of Rhode Island.

In June 2011, the company announced that it had reached agreements in principle with various plaintiffs’ law firms to settle the majority of its existing Hernia Product Claims. Each agreement was subject to certain conditions, including requirements for participation in the proposed settlements by a certain minimum number of plaintiffs. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Hernia Product Claims, and intends to vigorously defend Hernia Product Claims that do not settle, including through litigation. There are three trials currently scheduled in the second half of 2015. The company cannot give any assurances that the resolution of the Hernia Product Claims that have not settled, including asserted and unasserted claims and the putative class action lawsuit, will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Women’s Health Product Claims

As of April 1, 2015, product liability lawsuits involving individual claims by approximately 14,500 plaintiffs have been filed against the company in various federal and state jurisdictions alleging personal injuries associated with the use of certain of the company’s surgical continence products for women. In addition, five putative class actions in the United States and five putative class actions in Canada have been filed against the company. In addition, a limited number of claims have been filed or asserted in various non-U.S. jurisdictions (all lawsuits, collectively, the “Women’s Health Product Claims”). The Women’s Health Product Claims generally seek damages for personal injury resulting from use of the products. The putative class actions, none of which has been certified, seek: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2015, the Ontario Superior Court of Justice dismissed the plaintiffs’ motion for class certification in one Canadian putative class action. The plaintiffs may appeal this decision or may file an alternatives motion with the Ontario Superior Court to redefine the class. With respect to approximately half of the filed and asserted Women’s Health Product Claims, the company believes that two subsidiaries of Medtronic plc (as successor in interest to Covidien plc) (“Medtronic”), each a supplier of the company, have an obligation to defend and indemnify the company with respect to any product defect liability.

 

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In October 2010, the Women’s Health Product Claims involving solely Avaulta® products pending in federal courts nationwide were transferred into an MDL in the United States District Court for the Southern District of West Virginia (the “District Court”), the scope of which was later expanded to include lawsuits involving all women’s surgical continence products that are manufactured or distributed by the company. The first trial in a state court was completed in California in July 2012 and resulted in a judgment against the company of approximately $3.6 million. On appeal the decision was affirmed by the appellate court in November 2014. The company filed a petition for review to the California Supreme Court on December 24, 2014, which was denied on February 18, 2015. The judgment in this matter, including interest and costs, was paid on March 20, 2015 within amounts previously recorded by the company. The first trial in the MDL commenced in July 2013 and resulted in a judgment against the company of approximately $2 million. The company has appealed this decision. During the third quarter of 2013, the company settled one MDL case and one New Jersey state case. In addition, during the third quarter of 2013, one MDL case was voluntarily dismissed with prejudice. On January 16, 2014 and July 31, 2014, the District Court ordered that the company prepare 200 and then an additional 300 individual cases, respectively, for trial (the “WHP Pre-Trial Orders”) (the timing for which is currently unknown). These WHP Pre-Trial Orders resulted in significant additional litigation-related defense costs beginning in the second quarter of 2014 and are expected to result in material additional cost in 2015 in defending Women’s Health Product Claims. The District Court may also order that the company prepare additional cases for trial, which could result in material additional cost in future periods. During the second quarter of 2014, the company reached an agreement with two plaintiffs’ law firms to settle their inventory of cases, representing more than 500 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The company also settled one MDL case that was originally scheduled for trial in May 2014. In the third quarter of 2014, the company reached an agreement with a plaintiffs’ law firm to settle approximately 25 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The settlements reached in 2014 for Women’s Health Product Claims were within the amounts previously recorded by the company. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims, which may include additional inventory settlements. In February 2015, the District Court appointed a Special Master to assist with settlement resolution. A trial was scheduled to begin in the MDL in February 2015, however, the parties reached an agreement in principle to settle the case. A state court trial in Florida is scheduled for October 2015, and one in Missouri is scheduled for November 2015. The company anticipates that multiple additional trials, including a possible consolidated trial or trials, may occur in 2015.

In December 2014, Medtronic filed a motion for leave to amend its answer in the underlying MDL for Women’s Health Product Claims to assert cross-claims against the company challenging the indemnification provisions of certain of their supply agreements with the company. In March 2015, the court granted Medtronic’s motion. On January 22, 2015, the company initiated litigation and/or arbitration seeking, among other things, declaratory relief under these supply agreements with Medtronic in three separate jurisdictions - New Jersey state court, the English High Court of Justice in London and Atlanta, Georgia.

The company does not believe that any verdicts entered to date are representative of potential outcomes of all Women’s Health Product Claims. The case numbers set forth above do not include approximately 850 generic complaints involving women’s health products where the company cannot, based on the allegations in the complaints, determine whether any of those cases involves the company’s women’s health products. In addition, the case numbers set forth above do not include approximately 1,650 claims that have been threatened against the company but for which complaints have not yet been filed. While the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims and intends to vigorously defend the Women’s Health Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims and the related litigation with Medtronic will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Filter Product Claims

As of April 15, 2015, product liability lawsuits involving individual claims by approximately 45 plaintiffs are currently pending against the company in various federal and state jurisdictions alleging personal injuries associated with the use of the company’s vena cava filter products (all lawsuits, collectively, the “Filter Product Claims”). The first Filter Product Claim trial was completed in June 2012 and resulted in a judgment for the company. During the second quarter of 2013, the company finalized settlement agreements with respect to more than 30 Filter Product Claims and made payments with respect to such claims within the amounts previously recorded. The case numbers set forth above do not include approximately 150 claims that have been threatened against the company but for which complaints have not yet been filed. The company expects additional trials of Filter Product Claims to take place over the next 12 months. While the company intends to vigorously defend Filter Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

 

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General

In most product liability litigations (like those described above), plaintiffs allege a wide variety of claims, ranging from allegations of serious injury caused by the products to efforts to obtain compensation notwithstanding the absence of any injury. In many of these cases, the company has not yet received and reviewed complete information regarding the plaintiffs and their medical conditions and, consequently, is unable to fully evaluate the claims. The company expects that it will receive and review additional information regarding any remaining unsettled product liability matters.

The company believes that some settlements and judgments, as well as some legal defense costs, relating to product liability matters are or may be covered in whole or in part under its product liability insurance policies with a limited number of insurance carriers, or, in some circumstances, indemnification obligations to the company from other parties. In certain circumstances, insurance carriers reserve their rights with respect to coverage, or contest or deny coverage, as has occurred with respect to certain claims. In addition, other parties may dispute their indemnification obligations to the company, as has occurred with respect to certain claims. When either of these occur, the company intends to vigorously contest disputes with respect to its insurance coverage or indemnification and to enforce its rights, and accordingly, will record receivables with respect to amounts due under these policies or arrangements, when recovery is probable. Amounts recovered under the company’s product liability insurance policies or indemnification arrangements may be less than the stated coverage limits or less than otherwise expected and may not be adequate to cover damages and/or costs relating to claims. In addition, there is no guarantee that insurers or other parties will pay claims or that coverage or indemnity will be otherwise available.

The company’s insurance coverage with respect to the Hernia Product Claims has been exhausted. The company continues to evaluate its available insurance coverage as it relates to Women’s Health Product Claims and Filter Product Claims.

Other Legal Matters

Since early 2013, the company has received subpoenas or Civil Investigative Demands from a number of State Attorneys General seeking information related to the sales and marketing of certain of the company’s products that are the subject of the Hernia Product Claims and the Women’s Health Product Claims. The company is cooperating with these requests. Since it is not feasible to predict the outcome of these proceedings, the company cannot give any assurances that the resolution of these proceedings will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

In December 2007, a U.S. District Court jury in Arizona found that certain of W.L. Gore & Associates, Inc.’s (“Gore”) ePTFE vascular grafts and stent-grafts infringe the company’s patent number 6,436,135 (the “135 patent”). The jury upheld the validity of the company’s patent and awarded the company $185 million in past damages. The jury also found that Gore willfully infringed the patent. In a second phase of the trial, the District Court ruled that Gore failed to prove that the patent is unenforceable due to inequitable conduct. In March 2009, the District Court doubled the jury award to approximately $371 million for damages through June 2007. The District Court also awarded the company attorneys’ fees of $19 million and prejudgment interest of approximately $20 million. In addition, the District Court denied Gore’s remaining motions, including its motions for a new trial and to set aside the jury’s verdict. In July 2010, the District Court awarded the company approximately $109 million in additional damages for the period from July 2007 through March 2009. The District Court also assessed a royalty rate of between 12.5% and 20%, depending on the product, that will be used to calculate damages for Gore’s infringing sales from April 2009 through the expiration of the patent.

Gore appealed this matter to the Court of Appeals for the Federal Circuit (the “Court of Appeals”), which on February 10, 2012 affirmed the decision of the District Court. Gore filed a petition with the Court of Appeals for a rehearing of its appeal. On June 14, 2012, the Court of Appeals reaffirmed its February 10, 2012 decision, including the ongoing royalty rates as set by the District Court, with the exception of the issue of willfulness with respect to Gore’s infringement of the 135 patent, which was remanded to the District Court for further consideration. On October 12, 2012, Gore filed a petition for a writ of certiorari to the U.S. Supreme Court requesting a review of the portion of the decision that the Court of Appeals reaffirmed. The U.S. Supreme Court denied Gore’s petition on January 14, 2013.

On January 28, 2013, Gore filed with the U.S. District Court a Request for Judicial Notice that the U.S. Patent and Trademark Office (“USPTO”) granted Gore’s previously filed request for a re-examination of the 135 patent. On April 1, 2013, the USPTO issued a First Office Action initially rejecting all of the claims of the 135 patent that are the subject of the re-examination. On July 10, 2013, the USPTO issued a Notice of Intent to Issue an Ex Parte Reexamination Certificate upholding the patentability of all re-examined claims of the 135 patent. This action terminated the re-examination proceeding and upheld the claims involved in the re-examination.

On remand of the action from the Court of Appeals, the District Court heard oral argument on June 5, 2013 on three motions pending before it – Gore’s motion requesting a determination that Gore’s infringement was not willful, Gore’s motion for a new trial, and the company’s motion to execute on the judgment with respect to all amounts other than enhanced

 

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damages due to willfulness. On October 16, 2013, the District Court denied Gore’s motion for entry of a judgment holding that Gore’s infringement was not willful and Gore’s motion for a new trial. The District Court granted the company’s motion to execute on the judgment, holding that all aspects of the judgment relating to infringement were “final and non-appealable.” The District Court continued its stay on the execution of the judgment with respect to willfulness and the related enhanced damages.

On November 1, 2013, Gore paid to the company $894.3 million in cash (the “Gore Proceeds”), the total amount of the compensatory damages for infringement, including pre- and post-judgment interest, and the royalties accrued through September 30, 2013. Gore expressly reserved its right to appeal from the District Court’s rulings and notified the company that, if successful on appeal, it would seek to recover the amounts paid to the company. On December 5, 2013, Gore filed an appeal in the Court of Appeals on all of the District Court’s rulings, including the order denying Gore’s motion for a new trial. On August 8, 2014, the Court of Appeals heard oral argument on Gore’s appeal of the District Court’s rulings. On January 13, 2015, the Court of Appeals affirmed the decision of the District Court regarding its determination that the company established standing and that the 135 patent was willfully infringed. On February 12, 2015, Gore filed a petition for rehearing en banc at the Court of Appeals on the issue of willfulness. On April 8, 2015, the Court of Appeals denied Gore’s petition for rehearing en banc on the issue of willfulness. The Company filed a motion to execute on the judgment on the issue of willfulness, which was granted by the District Court on April 23, 2015. Gore may petition for review by the U.S. Supreme Court.

As of the third quarter of 2013, the company considered both the compensatory damages and the enhanced damages and the royalty awards to be contingent gains. In the fourth quarter of 2013, the company recorded a gain of $894.3 million ($557.4 million after tax) to other (income) expense, net, based on the District Court’s October 2013 rulings and the company’s receipt of the Gore Proceeds. In January 2015, the company received $38.4 million of royalty payments from Gore representing Gore’s calculation of royalties for its infringing sales for the quarter ended December 31, 2014. This royalty payment was recorded to revenue in the first quarter of 2015. The company has received cumulative proceeds from Gore of $1,084.5 million. The company has concluded that the chance of Gore establishing its right to recover this cash is remote. The company continues to account for the enhanced damages of approximately $209 million awarded by the District Court due to Gore’s willfulness as a contingent gain. The company anticipates receiving this amount in the second quarter of 2015.

The timing of final resolution of this litigation remains uncertain. The company cannot give any assurances that royalties for Gore’s future infringing sales will remain at or near historical levels.

In an unrelated matter, Gore filed suit in June 2011 in the U.S. District Court in Delaware alleging the company had infringed on several of Gore’s patents. Fact and expert discovery have been completed and in the fourth quarter of 2014, the parties both filed motions for summary judgment. Oral arguments on the motions occurred on January 30, 2015. The company intends to vigorously defend the allegations asserted by Gore. The company cannot give any assurances that an adverse resolution of this matter will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

The company is subject to numerous federal, state, local and foreign environmental protection laws governing, among other things, the generation, storage, use and transportation of hazardous materials and emissions or discharges into the ground, air or water. The company is or may become a party to proceedings brought under various federal laws including the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), commonly known as Superfund, the Resource Conservation and Recovery Act, the Clean Water Act, the Clean Air Act and similar state or foreign laws. These proceedings seek to require the owners or operators of contaminated sites, transporters of hazardous materials to the sites and generators of hazardous materials disposed of at the sites to clean up the sites or to reimburse the government for cleanup costs. In most cases, there are other potentially responsible parties that may be liable for remediation costs. In these cases, the government alleges that the defendants are jointly and severally liable for the cleanup costs; however, these proceedings are frequently resolved so that the allocation of cleanup costs among the parties more closely reflects the relative contributions of the parties to the site contamination. The company’s potential liability varies greatly from site to site. For some sites, the potential liability is de minimis and for others the costs of cleanup have not yet been determined. Accruals for estimated losses from environmental remediation obligations generally are recognized no later than completion of the remedial feasibility study and are adjusted as further information develops or circumstances change. Costs of future expenditures for environmental remediation obligations are not discounted to their present value. Recoveries of environmental remediation costs from other parties are recorded as assets when their receipt is deemed probable. The company believes that the proceedings and claims described above will likely be resolved over an extended period of time. While it is not feasible to predict the outcome of these proceedings, based upon the company’s experience, current information and applicable law, the company does not expect these proceedings to have a material adverse effect on its financial condition and/or liquidity. However, one or more of the proceedings could be material to the company’s business and/or results of operations.

The company regularly monitors and evaluates the status of product liability and other legal matters, and may, from time-to-time, engage in settlement and mediation discussions taking into consideration developments in the matters and the

 

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risks and uncertainties surrounding litigation. These discussions could result in settlements of one or more of these claims at any time.

Item 1A. Risk Factors

There have been no material changes to the risk factors disclosed in Part I, Item 1A. in Bard’s 2014 Annual Report on Form 10-K.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

The following table provides information with respect to the shares of the company’s common stock repurchased during the quarter ended March 31, 2015:

 

    Issuer Purchases of Equity Securities  

Period

  Total
Number
of Shares
Purchased(1)
  Average
Price
Paid
Per Share
  Total Number
of Shares
Purchased as
Part of Publicly
Announced
Programs(2)
  Maximum
Approximate
Dollar Value of
Shares
that May Yet
Be Purchased
Under Plans or
Programs(2)
 

January 1 – January 31, 2015

  779,524         $    172.26          775,074         $ 261,616,407       

February 1 – February 28, 2015

  546,339          172.95          409,479          190,929,826       

March 1 – March 31, 2015

  11,975          168.99          —          190,929,826       
     

 

 

    

 

 

    

 

 

    

 

 

 

Total

      1,337,838         $    172.51              1,184,553         $    190,929,826       
     

 

 

    

 

 

    

 

 

    

 

 

 

 

  (1) Includes 153,285 shares that the company repurchased during the three month period ended March 31, 2015 that were not part of the publicly announced share repurchase authorization. These shares were purchased from employees to satisfy tax withholding requirements on the vesting of restricted shares/units from equity-based awards.
  (2) On June 11, 2014, the company announced that its Board of Directors had authorized the repurchase of up to an additional $500 million of common stock of the company.

Item 5. Other Information

The company’s policy governing transactions in its securities by the company’s directors, executive officers and other specified employees permits such persons to adopt trading plans pursuant to Rule 10b5-1 of the Exchange Act. From time-to-time, the company’s executive officers have established trading plans relating to the company’s common stock under Rule 10b5-1, and the company anticipates additional trading plans may be established in the future. The company currently discloses details regarding individual trading plans on its website.

Item 6. Exhibits

 

Number        

Description  

12.1 Computation of Ratio of Earnings to Fixed Charges*
31.1 Rule 13a-14(a) / 15d-14(a) Certification of Chief Executive Officer*
31.2 Rule 13a-14(a) / 15d-14(a) Certification of Chief Financial Officer*
32.1 Section 1350 Certification of Chief Executive Officer (furnished herewith)
32.2 Section 1350 Certification of Chief Financial Officer (furnished herewith)
101.INS XBRL Instance Document*
101.SCH XBRL Taxonomy Extension Schema Document*
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB XBRL Taxonomy Extension Label Linkbase Document*
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document*

 

*               Filed herewith.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

C. R. BARD, INC.
      (Registrant)
Date: April 24, 2015

/s/    CHRISTOPHER S. HOLLAND

Christopher S. Holland

Senior Vice President and

Chief Financial Officer

/s/    FRANK LUPISELLA JR.

Frank Lupisella Jr.

Vice President and Controller

 

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INDEX TO EXHIBITS

 

Number        

Description       

12.1 Computation of Ratio of Earnings to Fixed Charges
31.1 Rule 13a-14(a) / 15d-14(a) Certification of Chief Executive Officer
31.2 Rule 13a-14(a) / 15d-14(a) Certification of Chief Financial Officer
32.1 Section 1350 Certification of Chief Executive Officer (furnished herewith)
32.2 Section 1350 Certification of Chief Financial Officer (furnished herewith)
101.INS XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF XBRL Taxonomy Extension Definition Linkbase Document
101.LAB XBRL Taxonomy Extension Label Linkbase Document
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document

 

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EXHIBIT 12.1

C. R. BARD, INC. AND SUBSIDIARIES

Exhibit 12.1 - Computation of Ratio of Earnings to Fixed Charges

 

  Three Months   Years Ended December 31,  
  Ended
March 31,
2015
  2014   2013   2012   2011   2010  
(dollars in millions)                                          

Earnings from operations before taxes

    $ 184.6          $ 445.8         $ 1,213.4         $ 732.4         $ 510.8         $ 717.7    

Add (Deduct):

                 

Fixed charges

     13.3           52.9          52.4          46.1          42.7          18.4    

Undistributed earnings of equity investments

     0.7           0.3          (1.0)         (9.6)         (3.8)         (3.6)   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Earnings available for fixed charges

 $     198.6       $     499.0      $   1,264.8      $     768.9      $     549.7      $     732.5    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Fixed charges:

Interest, including amounts capitalized(1)

 $ 11.3       $ 44.8      $ 45.0      $ 39.6      $ 36.4      $ 12.7    

Proportion of rent expense deemed to represent interest factor

  2.0        8.1       7.4       6.5       6.3       5.7    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Fixed charges

 $ 13.3       $ 52.9      $ 52.4      $ 46.1      $ 42.7      $ 18.4    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Ratio of earnings to fixed charges

  14.93        9.43       24.14       16.68       12.87       39.81    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1)  Interest related to unrecognized tax benefits is included as income tax expense and not included in fixed charges.


EXHIBIT 31.1

Certification of Chief Executive Officer

I, Timothy M. Ring, certify that:

 

  1. I have reviewed this quarterly report on Form 10-Q of C. R. Bard, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 24, 2015

/s/ Timothy M. Ring

Timothy M. Ring
Chief Executive Officer


EXHIBIT 31.2

Certification of Chief Financial Officer

I, Christopher S. Holland, certify that:

 

  1. I have reviewed this quarterly report on Form 10-Q of C. R. Bard, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 24, 2015

/s/ Christopher S. Holland

Christopher S. Holland
Senior Vice President and Chief Financial Officer


EXHIBIT 32.1

SECTION 1350 CERTIFICATIONS

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of C. R. Bard, Inc. on Form 10-Q for the period ended March 31, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Timothy M. Ring, Chairman and Chief Executive Officer of C. R. Bard, Inc., certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

  1. the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of C. R. Bard, Inc.

 

/s/ Timothy M. Ring

Name: Timothy M. Ring
Date: April 24, 2015


EXHIBIT 32.2

SECTION 1350 CERTIFICATIONS

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of C. R. Bard, Inc. on Form 10-Q for the period ended March 31, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Christopher S. Holland, Senior Vice President and Chief Financial Officer of C. R. Bard, Inc., certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

  1. the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of C. R. Bard, Inc.

 

/s/ Christopher S. Holland

Name: Christopher S. Holland
Date: April 24, 2015
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