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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 September 30, 2014

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 September 30, 2014
Common Stock - $0.25 par value		74,898,741

 

 

 

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C. R. BARD, INC. AND SUBSIDIARIES

INDEX

 

				Page
PART I – FINANCIAL INFORMATION
Item 1.		Financial Statements (unaudited)
		Condensed Consolidated Statements of Income for the Quarter and Nine Months Ended September 30, 2014 and 2013			3
		Condensed Consolidated Statements of Comprehensive Income for the Quarter and Nine Months Ended September 30, 2014 and 2013			4
		Condensed Consolidated Balance Sheets – September 30, 2014 and December 31, 2013			5
		Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2014 and 2013			6
		Notes to Condensed Consolidated Financial Statements			7
Item 2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations			19
Item 3.		Quantitative and Qualitative Disclosures About Market Risk			29
Item 4.		Controls and Procedures			29
PART II – OTHER INFORMATION
Item 1.		Legal Proceedings			30
Item 1A.		Risk Factors			33
Item 2.		Unregistered Sales of Equity Securities and Use of Proceeds			33
Item 5.		Other Information			34
Item 6.		Exhibits			34
Signatures					35

 

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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)

 

		Quarter Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Net sales		$	830,000			$	758,000			$	2,456,400			$	2,258,200
Costs and expenses:
Cost of goods sold			308,900				291,900				939,100				883,800
Marketing, selling and administrative expense			242,000				223,900				724,000				666,600
Research and development expense			73,100				99,400				222,800				224,800
Interest expense			11,200				11,200				33,600				33,700
Other (income) expense, net			14,500				12,600				265,800				338,600
Total costs and expenses			649,700				639,000				2,185,300				2,147,500
Income from operations before income taxes			180,300				119,000				271,100				110,700
Income tax provision			49,000				25,800				110,800				88,400
Net income		$	131,300			$	93,200			$	160,300			$	22,300
Basic earnings per share available to common shareholders		$	1.73			$	1.17			$	2.08			$	0.28
Diluted earnings per share available to common shareholders		$	1.69			$	1.15			$	2.04			$	0.27

 

The accompanying notes are an integral part of these condensed consolidated financial statements.   3

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(dollars in thousands, unaudited)

 

		Quarter       Ended September 30,								Nine Months         Ended September 30,
		2014				2013				2014				2013
Net income		$	131,300			$	93,200			$	160,300			$	22,300
Other comprehensive income (loss):
Change in derivative instruments designated as cash flow hedges, net of tax			(400)				(1,200)				1,300				1,600
Foreign currency translation adjustments			(18,000)				8,000				(14,600)				(700)
Benefit plan adjustments, net of tax			1,700				2,200				4,900				6,600
Other comprehensive income (loss)			(16,700)				9,000				(8,400)				7,500
Comprehensive income		$	114,600			$	102,200			$	151,900			$	29,800

 

The accompanying notes are an integral part of these condensed consolidated financial statements.   4

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

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

 

		September 30,      2014				December 31,      2013
ASSETS
Current assets
Cash and cash equivalents		$	971,700			$	1,066,900
Restricted cash			68,000				16,300
Accounts receivable, less allowances of $10,900 and $11,600, respectively			443,300				479,600
Inventories			379,900				356,200
Short-term deferred tax assets			62,900				78,200
Other current assets			105,300				93,200
Total current assets			2,031,100				2,090,400
Property, plant and equipment, at cost			745,500				667,500
Less accumulated depreciation and amortization			315,200				276,300
Net property, plant and equipment			430,300				391,200
Goodwill			1,097,700				1,099,500
Core and developed technologies, net			638,600				696,800
Other intangible assets, net			447,200				468,100
Deferred tax assets			10,900				3,900
Other assets			457,900				291,200
Total assets		$	5,113,700			$	5,041,100
LIABILITIES AND SHAREHOLDERS’ INVESTMENT
Current liabilities
Accounts payable		$	81,300			$	83,000
Accrued expenses			402,600				294,000
Accrued compensation and benefits			136,700				145,300
Income taxes payable			24,300				64,200
Total current liabilities			644,900				586,500
Long-term debt			1,402,800				1,405,700
Other long-term liabilities			1,107,700				798,800
Deferred income taxes			126,100				161,900
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 74,898,741 shares at September 30, 2014 and 77,436,263 shares at December 31, 2013			18,700				19,400
Capital in excess of par value			1,880,400				1,729,600
Accumulated deficit / retained earnings			(37,600)				360,100
Accumulated other comprehensive loss			(29,300)				(20,900)
Total shareholders’ investment			1,832,200				2,088,200
Total liabilities and shareholders’ investment		$	5,113,700			$	5,041,100

 

The accompanying notes are an integral part of these condensed consolidated financial statements.   5

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(dollars in thousands, unaudited)

		Nine Months Ended September 30,
		2014				2013
Cash flows from operating activities:
Net income		$	160,300			$	22,300
Adjustments to reconcile net income to net cash provided by operating activities, net of acquired businesses:
Depreciation and amortization			127,700				106,000
Litigation charges, net			274,500				318,200
Gain on sale of investment			(7,100)				—
Asset impairments			6,800				12,300
Restructuring and productivity initiative costs, net of payments			700				(1,400)
Acquired in-process research and development			—				30,000
Deferred income taxes			(29,500)				(16,800)
Share-based compensation			53,000				44,700
Inventory reserves and provision for doubtful accounts			17,300				17,100
Other items			2,300				1,600
Changes in assets and liabilities:
Accounts receivable			39,100				10,200
Inventories			(45,900)				(34,400)
Current liabilities			7,800				(96,700)
Taxes			(68,200)				6,000
Other, net			(400)				(2,100)
Net cash provided by operating activities			538,400				417,000
Cash flows from investing activities:
Capital expenditures			(90,000)				(47,300)
Change in restricted cash			(51,700)				6,000
Payments made for purchases of businesses, net of cash acquired			—				(35,000)
Payments made for intangibles			(10,400)				(33,500)
Proceeds from sale of investment			7,100				—
Other			—				1,900
Net cash used in investing activities			(145,000)				(107,900)
Cash flows from financing activities:
Change in short-term borrowings, net			—				97,500
Proceeds from exercises under share-based compensation plans, net			72,500				74,400
Excess tax benefit relating to share-based compensation plans			17,400				9,500
Purchases of common stock			(526,100)				(546,900)
Dividends paid			(49,400)				(49,800)
Other			(200)				(500)
Net cash used in financing activities			(485,800)				(415,800)
Effect of exchange rate changes on cash and cash equivalents			(2,800)				(7,900)
Decrease in cash and cash equivalents during the period			(95,200)				(114,600)
Balance at January 1			1,066,900				896,300
Balance at September 30		$	971,700			$	781,700
Supplemental cash flow information
Cash paid for:
Interest		$	37,300			$	36,200
Income taxes			191,100				89,700
Non-cash transactions:
Purchase of business and related costs			3,000				8,200
Purchase of common stock not settled			—				6,500

 

The accompanying notes are an integral part of these condensed consolidated financial statements.   6

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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 2013 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 2013 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 and nine months ended August 31, 2014 and August 31, 2013 and as of November 30, 2013. No events occurred related to these foreign subsidiaries during the months of September 2014, September 2013 or December 2013 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 that will replace most existing revenue recognition guidance in U.S. generally accepted accounting principles. 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:

 

		Quarter Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
(dollars and shares in millions)
EPS Numerator:
Net income		$	131.3			$	93.2			$	160.3			$	22.3
Less: Income allocated to participating securities			2.2				1.6				2.6				0.3
Net income available to common shareholders		$	129.1			$	91.6			$	157.7			$	22.0
EPS Denominator:
Weighted average common shares outstanding			74.8				78.5				75.7				79.9
Dilutive common share equivalents from share-based compensation plans			1.5				1.5				1.5				1.3
Weighted average common and common equivalent shares outstanding, assuming dilution			76.3				80.0				77.2				81.2

3. Income Taxes

The effective tax rate for both the quarter and nine months ended September 30, 2014 reflected the discrete tax effect of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction. The effective tax rate for the current nine month period also 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.

The effective tax rate for the quarter and nine months ended September 30, 2013 reflected the discrete tax effects of an in-process research and development charge related to the acquisition of 3DT Holdings LLC, which was incurred in a high tax jurisdiction, and a benefit associated with the remeasurement of an uncertain tax position as a result of a legal settlement. The effective tax rate for the nine months ended September 30, 2013 also reflected the discrete tax effects of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction, and a write-down of an insurance receivable, which was also incurred in a low tax jurisdiction. See Note 6 of the notes to condensed consolidated financial statements. In addition, the tax provision for the nine months ended September 30, 2013 was reduced

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

by approximately $3.7 million to recognize the 2012 benefit of the American Taxpayer Relief Act of 2012, which was signed into law on January 2, 2013 and retroactively reinstated the research tax credit.

At September 30, 2014, the total amount of liability for unrecognized tax benefits related to federal, state and foreign taxes was $35.1 million (of which $29.9 million would impact the effective tax rate, if recognized) plus $3.5 million of accrued interest. At December 31, 2013, the liability for unrecognized tax benefits was $58.0 million plus $6.6 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 $3.7 million within the next 12 months.

4. Financial Instruments

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 $231.5 million and $148.9 million at September 30, 2014 and December 31, 2013, respectively. For further discussion regarding the company’s use of derivative instruments, see Note 1 of the notes to consolidated financial statements in Bard’s 2013 Annual Report on Form 10-K.

Interest Rate Derivative Instrument

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 $250.0 million.

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

 

		Balance Sheet Location		Fair Value of Derivatives
Derivatives Designated as Hedging Instruments				September 30,     2014				December 31,     2013
(dollars in millions)
Forward currency contracts		Other current assets		$	0.8			$	1.2
Option currency contracts		Other current assets			4.3				1.3
Forward currency contracts		Other assets			0.2				—
Option currency contracts		Other assets			1.2				—
Interest rate swap contract		Other assets			5.7				8.9
				$	12.2			$	11.4
Forward currency contracts		Accrued expenses		$	1.3			$	0.5
Forward currency contracts		Other long-term liabilities			0.4				—
				$	1.7			$	0.5

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 to         Income		Gain/(Loss) Reclassified from Accumulated  Other Comprehensive Loss into Income
		Quarter Ended                September 30,										Quarter Ended September 30,
		2014				2013						2014				2013
(dollars in millions)
Forward currency contracts		$	(1.7)			$	(0.5)			Cost of goods sold		$	0.1			$	1.7
Option currency contracts			1.9				0.9			Cost of goods sold			(0.6)				(0.6)
		$	0.2			$	0.4					$	(0.5)			$	1.1

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

		Gain/(Loss)         Recognized in Other         Comprehensive Income (Loss)								Location of Gain/(Loss) Reclassified from Accumulated         Other Comprehensive Loss to         Income		Gain/(Loss) Reclassified from Accumulated Other Comprehensive Loss into Income
		Nine Months Ended September 30,										Nine Months Ended September 30,
		2014				2013						2014				2013
(dollars in millions)
Forward currency contracts		$	(0.8)			$	4.1			Cost of goods sold		$	0.9			$	1.7
Option currency contracts			1.9				1.0			Cost of goods sold			(1.6)				(1.1)
		$	1.1			$	5.1					$	(0.7)			$	0.6

The location and amounts of gains and losses on the derivative instrument designated as a fair value hedge are as follows:

 

		Location in Statement of Income		(Loss)/Gain Recognized on Swap																Gain/(Loss) Recognized on Long-Term Debt
				Quarter Ended September 30,								Nine Months Ended September 30,								Quarter Ended September 30,								Nine Months Ended September 30,
				2014				2013				2014				2013				2014				2013				2014				2013
(dollars in millions)
Interest rate swap contract		Interest expense		$	(1.3)			$	(0.3)			$	(3.2)			$	(3.5)			$	1.3			$	0.3			$	3.2			$	3.5

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 measured at fair value on a recurring basis:

 

		September 30,  2014				December 31,  2013
(dollars in millions)
Forward currency contracts		$	(0.7)			$	0.7
Option currency contracts			5.5				1.3
Interest rate swap contract			5.7				8.9

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 $118.6 million, of which $115.7 million was recorded to accrued expenses, and $95.7 million, of which $10.3 million was recorded to accrued expenses, at September 30, 2014 and December 31, 2013, respectively. The increase in the fair value of the liability for contingent consideration is primarily due to an increase in the probability of a regulatory-based milestone payment related to the Lutonix, Inc. acquisition, and is expected to be paid in October 2014 as a result of receipt of regulatory approval of the Lutonix drug coated balloon catheter on October 10, 2014. 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 September 2018. 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 rating and includes a financial covenant that limits the amount of total debt to total capitalization. At September 30, 2014 the company was in compliance with this covenant. There were no commercial paper borrowings outstanding at September 30, 2014 or December 31, 2013, respectively.

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

The estimated fair value of long-term debt including the effect of the related interest rate swap contract was approximately $1,478.9 million and $1,435.4 million at September 30, 2014 and December 31, 2013, respectively. The fair value was estimated using dealer quotes for similarly-rated debt instruments over the remaining contractual term of the company’s obligation. Long-term debt 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 continues to monitor sovereign debt issues and economic conditions in Europe and evaluates accounts receivable in certain countries for potential collection risks. Economic conditions and other factors in certain countries in Europe 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. The company has experienced significant delays in the collection of accounts receivable associated with the national healthcare systems in Spain, Italy, Greece and Portugal. At September 30, 2014, the company’s accounts receivable, net of allowances, from the national healthcare systems in these countries and amounts past due greater than 365 days are as follows:

 

		Accounts   Receivable, net				Greater than   365 Days Past   Due
(dollars in millions)
Spain		$	11.9			$	0.4
Italy			15.3				2.1
Greece			9.4				4.3
Portugal			3.3				1.1
		$	39.9			$	7.9

5. Inventories

Inventories consisted of:

 

		September 30,   2014				December 31,   2013
(dollars in millions)
Finished goods		$	221.6			$	218.3
Work in process			31.2				21.9
Raw materials			127.1				116.0
		$	379.9			$	356.2

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 October 9, 2014, approximately 230 federal and 110 state lawsuits involving individual claims by approximately

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

335 plaintiffs, as well as two putative class actions 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. One of the U.S. putative class action lawsuits consolidated ten previously-filed U.S. class action lawsuits. 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 the third quarter of 2013, a settlement was reached with respect to the three pending putative Canadian class actions within amounts previously recorded by the company and were fully resolved in April 2014. Approximately 90 of the state lawsuits, involving individual claims by approximately 90 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.

On June 30, 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. 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 lawsuits, 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 October 9, 2014, product liability lawsuits involving individual claims by approximately 13,525 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 four putative class actions in Canada have been filed against the company (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. With respect to approximately half of the filed and asserted Women’s Health Product Claims, the company believes that one of its suppliers has 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 July 2012 and resulted in a judgment against the company of approximately $3.6 million. The company has appealed this decision and oral argument is scheduled for October 23, 2014. The first trial in the MDL commenced in July 2013 and resulted in a verdict against the company of approximately $2 million. The company intends to appeal the judgment. 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, the District Court ordered that the company prepare 200 individual cases for trial (the timing for which is currently unknown), which resulted in additional cost beginning in the second quarter of 2014. On July 31, 2014, the District Court ordered that the Company prepare an additional 300 individual cases for trial, which has resulted in additional cost beginning in the third quarter of 2014. These pre-trial orders are expected to result in material additional cost in 2014 and 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 costs 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 its supplier’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 its supplier’s indemnification obligation. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product

 

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Claims, which may include additional inventory settlements. While no MDL trials are scheduled for the remainder of 2014, the company anticipates that multiple additional trials, including a possible consolidated trial, may occur in early 2015.

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 895 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 2,445 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 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 October 9, 2014, product liability lawsuits involving individual claims by 50 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. In addition, three putative class actions were filed against the company in various state courts on behalf of plaintiffs who are alleged to have no present injury (all lawsuits, collectively, the “Filter Product Claims”). Two of these putative class actions were dismissed during the second quarter of 2013, and class certification was denied for the third putative class action in July 2013. The first Filter Product Claim trial was completed in June 2012 and resulted in a judgment for the company. The company expects additional trials of Filter Product Claims to take place over the next 12 months. 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. While the company intends to vigorously defend the remaining unsettled Filter Product Claims, 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 of this nature, 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. When this occurs, the company intends to vigorously contest disputes with respect to its insurance coverage and to enforce its rights under the terms of its insurance policies, and accordingly, will record receivables with respect to amounts due under these policies, 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. In the first quarter of 2013 the company recorded a non-cash charge of $25.0 million ($24.5 million after tax) to other (income) expense, net, for the write-down of an insurance receivable related to a dispute with one of its excess insurance carriers in connection with these 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.

 

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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 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 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. The Court of Appeals heard oral argument on Gore’s appeal of the District Court’s rulings on August 8, 2014. A decision on this matter is pending.

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 addition, the company received $38.0 million from Gore in July 2014 representing Gore’s calculation of royalties for its infringing sales for the quarter ended June 30, 2014. This royalty payment was recorded to revenue in the third quarter of 2014. Royalty payments of $113.2 million were recorded to revenue for the nine months ended September 30, 2014. The company has received cumulative proceeds from Gore of $1,007.5 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 awarded by the District Court due to Gore’s willfulness as a contingent gain.

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 historic levels.

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

 

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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 ($236.0 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 $1,085.6 million, of which $145.9 million was recorded to accrued expenses, and $662.4 million, of which $117.5 million was recorded to accrued expenses, at September 30, 2014 and December 31, 2013, respectively. The company has made total payments of $236.4 million to qualified settlement funds (“QSFs”), of which $59.3 million were made during the nine months ended September 30, 2014, subject to certain settlement conditions, for certain product liability matters. Payments to QSFs are recorded as a component of restricted cash. Total payments of $168.4 million from these QSFs have been made to qualified claimants, of which $7.6

 

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million were made during the nine months ended September 30, 2014. In addition, other payments of $34.2 million have been made to qualified claimants, of which $4.8 million were made during the nine months ended September 30, 2014.

The company recorded receivables related to product liability matters amounting to $379.6 million and $234.9 million at September 30, 2014 and December 31, 2013, respectively. A substantial amount of the receivable at September 30, 2014 and December 31, 2013 is the subject of a dispute with a supplier who 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 two separate subsidiaries of the supplier. These agreements include indemnification provisions pursuant to which the company is indemnified by the supplier 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 the supplier’s obligation to defend and indemnify the company for product defect claims with respect to the products manufactured by the supplier that are the subject of the Women’s Health Product Claims. At this time, no litigation has been filed with respect to the dispute with the supplier. 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 the supplier; and other pertinent factors, the company believes that collectability of these receivables is probable.

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. At the company’s Annual Meeting of Shareholders on April 16, 2014, the shareholders authorized an additional 2,900,000 shares for issuance under the LTIP. The total number of remaining shares at September 30, 2014 that may be issued under the LTIP was 6,572,288 and under the Directors’ Plan was 35,707. 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 September 30, 2014 and 2013, amounts charged against income for share-based payment arrangements were $16.3 million and $16.2 million, respectively. For the nine months ended September 30, 2014 and 2013, amounts charged against income for share-based payment arrangements were $53.0 million and $44.7 million, respectively.

In the first quarter of each of 2014 and 2013, 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 2014 and 2013 grants were estimated based on the following assumptions: risk-free interest rate of 0.70% and 0.42%, respectively; dividend yield of 0.62% and 0.81%, respectively; and expected life of 2.88 years for both valuations.

Anticipated purchases under the Management Stock Purchase Program (the “MSPP”) are approximately 0.2 million shares for the 2014 grant. Purchases under the MSPP were approximately 0.2 million shares for the 2013 grant. The fair

 

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value of the 2014 annual MSPP purchases was $51.82 per share and was estimated in July 2014. The fair value of the 2013 MSPP purchase was $37.20 per share. These fair value calculations used the Black-Scholes model based on the following assumptions: risk free interest rate of 0.07% and 0.10%, respectively; expected volatility of 20% and 15%, respectively; dividend yield of 0.6% and 0.8%, respectively; and expected life of 0.6 years for both valuations.

As of September 30, 2014, there were $90.8 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 2014.

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:

 

		Quarter Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
(dollars in millions)
Service cost, net of employee contributions		$	6.7			$	7.5			$	20.2			$	22.6
Interest cost			5.4				4.6				15.9				13.7
Expected return on plan assets			(7.2)				(6.5)				(20.8)				(19.5)
Amortization			2.6				3.4				7.5				10.2
Net periodic pension cost		$	7.5			$	9.0			$	22.8			$	27.0

9. Shareholders’ Investment

The company repurchased approximately 3.7 million shares of common stock for $526.1 million in the nine months ended September 30, 2014 under its previously announced share repurchase authorizations.

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				Benefit Plans				Total
(dollars in millions)
Balance at December 31, 2012		$	(0.7)			$	32.6			$	(113.1)			$	(81.2)
Other comprehensive income (loss) before reclassifications			2.3				(0.7)				—				1.6
Tax (provision) benefit related to other comprehensive income (loss) before reclassifications(a)			(0.4)				—				—				(0.4)
Other comprehensive income (loss) before reclassifications, net of taxes			1.9				(0.7)				—				1.2
Amounts reclassified from accumulated other comprehensive income (loss)			(0.6)	(b)			—				10.3	(c)			9.7
Tax provision (benefit) related to amounts reclassified from accumulated other comprehensive income (loss)			0.3				—				(3.7)				(3.4)
Reclassifications, net of tax			(0.3)				—				6.6				6.3
Other comprehensive income (loss)			1.6				(0.7)				6.6				7.5
Balance at September 30, 2013		$	0.9			$	31.9			$	(106.5)			$	(73.7)

 

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		Derivative Instruments Designated as  Cash Flow Hedges				Foreign Currency Translation				Benefit Plans				Total
(dollars in millions)
Balance at December 31, 2013		$	—			$	47.3			$	(68.2)			$	(20.9)
Other comprehensive income (loss) before reclassifications			1.6				(14.6)				—				(13.0)
Tax (provision) benefit related to other comprehensive income (loss) before reclassifications(a)			(0.9)				—				—				(0.9)
Other comprehensive income (loss) before reclassifications, net of taxes			0.7				(14.6)				—				(13.9)
Amounts reclassified from accumulated other comprehensive income (loss)			0.7(b	)			—				7.5(	c)			8.2
Tax provision (benefit) related to amounts reclassified from accumulated other comprehensive income (loss)			(0.1)				—				(2.6)				(2.7)
Reclassifications, net of tax			0.6				—				4.9				5.5
Other comprehensive income (loss)			1.3				(14.6)				4.9				(8.4)
Balance at September 30, 2014		$	1.3			$	32.7			$	(63.3)			$	(29.3)

 

(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:

 

		Quarter Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
(dollars in millions)
United States		$	565.4			$	500.3			$	1,671.9			$	1,496.4
Europe(a)			118.8				113.8				365.3				347.9
Japan			41.9				43.4				123.1				123.4
Other(a)			103.9				100.5				296.1				290.5
		$	830.0			$	758.0			$	2,456.4			$	2,258.2

 

(a)

Beginning in 2014, certain emerging markets in Europe are included in the “other” geographic region. Prior year amounts have been reclassified to conform to the current year presentation.

 

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Total net sales by product group category are:

 

		Quarter Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
(dollars in millions)
Vascular		$	231.5			$	209.9			$	683.7			$	625.3
Urology			209.6				193.7				618.1				574.2
Oncology			229.7				215.5				673.4				636.7
Surgical Specialties			135.6				118.1				410.1				358.4
Other			23.6				20.8				71.1				63.6
		$	830.0			$	758.0			$	2,456.4			$	2,258.2

 

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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 2013 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 and Japan are the company’s largest markets, while certain emerging markets in Asia, Latin America, and 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 nine months ended September 30, 2014, the company’s research and development (“R&D”) expense as a percentage of net sales was 9.1%. 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.

Recent Developments

New Product Approval

On October 10, 2014, the company announced the U.S. Food and Drug Administration (“FDA”) approval of the Lutonix drug coated balloon (“DCB”) catheter for percutaneous transluminal angioplasty (“PTA”) for the treatment of vascular disease of the superficial femoral or popliteal arteries. This approval follows a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in June 2014. The Lutonix DCB, the first and only FDA-approved DCB in the U.S., is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel for the treatment of peripheral arterial disease. The FDA’s approval of the Lutonix DCB was supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized study. Following receipt of regulatory approval, the company launched the Lutonix DCB in the United States and expects to make the contingent milestone payment of $100 million related to this regulatory approval in October 2014. See Note 4 of the notes to condensed consolidated financial statements.

Legal Developments

In the second quarter of 2014, the company recorded an additional charge related to product liability matters, net of estimated recoveries, to other (income) expense, net, of approximately $259.0 million ($236.0 million after tax). See Note 6 of the notes to condensed consolidated financial statements.

Results of Operations

Net Sales

Bard’s consolidated net sales for the quarter ended September 30, 2014 increased 9% on both a reported basis and constant currency basis compared to the same period in the prior year. Bard’s consolidated net sales for the nine months ended September 30, 2014 increased 9% on a reported basis (8% 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 and nine months ended September 30, 2014 by approximately 130 basis points and 110 basis points, respectively, as compared to the same periods in the prior year. Exchange rate fluctuations had a nominal impact on consolidated net sales for the quarter ended September 30, 2014 as compared to the same period in the prior year. Exchange rate fluctuations had the effect of increasing consolidated net sales by approximately one percentage point for the nine months ended September 30, 2014 as compared to the same period in the prior year. The primary exchange rate

 

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movement that impacts net sales is the movement of the Euro compared to the U.S. dollar. The impact of exchange rate movements 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 $565.4 million for the quarter ended September 30, 2014 increased 13% compared to $500.3 million in the prior year quarter. International net sales of $264.6 million for the quarter ended September 30, 2014 increased 3% on a reported basis (1% on a constant currency basis) compared to $257.7 million in the prior year quarter. Bard’s United States net sales of $1,671.9 million for the nine months ended September 30, 2014 increased 12% compared to $1,496.4 million in the prior year period. International net sales of $784.5 million for the nine months ended September 30, 2014 increased 3% on a reported basis (2% on a constant currency basis) compared to $761.8 million in the prior year period.

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

Product Group Summary of Net Sales

 

		Quarter Ended September 30,												Nine Months Ended September 30,
		2014				2013				Change		Constant   Currency		2014				2013				Change		Constant   Currency
(dollars in millions)
Vascular		$	231.5			$	209.9			10%		9%		$	683.7			$	625.3			9%		8%
Urology			209.6				193.7			8%		8%			618.1				574.2			8%		7%
Oncology			229.7				215.5			7%		6%			673.4				636.7			6%		6%
Surgical Specialties			135.6				118.1			15%		15%			410.1				358.4			14%		14%
Other			23.6				20.8			13%		12%			71.1				63.6			12%		11%
Total net sales		$	830.0			$	758.0			9%		9%		$	2,456.4			$	2,258.2			9%		8%

 Vascular Products - Bard markets a wide range of products for the peripheral vascular market, including endovascular products and vascular graft products. In November 2013, Bard sold certain assets and liabilities of its electrophysiology division (the “EP Sale”) to Boston Scientific, Inc., retaining only the guidewire and temporary pacing electrode product lines. Consolidated net sales of vascular products for the quarter ended September 30, 2014 increased 10% on a reported basis (9% on a constant currency basis) compared to the prior year quarter. This increase includes growth of 18 percentage points on both a reported basis and constant currency basis due to a royalty payment from W.L. Gore & Associates Inc. (“Gore”) and a decrease of 14 percentage points on both a reported basis and constant currency basis related to divested electrophysiology products as a result of the EP Sale. Consolidated net sales of vascular products for the nine months ended September 30, 2014 increased 9% on a reported basis (8% on a constant currency basis) compared to the prior year period. This increase includes growth of 18 percentage points on a reported basis (17 percentage points on a constant currency basis) due to royalty payments from Gore and a decrease of 14 percentage points on both a reported basis and constant currency basis related to divested electrophysiology products as a result of the EP Sale. United States net sales of vascular products for the quarter and nine months ended September 30, 2014 increased 32% and 29%, respectively, compared to the prior year periods. These increases in United States net sales for both the quarter and nine months ended September 30, 2014 were primarily due to royalty payments from Gore, offset by divested electrophysiology products as a result of the EP Sale. International net sales of vascular products for the quarter ended September 30, 2014 decreased 14% on a reported basis (16% on a constant currency basis) compared to the prior year quarter. International net sales of vascular products for the nine months ended September 30, 2014 decreased 13% on a reported basis (14% on a constant currency basis) compared to the prior year period. These decreases in international net sales for both the quarter and nine months ended September 30, 2014 were primarily due to divested electrophysiology products as a result of the EP Sale and were partially offset by increases in sales of endovascular products.

Consolidated net sales of endovascular products for the quarter ended September 30, 2014 increased 27% on a reported basis (26% on a constant currency basis) compared to the prior year quarter. This increase includes growth of 24 percentage points on a reported basis (23 percentage points on a constant currency basis) due to a royalty payment from Gore. Consolidated net sales of endovascular products for the nine months ended September 30, 2014 increased 26% on a reported basis (25% on a constant currency basis) compared to the prior year period. This increase includes growth of 24 percentage points on a reported basis (23 percentage points on a constant currency basis) due to royalty payments from Gore. Net sales in this product line for both the quarter and nine months ended September 30, 2014 were also favorably impacted by growth in sales of PTA balloon catheters and biopsy products, partially offset by declines in sales of stents.

Consolidated net sales of vascular graft products for the quarter and nine months ended September 30, 2014 decreased 1% on a reported basis (2% on a constant currency basis) compared to the prior year periods. Declining sales of peripheral vascular grafts and dialysis access grafts were the primary contributors to the decreases in sales for vascular graft products for both the quarter and nine months ended September 30, 2014.

 

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Urology Products - Bard markets a wide range of products for the urology market, including basic drainage products, 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 September 30, 2014 increased 8% on both a reported basis and constant currency basis compared to the prior year quarter. This increase includes 7 percentage points of growth on a reported basis (8 percentage points on a constant currency basis) from the addition of the Rochester Medical, Inc. (“Rochester Medical”) products acquired in November 2013. Consolidated net sales of urology products for the nine months ended September 30, 2014 increased 8% on a reported basis (7% on a constant currency basis) compared to the prior year period, which includes 8 percentage points of growth on a reported basis (7 percentage points on a constant currency basis) from the addition of the Rochester Medical products. Net sales for the quarter and nine months ended September 30, 2014 were also favorably impacted by growth in sales of basic drainage products and were offset by declines in sales of surgical continence products, a trend that may continue. United States net sales of urology products for the quarter ended September 30, 2014 increased 5% compared to the prior year quarter. International net sales of urology products for the quarter ended September 30, 2014 increased 15% on a reported basis (14% on a constant currency basis) compared to the prior year quarter. United States net sales of urology products for the nine months ended September 30, 2014 increased 5% compared to the prior year period. International net sales of urology products for the nine months ended September 30, 2014 increased 13% on a reported basis (12% on a constant currency basis) compared to the prior year period.

Consolidated net sales of basic drainage products for the quarter ended September 30, 2014 increased 7% on a reported basis (6% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of basic drainage products for the nine months ended September 30, 2014 increased 7% on both a reported basis and constant currency basis. These increases were primarily due to sales of the Rochester Medical products.

Consolidated net sales of urological specialty products for the quarter ended September 30, 2014 increased 6% on both a reported basis and constant currency basis compared to the prior year quarter. Consolidated net sales of urological specialty products for the nine months ended September 30, 2014 increased 3% on both a reported basis and constant currency basis compared to the prior year period. These increases were primarily due to sales of the Rochester Medical products offset by declines 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 September 30, 2014 increased 39% on a reported basis (36% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of continence products for the nine months ended September 30, 2014 increased 38% on a reported basis (36% on a constant currency basis) compared to the prior year period. These increases were primarily due to sales of the Rochester Medical products and were partially offset by declines 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 September 30, 2014 decreased 2% on both a reported basis and constant currency basis compared to the prior year quarter. Consolidated net sales of the StatLock^® catheter stabilization product line for the nine months ended September 30, 2014 decreased 1% on both a reported basis and constant currency basis compared to the prior year period.

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, 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 September 30, 2014 increased 7% on a reported basis (6% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of oncology products for the nine months ended September 30, 2014 increased 6% on both a reported basis and constant currency basis compared to the prior year period. These increases were due to growth in sales of PICCs, dialysis access catheters and Ports. United States net sales of oncology products for the quarter ended September 30, 2014 increased 6% compared to the prior year quarter. International net sales of oncology products for the quarter ended September 30, 2014 increased 8% on both a reported basis and constant currency basis compared to the prior year quarter. United States net sales of oncology products for the nine months ended September 30, 2014 increased 5% compared to the prior year period. International net sales of oncology products for the nine months ended September 30, 2014 increased 9% on both a reported basis and constant currency basis compared to the prior year period.

Consolidated net sales of PICCs for the both the quarter and nine months ended September 30, 2014 increased 10% on both a reported basis and constant currency basis compared to the prior year quarter. Consolidated net sales of Ports for the quarter ended September 30, 2014 increased 2% on a reported basis (1% on a constant currency basis) compared to the prior

 

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year quarter. Consolidated net sales of Ports for the nine months ended September 30, 2014 increased 2% on both a reported basis and constant currency basis compared to the prior year period.

Consolidated net sales of dialysis access catheters for the quarter ended September 30, 2014 increased 5% on both a reported basis and constant currency basis compared to the prior year quarter. Consolidated net sales of dialysis access catheters for the nine months ended September 30, 2014 increased 8% on both a reported basis and constant currency basis compared to the prior year period. Consolidated net sales of vascular access ultrasound devices for the quarter ended September 30, 2014 increased 16% on both a reported basis and constant currency basis compared to the prior year quarter. Consolidated net sales of vascular access ultrasound devices for the nine months ended September 30, 2014 increased 1% on both a reported basis and constant currency basis compared to the prior year period. These increases in sales of vascular access ultrasound devices were primarily due to the variable nature of ultrasound systems sales and the timing of new product launches.

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 September 30, 2014 increased 15% on both a reported basis and constant currency basis compared to the prior year quarter. This increase includes 12 percentage points of growth on both a reported basis and constant currency basis from the addition of the Arista^® MHP hemostat product (“Arista”) through the acquisition of Medafor, Inc. in October 2013. Consolidated net sales of surgical specialty products for the nine months ended September 30, 2014 increased 14% on both a reported basis and constant currency basis compared to the prior year period, which includes 10 percentage points of growth on both a reported basis and constant currency basis from the addition of Arista. Net sales for the quarter and nine months ended September 30, 2014 were also favorably impacted by growth in sales of synthetic hernia repair products and were partially offset by declines in sales of natural tissue hernia repair products, performance irrigation products and hernia fixation products, trends that may continue. United States net sales of surgical specialty products for the quarter ended September 30, 2014 increased 16% compared to the prior year quarter. United States net sales of surgical specialty products for the nine months ended September 30, 2014 increased 14% compared to the prior year period. These increases in United States net sales were primarily due to sales of Arista and growth in sales of synthetic hernia repair products. These increases were offset by declines in sales of natural tissue hernia repair products, performance irrigation products, and hernia fixation products, trends that may continue. International net sales of surgical specialty products for the quarter ended September 30, 2014 increased 12% on a reported basis (11% on a constant currency basis) compared to the prior year quarter. International net sales of surgical specialty products for the nine months ended September 30, 2014 increased 15% on both a reported basis and constant currency basis compared to the prior year period. These increases in international net sales were primarily due to an increase in sales of synthetic hernia repair products and sales of Arista.

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 September 30, 2014 increased 6% on both a reported basis and constant currency basis compared to the prior year quarter. Consolidated net sales of soft tissue repair products for the nine months ended September 30, 2014 increased 5% on both a reported basis and constant currency basis compared to the prior year period. Net sales in this product line were favorably impacted by growth in sales of synthetic hernia repair products. This growth was partially offset by declines in sales of natural tissue hernia repair products and hernia fixation products, trends that may continue.

Other Products - The other product group includes irrigation, wound drainage and certain original equipment manufacturers’ products. Consolidated net sales of other products for the quarter ended September 30, 2014 increased 13% on a reported basis (12% on a constant currency basis) compared to the prior year quarter. This increase includes 9 percentage points of growth on both a reported basis and constant currency basis from the Rochester Medical products. Consolidated net sales of other products for the nine months ended September 30, 2014 increased 12% on a reported basis (11% on a constant currency basis) compared to the prior year period. This increase includes 12 percentage points of growth on a reported basis (11 percentage points on a constant currency basis) from the Rochester Medical products.

Costs and Expenses

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

 

		Quarter Ended September 30,								Nine Months Ended September 30,
		2014(A)				2013				2014				2013
Cost of goods sold			37.2%				38.5%				38.2%				39.1%
Marketing, selling and administrative expense			29.2%				29.5%				29.5%				29.5%
Research and development expense			8.8%				13.1%				9.1%				10.0%

 

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		Quarter Ended September 30,								Nine Months Ended September 30,
		2014(A)				2013				2014				2013
Interest expense			1.3%				1.5%				1.4%				1.5%
Other (income) expense, net			1.7%				1.7%				10.8%				15.0%
Total costs and expenses			78.3%				84.3%				89.0%				95.1%

 

^(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 and nine months ended September 30, 2014 decreased 130 basis points and 90 basis points, respectively, compared to the prior year periods primarily due to the impact of the royalty payments from Gore. Incremental amortization of intangible assets acquired in 2014 and 2013 increased cost of goods sold as a percentage of net sales by approximately 70 basis points over the prior year quarter and nine month 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 September 30, 2014 decreased 30 basis points compared to the prior year quarter. These costs as a percentage of net sales for the nine months ended September 30, 2014 were flat compared to the prior year period.

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 September 30, 2014 was $73.1 million, a decrease of approximately 26% compared to the prior year quarter. Research and development expense for the nine months ended September 30, 2014 was $222.8 million, a decrease of approximately 1% compared to the prior year period. Included in research and development expense for the quarter and nine months ended September 30, 2014 was a charge of $6.2 million related to the impairment of an IPR&D project, resulting from changes in cash flow assumptions. In addition, research and development expense for the nine months ended September 30, 2014 reflected a charge of $20.7 million primarily related to the change in the fair value of the liability for contingent consideration related to the Lutonix, Inc. acquisition. Charges of $29.5 million related to the acquisition of early stage technology and $3.4 million related to the impairment of an IPR&D project were recorded for the quarter and nine months ended September 30, 2013.

Interest expense - Interest expense was $11.2 million for the quarters ended September 30, 2014 and 2013, respectively. Interest expense was $33.6 million and $33.7 million for the nine months ended September 30, 2014 and 2013, respectively.

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

 

		Quarter Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
(dollars in millions)
Interest income		$	(0.3)			$	(0.3)			$	(1.7)			$	(0.9)
Foreign exchange losses (gains)			1.1				1.7				(0.1)				4.5
Litigation charges, net			13.2				—				275.9				318.2
Gain on sale of investment			—				—				(7.1)				—
Restructuring and productivity initiative costs			1.7				—				1.7				(1.4)
Divestiture-related charges			—				9.7				—				9.7
Asset impairments			—				—				—				6.4
Other, net			(1.2)				1.5				(2.9)				2.1
Total other (income) expense, net		$	14.5			$	12.6			$	265.8			$	338.6

Litigation charges, net – For the quarter ended September 30, 2014, the amount reflects litigation-related defense costs of $13.2 million in connection with the District Court’s pre-trial orders to prepare 500 individual cases for trial (the “WHP Pre-Trial Orders”). For the nine months ended September 30, 2014, the amount reflects the estimated costs for product liability matters, net of recoveries, and litigation-related defense costs of $17.4 million in connection with the WHP Pre-Trial Orders.

 

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For the nine months ended September 30, 2013, the amount reflects the estimated costs for product liability matters, net of recoveries, and a write-down of an insurance receivable. See Note 6 of the notes to condensed consolidated financial statements.

Gain on sale of investment – For the nine months ended September 30, 2014, the amount reflects the sale of an equity investment in an e-commerce technology company.

Restructuring and productivity initiative costs – For the quarter and nine months ended September 30, 2014, the amounts reflect costs incurred in connection with a productivity initiative to streamline certain general and administrative functions to better align resources to the company’s business strategies. Key activities under this initiative may include systems enhancements and the implementation of shared services centers designed to standardize and centralize certain functions. 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. For the nine months ended September 30, 2013, the amount reflects the reversal of certain restructuring costs recognized during the fourth quarter of 2012.

Divestiture-related charges – For the quarter and nine months ended September 30, 2013, the amounts reflect charges incurred in connection with the EP Sale including transaction costs, primarily consisting of legal costs, and other separation costs, including employee termination and consulting costs.

Asset impairments – For the nine months ended September 30, 2013, the amount reflects charges for the write-down of certain core technologies.

Income Tax Provision

The effective tax rate for both the quarter and nine months ended September 30, 2014 reflected the discrete tax effect of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction. The effective tax rate for the current nine month period also 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.

The effective tax rate for the quarter and nine months ended September 30, 2013 reflected the discrete tax effects of an IPR&D charge related to the acquisition of 3DT Holdings LLC, which was incurred in a high tax jurisdiction, and a benefit associated with the remeasurement of an uncertain tax position as a result of a legal settlement. The effective tax rate for the nine months ended September 30, 2013 also reflected the discrete tax effects of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction, and a write-down of an insurance receivable, which was also incurred in a low tax jurisdiction. See Note 6 of the notes to condensed consolidated financial statements. In addition, the tax provision for the nine months ended September 30, 2013 was reduced by approximately $3.7 million to recognize the 2012 benefit of the American Taxpayer Relief Act of 2012, which was signed into law on January 2, 2013 and retroactively reinstated the research tax credit.

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 September 30, 2014 of $131.3 million and $1.69, respectively. Net income and diluted earnings per share available to common shareholders for the prior year quarter were $93.2 million and $1.15, respectively. The current year quarter reflects amortization of intangible assets of $17.7 million, or $0.23 per diluted share, litigation charges of $14.4 million, or $0.18 per diluted share, an asset impairment of $3.9 million, or $0.05 per diluted share, a net benefit from acquisition-related items (primarily consisting of purchase accounting adjustments) of $1.5 million, or $0.02 per diluted share, and restructuring and productivity initiative costs of $1.1 million, or $0.01 per diluted share. The prior year quarter reflects charges from acquisition-related items (primarily consisting of an IPR&D charge and transaction costs) of $22.9 million, or $0.28 per diluted share, amortization of intangible assets of $14.2 million, or $0.18 per diluted share, divestiture-related charges of $6.2 million, or $0.08 per diluted share, and an asset impairment of $2.2 million, or $0.03 per diluted share. The prior year quarter also reflects a $2.2 million, or $0.03 per diluted share, benefit to the income tax provision associated with the remeasurement of an uncertain tax position as a result of a legal settlement.

The company reported net income and diluted earnings per share available to common shareholders for the nine months ended September 30, 2014 of $160.3 million and $2.04, respectively. Net income and diluted earnings per share available to common shareholders for the nine months ended September 30, 2013 were $22.3 million and $0.27, respectively. The current year nine month period reflects litigation charges, net, of $254.7 million, or $3.24 per diluted share, amortization of intangible assets of $53.1 million, or $0.68 per diluted share, net charges from acquisition-related items (primarily consisting of purchase accounting adjustments, integration costs and transaction costs) of $22.9 million, or $0.29 per diluted share, a gain on sale of an equity investment of $4.9 million, or $0.06 per diluted share, an asset impairment of $3.9 million or $0.05 per diluted share, and restructuring and productivity initiative costs of $1.1 million or $0.01 per diluted share. The current year nine

 

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month period 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. The prior year nine month period reflects litigation charges, net, of $300.1 million, or $3.63 per diluted share, amortization of intangible assets of $43.3 million, or $0.52 per diluted share, charges from acquisition-related items (primarily consisting of IPR&D charges, transaction costs and purchase accounting adjustments) of $25.3 million, or $0.31 per diluted share, asset impairments of $9.5 million, or $0.12 per diluted share, divestiture-related charges of $6.2 million, or $0.08 per diluted share, and a reversal of certain restructuring costs of $1.0 million, or $0.01 per diluted share. The prior year nine month period also reflects a $2.2 million, or $0.03 per diluted share, benefit to the income tax provision associated with the remeasurement of an uncertain tax position as a result of a legal settlement.

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 September 30, is as follows:

 

		2014				2013
(dollars in millions)
Working capital		$	1,386.2			$	1,246.9
Current ratio			3.15/1				3.47/1

Cash and cash equivalents held by the company’s foreign subsidiaries were $965.1 million and $874.0 million at September 30, 2014 and December 31, 2013, 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 nine months ended September 30, 2014 and 2013, net cash provided by operating activities was $538.4 million and $417.0 million, respectively. The increase in net cash provided by operating activities reflects improvements in accounts receivable collections in the current year period, a settlement payment for a certain legal matter in the prior year period and higher payments to claimants for certain product liability matters in the prior year period. These increases were partially offset by the timing of tax payments in the current year period.

For the nine months ended September 30, 2014 and 2013, net cash used by investing activities was $145.0 million and $107.9 million, respectively. Capital expenditures were approximately $90.0 million and $47.3 million for the nine month periods ended September 30, 2014 and 2013, respectively. The current year reflects an increase of $51.7 million in restricted cash related to payments to qualified settlement funds for certain product liability matters. The company spent $10.4 million and $68.5 million for the acquisition of businesses, products and technology to augment existing product lines for the nine months ended September 30, 2014 and 2013, respectively. In addition, the company received proceeds from the sale of an investment of $7.1 million during the nine months ended September 30, 2014.

For the nine months ended September 30, 2014, the company used $485.8 million in cash for financing activities, compared to the $415.8 million used in the prior year period. Total debt was $1.4 billion at both September 30, 2014 and December 31, 2013, respectively. Total debt to total capitalization was 43.4% and 40.2% at September 30, 2014 and December 31, 2013, respectively. Net cash used in financing activities reflects $526.1 million used to repurchase 3,712,560 shares of common stock in the nine months ended September 30, 2014 compared to approximately $546.9 million to repurchase 5,110,235 shares of common stock in the prior year period. The company paid cash dividends of $0.64 per share and $0.61 per share for the nine months ended September 30, 2014 and 2013, respectively.

The company maintains a $750 million five-year committed syndicated bank credit facility that expires in September 2018. 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 rating and includes a financial covenant that limits the amount of total debt to total capitalization. At September 30, 2014, the company was in compliance with this covenant. There were no commercial paper borrowings outstanding at September 30, 2014 or December 31, 2013, respectively.

 

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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.

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 2013 Annual Report on Form 10-K. There have been no significant changes to the company’s critical accounting policies since December 31, 2013.

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 2013 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 2013 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;

 

•

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 related to Gore’s infringing sales;

 

•

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 product liability insurance on reasonable terms;

 

•

the ability to recover for claims made to our insurance companies; 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 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;

 

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

 

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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;

 

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

 

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

 

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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;

 

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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;

 

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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

 

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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:

 

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the impact of continued healthcare cost containment;

 

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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 more vigorous compliance and enforcement activities affecting the healthcare industry in general or the company in particular;

 

•

changes in the 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 the environmental laws or standards affecting our business;

 

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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, including our patent infringement suit against Gore, the outcome of the Gore matters and the timing of final resolution of the Gore matters;

 

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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, 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 other countries in Europe.

Other factors beyond our control, including catastrophes, both natural and man-made, earthquakes, floods, fires, explosions, 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 2013 Annual Report on Form 10-K. There have been no material changes in the information reported since the year ended December 31, 2013.

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 September 30, 2014. Based upon that evaluation, the company’s Chief Executive Officer and Chief Financial Officer have concluded that, as of September 30, 2014, 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 September 30, 2014 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 October 9, 2014, approximately 230 federal and 110 state lawsuits involving individual claims by approximately 335 plaintiffs, as well as two putative class actions 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. One of the U.S. putative class action lawsuits consolidated ten previously-filed U.S. class action lawsuits. 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 the third quarter of 2013, a settlement was reached with respect to the three pending putative Canadian class actions within amounts previously recorded by the company and were fully resolved in April 2014. Approximately 90 of the state lawsuits, involving individual claims by approximately 90 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.

On June 30, 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. 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 lawsuits, 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 October 9, 2014, product liability lawsuits involving individual claims by approximately 13,525 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 four putative class actions in Canada have been filed against the company (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. With respect to approximately half of the filed and asserted Women’s Health Product Claims, the company believes that one of its suppliers has 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 July 2012 and resulted in a judgment against the company of approximately $3.6 million. The company has appealed this decision and oral

 

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argument is scheduled for October 23, 2014. The first trial in the MDL commenced in July 2013 and resulted in a verdict against the company of approximately $2 million. The company intends to appeal the judgment. 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, the District Court ordered that the company prepare 200 individual cases for trial (the timing for which is currently unknown), which resulted in additional cost beginning in the second quarter of 2014. On July 31, 2014, the District Court ordered that the Company prepare an additional 300 individual cases for trial, which has resulted in additional cost beginning in the third quarter of 2014. These pre-trial orders are expected to result in material additional cost in 2014 and 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 costs 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 its supplier’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 its supplier’s indemnification obligation. 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. While no MDL trials are scheduled for the remainder of 2014, the company anticipates that multiple additional trials, including a possible consolidated trial, may occur in early 2015.

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 895 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 2,445 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 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 October 9, 2014, product liability lawsuits involving individual claims by 50 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. In addition, three putative class actions were filed against the company in various state courts on behalf of plaintiffs who are alleged to have no present injury (all lawsuits, collectively, the “Filter Product Claims”). Two of these putative class actions were dismissed during the second quarter of 2013, and class certification was denied for the third putative class action in July 2013. The first Filter Product Claim trial was completed in June 2012 and resulted in a judgment for the company. The company expects additional trials of Filter Product Claims to take place over the next 12 months. 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. While the company intends to vigorously defend the remaining unsettled Filter Product Claims, 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 of this nature, 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. When this occurs, the company intends to vigorously contest disputes with respect to its insurance coverage and to enforce its rights under the terms of its insurance policies, and accordingly, will record receivables with respect to amounts due under these policies, 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

 

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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. In the first quarter of 2013 the company recorded a non-cash charge of $25.0 million ($24.5 million after tax) to other (income) expense, net, for the write-down of an insurance receivable related to a dispute with one of its excess insurance carriers in connection with these 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 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 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. The Court of Appeals heard oral argument on Gore’s appeal of the District Court’s rulings on August 8, 2014. A decision on this matter is pending.

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

 

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addition, the company received $38.0 million from Gore in July 2014 representing Gore’s calculation of royalties for its infringing sales for the quarter ended June 30, 2014. This royalty payment was recorded to revenue in the third quarter of 2014. Royalty payments of $113.2 million were recorded to revenue for the nine months ended September 30, 2014. The company has received cumulative proceeds from Gore of $1,007.5 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 awarded by the District Court due to Gore’s willfulness as a contingent gain.

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 historic levels.

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 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 2013 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 September 30, 2014:

 

		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)
July 1 – July 31, 2014			11,511			$	145.70				—			$	528,647,500
August 1 – August 31, 2014			799				148.90				—				528,647,500
September 1 – September 30, 2014			1,177				147.06				—				528,647,500
Total			13,487			$	146.01				—			$	528,647,500

 

(1)	These shares were purchased from employees to satisfy tax withholding requirements on the vesting of restricted shares from equity-based awards and were not part of publicly-announced share repurchase authorizations.

(2)	On January 30, 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. On June 11, 2014, the Board of Directors authorized the repurchase of up to an additional $500 million of common stock.

 

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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: October 23, 2014
						/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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