UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
   
þ 
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
for the quarterly period ended July 3, 20162, 2017
or
   
o 
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
for the transition period from            to
Commission file number 1-3215
jnjlogoa03a01a01a01a01a07.jpg
(Exact name of registrant as specified in its charter)
NEW JERSEY
(State or other jurisdiction of
incorporation or organization)
 
22-1024240
(I.R.S. Employer
Identification No.)

One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
(Address of principal executive offices)
Registrant’s telephone number, including area code (732) 524-0400
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. þ Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). þ Yes o 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, or an emerging growth company. See the definitions of “large accelerated filer”,filer,” “accelerated filer” andfiler,” “smaller reporting company”company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer þ
 
Accelerated filer o
 
Non-accelerated filer o
Smaller reporting company o
 (Do not check if a smaller reporting company) 
Smaller reporting company o
Emerging growth company o
 

If an emerging growth company, indicated by check mark if the registrant has elected not to use the extended transition  period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes þ No
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
On July 29, 2016, 2,735,876,84328, 2017, 2,683,999,728 shares of Common Stock, $1.00 par value, were outstanding.



JOHNSON & JOHNSON AND SUBSIDIARIES
TABLE OF CONTENTS
  Page
  No.
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
 EX-31.1
 EX-32.1
 EX-101 INSTANCE DOCUMENT
 EX-101 SCHEMA DOCUMENT
 EX-101 CALCULATION LINKBASE DOCUMENT
 EX-101 LABELS LINKBASE DOCUMENT
 EX-101 PRESENTATION LINKBASE DOCUMENT
 EX-101 DEFINITION LINKBASE DOCUMENT





CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q and Johnson & Johnson's other publicly available documents contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Management and representatives of Johnson & Johnson and its subsidiaries (the Company) also may from time to time make forward-looking statements. Forward-looking statements do not relate strictly to historical or current facts and reflect management’s assumptions, views, plans, objectives and projections about the future. Forward-looking statements may be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” “intends,” and other words of similar meaning in conjunction with, among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; expected savings from restructuring activities; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures.
Because forward-looking statements are based on current beliefs, expectations and assumptions regarding future events, they are subject to uncertainties, risks and changes that are difficult to predict and many of which are outside of the Company's control. Investors should realize that if underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, the Company’s actual results and financial condition could vary materially from expectations and projections expressed or implied in its forward-looking statements. Investors are therefore cautioned not to rely on these forward-looking statements. Risks and uncertainties include, but are not limited to:
Risks Related to Product Development, Market Success and Competition
Challenges and uncertainties inherent in innovation and development of new and improved products and technologies on which the Company’s continued growth and success depend, including uncertainty of clinical outcomes, obtaining regulatory approvals, health plan coverage and customer access, and initial and continued commercial success;
Challenges to the Company’s ability to obtain and protect adequate patent and other intellectual property rights for new and existing products and technologies in the U.S. and other important markets;
The impact of patent expirations, typically followed by the introduction of competing biosimilars and generics and resulting revenue and market share losses;
Increasingly aggressive and frequent challenges to the Company’s patents by competitors and others seeking to launch competing generic, biosimilar or other products, potentially resulting in loss of market exclusivity and rapid decline in sales for the relevant product;
Competition in research and development of new and improved products, processes and technologies, which can result in product and process obsolescence;
Competition to reach agreement with third parties for collaboration, licensing, development and marketing agreements for products and technologies;
Competition on the basis of cost-effectiveness, product performance, technological advances and patents attained by competitors; and
Allegations that the Company’s products infringe the patents and other intellectual property rights of third parties, which could adversely affect the Company’s ability to sell the products in question and require the payment of money damages and future royalties.
Risks Related to Product Liability, Litigation and Regulatory Activity
Product efficacy or safety concerns, whether or not based on scientific evidence, potentially resulting in product withdrawals, recalls, regulatory action on the part of the U.S. Food and Drug Administration (or international counterparts), declining sales and reputational damage;
Impact of significant litigation or government action adverse to the Company, including product liability claims;
Increased scrutiny of the health care industry by government agencies and state attorneys general resulting in investigations and prosecutions, which carry the risk of significant civil and criminal penalties, including, but not limited to, debarment from government business;
Failure to meet compliance obligations in the McNEIL-PPC, Inc. Consent Decree or the Corporate Integrity Agreements of the Johnson & Johnson Pharmaceutical Affiliates, or any other compliance agreements with governments or government agencies, which could result in significant sanctions;
Potential changes to applicable laws and regulations affecting U.S. and international operations, including relating to: approval of new products; licensing and patent rights; sales and promotion of health care products; access to, and reimbursement and pricing for, health care products and services; environmental protection and sourcing of raw materials;



Changes in tax laws and regulations, increasing audit scrutiny by tax authorities around the world and exposures to additional tax liabilities potentially in excess of reserves; and
Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the Securities and Exchange Commission.
Risks Related to the Company’s Strategic Initiatives and Health Care Market Trends
Pricing pressures resulting from trends toward health care cost containment, including the continued consolidation among health care providers, trends toward managed care and the shift toward governments increasingly becoming the primary payers of health care expenses;
Restricted spending patterns of individual, institutional and governmental purchasers of health care products and services due to economic hardship and budgetary constraints;
Challenges to the Company’s ability to realize its strategy for growth including through externally sourced innovations, such as development collaborations, strategic acquisitions, licensing and marketing agreements, and the potential heightened costs of any such external arrangements due to competitive pressures;
The potential that the expected strategic benefits and opportunities from any planned or completed acquisition or divestiture by the Company, including the acquisition of Actelion Ltd., may not be realized or may take longer to realize than expected; and
The potential that the expected benefits and opportunities related to the restructuring actions in the Medical Device segment may not be realized or may take longer to realize than expected, including due to any required consultation procedures relating to restructuring of workforce.
Risks Related to Economic Conditions, Financial Markets and Operating Internationally
Impact of inflation and fluctuations in interest rates and currency exchange rates and the potential effect of such fluctuations on revenues, expenses and resulting margins;
Potential changes in export/import and trade laws, regulations and policies of the U.S., U.K. and other countries, including any increased trade restrictions and potential drug reimportation legislation;
The impact on international operations from financial instability in international economies, sovereign risk, possible imposition of governmental controls and restrictive economic policies, and unstable international governments and legal systems;
Global climate changes, extreme weather and natural disasters that could affect demand for the Company's products and services, cause disruptions in manufacturing and distribution networks, alter the availability of goods and services within the supply chain, and affect the overall design and integrity of the Company's products and operations; and
The impact of armed conflicts and terrorist attacks in the U.S. and other parts of the world including social and economic disruptions and instability of financial and other markets.
Risks Related to Supply Chain and Operations
Difficulties and delays in manufacturing, internally or within the supply chain, that may lead to voluntary or involuntary business interruptions or shutdowns, product shortages, withdrawals or suspensions of products from the market, and potential regulatory action;
Interruptions and breaches of the Company's information technology systems, and those of the Company's vendors, potentially resulting in reputational, competitive, operational or other business harm as well as financial costs and regulatory action; and
Reliance on global supply chains and production and distribution processes that are complex and subject to increasing regulatory requirements that may adversely affect supply, sourcing and pricing of materials used in the Company’s products.
Investors also should carefully read the Risk Factors described in Item 1A of the Company's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, for a description of certain risks that could, among other things, cause the Company’s actual results to differ materially from those expressed in its forward-looking statements. Investors should understand that it is not possible to identify or predict all potential risks and uncertainties. The Company does not undertake to publicly update any forward-looking statement that may be made from time to time, whether as a result of new information or future events or developments.



Table of Contents

Part I — FINANCIAL INFORMATION

Item 1 — FINANCIAL STATEMENTS

JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions Except Share and Per Share Data)

 July 3, 2016 January 3, 2016 July 2, 2017 January 1, 2017
ASSETS
Current assets:        
Cash and cash equivalents $18,640
 13,732
 $12,598
 18,972
Marketable securities 23,944
 24,644
 255
 22,935
Accounts receivable, trade, less allowances for doubtful accounts $270 (2015, $268) 12,062
 10,734
Accounts receivable, trade, less allowances for doubtful accounts $292 (2016, $252) 13,283
 11,699
Inventories (Note 2) 8,523
 8,053
 9,699
 8,144
Prepaid expenses and other 3,122
 3,047
 2,954
 3,282
Total current assets 66,291
 60,210
 38,789
 65,032
Property, plant and equipment at cost 37,779
 36,648
 40,075
 37,773
Less: accumulated depreciation (21,807) (20,743) (23,617) (21,861)
Property, plant and equipment, net 15,972
 15,905
 16,458
 15,912
Intangible assets, net (Note 3) 25,694
 25,764
 54,942
 26,876
Goodwill (Note 3) 22,104
 21,629
 31,234
 22,805
Deferred taxes on income 5,776
 5,490
 6,111
 6,148
Other assets 3,977
 4,413
 5,273
 4,435
Total assets $139,814
 133,411
 $152,807
 141,208
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:        
Loans and notes payable $1,708
 7,004
 $7,209
 4,684
Accounts payable 6,061
 6,668
 6,135
 6,918
Accrued liabilities 5,650
 5,411
 6,076
 5,635
Accrued rebates, returns and promotions 5,259
 5,440
 6,319
 5,403
Accrued compensation and employee related obligations 2,168
 2,474
 2,374
 2,676
Accrued taxes on income 690
 750
 759
 971
Total current liabilities 21,536
 27,747
 28,872
 26,287
Long-term debt (Note 4) 24,535
 12,857
 27,363
 22,442
Deferred taxes on income 2,849
 2,562
 4,846
 2,910
Employee related obligations 8,359
 8,854
 9,687
 9,615
Other liabilities 10,062
 10,241
 10,117
 9,536
Total liabilities 67,341
 62,261
 80,885
 70,790
Shareholders’ equity:        
Common stock — par value $1.00 per share (authorized 4,320,000,000 shares; issued 3,119,843,000 shares) $3,120
 3,120
 $3,120
 3,120
Accumulated other comprehensive income (loss) (Note 7) (12,707) (13,165) (13,234) (14,901)
Retained earnings 106,738
 103,879
 113,208
 110,551
Less: common stock held in treasury, at cost (382,189,000 and 364,681,000 shares) 24,678
 22,684
Less: common stock held in treasury, at cost (434,653,000 and 413,332,000 shares) 31,172
 28,352
Total shareholders’ equity 72,473
 71,150
 71,922
 70,418
Total liabilities and shareholders' equity $139,814
 133,411
 $152,807
 141,208
See Notes to Consolidated Financial Statements

JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)
 Fiscal Second Quarters Ended Fiscal Second Quarters Ended
 July 3,
2016
 
Percent
to Sales
 June 28,
2015
 
Percent
to Sales
 July 2,
2017
 
Percent
to Sales
 July 3,
2016
 
Percent
to Sales
Sales to customers (Note 9) $18,482
 100.0 % $17,787
 100.0 % $18,839
 100.0 % $18,482
 100.0 %
Cost of products sold 5,336
 28.9
 5,357
 30.1
 5,823
 30.9
 5,336
 28.9
Gross profit 13,146
 71.1
 12,430
 69.9
 13,016
 69.1
 13,146
 71.1
Selling, marketing and administrative expenses 5,176
 28.0
 5,384
 30.3
 5,262
 28.0
 5,176
 28.0
Research and development expense 2,264
 12.2
 2,129
 12.0
 2,285
 12.1
 2,264
 12.2
In-process research and development 29
 0.2
 
 
 
 
 29
 0.2
Interest income (88) (0.5) (24) (0.1) (105) (0.6) (88) (0.5)
Interest expense, net of portion capitalized 190
 1.1
 131
 0.7
 227
 1.2
 190
 1.1
Other (income) expense, net 557
 3.0
 (931) (5.3) 588
 3.1
 557
 3.0
Restructuring (Note 12) 114
 0.6
 
 
 11
 0.1
 114
 0.6
Earnings before provision for taxes on income 4,904
 26.5
 5,741
 32.3
 4,748
 25.2
 4,904
 26.5
Provision for taxes on income (Note 5) 907
 4.9
 1,225
 6.9
 921
 4.9
 907
 4.9
NET EARNINGS $3,997
 21.6 % $4,516
 25.4 % $3,827
 20.3 % $3,997
 21.6 %
                
NET EARNINGS PER SHARE (Note 8)                
Basic $1.46
   $1.63
   $1.42
   $1.46
  
Diluted $1.43
   $1.61
   $1.40
   $1.43
  
CASH DIVIDENDS PER SHARE $0.80
   $0.75
   $0.84
   $0.80
  
AVG. SHARES OUTSTANDING                
Basic 2,745.4
   2,772.3
   2,691.9
   2,745.4
  
Diluted 2,794.2
   2,812.0
   2,741.5
   2,794.2
  
See Notes to Consolidated Financial Statements


JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)

                
 Fiscal Six Months Ended Fiscal Six Months Ended
 July 3,
2016
 
Percent
to Sales
 June 28,
2015
 
Percent
to Sales
 July 2,
2017
 
Percent
to Sales
 July 3,
2016
 
Percent
to Sales
Sales to customers (Note 9) $35,964
 100.0 % $35,161
 100.0 % $36,605
 100.0 % $35,964
 100.0 %
Cost of products sold 10,665
 29.6
 10,639
 30.2
 11,209
 30.6
 10,665
 29.6
Gross profit 25,299
 70.4
 24,522
 69.8
 25,396
 69.4
 25,299
 70.4
Selling, marketing and administrative expenses 9,864
 27.4
 10,231
 29.1
 9,999
 27.3
 9,864
 27.4
Research and development expense 4,277
 11.9
 4,028
 11.5
 4,345
 11.9
 4,277
 11.9
In-process research and development 29
 0.1
 
 
 
 
 29
 0.1
Interest income (171) (0.5) (43) (0.1) (226) (0.6) (171) (0.5)
Interest expense, net of portion capitalized 350
 1.0
 269
 0.7
 431
 1.2
 350
 1.0
Other (income) expense, net 518
 1.4
 (1,279) (3.6) 428
 1.2
 518
 1.4
Restructuring expense (Note 12) 234
 0.7
 
 
 96
 0.2
 234
 0.7
Earnings before provision for taxes on income 10,198
 28.4
 11,316
 32.2
 10,323
 28.2
 10,198
 28.4
Provision for taxes on income (Note 5) 1,744
 4.9
 2,480
 7.1
 2,074
 5.7
 1,744
 4.9
NET EARNINGS $8,454
 23.5 % $8,836
 25.1 % $8,249
 22.5 % $8,454
 23.5 %
                
NET EARNINGS PER SHARE (Note 8)                
Basic $3.07
   $3.18
   $3.06
   $3.07
  
Diluted $3.02
   $3.13
   $3.00
   $3.02
  
CASH DIVIDENDS PER SHARE $1.55
   $1.45
   $1.64
   $1.55
  
AVG. SHARES OUTSTANDING                
Basic 2,751.4
   2,777.7
   2,699.3
   2,751.4
  
Diluted 2,800.9
   2,821.0
   2,749.4
   2,800.9
  
                
See Notes to Consolidated Financial Statements


JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited; Dollars in Millions)

Fiscal Second Quarters Ended Fiscal Six Months EndedFiscal Second Quarters Ended Fiscal Six Months Ended
July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016
              
Net earnings$3,997
 4,516
 8,454
 8,836
$3,827
 3,997
 8,249
 8,454
              
Other comprehensive income (loss), net of tax              
Foreign currency translation(295) 903
 584
 (1,660)843
 (295) 1,238
 584
              
Securities:              
Unrealized holding gain (loss) arising during period156
 196
 100
 311
47
 156
 136
 100
Reclassifications to earnings(12) (24) (94) (81)(14) (12) (193) (94)
Net change144
 172
 6
 230
33
 144
 (57) 6
              
Employee benefit plans:              
Prior service cost amortization during period(6) (6) (10) (11)(5) (6) (9) (10)
Gain (loss) amortization during period101
 159
 207
 318
123
 101
 246
 207
Net change95
 153
 197
 307
118
 95
 237
 197
              
Derivatives & hedges:              
Unrealized gain (loss) arising during period(250) 61
 (441) (134)154
 (250) (70) (441)
Reclassifications to earnings(10) (43) 112
 (75)140
 (10) 319
 112
Net change(260) 18
 (329) (209)294
 (260) 249
 (329)
              
Other comprehensive income (loss)(316) 1,246
 458
 (1,332)1,288
 (316) 1,667
 458
              
Comprehensive income$3,681
 5,762
 8,912
 7,504
$5,115
 3,681
 9,916
 8,912
              
              
See Notes to Consolidated Financial Statements

The tax effects in other comprehensive income for the fiscal second quarters were as follows for 20162017 and 2015,2016, respectively: Securities: $77$17 million and $92$77 million; Employee Benefit Plans: $56$60 million and $75$56 million; Derivatives & Hedges: $140$158 million and $9$140 million.
 
The tax effects in other comprehensive income for the fiscal six months were as follows for 20162017 and 2015,2016, respectively: Securities: $3$31 million and $124$3 million; Employee Benefit Plans: $104$120 million and $151$104 million; Derivatives & Hedges: $177$134 million and $113$177 million.
 

JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
  Fiscal Six Months Ended
  July 3,
2016
 June 28,
2015
CASH FLOWS FROM OPERATING ACTIVITIES    
Net earnings $8,454
 8,836
Adjustments to reconcile net earnings to cash flows from operating activities:    
Depreciation and amortization of property and intangibles 1,791
 1,784
Stock based compensation 479
 474
Asset write-downs 187
 11
Net gain on sale of assets/businesses (185) (1,034)
Deferred tax provision 115
 284
Accounts receivable allowances (4) 5
Changes in assets and liabilities, net of effects from acquisitions and divestitures:    
Increase in accounts receivable (1,098) (1,186)
Increase in inventories (443) (537)
Decrease in accounts payable and accrued liabilities (1,047) (1,931)
(Increase)/Decrease in other current and non-current assets (630) 602
(Decrease)/Increase in other current and non-current liabilities (866) 1,036
     
NET CASH FLOWS FROM OPERATING ACTIVITIES 6,753
 8,344
     
CASH FLOWS FROM INVESTING ACTIVITIES    
Additions to property, plant and equipment (1,396) (1,308)
Proceeds from the disposal of assets/businesses, net 685
 1,193
Acquisitions, net of cash acquired (730) (233)
Purchases of investments (17,511) (20,813)
Sales of investments 18,775
 15,829
Other (38) (11)
     
NET CASH USED BY INVESTING ACTIVITIES (215) (5,343)
     
CASH FLOWS FROM FINANCING ACTIVITIES    
Dividends to shareholders (4,266) (4,025)
Repurchase of common stock (4,751) (3,094)
Proceeds from short-term debt 118
 1,024
Retirement of short-term debt (4,687) (345)
Proceeds from long-term debt, net of issuance costs 11,951
 3
Retirement of long-term debt (936) (21)
Proceeds from the exercise of stock options/employee withholding tax on stock awards, net 929
 506
Other 
 (50)
     
NET CASH USED BY FINANCING ACTIVITIES (1,642) (6,002)
     
Effect of exchange rate changes on cash and cash equivalents 12
 (883)
Increase/(Decrease) in cash and cash equivalents 4,908
 (3,884)
Cash and Cash equivalents, beginning of period 13,732
 14,523
CASH AND CASH EQUIVALENTS, END OF PERIOD $18,640
 10,639
     
Acquisitions    
Fair value of assets acquired $744
 477
Fair value of liabilities assumed and noncontrolling interests (14) (244)
Net cash paid for acquisitions 730
 233
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
  Fiscal Six Months Ended
  July 2,
2017
 July 3,
2016
CASH FLOWS FROM OPERATING ACTIVITIES    
Net earnings $8,249
 8,454
Adjustments to reconcile net earnings to cash flows from operating activities:    
Depreciation and amortization of property and intangibles 2,062
 1,791
Stock based compensation 522
 479
Asset write-downs 270
 187
Net gain on sale of assets/businesses (53) (185)
Deferred tax provision (72) 115
Accounts receivable allowances 24
 (4)
Changes in assets and liabilities, net of effects from acquisitions and divestitures:    
Increase in accounts receivable (476) (1,098)
Increase in inventories (421) (443)
Decrease in accounts payable and accrued liabilities (1,201) (1,047)
Increase in other current and non-current assets (541) (794)
Increase/(Decrease) in other current and non-current liabilities 322
 (702)
     
NET CASH FLOWS FROM OPERATING ACTIVITIES 8,685
 6,753
     
CASH FLOWS FROM INVESTING ACTIVITIES    
Additions to property, plant and equipment (1,249) (1,396)
Proceeds from the disposal of assets/businesses, net 125
 685
Acquisitions, net of cash acquired (34,072) (730)
Purchases of investments (5,227) (17,511)
Sales of investments 27,320
 18,775
Other (80) (38)
     
NET CASH USED BY INVESTING ACTIVITIES (13,183) (215)
     
CASH FLOWS FROM FINANCING ACTIVITIES    
Dividends to shareholders (4,433) (4,266)
Repurchase of common stock (5,232) (4,751)
Proceeds from short-term debt 2,635
 118
Retirement of short-term debt (180) (4,687)
Proceeds from long-term debt, net of issuance costs 4,464
 11,951
Retirement of long-term debt (15) (936)
Proceeds from the exercise of stock options/employee withholding tax on stock awards, net 719
 929
Other (25) 
     
NET CASH USED BY FINANCING ACTIVITIES (2,067) (1,642)
     
Effect of exchange rate changes on cash and cash equivalents 191
 12
(Decrease)/Increase in cash and cash equivalents (6,374) 4,908
Cash and Cash equivalents, beginning of period 18,972
 13,732
CASH AND CASH EQUIVALENTS, END OF PERIOD $12,598
 18,640
     
Acquisitions    
Fair value of assets acquired $36,161
 744
Fair value of liabilities assumed and noncontrolling interests (2,089) (14)
Net cash paid for acquisitions $34,072
 730
Prior year amounts have been reclassified to conform to current year presentation
See Notes to Consolidated Financial Statements

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

NOTE 1 — The accompanying unaudited interim consolidated financial statements and related notes should be read in conjunction with the audited Consolidated Financial Statements of Johnson & Johnson and its subsidiaries (the Company) and related notes as contained in the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 20161, 2017. The unaudited interim financial statements include all adjustments (consisting only of normal recurring adjustments) and accruals necessary in the judgment of management for a fair statement of the results for the periods presented.
New Accounting PronouncementsStandards
Recently Adopted Accounting Pronouncementsas of July 2, 2017

During the fiscal first quarter of 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update 2016-09 Compensation2016-07 Investments - Stock Compensation: ImprovementsEquity Method and Joint Ventures (Topic 323): Simplifying the Transition to Employee Share Based Paymentthe Equity Method of Accounting. The amendments in the update eliminate the requirement that when an investment qualifies for the use of the equity method as a result of an increase in the level of ownership interest or degree of influence, an investor must adjust the investment, results of operations, and retained earnings retroactively on a step by step basis as if the equity method had been in effect during all previous periods that the investment had been held. The amendments in this update are effective for annual periods beginning after December 15, 2016all entities for fiscal years, and interim periods within those annual periods. Early adoption is permitted for any entity in any interim or annual period. During the fiscal second quarter of 2016, the Company elected to early adopt this standard. The update requires the following changes to presentation of the financial statements:
All excess tax benefits and deficiencies to be recognized as a reduction or an increase to the provision for taxes on income. Previously, the Company recorded these benefits directly to Retained Earnings. The tax benefit for the Company was $123 million and $288 million for the fiscal second quarter and fiscal six months ended for 2016, respectively. The standard does not permit retroactive presentation of this benefit to prior fiscal years, on the Consolidated Statement of Earnings.
The tax benefit or deficiency is required to be classified and presented as a cash flow to/from operating activities. It was previously required to be presented as a cash flow to/from financing activities on the Consolidated Statement of Cash Flows. As permitted in the standard, the Company has elected to adopt this reclassification on a prospective basis and therefore prior fiscal years for the Consolidated Statement of Cash Flows have not been recast for this provision.
Clarifies that all cash payments made to taxing authorities on employees’ share-based compensation should be classified as a cash outflow from financing activities. This reclassification is required to be recast retrospectively. As a result, $262 million and $272 million of cash outflow was reclassified from an operating activity to a financing activity (Proceeds from the exercise of stock options/employee withholding tax on stock awards, net) for the first fiscal six months of 2016 and 2015, respectively.
In the diluted net earnings per share calculation, when applying the treasury stock method for shares that could be repurchased, the assumed proceeds no longer include the amount of excess tax benefit. This did not have a material impact on the Company's diluted net earnings per share calculation.

During the fiscal third quarter of 2015, the FASB issued Accounting Standards Update 2015-16 Business Combinations: Simplifying the Accounting for Measurement-Period Adjustments. The amendments in this update require that an acquirer recognize adjustments to provisional amounts that are identified during the measurement period in the reporting period in which the adjustment amounts are determined. This update is effective for the Company for all annual and interim periods beginning after December 15, 2015.2016. The amendments in this update should be applied prospectively to adjustments to provisional amounts that occur after theupon their effective date to increases in the level of this update with earlierownership interest or degree of influence that result in the application permitted for financial statements that have not been issued. This update did not have a material impact on the Company’s consolidated financial statements.

During the fiscal second quarter of 2015, the FASB issued Accounting Standards Update 2015-03: Simplifying the Presentation of Debt Issuance Costs. This update requires capitalized debt issuance costs to be presented as a reduction to the carrying value of debt instead of being classified as a deferred charge, as currently required. This update is effective for the Company for all annual and interim periods beginning after December 15, 2015 and is required to be applied retroactively for all periods presented. This update did not have a material impact on the presentation of the Company’s financial position.

During the fiscal second quarter of 2014, the FASB issued amended guidance Accounting Standards Update No. 2014-10: Development Stage Entities: Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entity Guidance in Topic 810, Consolidation.  The change in the current guidance will require the Company to determine if it should consolidate one of these entities based on the change in the consolidation analysis.  This update to the consolidation analysis became effective for all annual periods and interim reporting periods beginning after December 15, 2015.equity method. The adoption of this standard did not have a material impact on the presentation of the Company's consolidated financial statements.


During the fiscal second quarter of 2015, the FASB issued Accounting Standards Update 2015-11: Simplifying the Measurement of Inventory. This update requires inventory to be measured at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. This update is effective for the Company for all annual and interim periods beginning after December 15, 2016. The amendments in this update should be applied prospectively. This update did not have any material impact on the Company’s consolidated financial statements.
Recently Issued Accounting Standards
Not Adopted as of July 3, 20162, 2017

During the fiscal first quarter of 2017, the FASB issued Accounting Standards Update 2017-07: Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost. This update requires that an employer disaggregate the service cost component from the other components of net periodic benefit cost (“NPBC”). In addition, only the service cost component will be eligible for capitalization. This update is effective for the Company for all annual and interim periods beginning after December 15, 2017. Early adoption is permitted as of the beginning of an annual period for which financial statements (interim or annual) have not been issued or made available for issuance. The Company will adopt this new standard in 2018. The amendments in this Update should be applied retrospectively for the presentation of the service cost component and the other components of NPBC in the income statement and prospectively, on and after the effective date, for the capitalization of the service cost component of NPBC in assets. The Company is assessing the retroactive restatement methodology and impact to the individual line items on Consolidated Statement of Earnings. The Company does not expect there to be a material impact to net earnings.

During the fiscal first quarter of 2017, the FASB issued Accounting Standard Update 2017-05: Other Income-Gains and Losses from the Derecognition of Nonfinancial Assets. This update clarifies the scope of asset derecognition guidance, adds guidance for partial sales of nonfinancial assets and clarifies recognizing gains and losses from the transfer of nonfinancial assets in contracts with noncustomers. This update will be effective for the Company for its annual and interim reporting periods beginning after December 15, 2017, the same time as the amendments in Update 2014-09 Revenue from Contracts with Customers. This update allows the Company to choose either a full retrospective method or modified retrospective method upon adoption.  The Company is currently assessing the impact of the future adoption of this standard on its financial statements.

During the fiscal first quarter of 2017, the FASB issued Accounting Standard Update 2017-04: Simplifying the Test for Goodwill Impairment. This update simplifies how an entity is required to test goodwill for impairment. A goodwill impairment will now be measured by the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. This update will be effective for the Company for its annual or any interim goodwill impairment

tests in fiscal years beginning after December 15, 2019. Early adoption is permitted. This update should be applied prospectively. The Company is currently assessing the impact of the future adoption of this standard on its financial statements.

During the fiscal first quarter of 2017, the FASB issued Accounting Standard Update 2017-01: Clarifying the Definition of a Business. This update narrows the definition of a business by providing a screen to determine when an integrated set of assets and activities is not a business. The screen specifies that an integrated set of assets and activities is not a business if substantially all of the fair value of the gross assets acquired or disposed of is concentrated in a single or a group of similar identifiable assets. This update will be effective for the Company for annual periods beginning after December 15, 2017, including interim periods within those annual periods. Early adoption is permitted. This update should be applied prospectively. The Company is currently assessing the impact of the future adoption of this standard on its financial statements.

During the fiscal fourth quarter of 2016, the FASB issued Accounting Standards Update 2016-07 Investments - Equity Method2016-16 Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory. This update removes the current exception in US GAAP prohibiting entities from recognizing current and Joint Ventures (Topic 323): Simplifyingdeferred income tax expenses or benefits related to transfer of assets, other than inventory, within the Transitionconsolidated entity. The current exception to defer the Equity Methodrecognition of Accounting. The amendments inany tax impact on the update eliminatetransfer of inventory within the requirement that when an investment qualifies for the use of the equity method asconsolidated entity until it is sold to a result of an increase in the level of ownership interest or degree of influence, an investor must adjust the investment, results of operations, and retained earnings retroactively on a step by step basis as if the equity method had been in effect during all previous periods that the investment had been held.third party remains unaffected. The amendments in this update are effective for allpublic entities for annual reporting periods beginning after December 15, 2017. Early adoption is permitted and should be in the first interim period if an entity issues interim financial statements. The Company is currently assessing the impact of the future adoption of this standard on its consolidated financial statements and based upon the preliminary assessment expects to record a credit to retained earnings based on timing differences that exist as of the date of adoption.

During the fiscal third quarter of 2016, the FASB issued Accounting Standards Update 2016-15 Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. This update addresses whether to present certain specific cash flow items as operating, investing or financing activities. The amendments in this update are effective for public entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. The amendments should be applied prospectively upon their effective date to increases in the level of ownership interest or degree of influence that result in the application of the equity method. Earlier2017. Early adoption is permitted, for any entityincluding adoption in anyan interim or annual period. The Company is currently assessing the impact of the future adoption of this standard is not expected to have a material impact on the presentationits consolidated Statements of the Company's consolidated financial statements.Cash Flows.

During the fiscal first quarter of 2016, the FASB issued Accounting Standards Update 2016-02 Leases (Topic 842). This update requires the recognition of lease assets and lease liabilities on the balance sheet for all lease obligations and disclosing key information about leasing arrangements. This update requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previouscurrent generally accepted accounting principles. This update will be effective for the Company for all annual and interim periods beginning after December 15, 2018, including interim periods within those fiscal years. Early application is permitted. The update is required to be adopted using a modified retrospective approach. The Company is currently assessinganticipates that most of its operating leases will result in the recognition of additional assets and the corresponding liabilities on its Consolidated Balance Sheets, however does not expect to have a material impact on the financial position. The actual impact will depend on the Company's lease portfolio at the time of adoption. The Company continues to assess all implications of the future adoption of this standard on itsand related financial statements.disclosures.

During the fiscal first quarter of 2016, the FASB issued Accounting Standards Update 2016-01 Financial Instruments: Recognition and Measurement of Financial Assets and Financial Liabilities. The amendments in this update supersede the guidance to classify equity securities with readily determinable fair values into different categories (that is, trading or available-for-sale) and require equity securities to be measured at fair value with changes in the fair value recognized through net income. The standard amends financial reporting by providing relevant information about an entity’s equity investments and reducing the number of items that are recognized in other comprehensive income. This update will be effective for the Company for annual periods beginning after December 15, 2017, and interim periods within those annual periods. The Company is currently assessingunable to estimate the impact of the future adoption of this standard on its financial statements.

Duringstatements as it will depend on the fiscal second quarter of 2015, the FASB issued Accounting Standards Update 2015-11: Simplifying the Measurement of Inventory. This update requires inventory to be measured at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. This update will be effective for the Company for all annual and interim periods beginning after December 15, 2016. The amendments in this update should be applied prospectively with earlier application permittedequity investments as of the beginning of an interim or annual reporting period. This update will not have a material impact on the presentation of the Company’s financial position.adoption date.

During the fiscal second quarter of 2014, the FASB issued Accounting Standards Update 2014-09: Revenue from Contracts with Customers. This standard replacesCustomers, which, along with amendments issued in 2015 and 2016, will replace substantially all current revenue recognition accountingU.S. GAAP guidance on this topic and eliminate industry-specific guidance. During the fiscal third quarter of 2015, the FASB approved a one year deferral to the effective date to be adopted by all public companies for all annual periods and interim reporting periods beginning after December 15, 2017. During the fiscal first quarter of 2016, the FASB issued additional guidance and clarification relating to Identifying Performance Obligations, Licensing, and Principal verses Agent Considerations. During the second quarter of 2016, the FASB issued additional guidance and clarification relating to assessing collectability, presentation of sales taxes, noncash consideration, and contract modifications & completed contracts at transition. Early adoption of this standard is permitted but not before the original effective date for all annual periods and interim reporting periods beginning after December 15, 2016.2017. The guidance permits two methods of adoption: full retrospective method (retrospective application to each prior reporting period presented) or modified retrospective method (retrospective application with the cumulative effect of initially applying the guidance recognized at the date of initial application and providing certain additional disclosures). The Company is currently assessingplans to adopt the standard using the modified retrospective method. While the Company continues to evaluate the effect of the standard, preliminarily, it does not anticipate a material impact on its financial statements including the potential impact of additional disclosure requirements. To complete the assessment of the impact of the future adoptionstandard, the Company continues to assess all

implications of thisthe standard on its financial statements.

Duringstatements and disclosures. Additionally, the fiscal third quarter of 2014,Company continues to monitor modifications, clarifications and interpretations issued by the FASB issued Accounting Standards Update No. 2014-15: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This standard requires management to evaluate, for each annual and interim reporting period, whether there are conditions and events, considered in the aggregate, that raise

substantial doubt about an entity’s ability to continue as a going concern within one year after the date the financial statements are issued or are available to be issued. If substantial doubt is raised, additional disclosures around management’s plan to alleviate these doubts are required. This update will become effective for all annual periods and interim reporting periods ending after December 15, 2016.  This standard is not expected to have any impact onmay affect current disclosures in the financial statements.conclusions.


NOTE 2 — INVENTORIES

(Dollars in Millions) July 3, 2016 January 3, 2016 July 2, 2017 January 1, 2017
Raw materials and supplies $952
 936
 $1,138
 952
Goods in process 1,984
 2,241
 2,515
 2,185
Finished goods 5,587
 4,876
 6,046
 5,007
Total inventories $8,523
 8,053
 $9,699
 8,144

Inventory of $58 million was classified as held for sale, and reported in prepaid expenses and other on the Consolidated Balance Sheet, related to the divestiture of the Codman Neurosurgery business which was pending as of July 2, 2017.
See Note 10 to the Consolidated Financial Statements for additional details on inventory related to the Actelion acquisition.


NOTE 3 — INTANGIBLE ASSETS AND GOODWILL

Intangible assets that have finite useful lives are amortized over their estimated useful lives. The latest annual impairment assessment of goodwill and indefinite lived intangible assets was completed in the fiscal fourth quarter of 20152016. Future impairment tests for goodwill and indefinite lived intangible assets will be performed annually in the fiscal fourth quarter, or sooner, if warranted.
(Dollars in Millions) July 3, 2016 January 3, 2016 July 2, 2017 January 1, 2017
Intangible assets with definite lives:        
Patents and trademarks — gross $8,633
 8,299
 $35,804
 10,521
Less accumulated amortization 4,974
 4,745
 5,546
 5,076
Patents and trademarks — net 3,659
 3,554
 30,258
 5,445
Customer relationships and other intangibles — gross 17,799
 17,583
 20,048
 17,615
Less accumulated amortization 6,242
 5,816
 7,053
 6,515
Customer relationships and other intangibles — net 11,557
 11,767
 12,995
 11,100
Intangible assets with indefinite lives:        
Trademarks 7,085
 7,023
 7,069
 6,888
Purchased in-process research and development 3,393
 3,420
 4,620
 3,443
Total intangible assets with indefinite lives 10,478
 10,443
 11,689
 10,331
Total intangible assets — net $25,694
 25,764
 $54,942
 26,876

Goodwill as of July 3, 20162, 2017 was allocated by segment of business as follows:
(Dollars in Millions) Consumer Pharm Med Devices Total Consumer Pharm Med Devices Total
Goodwill, net at January 3, 2016 $7,240
 2,889
 11,500
 21,629
Goodwill, related to acquisitions 225
 
 180
 405
Goodwill, net at January 1, 2017 $8,263
 2,840
 11,702
 22,805
Goodwill, related to acquisitions* 11
 5,986
 2,081
 8,078
Goodwill, related to divestitures 
 (10) 
 (10) (13) 
 
 (13)
Currency translation/Other 50
 11
 19
 80
 369
 64
 (69)(1)364
Goodwill, net at July 3, 2016 $7,515
 2,890
 11,699
 22,104
Goodwill, net at July 2, 2017 $8,630
 8,890
 13,714
 31,234
(1) Net of $106 million classified as held for sale, reported in other assets on the Consolidated Balance Sheet, related to the divestiture of the Codman Neurosurgery business which was pending as of July 2, 2017.
* Includes measurement period adjustments

The weighted average amortization periods for patents and trademarks and customer relationships and other intangible assets are 1812 years and 2423 years, respectively. The amortization expense of amortizable intangible assets included in cost of products

sold was $576$809 million and $619$576 million for the fiscal six months ended July 2, 2017 and July 3, 2016, and June 28, 2015, respectively. The estimated amortization expense for the five succeeding years approximates $1.24.3 billion, before tax, per year. Intangible asset write-downs are included in Other (income) expense, net.

The primary driver of the increase to intangible assets and goodwill is related to the Actelion acquisition in the fiscal second quarter of 2017, which resulted in the recording of $25.0 billion to intangible assets and approximately $6.0 billion to goodwill. Additionally, the Abbott Medical Optics (AMO) acquisition in the fiscal first quarter of 2017, resulted in the recording of $2.3 billion to intangible assets and $1.8 billion to goodwill. The intangible assets and goodwill amounts related to the Actelion and AMO acquisitions are based on the preliminary purchase price allocation. See Note 10 to the Consolidated Financial Statements for additional details related to acquisitions and divestitures.


NOTE 4 — FAIR VALUE MEASUREMENTS

The Company uses forward foreign exchange contracts to manage its exposure to the variability of cash flows, primarily related to the foreign exchange rate changes of future intercompany products and third-party purchases of materials denominated in a foreign currency. The Company uses cross currency interest rate swaps to manage currency risk primarily related to borrowings.
The Company also uses equity collar contracts to manage exposure to market risk associated with certain equity investments.
All three types of derivatives are designated as cash flow hedges.

Additionally, the Company uses interest rate swaps as an instrument to manage interest rate risk related to fixed rate borrowings. These derivatives are designated as fair value hedges. The Company uses forward foreign exchange contracts designated as net investment hedges. Additionally, the Company uses forward foreign exchange contracts to offset its exposure to certain foreign currency assets and liabilities. These forward foreign exchange contracts are not designated as hedges and therefore, changes in the fair values of these derivatives are recognized in earnings, thereby offsetting the current earnings effect of the related foreign currency assets and liabilities.

The Company does not enter into derivative financial instruments for trading or speculative purposes, or that contain credit risk related contingent features or requirements to post collateral (excluding equity collar contracts) by eitherfeatures. During the fiscal second quarter of 2017, the Company orentered into credit support agreements (CSA) with our derivative counterparties establishing collateral thresholds based on respective credit ratings and netting agreements. As of July 2, 2017 the counter-party.total amount of collateral received under the credit support agreements (CSA) amounted to $20 million. For equity collar contracts, the Company pledged the underlying hedged marketable equity securities to the counter-party as collateral. On an ongoing basis, the Company monitors counter-party credit ratings. The Company considers credit non-performance risk to be low, because the Company primarily enters into agreements with commercial institutions that have at least an investment grade credit rating. Refer to the table on significant financial assets and liabilities measured at fair value contained in this footnote for receivables and payables with these commercial institutions. As of July 3, 2016,2, 2017, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps, interest rate swaps and equity collar contracts of $31.6$35.8 billion, $2.3 billion, $2.2$1.8 billion, and $0.5$0.2 billion respectively. As of January 1, 2017, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps, interest rate swaps and equity collar contracts of $36.0 billion, $2.3 billion, $1.8 billion, and $0.3 billion respectively.

All derivative instruments are recorded on the balance sheet at fair value. Changes in the fair value of derivatives are recorded each period in current earnings or other comprehensive income, depending on whether the derivative is designated as part of a hedge transaction, and if so, the type of hedge transaction.

The designation as a cash flow hedge is made at the entrance date of the derivative contract. At inception, all derivatives are expected to be highly effective. Changes in the fair value of a derivative that is designated as a cash flow hedge and is highly effective are recorded in accumulated other comprehensive income until the underlying transaction affects earnings, and are then reclassified to earnings in the same account as the hedged transaction. Gains and losses associated with interest rate swaps and changes in fair value of hedged debt attributable to changes in interest rates are recorded to interest expense in the period in which they occur. Gains and losses on net investment hedges are accounted for through the currency translation account. On an ongoing basis, the Company assesses whether each derivative continues to be highly effective in offsetting changes of hedged items. If and when a derivative is no longer expected to be highly effective, hedge accounting is discontinued. Hedge ineffectiveness, if any, is included in current period earnings in Other (income) expense, net for forward foreign exchange contracts, cross currency interest rate swaps, net investment hedges and equity collar contracts. For interest rate swaps designated as fair value hedges, hedge ineffectiveness, if any, is included in current period earnings within interest expense. For the current reporting period, hedge ineffectiveness associated with interest rate swaps was not material.


During the fiscal second quarter of 2016, the Company designated its Euro denominated notes issued in May 2016 with due dates ranging from 2022 to 2035 as a net investment hedge of the Company's investments in certain of its international subsidiaries that use the Euro as their functional currency in order to reduce the volatility caused by changes in exchange rates.
During the fiscal second quarter of 2016, theThe change in the carrying value due to remeasurement of these Euro notes resulted in a $116$268 million pretax gainloss during the fiscal second quarter of 2017 reflected in foreign currency translation adjustment, within the Consolidated Statements of Comprehensive Income.

The change in the carrying value due to remeasurement of these Euro notes resulted in a $378 million pretax loss during the fiscal six months of 2017, resulting in a cumulative $3 million pretax loss from hedge inception through the fiscal six months of 2017 reflected in foreign currency translation adjustment, within the Consolidated Statements of Comprehensive Income.

As of July 3, 2016,2, 2017, the balance of deferred net losses on derivatives included in accumulated other comprehensive income was $365$36 million after-tax. For additional information, see the Consolidated Statements of Comprehensive Income and Note 7. The Company expects that substantially all of the amounts related to forward foreign exchange contracts will be reclassified into earnings over the next 12 months as a result of transactions that are expected to occur over that period. The maximum length of time over which the Company is hedging transaction exposure is 18 months, excluding interest rate contracts, net investment hedges and equity collar contracts. The amount ultimately realized in earnings may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity of the derivative.

The following table is a summary of the activity related to derivatives designated as cash flow hedges for the fiscal second quarters in 20162017 and 20152016:
        
 
Gain/(Loss)
Recognized In
Accumulated
OCI(1)
 
Gain/(Loss) Reclassified From
Accumulated OCI
Into Income(1)
 
Gain/(Loss)
Recognized In
Other
Income/Expense(2)
 
Gain/(Loss)
Recognized In
Accumulated
OCI(1)
 
Gain/(Loss) Reclassified From
Accumulated OCI
Into Income(1)
 
Gain/(Loss)
Recognized In
Other
Income/Expense(2)
(Dollars in Millions) Fiscal Second Quarters Ended Fiscal Second Quarters Ended
Cash Flow Hedges By Income Statement Caption July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016
Sales to customers(3)
 $(27) 37
 (3) (30) 
 (1) $36
 (27) (6) (3) (1) 
Cost of products sold(3)
 (178) 52
 13
 47
 (2) 14
 218
 (178) (68) 13
 1
 (2)
Research and development expense(3)
 12
 (7) (1) 7
 (1) 
 (19) 12
 1
 (1) 1
 (1)
Interest (income)/Interest expense, net(4)
 (3) 7
 7
 
 
 
 (69) (3) (65) 7
 
 
Other (income) expense, net(3) (5)
 (54) (28) (6) 19
 
 1
 (12) (54) (2) (6) (1) 
Total $(250) 61
 10
 43
 (3) 14
 $154
 (250) (140) 10
 
 (3)
            

The following table is a summary of the activity related to derivatives designated as cash flow hedges for the first fiscal six months in 20162017 and 20152016:

        
 
Gain/(Loss)
Recognized In
Accumulated
OCI(1)
 
Gain/(Loss) Reclassified From
Accumulated OCI
Into Income(1)
 
Gain/(Loss)
Recognized In
Other
Income/Expense(2)
 
Gain/(Loss)
Recognized In
Accumulated
OCI(1)
 
Gain/(Loss) Reclassified From
Accumulated OCI
Into Income(1)
 
Gain/(Loss)
Recognized In
Other
Income/Expense(2)
(Dollars in Millions) Fiscal Six Months Ended Fiscal Six Months Ended
Cash Flow Hedges By Income Statement Caption July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016
Sales to customers(3)
 $(27) (55) (21) (71) 
 (2) $22
 (27) (39) (21) (1) 
Cost of products sold(3)
 (222) (116) (8) 116
 (6) 14
 121
 (222) (99) (8) (16) (6)
Research and development expense(3)
 (95) (3) (96) (9) (1) 
 (128) (95) (101) (96) 6
 (1)
Interest (income)/Interest expense, net(4)
 9
 (29) 15
 (3) 
 
 (41) 9
 (43) 15
 
 
Other (income) expense, net(3) (5)
 (106) 69
 (2) 42
 (3) 1
 (44) (106) (37) (2) 
 (3)
Total $(441) (134) (112) 75
 (10) 13
 $(70) (441) (319) (112) (11) (10)
                        
All amounts shown in the table above are net of tax.
(1) Effective portion
(2) Ineffective portion

(3) Forward foreign exchange contracts
(4) Cross currency interest rate swaps
(5) Includes equity collar contracts

For the fiscal second quarters ended July 2, 2017 and July 3, 2016, and June 28, 2015, a loss of $36 million and a gain of $124$63 million and loss $36 million, respectively, was recognized in Other (income) expense, net, relating to forward foreign exchange contracts not designated as hedging instruments.

For the fiscal six months ended July 2, 2017 and July 3, 2016, a gain of $34 million and June 28, 2015, a loss of $41 million and a gain of $40 million, respectively, was recognized in Other (income) expense, net, relating to forward foreign exchange contracts not designated as hedging instruments.

Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement determined using assumptions that market participants would use in pricing an asset or liability. The authoritative literature establishes a three-level hierarchy to prioritize the inputs used in measuring fair value. The levels within the hierarchy are described below with Level 1 having the highest priority and Level 3 having the lowest.

The fair value of a derivative financial instrument (i.e., forward foreign exchange contracts, interest rate contracts) is the aggregation by currency of all future cash flows discounted to its present value at the prevailing market interest rates and

subsequently converted to the U.S. Dollar at the current spot foreign exchange rate. The Company does not believe that fair values of these derivative instruments materially differ from the amounts that could be realized upon settlement or maturity, or that the changes in fair value will have a material effect on the Company’s results of operations, cash flows or financial position. The Company also holds equity investments which are classified as Level 1 and debt securities which are classified as Level 2. The Company did not have any other significant financial assets or liabilities which would require revised valuations under this standard that are recognized at fair value.

The following three levels of inputs are used to measure fair value:

Level 1 — Quoted prices in active markets for identical assets and liabilities.
Level 2 — Significant other observable inputs.
Level 3 — Significant unobservable inputs.



The Company’s significant financial assets and liabilities measured at fair value as of July 3, 20162, 2017 and January 3, 20161, 2017 were as follows:
 July 3, 2016   January 3, 2016 July 2, 2017   January 1, 2017
(Dollars in Millions) Level 1 Level 2 Level 3 Total 
Total(1)
 Level 1 Level 2 Level 3 Total 
Total(1)
Derivatives designated as hedging instruments:                    
Assets:                    
Forward foreign exchange contracts(7)
 $
 279
 
 279
 452
 $
 418
 
 418
 747
Interest rate contracts (2)(4)(7)
 
 55
 
 55
 28
 
 15
 
 15
 31
Total 
 334
 
 334
 480
 
 433
 
 433
 778
Liabilities:                    
Forward foreign exchange contracts(8)
 
 569
 
 569
 358
 
 454
 
 454
 723
Interest rate contracts (3)(4)(8)
 
 314
 
 314
 241
 
 273
 
 273
 382
Equity collar contracts (9)(8)
 
 108
 
 108
 
 
 50
 
 50
 57
Total 
 991
 
 991
 599
 
 777
 
 777
 1,162
Derivatives not designated as hedging instruments:                    
Assets:                    
Forward foreign exchange contracts(7)
 
 28
 
 28
 33
 
 56
 
 56
 34
Liabilities:                    
Forward foreign exchange contracts(8)
 
 62
 
 62
 41
 
 31
 
 31
 57
Available For Sale Other Investments:                    
Equity investments(5)
 1,276
 
 
 1,276
 1,494
 1,040
 
 
 1,040
 1,209
Debt securities(6)
 $
 12,046
 
 12,046
 8,316
 $
 3,599
 
 3,599
 12,087

(1)20152016 assets and liabilities are all classified as Level 2 with the exception of equity investments of $1,494$1,209 million, which are classified as Level 1.
(2)Includes $41$11 million and $20$23 million of non-current other assets for July 3, 20162, 2017 and January 3, 2016,1, 2017, respectively.
(3)Includes $314$273 million and $239$382 million of non-current other liabilities for July 3, 20162, 2017 and January 3, 2016,1, 2017, respectively.
(4)Includes cross currency interest rate swaps and interest rate swaps.
(5)Classified as non-current other assets with the exception of $272$204 million of current other assets for July 3, 2016.2, 2017. The carrying amountoriginal cost of the equity investments were $530$496 million and $528$520 million as of July 3, 20162, 2017 and January 3, 2016,1, 2017, respectively. The unrealized gains were $767$548 million and $979$757 million as of July 3, 20162, 2017 and January 3, 2016,1, 2017, respectively. The unrealized losses were $21$4 million and $13$68 million as of July 3, 20162, 2017 and January 3, 2016,1, 2017, respectively.
(6)Classified as cash equivalents and current marketable securities.
(7)Classified as other current assets.assets, including the net effect of the CSA
(8)Classified as accounts payable.
(9)Includes $41 millionpayable, including the net effect of non-current other liabilities for July 3, 2016.the CSA.



The Company's cash, cash equivalents and current marketable securities as of July 3, 20162, 2017 comprised:
July 3, 2016July 2, 2017
(Dollars in Millions)Carrying Amount Unrecognized Gain Unrecognized Loss Estimated Fair Value Cash & Cash Equivalents Current Marketable SecuritiesCarrying Amount Unrecognized Gain Unrecognized Loss Estimated Fair Value Cash & Cash Equivalents Current Marketable Securities
Cash$1,619
 
 
 1,619
 1,619
  $2,547
 
 
 2,547
 2,547
  
U.S. Gov't Securities(1)
6,548
 1
 
 6,549
 900
 5,648

 
 
 
 

 

Other Sovereign Securities(1)
2,494
 
 
 2,494
 1,359
 1,135
210
 
 
 210
 210
 

U.S. Reverse repurchase agreements(1)
11,288
 
 
 11,288
 9,587
 1,701
2,841
 
 
 2,841
 2,841
 
Other Reverse repurchase agreements(1)
1,600
 
 
 1,600
 1,600
  271
 
 
 271
 271
  
Corporate debt securities(1)
4,598
 1
 
 4,599
 1,456
 3,142
979
 
 
 979
 979
 

Money market funds882
 
 
 882
 882
  1,076
 
 
 1,076
 1,076
  
Time deposits(1)
1,237
 
 
 1,237
 1,237
  1,126
 
 
 1,126
 1,126
  
Subtotal30,266
 2
 
 30,268
 18,640
 11,626
9,050
 
 
 9,050
 9,050
 
  Unrealized Gain Unrealized Loss        Unrealized Gain Unrealized Loss      
Gov't securities10,036
 176
 
 10,212
 
 10,212
3,548
 
 
 3,548
 3,548
 

Other Sovereign Securities1
 
 
 1
 
 1
Corporate debt securities1,818
 17
 (1) 1,834
 
 1,834
50
 
 
 50
 
 50
Equity investments37
 246
 (11) 272
 
 272
17
 187
 

 204
 
 204
Subtotal Available for Sale(2)
$11,891
 439
 (12) 12,318
 
 12,318
$3,616
 187
 
 3,803
 3,548
 255
Total cash, cash equivalents and current marketable securities

 

 

 

 18,640
 23,944


 

 

 

 12,598
 255

(1) Held to maturity investments are reported at amortized cost and gains or losses are reported in earnings.
(2) Available for sale securities are reported at fair value with unrealized gains and losses reported net of taxes in other comprehensive income.

Fair value of government securities and obligations and corporate debt securities was estimated using quoted broker prices and significant other observable inputs.

The Company classifies all highly liquid investments with stated maturities of three months or less from date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months from the date of purchase as current marketable securities. Available for sale securities with stated maturities of greater than one year from the date of purchase are available for current operations and are classified as cash equivalents and current marketable securities.

The excess of the estimated fair value over the carrying value of cash equivalents and current marketable securities was the same as the amortized cost as of$0.2 billion at January 3, 2016.1, 2017.

The contractual maturities of substantially allthe available for sale securities were from one year to five years at July 3, 2016.2, 2017 are as follows:
(Dollars in Millions) Cost Basis Fair Value
Due within one year $3,588
 3,588
Due after one year through five years 11
 11
Due after five years through ten years 
 
Total debt securities $3,599
 3,599







Financial Instruments not measured at Fair Value:
The following financial liabilities are held at carrying amount on the consolidated balance sheet as of July 3, 20162, 2017:
(Dollars in Millions) Carrying Amount Estimated Fair Value Carrying Amount Estimated Fair Value
        
Financial Liabilities        
        
Current Debt $1,708
 1,708
 $7,209
 7,209
        
Non-Current Debt        
5.55% Debentures due 2017 999
 1,053
1.125% Notes due 2017 703
 709
5.15% Debentures due 2018 899
 975
 899
 933
1.65% Notes due 2018 609
 620
 599
 601
4.75% Notes due 2019 (1B Euro 1.1098) 1,105
 1,286
4.75% Notes due 2019 (1B Euro 1.1397) 1,136
 1,266
1.875% Notes due 2019 514
 528
 500
 508
0.89% Notes due 2019 299
 300
 300
 301
1.125% Notes due 2019 698
 704
 699
 696
3% Zero Coupon Convertible Subordinated Debentures due in 2020 110
 183
 69
 126
2.95% Debentures due 2020 545
 585
 546
 566
3.55% Notes due 2021 447
 492
 448
 476
2.45% Notes due 2021 348
 371
 349
 357
1.65% Notes due 2021 997
 1,015
 997
 991
0.250% Notes due 2022 (1B Euro 1.1098) 1,105
 1,123
0.250% Notes due 2022 (1B Euro 1.1397) 1,136
 1,136
2.25% Notes due 2022 995
 1,003
6.73% Debentures due 2023 249
 335
 250
 311
3.375% Notes due 2023 808
 905
 807
 866
2.05% Notes due 2023 497
 510
 497
 493
0.650% Notes due 2024 (750MM Euro 1.1098) 827
 848
5.50% Notes due 2024 (500 MM GBP 1.3418) 664
 879
0.650% Notes due 2024 (750MM Euro 1.1397) 850
 852
5.50% Notes due 2024 (500 MM GBP 1.2965) 642
 823
2.45% Notes due 2026 1,989
 2,063
 1,990
 1,946
1.150% Notes due 2028 (750MM Euro 1.1098) 823
 857
2.95% Notes due 2027 995
 1,034
1.150% Notes due 2028 (750MM Euro 1.1397) 846
 848
6.95% Notes due 2029 296
 444
 296
 409
4.95% Debentures due 2033 497
 643
 498
 596
4.375% Notes due 2033 857
 1,039
 857
 982
1.650% Notes due 2035 (1.5B Euro 1.1098) 1,645
 1,811
1.650% Notes due 2035 (1.5B Euro 1.1397) 1,691
 1,717
3.55% Notes due 2036 986
 1,096
 987
 1,027
5.95% Notes due 2037 990
 1,472
 990
 1,334
3.625% Notes due 2037 1,485
 1,556
5.85% Debentures due 2038 695
 1,031
 695
 933
4.50% Debentures due 2040 537
 680
 537
 608
4.85% Notes due 2041 296
 387
 296
 358
4.50% Notes due 2043 495
 617
 495
 578
3.70% Notes due 2046 1,970
 2,251
 1,971
 2,030
3.75% Notes due 2047 990
 1,033
Other 36
 36
 25
 25
Total Non-Current Debt $24,535
 27,848
 $27,363
 29,319

The weighted average effective interest rate on non-current debt is 3.30%3.27%.

The excess of the estimated fair value over the carrying value of debt was $1.71.6 billion at January 3, 2016.1, 2017.


Fair value of the non-current debt was estimated using market prices, which were corroborated by quoted broker prices and significant other observable inputs.


NOTE 5 — INCOME TAXES

The worldwide effective income tax rates for the first fiscal six months of 2017 and 2016 were 20.1% and 2015 were 17.1% and 21.9%, respectively. InThe Company completed its acquisition of AMO in the first fiscal six monthsquarter of 2016,2017, and incurred incremental tax costs that were discretely recorded in the Company had higher income in lower tax jurisdictions relative to higher tax jurisdictions as compared to 2015,first quarter, which decreasedhas increased the effective tax rate by approximately 1.7%.  As described in Note 1, the Company adopted a new accounting standard for the reporting of tax benefits on share-based compensation. The adoption of this new standard reduced the tax rate2.1% for the first six months of fiscal 2016 by approximately 2.8% versus 2015. The remainder of the change from prior year was primarily related2017 compared to the U.S. Research & Developmentsame period in 2016.  Additionally, the Company had more income in higher tax creditjurisdictions relative to lower tax jurisdictions as compared to 2016. These increases to the effective tax rate were partially offset by additional tax benefits received from stock-based compensation that either vested or were exercised during the first fiscal six months of 2017 and 2016, which reduced the Controlled Foreign Corporation look-through provisions, which were not enacted into law until the fiscal fourth quarter of 2015,effective tax rate by 2.7% and the settlement of certain open tax positions in several international jurisdictions.2.8%, respectively.

As of July 3, 2016,2, 2017, the Company had approximately $3.1$3.2 billion of liabilities from unrecognized tax benefits. The Company believes it is possible that audits may be completed by tax authorities in some jurisdictions over the next twelve months. The Company is not able to provide a reasonably reliable estimate of the timing of any future tax payments relating to uncertain tax positions.

NOTE 6 — PENSIONS AND OTHER POSTRETIREMENT BENEFITS

Components of Net Periodic Benefit Cost

Net periodic benefit cost for the Company’s defined benefit retirement plans and other benefit plans for the fiscal second quarters of 20162017 and 20152016 include the following components:
 Fiscal Second Quarters Ended Fiscal Second Quarters Ended
 Retirement Plans Other Benefit Plans Retirement Plans Other Benefit Plans
(Dollars in Millions) July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016
Service cost $226
 249
 55
 65
 $255
 226
 62
 55
Interest cost 233
 248
 39
 46
 231
 233
 40
 39
Expected return on plan assets (493) (455) (1) (1) (509) (493) (1) (1)
Amortization of prior service cost/(credit) (1) 1
 (8) (9) 1
 (1) (8) (8)
Recognized actuarial losses 124
 187
 34
 50
 150
 124
 35
 34
Curtailments and settlements 4
 
 
 
 (1) 4
 
 
Net periodic benefit cost $93
 230
 119
 151
 $127
 93
 128
 119


Net periodic benefit cost for the Company’s defined benefit retirement plans and other benefit plans for the first fiscal six months of 20162017 and 20152016 include the following components:

        
 Fiscal Six Months Ended Fiscal Six Months Ended
 Retirement Plans Other Benefit Plans Retirement Plans Other Benefit Plans
(Dollars in Millions) July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016
Service cost $452
 497
 110
 129
 $506
 452
 123
 110
Interest cost 466
 497
 79
 93
 461
 466
 79
 79
Expected return on plan assets (985) (910) (3) (3) (1,014) (985) (3) (3)
Amortization of prior service cost/(credit) 
 1
 (16) (17) 1
 
 (15) (16)
Recognized actuarial losses 248
 374
 68
 100
 302
 248
 69
 68
Curtailments and settlements 5
 4
 
 
 (1) 5
 
 
Net periodic benefit cost $186
 463
 238
 302
 $255
 186
 253
 238
                

Company Contributions

For the fiscal six months ended July 3, 20162, 2017, the Company contributed $283$34 million and $14$20 million to its U.S. and international retirement plans, respectively. The Company plans to continue to fund its U.S. defined benefit plans to comply with the Pension Protection Act of 2006. International plans are funded in accordance with local regulations.


NOTE 7 — ACCUMULATED OTHER COMPREHENSIVE INCOME

Components of other comprehensive income (loss) consist of the following:
                    
 Foreign Gain/(Loss) Employee Gain/(Loss) Total Accumulated Foreign Gain/(Loss) Employee Gain/(Loss) Total Accumulated
 Currency On Benefit On Derivatives Other Comprehensive Currency On Benefit On Derivatives Other Comprehensive
(Dollars in Millions) Translation Securities Plans & Hedges Income (Loss) Translation Securities Plans & Hedges Income (Loss)
January 3, 2016 $(8,435) 604
 (5,298) (36) (13,165)
January 1, 2017 $(9,047) 411
 (5,980) (285) (14,901)
Net change 584
 6
 197
 (329) 458
 1,238
 (57) 237
 249
 1,667
July 3, 2016 $(7,851) 610
 (5,101) (365) (12,707)
July 2, 2017 $(7,809) 354
 (5,743) (36) (13,234)

Amounts in accumulated other comprehensive income are presented net of the related tax impact. Foreign currency translation is not adjusted for income taxes where it relates to permanent investments in international subsidiaries. For additional details on comprehensive income see the Consolidated Statements of Comprehensive Income.

Details on reclassifications out of Accumulated Other Comprehensive Income:
Gain/(Loss) On Securities - reclassifications released to Other (income) expense, net.
Employee Benefit Plans - reclassifications are included in net periodic benefit cost. See Note 6 for additional details.
Gain/(Loss) On Derivatives & Hedges - reclassifications to earnings are recorded in the same account as the underlying transaction. See Note 4 for additional details.


NOTE 8 — EARNINGS PER SHARE

The following is a reconciliation of basic net earnings per share to diluted net earnings per share for the fiscal second quarters ended July 3, 20162, 2017 and June 28, 2015July 3, 2016:
 Fiscal Second Quarters Ended Fiscal Second Quarters Ended
(Shares in Millions) July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016
Basic net earnings per share $1.46
 1.63
 $1.42
 1.46
Average shares outstanding — basic 2,745.4
 2,772.3
 2,691.9
 2,745.4
Potential shares exercisable under stock option plans 146.3
 151.4
 143.2
 146.3
Less: shares which could be repurchased under treasury stock method (99.2) (113.9) (94.6) (99.2)
Convertible debt shares 1.7
 2.2
 1.0
 1.7
Average shares outstanding — diluted 2,794.2
 2,812.0
 2,741.5
 2,794.2
Diluted net earnings per share $1.43
 1.61
 $1.40
 1.43

The diluted net earnings per share calculation for both the fiscal second quarters ended July 3, 20162, 2017 and June 28, 2015July 3, 2016 included the dilutive effect of convertible debt that was offset by the related reduction in interest expense.

The diluted net earnings per share calculation for both the fiscal second quarters ended July 2, 2017 and July 3, 2016 and June 28, 2015 included all shares related to stock options, as there were no options or other instruments which were anti-dilutive.







The following is a reconciliation of basic net earnings per share to diluted net earnings per share for the fiscal six months ended July 2, 2017 and July 3, 2016 and June 28, 2015:2016:

    
 Fiscal Six Months Ended Fiscal Six Months Ended
(Shares in Millions) July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016
Basic net earnings per share $3.07
 3.18
 $3.06
 3.07
Average shares outstanding — basic 2,751.4
 2,777.7
 2,699.3
 2,751.4
Potential shares exercisable under stock option plans 145.8
 151.4
 142.2
 145.8
Less: shares which could be repurchased under treasury stock method (98.0) (110.3) (93.1) (98.0)
Convertible debt shares 1.7
 2.2
 1.0
 1.7
Average shares outstanding — diluted 2,800.9
 2,821.0
 2,749.4
 2,800.9
Diluted net earnings per share $3.02
 3.13
 $3.00
 3.02
        
The diluted net earnings per share calculation for both the fiscal six months ended July 2, 2017 and July 3, 2016 and June 28, 2015 included the dilutive effect of convertible debt that was offset by the related reduction in interest expense.

The diluted net earnings per share calculation for both the fiscal six months ended July 2, 2017 and July 3, 2016 and June 28, 2015 included all shares related to stock options, as there were no options or other instruments which were anti-dilutive.



NOTE 9 — SEGMENTS OF BUSINESS AND GEOGRAPHIC AREAS

SALES BY SEGMENT OF BUSINESS
 Fiscal Second Quarters Ended Fiscal Second Quarters Ended
(Dollars in Millions) July 3,
2016
 June 28,
2015
 
Percent
Change
 July 2,
2017
 July 3,
2016
 
Percent
Change
            
Consumer            
United States $1,384
 1,355
 2.1 % $1,487
 1,384
 7.4 %
International 2,035
 2,128
 (4.4) 1,991
 2,035
 (2.2)
Total 3,419
 3,483
 (1.8) 3,478
 3,419
 1.7
Pharmaceutical            
United States 5,144
 4,543
 13.2
 5,010
 5,144
 (2.6)
International 3,510
 3,403
 3.1
 3,625
 3,510
 3.3
Total 8,654
 7,946
 8.9
 8,635
 8,654
 (0.2)
Medical Devices            
United States 3,044
 3,013
 1.0
 3,229
 3,044
 6.1
International 3,365
 3,345
 0.6
 3,497
 3,365
 3.9
Total 6,409
 6,358
 0.8
 6,726
 6,409
 4.9
Worldwide            
United States 9,572
 8,911
 7.4
 9,726
 9,572
 1.6
International 8,910
 8,876
 0.4
 9,113
 8,910
 2.3
Total $18,482
 17,787
 3.9 % $18,839
 18,482
 1.9 %
            
 Fiscal Six Months Ended Fiscal Six Months Ended
(Dollars in Millions) July 3,
2016
 June 28,
2015
 
Percent
Change
 July 2,
2017
 July 3,
2016
 
Percent
Change
            
Consumer            
United States $2,742
 2,714
 1.0 % $2,901
 2,742
 5.8 %
International 3,872
 4,159
 (6.9) 3,805
 3,872
 (1.7)
Total 6,614
 6,873
 (3.8) 6,706
 6,614
 1.4
Pharmaceutical            
United States 10,081
 8,914
 13.1
 9,882
 10,081
 (2.0)
International 6,751
 6,758
 (0.1) 6,998
 6,751
 3.7
Total 16,832
 15,672
 7.4
 16,880
 16,832
 0.3
Medical Devices            
United States 6,070
 5,975
 1.6
 6,321
 6,070
 4.1
International 6,448
 6,641
 (2.9) 6,698
 6,448
 3.9
Total 12,518
 12,616
 (0.8) 13,019
 12,518
 4.0
Worldwide            
United States 18,893
 17,603
 7.3
 19,104
 18,893
 1.1
International 17,071
 17,558
 (2.8) 17,501
 17,071
 2.5
Total $35,964
 35,161
 2.3 % $36,605
 35,964
 1.8 %

INCOME BEFORE TAX BY SEGMENT
 Fiscal Second Quarters Ended Fiscal Second Quarters Ended
(Dollars in Millions) July 3,
2016
 June 28,
2015
 
Percent
Change
 July 2,
2017
 July 3,
2016
 
Percent
Change
Consumer $571
 317
 80.1 % $658
 571
 15.2 %
Pharmaceutical(1)
 3,687
 4,122
 (10.6) 3,414
 3,687
 (7.4)
Medical Devices(2)
 939
 1,584
 (40.7) 992
 939
 5.6
Segments operating profit 5,197
 6,023
 (13.7) 5,064
 5,197
 (2.6)
Less: Expense not allocated to segments (3)
 293
 282
   316
 293
  
Worldwide income before tax $4,904
 5,741
 (14.6)% $4,748
 4,904
 (3.2)%
            
 Fiscal Six Months Ended Fiscal Six Months Ended
(Dollars in Millions) July 3, 2016 June 28, 2015 
Percent
Change
 July 2, 2017 July 3, 2016 
Percent
Change
Consumer $1,137
 961
 18.3 % $1,254
 1,137
 10.3%
Pharmaceutical(1)
 7,031
 7,084
 (0.7) 7,077
 7,031
 0.7
Medical Devices(2)
 2,515
 3,805
 (33.9) 2,555
 2,515
 1.6
Segments operating profit 10,683
 11,850
 (9.8) 10,886
 10,683
 1.9
Less: Expense not allocated to segments (3)
 485
 534
   563
 485
  
Worldwide income before taxes $10,198
 11,316
 (9.9)% $10,323
 10,198
 1.2%
(1) Includes litigation expensea positive adjustment of $136 million recorded in the fiscal six months of 2015. Includes a gain of $981 million recorded$0.3 billion to previous reserve estimates in the fiscal second quarter and first fiscal six months of 2015 from the divestiture of the U.S. license rights to NUCYNTA® (tapentadol), NUCYNTA® ER (tapentadol extended-release tablets), and NUCYNTA® (tapentadol) oral solution.2016. Includes a positive adjustment of $539 million and $403 million$0.5 billion to previous reserve estimates in the fiscal six months of 2016 and 2015, respectively.2016. Includes a positive adjustmentacquisition costs related to the Actelion acquisition of $342 million and $199 million to previous reserve estimates in the fiscal second quarter of 2016 and 2015, respectively.
(2) Includes a restructuring charge of $141 million and $278 million$0.2 billion in the fiscal second quarter and fiscal six months of 2016, respectively.2017. Includes litigation expensea gain of $570 million and $676 million recorded$0.2 billion related to monetization of future royalty receivables in the fiscal second quarter and fiscal six months of 2017. Includes a gain of $0.2 billion and $0.1 billion in the fiscal six months of 2017 and 2016, respectively, related to the sale of certain investments in equity securities held by Johnson & Johnson Innovation - JJDC, Inc.
(2) Includes a restructuring related charge of $0.1 billion and $0.1 billion in the fiscal second quarters of 2017 and 2016, respectively. Includes a restructuring related charge of $0.3 billion and $0.3 billion in the fiscal six months of 2017 and 2016, respectively. Includes litigation expense of $134 million$0.4 billion and $0.6 billion in the fiscal second quarter of 20152017 and a net

2016, respectively. Includes litigation gainexpense of $404 million primarily related to a litigation settlement agreement with Guidant recorded$0.4 billion and $0.7 billion in the fiscal six months of 2015. The2017 and 2016, respectively. Includes an asset impairment of $0.2 billion primarily related to the insulin pump business in the fiscal second quarter and fiscal six months of 2015 included $148 million for costs associated with the DePuy ASRTM Hip program.2017.
(3) Amounts not allocated to segments include interest income/expense and general corporate income/expense.
SALES BY GEOGRAPHIC AREA
 Fiscal Second Quarters Ended Fiscal Second Quarters Ended
(Dollars in Millions) July 3, 2016 June 28, 2015 
Percent
Change
 July 2, 2017 July 3, 2016 
Percent
Change
United States $9,572
 8,911
 7.4 % $9,726
 9,572
 1.6 %
Europe 4,090
 4,151
 (1.5) 4,232
 4,090
 3.5
Western Hemisphere, excluding U.S. 1,542
 1,501
 2.7
 1,499
 1,542
 (2.8)
Asia-Pacific, Africa 3,278
 3,224
 1.7
 3,382
 3,278
 3.2
Total $18,482
 17,787
 3.9 % $18,839
 18,482
 1.9 %

            
 Fiscal Six Months Ended Fiscal Six Months Ended
(Dollars in Millions) July 3, 2016 June 28, 2015 
Percent
Change
 July 2, 2017 July 3, 2016 
Percent
Change
United States $18,893
 17,603
 7.3 % $19,104
 18,893
 1.1%
Europe 7,937
 8,191
 (3.1) 8,090
 7,937
 1.9
Western Hemisphere, excluding U.S. 2,873
 3,140
 (8.5) 2,953
 2,873
 2.8
Asia-Pacific, Africa 6,261
 6,227
 0.5
 6,458
 6,261
 3.1
Total $35,964
 35,161
 2.3 % $36,605
 35,964
 1.8%

NOTE 10— BUSINESS COMBINATIONS AND DIVESTITURES
Subsequent to the quarter
On June 16, 2017, the Company completed the acquisition of Vogue International LLC,Actelion Ltd. through an all cash tender offer in Switzerland for $280 per share, payable in U.S. dollars. As of July 2, 2017, the Company paid $28.8 billion, net of cash acquired, representing 97.86% of the shares to which the offer was extended. The Company recorded a privately-heldcurrent liability of $0.7 billion for the shares not tendered as of July 2, 2017, which the Company expects to pay in the second half of 2017 as it takes steps to acquire the remaining outstanding shares of Actelion. As part of the transaction, immediately prior to the completion of the acquisition, Actelion spun out its drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharmaceutical company, focusedIdorsia Ltd. The shares of Idorsia are listed on the marketing, developmentSIX Swiss Exchange (SIX). The Company currently holds 9.9% of the shares of Idorsia and distributionhas rights to an additional 22.1% of salon-influencedIdorsia equity through a convertible loan with a principal amount of approximately $0.5 billion. The convertible loan may be converted into Idorsia shares as follows: (i) up to an aggregate shareholding of 16% of Idorsia shares as a result of certain shareholders holding more than 20% of the issued Idorsia shares, and nature inspired hair care and other personal(ii) up to the balance of the remaining amount within 20 business days of the maturity date of the convertible loan, which has a ten year term, or if Idorsia undergoes a change of control transaction. The investment in Idorsia was recorded as a cost method investment in Other assets in the Company's consolidated Balance Sheet. The Company also acquired an option on ACT-132577, a product within Idorsia being developed for resistant hypertension currently in phase 2 of clinical development. The Company has also entered into an agreement to provide Idorsia with a Swiss franc denominated credit facility of approximately $250 million. As of July 2, 2017, Idorsia has not made any draw-downs under the credit facility. Actelion has entered into a transitional services agreement with Idorsia. Actelion has established a leading franchise of differentiated, innovative products for $3.3 billionpulmonary arterial hypertension (PAH) that are highly complementary to the existing portfolio of the Company. The addition of Actelion’s specialty in-market medicines and late-stage products is consistent with the Company's efforts to grow in cash. Theattractive and complementary therapeutic areas and serve patients with serious illnesses and significant unmet medical need.

Due to the timing of the close of the transaction, the Company is instill finalizing the processallocation of finalizing the purchase price allocation.to the individual assets acquired and liabilities assumed. The allocation of the purchase price included in the current period balance sheet is based on the best estimate of management and is preliminary and subject to change. To assist management in the allocation, the Company engaged valuation specialists to prepare independent appraisals. The Company will finalize the amounts recognized as the information necessary to complete the analysis is obtained. The Company expects to finalize these amounts as soon as possible but no later than one year from the acquisition date.

The following table presents the preliminary amounts recognized for assets acquired and liabilities assumed as of the acquisition date on June 16, 2017:

(Dollars in Millions) 
Cash & Cash equivalents$469
Inventory(1)
759
Accounts Receivable485
Other current assets93
Property, plant and equipment104
Goodwill5,986
Intangible assets25,010
Deferred Taxes3
Other non-current assets19
Total Assets Acquired32,928
  
Current liabilities531
Deferred Taxes1,960
Other non-current liabilities383
Total Liabilities Assumed2,874
  
Net Assets Acquired$30,054
(1) Includes adjustment of $642 million to write-up the acquired inventory to its estimated fair value.
The assets acquired are recorded in the Pharmaceutical segment. The acquisition of Actelion resulted in approximately $6.0 billion of goodwill. The goodwill is primarily attributable to synergies expected to arise from the acquisition. The goodwill is not expected to be deductible for tax purposes.

The purchase price allocation to the identifiable intangible assets is as follows:
(Dollars in Millions)  
Intangible assets with definite lives:  
Patents and trademarks $24,230
Total amortizable intangibles 24,230
   
In-process research and development 780
Total intangible assets $25,010

The patents and trademarks acquired are comprised of developed technology with a weighted average life of 9 years and was primarily based on the patent life of the marketed products. The intangible assets with definite lives were assigned asset lives ranging from 4 to 10 years. The in-process research and development intangible assets were valued for technology programs for unapproved products.

The value of the IPR&D was calculated using probability adjusted cash flow projections discounted for the risk inherent in such projects. The discount rate applied was 9%.

The acquisition was accounted for using the acquisition method and, accordingly, the results of operations of Actelion were reported in the Company's financial statements beginning on June 16, 2017, the date of acquisition. Total sales and a net loss for Actelion for the second quarter ended July 2, 2017 were $91 million and $116 million, respectively.

The following table provides pro forma results of operations for the fiscal second quarters and the fiscal six months ended July 2, 2017 and July 3, 2016, as if Actelion had been acquired as of January 4, 2016. The pro forma results include the effect of certain purchase accounting adjustments such as the estimated changes in depreciation and amortization expense on the acquired tangible and intangible assets. However, pro forma results do not include any anticipated cost savings or other effects

of the planned integration of Actelion. Accordingly, such amounts are not necessarily indicative of the results if the acquisition had occurred on the dates indicated or which may occur in the future.
 Unaudited Pro forma Consolidated Results
 Fiscal Six Months Ended Fiscal Second Quarters Ended
(Dollars in Millions Except Per Share Data)July 2, 2017July 3, 2016 July 2, 2017July 3, 2016
      
Net Sales37,836
37,165
 19,426
19,090
Net Earnings7,890
6,875
 3,788
3,495
Diluted Net Earnings per Common Share2.87
2.45
 1.38
1.25

In the fiscal second quarter of 2017, the Company recorded acquisition related costs of approximately $0.2 billion before tax, which was recorded in Other (income)/expense.

Additionally, during the fiscal second quarter of 2017, the Company completed the acquisition of Neuravi Limited, a privately-held medical device company that develops and markets medical devices for neurointerventional therapy.

During the fiscal first quarter of 2017, the Company acquired Abbott Medical Optics (AMO), a wholly-owned subsidiary of Abbott Laboratories, for $4.4 billion, net of cash acquired. The acquisition included ophthalmic products related to: cataract surgery, laser refractive surgery and consumer eye health. The net purchase price was primarily recorded as amortizable intangible assets for $2.3 billion and goodwill for $1.8 billion. The weighted average life of total amortizable intangibles, the majority being customer relationships, is approximately 14.5 years. The goodwill is primarily attributable to synergies expected to arise from the business acquisition and is not deductible for tax purposes. The intangible assets and goodwill amounts are based on the preliminary purchase price allocation which is under review by the Company and is subject to change. The assets acquired were recorded in the Medical Devices segment.

Additionally, during the fiscal first quarter of 2017, the Company completed the acquisition of Torax Medical, Inc., a privately-held medical device company that manufactures and markets the LINX™ Reflux Management System for the surgical treatment of gastroesophageal reflux disease and Megadyne Medical Products, Inc., a privately-held medical device company that develops, manufactures and markets electrosurgical tools.

During the fiscal first quarter of 2017, the Company received a binding offer from Integra LifeSciences Holdings Corporation to purchase the Company's Codman Neurosurgery business for approximately $1.0 billion. As of July 2, 2017, the assets held for sale were $58 million of inventory, classified as prepaid expenses and other on the Consolidated Balance Sheet. The non-current assets classified as held for sale were $33 million of property, plant and equipment, net and $106 million of goodwill, classified as other assets on the Consolidated Balance Sheet.

During the fiscal first quarter of 2017, the Company announced it is engaging in a process to evaluate potential strategic options for the Johnson & Johnson Diabetes Care Companies, specifically LifeScan, Inc., Animas Corporation, and Calibra Medical, Inc. Strategic options may include the formation of operating partnerships, joint ventures or strategic alliances, a sale of the businesses, or other alternatives either separately or together. During the fiscal second quarter of 2017, the Company recorded an impairment charge of $0.2 billion, primarily related to the insulin pump business. All strategic options are still being evaluated to determine the best opportunity to drive future growth and maximize shareholder value. There can be no assurance that this process will result in any transaction or other strategic alternative of any kind therefore, there were no assets held for sale as of July 2, 2017 related to the announcement.
During the fiscal second quarter of 2016, the Company completed the acquisitions of NeuWave Medical, Inc., a privately-held medical device company that manufactures and markets minimally invasive soft tissue microwave ablation systems and NeoStrata Company, Inc., a global leader in dermocosmetics. Additionally, during the fiscal second quarter of 2016, the Company completed the divestiture of its controlled substance raw material and active pharmaceutical ingredient (API) business. The proceeds from the divestiture were $650 million.

During the fiscal second quarter of 2015, the Company completed the divestiture of its U.S. license rights to NUCYNTA® (tapentadol), NUCYNTA ® ER (tapentadol extended-release tablets), and NUCYNTA® (tapentadol) oral solution for approximately $1.05$0.6 billion. The pre-tax gain on the divestiture was $981 million and was recognized in Other (income) expense, net.
During the fiscal first quarter of 2015, the Company acquired XO1 Limited, a privately-held biopharmaceutical company developing an anti-thrombin antibody.









NOTE 11 — LEGAL PROCEEDINGS

Johnson & Johnson and certain of its subsidiaries are involved in various lawsuits and claims regarding product liability, intellectual property, commercial and other matters; governmental investigations; and other legal proceedings that arise from time to time in the ordinary course of their business.

The Company records accruals for loss contingencies associated with these legal matters when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated. As of July 3, 2016,2, 2017, the Company has determined that the liabilities associated with certain litigation matters are probable and can be reasonably estimated. The Company has accrued for these matters and will continue to monitor each related legal issue and adjust accruals as might be warranted based on new information and further developments in accordance with ASC 450-20-25. For these and other litigation and regulatory matters discussed below for which a loss is probable or reasonably possible, the Company is unable to estimate the possible loss or range of loss beyond the amounts already accrued. Amounts accrued for legal contingencies often result from a complex series of judgments about future events and uncertainties that rely heavily on estimates and assumptions. The ability to make such estimates and judgments can be affected by various factors, including whether damages sought in the proceedings are unsubstantiated or indeterminate; scientific and legal discovery has not commenced or is not complete; proceedings are in early stages; matters present legal uncertainties; there are significant facts in dispute; or there are numerous parties involved.

In the Company's opinion, based on its examination of these matters, its experience to date and discussions with counsel, the ultimate outcome of legal proceedings, net of liabilities accrued in the Company's balance sheet, is not expected to have a material adverse effect on the Company's financial position. However, the resolution of, or increase in accruals for, one or more of these matters in any reporting period may have a material adverse effect on the Company's results of operations and cash flows for that period.

PRODUCT LIABILITY

Johnson & Johnson and certain of its subsidiaries are involved in numerous product liability claims and lawsuits involving multiple products. Claimants in these cases seek substantial compensatory and, where available, punitive damages. While the Company believes it has substantial defenses, it is not feasible to predict the ultimate outcome of litigation. The Company has established accruals for product liability claims and lawsuits in compliance with ASC 450-20 based on currently available information, which in some cases may be limited. The Company accrues an estimate of the legal defense costs needed to defend each matter when those costs are probable and can be reasonably estimated. For certain of these matters, the Company has accrued additional amounts such as estimated costs associated with settlements, damages and other losses. To the extent adverse verdicts have been rendered against the Company, the Company does not record an accrual until a loss is determined to be probable and can be reasonably estimated. Product liability accruals can represent projected product liability for thousands of claims around the world, each in different litigation environments and with different fact patterns. Changes to the accruals may be required in the future as additional information becomes available.

The most significant of these cases includeinclude: the DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System,System; the PINNACLE® Acetabular Cup System,System; pelvic meshes,meshes; RISPERDAL®,; XARELTO®and JOHNSON'S; body powders containing talc, primarily JOHNSONS® Baby Powder.Powder; and INVOKANA®. As of July 3, 2016,2, 2017, in the U.S. there were approximately 2,9002,000 plaintiffs with direct claims in pending lawsuits regarding injuries allegedly due to the DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System, 9,100System; 9,700 with respect to the PINNACLE® Acetabular Cup System, 50,100System; 55,500 with respect to pelvic meshes, 13,000meshes; 13,800 with respect to RISPERDAL®;, 13,900 20,000 with respect to XARELTO®; and 1,7004,800 with respect to JOHNSON'Sbody powders containing talc; and 800 with respect to INVOKANA® Baby Powder..

In August 2010, DePuy Orthopaedics, Inc. (DePuy) announced a worldwide voluntary recall of its ASR™ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement surgery. Claims for personal injury have been made against DePuy and Johnson & Johnson. The number of pending lawsuits is expected to fluctuate as certain lawsuits are settled or dismissed and additional lawsuits are filed. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Northern District of Ohio. Litigation has also been filed in countries outside of the United States, primarily in the United Kingdom, Canada, Australia, Ireland, Germany and Italy. In November 2013, DePuy reached an agreement with a Court-appointed committee of lawyers representing ASR Hip System plaintiffs to establish a program to settle claims with eligible ASR Hip patients in the United States who had surgery to replace their ASR Hips, known as revision surgery, as of August 31, 2013. This settlement covered approximately 8,000 patients. InDePuy reached additional agreements in February 2015 DePuy reached an additional agreement,and March 2017, which effectively extendsfurther extended the existing settlement program to include ASR Hip patients who had revision surgeries after August 31, 2013 and prior to February 1, 2015. This second agreement is estimated to cover approximately 1,800 additional patients. The estimated cost of these agreements is covered by existing accruals.15, 2017. This settlement program ishas resolved more than 9,500 claims, with more expected from the recent extension, therefore bringing to bring to a closeresolution significant ASR Hip litigation activity in the United States. However, many

lawsuits in the United States will remain, and the settlement program does not address litigation outside of the United States. In Australia, a settlement has been reached with representatives of a class action lawsuit pending in the Federal Court of New South Wales

settlement was reached that resolvesresolved the claims of the majority of ASR Hip patients in that country. The Company continues to receive information with respect to potential additional costs associated with this recall on a worldwide basis. The Company has established accruals for the costs associated with the DePuy ASR™ HipU.S. settlement program and relatedDePuy ASR Hip-related product liability litigation. Changes to these accruals may be required in the future as additional information becomes available.

Claims for personal injury have also been made against DePuy and Johnson & Johnson relating to DePuy'sthe PINNACLE® Acetabular Cup System used in hip replacement surgery. The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Northern District of Texas. Litigation has also been filed in some state courts and in countries outside of the United States, primarily in the United Kingdom. The Company has established an accrual for defense costs in connection with product liability litigation associated with DePuy'sthe PINNACLE® Acetabular Cup System. Changes to this accrual may be required in the future as additional information becomes available.

Claims for personal injury have been made against Ethicon, Inc. (Ethicon) and Johnson & Johnson arising out of Ethicon's pelvic mesh devices used to treat stress urinary incontinence and pelvic organ prolapse. The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Southern District of West Virginia. In addition, class actions and individual personal injury cases or claims have been commenced in various countries outside of the United States, including Australia, Belgium, Canada, England, Israel, Italy,claims and cases in the United Kingdom, the Netherlands Scotland and Venezuela,Belgium, and class actions in Israel, Australia and Canada, seeking damages for alleged injury resulting from Ethicon's pelvic mesh devices. The Company has established an accrual with respect to product liability litigation associated with Ethicon's pelvic mesh products. Changes to this accrual may be required in the future as additional information becomes available.

Claims for personal injury have been made against Janssen Pharmaceuticals, Inc. and Johnson & Johnson arising out of the use of RISPERDAL®, indicated for the treatment of schizophrenia, acute manic or mixed episodes associated with bipolar I disorder and irritability associated with autism, and related compounds. The number ofLawsuits have been primarily filed in state courts in Pennsylvania, California, and Missouri. Other actions are pending productin various courts in the United States and Canada. Product liability lawsuits continuescontinue to increase,be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has established an accrual with respect to product liability litigation associated with RISPERDAL®. Changes to this accrual may be required in the future as additional information becomes available.

Claims for personal injury have been made against Janssen Pharmaceuticals, Inc. and Johnson & Johnson arising out of the use of XARELTO®, an oral anticoagulant.anticoagulant, have been made against Janssen Pharmaceuticals, Inc. (JPI); Johnson & Johnson; and JPI's collaboration partner for XARELTO® Bayer AG and certain of its affiliates. The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Eastern District of Louisiana. In addition, cases have been filed in state courts across the United States and manyStates. Many of these cases have been consolidated into a state mass tort litigation in Philadelphia, Pennsylvania.Pennsylvania; and there are coordinated proceedings in Delaware, California and Missouri. Class action lawsuits also have been filed in Canada. The Company has established an accrual for defense costs in connection with product liability litigation associated with XARELTO®. Changes to this accrual may be required in the future as additional information becomes available.

Claims for personal injury have been made against Johnson & Johnson Consumer Inc. and Johnson & Johnson arising out of the use of JOHNSON'Sbody powders containing talc, primarily JOHNSONS® Baby Powder. The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. Lawsuits have been primarily filed in state courts in Missouri, New Jersey and California. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the District of New Jersey. The Company has established an accrual for defense costs in connection with product liability litigation associated with JOHNSON'Sbody powders containing talc. 

Claims for personal injury have been made against a number of Johnson & Johnson companies, including Janssen Pharmaceuticals, Inc. and Johnson & Johnson, arising out of the use of INVOKANA® Baby Powder. Changes, a prescription medication indicated to this accrual may be requiredimprove glycemic control in adults with Type 2 diabetes. The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. Cases filed in federal courts in the futureUnited States have been organized as additional information becomes available.a multi-district litigation in the United States District Court for the District of New Jersey. In addition, there are federal cases pending in the Southern District of California and the Eastern District of Missouri. Cases have also been filed in state courts in Pennsylvania, California and New Jersey. Class action lawsuits have been filed in Canada. The Company has established an accrual for defense costs in connection with product liability litigation associated with INVOKANA®.

INTELLECTUAL PROPERTY
Certain subsidiaries of Johnson & Johnson are subject, from time to time, to legal proceedings and claims related to patent, trademark and other intellectual property matters arising out of their businesses. Many of these matters involve challenges to the coverage and/or validity of the patents on various products and allegations that certain of the Company’s products infringe the patents of third parties. Although these subsidiaries believe that they have substantial defenses to these challenges and allegations with respect to all significant patents, there can be no assurance as to the outcome of these matters. A loss in any of these cases could adversely affect the ability of these subsidiaries to sell their products, result in loss of sales due to loss of market exclusivity, require the payment of past damages and future royalties, and may result in a non-cash impairment charge for any associated intangible asset. The most significant of these matters are described below.


Medical Devices
In November 2007, Roche Diagnostics Operations, Inc., et al. (Roche) filed a patent infringement lawsuit against LifeScan, Inc. (LifeScan) in the United States District Court for the District of Delaware, alleging LifeScan's OneTouch® Line of Blood Glucose Monitoring Systems infringe two patents related to the use of microelectrode sensors. Roche is seeking monetary damages and injunctive relief. In September 2009, LifeScan obtained a favorable ruling on claim construction that precluded a finding of infringement. Roche appealed and the Court of Appeals reversed the District Court's ruling on claim construction and remanded the case to the District Court for new findings on the issue. In December 2014, the District Court ruled in LifeScan's favor and reinstated the original claim construction. In February 2015, Roche appealed the ruling, and in February 2016, oral argument took place at the Court of Appeals.

In June 2009, Rembrandt Vision Technologies, L.P. (Rembrandt) filed a patent infringement lawsuit against Johnson & Johnson Vision Care, Inc. (JJVC)(JJVCI) in the United States District Court for the Eastern District of Texas alleging that JJVC'sJJVCI's manufacture and sale of its ACUVUE ADVANCE® ADVANCE and ACUVUE OASYS® Hydrogel Contact Lenses infringe theirinfringed Rembrandt’s U.S. Patent No. 5,712,327 (the '327 patent). Rembrandt isand seeking monetary relief. The case was transferred to the United States District Court for the Middle District of Florida. InFlorida, where a trial in May 2012 the jury returnedresulted in a verdict holdingof non-infringement that neither of the accused lenses infringes the '327 patent.was subsequently upheld on appeal. In July 2014, Rembrandt appealed, and in August 2013, the United States Court of Appeals for the Federal Circuit affirmed the District Court's judgment. Rembrandt asked the District Court to grant itsought a new trial based on alleged new evidence, and in July 2014,which the District Court denied Rembrandt’s motion. Rembrandt appealed anddenied. In April 2016, the Court of Appeals overturned that ruling in April 2016 and remanded the case to the District Court for a new trial. JJVC filed a motion to reconsider the decision, which was denied.

In December 2009, the State of Israel filed a lawsuit in the District Court in Tel Aviv Jaffa against Omrix Biopharmaceuticals, Inc. and various affiliates (Omrix). In the lawsuit, the State claims that an employee of a government-owned hospital was the inventor on several patents related to fibrin glue technology that the employee developed while he was a government employee. The State claims that he had no right to transfer any intellectual property to Omrix because it belongs to the State. The StateA new trial is seeking damages plus royalties on QUIXIL™ and EVICEL® products, or alternatively, transfer of the patents to the State. The case remains active, but no trial date has been set.

In September 2011, LifeScan, Inc. (LifeScan) filed a lawsuit against Shasta Technologies, LLC (Shasta), Instacare Corp (now Pharmatech Solutions, Inc. (Pharmatech)) and Conductive Technologies, Inc. (Conductive) in the United States District Courtscheduled for the Northern District of California for patent infringement and false advertising for the making and marketing of a strip for use in LifeScan's OneTouch® Blood Glucose Meters. The defendants alleged that the three LifeScan patents-in-suit are invalid and challenged the validity of the asserted patents in the United States Patent and Trademark Office (USPTO). In April 2013, the defendants brought counterclaims for alleged antitrust violations and false advertising and those claims were stayed pending resolution of the patent infringement case. The validity of two of the patents was confirmed by the USPTO, but the USPTO determined that the third patent, U.S. Patent No. 7,250,105, is invalid. LifeScan lost an appeal of that decision, but is seeking a rehearing. LifeScan entered into a settlement agreement with Shasta and Conductive. A motion brought by Pharmatech for summary judgment of patent invalidity was denied. In April 2016, LifeScan and Pharmatech entered into a settlement agreement and the case was dismissed.

LifeScan filed a patent infringement lawsuit against UniStrip Technologies, LLC (UniStrip) in the United States District Court for the District of North Carolina in May 2014, alleging that the making and marketing of UniStrip’s strips for use in LifeScan’s blood glucose monitors infringe U.S. Patent Nos. 6,241,862 (the ‘862 patent) and 7,250,105 (the ‘105 patent). In August 2014, the USPTO determined that the ‘105 patent is invalid. In January 2016, the invalidity decision was upheld on appeal. LifeScan filed a motion for rehearing, which was denied. In July 2014, UniStrip brought a lawsuit against LifeScan in the United States District Court for the Eastern District of Pennsylvania, alleging antitrust violations relating to marketing practices for LifeScan strips.2017.

In March 2013, Medinol Ltd. (Medinol) filed a patent infringement lawsuit against Cordis Corporation (Cordis) and Johnson & Johnson in the United States District Court for the Southern District of New York alleging that all of Cordis'sCordis’s sales of the CYPHER and CYPHER SELECT Stents made in the United States since 2005 willfully infringed four of Medinol's patents directed to the geometry of articulated stents. Medinol is seeking damages and attorney'sattorneys’ fees. After trial in January 2014, the District Court dismissed the case, finding Medinol unreasonably delayed bringing its claims and Medinol did not appeal the decision.(the laches defense). In September 2014, the District Court denied a motion by Medinol to vacate the judgment and grant it a new trial. Medinol'sMedinol appealed the decision to the United States Court of Appeals for the Federal Circuit, then dismissed the appeal of this decision has been dismissed. Medinol has filedin order to file a petition for review with the United States Supreme Court. FollowingIn March 2017, the divestitureUnited States Supreme Court held that the laches defense is not available in patent cases and remanded this case to the U.S. Court of Appeals for the Federal Circuit for further proceedings. Cordis was divested in 2015, and the Company retainsretained any liability that may result from this case.



Pharmaceutical
In 2012 and 2013, Noramco, Inc. (Noramco) moved to intervene in severalNovember 2016, MedIdea, L.L.C. (MedIdea) filed a patent infringement lawsuits filedlawsuit against DePuy Orthopaedics, Inc. in the United States District Court for the SouthernNorthern District of New YorkIllinois alleging infringement by Purdue Pharma L.P.the ATTUNE® Knee System. MedIdea alleges infringement of U.S. Patent Nos. 6,558,426; 8,273,132; 8,721,730 and others (Purdue) against Noramco oxycodone customers, Impax Laboratories, Inc. (Impax), Teva Pharmaceuticals USA, Inc. (Teva), Amneal Pharmaceuticals, LLC (Amneal), Watson Laboratories, Inc.- Florida (Watson)9,492,280 relating to posterior stabilized knee systems. Specifically, MedIdea alleges that the SOFCAMTM Contact feature of the ATTUNE® posterior stabilized knee products infringes the patents-in-suit. MedIdea is seeking monetary damages and Andrx Labs, LLC (Andrx). The lawsuits are in responseinjunctive relief. In June 2017, the case was transferred to the defendants' respective Abbreviated New Drug Applications seeking approval to market generic extended release oxycodone products before the expiration of certain Purdue patents. Three of the asserted patents relate to oxycodone and processes for making oxycodone, and Noramco agreed to defend the lawsuits on behalf of Impax, Teva, Amneal, Watson, and Andrx. In April 2013, Watson and Andrx entered into a settlement with Purdue. The trial against Impax and Teva (and others) took place in September 2013, and Noramco defended Teva and Impax. In November 2013, Impax entered into a settlement with Purdue, and in December 2014, Teva entered into a settlement with Purdue. TheUnited States District Court issued a decision in January 2014 invalidating the relevant Purdue patents and, based on that decision, subsequently dismissed the lawsuit against Amneal (and other parties not defended by Noramco). Purdue appealed the Court's decision. In February 2016, the Federal Circuit affirmed the District Court decision invalidating the Purdue patents. Purdue filed a petition for rehearing and the petition was denied. In December 2015, Purdue filed another patent infringement action against Amneal in the District of DelawareMassachusetts.

In December 2016, Ethicon Endo-Surgery, Inc. and Ethicon Endo-Surgery, LLC (now known as Ethicon LLC) sued Covidien, Inc. in the United States District Court for the District of Massachusetts seeking a declaration that U.S. Patent Nos. 6,585,735 (the ’735 patent); 7,118,587; 7,473,253; 8,070,748 and 8,241,284 (the ’284 patent), are either invalid or not infringed by Ethicon’s ENSEAL® X1 Large Jaw Tissue Sealer product. In April 2017, Covidien LP, Covidien Sales LLC, and Covidien AG (collectively, Covidien) answered and counterclaimed, denying the allegations, asserting among others,willful infringement of the three above-referenced patents’735 patent, the ’284 patent and U.S. Patent Nos. 8,323,310; 9,084,608; 9,241,759 and 9,113,882, and seeking damages and an injunction. Covidien filed a motion for preliminary injunction, and a newly issued patent relating to oxycodone and processeshearing on the motion is set for making oxycodone. Noramco was divested in July 2016 and, as a result, the Company is no longer involved in the defense of these actions.September 2017.

Johnson & Johnson acquired the prostate cancer business of Aragon Pharmaceuticals, Inc. (Aragon), including ARN-509, a compound being tested for treatment of prostate cancer, in September 2013. Prior to the acquisition, in May 2011, Medivation, Inc. (Medivation) had sued Aragon and the University of California seeking rights to ARN-509. In December 2012, the state court granted summary judgment to Aragon on Medivation's claims, awarding the rights of the ARN-509 compound to Aragon, and in January 2013, the Court dismissed the case against Aragon. Medivation has appealed.

Pharmaceutical
In April 2016, MorphosysMorphoSys AG, a German biotech company, filed a patent infringement lawsuit against Janssen Biotech, Inc. (JBI), Genmab U.S. Inc. and Genmab A/S (collectively, Genmab) in the United States District Court for the District of Delaware, allegingDelaware. MorphoSys alleges that JBI’s manufacture and sale of DARZALEX® (daratumumab) willfully infringes itsMorphoSys’ U.S. Patent No. 8,263,746. MorphosysNos. 8,263,746 and 9,200,061. MorphoSys is seeking money damages. JBI licenses patents and the commercial rights to DARZALEX® from Genmab. Trial in the case is scheduled to commence in August 2018.

In JuneAugust 2016, JBISandoz Ltd and Hexal AG (collectively, Sandoz) filed a motionlawsuit in the English High Court against G.D. Searle LLC (a Pfizer company) and Janssen Sciences Ireland UC (JSI) alleging that Searle’s supplementary protection certificate SPC/

GB07/038 (SPC), which is exclusively licensed to dismissJSI, is invalid and should be revoked. Janssen-Cilag Limited sells PREZISTA® (darunavir) in the lawsuit.UK pursuant to this license. In October 2016, Searle and JSI counterclaimed against Sandoz for threatened infringement of the SPC based on statements of its plans to launch generic darunavir in the UK. Sandoz admitted that its generic darunavir product would infringe the SPC if it is found valid. Searle and JSI are seeking an order enjoining Sandoz from marketing its generic darunavir before the expiration of the SPC. Following a trial in April 2017, the Court entered a decision holding that the SPC is valid and granting a final injunction. Sandoz has appealed the Court’s decision and the injunction will be stayed pending the appeal.

REMICADE® Related Cases

U.S. Proceedings
In September 2013, Janssen Biotech, Inc. (JBI) and NYU Langone Medical Center (NYU) received an Office Action from the United States Patent and Trademark Office (USPTO) rejecting the claims in U.S. Patent No. 6,284,471 relating to REMICADE® (infliximab) (the '471’471 patent) in a reexamination proceeding instituted by a third party. The '471’471 patent expires in September 2018 and is co-owned by JBI and NYU, andwith NYU having granted JBI an exclusive license to NYU’s rights under the patent. The '471 patent in the United States expires in September 2018. Following several office actions by the patent examiner, including two further rejections, and responses by JBI, the USPTO issued a further action maintaining its rejection of the '471’471 patent. In May 2015, JBI filed a notice of appeal to the USPTO'sUSPTO’s Patent Trial and Appeal Board, andwhich issued a decision in November 2016 upholding the examiner's rejection. JBI has filed an appeal is currently pending. The '471 patent remains a valid and enforceable patent as it undergoes reexamination atto the USPTO.United States Court of Appeals for the Federal Circuit.

In August 2014, Celltrion Healthcare Co. Ltd. and Celltrion Inc. (together, Celltrion) filed an application with the U.S. Food and Drug Administration (FDA) for approval to make and sell its own biosimilar version of REMICADE®.infliximab biosimilar. In March 2015, JBI filed a lawsuit in the United States District Court for the District of Massachusetts against Celltrion and Hospira Healthcare Corporation (Hospira), which has exclusive U.S. marketing rights for Celltrion's infliximab biosimilar version of REMICADE®,in the United States, seeking, among other things, a declaratory judgment that their biosimilar product infringes or potentially infringes several JBI patents, including the ’471 patent and that defendants failed to comply with certain procedural requirements of the Biologics Price Competition and Innovation Act (BPCIA)U.S. Patent No. 7,598,083 (the ’083 patent). In addition, JBI moved for an injunction to prohibit Celltrion and Hospira from launching their biosimilar product until 180 days after they had given JBI a Notice of Commercial Marketing under the BPCIA, such notice not to be given before FDA approval of Celltrion's product. JBI's motion to stay all proceedings inAugust 2016, the District Court with respect to the ‘471 patent, pending the outcome of the USPTO reexamination proceeding discussed above, was denied in May 2016. In February 2016, Celltriongranted both Celltrion's and Hospira filed twoHospira's motions for summary judgment of invalidity of the ‘471’471 patent. JBI appealed those decisions to the United States Court of Appeals for the Federal Circuit. This case and the appeal of the reexamination of the ’471 patent whichhave been designated companion cases and will be argued in August 2016.

In April 2016,heard by the FDA approved Celltrion’s biosimilar versionsame panel of REMICADE® for sale injudges at the United States. Celltrion and Hospira have agreed not to launch their biosimilar product before October 3, 2016, 180 days after the FDA's approval of their

biosimilar product, thereby eliminating litigation of the issue of the 180-day Notice of Commercial Marketing under the BPCIA.Federal Circuit.

In June 2016, JBI filed two newadditional patent infringement lawsuits asserting U.S. Patent No. 7,598,083 (the '083 patent),the ’083 patent, one against Celltrion in the United States District Court for the District of Massachusetts and the other against HyClone Laboratories, Inc., the manufacturer of the cell culture media that Celltrion uses to make its biosimilar product, in the United States District Court for the District of Utah. Although the '083’083 patent is already asserted in the existing lawsuit against Celltrion, the newadditional lawsuit against Celltrion expands the claims to include any use of the cell culture media made in the United States to manufacture Celltrion's biosimilar. The newThis additional lawsuit against Celltrion has been consolidated with the existing Massachusetts lawsuit.lawsuit discussed above. Hospira has moved to dismiss all counts of the lawsuit related to the ’083 patent as to it. Celltrion has moved to dismiss all counts of the lawsuit related to the ’083 patent without prejudice for failure to join all the co-owners of the ’083 patent as plaintiffs. The Courttrial has scheduled a claim construction hearing regarding the '083 patent for August 2016.been postponed pending resolution of these motions.

In the United States, if either of the REMICADE® related patents discussed above is found to be invalid following all appeals, such patent could not be relied upon to prevent the introduction ofThe FDA approved Celltrion’s infliximab biosimilar versions of REMICADE®. Biosimilar versions of REMICADE® have been introduced in certain markets outside the United States, resulting in a reduction in sales of REMICADE® in those markets. The timing of the possible introduction of a biosimilar version of REMICADE®for sale in the United States is subject to enforcementin April 2016. Hospira's parent company, Pfizer Inc., launched Celltrion's infliximab biosimilar in the United States in late 2016.

In April 2017, JBI received notice that the FDA approved a marketing application submitted by Samsung Bioepis Co. Ltd. (Samsung) for the sale of its infliximab biosimilar in the United States. In May 2017, JBI filed a patent rights and compliance withinfringement lawsuit against Samsung in the 180-day NoticeUnited States District Court for the District of Commercial Marketing provisionsNew Jersey alleging that the sale of the BPCIA. There is a risk that Celltrion and Hospira could launch theirits biosimilar versionproduct may infringe three of REMICADE® on or after October 3, 2016, even though one or more valid patents are in place and JBI will continue to assert its patent rights. Introduction toJBI’s patents. In July 2017, Samsung announced the U.S. marketlaunch of aits biosimilar, version of REMICADE® will resultwhich is being commercialized by Merck in a reduction in U.S. sales of REMICADE®.the United States.

Canadian Proceedings
In March 2013, Hospira filed an impeachment proceeding in the Federal Court of Canada against The Kennedy Institute of Rheumatology (Kennedy) challenging the validity of a Canadian patent related to REMICADE® (a Feldman patent), which is exclusively licensed to JBI. In October 2013, Kennedy, along with JBI, Janssen Inc. (Janssen) and Cilag GmbH International (both affiliates of JBI), filed a counterclaim for infringement against Celltrion and Hospira. The counterclaim alleges that the products described in Celltrion’s and Hospira’s marketing applications to Health Canada for their subsequent entry biologics (SEB) to REMICADE® would infringe the Feldman patents owned by Kennedy. DiscoveryJanssen and Kennedy are seeking damages and an injunction against Hospira. A trial in this patent action concluded in October 2016, and closing arguments took place in January 2017. The parties are awaiting a decision. The remaining REMICADE® patent at issue in the patent action is ongoing, and trial has been scheduled for September 2016.expired August 1, 2017.

In January 2014, Health Canada approved Celltrion’s SEB to REMICADE®, allowing Celltrion to market its infliximab biosimilar version of REMICADE® in Canada, regardless of the pending patent action. In June 2014, Health Canada approved Hospira’s SEB to REMICADE®. In July 2014, Janssen filed a lawsuit to compelin the Federal Court of Canada challenging the Canadian Minister of Health to withdraw the NoticeHealth’s marketing approval (Notice of ComplianceCompliance) for Hospira’s SEB because Hospira did not serve a Notice of Allegation on Janssen to address the patent listed by Janssen on the Patent Register. In March 2015, the parties entered into a settlement agreement whereby Health Canada agreed to a Consent Judgment setting aside Hospira’s Notice of Compliance, subject to Health Canada's appeal, which was filed in June 2015. Nevertheless, Hospira began marketing an infliximab biosimilar as a biosimilar versiondistributor under Celltrion’s Notice of Compliance. In October 2016, the appeals court reversed the Consent Judgment. In June 2017, the Supreme Court of Canada denied Janssen's application for leave to appeal. The REMICADE® as a distributor underpatent at issue in the lawsuit expired August 1, 2017. Hospira continues to market and sell Celltrion's Notice of Compliance. A hearing on the appeal concludedinfliximab biosimilar in June 2016 and the parties are awaiting a decision.

In Canada, if any of the REMICADE® related patents discussed above is found to be invalid following all appeals, such patent could not be relied upon to prevent the further introduction of biosimilar versions of REMICADE®.Canada.

Litigation Against Filers of Abbreviated New Drug Applications (ANDAs)
The following summarizes lawsuits pending against generic companies that have filed Abbreviated New Drug Applications (ANDAs) with the FDA, or undertaken similar regulatory processes outside of the United States, seeking to market generic forms of products sold by various subsidiaries of Johnson & Johnson prior to expiration of the applicable patents covering those products. These ANDAs typically include allegations of non-infringement, invalidity and unenforceability of the applicable patents. In the event the subsidiaries are not successful in these actions, or the statutory 30-month stays of the ANDAs expire before the United States District Court rulings are obtained, the third-party companies involved will have the ability, upon approval of the FDA, to introduce generic versions of the products at issue to the market, resulting in the potential for substantial market share and revenue losses for those products, and which may result in a non-cash impairment charge in any associated intangible asset. In addition, from time to time, subsidiaries may settle these actions and such settlements can involve the introduction of generic versions of the products at issue to the market prior to the expiration of the relevant patents.

The inter partes review (IPR) process with the United States Patent and Trademark Office (USPTO), created under the 2011 America Invents Act, is also being used by generic companies in conjunction with these ANDAs and lawsuits to challenge patents held by the Company’s subsidiaries.

PREZISTACONCERTA®
In November 2010, Tibotec, Inc. (predecessor-in-interest toOctober 2016, ALZA Corporation and Janssen Products, LP) and Tibotec Pharmaceuticals (predecessor-in-interest to Janssen Sciences Ireland UC) (individually or collectively, with one or more affiliates and successors-in-interest, Janssen) filed a series of patent infringement lawsuits, relating to several patents owned by Janssen or licensed to Janssen from G.D. Searle, against Lupin, Ltd. and Lupin Pharmaceuticals, Inc. (together, Lupin) in the United States District Court for the District of New Jersey in response to Lupin's ANDA seeking approval to market a generic version of Tibotec's PREZISTA® product in various dosage strengths before the expiration of patents relating to PREZISTA®. In June 2013, Lupin, agreed not to seek FDA approval of its ANDA until the November 2017 expiration of the G.D. Searle patents. After a trial regarding the remaining patents, the Court issued a decision in August 2014, holding that the asserted patents are valid and would be infringed by Lupin's marketing of its proposed products. Lupin appealed.

In May 2013, Lupin notified Janssen that it filed an ANDA seeking approval to market a new dosage strength of its generic version of PREZISTA®. In response, Janssen filedJanssen) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey, alleging that Lupin's new dosage strength would infringe the same patents that Janssen is assertingDelaware against Lupin in the original action. In March 2014, Janssen filed a patent infringement lawsuit against Lupin in the United States District Court for the DistrictAmneal Pharmaceuticals of New Jersey, alleging infringement of United States Patent No. 8,518,987 (the ‘987 patent). In January 2015, the Court stayed these cases pending Lupin's appeal of the Court's August 2014 decision in the first action. In April 2015, LupinYork, LLC and Amneal Pharmaceuticals LLC (together, Amneal), who filed a petition for Inter Partes review in the United States Patent and Trademark Office (USPTO) seeking to invalidate the ‘987 patent, which was denied in October 2015. In January 2016, Lupin amended itsan ANDA to reflect a new formulation of darunavir that Lupin alleges does not infringe the relevant Janssen patents. In February 2016, Janssen filed a lawsuit in the United States District Court for the District of New Jersey asserting that Lupin’s new formulation of darunavir infringes the relevant Janssen patents.

In the above lawsuits, Janssen sought orders enjoining Lupin from marketing its generic versions of PREZISTA® before the expiration of the relevant patents. In May 2016, Janssen and Lupin entered into a confidential settlement agreement, pursuant to which the above lawsuits have been dismissed.

CONCERTA®
In December 2014, Janssen Inc. and ALZA Corporation filed a Notice of Application against Actavis Pharma Company (Actavis) in response to Actavis’ Notice of Allegation seeking approval to market a generic version of CONCERTA® before the expiration of CanadianUnited States Patent No. 2,264,852 (the ‘852 patent). The hearingNos. 8,163,798 and 9,144,549. Janssen is scheduled for September 2016. Janssen and ALZA are seeking an order enjoining ActavisAmneal from marketing its generic version of CONCERTA® before the expiration of the patents. In July 2017, the parties filed a stipulation of dismissal based on Amneal's agreement not to market its generic version of CONCERTA® before the expiration of the ‘852 patent.patents.

ZYTIGA®
In June and July 2015, Janssen Biotech, Inc. (JBI) received notices of paragraph IV certification from several companies advising of their respective ANDAs seeking approval for a generic version of ZYTIGA® before the expiration of one or more patents relating to ZYTIGA®. In July 2015, JBI,, Janssen Oncology, Inc. (Janssen Oncology) and Janssen Research & Development, LLC (collectively, Janssen) and BTG International Ltd. (BTG) filedinitiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against severala number of generic ANDA applicantscompanies (and certain of their affiliates and/or suppliers) in response to their respectivewho filed ANDAs seeking approval to market a generic version of ZYTIGA® before the expiration of United States Patent Nos. 5,604,213 (the '213 patent) (expiring December 2016) and/orNo. 8,822,438 (the '438’438 patent) (expiring August 2027). The generic companies currently include Actavis Laboratories, FL, Inc. (Actavis); Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York, LLC (collectively, Amneal); Apotex Inc. and Apotex Corp. (collectively, Apotex); Citron Pharma LLC (Citron); Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy's)Reddy’s); Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively, Mylan); Par Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. (collectively, Par); Sun Pharmaceutical Industries Ltd. and Sun Pharmaceuticals Industries, Inc. (collectively, Sun); Teva Pharmaceuticals USA, Inc. (Teva); Wockhardt Bio A.G.; Wockhardt USA LLC and Wockhardt Ltd. (collectively, Wockhardt); West-Ward Pharmaceutical Corp. (West-Ward); and Hikma Pharmaceuticals, LLC (Hikma). The Court entered a stay of the lawsuit against Par and Citron, as each agreed to be bound by the decision against the other defendants in the action. In February 2016, the Courthas set a trial date of October 2017. Subsequently, Janssen and BTG initiated patent infringement lawsuits in the United States District Court for the District of New Jersey against Amerigen Pharmaceuticals Limited (Amerigen) in May 2016, and Glenmark Pharmaceuticals, Inc. in June 2016, each of whom filed an ANDA seeking approval to market its generic version of ZYTIGA® before the expiration of the ’438 patent.

In August 2015, Janssen and BTG filed an additional jurisdictional protective lawsuit against the Mylan defendants in the United States District Court for the Northern District of West Virginia, which has been stayed.


In August 2015, Janssen received a notice of paragraph IV certification from Hetero USA Inc., the U.S. Regulatory Agent for Hetero Labs Limited Unit-V, a division of Hetero Labs Limited (collectively, Hetero) advising of Hetero’s ANDA seeking approval for a generic version of ZYTIGA® before expiration of the '438 patent. In September 2015, Janssen and BTG filed an amended complaint in the New Jersey lawsuit to allege infringement of the '438 patent by Hetero.

In March 2016, Janssen filed a motion to correct inventorship of the ‘438 patent to add an inventor and requested that, should the Court order the requested correction, it grant Janssen leave to amend the complaint to recognize BTG as a co-owner of the ‘438 patent and a co-plaintiff with Janssen with regard to the ‘438 patent infringement claims.

In March 2016, Janssen received a notice from Amerigen Pharmaceuticals Limited (Amerigen) advising of Amerigen’s ANDA seeking approval for a generic version of ZYTIGA® before expiration of the ‘438 patent. In response, Janssen and BTG filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Amerigen in May 2016.

In May 2016, Janssen received a notice of paragraph IV certification from Glenmark Pharmaceuticals Inc., on behalf of Glenmark Pharmaceuticals SA, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. (collectively, Glenmark) advising of Glenmark’s ANDA seeking approval for a generic version of ZYTIGA® before expiration of the ‘438 patent. In response, in June 2016, Janssen and BTG filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Glenmark.

The filing of the above-referenced lawsuits triggered a stay until October 2018 during which the FDA will not grant final approval of the generics' ANDAs unless there is an earlier District Court decision finding the patents-in-suit invalid or not infringed.

In each of the above lawsuits, Janssen is seeking an order enjoining the defendants from marketing their generic versions of ZYTIGA® before the expiration of the relevant patents.’438 patent.

In December 2015,Several generic companies including Amerigen, Argentum Pharmaceuticals LLC (Argentum), Mylan, Wockhardt, Actavis, Amneal, Dr. Reddy’s, Sun, Teva, West-Ward and Hikma have filed a petitionPetitions for an Inter Partes Review in(IPR) with the USPTO, seeking to invalidate the '438’438 patent. In May 2016, the USPTO granted the Inter Partes Review, and a decision as to the validityThe Company is awaiting final written decisions in all of the ‘438 patent is expected by May 2017. In June 2016, Argentum Pharmaceuticals LLC and Mylan Pharmaceuticals Inc. filed petitions for Inter Partes Review in the USPTO seeking to invalidate the '438 patent and moved to join the Inter Partes Review filed by Amerigen.IPRs.

COMPLERA®
In August and September 2015, Janssen Pharmaceutica NV and Janssen Sciences Ireland UC (collectively, Janssen) and Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) filedinitiated patent infringement lawsuits in the United States District Courts for the District of Delaware and the District of West Virginia, respectively, against Mylan, Inc. and Mylan Pharmaceuticals, Inc. (collectively, Mylan) in response to Mylan’s, who filed an ANDA seeking approval to market a generic version of COMPLERA® before the expiration of United StatesU.S. Patent Nos. 8,841,310, (the '310 patent), 7,125,879 (the '879 patent) and 8,101,629 (the '629 patent).

8,101,629. In July 2017, the West Virginia action, in September 2015, Mylan filed an answer and counterclaims asserting invalidity and non-infringementlawsuit was dismissed without prejudice by stipulation of the '310 patent, '879 patent, and '629 patent, as well as United States Patent No. 8,080,551 (the ‘551 patent). In March 2016, the District of West Virginia Court stayed the lawsuit and scheduled a conditional trial date in February 2018, in accordance with the schedule in the first-filed Delaware lawsuit described below.parties.

In the Delaware action, in January and March 2016,lawsuit, Janssen and Gilead amended their complaint to add claims for patent infringement with respect to the ‘551 patent and United StatesU.S. Patent Nos. 7,399,856 (the '856 patent), 7,563,922 (the '922 patent),8,080,551; 7,399,856; 7,563,922; 8,101,752 (the '752 patent) and 8,618,291 (the '291 patent). In February 2016, Mylan moved to dismiss the suit for lack of personal jurisdiction and, in April 2016, Mylan filed a motion to dismiss, strike or sever the infringement claims regarding the ‘752 and ‘291 patents.8,618,291. A trial in the Delaware action has been scheduled for February 2018.

In each of these lawsuits, Janssen is seeking an order enjoining the defendants from marketing their generic versions of COMPLERA® before the expiration of the relevant patents.

XARELTO®
A number of generic companies have filed ANDAs seeking approval to market generic versions of XARELTOB®. Ineginning in October 2015, Janssen Pharmaceuticals, Inc. (JPI) and Bayer Pharma AG and Bayer Intellectual Property GmbH (collectively,(together, Bayer) filed patent infringement lawsuits in the United States District Court for the District of Delaware against Aurobindo Pharma

Limited, Aurobindo Pharma USA, Inc., Breckenridge Pharmaceutical, Inc., Micro Labs USA Inc. and Micro Labs Ltd. (collectively, Micro), Mylan Pharmaceuticals Inc., Mylan Inc. (Mylan), Prinston Pharmaceutical, Inc., Sigmapharm Laboratories, LLC, Torrent Pharmaceuticals, Limited and Torrent Pharma Inc., in response to those parties’ respectivea number of generic companies who filed ANDAs seeking approval to market generic versions of XARELTO® before the expiration of Bayer’s United StatesU.S. Patent Nos. 7,157,456 (the ‘456 patent), 7,585,860 (the ‘860 patent) and 7,592,339 (the ‘339 patent) relating to XARELTO®. JPI is the exclusive licensee of the asserted patents. The following generic companies are named defendants: Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. (together, Aurobindo); Breckenridge Pharmaceutical, Inc.; Invagen Pharmaceuticals Inc. (Invagen); Micro Labs USA Inc. and Micro Labs Ltd (together, Micro); Mylan Pharmaceuticals Inc. (Mylan); Prinston Pharmaceuticals, Inc.; Sigmapharm Laboratories, LLC (Sigmapharm); Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. Trial is scheduled for March 2018.

In November 2015, Mylan moved to dismissBeginning in April 2017, JPI and Bayer Intellectual Property GmbH and Bayer AG (together, Bayer AG) filed patent infringement lawsuits in the action. In December 2015, JPI, Bayer, and Mylan stipulated and agreed to dismiss the claims against Mylan, and suspend further briefing and argument on Mylan's motion to dismiss, pending appeals relating to personal jurisdiction over Mylan Pharmaceuticals Inc. inUnited States District Court for the District of Delaware. In February 2016,Delaware against a similar patent infringement action by JPI and Bayer against Invagen Pharmaceuticals Inc. (Invagen), in responsenumber of generic companies who filed ANDAs seeking approval to Invagen’s noticemarket generic versions of paragraph IV certification advising of its ANDA seeking FDA approval for a generic XARELTO® product before expiration of the relevant patents, was consolidated with the original case. The District Court has set a trial date of March 2018.

In April 2016, JPI and Bayer filed a separate patent infringement action in the District of Delaware against Micro, in responseAG’s U.S. Patent No. 9,539,218 relating to their notice of paragraph IV certification advising of their ANDA seeking FDA approval for a generic XARELTO® product before expiration of the ‘860. The following generic companies are named defendants: Taro Pharmaceutical Industries Ltd. and ‘339 patents. In May 2016, this action was consolidated with the original action.

In July 2016, JPITaro Pharmaceuticals U.S.A., Inc. (together, Taro); Aurobindo; Micro; Mylan; Sigmapharm; Invagen; Alembic Pharmaceuticals Limited, Alembic Global Holding SA and Bayer filed a separate patent infringement action in the District of Delaware against Breckenridge Pharmaceutical,Alembic Pharmaceuticals, Inc., in response to its notice of paragraph IV certification advising of its ANDA seeking FDA approval for a generic XARELTO® product before expiration of the ‘456 and ‘339 patents.

In each of these lawsuits, JPI is seeking an order enjoining the defendants from marketing their generic versions of XARELTO® before the expiration of the relevant patents.

RISPERDAL® CONSTA®

On November 30, 2016, the United States Patent and Trademark Office (USPTO) instituted an Inter Partes Review filed by Luye Pharma Group Ltd., Luye Pharma (USA) Ltd., Sandong Luye Pharmaceutical Co., Ltd. and Nanjing Luye Pharmaceutical Co., Ltd., seeking to invalidate U.S. Patent No. 6,667,061 relating to RISPERDAL CONSTA®. Janssen Pharmaceuticals, Inc. markets RISPERDAL CONSTA® pursuant to a license from Alkermes Pharma Ireland Ltd.  A decision by the USPTO is expected in November 2017.


INVOKANA®/INVOKAMET®

Beginning in July 2017, Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, Cilag GmbH International and Janssen Pharmaceutica NV (together, Janssen) and Mitsubishi Tanabe Pharma Corporation (MTPC) filed patent infringement lawsuits in the United States District Court for the District of New Jersey, the United States District Court for the District of Colorado and the United States District Court for the District of Delaware against a number of generic companies who filed ANDAs seeking approval to market generic versions of INVOKANA® and/or INVOKAMET® before expiration of MTPC’s U.S. Patent Nos. 7,943,582 and 8,513,202 relating to INVOKANA® and INVOKAMET®. Janssen is the exclusive licensee of the asserted patents. The following generic companies are named defendants:  Apotex Inc. and Apotex Corp.; Aurobindo Pharma USA Inc.; Macleods Pharmaceuticals Ltd.; Invagen Pharmaceuticals, Inc.; Prinston Pharmaceuticals Inc.; Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories Ltd; Hetero USA, Inc., Hetero Labs Limited Unit-V and Hetero Labs Limited; MSN Laboratories Private Ltd. and MSN Pharmaceuticals, Inc.; Laurus Labs Ltd.; Indoco Remedies Ltd.; Zydus Pharmaceuticals (USA) Inc. (Zydus); Sandoz, Inc. (Sandoz) and Teva Pharmaceuticals USA, Inc.

Beginning in July 2017, Janssen and MTPC filed patent infringement lawsuits in the United States District Court for the District of New Jersey and the United States District Court for the District of Colorado against Zydus and Sandoz, who filed ANDAs seeking approval to market generic versions of INVOKANA® and/or INVOKAMET® before expiration of MTPC’s U.S. Patent Nos. 7,943,788 and 8,222,219 relating to INVOKANA® and INVOKAMET® and MTPC’s U.S. Patent No. 8,785,403 relating to INVOKAMET®.  Janssen is the exclusive licensee of the asserted patents.

In each of these lawsuits, Janssen and MTPC are seeking an order enjoining the defendants from marketing their generic versions of INVOKANA® and/or INVOKAMET® before the expiration of the relevant patents.

VELETRI®

In July 2017, Actelion Pharmaceuticals Ltd. initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries Limited (collectively, Sun Pharmaceutical), who filed an ANDA seeking approval to market a generic version of VELETRI® before the expiration of United States Patent No. 8,598,227. Actelion is seeking an order enjoining Sun Pharmaceutical from marketing its generic version of VELETRI® before the expiration of the patent.
GOVERNMENT PROCEEDINGS
Like other companies in the pharmaceutical and medical devices industries, Johnson & Johnson and certain of its subsidiaries are subject to extensive regulation by national, state and local government agencies in the United States and other countries in which they operate. As a result, interaction with government agencies is ongoing. The most significant litigation brought by, and investigations conducted by, government agencies are listed below. It is possible that criminal charges and substantial fines and/or civil penalties or damages could result from government investigations or litigation.

Average Wholesale Price (AWP) Litigation
Johnson & Johnson and several of its pharmaceutical subsidiaries (the J&J AWP Defendants), along with numerous other pharmaceutical companies, arewere named as defendants in a series of lawsuits in state and federal courts involving allegations that the pricing and marketing of certain pharmaceutical products amounted to fraudulent and otherwise actionable conduct because, among other things, the companies allegedly reported an inflated Average Wholesale Price (AWP) for the drugs at issue. Payors alleged that they used those AWPs in calculating provider reimbursement levels. Many of these cases, both federal actions and state actions removed to federal court, were consolidated for pre-trial purposes in a Multi-District Litigation (MDL) in the United States District Court for the District of Massachusetts. The plaintiffs in these cases included three classes of private persons or entities that paid for any portion of the purchase of the drugs at issue based on AWP, and state government entities that made Medicaid payments for the drugs at issue based on AWP. In June 2007, afterMany of these cases, both federal actions and state actions removed to federal court, were consolidated for pre-trial purposes in a trial onmulti-district litigation in the merits,United States District Court for the MDL Court dismissed theDistrict of Massachusetts, where all claims of two of the plaintiff classes against the J&J AWP Defendants. In March 2011, the Court dismissed the claims of the third class against the J&J AWP Defendants without prejudice.

AWP cases brought by various Attorneys General have proceeded to trial against other manufacturers. Several state cases against certain Johnson & Johnson subsidiaries have been settled, including the case in Wisconsin, which settled in February 2016. Cases are still pending in Illinois, New Jersey, and Utah.were ultimately dismissed. The cases in Illinois and New Jersey have not yet proceeded to trial. In Utah, the claims brought by the Attorney General were dismissed by the Court in 2013, but the State may appeal the dismissal after the conclusion of similar pending matters against other defendants. In the AWP case against the J&J AWP Defendants also prevailed in a case brought by the Commonwealth of Pennsylvania, followingPennsylvania. Other AWP cases have been resolved through court order or settlement. Two cases remain pending. In a case brought by Illinois, the parties are awaiting assignment of a trial in 2010, the Pennsylvania Commonwealth Court found in favor of the Commonwealth with regard to certain of its claims under the Pennsylvania Unfair Trade Practicesdate. In New Jersey, a putative class action based upon AWP allegations is pending against Centocor, Inc. and Consumer Protection Law,Ortho Biotech Inc. (both now Janssen Biotech, Inc.), Johnson & Johnson and in favor of the J&J AWP Defendants on the Commonwealth’s remaining claims. Following an appeal to the Pennsylvania Supreme Court that vacated that judgment, the Commonwealth Court entered a subsequent judgment in favor of the J&J AWP Defendants on all claims. That subsequent judgment has been upheld by the Pennsylvania Supreme Court in a successive appeal.ALZA Corporation.

McNeil Consumer Healthcare
Starting in June 2010, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (now Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division) (McNeil Consumer Healthcare) and certain affiliates, including Johnson & Johnson (the Companies), received grand jury subpoenas from the United States Attorney's Office for the Eastern District of Pennsylvania requesting documents broadly relating to recalls of various products of McNeil Consumer Healthcare, and the FDA inspections of the Fort Washington, Pennsylvania and Lancaster, Pennsylvania manufacturing facilities, as well as certain documents relating to recalls of a small number of products of other subsidiaries.facilities. In addition, in February 2011, the government served McNEIL-PPC, Inc. (now Johnson & Johnson Consumer Inc.) (JJCI) with a Civil Investigative Demand seeking records relevant to its investigation to determine if there was a violation of the Federal False Claims Act. In March 2015, McNEIL-PPC, Inc. (now JJCI) entered a guilty plea in the United States District Court for the Eastern District of Pennsylvania to a misdemeanor violation of the U.S. Food, Drug, and Cosmetic Act. McNEIL-PPC, Inc. (now JJCI)Act and agreed to pay a $20 million fine and a $5 million forfeiture to resolve the matter.
The Companies have also received Civil Investigative Demands from multiple State Attorneys General Offices broadly relating to the McNeil recall issues. The Companies continue to cooperatecooperated with these inquiries, which are beingwere coordinated through a multi-state coalition. If a resolution cannot be reached with thisIn May 2017, the Companies and the multi-state coalition it is possibleagreed to a settlement that individual State Attorneys General Offices may file civil monetary claims against the Companies. resolves these matters.
In January 2011, the Oregon Attorney General filed a civil complaint against Johnson & Johnson, McNEIL-PPC, Inc. (now JJCI) and McNeil Healthcare LLC in state court alleging civil violations of the Oregon Unlawful Trade Practices Act relating to an earlier recall of a McNeil OTC product. In November 2012,Following the state court granted a motion by the Companies to dismiss Oregon's complaint in its entirety, with prejudice. In November 2015, the Court of Appealsappeal and reversal of the Statetrial court's grant of Oregon reversed the trial court and reinstated Oregon's consumer protection claims. In February 2016, the Oregon Supreme Court denied the Companies' petition for review, andmotion to dismiss, the case was sent back to the trial court. In March 2017, JJCI and McNeil Consumer Healthcare served an “Offer to Allow Judgment” in the case without any admission or finding of fact or wrongdoing. The offer allows the court to enter a judgment with specified relief without a trial. Oregon accepted the offer, and in May 2017 the court entered a stipulated judgment.
Opioids Litigation
Along with other pharmaceutical companies,Beginning in 2014 and continuing to the present, Johnson & Johnson (J&J) and Janssen Pharmaceuticals, Inc. (JPI), along with other pharmaceutical companies, have been named in threenumerous lawsuits alleging claimsbrought by certain states, counties and cities related to marketing of opioids, including DURAGESIC®, NUCYNTA® and NUCYNTA® ER. In May 2014, Santa Clara and Orange Counties in California filedThese actions allege a complaint in state court in Orange County, California against numerous pharmaceutical manufacturers, including J&J and JPI, allegingvariety of claims related to opioidopioids marketing practices, including false advertising, unfair competition, public nuisance, consumer fraud violations, deceptive acts and public nuisance.practices, false claims and unjust enrichment. The countiessuits generally seek penalties and/or injunctive and monetary relief. In February 2015, the defendants filed motions challenging the sufficiency of the complaint. In August 2015, the Court stayed the case until the FDA concludes its ongoing inquiry into the safety and effectiveness of long-term opioid treatment.

In June 2014,JPI and other pharmaceutical companies have received subpoenas or requests for information related to opioids marketing practices from three state Attorneys General: New Hampshire, New Jersey and Tennessee. JPI has also received a request for information from the Cityranking minority member of Chicago filed a complaint in Cook County Circuit Courtthe United States Senate Committee on Homeland Security and Governmental Affairs regarding the sales, marketing, and educational strategies related to the promotion of opioids use.

To date, complaints against the same group of pharmaceutical manufacturers, including J&J and JPI, alleging a numberwere filed by the following state and local governments: the State of claims related to opioid marketing practices, including consumer fraud violationsMississippi, in the Chancery Court of the First Judicial District of Hinds County; the State of Missouri in the Circuit Court of St. Louis City; the State of Ohio, in the Ross County Court of Common Pleas; the State of Oklahoma, in the District Court of Cleveland County; the California Counties of Santa Clara and false claims,Orange, in state court in Orange County, California; San Joaquin County and seeking injunctivethe City of Stockton and monetary relief. The case wasthe Montezuma Fire Protection District, in state court in San Joaquin County, California; the Illinois Counties of Jersey and Union, in the Illinois Circuit Court; the New York Counties of Broome, Dutchess, Erie, Nassau, Orange, Schenectady, Seneca, Suffolk and Sullivan, which have been consolidated in the New York Supreme Court in Suffolk County; the City of Chicago, initially in Cook County Circuit Court and later removed to the United States District Court for the Northern District of Illinois. In December 2014, J&J and JPI filed a motion to dismissIllinois; the City of Chicago's First Amended Complaint, which was granted with leave to file an amended complaint. TheDayton, Ohio and the City filed an amended complaint, and in November 2015, J&J and JPI filed a motion to dismiss the Second Amended Complaint.

In September 2014, the Tennessee Attorney General Division of Consumer Affairs issued a Request for Information to JPI and other pharmaceutical companies related to opioids marketing practices.

In August 2015, the New Hampshire Attorney General, Consumer Protection and Antitrust Bureau issued a subpoena to JPI and other pharmaceutical companies related to opioids marketing practices. In October 2015, the State filed a motionLorain, Ohio, each in the State of New Hampshire Superior Court to enforce the subpoena. JPI and the other pharmaceutical companies subsequently filed a joint motion for injunctive relief and a protective order to preclude the State from engaging private contingent fee counsel to participate in the State’s investigation or any subsequent enforcement action. In March 2016, the Court denied the State’s motion to enforce the subpoena and granted the protective order on the grounds that the State had not obtained requisite executive and legislative approvals to retain private counsel, but rejected the contention that the contingency fee agreement was otherwise unlawful. All parties have appealed the March 2016 ruling to the New Hampshire Supreme Court. In the interim, in May 2016, the New Hampshire Attorney General’s office obtained executive and legislative approvals to retain private counsel for the State’s investigation. In June 2016, in response to the State’s renewed demand (through its private counsel) to produce documents responsive to the subpoenas, JPI and the other pharmaceutical companies filed a joint motion to enforce the protective order.


In December 2015, the State of Mississippi filed a complaint in the ChanceryOhio Court of the First Judicial DistrictCommon Pleas. These cases are in early stages of Hinds County against substantially the same group of pharmaceutical manufacturers as in the suits brought by the California counties and City of Chicago, including J&J and JPI, alleging a number of claims related to opioid marketing practices and seeking penalties and injunctive and monetary relief. In March 2016, defendants filed motions to dismiss the complaint.litigation.

Other
In September 2011, Synthes, Inc. (Synthes) received a Civil Investigative Demand issued pursuant to the False Claims Act from the United States Attorney's Office for the Eastern District of Pennsylvania. The demand sought information regarding allegations that fellowships had been offered to hospitals in exchange for agreements to purchase products. Synthes has produced documents and information in response to the demand and is cooperating with the inquiry.
In May 2012, Acclarent, Inc. (Acclarent) received a subpoena from the United States Attorney's Office for the District of Massachusetts requesting documents broadly relating to the sales, marketing and alleged off-label promotion by Acclarent of the RELIEVA STRATUS® MicroFlow Spacer product (the RELIEVA STRATUS® Spacer). In March 2016, Acclarent executed a civil settlement with the United States Justice Department and other agencies to resolve this investigation. Johnson & Johnson was not a party to this settlement and there was no admission of liability. In a separate matter, in July 2016, the former President/CEO and Vice President of Sales of Acclarent (the former Acclarent officers), were convicted of misdemeanor violations in connection with the sale and marketing of the RELIEVA STRATUS® Spacer. There are no charges against Acclarent, Ethicon, Inc. or Johnson & Johnson in this matter.

In August 2012, DePuy Orthopaedics, Inc., DePuy, Inc. (now DePuy Synthes, Inc.), and Johnson & Johnson Services, Inc. received an informal request from the United States Attorney's Office for the District of Massachusetts and the Civil Division of the United States Department of Justice (the United States) for the production of materials relating to the DePuy ASR™ XL Hip device. In July 2014, the United States notified the United States District Court for the District of Massachusetts that it had declined to intervene in a qui tam case filed pursuant to the False Claims Act against the companies. In February 2016, the District Court granted the companies’ motion to dismiss with prejudice, unsealed the qui tam complaint, and denied the qui tam relators’ request for leave to file a further amended complaint. The qui tam relators' subsequent motionrelators appealed the case to the United States Court of Appeals for reconsideration was deniedthe First Circuit. In July 2017, the First Circuit affirmed the District Court’s dismissal in part and they have filedaffirmed the decision to deny the relators’ request to file a notice of appeal. In addition, inthird amended complaint. Since October 2013, a group of State Attorneys General have issued Civil Investigative Demands relating to the development, sales and marketing of several of DePuy Orthopaedics, Inc.’s's hip products. The Statesstates are seeking monetary and injunctive relief. In July 2014, the Oregon Department of Justice, which was investigating these matters independently of the other states, announced a settlement of its ASR XL Hip device investigation for a total payment of $4 million to the State of Oregon.
In October 2012, Johnson & Johnson was contacted by the California Attorney General's office regarding a multi-state Attorney General investigation of the marketing of surgical mesh products for hernia and urogynecological purposes by Johnson & Johnson's subsidiary, Ethicon, Inc. (Ethicon). Johnson & Johnson and Ethicon have since entered into a series of tolling agreements with the 47 states and the District of Columbia participating in the multi-state investigation and have responded to Civil Investigative Demands served by certain of the participating states. The states are seeking monetary and injunctive relief. In May 2016, California and Washington filed civil complaints against Johnson & Johnson, Ethicon Inc. and Ethicon US, LLC alleging violations of their consumer protection statutes. The companiesIn August 2016, Kentucky filed a similar complaint against the companies. Johnson & Johnson and Ethicon have entered into a new tolling agreement with the remaining 4544 states and the District of Columbia.
In December 2012, Therakos, Inc. (Therakos), formerly a subsidiary of Johnson & Johnson and part of the Ortho-Clinical Diagnostics, Inc. (OCD) franchise, received a letter from the civil division of the United States Attorney's Office for the Eastern District of Pennsylvania informing Therakos that the United States Attorney's Office was investigating the sales and marketing of Uvadex® (methoxsalen) and the Uvar Xts® Systemand Cellex® Systems during the period 2000 to the present. The United States Attorney's Office requested that OCD and Johnson & Johnson preserve documents that could relate to the investigation. Therakos was subsequently acquired by an affiliate of Gores Capital Partners III, L.P. in January 2013.2013, and OCD andwas divested in June 2014. Following the divestiture of OCD, Johnson & Johnson retain certain liabilitiesretains OCD’s portion of any liability that may result from the investigation for activity that occurred prior to the sale of Therakos. In March 2014 and March 2016, the United States Attorney’s Office requested that Johnson & Johnson produce certain documents, and Johnson & Johnson is cooperating with the request. Following the divestiture of OCD, Johnson & Johnson retains OCD’s portion of any liability that may result from the investigation for activity that occurred prior to the sale of Therakos.those requests.
In June 2014, the Mississippi Attorney General filed a complaint in Chancery Court of The First Judicial District of Hinds County, Mississippi against Johnson & Johnson and Johnson & Johnson Consumer Companies, Inc. (now Johnson & Johnson Consumer Inc.) (JJCI). The complaint alleges that defendants failed to disclose alleged health risks associated with female consumers' use of talc contained in JOHNSON'S® Baby Powder and JOHNSON'S® Shower to Shower (a product no longer sold by Johnson & Johnson)JJCI) and seeks injunctive and monetary relief. This matter isThe parties have agreed to adjourn the trial date and currently scheduled forexpect the trial in February 2017.to be re-scheduled to the spring of 2018.


In March 2016, Janssen Pharmaceuticals, Inc. (JPI) received a Civil Investigative Demand from the United States Attorney’s Office for the Southern District of New York related to JPI’s contractual relationships with pharmacy benefit managers over the period from January 1, 2006 to the present with regard to certain of JPI's pharmaceutical products. The demand was issued in connection with an investigation under the False Claims Act.

In recent years,January 2017, Janssen Pharmaceuticals, Inc. (JPI) received a Civil Investigative Demand from the United States Department of Justice (DOJ) relating to allegations concerning the sales and marketing practices of OLYSIOTM.

In February 2017, Johnson & Johnson received a subpoena from the United States Attorney's Office for the District of Massachusetts seeking the production of records pertaining to payments to any 501(c)(3) charitable organization that provides financial assistance to Medicare patients. Multiple pharmaceutical companies have publicly reported receipt of subpoenas and ongoing inquiries similar to this one and the one described below.

Actelion Pharmaceuticals US, Inc. (Actelion US), received a subpoena in May 2016, with follow-up requests in June and December 2016, from the United States Attorney's Office for the District of Massachusetts. The subpoena seeks the production of records pertaining to Actelion US’ payments to 501(c)(3) charitable organizations that provide financial assistance to Medicare patients.

In March 2017, Janssen Biotech, Inc. (JBI) received a Civil Investigative Demand from the United States Department of Justice regarding a False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased REMICADE® or SIMPONI ARIA®.

In April 2017, Johnson & Johnson received a subpoena from the United States Attorney for the District of Massachusetts seeking documents broadly relating to pharmaceutical copayment support programs for OLYSIOTM, SIMPONI® and STELARA®. The subpoena also seeks documents relating to Average Manufacturer Price and Best Price reporting to the Center for Medicare and Medicaid Services related to those products, as well as rebate payments to state Medicaid agencies.

In June 2017, Johnson & Johnson received a subpoena from the United States Attorney's Office for the District of Massachusetts seeking information regarding practices pertaining to the sterilization of DePuy Synthes spinal implants at three hospitals in Boston as well as interactions of Company employees with physicians at these hospitals.

From time to time, Johnson & Johnson has received numerous requests from a variety of United States Congressional Committees to produce information relevant to ongoing congressional inquiries. It is the policy of Johnson & Johnson to cooperate with these inquiries by producing the requested information.
GENERAL LITIGATION
In June 2009, following the public announcement that Ortho-Clinical Diagnostics, Inc. (OCD) had received a grand jury subpoena from the United States Department of Justice, Antitrust Division, in connection with an investigation that has since been closed, multiple class action complaints were filed against OCD by direct purchasers seeking damages for alleged price fixing. These cases were consolidated for pre-trial purposes in the United States District Court for the Eastern District of Pennsylvania as In re Blood Reagent Antitrust Litigation. Following the divestitureappeal and reversal of its initial grant of a motion for class certification, on remand, the District Court in October 2015 again granted a motion by the plaintiffs for class certification. OCD's motion for summary judgment was argued before the Court in January 2017 and the parties are awaiting a decision. OCD was divested in 2014 and Johnson & Johnson retainsretained any liability that may result from these cases. In August 2012, the District Court granted a motion filed by the plaintiffs for class certification. In April 2015, the United States Court of Appeals for the Third Circuit reversed the class certification ruling and remanded the case to the District Court for further proceedings. In October 2015, the District Court again granted the motion by the plaintiffs for class certification. In July 2016, OCD filed a motion for summary judgment.
In September 2011, Johnson & Johnson, Johnson & Johnson Inc. and McNeil Consumer Healthcare Division of Johnson & Johnson Inc. received a Notice of Civil Claim filed by Nick Field in the Supreme Court of British Columbia, Canada (the BC Civil Claim). The BC Civil Claim is a putative class action brought on behalf of persons who reside in British Columbia and who purchased during the period between September 20, 2001 and in or about December 2010 one or more various McNeil infants' or children's over-the-counter medicines that were manufactured at the Fort Washington, Pennsylvania facility. The BC Civil Claim alleges that the defendants violated the BC Business Practices and Consumer Protection Act, and other Canadian statutes and common laws, by selling medicines that were allegedly not safe and/or effective or did not comply with Canadian Good Manufacturing Practices. The class certification hearing scheduled for October 2015 was adjourned, and there is currently no date set for that hearing. In addition, in April 2016, a putative class action was filed against Johnson & Johnson, Johnson & Johnson Sales and Logistics Company, LLC and McNeil PPC, Inc. in New Jersey Superior Court, Camden County on behalf of persons who reside in the state of New Jersey who purchased various McNeil over-the-counter products from December 2008 through the present. The complaint alleges violations of the New Jersey Consumer Fraud Act. Following the grant of a motion to dismiss and the filing of an amended complaint, in May 2017, the Court denied a motion to dismiss the amended complaint.
In May 2014, two purported class actions were filed in federal court, one in the United States District Court for the Central District of California and one in the United States District Court for the Southern District of Illinois, against Johnson & Johnson (J&J) and Johnson & Johnson Consumer Companies, Inc. (now Johnson & Johnson Consumer Inc.) (JJCI), alleging violations of state consumer fraud statutes based on nondisclosure of alleged health risks associated with talc contained in JOHNSON'S® Baby Powder and JOHNSON'S® Shower to Shower (a product no longer sold by Johnson & Johnson)JJCI). The cases are pending in United States District Court for the Eastern District of California and United States District Court for the Southern District of Illinois. Both cases seek injunctive relief and monetary damages. Neither casedamages; neither includes a claim for personal injuries. In October 2016, both cases were transferred to the United States District Court for the District Court of New Jersey as part of a newly created federal multi-district litigation. In July 2017, the Court granted J&J and JJCI’s motion to dismiss one of the cases.

In August 2014, United States Customs and Border Protection (US CBP) issued a Penalty Notice against Janssen Ortho LLC (Janssen Ortho), assessing penalties for the alleged improper classification of darunavir ethanolate (the active pharmaceutical ingredient in PREZISTA®) in connection with its importation into the United States. In October 2014, Janssen Ortho submitted a Petition for Relief in response to the Penalty Notice. In May 2015, US CBP issued an Amended Penalty Notice assessing substantial penalties and Janssen Ortho filed its Petition for Relief in July 2015.

In March 2015, Costco Wholesale Corporation (Costco) filed a complaint against Johnson & Johnson Vision Care, Inc. (JJVCI) in the United States District Court of the Northern District of California, alleging antitrust claims of an unlawful vertical price fixing agreement between JJVCI, Costco and unnamed other distributors and retailers. Costco alleges that the alleged agreements harmed competition by causing increases in the price Costco customers pay for JJVCI contact lenses. Costco is seeking an injunction and monetary damages. In June 2015, the case was transferred to the United States District Court for the Middle District of Florida along with related class action cases described below. In May 2016, Costco dismissed its claims without prejudice.

In March and April 2015, over 30 putative class action complaints were filed by contact lens patients in a number of courts around the United States against Johnson & Johnson Vision Care, Inc. (JJVCI), other contact lens manufacturers, distributors, and retailers, alleging vertical and horizontal conspiracies to fix the retail prices of contact lenses. The complaints allege that the manufacturers reached agreements with each other and certain distributors and retailers concerning the prices at which some contact lenses could be sold to consumers. The plaintiffs are seeking damages and injunctive relief. All of the class action cases were transferred to the United States District Court for the Middle District of Florida in June 2015. The plaintiffs filed a

Consolidated Class Action consolidated class action complaint in November 2015, and in December 2015, JJVCI and other defendants filed motions to dismiss.2015. In June 2016, the Court denied the motions to dismiss.
dismiss filed by JJVCI and other defendants. Discovery is ongoing. In April 2015, Johnson & Johnson Vision Care, Inc. (JJVCI)March 2017, the plaintiffs filed a complaint in the United States District Court for the District of Utah against the State of Utah seeking a declaratory judgment that a law passed by the State to ban unilateral pricing policies solely in the contact lens market violates the Commerce Clause of the United States Constitution. The Court denied JJVCI's motion for a preliminary injunction. JJVCI appealed. Argument on the appeal was held in August 2015.class certification.
In April 2015, Adimmune Corporation Ltd (Adimmune) commenced an arbitration in the International Court of Arbitration - International Chamber of Commerce against Crucell Switzerland AG (now Janssen Vaccines AG) and Crucell Holland B.V. (now Janssen Vaccines & Prevention B.V.) (collectively, Crucell). Adimmune claims that Crucell breached certain agreements relating to the supply of flu antigen when Crucell ceased purchasing flu antigen from Adimmune. In December 2015, Adimmune filed its Statement of Claim seeking monetary damages. In April 2017, the Arbitration Panel ruled that Crucell breached its agreement with Adimmune, but awarded Adimmune zero damages.
In August 2015, two third-party payors filed a purported class action in the United States District Court for the Eastern District of Louisiana against Janssen Research & Development, LLC, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Johnson & Johnson (as well as certain Bayer entities), alleging that the defendants improperly marketed and promoted XARELTO® as safer and more effective than less expensive alternative medications while failing to fully disclose its risks. The complaint seeks damagesdamages.
In May 2017, a purported class action was filed in an unspecified amount.the United States District Court for the Western District of Washington against Lifescan Inc., Johnson & Johnson, other diabetes test strip manufacturers, and certain Pharmacy Benefit Managers (PBMs). The complaint alleges that consumers paid inflated prices for glucose monitor test strips as a consequence of undisclosed rebates and other incentives paid by manufacturers to PBMs. The complaint includes RICO, ERISA, and state consumer protection claims. The complaint seeks equitable relief and damages.
In May 2017, Lonza Sales AG (Lonza) filed a Request for Arbitration with the London Court of International Arbitration against Janssen Research & Development, LLC. Lonza alleges that Janssen breached a 2005 agreement between the parties by sublicensing certain Lonza technology used in the manufacture of daratumumab without Lonza’s consent. Lonza seeks monetary damages.
Johnson & Johnson or its subsidiaries are also parties to a number of proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly known as Superfund, and comparable state, local or foreign laws in which the primary relief sought is the cost of past and/or future remediation.



NOTE 12— RESTRUCTURING

The Company announced restructuring actions in its Medical Devices segment to better serve the needs of patients and customers in today’s evolving healthcare marketplace. The Company is undertaking actions to strengthen its go-to-market model, accelerate the pace of innovation, further prioritize key platforms and geographies, and streamline operations while maintaining high quality standards.

The Company estimates that, in connection with its plans, it will record pre-tax restructuring and other charges of approximately $2.0 billion to $2.4 billion, most of which are expected to be incurred by 2017.billion. In the fiscal six months of 2016,2017, the Company recorded a pre-tax charge of $278$289 million, of which $24$17 million was included in cost of products sold and $20$176 million was included in other (income) expense. In the fiscal second quarter of 2017, the Company recorded a pre-tax charge of $128 million, of which $13 million was included in cost of products sold and $104 million was included in other (income) expense. In the fiscal second quarter of 2017, the Company recorded a $90 million accrual adjustment to the severance reserve due to higher voluntary separation than anticipated. See the following table below for additional details. Total restructuring chargesproject costs of $868 million$1.6 billion have been recorded since the restructuring has been announced.announcement.

Additionally, as part of the plan, the Company expects that the restructuring actions will result in position eliminations of approximately 4 to 6 percent of the Medical Devices segment’s global workforce over the next two years,18 months, subject to any consultation procedures in countries, where required. Approximately 9002,100 positions have been eliminated of which 1,650 received separation payments since the restructuring has been announced.announcement.

The Company estimates that approximately one half of the cumulative pre-tax costs will result in cash outlays, including
approximately $500$400 million of employee severance. Approximately one half of the cumulative pre-tax costs are non-cash,
relating primarily to facility rationalization, inventory write-offs and intangible asset write-offs.

The following table summarizes the severance related reserves and the associated spending under this initiative through the first fiscal six months of 2016:2017:
(Dollars in Millions)

SeveranceAsset Write-offsOtherTotalSeveranceAsset Write-offsOther**Total
Reserve balance, January 3, 2016$484

17
501
Reserve balance, January 1, 2017$380

1
381
    
Current year activity:



Charges
150
128
278

112
267
379
Cash payments(56)
(142)(198)(39)
(264)(303)
Settled without cash
(150)
(150)
Settled non cash
(112)
(112)
Accrual adjustment(90)

(90)
    
Reserve balance, July 3, 2016*$428

3
431
Reserve balance, July 2, 2017*$251

4
255
    
*Cash outlays for severance are expected to be substantially paid out over the next 24 months2 years in accordance with the Company's plans and local laws.

**Other includes project expense such as salaries for employees supporting the initiative and consulting expenses.

Item 2 — MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

RESULTS OF OPERATIONS

Analysis of Consolidated Sales

For the first fiscal six months of 2016,2017, worldwide sales were $36.0$36.6 billion, a total increase of 2.3%1.8%, including operational growth of 4.6%2.5% as compared to 20152016 first fiscal six months sales of $35.2$36.0 billion. Currency fluctuations had a negative impact of 2.3%0.7% for the first fiscal six months of 2016.2017. In the first fiscal six months of 2016,2017, the net impact of acquisitions and divestitures and competitive products to the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir), on the worldwide operational sales growth was negative 2.8%a positive 1.7%. Operations in Venezuela negatively impacted the worldwide operational sales growth by 0.5%.

Sales by U.S. companies were $18.9$19.1 billion in the first fiscal six months of 2016,2017, which represented an increase of 7.3%1.1% as compared to the prior year. In the first fiscal six months of 2016,2017, the net impact of acquisitions divestitures and competitive products to the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir),divestitures on the U.S. operational sales growth was negativea positive 2.0%. Sales by international companies were $17.1$17.5 billion, a declinean increase of 2.8%2.5%, including operational growth of 1.8%4.0%, partially offset by a negative currency impact of 4.6%1.5% as compared to the first fiscal six months sales of 2015.2016. In the first fiscal six months of 2016,2017, the net impact of acquisitions divestitures and competitive products to the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir),divestitures on the international operational sales growth was negative 3.6%a positive 1.3%. Operations in Venezuela negatively impacted the international operational sales growth by 0.9%.

In the first fiscal six months of 2016,2017, sales by companies in Europe experiencedachieved growth of 1.9%, which included operational growth of 5.4% and a declinenegative currency impact of 3.1%3.5%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved growth of 2.8%, which included an operational decline of 0.6%0.2%, and a positive currency impact of 3.0%. Sales by companies in the Asia-Pacific, Africa region achieved growth of 3.1%, including operational growth of 4.1% partially offset by a negative currency impact of 1.0%.

For the fiscal second quarter of 2017, worldwide sales were $18.8 billion, a total increase of 1.9%, including operational growth of 2.9% as compared to 2016 fiscal second quarter sales of $18.5 billion. Currency fluctuations had a negative impact of 1.0% for the fiscal second quarter of 2017. In the fiscal second quarter of 2017, the net impact of acquisitions and divestitures on worldwide operational sales growth was a positive 2.4%.

Sales by U.S. companies were $9.7 billion in the fiscal second quarter of 2017, which represented an increase of 1.6% as compared to the prior year. In the fiscal second quarter of 2017, the net impact of acquisitions and divestitures on the U.S. operational sales growth was a positive 2.6%. Sales by international companies were $9.1 billion, an increase of 2.3%, including operational growth of 4.4%, partially offset by a negative currency impact of 2.1% as compared to the fiscal second quarter sales of 2016. In the fiscal second quarter of 2017, the net impact of acquisitions and divestitures on the international operational sales growth was a positive 2.4%.

In the fiscal second quarter of 2017, sales by companies in Europe achieved growth of 3.5%, which included operational growth of 6.7% and a negative currency impact of 2.5%3.2%. Sales by companies in the Western Hemisphere, excluding the U.S., experienced a decline of 8.5%2.8%, which included an operational growthdecrease of 7.1%2.7%, offset byand a negative currency impact of 15.6%0.1%. Sales by companies in the Asia-Pacific, Africa region achieved growth of 0.5%, which including operational growth of 2.5% and a negative currency impact of 2.0%.

For the fiscal second quarter of 2016, worldwide sales were $18.5 billion, a total increase of 3.9%3.2%, including operational growth of 5.3% as compared to 2015 fiscal second quarter sales of $17.8 billion. Currency fluctuations had a negative impact of 1.4% for the fiscal second quarter of 2016. In the fiscal second quarter of 2016, the impact of acquisitions, divestitures and competitive products to the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir), on the worldwide operational sales growth was negative 2.6%. Operations in Venezuela negatively impacted the worldwide operational sales growth by 0.3%.

Sales by U.S. companies were $9.6 billion in the fiscal second quarter of 2016, which represented an increase of 7.4% as compared to the prior year. In the fiscal second quarter of 2016, the impact of acquisitions, divestitures and competitive products to the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir), on the U.S. operational sales growth was negative 1.4%. Sales by international companies were $8.9 billion, an increase of 0.4%, including operational growth of 3.1%,4.9% partially offset by a negative currency impact of 2.7% as compared to the fiscal second quarter sales of 2015. In the fiscal second quarter of 2016, the impact of acquisitions, divestitures and competitive products to the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir), on the international operational sales growth was negative 3.8%. Operations in Venezuela negatively impacted the international operational sales growth by 0.7%.

In the fiscal second quarter of 2016, sales by companies in Europe experienced a decline of 1.5%, which included an operational decline of 0.6% and a negative currency impact of 0.9%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved growth of 2.7%, which included operational growth of 15.4%, and a negative currency impact of 12.7%. Sales by companies in the Asia-Pacific, Africa region achieved growth of 1.7%, including operational growth of 2.1% and a negative currency impact of 0.4%.








ANALYSIS OF SALES BY BUSINESS SEGMENTS

Consumer
Consumer segment sales in the first fiscal six months of 20162017 were $6.6$6.7 billion, a decreasean increase of 3.8%1.4% as compared to the same period a year ago, including operational growth of 0.6%1.6% partially offset by a negative currency impact of 4.4%0.2%. U.S. Consumer segment sales increased by 1.0%5.8%. International Consumer segment sales decreased by 6.9%1.7%, including an operational growthdecrease of 0.4% offset by1.3% and a negative currency impact of 7.3%0.4%. In the first fiscal six months of 2016,2017, the impact of acquisitions and divestitures on the Consumer segment operational sales growth was negative 2.3%. Operations in Venezuela negatively impacted the Consumer segment operational sales growth by 1.6%a positive 3.2%.

Major Consumer Franchise SalesSales* — Fiscal Six Months Ended
(Dollars in Millions) July 3, 2016 June 28, 2015 Total
Change
 Operations
Change
 Currency
Change
 July 2, 2017 July 3, 2016 Total
Change
 Operations
Change
 Currency
Change
OTC $2,027
 $1,967
 3.1 % 6.8% (3.7)% $2,019
 $1,995
 1.2 % 1.8% (0.6)%
Skin Care 1,815
 1,797
 1.0
 3.9
 (2.9)
Beauty 2,057
 1,855
 10.9
 11.4
 (0.5)
Baby Care 951
 1,054
 (9.8) (2.6) (7.2) 949
 1,013
 (6.3) (6.3) 0.0
Oral Care 788
 794
 (0.8) 3.8
 (4.6) 756
 788
 (4.1) (3.9) (0.2)
Women’s Health

 534
 607
 (12.0) (2.9) (9.1) 518
 534
 (3.0) (4.2) 1.2
Wound Care/Other 499
 654
 (23.7) (21.9) (1.8) 407
 429
 (5.1) (5.0) (0.1)
Total Consumer Sales $6,614
 $6,873
 (3.8)% 0.6% (4.4)% $6,706
 $6,614
 1.4 % 1.6% (0.2)%
*Prior year amounts have been reclassified to conform to current year presentation.

Consumer segment sales in the fiscal second quarter of 20162017 were $3.4$3.5 billion, a decreasean increase of 1.8%1.7% as compared to the same period a year ago, including operational growth of 1.5%2.3% and a negative currency impact of 3.3%0.6%. U.S. Consumer segment sales increased by 2.1%7.4%. International Consumer segment sales decreased by 4.4%2.2%, including an operational growthdecline of 1.0%1.1% and a negative currency impact of 5.4%1.1%. In the fiscal second quarter of 2016,2017, the net impact of acquisitions and divestitures on the Consumer segment operational sales growth was negative 2.4%. Operations in Venezuela negatively impacted the Consumer segment operational sales growth by 1.2%a positive 3.1%.

Major Consumer Franchise SalesSales*Fiscal Second Quarters Ended
(Dollars in Millions) July 3, 2016 June 28, 2015 Total
Change
 Operations
Change
 Currency
Change
 July 2, 2017 July 3, 2016 Total
Change
 Operations
Change
 Currency
Change
OTC $1,008
 $974
 3.5 % 6.2% (2.7)% $1,006
 $996
 1.0 % 2.1% (1.1)%
Skin Care 953
 894
 6.6
 8.7
 (2.1)
Beauty 1,076
 976
 10.2
 11.0
 (0.8)
Baby Care 500
 543
 (7.9) (2.1) (5.8) 494
 530
 (6.8) (6.5) (0.3)
Oral Care 403
 391
 3.1
 6.6
 (3.5) 394
 403
 (2.2) (1.7) (0.5)
Women’s Health 283
 320
 (11.6) (4.8) (6.8) 276
 283
 (2.5) (3.3) 0.8
Wound Care/Other 272
 361
 (24.7) (23.6) (1.1) 232
 231
 0.4
 0.9
 (0.5)
Total Consumer Sales $3,419
 $3,483
 (1.8)% 1.5% (3.3)% $3,478
 $3,419
 1.7 % 2.3% (0.6)%
*Prior year amounts have been reclassified to conform to current year presentation.

The OTC franchise achieved operational growth of 6.2%2.1% as compared to the prior year fiscal second quarter. The growthGrowth was primarily driven by analgesics, digestive healthsales of upper respiratory products, primarily ZYRTEC®,and sales outside the U.S. of anti-smoking aids.

The Skin CareBeauty franchise achieved operational growth of 8.7%11.0% as compared to the prior year fiscal second quarter. Growth was primarily driven by sales from recent acquisitions, primarily Vogue International LLC, which contributed approximately 9.6% of the operational growth. Additionally, sales of NEUTROGENA® sunprotectionproducts contributed to the growth.

The Baby Care franchise experienced an operational decline of 6.5% as compared to the prior year fiscal second quarter due to competitive pressure.

The Oral Care franchise experienced an operational decline of 1.7% as compared to the prior year fiscal second quarter primarily driven by category declines in the U.S. partially offset by growth in Asia Pacific.


The Women’s Health franchise experienced an operational decline of 3.3% as compared to the prior year fiscal second quarter primarily due to sales growthcategory slowdown in Europe and the U.S. divestiture of AVEENO and NEUTROGENA products.

The Baby Care franchise experienced an operational decline of 2.1% as compared to the prior year fiscal second quarter due to operations in Venezuela, lower sales in China and competitive pressure.

The Oral Care franchise achieved operational growth of 6.6% as compared to the prior year fiscal second quarter. Growth was driven by increased sales of LISTERINETUCKS®as a result of new product launches and successful marketing campaigns partially offset by operations in Venezuela..

The Women’s Health franchise experienced an operational decline of 4.8% as compared to the prior year fiscal second quarter. Strong sales of new products was offset by operations in Venezuela.

The Wound Care/Other franchise experienced an operational decline of 23.6%grew operationally by 0.9% as compared to the prior year fiscal second quarter primarily due to U.S. increased promotional activity partially offset by competitive pressure outside the SPLENDA® divestiture.

U.S.

Pharmaceutical
Pharmaceutical segment sales in the first fiscal six months of 20162017 were $16.8$16.9 billion, an increase of 7.4%0.3% as compared to the same period a year ago, with an operational increase of 9.1%1.2% and a negative currency impact of 1.7%0.9%. U.S. Pharmaceutical sales increased 13.1%decreased 2.0% as compared to the same period a year ago. International Pharmaceutical sales decreasedincreased by 0.1%3.7%, including operational growth of 3.8%5.9% partially offset by a negative currency impact of 3.9%2.2%. Acquisitions, divestitures and competitive products toIn the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir), had a negative impact of 3.4% on the operational growth of the Pharmaceutical segment in thefirst fiscal six months of 2016. In2017, the fiscal six monthsnet impact of 2016acquisitions and divestitures on the Pharmaceutical segment operational sales growth was impacted approximately 0.6% by a positive adjustmentnegative 0.1%. Adjustments to previous reserve estimates, as compared to the same period aprior year, ago.negatively impacted the Pharmaceutical segment operational growth for the first fiscal six months of 2017, by approximately 3.0%, primarily in the Immunology and Cardiovascular/Metabolism/Other therapeutic areas.

Major Pharmaceutical Therapeutic Area SalesSales* — Fiscal Six Months Ended


          
(Dollars in Millions) July 3, 2016 June 28, 2015 
Total
Change
 
Operations
Change
 
Currency
Change
 July 2, 2017 July 3, 2016 
Total
Change
 
Operations
Change
 
Currency
Change
Total Immunology $5,948
 $5,017
 18.6 % 20.2% (1.6)% $5,889
 $5,948
 (1.0)% (0.7)% (0.3)%
REMICADE®
 3,559
 3,268
 8.9
 10.5
 (1.6) 3,202
 3,559
 (10.0) (9.9) (0.1)
SIMPONI®/ SIMPONI ARIA®
 838
 608
 37.8
 39.5
 (1.7) 867
 838
 3.5
 3.8
 (0.3)
STELARA®
 1,539
 1,119
 37.5
 38.7
 (1.2) 1,806
 1,539
 17.3
 18.3
 (1.0)
Other Immunology 12
 22
 (45.5) (36.4) (9.1) 14
 12
 16.7
 14.0
 2.7
Total Infectious Diseases 1,605
 2,007
 (20.0) (18.6) (1.4) 1,541
 1,605
 (4.0) (3.0) (1.0)
EDURANT®
 259
 192
 34.9
 35.6
 (0.7)
OLYSIO®/SOVRIAD®
 75
 498
 (84.9) (84.5) (0.4)
EDURANT®/rilpivirine

 328
 259
 26.6
 29.2
 (2.6)
PREZISTA®/ PREZCOBIX®/REZOLSTA®
 911
 875
 4.1
 5.5
 (1.4) 884
 911
 (3.0) (2.0) (1.0)
Other Infectious Diseases 360
 442
 (18.6) (15.8) (2.8) 329
 435
 (24.4) (24.4) 0.0
Total Neuroscience 3,151
 3,182
 (1.0) 0.6
 (1.6) 2,964
 3,151
 (5.9) (4.9) (1.0)
CONCERTA®/methylphenidate
 469
 430
 9.1
 11.7
 (2.6) 390
 469
 (16.8) (16.2) (0.6)
INVEGA®/paliperidone
 168
 321
 (47.7) (47.3) (0.4)
INVEGA SUSTENNA®/XEPLION®/INVEGA TRINZA®
 1,073
 847
 26.7
 28.0
 (1.3)
INVEGA SUSTENNA®/XEPLION®/TRINZA®
 1,233
 1,073
 14.9
 16.2
 (1.3)
RISPERDAL® CONSTA®
 461
 501
 (8.0) (6.6) (1.4) 414
 461
 (10.2) (8.9) (1.3)
Other Neuroscience 980
 1,083
 (9.5) (7.5) (2.0) 927
 1,148
 (19.3) (18.4) (0.9)
Total Oncology 2,828
 2,252
 25.6
 28.1
 (2.5) 3,321
 2,828
 17.4
 19.2
 (1.8)
DARZALEX®
 554
 209
 ** ** ***
IMBRUVICA®
 556
 270
 *
 *
 **
 859
 556
 54.5
 56.8
 (2.3)
VELCADE®
 646
 683
 (5.4) (2.0) (3.4) 570
 646
 (11.8) (9.0) (2.8)
ZYTIGA®
 1,159
 1,102
 5.2
 6.8
 (1.6) 1,081
 1,159
 (6.7) (5.7) (1.0)
Other Oncology 467
 197
 *
 *
 **
 257
 258
 (0.4) 1.3
 (1.7)
Pulmonary Hypertension 91
 
 **** **** 
OPSUMIT®
 45
 
 **** **** 
TRACLEER®
 26
 
 **** **** 
UPTRAVI®
 9
 
 **** **** 
Other 11
 
 **** **** 
Cardiovascular / Metabolism / Other 3,300
 3,214
 2.7
 4.2
 (1.5) 3,074
 3,300
 (6.8) (6.0) (0.8)
XARELTO®
 1,161
 913
 27.2
 27.2
 
 1,155
 1,161
 (0.5) (0.5) 
INVOKANA®/ INVOKAMET®
 708
 596
 18.8
 19.5
 (0.7) 579
 708
 (18.2) (17.9) (0.3)
PROCRIT®/EPREX®
 596
 545
 9.4
 10.9
 (1.5) 502
 596
 (15.8) (15.3) (0.5)
Other 835
 1,160
 (28.0) (25.0) (3.0) 838
 835
 0.4
 3.1
 (2.7)
Total Pharmaceutical Sales $16,832
 $15,672
 7.4 % 9.1% (1.7)% $16,880
 $16,832
 0.3 % 1.2 % (0.9)%
          

*Prior year amounts have been reclassified to conform to current year product disclosure.
**Percentage greater than 100%
*** Not meaningful
****On June 16, 2017, the Company acquired Actelion.

Pharmaceutical segment sales in the fiscal second quarter of 20162017 were $8.7$8.6 billion, an increasea decrease of 8.9%0.2% as compared to the same period a year ago, with an operational increase of 9.7% and1.0% offset by a negative currency impact of 0.8%1.2%. U.S. Pharmaceutical sales increased 13.2%decreased 2.6% as compared to the same period a year ago. International Pharmaceutical sales increased by 3.1%3.3%, including operational growth of 4.9% and6.1% partially offset by a negative currency impact of 1.8%2.8%. Acquisitions, divestitures and competitive products to the Company's Hepatitis C products, OLYSIO®/SOVRIAD® (simeprevir) and INCIVO® (telaprevir), had a negative impact of 3.1% on the operational growth of the Pharmaceutical segment in the fiscal second quarter of 2016. In the fiscal second quarter of 2016,2017, the net impact of acquisitions and divestitures on the Pharmaceutical segment operational sales growth was impacted approximately 1.6% due to a higher positive adjustment0.5%. Adjustments to previous reserve estimates, as compared to the same period aprior year, ago.negatively impacted the Pharmaceutical segment operational growth for the fiscal second quarter of 2017, by approximately 4.0%, primarily in the Immunology and Cardiovascular/Metabolism/Other therapeutic areas.

Major Pharmaceutical Therapeutic Area SalesSales*Fiscal Second Quarters Ended
(Dollars in Millions) July 3, 2016 June 28, 2015 
Total
Change
 
Operations
Change
 
Currency
Change
 July 2, 2017 July 3, 2016 
Total
Change
 
Operations
Change
 
Currency
Change
Total Immunology $3,038
 $2,554
 19.0 % 19.8% (0.8)% $2,959
 $3,038
 (2.6)% (1.9)% (0.7)%
REMICADE®
 1,780
 1,668
 6.7
 7.7
 (1.0) 1,530
 1,780
 (14.0) (13.6) (0.4)
SIMPONI®/ SIMPONI ARIA®
 448
 308
 45.5
 45.4
 0.1
 439
 448
 (2.0) (1.0) (1.0)
STELARA®
 804
 570
 41.1
 41.4
 (0.3) 983
 804
 22.3
 23.4
 (1.1)
Other Immunology 6
 8
 (25.0) (15.2) (9.8) 7
 6
 16.7
 15.8
 0.9
Total Infectious Diseases 829
 1,032
 (19.7) (19.1) (0.6) 792
 829
 (4.5) (3.4) (1.1)
EDURANT®
 140
 101
 38.6
 36.9
 1.7
OLYSIO®/ SOVRIAD®
 43
 264
 (83.7) (83.5) (0.2)
EDURANT®/rilpivirine
 179
 140
 27.9
 30.0
 (2.1)
PREZISTA®/ PREZCOBIX®/ REZOLSTA®
 459
 448
 2.5
 3.1
 (0.6) 454
 459
 (1.1) (0.1) (1.0)
Other Infectious Diseases 187
 219
 (14.6) (12.5) (2.1) 159
 230
 (30.9) (30.4) (0.5)
Total Neuroscience 1,602
 1,564
 2.4
 2.8
 (0.4) 1,467
 1,602
 (8.4) (7.0) (1.4)
CONCERTA®/ methylphenidate
 238
 206
 15.5
 17.3
 (1.8) 181
 238
 (23.9) (22.8) (1.1)
INVEGA®/ paliperidone
 82
 166
 (50.6) (51.2) 0.6
INVEGA SUSTENNA®/XEPLION®/INVEGA TRINZA®
 560
 436
 28.4
 28.6
 (0.2)
INVEGA SUSTENNA®/XEPLION®/TRINZA®
 629
 560
 12.3
 13.7
 (1.4)
RISPERDAL CONSTA®
 230
 247
 (6.9) (6.7) (0.2) 207
 230
 (10.0) (8.5) (1.5)
Other Neuroscience 492
 509
 (3.3) (3.0) (0.3) 450
 574
 (21.6) (20.0) (1.6)
Total Oncology 1,474
 1,144
 28.8
 29.8
 (1.0) 1,727
 1,474
 17.2
 19.2
 (2.0)
DARZALEX®
 299
 108
 ** ** ***
IMBRUVICA®
 295
 154
 91.6
 93.1
 (1.5) 450
 295
 52.5
 55.1
 (2.6)
VELCADE®
 342
 344
 (0.6) 1.4
 (2.0) 290
 342
 (15.2) (12.6) (2.6)
ZYTIGA®
 601
 546
 10.1
 10.2
 (0.1) 558
 601
 (7.2) (5.8) (1.4)
Other Oncology 236
 100
 * * ** 130
 128
 1.6
 3.1
 (1.5)
Pulmonary Hypertension 91
 
 **** **** 
OPSUMIT®
 45
 
 **** **** 
TRACLEER®
 26
 
 **** **** 
UPTRAVI®
 9
 
 **** **** 
Other 11
 
 **** **** 
Cardiovascular / Metabolism / Other 1,711
 1,652
 3.6
 4.7
 (1.1) 1,599
 1,711
 (6.5) (5.5) (1.0)
XARELTO®
 594
 472
 25.8
 25.8
 
 642
 594
 8.1
 8.1
 
INVOKANA®/ INVOKAMET®
 383
 318
 20.4
 21.0
 (0.6) 295
 383
 (23.0) (22.5) (0.5)
PROCRIT®/ EPREX®
 322
 276
 16.7
 17.5
 (0.8) 255
 322
 (20.8) (20.1) (0.7)
Other 412
 586
 (29.7) (27.4) (2.3) 407
 412
 (1.2) 1.9
 (3.1)
Total Pharmaceutical Sales $8,654
 $7,946
 8.9 % 9.7% (0.8)% $8,635
 $8,654
 (0.2)% 1.0 % (1.2)%
*Prior year amounts have been reclassified to conform to current year product disclosure.
**Percentage greater than 100%

*** Not meaningful
****On June 16, 2017, the Company acquired Actelion.

Immunology products achievedexperienced an operational sales growthdecline of 19.8%1.9% as compared to the same period a year ago dueago. Immunology was negatively impacted by approximately 6.0% by a positive adjustment to strong market growth and increased share for both STELARA® (ustekinumab) and SIMPONI®/SIMPONI ARIA® (golimumab). Additionally,previous reserve estimates recorded in the fiscal second quarter of 2016 total immunologyand lower sales growth was positively impacted by approximately 6.0% due to an adjustment to previous reserve estimates. On a product basis, growth of REMICADE®(infliximab), SIMPONI®/SIMPONI ARIA® (golimumab) and due to biosimilar competition. The decline was partially offset by strong growth of STELARA® (ustekinumab) were positively impacted by approximately 5.5%, 7.0%, and 7.0%, respectively. .

The patents for REMICADE®(infliximab) in certain countries in Europe expired in February 2015. Biosimilar versions of REMICADE® have been introduced in certain markets outside the United States, resulting in a reduction in sales of REMICADE® in those markets. Additional biosimilar competition will likely result in a further reduction

in REMICADE® sales in markets outside the United States. The timing of the possible introduction of anya biosimilar version of REMICADE®in the United States is subject to enforcement of patent rights, approval by the U.S. Food and Drug Administration (FDA) and compliance with the 180-day notice provisions of the Biologics Price Competition and Innovation Act (the BPCIA).Act. In April 2016, the FDA approved a biosimilar version of REMICADE®for sale in the United States. There isStates an infliximab biosimilar to be marketed by a risk that thissubsidiary of Pfizer Inc., which was launched in the United States in late 2016. In addition in April 2017, the FDA approved for sale in the United States an infliximab biosimilar version of REMICADE® couldto be introduced tomarketed by Merck, which was launched in July 2017. Continued infliximab biosimilar competition in the U.S. market on or after October 3, 2016 (180 days after the FDA’s approval), even though one or more valid patents are in place and the Company will continue to assert its patent rights.Introduction to the U.S. market of a biosimilar version of REMICADE®will result in a further reduction in U.S. sales of REMICADE®. The launch of a biosimilar version ofCompany continues to assert REMICADE® in the U.S. is not expected to have a material adverse effect on the Company’s results of operations and cash flows in 2016.related patent rights. See Note 11 to the Consolidated Financial Statements for a description of legal matters regarding the REMICADE® patents.

Infectious disease products experienced an operational decline of 19.1%3.4% as compared to the same period a year ago. Competitive products to the Company's Hepatitis C products,Lower sales of OLYSIO® (simeprevir) and PREZISTA® (darunavir/cobicistat) were partially offset by strong sales growth of PREZCOBIX®/SOVRIADREZOLSTA® (simeprevir)(darunavir/cobicistat) and INCIVO® (telaprevir), had a significant negative impact on sales. The decline of Hepatitis C sales was partially offset by sales growth of EDURANT®(rilpivirine) and PREZISTA®/ PREZCOBIX®/ REZOLSTA® (darunavir/cobicistat).rilpivirine.

Neuroscience products achievedexperienced an operational sales growthdecline of 2.8%7.0% as compared to the same period a year ago primarily due to strongago. Strong sales of INVEGA SUSTENNA®/XEPLION®/ INVEGA TRINZA®(paliperidone palmitate). Neuroscience products sales were negatively impactedoffset by lower sales of INVEGACONCERTA®(paliperidone)/methylphenidate in the U.S. due to generic competition and RISPERDAL CONSTA® (risperidone).the impact of divestitures in the Neuroscience therapeutic area.
 
Oncology products achieved strong operational sales growth of 29.8%19.2% as compared to the same period a year ago. Contributors to the growth were strong sales of IMBRUVICA® (ibrutinib) and DARZALEX® (daratumumab) due to increased patient uptake and the launchnew launches of DARZALEX® (daratumumab) in Europe. SalesLower sales of ZYTIGA® (abiraterone acetate) grew in the U.S. and Asia primarily duewere partially offset by growth in Japan.

Pulmonary Hypertension is a new therapeutic area which was established with the acquisition of Actelion on June 16, 2017. See Note 10 to market growth and the launch in China. Additionally, sales growth of ZYTIGA® (abiraterone acetate) was positively impacted by approximately 3.5% due to an adjustment to previous reserve estimates.Consolidated Financial Statements for additional details regarding the acquisition.

Cardiovascular / Metabolism / Other products achievedexperienced an operational sales growthdecline of 4.7%5.5% as compared to the same period a year ago primarily due to strongago. Lower sales of XARELTO®(rivaroxaban) and INVOKANA®/INVOKAMET® (canagliflozin). The in the U.S. primarily due to an increase in price discounts were partially offset by sales growth of XARELTO®(rivaroxaban) due to increased market share. Additionally, Cardiovascular / Metabolism / Other was negatively impacted by approximately 2.0% due to a higher adjustment to previous reserve estimates in 2015. A positive adjustment to previous reserve estimates in the fiscal second quarter of 2015 was primarily related to hormonal contraceptives while a positive adjustment to previous reserve estimates, primarily PROCRIT®, recorded in the fiscal second quarter of 2016 was primarily related to PROCRIT2016.®/ EPREX® (Epoetin alfa).


Medical Devices
The Medical Devices segment sales in the first fiscal six months of 20162017 were $12.5$13.0 billion, a decreasean increase of 0.8%4.0% as compared to the same period a year ago, with operational growth of 1.2%4.7% and a negative currency impact of 2.0%0.7%. U.S. Medical Devices sales increased 1.6%4.1%. International Medical Devices sales decreasedincreased by 2.9%3.9%, including an operational increase of 0.8%5.3% and a negative currency impact of 3.7%1.4%. In the first fiscal six months of 2016,2017, the net impact of acquisitions and divestitures had a negative impact of 2.2% on the Medical Devices segment operational sales growth of the Medical Devices segment.was a positive 3.3%.

Major Medical Devices Franchise Sales*Sales — Fiscal Six Months Ended
          
(Dollars in Millions) July 3, 2016 June 28, 2015 
Total
Change
 
Operations
Change
 
Currency
Change
 July 2, 2017 July 3, 2016 
Total
Change
 
Operations
Change
 
Currency
Change
Orthopaedics $4,696
 $4,658
 0.8 % 2.4% (1.6)% $4,668
 $4,696
 (0.6)% 0.1 % (0.7)%
Hips 691
 669
 3.3
 5.3
 (2.0) 702
 691
 1.6
 2.4
 (0.8)
Knees 774
 748
 3.5
 5.1
 (1.6) 783
 774
 1.2
 2.0
 (0.8)
Trauma 1,278
 1,277
 0.1
 1.8
 (1.7) 1,285
 1,278
 0.5
 1.0
 (0.5)
Spine & Other 1,953
 1,964
 (0.6) 0.9
 (1.5) 1,898
 1,953
 (2.8) (2.1) (0.7)
Surgery 4,625
 4,584
 0.9
 3.4
 (2.5) 4,655
 4,625
 0.6
 1.5
 (0.9)
Advanced 1,725
 1,610
 7.1
 9.7
 (2.6) 1,810
 1,725
 4.9
 6.0
 (1.1)
General 2,197
 2,252
 (2.4) 0.2
 (2.6) 2,188
 2,197
 (0.4) 0.5
 (0.9)
Specialty 703
 722
 (2.6) (0.4) (2.2) 657
 703
 (6.5) (6.5) 0.0
Vision Care 1,325
 1,277
 3.8
 5.0
 (1.2) 1,853
 1,325
 39.8
 40.2
 (0.4)
Contact Lenses/Other 1,436
 1,325
 8.4
 8.8
 (0.4)
Surgical 417
 
 * * 
Cardiovascular 913
 1,073
 (14.9) (14.0) (0.9) 1,022
 913
 11.9
 12.8
 (0.9)
Diabetes Care 900
 978
 (8.0) (5.8) (2.2) 820
 900
 (8.9) (8.1) (0.8)
Diagnostics 59
 46
 28.3
 47.8
 (19.5) 1
 59
 ** ** **
Total Medical Devices Sales $12,518
 $12,616
 (0.8)% 1.2% (2.0)% $13,019
 $12,518
 4.0 % 4.7 % (0.7)%
*Prior year amounts have been reclassified to conform to current year product disclosure.On February 27, 2017, the Company acquired Abbott Medical Optics (AMO)

**On June 30, 2014, the Company divested the Ortho-Clinical Diagnostics business (the Diagnostics Franchise)

The Medical Devices segment sales in the fiscal second quarter of 20162017 were $6.4$6.7 billion, an increase of 0.8%4.9% as compared to the same period a year ago, with operational growth of 1.8% and5.9% partially offset by a negative currency impact of 1.0%. U.S. Medical Devices sales increased 1.0%6.1%. International Medical Devices sales increased by 0.6%3.9%, including an operational increase of 2.6% and5.8% partially offset by a negative currency impact of 2.0%1.9%. In the fiscal second quarter of 2016,2017, the net impact of acquisitions and divestitures had a negative impact of 2.1% on the Medical Devices segment operational sales growth of the Medical Devices segment.

was a positive 4.8%.

Major Medical Devices Franchise Sales*SalesFiscal Second Quarters Ended
(Dollars in Millions) July 3, 2016 June 28, 2015 
Total
Change
 
Operations
Change
 
Currency
Change
 July 2, 2017 July 3, 2016 
Total
Change
 
Operations
Change
 
Currency
Change
Orthopaedics $2,355
 $2,330
 1.1 % 2.0 % (0.9)% $2,343
 $2,355
 (0.5)% 0.4 % (0.9)%
Hips 349
 336
 3.9
 5.3
 (1.4) 350
 349
 0.3
 1.3
 (1.0)
Knees 385
 372
 3.5
 4.6
 (1.1) 385
 385
 0.0 0.8
 (0.8)
Trauma 636
 621
 2.4
 3.2
 (0.8) 643
 636
 1.1
 1.9
 (0.8)
Spine & Other 985
 1,001
 (1.6) (0.9) (0.7) 965
 985
 (2.0) (1.1) (0.9)
Surgery 2,397
 2,328
 3.0
 4.6
 (1.6) 2,384
 2,397
 (0.5) 0.6
 (1.1)
Advanced 909
 840
 8.2
 9.7
 (1.5) 933
 909
 2.6
 4.0
 (1.4)
General 1,127
 1,119
 0.7
 2.3
 (1.6) 1,114
 1,127
 (1.2) 0.0
 (1.2)
Specialty 361
 369
 (2.2) (0.7) (1.5) 337
 361
 (6.6) (6.2) (0.4)
Vision Care 685
 646
 6.0
 5.8
 0.2
 1,055
 685
 54.0
 55.0
 (1.0)
Contact Lenses/Other 753
 685
 9.9
 10.9
 (1.0)
Surgical 302
 
 * * 
Cardiovascular 470
 544
 (13.6) (13.6) 0.0
 523
 470
 11.3
 12.6
 (1.3)
Diabetes Care 471
 494
 (4.7) (3.5) (1.2) 421
 471
 (10.6) (9.5) (1.1)
Diagnostics 31
 16
 93.8
 **
 ***
 
 31
 ** ** **
Total Medical Devices Sales $6,409
 $6,358
 0.8 % 1.8 % (1.0)% $6,726
 $6,409
 4.9 % 5.9 % (1.0)%
*Prior year amounts have been reclassified to conform to current year product disclosure.On February 27, 2017, the Company acquired Abbott Medical Optics (AMO)
** Percentage greater than 100%
***Not meaningfulOn June 30, 2014, the Company divested the Ortho-Clinical Diagnostics business (the Diagnostics Franchise)
        
The Orthopaedics franchise achieved operational sales growth of 2.0%0.4% as compared to the prior year fiscal second quarter. Sales growth was primarily driven by worldwideU.S. sales of the hip primary stem platform, U.S. sales of the trauma TFNA nailing system, the ATTUNE® Knee System, and sports medicine ORTHOVISC®/MONOVISC® products. Growth was negatively impacted by softer demandcompetitive and a reduction in customer inventory levels primarily in China and continued pricing pressures.

The Surgery franchise achieved operational sales growth of 4.6%0.6% as compared to the prior year fiscal second quarter. Operational growth in Advanced Surgery was primarily driven by endocutter, energy, including recent acquisitions, and biosurgery and energy products, primarily attributable to market growth, increased penetration in certain markets and new product launches. The acquisition of NeuWave Medical, Inc. also contributed to growth this quarter. Operational growth inproducts. General Surgery was driven byflat as compared to the prior year fiscal second quarter. Sales growth of sutures partially offset by lower sales of women's health and urology products. Growth of Mentor products was offset by lower sales ofdeclines in mechanical products. The operational decline in Specialty Surgery was primarily driven by aesthetic products and Advanced Sterilization Products in Specialty Surgery.Products.

The Vision Care franchise achieved operational sales growth of 5.8%55.0% as compared to the prior year fiscal second quarter due toquarter. Operational growth was driven by sales growth across allfrom the major regions driven byrecent acquisition of AMO, with the majority of AMO sales in the surgical category, and new product launches and line extensions. Growth was partially offset in the U.S. by a customer reward program.contact lenses category.

The Cardiovascular Care franchise experienced anachieved strong operational sales declinegrowth of 13.6%12.6% as compared to the prior year fiscal second quarter. Strong operational growth in the electrophysiology business was driven by market growth and new product launches was offset by the impact of divesting the Cordis business. The Company completed the divestiturecontinued uptake of the Cordis business to Cardinal Health on October 4, 2015. The Cordis business generated annual net revenues of approximately $535 million in 2015.THERMOCOOL SMARTTOUCH® Contact ForceSensing Catheter.


The Diabetes Care franchise experienced an operational sales decline of 3.5%9.5% as compared to the prior year fiscal second quarter primarily due to price decline of self-monitoring blood glucose (SMBG) productsdeclines and competition in the U.S., partially offset by the success of the ANIMAS® VIBE® in Europe and Canada and SMBG products in emerging markets.competitive pressure.

ANALYSIS OF CONSOLIDATED EARNINGS BEFORE PROVISION FOR TAXES ON INCOME

Consolidated earnings before provision for taxes on income for the first fiscal six months of 20162017 was $10.2$10.3 billion representing 28.2% of sales as compared to $11.3$10.2 billion in the first fiscal six months of 2015, a decrease2016, representing 28.4% of 9.9%. The decrease was primarily due to litigation expense of $0.7 billion included in the fiscal six months of 2016 versus the fiscal six months of 2015, which included a net litigation gain of $0.3 billion primarily related to a settlement agreement of $0.6 billion with Guidant. Additionally, the fiscal six months of 2016 had lower gains of $0.8 billion on the sale of assets/businesses as compared to the fiscal six months of 2015 and included a restructuring charge of $0.3 billion. The fiscal six months of 2016 included the divestiture of the controlled substance raw material and active pharmaceutical ingredient (API) business. The fiscal six months of 2015 included the U.S. divestiture of NUCYNTA®. This was partially offset by higher sales volume, favorable mix in the business and lower selling, marketing and administrative costs as compared to the fiscal six months of 2015.

sales. Consolidated earnings before provision for taxes on income for the fiscal second quarter of 20162017 was $4.9$4.7 billion representing 25.2% of sales as compared to $5.7$4.9 billion in the fiscal second quarter of 2015,2016, representing 26.5% of sales. The decrease as a decrease of 14.6%. The decreasepercent to sales in both periods was primarily due to lower gainshigher amortization and other costs related to the recent acquisitions, primarily Actelion and AMO and an asset impairment charge of $0.8$0.2 billion onprimarily related to the sale of assets/businesses and higher litigation expense of $0.5 billion recorded in 2016,insulin pump business as compared to the fiscal second quarterprior period. This was partially offset by lower litigation costs in 2017 and a lower restructuring charge of 2015. The fiscal second quarter of 2016 included the divestiture of the controlled substance raw material and API business. The fiscal second quarter of 2015 included the U.S. divestiture of NUCYNTA®.

$0.1 billion as compared to 2016. Additionally, the fiscal second quarter and six months of 20162017 included a restructuring chargegain of $0.1 billion. This was partially offset by higher sales volume, favorable mix and lower selling, marketing and administrative costs as compared$0.2 billion related to the fiscal second quartermonetization of 2015.future royalty receivables.

Cost of Products Sold

Consolidated costs of products sold for the first fiscal six months of 2016 decreased2017 increased to 29.6%30.6% from 30.2%29.6% of sales as compared to the same period a year ago. Consolidated costs of products sold for the fiscal second quarter of 2016 decreased2017 increased to 28.9%30.9% from 30.1%28.9% of sales as compared to the same period a year ago. The decreaseunfavorable increase in both periods was primarily duedriven by higher amortization expense related to favorable mix in the businessrecent acquisitions, transactional currency impacts and manufacturing efficiencies partially offset by the unfavorable impact of transactional currency.product mix. The intangible asset amortization expense for the fiscal six months of 2017 and 2016 and 2015 was $576$809 million and $619$576 million, respectively.

Selling, Marketing and Administrative Expenses

Consolidated selling, marketing and administrative expenses for the first fiscal six months of 20162017 decreased slightly to 27.4%27.3% from 29.1%27.4% of sales as compared to the same period a year ago. Consolidated selling, marketing and administrative expenses for the fiscal second quarter of 2016 decreased to2017 was 28.0% from 30.3% of sales, which is flat as compared to the same period a year ago. The decrease in both periods was primarily due to cost management and favorable mix, primarily due to faster growth in the Pharmaceutical segment.

Research and Development Expense

Worldwide costs of research and development activities for the first fiscal six months of 2016 increased to2017 was 11.9% from 11.5% of sales, which was flat as compared to the same period a year ago. Worldwide costs of research and development activities for the fiscal second quarter of 2016 increased2017 decreased slightly to 12.2%12.1% from 12.0%12.2% of sales as compared to the same period a year ago. The increase was primarily due to increased investment spendingBoth periods in 2017 are consistent with the Pharmaceutical segment to advance the pipeline.

In-Process Research and Development (IPR&D)

During the first fiscal six months of 2016, the Company recorded a charge of $29 million for the discontinuation of a development program related to Crucell.prior year.

Interest (Income) Expense

Interest income in the first fiscal six months and fiscal second quarter of 20162017 was higher than the same periodsperiod a year ago due to a higher average balance of cash, cash equivalents and marketable securities balances during the period and higher average interest rates. The ending balance of cash, cash equivalents and marketable securities was $42.6$12.9 billion at the end of the fiscal second quarter of 2016,2017, which is an

increasea decrease of $8.6$29.7 billion as compared to the same period a year ago. The increasedecrease in the balance of cash, cash equivalents and marketable securities was primarily due to the use of cash generated from operating activities.for general corporate purposes including, acquisitions, primarily the Actelion acquisition for $28.8 billion, net of cash acquired, on June 16, 2017.

Interest expense in the first fiscal six months and fiscal second quarter of 20162017 was higher as compared to the same periods a year ago. At the end of the fiscal second quarter of 2016,2017, the Company’s debt position was $26.2$34.6 billion as compared to $19.3$26.2 billion the same period a year ago. The higher debt balance of approximately $6.9$8.4 billion was primarily due to increased borrowings in February and May of 2016.borrowings. The Company increased borrowings, capitalizing on favorable terms in the capital markets. The proceeds of the borrowings were used for general corporate purposes, primarily the stock repurchase program.

Other (Income) Expense, Net

Other (income) expense, net is the account where the Company records gains and losses related to the sale and write-down of certain investments in equity securities held by Johnson & Johnson Innovation - JJDC, Inc., gains and losses on divestitures, transactional currency gains and losses, acquisition-related costs, litigation accruals and settlements, as well as royalty income.
The change in other (income) expense, net for the first fiscal six months of 20162017 was unfavorableslightly favorable by $1.8$0.1 billion as compared to the same period a year ago. The fiscal six months of 2015 included higher gains of $0.8 billion on the sale of assets/businesses. The first fiscal six months of 20162017 included the divestiturea gain of the controlled substance raw material and API business. The first fiscal six months$0.2 billion related to monetization of 2015 included the U.S. divestiture of NUCYNTA®. Additionally, the fiscal six months of 2016 includedfuture royalty receivables, lower litigation expense of $0.7$0.2 billion and a higher gain of $0.1 billion related to the sale of certain investments in equity securities as compared to the same period a year ago. This was offset by $0.2 billion of acquisition costs related to Actelion and AMO, an asset impairment charge of $0.2 billion primarily related to the insulin pump business and a higher restructuring related charge of $0.1 billion as compared to the same period a net litigation gain of $0.3 billion in the fiscal six months of 2015, primarily due to a litigation settlement agreement of $0.6 billion with Guidant.year ago.

The change in otherOther (income) expense, net for the fiscal second quarter of 20162017 was slightly unfavorable by $1.5 billion as compared to the same period a year ago. The fiscal second quarter of 20152017 included $0.2 billion of acquisition costs related to Actelion and AMO, an asset impairment charge of $0.2 billion primarily related to the insulin pump business and a higher gainsrestructuring related charge of $0.8$0.1 billion onas compared to the salesame period a year ago. This was partially offset by a gain of assets/businesses and$0.2 billion related to monetization of future royalty receivables, lower litigation expense of $0.5$0.1 billion and lower asset write-downs of $0.1 billion as compared to the fiscal second quarter of 2016. The fiscal second quarter of 2016 included the divestiture of the controlled substance raw material and API business. The fiscal second quarter of 2015 included the U.S. divestiture of NUCYNTA®.





INCOME BEFORE TAX BY SEGMENT

Income before tax by segment of business for the first fiscal six months were as follows:
            
            
 Income Before Tax Segment Sales Percent of Segment Sales Income Before Tax Segment Sales Percent of Segment Sales
(Dollars in Millions) July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016
Consumer $1,137
 $961
 $6,614
 $6,873
 17.2% 14.0% $1,254
 $1,137
 $6,706
 $6,614
 18.7% 17.2%
Pharmaceutical 7,031
 7,084
 16,832
 15,672
 41.8
 45.2
 7,077
 7,031
 16,880
 16,832
 41.9
 41.8
Medical Devices 2,515
 3,805
 12,518
 12,616
 20.1
 30.2
 2,555
 2,515
 13,019
 12,518
 19.6
 20.1
Segment total 10,683
 11,850
 35,964
 35,161
 29.7
 33.7
 10,886
 10,683
 36,605
 35,964
 29.7
 29.7
Less: Expenses not allocated to segments (1)
 485
 534
      
  
 563
 485
      
  
Worldwide total $10,198
 $11,316
 $35,964
 $35,161
 28.4% 32.2% $10,323
 $10,198
 $36,605
 $35,964
 28.2% 28.4%
(1) Amounts not allocated to segments include interest (income) expense and general corporate (income) expense.

Income before tax by segment of business for the fiscal second quarters were as follows:
 Income Before Tax Segment Sales Percent of Segment Sales Income Before Tax Segment Sales Percent of Segment Sales
(Dollars in Millions) July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 3, 2016 June 28, 2015 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016 July 2, 2017 July 3, 2016
Consumer $571
 $317
 $3,419
 $3,483
 16.7% 9.1% $658
 $571
 $3,478
 $3,419
 18.9% 16.7%
Pharmaceutical 3,687
 4,122
 8,654
 7,946
 42.6
 51.9
 3,414
 3,687
 8,635
 8,654
 39.5
 42.6
Medical Devices 939
 1,584
 6,409
 6,358
 14.7
 24.9
 992
 939
 6,726
 6,409
 14.7
 14.7
Segment operating profit 5,197
 6,023
 18,482
 17,787
 28.1
 33.9
 5,064
 5,197
 18,839
 18,482
 26.9
 28.1
Less: Expenses not allocated to segments (1)
 293
 282
      
  
 316
 293
      
  
Worldwide income before tax $4,904
 $5,741
 $18,482
 $17,787
 26.5% 32.3% $4,748
 $4,904
 $18,839
 $18,482
 25.2% 26.5%
(1) Amounts not allocated to segments include interest (income) expense and general corporate (income) expense.



Consumer Segment

The Consumer segment income before tax as a percent of sales in the first fiscal six months of 20162017 was 17.2%18.7% versus 14.0%17.2% for the same period a year ago. The Consumer segment income before tax as a percent of sales in the fiscal second quarter of 20162017 was 16.7%18.9% versus 9.1%16.7% for the same period a year ago. The increase in the income before tax as a percent to sales forin both periodsthe first fiscal six months and fiscal second quarter of 2016 was primarily due to higher gains on divestitures in 2017 as compared to 2016 and favorable selling, marketing and administrative expenses due to cost management and higher gross profit margins due to cost improvement projects and favorable mix.efficiencies. This was partially offset by higher amortization expense in 2017 related to acquisitions. Additionally, the fiscal six months of 2016 were negatively impacted by operations in Venezuela.

Pharmaceutical Segment

The Pharmaceutical segment income before tax as a percent of sales in the first fiscal six months of 20162017 was 41.8%41.9% versus 45.2%41.8% for the same period a year ago. The Pharmaceutical segment income before tax as a percent of sales in the fiscal second quarter of 20162017 was 42.6%39.5% versus 51.9% for the same period a year ago. The decrease in the income before tax as a percent to sales for both periods was primarily due to higher divestiture gains of $0.8 million in 2015 as compared to 2016. The second quarter and first fiscal six months of 2016 included the divestiture of the controlled substance raw material and API business. The second quarter and first fiscal six months of 2015 included the U.S. divestiture of NUCYNTA®. This was partially offset bystrong sales volume growth, a higher positive adjustment of $0.1 billion to previous reserve estimates as compared to the prior year and favorable selling, marketing and administrative expenses. Additionally, the fiscal six months of 2016, had a lower net litigation expense of $0.2 billion as compared to the prior year.

Medical Devices Segment

The Medical Devices segment income before tax as a percent of sales in the first fiscal six months of 2016 was 20.1% versus 30.2% for the same period a year ago. The decrease in the income before tax as a percent to sales for the fiscal six months was primarily due to litigation expense of $0.7 billion in the fiscal six months of 2016 as compared to the fiscal six months of 2015, which included a net litigation gain of $0.4 billion primarily related to a litigation settlement agreement of $0.6 billion with Guidant. Additionally, the fiscal six months of 2016 included a restructuring charge of $0.3 billion and was impacted by unfavorable transactional currency. This was partially offset by lower costs of $0.1 billion associated with the DePuy ASR Hip program as compared to the fiscal six months of 2015.

The Medical Devices segment income before tax as a percent of sales in the fiscal second quarter of 2016 was 14.7% versus 24.9%42.6% for the same period a year ago. The decrease in the income before tax as a percent to sales for the fiscal second quarter of 2017 was primarily due to $0.3 billion of higher litigationamortization expense of $0.4 billion in the fiscal second quarter of 2016 as comparedand other costs related to the fiscal second quarterActelion acquisition. This was partially offset by a gain of 2015.$0.2 billion related to monetization of future royalty receivables. Additionally, the fiscal second quarter of 2016 included a restructuringpositive adjustment of $0.3 billion to previous reserve estimates.


Medical Devices Segment


The Medical Devices segment income before tax as a percent of sales in the first fiscal six months of 2017 was 19.6% versus 20.1% for the same period a year ago. The Medical Devices segment income before tax as a percent of sales was flat at 14.7% for both the fiscal second quarter of 2017 and 2016. The decrease in the income before tax as a percent to sales for the fiscal six months of 2017 as compared to 2016 was primarily due to an asset impairment charge of $0.1$0.2 billion primarily related to the insulin pump business, $0.2 billion of higher amortization expense and was impacted byother acquisition costs related to AMO and the impact of unfavorable transactional currency.currency and mix as compared to the fiscal six months of 2016. This was partially offset by sales volume growth and favorable selling, marketing and administrative expenses due to cost efficiencies in 2017. Additionally, the fiscal six months of 2016 included $0.2 billion of higher litigation expense as compared to 2017.

Restructuring

The Company announced restructuring actions in its Medical Devices segment that are expected to result in annualized pre-tax cost savings of $800 million to $1.0 billion, the majority of which is expected to be realized by the end of 2018, including2018. Approximately $250 million in savings were realized in 2016 and approximately $200 million additional savings is expected in 2016.2017. The savings will provide the Company with added flexibility and resources to fund investment in new growth opportunities and innovative solutions for customers and patients. The Company estimates that, in connection with its plans, it will record pre-tax restructuring related charges of approximately $2.0 billion to $2.4 billion, most of which are expected to be incurred by the end of 2017. In the fiscal second quarter of 2016,2017, the Company recorded a pre-tax charge of $141$128 million, of which $7$13 million is included in cost of products sold and $20$104 million is included in other (income) expense. In the first fiscal six months of 2016,2017, the Company recorded a pre-tax charge of $278$289 million, of which $24$17 million wasis included in cost of products sold and $20$176 million wasis included in other (income) expense. Restructuring charges of $868 million$1.6 billion have been recorded since the restructuring was announced. See Note 12 to the Consolidated Financial Statements for additional details related to the restructuring.


Provision for Taxes on Income

The worldwide effective income tax rates for the first fiscal six months of 2017 and 2016 were 20.1% and 2015 were 17.1% and 21.9%, respectively. InThe Company completed its acquisition of AMO in the first fiscal quarter of 2017, and incurred incremental tax costs that were discretely recorded in the first quarter, which has increased the effective tax rate by 2.1% for the first six months of 2017, as compared to the same period in 2016.  Additionally, the Company had more income in higher tax jurisdictions relative to lower tax jurisdictions as compared to 2016. These increases to the effective tax rate were partially offset by additional tax benefits received from stock-based compensation that either vested or were exercised during the first fiscal six months of 2017 and 2016, the Company had higher income in lower tax jurisdictions relative to higher tax jurisdictions as compared to 2015, which decreasedreduced the effective tax rate by approximately 1.7%.  The Company adopted the new accounting standard for the reporting of tax benefits on share-based compensation. As described in Note 1 to the Consolidated Financial Statements, the adoption of this new standard reduced the tax rate for the first six months of fiscal

2016, by approximately2.7% and 2.8% versus 2015. The remainder of the change from prior year was primarily related to the U.S. Research & Development tax credit and the Controlled Foreign Corporation look-through provisions, which were not enacted into law until the fiscal fourth quarter of 2015, and the settlement of certain open tax positions in several international jurisdictions., respectively.

As of July 3, 2016,2, 2017, the Company had approximately $3.1$3.2 billion of liabilities from unrecognized tax benefits. The Company believes it is possible that audits may be completed by tax authorities in some jurisdictions over the next twelve months. The Company is not able to provide a reasonably reliable estimate of the timing of any future tax payments relating to uncertain tax positions.

See Note 8 to the Consolidated Financial Statements in the Annual Report on Form 10-K for the fiscal year ended January 3, 20161, 2017 for more detailed information regarding unrecognized tax benefits.


LIQUIDITY AND CAPITAL RESOURCES

Cash Flows

Cash and cash equivalents were $18.6$12.6 billion at the end of the fiscal second quarter of 20162017 as compared with $13.7$19.0 billion at the end of fiscal year end of 2015.2016. The primary sources of cash were approximately $6.8$8.7 billion net cash generated from operating activities offset by $0.2$13.2 billion used by investing activities and $1.6$2.1 billion used by financing activities. In addition, the Company had $23.9$0.3 billion in marketable securities at the end of the fiscal second quarter of 20162017 and $24.6$22.9 billion at the end of 2015.2016.

Cash flow from operations of $6.8$8.7 billion was the result of $8.5$8.2 billion of net earnings, $2.5$2.9 billion of non-cash charges and other adjustments for depreciation and amortization, stock-based compensation and asset write-downs and $0.1a $0.3 billion related to deferred taxes.increase in other liabilities. Cash flow from operations was reduced by $1.0$1.2 billion related to accounts payable and accrued

liabilities, primarily due to the timing of payments and receipts for tax and legal liabilities, $1.5accounts payable, $0.9 billion related to accounts receivable and inventories $1.5and $0.5 billion of other assets and liabilities and $0.2 billion from net gains on sale of assets/businesses.assets.

Investing activities use of $0.2$13.2 billion of cash was primarily used for acquisitions of $34.1 billion and additions to property, plant and equipment of $1.4 billion and $0.7 billion for acquisitions.$1.2 billion. Investing activities also included a source of $1.2$22.1 billion from the net sales of investments in marketable securities and proceeds from the disposal of assets/businesses of $0.7 billion.securities.

Financing activities use of $1.6$2.1 billion of cash was primarily for the repurchase of common stock of $5.2 billion and dividends to shareholders of $4.3 billion and $4.8 billion for the repurchase of common stock.$4.4 billion. Financing activities also included a source of $6.5$6.9 billion from the net proceeds of short and long-term debt and $0.9$0.7 billion of proceeds from stock options exercised/employee withholding tax on stock awards, net.

During the fiscal second quarter of 2017, the Company acquired Actelion Ltd. for approximately $28.8 billion net of cash acquired. The Company used cash held by its foreign subsidiaries to pay for the acquisition.

The Company has access to substantial sources of funds at numerous banks worldwide. In September 2015,2016, the Company secured a new 364-day Credit Facility. Total credit available to the Company under the facility, which expires September 15, 2016,14, 2017, approximates $10.0 billion. Interest charged on borrowings under the credit line agreement is based on either bids provided by banks, the prime rate or London Interbank Offered Rates (LIBOR), plus applicable margins. Commitment fees under the agreement are not material.

In the fiscal second quarter of 20162017, the Company continued to have access to liquidity through the commercial paper market.Company's notes payable and long-term debt was in excess of cash, cash equivalents and marketable securities. The Company anticipates that operating cash flows, the ability to raise funds from external sources, borrowing capacity from existing committed credit facilities and access to the commercial paper markets will continue to provide sufficient resources to fund operating needs. However, theThe Company monitors the global capital markets on an ongoing basis and from time to time may raise capital when market conditions are favorable. The Company filed a new shelf registration on February 27, 2017. In the fiscal first quarter and fiscal second quarter of 2016,2017, the Company issued bonds for a total of $7.5$4.5 billion and $4.4 billion, respectively, for general corporate purposes.

On October 13, 2015, the Company announced that its Board of Directors approved a share repurchase program, authorizing the Company to purchase up to $10.0 billion of the Company's shares of common stock. As of July 3, 2016, $4.32, 2017, $10.0 billion has been repurchased under the program. The repurchaseprogram and the program has no time limit and may be delayed or suspended for periods or discontinued at any time.been completed. Any shares acquired will be available for general corporate purposes. The Company intends to financefinanced the share repurchase program through available cash and access to the capital markets.




Dividends

On April 28, 2016,27, 2017, the Board of Directors declared a regular cash dividend of $0.80$0.84 per share, payable on June 7, 201613, 2017 to shareholders of record as of May 24, 2016.30, 2017.

On July 18, 2016,17, 2017, the Board of Directors declared a regular cash dividend of $0.80$0.84 per share, payable on September 6, 201612, 2017 to shareholders of record as of August 23, 2016.29, 2017. The Company expects to continue the practice of paying regular quarterly cash dividends.

Concentration of Credit Risk

Global concentration of credit risk with respect to trade accounts receivables continues to be limited due to the large number of customers globally and adherence to internal credit policies and credit limits. Economic challenges in Italy, Spain, Greece and Portugal (the Southern European Region) have impacted certain payment patterns, which have historically been longer than those experienced in the U.S. and other international markets. The total net trade accounts receivable balance in the Southern European Region was approximately $1.4 billion as of July 3, 2016 and $1.3 billion as of January 3, 2016. Approximately $0.9 billion as of July 3, 2016 and approximately $0.8 billion as of January 3, 2016 of the Southern European Region net trade accounts receivable balance related to the Company's Consumer, Vision Care and Diabetes Care businesses as well as certain Pharmaceutical and Medical Devices customers, which are in line with historical collection patterns.
The remaining balance of net trade accounts receivable in the Southern European Region has been negatively impacted by the timing of payments from certain government owned or supported health care customers as well as certain distributors of the Pharmaceutical and Medical Devices local affiliates. The total net trade accounts receivable balance for these customers was approximately $0.5 billion at July 3, 2016 and January 3, 2016. The Company continues to receive payments from these customers and in some cases late payments with interest. For customers where payment is expected over periods of time longer than one year, revenue and trade receivables have been discounted over the estimated period of time for collection. Allowances for doubtful accounts have been increased for these customers, but have been immaterial to date. The Company will continue to work closely with these customers on payment plans, monitor the economic situation and take appropriate actions, as necessary.
OTHER INFORMATION

New Accounting Pronouncements

Refer to Note 1 to the Consolidated Financial Statements for new accounting pronouncements.

Economic and Market Factors

The Company operates in certain countries where the economic conditions continue to present significant challenges. The Company continues to monitor these situations and take appropriate actions. Inflation rates and currency exchange rates continue to have an effect on worldwide economies and, consequently, on the way the Company operates. In the face of increasing costs, the Company strives to maintain its profit margins through cost reduction programs, productivity improvements and periodic price increases.

As described above, while the Company continues to do business in Greece, the Company closely monitors the economic situation. As of July 3, 2016, the business of the Company’s Greek subsidiaries represented 0.3% and 0.4% of the Company's consolidated assets and fiscal six months revenues, respectively.

OnIn June 23, 2016, the United Kingdom (U.K.) held a referendum in which voters approved an exit from the European Union (E.U.), commonly referred to as “Brexit.”“Brexit” and in March 2017 the U.K. formally started the process for the U.K. to leave the E.U.  Given the lack of comparable precedent, it is unclear what financial, trade, regulatory and legal implications the withdrawal of the U.K. from the E.U. will have.  Brexit creates global political and economic uncertainty, which may cause, among other consequences, volatility in exchange rates and interest rates, additional cost containment by third-party payors and changes in regulations.  However, the Company currently does not believe that these and other related effects will have a material impact on the Company’s consolidated financial position or operating results. As of July 3, 2016,2, 2017, the business of the Company’s U.K. subsidiaries represented less than 3% of both the Company’s consolidated assets and fiscal six months revenues.



The Company faces various worldwide health care changes that may continue to result in pricing pressures that include health care cost containment and government legislation relating to sales, promotions and reimbursement of health care products.

Changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and foregoing health care insurance coverage, as a result of the current global economic downturn, may continue to impact the Company’s businesses.

The Company also operates in an environment increasingly hostile to intellectual property rights. Firms have filed Abbreviated New Drug Applications or Biosimilar Biological Product Applications with the FDA, initiated inter partes review proceedings in the United States Patent and Trademark Office, or otherwise challenged the coverage and/or validity of the Company's patents, seeking to market generic or biosimilar forms of many of the Company’s key pharmaceutical products prior to expiration of the applicable patents covering those products. In the event the Company is not successful in defending the patent claims challenged in the resulting lawsuits,these actions, generic or biosimilar versions of the products at issue willmay be introduced to the market, resulting in the potential for substantial market share and revenue losses for those products, and which may result in a non-cash impairment charge in any associated intangible asset. For further information, see the discussion on “REMICADE® Related Cases” and “Litigation Against Filers of Abbreviated New Drug Applications” in Note 11 to the Consolidated Financial Statements.

CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS

This Form 10-Q contains forward-looking statements. Forward-looking statements do not relate strictly to historical or current facts and anticipate results based on management’s plans that are subject to uncertainty. Forward-looking statements may be identified by the use of words like “plans,” “expects,” “will,” “anticipates,” “estimates” and other words of similar meaning in conjunction with, among other things, discussions of future operations, financial performance, the Company’s strategy for growth, product development, regulatory approval, market position and expenditures.

Forward-looking statements are based on current expectations of future events. The Company cannot guarantee that any forward-looking statement will be accurate, although the Company believes that it has been reasonable in its expectations and assumptions. Investors should realize that if underlying assumptions prove inaccurate or that known or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.

Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges and uncertainties inherent in new product development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success of new and existing products; challenges to patents; the impact of patent expirations; the ability of the company to successfully execute strategic plans, including restructuring plans; the potential that the expected benefits and opportunities related to the restructuring may not be realized or may take longer to realize than expected; significant adverse litigation or government action, including related to product liability claims; impact of business combinations and divestitures; market conditions and the possibility that the on-going share repurchase program may be delayed, suspended or discontinued; significant changes in customer relationships or changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; financial instability of international economies and legal systems and sovereign risk; manufacturing difficulties or delays, internally or within the supply chain; complex global supply chains with increasing regulatory requirements; product efficacy or safety concerns resulting in product recalls or regulatory action; disruptions due to natural disasters; and the potential failure to meet obligations in compliance agreements with government bodies.


The Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including Exhibit 99 thereto, contains a discussion of additional factors that could cause actual results to differ from expectations. The Company notes these factors as permitted by the Private Securities Litigation Reform Act of 1995.


Item 3 — QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There has been no material change in the Company’s assessment of its sensitivity to market risk since its presentation set forth in Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” in its Annual Report on Form 10-K for the fiscal year ended January 3, 20161, 2017.

Item 4 — CONTROLS AND PROCEDURES

Disclosure controls and procedures. At the end of the period covered by this report, the Company evaluated the effectiveness of the design and operation of its disclosure controls and procedures. The Company’s disclosure controls and procedures are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Alex Gorsky, Chairman Board of Directors and Chief Executive Officer, and Dominic J. Caruso, Executive Vice President, Finance and Chief Financial Officer, reviewed and participated in this evaluation. Based on this evaluation, Messrs. Gorsky and Caruso concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were effective.

Internal control. During the period covered by this report, there were no changes in the Company’s internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
The Company is implementing a multi-year, enterprise-wide initiative to integrate, simplify and standardize processes and systems for the human resources, information technology, procurement, supply chain and finance functions. These are enhancements to support the growth of the Company’s financial shared service capabilities and standardize financial systems. This initiative is not in response to any identified deficiency or weakness in the Company’s internal control over financial reporting. In response to this initiative, the Company has and will continue to align and streamline the design and operation of its financial control environment.

Part II — OTHER INFORMATION

Item 1 — LEGAL PROCEEDINGS

The information called for by this item is incorporated herein by reference to Note 11 included in Part I, Item 1, Financial Statements (unaudited) — Notes to Consolidated Financial Statements.

Item 2 — UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

(c) Purchases of Equity Securities by the Issuer and Affiliated Purchasers.

On October 13, 2015, the Company announced that its Board of Directors approved a share repurchase program, authorizing the Company to purchase up to $10.0 billion of the Company's shares of common stock. The repurchase program has no time limit and may be delayed or suspended for periods or discontinued at any time.was completed on June 16, 2017.

The following table provides information with respect to Common Stock purchases by the Company during the fiscal second quarter of 2016.2017. The repurchases below also include the stock-for-stock option exercises that settled in the fiscal second quarter.

Period 
Total Number
of Shares Purchased(1)
 
Avg. Price
Per Share
 
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs(2)
 
Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs(3)
April 4, 2016 through May 1, 2016 4,178,207
 110.15
 
 
May 2, 2016 through May 29, 2016 7,611,271
 113.14
 5,675,241
 
May 30, 2016 through July 3, 2016 9,037,789
 115.79
 8,537,333
 
Total 20,827,267
   14,212,574
 47,361,210
Period 
Total Number
of Shares Purchased(1)
 
Avg. Price
Per Share
 
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs(2)
 
Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs(3)
April 3, 2017 through April 30, 2017 1,814,412
 123.35
 1,805,461
 
May 1, 2017 through May 28, 2017 2,200,986
 125.37
 2,196,268
 
May 29, 2017 through July 2, 2017 10,497,064
 132.70
 6,547,611
 
Total 14,512,462
   10,549,340
 

(1) During the fiscal second quarter of 2016,2017, the Company repurchased an aggregate of 20,827,26714,512,462 shares of Johnson & Johnson Common Stock in open-market transactions, of which 14,212,57410,549,340 shares were purchased pursuant to the repurchase program that was publicly announced on October 13, 2015, and of which 6,614,6933,963,122 shares were purchased in open-market transactions as part of a systematic plan to meet the needs of the Company’s compensation programs.

(2) As of July 3, 2016,2, 2017, an aggregate of 39,679,02386,592,946 shares were purchased for a total of $4.3$10.0 billion since the inception of the repurchase program announced on October 13, 2015.

(3) As of July 3, 2016,2, 2017 the maximum number of shares that may yet be purchased under the plan is 47,361,210 based on the closing price of the Company’s Common Stock on the New York Stock Exchange on July 1, 2016 of $121.29 per share.repurchase program was completed.



Item 6 — EXHIBITS

Exhibit 31.1 Certifications under Rule 13a-14(a) of the Securities Exchange Act pursuant to Section 302 of the Sarbanes- Oxley Act of 2002 — Filed with this document.

Exhibit 32.1 Certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 — Furnished with this document.

Exhibit 101 XBRL (Extensible Business Reporting Language) The following materials from Johnson & Johnson’s Quarterly Report on Form 10-Q for the quarter ended July 3, 20162, 2017, formatted in Extensive Business Reporting Language (XBRL), (i) consolidated balance sheets, (ii) consolidated statements of earnings, (iii) consolidated statements of comprehensive income (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.


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.

 
JOHNSON & JOHNSON
(Registrant) 
  
Date: August 4, 20163, 2017By /s/ D. J. CARUSO  
 D. J. CARUSO 
 Executive Vice President, Chief Financial Officer (Principal Financial Officer) 
  
Date: August 4, 20163, 2017By /s/ R. A. KAPUSTA  
 R. A. KAPUSTA 
 Controller (Principal Accounting Officer) 


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