UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
   
 Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
for the quarterly period ended July 3, 20222, 2023

or
   
 Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
for the transition period from            to
Commission file number 1-3215
Johnson & Johnson
(Exact name of registrant as specified in its charter)
New Jersey 22-1024240
(State or other jurisdiction of
incorporation or organization)
(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. Yes No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging“emerging growth company"company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
Emerging growth company

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






SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT
Title of each classTrading SymbolName of each exchange on which registered
Common Stock, Par Value $1.00JNJNew York Stock Exchange
0.650% Notes Due May 2024JNJ24CNew York Stock Exchange
5.50% Notes Due November 2024JNJ24BPNew York Stock Exchange
1.150% Notes Due November 2028JNJ28New York Stock Exchange
1.650% Notes Due May 2035JNJ35New York Stock Exchange
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
On July 22, 2022, 2,629,179,89524, 2023, 2,598,969,594 shares of Common Stock, $1.00 par value, were outstanding.



























JOHNSON & JOHNSON AND SUBSIDIARIES
TABLE OF CONTENTS
 Page
 No.
  
  
  
 
 
  
  
  
  
  
  
  
  





CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q and Johnson & Johnson'sJohnsons other publicly available documents contain forward-looking statements within the meaning of the safe harbor provisions of the United States 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,” and other words of similar meaning in conjunction with, among other things: discussions of future operations, expected operating results, financial performance; impact of planned acquisitions and dispositions; impact and timing of restructuring initiatives including associated cost savings and other benefits; the Company'sCompany’s strategy for growth; product development activities; 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'sCompany’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, additional analysis of existing clinical data, 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 United States and other important markets;
The impact of patent expirations, typically followed by the introduction of competing generic, biosimilar or other products 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 and increased receptivity of courts, the United States Patent and Trademark Office and other decision makers to such challenges, potentially resulting in loss of market exclusivity and rapid decline in sales for the relevant product sooner than expected;
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 based on 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 United States Food and Drug Administration (or international counterparts), declining sales, reputational damage, increased litigation expense and share price impact;
The impact, including declining sales and reputational damage, of significant litigation or government action adverse to the Company, including product liability claims and allegations related to pharmaceutical marketing practices and contracting strategies;
The impact of an adverse judgment or settlement and the adequacy of reserves related to legal proceedings, including patent litigation, product liability, personal injury claims, securities class actions, government investigations, employment and other legal proceedings;



Increased scrutiny of the healthcare 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 compliance agreements with governments or government agencies, which could result in significant sanctions;
Potential changes to applicable laws and regulations affecting United States and international operations, including relating to: approval of new products; licensing and patent rights; sales and promotion of healthcare products; access to, and reimbursement and pricing for, healthcare products and services; environmental protection; and sourcing of raw materials;
Compliance with local regulations and laws that may restrict the Company’s ability to manufacture or sell its products in relevant markets, including requirements to comply with medical device reporting regulations and other requirements such as the European Union’s Medical Devices Regulation;
Changes in domestic and international tax laws and regulations, increasing audit scrutiny by tax authorities around the world and exposures to additional tax liabilities potentially in excess of existing reserves; and
The issuance of new or revised accounting standards by the Financial Accounting Standards Board and regulations by the Securities and Exchange Commission.
Risks Related to the Company’s Strategic Initiatives, Healthcare Market Trends and the Planned Separation of the Company’s Consumer Health Business
Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants, trends toward managed care, the shift toward governments increasingly becoming the primary payers of healthcare expenses, significant new entrants to the healthcare markets seeking to reduce costs and government pressure on companies to voluntarily reduce costs and price increases;
Restricted spending patterns of individual, institutional and governmental purchasers of healthcare 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 may not be realized or may take longer to realize than expected;
The potential that the expected benefits and opportunities related to past and ongoing restructuring actions may not be realized or may take longer to realize than expected;
The Company’s ability to consummate the planned full separation of the Company’s Consumer Health business on a timely basis or at all;
The Company’s ability to successfully separate the Company’s Consumer Health business and realize the anticipated benefits from the planned full separation; and
The New Consumer Health Company’sKenvue, Inc.'s (Kenvue) ability to succeed as a standalone publicly traded company.
Risks Related to Economic Conditions, Financial Markets and Operating Internationally
The risks associated with global operations on the Company and its customers and suppliers, including foreign governments in countries in which the Company operates;
The 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 United States and other countries, including any increased trade restrictions or tariffs 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;
The impact of global public health crises and pandemics, including the novel coronavirus (COVID-19) pandemic;pandemics;
Changes to global climate, 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 United States 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, through third-party providers or otherwise 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 or those of the Company’s vendors, which could result in reputational, competitive, operational or other business harm as well as financial costs and regulatory action;
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; and
The potential that the expected benefits and opportunities related to restructuring actions contemplated for the global supply chain may not be realized or may take longer to realize than expected, including due to any required approvals from applicable regulatory authorities.

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 2, 2022,1, 2023, 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 predict or identify all such factors and should not consider the risks described above to be a complete statement of 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, 2022January 2, 2022July 2, 2023January 1, 2023
ASSETSASSETSASSETS
Current assets:Current assets:  Current assets:  
Cash and cash equivalents$10,983 14,487 
Cash and cash equivalents (Note 4)Cash and cash equivalents (Note 4)$21,183 14,127 
Marketable securitiesMarketable securities21,585 17,121 Marketable securities7,322 9,392 
Accounts receivable, trade, less allowances $223 (2021, $230)16,139 15,283 
Accounts receivable, trade, less allowances $205 (2022, $203)Accounts receivable, trade, less allowances $205 (2022, $203)16,777 16,160 
Inventories (Note 2)Inventories (Note 2)11,437 10,387 Inventories (Note 2)12,888 12,483 
Prepaid expenses and otherPrepaid expenses and other3,703 3,701 Prepaid expenses and other2,397 3,132 
Total current assetsTotal current assets63,847 60,979 Total current assets60,567 55,294 
Property, plant and equipment at costProperty, plant and equipment at cost47,144 47,679 Property, plant and equipment at cost51,218 49,253 
Less: accumulated depreciationLess: accumulated depreciation(28,790)(28,717)Less: accumulated depreciation(30,642)(29,450)
Property, plant and equipment, netProperty, plant and equipment, net18,354 18,962 Property, plant and equipment, net20,576 19,803 
Intangible assets, net (Note 3)Intangible assets, net (Note 3)42,408 46,392 Intangible assets, net (Note 3)46,246 48,325 
Goodwill (Note 3)Goodwill (Note 3)34,166 35,246 Goodwill (Note 3)45,440 45,231 
Deferred taxes on income (Note 5)Deferred taxes on income (Note 5)9,514 10,223 Deferred taxes on income (Note 5)8,779 9,123 
Other assetsOther assets9,435 10,216 Other assets10,078 9,602 
Total assetsTotal assets$177,724 182,018 Total assets$191,686 187,378 
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:Current liabilities:  Current liabilities:  
Loans and notes payableLoans and notes payable$4,305 3,766 Loans and notes payable$11,701 12,771 
Accounts payableAccounts payable9,765 11,055 Accounts payable10,443 11,703 
Accrued liabilitiesAccrued liabilities12,607 13,612 Accrued liabilities10,605 11,456 
Accrued rebates, returns and promotionsAccrued rebates, returns and promotions13,447 12,095 Accrued rebates, returns and promotions15,672 14,417 
Accrued compensation and employee related obligationsAccrued compensation and employee related obligations2,717 3,586 Accrued compensation and employee related obligations3,062 3,328 
Accrued taxes on income (Note 5)Accrued taxes on income (Note 5)1,980 1,112 Accrued taxes on income (Note 5)2,687 2,127 
Total current liabilitiesTotal current liabilities44,821 45,226 Total current liabilities54,170 55,802 
Long-term debt (Note 4)Long-term debt (Note 4)28,292 29,985 Long-term debt (Note 4)33,901 26,888 
Deferred taxes on income (Note 5)Deferred taxes on income (Note 5)5,015 7,487 Deferred taxes on income (Note 5)3,627 6,374 
Employee related obligations (Note 6)Employee related obligations (Note 6)8,553 8,898 Employee related obligations (Note 6)6,461 6,767 
Long-term taxes payable (Note 5)Long-term taxes payable (Note 5)4,162 5,713 Long-term taxes payable (Note 5)2,536 4,306 
Other liabilitiesOther liabilities10,524 10,686 Other liabilities14,582 10,437 
Total liabilitiesTotal liabilities$101,367 107,995 Total liabilities$115,277 110,574 
Commitments and Contingencies (Note 11)Commitments and Contingencies (Note 11)00Commitments and Contingencies (Note 11)
Shareholders’ equity:Shareholders’ equity:  Shareholders’ equity:  
Common stock — par value $1.00 per share (authorized 4,320,000,000 shares; issued 3,119,843,000 shares)Common stock — par value $1.00 per share (authorized 4,320,000,000 shares; issued 3,119,843,000 shares)$3,120 3,120 Common stock — par value $1.00 per share (authorized 4,320,000,000 shares; issued 3,119,843,000 shares)$3,120 3,120 
Accumulated other comprehensive income (loss) (Note 7)Accumulated other comprehensive income (loss) (Note 7)(13,843)(13,058)Accumulated other comprehensive income (loss) (Note 7)(13,135)(12,967)
Retained earnings126,216 123,060 
Less: common stock held in treasury, at cost (490,811,000 and 490,878,000 shares)39,136 39,099 
Total shareholders’ equity76,357 74,023 
Total liabilities and shareholders' equity$177,724 182,018 
Retained earnings and Additional paid-in capitalRetained earnings and Additional paid-in capital129,381 128,345 
Less: common stock held in treasury, at cost (521,700,000 and 506,246,000 shares)Less: common stock held in treasury, at cost (521,700,000 and 506,246,000 shares)44,217 41,694 
Total Johnson & Johnson shareholders’ equityTotal Johnson & Johnson shareholders’ equity75,149 76,804 
Equity attributable to non-controlling interest (Note 12)Equity attributable to non-controlling interest (Note 12)1,260 — 
Total equityTotal equity$76,409 76,804 
Total liabilities and shareholders’ equityTotal liabilities and shareholders’ equity$191,686 187,378 
See Notes to Consolidated Financial Statements
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)
 Fiscal Second Quarter Ended
July 3,
2022
Percent
to Sales
July 4,
2021
Percent
to Sales
Sales to customers (Note 9)$24,020 100.0 %$23,312 100.0 %
Cost of products sold7,919 33.0 7,587 32.5 
Gross profit16,101 67.0 15,725 67.5 
Selling, marketing and administrative expenses6,226 25.9 6,073 26.1 
Research and development expense3,703 15.4 3,394 14.6 
Interest income(64)(0.3)(12)(0.1)
Interest expense, net of portion capitalized38 0.2 40 0.2 
Other (income) expense, net273 1.1 (488)(2.1)
Restructuring (Note 12)85 0.4 56 0.2 
Earnings before provision for taxes on income5,840 24.3 6,662 28.6 
Provision for taxes on income (Note 5)1,026 4.3 384 1.7 
NET EARNINGS$4,814 20.0 %$6,278 26.9 %
NET EARNINGS PER SHARE (Note 8)    
Basic$1.83  $2.38  
Diluted$1.80  $2.35  
AVG. SHARES OUTSTANDING    
Basic2,629.6  2,632.5  
Diluted2,667.9  2,671.6  


See Notes to Consolidated Financial Statements


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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)
 Fiscal Second Quarter Ended
July 2,
2023
Percent
to Sales
July 3,
2022
Percent
to Sales
Sales to customers (Note 9)$25,530 100.0 %$24,020 100.0 %
Cost of products sold8,212 32.2 7,919 33.0 
Gross profit17,318 67.8 16,101 67.0 
Selling, marketing and administrative expenses6,665 26.1 6,226 25.9 
Research and development expense3,829 15.0 3,703 15.4 
Interest income(369)(1.5)(64)(0.3)
Interest expense, net of portion capitalized346 1.4 38 0.2 
Other (income) expense, net*(60)(0.2)273 1.1 
Restructuring145 0.5 85 0.4 
Earnings before provision for taxes on income6,762 26.5 5,840 24.3 
Provision for taxes on income (Note 5)1,618 6.4 1,026 4.3 
NET EARNINGS$5,144 20.1 %$4,814 20.0 %
NET EARNINGS PER SHARE (Note 8)    
Basic$1.98  $1.83  
Diluted$1.96  $1.80  
AVG. SHARES OUTSTANDING    
Basic2,598.4  2,629.6  
Diluted2,625.7  2,667.9  

Fiscal Six Months Ended
July 3,
2022
Percent
to Sales
July 4,
2021
Percent
to Sales
Sales to customers (Note 9)$47,446 100.0 %$45,633 100.0 %
Cost of products sold15,517 32.7 14,650 32.1 
Gross profit31,929 67.3 30,983 67.9 
Selling, marketing and administrative expenses12,164 25.6 11,505 25.2 
Research and development expense7,165 15.1 6,572 14.4 
In-process research and development610 1.3 00.0
Interest income(86)(0.2)(27)0.0
Interest expense, net of portion capitalized48 0.1 103 0.2 
Other (income) expense, net171 0.4 (1,370)(3.0)
Restructuring (Note 12)155 0.3 109 0.2 
Earnings before provision for taxes on income11,702 24.7 14,091 30.9 
Provision for taxes on income (Note 5)1,739 3.7 1,616 3.6 
NET EARNINGS$9,963 21.0 %$12,475 27.3 %
NET EARNINGS PER SHARE (Note 8)    
Basic$3.79  $4.74  
Diluted$3.73  $4.67  
AVG. SHARES OUTSTANDING    
Basic2,629.4  2,632.0  
Diluted2,669.2  2,674.0  
See Notes to Consolidated Financial Statements
*Fiscal second quarter of 2023 Other (income) expense, net includes $37 million related to the 10.4% non-controlling interest in Kenvue from the time of the initial public offering on May 8, 2023 through the end of the fiscal second quarter.


See Notes to Consolidated Financial Statements



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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)
Fiscal Six Months Ended
July 2,
2023
Percent
to Sales
July 3,
2022
Percent
to Sales
Sales to customers (Note 9)$50,276 100.0 %$47,446 100.0 %
Cost of products sold16,607 33.0 15,517 32.7 
Gross profit33,669 67.0 31,929 67.3 
Selling, marketing and administrative expenses12,803 25.5 12,164 25.6 
Research and development expense7,392 14.7 7,165 15.1 
In-process research and development impairments49 0.1 6101.3 
Interest income(604)(1.2)(86)(0.2)
Interest expense, net of portion capitalized561 1.1 48 0.1 
Other (income) expense, net*7,168 14.3 171 0.4 
Restructuring275 0.5 155 0.3 
Earnings before provision for taxes on income6,025 12.0 11,702 24.7 
Provision for taxes on income (Note 5)949 1.9 1,739 3.7 
NET EARNINGS$5,076 10.1 %$9,963 21.0 %
NET EARNINGS PER SHARE (Note 8)    
Basic$1.95  $3.79  
Diluted$1.93  $3.73  
AVG. SHARES OUTSTANDING    
Basic2,601.9  2,629.4  
Diluted2,630.7  2,669.2  

* Fiscal six months of 2023 Other (income) expense, net includes $37 million related to the 10.4% non-controlling interest in Kenvue from the time of the initial public offering on May 8, 2023 through the end of the fiscal second quarter.

See Notes to Consolidated Financial Statements
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited; Dollars in Millions)
Fiscal Second Quarter EndedFiscal Six Months EndedFiscal Second Quarter EndedFiscal Six Months Ended
July 3, 2022July 4, 2021July 3, 2022July 4, 2021July 2, 2023July 3, 2022July 2, 2023July 3, 2022
Net earningsNet earnings$4,814 6,278 $9,963 12,475 Net earnings$5,144 4,814 $5,076 9,963 
Other comprehensive income (loss), net of taxOther comprehensive income (loss), net of taxOther comprehensive income (loss), net of tax
Foreign currency translationForeign currency translation(151)(135)(705)141 Foreign currency translation(715)(151)(896)(705)
Securities:Securities:Securities:
Unrealized holding gain (loss) arising during period Unrealized holding gain (loss) arising during period(20)(1)(33)(1) Unrealized holding gain (loss) arising during period(20)21 (33)
Reclassifications to earnings Reclassifications to earnings— — — —  Reclassifications to earnings— — — — 
Net change Net change(20)(1)(33)(1) Net change(20)21 (33)
Employee benefit plans:Employee benefit plans:Employee benefit plans:
Prior service cost amortization during period Prior service cost amortization during period(20)(41)(73)(82) Prior service cost amortization during period(36)(20)(71)(73)
Gain (loss) amortization during period Gain (loss) amortization during period86 275 303 549  Gain (loss) amortization during period(34)86 (67)303 
Net change Net change66 234 230 467  Net change(70)66 (138)230 
Derivatives & hedges:Derivatives & hedges:Derivatives & hedges:
Unrealized gain (loss) arising during period Unrealized gain (loss) arising during period145 400 (50)(122) Unrealized gain (loss) arising during period(137)145 433 (50)
Reclassifications to earnings Reclassifications to earnings(126)(270)(227)(343) Reclassifications to earnings(139)(126)(136)(227)
Net change Net change19 130 (277)(465) Net change(276)19 297 (277)
Other comprehensive income (loss)Other comprehensive income (loss)(86)228 (785)142 Other comprehensive income (loss)(1,057)(86)(716)(785)
Comprehensive incomeComprehensive income$4,728 6,506 $9,178 12,617 Comprehensive income$4,087 4,728 $4,360 9,178 
See Notes to Consolidated Financial Statements

The tax effects in other comprehensive incomeincome/(loss) for the fiscal second quarter were as follows for 20222023 and 2021,2022, respectively: Foreign Currency Translation: $533$32 million and $90$533 million; Securities: $1 million and $6 million in 2022;million; Employee Benefit Plans: $84$21 million and $66$84 million; Derivatives & Hedges: $5$74 million and $33$5 million.
The tax effects in other comprehensive incomeincome/(loss) for the fiscal six months were as follows for 20222023 and 2021,2022, respectively: Foreign Currency Translation: $678$266 million and $229$678 million; Securities: $6 million and $9 million in 2022;million; Employee Benefit Plans: $65$43 million and $132$65 million; Derivatives & Hedges: $73$80 million and $124$73 million.
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EQUITY
(Unaudited; Dollars in Millions)


Fiscal Second Quarter Ended July 2, 2023

TotalRetained
Earnings and Additional paid-in capital
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
Non-controlling interest (NCI)
Balance, April 2, 2023$70,869 124,558 (12,626)3,120 (44,183) 
Net earnings5,144 5,144 — — — — 
Cash dividends paid ($1.19 per share)(3,092)(3,092)— — — — 
Employee compensation and stock option plans649 301 — — 348 
Repurchase of common stock(381)— — (381)
Other(1)— — — (1)— 
Kenvue IPO4,278 2,470 548 1,260 *
Other comprehensive income (loss), net of tax(1,057)— (1,057)— — — 
Balance, July 2, 2023$76,409 129,381 (13,135)3,120 (44,217)1,260 



Fiscal Six Months Ended July 2, 2023
TotalRetained
Earnings and Additional paid-in capital
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
Non-controlling interest (NCI)
Balance, January 1, 2023$76,804 128,345 (12,967)3,120 (41,694) 
Net earnings5,076 5,076 — — — — 
Cash dividends paid ($2.32 per share)(6,034)(6,034)— — — — 
Employee compensation and stock option plans944 (476)— — 1,420 — 
Repurchase of common stock(3,918)— — — (3,918)— 
Other(25)— — — (25)— 
Kenvue IPO4,278 2,470 548 — — 1,260 *
Other comprehensive income (loss), net of tax(716)— (716)— — — 
Balance, July 2, 2023$76,409 129,381 (13,135)3,120 (44,217)1,260 

*Includes $37 million recorded in net earnings related to the 10.4% non-controlling interest of Kenvue.



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Fiscal Second Quarter Ended July 3, 2022
TotalRetained
Earnings
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
Balance, April 3, 2022$74,709 124,380 (13,757)3,120 (39,034)
Net earnings4,814 4,814 — — — 
Cash dividends paid ($1.13 per share)(2,971)(2,971)— — — 
Employee compensation and stock option plans864 (7)— — 871 
Repurchase of common stock(973)— — — (973)
Other comprehensive income (loss), net of tax(86)— (86)— — 
Balance, July 3, 2022$76,357 126,216 (13,843)3,120 (39,136)

TotalRetained
Earnings and Additional paid-in capital
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
Balance, April 3, 2022$74,709 124,380 (13,757)3,120 (39,034)
Net earnings4,814 4,814 — — — 
Cash dividends paid ($1.13 per share)(2,971)(2,971)— — — 
Employee compensation and stock option plans864 (7)— — 871 
Repurchase of common stock(973)— — — (973)
Other comprehensive income (loss), net of tax(86)— (86)— — 
Balance, July 3, 2022$76,357 126,216 (13,843)3,120 (39,136)



Fiscal Six Months Ended July 3, 2022
TotalRetained
Earnings
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
Balance, January 2, 2022$74,023 123,060 (13,058)3,120 (39,099)
Net earnings9,963 9,963 — — — 
Cash dividends paid ($2.19 per share)(5,758)(5,758)— — — 
Employee compensation and stock option plans1,464 (1,049)— — 2,513 
Repurchase of common stock(2,550)— — — (2,550)
Other comprehensive income (loss), net of tax(785)— (785)— — 
Balance, July 3, 2022$76,357 126,216 (13,843)3,120 (39,136)


















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Fiscal Second Quarter Ended July 4, 2021


TotalRetained
Earnings
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
Balance, April 4, 2021$65,834 116,508 (15,328)3,120 (38,466)
Net earnings6,278 6,278 — — — 
Cash dividends paid ($1.06 per share)(2,791)(2,791)— — — 
Employee compensation and stock option plans662 159 — — 503 
Repurchase of common stock(631)— — — (631)
Other comprehensive income (loss), net of tax228 — 228 — — 
Balance, July 4, 2021$69,580 120,154 (15,100)3,120 (38,594)


Fiscal Six Months Ended July 4, 2021

Fiscal Six Months Ended July 3, 2022Fiscal Six Months Ended July 3, 2022
TotalRetained
Earnings
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
TotalRetained
Earnings
Accumulated
Other
Comprehensive
Income
Common Stock
Issued Amount
Treasury
Stock
Amount
Balance, January 3, 2021$63,278 113,890 (15,242)3,120 (38,490)
Balance, January 2, 2022Balance, January 2, 2022$74,023 123,060 (13,058)3,120 (39,099)
Net earningsNet earnings12,475 12,475 — — — Net earnings9,963 9,963 — — — 
Cash dividends paid ($2.07 per share)(5,450)(5,450)— — — 
Cash dividends paid ($2.19 per share)Cash dividends paid ($2.19 per share)(5,758)(5,758)— — — 
Employee compensation and stock option plansEmployee compensation and stock option plans1,204 (761)— — 1,965 Employee compensation and stock option plans1,464 (1,049)— — 2,513 
Repurchase of common stockRepurchase of common stock(2,069)— — — (2,069)Repurchase of common stock(2,550)— — — (2,550)
Other comprehensive income (loss), net of taxOther comprehensive income (loss), net of tax142 — 142 — — Other comprehensive income (loss), net of tax(785)— (785)— — 
Balance, July 4, 2021$69,580 120,154 (15,100)3,120 (38,594)
Balance, July 3, 2022Balance, July 3, 2022$76,357 126,216 (13,843)3,120 (39,136)


See Notes to Consolidated Financial Statements
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
Fiscal Six Months Ended Fiscal Six Months Ended
July 3,
2022
July 4,
2021
July 2,
2023
July 3,
2022
CASH FLOWS FROM OPERATING ACTIVITIESCASH FLOWS FROM OPERATING ACTIVITIES ��CASH FLOWS FROM OPERATING ACTIVITIES  
Net earningsNet earnings$9,963 12,475 Net earnings$5,076 9,963 
Adjustments to reconcile net earnings to cash flows from operating activities:Adjustments to reconcile net earnings to cash flows from operating activities:  Adjustments to reconcile net earnings to cash flows from operating activities:  
Depreciation and amortization of property and intangiblesDepreciation and amortization of property and intangibles3,513 3,733 Depreciation and amortization of property and intangibles3,814 3,513 
Stock based compensationStock based compensation644 661 Stock based compensation688 644 
Asset write-downsAsset write-downs747 26 Asset write-downs388 747 
Net gain on sale of assets/businessesNet gain on sale of assets/businesses(213)(601)Net gain on sale of assets/businesses(47)(213)
Deferred tax provisionDeferred tax provision(2,349)(685)Deferred tax provision(2,342)(2,349)
Credit losses and accounts receivable allowancesCredit losses and accounts receivable allowances(3)(52)Credit losses and accounts receivable allowances— (3)
Changes in assets and liabilities, net of effects from acquisitions and divestitures:Changes in assets and liabilities, net of effects from acquisitions and divestitures:  Changes in assets and liabilities, net of effects from acquisitions and divestitures:  
Increase in accounts receivableIncrease in accounts receivable(1,386)(1,566)Increase in accounts receivable(599)(1,386)
Increase in inventoriesIncrease in inventories(1,257)(818)Increase in inventories(741)(1,257)
Decrease in accounts payable and accrued liabilitiesDecrease in accounts payable and accrued liabilities(1,170)(4,050)Decrease in accounts payable and accrued liabilities(1,061)(1,170)
Decrease in other current and non-current assets3,527 1,415 
Decrease in other current and non-current liabilities(2,456)(1,150)
(Increase)/Decrease in other current and non-current assets(Increase)/Decrease in other current and non-current assets(1,144)3,527 
Increase/(Decrease) in other current and non-current liabilitiesIncrease/(Decrease) in other current and non-current liabilities3,407 (2,456)
NET CASH FLOWS FROM OPERATING ACTIVITIESNET CASH FLOWS FROM OPERATING ACTIVITIES9,560 9,388 NET CASH FLOWS FROM OPERATING ACTIVITIES7,439 9,560 
CASH FLOWS FROM INVESTING ACTIVITIESCASH FLOWS FROM INVESTING ACTIVITIES  CASH FLOWS FROM INVESTING ACTIVITIES  
Additions to property, plant and equipmentAdditions to property, plant and equipment(1,470)(1,490)Additions to property, plant and equipment(1,987)(1,470)
Proceeds from the disposal of assets/businesses, net (Note 10)Proceeds from the disposal of assets/businesses, net (Note 10)314 654 Proceeds from the disposal of assets/businesses, net (Note 10)116 314 
Acquisitions, net of cash acquired (Note 10)Acquisitions, net of cash acquired (Note 10)(523)— Acquisitions, net of cash acquired (Note 10)— (523)
Purchases of investmentsPurchases of investments(22,048)(12,264)Purchases of investments(9,688)(22,048)
Sales of investmentsSales of investments17,634 12,453 Sales of investments11,877 17,634 
Credit support agreements activity, netCredit support agreements activity, net(10)441 Credit support agreements activity, net(798)(10)
Other (primarily licenses and milestones)Other (primarily licenses and milestones)(170)(398)Other (primarily licenses and milestones)19 (170)
NET CASH USED BY INVESTING ACTIVITIESNET CASH USED BY INVESTING ACTIVITIES(6,273)(604)NET CASH USED BY INVESTING ACTIVITIES(461)(6,273)
CASH FLOWS FROM FINANCING ACTIVITIESCASH FLOWS FROM FINANCING ACTIVITIES  CASH FLOWS FROM FINANCING ACTIVITIES  
Dividends to shareholdersDividends to shareholders(5,758)(5,450)Dividends to shareholders(6,034)(5,758)
Repurchase of common stockRepurchase of common stock(2,550)(2,069)Repurchase of common stock(3,918)(2,550)
Proceeds from short-term debt4,371 498 
Proceeds from short-term debt (Note 4)Proceeds from short-term debt (Note 4)12,221 4,371 
Repayment of short-term debtRepayment of short-term debt(2,201)(689)Repayment of short-term debt(13,611)(2,201)
Proceeds from long-term debt, net of issuance costs
Proceeds from long-term debt, net of issuance costs (Note 4)Proceeds from long-term debt, net of issuance costs (Note 4)7,674 
Repayment of long-term debtRepayment of long-term debt(2,132)(1,451)Repayment of long-term debt(501)(2,132)
Proceeds from the exercise of stock options/employee withholding tax on stock awards, netProceeds from the exercise of stock options/employee withholding tax on stock awards, net820 543 Proceeds from the exercise of stock options/employee withholding tax on stock awards, net254 820 
Credit support agreements activity, netCredit support agreements activity, net813 130 Credit support agreements activity, net(126)813 
Proceeds from Kenvue initial public offering (Note 12)Proceeds from Kenvue initial public offering (Note 12)4,241 — 
OtherOther(11)83 Other(53)(11)
NET CASH USED BY FINANCING ACTIVITIES(6,646)(8,404)
NET CASH FROM/(USED BY) FINANCING ACTIVITIESNET CASH FROM/(USED BY) FINANCING ACTIVITIES147 (6,646)
Effect of exchange rate changes on cash and cash equivalentsEffect of exchange rate changes on cash and cash equivalents(145)(33)Effect of exchange rate changes on cash and cash equivalents(69)(145)
(Decrease)/Increase in cash and cash equivalents(3,504)347 
Cash and Cash equivalents, beginning of period14,487 13,985 
Increase/(Decrease) in cash and cash equivalentsIncrease/(Decrease) in cash and cash equivalents7,056 (3,504)
Cash and Cash equivalents beginning of periodCash and Cash equivalents beginning of period14,127 14,487 
CASH AND CASH EQUIVALENTS, END OF PERIODCASH AND CASH EQUIVALENTS, END OF PERIOD$10,983 14,332 CASH AND CASH EQUIVALENTS, END OF PERIOD$21,183 10,983 
AcquisitionsAcquisitionsAcquisitions
Fair value of assets acquiredFair value of assets acquired$621 — Fair value of assets acquired$— 621 
Fair value of liabilities assumed and noncontrolling interests(98)— 
Fair value of liabilities assumedFair value of liabilities assumed— (98)
Net cash paid for acquisitionsNet cash paid for acquisitions$523 — Net cash paid for acquisitions$— 523 
See Notes to Consolidated Financial Statements
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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 2, 2022.1, 2023. 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.

For details regarding the Kenvue separation see Note 12 to the Consolidated Financial Statements.

Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures.

Use of Estimates
The extent to which COVID-19 impacts the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of COVID-19, the extent to which it will impact worldwide macroeconomic conditions including interest rates, inflation, employment rates and health insurance coverage, the speed of the anticipated recovery, and governmental and business reactions to the pandemic. The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts COVID-19 as of July 3, 2022 and through the date of this report. The accounting matters assessed included, but were not limited to, the Company’s allowance for credit losses, inventory and related reserves, accrued rebates and associated reserves, and the carrying value of the goodwill and other assets. While there was not a material impact to the Company’s consolidated financial statements as of and for the quarter ended July 3, 2022, the Company’s future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in material impacts to the Company’s consolidated financial statements in future reporting periods.

New Accounting Standards
The Company assesses the adoption impacts of recently issued accounting standards by the Financial Accounting Standards Board on the Company's financial statements as well as material updates to previous assessments, if any, from the Company’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023.

Recently Adopted Accounting Standards
ASU 2022-04: Liabilities-Supplier Finance Programs (Topic 405-50) – Disclosure of Supplier Finance Program Obligations
The Company adopted the standard as of the beginning of fiscal year 2023, which requires that a buyer in a supplier finance program disclose additional information about the program for financial statement users.

The Company has agreements for supplier finance programs with third-party financial institutions. These programs provide participating suppliers the ability to finance payment obligations from the Company with the third-party financial institutions. The Company is not a party to the arrangements between the suppliers and the third-party financial institutions. The Company’s obligations to its suppliers, including amounts due, and scheduled payment dates (which have general payment terms of 90 days), are not affected by a participating supplier’s decision to participate in the program.

As of July 2, 2022. 2023, and January 1, 2023, $0.9 billion and $1.0 billion, respectively, were valid obligations under the program. The obligations are presented as Accounts payable on the Consolidated Balance Sheets.

Recently Issued Accounting Standards
Not Adopted as of July 2, 2023
There were no new material accounting standards issued in the fiscal second quartersix months of 2022 that impacted the Company.

Recently Adopted Accounting Standards
There were no new material accounting standards adopted in the fiscal second quarter of 2022.2023.

Reclassification
Certain prior period amounts have been reclassified to conform to current year presentation.




NOTE 2 — INVENTORIES
(Dollars in Millions)(Dollars in Millions)July 3, 2022January 2, 2022(Dollars in Millions)July 2, 2023January 1, 2023
Raw materials and suppliesRaw materials and supplies$1,696 1,592 Raw materials and supplies$2,419 2,070 
Goods in processGoods in process2,324 2,287 Goods in process1,944 1,700 
Finished goodsFinished goods7,417 6,508 Finished goods8,525 8,713 
Total inventoriesTotal inventories$11,437 10,387 Total inventories$12,888 12,483 


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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 2021.2022. 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)(Dollars in Millions)July 3, 2022January 2, 2022(Dollars in Millions)July 2, 2023January 1, 2023
Intangible assets with definite lives:Intangible assets with definite lives:  Intangible assets with definite lives:  
Patents and trademarks — grossPatents and trademarks — gross$36,885 38,572 Patents and trademarks — gross$44,637 44,012 
Less accumulated amortizationLess accumulated amortization(20,336)(20,088)Less accumulated amortization(24,460)(22,266)
Patents and trademarks — netPatents and trademarks — net16,549 18,484 Patents and trademarks — net20,177 21,746 
Customer relationships and other intangibles — grossCustomer relationships and other intangibles — gross22,558 23,011 Customer relationships and other intangibles — gross23,055 22,987 
Less accumulated amortizationLess accumulated amortization(12,269)(11,925)Less accumulated amortization(13,516)(12,901)
Customer relationships and other intangibles — net(1)
Customer relationships and other intangibles — net(1)
10,289 11,086 
Customer relationships and other intangibles — net(1)
9,539 10,086 
Intangible assets with indefinite lives:Intangible assets with indefinite lives:  Intangible assets with indefinite lives:  
TrademarksTrademarks6,794 6,985 Trademarks6,834 6,807 
Purchased in-process research and development(2)
Purchased in-process research and development(2)
8,776 9,837 
Purchased in-process research and development(2)
9,696 9,686 
Total intangible assets with indefinite livesTotal intangible assets with indefinite lives15,570 16,822 Total intangible assets with indefinite lives16,530 16,493 
Total intangible assets — netTotal intangible assets — net$42,408 46,392 Total intangible assets — net$46,246 48,325 
(1)The majority is comprised of customer relationships
(2)In the fiscal first quarter of 2022, the Company recorded an intangible asset impairment charge of approximately$0.6 billion related to an in-process research and development asset, bermekimab (JnJ-77474462), an investigational drug for the treatment of Atopic Dermatitis (AD) and Hidradenitis Suppurativa (HS). Additional information regarding efficacy of the AD indication became available which led the Company to the decision to terminate the development of bermekimab for AD. The Company acquired all rights to bermekimab from XBiotech, Inc.in the fiscal year 2020. The remaining reduction was driven by assets that reached commercialization and are now classified as having definite lives.

Goodwill as of July 3, 20222, 2023 was allocated by segment of business as follows:
(Dollars in Millions)(Dollars in Millions)Consumer HealthPharmaceuticalMedTechTotal(Dollars in Millions)Consumer HealthPharmaceuticalMedTechTotal
Goodwill at January 2, 2022$9,810 10,580 14,856 35,246 
Goodwill at January 1, 2023Goodwill at January 1, 2023$9,184 10,184 25,863 45,231 
Goodwill, related to acquisitionsGoodwill, related to acquisitions— — 195 195 Goodwill, related to acquisitions— — — — 
Goodwill, related to divestituresGoodwill, related to divestitures— — — — 
Currency translation/OtherCurrency translation/Other(665)(545)(65)(1,275)Currency translation/Other(103)137 175 *209 
Goodwill at July 3, 2022$9,145 10,035 14,986 34,166 
Goodwill at July 2, 2023Goodwill at July 2, 2023$9,081 10,321 26,038 45,440 
*Includes purchase price allocation adjustment for Abiomed

The weighted average amortization period for patents and trademarks is 12 years. The weighted average amortization period for customer relationships and other intangible assets is 21 years. The amortization expense of amortizable intangible assets included in cost of products sold was $1.1$1.2 billion and $1.2$1.1 billion for the fiscal second quarters ended July 3, 20222, 2023 and July 4, 2021,3, 2022, respectively. The amortization expense of amortizable intangible assets included in cost of products sold was $2.2$2.4 billion and $2.4$2.2 billion for the fiscal six months ended July 3, 20222, 2023 and July 4, 2021,3, 2022, respectively. Intangible asset write-downs are included in Other (income) expense, net.net, with the exception of In-Process research and development which are included in the In-Process research and development impairments line.

The estimated amortization expense for approved products, before tax, for the five succeeding years is approximately:
(Dollars in Millions)
20222023202420252026
$4,4004,4004,2003,4002,800
(Dollars in Millions)
20232024202520262027
$4,8004,6003,8003,2002,600

See Note 10 to the Consolidated Financial Statements for additional details related to acquisitions and divestitures.

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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 product 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. Both 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 cross currency interest rate swaps and 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. The Company maintains credit support agreements (CSA) with certain derivative counterparties establishing collateral thresholds based on respective credit ratings and netting agreements. As of July 3, 2022,2, 2023, the cumulative amount of cash collateral receivedpaid by the Company under the CSA amounted to $233.0 million$1.8 billion net, related to net investment and cash flow hedges. 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, 2022,2, 2023, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps and interest rate swaps of $46.7$46.9 billion, $37.2$39.5 billion and $10.0 billion, respectively. As of January 2, 2022,1, 2023, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps and interest rate swaps of $45.8$43.3 billion, $37.4$36.2 billion and $10.0$12.4 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. Foreign exchange contracts designated as cash flow hedges are accounted for under the forward method and all gains/losses associated with these contracts will be recognized in the income statement when the hedged item impacts earnings. Changes in the fair value of these derivatives 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 within accumulated other comprehensive income. The portion excluded from effectiveness testing is recorded through interest (income) expense using the spot method. 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.

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.

As of July 3, 2022,2, 2023, the balance of deferred net lossgain on derivatives included in accumulated other comprehensive income was $613$67 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 and net investment hedge 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.


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Table of Contents


The following table is a summary of the activity related to derivatives and hedges for the fiscal second quarters ended inJuly 2, 2023 and July 3, 2022, and 2021, net of tax:
July 3, 2022July 4, 2021
(Dollars in Millions)SalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) ExpenseSalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) Expense
The effects of fair value, net investment and cash flow hedging:
Gain (Loss) on fair value hedging relationship:
Interest rate swaps contracts:
    Hedged items$— — — (241)— — — — (6)— 
    Derivatives designated as hedging instruments— — — 241 — — — — — 
Gain (Loss) on net investment hedging relationship:
Cross currency interest rate swaps contracts:
   Amount of gain or (loss) recognized in income on derivative amount excluded from effectiveness testing— — — 44 — — — — 40 — 
   Amount of gain or (loss) recognized in AOCI— — — 44 — — — — 40 — 
Gain (Loss) on cash flow hedging relationship:
Forward foreign exchange contracts:
   Amount of gain or (loss) reclassified from AOCI into income(17)(6)42 — (39)11 14 104 — 
   Amount of gain or (loss) recognized in AOCI(25)35 69 — (38)(3)(50)119 — 
Cross currency interest rate swaps contracts:
   Amount of gain or (loss) reclassified from AOCI into income— — — 102 — — 0— 99 — 
   Amount of gain or (loss) recognized in AOCI$— — — 60 — — — — 286 — 

July 2, 2023July 3, 2022
(Dollars in Millions)SalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) ExpenseSalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) Expense
The effects of fair value, net investment and cash flow hedging:
Gain (Loss) on fair value hedging relationship:
Interest rate swaps contracts:
    Hedged items$— — — (175)— — — — (241)— 
    Derivatives designated as hedging instruments— — — 175 — — — — 241 — 
Gain (Loss) on net investment hedging relationship:
Cross currency interest rate swaps contracts:
   Amount of gain or (loss) recognized in income on derivative amount excluded from effectiveness testing— — — 33 — — — — 44 — 
   Amount of gain or (loss) recognized in AOCI— — — 33 — — — — 44 — 
Gain (Loss) on cash flow hedging relationship:
Forward foreign exchange contracts:
   Amount of gain or (loss) reclassified from AOCI into income(15)56 (12)— (17)(6)42 — (39)
   Amount of gain or (loss) recognized in AOCI(14)251 — 18 (25)35 69 — (38)
Cross currency interest rate swaps contracts:
   Amount of gain or (loss) reclassified from AOCI into income— — — 74 — — — — 102 — 
   Amount of gain or (loss) recognized in AOCI$— — — (432)— — — — 60 — 
















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The following table is a summary of the activity related to derivatives and hedges for the fiscal six months ended inJuly 2, 2023 and July 3, 2022, and 2021, net of tax:


July 3, 2022July 4, 2021July 2, 2023July 3, 2022
(Dollars in Millions)(Dollars in Millions)SalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) ExpenseSalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) Expense(Dollars in Millions)SalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) ExpenseSalesCost of Products SoldR&D ExpenseInterest (Income) ExpenseOther (Income) Expense
The effects of fair value, net investment and cash flow hedging:The effects of fair value, net investment and cash flow hedging:The effects of fair value, net investment and cash flow hedging:
Gain (Loss) on fair value hedging relationship:Gain (Loss) on fair value hedging relationship:Gain (Loss) on fair value hedging relationship:
Interest rate swaps contracts:Interest rate swaps contracts:Interest rate swaps contracts:
Hedged items Hedged items$— — — (772)— — — — (6)—  Hedged items$— — — (1,104)— — — — (772)— 
Derivatives designated as hedging instruments Derivatives designated as hedging instruments— — — 772 — — — — —  Derivatives designated as hedging instruments— — — 1,104 — — — — 772 — 
Gain (Loss) on net investment hedging relationship:Gain (Loss) on net investment hedging relationship:Gain (Loss) on net investment hedging relationship:
Cross currency interest rate swaps contracts:Cross currency interest rate swaps contracts:Cross currency interest rate swaps contracts:
Amount of gain or (loss) recognized in income on derivative amount excluded from effectiveness testing Amount of gain or (loss) recognized in income on derivative amount excluded from effectiveness testing— — — 89 — — — — 80 —  Amount of gain or (loss) recognized in income on derivative amount excluded from effectiveness testing— — — 67 — — — — 89 — 
Amount of gain or (loss) recognized in AOCI Amount of gain or (loss) recognized in AOCI— — — 89 — — — — 80 —  Amount of gain or (loss) recognized in AOCI— — — 67 — — — — 89 — 
Gain (Loss) on cash flow hedging relationship:Gain (Loss) on cash flow hedging relationship:Gain (Loss) on cash flow hedging relationship:
Forward foreign exchange contracts:Forward foreign exchange contracts:Forward foreign exchange contracts:
Amount of gain or (loss) reclassified from AOCI into income Amount of gain or (loss) reclassified from AOCI into income(34)(58)65 — (57)28 48 (9)—  Amount of gain or (loss) reclassified from AOCI into income(3)(90)(25)— (34)(58)65 — (57)
Amount of gain or (loss) recognized in AOCI Amount of gain or (loss) recognized in AOCI(3)(59)102 — (111)(6)(243)43 — 25  Amount of gain or (loss) recognized in AOCI10 396 (29)— (3)(59)102 — (111)
Cross currency interest rate swaps contracts:Cross currency interest rate swaps contracts:Cross currency interest rate swaps contracts:
Amount of gain or (loss) reclassified from AOCI into income Amount of gain or (loss) reclassified from AOCI into income— — — 222 — — — — 191 —  Amount of gain or (loss) reclassified from AOCI into income— — — 182 — — — — 222 — 
Amount of gain or (loss) recognized in AOCI Amount of gain or (loss) recognized in AOCI$— — — (68)— — — — (21)—  Amount of gain or (loss) recognized in AOCI$— — — (15)— — — — (68)— 








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As of July 3, 2022,2, 2023, and January 2, 2022,1, 2023, the following amounts were recorded on the Consolidated Balance Sheet related to cumulative basis adjustment for fair value hedges
Line item in the Consolidated Balance Sheet in which the hedged item is includedCarrying Amount of the Hedged Liability
Cumulative Amount of Fair Value Hedging Gain/ (Loss) Included in the Carrying Amount of the Hedged Liability
(Dollars in Millions)July 3, 2022January 2, 2022July 3, 2022January 2, 2022
Long-term Debt$9,035 9,793 (1,010)(142)

Line item in the Consolidated Balance Sheet in which the hedged item is includedCarrying Amount of the Hedged Liability
Cumulative Amount of Fair Value Hedging Gain/ (Loss) Included in the Carrying Amount of the Hedged Liability
(Dollars in Millions)July 2, 2023January 1, 2023July 2, 2023January 1, 2023
Long-term Debt$8,662 8,665 (1,443)(1,435)


The following table is the effect of derivatives not designated as hedging instruments for the fiscal second quarters ended 20222023 and 2021:2022:
Gain/(Loss)
Recognized In
Income on Derivative
Gain/(Loss)
Recognized In
Income on Derivative
Gain/(Loss)
Recognized In
Income on Derivative
Gain/(Loss)
Recognized In
Income on Derivative
(Dollars in Millions)(Dollars in Millions)Location of Gain /(Loss) Recognized in Income on DerivativeFiscal Second Quarter EndedFiscal Six Months Ended(Dollars in Millions)Location of Gain /(Loss) Recognized in Income on DerivativeFiscal Second Quarter EndedFiscal Six Months Ended
Derivatives Not Designated as Hedging InstrumentsDerivatives Not Designated as Hedging InstrumentsJuly 3, 2022July 4, 2021July 3, 2022July 4, 2021Derivatives Not Designated as Hedging InstrumentsJuly 2, 2023July 3, 2022July 2, 2023July 3, 2022
Foreign Exchange ContractsForeign Exchange ContractsOther (income) expense$73 (21)102 (37)Foreign Exchange ContractsOther (income) expense$33 73 102 


The following table is the effect of net investment hedges for the fiscal second quarters ended in 20222023 and 2021:2022:
Gain/(Loss)
Recognized In
Accumulated
OCI
Location of Gain or (Loss) Reclassified from Accumulated Other Comprehensive Income Into IncomeGain/(Loss) Reclassified From
Accumulated OCI
Into Income
Gain/(Loss)
Recognized In
Accumulated
OCI
Location of Gain or (Loss) Reclassified from Accumulated Other Comprehensive Income Into IncomeGain/(Loss) Reclassified From
Accumulated OCI
Into Income
(Dollars in Millions)(Dollars in Millions)July 3, 2022July 4, 2021July 3, 2022July 4, 2021(Dollars in Millions)July 2, 2023July 3, 2022July 2, 2023July 3, 2022
DebtDebt$202 (45)Interest (income) expense— — Debt$11 202 Interest (income) expense— — 
Cross Currency interest rate swapsCross Currency interest rate swaps$313 (70)Interest (income) expense— — Cross Currency interest rate swaps$(24)313 Interest (income) expense— — 

The following table is the effect of net investment hedges for the fiscal six months ended in 20222023 and 20212022
Gain/(Loss)
Recognized In
Accumulated OCI
Location of Gain or (Loss) Reclassified from Accumulated Other Comprehensive Income Into IncomeGain/(Loss) Reclassified From
Accumulated OCI
Into Income
(Dollars in Millions)July 3, 2022July 4, 2021July 3, 2022July 4, 2021
Debt$270 164 Interest (income) expense— — 
Cross Currency interest rate swaps$873 291 Interest (income) expense— — 

Gain/(Loss)
Recognized In
Accumulated OCI
Location of Gain or (Loss) Reclassified from Accumulated Other Comprehensive Income Into IncomeGain/(Loss) Reclassified From
Accumulated OCI
Into Income
(Dollars in Millions)July 2, 2023July 3, 2022July 2, 2023July 3, 2022
Debt$(66)270 Interest (income) expense— — 
Cross Currency interest rate swaps$666 873 Interest (income) expense— — 
The Company holds equity investments with readily determinable fair values and equity investments without readily determinable fair values. The Company has elected to measure equity investments that do not have readily determinable fair
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values at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
The following table is a summary of the activity related to equity investments:
(Dollars in Millions)(Dollars in Millions)January 2, 2022July 3, 2022(Dollars in Millions)January 1, 2023July 2, 2023
Carrying Value
Changes in Fair Value Reflected in Net Income (1)
Sales/ Purchases/Other (2)
Carrying ValueNon Current Other AssetsCarrying Value
Changes in Fair Value Reflected in Net Income (1)
Sales/ Purchases/Other (2)
Carrying ValueNon Current Other Assets
Equity Investments with readily determinable valueEquity Investments with readily determinable value$1,884 (508)(36)1,340 1,340 Equity Investments with readily determinable value$576 (30)(53)493 493 
Equity Investments without readily determinable valueEquity Investments without readily determinable value$500 (14)35 521 521 Equity Investments without readily determinable value$698 (26)75 747 747 
(1) Recorded in Other Income/Expense
(2) Other includes impact of currency

For equity investments without readily determinable market values, there was a decrease of $14 million in the fair value reflected in net income as a result of impairments.

Subsequent to the fiscal second quarter ended July 3, 2022, the Company sold all of its shares in argenx SE for proceeds of $0.6 billion.

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. In accordance with ASC 820, a three-level hierarchy was established to prioritize the inputs used in measuring fair value. The levels within the hierarchy are described below with Level 1 inputs having the highest priority and Level 3 inputs 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 holds acquisition related contingent liabilities based upon certain regulatory and commercial events, which are classified as Level 3, whose values are determined using discounted cash flow methodologies or similar techniques for which the determination of fair value requires significant judgment or estimations.

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.

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The Company’s significant financial assets and liabilities measured at fair value as of July 3, 20222, 2023 and January 2, 20221, 2023 were as follows:
July 3, 2022 January 2, 2022 July 2, 2023 January 1, 2023
(Dollars in Millions)(Dollars in Millions)Level 1Level 2Level 3Total
Total(1)
(Dollars in Millions)Level 1Level 2Level 3Total
Total(1)
Derivatives designated as hedging instruments:Derivatives designated as hedging instruments:     Derivatives designated as hedging instruments:     
Assets:Assets:     Assets:     
Forward foreign exchange contractsForward foreign exchange contracts$— 1,314 — 1,314 540 Forward foreign exchange contracts$— 893 — 893 629 
Interest rate contracts (2)
Interest rate contracts (2)
— 1,979 — 1,979 796 
Interest rate contracts (2)
— 1,310 — 1,310 1,534 
TotalTotal— 3,293 — 3,293 1,336 Total— 2,203 — 2,203 2,163 
Liabilities:Liabilities:     Liabilities:     
Forward foreign exchange contractsForward foreign exchange contracts— 1,513 — 1,513 881 Forward foreign exchange contracts— 446 — 446 511 
Interest rate contracts (2)
Interest rate contracts (2)
— 1,540 — 1,540 979 
Interest rate contracts (2)
— 3,691 — 3,691 2,778 
TotalTotal— 3,053 — 3,053 1,860 Total— 4,137 — 4,137 3,289 
Derivatives not designated as hedging instruments:Derivatives not designated as hedging instruments:     Derivatives not designated as hedging instruments:     
Assets:Assets:     Assets:     
Forward foreign exchange contractsForward foreign exchange contracts— 47 — 47 24 Forward foreign exchange contracts— 55 — 55 38 
Liabilities:Liabilities:     Liabilities:     
Forward foreign exchange contractsForward foreign exchange contracts— 44 — 44 28 Forward foreign exchange contracts— 22 — 22 68 
Other Investments:Other Investments:Other Investments:
Equity investments (3)
Equity investments (3)
1,340 — — 1,340 1,884 
Equity investments (3)
493 — — 493 576 
Debt securities (4)
Debt securities (4)
— 21,123 — 21,123 19,727 
Debt securities (4)
— 9,831 — 9,831 10,487 
Other LiabilitiesOther LiabilitiesOther Liabilities
Contingent consideration (5)
Contingent consideration (5)
$— — 536 536 533 
Contingent consideration (5)
$— — 1,142 1,142 1,120 

Gross to Net Derivative ReconciliationJuly 3, 2022January 2, 2022
(Dollars in Millions)
Total Gross Assets$3,340 1,360 
Credit Support Agreement (CSA)(3,226)(1,285)
Total Net Asset114 75 
Total Gross Liabilities3,097 1,888 
Credit Support Agreement (CSA)(2,993)(1,855)
Total Net Liabilities$104 33 

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Gross to Net Derivative ReconciliationJuly 2, 2023January 1, 2023
(Dollars in Millions)
Total Gross Assets$2,258 2,201 
Credit Support Agreement (CSA)(2,119)(2,176)
Total Net Asset139 25 
Total Gross Liabilities4,159 3,357 
Credit Support Agreement (CSA)(3,890)(3,023)
Total Net Liabilities$269 334 


Summarized information about changes in liabilities for contingent consideration for the fiscal second quarters ended July 2, 2023 and July 3, 2022 is as follows:
July 3, 2022July 4, 2021July 2, 2023July 3, 2022
(Dollars in Millions)(Dollars in Millions)(Dollars in Millions)
Beginning BalanceBeginning Balance$533 $633 Beginning Balance$1,120 533 
Changes in estimated fair value (6)
Changes in estimated fair value (6)
(88)
Changes in estimated fair value (6)
25 (88)
AdditionsAdditions91 — Additions— 91 
PaymentsPayments— (48)Payments(3)— 
Ending BalanceEnding Balance$536 $593 Ending Balance$1,142 536 



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(1)20212022 assets and liabilities are all classified as Level 2 with the exception of equity investments of $1,884$576 million, which are classified as Level 1 and contingent consideration of $533$1,120 million, classified as Level 3.
(2) Includes cross currency interest rate swaps and interest rate swaps.
(3)    Classified as non-current other assets.
(4)    Classified within cash equivalents and current marketable securities.
(5)    Includes $519$1,137 million and $520$1,116 million, classified as non-current other liabilities as of July 3, 20222, 2023 and January 2, 2022, respectively. Includes $17 million and $13 million classified as current liabilities as of July 3, 2022 and January 2, 2022,1, 2023, respectively.
(6) Ongoing fair value adjustment amounts are primarily recorded in Research and Development expense.
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The Company's cash, cash equivalents and current marketable securities as of July 3, 20222, 2023 comprised:
(Dollars in Millions)(Dollars in Millions)Carrying AmountGain/( Loss)Estimated Fair ValueCash & Cash EquivalentsCurrent Marketable Securities(Dollars in Millions)Carrying AmountGain/(Loss)Estimated Fair ValueCash & Cash EquivalentsCurrent Marketable Securities
CashCash$3,337 — 3,337 3,337 — Cash$4,430 — 4,430 4,430 — 
Non-U.S. sovereign securities(1)
Non-U.S. sovereign securities(1)
538 (1)537 — 538 
Non-U.S. sovereign securities(1)
423 — 423 423 — 
U.S. reverse repurchase agreementsU.S. reverse repurchase agreements2,112 — 2,112 2,112 — U.S. reverse repurchase agreements8,991 — 8,991 8,991 — 
Corporate debt securities(1)
Corporate debt securities(1)
2,443 (8)2,435 240 2,203 
Corporate debt securities(1)
641 — 641 368 273 
Money market fundsMoney market funds1,968 — 1,968 1,968 — Money market funds3,570 — 3,570 3,570 — 
Time deposits(1)
Time deposits(1)
1,047 — 1,047 1,047 — 
Time deposits(1)
619 — 619 619 — 
Subtotal Subtotal11,445 (9)11,436 8,704 2,741  Subtotal18,674 — 18,674 18,401 273 
Unrealized LossUnrealized Loss
U.S. Gov't securities20,919 (45)20,874 2,251 18,623 
U.S. Gov’t securitiesU.S. Gov’t securities9,416 (5)9,411 2,729 6,682 
U.S. Gov’t AgenciesU.S. Gov’t Agencies123 (2)121 — 121 
Other sovereign securitiesOther sovereign securities— — Other sovereign securities— 
Corporate debt securitiesCorporate debt securities247 (1)246 28 218 Corporate debt securities291 (1)290 46 244 
Subtotal available for sale debt(2)
Subtotal available for sale debt(2)
$21,169 (46)21,123 2,279 18,844 
Subtotal available for sale debt(2)
$9,839 (8)9,831 2,782 7,049 
Total cash, cash equivalents and current marketable securitiesTotal cash, cash equivalents and current marketable securities$32,614 (55)32,559 10,983 21,585 Total cash, cash equivalents and current marketable securities$28,513 (8)28,505 21,183 7,322 
(1) Held to maturity investments are reported at amortized cost and gains or losses are reported in earnings.
(2) Available for sale debt securities are reported at fair value with unrealized gains and losses reported net of taxes in other comprehensive income.

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As of the fiscal year ended January 2, 20221, 2023, the carrying amount was approximately the same as the estimated fair value.

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 to fund current operations and are classified as either cash equivalents andor current marketable securities.

The contractual maturities of the available for sale securities as of July 3, 20222, 2023 are as follows:
(Dollars in Millions)Cost BasisFair Value
Due within one year$21,155 21,109 
Due after one year through five years14 14 
Due after five years through ten years— — 
Total debt securities$21,169 21,123 
(Dollars in Millions)Cost BasisFair Value
Due within one year$9,823 9,815 
Due after one year through five years16 16 
Due after five years through ten years— — 
Total debt securities$9,839 9,831 
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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, 2022:2, 2023:
(Dollars in Millions)(Dollars in Millions)Carrying AmountEstimated Fair Value(Dollars in Millions)Carrying AmountEstimated Fair Value
Financial LiabilitiesFinancial Liabilities  Financial Liabilities  
Current DebtCurrent Debt$4,305 4,304 Current Debt$11,701 11,676 
Non-Current DebtNon-Current Debt  Non-Current Debt  
6.73% Debentures due 2023250 263 
3.375% Notes due 2023802 805 
0.650% Notes due 2024 (750MM Euro 1.0408)774 766 
5.50% Notes due 2024 (500MM GBP 1.2143)605 647 
5.50% Notes due 2024 (500MM GBP 1.2605)5.50% Notes due 2024 (500MM GBP 1.2605)629 627 
2.625% Notes due 20252.625% Notes due 2025749 745 2.625% Notes due 2025749 726 
0.550% Notes due 2025940 872 
0.55% Notes due 20250.55% Notes due 2025926 914 
2.45% Notes due 20262.45% Notes due 20261,995 1,950 2.45% Notes due 20261,997 1,890 
2.95% Notes due 20272.95% Notes due 2027911 899 2.95% Notes due 2027875 954 
0.95% Notes due 20270.95% Notes due 20271,423 1,264 0.95% Notes due 20271,394 1,313 
2.90% Notes due 20282.90% Notes due 20281,496 1,462 2.90% Notes due 20281,497 1,411 
1.150% Notes due 2028 (750MM Euro 1.0408)776 735 
1.150% Notes due 2028 (750MM Euro 1.0873)1.150% Notes due 2028 (750MM Euro 1.0873)811 728 
6.95% Notes due 20296.95% Notes due 2029298 372 6.95% Notes due 2029298 347 
1.30% Notes due 20301.30% Notes due 20301,646 1,404 1.30% Notes due 20301,605 1,435 
4.95% Debentures due 20334.95% Debentures due 2033498 554 4.95% Debentures due 2033498 525 
4.375% Notes due 20334.375% Notes due 2033855 895 4.375% Notes due 2033854 857 
1.650% Notes due 2035 (1.5B Euro 1.0408)1,554 1,370 
1.650% Notes due 2035 (1.5B Euro 1.0873)1.650% Notes due 2035 (1.5B Euro 1.0873)1,619 1,400 
3.55% Notes due 20363.55% Notes due 2036885 848 3.55% Notes due 2036840 901 
5.95% Notes due 20375.95% Notes due 2037993 1,181 5.95% Notes due 2037993 1,126 
3.625% Notes due 20373.625% Notes due 20371,381 1,328 3.625% Notes due 20371,334 1,355 
3.40% Notes due 20383.40% Notes due 2038992 898 3.40% Notes due 2038992 889 
5.85% Debentures due 20385.85% Debentures due 2038697 817 5.85% Debentures due 2038697 783 
4.50% Debentures due 20404.50% Debentures due 2040540 546 4.50% Debentures due 2040541 539 
2.10% Notes due 20402.10% Notes due 2040876 647 2.10% Notes due 2040826 704 
4.85% Notes due 20414.85% Notes due 2041297 312 4.85% Notes due 2041297 299 
4.50% Notes due 20434.50% Notes due 2043496 506 4.50% Notes due 2043496 499 
3.70% Notes due 20463.70% Notes due 20461,975 1,830 3.70% Notes due 20461,977 1,758 
3.75% Notes due 20473.75% Notes due 2047863 806 3.75% Notes due 2047811 871 
3.50% Notes due 20483.50% Notes due 2048743 677 3.50% Notes due 2048743 640 
2.25% Notes due 20502.25% Notes due 2050864 599 2.25% Notes due 2050807 666 
2.45% Notes due 20602.45% Notes due 20601,108 773 2.45% Notes due 20601,053 811 
5.50% Debentures due 2025*5.50% Debentures due 2025*748 752 
5.35% Debentures due 2026*5.35% Debentures due 2026*747 756 
5.05% Debentures due 2028*5.05% Debentures due 2028*994 1,006 
5.00% Debentures due 2030*5.00% Debentures due 2030*992 1,006 
4.90% Debentures due 2033*4.90% Debentures due 2033*1,240 1,264 
5.10% Debentures due 2043*5.10% Debentures due 2043*741 763 
5.05% Debentures due 2053*5.05% Debentures due 2053*1,476 1,531 
5.20% Debentures due 2063*5.20% Debentures due 2063*738 765 
OtherOther10 10 Other66 66 
Total Non-Current DebtTotal Non-Current Debt$28,292 26,781 Total Non-Current Debt$33,901 32,877 
*Tranches related to Kenvue
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The weighted average effective interest rate on non-current debt is 3.04%3.54%.

The excess of the estimated faircarrying value over the carryingestimated fair value of debt was $3.2$1.6 billion at January 2, 2022.

The current debt balance as of July 3, 2022 includes $3.8 billion of commercial paper which has a weighted average interest rate of 0.98% and a weighted average maturity of approximately two months.
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1, 2023.

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

In March 2023, Kenvue priced an offering of senior unsecured notes (the Notes) in an aggregate principal amount of $7.75 billion (tranches with an * in the above table). The Notes were initially fully and unconditionally guaranteed (the Guarantees) on a senior unsecured basis by the Company. The Guarantees terminated on April 5, 2023, upon completion of the Consumer Health Business transfer.

The current debt balance as of July 2, 2023 includes $9.8 billion of commercial paper ($0.7 billion of which relates to Kenvue) which has a weighted average interest rate of 4.99% and a weighted average maturity of approximately forty days.



NOTE 5 — INCOME TAXES

The worldwide effective income tax rates for the fiscal six months quarters of 2023 and 2022 were 15.8% and 2021 were 14.9% and 11.5%, respectively. ThisThe increase in the consolidated tax rate as compared to the prior year fiscal quarter is primarily due to the Company reorganizing the ownership structure of certain wholly-owned international subsidiaries in the second fiscal quarter of 2021. As part of this reorganization, the Company increased the tax basis of certain assets to fair value in accordance with the applicable local regulations. Accordingly the Company recorded a local deferred tax benefit of approximately $2.3 billion which was partially offset by a related increase in the U.S. GILTI deferred tax liability of approximately $1.7 billion. The net impact of this reorganization was approximately $0.6 billion net benefit or a 4.4% decrease to the effective tax rate of the fiscal six months of 2021.

Additionally, the Company had lower income in higher tax jurisdictions, primarily in the U.S., compared to the same period in the prior year and certain one-time tax costs. This lower income in the fiscal six months of 2022 was primarily caused by a mark to market adjustment to the Company’s investment portfolio, the impairment of the Bermekimab AD IPR&D (for further information see Note 3 to the Consolidated Financial Statements), both at the U.S. statutory rate, and litigation expenses. The impact of the income mix was partially offset by incremental tax costs directly related to the planned separation of the Company’s Consumer Health businessbusiness. The Company has recognized approximately $0.6 billion in incremental international tax costs due to the reorganization of certain international subsidiaries which was recorded in the fiscal second quarter. The Company also had more income in lower tax jurisdictions relative to higher tax jurisdictions versus the prior year, due primarily to the approximately $7 billion charge related to the talc settlement proposal in the United States at an effective tax rate of 23.5% in the fiscal six months of 2023 (for further information see Note 111 to the Consolidated Financial Statements).

The Company also had additional tax benefits received from stock-based compensation that were either exercised or vested during each of the fiscal second quarters. Additionally, the Company’sprior year’s effective tax rate benefited from the impact of certain provisions of the Tax Cuts and Jobs Act of 2017 that became effective in 2022, which were partially offset by one-time tax costs in the fiscal six months of 2022.

On July 21, 2023, the IRS issued Notice 2023-55 which provides guidance to taxpayers in determining whether a foreign tax is eligible for a U.S. foreign tax credit for tax years 2022 and 2023, specifically delaying until 2024 the application of unfavorable foreign tax credit regulations that were originally issued late last year. As a result of this new guidance, the Company has concluded that it is applicable to certain of its tax positions and therefore will record a tax benefit of approximately $0.5 billion in the fiscal third quarter of 2023.

The Company also received tax benefits from stock-based compensation that were either exercised or vested during each of the fiscal six months ended.

As of July 3, 2022,2, 2023, the Company had approximately $3.4$3.0 billion of liabilities from unrecognized tax benefits. The Company conducts business and files tax returns in numerous countries and currently has tax audits in progress in a number of jurisdictions. With respect to the United States, the IRS has completed its audit for the tax years through 2012 and is currently auditing tax years 2013 through 2016. The Company currently expects completion of this audit and settlement of the related tax liabilities in the next 12 months. As a result, the Company has classified approximately $0.5 billion of unrecognized tax benefits and associated interest as a current liability on the “Accrued taxes on Income” line of the Consolidated Balance Sheet as of the end of the second fiscal quarter of 2023 in anticipation of final settlement. The Company made a payment in the fiscal second quarter for approximately $1.4 billion to the U.S. Treasury for the previously reserved estimated liability of the 2013-2016 IRS Audit. The completion of this tax audit may result in additional adjustments to the Company’s unrecognized tax benefit liability. In other major jurisdictions where the Company conducts business, the years that remain open to tax audit go back to the year 2008. The Company believes it is possible that some tax audits may be completed over the next twelve months by taxing authorities in some jurisdictions outside of the United States.jurisdictions. However, the Company is not able to provide a reasonably reliable estimate of the timing of any other future tax payments relating to uncertain tax positions.

Subsequent to July 3, 2022, as part of the planned separation of the Company’s Consumer Health business the Company has recognized approximately $0.3 billion in incremental tax costs due to the reorganization of certain international subsidiaries which will be recorded in the fiscal third quarter.




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NOTE 6 — PENSIONS AND OTHER BENEFIT PLANS

Components of Net Periodic Benefit Cost
Net periodic benefit costs for the Company’s defined benefit retirement plans and other benefit plans include the following components:
Fiscal Second Quarter EndedFiscal Six Months Ended
 Retirement PlansOther Benefit PlansRetirement PlansOther Benefit Plans
(Dollars in Millions)July 3, 2022July 4, 2021July 3, 2022July 4, 2021July 3, 2022July 4, 2021July 3, 2022July 4, 2021
Service cost$319 327 80 77 640 680 160 154 
Interest cost229 193 27 21 459 386 53 41 
Expected return on plan assets(693)(647)(2)(2)(1,392)(1,327)(4)(4)
Amortization of prior service cost/(credit)(46)(45)(2)(7)(92)(90)(3)(15)
Recognized actuarial losses167 316 31 37 329 630 61 75 
Curtailments and settlements— — — — — — 
Net periodic benefit cost/(credit)$(24)144 134 126 (55)280 267 251 
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Fiscal Second Quarter EndedFiscal Six Months Ended
 Retirement PlansOther Benefit PlansRetirement PlansOther Benefit Plans
(Dollars in Millions)July 2, 2023July 3, 2022July 2, 2023July 3, 2022July 2, 2023July 3, 2022July 2, 2023July 3, 2022
Service cost$216 319 69 80 428 640 137 160 
Interest cost373 229 55 27 727 459 109 53 
Expected return on plan assets(694)(693)(2)(2)(1,362)(1,392)(3)(4)
Amortization of prior service cost/(credit)(46)(46)(1)(2)(92)(92)(1)(3)
Recognized actuarial (gains) losses(50)167 31 (100)329 13 61 
Curtailments and settlements— — — — — — — 
Net periodic benefit cost/(credit)$(201)(24)128 134 (399)(55)255 267 

The service cost component of net periodic benefit cost is presented in the same line items on the Consolidated Statement of Earnings where other employee compensation costs are reported, including Cost of products sold, Research and development expense, and Selling, marketing and administrative expenses. All other components of net periodic benefit cost are presented as part of Other (income) expense, net on the Consolidated Statement of Earnings.

Company Contributions
For the fiscal six months ended July 3, 2022,2, 2023, the Company contributed $54$58 million and $10$12 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:
ForeignGain/(Loss)EmployeeGain/(Loss)Total Accumulated ForeignGain/(Loss)EmployeeGain/(Loss)Total Accumulated
CurrencyOnBenefitOn DerivativesOther ComprehensiveCurrencyOnBenefitOn DerivativesOther Comprehensive
(Dollars in Millions)(Dollars in Millions)TranslationSecuritiesPlans& HedgesIncome (Loss)(Dollars in Millions)TranslationSecuritiesPlans& HedgesIncome (Loss)
January 2, 2022$(10,017)(3)(2,702)(336)(13,058)
January 1, 2023January 1, 2023$(11,813)(27)(897)(230)(12,967)
Net changeNet change(705)(33)230 (277)(785)Net change(896)21 (138)297 (716)
July 3, 2022$(10,722)(36)(2,472)(613)(13,843)
Amount attributable to non-controlling interestAmount attributable to non-controlling interest548 548 
July 2, 2023July 2, 2023$(12,161)(6)(1,035)67 (13,135)

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.
20

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NOTE 8 — EARNINGS PER SHARE

The following is a reconciliation of basic net earnings per share to diluted net earnings per share:
Fiscal Second Quarter EndedFiscal Six Months Ended Fiscal Second Quarter EndedFiscal Six Months Ended
(Shares in Millions)(Shares in Millions)July 3, 2022July 4, 2021July 3, 2022July 4, 2021(Shares in Millions)July 2, 2023July 3, 2022July 2, 2023July 3, 2022
Basic net earnings per shareBasic net earnings per share$1.83 2.38 3.79 4.74 Basic net earnings per share$1.98 1.83 1.95 3.79 
Average shares outstanding — basicAverage shares outstanding — basic2,629.6 2,632.5 2,629.4 2,632.0 Average shares outstanding — basic2,598.4 2,629.6 2,601.9 2,629.4 
Potential shares exercisable under stock option plansPotential shares exercisable under stock option plans143.7 141.9 141.8 126.0 Potential shares exercisable under stock option plans95.2 143.7 96.9 141.8 
Less: shares which could be repurchased under treasury stock methodLess: shares which could be repurchased under treasury stock method(105.4)(102.8)(102.0)(84.0)Less: shares which could be repurchased under treasury stock method(67.9)(105.4)(68.1)(102.0)
Average shares outstanding — dilutedAverage shares outstanding — diluted2,667.9 2,671.6 2,669.2 2,674.0 Average shares outstanding — diluted2,625.7 2,667.9 2,630.7 2,669.2 
Diluted net earnings per shareDiluted net earnings per share$1.80 2.35 3.73 4.67 Diluted net earnings per share$1.96 1.80 1.93 3.73 

The diluted net earnings per share calculation for boththe fiscal second quarter ended July 2, 2023 excluded 50.8 million shares related to stock options, as the exercise price of these options was greater than the average market value of the Company’s stock. The diluted net earnings per share calculation for the fiscal second quarter ended July 3, 2022 and July 4, 2021 included all shares related to stock options, as the exercise price of all options was less than the average market value of the Company’s stock.

The diluted net earnings per share calculation for the fiscal six months ended July 2, 2023 excluded 46.8 million shares related to stock options, as the exercise price of these options was greater than the average market value of the Company’s stock. The diluted net earnings per share calculation for the fiscal six months ended July 3, 2022 included all shares related to stock options, as the exercise price of all options was less than the average market value of the Company’s stock. The diluted net earnings per share calculation for the fiscal six months ended July 4, 2021 excluded 14 million shares related to stock options, as the exercise price of these options was greater than the average market value of the Company's stock.


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NOTE 9 — SEGMENTS OF BUSINESS AND GEOGRAPHIC AREAS

SALES BY SEGMENT OF BUSINESS
Fiscal Second Quarter EndedFiscal Six Months Ended Fiscal Second Quarter EndedFiscal Six Months Ended
(Dollars in Millions)(Dollars in Millions)July 3,
2022
July 4,
2021
Percent
Change
July 3,
2022
July 4,
2021
Percent Change(Dollars in Millions)July 2,
2023
July 3,
2022
Percent
Change
July 2,
2023
July 3,
2022
Percent Change
CONSUMER HEALTH (1)
CONSUMER HEALTH (1)
   
CONSUMER HEALTH (1)
   
OTCOTCOTC
U.S. U.S.$663 675 (1.8)%$1,333 1,274 4.6 % U.S.$712 663 7.5 %$1,457 1,333 9.3 %
International International818 752 8.8 1,609 1,425 12.9  International947 818 15.7 1,844 1,609 14.6 
Worldwide Worldwide1,482 1,426 3.8 2,943 2,699 9.0  Worldwide1,659 1,482 12.0 3,301 2,943 12.2 
Skin Health/BeautySkin Health/BeautySkin Health/Beauty
U.S. U.S.629 659 (4.5)1,173 1,293 (9.2) U.S.650 629 3.4 1,267 1,173 8.0 
International International497 511 (2.8)965 1,040 (7.2) International498 497 0.3 991 965 2.7 
Worldwide Worldwide1,126 1,170 (3.7)2,138 2,333 (8.3) Worldwide1,148 1,126 2.0 2,258 2,138 5.6 
Oral CareOral CareOral Care
U.S. U.S.170 165 3.4 313 328 (4.6) U.S.173 170 1.7 332 313 6.2 
International International224 260 (14.1)447 514 (13.0) International225 224 0.3 427 447 (4.7)
Worldwide Worldwide394 426 (7.3)760 843 (9.7) Worldwide398 394 0.9 759 760 (0.2)
Baby CareBaby CareBaby Care
U.S. U.S.88 97 (9.1)173 193 (10.3) U.S.99 88 12.5 195 173 12.7 
International International287 290 (1.0)557 583 (4.4) International261 287 (9.1)524 557 (6.0)
Worldwide Worldwide375 387 (3.1)730 776 (5.9) Worldwide360 375 (4.0)719 730 (1.6)
Women's Health
Women’s HealthWomen’s Health
U.S. U.S.8.9 8.1  U.S.(2.1)(0.1)
International International228 227 0.1 452 446 1.3  International235 228 3.5 449 452 (0.7)
Worldwide Worldwide230 230 0.2 458 452 1.4  Worldwide238 230 3.4 455 458 (0.6)
Wound Care/OtherWound Care/OtherWound Care/Other
U.S. U.S.133 153 (12.7)245 268 (8.6) U.S.149 133 12.3 264 245 7.9 
International International65 64 1.7 117 125 (6.6) International58 65 (10.3)107 117 (8.4)
Worldwide Worldwide197 216 (8.4)361 393 (8.0) Worldwide207 197 4.9 371 361 2.6 
TOTAL CONSUMER HEALTHTOTAL CONSUMER HEALTHTOTAL CONSUMER HEALTH
U.S. U.S.1,687 1,751 (3.6)3,244 3,362 (3.5) U.S.1,787 1,687 6.0 3,522 3,244 8.6 
International International2,118 2,103 0.6 4,147 4,133 0.3  International2,224 2,118 5.0 4,341 4,147 4.7 
Worldwide Worldwide3,805 3,854 (1.3)7,391 7,495 (1.4) Worldwide4,011 3,805 5.4 7,863 7,391 6.4 
22

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PHARMACEUTICAL(1)
PHARMACEUTICAL(1)
PHARMACEUTICAL(1)
ImmunologyImmunologyImmunology
U.S. U.S.2,853 2,748 3.8 5,354 5,161 3.7  U.S.2,865 2,853 0.4 5,313 5,354 (0.8)
International International1,559 1,483 5.1 3,176 2,984��6.4  International1,631 1,559 4.7 3,295 3,176 3.8 
Worldwide Worldwide4,411 4,231 4.3 8,530 8,145 4.7  Worldwide4,496 4,411 1.9 8,608 8,530 0.9 
REMICADE REMICADE
REMICADE
U.S. U.S.391 540 (27.4)749 1,029 (27.1) U.S.277 391 (29.3)553 749 (26.2)
U.S. Exports U.S. Exports44 93 (53.0)124 150 (17.5) U.S. Exports33 44 (24.9)74 124 (40.3)
International International212 255 (17.2)437 487 (10.3) International152 212 (28.2)322 437 (26.2)
Worldwide Worldwide647 888 (27.2)1,310 1,665 (21.4) Worldwide462 647 (28.6)949 1,310 (27.5)
SIMPONI / SIMPONI ARIA
SIMPONI / SIMPONI ARIA
SIMPONI / SIMPONI ARIA
U.S. U.S.301 290 3.8 588 545 7.9  U.S.285 301 (5.1)556 588 (5.4)
International International266 294 (9.7)549 601 (8.6) International244 266 (8.2)510 549 (7.1)
Worldwide Worldwide566 584 (3.0)1,137 1,146 (0.8) Worldwide529 566 (6.6)1,066 1,137 (6.2)
STELARA
STELARA
STELARA
U.S. U.S.1,731 1,496 15.7 3,110 2,827 10.0  U.S.1,817 1,731 4.9 3,268 3,110 5.1 
International International868 778 11.6 1,777 1,595 11.4  International981 868 13.0 1,974 1,777 11.1 
Worldwide Worldwide2,599 2,274 14.3 4,887 4,422 10.5  Worldwide2,797 2,599 7.6 5,241 4,887 7.2 
TREMFYA
TREMFYA
TREMFYA
U.S. U.S.382 325 17.7 773 599 29.1  U.S.450 382 17.8 856 773 10.7 
International International214 155 38.3 413 298 38.6  International255 214 19.4 489 413 18.4 
Worldwide Worldwide597 479 24.4 1,187 897 32.3  Worldwide706 597 18.3 1,346 1,187 13.4 
OTHER IMMUNOLOGY
OTHER IMMUNOLOGY
OTHER IMMUNOLOGY
U.S. U.S.(50.1)12 (24.8) U.S.17.8 (30.2)
International International0*0* International00— 00
Worldwide Worldwide(59.2)15 (39.0) Worldwide17.8 (30.2)
Infectious DiseasesInfectious DiseasesInfectious Diseases
U.S. U.S.415 444 (6.4)876 956 (8.3) U.S.395 415 (4.9)787 876 (10.2)
International International901 575 56.8 1,737 1,060 63.9  International727 901 (19.4)1,920 1,737 10.5 
Worldwide Worldwide1,316 1,018 29.3 2,613 2,016 29.6  Worldwide1,121 1,316 (14.8)2,707 2,613 3.6 
COVID-19 VACCINE
COVID-19 VACCINE
COVID-19 VACCINE
U.S. U.S.45 51 (11.5)120 151 (20.4) U.S.— 45 *— 120 *
International International499 113*881 113 * International285 499 (43.0)1,032 881 17.1
Worldwide Worldwide544 164 *1,001 264 * Worldwide285 544 (47.7)1,032 1,001 3.0
EDURANT / rilpivirine
EDURANT / rilpivirine
EDURANT / rilpivirine
U.S. U.S.(1.7)18 19 (7.4) U.S.(9.0)17 18 (5.3)
International International215 253 (14.7)454 486 (6.5) International258 215 19.9 529 454 16.4 
Worldwide Worldwide225 262 (14.3)473 505 (6.5) Worldwide266 225 18.6 546 473 15.6 
PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA
PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA
PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA
U.S. U.S.355 368 (3.4)724 748 (3.2) U.S.382 355 7.6 760 724 5.0 
International International110 137 (20.2)242 303 (20.3) International109 110 (0.2)208 242 (13.9)
Worldwide Worldwide464 505 (7.9)965 1,051 (8.1) Worldwide491 464 5.8 968 965 0.3 
23

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OTHER INFECTIOUS DISEASES
OTHER INFECTIOUS DISEASES
OTHER INFECTIOUS DISEASES
U.S. U.S.16 (62.5)14 37 (62.5) U.S.(27.2)10 14 (30.6)
International International77 71 7.4 160 158 1.3  International74 77 (3.5)151 160 (5.6)
Worldwide Worldwide83 88 (5.4)174 196 (10.9) Worldwide79 83 (5.2)161 174 (7.6)
NeuroscienceNeuroscienceNeuroscience
U.S. U.S.896 842 6.5 1,739 1,613 7.9  U.S.1,029 896 14.9 2,007 1,739 15.4 
International International837 963 (13.0)1,735 1,906 (8.9) International764 837 (8.8)1,590 1,735 (8.4)
Worldwide Worldwide1,734 1,804 (3.9)3,475 3,519 (1.2) Worldwide1,793 1,734 3.5 3,597 3,475 3.5 
CONCERTA / methylphenidate
CONCERTA / methylphenidate
CONCERTA / methylphenidate
U.S. U.S.38 35 9.4 73 82 (11.3) U.S.64 38 68.2 134 73 84.0 
International International123 127 (2.2)245 250 (1.7) International143 123 16.3 279 245 13.9 
Worldwide Worldwide161 161 0.3 318 332 (4.1) Worldwide208 161 28.6 414 318 30.0 
INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA
INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA
INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA
U.S. U.S.691 645 7.3 1,352 1,234 9.6  U.S.721 691 4.3 1,434 1,352 6.0 
International International362 380 (4.6)749 756 (0.8) International310 362 (14.4)641 749 (14.5)
Worldwide Worldwide1,054 1,024 2.9 2,102 1,989 5.7  Worldwide1,031 1,054 (2.1)2,075 2,102 (1.3)
RISPERDAL CONSTA
SPRAVATO
SPRAVATO
U.S. U.S.65 72 (8.9)128 139 (7.7) U.S.144 74 93.2 255 135 88.3 
International International60 84 (28.0)126 173 (27.1) International25 11 *45 20 *
Worldwide Worldwide125 155 (19.3)254 312 (18.4) Worldwide169 85 98.2 300 155 93.1 
OTHER NEUROSCIENCE(1)
OTHER NEUROSCIENCE(1)
OTHER NEUROSCIENCE(1)
U.S. U.S.102 91 11.8 186 158 17.6  U.S.100 93 9.3 184 179 3.1 
International International292 373 (21.8)615 728 (15.5) International286 341 (16.4)625 721 (13.4)
Worldwide Worldwide393 464 (15.2)800 886 (9.6) Worldwide386 433 (10.9)809 900 (10.1)
OncologyOncologyOncology
U.S. U.S.2,069 1,679 23.2 3,958 3,261 21.4 
International International2,329 2,362 (1.4)4,552 4,731 (3.8)
Worldwide Worldwide4,398 4,042 8.8 8,510 7,992 6.5 
CARVYKTI
CARVYKTI
U.S. U.S.1,679 1,462 14.9 3,261 2,839 14.9  U.S.114 24 *184 24 *
International International2,362 2,073 14.0 4,731 4,266 10.9  International— *— *
Worldwide Worldwide4,042 3,535 14.3 7,992 7,105 12.5  Worldwide117 24 *189 24 *
DARZALEX
DARZALEX
DARZALEX
U.S. U.S.1,021 770 32.6 1,974 1,461 35.1  U.S.1,322 1,021 29.5 2,513 1,974 27.3 
International International965 663 45.5 1,868 1,337 39.7  International1,110 965 15.0 2,182 1,868 16.8 
Worldwide Worldwide1,986 1,433 38.6 3,842 2,798 37.3  Worldwide2,431 1,986 22.4 4,695 3,842 22.2 
ERLEADA
ERLEADA
ERLEADA
U.S. U.S.233 193 20.6 43936420.4  U.S.241 233 3.6 49043911.8 
International International218 109  *412199 * International326 218 49.7 61941250.3 
Worldwide Worldwide450 302 49.5 85056351.1  Worldwide567 450 25.9 1,109 85030.4 
IMBRUVICA
IMBRUVICA
IMBRUVICA
U.S. U.S.349 454 (23.1)719 898 (19.9) U.S.262 349 (24.9)532 719 (26.0)
International International620 662 (6.3)1,288 1,342 (4.0) International579 620 (6.7)1,136 1,288 (11.8)
Worldwide Worldwide970 1,116 (13.1)2,008 2,241 (10.4) Worldwide841 970 (13.2)1,668 2,008 (16.9)
ZYTIGA / abiraterone acetate
ZYTIGA / abiraterone acetate
ZYTIGA / abiraterone acetate
U.S.19 21 (12.2)38 71 (47.0)
International486 542 (10.2)1,006 1,130 (11.0)
Worldwide505 563 (10.3)1,044 1,201 (13.1)
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Table of Contents
U.S. U.S.19 (55.2)25 38 (34.7)
International International218 486 (55.1)447 1,006 (55.6)
Worldwide Worldwide227 505 (55.1)472 1,044 (54.8)
OTHER ONCOLOGY
OTHER ONCOLOGY
OTHER ONCOLOGY
U.S. U.S.57 23 *91 44 * U.S.122 33 *214 67 *
International International72 97 (25.7)156 258 (39.4) International92 72 27.8 162 156 3.6 
Worldwide Worldwide130 120 7.5 248 302 (18.0) Worldwide214 106 *376 224 68.0 
Pulmonary HypertensionPulmonary HypertensionPulmonary Hypertension
U.S. U.S.560 595 (5.8)1,132 1,168 (3.1) U.S.684 560 22.0 1,284 1,132 13.4 
International International284 275 2.8 563 563 (0.1) International289 284 2.0 561 563 (0.4)
Worldwide Worldwide843 870 (3.1)1,695 1,731 (2.1) Worldwide972 843 15.3 1,844 1,695 8.8 
OPSUMIT
OPSUMIT
OPSUMIT
U.S. U.S.265 290 (8.7)538 562 (4.3) U.S.328 265 23.7 601 538 11.6 
International International173 172 0.5 343 351 (2.2) International179 173 3.4 346 343 0.9 
Worldwide Worldwide438 463 (5.3)881 913 (3.5) Worldwide507 438 15.7 947 881 7.5 
UPTRAVI
UPTRAVI
UPTRAVI
U.S. U.S.272 268 1.4 541 527 2.6  U.S.338 272 24.2 642 541 18.7 
International International56 45 26.2 112 91 23.5  International61 56 10.0 119 112 6.6 
Worldwide Worldwide328 313 4.9 653 618 5.7  Worldwide399 328 21.8 761 653 16.6 
OTHER PULMONARY HYPERTENSION
OTHER PULMONARY HYPERTENSION
OTHER PULMONARY HYPERTENSION
U.S. U.S.23 36 (36.2)53 78 (32.3) U.S.18 23 (23.8)41 53 (23.0)
International International55 59 (8.1)108 122 (11.7) International48 55 (10.9)95 108 (11.7)
Worldwide Worldwide78 95 (18.7)161 200 (19.8) Worldwide66 78 (14.7)136 161 (15.5)
Cardiovascular / Metabolism / OtherCardiovascular / Metabolism / OtherCardiovascular / Metabolism / Other
U.S. U.S.757 780 (3.0)1,429 1,579 (9.5) U.S.776 757 2.6 1,491 1,429 4.3 
International International215 241 (10.9)453 486 (6.9) International174 215 (19.0)386 453 (14.7)
Worldwide Worldwide972 1,021 (4.8)1,882 2,065 (8.9) Worldwide950 972 (2.2)1,877 1,882 (0.3)
XARELTO
XARELTO
XARELTO
U.S. U.S.609 569 7.1 1,117 1,158 (3.5) U.S.637 609 4.7 1,215 1,117 8.8 
International International— — — — — —  International— — — — — — 
Worldwide Worldwide609 569 7.1 1,117 1,158 (3.5) Worldwide637 609 4.7 1,215 1,117 8.8 
INVOKANA / INVOKAMET
U.S.55 96 (42.9)115 183 (37.1)
International65 64 2.4 133 127 4.9 
Worldwide120 160 (24.9)248 310 (19.9)
OTHER(2)
OTHER(2)
OTHER(2)
U.S. U.S.93 116 (19.5)197 238 (17.2) U.S.138 148 (6.3)275 312 (11.8)
International International150 178 (15.6)320 360 (11.1) International174 215 (19.0)386 453 (14.7)
Worldwide Worldwide243 293 (17.2)517 598 (13.5) Worldwide313 363 (13.8)662 765 (13.5)
TOTAL PHARMACEUTICALTOTAL PHARMACEUTICAL  TOTAL PHARMACEUTICAL  
U.S. U.S.7,159 6,869 4.2 13,791 13,315 3.6  U.S.7,818 7,159 9.2 14,841 13,791 7.6 
International International6,158 5,611 9.8 12,395 11,266 10.0  International5,913 6,158 (4.0)12,303 12,395 (0.7)
Worldwide Worldwide13,317 12,480 6.7 26,186 24,581 6.5  Worldwide13,731 13,317 3.1 27,144 26,186 3.7 
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MEDTECH(3)
MEDTECH(3)
MEDTECH(3)
Interventional SolutionsInterventional SolutionsInterventional Solutions
U.S. U.S.908 525 73.1 1,771 1,019 73.8 
International International712 525 35.7 1,352 1,123 20.5 
Worldwide Worldwide1,620 1,049 54.4 3,123 2,141 45.8 
ELECTROPHYSIOLOGY
ELECTROPHYSIOLOGY
U.S. U.S.609 499 22.0 1,180 969 21.7 
International International587 469 25.1 1,109 1,001 10.8 
Worldwide Worldwide1,196 968 23.5 2,288 1,970 16.2 
ABIOMED(3)
ABIOMED(3)
U.S. U.S.272 — *536 — *
International International59 — *119 — *
Worldwide Worldwide331 — *655 — *
OTHER INTERVENTIONAL SOLUTIONS
OTHER INTERVENTIONAL SOLUTIONS
U.S. U.S.525 475 10.5 1,019 909 12.1  U.S.27 26 4.5 55 51 10.8 
International International525 572 (8.1)1,123 1,086 3.4  International67 56 20.0 125 121 2.8 
Worldwide Worldwide1,049 1,046 0.3 2,141 1,995 7.4  Worldwide93 81 15.1 180 171 5.1 
OrthopaedicsOrthopaedicsOrthopaedics
U.S. U.S.1,338 1,323 1.1 2,627 2,572 2.1  U.S.1,388 1,338 3.7 2,751 2,627 4.7 
International International820 904 (9.3)1,719 1,768 (2.8) International878 820 7.0 1,759 1,719 2.3 
Worldwide Worldwide2,157 2,227 (3.1)4,345 4,340 0.1  Worldwide2,265 2,157 5.0 4,510 4,345 3.8 
HIPS
HIPS
HIPS
U.S. U.S.240 233 3.4 465 442 5.2  U.S.250 240 4.1 491 465 5.6 
International International148 159 (6.6)312 305 2.4  International147 148 (0.8)296 312 (5.1)
Worldwide Worldwide388 391 (0.7)777 747 4.1  Worldwide397 388 2.2 787 777 1.3 
KNEES
KNEES
KNEES
U.S. U.S.216 210 2.9 417 395 5.6  U.S.221 216 2.4 447 417 7.2 
International International133 140 (4.6)271 272 (0.4) International142 133 6.3 284 271 4.8 
Worldwide Worldwide349 350 (0.1)688 667 3.1  Worldwide363 349 3.9 731 688 6.3 
TRAUMA
TRAUMA
TRAUMA
U.S. U.S.464 447 3.9 939 897 4.7  U.S.483 464 4.3 974 939 3.7 
International International232 263 (11.8)505 545 (7.4) International255 232 9.9 522 505 3.2 
Worldwide Worldwide696 710 (1.9)1,444 1,443 0.1  Worldwide739 696 6.1 1,496 1,444 3.6 
SPINE, SPORTS & OTHER
SPINE, SPORTS & OTHER
SPINE, SPORTS & OTHER
U.S. U.S.418 434 (3.7)805 838 (3.9) U.S.433 418 3.5 839 805 4.1 
International International306 343 (10.6)630 646 (2.4) International334 306 9.0 657 630 4.2 
Worldwide Worldwide724 777 (6.8)1,436 1,484 (3.2) Worldwide766 724 5.8 1,495 1,436 4.2 
SurgerySurgerySurgery
U.S. U.S.992 1,035 (4.1)1,913 1,933 (1.0) U.S.1,015 992 2.2 1,990 1,913 4.0 
International International1,458 1,487 (2.0)2,971 2,961 0.3  International1,580 1,458 8.4 3,039 2,971 2.3 
Worldwide Worldwide2,450 2,522 (2.8)4,884 4,894 (0.2) Worldwide2,594 2,450 5.9 5,028 4,884 3.0 
ADVANCED
ADVANCED
ADVANCED
U.S. U.S.454 459 (1.1)871 864 0.8  U.S.466 454 2.7 910 871 4.5 
International International702 708 (0.9)1,431 1,421 0.7  International757 702 7.8 1,430 1,431 0.0
Worldwide Worldwide1,156 1,168 (1.0)2,302 2,286 0.7  Worldwide1,222 1,156 5.8 2,340 2,302 1.7 
GENERAL
GENERAL
GENERAL
U.S. U.S.538 576 (6.4)1,042 1,069 (2.5) U.S.548 538 1.9 1,079 1,042 3.6 
International756 779 (3.0)1,540 1,540 0.0
Worldwide1,294 1,354 (4.5)2,582 2,608 (1.0)
Vision
U.S.496 467 6.2 1,017 939 8.3 
International745 716 4.0 1,481 1,389 6.6 
Worldwide1,241 1,183 4.9 2,498 2,328 7.3 
CONTACT LENSES / OTHER
U.S.374 352 6.6 774 723 7.2 
International519 517 0.4 1,030 1,003 2.7 
Worldwide894 868 2.9 1,804 1,725 4.5 
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International International823 756 8.9 1,608 1,540 4.5 
Worldwide Worldwide1,372 1,294 6.0 2,688 2,582 4.1 
VisionVision
U.S. U.S.529 496 6.6 1,087 1,017 6.9 
International International778 745 4.6 1,521 1,481 2.7 
Worldwide Worldwide1,308 1,241 5.4 2,608 2,498 4.4 
CONTACT LENSES / OTHER
CONTACT LENSES / OTHER
U.S. U.S.409 374 9.1 853 774 10.1 
International International530 519 2.2 1,039 1,030 0.9 
Worldwide Worldwide939 894 5.1 1,892 1,804 4.9 
SURGICAL
SURGICAL
SURGICAL
U.S. U.S.122 115 5.1 243 216 12.1  U.S.120 122 (1.1)234 243 (3.6)
International International225 199 13.6 451 386 17.0  International249 225 10.1 482 451 6.7 
Worldwide Worldwide347 314 10.5 694 602 15.2  Worldwide369 347 6.2 716 694 3.1 
TOTAL MEDTECHTOTAL MEDTECH    TOTAL MEDTECH    
U.S. U.S.3,351 3,299 1.6 6,576 6,353 3.5  U.S.3,839 3,351 14.6 7,598 6,576 15.5 
International International3,547 3,679 (3.6)7,293 7,204 1.2  International3,949 3,547 11.3 7,671 7,293 5.2 
Worldwide Worldwide6,898 6,978 (1.1)13,869 13,557 2.3  Worldwide7,788 6,898 12.9 15,269 13,869 10.1 
WORLDWIDEWORLDWIDE      WORLDWIDE      
U.S. U.S.12,197 11,919 2.3 23,611 23,030 2.5  U.S.13,444 12,197 10.2 25,961 23,611 10.0 
International International11,823 11,393 3.8 23,835 22,603 5.5  International12,086 11,823 2.2 24,315 23,835 2.0 
Worldwide Worldwide$24,020 23,312 3.0 %$47,446 45,633 4.0 % Worldwide$25,530 24,020 6.3 %$50,276 47,446 6.0 %
*Percentage greater than 100% or not meaningful
(1) Approximately $0.1 billion in the fiscal second quarterInclusive of 2021 and $0.2 billion in the fiscal six months of 2021, of certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changesRISPERDAL CONSTA which was previously disclosed separately
(2) Inclusive of PROCRIT / EPREXINVOKANA which was previously disclosed separately
(3) Previously referred to as Medical DevicesAcquired on December 22, 2022

EARNINGS BEFORE PROVISION FOR TAXES BY SEGMENT*SEGMENT
Fiscal Second Quarter EndedFiscal Six Months Ended Fiscal Second Quarter EndedFiscal Six Months Ended
(Dollars in Millions)(Dollars in Millions)July 3,
2022
July 4,
2021
Percent
Change
July 3,
2022
July 4,
2021
Percent
Change
(Dollars in Millions)July 2,
2023
July 3,
2022
Percent
Change
July 2,
2023
July 3,
2022
Percent
Change
Consumer Health (1)
Consumer Health (1)
$784 866 (9.5)%$1,470 1,708 (13.9)%
Consumer Health(1)
$860 784 9.7 %$1,636 1,470 11.3%
Pharmaceutical(2)
Pharmaceutical(2)
4,420 4,294 2.9 8,344 9,463 (11.8)
Pharmaceutical(2)
4,862 4,420 10.0 9,306 8,344 11.5 
MedTech(3)
MedTech(3)
1,141 1,746 (34.7)2,618 3,375 (22.4)
MedTech(3)
1,699 1,141 48.93,144 2,618 20.1 
Segment earnings before provision for taxesSegment earnings before provision for taxes6,345 6,906 (8.1)12,432 14,546 (14.5)Segment earnings before provision for taxes7,421 6,345 17.0 14,086 12,432 13.3 
Less: Expense not allocated to segments (4)
Less: Expense not allocated to segments (4)
237 244  360 455 
Less: Expense not allocated to segments (4)
377 237  7,479 360 
Less: Consumer Health separation costsLess: Consumer Health separation costs268 — 370 — Less: Consumer Health separation costs282 268 582 370 
Worldwide income before taxWorldwide income before tax$5,840 6,662 (12.3)%$11,702 14,091 (17.0)%Worldwide income before tax$6,762 5,840 15.8%$6,025 11,702 (48.5)%
*The 2021 fiscal second quarter and six months earnings before provision for taxes has been reclassified as certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changesPercentage greater than 100% or not meaningful
(1) Consumer Health includes:
Intangible amortization expense of $0.1 billion in both the fiscal second quarter of 20222023 and 2021 and2022.
Intangible amortization expense of $0.2 billion in both the fiscal six months of 20222023 and 2021.2022.

Litigation expense of $0.1 billion in both the fiscal second quarters and fiscal six months of 2022 and 2021, primarily for talc related costs.
(2) Pharmaceutical includes:
Divestiture gains of $0.6 billion in the fiscal six months of 2021 related to two brands outside the U.S.
Intangible amortization expense of $0.7 billion in both the fiscal second quarter of 2023 and $0.82022.
Intangible amortization expense of $1.5 billion in both the fiscal six months of 2023 and 2022.
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One-time COVID-19 Vaccine related exit costs of $0.2 billion and $0.3 billion in the fiscal second quarter of 2023 and 2022, and 2021, respectively. Intangible amortization expenseOne-time COVID-19 Vaccine related exit costs of $1.5$0.6 billion and $1.7$0.3 billion in the fiscal six months of 2023 and 2022, respectively.
A restructuring related charge of $0.1 billion and 2021,$0.3 billion in the fiscal second quarter and fiscal six months of 2023, respectively.
In the fiscal six months of 2022, the Company recorded an intangible asset impairment charge of approximately $0.6 billion related to an in-process research and development asset, bermekimab (JnJ-77474462), an investigational drug for the treatment of Atopic Dermatitis (AD) and Hidradenitis Suppurativa (HS). Additional information regarding efficacy of the AD indication became available which led the Company to the decision to terminate the development of bermekimab for AD.
A loss of $0.1 billion and a gain of $0.2 billion related to the changeUnfavorable changes in the fair value of securities of $0.1 billion in the fiscal second quarter of 2022 and 2021, respectively. A loss of $0.5 billion and a gain of $0.1 billion related to the change2022. Unfavorable changes in the fair value of securities of $0.1 billion and $0.5 billion in the fiscal six months of 2023 and 2022, and 2021, respectively.
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COVID-19 Vaccine supply networkFavorable litigation related costsitems of $0.1 billion in both the fiscal second quarter and fiscal six months of 2023.

(3) MedTech includes:
Intangible amortization expense of $0.4 billion and $0.3 billion in the fiscal second quarter of 2023 and 2022, respectively. Intangible amortization expense of $0.8 billion and $0.5 billion in the fiscal six months of 2023 and 2022, respectively.
Net favorable litigation matters of $0.2 billion in both the fiscal second quarter and fiscal six months 2022

In fiscal 2021of 2023 and 2020, the Company entered into a series$0.3 billion of contract manufacturing arrangements for vaccine production with third party contract manufacturing organizations. These arrangements provide the Company with future supplemental commercial capacity for vaccine production and potentially transferable rights to such production if capacity is not required. In the fiscal second quarter of 2022, amounts paid for services to be delivered and contractually obligated to be paid to these contract manufacturing organizations of approximately $0.9 billion are reflected in the prepaid expenses and other and the accrued liabilities accounts in the Company's consolidated balance sheet. Additionally, the Company has entered into certain vaccine development cost sharing arrangements with government related organizations.


(3) MedTech includes:
Litigation expense of $0.3 billion in both the fiscal second quartersquarter and fiscal six months of 2022 primarily pelvic mesh2022.
Acquisition and integration related costs.expense of $0.1 billion in the fiscal six months of 2023.
A restructuring related charge of $0.2$0.1 billion in the fiscal second quarter of 2022 and $0.1$0.2 billion in the fiscal six months of 2022 and 2021, respectively.
Intangible amortization expense of $0.3 billion in both the fiscal second quarter of 2022 and 2021 and $0.5 billion in both the fiscal six months of 2022 and 2021.2022.

(4)Amounts not allocated to segments include interest income/expense and general corporate income/expense. The fiscal six months of 2023 includes an approximately $7 billion incremental charge primarily related to the talc settlement proposal. See Note 11, Legal Proceedings, for additional details.

SALES BY GEOGRAPHIC AREA
Fiscal Second Quarter EndedFiscal Six Months Ended Fiscal Second Quarter EndedFiscal Six Months Ended
(Dollars in Millions)(Dollars in Millions)July 3, 2022July 4, 2021Percent
Change
July 3, 2022July 4, 2021Percent Change(Dollars in Millions)July 2, 2023July 3, 2022Percent
Change
July 2, 2023July 3, 2022Percent Change
United StatesUnited States$12,197 11,919 2.3 %$23,611 23,030 2.5 %United States$13,444 12,197 10.2 %$25,961 23,611 10.0 %
EuropeEurope6,085 5,668 7.3 12,109 11,082 9.3 Europe5,894 6,085 (3.1)12,226 12,109 1.0 
Western Hemisphere, excluding U.S.Western Hemisphere, excluding U.S.1,536 1,367 12.4 3,018 2,791 8.1 Western Hemisphere, excluding U.S.1,713 1,536 11.5 3,300 3,018 9.3 
Asia-Pacific, AfricaAsia-Pacific, Africa4,202 4,358 (3.6)8,708 8,730 (0.2)Asia-Pacific, Africa4,479 4,202 6.6 8,789 8,708 0.9 
TotalTotal$24,020 23,312 3.0 %$47,446 45,633 4.0 %Total$25,530 24,020 6.3 %$50,276 47,446 6.0 %


NOTE 10— ACQUISITIONS AND DIVESTITURES

There were no material acquisitions or divestitures in the fiscal first quarter andor fiscal second quarter of 2022.2023.

DuringOn December 22, 2022, the Company completed the acquisition of Abiomed, a leading, first-to-market provider of cardiovascular medical technology with a first-in-kind portfolio for the treatment of coronary artery disease and heart failure which also has an extensive innovation pipeline of life-saving technologies. The transaction broadens the Company’s position as a growing cardiovascular innovator, advancing the standard of care in heart failure and recovery, one of healthcare’s largest areas of unmet need. The transaction was accounted for as a business combination and the results of operations were included in the MedTech segment as of the date of the acquisition. The acquisition was completed through a tender offer for all outstanding shares. The consideration paid in the acquisition consisted of an upfront payment of $380.00 per share in cash, amounting to $17.1 billion, net of cash acquired, as well as a non-tradeable contingent value right (CVR) entitling the holder to receive up to $35.00 per share in cash (which with respect to the CVRs total approximately $1.6 billion in the aggregate) if certain commercial and clinical milestones are achieved. The corresponding enterprise value (without taking into account the CVRs) of approximately $16.5 billion includes cash, cash equivalents and marketable securities acquired.
The milestones of the CVR consist of:
a.$17.50 per share, payable if net sales for Abiomed products exceeds $3.7 billion during Johnson & Johnson’s fiscal second quarter of 2027 through fiscal first quarter of 2028, or if this threshold is not met during this period and is
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subsequently met during any rolling four quarter period up to the end of Johnson & Johnson’s fiscal first quarter of 2029, $8.75per share;
b.$7.50 per share payable upon FDA premarket application approval of the use of Impella products in ST-elevated myocardial infarction (STEMI) patients without cardiogenic shock by January 1, 2028; and
c.$10.00 per share payable upon the first fiscal quarterpublication of 2021,a Class I recommendation for the use of Impella products in separate transactions,high risk PCI or STEMI with or without cardiogenic shock within four years from their respective clinical endpoint publication dates, but in all cases no later than December 31, 2029.

The fair value of the Company divested 2 brands outsideacquisition was initially allocated to assets acquired of $19.9 billion (net of $0.3 billion cash acquired), primarily to goodwill for $10.9 billion, amortizable intangible assets for $6.6 billion, IPR&D for $1.1 billion, marketable securities of $0.6 billion and liabilities assumed of $2.8 billion, which includes the U.S. withinfair value of the Pharmaceutical segment.contingent consideration mentioned above for $0.7 billion and deferred taxes of $1.8 billion. The Company recognized a pre-tax gaingoodwill is primarily attributable to the commercial acceleration and expansion of the portfolio and is not expected to be deductible for tax purposes. The contingent consideration was recorded in Other (income) expense, net,Liabilities on the Consolidated Balance Sheet.
As the acquisition occurred in December 2022, the Company is still finalizing the allocation of the purchase price 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 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. In the fiscal first quarter of 2023, there were purchase price allocation adjustments netting to approximately $0.1 billion with an offsetting increase to goodwill. In the fiscal second quarter of 2023, there were no purchase price allocation adjustments.
The amortizable intangible assets were primarily comprised of already in-market products of the Impella platform with an average weighted life of 14 years. The IPR&D 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 probability of success factor ranged from 52% to 70%. The discount rate applied was 9.5%.
In 2022, the Company recorded acquisition related costs before tax of approximately $0.6 billion.$0.3 billion, which was recorded in Other (income)/expense. In the fiscal six months of 2023, the Company recorded acquisition related costs before tax of approximately $0.1 billion, which was primarily recorded in Other (income)/expense.

There were no material acquisitions or divestitures in the fiscal first quarter or fiscal second quarter of 2022.


NOTE 11 — LEGAL PROCEEDINGS

Johnson & Johnson and certain of its subsidiaries are involved in various lawsuits and claims regarding product liability; intellectual property; commercial; indemnification 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, 2022,2, 2023, 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 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 including timing of related payments. The ability to make such estimates and judgments can be affected by various factors including, among other things, 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
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dispute; procedural or jurisdictional issues; the uncertainty and unpredictability of the number of potential claims; ability to achieve comprehensive multi-party settlements; complexity of related cross-claims and counterclaims; and/or there are numerous parties involved. To the extent adverse awards, judgments or 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.

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.


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MATTERS CONCERNING TALC

A significant number of personal injury claims alleging that talc causes cancer were made against Johnson & Johnson Consumer Inc. and the Company arising out of the use of body powders containing talc, primarily JOHNSON’S Baby Powder. The number of these personal injury lawsuits, filed in state and federal courts in the United States as well as outside of the United States, continued to increase.

In talc cases that previously have gone to trial, the Company has obtained a number of defense verdicts, but there also have been verdicts against the Company, many of which have been reversed on appeal. In June 2020, the Missouri Court of Appeals reversed in part and affirmed in part a July 2018 verdict of $4.7 billion in Ingham v. Johnson & Johnson, et al., No. ED 207476 (Mo. App.), reducing the overall award to $2.1 billion. An application for transfer of the case to the Missouri Supreme Court was subsequently denied and in June 2021, a petition for certiorari, seeking a review of the Ingham decision by the United States Supreme Court, was denied. In June 2021, the Company paid the award, which, including interest, totaled approximately $2.5 billion. The facts and circumstances, including the terms of the award, were unique to the Ingham decision and not representative of other claims brought against the Company. The Company continues to believe that it has strong legal grounds to contest the other talc verdicts that it has appealed. Notwithstanding the Company’s confidence in the safety of its talc products, in certain circumstances the Company has settled cases.

In October 2021, Johnson & Johnson Consumer Inc. (Old JJCI) implemented a corporate restructuring (the 2021 Corporate Restructuring). As a result of that restructuring, Old JJCI ceased to exist and three new entities were created: (a) LTL Management LLC, a North Carolina limited liability company (LTL or Debtor); (b) Royalty A&M LLC, a North Carolina limited liability company and a direct subsidiary of LTL (RAM); and (c) the Debtor’s direct parent, Johnson & Johnson Consumer Inc., a New Jersey company (New JJCI). The Debtor received certain of Old JJCI’s assets and became solely responsible for the talc-related liabilities of Old JJCI, including all liabilities related in any way to injury or damage, or alleged injury or damage, sustained or incurred in the purchase or use of, or exposure to, talc, including talc contained in any product, or to the risk of, or responsibility for, any such damage or injury, except for any liabilities for which the exclusive remedy is provided under a workers’ compensation statute or act (the Talc-Related Liabilities).

In October 2021, notwithstanding the Company’s confidence in the safety of its talc products, the Debtor filed a voluntary petition with the United States Bankruptcy Court for the Western District of North Carolina, Charlotte Division, seeking relief under chapter 11 of the Bankruptcy Code (the LTL Bankruptcy Case). All litigation against LTL, Old JJCI, New JJCI, the Company, other of their corporate affiliates, identified retailers, insurance companies, and certain other parties (the Protected Parties) was stayed, although LTL did agree to lift the stay on a small number of appeals where appeal bonds had been filed. The LTL Bankruptcy Case was transferred to the United States Bankruptcy Court for the District of New Jersey. Claimants filed motions to dismiss the LTL Bankruptcy Case and, following a multiple day hearing, the New Jersey Bankruptcy Court denied those motions in March 2022.

The claimants subsequently filed notices of appeal as to the denial of the motions to dismiss the LTL Bankruptcy Case and the extension of the stay to the Protected Parties. On January 30, 2023, the Third Circuit reversed the Bankruptcy Court’s ruling and remanded to the Bankruptcy Court to dismiss the LTL bankruptcy.

LTL filed a petition for rehearing of the Third Circuit’s decision, which was denied in March 2023.LTL subsequently filed a motion in the Third Circuit to stay the mandate directing the New Jersey Bankruptcy Court to dismiss the LTL bankruptcy pending filing and disposition of a petition for writ of certiorari to the United States Supreme Court. The Third Circuit denied the motion to stay the mandate and issued the mandate.

In April 2023, the New Jersey Bankruptcy Court dismissed the LTL Bankruptcy Case, effectively lifting the stay as to all parties and returning the talc litigation to the tort system. LTL re-filed in the United States Bankruptcy Court for the District of New Jersey seeking relief under chapter 11 of the Bankruptcy Code (the LTL 2 Bankruptcy Case).As a result of the new filing, all talc claims against LTL were again automatically stayed pursuant to section 362 of the Bankruptcy Code.Additionally, the New Jersey Bankruptcy Court issued a temporary restraining order staying all litigation as to LTL, Old JJCI, New JJCI, the Company, identified retailers, and certain other parties (the New Protected Parties).

Also in April 2023, the New Jersey Bankruptcy Court issued a decision that granted limited injunctive relief to the Company and the New Protected Parties (the LTL 2 Preliminary Injunction).The LTL 2 Preliminary Injunction remains in force until late August 2023, following the Bankruptcy Court’s extension of the initial LTL 2 Preliminary Injunction in June 2023. Under the LTL 2 Preliminary Injunction, except for in those cases filed in the federal court ovarian cancer multi-district litigation, discovery in all personal injury and wrongful death matters is permitted to proceed. No trials may occur in any of the personal injury and wrongful death matters except for the Valadez trial after the Bankruptcy Court partially lifted the stay for Valadez and allowed it to proceed to trial.In July 2023, the jury returned a verdict in favor of Valadez for $18.8 million in
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compensatory damages but declined to award punitive damages.The Company will appeal.The terms of the court’s lifting of the automatic stay will prevent any collection of judgment.

Furthermore, in April 2023, the Talc Claimants' Committee filed a motion to dismiss the LTL 2 Bankruptcy followed by similar motions from other claimants. Hearings on the motions to dismiss occurred in June 2023. On July 28, 2023, the court dismissed the LTL 2 Bankruptcy case and, the same day, the Company stated its intent to appeal the decision and to continue its efforts to obtain a resolution of the talc claims.

In the original bankruptcy case, the Company agreed to provide funding to LTL for the payment of amounts the New Jersey Bankruptcy Court determines are owed by LTL and the establishment of a $2 billion trust in furtherance of this purpose. The Company established a reserve for approximately $2 billion in connection with the aforementioned trust. After and as a result of the filing of the LTL Bankruptcy Case, the Company de-consolidated LTL through the second fiscal quarter, which is a related party. The impact of the de-consolidation is not material to the Company. In the LTL 2 Bankruptcy Case, the Company had agreed to contribute an additional amount which, when added to the prior $2 billion, would be a total reserve of present value of approximately $9 billion payable over 25 years (nominal value approximately $12 billion discounted at a rate of 4.41%), to resolve all the current and future talc claims. The approximate $9 billion reserve remains the Company’s estimate of probable loss after the dismissal.

The parties have not yet reached a resolution of all talc matters and the Company is unable to estimate the possible loss or range of loss beyond the amount accrued.

A class action advancing claims relating to industrial talc was filed against the Company and others in New Jersey state court in May 2022 (the Edley Class Action). The Edley Class Action asserts, among other things, that the Company fraudulently defended past asbestos personal injury lawsuits arising from exposure to industrial talc mined, milled, and manufactured before January 6, 1989 by the Company’s then wholly owned subsidiary, Windsor Minerals, Inc., which is currently a debtor in the Imerys Bankruptcy described hereafter. The Company removed the Edley Class Action to federal court in the District of New Jersey. In October 2022, the Company filed motions to dismiss and to deny certification of a class to pursue the Edley Class Action in the New Jersey District Court.

In February 2019, the Company’s talc supplier, Imerys Talc America, Inc. and two of its affiliates, Imerys Talc Vermont, Inc. and Imerys Talc Canada, Inc. (collectively, Imerys) filed a voluntary petition under chapter 11 of the United States Code (the Bankruptcy Code) in the United States Bankruptcy Court for the District of Delaware (Imerys Bankruptcy). The Imerys Bankruptcy relates to Imerys’s potential liability for personal injury from exposure to talcum powder sold by Imerys. In its bankruptcy, Imerys alleges it has claims against the Company for indemnification and rights to joint insurance proceeds.

In June 2020, Cyprus Mines Corporation and its parent, Cyprus Amax Minerals Company (CAMC) (together, Cyprus), which had owned certain Imerys talc mines, filed an adversary proceeding against the Company and Imerys in the Imerys Bankruptcy seeking a declaration of indemnity rights under certain contractual agreements (the Cyprus Adversary Proceeding). The Company denies such indemnification is owed and filed a motion to dismiss the adversary complaint. In February 2021, Cyprus filed a voluntary petition for relief under chapter 11 of the Bankruptcy Code and filed its Disclosure Statement and Plan (the Cyprus Plan). The Cyprus Plan contemplates a settlement with Imerys and talc claimants where Cyprus would make a monetary contribution to a trust established under the Imerys Plan in exchange for an injunction against talc claims asserted against it and certain protected parties. Cyprus has not yet sought approval of its Disclosure Statement and Plan. Cyprus, along with the Tort Claimants’ Committee (TCC) and Future Claimants’ Representative (FCR) appointed in the Cyprus chapter 11 case, have agreed to participate in the mediation with the Mediation Parties. In October 2021, the Company filed a Notice of Bankruptcy Filing and Stay of Proceedings clarifying that the automatic stay arising upon the filing of the LTL Bankruptcy Case should apply to the Cyprus Adversary Proceeding. In June 2022, Cyprus commenced an Adversary Proceeding in its chapter 11 case seeking an order enforcing the automatic stay by enjoining parties from commencing or continuing “talc-related claims” against CAMC. In June 2022, the court entered a preliminary injunction order enjoining claimants from pursuing talc-related claims against CAMC through January 2023. The court subsequently extended the preliminary injunction through the end of July 2023. In June 2023, Cyprus filed a motion seeking to further extend the preliminary injunction through the end of February 2024.

Imerys, the TCC, the FCR, certain of Imerys’s insurers, and certain parties in the Cyprus Mines chapter 11 case (collectively the Mediation Parties) have been engaged in mediation since October 2021. In June 2023, the bankruptcy court entered an order extending the term of the mediation through the end of July 2023.

In July 2021, Imerys commenced an adversary proceeding against the Company in the Imerys Bankruptcy (the Imerys Adversary Proceeding). The Imerys Adversary Proceeding sought, among other things, certain declarations with respect to the indemnification obligations allegedly owed by the Company to Imerys. The Company filed a motion to dismiss the adversary proceeding.

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In February 2021, several of the Company’s insurers involved in coverage litigation in New Jersey State Court (the Coverage Action) filed a motion in the Imerys Bankruptcy Court proceeding seeking a determination that the automatic stay does not apply to the Coverage Action and, in the alternative, seeking relief from the automatic stay to allow them to continue to litigate their claims in the Coverage Action. The Court entered an agreed order modifying the stay to allow the litigation in the Coverage Action to continue.

In February 2018, a securities class action lawsuit was filed against the Company and certain named officers in the United States District Court for the District of New Jersey, alleging that the Company violated the federal securities laws by failing to disclose alleged asbestos contamination in body powders containing talc, primarily JOHNSON’S Baby Powder, and that purchasers of the Company’s shares suffered losses as a result. In April 2019, the Company moved to dismiss the complaint. In December 2019, the Court denied, in part, the motion to dismiss. In April 2021, briefing on Plaintiff’s motion for class certification was completed. The case was stayed in May 2022 pursuant to the LTL Bankruptcy Case and was reopened in May 2023. Defendants have requested that further fact discovery be stayed until the Court rules on Plaintiff’s motion for class certification.

A lawsuit was brought against the Company in the Superior Court of California for the County of San Diego alleging violations of California’s Consumer Legal Remedies Act (CLRA) relating to JOHNSON’S Baby Powder. In that lawsuit, the plaintiffs allege that the Company violated the CLRA by failing to provide required Proposition 65 warnings. In July 2019, the Company filed a notice of removal to the United States District Court for the Southern District of California and plaintiffs filed a second amended complaint shortly thereafter. In October 2019, the Company moved to dismiss the second amended complaint for failure to state a claim upon which relief may be granted. In response to those motions, plaintiffs filed a third amended complaint. In December 2019, the Company moved to dismiss the third amended complaint for failure to state a claim upon which relief may be granted. In April 2020, the Court granted the motion to dismiss but granted leave to amend. In May 2020, plaintiffs filed a Fourth Amended Complaint but indicated that they would be filing a motion for leave to file a fifth amended complaint. Plaintiffs filed a Fifth Amended Complaint in August 2020. The Company moved to dismiss the Fifth Amended Complaint for failure to state a claim upon which relief may be granted. In January 2021, the Court issued an Order and opinion ruling in the Company’s favor and granting the motion to dismiss with prejudice. In February 2021, Plaintiffs filed a Notice of Appeal with the Ninth Circuit. Plaintiffs filed their opening brief in July 2021. The company filed its responsive brief in October 2021. After the Notice of Suggestion of Bankruptcy was filed with the Ninth Circuit, a stay was imposed, and the Court held the reply deadline in abeyance. The appeal continues to be held in abeyance, with the Company being required to file periodic status updates.

In June 2014, the Mississippi Attorney General filed a complaint in Chancery Court of The First Judicial District of Hinds County, Mississippi against the Company and Johnson & Johnson Consumer Companies, Inc. (now known as Johnson & Johnson Consumer Inc.) (collectively, JJCI). The complaint alleges that JJCI violated the Mississippi Consumer Protection Act by failing 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 divested in 2012) and seeks injunctive and monetary relief. In February 2022, the trial court set the case for trial to begin in February 2023. However, in October 2022, the LTL bankruptcy court issued an order staying the case. In March 2023, the Third Circuit issued the mandate to dismiss the LTL Bankruptcy Case and in April 2023, the New Jersey Bankruptcy Court dismissed the LTL Bankruptcy Case, effectively lifting the stay as to this matter. The State requested a new trial setting. Later in April 2023, the trial court set a new trial date in April 2024. The parties are currently engaged in expert work, extensive discovery, and preparations for the upcoming trial.

In January 2020, the State of New Mexico filed a consumer protection case alleging that the Company deceptively marketed and sold its talcum powder products by making misrepresentations about the safety of the products and the presence of carcinogens, including asbestos. In March 2022, the New Mexico court denied the Company’s motion to compel the State of New Mexico to engage in discovery of state agencies and denied the Company’s request for interlocutory appeal of that decision. The Company then filed a Petition for Writ of Superintending Control and a Request for a Stay to the New Mexico Supreme Court on the issue of the State of New Mexico’s discovery obligations. In April 2022, in view of the efforts to resolve talc-related claims in the LTL Bankruptcy Case, the Company and the State agreed to a 60-day stay of all matters except for the pending writ before the New Mexico Supreme Court, which expired in June 2022. Thereafter, the Company moved to enjoin prosecution of the case in the LTL Bankruptcy Case. In October 2022, the bankruptcy court issued an order staying the case. In December 2022, the State filed an appeal to the Third Circuit concerning the stay order. Separately, in September 2022, the New Mexico Supreme Court granted the Company's request for a stay pending further briefing on the scope of the State of New Mexico’s discovery obligations. In March 2023, the Third Circuit issued the mandate to dismiss the LTL Bankruptcy Case and in April 2023, the New Jersey Bankruptcy Court dismissed the LTL Bankruptcy Case, effectively lifting the stay as to this matter. However, this case remains stayed as a result of the New Mexico Supreme Court’s stay until such time as the Supreme Court issues an order concerning the State of New Mexico’s discovery obligations.

Forty-two states and the District of Columbia (including Mississippi and New Mexico) have commenced a joint investigation into the Company’s marketing of its talcum powder products. At this time, the multi-state group has not asserted any claims against the Company. Five states have issued Civil Investigative Demands seeking documents and other information. The Company has produced documents to Arizona, North Carolina, Texas, and Washington and entered into confidentiality
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agreements. The Company has not received any follow up requests from those states. In March 2022, each of the forty-two states agreed to mediation of their claims in the LTL Bankruptcy Case. In July 2022, New Mexico and Mississippi indicated they would no longer voluntarily submit to further mediation in the LTL Bankruptcy and would proceed with their respective cases in state court. In March 2023, the mediation was terminated. The procedural history and status of the New Mexico and Mississippi matters specifically have been discussed above.

In addition, the Company has received inquiries, subpoenas, and requests to produce documents regarding talc matters and the LTL Bankruptcy Case from various governmental authorities. The Company has produced documents and responded to inquiries, and will continue to cooperate with government inquiries.

MATTERS CONCERNING OPIOIDS

Beginning in 2014 and continuing to the present, the Company and Janssen Pharmaceuticals, Inc. (JPI), along with other pharmaceutical companies, have been named in close to 3,500 lawsuits related to the marketing of opioids, including DURAGESIC, NUCYNTA and NUCYNTA ER. The majority of the cases have been filed by state and local governments. Similar lawsuits have also been filed by private plaintiffs and organizations, including but not limited to the following: individual plaintiffs on behalf of children born with Neonatal Abstinence Syndrome (NAS); hospitals; and health insurers/payors.

To date, the Company and JPI have litigated two of the cases to judgment and have prevailed in both, either at trial or on appeal.

In October 2019, the Company announced a proposed agreement in principle with a negotiating committee of state Attorneys General to settle all remaining government opioid litigation claims nationwide. Under the final national settlement agreement, which was announced in July 2021, the Company agreed to pay up to $5.0 billion to resolve all opioid lawsuits and future opioid claims by states, cities, counties, local school districts and other special districts, and tribal governments, contingent on sufficient participation by eligible government entities, and with credits back for entities that declined or were ineligible to participate. In July 2021, the Company announced that the terms of the agreement to settle the state and subdivision claims had been finalized and approximately 60% of the all-in settlement was paid by the second fiscal quarter of 2023. The expected payment schedule provides that approximately $0.6 billion of payments are to be paid by the end of the second fiscal quarter of 2024. The agreement is not an admission of liability or wrongdoing, and it provides for the release of all opioid-related claims against the Company, JPI, and their affiliates (including the Company’s former subsidiaries Tasmanian Alkaloids Pty, Ltd. and Noramco, Inc.). As of July 2023, the Company and JPI had settled or otherwise resolved the opioid claims advanced by all government entity claimants except the State of Washington and its subdivisions, the City of Baltimore, a number of school districts and other special district claimants, and a handful of others.

The Company and JPI continue to defend the cases brought by the remaining government entity litigants as well as the cases brought by private litigants, including NAS claimants, hospitals, and health insurers/payors. Counting the private litigant cases, there are approximately 35 remaining opioid cases against the Company and JPI in various state courts, 475 remaining cases in the Ohio MDL, and 2 additional cases in other federal courts. Some of these cases have been dismissed and are being appealed by the plaintiffs; several others, including a case brought by DCH Health Systems in Alabama state court, are scheduled for trial in 2023, 2024, or 2025.

In addition, the Province of British Columbia filed suit against the Company and its Canadian affiliate Janssen Inc., and many other industry members, in Canada, and is seeking to have that action certified as an opt in class action on behalf of other provincial/territorial and the federal governments in Canada. Additional proposed class actions have been filed in Canada against the Company and Janssen Inc., and many other industry members, by and on behalf of people who used opioids (for personal injuries), municipalities and First Nations bands. These actions allege a variety of claims related to opioid marketing practices, including false advertising, unfair competition, public nuisance, consumer fraud violations, deceptive acts and practices, false claims and unjust enrichment. An adverse judgment in any of these lawsuits could result in the imposition of large monetary penalties and significant damages including, punitive damages, cost of abatement, substantial fines, equitable remedies and other sanctions.

From June 2017 through December 2019, the Company’s Board of Directors received a series of shareholder demand letters alleging breaches of fiduciary duties related to the marketing of opioids. The Board retained independent counsel to investigate the allegations in the demands, and in April 2020, independent counsel delivered a report to the Board recommending that the Company reject the shareholder demands and take the steps that are necessary or appropriate to secure dismissal of related derivative litigation. The Board unanimously adopted the recommendations of the independent counsel’s report.

In November 2019, one of the shareholders who sent a demand filed a derivative complaint against the Company as the nominal defendant and certain current and former directors and officers as defendants in the Superior Court of New Jersey. The complaint alleges breaches of fiduciary duties related to the marketing of opioids, and that the Company has suffered damages as a result of those alleged breaches. A series of additional derivative complaints making similar allegations against the same
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and similar defendants were filed in New Jersey state and federal courts in 2019 and 2020. By 2022, all but two state court cases had been voluntarily dismissed. In February 2022, the state court granted the Company’s motion to dismiss one of the two cases, and the shareholder that brought the second case filed a notice of dismissal. The shareholder whose complaint was dismissed filed a motion for reconsideration. In May 2022, the state court held oral argument on the motion for reconsideration and subsequently denied the motion. The shareholder has appealed the state court’s dismissal order.

PRODUCT LIABILITY

Johnson & JohnsonThe Company 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. From time to time, even if it has substantial defenses, the Company considers isolated settlements based on a variety of circumstances. The Company has establishedaccrued for these matters and will continue to monitor each related legal issue and adjust accruals for product liability claimsas might be warranted based on new information and lawsuitsfurther developments in complianceaccordance with ASC 450-20 based on currently available information, which in some cases may be limited.450-20-25. 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. 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 table below contains the most significant of these cases include:and provides the DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System; the PINNACLE Acetabular Cup System; pelvic meshes; RISPERDAL; XARELTO; body powders containing talc, primarily JOHNSON’S Baby Powder; INVOKANA; and ETHICON PHYSIOMESH Flexible Composite Mesh. Asapproximate number of July 3, 2022,plaintiffs in the United States there were approximately 190 plaintiffs with direct claims in pending lawsuits regarding injuries allegedly due to the DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System; 1,900 with respect to the PINNACLE Acetabular Cup System; 9,500 with respect to pelvic meshes; 2,100 with respect to RISPERDAL; 3,000 with respect to XARELTO; 40,300 with respect to body powders containing talc; 10 with respect to INVOKANA;relevant product or product category as of July 2, 2023:

Product or product categoryNumber of Plaintiffs
Body powders containing talc, primarily JOHNSON’S Baby Powder40,480 
DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System160 
PINNACLE Acetabular Cup System940 
Pelvic meshes7,160 
ETHICON PHYSIOMESH Flexible Composite Mesh910 
RISPERDAL240 
ELMIRON2,130 
TYLENOL520 

4,700 with respect to ETHICON PHYSIOMESH Flexible Composite Mesh; and 1,300 with respect to ELMIRON.
The number of pending lawsuits is expected to fluctuate as certain lawsuits are settled or dismissed and additional lawsuits are filed. There may be additional claims that have not yet been filed.

MedTech

DePuy ASR XL Acetabular System and ASR Hip Resurfacing System
In August 2010, DePuy Orthopaedics, Inc. (DePuy) announced a worldwide voluntary recall of its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System (ASR Hip) used in hip replacement surgery. Claims for personal injury have been made against DePuy and Johnson & Johnson.the Company. 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, India and Italy. In November 2013, DePuy reached an agreement with a Court-appointed committee of lawyers representing ASR Hip 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 2013. DePuy reached additional agreements in February 2015 and March 2017, which further extended the settlement program to include ASR Hip patients who had revision surgeries after August 2013 and prior to February 15, 2017. This settlement program has resolved more than 10,000 claims, thereby bringing to resolution significant ASR Hip litigation activity in the United States. However, lawsuits in the United States remain, and the settlement program does not address litigation outside of the United States. In Australia, a class action settlement was reached that resolved the claims of the majority of ASR Hip patients in that country. In Canada, the Company has reached agreements to settle the class actions filed 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 United States settlement program and ASR Hip-related product liability litigation.

DePuy PINNACLE Acetabular Cup System
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Claims for personal injury have also been made against DePuy Orthopaedics, Inc. and Johnson & Johnsonthe Company (collectively, DePuy) relating to the PINNACLE Acetabular Cup System used in hip replacement surgery. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. CasesMost 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.Texas (Texas MDL). Beginning on June 1, 2022, the Judicial Panel on Multidistrict Litigation ceased transfer of new cases into the Texas MDL, and there are now cases pending in federal court outside the Texas MDL. Litigation also has been filed in some state courts and in countries outside of the United States. Several adverse verdicts have been rendered against DePuy, one of which was reversed on appeal and remanded for retrial. During the first quarter of 2019, DePuy established a United States settlement program to resolve these cases. As
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part of the settlement program, adverse verdicts have been settled. The Company has established an accrual for product liability litigation associated with the PINNACLE Acetabular Cup System and the related settlement program.


Ethicon Pelvic Mesh
Claims for personal injury have been made against Ethicon, Inc. (Ethicon) and Johnson & Johnsonthe Company arising out of Ethicon’s pelvic mesh devices used to treat stress urinary incontinence and pelvic organ prolapse. The Company continues to receive information with respect to potential costs and additional cases. Cases filed in federal courts in the United States had been organized as a multi-district litigation (MDL) in the United States District Court for the Southern District of West Virginia. In March 2021, the MDL Court entered an order closing the MDL. The MDL Court has remanded cases for trial to the jurisdictions where the case was originally filed and additional pelvic mesh lawsuits have been filed, and remain, outside of the MDL. The Company has settled or otherwise resolved the majority of the United States cases and the estimated costs associated with these settlements and the remaining cases are reflected in the Company’s accruals. In addition, class actions and individual personal injury cases or claims seeking damages for alleged injury resulting from Ethicon’s pelvic mesh devices have been commenced in various countries outside of the United States, including claims and cases in the United Kingdom, the Netherlands, Belgium, France, Ireland, Italy, Spain and Slovenia and class actions in Israel, Australia, Canada and Canada.South Africa. In November 2019, the Federal Court of Australia issued a judgment regarding its findings with respect to liability in relation to the three Lead Applicants and generally in relation to the design, manufacture, prepre- and post-market assessments and testing, and supply and promotion of the devices in Australia used to treat stress urinary incontinence and pelvic organ prolapse. In March 2020,September 2022, after exhausting its appeals, the Court issued a decision and entered damages awardsCompany reached an in-principle agreement to resolve the three Lead Applicants. The Company appealed the decision to the intermediate appellate court, the Full Court. The appeal was heardtwo pelvic mesh class actions in February 2021Australia and in March 2021,2023 the FullFederal Court entered a judgment dismissingapproved the appeal. An application for special leave to the High Court of Australia was filed in April 2021, and the High Court heard oral argument on the application in November 2021. Special leave was refused. While this brings an end to the appellate process, there will now be an individual case assessment process for the remaining group member claims. In March 2022, the Court appointed a barrister to prepare a written report and recommendation on the form and mechanism of the individual case assessment process, due by August 2022, with a court hearing on those findings later that month.settlement. The class actions in Canada were discontinued in 2020 as a result of a settlement of a group of cases and an agreement to resolve the Israeli class action was reached in May 2021. The parties in the Israeli class action are currently finalizing the terms of the settlement. A motion to approve the settlement was filed with the Court. The Company has established accruals with respect to product liability litigation associated with Ethicon’s pelvic mesh products.

Ethicon Physiomesh
Following a June 2016 worldwide market withdrawal of ETHICON PHYSIOMESHEthicon Physiomesh Flexible Composite Mesh (Physiomesh), claims for personal injury have been made against Ethicon, Inc. (Ethicon) and Johnson & Johnsonthe Company alleging personal injury arising out of the use of this hernia mesh device. Cases filed in federal courts in the United States have been organized as a multi-district litigation (MDL) in the United States District Court for the Northern District of Georgia. A multi-county litigation (MCL) also has been formed in New Jersey state court and assigned to Atlantic County for cases pending in New Jersey. In addition to the matters in the MDL and MCL, there are additional lawsuits pending in the United States District Court for the Southern District of Ohio, which are part of the MDL for polypropylene mesh devices manufactured by C.R. Bard, Inc., and lawsuits pending in two New Jersey MCLs formed for Proceed/Proceed Ventral Patch and Prolene Hernia systems, one multi-plaintiff lawsuit pending in Oklahoma state court and lawsuits pending outside the United States. In May 2021, Ethicon and lead counsel for the plaintiffs entered into a term sheet to resolve approximately 3,600 Physiomesh cases (covering approximately 4,300 plaintiffs) pending in the MDL and MCL at that time. A master settlement agreement (MSA) was entered into in September 2021 and includes 3,729 cases in the MDL and MCL. All deadlines and trial settings in those proceedings are currently stayed pending the completion of the settlement agreement. Of the cases subject to the MSA, 3,244 have been dismissed with prejudice. Ethicon has received releases from 3,559 plaintiffs, and releases continue to be submitted as part of the settlement process. Post-settlement cases in the Physiomesh MDL and MCL are subject to docket control orders requiring early expert reports and discovery requirements. AsIn May 2023, Ethicon entered an additional settlement to resolve the claims of July 2022, there292 Physiomesh claimants. That settlement is proceeding, and releases are approximately 126 activebeing returned.There are two cases in the MDL and two in the MCL which are not included in either settlement and which remain subject to these orders which are being reviewed and evaluated.the docket control orders.

Claims have also been filed against Ethicon and Johnson & Johnsonthe Company alleging personal injuries arising from the PROCEED Mesh and PROCEED Ventral Patch hernia mesh products. In March 2019, the New Jersey Supreme Court entered an order consolidating these cases pending in New Jersey as an MCL in Atlantic County Superior Court. Additional cases have been filed in various federal and state courts in the United States, and in jurisdictions outside the United States.

Ethicon and Johnson & Johnsonthe Company also have been subject to claims for personal injuries arising from the PROLENE Polypropylene Hernia System. In January 2020, the New Jersey Supreme Court created an MCL in Atlantic County Superior Court to handle such cases. Cases involving this product have also been filed in other federal and state courts in the United States.
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In October 2022, an agreement in principle, subject to various conditions, was reached to settle the majority of the pending cases involving Proceed, Proceed Ventral Patch, Prolene Hernia System and related multi-layered mesh products, as well as a number of unfiled claims. All litigation activities in the two New Jersey MCLs are stayed pending effectuation of the proposed settlement. Future cases that are filed in the New Jersey MCLs will be subject to docket control orders requiring early expert reports and discovery requirements.

The Company has established accruals with respect to product liability litigation associated with ETHICON PHYSIOMESHEthicon Physiomesh Flexible Composite Mesh, PROCEED Mesh and PROCEED Ventral Patch, and PROLENE Polypropylene Hernia System products.

Pharmaceuticals

RISPERDAL
Claims for personal injury have been made against Janssen Pharmaceuticals, Inc. and Johnson & Johnsonthe Company arising out of the use of RISPERDAL, and related compounds, indicated for the treatment of schizophrenia, acute manic or mixed episodes associated with bipolar I disorder and irritability associated with autism. Lawsuits primarily have been filed in state courts in Pennsylvania, California, and Missouri. Other actions are pending in various courts in the United States and Canada. Product
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liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has successfully defended a number of these cases but there have been verdicts against the Company, including a verdict in October 2019 of $8.0 billion of punitive damages related to one plaintiff, which the trial judge reduced to $6.8 million in January 2020. In September 2021, the Company entered into a settlement in principle with the counsel representing plaintiffs in this matter and in substantially all of the outstanding cases in the United States. The costs associated with this and other settlements are reflected in the Company’s accruals.

Claims for personal injury arising out of the use of XARELTO, an oral anticoagulant, have been made against Janssen Pharmaceuticals, Inc. (JPI); Johnson & Johnson; and JPI’s collaboration partner for XARELTO, Bayer Healthcare AG, and certain of its affiliates. 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 were filed in state courts across the United States. Many of these cases were consolidated into a state mass tort litigation in Philadelphia, Pennsylvania and in a coordinated proceeding in Los Angeles, California. Class action lawsuits also have been filed in Canada. In March 2019, JPI and Johnson & Johnson announced an agreement in principle to settle the XARELTO cases in the United States; the settlement agreement was executed in May 2019, the settlement became final in December 2019, and the settlement was funded in January 2020. This resolved the majority of cases pending in the United States. The Company has established accruals for its costs associated with the United States settlement program and XARELTO related product liability litigation.

A significant number of personal injury claims alleging that talc causes cancer were made against Johnson & Johnson Consumer Inc. and Johnson & Johnson arising out of the use of body powders containing talc, primarily JOHNSON’S Baby Powder. The number of these personal injury lawsuits, filed in state and federal courts in the United States as well as outside of the United States, continued to increase.

In talc cases that previously have gone to trial, the Company has obtained a number of defense verdicts, but there also have been verdicts against the Company, many of which have been reversed on appeal. In June 2020, the Missouri Court of Appeals reversed in part and affirmed in part a July 2018 verdict of $4.7 billion in Ingham v. Johnson & Johnson, et al., No. ED 207476 (Mo. App.), reducing the overall award to $2.1 billion. An application for transfer of the case to the Missouri Supreme Court was subsequently denied and in June 2021, a petition for certiorari, seeking a review of the Ingham decision by the United States Supreme Court, was denied. In June 2021, the Company paid the award, which, including interest, totaled approximately $2.5 billion. The facts and circumstances, including the terms of the award, were unique to the Ingham decision and not representative of other claims brought against the Company. The Company continues to believe that it has strong legal grounds to contest the other talc verdicts that it has appealed. Notwithstanding the Company’s confidence in the safety of its talc products, in certain circumstances the Company has settled cases.

In October 2021, Johnson & Johnson Consumer Inc. (Old JJCI) implemented a corporate restructuring (the 2021 Corporate Restructuring). As a result of that restructuring, Old JJCI ceased to exist and three new entities were created: (a) LTL Management LLC, a North Carolina limited liability company (LTL or Debtor); (b) Royalty A&M LLC, a North Carolina limited liability company and a direct subsidiary of LTL (RAM); and (c) the Debtor’s direct parent, Johnson & Johnson Consumer Inc., a New Jersey company (New JJCI). The Debtor received certain of Old JJCI’s assets and became solely responsible for the talc-related liabilities of Old JJCI, including all liabilities related in any way to injury or damage, or alleged injury or damage, sustained or incurred in the purchase or use of, or exposure to, talc, including talc contained in any product, or to the risk of, or responsibility for, any such damage or injury, except for any liabilities for which the exclusive remedy is provided under a workers’ compensation statute or act (the Talc-Related Liabilities).

In October 2021, notwithstanding the Company’s confidence in the safety of its talc products, the Debtor filed a voluntary petition with the United States Bankruptcy Court for the Western District of North Carolina, Charlotte Division, seeking relief under chapter 11 of the Bankruptcy Code (the LTL Bankruptcy Case). As a result of the LTL Bankruptcy Case, the North Carolina Bankruptcy Court entered a temporary restraining order staying all litigation against LTL and Old JJCI. On November 15, 2021, the North Carolina Bankruptcy Court confirmed the scope of the stay, issuing a Preliminary Injunction (PI) prohibiting and enjoining the commencement and prosecution of talc-related claims against LTL, Old JJCI, New JJCI, Johnson & Johnson, other of their corporate affiliates, identified retailers, insurance companies, and certain other parties (the Protected Parties). The LTL Bankruptcy Case was transferred to the United States Bankruptcy Court for the District of New Jersey in November 2021, and that court extended the PI through the end of February 2022. Claimants filed motions to dismiss the LTL Bankruptcy Case and, following a multiple day hearing, the New Jersey Bankruptcy Court denied those motions by order issued in March 2022. The New Jersey Bankruptcy Court simultaneously issued another order extending the stay as to the Protected Parties. The claimants subsequently filed notices of appeal as to the denial of the motions to dismiss and the extension of the stay. In May 2022, the Third Circuit Court of Appeals granted the petitions to appeal. Opening briefs were filed in June 2022 and briefing is to be completed by September 2022. Additionally, an industrial talc class action was filed against the Company and others in New Jersey state court in May 2022. The case was subsequently removed to federal court. In July 2022, Imerys, and LTL, filed a motion to stay the industrial talc class action. The court heard oral argument and a ruling is expected at any time. While the New Jersey Bankruptcy Court’s order effectively stays all of the Company’s talc-related personal injury litigation, LTL has agreed to lift the stay on a small number of appeals where appeal bonds have been filed.
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The Company has agreed to provide funding to LTL for the payment of amounts the New Jersey Bankruptcy Court determines are owed by LTL and the establishment of a $2 billion trust in furtherance of this purpose. The Company has established a reserve for approximately $2 billion in connection with the aforementioned trust. After and as a result of the filing of the LTL Bankruptcy Case, the Company de-consolidated LTL, which is a related party. The impact of the de-consolidation is not material to the Company. The parties have not yet reached a resolution of all talc matters in the LTL Bankruptcy Case, and the Company is unable to estimate the possible loss or range of loss beyond the amount accrued.

In February 2019, the Company’s talc supplier, Imerys Talc America, Inc. and two of its affiliates, Imerys Talc Vermont, Inc. and Imerys Talc Canada, Inc. (collectively, Imerys) filed a voluntary petition under chapter 11 of the United States Code (the Bankruptcy Code) in the United States Bankruptcy Court for the District of Delaware (Imerys Bankruptcy). The Imerys Bankruptcy relates to Imerys’s potential liability for personal injury from exposure to talcum powder sold by Imerys. In its bankruptcy, Imerys alleges it has claims against the Company for indemnification and rights to joint insurance proceeds. In May 2020, Imerys, its parent Imerys S.A., the Tort Claimants’ Committee (TCC), and the Future Claimants’ Representative (FCR) (collectively, the Plan Proponents) filed their Plan of Reorganization (the Plan) and the Disclosure Statement related thereto. The Plan Proponents have since filed numerous amendments to the Plan and Disclosure Statement. A hearing on the Plan Proponent’s Disclosure Statement was held in January 2021, and the Court entered an order approving the Disclosure Statement, allowing Imerys to proceed with soliciting votes on the Plan.

In March 2021, the Company voted to reject the Plan and opted out of the consensual releases in the Plan. In April 2021, the Plan Proponents announced the Plan had received the requisite number of accepting votes to confirm the Plan. The Company challenged certain improprieties with respect to portions of the vote and sought to disqualify those votes. In October 2021, the Bankruptcy Court issued a ruling deeming thousands of votes as withdrawn.

In October 2021, Imerys cancelled the confirmation hearing on the Plan. Imerys, the TCC, the FCR, and certain of Imerys’s insurers (the Mediation Parties) have since agreed to engage in mediation, which remains ongoing.

In July 2021, Imerys commenced an adversary proceeding against the Company in the Imerys Bankruptcy (the Imerys Adversary Proceeding). The Imerys Adversary Proceeding sought, among other things, certain declarations with respect to the indemnification obligations allegedly owed by the Company to Imerys. The TCC and FCR simultaneously filed a motion for temporary restraining order and preliminary injunction seeking to enjoin the Company from undergoing a corporate restructuring that would separate the Company’s talc liabilities from its other assets. The Bankruptcy Court denied the motion. The Company thereafter filed a motion to dismiss the adversary proceeding. The Bankruptcy Court has not yet decided the motion to dismiss. In October 2021, the Company filed a Notice of Bankruptcy Filing and Stay of Proceedings clarifying that the automatic stay arising upon the filing of the LTL Bankruptcy Case should apply to the Imerys Adversary Proceeding.

In June 2020, Cyprus Mines Corporation and its parent, Cyprus Amax Minerals Company (CAMC) (together, Cyprus), which had owned certain Imerys talc mines, filed an adversary proceeding against the Company and Imerys in the Imerys Bankruptcy seeking a declaration of indemnity rights under certain contractual agreements (the Cyprus Adversary Proceeding). The Company denies such indemnification is owed, and filed a motion to dismiss the adversary complaint. In February 2021, Cyprus filed a voluntary petition for relief under chapter 11 of the Bankruptcy Code and filed its Disclosure Statement and Plan (the Cyprus Plan). The Cyprus Plan contemplates a settlement with Imerys and talc claimants where Cyprus would make a monetary contribution to a trust established under the Imerys Plan in exchange for an injunction against talc claims asserted against it and certain protected parties. Cyprus has not yet sought approval of its Disclosure Statement and Plan. Cyprus, along with the TCC and FCR appointed in the Cyprus chapter 11 case, have agreed to participate in the mediation with the Mediation Parties. In October 2021, the Company filed a Notice of Bankruptcy Filing and Stay of Proceedings clarifying that the automatic stay arising upon the filing of the LTL Bankruptcy Case should apply to the Cyprus Adversary Proceeding. In June 2022, Cyprus commenced an Adversary Proceeding in its chapter 11 case seeking an order enforcing the automatic stay by enjoining parties from commencing or continuing “talc-related claims” against CAMC. In June 2022, the court entered a preliminary injunction order enjoining claimants from pursuing talc-related claims against CAMC through January 2023.

In February 2021, several of the Company’s insurers involved in coverage litigation in New Jersey State Court (the Coverage Action) filed a motion in the Imerys Bankruptcy Court proceeding seeking a determination that the automatic stay does not apply to the Coverage Action and, in the alternative, seeking relief from the automatic stay to allow them to continue to litigate their claims in the Coverage Action. In March 2021, the Company filed a limited response and reservation of rights with respect to the motion. The Court entered an agreed order modifying the stay to allow the litigation in the Coverage Action to continue. In October 2021, LTL filed a Notice of Bankruptcy Filing and Stay of Proceedings clarifying that the automatic stay arising upon the filing of the LTL Bankruptcy Case should apply to the Coverage Action. In March 2022, the New Jersey Bankruptcy Court ruled that the LTL automatic stay applied to the Coverage Action.

In February 2018, a securities class action lawsuit was filed against Johnson & Johnson and certain named officers in the United States District Court for the District of New Jersey, alleging that Johnson & Johnson violated the federal securities laws by failing to disclose alleged asbestos contamination in body powders containing talc, primarily JOHNSON’S Baby Powder,
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and that purchasers of Johnson & Johnson’s shares suffered losses as a result. Plaintiff is seeking damages. In April 2019, the Company moved to dismiss the complaint and briefing on the motion was complete as of August 2019. In December 2019, the Court denied, in part, the motion to dismiss. In March 2020, the Company answered the complaint. In April 2021, briefing on Plaintiffs’ motion for class certification was completed. In July 2021, the Company filed a notice of supplemental authority in opposition to Plaintiff’s motion for class certification, and Plaintiff filed a response. In December 2021, the Company filed a motion to supplement the class certification record, and in January 2022, Plaintiff responded. In March 2022, LTL asked the New Jersey Bankruptcy Court to stay the securities class action. In April 2022, Defendants filed a second motion to supplement the class certification record. In May 2022, the New Jersey Bankruptcy Court entered an order staying the securities class action, and Plaintiff filed a notice of appeal regarding the Bankruptcy Court’s order.

In October 2019, December 2019, and January 2020, four shareholders filed four separate derivative lawsuits against Johnson & Johnson as the nominal defendant and its current directors and certain officers as defendants in the United States District Court for the District of New Jersey, alleging a breach of fiduciary duties related to the alleged asbestos contamination in body powders containing talc, primarily JOHNSON’SBaby Powder, and that Johnson & Johnson has suffered damages as a result of those alleged breaches. In February 2020, the four cases were consolidated into a single action under the caption In re Johnson & Johnson Talc Stockholder Derivative Litigation. In July 2020, a report was delivered to the Company’s Board of Directors by independent counsel retained by the Board to investigate the allegations in the derivative lawsuits and in a series of shareholder letters that the Board received raising similar issues and demanding that suit be brought against certain Directors. Four of the shareholders who sent demands are plaintiffs in the In re Johnson & Johnson Talc Stockholder Derivative Litigation. The independent counsel recommended that the Company reject the shareholder demands and take the steps that are necessary or appropriate to secure dismissal of the derivative lawsuits. The Board unanimously adopted the recommendations of the independent counsel’s report. In October 2020, the shareholders filed a consolidated complaint, and in January 2021, Johnson & Johnson moved to dismiss the consolidated complaint. In March 2021, Plaintiffs filed a motion for discovery. The Court temporarily terminated Johnson & Johnson’s motion to dismiss pending a decision on Plaintiff’s motion for discovery. In July 2022, the Court denied Plaintiff's discovery motion.

In January 2019, two ERISA class action lawsuits were filed by participants in the Johnson & Johnson Savings Plan against Johnson & Johnson, its Pension and Benefits Committee, and certain named officers in the United States District Court for the District of New Jersey, alleging that the defendants breached their fiduciary duties by offering Johnson & Johnson stock as a Johnson & Johnson Savings Plan investment option when it was imprudent to do so because of failures to disclose alleged asbestos contamination in body powders containing talc, primarily JOHNSON’S Baby Powder. Plaintiffs are seeking damages and injunctive relief. In September 2019, Defendants filed a motion to dismiss. In April 2020, the Court granted Defendants’ motion but granted leave to amend. In June 2020, Plaintiffs filed an amended complaint, and in July 2020, Defendants moved to dismiss the amended complaint. As of October 2020, briefing on Defendants’ motion was complete. In February 2021, the Court granted Defendants’ motion, and granted Plaintiffs leave to amend. In April 2021, Plaintiffs informed the Court that they did not intend to file an amended complaint, and the Court dismissed the case with prejudice. In May 2021, Plaintiffs filed a notice of appeal with the Third Circuit. In July 2021, Plaintiffs filed their opening brief in the Third Circuit and in September 2021, Defendants filed their response brief, and in October 2021, Plaintiffs filed their reply brief. In January 2022, the Third Circuit heard oral argument.

A lawsuit was brought against the Company in the Superior Court of California for the County of San Diego alleging violations of California’s Consumer Legal Remedies Act (CLRA) relating to JOHNSON’S Baby Powder. In that lawsuit, the plaintiffs allege that Johnson & Johnson violated the CLRA by failing to provide required Proposition 65 warnings. In July 2019, the Company filed a notice of removal to the United States District Court for the Southern District of California and plaintiffs filed a second amended complaint shortly thereafter. In October 2019, the Company moved to dismiss the second amended complaint for failure to state a claim upon which relief may be granted. In response to those motions, plaintiffs filed a third amended complaint. In December 2019, the Company moved to dismiss the third amended complaint for failure to state a claim upon which relief may be granted. In April 2020, the Court granted the motion to dismiss but granted leave to amend. In May 2020, plaintiffs filed a Fourth Amended Complaint but indicated that they would be filing a motion for leave to file a fifth amended complaint. Plaintiffs filed a Fifth Amended Complaint in August 2020. The Company moved to dismiss the Fifth Amended Complaint for failure to state a claim upon which relief may be granted. In January 2021, the Court issued an Order and opinion ruling in the Company’s favor and granting the motion to dismiss with prejudice. In February 2021, Plaintiffs filed a Notice of Appeal with the Ninth Circuit. Plaintiffs filed their opening brief in July 2021. The company filed its responsive brief in October 2021. In October 2021, Notice of Suggestion of Bankruptcy was filed with the Ninth Circuit. A bankruptcy stay was imposed in December 2021, and the Court held the reply deadline in abeyance. In February 2022, the Bankruptcy Court issued an order extending the stay. The appeal continues to be held in abeyance, with the Company being required to file periodic status updates.

In addition, the Company has received inquiries, subpoenas, and requests to produce documents regarding talc matters and the LTL Bankruptcy Case from various governmental authorities. The Company has produced documents and responded to inquiries, and will continue to cooperate with government inquiries.

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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, a prescription medication indicated to improve glycemic control in adults with Type 2 diabetes. In December 2016, lawsuits filed in federal courts in the United States were organized as a multi-district litigation in the United States District Court for the District of New Jersey. Cases have also been filed in state courts. Class action lawsuits have been filed in Canada. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has settled or otherwise resolved many of the cases and claims in the United States and the costs associated with these settlements are reflected in the Company’s accruals.

ELMIRON
Claims for personal injury have been made against a number of Johnson & Johnson companies, including Janssen Pharmaceuticals, Inc. and Johnson & Johnson,the Company, arising out of the use of ELMIRON, a prescription medication indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. These lawsuits, which allege that ELMIRON contributes to the development of permanent retinal injury and vision loss, have been filed in both state and federal courts across the United States. In December 2020, lawsuits filed in federal courts in the United States, including putative class action cases seeking medical monitoring, were organized as a multi-district litigation in the United States District Court for the District of New Jersey. In addition, cases have been filed in various state courts of New Jersey, which have been coordinated in a multi-county litigation in Bergen County, as well as the Court of Common Pleas in Philadelphia, where an application is pending forwhich have been coordinated and granted mass tort designation. Cases also have been filed in various state courts. In addition, three class action lawsuits have been filed in Canada. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has established accruals for defense and indemnity costs associated with ELMIRON related product liability litigation.

Consumer Health

TYLENOL
Claims for personal injury have been made against Johnson and Johnson Consumer Inc. (JJCI) in federal court, arising out of the use of TYLENOL, an over-the-counter pain medication, alleging that prenatal exposure to acetaminophen is associated with the development of autism spectrum disorder and/or attention-deficit/hyperactivity disorder. In October 2022, lawsuits filed in federal courts in the United States were organized as a multi-district litigation in the United States District Court for the Southern District of New York. In addition, a lawsuit has been filed in state court against JJCI, Kenvue and the Company, and lawsuits have been filed in Canada against Johnson & Johnson Inc. and the Company. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has established accruals for defense costs associated with TYLENOL related product liability litigation.

INTELLECTUAL PROPERTY

Certain subsidiaries of Johnson & Johnsonthe Company 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. Significant matters are described below.

MedTech
In August 2018, Intuitive Surgical, Inc. and Intuitive Surgical Operations, Inc. (collectively, Intuitive) filed a patent infringement suit against Auris Health, Inc. (Auris) in United States District Court for the District of Delaware. In the suit, Intuitive alleges willful infringement of U.S. Patent Nos. 6,522,906 (’906); 6,800,056 (’056); 8,142,447 (’447); and 9,452,276 (’276) based on Auris’ MONARCH Platform. Auris filed IPR Petitions with the U.S. Patent and Trademark Office (USPTO) regarding the ’056, ’447, ’276 and ’906 patents. In December 2019, the USPTO denied review of the ’056 patent. In February and March 2020, the USPTO instituted review of the ’447, and ’906 patents and denied review of the ’276 patent. In March 2021, the USPTO ruled that the challenged claims of the ’447 and ’906 patents are not invalid. Auris appealed, and in April 2022, the United States Court of Appeals for the Federal Circuit vacated the decision that the ’447 patent was not invalid and remanded the decision to the USPTO for further review. In May 2022, the United States Court of Appeals for the Federal Circuit confirmed the ruling that claim 53 of the ’906 patent was not invalid, vacated the decision that the remaining claims of the ’906 patent were not invalid and remanded the decision to the USPTO for further review. Auris filed a request for reexamination of the ’276 patent in November 2021, and in January 2022, the USPTO granted the reexamination request. Trial is scheduled to begin in January 2023.

In August 2019, RSB Spine LLC (RSB Spine) filed a patent infringement suit against DePuy Synthes, Inc. in the United States District Court for the District of Delaware. In October 2019, RSB Spine amended the complaint to change the named defendants to DePuy Synthes Sales, Inc. and DePuy Synthes Products, Inc. In the suit, RSB Spine alleges willful infringement of United States Patent Nos. 6,984,234 (’234) and 9,713,537 (’537) by one or more of the following products: ZERO-P-VA Spacer, ZERO-P Spacer, ZERO-P NATURAL Plate, SYNFIX LR Spacer and SYNFIX Evolution System. RSB Spine seeks monetary damages and injunctive relief. In November 2019, the suit was consolidated for pre-trial purposes with other patent infringement suits brought by RSB Spine in the United States District Court for the District of Delaware against Life Spine, Inc., Medacta USA, Inc., and Precision Spine, Inc. Trial is scheduled to begin in December 2022. In June 2022, DePuy filed potentially dispositive summary judgment motions that the ’234 patent is invalid as anticipated and the ’537 patent is not infringed.

In October 2020, Rasmussen Instruments, LLC (Rasmussen) filed a patent infringement suit against DePuy Synthes Products, Inc., DePuy Synthes Sales, Inc. and Medical Device Business Services, Inc. (collectively, DePuy) in the United States District
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Court for the District of Massachusetts. Rasmussen alleges that DePuy willfully infringes U.S. Patent Nos. 9,492,180 (’180) and 10,517,583 (’583) by making and selling the Attune Balanced Sizer. In April 2021, Rasmussen sought permission to amend its infringement contentions to allege that DePuy also willfully infringes the ’583 patent by making and selling the Attune Balancing Blocks. Rasmussen seeks treble damages for willful infringement. Trial concluded in March 2022, with the jury returning a verdict in favor of Rasmussen, finding willful infringement of the ’180 patent, and awarding damages in the amount of $20 million. DePuy is challenging the verdict in its post-trial motions. In July 2022, a hearing was held on the post-trial motions.

Pharmaceutical
Pharmaceuticals - Litigation Against Filers of Abbreviated New Drug Applications (ANDAs)

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The following summarizes lawsuits the Company’s subsidiaries have brought lawsuits against generic companies that have filed ANDAs with the U.S. FDA or undertaken(or similar regulatory processeslawsuits outside of the United States,States) seeking to market generic formsversions of products sold by various subsidiaries of Johnson & Johnsonthe Company prior to expiration of the applicable patents covering those products. These ANDAslawsuits typically include allegations of non-infringement andand/or invalidity of patents listed in FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the applicable patents. The Inter Partes Review (IPR) process withOrange Book). In each of these lawsuits, the USPTO, created underCompany’s subsidiaries are seeking an order enjoining the 2011 America Invents Act, is also being used at times bydefendant from marketing a generic companies in conjunction with ANDAs and lawsuits, to challengeversion of a product before the applicable patents.expiration of the relevant patents (Orange Book Listed Patents). In the event the Company’s subsidiaries are not successful in an action, or theany automatic statutory stay of the ANDAs expires before the United States District Courtcourt rulings are obtained, the generic companies involved would have the ability, upon regulatory approval, of the U.S. FDA, to introduce generic versions of their products to the market, resulting in the potential for substantial market share and revenue losses for the applicable products, and which may result in a non-cash impairment charge in any associated intangible asset. In addition, from time to time, the Company’s subsidiaries may settle these types of 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.

ZYTIGA

BeginningThe 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 at times by generic companies in January 2019, Janssen Inc., Janssen Oncology, Inc.,conjunction with ANDAs and BTG International Ltd. (collectively, Janssen) initiated Statements of Claim under Section 6 oflawsuits to challenge the Patented Medicines (Notice of Compliance) Regulations in Canada against Apotex Inc. (Apotex), Pharmascience Inc. (Pharmascience) and Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) in response to those parties’ filing of Abbreviated New Drug Submissions (ANDS) seeking approval to market generic versions of ZYTIGA before the expiration of the Canadian Patent No. 2,661,422 (’422). The trial in these actions concluded in November 2020, and the Court issued a decision holding the ’422 patent invalid in January 2021. In February 2021, Janssen appealed the decision. The appeal hearing has been scheduled to take place in September 2022.

In April 2021, July 2021 and April 2022, respectively, Apotex, DRL and Pharmascience initiated Statements of Claim under Section 8 of the Patented Medicines (Notice of Compliance) Regulations against Janssen seeking damages in respect of those parties generic Zytiga tablets. Trials against Apotex and DRL are scheduled for June 2023. A trial date for the Pharmascience action has not been set.applicable patents.

XARELTO

Beginning in March 2021, Janssen Pharmaceuticals, Inc. (JPI); Bayer Pharma AG; Bayer AG; and Bayer Pharma AG and Bayer AG (collectively, Bayer)Intellectual Property GmbH filed patent infringement lawsuits in the United States District Court for the District of Delawaredistrict courts against a number of generic companiesmanufacturers who have filed ANDAs seeking approval to market generic versions of XARELTO (2.5 mg) before expiration of U.S. Patent No. 10,828,310 (’310).certain Orange Book Listed Patents. The following generic drug companiesentities are named defendants: Dr. Reddy’s Laboratories, Inc. and; Dr. Reddy’s Laboratories, Ltd.; Lupin Limited andLimited; Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd. and; Taro Pharmaceuticals U.S.A., Inc.; and Teva Pharmaceuticals USA, Inc. In October 2021, the court consolidated the Delaware lawsuits for all purposes, including trial. Trial for the consolidated Delaware lawsuits is scheduled to begin in May 2023.

In July 2021, JPI and Bayer filed a patent infringement lawsuit in the United States District Court for the Northern District of West Virginia against; Mylan Pharmaceuticals Inc.; Mylan Inc.; USV Private Limited; Mankind Pharma Limited; Apotex Inc.; Apotex Corp.; Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc.; ScieGen Pharmaceuticals, Inc.; Auson Pharmaceuticals Inc.; Macleods Pharmaceuticals Ltd; Macleods Pharma USA, Inc.; Indoco Remedies Limited; and Mylan Inc. which filed an ANDA seeking approval to market a generic version of XARELTO (2.5 mg) before expiration ofFPP Holding Company LLC. The following U.S. patents are included in one or more cases: 9,539,218; and 10,828,310. In April 2023, the ’310 patent. In August 2021, JPI and Bayer filed a motion before the United States Judicial Panel on Multidistrict Litigation (the MDL panel) to transfer this lawsuit to the United States District Court for the District of Delaware for coordinated and consolidated pretrial proceedings. In December 2021, the MDL panel granted the motion. No trial date has been set in this lawsuit.

In February 2022, JPI and Bayer filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Micro Labs Ltd. and Micro Labs USA Inc. (collectively, Micro) which filed an ANDA seeking approval to market a generic version of XARELTO (2.5 mg) before expiration of the ’310 patent. In March 2022, the case against Micro was consolidated for all purposes, including trial, with the consolidated Delaware lawsuits. In July 2022, the partiesCompany entered into a confidential settlement agreement and the action was dismissed.
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In each of these lawsuits, JPI and Bayer are seeking an order enjoining defendants from marketing their generic version of XARELTO (2.5 mg) before the expiration of the ’310 patent.

In February 2022, Mylanwith ScieGen Pharmaceuticals, Inc. filed a Petition for Inter Partes Review with the United States Patent and Trademark Office, seeking to invalidate the ’310 patent.

In April 2022, Janssen Pharmaceuticals, Inc. (JPI), Bayer Intellectual Property GmbH and Bayer AG filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Changzhou Pharmaceutical Factory, which filed an ANDA seeking approval to market generic a version of XARELTO (10 mg, 15 mg, and 20 mg) before expiration of U.S. Patent No. 9,539,218 (’218). In this lawsuit, JPI, Bayer Intellectual Property GmbH and Bayer AG are seeking an order enjoining Changzhou from marketing its generic version of XARELTO (10 mg, 15 mg, and 20 mg) before the expiration of the ’218 patent. In June 2022,2023, the partiesCompany entered into a confidential settlement agreement and the action was dismissed.with USV Private Limited.

INVOKANA/INVOKAMET/INVOKAMET XRU.S. Patent No. 10,828,310 is also under consideration by the USPTO in an IPR proceeding.

In October 2019, Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, Cilag GmbH International and Janssen Pharmaceutica NV (collectively, Janssen) and Mitsubishi Tanabe Pharma Corporation (MTPC) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories Ltd (DRL), who filed an ANDA seeking approval to market a generic version of INVOKAMET before expiration of MTPC’s United States Patent No. 7,943,788 (’788) relating to INVOKAMET. In this lawsuit, Janssen and MTPC are seeking an order enjoining DRL from marketing its generic version of INVOKAMET before the expiration of the ’788 patent. In June 2022, the parties entered into a confidential settlement agreement and the lawsuit was dismissed.

OPSUMIT
Beginning in January 2023 Actelion Pharmaceuticals Ltd and Actelion Pharmaceuticals US, Inc. filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of OPSUMIT before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Sun Pharmaceutical Industries Limited; Sun Pharmaceutical Industries, Inc.; Alembic Pharmaceuticals Ltd.; Alembic Pharmaceuticals, Inc.; MSN Laboratories Private Limited; MSN Pharmaceuticals Inc.; Apotex Inc.; and Apotex Corp. The following U.S. patents are included in one or more cases: 7,094,781; and 10,946,015.

INVEGA SUSTENNA
Beginning in January 2018, Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc. filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of INVEGA SUSTENNA before expiration of the Orange Book Listed Patent. The following entities are named defendants: Teva Pharmaceuticals USA, Inc.; Mylan Laboratories Limited; Pharmascience Inc.; Mallinckrodt PLC; Specgx LLC; Tolmar, Inc.; and Accord Healthcare, Inc. The following U.S. patent is included in one or more cases: 9,439,906.
In May 2020,
Beginning in February 2018, Janssen Inc. (Janssen) and Actelion Pharmaceuticals Ltd (Actelion)Janssen Pharmaceutica NV initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. (Sandoz) in Canada in response to Sandoz’s filing of an ANDSgeneric manufacturers who have filed ANDSs seeking approval to market a generic versionversions of OPSUMIT10 mg,INVEGA SUSTENNA before the expiration of the listed patent. The following entities are named defendants: Teva Canada Limited; Pharmascience Inc.; and Apotex Inc. The following Canadian Patent No. 2,659,770 (’770). Sandoz stipulated to infringementpatent is included in one or more cases: 2,655,335. In March 2023, the Federal Appeals Court dismissed Teva Canada Limited’s appeal of the ’770 patent. TrialFederal Court’s decision finding that its proposed generic product infringes the asserted patent and that the patent is not invalid.

INVEGA TRINZA
Beginning in September 2020, Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Research & Development, LLC filed patent infringement lawsuits in United States district courts against Sandoz ongeneric manufacturers who have filed ANDAs seeking approval to market generic versions of INVEGA TRINZA before expiration of the issueOrange Book Listed Patent. The following entities are named defendants: Mylan Laboratories Limited; Mylan Pharmaceuticals Inc.; and Mylan Institutional LLC. The following U.S. patent is included in one or more cases: 10,143,693. In May 2023, the District Court
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issued a decision in favor of Janssenfinding that Mylan’s proposed generic product infringes the asserted patent and Actelion. In June 2022, Sandozthat the patent is not invalid.Mylan has appealed the decision.verdict.

In May 2020,IMBRUVICA
Beginning in September 2021, Pharmacyclics LLC and Janssen and ActelionInc. initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Apotex Inc. (Apotex) in Canada in response to Apotex’s filing of an ANDS seeking approval to market a generic version of OPSUMIT10 mg,before the expiration of the ’770 patent. Apotex stipulated to validity of the ’770 patent. Trial against Apotex on the issue of infringement concluded in March 2022, and in May 2022, the Court issued a decision in favor of Janssen and Actelion. In June 2022, Apotex appealed the decision.

In each of these Canadian actions, Janssen and Actelion are seeking an order enjoining the defendants from marketing their generic versions of OPSUMIT before the expiration of the relevant patents.

INVEGA SUSTENNA

In January 2018, Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc. (collectively, Janssen) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Teva Pharmaceuticals USA, Inc. (Teva), whichmanufacturers who have filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of United States Patent No. 9,439,906 (’906). Trial concluded in October 2020. In October 2021, the court issued a decision in Janssen’s favor. Teva has appealed the decision.

In August 2019, Janssen initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Mylan Laboratories Limited (Mylan), which filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of the ’906 patent. Pursuant to an agreement by the parties, judgment in favor of Janssen was entered in December 2021. Mylan appealed.

In December 2019, Janssen initiated a patent infringement lawsuit in the United States District Courts for the Districts of New Jersey and Delaware against Pharmascience Inc., Mallinckrodt PLC and Specgx LLC (collectively, Pharmascience), which filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of the ’906 patent.

In November 2021, Janssen initiated a patent infringement lawsuit in the United States District Court for the District of Delaware against Tolmar, Inc., Tolmar Therapeutics, Inc., Tolmar Pharmaceuticals, Inc. and Tolmar Holding, Inc. (collectively,
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Tolmar), which filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of the ’906 patent. A trial is scheduled to begin in October 2023.

In February 2022, Janssen initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Accord Healthcare, Inc., Accord Healthcare, Ltd. and Intas Pharmaceuticals, Ltd. (collectively, Accord), who filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of the ’906 patent.

In each of these U.S. lawsuits, Janssen is seeking an order enjoining the defendant from marketing a generic version of INVEGA SUSTENNA before the expiration of the relevant patents.

In February 2018, Janssen Inc. and Janssen Pharmaceutica NV (collectively, Janssen Canada) initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Teva Canada Limited (Teva Canada) in response to Teva’s filing of an ANDS seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of Canadian Patent Nos. 2,309,629 (’629) and 2,655,335 (’335). Janssen subsequently discontinued the portion of the lawsuit relating to the ’629 patent. In May 2020, the Canadian Federal Court issued a Public Judgment and Reasons declaring that Teva Canada’s generic version of INVEGA SUSTENNA, if approved, would infringe certain claims of the ’335 patent and that the claims of the ’335 patent are not invalid. Teva Canada appealed.

In November 2020, Janssen Canada initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Pharmascience Inc. in response to Pharmascience Inc.’s filing of an ANDS seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of the ’335 patent. A summary trial on the issue of infringement took place in November 2021. In January 2022, the Court issued a decision in favor of Janssen on the issue of infringement. Pharmascience filed an appeal. In March 2022, Janssen Canada initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Pharmascience in response to Pharmascience’s filing of an ANDS seeking approval to market a generic version of an additional strength of INVEGA SUSTENNA before the expiration of the ’335 patent. The action has been consolidated with the November 2020 action for trial, which took place in July 2022.

In January 2021, Janssen Canada initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Apotex Inc. (Apotex) in response to Apotex’s filing of an ANDS (original ANDS) seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of the ’335 patent. A summary trial on the issue of infringement took place in December 2021. In January 2022, the Court issued a decision in favor of Janssen on the issue of infringement. Apotex appealed.

In June 2022, Janssen Canada initiated Statements of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Apotex in response to Apotex’s Notice of Allegation of invalidity with respect to the original ANDS and in response to Apotex’s filing of an ANDS seeking approval to market a generic version of an additional strength of INVEGA SUSTENNA before the expiration of the ’335 patent.

In each of these Canadian lawsuits, Janssen Canada is seeking an order enjoining the defendant from marketing a generic version of INVEGA SUSTENNA before the expiration of the relevant patents.

INVEGA TRINZA

In September 2020, Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Research & Development, LLC (collectively, Janssen) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Mylan Laboratories Limited, Mylan Pharmaceuticals Inc., and Mylan Institutional LLC (collectively, Mylan). Mylan filed an ANDA seeking approval to market generic versions of INVEGA TRINZA (546 mg) before expiration of United States Patent No. 10,143,693 (’693) relating to INVEGA TRINZA(546 mg). Trial is scheduled to begin in October 2022.

In August 2021, Janssen initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Mylan. Mylan filed an ANDA seeking approval to market generic versions of INVEGA TRINZA(819 mg) before expiration of the ’693 patent.

In October 2021, Janssen initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Mylan. Mylan filed an ANDA seeking approval to market generic versions of INVEGA TRINZA (273 mg and 410 mg) before expiration of the ’693 patent.

In January 2022, the court consolidated the three cases into the case filed in September 2020. In each of these consolidated cases, Janssen is seeking an order enjoining Mylan from marketing its generic versions of INVEGA TRINZAbefore expiration of the ’693 patent.
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IMBRUVICA

In March 2019, Pharmacyclics LLC (Pharmacyclics) and Janssen Biotech, Inc. (JBI) filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Alvogen Pine Brook LLC and Natco Pharma Ltd. (collectively, Alvogen), which filed an ANDAANDSs seeking approval to market generic versions of IMBRUVICA tablets, asserting infringementbefore expiration of United States Patent Nos. 7,514,444; 8,003,309; 8,476,284; 8,497,277; 8,697,711; 8,753,403; 8,754,090; 8,754,091; 8,952,015; 8,957,079; 9,181,257; 9,296,753; 9,655,857; 9,725,455; 10,010,507; 10,106,548; and 10,125,140. In June 2019, Pharmacyclics and JBI amended their complaint against Alvogen to further allege infringement of United States Patent No. 10,213,386.

Trial against Alvogen took place in October 2020. In August 2021, the District Court issued a decision in favor of Pharmacyclics and Janssen finding the asserted claims against Alvogen to be infringed and not invalid. Alvogen has appealed that decision.

In September 2021, Pharmacyclics and Janssen Inc. (Janssen Canada) initiated Statements of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations againstcertain listed patents. The following entities are named defendants: Natco Pharma (Canada) Inc. (Natco); and Sandoz Canada Inc. (Sandoz). The following patents are included in response to Natco’s filing of two ANDSs seeking approval to market generic versions of IMBRUVICAcapsules before the expiration of Canadian Patent Nos.one or more cases: 2,663,116; 2,928,721; 2,800,913; 3,007,787; 3,007,788; 2,875,986; and 3,022,256. In this lawsuit, PharmacyclicsJuly 2023, the Company entered into confidential settlement agreements with Natco and Janssen Canada are seeking an order enjoining Natco from marketing its generic version of IMBRUVICA before the expiration of the relevant patents. The trial is scheduled to begin in July 2023.Sandoz.

SYMTUZA

InBeginning in November 2021, Janssen Products, L.P. and, Janssen Sciences Ireland Unlimited Company, (collectively, Janssen) and Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) initiated afiled patent infringement lawsuitlawsuits in the United States District Court for the Districtdistrict courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of Delaware againstSYMTUZA before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Lupin Limited,Limited; Lupin Pharmaceuticals, Inc.,; MSN Laboratories Private Ltd.,; MSN Life Sciences Private Ltd., and; MSN Pharmaceuticals Inc. (collectively, Lupin), which filed an ANDA seeking approval to market a generic version of SYMTUZA before the expiration of United States Patent Nos.; Apotex Inc.; and Apotex Corp. The following U.S. patents are included in one or more cases: 10,039,718 (the ’718 patent) and 10,786,518 (the ’518 patent). Janssen is seeking an order enjoining Lupin from marketing its generic version of SYMTUZA before the expiration of the ’718 and ’518 patents. The trial is scheduled to begin in October 2023.10,786,518.

ERLEADA

InBeginning in May 2022, Aragon Pharmaceuticals, Inc. and, Janssen Biotech, Inc. (collectively, Janssen) and, Sloan Kettering Institute for Cancer Research (SKI) initiated patent infringement lawsuits in United States District Court for the Districts of New Jersey and Delaware against Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, Lupin), which filed an ANDA seeking approval to market a generic version of ERLEADA before the expiration of United States Patent No. 9,481,663 (the ’663 patent). Janssen and SKI are seeking an order enjoining Lupin from marketing its generic version of ERLEADA before the expiration of the ’663 patent.

In May 2022, Aragon Pharmaceuticals, Inc. and Janssen Biotech, Inc. (collectively, Janssen) and Sloan Kettering Institute for Cancer Research (SKI) initiated a patent infringement lawsuit in United States District Court for the District of New Jersey against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA), Inc., and Zydus Lifesciences Limited (collectively, Zydus), which filed an ANDA seeking approval to market a generic version of ERLEADA before the expiration of the ’663 patent and United States Patent Nos. 9,884,054 (the ’054 patent), 10,052,314 (the ’314 patent), 10,702,508 (the ’508 patent), and 10,849,888 (the ’888 patent). Janssen and SKI are seeking an order enjoining Zydus from marketing its generic version of ERLEADA before the expiration of the ’663, ’054, ’314, ’508, and ’888 patents.

In May 2022, Aragon Pharmaceuticals, Inc. and Janssen Biotech, Inc. (collectively, Janssen), The Regents of the University of California (UC), and Sloan Kettering Institute for Cancer Research (SKI) initiatedfiled patent infringement lawsuits in United States District Court for the Districts of New Jersey and Delawaredistrict courts against Sandoz Inc. (Sandoz), whichgeneric manufacturers who have filed an ANDAANDAs seeking approval to market a generic versionversions of ERLEADA before the expiration of the ’663 patentcertain Orange Book Listed Patents. The following entities are named defendants: Lupin Limited; Lupin Pharmaceuticals, Inc.; Zydus Worldwide DMCC; Zydus Pharmaceuticals (USA), Inc.; Zydus Lifesciences Limited; Sandoz Inc.; Eugia Pharma Specialities Limited; Aurobindo Pharma USA, Inc.; Auromedics Pharma LLC; Hetero Labs Limited Unit V; and United States Patent Nos. 8,445,507 (the ’507 patent), 8,802,689 (the ’689 patent), 9,338,159 (the ’159 patent),Hetero USA, Inc. The following U.S. patents are included in one or more cases: 9,481,663; 9,884,054; 10,052,314; 10,702,508; 10,849,888; 8,445,507; 8,802,689; 9,388,159; 9,987,261; and 9,987,261 (the ’261 patent). Janssen, UC, and SKI are seeking an order enjoining Sandoz from marketing its generic version of ERLEADA before the expiration of the ’663, ’507, ’689, ’159, and ’261 patents.RE49,353.

In MayUPTRAVI
Beginning in November 2022, AragonActelion Pharmaceuticals US Inc., Actelion Pharmaceuticals Ltd and Janssen Biotech, Inc. (collectively, Janssen)Nippon Shinyaku Co., The Regents of the University of California (UC), and Sloan Kettering Institute for Cancer Research (SKI) initiatedLtd. filed patent infringement lawsuits in United States District Court for the Districts of New Jersey and Delawaredistrict courts against Eugia Pharma Specialities Limited, Aurobindo Pharma USA, Inc., and Auromedics Pharma LLC (collectively, Eugia), whichgeneric manufacturers who have filed an ANDAANDAs seeking approval to market a generic versionversions of ERLEADAUPTRAVI before the expiration of certain Orange Book Listed Patents. The following entities are named defendants: Alembic Pharmaceuticals Limited, Alembic Pharmaceuticals Inc.; Lupin Ltd.; Lupin Pharmaceuticals, Inc.; Cipla Limited; Cipla USA Inc.; MSN Laboratories Private Ltd.; and MSN Pharmaceuticals Inc. The following U.S. patents are included in one or more cases: 8,791,122; 9,284,280; and 7,205,302 (‘302 patent). In June 2023, the ’663, ’507, ’689, ’159Company reached a confidential settlement agreement with respect to the ’302 patent with Alembic Pharmaceuticals Limited and ’261 patents. Janssen, UC, and SKI are seeking
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an order enjoining Eugia from marketing its generic version of ERLEADA before the expiration of the ’663,’507, ’689, ’159, and ’261 patents.Alembic Pharmaceuticals Inc.

InSPRAVATO
Beginning in May 2022, Aragon2023, Janssen Pharmaceuticals, Inc. and Janssen Biotech, Inc. (collectively, Janssen), The Regents of the University of California (UC), and Sloan Kettering Institute for Cancer Research (SKI) initiatedPharmaceutica NV filed patent infringement lawsuits in United States District Court for the Districts of New Jersey and Delawaredistrict courts against Hetero Labs Limited Unit V and Hetero USA, Inc. (collectively, Hetero), whichgeneric manufacturers who have filed an ANDAANDAs seeking approval to market a generic versionversions of ERLEADASPRAVATO before the expiration of the ’663, ’507,’054, ’314,’508, and’888 patents. Janssen, UC,certain Orange Book Listed Patents. The following entities are named defendants: Sandoz Inc.; Hikma Pharmaceuticals Inc. USA; Hikma Pharmaceuticals PLC; Westward Columbus Inc.; Alkem Laboratories Ltd; and SKIAscend Laboratories, LLC.The following U.S. patents are seeking an order enjoining Hetero from marketing its generic version of ERLEADA before the expiration of the ’663, ’507, ’054, ’314, ’508,included in one or more cases: 10,869,844; 11,173,134; 11,311,500; and ’888 patents.
11,446,260
Other Litigation

In November 2021, Janssen Pharmaceutica N.V. (Janssen) provided to Alkermes Pharma Ireland Limited, Elan Pharma International Limited, and Elan Drug Delivery, Inc. three-months’ notice of termination of a License Agreement by and among Elan Pharmaceutical Research Corp., d/b/a Nanosystems, Elan Pharma International Limited and Janssen, executed in March, 1999. In November 2021, Janssen also provided to Alkermes Pharma Ireland Limited three-months’ notice of termination of a License Agreement between Elan Pharma International Limited and Janssen executed in July 2003. In April 2022, in response to these notices, Alkermes Pharma Ireland Limited (Alkermes) initiated arbitration in the International Institute for Conflict Prevention and Resolution.

.

GOVERNMENT PROCEEDINGS

Like other companies in the pharmaceutical, consumer health and medical devices industries, Johnson & Johnsonthe Company 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. Such regulation has been the basis of government investigations and litigations. 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, were 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. 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. 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 in the United States District Court for the District of Massachusetts, where all claims against the J&J AWP Defendants were ultimately dismissed. The J&J AWP Defendants also prevailed in a case brought by the Commonwealth of Pennsylvania. Other AWP cases have been resolved through court order or settlement. The case brought by Illinois was settled after trial. In New Jersey, a putative class action based upon AWP allegations is pending against Centocor, Inc. and Ortho Biotech Inc. (both now Janssen Biotech, Inc.), Johnson & Johnson and ALZA Corporation. All other cases have been resolved.MedTech

Opioid Litigation
Beginning in 2014 and continuing to the present, Johnson & Johnson and Janssen Pharmaceuticals, Inc. (JPI), along with other pharmaceutical companies, have been named in close to 3,500 lawsuits related to the marketing of opioids, including DURAGESIC, NUCYNTA and NUCYNTA ER. The suits also raise allegations related to previously owned active pharmaceutical ingredient supplier subsidiaries, Tasmanian Alkaloids Pty, Ltd. and Noramco, Inc. (both subsidiaries were divested in 2016). The majority of the cases have been filed by state and local governments. Similar lawsuits have also been filed by private plaintiffs and organizations, including but not limited to the following: individual plaintiffs on behalf of children suffering from Neonatal Abstinence Syndrome; hospitals; and health insurers/payors. To date, complaints against pharmaceutical manufacturers, including Johnson & Johnson and JPI, have been filed by the state Attorneys General in Arkansas, Florida, Idaho, Illinois, Kentucky, Louisiana, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, South Dakota, Texas, Washington and West Virginia. Complaints against the manufacturers also have been filed in state or federal court by city, county and local government agencies in the following states: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri,
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Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. The Government of Puerto Rico filed suit in Superior Court of San Juan.

Johnson & Johnson, JPI and other pharmaceutical companies had also received subpoenas or requests for information related to opioids marketing practices from the following state Attorneys General: Alaska, Indiana, Montana, New Hampshire, South Carolina, Tennessee, Texas and Washington. In September 2017, Johnson & Johnson and JPI were contacted by the Texas and Colorado Attorney General’s Offices on behalf of approximately 38 states regarding a multi-state Attorney General investigation.

In 2019, the trial in the matter filed by the Oklahoma Attorney General resulted in a judgment against Johnson & Johnson and JPI in the amount of $465 million. Johnson & Johnson and JPI appealed the judgment, and in November 2021, the Oklahoma Supreme Court reversed the trial court’s judgment and directed entry of judgment for Defendants. In October 2019 Johnson & Johnson and JPI announced a settlement of the first case set for trial in the MDL with two counties in Ohio. In April 2021, three California counties and the City of Oakland commenced a trial in California state court against Johnson & Johnson and JPI, and other affiliates, as well as three other pharmaceutical manufacturers. The trial concluded in October 2021, and in December 2021, the Court entered a final trial judgment in favor of Defendants on all claims. In February 2022, Plaintiffs’ motion to set aside and vacate the judgment was denied. Plaintiffs appealed the judgment, but later filed a request to dismiss the appeal after electing to participate in the national settlement agreement.

In October 2019, the Company announced a proposed agreement in principle that would include the Company paying $4 billion as settlement of these matters that had not been tried or settled. In October 2020, the Company agreed to contribute up to an additional $1 billion to an all-in settlement amount that would resolve opioid lawsuits filed and future claims by states, cities, counties and tribal governments, for a total of $5 billion which has been accrued, subject to various conditions and an agreement being finalized. This agreement is not an admission of liability or wrong-doing. In July 2021, the Company announced that the terms of the agreement to settle the state and subdivision claims had been finalized and approximately half of the all-in settlement is expected to be paid by the end of fiscal year 2022, depending upon the level of participation by the states and their subdivisions. The terms provided a period of time for states to elect to participate in the agreement and, thereafter, a period for the subdivisions of the participating states to opt-in. Based on expected participation, the Company committed in advance to proceed with the settlement in five of the participating states (New York, Texas, Florida, Nevada, and New Mexico) and with tribal governments. By late February 2022, 45 states, five territories, the District of Columbia, and the vast majority of eligible subdivisions had elected to participate in the settlement, and the Company confirmed that the level of participation was sufficient to proceed with the agreement as to all participants. The agreement was effective in April 2022 and initial payments were made in July 2022. In April 2022, the Company entered into settlement agreements with the states of Alabama and West Virginia and their participating subdivisions. Consequently, by July 2022, the Company had settled the opioid claims advanced by all states except Washington and New Hampshire. A trial of claims brought by the Attorney General of New Hampshire is scheduled to begin in September 2022.

There are approximately 60 cases remaining post-settlement in various state courts. There are approximately 1,000 remaining federal cases coordinated in a federal Multi-District Litigation (MDL) pending in the U.S. District Court for the Northern District of Ohio. In addition, the Province of British Columbia filed suit against Johnson & Johnson and its Canadian affiliate Janssen Inc., and many other industry members, in Canada, and is seeking to have that action certified as an opt in class action on behalf of other provincial/territorial and the federal governments in Canada. Additional proposed class actions have been filed in Canada against Johnson & Johnson and Janssen Inc., and many other industry members, by and on behalf of people who used opioids (for personal injuries), municipalities and First Nations bands. In October 2019, an antitrust complaint was filed by private plaintiffs in federal court in Tennessee and is pending transfer to the MDL. These actions allege a variety of claims related to opioid marketing practices, including false advertising, unfair competition, public nuisance, consumer fraud violations, deceptive acts and practices, false claims and unjust enrichment. The suits generally seek penalties and/or injunctive and monetary relief and, in some of the suits, the plaintiffs are seeking joint and several liability among the defendants. An adverse judgment in any of these lawsuits could result in the imposition of large monetary penalties and significant damages including, punitive damages, cost of abatement, substantial fines, equitable remedies and other sanctions.
In August 2019, Johnson & Johnson received a grand jury subpoena from the United States Attorney’s Office for the Eastern District of New York for documents related to the Company’s anti-diversion policies and procedures and distribution of its opioid medications, in what the Company understands to be part of a broader investigation into manufacturers’ and distributors’ monitoring programs and reporting under the Controlled Substances Act.

From June 2017 through December 2019, the Company’s Board of Directors received a series of shareholder demand letters alleging breaches of fiduciary duties related to the marketing of opioids. The Board retained independent counsel to investigate the allegations in the demands, and in April 2020, independent counsel delivered a report to the Board recommending that the Company reject the shareholder demands and take the steps that are necessary or appropriate to secure dismissal of related derivative litigation. The Board unanimously adopted the recommendations of the independent counsel’s report.
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In November 2019, one of the shareholders who sent a demand filed a derivative complaint against Johnson & Johnson as the nominal defendant and certain current and former directors and officers as defendants in the Superior Court of New Jersey. The complaint alleges breaches of fiduciary duties related to the marketing of opioids, and that Johnson & Johnson has suffered damages as a result of those alleged breaches. A series of additional derivative complaints making similar allegations against the same and similar defendants were filed in New Jersey state and federal courts in 2019 and 2020. By 2022, all but two state court cases had been voluntarily dismissed. In February 2022, the state court granted Johnson & Johnson’s motion to dismiss one of the two cases, and the shareholder that brought the second case filed a notice of dismissal. The shareholder whose complaint was dismissed filed a motion for reconsideration. In May 2022, the state court held oral argument on the motion for reconsideration and subsequently denied the motion. The shareholder filed a notice of appeal regarding the state court’s dismissal order.

Other
In August 2012, DePuy Orthopaedics, Inc., DePuy, Inc. (now known as DePuy Synthes, Inc.), and Johnson & Johnson Services, Inc. (collectively DePuy) 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
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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 concerning the hip devices. 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 appealed the case to the United States Court of Appeals for the First Circuit. In July 2017, the First Circuit affirmed the District Court’s dismissal in part, reversed in part, and affirmed the decision to deny the relators’ request to file a third amended complaint. In March 2021, DePuy filed its motion to strike and dismiss the relators’ second amended complaint; the District Court denied DePuy’s motion to strike and dismiss in July 2021. DePuy filed a motion for reconsideration of the District Court’s July 2021 ruling. In November 2021, the District Court granted DePuy’s motion for reconsideration and dismissed the case with prejudice. The District Court’s order was unsealed in December 2021. The relators filed several post-dismissal motions, including a January 2022 omnibus motion for reconsideration, which the District Court denied. Following the District Court’s order dismissing the case with prejudice, DePuy filed a December 2021 motion seeking the recovery of attorneys’ fees and costs, which the District Court denied except as to costs. The Relators have appealed the District Court’s dismissal of the case to the First Circuit. The relators’ opening brief was filed inOn May 2022 and was accepted for filing by18, 2023, the First Circuit in June 2022. DePuy’s opposition brief is due in August 2022.affirmed the District Court’s dismissal of the case.

In December 2018, Janssen Biotech, Inc., Janssen Oncology, Inc., Janssen Research & Development, LLC, and Johnson & Johnson (collectively, Janssen) were served with a qui tam complaint filed on behalf of the United States, 28 states, and the District of Columbia. The complaint, which was filed in December 2017 in United States District Court for the Northern District of California, alleges that Janssen violated the federal False Claims Act and state law when providing pricing information for ZYTIGA to the government in connection with direct government sales and government-funded drug reimbursement programs. At this time, the federal and state governments have declined to intervene. The case has been transferred to the United States District Court for the District of New Jersey. Janssen’s motion to dismiss was denied in December 2021, and discovery is proceeding.

In October 2012, Johnson & Johnsonthe Company 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’sthe Company’s subsidiary, Ethicon, Inc. (Ethicon). In May 2016, California and Washington filed civil complaints against Johnson & Johnson,the Company, Ethicon and Ethicon US, LLC alleging violations of their consumer protection statutes. Similar complaints were filed against the companies by the following states:Kentucky, Mississippi, West Virginia and Oregon. In April 2019, Johnson & Johnson and Ethicon settled the Washington case. In October 2019, Johnson & Johnsonthe Company and Ethicon settled the multi-state investigation with 41 other states and the District of Columbia. InBetween April 2020, the Company settled the West Virginia case. In October 2020,2019 and February 2023, the Company settled with the Attorney General of Oregon. In November 2020,Washington, West Virginia, Oregon, Mississippi and Kentucky. After a trial in California and various appeals, the Company settled withsatisfied the Attorney Generaljudgment of Mississippi. Trial in the Kentucky matter is scheduled for May 2023. The California case started trial in July 2019 and concluded in September 2019. In January 2020, the Court in California issued a statement of decision, finding in favor of the State of California, and awarded civil penalties in the amount of $344 million. In April 2020, the Court in California denied the Company’s motion for a new trial. In August 2020, the Court entered judgment with respect to the penalties of $344 million, but denied the Attorney General’s request for injunctive relief. The Company appealed the penalty judgment. In April 2022, the Court of Appeals reduced the judgment to $302 million, but otherwise denied the appeal. In July 2022, the Supreme Court of California denied the Company's petition to review the Court of Appeals decision, and the Company recorded a charge to reflect the judgment in the second quarter of 2022. The Company plans to petition for review by the United States Supreme Court.

California.
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 known as Johnson & Johnson Consumer Inc.) (collectively, JJCI). The complaint alleges that JJCI violated the Mississippi Consumer Protection Act
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by failing 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 divested in 2012) and seeks injunctive and monetary relief. Johnson & Johnson and JJCI moved for summary judgment on the grounds that the State’s claim was barred by preemption, which the trial court denied. The Mississippi Supreme Court granted Johnson & Johnson and JJCI’s request to file an interlocutory appeal of the denial of the motion for summary judgment in late 2019. Briefing and oral argument were completed. Thereafter, the Court rejected the interlocutory appeal in April 2021 and remanded the matter to the trial court. In August 2021, JJCI filed a Petition for Writ of Certiorari in the United States Supreme Court as to the Mississippi Supreme Court’s ruling of April 2021. In December 2021 the United States Supreme Court denied the Petition for Writ of Certiorari. After the Mississippi Supreme Court remanded the matter to the trial court, the State moved for a trial setting. JJCI objected to any trial setting as barred by the stay arising from the LTL Bankruptcy Case, while the State argued that the stay did not apply. In January 2022, the Court granted plaintiff’s motion for trial setting and directed the parties to consult with the Court administrator to secure a trial date. In February 2022, the trial court set the case for trial to begin in February 2023. However, given the efforts to resolve talc-related claims in the LTL Bankruptcy Case, the Company and the State agreed to a temporary stay of discovery until May 2022. The temporary stay expired in May 2022. The State has proposed a scheduling order for further proceedings.

In January 2020, the State of New Mexico filed a consumer protection case alleging that the Company deceptively marketed and sold its talcum powder products by making misrepresentations about the safety of the products and the presence of carcinogens, including asbestos. The State of New Mexico filed an Amended Complaint in March 2020. The Company moved to dismiss certain of the claims in the Amended Complaint, which was granted. The Company then filed a motion for partial judgment on the pleadings in December 2020, which was denied. In March 2022, the New Mexico court denied the Company’s motion to compel the State of New Mexico to engage in discovery of state agencies and denied the Company’s request for interlocutory appeal of that decision. The Company then filed a Petition for Writ of Superintending Control and a Request for a Stay to the New Mexico Supreme Court on the issue of the State of New Mexico’s discovery obligations. In April 2022, in view of the efforts to resolve talc-related claims in the LTL Bankruptcy Case, the Company and the State agreed to a 60-day stay of all matters except for the pending writ before the New Mexico Supreme Court. The 60-day stay expired in June 2022, and the State made a motion for a modified scheduling order. A motion is before the court. In June 2022, the New Mexico Supreme Court granted oral argument on the Company's Writ for Superintending Control on the issue of the State of New Mexico’s discovery obligations.

Forty-two states and the District of Columbia have commenced a joint investigation into the Company’s marketing of its talcum powder products. At this time, the multi-state group has not asserted any claims against the Company. Five states have issued Civil Investigative Demands seeking documents and other information. The Company has produced documents to Arizona, North Carolina, Texas, and Washington and entered into confidentiality agreements. The Company has not received any follow up requests from those states. In March 2022, each of the forty-two states (including Mississippi and New Mexico) agreed to enter into negotiations to determine if they would resolve their claims through the LTL Bankruptcy Case.

In July 2016, Johnson & Johnson and Janssen Products, LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA and INTELENCE, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. The Court denied summary judgment on all claims in December 2021. Daubert motions were granted in part and denied in part in January 2022, and the case is proceeding to trial.

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 August 2019, the United States Department of Justice notified JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The Department of Justice had declined to intervene in the qui tam lawsuit in August 2019. The Company filed a motion to dismiss, which was granted in part and denied in part. Discovery is underway.

In April and September 2017, Johnson & Johnson received subpoenas from the United States Attorney for the District of Massachusetts seeking documents broadly relating to pharmaceutical copayment support programs for DARZALEX, OLYSIO, REMICADE, SIMPONI, STELARA and ZYTIGA. The subpoenas also seek 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. The Company has provided documents in response to the subpoenas.

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, Inc. (DePuy) spinal implants at three hospitals in Boston as well as interactions of employees of Company subsidiaries with physicians at these
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hospitals. Johnson & Johnson and DePuy have produced documents in response to the subpoena and are fully cooperating with the government’s investigation.

In July 2018, the Public Prosecution Service in Rio de Janeiro and representatives from the Brazilian antitrust authority CADE inspected the offices of more than 30 companies including Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda. The authorities appear to be investigating allegations of possible anti-competitive behavior and possible improper payments in the medical device industry. The Company continues to respond to inquiries regarding the Foreign Corrupt Practices Act from the United States Department of Justice and the United States Securities and Exchange Commission.

Pharmaceuticals

The Company and several of its pharmaceutical subsidiaries (the J&J AWP Defendants), along with numerous other pharmaceutical companies, were 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. 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. 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 in the United States District Court for the District of Massachusetts, where all claims against the J&J AWP Defendants were ultimately dismissed. The J&J AWP Defendants also prevailed in a case brought by the Commonwealth of Pennsylvania. Other AWP cases have been resolved through court order or settlement. The case brought by Illinois was settled after trial. In New Jersey, a putative class action based upon AWP allegations is pending against Centocor, Inc. and Ortho Biotech Inc. (both now Janssen Biotech, Inc.), the Company and ALZA Corporation. In June 2023, an action alleging AWP-related claims was filed in a Pennsylvania state court against the same Company subsidiaries by a putative class of payors.

In July 2016, the Company and Janssen Products, LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA and INTELENCE, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. The Court denied summary judgment on all claims in December 2021. Daubert motions were granted in part and denied in part in January 2022, and the case is proceeding to trial.

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 August 2019, the United States Department of Justice notified JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The Department of Justice had declined to intervene in the qui tam lawsuit in August 2019. The Company filed a motion to dismiss, which was granted in part and denied in part. Discovery is underway.

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From time to time, the Company has received 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 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) and 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 complaint in November 2015. This case was settled in March 2022, subject to Court approval.

Beginning in September 2017, multiple purported class actions were filed on behalf of indirect purchasers of REMICADE againstThe Company (subsequently substituted by Johnson & Johnson Consumer Inc. (JJCI)) along with more than 120 other companies, is a defendant in a cost recovery and Janssen Biotech, Inc. (collectively, Janssen) alleging that Janssen has violated federal antitrust laws through its contracting strategies for REMICADE. The cases were consolidated for pre-trial purposes as In re REMICADE Antitrust Litigation contribution action brought by Occidental Chemical Corporation in United States District Court for the Eastern District of Pennsylvania. This case was settled in February 2022, subject to Court approval.

In June 2018 Walgreen Co. and Kroger Co., filed an antitrust complaint against Johnson & Johnson and Janssen Biotech, Inc. (collectively, Janssen) in the United States District Court for the Eastern District of Pennsylvania. The complaint alleges that Janssen has violated federal antitrust laws through its contracting strategies for REMICADE. The complaint seeks damages and injunctive relief. In March 2019, summary judgment was grantedNew Jersey, related to the clean-up of a section of the Lower Passaic River in favor of Janssen. In February 2020, the United States Court of Appeals for the Third Circuit reversed the District Court’s decision. This case was settled in January 2022.New Jersey.

In June 2019, the United States Federal Trade Commission (FTC) issued a Civil Investigative Demand to Johnson & Johnson and Janssen Biotech, Inc. (collectively, Janssen) in connection with its investigation of whether Janssen’s REMICADE contracting practices violate federal antitrust laws. The Company has produced documentsor its subsidiaries are also parties to various proceedings brought under the Comprehensive Environmental Response, Compensation, and information responsiveLiability Act, commonly known as Superfund, and comparable state, local or foreign laws in which the primary relief sought is the Company’s agreement to implement remediation activities at designated hazardous waste sites or to reimburse the Civil Investigative Demand. Janssen isgovernment or third parties for the costs they have incurred in ongoing discussions with the FTC staff regarding its inquiry.

In February 2022, the United States Federal Trade Commission (FTC) issued Civil Investigative Demands to Johnson & Johnson and Janssen Biotech, Inc. (collectively, Janssen) in connection with its investigation of whether advertising practices for REMICADE violate federal law. Janssen has produced documents and information responsive to the Civil Investigative Demands.

In June 2022, Genmab A/S filed a Notice for Arbitration with International Institute for Conflict Prevention and Resolution (CPR) against Janssen Biotech, Inc. seeking milestones and an extended royalty term for Darzalex FASPRO. Janssen filed its Notice of Defense in July 2022.performing remediation as such sites.

In October 2017, certain United States service members and their families brought a complaint against a number of pharmaceutical and medical devices companies, including Johnson & Johnson and certain of its subsidiaries in United States District Court for the District of Columbia, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health. In July 2020, the District Court dismissed the complaint. In January 2022, the United States Court of Appeals for the District of Columbia Circuit reversed the District Court’s decision. In June 2023, defendants filed a petition for a writ of certiorari to the United States Supreme Court.

MedTech

In October 2020, Fortis Advisors LLC (Fortis), in its capacity as representative of the former stockholders of Auris Health Inc. (Auris), filed a complaint against the Company, Ethicon Inc., and certain named officers and employees (collectively, Ethicon) in the Court of Chancery of the State of Delaware. The complaint alleges breach of contract, fraud, and other causes of action against Ethicon in connection with Ethicon’s acquisition of Auris in 2019. The complaint seeks damages and other relief. In December 2021, the Court granted in part and denied in part defendants’ motion to dismiss certain causes of action. All claims against the individual defendants were dismissed. The trial is scheduled for January 2024.

Pharmaceuticals

In June 2019, the United States Federal Trade Commission (FTC) issued a Civil Investigative Demand to the Company and Janssen Biotech, Inc. (collectively, Janssen) in connection with its investigation of whether Janssen’s REMICADE contracting practices violate federal antitrust laws. The Company has produced documents and information responsive to the Civil Investigative Demand. Janssen is in ongoing discussions with the FTC staff regarding its inquiry.

In February 2022, defendants petitionedthe United States Federal Trade Commission (FTC) issued Civil Investigative Demands to Johnson & Johnson and Janssen Biotech, Inc. (collectively, Janssen) in connection with its investigation of whether advertising practices for rehearing en banc.REMICADE violate federal law. Janssen has produced documents and information responsive to the Civil Investigative Demands. Janssen is in ongoing discussions with the FTC staff regarding the inquiry.

In June 2022, Genmab A/S filed a Notice for Arbitration with International Institute for Conflict Prevention and Resolution (CPR) against Janssen Biotech, Inc. seeking milestones and an extended royalty term for Darzalex FASPRO. In April 2023, the Arbitration Panel ruled in Janssen's favor and dismissed Genmab's claims. In May 2023, Genmab appealed that award.

In October 2018, two separate putative class actions were filed against Actelion Pharmaceutical Ltd., Actelion Pharmaceuticals U.S., Inc., and Actelion Clinical Research, Inc. (collectively Actelion) in United States District Court for the District of Maryland and United States District Court for the District of Columbia. The complaints allege that Actelion violated state and federal antitrust and unfair competition laws by allegedly refusing to supply generic pharmaceutical manufacturers with
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samples of TRACLEER. TRACLEER is subject to a Risk Evaluation and Mitigation Strategy required by the U.S. Food and Drug Administration, which imposes restrictions on distribution of the product. In January 2019, the plaintiffs dismissed the District of Columbia case and filed a consolidated complaint in the United States District Court for the District of Maryland. In October 2019, the Court granted Actelion’s motion to dismiss the amended complaint. In April 2021, the United States Court of Appeals for the Fourth Circuit reversed and remanded. Discovery is ongoing.

In May 2019,June 2022, Janssen Pharmaceuticals, Inc. filed a class action antitrust complaint was filedDemand for Arbitration against Janssen R&D Ireland (Janssen) and Johnson & Johnson inEmergent Biosolutions Inc. et al (EBSI) with the United States District CourtAmerican Arbitration Association, alleging that EBSI breached the parties’ Manufacturing Services Agreement for the Northern District of California. The complaint alleges that Janssen violated federal and state antitrust and consumer protection laws by agreeing to exclusivity provisions in its agreements with Gilead concerning the development and marketing of combination antiretroviral therapies (cART) to treat HIV. The complaint also alleges that Gilead entered into similar agreements with Bristol-Myers Squibb and Japan Tobacco. In March 2020, the Court granted in part and denied in part defendants’ motions to dismiss. Plaintiffs filed an amended complaint in April 2020. Defendants moved to dismiss the amended complaint.Company’s COVID-19 vaccine. In July 2020, the Court granted in part2022, Emergent filed its answering statement and denied in part the renewed motion to dismiss. In December 2021, several insurance companies and other payers filed individual “Opt-Out” complaints containing allegations similar to the original complaint. Discoverycounterclaims. The hearing is ongoing.scheduled for March 2024.

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In October 2019, Innovative Health, LLC2022, Janssen Pharmaceuticals, Inc. (Janssen) filed a complaintDemand for Arbitration against Biosense Webster, Inc. (BWI) inMerck Sharp & Dohme Corp. (Merck) with the United States District CourtAmerican Arbitration Association pursuant to the Parties’ agreements relating to production of drug substance and drug product for the Middle District of California. The complaint alleges that certain of BWI’s business practicesCompany’s COVID-19 vaccine. Janssen and contractual terms violateMerck settled the antitrust laws of the United States and the State of California by restricting competitionmatter in the sale of High Density Mapping Catheters and Ultrasound Catheters. In January 2020, BWI filed a motion to dismiss the complaint. In August 2020, the Court granted in part and denied in part BWI’s motion to dismiss. In December 2021, BWI filed a motion for summary judgment. In March 2022, the Court granted BWI’s motion for summary judgment. In April 2022, Innovative appealed this ruling to the United States Court of Appeals for the Ninth Circuit.May 2023.

Consumer Health

In November 2019, Johnson & Johnsonthe Company received a demand for indemnification from Pfizer Inc. (Pfizer), pursuant to the 2006 Stock and Asset Purchase Agreement between the Company and Pfizer. Also in November 2019, Johnson & Johnson Inc. received notice reserving rights to claim indemnification from Sanofi Consumer Health, Inc. (Sanofi), pursuant to the 2016 Asset Purchase Agreement between Johnson & Johnson Inc. and Sanofi. In January 2020, Johnson & Johnson received a demand for indemnification from Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer Ingelheim), pursuant to the 2006 Asset Purchase Agreement among the Company, Pfizer, and Boehringer Ingelheim. In November 2022, Johnson & Johnson received a demand for indemnification from GlaxoSmithKline LLC (GSK), pursuant to the 2006 Stock and Asset Purchase Agreement between the Company and Pfizer, and certain 1993, 1998, and 2002 agreements between Glaxo Wellcome and Warner-Lambert entities. The notices seek indemnification for legal claims related to over-the-counter ZANTAC (ranitidine) products. Plaintiffs in the underlying actions allege that ZANTAC and other over-the-counter ranitidine medications contain unsafe levels of NDMA (N-nitrosodimethylamine) and can cause and/or have caused various cancers in patients using the products, and seek injunctive and monetary relief. The Company and Johnson & Johnson Inc. have also been named in putative class actions filed in Canada with similar allegations regarding ZANTAC or ranitidine use. Johnson & Johnson Inc. was also named as a defendant along with other manufacturers in various personal injury actions in Canada related to ZANTAC products. Johnson & Johnson Inc. has provided Sanofi notice reserving rights to claim indemnification pursuant to the 2016 Asset Purchase Agreement related to the class actions and personal injury actions.

In October 2020, Fortis Advisors LLC (Fortis), in its capacity as representative of the former stockholders of Auris Health Inc. (Auris), filed a complaint against Johnson & Johnson, Ethicon Inc., and certain named officers and employees (collectively, Ethicon) in the Court of Chancery of the State of Delaware. The complaint alleges breach of contract, fraud, and other causes of action against Ethicon in connection with Ethicon’s acquisition of Auris in 2019. The complaint seeks damages and other relief. In December 2021, the Court granted in part and denied in part defendants’ motion to dismiss certain causes of action. All claims against the individual defendants were dismissed. The trial is scheduled for February 2023.


In June 2022, Janssen Pharmaceuticals, Inc. filed an arbitration demand against Emergent Biosolutions Inc. et al (“EBSI”) with the American Arbitration Association, alleging that EBSI breached the parties’ Manufacturing Services Agreement for the Company’s COVID-19 vaccine.

Beginning in May 2021, multiple putative class actions were filed in state and federal courts (California,(California, Florida, New York, and New Jersey) against various Johnson & Johnson entities alleging violations of state consumer fraud statutes based on nondisclosure of alleged benzene contamination of certain Neutrogena and Aveeno sunscreen products and the affirmative promotion of those products as “safe”; and, in at least one case, alleging astrict liability manufacturing defect and failure to warn claims, asserting that the named plaintiffs suffered unspecified injuries as a result of alleged exposure to benzene. The Judicial Panel on Multi-District Litigation has consolidated all pending actions, except one product liability case and one case pending in New Jersey state court, in the United States District Court for the Southern District of Florida, Fort Lauderdale Division. In October 2021, the Company reached an agreement in principle for the settlement of a nationwide class, encompassing the claims of the consolidated actions, subject to approval by the Florida federal Court. In December 2021, plaintiffs in the consolidated actions filed a motion for preliminary approval of a nationwide class settlement. The court issued an order granting final approval of the settlement in February 2023. A Notice of Appeal was filed in April 2023.

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Johnson & Johnson (subsequently substituted by Johnson & Johnson Consumer Inc. (JJCI)) along with more than 120 other companies, is a defendant in a cost recovery and contribution action brought by Occidental Chemical Corporation in June 2018 in the United States District Court for the District of New Jersey, related to the clean-up of a section of the Lower Passaic River in New Jersey.

s
Johnson & Johnson or its subsidiaries are also parties to various 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— RESTRUCTURINGKENVUE SEPARATION

In the fiscal second quarter of 2018 the Company announced plans to implement a series of actions across its Global Supply Chain that are intended to focus resources and increase investments in the critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio, enhance agility and drive growth. The Global Supply Chain actions will include expanding the use of strategic collaborations and bolstering initiatives to reduce complexity, improve cost-competitiveness, enhance capabilities and optimize the Supply Chain network. In the fiscal second quarter of 2022, the Company recorded a net pre-tax charge of $128 million, which is included on the following lines of the Consolidated Statement of Earnings, $85 million in restructuring, $17 million in cost of products sold and $26 million in other (income) expense, net. InDuring the fiscal six months of 2022,2023 the Company recorded a net pre-tax chargefinancial statements and accompanying footnotes continue to reflect the Company's consolidation of $200 million, which is included on the following lines of the Consolidated Statement of Earnings, $155 million in restructuring, $33 million in cost of products sold and $12 million in other (income) expense, net. Total project costs of approximately $2.0 billion have been recorded since the restructuring was announced. See the following table for additional details on the restructuring program.Kenvue.

In total,On May 8, 2023, Kenvue, completed an initial public offering (the IPO) of 198,734,444 shares of its common stock, par value $0.01 per share (the “Kenvue Common Stock”), including the Company expectsunderwriters’ full exercise of their option to purchase 25,921,884 shares to cover over-allotments, at an initial public offering price of $22.00 per share for net proceeds of $4.2 billion. Kenvue shares began trading on the Global Supply Chain actions to generate approximately $0.6New York Stock Exchange under the symbol “KVUE”. Additionally, on May 8, 2023, as partial consideration for the transfer of the Consumer Health business, Kenvue paid $13.2 billion to $0.8 billion in annual pre-tax cost savings that will be substantially delivered byJohnson & Johnson from the end of 2022. The Company expects to record pre-tax restructuring charges of approximately $2.1 billion to $2.3 billion by the completionnet proceeds of the programinitial public offering and debt financing transactions (approximately $7.7 billion of unsecured notes and $1.2 billion of commercial paper) in December 2022. These costs are associatedconnection with network optimizations, exit coststhe separation (See Note 4 to the Consolidated Financial Statements for additional details). The excess of the net proceeds from the IPO over the net book value of the Johnson & Johnson divested interest was $2.5 billion and accelerated depreciation and amortization.   was recorded in additional paid-in capital.

The following table summarizesAs of the severance related reservesclosing of the IPO, Johnson & Johnson owns 1,716,160,000 shares of Kenvue Common Stock, or approximately 89.6% of the total outstanding shares of Kenvue Common Stock, and continues to consolidate the financial results of Kenvue. As of July 2, 2023, the non-controlling interest of $1.3 billion associated restructuring expenses throughwith Kenvue is reflected in equity attributable to non-controlling interests in the consolidated balance sheet. Other (income) expense, net on the consolidated statement of earnings for the fiscal second quarter and fiscal six months ended July 2, 2023, includes $37 million related to the 10.4% non-controlling interest in Kenvue from the time of 2022:
(Dollars in Millions)SeveranceAsset Write-offs/Sales
Other(2)
Total
Reserve balance, January 2, 2022$112 — 25 137 
Current year activity:
   Charges— (11)211 200 
   Cash settlements(23)35 (3)(214)(202)
   Settled non cash— (24)— (24)
Reserve balance, July 3, 2022(1)
$89 — 22 111 
the initial public offering on May 8, 2023 through the end of the fiscal second quarter.
(1)
Cash outlays
Subsequent to the fiscal second quarter on July 24, 2023, the Company announced its intention to split-off at least 80.1% of the shares of Kenvue through an exchange offer. Through the planned exchange offer, Johnson & Johnson shareholders can exchange all, some or none of their shares of Johnson & Johnson Common Stock for severanceshares of Kenvue Common Stock, subject to the terms of the offer. The exchange offer will permit Johnson & Johnson shareholders to exchange some, all or none of their shares of Johnson & Johnson Common Stock for shares of Kenvue Common Stock at a 7% discount, subject to an upper limit of 8.0549 shares of Kenvue Common Stock per share of Johnson & Johnson Common Stock tendered and accepted in the exchange offer. If the upper limit is not in effect, tendering shareholders are expected to receive approximately $107.53 of Kenvue Common Stock for every $100 of Johnson & Johnson Common Stock tendered. Once the exchange offer is consummated (including all related transactions), the Company will no longer be substantially paid outthe majority shareholder of Kenvue, and Kenvue will be a separate and independent company. The shares of Johnson & Johnson Common Stock acquired by the Company in the exchange offer will be recorded as an acquisition of treasury stock at a cost equal to the market value of the shares of Johnson & Johnson Common Stock accepted in the exchange offer at its expiration. Any difference between the net book value of Kenvue attributable to Johnson & Johnson and the market value of the shares of Johnson & Johnson Common Stock acquired at that date will be recognized by the Company as a gain on disposal of discontinued operations net of any direct and incremental expenses of the exchange offer on the disposal of its Kenvue Common Stock. Upon completion of the programexchange offer, and assuming the Company no longer has a controlling financial interest in December 2022.
(2) Other includes project expense suchKenvue, Kenvue’s historical results will be shown in the Company's financial statements as salaries for employees supporting these initiativesdiscontinued operations, and, consulting expenses.
(3) Represents gain on salein subsequent periods, the Company's financial statements will no longer reflect the assets, liabilities, results of assets

The Company continuously reevaluates its severance reserves relatedoperations or cash flows attributable to restructuring and the timing of payments due to the planned release of associates regarding several longer-term projects. The Company believes that the existing severance reserves are sufficient to cover the Global Supply Chain plans given the period over which the actions will take place. The Company will continue to assess and make adjustments as necessary if additional amounts become probable and estimable.

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

RESULTS OF OPERATIONS

Sales to Customers

Analysis of Consolidated Sales

For the fiscal six months of 2022,2023, worldwide sales were $47.4$50.3 billion, a total increase of 4.0%6.0%, including an operational increase of 7.8%8.2% as compared to 20212022 fiscal six months sales of $45.6$47.4 billion. Currency fluctuations had a negative impact of 3.8%2.2% for the fiscal six months of 2022.2023. In the fiscal six months of 2022,2023, the net impact of acquisitions and divestitures on worldwide operational sales growth was a negative 0.2%positive 1.3%.

Sales by U.S. companies were $23.6$26.0 billion in the fiscal six months of 2022,2023, which represented an increase of 2.5%10.0% as compared to the prior year. In the fiscal six months of 2022,2023, the net impact of acquisitions and divestitures on the U.S. operational sales growth was a negative 0.1%positive 2.3%. Sales by international companies were $23.8$24.3 billion, an increase of 5.5%2.0%, including an operational increase of 13.3%6.5%, and a negative currency impact of 7.8%4.5% as compared to the fiscal six months sales of 2021.2022. In the fiscal six months of 2022,2023, the net impact of acquisitions and divestitures on the international operational sales growth was a negativepositive 0.3%.

In the fiscal six months of 2022,2023, sales by companies in Europe achieved growth of 9.3%1.0%, which included an operational increase of 20.1%3.0% and a negative currency impact of 10.8%2.0%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved growth of 8.1%9.3%, which included an operational increase of 9.9%16.1%, and a negative currency impact of 1.8%6.8%. Sales by companies in the Asia-Pacific, Africa region experienced a declineachieved growth of 0.2%0.9%, including an operational increase of 5.6%8.2% and a negative currency impact of 5.8%7.3%.




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For the fiscal second quarter of 2022, worldwide sales were $24.0 billion, a total increase of 3.0%, which included operational growth of 8.0% and a negative currency impact of 5.0% as compared to 2021 fiscal second quarter sales of $23.3 billion. In the fiscal second quarter of 2022, the net impact of acquisitions and divestitures on worldwide operational sales growth was a negative 0.1%.

Sales by U.S. companies were $12.2 billion in the fiscal second quarter of 2022, which represented an increase of 2.3% as compared to the prior year. In the fiscal second quarter of 2022, the net impact of acquisitions and divestitures on the U.S. operational sales growth was a negative 0.1%. Sales by international companies were $11.8 billion, a total increase of 3.8%, which included operational growth of 13.9% and a negative currency impact of 10.1%. In the fiscal second quarter of 2022, the net impact of acquisitions and divestitures on the international operational sales growth was a negative 0.3%.

In the fiscal second quarter of 2022, sales by companies in Europe achieved growth of 7.3%, which included operational growth of 20.7% and a negative currency impact of 13.4%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved growth of 12.4%, including operational growth of 14.9% and a negative currency impact of 2.5%. Sales by companies in the Asia-Pacific, Africa region experienced a decline of 3.6%, including operational growth of 4.7% and a negative currency impact of 8.3%.



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For the fiscal second quarter of 2023, worldwide sales were $25.5 billion, a total increase of 6.3%, which included operational growth of 7.5% and a negative currency impact of 1.2% as compared to 2022 fiscal second quarter sales of $24.0 billion. In the fiscal second quarter of 2023, the net impact of acquisitions and divestitures on worldwide operational sales growth was a positive 1.3%.

Sales by U.S. companies were $13.4 billion in the fiscal second quarter of 2023, which represented an increase of 10.2% as compared to the prior year. In the fiscal second quarter of 2023, the net impact of acquisitions and divestitures on the U.S. operational sales growth was a positive 2.2%. Sales by international companies were $12.1 billion, a total increase of 2.2%, which included operational growth of 4.7% and a negative currency impact of 2.5%. In the fiscal second quarter of 2023, the net impact of acquisitions and divestitures on the international operational sales growth was a positive 0.3%.

In the fiscal second quarter of 2023, sales by companies in Europe experienced a decline of 3.1%, which included an operational decline of 3.9% and a positive currency impact of 0.8%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved growth of 11.5%, including operational growth of 17.7% and a negative currency impact of 6.2%. Sales by companies in the Asia-Pacific, Africa region achieved growth of 6.6%, including operational growth of 12.5% and a negative currency impact of 5.9%.



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Analysis of Sales by Business Segments

Consumer Health

Consumer Health segment sales in the fiscal six months of 20222023 were $7.4$7.9 billion, a decreasean increase of 1.4%6.4% as compared to the same period a year ago, including operational growth of 1.6%9.5% and a negative currency impact of 3.0%3.1%. U.S. Consumer Health segment sales decreasedincreased by 3.5%8.6%. International Consumer Health segment sales increased by 0.3%4.7%, including operational growth of 5.7%10.1% and a negative currency impact of 5.4%. In the fiscal six months of 2022,2023, the net impact of acquisitions and divestitures on the Consumer Health segment operational sales growth was a negative 0.6%.negligible.

Major Consumer Health Franchise Sales*Sales — Fiscal Six Months Ended
(Dollars in Millions)July 3, 2022July 4, 2021Total
Change
Operations
Change
Currency
Change
OTC(1)
$2,943 $2,699 9.0 %12.0 %(3.0)%
Skin Health/Beauty2,138 2,333 (8.3)(5.6)(2.7)
Oral Care760 843 (9.7)(7.1)(2.6)
Baby Care730 776 (5.9)(3.0)(2.9)
Women’s Health458 452 1.4 7.7 (6.3)
Wound Care/Other361 393 (8.0)(7.3)(0.7)
Total Consumer Health Sales$7,391 $7,495 (1.4)%1.6 %(3.0)%
*Certain prior year amounts have been reclassified to conform to current year presentation
(1)In the first fiscal six months of 2021, approximately $0.2 billion of certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changes
(Dollars in Millions)July 2, 2023July 3, 2022Total
Change
Operations
Change
Currency
Change
OTC$3,301 $2,943 12.2 %14.8 %(2.6)%
Skin Health/Beauty2,258 2,138 5.6 8.0 (2.4)
Oral Care759 760 (0.2)2.4 (2.6)
Baby Care719 730 (1.6)3.1 (4.7)
Women’s Health455 458 (0.6)7.1 (7.7)
Wound Care/Other371 361 2.6 4.9 (2.3)
Total Consumer Health Sales$7,863 $7,391 6.4 %9.5 %(3.1)%

Consumer Health segment sales in the fiscal second quarter of 20222023 were $3.8$4.0 billion, a decreasean increase of 1.3%5.4% as compared to the same period a year ago, including operational growth of 2.3% offset by7.7% and a negative currency impact of 3.6%2.3%. U.S. Consumer Health segment sales decreasedincreased by 3.6%6.0%. International Consumer Health segment sales increased by 0.6%5.0% including operational growth of 7.3%9.0% and a negative currency impact of 6.7%4.0%. In the fiscal second quarter of 2022,2023, the net impact of acquisitions and divestitures on the Consumer Health segment operational sales growth was a negative 0.6% primarily due to the DR. CI:LABO - Sedona divestiture in Asia Pacific.negligible.

Major Consumer Health Franchise Sales*Sales — Fiscal Second Quarter Ended
(Dollars in Millions)July 3, 2022July 4, 2021Total
Change
Operations
Change
Currency
Change
OTC(1)
$1,482 $1,426 3.8 %7.5 %(3.7)%
Skin Health/Beauty1,126 1,170 (3.7)(0.3)(3.4)
Oral Care394 426 (7.3)(4.0)(3.3)
Baby Care375 387 (3.1)0.5 (3.6)
Women’s Health230 230 0.2 7.2 (7.0)
Wound Care/Other197 216 (8.4)(7.4)(1.0)
Total Consumer Health Sales$3,805 $3,854 (1.3)%2.3 %(3.6)%
*Certain prior year amounts have been reclassified to conform to current year presentation
(1)In the fiscal second quarter of 2021, approximately $0.1 billion of certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changes
(Dollars in Millions)July 2, 2023July 3, 2022Total
Change
Operations
Change
Currency
Change
OTC$1,659 $1,482 12.0 %13.9 %(1.9)%
Skin Health/Beauty1,148 1,126 2.0 3.5 (1.5)
Oral Care398 394 0.9 2.7 (1.8)
Baby Care360 375 (4.0)(0.2)(3.8)
Women’s Health238 230 3.4 10.0 (6.6)
Wound Care/Other207 197 4.9 6.8 (1.9)
Total Consumer Health Sales$4,011 $3,805 5.4 %7.7 %(2.3)%

The OTC franchise achieved operational growth of 7.5%13.9% as compared to the prior year fiscal second quarter. GrowthThe growth was driven by upper respiratoryprice actions and analgesic products outside the U.S.strong TYLENOL and IMODIUM in digestive health. This was partially offset by supply constraints and a softer allergy season in the U.S.MOTRIN performance due to increased global Cough/Cold/Flu incidences.

The Skin Health/Beauty franchise achieved operational growth of 3.5% as compared to the prior year fiscal second quarter. The growth was driven by price actions and strength in NEUTROGENA particularly in Sun Care, driven by innovation and supply repositioning.

The Oral Care franchise achieved operational growth of 2.7% as compared to the prior year fiscal second quarter. The growth was driven by price actions, partially offset by category deceleration in Asia and the negative impact from the suspension of personal care sales in Russia.

The Baby Care franchise experienced an operational decline of 0.3%0.2% as compared to the prior year fiscal second quarter. The decline was driven by external supply constraints, competitive pressures the DR. CI:LABO - Sedona divestiture in Asia Pacific and regional COVID-19 related mobility restrictions. The decline was partially offset by pricing actions coupled with new product introductionsthe negative impact from the suspension of personal care sales in ASPAC.Russia.

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The Oral Care franchise experienced an operational decline of 4.0% as compared to the prior year fiscal second quarter. The decline was driven by regional COVID-19 related mobility restrictions, a divestiture primarily in the EMEA region and lapping of prior year COVID-19 related demand increases.

s
The Baby Care franchise achieved operational growth of 0.5% as compared to the prior year fiscal second quarter. Slight growth was driven by performance outside the U.S. due to price actions in the Latin America region and higher demand in the Asia Pacific region. The growth was mostly offset by supply constraints primarily in the U.S.

The Women’s Health franchise achieved operational growth of 7.2% as compared to the prior year fiscal second quarter which was primarily driven by growth in the Asia Pacific region due to price increases and strong consumer demand and increased distribution in EMEA.
The Wound Care/Other franchise experienced an operational decline of 7.4%10.0% as compared to the prior year fiscal second quarter primarily driven by lapping of prior year higher demandprice actions and the professional tape divestiturecontinued strong growth in India partially offset by supply recoverythe negative impact from the suspension of personal care sales in Canada.Russia.
The Wound Care/Other franchise achieved operational growth of 6.8% as compared to the prior year fiscal second quarter primarily driven by price actions and innovation.

In November 2021, the Company announced its intention to separate the Company’s Consumer Health business (Kenvue, the New Consumer Health Company), with the intention to create a new, publicly traded company. The Company is targeting completioncompany by the end of the planned separation in 18fiscal year 2023, pending market conditions. On May 8, 2023, Kenvue completed an initial public offering (the IPO). As of the closing of the IPO, the Company owns approximately 89.6% of the total outstanding shares of Kenvue Common Stock, and has continued to 24 months afterconsolidate the initial announcement.financial results of Kenvue (See Note 12 to the Consolidated Financial Statements for additional details).

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Pharmaceutical

Pharmaceutical segment sales in the fiscal six months of 20222023 were $26.2$27.1 billion, an increase of 6.5%3.7% as compared to the same period a year ago, with an operational increase of 10.8%5.5% and a negative currency impact of 4.3%1.8%. U.S. Pharmaceutical sales increased 3.6%7.6% as compared to the same period a year ago. International Pharmaceutical sales increaseddecreased by 10.0%0.7%, including operational growth of 19.4% and3.1% offset by a negative currency impact of 9.4%3.8%. In the fiscal six months of 2022,2023, the net impact of acquisitions and divestitures on the Pharmaceutical segment operational sales growth was a negative 0.1%.

Major Pharmaceutical Therapeutic Area Sales** — Fiscal Six Months Ended
(Dollars in Millions)July 3, 2022July 4, 2021Total
Change
Operations
Change
Currency
Change
Immunology$8,530 $8,145 4.7 %7.8 %(3.1)%
     REMICADE1,310 1,665 (21.4)(20.3)(1.1)
     SIMPONI/ SIMPONI ARIA1,137 1,146 (0.8)3.3 (4.1)
     STELARA4,887 4,422 10.5 13.9 (3.4)
     TREMFYA1,187 897 32.3 36.6 (4.3)
     Other Immunology15 (39.0)(39.0)0.0
Infectious Diseases2,613 2,016 29.6 37.6 (8.0)
     COVID-19 VACCINE1,001 264 **  *
     EDURANT/rilpivirine473 505 (6.5)1.9 (8.4)
     PREZISTA/ PREZCOBIX/ REZOLSTA/ SYMTUZA965 1,051 (8.1)(6.1)(2.0)
     Other Infectious Diseases(2)
174 196 (10.9)(7.2)(3.7)
Neuroscience3,475 3,519 (1.2)2.7 (3.9)
     CONCERTA/methylphenidate318 332 (4.1)1.5 (5.6)
     INVEGA SUSTENNA/ XEPLION/ INVEGA TRINZA/ TREVICTA2,102 1,989 5.7 9.0 (3.3)
     RISPERDAL CONSTA254 312 (18.4)(14.1)(4.3)
     Other Neuroscience(2)
800 886 (9.6)(5.2)(4.4)
Oncology7,992 7,105 12.5 18.4 (5.9)
     DARZALEX3,842 2,798 37.3 43.3 (6.0)
     ERLEADA85056351.1 57.2 (6.1)
     IMBRUVICA2,008 2,241 (10.4)(5.6)(4.8)
     ZYTIGA/ abiraterone acetate1,044 1,201 (13.1)(4.9)(8.2)
     Other Oncology248 302 (18.0)(13.7)(4.3)
Pulmonary Hypertension1,695 1,731 (2.1)1.1 (3.2)
     OPSUMIT881 913 (3.5)0.2 (3.7)
     UPTRAVI653 618 5.7 7.1 (1.4)
     Other Pulmonary Hypertension161 200 (19.8)(13.9)(5.9)
Cardiovascular / Metabolism / Other1,882 2,065 (8.9)(7.5)(1.4)
     XARELTO1,117 1,158 (3.5)(3.5)— 
     INVOKANA/ INVOKAMET248 310 (19.9)(17.6)(2.3)
     Other(1,2)
517 598 (13.5)(10.1)(3.4)
Total Pharmaceutical Sales$26,186 $24,581 6.5 %10.8 %(4.3)%

(Dollars in Millions)July 2, 2023July 3, 2022Total
Change
Operations
Change
Currency
Change
Immunology$8,608 $8,530 0.9 %2.6 %(1.7)%
     REMICADE949 1,310 (27.5)(26.3)(1.2)
     SIMPONI/ SIMPONI ARIA1,066 1,137 (6.2)(3.3)(2.9)
     STELARA5,241 4,887 7.2 8.7 (1.5)
     TREMFYA1,346 1,187 13.4 15.0 (1.6)
     Other Immunology(30.2)(30.2)— 
Infectious Diseases2,707 2,613 3.6 4.7 (1.1)
     COVID-19 VACCINE1,032 1,001 3.04.2(1.2)
     EDURANT/rilpivirine546 473 15.6 17.1 (1.5)
     PREZISTA/ PREZCOBIX/ REZOLSTA/ SYMTUZA968 965 0.3 0.7 (0.4)
     Other Infectious Diseases161 174 (7.6)(3.6)(4.0)
Neuroscience3,597 3,475 3.5 5.8 (2.3)
     CONCERTA/methylphenidate414 318 30.0 35.3 (5.3)
     INVEGA SUSTENNA/ XEPLION/ INVEGA TRINZA/ TREVICTA2,075 2,102 (1.3)0.1 (1.4)
     SPRAVATO300 155 93.1 93.8 (0.7)
     Other Neuroscience(1)
809 900 (10.1)(6.4)(3.7)
Oncology8,510 7,992 6.5 8.8 (2.3)
     CARVYKTI189 24 ***
     DARZALEX4,695 3,842 22.2 24.5 (2.3)
     ERLEADA1,109 85030.4 33.2 (2.8)
     IMBRUVICA1,668 2,008 (16.9)(15.0)(1.9)
     ZYTIGA/ abiraterone acetate472 1,044 (54.8)(52.3)(2.5)
     Other Oncology376 224 68.0 70.4 (2.4)
Pulmonary Hypertension1,844 1,695 8.8 10.8 (2.0)
     OPSUMIT947 881 7.5 9.5 (2.0)
     UPTRAVI761 653 16.6 17.5 (0.9)
     Other Pulmonary Hypertension136 161 (15.5)(9.5)(6.0)
Cardiovascular / Metabolism / Other1,877 1,882 (0.3)0.4 (0.7)
     XARELTO1,215 1,117 8.8 8.8 — 
     Other(2)
662 765 (13.5)(11.9)(1.6)
Total Pharmaceutical Sales$27,144 $26,186 3.7 %5.5 %(1.8)%
* Percentage greater than 100% or not meaningful
**Certain prior year amounts have been reclassified to conform to current year presentation
(1)Inclusive of PROCRIT / EPREXRISPERDAL CONSTA which was previously disclosed separately
(2)In the fiscal six monthsInclusive of 2021, approximately $0.2 billion of certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changesINVOKANA which was previously disclosed separately

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Pharmaceutical segment sales in the fiscal second quarter of 20222023 were $13.3$13.7 billion, an increase of 6.7%3.1% as compared to the same period a year ago, including an operational increase of 12.3%3.8% and a negative currency impact of 5.6%0.7%. U.S. Pharmaceutical sales increased 4.2%9.2% as compared to the same period a year ago. International Pharmaceutical sales increaseddecreased by 9.8%4.0%, including an operational growthdecline of 22.1%2.5% and a negative currency impact of 12.3%1.5%. In the fiscal second quarter of 2022,2023, the net impact of acquisitions and divestitures on the Pharmaceutical segment operational sales growth was a negative 0.1%. Adjustments to previous sales reserve estimates were approximately $0.1 billion unfavorable in the fiscal second quarter of 2022 and approximately $0.2 billion favorable in the fiscal second quarter of 2021.

Major Pharmaceutical Therapeutic Area Sales** — Fiscal Second Quarter Ended
(Dollars in Millions)(Dollars in Millions)July 3, 2022July 4, 2021Total
Change
Operations
Change
Currency
Change
(Dollars in Millions)July 2, 2023July 3, 2022Total
Change
Operations
Change
Currency
Change
ImmunologyImmunology$4,411 $4,231 4.3 %8.1 %(3.8)%Immunology$4,496 $4,411 1.9 %2.6 %(0.7)%
REMICADE REMICADE647 888 (27.2)(25.6)(1.6) REMICADE462 647 (28.6)(27.6)(1.0)
SIMPONI/ SIMPONI ARIA SIMPONI/ SIMPONI ARIA566 584 (3.0)2.0 (5.0) SIMPONI/ SIMPONI ARIA529 566 (6.6)(4.7)(1.9)
STELARA STELARA2,599 2,274 14.3 18.6 (4.3) STELARA2,797 2,599 7.6 8.0 (0.4)
TREMFYA TREMFYA597 479 24.4 29.7 (5.3) TREMFYA706 597 18.3 18.9 (0.6)
Other Immunology Other Immunology(59.2)(59.2)0.0 Other Immunology17.817.8
Infectious Diseases Infectious Diseases1,316 1,018 29.3 42.0 (12.7) Infectious Diseases1,121 1,316 (14.8)(16.6)1.8 
COVID-19 VACCINE COVID-19 VACCINE544 164 **  * COVID-19 VACCINE285 544 (47.7)(51.8)4.1 
EDURANT/rilpivirine EDURANT/rilpivirine225 262 (14.3)(5.3)(9.0) EDURANT/rilpivirine266 225 18.6 16.2 2.4 
PREZISTA/ PREZCOBIX/ REZOLSTA/ SYMTUZA
PREZISTA/ PREZCOBIX/ REZOLSTA/ SYMTUZA
464 505 (7.9)(5.3)(2.6)
PREZISTA/ PREZCOBIX/ REZOLSTA/ SYMTUZA
491 464 5.8 5.6 0.2 
Other Infectious Diseases(2)
Other Infectious Diseases(2)
83 88 (5.4)(2.6)(2.8)
Other Infectious Diseases(2)
79 83 (5.2)1.3 (6.5)
Neuroscience Neuroscience1,734 1,804 (3.9)0.5 (4.4) Neuroscience1,793 1,734 3.55.5 (2.0)
CONCERTA/ methylphenidate CONCERTA/ methylphenidate161 161 0.3 8.3 (8.0) CONCERTA/ methylphenidate208 161 28.6 32.4 (3.8)
INVEGA SUSTENNA/ XEPLION/ INVEGA TRINZA/ TREVICTA
INVEGA SUSTENNA/ XEPLION/ INVEGA TRINZA/ TREVICTA
1,054 1,024 2.9 6.9 (4.0)
INVEGA SUSTENNA/ XEPLION/ INVEGA TRINZA/ TREVICTA
1,031 1,054 (2.1)(1.5)(0.6)
RISPERDAL CONSTA125 155 (19.3)(14.4)(4.9)
SPRAVATO SPRAVATO169 85 98.2 98.5 (0.3)
Other Neuroscience(2)(1)
Other Neuroscience(2)(1)
393 464 (15.2)(11.6)(3.6)
Other Neuroscience(2)(1)
386 433 (10.9)(5.8)(5.1)
Oncology Oncology4,042 3,535 14.3 21.9 (7.6) Oncology4,398 4,042 8.8 9.7 (0.9)
CARVYKTI CARVYKTI117 24 ***
DARZALEX DARZALEX1,986 1,433 38.6 46.1 (7.5) DARZALEX2,431 1,986 22.4 23.4 (1.0)
ERLEADA ERLEADA450 302 49.5 56.9 (7.4) ERLEADA567 450 25.9 26.9 (1.0)
IMBRUVICA IMBRUVICA970 1,116 (13.1)(7.2)(5.9) IMBRUVICA841 970 (13.2)(12.6)(0.6)
ZYTIGA/ abiraterone acetate ZYTIGA/ abiraterone acetate505 563 (10.3)0.9 (11.2) ZYTIGA/ abiraterone acetate227 505 (55.1)(53.8)(1.3)
Other Oncology Other Oncology130 120 7.5 14.4 (6.9) Other Oncology214 106 ***
Pulmonary Hypertension Pulmonary Hypertension843 870 (3.1)0.9 (4.0) Pulmonary Hypertension972 843 15.3 16.5 (1.2)
OPSUMIT OPSUMIT438 463 (5.3)(0.6)(4.7) OPSUMIT507 438 15.7 16.7 (1.0)
UPTRAVI UPTRAVI328 313 4.9 6.6 (1.7) UPTRAVI399 328 21.8 22.5 (0.7)
Other Pulmonary Hypertension Other Pulmonary Hypertension78 95 (18.7)(10.7)(8.0) Other Pulmonary Hypertension66 78 (14.7)(9.7)(5.0)
Cardiovascular / Metabolism / Other Cardiovascular / Metabolism / Other972 1,021 (4.8)(3.1)(1.7) Cardiovascular / Metabolism / Other950 972 (2.2)(2.0)(0.2)
XARELTO XARELTO609 569 7.1 7.1 —  XARELTO637 609 4.7 4.7 — 
INVOKANA/ INVOKAMET120 160 (24.9)(21.8)(3.1)
Other(1,2)
243 293 (17.2)(12.7)(4.5)
Other(2)
Other(2)
313 363 (13.8)(13.4)(0.4)
Total Pharmaceutical SalesTotal Pharmaceutical Sales$13,317 $12,480 6.7 %12.3 %(5.6)%Total Pharmaceutical Sales$13,731 $13,317 3.1 %3.8 %(0.7)%
* Percentage greater than 100% or not meaningful
**Certain prior year amounts have been reclassified to conform to current year presentation
(1)Inclusive of PROCRIT / EPREXRISPERDAL CONSTA which was previously disclosed separately
(2)In the fiscal second quarterInclusive of 2021, approximately $0.1 billion of certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changesINVOKANA which was previously disclosed separately





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Immunology products achieved operational growth of 8.1%2.6% as compared to the same period a year ago driven by continued strong uptakemarket growth of STELARA (ustekinumab) in Crohn's disease and Ulcerative Colitis, as well as the net benefit of favorable discounts partially offset by unfavorable adjustments to previous sales reserves.patient mix and rebates. Additionally, strong growth of TREMFYA (guselkumab) was due to market share gains in Psoriasis and Psoriatic Arthritis wasmarket growth partially offset by unfavorable adjustments to previous sales reserves. This was partially offset by lowerpatient mix. Lower sales of REMICADE (infliximab) were due to biosimilar competition.

Biosimilar versions of REMICADE have been introduced in the United States and certain markets outside the United States and additional competitors continue to enter the market. Continued infliximab biosimilar competition will result in a further reduction in sales of REMICADE.

The latest expiring United States composition of matter patent for STELARA (ustekinumab) will expireexpires in September 2023. STELARA (ustekinumab) U.S. sales in fiscal 20212022 were approximately $5.9$6.4 billion. The expirationThird parties have filed abbreviated Biologics License Applications with the FDA seeking approval to market biosimilar versions of STELARA. In May 2023, the Company settled litigation with Amgen under the Biosimilar Price Competition and Innovation Act of 2009. As a result of the settlement and other agreements with separate third parties, the Company does not anticipate the launch of a product patent or lossbiosimilar version of market exclusivity is likely to result in a reduction in sales.STELARA until January 1, 2025.

Infectious disease products achievedexperienced an operational growthdecline of 42.0%16.6% as compared to the same period a year ago. Growth wasago primarily driven by the contribution of thea decline in COVID-19 vaccine.This was partially offset by lower sales of PREZISTAand PREZCOBIX/REZOLSTA (darunavir/cobicistat) due to increased competition and loss of exclusivity of PREZISTAin certain countries outside the U.S.vaccine revenue.

Neuroscience products achieved operational sales growth of 0.5%5.5% as compared to the same period a year ago. The growth of SPRAVATO (esketamine) was driven by ongoing launches in the U.S. and Europe. Growth of Paliperidonewas partially offset by declines from the paliperidone long-acting injectables, INVEGA SUSTENNA/XEPLION (paliperidone palmitate) and INVEGA TRINZA/TREVICTA was due to new patient starts and persistencethe XEPLION loss of treatment as well asexclusivity in the launch of INVEGA HAFYERA.European Union.
Oncology products achieved operational sales growth of 21.9%9.7% as compared to the same period a year ago. Contributors to the growth were strongStrong sales of DARZALEX (daratumumab) were driven by share gains in all regions and continued market growth. Growth of ERLEADA (apalutamide) was due to continued strong share gains, market growth, and solid uptakeincreased penetration from new launches. Sales of CARVYKTI (ciltacabtagene autoleucel) were driven by continued market share gains from the subcutaneous formulation andongoing launch. Additionally, sales from the continued global launch uptake of ERLEADA (apalutamide). IMBRUVICA (ibrutinib) declined dueTECVAYLI (teclistamab-cqyv), included in Other Oncology, contributed to competitive pressures. The U.S. declinethe growth. Growth was partially offset by growth in all regions outside the U.S.ZYTIGA (abiraterone acetate) due to loss of exclusivity and IMBRUVICA (ibrutinib) due to global competitive pressures.

Pulmonary Hypertension achieved operational sales growth of 0.9%16.5% as compared to the same period a year ago. Sales growth was due to demandfavorable patient mix, share gains and share gainsmarket growth from UPTRAVI (selexipag) and OPSUMIT (macitentan) partially offset by COVID-19 related market constraints and unfavorable patient mix in OPSUMIT (macitentan) as well as entrantsdeclines in Other Pulmonary Hypertension.

Cardiovascular / Metabolism / Other products experienced an operational decline of 3.1%2.0% as compared to the same period a year ago. The growth of XARELTO (rivaroxaban) was primarily driven by volumefavorable patient mix and market growth andpartially offset by share gains from commercial access changes. The decline in sales of INVOKANA/INVOKAMET (canagliflozin) were due to continued share erosion.loss.

Starting in the second quarter of fiscal 2022, theThe Company updated itsmaintains a policy so that no end customer will be permitted direct delivery of product to a location other than the billing location. The updatedThis policy impacts contract pharmacy transactions involving non-grantee 340B covered entities for most of the Company’s drugs, subject to multiple exceptions. Both grantee and non-grantee covered entities can maintain unlimitedcertain contract pharmacy arrangements under policy exceptions. The Company has been and will continue to offer 340B discounts to covered entities on all of its covered outpatient drugs, and it believes its policy will improve its ability to identify inappropriate duplicate discounts and diversion prohibited by the 340B statute. The 340B Drug Pricing Program is a U.S. federal government program requiring drug manufacturers to provide significant discounts on covered outpatient drugs to covered entities. This policy update hashad discount and volume implications which positively impacted sales to customers in the current year and going forward.

fiscal 2023.
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MedTech*MedTech

The MedTech segment sales in the fiscal six months of 20222023 were $13.9$15.3 billion, an increase of 2.3%10.1% as compared to the same period a year ago, with an operational increase of 5.9%12.8% and a negative currency impact of 3.6%2.7%. U.S. MedTech sales increased 3.5%15.5%. International MedTech sales increased by 1.2%5.2%, including an operational increase of 8.0%10.3% and a negative currency impact of 6.8%5.1%. In the fiscal six months of 2022,2023, the net impact of acquisitions and divestitures on the MedTech segment operational sales growth was a negative 0.1%.positive 4.7% related to the Abiomed acquisition on December 22, 2022.

Major MedTech Franchise SalesSales** — Fiscal Six Months Ended
(Dollars in Millions)(Dollars in Millions)July 3, 2022July 4, 2021Total
Change
Operations
Change
Currency
Change
(Dollars in Millions)July 2, 2023July 3, 2022Total
Change
Operations
Change
Currency
Change
SurgerySurgery$4,884 $4,894 (0.2)%3.4 %(3.6)%Surgery$5,028 $4,884 3.0 %6.3 %(3.3)%
Advanced Advanced2,302 2,286 0.7 4.0 (3.3) Advanced2,340 2,302 1.7 5.0 (3.3)
General General2,582 2,608 (1.0)2.8 (3.8) General2,688 2,582 4.1 7.4 (3.3)
OrthopaedicsOrthopaedics4,345 4,340 0.1 3.0 (2.9)Orthopaedics4,510 4,345 3.8 5.4 (1.6)
Hips Hips777 747 4.1 6.8 (2.7) Hips787 777 1.3 2.8 (1.5)
Knees Knees688 667 3.1 5.9 (2.8) Knees731 688 6.3 7.9 (1.6)
Trauma Trauma1,444 1,443 0.1 3.0 (2.9) Trauma1,496 1,444 3.6 4.9 (1.3)
Spine, Sports & Other Spine, Sports & Other1,436 1,484 (3.2)(0.4)(2.8) Spine, Sports & Other1,495 1,436 4.2 6.1 (1.9)
Interventional SolutionsInterventional Solutions3,123 2,141 45.8 49.3 (3.5)
Electrophysiology Electrophysiology2,288 1,970 16.2 19.5 (3.3)
Abiomed
Abiomed
655 — ***
Other Interventional Solutions
Other Interventional Solutions
180 171 5.1 9.5 (4.4)
VisionVision2,498 2,328 7.3 12.4 (5.1)Vision2,608 2,498 4.4 7.2 (2.8)
Contact Lenses/Other Contact Lenses/Other1,804 1,725 4.5 9.9 (5.4) Contact Lenses/Other1,892 1,804 4.9 8.0 (3.1)
Surgical Surgical694 602 15.2 19.4 (4.2) Surgical716 694 3.1 5.4 (2.3)
Interventional Solutions2,141 1,995 7.4 11.1 (3.7)
Total MedTech SalesTotal MedTech Sales$13,869 $13,557 2.3 %5.9 %(3.6)%Total MedTech Sales$15,269 $13,869 10.1 %12.8 %(2.7)%
*Previously referred Percentage greater than 100% or not meaningful
**Certain prior year amounts have been reclassified to as Medical Devicesconform to current year presentation

The MedTech segment sales in the fiscal second quarter of 20222023 were $6.9$7.8 billion, a decreasean increase of 1.1%12.9% as compared to the same period a year ago, which included operational growth of 3.4% offset by14.7% and a negative currency impact of 4.5%1.8%. U.S. MedTech sales increased 1.6%14.6%. International MedTech sales decreasedincreased by 3.6%11.3%, including operational growth of 5.1%14.7% partially offset by a negative currency impact of 8.7%3.4%. In the fiscal second quarter of 2022,2023, the net impact of acquisitions and divestitures on the MedTech segment operational sales growth was negligible.a positive 4.8%, related to the Abiomed acquisition.

















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Major MedTech Franchise SalesSales** — Fiscal Second Quarter Ended
(Dollars in Millions)(Dollars in Millions)July 3, 2022July 4, 2021Total
Change
Operations
Change
Currency
Change
(Dollars in Millions)July 2, 2023July 3, 2022Total
Change
Operations
Change
Currency
Change
SurgerySurgery$2,450 $2,522 (2.8)%1.8 %(4.6)%Surgery$2,594 $2,450 5.9 %8.4 %(2.5)%
Advanced Advanced1,156 1,168 (1.0)3.6 (4.6) Advanced1,222 1,156 5.8 8.4 (2.6)
General General1,294 1,354 (4.5)0.3 (4.8) General1,372 1,294 6.0 8.4 (2.4)
OrthopaedicsOrthopaedics2,157 2,227 (3.1)0.5 (3.6)Orthopaedics2,265 2,157 5.0 5.7 (0.7)
Hips Hips388 391 (0.7)2.7 (3.4) Hips397 388 2.2 3.0 (0.8)
Knees Knees349 350 (0.1)3.3 (3.4) Knees363 349 3.9 4.5 (0.6)
Trauma Trauma696 710 (1.9)1.8 (3.7) Trauma739 696 6.1 6.5 (0.4)
Spine, Sports & Other Spine, Sports & Other724 777 (6.8)(3.2)(3.6) Spine, Sports & Other766 724 5.8 7.0 (1.2)
Interventional SolutionsInterventional Solutions1,620 1,049 54.4 56.9 (2.5)
Electrophysiology Electrophysiology1,196 968 23.5 25.9 (2.4)
Abiomed
Abiomed
331 — ***
Other Interventional Solutions
Other Interventional Solutions
93 81 15.1 18.8 (3.7)
VisionVision1,241 1,183 4.9 10.9 (6.0)Vision1,308 1,241 5.4 6.9 (1.5)
Contact Lenses/Other Contact Lenses/Other894 868 2.9 9.2 (6.3) Contact Lenses/Other939 894 5.1 6.6 (1.5)
Surgical Surgical347 314 10.5 15.5 (5.0) Surgical369 347 6.2 7.6 (1.4)
Interventional Solutions1,049 1,046 0.3 5.3 (5.0)
Total MedTech SalesTotal MedTech Sales$6,898 $6,978 (1.1)%3.4 %(4.5)%Total MedTech Sales$7,788 $6,898 12.9 %14.7 %(1.8)%
*Previously referred Percentage greater than 100% or not meaningful
**Certain prior year amounts have been reclassified to as Medical Devicesconform to current year presentation

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The Surgery franchise achieved operational sales growth of 1.8%8.4% as compared to the prior year fiscal second quarter. The operational growth in Advanced Surgery was primarily driven by the following: Biosurgery global procedure growth and strength of the portfolio; Endocutter procedure recovery outside the U.S. and Biosurgeryuptake of recently launched products attributable to market expansion and the success of new products. Growth of Endocutter products was partially offset by regional COVID-19 related mobility restrictions andvolume-based procurement impacts in China, competitive pressures predominantly in the U.S. Growthand supply challenges; and Energy products procedure recovery outside the U.S. and strength of Biosurgerynew products was partially offset by strong market demandvolume-based procurement impacts in the prior year for infection prevention productsChina and by regional COVID-19 related mobility restrictions. Energy products growth was due to new product penetration coupled with competitive supply challenges and stocking outside the U.S. partially offset by regional COVID-19 related mobility restrictions.challenges. The operational growth in General Surgery was primarily driven by strength ofprocedure recovery outside the Suture portfolio andU.S. coupled with technology penetration mostly offset by regional COVID-19 related mobility restrictions.and benefits from the differentiated Wound Closure portfolio.

The Orthopaedics franchise achieved operational sales growth of 0.5%5.7% as compared to the prior year fiscal second quarter. The operational growth in hips reflects theglobal procedure growth and continued strength of the portfolio including the ACTIS stem and enabling technologies – KINCISE and VELYS Hip Navigation and momentum in the U.S. Ambulatory Surgery Center channelportfolio. This was partially offset by the negative impact of regional COVID-19 related mobility restrictions.supply challenges. The operational growth in knees was primarily driven by marketglobal procedure recovery, benefits from launches in the ATTUNE portfolio and uptake of new productspull through related to the VELYS Robotic assisted solution. This was partially offset by regional COVID-19 related mobility restrictions and the timing of tenders outside the U.S.supply constraints. The operational growth in Trauma was driven by procedure recovery and the uptakeadoption of new productsrecently launched products. This was partially offset by the negative impact of regional COVID-19 related mobility restrictions.volume-based procurement impacts in China. The operational declinegrowth in Spine, Sports & Other was primarily driven by continued procedural softnessprocedure growth, positive uptake from new products and growth in Spine and regional COVID-19 related mobility restrictionsVELYS Digital Solutions. This was partially offset by volume-based procurement impacts in China and continued competitive pressures in Spine.

The Interventional Solutions franchise achieved operational sales growth of 56.9% as compared to the prior year fiscal second quarter which includes sales from Abiomed acquired on December 22, 2022. Electrophysiology grew by double digits due to global procedure growth, new productsproduct performance and commercial execution. This was partially offset by the impacts of volume-based procurement in Sports, Spine & VELYS Digital Solutions.China. Abiomed sales reflect the strength of all commercialized regions and continued adoption of Impella 5.5 and Impella RP.

The Vision franchise achieved operational sales growth of 10.9%6.9% as compared to the prior year fiscal second quarter. The Contact Lenses/Other operational growth was primarily driven by market growth,the continued strong performance in the ACUVUE OASYS 1-Day family (including recent launches) and commercial execution and new products. The growthexecution. This was partially offset by the negative impactimpacts from prior year stocking.strategic portfolio decisions and supply challenges. The Surgical operational growth was primarily driven by Cataract market recovery, uptakecataract procedure growth and continued strength of recently launched products, timing of stocking in ASPAC partially offset by high prior year comparison in Refractive.

The Interventional Solutions franchise achieved operational sales growth of 5.3% as compared to the prior year fiscal second quarter was driven by market growth in the U.S., EMEA and LATAM coupled with success of new products and commercial strategies. Growthrecent innovations. This was partially offset by the negative impact of regional COVID-19 related mobility restrictions.softer Refractive and premium IOL markets challenges.

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ANALYSIS OF CONSOLIDATED EARNINGS BEFORE PROVISION FOR TAXES ON INCOME

Consolidated earnings before provision for taxes on income for the fiscal six months of 20222023 was $11.7$6.0 billion representing 24.7%12.0% of sales as compared to $14.1$11.7 billion in the fiscal six months of 2021,2022, representing 30.9%24.7% of sales. The decline was primarily related to the talc settlement proposal in the fiscal first quarter.

Consolidated earnings before provision for taxes on income for the fiscal second quarter of 20222023 was $5.8$6.8 billion representing 24.3%26.5% of sales as compared to $6.7$5.8 billion in the fiscal second quarter of 2021,2022, representing 28.6%24.3% of sales.


Cost of Products Sold
jnj-20220703_g5.jpgjnj-20220703_g6.jpg54975585357513974
(Dollars in billions. Percentages in chart are as a percent to total sales)

Fiscal Sixsix months Q2 20222023 versus Fiscal Sixsix months Q2 20212022
Cost of products sold increased as a percent to sales driven by:
InflationCommodity inflation and unfavorable mixAbiomed amortization in the MedTech segmentbusiness
Commodity inflation in the Consumer Health segment
COVID-19 vaccine supply network related costs in the Pharmaceutical segment
partially offset by
Favorable segment mix with a higher percentage of sales coming from the Pharmaceutical segment
Supply chain benefits in the Consumer Health segmentbusiness

The intangible asset amortization expense included in cost of products sold for the fiscal six months of 2023 and 2022 and 2021 was $2.2$2.4 billion and $2.4$2.2 billion, respectively.

Q2 20222023 versus Q2 20212022
Cost of products increasedsold decreased as a percent to sales primarily driven by:
InflationFavorable mix and unfavorable mixlower one-time COVID-19 vaccine manufacturing related exit costs in 2023 in the Pharmaceutical business
partially offset by
Commodity inflation and Abiomed amortization in the MedTech segmentbusiness
Commodity inflation in the Consumer Health segment
COVID-19 vaccine supply network related costs in the Pharmaceutical segment
partially offset by
Supply chain benefits in the Consumer Health segment
Favorable segment mix with a higher percentage of sales coming from the Pharmaceutical segmentbusiness

The intangible asset amortization expense included in cost of products sold for the fiscal second quarters of 2023 and 2022 was $1.2 billion and 2021 was $1.1 billion, and $1.2 billion, respectively.












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Selling, Marketing and Administrative Expenses

jnj-20220703_g7.jpgjnj-20220703_g8.jpg54975585458514478
(Dollars in billions. Percentages in chart are as a percent to total sales)

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Fiscal Sixsix months Q2 20222023 versus Fiscal Sixsix months Q2 20212022
Selling, Marketing and Administrative Expenses decreased slightly as a percent to sales driven by:
Leveraging in the Pharmaceutical and MedTech businesses
partially offset by
An increase in Kenvue standalone start-up costs

Q2 2023 versus Q2 2022
Selling, Marketing and Administrative Expenses increased as a percent to sales primarily driven by:
Increased spending to support product launchesAn increase in the MedTech business
Higher brand marketing expenses in the Consumer Health business

Q2 2022 versus Q2 2021
Selling, Marketing and Administrative Expenses decreased as a percent to sales driven by:
Leveraging in Pharmaceutical brand marketing expense spending
Favorable segment mix with a higher percentage of sales coming from the Pharmaceutical segmentKenvue standalone start-up costs
partially offset by
Increased spending to support product launchesLeveraging in the Pharmaceutical and MedTech businessbusinesses


Research and Development Expense

jnj-20220703_g9.jpgjnj-20220703_g10.jpg54975585491214774
(Dollars in billions. Percentages in chart are as a percent to total sales)

Fiscal Sixsix months Q2 20222023 versus Fiscal Sixsix months Q2 20212022
Research and Development increaseddecreased as a percent to sales driven by:
General portfolio progressionCost management initiatives in the MedTech business
Portfolio prioritization in the Pharmaceutical business
partially offset by
Increased investment across all franchisesacquired in-process research & development costs in the MedTechPharmaceutical business

Q2 20222023 versus Q2 20212022
Research and Development increaseddecreased as a percent to sales driven by:
General portfolio progressionCost management initiatives in the MedTech business
Portfolio prioritization in the Pharmaceutical business
partially offset by
Increased investment across all franchisesacquired in-process research & development costs in the MedTechPharmaceutical business




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In-Process Research and Development (IPR&D) Impairments

In the fiscal first quarter of 2023, the Company recorded a charge of approximately $0.1 billion associated with the IPR&D acquired with Pulsar Vascular in 2016. In the first fiscal six months of 2022, the Company recorded an intangible asset impairment charge of approximately $0.6 billion related to an in-process research and development asset, bermekimab (JnJ-77474462), an investigational drug for the treatment of Atopic Dermatitis (AD) and Hidradenitis Suppurativa (HS). Additional information regarding efficacy of the AD indication became available which led the Company to the decision to terminate the development of bermekimab for AD. The Company acquired all rights to bermekimab from XBiotech, Inc. in the fiscal year 2020.

Interest (Income) Expense

Interest (Income) Expenseincome in the first fiscal six months of 20222023 was a net interest income of $38$604 million as compared to interest expense of $76 million in the same period a year ago primarily due to higher rates of interest earned on cash balances and the benefit from net investment hedging. Interest (Income) Expense in the fiscal second quarter of 2022 was a net interest income of $26 million as compared to interest expense of $28$86 million in the same period a year ago primarily due to higher rates of interest earned on cash balances. Interest income in the fiscal second quarter of 2023 was $369 million as compared to $64 million in the fiscal second quarter of 2022 primarily due to higher rates of interest earned on cash balances. Interest expense in the first fiscal six months of 2023 was $561 million as compared to $48 million in the same period a year ago primarily due to a higher debt balance at higher interest rates. Interest expense in the fiscal second quarter of 2023 was $346 million as compared to $38 million in the same period a year ago primarily due to a higher debt balance at higher
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interest rates. The balance of cash, cash equivalents and current marketable securities was $28.5 billion at the end of the fiscal second quarter of 2023 as compared to $32.6 billion at the end of the fiscal second quarter of 2022 as compared to $25.3 billion at the end of the fiscal second quarter of 2021.2022. The Company’s debt position was $32.6$45.6 billion as of July 3, 20222, 2023, as compared to $33.5$32.6 billion the same period a year ago.

Other (Income) Expense, Net*

Fiscal Sixsix months Q2 20222023 versus Fiscal Sixsix months Q2 20212022
Other (income) expense, net for the fiscal six months of 20222023 was unfavorable by $1.6$7.0 billion as compared to the prior year primarily due to the following:
Fiscal Six Months
(Dollars in Billions)(Income)/Expense20222021Change
Changes in the fair value of securities$0.5 (0.2)0.7 
Consumer Health separation costs0.4 0.0 0.4 
Litigation related0.4 0.0 0.4 
Employee benefit plan related(0.6)(0.3)(0.3)
Acquisition, integration and divestiture related(1)
0.0 (0.5)0.5 
Other(0.5)(0.4)(0.1)
Total Other (Income) Expense, Net$0.2 (1.4)1.6 

Fiscal Six Months
(Dollars in Billions)(Income)/Expense20232022Change
Litigation related(1)
$6.8 0.4 6.4 
Consumer Health separation costs0.5 0.4 0.1 
COVID-19 Vaccine related exit costs0.4 0.0 0.4 
Changes in the fair value of securities0.1 0.5 (0.4)
Employee benefit plan related(0.7)(0.6)(0.1)
Other(2)
0.1 (0.5)0.6 
Total Other (Income) Expense, Net$7.2 0.2 7.0 
(1) Primarily related to divestiture gains of two pharmaceutical brands outside the U.S. in thetalc settlement proposal. The fiscal six months of 2021.2023 includes favorable intellectual property related litigation settlements of approximately $0.3 billion.
(2) Fiscal 2023 includes $37 million related to the 10.4% non-controlling interest in Kenvue from the time of the initial public offering on May 8, 2023 through the end of the fiscal second quarter

Q2 20222023 versus Q2 20212022
Other (income) expense, net for the fiscal second quarter of 20222023 was unfavorablefavorable by $0.8$0.3 billion as compared to the prior year primarily due to the following:
Fiscal Second QuarterFiscal Second QuarterFiscal Second Quarter
(Dollars in Billions)(Income)/Expense(Dollars in Billions)(Income)/Expense20222021Change(Dollars in Billions)(Income)/Expense20232022Change
Litigation related$0.4 0.0 0.4 
Consumer Health separation costsConsumer Health separation costs0.3 0.0 0.3 Consumer Health separation costs$0.2 0.3 (0.1)
COVID-19 Vaccine related exit costsCOVID-19 Vaccine related exit costs0.2 0.0 0.2 
Employee benefit plan relatedEmployee benefit plan related(0.4)(0.3)(0.1)
Litigation related(1)
Litigation related(1)
(0.1)0.4 (0.5)
Changes in the fair value of securitiesChanges in the fair value of securities0.1 (0.2)0.3 Changes in the fair value of securities0.00.1 (0.1)
Employee benefit plan related(0.3)(0.1)(0.2)
Other(0.2)(0.2)— 
Other(2)
Other(2)
0.0(0.2)0.2 
Total Other (Income) Expense, NetTotal Other (Income) Expense, Net$0.3 (0.5)0.8 Total Other (Income) Expense, Net$(0.1)0.3 (0.4)
(1) The fiscal second quarter of 2023 includes favorable intellectual property related litigation settlements of approximately $0.3 billion.
(2) Fiscal 2023 includes $37 million related to the 10.4% non-controlling interest in Kenvue from the time of the initial public offering on May 8, 2023 through the end of the fiscal second quarter

*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. (JJDC), changes in the fair value of securities, gains and losses on divestitures, gains and losses on sale of assets, certain transactional currency gains and losses, acquisition-related costs, litigation accruals and settlements, investment (income)/loss related to employee benefit plans, as well as royalty income.


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EARNINGS BEFORE PROVISION FOR TAXES BY SEGMENT

Income before tax by segment of business for the fiscal six months were as follows:
Income Before TaxSegment SalesPercent of Segment Sales Income Before TaxSegment SalesPercent of Segment Sales
(Dollars in Millions)(Dollars in Millions)July 3, 2022July 4, 2021July 3, 2022July 4, 2021July 3, 2022July 4, 2021(Dollars in Millions)July 2, 2023July 3, 2022July 2, 2023July 3, 2022July 2, 2023July 3, 2022
Consumer HealthConsumer Health$1,470 $1,708 $7,391 $7,495 19.9 %22.8 %Consumer Health$1,636 $1,470 $7,863 $7,391 20.8 %19.9 %
PharmaceuticalPharmaceutical8,344 9,463 26,186 24,581 31.9 38.5 Pharmaceutical9,306 8,344 27,144 26,186 34.3 31.9 
MedTechMedTech2,618 3,375 13,869 13,557 18.9 24.9 MedTech3,144 2,618 15,269 13,869 20.6 18.9 
Segment earnings before taxSegment earnings before tax12,432 14,546 47,446 45,633 26.2 31.9 Segment earnings before tax14,086 12,432 50,276 47,446 28.0 26.2 
Less: Expenses not allocated to segments(1)
Less: Expenses not allocated to segments(1)
360 455   
Less: Expenses not allocated to segments(1)
7,479 360   
Less: Consumer Health separation costsLess: Consumer Health separation costs370 — Less: Consumer Health separation costs582 370 
Worldwide income before taxWorldwide income before tax$11,702 $14,091 $47,446 $45,633 24.7 %30.9 %Worldwide income before tax$6,025 $11,702 $50,276 $47,446 12.0 %24.7 %

(1)Amounts not allocated to segments include interest (income) expense and general corporate (income) expense. The fiscal six months of 2023 includes an approximately $7 billion incremental charge primarily related to the talc settlement proposal.

Consumer Health Segment
The Consumer Health segment income before tax as a percent of sales in the fiscal six months of 20222023 was 19.9%20.8% versus 22.8%19.9% for the same period a year ago. The declineincrease in the income before tax as a percent of sales in the fiscal six months of 20222023 as compared to the prior year was primarily driven by the following:
Commodity inflationPricing actions
partially offset by
Supply chain benefitsCommodity inflation
Increased Kenvue standalone start-up costs

Pharmaceutical Segment
The Pharmaceutical segment income before tax as a percent of sales in the fiscal six months of 20222023 was 31.9%34.3% versus 38.5%31.9% for the same period a year ago. The declineincrease in the income before tax as a percent of sales for the fiscal six months of 20222023 as compared to the prior year was primarily driven by the following:
An IPR&D charge of $0.6 billion in 2022 related to bermekimab (JnJ-77474462), an investigational drug for the treatment of AD and Hidradenitis Suppurativa (HS)
Divestiture gains of $0.6 billion in 2021, primarily related to divestiture gains of two pharmaceutical brands outside the U.S.
Net mark-to-market loss related to the changeFavorable changes in the fair value of securities ($0.5in 2023 of $0.4 billion loss in 2022 vs. $0.1 billion gain in 2021)
COVID-19 Vaccine supply network related costs of $0.2 billion inas compared to 2022
Increased Research & Development investment for general portfolio progressionLeveraging in selling, marketing and administrative expenses
Portfolio prioritization
partially offset by
Favorable product mixOne-time COVID-19 Vaccine related exit costs of $0.6 billion in 2023 as compared to $0.3 billion in 2022
Lower intangible asset amortization expense ($1.5Restructuring charges of $0.3 billion in 2022 vs. $1.72023
Acquired in-process research & development costs of $0.2 billion in 2021)

MedTech Segment
The MedTech segment income before tax as a percent of sales in the fiscal six months of 20222023 was 18.9%20.6% versus 24.9%18.9% for the same period a year ago. The declineincrease in the income before tax as a percent of sales for the fiscal six months of 20222023 was primarily driven by the following:
Litigation relatedNet favorable litigation matters of $0.2 billion in 2023 as compared to expense of $0.3 billion in 2022 vs. income of $0.1 billion in 2021
Inflation and unfavorable product mixNo Restructuring charges in 2023 versus $0.2 billion in 2022
Increased investmentLeveraging in Research & Developmentselling and marketing expenses
partially offset by
Higher amortization expense of $0.3 billion in 2023 related to Abiomed

An IPR&D charge in 2023 of approximately $0.1 billion related to the Pulsar Vascular acquisition

Acquisition costs related to Abiomed of $0.1 billion


Commodity inflation in 2023



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s


Income before tax by segment of business for the fiscal second quarters were as follows:
Income Before TaxSegment SalesPercent of Segment Sales Income Before TaxSegment SalesPercent of Segment Sales
(Dollars in Millions)(Dollars in Millions)July 3, 2022July 4, 2021July 3, 2022July 4, 2021July 3, 2022July 4, 2021(Dollars in Millions)July 2, 2023July 3, 2022July 2, 2023July 3, 2022July 2, 2023July 3, 2022
Consumer HealthConsumer Health$784 $866 $3,805 $3,854 20.6 %22.5 %Consumer Health$860 $784 $4,011 $3,805 21.4 %20.6 %
PharmaceuticalPharmaceutical4,420 4,294 13,317 12,480 33.2 34.4 Pharmaceutical4,862 4,420 13,731 13,317 35.4 33.2 
MedTechMedTech1,141 1,746 6,898 6,978 16.5 25.0 MedTech1,699 1,141 7,788 6,898 21.8 16.5 
Segment earnings before taxSegment earnings before tax6,345 6,906 24,020 23,312 26.4 29.6 Segment earnings before tax7,421 6,345 25,530 24,020 29.1 26.4 
Less: Expenses not allocated to segments (1)
Less: Expenses not allocated to segments (1)
237 244   
Less: Expenses not allocated to segments(1)
377 237   
Less: Consumer Health separation costsLess: Consumer Health separation costs268 — Less: Consumer Health separation costs282 268 
Worldwide income before taxWorldwide income before tax$5,840 $6,662 $24,020 $23,312 24.3 %28.6 %Worldwide income before tax$6,762 $5,840 $25,530 $24,020 26.5 %24.3 %
(1)Amounts not allocated to segments include interest (income) expense, certain litigation expenses and general corporate (income) expense.

Consumer Health Segment
The Consumer Health segment income before tax as a percent of sales in the fiscal second quarter of 20222023 was 20.6%21.4% versus 22.5%20.6% for the same period a year ago. The decreaseincrease in the income before tax as a percent of sales in the fiscal second quarter of 20222023 as compared to the prior year was primarily driven by the following:
Commodity inflationPricing actions
Supply chain efficiencies
partially offset by
Supply chain benefitsCommodity inflation
Increased Kenvue standalone start-up costs

Pharmaceutical Segment
The Pharmaceutical segment income before tax as a percent of sales in the fiscal second quarter of 20222023 was 33.2%35.4% versus 34.4%33.2% for the same period a year ago. The decreaseincrease in the income before tax as a percent of sales for the fiscal second quarter of 2021 as compared to the prior year was primarily driven by the following:
Net mark-to-market lossFavorable litigation related to the changeitems of $0.1 billion in 2023
Favorable changes in the fair value of securities ($0.1in 2023 of $0.1 billion loss inas compared to 2022 vs. $0.2 billion gain in 2021)
One-time COVID-19 Vaccine supply network related exit costs of $0.2 billion in 2023 as compared to $0.3 billion in 2022
Increased Research & Development investment for general portfolio progressionFavorable mix
Leveraging in selling, marketing and administrative expenses
Portfolio prioritization
partially offset by
Lower intangible asset amortization expense ($0.7Restructuring charges of $0.1 billion in 2022 vs. $0.8 billion in 2021)2023
Brand marketing expense leveraging
Favorable product mixAcquired in-process research & development costs of $0.2 billion
MedTech Segment
The MedTech segment income before tax as a percent of sales in the fiscal second quarter of 20222023 was 16.5%21.8% versus 25.0%16.5% for the same period a year ago. The decreaseincrease in the income before tax as a percent of sales for the fiscal second quarter was primarily driven by the following:
Litigation relatedNet favorable litigation matters of $0.2 billion in 2023 as compared to expense of $0.3 billion in 2022 vs. income
No Restructuring charges in 2023 versus $0.1 billion in 2022
Leveraging in selling, marketing and administrative expenses
partially offset by
Higher amortization expense of $0.1 billion in 20212023 related to Abiomed
Inflation and unfavorable product mix
Increased investmentCommodity inflation in Research & Development2023
Restructuring

In the fiscal first and second quarterquarters of 2018,2023, the Company announced plans to implement actions acrosscompleted a prioritization of its Global Supply Chain that are intended to enableresearch and development (R&D) investment within the CompanyPharmaceutical segment to focus resourceson the most promising medicines with the greatest benefit to patients. This resulted in the exit of certain programs within therapeutic areas. The R&D program exits are primarily in infectious diseases and increase investments in critical capabilities, technologiesvaccines including the discontinuation of its respiratory syncytial virus (RSV) adult vaccine program, hepatitis and solutions necessary to manufacture and supply its product portfolio of the future, enhance agility and drive growth. The Company expects these supply chain actions will include expanding its use of strategic collaborations, and bolstering its initiatives to reduce complexity, improving cost-competitiveness, enhancing capabilities and optimizing its network. Discussions regarding specific future actions are ongoing and are subject to all relevant consultation requirements before they are finalized. In total, the Company expects these actions to generate approximately $0.6 to $0.8 billion in annual pre-tax cost savings that will be substantially delivered by the end of 2022. The Company expects to record pre-tax
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HIV development. The pre-tax restructuring chargescharge of approximately $2.1 to $2.3$0.1 billion byand $0.3 billion in the completionfiscal second quarter and fiscal six months of 2023, respectively, includes the termination of partnered and non-partnered program costs and asset impairments. The Company recorded a pre-tax charge of $0.1 billion in December 2022. Inthe fiscal second quarter and $0.2 billion in the first fiscal six months of 2022, the Company recordedrelated to a net pre-tax chargerestructuring program of $200 million, which is included onits Global Supply Chain. The Global Supply Chain program was announced in the following lines of the Consolidated Statement of Earnings, $155 million in restructuring, $33 million in cost of products sold and $12 million in other (income) expense, net. In the first fiscal six months of 2021, the Company recorded a pre-tax charge of $212 million, which is included on the following lines of the Consolidated Statement of Earnings, $109 million in restructuring, $47 million in cost of products sold and $56 million in other (income) expense, net. In the fiscal second quarter of 2022, the Company recorded a net pre-tax charge of $128 million, which is included on the following lines of the Consolidated Statement of Earnings, $85 million2018 and was completed in restructuring, $17 million in cost of products sold and $26 million in other (income) expense, net. In the fiscal secondfourth quarter of 2021, the Company recorded a pre-tax charge of $108 million, which is included on the following lines of the Consolidated Statement of Earnings, $56 million in restructuring, $20 million in cost of products sold and $32 million in other (income) expense, net. Restructuring charges of approximately $2.0 billion have been recorded since the restructuring was announced.2022.

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 rate for the first fiscal six months of 20222023 was 15.8% in 2023 and 14.9% in 2022.

On December 15, 2022, the European Union (EU) Member States formally adopted the EU’s Pillar Two Directive, which generally provides for a minimum effective tax rate of 15%, as established by the Organization for Economic Co-operation and Development (OECD) Pillar Two Framework that was supported by over 130 countries worldwide. The EU’s Pillar Two Directive effective dates are January 1, 2024, and January 1, 2025, for different aspects of the directive. On July 17, 2023, the OECD published Administrative Guidance proposing certain safe harbor rules that effectively extend certain effective dates to January 1, 2027. EU Member States will still need to adopt the OECD Administrative Guidance in their local Pillar Two legislation for such safe harbor rules to apply. A significant number of other countries are also considering implementing similar legislation. The Company is continuing to evaluate the potential impact on future periods of the Pillar Two Framework, pending legislative adoption by additional individual countries, including those within the European Union.

On July 21, 2023, the IRS issued Notice 2023-55 which provides guidance to taxpayers in determining whether a foreign tax is eligible for a U.S. foreign tax credit for tax years 2022 and 11.5% in 2021. Subsequent to July 3, 2022, as part2023, specifically delaying until 2024 the application of the planned separationunfavorable foreign tax credit regulations that were originally issued late last year. As a result of the Company’s Consumer Health businessthis new guidance, the Company has recognizedconcluded that it is applicable to certain of its tax positions and therefore will record a tax benefit of approximately $0.3$0.5 billion in incremental tax costs due to the reorganization of certain international subsidiaries which will be recorded in the fiscal third quarter. During fiscal year 2022, the Company is expected to incur significant additional international tax costs related to the legal separationquarter of the Consumer Health business.2023.

For discussion related to the fiscal six months of 20222023 provision for taxes refer to Note 5 to the Consolidated Financial Statements.

LIQUIDITY AND CAPITAL RESOURCES

jnj-20220703_g11.jpg549755864161jnj-20220703_g12.jpg549755864166jnj-20220703_g13.jpg

549755864171

Cash Flows

Cash and cash equivalents were $11.0$21.2 billion at the end of the fiscal second quarter of 20222023 as compared with $14.5$14.1 billion at the end of fiscal year 2021.2022. The primary sources and uses of cash that contributed to the $3.5$7.1 billion decreaseincrease were:
(Dollars In Billions)
$14.514.1 Q4 20212022 Cash and cash equivalents balance
9.67.4 net cash generated from operating activities
(6.3)(0.5)net cash used by investing activities
(6.6)0.1 net cash used bygenerated from financing activities
0.1 rounding
(0.2)effect of exchange rate and rounding
$11.021.2 Q2 20222023 Cash and cash equivalents balance

In addition, the Company had $21.6$7.3 billion in marketable securities at the end of the fiscal second quarter of 20222023 and $17.1$9.4 billion at the end of fiscal year 2021.2022.
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Cash flow from operations of $9.6$7.4 billion was the result of:
(Dollars In Billions)
$10.05.1 Net Earningsearnings
2.32.5 non-cash expenses and other adjustments primarily for depreciation and amortization, stock-based compensation and asset write-downs and credit losses and accounts receivable allowances partially offset by the deferred tax provision and net gain on sale of assets/businesses
(2.6)(1.3)an increase in accounts receivable and inventories
(1.2)(1.1)a decrease in accounts payable and accrued liabilities
3.5 (1.1)a decreasean increase in other current and non-current assets
(2.4)3.4 a decreasean increase in other current and non-current liabilities and rounding
(0.1)Rounding
$9.67.4 Cash Flow from operations

InvestingCash flow used by investing activities use of $6.3$0.5 billion of cash was primarily used for:from:
(Dollars In Billions)
(2.0)additions to property, plant and equipment
0.1 proceeds from the disposal of assets/businesses, net
2.2 net sales of investments
(0.8)credit support agreements activity, net and other
$(0.5)Net cash used by investing activities

Cash flow from financing activities of $0.1 billion was primarily from:
(Dollars In Billions)
$(1.5)additions to property, plant and equipment
0.3 proceeds from the disposal of assets/businesses, net
(0.5)acquisitions, net of cash acquired and other
(4.4)net purchases of investments
(0.2)Other
$(6.3)Net cash used for investing activities

Financing activities use of $6.6 billion of cash was primarily used for:
(Dollars In Billions)
$(5.8)(6.0)dividends to shareholders
(2.6)(3.9)repurchase of common stock
(1.9)net repayment of short and long term debt and other
0.87.7 proceeds from stock options exercised/employee withholding tax on stock awards,Kenvue long term debt, net of issuance cost
0.84.2 credit support agreements activity, netproceeds from Kenvue initial public offering
0.2 other and rounding
$(6.6)0.1 Net cash used forfrom financing activities

The Company has access to substantial sources of funds at numerous banks worldwide. In September 2021,2022, the Company secured a new 364-day Credit Facility. Total credit available to the Company approximatesFacility of $10 billion, which expires on September 8, 2022.7, 2023. In November 2022, the Company secured an additional 364-day revolving Credit Facility of $10 billion, which has an expiration of November 21, 2023. Interest charged on borrowings under the credit line agreement is based on either Term Secured Overnight Financing Rate (SOFR) Reference Rate or other applicable market ratesrate as allowed under the terms of the agreement, plus applicable margins. Commitment fees under the agreement are not material.

In March 2023, Kenvue, priced an offering of senior unsecured notes (the Notes) in an aggregate principal amount of $7.75 billion (See Note 4 to the Consolidated Financial Statements for additional details). The Notes were initially fully and unconditionally guaranteed (the Guarantees) on a senior unsecured basis by the Company. The Guarantees terminated on April 5, 2023, upon completion of the Consumer Health Business transfer.

Further, in March 2023, Kenvue entered into a credit agreement providing for a five-year senior unsecured revolving credit facility (the Revolving Credit Facility) in an aggregate principal amount of $4.0 billion to be made available in U.S. dollars and Euros. The Revolving Credit Facility contains representations and warranties, covenants and events of default that are customary for this type of financing, including covenants restricting the incurrence of liens and the entry into certain merger transactions. In addition, Kenvue entered into a commercial paper program (the Commercial Paper Program) of up to $4.0
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billion in aggregate principal amount of commercial paper under the Commercial Paper Program. The Commercial Paper Program contains representations and warranties, covenants and default that are customary for this type of financing.

On May 8, 2023, Kenvue completed an initial public offering (the IPO) of 198,734,444 shares of its common stock, par value $0.01 per share (the “Kenvue Common Stock”), including the underwriters’ full exercise of their option to purchase 25,921,884 shares to cover over-allotments, at an initial public offering price of $22.00 per share for net proceeds of $4.2 billion. Kenvue shares began trading on the New York Stock Exchange under the symbol “KVUE”. Additionally, on May 8,2023, as partial consideration for the transfer of the Consumer Health business, Kenvue paid $13.2 billion to Johnson & Johnson from the net proceeds of the initial public offering and debt financing transactions (approximately $7.7 billion of unsecured notes and $1.2 billion of commercial paper) in connection with the separation. The excess of the net proceeds from the IPO over the net book value of the Johnson & Johnson divested interest was 2.5 billion and was recorded in additional paid-in capital.

As of the closing of the IPO, Johnson & Johnson owns 1,716,160,000 shares of Kenvue Common Stock, or approximately 89.6% of the total outstanding shares of Kenvue Common Stock, and continues to consolidate the financial results of Kenvue. As of July 3, 2022,2, 2023, the non-controlling interest of $1.3 billion associated with Kenvue is reflected in equity attributable to non-controlling interests in the consolidated balance sheet. Other (income) expense, net on the consolidated statement of earnings for the fiscal second quarter and fiscal six months ended July 2, 2023, includes $37 million related to the 10.4% non-controlling interest in Kenvue from the time of the initial public offering on May 8, 2023 through the end of the fiscal second quarter.

Subsequent to the fiscal second quarter on July 24, 2023, the Company announced its intention to split-off at least 80.1% of the shares of Kenvue through an exchange offer. Through the planned exchange offer, Johnson & Johnson shareholders can exchange all, some or none of their shares of Johnson & Johnson Common Stock for shares of Kenvue Common Stock, subject to the terms of the offer. (See Note 12 to the Consolidated Financial Statements for additional details). The shares of Johnson & Johnson Common Stock acquired by the Company in the exchange offer will be recorded as an acquisition of treasury stock at a cost equal to the market value of the shares of Johnson & Johnson Common Stock accepted in the exchange offer at its expiration. Any difference between the net book value of Kenvue attributable to Johnson & Johnson and the market value of the shares of Johnson & Johnson Common Stock acquired at that date will be recognized by the Company as a gain on disposal of discontinued operations net of any direct and incremental expenses of the exchange offer on the disposal of its Kenvue Common Stock. Upon completion of the exchange offer, and assuming the Company no longer has a controlling financial interest in Kenvue, Kenvue’s historical results will be shown in the Company's financial statements as discontinued operations, and, in subsequent periods, the Company's financial statements will no longer reflect the assets, liabilities, results of operations or cash flows attributable to Kenvue.

As of July 2, 2023, the Company's cash, cash equivalents and marketable securities was approximately $32.6$28.5 billion and had approximately $32.6$45.6 billion of notes payable and long-term debt for a net neutral cashdebt position of $17.1 billion as compared to the prior year net debt position of $8.2 billion. Considering recent market conditions and the on-going COVID-19 crisis, the Company has re-evaluated its operating cash flows and liquidity profile and does not foresee any significant incremental risk.neutral position. 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, including the Company's approximate $0.9 billion in contractual supply commitments associated with its development of the COVID-19 vaccine, theCompany’s remaining balance to be paid on the agreement to settle opioid litigation for approximately $4.2$2.2 billion and the establishment of the $2.0approximately $9 billion trustreserve (present value) for the talc related liabilitiessettlement proposal (See Note 11 to the Consolidated Financial Statements for additional details). In addition, the Company monitors the global capital markets on an ongoing basis and from time to time may raise capital when market conditions are favorable.
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In the fiscal second quarter of 2022,2023, the Company paid approximately $1.7$4.3 billion to the U.S. Treasury which included $0.8including $1.5 billion related to the current installment due on foreign undistributed earnings as part of the TCJA charge (see Note 1 to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2022)1, 2023), $1.4 billion in pre-payments to resolve certain items previously reserved for and $0.9under examination in its 2013 through 2016 U.S. IRS audit, and $1.4 billion primarily related to the normal estimated payments for the first six months of fiscal 2022.2023.

Subsequent to the fiscal second quarter ended July 3,On September 14, 2022, the Company sold allannounced that its Board of its shares in argenx SE for proceedsDirectors approved a share repurchase program, authorizing the Company to purchase up to $5.0 billion of $0.6 billion.the Company’s Common Stock. As of April 2, 2023, $5.0 billion has been repurchased and the repurchase program was completed.


Dividends

On April 19, 2022,18, 2023, the Board of Directors declared a regular cash dividend of $1.13$1.19 per share, payable on June 7, 20226, 2023, to shareholders of record as of May 24, 2022.23, 2023.

On July 18, 2022,20, 2023, the Board of Directors declared a regular cash dividend of $1.13$1.19 per share, payable on September 6, 20227, 2023, to shareholders of record as of August 23, 2022.28, 2023. The Company expects to continue the practice of paying regular quarterly cash dividends.

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OTHER INFORMATION

New Accounting Pronouncements

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

Economic and Market Factors

COVID-19 considerationsIn July 2023, Janssen Pharmaceuticals, Inc. (Janssen) filed litigation against the U.S. Department of Health and business continuity
The Company has considered various internal and external factors in assessing the potential impact of COVID-19 on its business and financial results based upon information available at this time, as follows:
Operating Model: The Company has a diversified business model across the healthcare industry with flexibility designed into its manufacturing, research and development clinical operations and commercial capabilities.
Supply Chain: The Company continues to leverage its global manufacturing footprint and dual-source capabilities while closely monitoring and maintaining critical inventory at major distribution centers away from high-risk areas to ensure adequate and effective distribution.
Business Continuity: The robust, active business continuity plans across the Company's network have been instrumental in preparing the Company for events like COVID-19 and the ability to meet the majority of patient and consumer needs remains uninterrupted.
Workforce: The Company has put procedures in place to protect its essential workforce in manufacturing, distribution, commercial and research operations while ensuring appropriate remote working protocols have been established for other employees.
Liquidity: The Company's high-quality credit rating allows the Company superior access to the financial capital markets for the foreseeable future.
Domestic and Foreign Legislation: The Company will continue to assess and evaluate the on-going global legislative efforts to combat the COVID-19 impact on economies and the sectors in which it participates. Currently, the recent legislative acts put in place are not expected to have a material impact on the Company’s operations.
In fiscal 2021 and 2020, the Company entered into a series of contract manufacturing arrangements for vaccine production with third party contract manufacturing organizations. These arrangements provide the Company with future supplemental commercial capacity for vaccine production and potentially transferable rights to such production if capacity is not required. In the fiscal second quarter of 2022, amounts paid for services to be deliveredand contractually obligated to be paid to these contract manufacturing organizations of approximately $0.9 billion are reflected in the prepaid expenses and other and the accrued liabilities accounts in the Company's consolidated balance sheet. Additionally, the Company has entered into certain vaccine development cost sharing arrangements with government related organizations.

Based on the global progress on vaccine development and distributionHuman Services as well as the amount of existing global supply,Centers for Medicare and Medicaid Services challenging the Company is modifying its COVID-19 vaccine research programs and manufacturing capacity to levels that meet all customer contractual commitments which will result in incremental costs for the year. The Company continues to evaluate the global demand for the COVID-19 vaccine and its related supply.

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The Company continues to evaluate and monitor both its internal and external supply arrangements. The Company has established a global vaccine supply network, where, in addition to its internal manufacturing site in Leiden, the Netherlands, ten other manufacturing sites have been involved in the productionconstitutionality of the vaccine across different countriesInflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program. The litigation requests a declaration that the IRA violates Janssen’s rights under the First Amendment and continents. The Company doesthe Fifth Amendment to the Constitution and therefore that Janssen is not believe that a disruption relatingsubject to vaccine manufacturing, or the resulting delay would have a material financial impact on the Company’s consolidated financial statements or results.IRA’s mandatory pricing scheme.

Russia-Ukraine War
Although the long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time, the financial impact of the conflict in the fiscal second quarter and fiscal six months of 2022,2023, including accounts receivable or inventory reserves, was not material. As of both the 2021 fiscal year ending January 2, 2022, and the fiscal second quarter ending July 3,2, 2023, and the 2022 fiscal year ending January 1, 2023, the business of the Company’s Ukraine subsidiaries represented less than 1% of the Company’s consolidated assets and revenues. As of both the 2021 fiscal year ending January 2, 2022, and the fiscal second quarter ending July 3,2, 2023, and the 2022 fiscal year ending January 1, 2023, the business of the Company’s Russian subsidiaries represented less than 1% of the Company’s consolidated assets and represented 1% of revenues.

In early March of 2022, the Company took steps to suspend all advertising, enrollment in clinical trials, and any additional investment in Russia. Additionally, at the end of March 2022, the Company made the decision to suspend supply of personal care products in Russia. The Company continuedcontinues to supply its other products throughout the second quarter as patients rely on many of the products for healthcare purposes.

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. The Company has accounted for operations in Venezuela, Argentina and ArgentinaTurkey (beginning in the fiscal second quarter of 2022) as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%. Beginning in the fiscal second quarter of 2022, the Company accounted for operations in Turkey as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%. This did not have a material impact on the Company's results in the period. In the face of increasing costs, the Company strives to maintain its profit margins through cost reduction programs, productivity improvements and periodic price increases.

Governments around the world consider various proposals to make changes to tax laws, which may include increasing or decreasing existing statutory tax rates. In connection with various government initiatives, companies are required to disclose more information to tax authorities on operations around the world, which may lead to greater audit scrutiny of profits earned in other countries. A change in statutory tax rate in any country would result in the revaluation of the Company’s deferred tax assets and liabilities related to that particular jurisdiction in the period in which the new tax law is enacted. This change would result in an expense or benefit recorded to the Company’s Consolidated Statement of Earnings.  The Company closely monitors these proposals as they arise in the countries where it operates. Changes to the statutory tax rate may occur at any time, and any related expense or benefit recorded may be material to the fiscal quarter and year in which the law change is enacted.

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 healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and foregoing healthcare 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 tofaces regular intellectual property rights. Firms have filedchallenges from third parties, including generic and biosimilar manufacturers, seeking to manufacture and market generic and biosimilar versions of key pharmaceutical products prior to the expiration of the applicable patents. These challengers file Abbreviated New Drug Applications or Biosimilar Biological Productabbreviated Biologics License Applications with the FDA 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.patents. In the event the Company is not successful in defending the patent claims challenged in the resulting lawsuits, 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. There is also a risk that one or more competitors could launch a generic or biosimilar version of the product at issue following regulatory approval even though one or more valid patents are in place.

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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 2, 2022.1, 2023.


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. Joaquin Duato, Chief Executive Officer; Chairman, Executive Committee and Joseph J. Wolk, Executive Vice President, Chief Financial Officer, reviewed and participated in this evaluation. Based on this evaluation, Messrs. Duato and Wolk 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 has not experienced any material impact to its internal controls over financial reporting despite the fact that many of its employees are working remotely due to the COVID-19 pandemic. The Company proactively took actions to re-evaluate and refine its financial reporting process through additional monitoring controls to provide reasonable assurance that the financial results are reported accurately and timely. The Company continues to monitor and assess the effectiveness of the design and operation of its disclosure controls and procedures.

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.

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

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

On September 14, 2022, the Company announced that its Board of Directors approved a share repurchase program, authorizing the Company to purchase up to $5.0 billion of the Company's Common Stock. The repurchase program was completed during the fiscal first quarter of 2023.

The following table provides information with respect to Common Stock purchases by the Company during the fiscal second quarter of 2022.2023. Common stock purchases on the open market are made as part of a systematic plan to meet the needs of the Company's compensation programs. The repurchases below also include the stock-for-stock option exercises that settled in the fiscal second quarter.
Fiscal Month Period
Total Number
of Shares Purchased(1)
Avg. Price
Per Share
Total Number of Shares Purchased as Part of Publicly Announced Plans or ProgramsMaximum Number of Shares that May Yet Be Purchased Under the Plans or Programs
April 4, 2022 through May 1, 20223,005,708 183.98 
May 2, 2022 through May 29, 20221,313,888 178.47 
May 30, 2022 through July 3, 20221,035,400 179.80 
Total5,354,996 
Fiscal Month 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
April 3, 2023 through April 30, 20231,011,500 162.35 — 
May 1, 2023 through May 28, 2023383,500 161.73 — 
May 29, 2023 through July 2, 2023962,825 160.35 — 
Total2,357,825 161.44 — 

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(1)     During the fiscal second quarter of 2022,2023, the Company repurchased an aggregate of 5,354,9962,357,825 shares of Johnson & Johnson Common Stock in open-market transactions, all of which were purchased pursuant as part of a systematic plan to meet the needs of the Company’s compensation programs.
(2)    As of April 2, 2023, an aggregate of 30,546,218 shares were purchased for a total of $5.0 billion since the inception of the repurchase program announced on September 14, 2022.


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Item 6 — EXHIBITS

Exhibit 31.1 Certification of Chief Executive Officer 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 31.2 Certification of Chief Financial Officer 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 Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 — Furnished with this document.

Exhibit 32.2 Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 — Furnished with this document.

Exhibit 101:
EX-101.INSInstance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
EX-101.SCHInline XBRL Taxonomy Extension Schema
EX-101.CALInline XBRL Taxonomy Extension Calculation Linkbase
EX-101.LABInline XBRL Taxonomy Extension Label Linkbase
EX-101.PREInline XBRL Taxonomy Extension Presentation Linkbase
EX-101.DEFInline XBRL Taxonomy Extension Definition Document
Exhibit 104:Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 JOHNSON & JOHNSON
(Registrant) 
Date: July 29, 202231, 2023By /s/ J. J. WOLK
J. J. WOLK
 Executive Vice President, Chief Financial Officer (Principal Financial Officer) 
  
Date: July 29, 202231, 2023By /s/ R. J. DECKER Jr.
 R. J. DECKER Jr.
 Controller (Principal Accounting Officer) 

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