JOHNSON & JOHNSON 10-K

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Index to Audited Consolidated Financial Statements 40 Consolidated Balance Sheets 41 Consolidated Statements of Earnings 42 Consolidated Statements of Comprehensive Income 43 Consolidated Statements of Equity 44 Consolidated Statements of Cash Flows 46 Notes to Consolidated Financial Statements 103 Report of Independent Registered Public Accounting Firm (PCAOB ID 238 ) 106 Management’s Report on Internal Control Over Financial Reporting 39 JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS At January 1, 2023 and January 2, 2022 (Dollars in Millions Except Share and Per Share Amounts) (Note 1) 2022 2021 Assets Current assets Cash and cash equivalents (Notes 1 and 2) $ 14,127 14,487 Marketable securities (Notes 1 and 2) 9,392 17,121 Accounts receivable trade, less allowances for doubtful accounts $ 203 (2021, $ 230 ) 16,160 15,283 Inventories (Notes 1 and 3) 12,483 10,387 Prepaid expenses and other receivables 3,132 3,701 Total current assets 55,294 60,979 Property, plant and equipment, net (Notes 1 and 4) 19,803 18,962 Intangible assets, net (Notes 1 and 5) 48,325 46,392 Goodwill (Notes 1 and 5) 45,231 35,246 Deferred taxes on income (Note 8) 9,123 10,223 Other assets 9,602 10,216 Total assets $ 187,378 182,018 Liabilities and Shareholders’ Equity Current liabilities Loans and notes payable (Note 7) $ 12,771 3,766 Accounts payable 11,703 11,055 Accrued liabilities 11,456 13,612 Accrued rebates, returns and promotions 14,417 12,095 Accrued compensation and employee related obligations 3,328 3,586 Accrued taxes on income (Note 8) 2,127 1,112 Total current liabilities 55,802 45,226 Long-term debt (Note 7) 26,888 29,985 Deferred taxes on income (Note 8) 6,374 7,487 Employee related obligations (Notes 9 and 10) 6,767 8,898 Long-term taxes payable (Note 1) 4,306 5,713 Other liabilities 10,437 10,686 Total liabilities 110,574 107,995 Commitments and Contingencies (Note 19) Shareholders’ equity Preferred stock — without par value (authorized and unissued 2,000,000 shares) — — Common stock — par value $ 1.00 per share (Note 12) (authorized 4,320,000,000 shares; issued 3,119,843,000 shares) 3,120 3,120 Accumulated other comprehensive income (loss) (Note 13) ( 12,967 ) ( 13,058 ) Retained earnings 128,345 123,060 118,498 113,122 Less: common stock held in treasury, at cost (Note 12) ( 506,246,000 shares and 490,878,000 shares) 41,694 39,099 Total shareholders’ equity 76,804 74,023 Total liabilities and shareholders’ equity $ 187,378 182,018 See Notes to Consolidated Financial Statements 40 JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF EARNINGS (Dollars and Shares in Millions Except Per Share Amounts) (Note 1) 2022 2021 2020 Sales to customers $ 94,943 93,775 82,584 Cost of products sold 31,089 29,855 28,427 Gross profit 63,854 63,920 54,157 Selling, marketing and administrative expenses 24,765 24,659 22,084 Research and development expense 14,603 14,714 12,159 In-process research and development (Note 5) 783 900 181 Interest income ( 490 ) ( 53 ) ( 111 ) Interest expense, net of portion capitalized (Note 4) 276 183 201 Other (income) expense, net 1,871 489 2,899 Restructuring (Note 20) 321 252 247 Earnings before provision for taxes on income 21,725 22,776 16,497 Provision for taxes on income (Note 8) 3,784 1,898 1,783 Net earnings $ 17,941 20,878 14,714 Net earnings per share (Notes 1 and 15) Basic $ 6.83 7.93 5.59 Diluted $ 6.73 7.81 5.51 Average shares outstanding (Notes 1 and 15) Basic 2,625.2 2,632.1 2,632.8 Diluted 2,663.9 2,674.0 2,670.7 See Notes to Consolidated Financial Statements 41 JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (Dollars in Millions) (Note 1) 2022 2021 2020 Net earnings $ 17,941 20,878 14,714 Other comprehensive income (loss), net of tax Foreign currency translation ( 1,796 ) ( 1,079 ) ( 233 ) Securities: Unrealized holding gain (loss) arising during period ( 24 ) ( 4 ) 1 Reclassifications to earnings — — — Net change ( 24 ) ( 4 ) 1 Employee benefit plans: Prior service credit (cost), net of amortization ( 160 ) ( 169 ) 1,298 Gain (loss), net of amortization 1,854 4,318 ( 1,135 ) Effect of exchange rates 111 106 ( 229 ) Net change 1,805 4,255 ( 66 ) Derivatives & hedges: Unrealized gain (loss) arising during period 454 ( 199 ) 1,000 Reclassifications to earnings ( 348 ) ( 789 ) ( 53 ) Net change 106 ( 988 ) 947 Other comprehensive income (loss) 91 2,184 649 Comprehensive income $ 18,032 23,062 15,363 The tax effects in other comprehensive income for the fiscal years 2022, 2021 and 2020 respectively: Foreign Currency Translation; $ 460 million, $ 346 million and $ 536 million; Securities: $ 6 million and $ 1 million in 2022 and 2021, Employee Benefit Plans: $ 461 million, $ 1,198 million and $ 21 million, Derivatives & Hedges: $ 30 million, $ 263 million and $ 252 million. See Notes to Consolidated Financial Statements 42 JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF EQUITY (Dollars in Millions) (Note 1) Total Retained Earnings Accumulated Other Comprehensive Income (Loss) Common Stock Issued Amount Treasury Stock Amount Balance, December 29, 2019 $ 59,471 110,659 ( 15,891 ) 3,120 ( 38,417 ) Net earnings 14,714 14,714 Cash dividends paid ($ 3.98 per share) ( 10,481 ) ( 10,481 ) Employee compensation and stock option plans 2,217 ( 931 ) 3,148 Repurchase of common stock ( 3,221 ) ( 3,221 ) Other ( 71 ) ( 71 ) Other comprehensive income (loss), net of tax 649 649 Balance, January 3, 2021 63,278 113,890 ( 15,242 ) 3,120 ( 38,490 ) Net earnings 20,878 20,878 Cash dividends paid ($ 4.19 per share) ( 11,032 ) ( 11,032 ) Employee compensation and stock option plans 2,171 ( 676 ) 2,847 Repurchase of common stock ( 3,456 ) ( 3,456 ) Other comprehensive income (loss), net of tax 2,184 2,184 Balance, January 2, 2022 74,023 123,060 ( 13,058 ) 3,120 ( 39,099 ) Net earnings 17,941 17,941 Cash dividends paid ($ 4.45 per share) ( 11,682 ) ( 11,682 ) Employee compensation and stock option plans 2,466 ( 974 ) 3,440 Repurchase of common stock ( 6,035 ) ( 6,035 ) Other comprehensive income (loss), net of tax 91 91 Balance, January 1, 2023 $ 76,804 128,345 ( 12,967 ) 3,120 ( 41,694 ) See Notes to Consolidated Financial Statements 43 JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (Dollars in Millions) (Note 1) 2022 2021 2020 Cash flows from operating activities Net earnings $ 17,941 20,878 14,714 Adjustments to reconcile net earnings to cash flows from operating activities: Depreciation and amortization of property and intangibles 6,970 7,390 7,231 Stock based compensation 1,138 1,135 1,005 Asset write-downs 1,216 989 233 Contingent consideration reversal — — ( 1,148 ) Net gain on sale of assets/businesses ( 380 ) ( 617 ) ( 111 ) Deferred tax provision ( 1,663 ) ( 2,079 ) ( 1,141 ) Credit losses and accounts receivable allowances ( 17 ) ( 48 ) 63 Changes in assets and liabilities, net of effects from acquisitions and divestitures: (Increase)/Decrease in accounts receivable ( 1,290 ) ( 2,402 ) 774 Increase in inventories ( 2,527 ) ( 1,248 ) ( 265 ) Increase in accounts payable and accrued liabilities 1,098 2,437 5,141 Decrease/(Increase) in other current and non-current assets 687 ( 1,964 ) ( 3,704 ) (Decrease)/Increase in other current and non-current liabilities ( 1,979 ) ( 1,061 ) 744 Net cash flows from operating activities 21,194 23,410 23,536 Cash flows from investing activities Additions to property, plant and equipment ( 4,009 ) ( 3,652 ) ( 3,347 ) Proceeds from the disposal of assets/businesses, net 543 711 305 Acquisitions, net of cash acquired (Note 18) ( 17,652 ) ( 60 ) ( 7,323 ) Purchases of investments ( 32,384 ) ( 30,394 ) ( 21,089 ) Sales of investments 41,609 25,006 12,137 Credit support agreements activity, net ( 249 ) 214 ( 987 ) Other (primarily licenses and milestones) ( 229 ) ( 508 ) ( 521 ) Net cash used by investing activities ( 12,371 ) ( 8,683 ) ( 20,825 ) Cash flows from financing activities Dividends to shareholders ( 11,682 ) ( 11,032 ) ( 10,481 ) Repurchase of common stock ( 6,035 ) ( 3,456 ) ( 3,221 ) Proceeds from short-term debt 16,134 1,997 3,391 Repayment of short-term debt ( 6,550 ) ( 1,190 ) ( 2,663 ) Proceeds from long-term debt, net of issuance costs 2 5 7,431 Repayment of long-term debt ( 2,134 ) ( 1,802 ) ( 1,064 ) Proceeds from the exercise of stock options/employee withholding tax on stock awards, net 1,329 1,036 1,114 Credit support agreements activity, net ( 28 ) 281 ( 333 ) Other 93 114 ( 294 ) Net cash used by financing activities ( 8,871 ) ( 14,047 ) ( 6,120 ) Effect of exchange rate changes on cash and cash equivalents ( 312 ) ( 178 ) 89 (Decrease)/Increase in cash and cash equivalents ( 360 ) 502 ( 3,320 ) Cash and cash equivalents, beginning of year (Note 1) 14,487 13,985 17,305 Cash and cash equivalents, end of year (Note 1) $ 14,127 14,487 13,985 Supplemental cash flow data Cash paid during the year for: Interest $ 982 990 904 Interest, net of amount capitalized 933 941 841 Income taxes 5,223 4,768 4,619 44 Supplemental schedule of non-cash investing and financing activities Treasury stock issued for employee compensation and stock option plans, net of cash proceeds/ employee withholding tax on stock awards $ 2,114 1,811 1,937 Conversion of debt — — 27 Acquisitions Fair value of assets acquired $ 18,710 61 7,755 Fair value of liabilities assumed ( 1,058 ) ( 1 ) ( 432 ) Net cash paid for acquisitions (Note 18) $ 17,652 60 7,323 See Notes to Consolidated Financial Statements 45 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of Johnson & Johnson and its subsidiaries (the Company). Intercompany accounts and transactions are eliminated. Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures. Description of the Company and Business Segments The Company has approximately 152,700 employees worldwide engaged in the research and development, manufacture and sale of a broad range of products in the healthcare field. The Company conducts business in virtually all countries of the world and its primary focus is on products related to human health and well-being. The Company is organized into three business segments: Consumer Health, Pharmaceutical and MedTech. The Consumer Health segment includes a broad range of products used in the Baby Care, Oral Care, Skin Health/Beauty, Over-the-Counter pharmaceutical, Women’s Health and Wound Care markets. These products are marketed to the general public and sold online (eCommerce) and to retail outlets and distributors throughout the world. The Pharmaceutical segment is focused on the following therapeutic areas, including Immunology, Infectious diseases, Neuroscience, Oncology, Pulmonary Hypertension, and Cardiovascular and Metabolic diseases. Products in this segment are distributed directly to retailers, wholesalers, distributors, hospitals and healthcare professionals for prescription use. The MedTech segment includes a broad portfolio of products used in the Orthopaedic, Surgery, Interventional Solutions (cardiovascular and neurovascular) and Vision fields. These products are distributed to wholesalers, hospitals and retailers, and used principally in the professional fields by physicians, nurses, hospitals, eye care professionals and clinics. In November 2021, the Company announced its intention to separate the Company’s Consumer Health business (Kenvue as the name for the planned New Consumer Health Company), with the intention to create a new, publicly traded company by the end of the fiscal year 2023. New Accounting Standards Recently Adopted Accounting Standards There were no new material accounting standards adopted in fiscal 2022. Recently Issued Accounting Standards Not Adopted as of January 1, 2023 ASU 2022-04: Liabilities-Supplier Finance Programs (Topic 405-50) – Disclosure of Supplier Finance Program Obligations This update requires that a buyer in a supplier finance program disclose additional information about the program to allow financial statement users to better understand the effect of the programs on an entity’s working capital, liquidity, and cash flows. This update will be effective for the Company for fiscal years beginning after December 15, 2022, except for the amendment on roll forward information, which is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted. The Company is currently assessing the impact of this update on its disclosures and will adopt this standard in the fiscal first quarter of 2023. Cash Equivalents 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. The Company has a policy of making investments only with commercial institutions that have at least an investment grade credit rating. The Company invests its cash primarily in government securities and obligations, corporate debt securities, money market funds and reverse repurchase agreements (RRAs). RRAs are collateralized by deposits in the form of Government Securities and Obligations for an amount not less than 102 % of their value. The Company does not record an asset or liability as the Company is not permitted to sell or repledge the associated collateral. The Company has a policy that the collateral has at least an A (or equivalent) credit rating. The Company utilizes a third party custodian to manage the exchange of funds and ensure that collateral received is maintained at 102 % of the value of the RRAs on a daily basis. RRAs with stated maturities of greater than three months from the date of purchase are classified as marketable securities. Investments Investments classified as held to maturity investments are reported at amortized cost and realized gains or losses are reported in earnings. Investments classified as available-for-sale debt securities are carried at estimated fair value with unrealized gains and 46 losses recorded as a component of accumulated other comprehensive income. Available-for-sale securities available for current operations are classified as current assets otherwise, they are classified as long term. Management determines the appropriate classification of its investment in debt and equity securities at the time of purchase and re-evaluates such determination at each balance sheet date. The Company reviews its investments for impairment and adjusts these investments to fair value through earnings, as required. Property, Plant and Equipment and Depreciation Property, plant and equipment are stated at cost. The Company utilizes the straight-line method of depreciation over the estimated useful lives of the assets: Building and building equipment 30 years Land and leasehold improvements 10 - 20 years Machinery and equipment 2 - 13 years The Company capitalizes certain computer software and development costs, included in machinery and equipment, when incurred in connection with developing or obtaining computer software for internal use. Capitalized software costs are amortized over the estimated useful lives of the software, which generally range from 3 to 8 years. The Company reviews long-lived assets to assess recoverability using undiscounted cash flows. When certain events or changes in operating or economic conditions occur, an impairment assessment may be performed on the recoverability of the carrying value of these assets. If the asset is determined to be impaired, the loss is measured based on the difference between the asset’s fair value and its carrying value. If quoted market prices are not available, the Company will estimate fair value using a discounted value of estimated future cash flows. Revenue Recognition The Company recognizes revenue from product sales when obligations under the terms of a contract with the customer are satisfied; generally, this occurs with the transfer of control of the goods to customers. The Company's global payment terms are typically between 30 to 90 days. Provisions for certain rebates, sales incentives, trade promotions, coupons, product returns, discounts to customers and governmental clawback provisions are accounted for as variable consideration and recorded as a reduction in sales. The liability is recognized within Accrued Rebates, Returns, and Promotions on the consolidated balance sheet. Product discounts granted are based on the terms of arrangements with direct, indirect and other market participants, as well as market conditions, including consideration of competitor pricing. Rebates are estimated based on contractual terms, historical experience, patient outcomes, trend analysis and projected market conditions in the various markets served. A significant portion of the liability related to rebates is from the sale of the Company's pharmaceutical products within the U.S., primarily t he Managed Care, Medicare and Medicaid programs, which amounted to $ 9.6 billion and $ 7.7 billion as of January 1, 2023 and January 2, 2022, respectively. The Company evaluates market conditions for products or groups of products primarily through the analysis of wholesaler and other third-party sell-through and market research data, as well as internally generated information. Sales returns are estimated and recorded based on historical sales and returns information. Products that exhibit unusual sales or return patterns due to dating, competition or other marketing matters are specifically investigated and analyzed as part of the accounting for sales return accruals. Sales returns allowances represent a reserve for products that may be returned due to expiration, destruction in the field, or in specific areas, product recall. The sales returns reserve is based on historical return trends by product and by market as a percent to gross sales. In accordance with the Company’s accounting policies, the Company generally issues credit to customers for returned goods. The Company’s sales returns reserves are accounted for in accordance with the U.S. GAAP guidance for revenue recognition when right of return exists. Sales returns reserves are recorded at full sales value. Sales returns in the Consumer Health and Pharmaceutical segments are almost exclusively not resalable. Sales returns for certain franchises in the MedTech segment are typically resalable but are not material. The Company infrequently exchanges products from inventory for returned products. The sales returns reserve for the total Company has been approximately 1.0 % of annual net trade sales during each of the fiscal years 2022, 2021 and 2020. Promotional programs, such as product listing allowances and cooperative advertising arrangements, are recorded in the same period as related sales. Continuing promotional programs include coupons and volume-based sales incentive programs. The redemption cost of consumer coupons is based on historical redemption experience by product and value. Volume-based incentive programs are based on the estimated sales volumes for the incentive period and are recorded as products are sold. These arrangements are evaluated to determine the appropriate amounts to be deferred or recorded as a reduction of revenue. The Company also earns profit-share payments through collaborative arrangements for certain products, which are included in sales to customers. Profit-share payments were less than 2.0 % of the total revenues in fiscal year 2022 and less than 3.0 % of the total revenues in fiscal years 2021 and 2020 and are included in sales to customers. 47 See Note 17 to the Consolidated Financial Statements for further disaggregation of revenue. Shipping and Handling Shipping and handling costs incurred were $ 1.1 billion, $ 1.1 billion and $ 1.0 billion in fiscal years 2022, 2021 and 2020, respectively, and are included in selling, marketing and administrative expense. The amount of revenue received for shipping and handling is less than 1.0 % of sales to customers for all periods presented. Inventories Inventories are stated at the lower of cost or net realizable value determined by the first-in, first-out method. Intangible Assets and Goodwill The authoritative literature on U.S. GAAP requires that goodwill and intangible assets with indefinite lives be assessed annually for impairment. The Company completed its annual impairment test for 2022 in the fiscal fourth quarter. Future impairment tests will be performed annually in the fiscal fourth quarter, or sooner if warranted. Purchased in-process research and development is accounted for as an indefinite lived intangible asset until the underlying project is completed, at which point the intangible asset will be accounted for as a definite lived intangible asset. If warranted the purchased in-process research and development could be written off or partially impaired depending on the underlying program. Intangible assets that have finite useful lives continue to be amortized over their useful lives, and are reviewed for impairment when warranted by economic conditions. See Note 5 for further details on Intangible Assets and Goodwill. Financial Instruments As required by U.S. GAAP, all derivative instruments are recorded on the balance sheet at fair value. Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement determined using assumptions that market participants would use in pricing an asset or liability. The authoritative literature establishes a three-level hierarchy to prioritize the inputs used in measuring fair value, with Level 1 having the highest priority and Level 3 having the lowest. 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 Company documents all relationships between hedged items and derivatives. The overall risk management strategy includes reasons for undertaking hedge transactions and entering into derivatives. The objectives of this strategy are: (1) minimize foreign currency exposure’s impact on the Company’s financial performance; (2) protect the Company’s cash flow from adverse movements in foreign exchange rates; (3) ensure the appropriateness of financial instruments; and (4) manage the enterprise risk associated with financial institutions. See Note 6 for additional information on Financial Instruments. Leases The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Right of Use (ROU) Assets and Lease Liabilities for operating leases are included in Other assets , Accrued liabilities , and Other liabilities on the consolidated balance sheet. The ROU Assets represent the right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Commitments under finance leases are not significant, and are included in Property, plant and equipment, Loans and notes payable, and Long-term debt on the consolidated balance sheet. ROU Assets and Lease Liabilities are recognized at the lease commencement date based on the present value of all minimum lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, when the implicit rate is not readily determinable. Lease terms may include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected the following policy elections on adoption: use of portfolio approach on leases of assets under master service agreements, exclusion of short term leases on the balance sheet, and not separating lease and non-lease components. The Company primarily has operating lease for space, vehicles, manufacturing equipment and data processing equipment. The ROU asset pertaining to operating leases was $ 1.1 billion and $ 0.9 billion in fiscal years 2022 and 2021, respectively. The lease liability was $ 1.3 billion and $ 1.0 billion in fiscal years 2022 and 2021, respectively. The operating lease costs were $ 0.3 billion in fiscal years 2022, 2021 and 2020, respectively. Cash paid for amounts included in the measurement of lease liabilities were $ 0.3 billion in fiscal years 2022, 2021 and 2020, respectively. Product Liability Accruals for product liability claims are recorded, on an undiscounted basis, when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated based on existing information and actuarially determined estimates where applicable. The accruals are adjusted periodically as additional information becomes available. The Company 48 accrues an estimate of the legal defense costs needed to defend each matter when those costs are probable and can be reasonably estimated. To the extent adverse verdicts have been rendered against the Company, the Company does not record an accrual until a loss is determined to be probable and can be reasonably estimated. The Company has self insurance through a wholly-owned captive insurance company. In addition to accruals in the self insurance program, claims that exceed the insurance coverage are accrued when losses are probable and amounts can be reasonably estimated. Research and Development Research and development expenses are expensed as incurred in accordance with ASC 730, Research and Development. Upfront and milestone payments made to third parties in connection with research and development collaborations are expensed as incurred up to the point of regulatory approval. Payments made to third parties subsequent to regulatory approval are capitalized and amortized over the remaining useful life of the related product. Amounts capitalized for such payments are included in other intangibles, net of accumulated amortization. The Company enters into collaborative arrangements, typically with other pharmaceutical or biotechnology companies, to develop and commercialize drug candidates or intellectual property. These arrangements typically involve two (or more) parties who are active participants in the collaboration and are exposed to significant risks and rewards dependent on the commercial success of the activities. These collaborations usually involve various activities by one or more parties, including research and development, marketing and selling and distribution. Often, these collaborations require upfront, milestone and royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development. Amounts due from collaborative partners related to development activities are generally reflected as a reduction of research and development expense because the performance of contract development services is not central to the Company’s operations. In general, the income statement presentation for these collaborations is as follows: Nature/Type of Collaboration Statement of Earnings Presentation Third-party sale of product & profit share payments received Sales to customers Royalties/milestones paid to collaborative partner (post-regulatory approval)* Cost of products sold Royalties received from collaborative partner Other income (expense), net Upfront payments & milestones paid to collaborative partner (pre-regulatory approval) Research and development expense Research and development payments to collaborative partner Research and development expense Research and development payments received from collaborative partner or government entity Reduction of Research and development expense * Milestones are capitalized as intangible assets and amortized to cost of products sold over the useful life. For all years presented, there was no individual project that represented greater than 5 % of the total annual consolidated research and development expense. The Company has a number of products and compounds developed in collaboration with strategic partners including XARELTO, co-developed with Bayer HealthCare AG and IMBRUVICA, developed in collaboration and co-marketed with Pharmacyclics LLC, an AbbVie company. Separately, the Company has a number of licensing arrangements for products and compounds including DARZALEX, licensed from Genmab A/S. Advertising Costs associated with advertising are expensed in the year incurred and are included in selling, marketing and administrative expenses. Advertising expenses worldwide, which comprised television, radio, print media and Internet advertising, were $ 2.1 billion, $ 2.7 billion and $ 2.1 billion in fiscal years 2022, 2021 and 2020, respectively. Income Taxes Income taxes are recorded based on amounts refundable or payable for the current year and include the results of any difference between U.S. GAAP accounting and tax reporting, recorded as deferred tax assets or liabilities. The Company estimates deferred tax assets and liabilities based on enacted tax regulations and rates. Future changes in tax laws and rates may affect recorded deferred tax assets and liabilities in the future. The Company has unrecognized tax benefits for uncertain tax positions. The Company follows U.S. GAAP which prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Management believes that changes in these estimates would not have a material effect on the Company's results of operations, cash flows or financial position. In 2017, the United States enacted into law new U.S. tax legislation, the U.S. Tax Cuts and Jobs Act (TCJA). This law included provisions for a comprehensive overhaul of the corporate income tax code, including a reduction of the statutory corporate tax rate from 35 % to 21 %, effective on January 1, 2018. The TCJA included a provision for a tax on all previously 49 undistributed earnings of U.S. companies located in foreign jurisdictions. Undistributed earnings in the form of cash and cash equivalents were taxed at a rate of 15.5 % and all other earnings were taxed at a rate of 8.0 %. This tax is payable over 8 years and will not accrue interest. These payments began in 2018 and will continue through 2025. The remaining balance at the end of the 2022 was approximately $ 6.1 billion, of which $ 4.6 billion is classified as noncurrent and reflected as “Long-term taxes payable” on the Company’s balance sheet. The balance of this account is related to receivables from tax authorities not expected to be received in the next 12 months. The TCJA also includes provisions for a tax on global intangible low-taxed income (GILTI). GILTI is described as the excess of a U.S. shareholder’s total net foreign income over a deemed return on tangible assets, as provided by the TCJA. In January 2018, the FASB issued guidance that allows companies to elect as an accounting policy whether to record the tax effects of GILTI in the period the tax liability is generated (i.e., “period cost”) or provide for deferred tax assets and liabilities related to basis differences that exist and are expected to effect the amount of GILTI inclusion in future years upon reversal (i.e., “deferred method”). The Company has elected to account for GILTI under the deferred method. The deferred tax amounts recorded are based on the evaluation of temporary differences that are expected to reverse as GILTI is incurred in future periods. The Company has recorded deferred tax liabilities on all undistributed earnings prior to December 31, 2017 from its international subsidiaries. The Company has not provided deferred taxes on the undistributed earnings subsequent to January 1, 2018 from certain international subsidiaries where the earnings are considered to be indefinitely reinvested. The Company intends to continue to reinvest these earnings in those international operations. If the Company decides at a later date to repatriate these earnings to the U.S., the Company would be required to provide for the net tax effects on these amounts. The Company estimates that the tax effect of this repatriation would be approximately $ 0.5 billion under currently enacted tax laws and regulations and at current currency exchange rates. This amount does not include the possible benefit of U.S. foreign tax credits, which may substantially offset this cost. See Note 8 to the Consolidated Financial Statements for further information regarding income taxes. Net Earnings Per Share Basic earnings per share is computed by dividing net earnings available to common shareholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share reflects the potential dilution that could occur if securities were exercised or converted into common stock using the treasury stock method. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported. Estimates are used when accounting for sales discounts, rebates, allowances and incentives, product liabilities, income taxes, withholding taxes, depreciation, amortization, employee benefits, contingencies and intangible asset and liability valuations. Actual results may or may not differ from those estimates. The Company follows the provisions of U.S. GAAP when recording litigation related contingencies. A liability is recorded when a loss is probable and can be reasonably estimated. The best estimate of a loss within a range is accrued; however, if no estimate in the range is better than any other, the minimum amount is accrued. Annual Closing Date The Company follows the concept of a fiscal year, which ends on the Sunday nearest to the end of the month of December. Normally each fiscal year consists of 52 weeks, but every five or six years the fiscal year consists of 53 weeks, and therefore includes additional shipping days, as was the case in fiscal year 2020, and will be the case again in fiscal year 2026. Reclassification Certain prior period amounts have been reclassified to conform to current year presentation. 50 2. Cash, Cash Equivalents and Current Marketable Securities At the end of the fiscal year 2022 and 2021, cash, cash equivalents and current marketable securities were comprised of: (Dollars in Millions) 2022 Carrying Amount Unrecognized Loss Estimated Fair Value Cash & Cash Equivalents Current Marketable Securities Cash $ 4,926 — 4,926 4,926 — U.S. Reverse repurchase agreements 1,419 — 1,419 1,419 — Corporate debt securities (1) 873 ( 1 ) 872 — 873 Money market funds 5,368 — 5,368 5,368 — Time deposits (1) 446 — 446 446 — Subtotal $ 13,032 ( 1 ) 13,031 12,159 873 U.S. Gov't Securities $ 9,959 ( 28 ) 9,931 1,922 8,009 U.S. Gov't Agencies 210 ( 5 ) 205 — 205 Corporate and other debt securities 352 ( 1 ) 351 46 305 Subtotal available for sale (2) $ 10,521 ( 34 ) 10,487 1,968 8,519 Total cash, cash equivalents and current marketable securities $ 14,127 9,392 (Dollars in Millions) 2021 Carrying Amount Unrecognized Loss Estimated Fair Value Cash & Cash Equivalents Current Marketable Securities Cash $ 2,936 — 2,936 2,936 — Non-U.S. Sovereign Securities (1) 1,006 — 1,006 90 916 U.S. Reverse repurchase agreements 1,659 — 1,659 1,659 — Corporate debt securities (1) 3,479 ( 1 ) 3,478 200 3,279 Money market funds 1,901 — 1,901 1,901 — Time deposits (1) 900 — 900 900 — Subtotal 11,881 ( 1 ) 11,880 7,686 4,195 U.S. Gov't Securities $ 19,485 ( 4 ) 19,481 6,785 12,696 Corporate and other debt securities 246 — 246 16 230 Subtotal available for sale (2) $ 19,731 ( 4 ) 19,727 6,801 12,926 Total cash, cash equivalents and current marketable securities $ 14,487 17,121 (1) Held to maturity investments are reported at amortized cost and realized 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. Fair value of government securities and obligations and corporate debt securities were estimated using quoted broker prices and significant other observable inputs. 51 The contractual maturities of the available for sale debt securities at January 1, 2023 are as follows: (Dollars in Millions) Cost Basis Fair Value Due within one year $ 10,430 10,399 Due after one year through five years 91 88 Due after five years through ten years — — Total debt securities $ 10,521 10,487 The Company invests its excess cash in both deposits with major banks throughout the world and other high-quality money market instruments. The Company has a policy of making investments only with commercial institutions that have at least an investment grade credit rating. 3. Inventories At the end of fiscal years 2022 and 2021, inventories were comprised of: (Dollars in Millions) 2022 2021 Raw materials and supplies $ 2,070 1,592 Goods in process 1,700 2,287 Finished goods 8,713 6,508 Total inventories $ 12,483 10,387 4. Property, Plant and Equipment At the end of fiscal years 2022 and 2021, property, plant and equipment at cost and accumulated depreciation were: (Dollars in Millions) 2022 2021 Land and land improvements $ 859 884 Buildings and building equipment 12,989 12,882 Machinery and equipment 30,431 29,774 Construction in progress 4,974 4,139 Total property, plant and equipment, gross $ 49,253 47,679 Less accumulated depreciation 29,450 28,717 Total property, plant and equipment, net $ 19,803 18,962 The Company capitalizes interest expense as part of the cost of construction of facilities and equipment. Interest expense capitalized in fiscal years 2022, 2021 and 2020 was $ 49 million, $ 49 million and $ 63 million, respectively. Depreciation expense, including the amortization of capitalized interest in fiscal years 2022, 2021 and 2020 was $ 2.7 billion, $ 2.7 billion and $ 2.6 billion, respectively. Upon retirement or other disposal of property, plant and equipment, the costs and related amounts of accumulated depreciation or amortization are eliminated from the asset and accumulated depreciation accounts, respectively. The difference, if any, between the net asset value and the proceeds are recorded in earnings. 52 5. Intangible Assets and Goodwill At the end of fiscal years 2022 and 2021, the gross and net amounts of intangible assets were: (Dollars in Millions) 2022 2021 Intangible assets with definite lives: Patents and trademarks — gross $ 44,012 38,572 Less accumulated amortization ( 22,266 ) ( 20,088 ) Patents and trademarks — net (1) $ 21,746 18,484 Customer relationships and other intangibles — gross $ 22,987 23,011 Less accumulated amortization ( 12,901 ) ( 11,925 ) Customer relationships and other intangibles — net (2) $ 10,086 11,086 Intangible assets with indefinite lives: Trademarks $ 6,807 6,985 Purchased in-process research and development (3) 9,686 9,837 Total intangible assets with indefinite lives $ 16,493 16,822 Total intangible assets — net $ 48,325 46,392 (1) The change was primarily related to the intangible assets acquired with the acquisition of Abiomed, Inc. which was partially offset by amortization expense of previously existing intangible assets and the result of currency translation effects. (2) The majority is comprised of customer relationships (3) The reduction was primarily related to an intangible asset impairment charge of approximately $ 0.8 billion recorded in the fiscal year 2022 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) acquired with the acquisition of XBiotech, Inc. in the fiscal year 2020. Additional information regarding efficacy of the AD and HS indications became available which led the Company to the decision to terminate the development of bermekimab for AD and HS. An additional reduction of $ 0.7 billion was driven by Monarch assets that reached commercialization and are now classified as having definite lives. This was partially offset by approximately $ 1.1 billion of IPR&D acquired with Abiomed, Inc. Goodwill as of January 1, 2023 and January 2, 2022, as allocated by segment of business, was as follows: (Dollars in Millions) Consumer Health Pharmaceutical MedTech Total Goodwill at January 3, 2021 $ 10,336 11,009 15,048 36,393 Goodwill, related to acquisitions — — — — Goodwill, related to divestitures ( 9 ) — — ( 9 ) Currency translation/other ( 517 ) ( 429 ) ( 192 ) ( 1,138 ) Goodwill at January 2, 2022 $ 9,810 10,580 14,856 35,246 Goodwill, related to acquisitions — — 11,056 11,056 Goodwill, related to divestitures — — — — Currency translation/other ( 626 ) ( 396 ) ( 49 ) ( 1,071 ) Goodwill at January 1, 2023 $ 9,184 10,184 25,863 45,231 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 assets included in Cost of products sold was $ 4.3 billion, $ 4.7 billion and $ 4.7 billion before tax, for the fiscal years ended January 1, 2023, January 2, 2022 and January 3, 2021, respectively. Intangible asset write-downs are included in Other (income) expense, net. The estimated amortization expense for approved products, before tax, for the five succeeding years is approximately: (Dollars in Millions) 2023 2024 2025 2026 2027 $ 4,600 4,400 3,600 3,000 2,400 See Note 18 to the Consolidated Financial Statements for additional details related to acquisitions and divestitures. 53 6. Fair Value Measurements The Company uses forward foreign exchange contracts to manage its exposure to the variability of cash flows, primarily related to the foreign exchange rate changes of future intercompany products and third-party purchases of materials denominated in a foreign currency. The Company uses cross currency interest rate swaps to manage currency risk primarily related to borrowings. Both types of derivatives are designated as cash flow hedges. Additionally, the Company primarily 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. In the fiscal fourth quarter of 2022, the Company entered into forward starting interest rate swaps with notional amounts totaling $ 2.4 billion in contemplation of hedging interest rate risk associated with long-term financing for the Consumer Health segment separation. These forward starting interest rate swaps are not designated as hedges and therefore, changes in the fair values of these derivatives are recognized in earnings. At the end of the fiscal year 2022, the changes in fair value was not material and therefore not included in the table below. 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 January 1, 2023, the total amount of cash collateral paid by the Company under the CSA amounted to $ 0.8 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 January 1, 2023, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps and interest rate swaps of $ 43.3 billion, $ 36.2 billion and $ 12.4 billion, respectively. As of January 2, 2022, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps and interest rate swaps of $ 45.8 billion, $ 37.4 billion and $ 10.0 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 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 January 1, 2023, the balance of deferred net loss on derivatives included in accumulated other comprehensive income was $ 230 million after-tax. For additional information, see the Consolidated Statements of Comprehensive Income and Note 13. 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 hedges. 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. 54 The following table is a summary of the activity related to derivatives and hedges for the fiscal years ended January 1, 2023 and January 2, 2022, net of tax: January 1, 2023 January 2, 2022 (Dollars in Millions) Sales Cost of Products Sold R&D Expense Interest (Income) Expense Other (Income) Expense Sales Cost of Products Sold R&D Expense Interest (Income) Expense Other (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 $ — — — ( 1,098 ) — — — — ( 109 ) — Derivatives designated as hedging instruments — — — 1,098 — — — — 109 — 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 $ — — — 140 — — — — 174 — Amount of gain or (loss) recognized in AOCI — — — 140 — — — — 174 — Gain (Loss) on cash flow hedging relationship: Forward foreign exchange contracts: Amount of gain or (loss) reclassified from AOCI into income ( 72 ) ( 271 ) 149 — ( 23 ) 17 119 30 — 47 Amount of gain or (loss) recognized in AOCI 5 319 61 — ( 113 ) ( 94 ) ( 557 ) 123 — 146 Cross currency interest rate swaps contracts: Amount of gain or (loss) reclassified from AOCI into income — — — 425 — — — — 402 — Amount of gain or (loss) recognized in AOCI $ — — — 42 — — — — 9 — As of January 1, 2023 and January 2, 2022, 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 included Carrying Amount of the Hedged Liability Cumulative Amount of Fair Value Hedging Adjustment Included in the Carrying Amount of the Hedged Liability (Dollars in Millions) January 1, 2023 January 2, 2022 January 1, 2023 January 2, 2022 Long-term Debt $ 8,665 $ 9,793 $ ( 1,435 ) $ ( 142 ) 55 The following table is the effect of derivatives not designated as hedging instrument for the fiscal years ended January 1, 2023 and January 2, 2022: (Dollars in Millions) Location of Gain /(Loss) Recognized in Income on Derivative Gain/(Loss) Recognized In Income on Derivative Derivatives Not Designated as Hedging Instruments January 1, 2023 January 2, 2022 Foreign Exchange Contracts Other (income) expense $ 94 ( 70 ) The following table is the effect of net investment hedges for the fiscal years ended January 1, 2023 and January 2, 2022: Gain/(Loss) Recognized In Accumulated OCI Location of Gain or (Loss) Reclassified from Accumulated Other Comprehensive Income Into Income Gain/(Loss) Reclassified From Accumulated OCI Into Income (Dollars in Millions) January 1, 2023 January 2, 2022 January 1, 2023 January 2, 2022 Debt $ 197 387 Interest (income) expense — — Cross Currency interest rate swaps $ 766 548 Interest (income) expense — — The Company holds equity investments with readily determinable fair values and equity investments without readily determinable fair values. The Company measures equity investments that do not have readily determinable fair 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 for the fiscal years ended January 1, 2023 and January 2, 2022: January 2, 2022 January 1, 2023 (Dollars in Millions) Carrying Value Changes in Fair Value Reflected in Net Income (1) Sales/ Purchases/Other (2) Carrying Value Non Current Other Assets Equity Investments with readily determinable value $ 1,884 ( 538 ) ( 770 ) 576 576 Equity Investments without readily determinable value $ 500 91 107 698 698 January 3, 2021 January 2, 2022 (Dollars in Millions) Carrying Value Changes in Fair Value Reflected in Net Income (1) Sales/ Purchases/Other (2) Carrying Value Non Current Other Assets Equity Investments with readily determinable value $ 1,481 198 205 1,884 1,884 Equity Investments without readily determinable value $ 738 394 ( 632 ) 500 500 (1) Recorded in Other Income/Expense (2) Other includes impact of currency 56 For the fiscal years ended January 1, 2023 and January 2, 2022 for equity investments without readily determinable market values, $ 51 million and $ 28 million, respectively, of the changes in fair value reflected in net income were the result of impairments. There were offsetting impacts of $ 142 million and $ 422 million, respectively, of changes in the fair value reflected in net income due to changes in observable prices and gains on the disposal of investments. The impact in fiscal year 2021, was driven by the gain on disposal of the Grail investment. In fiscal year 2022, the Company sold all of its equity investments 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 to prioritize the inputs used in measuring fair value. The levels within the hierarchy are described below with Level 1 having the highest priority and Level 3 having the lowest. The fair value of a derivative financial instrument (i.e., forward foreign exchange contracts, interest rate contracts) is the aggregation by currency of all future cash flows discounted to its present value at the prevailing market interest rates and subsequently converted to the U.S. Dollar at the current spot foreign exchange rate. The Company does not believe that fair values of these derivative instruments materially differ from the amounts that could be realized upon settlement or maturity, or that the changes in fair value will have a material effect on the Company’s results of operations, cash flows or financial position. The Company also holds equity investments which are classified as Level 1 and debt securities which are classified as Level 2. The Company 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. 57 The Company’s significant financial assets and liabilities measured at fair value as of the fiscal year ended January 1, 2023 and January 2, 2022 were as follows: 2022 2021 (Dollars in Millions) Level 1 Level 2 Level 3 Total Total (1) Derivatives designated as hedging instruments: Assets: Forward foreign exchange contracts $ — 629 — 629 540 Interest rate contracts (2) — 1,534 — 1,534 796 Total $ — 2,163 — 2,163 1,336 Liabilities: Forward foreign exchange contracts — 511 — 511 881 Interest rate contracts (2) — 2,778 — 2,778 979 Total $ — 3,289 — 3,289 1,860 Derivatives not designated as hedging instruments: Assets: Forward foreign exchange contracts $ — 38 — 38 24 Liabilities: Forward foreign exchange contracts — 68 — 68 28 Available For Sale Other Investments: Equity investments (3) 576 — — 576 1,884 Debt securities (4) — 10,487 — 10,487 19,727 Other Liabilities Contingent Consideration (5) $ 1,120 1,120 533 Gross to Net Derivative Reconciliation 2022 2021 (Dollars in Millions) Total Gross Assets $ 2,201 1,360 Credit Support Agreement (CSA) ( 2,176 ) ( 1,285 ) Total Net Asset 25 75 Total Gross Liabilities 3,357 1,888 Credit Support Agreement (CSA) ( 3,023 ) ( 1,855 ) Total Net Liabilities $ 334 33 Summarized information about changes in liabilities for contingent consideration is as follows: 2022 2021 2020 (Dollars in Millions) Beginning Balance $ 533 633 1,715 Changes in estimated fair value (6) ( 194 ) ( 52 ) ( 1,089 ) Additions (7) 792 — 106 Payments ( 11 ) ( 48 ) ( 99 ) Ending Balance $ 1,120 533 633 (1) 2021 assets and liabilities are all classified as Level 2 with the exception of equity investments of $ 1,884 million, which are classified as Level 1 and contingent consideration of $ 533 million, classified as Level 3. (2) Includes cross currency interest rate swaps and interest rate swaps. 58 (3) Classified as non-current other assets. (4) Classified as cash equivalents and current marketable securities. (5) Includes $ 1,116 million, $ 520 million and $ 594 million, classified as non-current other liabilities as of January 1, 2023, January 2, 2022 and January 3, 2021, respectively. Includes $ 4 million, $ 13 million and $ 39 million classified as current liabilities as of January 1, 2023, January 2, 2022 and January 3, 2021, respectively. (6) Ongoing fair value adjustment amounts are recorded primarily in Research and Development expense. The Company recorded a contingent consideration reversal of $ 1,148 million in 2020 related to the timing of certain developmental milestones associated with the Auris Health acquisition. The reversal of the contingent consideration was recorded in Other income and expense. (7) In fiscal year 2022, the Company recorded $ 704 million of contingent consideration related to Abiomed. See Notes 2 and 7 for financial assets and liabilities held at carrying amount on the Consolidated Balance Sheet. 59 7. Borrowings The components of long-term debt are as follows: (Dollars in Millions) 2022 Effective Rate % 2021 Effective Rate % 0.250 % Notes due 2022 ( 1 B Euro 1.1311 ) (3) $ — — % $ 1,131 (3) 0.26 % 2.25 % Notes due 2022 — — 1,000 2.31 6.73 % Debentures due 2023 250 6.73 250 6.73 3.375 % Notes due 2023 801 3.17 802 3.18 2.05 % Notes due 2023 500 2.09 499 2.09 0.650 % Notes due 2024 ( 750 MM Euro 1.0651 ) (2) /( 750 MM Euro 1.1311 ) (3) 792 (2) 0.68 847 (3) 0.68 5.50 % Notes due 2024 ( 500 MM 1.2037 GBP ) (2) /( 500 MM GBP 1.3485 ) (3) 600 (2) 6.75 672 (3) 6.75 2.625 % Notes due 2025 749 2.63 749 2.63 0.55 % Notes due 2025 918 0.57 983 0.57 2.45 % Notes due 2026 1,996 2.47 1,995 2.47 2.95 % Notes due 2027 877 2.96 978 2.96 0.95 % Notes due 2027 1,394 0.96 1,478 0.96 1.150 % Notes due 2028 ( 750 MM Euro 1.0651 ) (2) /( 750 MM Euro 1.1311 ) (3) 794 (2) 1.21 843 (3) 1.21 2.90 % Notes due 2028 1,496 2.91 1,495 2.91 6.95 % Notes due 2029 298 7.14 298 7.14 1.30 % Notes due 2030 1,607 1.30 1,723 1.30 4.95 % Debentures due 2033 498 4.95 498 4.95 4.375 % Notes due 2033 854 4.24 854 4.24 1.650 % Notes due 2035 ( 1.5 B Euro 1.0651 ) (2) /( 1.5 B Euro 1.1311 ) (3) 1,591 (2) 1.68 1,683 (3) 1.68 3.55 % Notes due 2036 842 3.59 974 3.59 5.95 % Notes due 2037 993 5.99 993 5.99 3.625 % Notes due 2037 1,336 3.64 1,475 3.64 5.85 % Debentures due 2038 697 5.85 696 5.85 3.400 % Notes due 2038 992 3.42 992 3.42 4.50 % Debentures due 2040 540 4.63 540 4.63 2.10 % Notes due 2040 828 2.14 974 2.14 4.85 % Notes due 2041 297 4.89 297 4.89 4.50 % Notes due 2043 496 4.52 496 4.52 3.70 % Notes due 2046 1,976 3.74 1,975 3.74 3.75 % Notes due 2047 812 3.76 971 3.76 3.500 % Notes due 2048 743 3.52 743 3.52 2.250 % Notes due 2050 808 2.29 983 2.29 2.450 % Notes due 2060 1,055 2.49 1,222 2.49 Other 9 — 7 — Subtotal 28,439 (4) 3.04 % (1) 32,116 (4) 2.89 % (1) Less current portion 1,551 2,131 Total long-term debt $ 26,888 $ 29,985 (1) Weighted average effective rate. (2) Translation rate at January 1, 2023. (3) Translation rate at January 2, 2022. 60 (4) The excess of the carrying value over the fair value of debt was $ 1.6 billion at the end of fiscal year 2022 and the excess of the fair value over the carrying value of debt was $ 3.2 billion at the end of fiscal year 2021. Fair value of the long-term debt was estimated using market prices, which were corroborated by quoted broker prices and significant other observable inputs. The Company has access to substantial sources of funds at numerous banks worldwide. In September 2022, the Company secured a new 364-day Credit Facility of $ 10 billion, which expires on September 7, 2023. In November 2022, the Company secured an additional 364-day Credit Facility of $ 10 billion, which expires on November 21, 2023. Interest charged on borrowings under the credit line agreement is based on either the Term SOFR Reference Rate or other applicable market rates as allowed under the terms of the agreement, plus applicable margins. Commitment fees under the agreements are not material. Throughout fiscal years 2022 and 2021, the Company continued to have access to liquidity through the commercial paper market. Short-term borrowings and the current portion of long-term debt amounted to approximately $ 12.8 billion and $ 3.8 billion at the end of fiscal years 2022 and 2021, respectively. The current portion of the long term debt was $ 1.6 billion and $ 2.1 billion in 2022 and 2021, respectively, and the remainder is commercial paper and local borrowing by international subsi diaries. The current debt balance as of January 1, 2023 includes $ 11.2 billion of commercial paper which has a weighted average interest rate of 4.23 % and a weighted average maturity of approximately two months . Aggregate maturities of long-term debt obligations commencing in 2023 are: (Dollars in Millions) 2023 2024 2025 2026 2027 After 2026 $ 1,551 1,392 1,667 1,996 2,271 19,562 8. Income Taxes The provision for taxes on income consists of: (Dollars in Millions) 2022 2021 2020 Currently payable: U.S. taxes $ 2,378 1,525 1,026 International taxes 3,069 2,452 1,898 Total currently payable 5,447 3,977 2,924 Deferred: U.S. taxes ( 2,081 ) 583 ( 76 ) International taxes 418 ( 2,662 ) ( 1,065 ) Total deferred ( 1,663 ) ( 2,079 ) ( 1,141 ) Provision for taxes on income $ 3,784 1,898 1,783 61 A comparison of income tax expense at the U.S. statutory rate of 21 % in fiscal years 2022, 2021 and 2020, to the Company’s effective tax rate is as follows: (Dollars in Millions) 2022 2021 2020 U.S. $ 5,369 6,110 4,312 International 16,356 16,666 12,185 Earnings before taxes on income: $ 21,725 22,776 16,497 Tax rates: U.S. statutory rate 21.0 % 21.0 21.0 International operations (1) ( 4.5 ) ( 16.4 ) ( 9.9 ) Consumer health separation 2.2 — — U.S. taxes on international income (2) ( 1.9 ) 6.7 2.7 Tax benefits from loss on capital assets — ( 1.3 ) ( 1.2 ) Tax benefits on share-based compensation ( 1.3 ) ( 1.0 ) ( 1.5 ) All other (3) 1.9 ( 0.7 ) ( 0.3 ) Effective Rate 17.4 % 8.3 10.8 (1) For all periods presented the Company has subsidiaries operating in Puerto Rico under various tax incentives. International operations reflect the impacts of operations in jurisdictions with statutory tax rates different than the U.S., particularly Ireland, Switzerland and Puerto Rico, which is a favorable impact on the effective tax rate as compared with the U.S. statutory rate. The 2021 amounts include the reorganization of international subsidiaries; the 2020 amounts include the impact of the new tax legislation enactment in Switzerland, both of which are further described below. (2) Includes the impact of the GILTI tax, the Foreign-Derived Intangible Income deduction and other foreign income that is taxable under the U.S. tax code. The 2022 amount includes the impact of certain provisions of the 2017 TCJA that became effective in fiscal 2022. The 2021 amounts include the reorganization of international subsidiaries; the 2020 amounts include the impact of the new tax legislation enactment in Switzerland, both of which are further described below. (3) Certain prior year amounts have been reclassified to conform to current year presentation. The fiscal year 2022 effective tax rate increased 9.1 % as compared to the fiscal year 2021 effective tax rate. As part of the planned separation of the Company’s Consumer Health business, the Company has recognized approximately $ 0.5 billion in net incremental tax costs in fiscal year 2022, which increased the 2022 effective tax rate by approximately 2.2 %. Additionally, the Company recorded certain non-recurring favorable tax items in fiscal year 2021 which resulted in an unfavorable impact to the Company’s fiscal 2022 effective tax rate when compared to the prior fiscal year. These items are described below. The Company’s 2022 tax rate also benefited from certain provisions of the Tax Cuts and Jobs Act of 2017 that became effective in fiscal 2022, the impairment of bermekimab for AD and HS IPR&D (for further information see Note 5 of the 2022 10-K Consolidated Financial Statements) and changes in the fair value of securities in the Company’s investment portfolio, both recorded at the U.S. statutory rate. The fiscal year 2021 tax rate decreased by 2.5 % compared to the fiscal year 2020 tax rate, which was primarily driven by the following items. In fiscal year 2021, the Company reorganized the ownership structure of certain wholly-owned international subsidiaries. As part of this reorganization, the Company increased the tax basis of certain assets to fair value in accordance with applicable local regulations. The net impact of this restructuring was approximately $ 0.6 billion net benefit or 2.7 % benefit to the Company’s annual effective tax rate, comprised of the following items: • approximately $ 2.3 billion of local deferred tax assets to record the remeasurement of the tax basis of these assets to fair value, this benefit has been reflected as “International Operations” on the Company’s effective tax rate reconciliation. • approximately $ 1.7 billion of U.S. deferred tax expense relating to the GILTI deferred tax liability resulting from the remeasurement of these deferred tax assets. This expense has been reflected as “U.S. tax on international income” on the Company’s effective tax rate reconciliation. Also, in the fiscal fourth quarter of 2021, the Company recognized a loss on certain U.S. affiliates related to the previously impaired book value of certain intangibles, which reduced the 2021 tax rate by approximately 1.3 % which is reflected as a “Tax benefits from loss on capital assets” on the effective tax rate reconciliation. Additionally other fiscal 2021 impacts to the rate were primarily driven by litigation and acquisition related items as follows: 62 • the Company accrued additional legal expenses, of approximately $ 1.6 billion for talc at an effective tax rate of 23.5 % and $ 0.8 billion for Risperdal Gynecomastia settlements at an effective tax rate of 16.4 % (See Note 19 to the Consolidated Financial Statements for more details). • the Company recorded a partial IPR&D charge of $ 0.9 billion for the Ottava intangible asset (acquired with the Auris Health acquisition in 2019) at an effective rate of 22.4 %. In fiscal year 2019, Switzerland enacted the Federal Act on Tax Reform and AHV Financing (TRAF) and became effective for fiscal year 2020. The Federal transitional provisions of TRAF allow companies, under certain conditions, to adjust the tax basis in certain assets to fair value (i.e., “step-up”) to be depreciated and amortized resulting in an incremental Swiss tax deduction over the transitional period. TRAF also provides for parameters which enable the Swiss cantons to establish localized tax rates and regulations for companies. The new cantonal tax parameters include favorable tax benefits for patents and additional research and development tax deductions. The cantonal transitional provisions of TRAF allowed companies to elect either 1) tax basis step-up similar to the Federal transition benefit or 2) alternative statutory tax rate for a period not to exceed 5 years. The Company has operations located in various Swiss cantons. During the fiscal year 2020, the final canton where the Company maintains significant operations enacted TRAF legislation. Additionally, the Company received rulings from the Swiss Federal and cantonal tax authorities in the remaining jurisdictions where it has significant operations. These rulings resulted in the Company revising its estimate on the tax basis adjustment (i.e., “step-up”) for its assets and as a result, the Company recorded additional deferred tax benefits in 2020. The Company recognized a net benefit in the fiscal year 2020 for Swiss Tax Reform of approximately $ 0.4 billion or 2.6 % benefit to the Company’s annual effective tax rate, comprised of the following items: • approximately $ 0.3 billion tax benefit relating to the remeasurement of Swiss deferred tax assets and liabilities for the change in the Federal and cantonal tax rates, where enactment occurred in the fiscal year 2020; this benefit has been reflected as “International Operations” on the Company’s effective tax rate reconciliation. • a $ 450 million deferred tax asset related to the estimated value of a Federal tax basis step-up of the Company’s Swiss subsidiaries’ assets as described above; this benefit has been reflected as “International Operations” on the Company’s effective tax rate reconciliation. • approximately $ 0.3 billion of U.S. deferred tax expense relating to the GILTI deferred tax liability resulting from the remeasurement of the Swiss deferred tax assets and liabilities in the fiscal year 2020. This benefit has been reflected as “U.S. tax on international income” on the Company’s effective tax rate reconciliation. The Company does not expect to receive future rulings regarding the transitional provisions of TRAF. Also, in the fiscal year 2020, the Company recognized a capital loss on certain U.S. affiliates related to the previously impaired book value of certain intangibles, which reduced the 2020 tax rate by approximately 1.2 % which is reflected as a “Tax benefits from loss on capital assets” on the effective tax rate reconciliation. In addition, in the fiscal year 2020, the Company had lower income in higher tax jurisdictions, primarily driven by: • the impact of the accrual of litigation costs related to talc for $ 4.0 billion which reduced the U.S. earnings before taxes at an effective tax rate of 23.5 %; • the accrual of additional legal costs, including an additional $ 1.0 billion associated with a revised agreement in principle to settle opioid litigation at an effective tax rate of 21.4 % The Company also reduced the contingent consideration liability related to the Auris Health acquisition in 2019 and reversed some of its unrecognized tax benefits due to the completion of several years of tax examinations in certain jurisdictions during the fiscal year 2020. 63 Temporary differences and carryforwards at the end of fiscal years 2022 and 2021 were as follows: 2022 Deferred Tax 2021 Deferred Tax (1) (Dollars in Millions) Asset Liability Asset Liability Employee related obligations $ 725 1,244 Stock based compensation 687 679 Depreciation of property, plant and equipment ( 858 ) ( 876 ) Goodwill and intangibles ( 4,271 ) (3) ( 2,659 ) (2) R&D capitalized for tax 2,611 1,664 Reserves & liabilities 2,761 2,882 Income reported for tax purposes 2,045 2,566 Net realizable operating loss carryforwards (4) 1,260 1,720 Undistributed foreign earnings 1,565 ( 1,693 ) 1,015 ( 1,461 ) Global intangible low-taxed income ( 3,547 ) ( 4,853 ) Miscellaneous international 1,053 ( 65 ) 870 ( 39 ) Miscellaneous U.S. 476 ( 16 ) Total deferred income taxes $ 13,183 ( 10,434 ) 12,640 ( 9,904 ) (1) Certain prior year amounts have been reclassified to conform to current year presentation. (2) Amount is inclusive of the $ 2.3 billion deferred tax asset established as part of the reorganized ownership structure of certain wholly-owned international subsidiaries, as previously described. (3) Amount is inclusive of the $ 1.8 billion deferred tax liability due to the acquisition of Abiomed. (4) Net of valuation allowances of $ 0.9 billion in both 2022 and 2021. The Company has wholly-owned international subsidiaries that have cumulative net losses. The Company believes that it is more likely than not that these subsidiaries will generate future taxable income sufficient to utilize these deferred tax assets. However, in certain jurisdictions, valuation allowances have been recorded against deferred tax assets for loss carryforwards that are not more likely than not to be realized. The following table summarizes the activity related to unrecognized tax benefits: (Dollars in Millions) 2022 2021 2020 Beginning of year $ 3,323 3,373 3,853 Increases related to current year tax positions 523 242 265 Increases related to prior period tax positions 143 23 668 Decreases related to prior period tax positions ( 148 ) ( 128 ) ( 551 ) Settlements ( 1 ) ( 187 ) ( 839 ) Lapse of statute of limitations ( 11 ) — ( 23 ) End of year $ 3,829 3,323 3,373 The unrecognized tax benefits of $ 3.8 billion at January 1, 2023, if recognized, would affect the Company’s annual effective tax rate. The Company conducts business and files tax returns in numerous countries and currently has tax audits in progress with a number of tax authorities. 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. In the fiscal year 2020, the Company made its final payments for approximately $ 0.7 billion to the U.S. Treasury related to the final settlement of 2010-2012 tax audit liability. In other major jurisdictions where the Company conducts business, the years that remain open to tax audits 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, including in the United States. However, the Company is not able to provide a reasonably reliable estimate of the timing of any other future tax payments or change in uncertain tax positions, if any. The Company classifies liabilities for unrecognized tax benefits and related interest and penalties as long-term liabilities. Interest expense and penalties related to unrecognized tax benefits are classified as income tax expense. The Company recognized after tax interest expense of $ 139 million, $ 44 million and $ 32 million in fiscal years 2022, 2021 and 2020, respectively. The total amount of accrued interest was $ 651 million and $ 512 million in fiscal years 2022 and 2021, respectively. 64 9. Employee Related Obligations At the end of fiscal 2022 and fiscal 2021, employee related obligations recorded on the Consolidated Balance Sheets were: (Dollars in Millions) 2022 2021 Pension benefits $ 2,698 4,088 Postretirement benefits 1,734 2,069 Postemployment benefits 2,832 3,117 Deferred compensation 100 181 Total employee obligations 7,364 9,455 Less current benefits payable 597 557 Employee related obligations — non-current $ 6,767 8,898 Prepaid employee related obligations of $ 4,581 million and $ 4,436 million for 2022 and 2021, respectively, are included in Other assets on the Consolidated Balance Sheets. 10. Pensions and Other Benefit Plans The Company sponsors various retirement and pension plans, including defined benefit, defined contribution and termination indemnity plans, which cover most employees worldwide. The Company also provides post-retirement benefits, primarily healthcare, to all eligible U.S. retired employees and their dependents. Many international employees are covered by government-sponsored programs and the cost to the Company is not significant. In the U.S, non-union pension benefits for employees hired before January 1, 2015 are primarily based on the employee’s compensation during the last five years before retirement and the number of years of service (the Final Average Pay formula). U.S. pension benefits for employees hired after 2014, are calculated using a different formula based on employee compensation over total years of service (the Retirement Value formula). In January 2021, the Company announced that, effective on January 1, 2026, all eligible U.S. non-union employees, regardless of hire date, will earn benefits under the Retirement Value formula. This amendment does not affect the benefits accrued under the Final Average Pay formula for service before January 1, 2026. International subsidiaries have plans under which funds are deposited with trustees, annuities are purchased under group contracts, or reserves are provided. The Company does not fund retiree healthcare benefits in advance and has the right to modify these plans in the future. In 2022 and 2021 the Company used December 31, 2022 and December 31, 2021, respectively, as the measurement date for all U.S. and international retirement and other benefit plans. Net periodic benefit costs for the Company’s defined benefit retirement plans and other benefit plans for 2022, 2021 and 2020 include the following components: Retirement Plans Other Benefit Plans (Dollars in Millions) 2022 2021 2020 2022 2021 2020 Service cost $ 1,327 1,421 1,380 320 309 287 Interest cost 911 770 955 105 81 133 Expected return on plan assets ( 2,757 ) ( 2,645 ) ( 2,461 ) ( 8 ) ( 7 ) ( 7 ) Amortization of prior service cost ( 184 ) ( 181 ) 2 ( 5 ) ( 31 ) ( 31 ) Recognized actuarial losses (gains) 655 1,257 891 121 151 142 Curtailments and settlements 1 1 23 — — — Net periodic benefit cost (credit) $ ( 47 ) 623 790 533 503 524 65 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. Unrecognized gains and losses for the U.S. pension plans are amortized over the average remaining future service for each plan. For plans with no active employees, they are amortized over the average life expectancy. The amortization of gains and losses for the other U.S. benefit plans is determined by using a 10 % corridor of the greater of the market value of assets or the accumulated postretirement benefit obligation. Total unamortized gains and losses in excess of the corridor are amortized over the average remaining future service. Prior service costs/benefits for the U.S. pension plans are amortized over the average remaining future service of plan participants at the time of the plan amendment. Prior service cost/benefit for the other U.S. benefit plans is amortized over the average remaining service to full eligibility age of plan participants at the time of the plan amendment. The following table represents the weighted-average actuarial assumptions: Retirement Plans Other Benefit Plans Worldwide Benefit Plans 2022 2021 2020 2022 2021 2020 Net Periodic Benefit Cost Service cost discount rate 2.46 % 2.14 2.82 2.59 2.09 3.04 Interest cost discount rate 2.80 % 2.34 3.13 2.64 2.33 3.08 Rate of increase in compensation levels 4.02 % 4.01 4.00 4.21 4.25 4.25 Expected long-term rate of return on plan assets 7.25 % 7.71 8.12 Benefit Obligation Discount rate 5.01 % 2.49 2.14 5.42 2.68 2.23 Rate of increase in compensation levels 4.00 % 4.01 4.00 4.21 4.21 4.27 The Company’s discount rates are determined by considering current yield curves representing high quality, long-term fixed income instruments. The resulting discount rates are consistent with the duration of plan liabilities. The Company's methodology in determining service and interest cost uses duration specific spot rates along that yield curve to the plans' liability cash flows. The expected rates of return on plan asset assumptions represent the Company's assessment of long-term returns on diversified investment portfolios globally. The assessment is determined using projections from external financial sources, long-term historical averages, actual returns by asset class and the various asset class allocations by market. The following table displays the assumed healthcare cost trend rates, for all individuals: Healthcare Plans 2022 2021 Healthcare cost trend rate assumed for next year 5.99 % 5.33 % Rate to which the cost trend rate is assumed to decline (ultimate trend) 4.01 % 3.73 % Year the rate reaches the ultimate trend rate 2047 2046 66 The following table sets forth information related to the benefit obligation and the fair value of plan assets at fiscal year-end 2022 and 2021 for the Company’s defined benefit retirement plans and other post-retirement plans: Retirement Plans Other Benefit Plans (Dollars in Millions) 2022 2021 2022 2021 Change in Benefit Obligation Projected benefit obligation — beginning of year $ 41,582 43,300 4,878 5,028 Service cost 1,327 1,421 320 309 Interest cost 911 770 105 81 Plan participant contributions 67 67 — — Amendments 7 5 — — Actuarial (gains) losses (1) ( 12,213 ) ( 2,132 ) ( 704 ) ( 188 ) Divestitures & acquisitions — ( 2 ) — — Curtailments, settlements & restructuring ( 7 ) ( 7 ) — — Benefits paid from plan ( 1,228 ) ( 1,157 ) ( 393 ) ( 348 ) Effect of exchange rates ( 815 ) ( 683 ) ( 9 ) ( 4 ) Projected benefit obligation — end of year $ 29,631 41,582 4,197 4,878 Change in Plan Assets Plan assets at fair value — beginning of year $ 41,930 38,195 102 90 Actual return (loss) on plan assets ( 8,665 ) 4,439 ( 17 ) 17 Company contributions 270 969 386 343 Plan participant contributions 67 67 — — Settlements ( 5 ) ( 7 ) — — Divestitures & acquisitions — ( 2 ) — — Benefits paid from plan assets ( 1,228 ) ( 1,157 ) ( 393 ) ( 348 ) Effect of exchange rates ( 855 ) ( 574 ) — — Plan assets at fair value — end of year $ 31,514 41,930 78 102 Funded status — end of year $ 1,883 348 ( 4,119 ) ( 4,776 ) Amounts Recognized in the Company’s Balance Sheet consist of the following: Non-current assets $ 4,581 4,436 — — Current liabilities ( 132 ) ( 115 ) ( 461 ) ( 438 ) Non-current liabilities ( 2,566 ) ( 3,973 ) ( 3,658 ) ( 4,338 ) Total recognized in the consolidated balance sheet — end of year $ 1,883 348 ( 4,119 ) ( 4,776 ) Amounts Recognized in Accumulated Other Comprehensive Income consist of the following: Net actuarial loss $ 3,948 5,539 239 1,113 Prior service cost (credit) (1) ( 1,417 ) ( 1,610 ) ( 7 ) ( 13 ) Unrecognized net transition obligation — — — — Total before tax effects $ 2,531 3,929 232 1,100 Accumulated Benefit Obligations — end of year $ 28,023 39,049 (1) The actuarial gain for retirement plans in 2022 and 2021 was primarily related to increases in discount rates. 67 Retirement Plans Other Benefit Plans (Dollars in Millions) 2022 2021 2022 2021 Amounts Recognized in Net Periodic Benefit Cost and Other Comprehensive Income Net periodic benefit cost (credit) $ ( 47 ) 623 533 503 Net actuarial (gain) loss ( 793 ) ( 3,927 ) ( 751 ) ( 199 ) Amortization of net actuarial loss ( 655 ) ( 1,257 ) ( 121 ) ( 151 ) Prior service cost (credit) 7 5 — — Amortization of prior service (cost) credit 183 181 5 31 Effect of exchange rates ( 140 ) ( 136 ) ( 1 ) — Total loss/(income) recognized in other comprehensive income, before tax $ ( 1,398 ) ( 5,134 ) ( 868 ) ( 319 ) Total recognized in net periodic benefit cost and other comprehensive income $ ( 1,445 ) ( 4,511 ) ( 335 ) 184 The Company plans to continue to fund its U.S. Qualified Plans to comply with the Pension Protection Act of 2006. International Plans are funded in accordance with local regulations. Additional discretionary contributions are made when deemed appropriate to meet the long-term obligations of the plans. For certain plans, funding is not a common practice, as funding provides no economic benefit. Consequently, the Company has several pension plans that are not funded. In 2022, the Company contributed $ 119 million and $ 151 million to its U.S. and international pension plans, respectively. The following table displays the funded status of the Company's U.S. Qualified & Non-Qualified pension plans and international funded and unfunded pension plans at December 31, 2022 and December 31, 2021, respectively: U.S. Plans International Plans Qualified Plans Non-Qualified Plans Funded Plans Unfunded Plans (Dollars in Millions) 2022 2021 2022 2021 2022 2021 2022 2021 Plan Assets $ 20,937 27,944 — — 10,577 13,986 — — Projected Benefit Obligation 18,394 25,041 1,937 2,703 9,024 13,428 276 410 Accumulated Benefit Obligation 17,696 23,985 1,872 2,479 8,202 12,212 253 373 Over (Under) Funded Status Projected Benefit Obligation $ 2,543 2,903 ( 1,937 ) ( 2,703 ) 1,553 558 ( 276 ) ( 410 ) Accumulated Benefit Obligation 3,241 3,959 ( 1,872 ) ( 2,479 ) 2,375 1,774 ( 253 ) ( 373 ) Plans with accumulated benefit obligations in excess of plan assets have an accumulated benefit obligation, projected benefit obligation and plan assets of $ 2.9 billion, $ 2.9 billion and $ 0.3 billion, respectively, at the end of 2022, and $ 3.9 billion, $ 4.2 billion and $ 0.3 billion, respectively, at the end of 2021. The following table displays the projected future benefit payments from the Company’s retirement and other benefit plans: (Dollars in Millions) 2023 2024 2025 2026 2027 2028-2032 Projected future benefit payments Retirement plans $ 1,445 1,457 1,532 1,609 1,708 10,034 Other benefit plans $ 471 485 433 447 462 2,539 The following table displays the projected future minimum contributions to the unfunded retirement plans. These amounts do not include any discretionary contributions that the Company may elect to make in the future. (Dollars in Millions) 2023 2024 2025 2026 2027 2028-2032 Projected future contributions $ 123 128 136 141 146 816 68 Each pension plan is overseen by a local committee or board that is responsible for the overall administration and investment of the pension plans. In determining investment policies, strategies and goals, each committee or board considers factors including, local pension rules and regulations; local tax regulations; availability of investment vehicles (separate accounts, commingled accounts, insurance funds, etc.); funded status of the plans; ratio of actives to retirees; duration of liabilities; and other relevant factors including: diversification, liquidity of local markets and liquidity of base currency. A majority of the Company’s pension funds are open to new entrants and are expected to be on-going plans. Permitted investments are primarily liquid and/or listed, with little reliance on illiquid and non-traditional investments such as hedge funds. The Company’s retirement plan asset allocation at the end of 2022 and 2021 and target allocations for 2023 are as follows: Percent of Plan Assets Target Allocation 2022 2021 2023 Worldwide Retirement Plans Equity securities 62 % 65 % 61 % Debt securities 38 35 39 Total plan assets 100 % 100 % 100 % Determination of Fair Value of Plan Assets The Plan has an established and well-documented process for determining fair values. Fair value is based upon quoted market prices, where available. If listed prices or quotes are not available, fair value is based upon models that primarily use, as inputs, market-based or independently sourced market parameters, including yield curves, interest rates, volatilities, equity or debt prices, foreign exchange rates and credit curves. While the Plan believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date. Valuation Hierarchy The authoritative literature establishes a three-level hierarchy to prioritize the inputs used in measuring fair value. The levels within the hierarchy are described in the table below with Level 1 having the highest priority and Level 3 having the lowest. The Net Asset Value (NAV) is based on the value of the underlying assets owned by the fund, minus its liabilities, and then divided by the number of shares outstanding. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Following is a description of the valuation methodologies used for the investments measured at fair value. • Short-term investment funds — Cash and quoted short-term instruments are valued at the closing price or the amount held on deposit by the custodian bank. Other investments are through investment vehicles valued using the NAV provided by the administrator of the fund. The NAV is a quoted price in a market that is not active and classified as Level 2. • Government and agency securities — A limited number of these investments are valued at the closing price reported on the major market on which the individual securities are traded. Where quoted prices are available in an active market, the investments are classified within Level 1 of the valuation hierarchy. If quoted market prices are not available for the specific security, then fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows. When quoted market prices for a security are not available in an active market, they are classified as Level 2. • Debt instruments — A limited number of these investments are valued at the closing price reported on the major market on which the individual securities are traded. Where quoted prices are available in an active market, the investments are classified as Level 1. If quoted market prices are not available for the specific security, then fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows and are classified as Level 2. Level 3 debt instruments are priced based on unobservable inputs. • Equity securities — Equity securities are valued at the closing price reported on the major market on which the individual securities are traded. Substantially all equity securities are classified within Level 1 of the valuation hierarchy. • Commingled funds — These investment vehicles are valued using the NAV provided by the fund administrator. Assets in the Level 2 category have a quoted market price. 69 • Other assets — Other assets are represented primarily by limited partnerships. These investment vehicles are valued using the NAV provided by the fund administrator. Other assets that are exchange listed and actively traded are classified as Level 1, while inactively traded assets are classified as Level 2. The following table sets forth the Retirement Plans' investments measured at fair value as of December 31, 2022 and December 31, 2021: Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs (1) Investments Measured at Net Asset Value (Level 1) (Level 2) (Level 3) Total Assets (Dollars in Millions) 2022 2021 2022 2021 2022 2021 2022 2021 2022 2021 Short-term investment funds $ 33 102 13 1,033 — — — — 46 1,135 Government and agency securities — — 5,863 7,016 — — — — 5,863 7,016 Debt instruments — — 3,681 3,505 — — — — 3,681 3,505 Equity securities 8,846 14,107 2 2 — — — — 8,848 14,109 Commingled funds — — 4,362 5,496 56 105 6,106 8,708 10,524 14,309 Other assets — — 33 34 13 15 2,506 1,807 2,552 1,856 Investments at fair value $ 8,879 14,209 13,954 17,086 69 120 8,612 10,515 31,514 41,930 (1) The activity for the Level 3 assets is not significant for all years presented. The Company's Other Benefit Plans are unfunded except for U.S. commingled funds (Level 2) of $ 78 million and $ 102 million at December 31, 2022 and December 31, 2021, respectively. The fair value of Johnson & Johnson Common Stock directly held in plan assets was $ 21 million ( 0.1 % of total plan assets) at December 31, 2022 and $ 385 million ( 0.9 % of total plan assets) at December 31, 2021. 11. Savings Plan The Company has voluntary 401(k) savings plans designed to enhance the existing retirement programs covering eligible employees. The Company matches a percentage of each employee’s contributions consistent with the provisions of the plan for which he/she is eligible. Total Company matching contributions to the plans were $ 275 million, $ 256 million and $ 243 million in fiscal years 2022, 2021 and 2020, respectively. 70 12. Capital and Treasury Stock Changes in treasury stock were: Treasury Stock (Amounts in Millions Except Treasury Stock Shares in Thousands) Shares Amount Balance at December 29, 2019 487,336 $ 38,417 Employee compensation and stock option plans ( 21,765 ) ( 3,148 ) Repurchase of common stock 21,760 3,221 Balance at January 3, 2021 487,331 38,490 Employee compensation and stock option plans ( 17,399 ) ( 2,847 ) Repurchase of common stock 20,946 3,456 Balance at January 2, 2022 490,878 39,099 Employee compensation and stock option plans ( 20,007 ) ( 3,440 ) Repurchase of common stock 35,375 6,035 Balance at January 1, 2023 506,246 $ 41,694 Aggregate shares of common stock issued were approximately 3,119,843,000 shares at the end of fiscal years 2022, 2021 and 2020. Cash dividends paid were $ 4.45 per share in fiscal year 2022, compared with dividends of $ 4.19 per share in fiscal year 2021, and $ 3.98 per share in fiscal year 2020. On January 3, 2023, the Board of Directors declared a regular cash dividend of $ 1.13 per share, payable on March 7, 2023 to shareholders of record as of February 21, 2023. 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 shares of common stock. Share repurchases may be made at management’s discretion from time to time on the open market or through privately negotiated transactions. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. Through January 1, 2023, approximately $ 2.5 billion has been repurchased under the program. 13. Accumulated Other Comprehensive Income (Loss) Components of other comprehensive income (loss) consist of the following: (Dollars in Millions) Foreign Currency Translation Gain/(Loss) On Securities Employee Benefit Plans Gain/ (Loss) On Derivatives & Hedges Total Accumulated Other Comprehensive Income (Loss) December 29, 2019 $ ( 8,705 ) — ( 6,891 ) ( 295 ) ( 15,891 ) Net 2020 changes ( 233 ) 1 ( 66 ) 947 649 January 3, 2021 ( 8,938 ) 1 ( 6,957 ) 652 ( 15,242 ) Net 2021 changes ( 1,079 ) ( 4 ) 4,255 ( 988 ) 2,184 January 2, 2022 ( 10,017 ) ( 3 ) ( 2,702 ) ( 336 ) ( 13,058 ) Net 2022 changes ( 1,796 ) ( 24 ) 1,805 106 91 January 1, 2023 $ ( 11,813 ) ( 27 ) ( 897 ) ( 230 ) ( 12,967 ) 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 10 for additional details. Gain/(Loss) On Derivatives & Hedges - reclassifications to earnings are recorded in the same account as the hedged transaction. See Note 6 for additional details. 71 14. International Currency Translation For translation of its subsidiaries operating in non-U.S. Dollar currencies, the Company has determined that the local currencies of its international subsidiaries are the functional currencies except those in highly inflationary economies, which are defined as those which have had compound cumulative rates of inflation of 100% or more during the past three years, or where a substantial portion of its cash flows are not in the local currency. For the majority of the Company's subsidiaries the local currency is the functional currency. In consolidating international subsidiaries, balance sheet currency effects are recorded as a component of accumulated other comprehensive income. The other current and non-current assets line within the Statement of Cash flows includes the impact of foreign currency translation. This equity account includes the results of translating certain balance sheet assets and liabilities at current exchange rates and some accounts at historical rates, except for those located in highly inflationary economies, (Argentina and Venezuela). Beginning in the fiscal second quarter of 2022, the Company also accounted for operations in Turkey as highly inflationary. The translation of balance sheet accounts for highly inflationary economies are reflected in the operating results. A rollforward of the changes during fiscal years 2022, 2021 and 2020 for foreign currency translation adjustments is included in Note 13. Net currency transaction gains and losses included in Other (income) expense were losses of $ 328 million, $ 236 million and $ 209 million in fiscal years 2022, 2021 and 2020, respectively. 15. Earnings Per Share The following is a reconciliation of basic net earnings per share to diluted net earnings per share for the fiscal years ended January 1, 2023, January 2, 2022 and January 3, 2021: (In Millions Except Per Share Amounts) 2022 2021 2020 Basic net earnings per share $ 6.83 7.93 5.59 Average shares outstanding — basic 2,625.2 2,632.1 2,632.8 Potential shares exercisable under stock option plans 140.1 138.0 118.3 Less: shares repurchased under treasury stock method ( 101.4 ) ( 96.1 ) ( 80.4 ) Adjusted average shares outstanding — diluted 2,663.9 2,674.0 2,670.7 Diluted net earnings per share $ 6.73 7.81 5.51 The diluted net earnings per share calculation for the fiscal years 2022 and 2021 included all shares related to stock options, as the exercise price of these options was less than the average market value of the Company's stock. The diluted net earnings per share calculation for fiscal year 2020 excluded 18 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. 16. Common Stock, Stock Option Plans and Stock Compensation Agreements At January 1, 2023, the Company had one stock-based compensation plan. The shares outstanding are for contracts under the Company's 2012 Long-Term Incentive Plan and the 2022 Long-Term Incentive Plan. The 2012 Long-Term Incentive Plan expired on April 26, 2022. All awards (stock options, restricted shares units and performance share units) granted subsequent to that date were under the 2022 Long-Term Incentive Plan. Under the 2022 Long-Term Incentive Plan, the Company may issue up to 150 million shares of common stock, of which up to 110 million shares of common stock may be issued subject to stock options or stock appreciation rights and up to 40 million shares of common stock may be issued subject to full value awards. Awards will generally be counted on a 1-for-1 basis against the share reserve, provided that if more than 40 million full value awards are granted, each full value award in excess of 40 million will be counted on a 5-for-1 basis against the share reserve. Shares available for future grants under the 2022 Long-Term Incentive Plan were 150 million at the end of fiscal year 2022. The compensation cost that has been charged against income for these plans was $ 1,138 million, $ 1,135 million and $ 1,005 million for fiscal years 2022, 2021 and 2020, respectively. The total income tax benefit recognized in the income statement for share-based compensation costs was $ 196 million, $ 218 million and $ 210 million for fiscal years 2022, 2021 and 2020, respectively. The Company also recognized additional income tax benefits of $ 282 million, $ 223 million and $ 248 million for fiscal years 2022, 2021 and 2020, respectively, for which options were exercised or restricted shares were vested. The total unrecognized compensation cost was $ 939 million, $ 862 million and $ 804 million for fiscal years 2022, 2021 and 2020, respectively. The weighted average period for this cost to be recognized was 1.80 years, 1.78 years and 1.76 years for fiscal years 2022, 2021, and 2020, respectively. Share-based compensation costs capitalized as part of inventory were insignificant in all periods. The Company settles employee benefit equity issuances with treasury shares. Treasury shares are replenished through market purchases throughout the year for the number of shares used to settle employee benefit equity issuances. 72 Stock Options Stock options expire 10 years from the date of grant and vest over service periods that range from 6 months to 4 years. All options are granted at the average of the high and low prices of the Company’s Common Stock on the New York Stock Exchange on the date of grant. The fair value of each option award was estimated on the date of grant using the Black-Scholes option valuation model that uses the assumptions noted in the following table. For 2022, 2021, and 2020 grants, expected volatility represents a blended rate of 10-year weekly historical overall volatility rate, and a 5-week average implied volatility rate based on at-the-money traded Johnson & Johnson options with a life of 2 years. For all grants, historical data is used to determine the expected life of the option. The risk-free rate was based on the U.S. Treasury yield curve in effect at the time of grant. The average fair value of options granted was $ 23.23 , $ 20.86 and $ 16.42 , in fiscal years 2022, 2021 and 2020, respectively. The fair value was estimated based on the weighted average assumptions of: 2022 2021 2020 Risk-free rate 1.98 % 0.83 % 1.47 % Expected volatility 18.00 % 18.59 % 15.33 % Expected life (in years) 7.0 7.0 7.0 Expected dividend yield 2.70 % 2.50 % 2.60 % A summary of option activity under the Plan as of January 1, 2023, January 2, 2022 and January 3, 2021, and changes during the years ending on those dates is presented below: (Shares in Thousands) Outstanding Shares Weighted Average Exercise Price Aggregate Intrinsic Value (Dollars in Millions) Shares at December 29, 2019 111,637 $ 105.63 $ 4,478 Options granted 20,723 151.41 Options exercised ( 16,275 ) 86.05 Options canceled/forfeited ( 1,835 ) 137.62 Shares at January 3, 2021 114,250 116.22 4,703 Options granted 18,525 164.62 Options exercised ( 13,248 ) 97.48 Options canceled/forfeited ( 2,166 ) 149.75 Shares at January 2, 2022 117,361 125.36 5,364 Options granted 19,809 165.89 Options exercised ( 16,310 ) 100.15 Options canceled/forfeited ( 2,188 ) 160.56 Shares at January 1, 2023 118,672 $ 134.95 $ 4,949 The total intrinsic value of options exercised was $ 1,228 million, $ 919 million and $ 1,021 million in fiscal years 2022, 2021 and 2020, respectively. 73 The following table summarizes stock options outstanding and exercisable at January 1, 2023: (Shares in Thousands) Outstanding Exercisable Exercise Price Range Options Average Life (1) Weighted Average Exercise Price Options Weighted Average Exercise Price $ 72.54 -$ 100.48 17,221 1.5 $ 93.07 17,221 $ 93.07 $ 101.87 -$ 115.67 22,039 3.6 $ 108.78 22,039 $ 108.78 $ 129.51 -$ 141.06 24,870 5.7 $ 130.88 24,228 $ 130.85 $ 151.41 -$ 164.62 35,465 7.6 $ 157.75 150 $ 156.21 $ 164.63 -$ 165.89 19,077 9.1 $ 165.89 23 $ 165.89 118,672 5.8 $ 134.95 63,661 $ 113.06 (1) Average contractual life remaining in years. Stock options outstanding at January 2, 2022 and January 3, 2021 were 117,361 and an average life of 5.8 years and 114,250 and an average life of 6.0 years, respectively. Stock options exercisable at January 2, 2022 and January 3, 2021 were 62,742 at an average price of $ 104.42 and 61,289 at an average price of $ 96.97 , respectively. Restricted Share Units and Performance Share Units The Company grants restricted share units which vest over service periods that range from 6 months to 3 years. The Company also grants performance share units, which are paid in shares of Johnson & Johnson Common Stock after the end of a three-year performance period. Performance shares were granted with two equally-weighted goals that directly align with or help drive long-term total shareholder return: adjusted operational earnings per share and relative total shareholder return. The number of shares actually earned at the end of the three-year period will vary, based only on actual performance, from 0 % to 200 % of the target number of performance share units granted . A summary of the restricted share units and performance share units activity under the Plans as of January 1, 2023 is presented below: (Shares in Thousands) Outstanding Restricted Share Units Outstanding Performance Share Units Shares at January 2, 2022 14,122 2,312 Granted 5,154 753 Issued ( 4,866 ) ( 637 ) Canceled/forfeited/adjusted ( 794 ) ( 71 ) Shares at January 1, 2023 13,616 2,357 The average fair value of the restricted share units granted was $ 153.67 , $ 152.62 and $ 139.58 in fiscal years 2022, 2021 and 2020, respectively, using the fair market value at the date of grant. The fair value of restricted share units was discounted for dividends, which are not paid on the restricted share units during the vesting period. The fair value of restricted share units issued was $ 591 million, $ 611 million and $ 650 million in 2022, 2021 and 2020, respectively. The weighted average fair value of the performance share units granted was $ 170.46 , $ 179.35 and $ 160.54 in fiscal years 2022, 2021 and 2020, calculated using the weighted average fair market value for each of the component goals at the date of grant. The fair values for the sales and earnings per share goals of each performance share unit were estimated on the date of grant using the fair market value of the shares at the time of the award discounted for dividends, which are not paid on the performance share units during the vesting period. The fair value for the relative total shareholder return goal of each performance share unit was estimated on the date of grant using the Monte Carlo valuation model. The fair value of performance share units issued was $ 94 million, $ 83 million and $ 91 million in fiscal years 2022, 2021 and 2020, respectively. 74 17. Segments of Business* and Geographic Areas Sales to Customers % Change (Dollars in Millions) 2022 2021 2020 ’22 vs. ’21 ’21 vs. ’20 CONSUMER HEALTH (1) OTC U.S. $ 2,782 2,594 2,460 7.3 % 5.4 International 3,249 3,034 2,761 7.1 9.9 Worldwide 6,031 5,627 5,221 7.2 7.8 Skin Health/Beauty U.S. 2,337 2,400 2,350 ( 2.6 ) 2.1 International 2,015 2,141 2,100 ( 5.9 ) 1.9 Worldwide 4,352 4,541 4,450 ( 4.2 ) 2.0 Oral Care U.S. 635 637 683 ( 0.3 ) ( 6.7 ) International 871 1,008 958 ( 13.6 ) 5.1 Worldwide 1,505 1,645 1,641 ( 8.5 ) 0.2 Baby Care U.S. 357 378 376 ( 5.5 ) 0.5 International 1,104 1,188 1,141 ( 7.1 ) 4.1 Worldwide 1,461 1,566 1,517 ( 6.7 ) 3.2 Women's Health U.S. 13 13 13 1.7 ( 1.6 ) International 891 905 888 ( 1.5 ) 1.8 Worldwide 904 917 901 ( 1.5 ) 1.8 Wound Care/Other U.S. 475 495 480 ( 4.0 ) 3.1 International 224 243 240 ( 8.0 ) 1.7 Worldwide 700 739 720 ( 5.3 ) 2.6 TOTAL CONSUMER HEALTH U.S. 6,599 6,516 6,362 1.3 2.4 International 8,354 8,519 8,088 ( 1.9 ) 5.3 Worldwide 14,953 15,035 14,450 ( 0.5 ) 4.0 75 PHARMACEUTICAL (1) Immunology U.S. 11,036 10,843 10,175 1.8 6.6 International 5,899 5,907 4,880 ( 0.1 ) 21.0 Worldwide 16,935 16,750 15,055 1.1 11.3 REMICADE U.S. 1,417 2,019 2,508 ( 29.8 ) ( 19.5 ) U.S. Exports 204 236 346 ( 13.6 ) ( 31.9 ) International 722 935 893 ( 22.8 ) 4.8 Worldwide 2,343 3,190 3,747 ( 26.6 ) ( 14.9 ) SIMPONI / SIMPONI ARIA U.S. 1,166 1,127 1,155 3.5 ( 2.4 ) International 1,017 1,148 1,088 ( 11.4 ) 5.5 Worldwide 2,184 2,276 2,243 ( 4.0 ) 1.4 STELARA U.S. 6,388 5,938 5,240 7.6 13.3 International 3,335 3,196 2,467 4.4 29.6 Worldwide 9,723 9,134 7,707 6.5 18.5 TREMFYA U.S. 1,844 1,503 926 22.7 62.3 International 824 624 421 32.0 48.2 Worldwide 2,668 2,127 1,347 25.4 57.9 OTHER IMMUNOLOGY U.S. 17 21 — ( 18.4 ) ** International 0 3 11 ** ( 73.3 ) Worldwide 17 24 11 ( 28.2 ) ** Infectious Diseases U.S. 1,680 2,249 1,735 ( 25.3 ) 29.7 International 3,769 3,576 1,808 5.4 97.8 Worldwide 5,449 5,825 3,543 ( 6.5 ) 64.4 COVID-19 VACCINE U.S. 120 634 — ( 81.1 ) ** International 2,059 1,751 — 17.6 ** Worldwide 2,179 2,385 — ( 8.6 ) ** EDURANT / rilpivirine U.S. 36 41 44 ( 10.8 ) ( 7.6 ) International 972 953 920 2.0 3.6 Worldwide 1,008 994 964 1.5 3.1 PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA U.S. 1,494 1,508 1,587 ( 1.0 ) ( 4.9 ) International 449 575 597 ( 21.9 ) ( 3.6 ) Worldwide 1,943 2,083 2,184 ( 6.7 ) ( 4.6 ) OTHER INFECTIOUS DISEASES U.S. 30 66 104 ( 55.5 ) ( 36.0 ) International 289 297 292 ( 2.6 ) 1.7 Worldwide 318 363 396 ( 12.3 ) ( 8.3 ) 76 Neuroscience U.S. 3,570 3,347 3,091 6.7 8.3 International 3,323 3,641 3,435 ( 8.7 ) 6.0 Worldwide 6,893 6,988 6,526 ( 1.4 ) 7.1 CONCERTA / methylphenidate U.S. 151 172 183 ( 12.5 ) ( 5.8 ) International 493 495 439 ( 0.4 ) 12.8 Worldwide 644 667 622 ( 3.5 ) 7.3 INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA U.S. 2,714 2,550 2,314 6.5 10.2 International 1,426 1,472 1,339 ( 3.1 ) 10.0 Worldwide 4,140 4,022 3,653 3.0 10.1 RISPERDAL CONSTA U.S. 257 287 296 ( 10.4 ) ( 2.9 ) International 228 305 346 ( 25.3 ) ( 11.8 ) Worldwide 485 592 642 ( 18.1 ) ( 7.7 ) OTHER NEUROSCIENCE U.S. 447 338 298 32.4 13.3 International 1,176 1,368 1,312 ( 14.1 ) 4.3 Worldwide 1,623 1,706 1,610 ( 4.9 ) 6.0 Oncology U.S. 6,930 5,958 5,092 16.3 17.0 International 9,052 8,590 7,275 5.4 18.1 Worldwide 15,983 14,548 12,367 9.9 17.6 DARZALEX U.S. 4,210 3,169 2,232 32.8 42.0 International 3,767 2,854 1,958 32.0 45.8 Worldwide 7,977 6,023 4,190 32.4 43.8 ERLEADA U.S. 968 813 583 19.2 39.3 International 913 478 176 ** * * Worldwide 1,881 1,291 760 45.7 70.0 IMBRUVICA U.S. 1,390 1,747 1,821 ( 20.4 ) ( 4.0 ) International 2,394 2,622 2,307 ( 8.7 ) 13.6 Worldwide 3,784 4,369 4,128 ( 13.4 ) 5.8 ZYTIGA / abiraterone acetate U.S. 74 119 373 ( 37.8 ) ( 68.1 ) International 1,696 2,178 2,097 ( 22.1 ) 3.9 Worldwide 1,770 2,297 2,470 ( 22.9 ) ( 7.0 ) OTHER ONCOLOGY U.S. 289 110 83 ** 31.7 International 283 458 738 ( 38.3 ) ( 37.9 ) Worldwide 571 568 821 0.6 ( 30.8 ) 77 Pulmonary Hypertension U.S. 2,346 2,365 2,133 ( 0.8 ) 10.9 International 1,071 1,085 1,015 ( 1.3 ) 6.9 Worldwide 3,417 3,450 3,148 ( 1.0 ) 9.6 OPSUMIT U.S. 1,132 1,147 1,008 ( 1.3 ) 13.7 International 651 672 631 ( 3.2 ) 6.6 Worldwide 1,783 1,819 1,639 ( 2.0 ) 11.0 UPTRAVI U.S. 1,104 1,056 955 4.5 10.5 International 218 181 138 20.4 31.1 Worldwide 1,322 1,237 1,093 6.9 13.1 OTHER U.S. 110 163 169 ( 32.3 ) ( 3.7 ) International 202 232 247 ( 12.8 ) ( 5.9 ) Worldwide 313 395 416 ( 20.8 ) ( 5.0 ) Cardiovascular / Metabolism / Other U.S. 3,042 3,192 3,509 ( 4.7 ) ( 9.0 ) International 845 927 1,025 ( 8.9 ) ( 9.6 ) Worldwide 3,887 4,119 4,534 ( 5.6 ) ( 9.2 ) XARELTO U.S. 2,473 2,438 2,345 1.4 4.0 International — — — — — Worldwide 2,473 2,438 2,345 1.4 4.0 INVOKANA/ INVOKAMET U.S. 193 308 564 ( 37.4 ) ( 45.4 ) International 255 254 231 0.1 9.9 Worldwide 448 563 795 ( 20.4 ) ( 29.3 ) OTHER (2) U.S. 376 446 600 ( 15.5 ) ( 25.7 ) International 590 673 794 ( 12.3 ) ( 15.2 ) Worldwide 966 1,119 1,394 ( 13.6 ) ( 19.7 ) TOTAL PHARMACEUTICAL U.S. 28,604 27,954 25,735 2.3 8.6 International 23,959 23,726 19,440 1.0 22.0 Worldwide 52,563 51,680 45,175 1.7 14.4 78 MEDTECH* (3) Interventional Solutions U.S. 2,169 1,836 1,452 18.2 26.4 International 2,131 2,135 1,594 ( 0.2 ) 34.0 Worldwide 4,300 3,971 3,046 8.3 30.4 Orthopaedics U.S. 5,321 5,126 4,779 3.8 7.3 International 3,267 3,462 2,984 ( 5.6 ) 16.0 Worldwide 8,587 8,588 7,763 0.0 10.6 HIPS U.S. 943 878 793 7.3 10.7 International 571 602 487 ( 5.1 ) 23.6 Worldwide 1,514 1,480 1,280 2.3 15.6 KNEES U.S. 851 787 743 8.2 5.9 International 508 538 427 ( 5.7 ) 26.1 Worldwide 1,359 1,325 1,170 2.6 13.3 TRAUMA U.S. 1,882 1,819 1,648 3.5 10.4 International 989 1,066 966 ( 7.2 ) 10.4 Worldwide 2,871 2,885 2,614 ( 0.5 ) 10.4 SPINE, SPORTS & OTHER U.S. 1,645 1,642 1,595 0.2 2.9 International 1,198 1,256 1,104 ( 4.6 ) 13.8 Worldwide 2,843 2,898 2,699 ( 1.9 ) 7.4 Surgery U.S. 3,897 3,867 3,249 0.8 19.0 International 5,793 5,945 4,983 ( 2.6 ) 19.3 Worldwide 9,690 9,812 8,232 ( 1.2 ) 19.2 ADVANCED U.S. 1,784 1,761 1,535 1.3 14.9 International 2,785 2,861 2,304 ( 2.6 ) 24.1 Worldwide 4,569 4,622 3,839 ( 1.1 ) 20.4 GENERAL U.S. 2,113 2,105 1,714 0.4 22.7 International 3,008 3,085 2,679 ( 2.5 ) 15.2 Worldwide 5,121 5,190 4,392 ( 1.3 ) 18.1 Vision U.S. 1,990 1,857 1,557 7.2 19.3 International 2,859 2,831 2,362 1.0 19.8 Worldwide 4,849 4,688 3,919 3.4 19.6 CONTACT LENSES / OTHER U.S. 1,522 1,398 1,213 8.9 15.2 International 2,022 2,043 1,781 ( 1.0 ) 14.7 Worldwide 3,543 3,440 2,994 3.0 14.9 79 SURGICAL U.S. 468 459 344 2.0 33.5 International 837 788 581 6.2 35.7 Worldwide 1,306 1,248 925 4.6 34.9 TOTAL MEDTECH U.S. 13,377 12,686 11,036 5.4 14.9 International 14,050 14,374 11,923 ( 2.3 ) 20.6 Worldwide 27,427 27,060 22,959 1.4 17.9 WORLDWIDE U.S. 48,580 47,156 43,133 3.0 9.3 International 46,363 46,619 39,451 ( 0.6 ) 18.2 Worldwide $ 94,943 93,775 82,584 1.3 % 13.6 *Certain prior year amounts have been reclassified to conform to current year presentation **Percentage greater than 100% or not meaningful (1) Approximately $ 0.4 billion in both the fiscal 2021 and 2020, of certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changes (2) Inclusive of PROCRIT / EPREX which was previously disclosed separately (3) Pr eviously referred to as Medical Devices Income (Loss) Before Tax* Identifiable Assets (Dollars in Millions) 2022 (3) 2021 (4) 2020 (5) 2022 2021 Consumer Health $ 2,930 1,573 ( 852 ) $ 24,068 25,081 Pharmaceutical 15,901 17,969 15,250 58,436 64,376 MedTech 4,607 4,373 3,044 70,956 53,372 Total 23,438 23,915 17,442 153,460 142,829 Less: Expense not allocated to segments (1) 624 1,072 945 Less: Consumer Health separation costs 1,089 67 General corporate (2) 33,918 39,189 Worldwide total $ 21,725 22,776 16,497 $ 187,378 182,018 *Income before tax of approximately $ 0.2 billion and $ 0.2 billion in the fiscal years 2021 and 2020, respectively, 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 changes Additions to Property, Plant & Equipment Depreciation and Amortization (Dollars in Millions) 2022 2021 2020 2022 2021 2020 Consumer Health $ 323 331 248 $ 658 759 785 Pharmaceutical 1,374 1,198 863 3,687 4,029 4,006 MedTech 2,120 1,933 1,980 2,302 2,286 2,140 Segments total 3,817 3,462 3,091 6,647 7,074 6,931 General corporate 192 190 256 323 316 300 Worldwide total $ 4,009 3,652 3,347 $ 6,970 7,390 7,231 80 Sales to Customers Long-Lived Assets (6) (Dollars in Millions) 2022 2021 2020 2022 2021 United States $ 48,580 47,156 43,133 $ 66,283 48,586 Europe 23,449 23,594 18,980 38,774 43,257 Western Hemisphere excluding U.S. 6,125 5,750 5,335 2,737 2,708 Asia-Pacific, Africa 16,789 17,275 15,136 4,431 5,035 Segments total 94,943 93,775 82,584 112,225 99,586 General corporate 1,134 1,014 Other non long-lived assets 74,019 81,418 Worldwide total $ 94,943 93,775 82,584 $ 187,378 182,018 See Note 1 for a description of the segments in which the Company operates. Export sales are not significant. In fiscal year 2022, the Company utilized three wholesalers distributing products for all three segments that represented approximately 16.5 %, 13.0 % and 12.0 % of the total consolidated revenues. In fiscal year 2021, the Company had three wholesalers distributing products for all three segments that represented approximately 14.0 %, 11.0 % and 11.0 % of the total consolidated revenues. In fiscal year 2020, the Company had three wholesalers distributing products for all three segments that represented approximately 16.0 %, 12.0 %, and 12.0 % of the total consolidated revenues. (1) Amounts not allocated to segments include interest (income) expense and general corporate (income) expense. (2) General corporate includes cash, cash equivalents and marketable securities. (3) Consumer Health includes: • Litigation expense of $ 0.2 billion • A restructuring related charge of $ 0.1 billion Pharmaceutical includes: • One-time COVID-19 Vaccine manufacturing exit related costs of $ 1.5 billion • An intangible asset impairment charge of approximately $ 0.8 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) acquired with the acquisition of XBiotech, Inc. in the fiscal year 2020. Additional information regarding efficacy of the AD and HS indications became available which led the Company to the decision to terminate the development of bermekimab for AD and HS • Litigation expense of $ 0.1 billion • Loss of $ 0.7 billion related to the change in the fair value of securities • A restructuring related charge of $ 0.1 billion MedTech includes: • Litigation expense of $ 0.6 billion primarily for pelvic mesh related costs • A restructuring related charge of $ 0.3 billion • Acquisition and integration related costs of $ 0.3 billion primarily related to the acquisition of Abiomed • A Medical Device Regulation charge of $ 0.3 billion (4) Consumer Health includes: • Litigation expense of $ 1.6 billion, primarily talc related costs • A restructuring related charge of $ 0.1 billion Pharmaceutical includes: • Litigation expense of $ 0.6 billion, primarily related to Risperdal Gynecomastia • Divestiture gains of $ 0.6 billion • Gains of $ 0.5 billion related to the change in the fair value of securities • A restructuring related charge of $ 0.1 billion 81 MedTech includes: • A restructuring related charge of $ 0.3 billion • An in-process research and development expense of $ 0.9 billion related to Ottava • A Medical Device Regulation charge of $ 0.2 billion • Litigation expense of $ 0.1 billion (5) Consumer Health includes: • Litigation expense of $ 3.9 billion, primarily talc related costs and certain settlements. Pharmaceutical includes: • Litigation expense of $ 0.8 billion, primarily related to the agreement in principle to settle opioid litigation • A gain of $ 0.5 billion related to the change in the fair value of securities • A restructuring related charge of $ 0.1 billion MedTech includes: • A contingent consideration reversal of $ 1.1 billion related to the timing of certain developmental milestones associated with the Auris Health acquisition. • Litigation expense of $ 0.3 billion • A restructuring related charge of $ 0.3 billion • An in-process research and development expense of $ 0.2 billion • A Medical Device Regulation charge of $ 0.1 billion (6) Long-lived assets include property, plant and equipment, net for fiscal years 2022, and 2021 of $ 19,803 and $ 18,962 , respectively, and intangible assets and goodwill, net for fiscal years 2022 and 2021 of $ 93,556 and $ 81,638 , respectively. 18. Acquisitions and Divestitures During the fiscal year 2022, certain businesses were acquired for $ 17.7 billion in cash and $ 1.1 billion of liabilities assumed. These acquisitions were accounted for using the acquisition method and, accordingly, results of operations have been included in the financial statements from their respective dates of acquisition. The excess of purchase price over the estimated fair value of tangible assets acquired amounted to $ 17.3 billion and has been assigned to identifiable intangible assets, with any residual recorded to goodwill. The fiscal year 2022 acquisitions primarily included Abiomed, Inc. (Abiomed). The remaining acquisitions were not material. On 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 subsequently met during any rolling four quarter period up to the end of Johnson & Johnson’s fiscal first quarter of 2029, $ 8.75 per 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 publication of a Class I recommendation for the use of Impella ® products in 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 acquisition was 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 82 securities of $ 0.6 billion and liabilities assumed of $ 2.8 billion, which includes the fair value of the contingent consideration mentioned above for $ 0.7 billion and deferred taxes of $ 1.8 billion. The goodwill 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 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. 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 $ 0.3 billion, which was recorded in Other (income)/expense. During fiscal year 2021, the Company did not make any material acquisitions. During fiscal year 2020, certain businesses were acquired for $ 7.3 billion in cash and $ 0.4 billion of liabilities assumed. These acquisitions were accounted for using the acquisition method and, accordingly, results of operations have been included in the financial statements from their respective dates of acquisition. The excess of purchase price over the estimated fair value of tangible assets acquired amounted to $ 7.5 billion and has been assigned to identifiable intangible assets, with any residual recorded to goodwill. The fiscal year 2020 acquisitions primarily included: all rights to the investigational compound bermekimab, which has multiple dermatological indications, along with certain employees from XBiotech Inc. (XBiotech), Momenta Pharmaceuticals, Inc. (Momenta), a company that discovers and develops novel therapies for immune-mediated diseases and the outstanding shares in Verb Surgical Inc., a company with significant robotics and data science capabilities. During the fiscal first quarter of 2020, the Company completed the acquisition of all rights to the investigational compound bermekimab, which has multiple dermatological indications, along with certain employees from XBiotech Inc., for a purchase price of $ 0.8 billion. The fair value of the acquisition was allocated primarily to non-amortizable intangible assets, primarily IPR&D, for $ 0.8 billion applying a probability of success factor that ranged from 20 % to 60 % to reflect inherent development, regulatory and commercial risk for the different indications. The discount rate applied was approximately 16 %. The transaction was accounted for as a business combination and included in the Pharmaceutical segment. In fiscal 2022, the Company recorded an intangible asset impairment charge of approximately $ 0.8 billion related to this in-process research and development asset. Additionally, in the fiscal first quarter of 2020, the Company completed the acquisition of all outstanding shares in Verb Surgical Inc., a company with significant robotics and data science capabilities, including those shares previously held by Verily. The transaction was accounted for as a business combination and included in the MedTech segment. The fair value of the acquisition was allocated primarily to non-amortizable intangible assets, primarily IPR&D, for $ 0.4 billion, goodwill for $ 0.2 billion, other assets of $ 0.2 billion and liabilities assumed of $ 0.3 billion. The fair value of the Company's previously held equity investment in Verb Surgical Inc. was $ 0.4 billion. On October 1, 2020, the Company completed the acquisition of Momenta for a purchase price of approximately $ 6.1 billion, net of cash acquired. The fair value of the acquisition was allocated primarily to non-amortizable intangible assets (IPR&D) of $ 6.0 billion, goodwill of $ 1.2 billion, other assets of $ 0.5 billion and liabilities of $ 1.6 billion. The assets acquired are intended to address substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. Depending on the asset, probability of success factors ranging from 20 % to 77 % were used in the fair value calculation to reflect inherent development and regulatory risk of the IPR&D. The discount rate applied was approximately 13 %. The goodwill is primarily attributable to synergies expected to arise from the business acquisition and is not expected to be deductible for tax purposes. The transaction was accounted for as a business combination and included in the Pharmaceutical segment. In accordance with U.S. GAAP standards related to business combinations, and goodwill and other intangible assets, supplemental pro forma information for fiscal years 2022, 2021 and 2020 is not provided, as the impact of the aforementioned acquisitions did not have a material effect on the Company’s results of operations. Divestitures During fiscal year 2022, the Company did not make any material divestitures. During fiscal year 2021, in separate transactions, the Company divested two brands outside the U.S. within the Pharmaceutical segment. The Company recognized a pre-tax gain recorded in Other (income) expense, net, of approximately $ 0.6 billion. 83 During fiscal year 2020, the Company sold 11.8 million shares of Idorsia LTD (Idorsia), or its 8.3 % ownership in the company at that time. The transaction resulted in gross proceeds of approximately CHF 337 million ($ 357 million) based on a sales price of CHF 28.55 /share and resulted in an immaterial net loss. At the end of fiscal 2020, the Company had rights to approximately 38.7 million shares through a convertible loan with a principal amount of CHF 445 million (due June 2027). During fiscal year 2021, the Company converted CHF 110 million ($ 120 million) of this loan into approximately 9.6 million shares of Idorsia which were reflected at fair value as of January 2, 2022. During the fiscal third quarter of 2021, the Company's undrawn credit facility with Idorsia was terminated. 19. 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 January 1, 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 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. PRODUCT LIABILITY The 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 established accruals for product liability claims and lawsuits in compliance with ASC 450-20 based on currently available information, which in some cases may be limited. The Company accrues an estimate of the legal defense costs needed to defend each matter when those costs are probable and can be reasonably estimated. For certain of these matters, the Company has accrued additional amounts such as estimated costs associated with settlements, damages and other losses. Product liability accruals can represent projected product liability for thousands of claims around the world, each in different litigation environments and with different fact patterns. Changes to the accruals may be required in the future as additional information becomes available. The most significant of these cases include: the DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System; the PINNACLE Acetabular Cup System; pelvic meshes; RISPERDAL; body powders containing talc, primarily JOHNSON'S Baby Powder; ETHICON PHYSIOMESH Flexible Composite Mesh; ELMIRON; and TYLENOL. As of January 1, 2023, in the United States there were approximately 170 plaintiffs with direct claims in pending lawsuits regarding injuries allegedly due to the DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System; 1,400 with respect to the PINNACLE Acetabular Cup System; 9,000 with respect to pelvic meshes; 1,100 with respect to RISPERDAL; 40,300 with respect to body powders containing talc; 2,100 with respect to ETHICON PHYSIOMESH Flexible Composite Mesh; 2,000 with respect to ELMIRON; and 170 with respect to TYLENOL. The number of pending lawsuits is expected to fluctuate as certain lawsuits are settled or dismissed and additional lawsuits are filed. 84 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 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. Claims for personal injury have also been made against DePuy Orthopaedics, Inc. and the 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. Most 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 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 state courts and in countries outside of the United States. Prior to 2019, several adverse verdicts had 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 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. Claims for personal injury have been made against Ethicon, Inc. (Ethicon) and the 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 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, pre 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 September 2022, after exhausting its appeals, the Company reached an in-principle agreement to resolve the two pelvic mesh class actions in Australia, pending Federal Court approval. In November 2022, the application for approval of the settlement was filed, and a hearing on the settlement has been scheduled for the end of February 2023. 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. Following a June 2016 worldwide market withdrawal of ETHICON PHYSIOMESH Flexible Composite Mesh (Physiomesh), claims for personal injury have been made against Ethicon, Inc. (Ethicon) and the 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 85 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, 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, 2,236 have been dismissed with prejudice. Post-settlement cases in the Physiomesh MDL and MCL are subject to docket control orders requiring early expert reports and discovery requirements. As of January 2023, there are approximately 208 active cases subject to these orders which are being reviewed and evaluated. Claims have also been filed against Ethicon and the 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 the 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. 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. All litigation activities in the two New Jersey MCLs are stayed pending resolution 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 PHYSIOMESH Flexible Composite Mesh, PROCEED Mesh and PROCEED Ventral Patch, and PROLENE Polypropylene Hernia System products. Claims for personal injury have been made against Janssen Pharmaceuticals, Inc. and the 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 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); the Company; 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 the Company 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 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 86 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, the Company, 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. The briefing and oral argument on the appeal were completed in September 2022. 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 on the decision. 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. 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. 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 July 2022, Imerys filed a motion in the Imerys Bankruptcy to stay the Edley Class Action, which was denied in August 2022. 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 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 87 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, certain of Imerys’s insurers, and certain parties in the Cyprus Mines chapter 11 case (described below) (collectively the Mediation Parties) agreed to engage in mediation. The most recent term of the mediation ended on December 31, 2022. 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 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. 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 Plaintiff’s 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. Plaintiff has appealed the Bankruptcy Court’s order. 88 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. 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. Claims for personal injury have been made against a number of Johnson & Johnson companies, including Janssen Pharmaceuticals, Inc. and the Company, 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. Claims for personal injury have been made against a number of Johnson & Johnson companies, including Janssen Pharmaceuticals, Inc. and 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, which have been coordinated and granted mass tort designation. 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. Claims for personal injury have been made against Johnson and Johnson Consumer Inc. (JJCI), 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, 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 costs associated with TYLENOL related product liability litigation. INTELLECTUAL PROPERTY Certain subsidiaries of the 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, 89 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 September 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 U.S. 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. 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 November 2022, the Court granted DePuy’s summary judgment motion that the ’234 patent is invalid as anticipated and denied DePuy’s motion that the ’537 patent is not infringed. In December 2022, the Court conducted a jury trial on the ’537 patent where the jury found that the ’537 patent was not literally infringed, but that DePuy infringed under the doctrine of equivalents (DOE). The jury awarded RSB $12 million in damages subject to post-trial motions and appeals. 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 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 challenged the verdict in its post-trial motions. In July 2022, a hearing was held on the post-trial motions. Pharmaceutical Litigation Against Filers of Abbreviated New Drug Applications (ANDAs) The following summarizes lawsuits the Company’s subsidiaries have brought against generic companies that have filed ANDAs with the U.S. FDA or undertaken similar regulatory processes outside of the United States, seeking to market generic forms of products sold by various subsidiaries of the Company prior to expiration of the applicable patents covering those products. These ANDAs typically include allegations of non-infringement and invalidity of the applicable patents. The Inter Partes Review (IPR) process with the USPTO, created under the 2011 America Invents Act, is also being used at times by generic companies in conjunction with ANDAs and lawsuits, to challenge the applicable patents. In the event the Company’s subsidiaries are not successful in an action, or the automatic statutory stay of the ANDAs expires before the United States District Court rulings are obtained, the generic companies involved would have the ability, upon 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. 90 ZYTIGA Beginning in January 2019, Janssen Inc., Janssen Oncology, Inc., and BTG International Ltd. (collectively, Janssen) initiated Statements of Claim under Section 6 of 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 took place in September 2022. In November 2022, Janssen's appeal was dismissed. 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. XARELTO Beginning in March 2021, Janssen Pharmaceuticals, Inc. (JPI) and Bayer Pharma AG and Bayer AG (collectively, Bayer) filed patent infringement lawsuits in the United States District Court for the District of Delaware against a number of generic companies who filed ANDAs seeking approval to market generic versions of XARELTO (2.5 mg) before expiration of U.S. Patent No. 10,828,310 (’310). The following generic drug companies are named defendants: Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.; Lupin Limited and 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. and Mylan Inc. (collectively, Mylan) which filed an ANDA seeking approval to market a generic version of XARELTO (2.5 mg) before expiration of 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. In August 2022, after receiving a second notice letter from Mylan regarding the same ANDA, JPI and Bayer filed a second patent infringement lawsuit in the United States District Court for the Northern District of West Virginia against Mylan. In September 2022, Mylan moved to dismiss the second lawsuit. In September 2022, the MDL panel transferred the second lawsuit to the District of Delaware. No trial date has been set for these two lawsuits. In October 2022, Mylan voluntarily withdrew its motion to dismiss. 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 January 2023, the court issued an order staying the lawsuits until after a final written decision is issued in the Inter Partes Review proceedings on the ’310 patent. In February 2022, Mylan Pharmaceuticals Inc. filed a Petition for Inter Partes Review (IPR) with the United States Patent and Trademark Office (USPTO), seeking to invalidate the ’310 patent. In August 2022, the Patent Trial and Appeal Board (PTAB) issued a decision instituting IPR. In September 2022, InvaGen Pharmaceuticals, Inc. filed a Petition for IPR with the USPTO seeking to invalidate the ’310 patent. Also in September 2022, Teva Pharmaceuticals USA, Inc. filed a Petition for IPR with the USPTO seeking to invalidate the ’310 patent. In October 2022, the PTAB issued decisions instituting IPR in both proceedings and joining them with the earlier IPR proceeding filed by Mylan Pharmaceuticals Inc. In September 2022, JPI, Bayer, and Bayer Intellectual Property GmbH (BIP) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against USV Private Limited (USV), who filed an ANDA seeking approval to market generic versions of XARELTO (2.5 mg, 10 mg, 15 mg, and 20 mg) before the expiration of the '310 patent and U.S. Patent No. 9,539,218 (’218). JPI, Bayer, and BIP are seeking an order enjoining USV from marketing its generic version of XARELTO (2.5 mg) before the expiration of the ’310 patent, and its generic versions of XARELTO (10 mg, 15 mg, and 20 mg) before the expiration of the ’218 patent. In November 2022, the MDL panel transferred this lawsuit to the United States District Court for the District of Delaware. 91 In September 2022, JPI, Bayer AG, and BIP initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Mankind Pharma Limited (Mankind), who filed an ANDA seeking approval to market generic versions of XARELTO (10 mg, 15 mg, and 20 mg) before the expiration of the ’218 patent. JPI, Bayer AG, and BIP are seeking an order enjoining Mankind from marketing its generic versions of XARELTO before the expiration of the ’218 patent. In November 2022, JPI, Bayer, and BIP initiated a patent infringement lawsuit in the United States District Court for the District of Delaware against Epic Pharma, LLC (Epic), who filed an ANDA seeking approval to market generic versions of XARELTO (2.5 mg, 10 mg, 15 mg, and 20 mg) before the expiration of the ’310 patent and the ’218 patent. JPI, Bayer, and BIP are seeking an order enjoining Epic from marketing its generic version of XARELTO (2.5 mg) before the expiration of the ’310 patent, and its generic versions of XARELTO (10 mg, 15 mg, and 20 mg) before the expiration of the ’218 patent. In December 2022, JPI and Bayer initiated a patent infringement lawsuit in the United States District Court for the District of Delaware against Apotex Inc. and Apotex Corp. (collectively, Apotex), who filed an ANDA seeking approval to market generic versions of XARELTO (2.5 mg) before the expiration of the ’310 patent. JPI and Bayer are seeking an order enjoining Apotex from marketing its generic version of XARELTO (2.5 mg) before the expiration of the ’310 patent. OPSUMIT In May 2020, Janssen Inc. (Janssen) and Actelion Pharmaceuticals Ltd (Actelion) 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 ANDS seeking approval to market a generic version of OPSUMIT 10 mg, before the expiration of Canadian Patent No. 2,659,770 (’770). Sandoz stipulated to infringement of the ’770 patent. Trial against Sandoz on the issue of validity concluded in February 2022, and in May 2022, the Court issued a decision in favor of Janssen and Actelion. In June 2022, Sandoz appealed the decision. In May 2020, Janssen and Actelion 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 OPSUMIT 10 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 January 2023, Janssen and Actelion initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Generic Medical Partners Inc. (GMP) in Canada in response to GMP’s filing of an ANDS seeking approval to market a generic version of OPSUMIT 10 mg, before the expiration of Canadian Patent Nos. 2,659,770 and 2,621,273. 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. In January 2023, Actelion Pharmaceuticals Ltd and Actelion Pharmaceuticals US, Inc. (collectively, Actelion) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Sun Pharmaceutical Industries Limited and Sun Pharmaceutical Industries, Inc. (collectively, Sun) who filed an ANDA seeking approval to market a generic version of OPSUMIT before the expiration of U.S. Patent Nos. 7,094,781 (’781) and 10,946,015 (’015). Actelion is seeking an order enjoining Sun from marketing their generic versions of OPSUMIT before the expiration of the ’781 and ’015 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), which filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of U.S. 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. 92 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, 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 August 2022, the Court issued a decision finding the claims of the’335 patent are not invalid. Pharmascience appealed. 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. A trial is scheduled to begin in March 2024. 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 U.S. Patent No. 10,143,693 (’693) relating to INVEGA TRINZA (546 mg). 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. 93 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 TRINZA before expiration of the ’693 patent. Trial was conducted in November and December 2022, and post-trial briefing is proceeding. Closing arguments will be held in March 2023. 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 ANDA seeking approval to market generic versions of IMBRUVICA tablets, asserting infringement of U.S. 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 U.S. 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. In November 2022, the United States Court of Appeals for the Federal Circuit affirmed the District Court’s 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 against Natco Pharma (Canada) Inc. (Natco) in response to Natco’s filing of two ANDSs seeking approval to market generic versions of IMBRUVICA capsules before the expiration of Canadian Patent Nos. 2,663,116 (’116); 2,928,721 (’721); 2,800,913 (’913); 3,007,787 (’787); 3,007,788 (’788); 2,875,986 (’986); and 3,022,256 (’256). In this lawsuit, Pharmacyclics and Janssen Canada are seeking an order enjoining Natco from marketing its generic version of IMBRUVICA before the expiration of the relevant patents. Trial is scheduled to begin in July 2023. In October 2022, Pharmacyclics and Janssen Canada initiated a second Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Natco in response to Natco’s filing of an ANDS seeking approval to market a generic version of IMBRUVICA capsules before the expiration of the ’116, ’721, ’913, ’787, and ’788 patents and Canadian Patent No. 2,851,808. In this lawsuit, Pharmacyclics and Janssen Canada are seeking an order enjoining Natco from marketing its generic version of IMBRUVICA capsules before the expiration of the relevant patents. Trial in this second action is scheduled to begin in August 2024. In February 2023, Pharmacyclics and Janssen Canada initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. (Sandoz) in response to Sandoz’s filing of an ANDS seeking approval to market a generic version of IMBRUVICA capsules before the expiration of the ’116, ’913, ’787, and ’788 patents. Also in February 2023, Pharmacyclics and Janssen initiated a Statement of Claim under Section 8.2 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz asserting the ’721 and ’256 patents, which are also listed in Health Canada’s Patent Register for IMBRUVICA. In these lawsuits, Pharmacyclics and Janssen Canada are seeking an order enjoining Sandoz from marketing its generic version of IMBRUVICA capsules before the expiration of the relevant patents. A trial date for these actions has not been set. SYMTUZA 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 a patent infringement lawsuit in the United States District Court for the District of Delaware against Lupin 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 U.S. Patent Nos. 10,039,718 (’718) and 10,786,518 (’518). The trial is scheduled to begin in October 2023. In October 2022, Janssen Products, L.P. and Janssen Sciences Ireland Unlimited Company (collectively, Janssen) and Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) initiated a patent infringement lawsuit in the United States District Court for the District of Delaware against Apotex Inc. and Apotex Corp. (collectively, Apotex), which filed an ANDA seeking approval to market a generic version of SYMTUZA before the expiration of the ’718 and ’518 patents. 94 In each of these U.S. lawsuits, Janssen is seeking an order enjoining the defendant from marketing a generic version of SYMTUZA before the expiration of the relevant patents. ERLEADA 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 U.S. Patent No. 9,481,663 (’663). In August 2022, Janssen and SKI filed a first amended complaint against Lupin adding U.S. Patent Nos. 9,884,054 (’054), 10,052,314 (’314), 10,702,508 (’508) and 10,849,888 (’888) to the suit. Janssen and SKI are seeking an order enjoining Lupin from marketing its generic version of ERLEADA before the expiration of the ’663, ’054, ’314, ’508, and ’888 patents. In August 2022, Janssen and SKI voluntarily dismissed the Delaware complaint. The New Jersey action is proceeding. In May 2022, Janssen and 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, ’054, ’314, ’508, and ’888 patents. 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, Janssen, The Regents of the University of California (UC), and SKI initiated patent infringement lawsuits in United States District Court for the Districts of New Jersey and Delaware against Sandoz Inc. (Sandoz), which filed an ANDA seeking approval to market a generic version of ERLEADA before the expiration of the ’663 patent and U.S. Patent Nos. 8,445,507 (’507), 8,802,689 (’689), 9,338,159 (’159), and 9,987,261 (’261). In August 2022, Janssen, UC, and SKI filed a first amended complaint against Sandoz adding the ’054, ’314, ’508, and ’888 patents to the suit. In August 2022, Janssen, UC, and SKI voluntarily dismissed the Delaware complaint. In December 2022, Janssen, UC, and SKI filed a second amended complaint against Sandoz withdrawing the ’054, ’314, ’508, and ’888 patents from the suit without prejudice. 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. The New Jersey action is proceeding. In May 2022, Janssen, UC, and SKI initiated patent infringement lawsuits in United States District Court for the Districts of New Jersey and Delaware against Eugia Pharma Specialities Limited, Aurobindo Pharma USA, Inc., and Auromedics Pharma LLC (collectively, Eugia), which filed an ANDA seeking approval to market a generic version of ERLEADA before the expiration of the ’663, ’507, ’689, ’159 and ’261 patents. In September 2022, Janssen, UC, and SKI filed a first amended complaint against Eugia adding U.S. Patent Nos. 9,884,054 (’054), 10,052,314 (’314), 10,702,508 (’508) and 10,849,888 (’888) to the suit. In September 2022, Janssen, UC, and SKI voluntarily dismissed the Delaware complaint. Janssen, UC, and SKI are seeking an order enjoining Eugia from marketing its generic version of ERLEADA before the expiration of the ’663,’507, ’689, ’159, ’261, ’054, ’314, ’508, and ’888 patents. The New Jersey action is proceeding. In May 2022, Janssen, UC, and SKI initiated patent infringement lawsuits in United States District Court for the Districts of New Jersey and Delaware against Hetero Labs Limited Unit V and Hetero USA, Inc. (collectively, Hetero), which filed an ANDA seeking approval to market a generic version of ERLEADA before the expiration of the ’663, ’507,’054, ’314,’508, and ’888 patents. Janssen, UC, and SKI are seeking an order enjoining Hetero from marketing its generic version of ERLEADA before the expiration of the ’663, ’507, ’054, ’314, ’508 and ’888 patents. In August 2022, Janssen, UC, and SKI voluntarily dismissed the Delaware complaint. The New Jersey action is proceeding. UPTRAVI In August 2022, Actelion Pharmaceuticals Ltd, and Janssen Inc. (collectively, Janssen) and Nippon Shinyaku Co. (Nippon Shinyaku) initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. in response to Sandoz’s filing of an ANDS seeking approval to market generic versions of UPTRAVI tablets before the expiration of Canadian Patent Nos. 2,731,370 and 2,764,475. In this lawsuit, Janssen and Nippon Shinyaku are seeking an order enjoining Sandoz from marketing its generic version of UPTRAVI before the expiration of the relevant patents. A trial is scheduled to begin in May 2024. In November 2022, Actelion Pharmaceuticals US Inc. and Actelion Pharmaceuticals Ltd (collectively, Actelion) and Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) initiated a patent infringement lawsuit in the United States District Court for the District of Delaware against Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc. (collectively, Alembic) who filed an 95 ANDA seeking approval to market generic versions of UPTRAVI injection for intravenous use before expiration of U.S. Patent Nos. 8,791,122 (’122) and 9,284,280 (’280) relating to UPTRAVI. In this lawsuit, Actelion and Nippon Shinyaku are seeking an order enjoining Alembic from marketing a generic version of UPTRAVI before the expiration of the relevant patents. A trial date has not been set. In February 2023, Actelion and Nippon Shinyaku initiated a patent infringement lawsuit in the United States District Court for the District of Delaware against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin) who filed an ANDA seeking approval to market generic versions of UPTRAVI injection for intravenous use before expiration of the ’122 and ’280 patents relating to UPTRAVI. In this lawsuit, Actelion and Nippon Shinyaku are seeking an order enjoining Lupin from marketing a generic version of UPTRAVI before the expiration of the relevant patents. A trial date has not been set. 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. The parties exchanged opening briefs in July 2022 and responsive briefs in September 2022. In December 2022, the Arbitration Tribunal issued an Interim Decision finding that Janssen may terminate the agreements, but it may not continue to sell products developed during the term of the agreements without continuing to pay royalties to Alkermes. GOVERNMENT PROCEEDINGS Like other companies in the pharmaceutical, consumer health and medical devices industries, the 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 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. All other cases have been resolved. Opioid Litigation 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 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 born with Neonatal Abstinence Syndrome; hospitals; and health insurers/payors. To date, complaints against pharmaceutical manufacturers, including the Company 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 every state but Alaska. The Government of Puerto Rico filed suit in Superior Court of San Juan. 96 The Company, 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, the Company 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 the Company and JPI in the amount of $ 465 million. The Company 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 the Company 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 the Company 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 was 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. Also in April 2022, the Company entered into settlement agreements with the states of Alabama and West Virginia and their participating subdivisions. In July 2022, the Company reached a settlement agreement with all litigating Oklahoma subdivisions, and in September 2022, the Company settled with the State of New Hampshire and its participating subdivisions. Consequently, by the end of the fiscal year 2022, the Company had settled the opioid claims advanced by all states except Washington. There are approximately 60 cases remaining post-settlement in various state courts. There are approximately 570 remaining federal cases against the Company and JPI coordinated in a federal Multi-District Litigation (MDL) pending in the U.S. District Court for the Northern District of Ohio, and approximately 20 additional cases pending against the Company and JPI in other federal courts. 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. 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, the Company 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 97 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 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. 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 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 briefing on the appeal is complete, the First Circuit held oral argument on December 6, 2022, and the First Circuit’s decision remains pending. In October 2012, the 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 the Company’s subsidiary, Ethicon, Inc. (Ethicon). In May 2016, California and Washington filed civil complaints against 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, the Company and Ethicon settled the Washington case. In October 2019, the Company and Ethicon settled the multi-state investigation with 41 other states and the District of Columbia. In April 2020, the Company settled the West Virginia case. In October 2020, the Company settled with the Attorney General of Oregon. In November 2020, the Company settled with the Attorney General of Mississippi. Trial in the Kentucky matter is scheduled for June 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. In November 2022, the Company petitioned the United States Supreme Court for review. 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. The Company 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 the Company 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 98 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, referenced above, while the State argued that the stay did not apply. In January 2022, the Court granted the State’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. LTL thereafter moved to enjoin prosecution of the case in the LTL Bankruptcy Case. In October 2022, the bankruptcy court issued an order staying the case. The State filed an appeal to the Third Circuit concerning the stay order. 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, 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. 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 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. LTL moved the New Jersey Bankruptcy Court for an order staying further proceedings in those two actions, which the Bankruptcy Court granted in October 2022. In December 2022, the Bankruptcy Court allowed New Mexico and Mississippi to file a direct appeal of its stay. 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. In April and September 2017, the Company 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. 99 In June 2017, the Company 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 hospitals. The Company and DePuy fully cooperated with the government’s investigation. In January 2023, the Company, DePuy Synthes, Inc., and DePuy Synthes Sales Inc. entered into a settlement agreement with the United States resolving the matter for an immaterial amount. 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. 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 Beginning in September 2017, multiple purported class actions were filed on behalf of indirect purchasers of REMICADE against the Company 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 in United States District Court for the Eastern District of Pennsylvania. This case was settled in February 2022. The final approval hearing is scheduled for February 2023. 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, 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. 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. Janssen filed its Notice of Defense in July 2022. Genmab and Janssen have cross-moved for early disposition of the arbitration. Argument was had in January 2023. 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 February 2022, defendants petitioned for rehearing en banc. 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 samples of TRACLEER. TRACLEER is subject to a Risk Evaluation and Mitigation Strategy required by the 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, a class action antitrust complaint was filed against Janssen R&D Ireland (Janssen) and Johnson & Johnson in the United States District Court for the Northern District of California. The complaint alleges that Janssen violated federal and state 100 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. In July 2020, the Court granted in part 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. In September 2022, the Court granted in part and denied in part plaintiff’s motion for class certification. In January 2023, the Court granted in part and denied in part defendants’ motion for summary judgment. Trial is scheduled for May 2023. In October 2019, Innovative Health, LLC filed a complaint against Biosense Webster, Inc. (BWI) in the United States District Court for the Middle District of California. The complaint alleges that certain of BWI’s business practices and contractual terms violate the antitrust laws of the United States and the State of California by restricting competition 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. In November 2019, the 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 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. In June 2022, Janssen Pharmaceuticals, Inc. filed a Demand for Arbitration 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. In July 2022, Emergent filed its answering statement and counterclaims. In October 2022, Janssen Pharmaceuticals, Inc. filed a Demand for Arbitration against Merck Sharp & Dohme Corp. with the American Arbitration Association pursuant to the Parties’ agreements relating to production of drug substance and drug product for the Company’s COVID-19 vaccine. Also in October 2022, Merck filed its answer and counterclaims. Beginning in May 2021, multiple putative class actions were filed in state and federal courts (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 a strict 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, 101 plaintiffs in the consolidated actions filed a motion for preliminary approval of a nationwide class settlement. The settlement was preliminarily approved by the court in March 2022. The Company (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. The Company 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. 20. Restructuring 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 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 fiscal year 2022, the Company recorded a pre-tax charge of $ 0.5 billion, which is included on the following lines of the Consolidated Statement of Earnings, $ 0.3 billion in restructuring, $ 0.1 billion in other (income) expense and $ 0.1 billion in cost of products sold. Total project costs of approximately $ 2.2 billion have been recorded since the restructuring was announced. The program was completed in the fiscal fourth quarter of 2022. The following table summarizes the severance charges and the associated spending under these initiatives through the fiscal year ended 2022: (Dollars in Millions) Severance Asset Write-offs/Sales Other (2) Total Reserve balance, January 3, 2021 $ 135 — 9 144 2021 activity ( 23 ) — 16 ( 7 ) Reserve balance, January 2, 2022 112 — 25 137 Current year activity: Charges — 15 448 463 Cash settlements ( 37 ) 44 (3) ( 439 ) ( 432 ) Settled non cash — ( 59 ) ( 59 ) Reserve balance, January 1, 2023 (1) $ 75 — 34 109 (1) Although the restructuring program has been completed in the fiscal year 2022, the Company expects that severance charges will continue beyond that date. The reserve balance as of January 1, 2023 is recorded in the Employee Related Obligation account in the Consolidated Balance Sheet. (2) Other includes project expense such as salaries for employees supporting these initiatives and consulting expenses. (3) Represents gain on sale of assets 102 Report of Independent Registered Public Accounting Firm To the Board of Directors and Shareholders of Johnson & Johnson Opinions on the Financial Statements and Internal Control over Financial Reporting We have audited the accompanying consolidated balance sheets of Johnson & Johnson and its subsidiaries (the “Company”) as of January 1, 2023 and January 2, 2022, and the related consolidated statements of earnings, of comprehensive income, of equity and of cash flows for each of the three fiscal years in the period ended January 1, 2023, including the related notes (collectively referred to as the “consolidated financial statements”). We also have audited the Company's internal control over financial reporting as of January 1, 2023, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of January 1, 2023 and January 2, 2022, and the results of its operations and its cash flows for each of the three fiscal years in the period ended January 1, 2023 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of January 1, 2023, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO. Basis for Opinions The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions. As described in Management’s Report on Internal Control Over Financial Reporting, management has excluded Abiomed, Inc., (“Abiomed”) from its assessment of internal control over financial reporting as of January 1, 2023, because it was acquired by the Company in a business combination during 2022. We have also excluded Abiomed from our audit of internal control over financial reporting. Abiomed is a wholly-owned subsidiary whose total assets and total sales excluded from management’s assessment and our audit of internal control over financial reporting represent less than 1% of each of the related consolidated financial statement amounts as of and for the fiscal year ended January 1, 2023. Definition and Limitations of Internal Control over Financial Reporting A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. 103 Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Critical Audit Matters The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate. U.S. Pharmaceutical Rebate Reserves – Managed Care, Medicare and Medicaid As described in Note 1 to the consolidated financial statements, the Company recognizes revenue from product sales when obligations under the terms of a contract with the customer are satisfied. Rebates and discounts provided to customers are accounted for as variable consideration and recorded as a reduction in sales. The liability for such rebates and discounts is recognized within Accrued Rebates, Returns, and Promotions on the consolidated balance sheet. A significant portion of the liability related to rebates is from the sale of pharmaceutical goods within the U.S., primarily the Managed Care, Medicare and Medicaid programs, which amounted to $9.6 billion as of January 1, 2023. For significant rebate programs, which include the U.S. Managed Care, Medicare and Medicaid rebate programs, rebates and discounts estimated by management are based on contractual terms, historical experience, patient outcomes, trend analysis, and projected market conditions in the U.S. pharmaceutical market. The principal considerations for our determination that performing procedures relating to U.S. pharmaceutical rebate reserves - Managed Care, Medicare and Medicaid is a critical audit matter are the significant judgment by management due to the significant measurement uncertainty involved in developing these reserves and the high degree of auditor judgment, subjectivity and audit effort in performing procedures and evaluating the assumptions related to contractual terms, historical experience, patient outcomes, trend analysis, and projected market conditions in the U.S. pharmaceutical market. Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to U.S. pharmaceutical rebate reserves - Managed Care, Medicare and Medicaid, including controls over the assumptions used to estimate these rebates. These procedures also included, among others, (i) developing an independent estimate of the rebates by utilizing third party information on price and market conditions in the U.S. pharmaceutical market, the terms of the specific rebate programs, and the historical experience and trend analysis of actual rebate claims paid; (ii) testing rebate claims processed by the Company, including evaluating those claims for consistency with the contractual and mandated terms of the Company’s rebate arrangements; and (iii) comparing the independent estimates to management’s estimates. Litigation Contingencies – Talc As described in Notes 1 and 19 to the consolidated financial statements, the Company records accruals for loss contingencies associated with legal matters, including talc, when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated. To the extent adverse awards, judgments, or verdicts have been rendered against the Company, management does not record an accrual until a loss is determined to be probable and can be reasonably estimated. For these matters, management 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 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. Management continues to believe that the Company has strong legal grounds to contest the talc verdicts it has appealed. Notwithstanding management’s confidence in the safety of the Company’s talc products, in certain circumstances the Company has settled cases. In October 2021, Johnson & Johnson Consumer Inc. (Old JJCI), a wholly-owned subsidiary of Johnson & Johnson, implemented a corporate restructuring and created a subsidiary, LTL Management LLC (LTL), which became solely responsible for the talc-related liabilities, and another subsidiary, New JJCI, which became responsible for the remaining business of Old JJCI. LTL filed a voluntary petition, seeking relief under chapter 11 of the Bankruptcy Code. As a result of the LTL bankruptcy case, the 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 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 104 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. The briefing and oral argument on the appeal were completed in September 2022. 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 has filed a petition for rehearing on the decision. The principal considerations for our determination that performing procedures relating to the talc litigation is a critical audit matter are the significant judgment by management when assessing the likelihood of a loss being incurred and when determining whether a reasonable estimate of the loss or range of loss for the future and existing talc claims can be made, which in turn led to a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating management’s assessment of the loss contingencies associated with this litigation. Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s evaluation of the talc litigation, including controls over determining whether a loss is probable and whether the amount of loss can be reasonably estimated, as well as financial statement disclosures. These procedures also included, among others, (i) gaining an understanding of the Company’s process around the accounting and reporting for the talc litigation; (ii) discussing the status of significant known actual and potential litigation and the ongoing LTL bankruptcy proceedings with the Company’s in-house legal counsel, as well as external counsel when deemed necessary; (iii) obtaining and evaluating the letters of audit inquiry with internal and external legal counsel for significant litigation; (iv) evaluating the reasonableness of management’s assessment regarding whether an unfavorable outcome is reasonably possible or probable and reasonably estimable; and (v) evaluating the sufficiency of the Company’s litigation contingencies disclosures. /s/ PricewaterhouseCoopers LLP Florham Park, New Jersey February 16, 2023 We have served as the Company’s auditor since at least 1920. We have not been able to determine the specific year we began serving as auditor of the Company. 105 Management’s Report on Internal Control Over Financial Reporting Under Section 404 of the Sarbanes-Oxley Act of 2002, management is required to assess the effectiveness of the Company’s internal control over financial reporting as of the end of each fiscal year and report, based on that assessment, whether the Company’s internal control over financial reporting is effective. Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is designed to provide reasonable assurance as to the reliability of the Company’s financial reporting and the preparation of external financial statements in accordance with generally accepted accounting principles. Internal controls over financial reporting, no matter how well designed, have inherent limitations. Therefore, internal control over financial reporting determined to be effective can provide only reasonable assurance with respect to financial statement preparation and may not prevent or detect all misstatements. Moreover, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. The Company’s management has assessed the effectiveness of the Company’s internal control over financial reporting as of January 1, 2023. In making this assessment, the Company used the criteria established by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in “Internal Control-Integrated Framework (2013).” These criteria are in the areas of control environment, risk assessment, control activities, information and communication, and monitoring. The Company’s assessment included extensive documenting, evaluating and testing the design and operating effectiveness of its internal controls over financial reporting. The Company acquired Abiomed, Inc. (Abiomed), in a business combination in December 2022. Abiomed's total assets, excluding intangible assets and goodwill, and total sales represented less than 1% of each of the related consolidated financial statement amounts as of and for the fiscal year ended January 1, 2023. As the acquisition occurred in the fiscal year 2022, the scope of the Company's assessment of the design and effectiveness of internal control over financial reporting for the fiscal year 2022 excluded the above mentioned acquisition. This exclusion is in accordance with the SEC's general guidance that an assessment of a recently acquired business may be omitted from the scope in the year of acquisition. Based on the Company’s processes and assessment, as described above, management has concluded that, as of January 1, 2023, the Company’s internal control over financial reporting was effective. The effectiveness of the Company’s internal control over financial reporting as of January 1, 2023 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which appears herein. /s/ J. Duato /s/ Joseph J. Wolk Joaquin Duato Joseph J. Wolk Chairman, Board of Directors Executive Vice President, Chief Financial Officer Chief Executive Officer 106 Shareholder Return Performance Graphs Set forth below are line graphs comparing the cumulative total shareholder return on the Company’s Common Stock for periods of five years and ten years ending January 1, 2023, against the cumulative total return of the Standard & Poor’s 500 Stock Index, the Standard & Poor’s Pharmaceutical Index and the Standard & Poor’s Healthcare Equipment Index. The graphs and tables assume that $100 was invested on December 31, 2017 and December 31, 2012 in each of the Company’s Common Stock, the Standard & Poor’s 500 Stock Index, the Standard & Poor’s Pharmaceutical Index and the Standard & Poor’s Healthcare Equipment Index and that all dividends were reinvested. 5 Year Shareholder Return Performance J&J vs. Indices 2017 2018 2019 2020 2021 2022 Johnson & Johnson $100.00 $94.86 $110.24 $122.20 $136.19 $144.32 S&P 500 Index $100.00 $95.61 $125.70 $148.81 $191.48 $156.77 S&P Pharmaceutical Index $100.00 $108.09 $124.40 $133.76 $168.21 $182.43 S&P Healthcare Equipment Index $100.00 $116.24 $150.32 $176.83 $211.05 $171.25 10 Year Shareholder Return Performance J&J vs. Indices 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Johnson & Johnson $100.00 $134.62 $157.95 $159.78 $184.26 $229.23 $217.46 $252.71 $280.13 $312.20 $330.83 S&P 500 Index $100.00 $132.37 $150.47 $152.53 $170.76 $208.02 $198.87 $261.47 $309.54 $398.32 $326.12 S&P Pharmaceutical Index $100.00 $135.23 $165.27 $174.84 $172.10 $193.74 $209.41 $241.01 $259.15 $325.89 $353.44 S&P Healthcare Equipment Index $100.00 $127.69 $161.24 $170.87 $181.95 $238.17 $276.85 $358.03 $421.16 $502.66 $407.86 107 Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE Not applicable.