Notes to Consolidated Financial Statements
Background
The principal business of AbbVie Inc. (AbbVie or the company) is the discovery, development, manufacturing and sale of a broad line of therapies that address some of the world's most complex and serious diseases. AbbVie's products are generally sold worldwide directly to wholesalers, distributors, government agencies, health care facilities, specialty pharmacies and independent retailers from AbbVie-owned distribution centers and public warehouses. Certain products (including aesthetic products and devices) are also sold directly to physicians and other licensed healthcare providers. In the United States, AbbVie distributes pharmaceutical products principally through independent wholesale distributors, with some sales directly to retailers, pharmacies, patients or other customers. Outside the United States, AbbVie sells products primarily to customers or through distributors, depending on the market served.
AbbVie was incorporated in Delaware on April 10, 2012. On January 1, 2013, AbbVie became an independent, publicly-traded company as a result of the distribution by Abbott Laboratories (Abbott) of 100% of the outstanding common stock of AbbVie to Abbott's shareholders.
On May 8, 2020, AbbVie completed its acquisition of Allergan plc (Allergan). Refer to Note 5 for additional information regarding this acquisition.
Note 2 Summary of Significant Accounting Policies Use of Estimates
The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and necessarily include amounts based on estimates and assumptions by management. Actual results could differ from those amounts. Significant estimates include amounts for rebates, pension and other post-employment benefits, income taxes, litigation, valuation of goodwill and intangible assets, contingent consideration liabilities, financial instruments and inventory and accounts receivable exposures.
Basis of Consolidation
The consolidated financial statements include the accounts of AbbVie and all of its subsidiaries in which a controlling interest is maintained. Controlling interest is determined by majority ownership interest and the absence of substantive third-party participating rights or, in the case of variable interest entities, where AbbVie is determined to be the primary beneficiary. Investments in companies over which AbbVie has a significant influence but not a controlling interest are accounted for using the equity method with AbbVie's share of earnings or losses reported in other expense, net in the consolidated statements of earnings. Intercompany balances and transactions are eliminated.
Certain reclassifications have been made to conform the prior period consolidated financial statements to the current period presentation.
Revenue Recognition
AbbVie recognizes revenue when control of promised goods or services is transferred to the company’s customers, in an amount that reflects the consideration AbbVie expects to be entitled to in exchange for those goods or services. Sales, value add and other taxes collected concurrent with revenue-producing activities are excluded from revenue. AbbVie generates revenue primarily from product sales. For the majority of sales, the company transfers control, invoices the customer and recognizes revenue upon shipment to the customer. The company recognizes shipping and handling costs as an expense in cost of products sold when the company transfers control to the customer. Payment terms vary depending on the type and location of the customer, are based on customary commercial terms and are generally less than one year. AbbVie does not adjust revenue for the effects of a significant financing component for contracts where AbbVie expects the period between the transfer of the good or service and collection to be one year or less.
Discounts, rebates, sales incentives to customers, returns and certain other adjustments are accounted for as variable consideration. Provisions for variable consideration are based on current pricing, executed contracts, government pricing legislation and historical data and are provided for in the period the related revenues are recorded. Rebate amounts are
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typically based upon the volume of purchases using contractual or statutory prices, which may vary by product and by payer. For each type of rebate, factors used in the calculation of the accrual include the identification of the products subject to the rebate, the applicable price terms and the estimated lag time between sale and payment of the rebate, which can be significant. Sales incentives to customers are insignificant.
In addition to revenue from contracts with customers, the company also recognizes certain collaboration revenues. See Note 6 for additional information related to the collaborations with Janssen Biotech, Inc. and Genentech, Inc. Additionally, see Note 16 for disaggregation of revenue by product and geography.
Research and Development Expenses
Internal research and development (R&D) costs are expensed as incurred. Clinical trial costs incurred by third parties are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development collaborations, prior to regulatory approval, the payment obligations are expensed when the milestone results are achieved. Payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of products sold over the remaining useful life of the related product.
Collaborations and Other Arrangements
The company enters into collaborative agreements with third parties to develop and commercialize drug candidates. Collaborative activities may include joint research and development and commercialization of new products. AbbVie generally receives certain licensing rights under these arrangements. These collaborations often require upfront payments and may include additional milestone, research and development cost sharing, royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development and commercialization. Upfront payments associated with collaborative arrangements during the development stage are expensed to acquired in-process research and development (IPR&D) expenses in the consolidated statements of earnings. Subsequent payments made to the partner for the achievement of milestones during the development stage are expensed to R&D expense in the consolidated statements of earnings when the milestone is achieved. Milestone payments made to the partner subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of products sold over the estimated useful life of the related asset. Royalties are expensed to cost of products sold in the consolidated statements of earnings when incurred.
Advertising
Costs associated with advertising are expensed as incurred and are included in selling, general and administrative (SG&A) expense in the consolidated statements of earnings. Advertising expenses were $2.1 billion in 2021, $1.8 billion in 2020 and $1.1 billion in 2019.
Pension and Other Post-Employment Benefits
AbbVie records annual expenses relating to its defined benefit pension and other post-employment benefit plans based on calculations which utilize various actuarial assumptions, including discount rates, rates of return on assets, compensation increases, turnover rates and health care cost trend rates. AbbVie reviews its actuarial assumptions on an annual basis and makes modifications to the assumptions based on current rates and trends. Actuarial gains and losses are deferred in accumulated other comprehensive income (loss) (AOCI), net of tax and are amortized over the remaining service attribution periods of the employees under the corridor method. Differences between the expected long-term return on plan assets and the actual annual return are generally amortized to net periodic benefit cost over a five-year period.
Income Taxes
Income taxes are accounted for under the asset and liability method. Provisions for federal, state and foreign income taxes are calculated on reported pretax earnings based on current tax laws. Deferred taxes are provided using enacted tax rates on the future tax consequences of temporary differences, which are the differences between the financial statement carrying amounts of assets and liabilities and their respective tax bases and the tax benefits of carryforwards. A valuation allowance is established or maintained when, based on currently available information, it is more likely than not that all or a portion of a deferred tax asset will not be realized.
Cash and Equivalents
Cash and equivalents include money market funds and time deposits with original maturities of three months or less.
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Investments
Investments consist primarily of equity securities, held-to-maturity debt securities, marketable debt securities and time deposits. Investments in equity securities that have readily determinable fair values are recorded at fair value. Investments in equity securities that do not have readily determinable fair values are recorded at cost and are remeasured to fair value based on certain observable price changes or impairment events as they occur. Held-to-maturity debt securities are recorded at cost. Gains or losses on investments are included in other expense, net in the consolidated statements of earnings. Investments in marketable debt securities are classified as available-for-sale and are recorded at fair value with any unrealized holding gains or losses, net of tax, included in AOCI on the consolidated balance sheets until realized, at which time the gains or losses are recognized in earnings.
AbbVie periodically assesses its marketable debt securities for impairment and credit losses. When a decline in fair value of marketable debt security is due to credit related factors, an allowance for credit losses is recorded with a corresponding charge to other expense, net in the consolidated statements of earnings. When AbbVie determines that a non-credit related impairment has occurred, the amortized cost basis of the investment, net of allowance for credit losses, is written down with a charge to other expense, net in the consolidated statements of earnings and an available-for-sale investment's unrealized loss is reclassified from AOCI to other expense, net in the consolidated statements of earnings. Realized gains and losses on sales of investments are computed using the first-in, first-out method adjusted for any impairments and credit losses that were recorded in net earnings.
Accounts Receivable
Accounts receivable are stated at amortized cost less allowance for credit losses. The allowance for credit losses reflects the best estimate of future losses over the contractual life of outstanding accounts receivable and is determined on the basis of historical experience, specific allowances for known troubled accounts, other currently available information including customer financial condition, and both current and forecasted economic conditions.
Inventories
Inventories are valued at the lower of cost (first-in, first-out basis) or market. Cost includes material and conversion costs. Inventories consisted of the following: | | | | | | | | | | | |
as of December 31 (in millions) | 2021 | | 2020 |
Finished goods | $ | 932 | | | $ | 1,318 | |
Work-in-process | 1,193 | | | 1,201 | |
Raw materials | 1,003 | | | 791 | |
Inventories | $ | 3,128 | | | $ | 3,310 | |
Property and Equipment | | | | | | | | | | | |
as of December 31 (in millions) | 2021 | | 2020 |
Land | $ | 287 | | | $ | 288 | |
Buildings | 2,791 | | | 2,555 | |
Equipment | 6,850 | | | 6,976 | |
Construction in progress | 799 | | | 1,040 | |
Property and equipment, gross | 10,727 | | | 10,859 | |
Less accumulated depreciation | (5,617) | | | (5,611) | |
Property and equipment, net | $ | 5,110 | | | $ | 5,248 | |
Depreciation for property and equipment is recorded on a straight-line basis over the estimated useful lives of the assets. The estimated useful life for buildings ranges from 10 to 50 years. Buildings include leasehold improvements which are amortized over the life of the related facility lease (including any renewal periods, if appropriate) or the asset, whichever is shorter. The estimated useful life for equipment ranges from 2 to 25 years. Equipment includes certain computer software and software development costs incurred in connection with developing or obtaining software for internal use and is amortized over 3 to 10 years. Depreciation expense was $803 million in 2021, $666 million in 2020 and $464 million in 2019.
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Leases
Short-term leases with a term of 12 months or less are not recorded on the balance sheet. For leases commencing or modified in 2019 or later, AbbVie does not separate lease components from non-lease components.
The company records lease liabilities based on the present value of lease payments over the lease term. AbbVie generally uses an incremental borrowing rate to discount its lease liabilities, as the rate implicit in the lease is typically not readily determinable. Certain lease agreements include renewal options that are under the company's control. AbbVie includes optional renewal periods in the lease term only when it is reasonably certain that AbbVie will exercise its option.
Variable lease payments include payments to lessors for taxes, maintenance, insurance and other operating costs as well as payments that are adjusted based on an index or rate. The company's lease agreements do not contain any significant residual value guarantees or restrictive covenants.
Litigation and Contingencies
Loss contingency provisions are recorded when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated based on existing information. When a best estimate cannot be made, the minimum loss contingency amount in a probable range is recorded. Legal fees are expensed as incurred. AbbVie accrues for product liability claims on an undiscounted basis. The liabilities are evaluated quarterly and adjusted if necessary as additional information becomes available. Receivables for insurance recoveries for product liability claims, if any, are recorded as assets on an undiscounted basis when it is probable that a recovery will be realized.
Business Combinations
AbbVie utilizes the acquisition method of accounting for business combinations. This method requires, among other things, that results of operations of acquired companies are included in AbbVie's results of operations beginning on the respective acquisition dates and that assets acquired and liabilities assumed are recognized at fair value as of the acquisition date. Any excess of the fair value of consideration transferred over the fair values of the net assets acquired is recognized as goodwill. Contingent consideration liabilities are recognized at the estimated fair value on the acquisition date. Subsequent changes to the fair value of contingent consideration liabilities are recognized in other expense, net in the consolidated statements of earnings. The fair value of assets acquired and liabilities assumed in certain cases may be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition date. Legal costs, due diligence costs, business valuation costs and all other business acquisition costs are expensed when incurred.
Goodwill and Intangible Assets
Intangible assets acquired in a business combination are recorded at fair value using a discounted cash flow model. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, risk, the cost of capital and terminal values of market participants. Definite-lived intangibles are amortized over their estimated useful lives using the estimated pattern of economic benefit. AbbVie reviews the recoverability of definite-lived intangible assets whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable. AbbVie first compares the projected undiscounted cash flows to be generated by the asset to its carrying value. If the undiscounted cash flows of an intangible asset are less than the carrying value, the intangible asset is written down to its fair value. Where cash flows cannot be identified for an individual asset, the review is applied at the lowest level for which cash flows are largely independent of the cash flows of other assets and liabilities.
Goodwill and indefinite-lived assets are not amortized, but are subject to an impairment review annually and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value.
The company tests its goodwill for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the company concludes it is more likely than not that the fair value of the reporting unit is less than its carrying amount, a quantitative impairment test is performed. AbbVie tests indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the company concludes it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed. For its quantitative impairment tests, the company uses an estimated future cash flow approach that requires significant judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, the selection of an appropriate discount rate, asset groupings and other assumptions and estimates. The estimates and assumptions used are consistent with the company's business plans and a market participant's views. The use of alternative estimates and assumptions could increase or decrease
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the estimated fair value of the assets and potentially result in different impacts to the company's results of operations. Actual results may differ from the company's estimates.
Acquired In-Process Research and Development
In an asset acquisition, the initial costs to acquire rights to IPR&D projects are expensed as IPR&D in the consolidated statements of earnings unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development collaboration agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products. In a business combination, the fair value of IPR&D projects acquired are capitalized and accounted for as indefinite-lived intangible assets until the underlying project receives regulatory approval, at which point the intangible asset will be accounted for as a definite-lived intangible asset, or discontinuation, at which point the intangible asset will be written off. R&D costs incurred after the acquisition are expensed as incurred.
Foreign Currency Translation
Foreign subsidiary earnings are translated into U.S. dollars using average exchange rates. The net assets of foreign subsidiaries are translated into U.S. dollars using period-end exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recognized in other comprehensive income (loss) in the consolidated statements of comprehensive income. The net assets of subsidiaries in highly inflationary economies are remeasured as if the functional currency were the reporting currency. The remeasurement is recognized in net foreign exchange loss in the consolidated statements of earnings.
Derivatives
All derivative instruments are recognized as either assets or liabilities at fair value on the consolidated balance sheets and are classified as current or long-term based on the scheduled maturity of the instrument.
For derivatives formally designated as hedges, the company assesses at inception and quarterly thereafter whether the hedging derivatives are highly effective in offsetting changes in the fair value or cash flows of the hedged item. The changes in fair value of a derivative designated as a fair value hedge and of the hedged item attributable to the hedged risk are recognized in earnings immediately. The effective portions of changes in the fair value of a derivative designated as a cash flow hedge are reported in AOCI and are subsequently recognized in earnings consistent with the underlying hedged item. If it is determined that a derivative is no longer highly effective as a hedge, the company discontinues hedge accounting prospectively. If a hedged forecasted transaction becomes probable of not occurring, any gains or losses are reclassified from AOCI to earnings. Derivatives that are not designated as hedges are adjusted to fair value through current earnings.
The company also uses derivative instruments or foreign currency denominated debt to hedge its net investments in certain foreign subsidiaries and affiliates. Realized and unrealized gains and losses from these hedges are included in AOCI.
Derivative cash flows, with the exception of net investment hedges, are principally classified in the operating section of the consolidated statements of cash flows, consistent with the underlying hedged item. Cash flows related to net investment hedges are classified in the investing section of the consolidated statements of cash flows.
Recent Accounting Pronouncements
Recently Adopted Accounting Pronouncements
ASU No. 2019-12
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740). The standard includes simplifications related to accounting for income taxes including removing certain exceptions related to the approach for intraperiod tax allocation and the recognition of deferred tax liabilities for outside basis differences. The standard also clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. AbbVie adopted the standard in the first quarter of 2021. The adoption did not have a material impact on its consolidated financial statements.
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Note 3 Supplemental Financial Information Interest Expense, Net | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Interest expense | $ | 2,423 | | | $ | 2,454 | | | $ | 1,784 | |
Interest income | (39) | | | (174) | | | (275) | |
Interest expense, net | $ | 2,384 | | | $ | 2,280 | | | $ | 1,509 | |
Accounts Payable and Accrued Liabilities | | | | | | | | | | | |
as of December 31 (in millions) | 2021 | | 2020 |
Sales rebates | $ | 8,254 | | | $ | 7,188 | |
Dividends payable | 2,543 | | | 2,335 | |
Accounts payable | 2,882 | | | 2,276 | |
Salaries, wages and commissions | 1,785 | | | 1,669 | |
Royalty and license arrangements | 661 | | | 483 | |
Other | 6,574 | | | 6,208 | |
Accounts payable and accrued liabilities | $ | 22,699 | | | $ | 20,159 | |
Other Long-Term Liabilities | | | | | | | | | | | |
as of December 31 (in millions) | 2021 | | 2020 |
Contingent consideration liabilities | $ | 13,638 | | | $ | 12,289 | |
Liabilities for unrecognized tax benefits | 5,970 | | | 5,680 | |
Income taxes payable | 3,442 | | | 3,847 | |
Pension and other post-employment benefits | 3,153 | | | 3,413 | |
Other | 2,498 | | | 2,378 | |
Other long-term liabilities | $ | 28,701 | | | $ | 27,607 | |
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Note 4 Earnings Per Share AbbVie grants certain restricted stock units (RSUs) that are considered to be participating securities. Due to the presence of participating securities, AbbVie calculates earnings per share (EPS) using the more dilutive of the treasury stock or the two-class method. For all periods presented, the two-class method was more dilutive.
The following table summarizes the impact of the two-class method: | | | | | | | | | | | | | | | | | |
| Years ended December 31, |
(in millions, except per share data) | 2021 | | 2020 | | 2019 |
Basic EPS | | | | | |
Net earnings attributable to AbbVie Inc. | $ | 11,542 | | | $ | 4,616 | | | $ | 7,882 | |
Earnings allocated to participating securities | 74 | | | 60 | | | 40 | |
Earnings available to common shareholders | $ | 11,468 | | | $ | 4,556 | | | $ | 7,842 | |
Weighted average basic shares of common stock outstanding | 1,770 | | | 1,667 | | | 1,481 | |
Basic earnings per share attributable to AbbVie Inc. | $ | 6.48 | | | $ | 2.73 | | | $ | 5.30 | |
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Diluted EPS | | | | | |
Net earnings attributable to AbbVie Inc. | $ | 11,542 | | | $ | 4,616 | | | $ | 7,882 | |
Earnings allocated to participating securities | 74 | | | 60 | | | 40 | |
Earnings available to common shareholders | $ | 11,468 | | | $ | 4,556 | | | $ | 7,842 | |
Weighted average shares of common stock outstanding | 1,770 | | | 1,667 | | | 1,481 | |
Effect of dilutive securities | 7 | | | 6 | | | 3 | |
Weighted average diluted shares of common stock outstanding | 1,777 | | | 1,673 | | | 1,484 | |
Diluted earnings per share attributable to AbbVie Inc. | $ | 6.45 | | | $ | 2.72 | | | $ | 5.28 | |
Certain shares issuable under stock-based compensation plans were excluded from the computation of EPS because the effect would have been antidilutive. The number of common shares excluded was insignificant for all periods presented.
Note 5 Licensing, Acquisitions and Other Arrangements Acquisition of Allergan
On May 8, 2020, AbbVie completed its acquisition of all outstanding equity interests in Allergan in a cash and stock transaction. Allergan is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. The combination created a diverse entity with leadership positions across immunology, hematologic oncology, aesthetics, neuroscience, eye care and women's health. AbbVie's existing product portfolio and pipeline is enhanced with numerous Allergan assets and Allergan's product portfolio benefits from AbbVie's commercial strength, expertise and international infrastructure. Under the terms of the acquisition, each ordinary share of Allergan common stock was converted into the right to receive (i) $120.30 in cash and (ii) 0.8660 of a share of AbbVie common stock.
Total consideration for the acquisition of Allergan is summarized as follows: | | | | | |
(in millions) | |
Cash consideration paid to Allergan shareholders (a) | $ | 39,675 | |
Fair value of AbbVie common stock issued to Allergan shareholders (b) | 23,979 | |
Fair value of AbbVie equity awards issued to Allergan equity award holders (c) | 430 | |
Total consideration | $ | 64,084 | |
(a)Represents cash consideration transferred of $120.30 per outstanding Allergan ordinary share based on 330 million Allergan ordinary shares outstanding at closing.
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(b)Represents the acquisition date fair value of 286 million shares of AbbVie common stock issued to Allergan shareholders based on the exchange ratio of 0.8660 AbbVie shares for each outstanding Allergan ordinary share at the May 8, 2020 closing price of $83.96 per share.
(c)Represents the pre-acquisition service portion of the fair value of 11 million AbbVie stock options and 8 million RSUs issued to Allergan equity award holders.
The acquisition of Allergan has been accounted for as a business combination using the acquisition method of accounting. The acquisition method requires, among other things, that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date. The valuation of assets acquired and liabilities assumed was finalized during the second quarter of 2021. Measurement period adjustments to the preliminary purchase price allocation during 2021 included (i) an increase to intangible assets of $710 million; (ii) an increase to deferred income tax liabilities of $148 million; (iii) other individually insignificant adjustments for a net increase to identifiable net assets of $2 million; and (iv) a corresponding decrease to goodwill of $564 million. The measurement period adjustments primarily resulted from the completion of the valuation of certain license agreement intangible assets based on facts and circumstances that existed as of the acquisition date and did not result from intervening events subsequent to such date. These adjustments did not have a significant impact on AbbVie's results of operations in 2021 and would not have had a significant impact on prior period results if these adjustments had been made as of the acquisition date.
The following table summarizes the final fair value of assets acquired and liabilities assumed as of the acquisition date: | | | | | |
(in millions) | |
Assets acquired and liabilities assumed | |
Cash and equivalents | $ | 1,537 | |
Short-term investments | 1,421 | |
Accounts receivable | 2,374 | |
Inventories | 2,340 | |
Prepaid expenses and other current assets | 1,982 | |
Investments | 137 | |
Property and equipment | 2,129 | |
Intangible assets | |
Definite-lived intangible assets | 68,190 | |
In-process research and development | 1,600 | |
Other noncurrent assets | 1,395 | |
Short-term borrowings | (60) | |
Current portion of long-term debt and finance lease obligations | (1,899) | |
Accounts payable and accrued liabilities | (5,852) | |
Long-term debt and finance lease obligations | (18,937) | |
Deferred income taxes | (3,940) | |
Other long-term liabilities | (4,765) | |
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Total identifiable net assets | 47,652 | |
Goodwill | 16,432 | |
Total assets acquired and liabilities assumed | $ | 64,084 | |
The fair value step-up adjustment to inventories of $1.2 billion was amortized to cost of products sold when the inventory was sold to customers and was fully amortized as of December 31, 2021.
Intangible assets relate to $68.2 billion of definite-lived intangible assets and $1.6 billion of IPR&D. The acquired definite-lived intangible assets consist of developed product rights and license agreements and are being amortized over a weighted-average estimated useful life of approximately twelve years using the estimated pattern of economic benefit. The estimated fair values of identifiable intangible assets were determined using the "income approach" which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. Some of the more significant assumptions inherent in the development of these asset valuations include the estimated net cash flows for each year for each asset or product, the appropriate discount rate necessary to measure the risk inherent in each future cash flow stream, the life cycle of each asset, the potential regulatory and commercial success risk, competitive trends impacting the asset and each cash flow stream, as well as other factors.
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The fair value of long-term debt was determined by quoted market prices as of the acquisition date and the total purchase price adjustment of $1.3 billion is being amortized as a reduction to interest expense, net over the lives of the related debt.
Goodwill was calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from the other assets acquired that could not be individually identified and separately recognized. Specifically, the goodwill recognized from the acquisition of Allergan represents the value of additional growth platforms and an expanded revenue base as well as anticipated operational synergies and cost savings from the creation of a single combined global organization. The goodwill is not deductible for tax purposes.
Following the acquisition date, the operating results of Allergan have been included in the consolidated financial statements. For the period from the acquisition date through December 31, 2020, net revenues attributable to Allergan were $10.3 billion and operating losses attributable to Allergan were $1.1 billion, inclusive of $4.0 billion of intangible asset amortization and $1.2 billion of inventory fair value step-up amortization.
Acquisition-related expenses, which were comprised primarily of regulatory, financial advisory and legal fees, totaled $781 million for the year ended December 31, 2020 and $103 million for the year ended December 31, 2019 which were included in SG&A expenses in the consolidated statements of earnings. In the fourth quarter of 2021, AbbVie recovered certain acquisition-related regulatory fees totaling $401 million which was recorded as a reduction to SG&A expenses in the consolidated statement of earnings for the year ended December 31, 2021.
Pro Forma Financial Information
The following table presents the unaudited pro forma combined results of AbbVie and Allergan for 2020 and 2019 as if the acquisition of Allergan had occurred on January 1, 2019: | | | | | | | | | | | | | | |
years ended December 31 (in millions) | | 2020 | | 2019 |
Net revenues | | $ | 50,521 | | | $ | 49,028 | |
Net earnings (loss) | | 6,746 | | | (38) | |
The unaudited pro forma combined financial information was prepared using the acquisition method of accounting and was based on the historical financial information of AbbVie and Allergan. In order to reflect the occurrence of the acquisition on January 1, 2019 as required, the unaudited pro forma financial information includes adjustments to reflect incremental amortization expense to be incurred based on the final fair values of the identifiable intangible assets acquired; the incremental cost of products sold related to the fair value adjustments associated with acquisition date inventory; the additional interest expense associated with the issuance of debt to finance the acquisition; and the reclassification of acquisition-related costs incurred during the year ended December 31, 2020 to the year ended December 31, 2019. The unaudited pro forma financial information is not necessarily indicative of what the consolidated results of operations would have been had the acquisition been completed on January 1, 2019. In addition, the unaudited pro forma financial information is not a projection of future results of operations of the combined company nor does it reflect the expected realization of any synergies or cost savings associated with the acquisition.
Acquisition of Soliton, Inc.
In December 2021, AbbVie completed its previously announced acquisition of Soliton, Inc. (Soliton). Soliton's RESONIC (Rapid Acoustic Pulse device) has U.S. Food and Drug Administration (FDA) 510(k) clearance for the long-term improvement in the appearance of cellulite up to one year. The transaction was accounted for as a business combination using the acquisition method of accounting. Total consideration transferred allocated to the purchase price consisted of cash consideration of $535 million paid to holders of Soliton common stock, equity-based awards and warrants. As of the transaction date, AbbVie acquired $407 million of intangible assets for developed product rights and assumed deferred tax liabilities totaling $63 million. Other assets and liabilities were insignificant. The acquisition resulted in the recognition of $177 million of goodwill which is not deductible for tax purposes.
Acquisition of Luminera
In October 2020, AbbVie entered into an agreement with Luminera, a privately held aesthetics company based in Israel, to acquire Luminera's full dermal filler portfolio and R&D pipeline including HArmonyCa, a dermal filler intended for facial soft tissue augmentation. The aggregate accounting purchase price of $186 million was comprised of a $122 million upfront cash payment and $64 million for the acquisition date fair value of contingent consideration liabilities, for which AbbVie may owe up to $90 million in future payments upon achievement of certain commercial milestones. The agreement was accounted for as a business combination using the acquisition method of accounting. As of the acquisition date, AbbVie acquired $127 million of intangible assets for in-process research and development and $33 million of intangible assets for developed
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product rights. Other assets and liabilities assumed were insignificant. The acquisition resulted in the recognition of $12 million of goodwill which is not deductible for tax purposes.
Other Licensing & Acquisitions Activity
Cash outflows related to other acquisitions and investments totaled $1.4 billion in 2021, $1.4 billion in 2020 and $1.1 billion in 2019. AbbVie recorded acquired IPR&D charges of $962 million in 2021, $1.2 billion in 2020 and $385 million in 2019. Significant arrangements impacting 2021, 2020 and 2019, some of which require contingent milestone payments, are summarized below.
Calico Life Sciences LLC
In July 2021, AbbVie and Calico Life Sciences LLC (Calico) entered into an extension of their collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer. This is the second collaboration extension and builds on the partnership established in 2014 and extended in 2018. Under the terms of the agreement, AbbVie and Calico will each contribute an additional $500 million and the term is extended for an additional three years. AbbVie’s contribution is payable in two equal installments beginning in 2023. Calico will be responsible for research and early development until 2025 and will advance collaboration projects into Phase 2a through 2030. Following completion of the Phase 2a studies, AbbVie will have the option to exclusively license the collaboration compounds. Upon exercise, AbbVie would be responsible for late-stage development and commercial activities. Collaboration costs and profits will be shared equally by both parties post option exercise. During the third quarter of 2021, AbbVie recorded $500 million as other operating expense in the consolidated statement of earnings related to its commitments under the agreement.
TeneoOne and TNB-383B
In September 2021, AbbVie acquired TeneoOne, an affiliate of Teneobio, Inc., and TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of relapsed or refractory multiple myeloma (R/R MM). In February 2019, AbbVie and TeneoOne entered a strategic transaction to develop and commercialize TNB-383B, a bispecific antibody that simultaneously targets BCMA and CD3 and is designed to direct the body's own immune system to target and kill BCMA-expressing tumor cells. AbbVie exercised its exclusive right to acquire TeneoOne and TNB-383B based on an interim analysis of an ongoing Phase 1 study and accounted for the transaction as an asset acquisition. Under the terms of the agreement, AbbVie made an exercise payment of $400 million which was recorded to IPR&D in the consolidated statement of earnings in the third quarter of 2021. The agreement also included additional payments of up to $250 million upon the achievement of certain development, regulatory and commercial milestones.
REGENXBIO Inc.
In September 2021, AbbVie and REGENXBIO Inc. (REGENXBIO) entered into a collaboration to develop and commercialize RGX-314, an investigational gene therapy for wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases. The collaboration provides AbbVie with an exclusive global license to develop and commercialize RGX-314. REGENXBIO will be responsible for completion of ongoing trials, AbbVie and REGENXBIO will collaborate and share costs of additional trials, and AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO and AbbVie will share equally in pre-tax profits from net revenues of RGX-314 in the U.S. and AbbVie will pay REGENXBIO tiered royalties on net revenues outside the U.S. Upon closing in the fourth quarter of 2021, AbbVie made an upfront payment of $370 million to exclusively license RGX-314 which was recorded to IPR&D in the consolidated statement of earnings for the year ended December 31, 2021. The agreement also included additional payments of up to $1.4 billion upon the achievement of certain development, regulatory and commercial milestones.
I-Mab Biopharma
In September 2020, AbbVie and I-Mab Biopharma (I-Mab) entered into a collaboration agreement for the development and commercialization of lemzoparlimab, an anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab. The collaboration provides AbbVie an exclusive global license, excluding greater China, to develop and commercialize lemzoparlimab. The companies will share manufacturing responsibilities with AbbVie being the primary manufacturer for global supply. The agreement also allows for potential collaboration on future CD47-related therapeutic agents, subject to further licenses to explore each other's related programs in their respective territories. The terms of the arrangement include an initial upfront payment of $180 million to exclusively license lemzoparlimab along with a milestone payment of $20 million based on the Phase I results, for a total of $200 million, which was recorded to IPR&D in the consolidated statement of earnings in the fourth quarter of 2020 after regulatory approval of the transaction. In addition, I-Mab will be eligible to receive up to $1.7 billion upon the achievement of certain clinical development, regulatory and
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commercial milestones, and AbbVie will pay tiered royalties from low-to-mid teen percentages on global net revenues outside of greater China.
Genmab A/S
In June 2020, AbbVie and Genmab A/S (Genmab) entered into a collaboration agreement to jointly develop and commercialize three of Genmab's early-stage investigational bispecific antibody therapeutics and entered into a discovery research collaboration for future differentiated antibody therapeutics for the treatment of cancer. Under the terms of the agreement, Genmab granted to AbbVie an exclusive license to its epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 programs. For epcoritamab, the companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab will record net revenues in the U.S. and Japan, and the parties will share equally in pre-tax profits from these sales. Genmab will receive tiered royalties on remaining global sales. For the discovery research partnership, Genmab will conduct Phase 1 studies for these programs and AbbVie retains the right to opt-in to program development. During 2020, AbbVie made an upfront payment of $750 million, which was recorded to IPR&D in the consolidated statement of earnings. AbbVie could make additional payments of up to $3.2 billion upon the achievement of certain development, regulatory and commercial milestones for all programs.
Reata Pharmaceuticals, Inc.
In October 2019, AbbVie and Reata Pharmaceuticals, Inc. (Reata) entered into an amended and restated license agreement. Under the terms of the agreement, Reata reacquired exclusive development, manufacturing and commercialization rights concerning its proprietary Nrf2 activator product platform originally licensed to AbbVie for territories outside of the United States with respect to bardoxolone methyl and worldwide with respect to omaveloxolone and other next-generation Nrf2 activators. As consideration for the rights reacquired by Reata, AbbVie received a total of $250 million as of December 31, 2020 and $80 million in cash in 2021. Total consideration of $330 million was recognized in other operating (income) expense in the consolidated statement of earnings in 2019. In addition, AbbVie will receive low single-digit, tiered royalties from worldwide sales of omaveloxolone and certain next-generation Nrf2 activators.
Other Arrangements
In addition to the significant arrangements described above, AbbVie entered into several other arrangements resulting in charges to IPR&D of $192 million in 2021, $248 million in 2020 and $385 million in 2019. In connection with the other individually insignificant early-stage arrangements entered into in 2021, AbbVie could make additional payments of up to $5.5 billion upon the achievement of certain development, regulatory and commercial milestones.
The company has ongoing transactions with other entities through collaboration agreements. The following represent the significant collaboration agreements impacting 2021, 2020 and 2019.
Collaboration with Janssen Biotech, Inc.
In December 2011, Pharmacyclics, a wholly-owned subsidiary of AbbVie, entered into a worldwide collaboration and license agreement with Janssen Biotech, Inc. and its affiliates (Janssen), one of the Janssen Pharmaceutical companies of Johnson & Johnson, for the joint development and commercialization of Imbruvica, a novel, orally active, selective covalent inhibitor of Bruton's tyrosine kinase (BTK) and certain compounds structurally related to Imbruvica, for oncology and other indications, excluding all immune and inflammatory mediated diseases or conditions and all psychiatric or psychological diseases or conditions, in the United States and outside the United States.
The collaboration provides Janssen with an exclusive license to commercialize Imbruvica outside of the United States and co-exclusively with AbbVie in the United States. Both parties are responsible for the development, manufacturing and marketing of any products generated as a result of the collaboration. The collaboration has no set duration or specific expiration date and provides for potential future development, regulatory and approval milestone payments of up to $200 million to AbbVie. The collaboration also includes a cost sharing arrangement for associated collaboration activities. Except in certain cases, Janssen is responsible for approximately 60% of collaboration development costs and AbbVie is responsible for the remaining 40% of collaboration development costs.
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In the United States, both parties have co-exclusive rights to commercialize the products; however, AbbVie is the principal in the end-customer product sales. AbbVie and Janssen share pre-tax profits and losses equally from the commercialization of products. Sales of Imbruvica are included in AbbVie's net revenues. Janssen's share of profits is included in AbbVie's cost of products sold. Other costs incurred under the collaboration are reported in their respective expense line items, net of Janssen's share.
Outside the United States, Janssen is responsible for and has exclusive rights to commercialize Imbruvica. AbbVie and Janssen share pre-tax profits and losses equally from the commercialization of products. AbbVie's share of profits is included in AbbVie's net revenues. Other costs incurred under the collaboration are reported in their respective expense line items, net of Janssen's share.
The following table shows the profit and cost sharing relationship between Janssen and AbbVie: | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
United States - Janssen's share of profits (included in cost of products sold) | $ | 2,018 | | | $ | 2,012 | | | $ | 1,803 | |
International - AbbVie's share of profits (included in net revenues) | 1,087 | | | 1,009 | | | 844 | |
Global - AbbVie's share of other costs (included in respective line items) | 304 | | | 295 | | | 321 | |
AbbVie’s receivable from Janssen, included in accounts receivable, net, was $294 million at December 31, 2021 and $283 million at December 31, 2020. AbbVie’s payable to Janssen, included in accounts payable and accrued liabilities, was $509 million at December 31, 2021 and $562 million at December 31, 2020.
Collaboration with Genentech, Inc.
AbbVie and Genentech, Inc. (Genentech), a member of the Roche Group, are parties to a collaboration and license agreement executed in 2007 to jointly research, develop and commercialize human therapeutic products containing BCL-2 inhibitors and certain other compound inhibitors which includes Venclexta, a BCL-2 inhibitor used to treat certain hematological malignancies. AbbVie shares equally with Genentech all pre-tax profits and losses from the development and commercialization of Venclexta in the United States. AbbVie pays royalties on Venclexta net revenues outside the United States.
AbbVie manufactures and distributes Venclexta globally and is the principal in the end-customer product sales. Sales of Venclexta are included in AbbVie's net revenues. Genentech's share of United States profits is included in AbbVie's cost of products sold. AbbVie records sales and marketing costs associated with the United States collaboration as part of SG&A expenses and global development costs as part of R&D expenses, net of Genentech’s share. Royalties paid for Venclexta revenues outside the United States are also included in AbbVie’s cost of products sold.
The following table shows the profit and cost sharing relationship between Genentech and AbbVie: | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Genentech's share of profits, including royalties (included in cost of products sold) | $ | 703 | | | $ | 533 | | | $ | 320 | |
AbbVie's share of sales and marketing costs from U.S. collaboration (included in SG&A) | 40 | | | 46 | | | 41 | |
AbbVie's share of development costs (included in R&D) | 140 | | | 129 | | | 128 | |
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Note 7 Goodwill and Intangible Assets Goodwill
The following table summarizes the changes in the carrying amount of goodwill: | | | | | |
(in millions) | |
Balance as of December 31, 2019 | $ | 15,604 | |
Additions(a) | 17,008 | |
Foreign currency translation adjustments | 512 | |
Balance as of December 31, 2020 | 33,124 | |
Additions(b) | 177 | |
Measurement period adjustments(c) | (564) | |
Foreign currency translation adjustments and other | (358) | |
Balance as of December 31, 2021 | $ | 32,379 | |
(a)Goodwill additions related to the acquisition of Allergan in the second quarter of 2020 and the acquisition of Luminera in the fourth quarter of 2020 (see Note 5).
(b)Goodwill additions related to the acquisition of Soliton in the fourth quarter of 2021 (see Note 5).
(c)Measurement period adjustments recorded in 2021 related to the acquisition of Allergan (see Note 5).
The company performs its annual goodwill impairment assessment in the third quarter, or earlier if impairment indicators exist. As of December 31, 2021, there were no accumulated goodwill impairment losses.
Intangible Assets, Net
The following table summarizes intangible assets: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2021 | | 2020 |
as of December 31 (in millions) | Gross carrying amount | | Accumulated amortization | | Net carrying amount | | Gross carrying amount | | Accumulated amortization | | Net carrying amount |
Definite-lived intangible assets | | | | | | | | | | | |
Developed product rights | $ | 88,945 | | | $ | (18,463) | | | $ | 70,482 | | | $ | 87,707 | | | $ | (11,620) | | | $ | 76,087 | |
License agreements | 8,487 | | | (3,688) | | | 4,799 | | | 7,828 | | | (2,916) | | | 4,912 | |
Total definite-lived intangible assets | 97,432 | | | (22,151) | | | 75,281 | | | 95,535 | | | (14,536) | | | 80,999 | |
Indefinite-lived research and development | 670 | | | — | | | 670 | | | 1,877 | | | — | | | 1,877 | |
Total intangible assets, net | $ | 98,102 | | | $ | (22,151) | | | $ | 75,951 | | | $ | 97,412 | | | $ | (14,536) | | | $ | 82,876 | |
Definite-Lived Intangible Assets
The increase in definite-lived intangible assets during 2021 was primarily due to the measurement period adjustments from the completion of the valuation of certain license agreements acquired in the Allergan acquisition as well as the acquisition of Soliton. Refer to Note 5 for additional information regarding these acquisitions and related adjustments. In 2021, AbbVie also reclassified $1.0 billion of indefinite-lived research and development intangible assets to developed product rights upon receiving certain regulatory approvals for Vuity, Qulipta, and HArmonyCa.
Definite-lived intangible assets are amortized over their estimated useful lives, which range between 1 to 16 years with an average of 12 years for developed product rights and 11 years for license agreements. Amortization expense was $7.7 billion in 2021, $5.8 billion in 2020 and $1.6 billion in 2019 and was included in cost of products sold in the consolidated statements of earnings. The anticipated annual amortization expense for definite-lived intangible assets recorded as of December 31, 2021 is as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(in billions) | 2022 | | 2023 | | 2024 | | 2025 | | 2026 |
Anticipated annual amortization expense | $ | 7.2 | | | $ | 7.5 | | | $ | 8.0 | | | $ | 8.4 | | | $ | 7.9 | |
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Indefinite-Lived Intangible Assets
Indefinite-lived intangible assets represent acquired IPR&D associated with products that have not yet received regulatory approval. Indefinite-lived intangible assets as of December 31, 2021 primarily relate to the acquisition of Allergan.
The company performs its annual impairment assessment of indefinite-lived intangible assets in the third quarter, or earlier if impairment indicators exist.
In 2019, following the announcement of the decision to terminate the rovalpituzumab tesirine (Rova-T) R&D program, the company recorded an impairment charge of $1.0 billion which represented the remaining value of the IPR&D acquired as part of the 2016 Stemcentrx acquisition. The impairment charge was recorded to R&D expense in the consolidated statements of earnings in 2019.
Note 8 Integration and Restructuring Plans Allergan Integration Plan
Following the closing of the Allergan acquisition, AbbVie implemented an integration plan designed to reduce costs, integrate and optimize the combined organization. To achieve these integration objectives, AbbVie expects to incur total cumulative charges of approximately $2 billion of charges through 2022. These costs will consist of severance and employee benefit costs (cash severance, non-cash severance, including accelerated equity award compensation expense, retention and other termination benefits) and other integration expenses.
The following table summarizes the charges associated with the Allergan acquisition integration plan: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Severance and employee benefits | | Other integration |
year ended December 31 (in millions) | | 2021 | | 2020 | | 2021 | | 2020 |
Cost of products sold | | $ | 5 | | | $ | 109 | | | $ | 127 | | | $ | 21 | |
Research and development | | — | | | 199 | | | 102 | | | 177 | |
Selling, general and administrative | | 64 | | | 388 | | | 289 | | | 237 | |
Total charges | | $ | 69 | | | $ | 696 | | | $ | 518 | | | $ | 435 | |
The following table summarizes the cash activity in the recorded liability associated with the integration plan: | | | | | | | | | | | | |
year ended December 31 (in millions) | Severance and employee benefits | | | Other integration |
| | | | |
Charges | $ | 594 | | | | $ | 435 | |
Payments and other adjustments | (227) | | | | (415) | |
Accrued balance as of December 31, 2020 | $ | 367 | | | | $ | 20 | |
Charges | 65 | | | | 461 | |
Payments and other adjustments | (210) | | | | (448) | |
Accrued balance as of December 31, 2021 | $ | 222 | | | | $ | 33 | |
Other Restructuring
AbbVie continuously evaluates its operations to identify opportunities to optimize its manufacturing and R&D operations, commercial infrastructure and administrative costs and to respond to changes in its business environment. As a result, AbbVie management periodically approves individual restructuring plans to achieve these objectives. In 2021, 2020 and 2019, no such plans were individually significant. Restructuring charges recorded were $59 million in 2021, $60 million in 2020 and $234 million in 2019 and were primarily related to employee severance and contractual obligations. These charges were recorded in cost of products sold, R&D expense and SG&A expenses in the consolidated statements of earnings based on the classification of the affected employees or operations.
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The following table summarizes the cash activity in the restructuring reserve for 2021, 2020 and 2019:
| | | | | |
(in millions) | |
Accrued balance as of December 31, 2018 | $ | 99 | |
Restructuring charges | 219 | |
Payments and other adjustments | (178) | |
Accrued balance as of December 31, 2019 | 140 | |
Restructuring charges | 58 | |
Payments and other adjustments | (108) | |
Accrued balance as of December 31, 2020 | 90 | |
Restructuring charges | 54 | |
Payments and other adjustments | (111) | |
Accrued balance as of December 31, 2021 | $ | 33 | |
AbbVie's lease portfolio primarily consists of real estate properties, vehicles and equipment. The following table summarizes the amounts and location of operating and finance leases on the consolidated balance sheets:
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as of December 31 (in millions) | Balance sheet caption | 2021 | | 2020 |
Assets | | | | |
Operating | Other assets | $ | 762 | | | $ | 895 | |
Finance | Property and equipment, net | 33 | | | 27 | |
Total lease assets | | $ | 795 | | | $ | 922 | |
Liabilities | | | | |
Operating | | | | |
Current | Accounts payable and accrued liabilities | $ | 178 | | | $ | 175 | |
Noncurrent | Other long-term liabilities | 713 | | | 832 | |
Finance | | | | |
Current | Current portion of long-term debt and finance lease obligations | 9 | | | 8 | |
Noncurrent | Long-term debt and finance lease obligations | 25 | | | 21 | |
Total lease liabilities | | $ | 925 | | | $ | 1,036 | |
The following table summarizes the lease costs recognized in the consolidated statements of earnings:
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years ended December 31 (in millions) | | 2021 | | 2020 | | 2019 |
Operating lease cost | | $ | 226 | | | $ | 192 | | | $ | 124 | |
| | | | | | |
| | | | | | |
| | | | | | |
Short-term lease cost | | 56 | | | 59 | | | 34 | |
Variable lease cost | | 71 | | | 60 | | | 62 | |
Total lease cost | | $ | 353 | | | $ | 311 | | | $ | 220 | |
Sublease income and finance lease costs were insignificant in 2021, 2020 and 2019.
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The following table presents the weighted-average remaining lease term and weighted-average discount rate for operating and finance leases: | | | | | | | | | | | | | | | | | |
years ended December 31 | 2021 | | 2020 | | 2019 |
Weighted-average remaining lease term (years) | | | | | |
Operating | 7 | | 8 | | 5 |
Finance | 3 | | 3 | | 3 |
Weighted-average discount rate | | | | | |
Operating | 2.4 | % | | 2.5 | % | | 3.9 | % |
Finance | 1.1 | % | | 1.4 | % | | 3.9 | % |
The following table presents supplementary cash flow information regarding the company's leases: | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Cash paid for amounts included in the measurement of lease liabilities | | | | | |
Operating cash flows from operating leases | $ | 236 | | | $ | 185 | | | $ | 125 | |
| | | | | |
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| | | | | |
Right-of-use assets obtained in exchange for new operating lease liabilities | 66 | | | 692 | | | 26 | |
Finance lease cash flows were insignificant in 2021, 2020 and 2019. Right-of-use assets obtained in exchange for new operating lease liabilities as of December 31, 2020 included $453 million of right-of-use assets acquired in the Allergan acquisition.
The following table summarizes the future maturities of AbbVie's operating and finance lease liabilities as of December 31, 2021: | | | | | | | | | | | | | | | | | |
(in millions) | Operating leases | | Finance leases | | Total (a) |
2022 | $ | 179 | | | $ | 9 | | | $ | 188 | |
2023 | 162 | | | 9 | | | 171 | |
2024 | 126 | | | 7 | | | 133 | |
2025 | 105 | | | 5 | | | 110 | |
2026 | 91 | | | 9 | | | 100 | |
Thereafter | 317 | | | — | | | 317 | |
Total lease payments | 980 | | | 39 | | | 1,019 | |
Less: Interest | 89 | | | 5 | | | 94 | |
Present value of lease liabilities | $ | 891 | | | $ | 34 | | | $ | 925 | |
(a)Lease payments recognized as part of lease liabilities for optional renewal periods are insignificant.
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Note 10 Debt, Credit Facilities and Commitments and Contingencies The following table summarizes long-term debt: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
as of December 31 (dollars in millions) | Effective interest rate in 2021(a) | | 2021 | | Effective interest rate in 2020(a) | | 2020 | | | | | |
Senior notes issued in 2012 | | | | | | | | | | | | |
2.90% notes due 2022 | 2.97 | % | | $ | 3,100 | | | 2.97 | % | | $ | 3,100 | | | | | | |
4.40% notes due 2042 | 4.46 | % | | 2,600 | | | 4.46 | % | | 2,600 | | | | | | |
Senior notes issued in 2015 | | | | | | | | | | | | |
3.20% notes due 2022 | 3.28 | % | | 1,000 | | | 3.28 | % | | 1,000 | | | | | | |
3.60% notes due 2025 | 3.66 | % | | 3,750 | | | 3.66 | % | | 3,750 | | | | | | |
4.50% notes due 2035 | 4.58 | % | | 2,500 | | | 4.58 | % | | 2,500 | | | | | | |
4.70% notes due 2045 | 4.73 | % | | 2,700 | | | 4.73 | % | | 2,700 | | | | | | |
Senior notes issued in 2016 | | | | | | | | | | | | |
2.30% notes due 2021 | 2.40 | % | | — | | | 2.40 | % | | 1,800 | | | | | | |
2.85% notes due 2023 | 2.91 | % | | 1,000 | | | 2.91 | % | | 1,000 | | | | | | |
3.20% notes due 2026 | 3.28 | % | | 2,000 | | | 3.28 | % | | 2,000 | | | | | | |
4.30% notes due 2036 | 4.37 | % | | 1,000 | | | 4.37 | % | | 1,000 | | | | | | |
4.45% notes due 2046 | 4.50 | % | | 2,000 | | | 4.50 | % | | 2,000 | | | | | | |
Senior Euro notes issued in 2016 | | | | | | | | | | | | |
1.375% notes due 2024 (€1,450 principal) | 1.46 | % | | 1,643 | | | 1.46 | % | | 1,783 | | | | | | |
2.125% notes due 2028 (€750 principal) | 2.18 | % | | 850 | | | 2.18 | % | | 922 | | | | | | |
Senior notes issued in 2018 | | | | | | | | | | | | |
3.375% notes due 2021 | 3.51 | % | | — | | | 3.51 | % | | 1,250 | | | | | | |
3.75% notes due 2023 | 3.84 | % | | 1,250 | | | 3.84 | % | | 1,250 | | | | | | |
4.25% notes due 2028 | 4.38 | % | | 1,750 | | | 4.38 | % | | 1,750 | | | | | | |
4.875% notes due 2048 | 4.94 | % | | 1,750 | | | 4.94 | % | | 1,750 | | | | | | |
Senior Euro notes issued in 2019 | | | | | | | | | | | | |
0.75% notes due 2027 (€750 principal) | 0.86 | % | | 850 | | | 0.86 | % | | 922 | | | | | | |
1.25% notes due 2031 (€650 principal) | 1.30 | % | | 737 | | | 1.30 | % | | 799 | | | | | | |
Senior notes issued in 2019 | | | | | | | | | | | | |
Floating rate notes due May 2021 | 0.74 | % | | — | | | 1.33 | % | | 750 | | | | | | |
Floating rate notes due November 2021 | 0.78 | % | | — | | | 1.42 | % | | 750 | | | | | | |
Floating rate notes due 2022 | 0.99 | % | | 750 | | | 1.62 | % | | 750 | | | | | | |
2.15% notes due 2021 | 2.23 | % | | — | | | 2.23 | % | | 1,750 | | | | | | |
2.30% notes due 2022 | 2.42 | % | | 3,000 | | | 2.42 | % | | 3,000 | | | | | | |
2.60% notes due 2024 | 2.69 | % | | 3,750 | | | 2.69 | % | | 3,750 | | | | | | |
2.95% notes due 2026 | 3.02 | % | | 4,000 | | | 3.02 | % | | 4,000 | | | | | | |
3.20% notes due 2029 | 3.25 | % | | 5,500 | | | 3.25 | % | | 5,500 | | | | | | |
4.05% notes due 2039 | 4.11 | % | | 4,000 | | | 4.11 | % | | 4,000 | | | | | | |
4.25% notes due 2049 | 4.29 | % | | 5,750 | | | 4.29 | % | | 5,750 | | | | | | |
Term loan facilities | | | | | | | | | | | | |
Floating rate notes due 2023 | 1.23 | % | | — | | | 1.29 | % | | 1,000 | | | | | | |
Floating rate notes due 2023 | 0.81 | % | | 1,000 | | | — | % | | — | | | | | | |
Floating rate notes due 2025 | 1.36 | % | | 2,000 | | | 1.42 | % | | 2,000 | | | | | | |
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71 | | 2021 Form 10-K | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
as of December 31 (dollars in millions) | Effective interest rate in 2021(a) | | 2021 | | Effective interest rate in 2020(a) | | 2020 | | | | | |
Senior notes acquired in 2020 | | | | | | | | | | | | |
5.000% notes due 2021 | 1.53 | % | | — | | | 1.53 | % | | 1,200 | | | | | | |
3.450% notes due 2022 | 1.97 | % | | 2,878 | | | 1.97 | % | | 2,878 | | | | | | |
3.250% notes due 2022 | 1.92 | % | | 1,700 | | | 1.92 | % | | 1,700 | | | | | | |
2.800% notes due 2023 | 2.13 | % | | 350 | | | 2.13 | % | | 350 | | | | | | |
3.850% notes due 2024 | 2.07 | % | | 1,032 | | | 2.07 | % | | 1,032 | | | | | | |
3.800% notes due 2025 | 2.09 | % | | 3,021 | | | 2.09 | % | | 3,021 | | | | | | |
4.550% notes due 2035 | 3.52 | % | | 1,789 | | | 3.52 | % | | 1,789 | | | | | | |
4.625% notes due 2042 | 4.00 | % | | 457 | | | 4.00 | % | | 457 | | | | | | |
4.850% notes due 2044 | 4.11 | % | | 1,074 | | | 4.11 | % | | 1,074 | | | | | | |
4.750% notes due 2045 | 4.20 | % | | 881 | | | 4.20 | % | | 881 | | | | | | |
Senior Euro notes acquired in 2020 | | | | | | | | | | | | |
0.500% notes due 2021 (€750 principal) | 0.72 | % | | — | | | 0.72 | % | | 922 | | | | | | |
1.500% notes due 2023 (€500 principal) | 0.49 | % | | 567 | | | 0.49 | % | | 615 | | | | | | |
1.250% notes due 2024 (€700 principal) | 0.65 | % | | 793 | | | 0.65 | % | | 861 | | | | | | |
2.625% notes due 2028 (€500 principal) | 1.20 | % | | 567 | | | 1.20 | % | | 615 | | | | | | |
2.125% notes due 2029 (€550 principal) | 1.19 | % | | 623 | | | 1.19 | % | | 677 | | | | | | |
Other | | | 33 | | | | | 29 | | | | | | |
Fair value hedges | | | 102 | | | | | 278 | | | | | | |
Unamortized bond discounts | | | (130) | | | | | (146) | | | | | | |
Unamortized deferred financing costs | | | (251) | | | | | (287) | | | | | | |
Unamortized bond premiums (b) | | | 954 | | | | | 1,200 | | | | | | |
Total long-term debt and finance lease obligations | | | 76,670 | | | | | 86,022 | | | | | | |
Current portion | | | 12,481 | | | | | 8,468 | | | | | | |
Noncurrent portion | | | $ | 64,189 | | | | | $ | 77,554 | | | | | | |
(a)Excludes the effect of any related interest rate swaps.
(b)Represents unamortized purchase price adjustments of Allergan debt.
In April 2021, the company repaid $1.8 billion aggregate principal amount of 2.3% senior notes that were scheduled to mature in May 2021. In May 2021, the company repaid €750 million aggregate principal amount of 0.5% senior Euro notes that were scheduled to mature in June 2021. These repayments were made by exercising, under the terms of the notes, 30-day early redemptions at 100% of the principal amounts. The company also repaid $750 million aggregate principal amount of floating rate senior notes at maturity in May 2021.
In September 2021, the company refinanced its $1.0 billion floating rate three-year term loan. As part of the refinancing, the company repaid the existing $1.0 billion term loan due May 2023 and borrowed $1.0 billion under a new term loan at a lower floating rate. All other significant terms of the loan, including the maturity date, remained unchanged after the refinancing.
In September 2021, the company repaid $1.2 billion aggregate principal amount of 5.0% senior notes that were scheduled to mature in December 2021. This repayment was made by exercising, under the terms of the notes, 90-day early redemption at 100% of the principal amount.
In November 2021, the company repaid $1.3 billion aggregate principal amount of 3.375% senior notes and $1.8 billion aggregate principal amount of 2.15% senior notes at maturity. The company also repaid $750 million aggregate principal amount of floating rate senior notes at maturity in November 2021.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 72 |
In January 2022, the company repaid $2.9 billion aggregate principal amount of 3.450% senior notes that were scheduled to mature in March 2022. This repayment was made by exercising, under the terms of the notes, 60-day early redemption at 100% of the principal amount.
In connection with the acquisition of Allergan, in May 2020, the company borrowed $3.0 billion under a $6.0 billion term loan credit agreement, of which $1.0 billion was outstanding under a floating rate three-year term loan tranche and $2.0 billion outstanding under a floating rate five-year term loan tranche as of December 31, 2021. Subsequent to these borrowings, AbbVie terminated the unused commitments of the lenders under the term loan.
In May 2020, AbbVie completed its previously announced offers to exchange any and all outstanding notes of certain series issued by Allergan for new notes to be issued by AbbVie and cash. Following the settlement of the exchange offers, AbbVie issued $14.0 billion and €3.1 billion of new notes in exchange for the Allergan notes tendered in the exchange offers. The aggregate principal amount of Allergan notes that remained outstanding following the settlement of the exchange offers was approximately $1.5 billion and €635 million. The exchange transaction was accounted for as a modification of the assumed debt instruments.
In May 2020, the company repaid $3.8 billion aggregate principal amount of 2.5% senior notes at maturity.
In September 2020, the company repaid $650 million aggregate principal amount of 3.375% senior notes at maturity.
In November 2020, the company repaid €700 million aggregate principal amount of floating rate senior Euro notes at maturity and $450 million aggregate principal amount of 4.875% senior notes due February 2021 three months prior to maturity.
In September 2019, the company issued €1.4 billion aggregate principal amount of unsecured senior Euro notes. These senior notes rank equally with all other unsecured and unsubordinated indebtedness of the company. AbbVie may redeem the senior notes prior to maturity at a redemption price equal to the principal amount of the senior notes redeemed plus a make-whole premium and may redeem the senior notes at par between one and three months prior to maturity. In connection with the offering, debt issuance costs incurred totaled $9 million and debt discounts totaled $5 million and are being amortized over the respective terms of the notes to interest expense, net in the consolidated statements of earnings. In October 2019, the company used the proceeds to redeem €1.4 billion aggregate principal amount of 0.375% senior Euro notes that were due to mature in November 2019.
In November 2019, the company issued $30.0 billion aggregate principal amount of unsecured senior notes. These senior notes rank equally with all other unsecured and unsubordinated indebtedness of the company. AbbVie may redeem the fixed-rate senior notes prior to maturity at a redemption price equal to the greater of the principal amount or the sum of present values of the remaining scheduled payments of principal and interest on the fixed-rate senior notes to be redeemed plus a make-whole premium. With exception of the fixed-rate notes due 2021 and 2022, AbbVie may also redeem the fixed-rate senior notes at par between one and six months prior to maturity. In connection with the offering, debt issuance costs incurred totaled $173 million and debt discounts totaled $52 million, which are being amortized over the respective terms of the notes to interest expense, net in the consolidated statements of earnings. AbbVie used the net proceeds to fund a portion of the aggregate cash consideration due to Allergan shareholders in connection with the acquisition described in Note 5 and to pay related fees and expenses.
AbbVie has outstanding $4.8 billion aggregate principal amount of unsecured senior notes which were issued in 2018. AbbVie may redeem the senior notes prior to maturity at a redemption price equal to the principal amount of the senior notes redeemed plus a make-whole premium and AbbVie may redeem the senior notes at par between one month and six months prior to maturity.
AbbVie has outstanding €2.2 billion aggregate principal amount of unsecured senior Euro notes which were issued in 2016. AbbVie may redeem the senior notes prior to maturity at a redemption price equal to the principal amount of the senior notes redeemed plus a make-whole premium and AbbVie may redeem the senior notes at par between one and three months prior to maturity.
AbbVie has outstanding $6.0 billion aggregate principal amount of unsecured senior notes which were issued in 2016 and $10.0 billion aggregate principal amount of unsecured senior notes which were issued in 2015. AbbVie may redeem the senior notes, at any time, prior to maturity at a redemption price equal to the principal amount of the senior notes redeemed plus a make-whole premium and AbbVie may redeem the senior notes at par between one and six months prior to maturity.
AbbVie has outstanding $5.7 billion aggregate principal amount of unsecured senior notes which were issued in 2012. AbbVie may redeem all of the senior notes of each series, at any time, or some of the senior notes of each series, from time to time, at a redemption price equal to the principal amount of the senior notes redeemed plus a make-whole premium.
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73 | | 2021 Form 10-K | | |
At December 31, 2021, the company was in compliance with its senior note covenants and term loan covenants.
Short-Term Borrowings
There were no commercial paper borrowings outstanding as of December 31, 2021 and December 31, 2020. No commercial paper borrowings were issued during 2021. The weighted-average interest rate on commercial paper borrowings was 1.8% in 2020 and 2.5% in 2019.
In August 2019, AbbVie entered into an amended and restated $4.0 billion five-year revolving credit facility that matures in August 2024. This amended facility enables the company to borrow funds on an unsecured basis at variable interest rates and contains various covenants, all of which the company was in compliance with as of December 31, 2021. Commitment fees under AbbVie's revolving credit facilities were insignificant in 2021, 2020 and 2019. No amounts were outstanding under the company's credit facilities as of December 31, 2021 and December 31, 2020.
In March 2019, AbbVie repaid a $3.0 billion 364-day term loan credit agreement that was drawn on in June 2018 and was scheduled to mature in June 2019.
Maturities of Long-Term Debt
The following table summarizes AbbVie's debt maturities as of December 31, 2021: | | | | | |
as of and for the years ending December 31 (in millions) | |
2022 | $ | 12,428 | |
2023 | 4,167 | |
2024 | 7,219 | |
2025 | 8,771 | |
2026 | 6,000 | |
Thereafter | 37,377 | |
Total obligations and commitments | 75,962 | |
Fair value hedges, unamortized bond premiums and discounts, deferred financing costs and finance lease obligations | 708 | |
Total long-term debt and finance lease obligations | $ | 76,670 | |
Contingencies and Guarantees
In connection with the separation, AbbVie has indemnified Abbott for all liabilities resulting from the operation of AbbVie's business other than income tax liabilities with respect to periods prior to the distribution date and other liabilities as agreed to by AbbVie and Abbott. AbbVie has no material exposures to off-balance sheet arrangements and no special-purpose entities. In the ordinary course of business, AbbVie has periodically entered into third-party agreements, such as the assignment of product rights, which have resulted in AbbVie becoming secondarily liable for obligations for which AbbVie had previously been primarily liable. Based upon past experience, the likelihood of payments under these agreements is remote.
Note 11 Financial Instruments and Fair Value Measures Risk Management Policy
The company is exposed to foreign currency exchange rate and interest rate risks related to its business operations. AbbVie's hedging policy attempts to manage these risks to an acceptable level based on the company's judgment of the appropriate trade-off between risk, opportunity and costs. The company uses derivative and nonderivative instruments to reduce its exposure to foreign currency exchange rates. AbbVie also periodically enters into interest rate swaps in which the company agrees to exchange, at specified intervals, the difference between fixed and floating interest amounts calculated by reference to an agreed-upon notional amount. Derivative instruments are not used for trading purposes or to manage exposure to changes in interest rates for investment securities, and none of the company's outstanding derivative instruments contain credit risk related contingent features; collateral is generally not required.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 74 |
Financial Instruments
Various AbbVie foreign subsidiaries enter into foreign currency forward exchange contracts to manage exposures to changes in foreign exchange rates for anticipated intercompany transactions denominated in a currency other than the functional currency of the local entity. These contracts, with notional amounts totaling $1.1 billion at December 31, 2021 and $1.5 billion at December 31, 2020, are designated as cash flow hedges and are recorded at fair value. The durations of these forward exchange contracts were generally less than 18 months. Accumulated gains and losses as of December 31, 2021 will be reclassified from AOCI and included in cost of products sold at the time the products are sold, generally not exceeding six months from the date of settlement.
In the third quarter of 2019, the company entered into treasury rate lock agreements with notional amounts totaling $10.0 billion to hedge exposure to variability in future cash flows resulting from changes in interest rates related to the issuance of long-term debt in connection with the acquisition of Allergan. The treasury rate lock agreements were designated as cash flow hedges and recorded at fair value. The agreements were net settled upon issuance of the senior notes in November 2019 resulting in a pre-tax gain of $383 million recognized in other comprehensive income (loss). This gain is reclassified to interest expense, net over the term of the related debt.
The company is a party to interest rate swap contracts designed as cash flow hedges with notional amounts totaling $750 million at December 31, 2021 and $2.3 billion at December 31, 2020. The effect of the hedge contracts is to change a floating-rate interest obligation to a fixed rate for that portion of the floating-rate debt. Realized and unrealized gains or losses are included in AOCI and are reclassified to interest expense, net over the lives of the floating-rate debt.
The company also enters into foreign currency forward exchange contracts to manage its exposure to foreign currency denominated trade payables and receivables and intercompany loans. These contracts are not designated as hedges and are recorded at fair value. Resulting gains or losses are reflected in net foreign exchange loss in the consolidated statements of earnings and are generally offset by losses or gains on the foreign currency exposure being managed. These contracts had notional amounts totaling $8.2 billion at December 31, 2021 and $8.6 billion at December 31, 2020.
The company also uses foreign currency forward exchange contracts or foreign currency denominated debt to hedge its net investments in certain foreign subsidiaries and affiliates. The company had an aggregate principal amount of senior Euro notes designated as net investment hedges of €5.9 billion at December 31, 2021 and €6.6 billion at December 31, 2020. In addition, the company had foreign currency forward exchange contracts designated as net investment hedges with notional amounts totaling €4.3 billion at December 31, 2021 and €971 million at December 31, 2020. The company uses the spot method of assessing hedge effectiveness for derivative instruments designated as net investment hedges. Realized and unrealized gains and losses from these hedges are included in AOCI and the initial fair value of hedge components excluded from the assessment of effectiveness is recognized in interest expense, net over the life of the hedging instrument.
The company is a party to interest rate swap contracts designated as fair value hedges with notional amounts totaling $4.5 billion at December 31, 2021 and $4.8 billion at December 31, 2020. The effect of the hedge contracts is to change a fixed-rate interest obligation to a floating rate for that portion of the debt. AbbVie records the contracts at fair value and adjusts the carrying amount of the fixed-rate debt by an offsetting amount.
No amounts are excluded from the assessment of effectiveness for cash flow hedges or fair value hedges.
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75 | | 2021 Form 10-K | | |
The following table summarizes the amounts and location of AbbVie's derivative instruments on the consolidated balance sheets: | | | | | | | | | | | | | | | | | | | | | | | |
| Fair value - Derivatives in asset position | | Fair value - Derivatives in liability position |
as of December 31 (in millions) | Balance sheet caption | 2021 | 2020 | | Balance sheet caption | 2021 | 2020 |
Foreign currency forward exchange contracts | | | | | | | |
Designated as cash flow hedges | Prepaid expenses and other | $ | 51 | | $ | 2 | | | Accounts payable and accrued liabilities | $ | 2 | | $ | 82 | |
| | | | | | | |
Designated as cash flow hedges | Other assets | — | | — | | | Other long-term liabilities | — | | 6 | |
Designated as net investment hedges | Prepaid expenses and other | 149 | | — | | | Accounts payable and accrued liabilities | — | | 11 | |
Designated as net investment hedges | Other assets | 15 | | — | | | Other long-term liabilities | — | | — | |
Not designated as hedges | Prepaid expenses and other | 26 | | 49 | | | Accounts payable and accrued liabilities | 13 | | 33 | |
Interest rate swap contracts | | | | | | | |
Designated as cash flow hedges | Prepaid expenses and other | — | | — | | | Accounts payable and accrued liabilities | 7 | | 14 | |
Designated as cash flow hedges | Other assets | — | | — | | | Other long-term liabilities | — | | 20 | |
Designated as fair value hedges | Prepaid expenses and other | — | | 7 | | | Accounts payable and accrued liabilities | — | | — | |
Designated as fair value hedges | Other assets | 26 | | 131 | | | Other long-term liabilities | 15 | | — | |
Total derivatives | | $ | 267 | | $ | 189 | | | | $ | 37 | | $ | 166 | |
While certain derivatives are subject to netting arrangements with the company's counterparties, the company does not offset derivative assets and liabilities within the consolidated balance sheets.
The following table presents the pre-tax amounts of gains (losses) from derivative instruments recognized in other comprehensive income (loss): | | | | | | | | | | | | | | | | | | | | |
years ended in December 31 (in millions) | | 2021 | | 2020 | | 2019 |
Foreign currency forward exchange contracts | | | | | | |
Designated as cash flow hedges | | $ | 82 | | | $ | (71) | | | $ | (5) | |
Designated as net investment hedges | | 341 | | | (95) | | | 33 | |
Interest rate swap contracts designated as cash flow hedges | | 2 | | | (53) | | | 4 | |
Treasury rate lock agreements designated as cash flow hedges | | — | | | — | | | 383 | |
Assuming market rates remain constant through contract maturities, the company expects to reclassify pre-tax gains of $65 million into cost of products sold for foreign currency cash flow hedges, pre-tax losses of $7 million into interest expense, net for interest rate swap cash flow hedges and pre-tax gains of $24 million into interest expense, net for treasury rate lock agreement cash flow hedges during the next 12 months.
Related to AbbVie’s non-derivative, foreign currency denominated debt designated as net investment hedges, the company recognized in other comprehensive income (loss) pre-tax gains of $577 million in 2021, pre-tax losses of $907 million in 2020 and pre-tax gains of $90 million in 2019.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 76 |
The following table summarizes the pre-tax amounts and location of derivative instrument net gains (losses) recognized in the consolidated statements of earnings, including the net gains (losses) reclassified out of AOCI into net earnings. See Note 13 for the amount of net gains (losses) reclassified out of AOCI. | | | | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | Statement of earnings caption | 2021 | | 2020 | | 2019 |
Foreign currency forward exchange contracts | | | | | | |
Designated as cash flow hedges | Cost of products sold | $ | (87) | | | $ | 23 | | | $ | 167 | |
Designated as net investment hedges | Interest expense, net | 26 | | | 18 | | | 27 | |
Not designated as hedges | Net foreign exchange loss | (100) | | | 58 | | | (70) | |
Treasury rate lock agreements designated as cash flow hedges | Interest expense, net | 24 | | | 24 | | | 3 | |
Interest rate swap contracts | | | | | | |
Designated as cash flow hedges | Interest expense, net | (24) | | | (17) | | | 1 | |
Designated as fair value hedges | Interest expense, net | (127) | | | 365 | | | 418 | |
Debt designated as hedged item in fair value hedges | Interest expense, net | 127 | | | (365) | | | (418) | |
Fair Value Measures
The fair value hierarchy consists of the following three levels:
•Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets that the company has the ability to access;
•Level 2—Valuations based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuations in which all significant inputs are observable in the market; and
•Level 3—Valuations using significant inputs that are unobservable in the market and include the use of judgment by the company's management about the assumptions market participants would use in pricing the asset or liability.
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77 | | 2021 Form 10-K | | |
The following table summarizes the bases used to measure certain assets and liabilities carried at fair value on a recurring basis on the consolidated balance sheet as of December 31, 2021: | | | | | | | | | | | | | | | | | | | | | | | |
| | | Basis of fair value measurement |
(in millions) | Total | | Quoted prices in active markets for identical assets (Level 1) | | Significant other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
Assets | | | | | | | |
Cash and equivalents | $ | 9,746 | | | $ | 4,451 | | | $ | 5,295 | | | $ | — | |
Money market funds and time deposits | 45 | | | — | | | 45 | | | — | |
Debt securities | 46 | | | — | | | 46 | | | — | |
Equity securities | 121 | | | 100 | | | 21 | | | — | |
Interest rate swap contracts | 26 | | | — | | | 26 | | | — | |
Foreign currency contracts | 241 | | | — | | | 241 | | | — | |
| | | | | | | |
Total assets | $ | 10,225 | | | $ | 4,551 | | | $ | 5,674 | | | $ | — | |
Liabilities | | | | | | | |
Interest rate swap contracts | $ | 22 | | | $ | — | | | $ | 22 | | | $ | — | |
Foreign currency contracts | 15 | | | — | | | 15 | | | — | |
Contingent consideration | 14,887 | | | — | | | — | | | 14,887 | |
Total liabilities | $ | 14,924 | | | $ | — | | | $ | 37 | | | $ | 14,887 | |
The following table summarizes the bases used to measure certain assets and liabilities carried at fair value on a recurring basis on the consolidated balance sheet as of December 31, 2020: | | | | | | | | | | | | | | | | | | | | | | | |
| | | Basis of fair value measurement |
(in millions) | Total | | Quoted prices in active markets for identical assets (Level 1) | | Significant other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
Assets | | | | | | | |
Cash and equivalents | $ | 8,449 | | | $ | 2,758 | | | $ | 5,691 | | | $ | — | |
Money market funds and time deposits | 12 | | | — | | | 12 | | | — | |
Debt securities | 50 | | | — | | | 50 | | | — | |
Equity securities | 159 | | | 149 | | | 10 | | | — | |
Interest rate swap contracts | 138 | | | — | | | 138 | | | — | |
Foreign currency contracts | 51 | | | — | | | 51 | | | — | |
Total assets | $ | 8,859 | | | $ | 2,907 | | | $ | 5,952 | | | $ | — | |
Liabilities | | | | | | | |
Interest rate swap contracts | $ | 34 | | | $ | — | | | $ | 34 | | | $ | — | |
Foreign currency contracts | 132 | | | — | | | 132 | | | — | |
Contingent consideration | 12,997 | | | — | | | — | | | 12,997 | |
Total liabilities | $ | 13,163 | | | $ | — | | | $ | 166 | | | $ | 12,997 | |
Equity securities primarily consist of investments for which the fair values were determined by using the published market prices per unit multiplied by the number of units held, without consideration of transaction costs. The derivatives entered into by the company were valued using observable market inputs including published interest rate curves and both forward and spot prices for foreign currencies.
The fair value measurements of the contingent consideration liabilities were determined based on significant unobservable inputs, including the discount rate, estimated probabilities and timing of achieving specified development, regulatory and commercial milestones and the estimated amount of future sales of the acquired products. The potential contingent consideration payments are estimated by applying a probability-weighted expected payment model for contingent milestone payments and a Monte Carlo simulation model for contingent royalty payments, which are then discounted to present value. Changes to the fair value of the contingent consideration liabilities can result from changes to one or a number of inputs, including discount rates, the probabilities of achieving the milestones, the time required to achieve the milestones
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 78 |
and estimated future sales. Significant judgment is employed in determining the appropriateness of certain of these inputs. Changes to the inputs described above could have a material impact on the company's financial position and results of operations in any given period.
The fair value of the company's contingent consideration liabilities was calculated using the following significant unobservable inputs: | | | | | | | | | | | | | | | | | |
| 2021 | | 2020 |
years ended December 31 (in millions) | Range | Weighted Average(a) | | Range | Weighted Average(a) |
Discount rate | 0.2% - 2.6% | 1.7% | | 0.1% - 2.2% | 1.1 | % |
Probability of payment for unachieved milestones | 89% - 100% | 90% | | 56% - 92% | 64 | % |
Probability of payment for royalties by indication(b) | 56% - 100% | 96% | | 56% - 100% | 91 | % |
| | | | | |
Projected year of payments | 2022 - 2034 | 2027 | | 2021 - 2034 | 2027 |
(a)Unobservable inputs were weighted by the relative fair value of the contingent consideration liabilities.
(b)Excluding approved indications, the estimated probability of payment ranged from 56% to 89% at December 31, 2021 and 56% to 89% at December 31, 2020.
There have been no transfers of assets or liabilities into or out of Level 3 of the fair value hierarchy. The following table presents the changes in fair value of contingent consideration liabilities which are measured using Level 3 inputs: | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Beginning balance | $ | 12,997 | | | $ | 7,340 | | | $ | 4,483 | |
Additions(a) | — | | | 225 | | | — | |
Change in fair value recognized in net earnings | 2,679 | | | 5,753 | | | 3,091 | |
Payments | (789) | | | (321) | | | (234) | |
Ending balance | $ | 14,887 | | | $ | 12,997 | | | $ | 7,340 | |
(a)Additions during the year ended December 31, 2020 represent contingent consideration liabilities assumed in the Allergan acquisition as well as contingent consideration resulting from the Luminera acquisition (see Note 5).
The change in fair value recognized in net earnings is recorded in other expense, net in the consolidated statements of earnings. During the year-ended December 31, 2021, the company recorded a $2.7 billion increase in the Skyrizi contingent consideration liability due to higher estimated sales driven by stronger market share uptake, favorable clinical trial results and the passage of time, partially offset by higher discount rates. During the year-ended December 31, 2020, the company recorded a $5.7 billion increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake, lower discount rates, the passage of time and favorable clinical trial results. During the second quarter of 2019, the company recorded a $2.3 billion increase in the Skyrizi contingent consideration liability due to higher probabilities of success, higher estimated future sales and lower discount rates. The higher probabilities of success resulted from the April 2019 regulatory approvals of Skyrizi for the treatment of moderate to severe plaque psoriasis. During the third quarter of 2019, the company recorded a $91 million decrease in the Stemcentrx contingent consideration liability due to the termination of the Rova-T R&D program.
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79 | | 2021 Form 10-K | | |
Certain financial instruments are carried at historical cost or some basis other than fair value. The book values, approximate fair values and bases used to measure the approximate fair values of certain financial instruments as of December 31, 2021 are shown in the table below: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Basis of fair value measurement |
(in millions) | Book value | Approximate fair values | | Quoted prices in active markets for identical assets (Level 1) | | Significant other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
Liabilities | | | | | | | | |
Short-term borrowings | $ | 14 | | $ | 14 | | | $ | — | | | $ | 14 | | | $ | — | |
Current portion of long-term debt and finance lease obligations, excluding fair value hedges | 12,455 | | 11,830 | | | 11,329 | | | 501 | | | — | |
Long-term debt and finance lease obligations, excluding fair value hedges | 64,113 | | 71,810 | | | 70,757 | | | 1,053 | | | — | |
Total liabilities | $ | 76,582 | | $ | 83,654 | | | $ | 82,086 | | | $ | 1,568 | | | $ | — | |
The book values, approximate fair values and bases used to measure the approximate fair values of certain financial instruments as of December 31, 2020 are shown in the table below: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Basis of fair value measurement |
(in millions) | Book value | Approximate fair values | | Quoted prices in active markets for identical assets (Level 1) | | Significant other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
Liabilities | | | | | | | | |
Short-term borrowings | $ | 34 | | $ | 34 | | | $ | — | | | $ | 34 | | | $ | — | |
Current portion of long-term debt and finance lease obligations, excluding fair value hedges | $ | 8,461 | | $ | 8,542 | | | $ | 8,249 | | | $ | 293 | | | $ | — | |
Long-term debt and finance lease obligations, excluding fair value hedges | 77,283 | | 87,761 | | | 86,137 | | | 1,624 | | | — | |
Total liabilities | $ | 85,778 | | $ | 96,337 | | | $ | 94,386 | | | $ | 1,951 | | | $ | — | |
AbbVie also holds investments in equity securities that do not have readily determinable fair values. The company records these investments at cost and remeasures them to fair value based on certain observable price changes or impairment events as they occur. The carrying amount of these investments was $149 million as of December 31, 2021 and $102 million as of December 31, 2020. No significant cumulative upward or downward adjustments have been recorded for these investments as of December 31, 2021.
Concentrations of Risk
Of total net accounts receivable, three U.S. wholesalers accounted for 75% as of December 31, 2021 and 72% as of December 31, 2020, and substantially all of AbbVie's pharmaceutical product net revenues in the United States were to these three wholesalers.
Humira (adalimumab) is AbbVie's single largest product and accounted for approximately 37% of AbbVie's total net revenues in 2021, 43% in 2020 and 58% in 2019.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 80 |
Note 12 Post-Employment Benefits AbbVie sponsors various pension and other post-employment benefit plans, including defined benefit, defined contribution and termination indemnity plans, which cover most employees worldwide. In addition, AbbVie provides medical benefits, primarily to eligible retirees in the United States and Puerto Rico, through other post-retirement benefit plans. Net obligations for these plans have been reflected on the consolidated balance sheets as of December 31, 2021 and 2020.
The following table summarizes benefit plan information for the global AbbVie-sponsored defined benefit and other post-employment plans: | | | | | | | | | | | | | | | | | | | | | | | |
| Defined benefit plans | | Other post-employment plans |
as of and for the years ended December 31 (in millions) | 2021 | | 2020 | | 2021 | | 2020 |
Projected benefit obligations | | | | | | | |
Beginning of period | $ | 11,792 | | | $ | 8,646 | | | $ | 795 | | | $ | 1,050 | |
Service cost | 440 | | | 370 | | | 48 | | | 42 | |
Interest cost | 237 | | | 264 | | | 19 | | | 34 | |
Employee contributions | 2 | | | 2 | | | — | | | — | |
Amendments | — | | | — | | | — | | | (397) | |
Actuarial (gain) loss | (8) | | | 1,105 | | | 10 | | | 40 | |
Benefits paid | (281) | | | (249) | | | (22) | | | (17) | |
| | | | | | | |
Acquisition | — | | | 1,409 | | | — | | | 43 | |
Other, primarily foreign currency translation adjustments | (176) | | | 245 | | | — | | | — | |
End of period | 12,006 | | | 11,792 | | | 850 | | | 795 | |
Fair value of plan assets | | | | | | | |
Beginning of period | 9,702 | | | 7,116 | | | — | | | — | |
Actual return on plan assets | 1,000 | | | 979 | | | — | | | — | |
Company contributions | 376 | | | 367 | | | 22 | | | 17 | |
Employee contributions | 2 | | | 2 | | | — | | | — | |
Benefits paid | (281) | | | (249) | | | (22) | | | (17) | |
| | | | | | | |
Acquisition | — | | | 1,296 | | | — | | | — | |
Other, primarily foreign currency translation adjustments | (144) | | | 191 | | | — | | | — | |
End of period | 10,655 | | | 9,702 | | | — | | | — | |
Funded status, end of period | $ | (1,351) | | | $ | (2,090) | | | $ | (850) | | | $ | (795) | |
| | | | | | | |
Amounts recognized on the consolidated balance sheets | | | | | | | |
Other assets | $ | 991 | | | $ | 563 | | | $ | — | | | $ | — | |
Accounts payable and accrued liabilities | (13) | | | (12) | | | (26) | | | (23) | |
Other long-term liabilities | (2,329) | | | (2,641) | | | (824) | | | (772) | |
Net obligation | $ | (1,351) | | | $ | (2,090) | | | $ | (850) | | | $ | (795) | |
Actuarial loss, net | $ | 3,504 | | | $ | 4,163 | | | $ | 461 | | | $ | 482 | |
Prior service cost (credit) | 5 | | | 8 | | | (370) | | | (408) | |
Accumulated other comprehensive loss | $ | 3,509 | | | $ | 4,171 | | | $ | 91 | | | $ | 74 | |
The projected benefit obligations in the table above included $3.2 billion at December 31, 2021 and $3.5 billion at December 31, 2020, related to international defined benefit plans.
For plans reflected in the table above, the accumulated benefit obligations were $10.5 billion at December 31, 2021 and December 31, 2020.
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81 | | 2021 Form 10-K | | |
Information For Pension Plans With An Accumulated Benefit Obligation In Excess Of Plan Assets | | | | | | | | | | | |
as of December 31 (in millions) | 2021 | | 2020 |
Accumulated benefit obligation | $ | 6,395 | | | $ | 7,527 | |
Fair value of plan assets | 5,412 | | | 6,066 | |
Information For Pension Plans With A Projected Benefit Obligation In Excess Of Plan Assets | | | | | | | | | | | |
as of December 31 (in millions) | 2021 | | 2020 |
Projected benefit obligation | $ | 7,788 | | | $ | 8,719 | |
Fair value of plan assets | 5,447 | | | 6,066 | |
The 2021 actuarial gain of $8 million for qualified pension plans and actuarial loss of $10 million for other post-employment plans were primarily driven by an increase in the assumed discount rate offset by change in demographic assumptions from 2020. The 2020 actuarial losses of $1.1 billion for qualified pension plans and $40 million for other post-employment plans were primarily driven by a decrease in the assumed discount rate from 2019.
AbbVie's U.S. pension plan was modified to close the plan to new entrants effective January 1, 2022. In addition, a change to AbbVie's U.S. retiree health benefit plan was approved in 2020 and communicated to employees and retirees in October 2020. Beginning in 2022, Medicare-eligible retirees and Medicare-eligible dependents will choose health care coverage from insurance providers through a private Medicare exchange. AbbVie will continue to provide financial support to Medicare-eligible retirees. This change to the U.S. retiree health benefit plan decreased AbbVie's post-employment benefit obligation and increased AbbVie's unrecognized prior service credit as of December 31, 2020 by $397 million.
In connection with the Allergan acquisition, AbbVie assumed certain post-employment benefit obligations which were recorded at fair value. Upon acquisition in the second quarter of 2020, the excess of projected benefit obligations over the plan assets was recognized as a liability totaling $156 million.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 82 |
Amounts Recognized in Other Comprehensive Income (Loss)
The following table summarizes the pre-tax losses (gains) included in other comprehensive income (loss): | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Defined benefit plans | | | | | |
Actuarial loss (gain) | $ | (345) | | | $ | 701 | | | $ | 1,231 | |
| | | | | |
Amortization of prior service cost | (2) | | | (2) | | | — | |
Amortization of actuarial loss | (288) | | | (227) | | | (109) | |
Foreign exchange loss (gain) and other | (27) | | | 56 | | | (6) | |
Total loss (gain) | $ | (662) | | | $ | 528 | | | $ | 1,116 | |
Other post-employment plans | | | | | |
Actuarial loss | $ | 10 | | | $ | 40 | | | $ | 451 | |
Prior service credit | — | | | (397) | | | — | |
Amortization of prior service credit | 39 | | | 4 | | | — | |
Amortization of actuarial loss | (32) | | | (26) | | | (1) | |
Total loss (gain) | $ | 17 | | | $ | (379) | | | $ | 450 | |
Net Periodic Benefit Cost | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Defined benefit plans | | | | | |
Service cost | $ | 440 | | | $ | 370 | | | $ | 269 | |
Interest cost | 237 | | | 264 | | | 259 | |
Expected return on plan assets | (663) | | | (575) | | | (474) | |
Amortization of prior service cost | 2 | | | 2 | | | — | |
Amortization of actuarial loss | 288 | | | 227 | | | 109 | |
Net periodic benefit cost | $ | 304 | | | $ | 288 | | | $ | 163 | |
Other post-employment plans | | | | | |
Service cost | $ | 48 | | | $ | 42 | | | $ | 25 | |
Interest cost | 19 | | | 34 | | | 29 | |
Amortization of prior service credit | (39) | | | (4) | | | — | |
Amortization of actuarial loss | 32 | | | 26 | | | 1 | |
Net periodic benefit cost | $ | 60 | | | $ | 98 | | | $ | 55 | |
The components of net periodic benefit cost other than service cost are included in other expense, net in the consolidated statements of earnings.
Weighted-Average Assumptions Used in Determining Benefit Obligations at the Measurement Date | | | | | | | | | | | |
as of December 31 | 2021 | | 2020 |
Defined benefit plans | | | |
Discount rate | 2.8 | % | | 2.4 | % |
Rate of compensation increases | 5.2 | % | | 4.6 | % |
Cash balance interest crediting rate | 2.7 | % | | 2.8 | % |
Other post-employment plans | | | |
Discount rate | 3.1 | % | | 2.8 | % |
The assumptions used in calculating the December 31, 2021 measurement date benefit obligations will be used in the calculation of net periodic benefit cost in 2022.
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83 | | 2021 Form 10-K | | |
Weighted-Average Assumptions Used in Determining Net Periodic Benefit Cost | | | | | | | | | | | | | | | | | |
years ended December 31 | 2021 | | 2020 | | 2019 |
Defined benefit plans | | | | | |
Discount rate for determining service cost | 2.6 | % | | 3.1 | % | | 4.0 | % |
Discount rate for determining interest cost | 2.2 | % | | 3.0 | % | | 4.0 | % |
Expected long-term rate of return on plan assets | 7.1 | % | | 7.1 | % | | 7.6 | % |
Expected rate of change in compensation | 4.6 | % | | 4.6 | % | | 4.6 | % |
Cash balance interest crediting rate | 2.8 | % | | 2.8 | % | | 2.8 | % |
Other post-employment plans | | | | | |
Discount rate for determining service cost | 3.0 | % | | 3.7 | % | | 4.7 | % |
Discount rate for determining interest cost | 2.2 | % | | 3.2 | % | | 4.3 | % |
For the December 31, 2021 post-retirement health care obligations remeasurement, the company assumed a 5.9% pre-65 (2.1% post-65) annual rate of increase in the per capita cost of covered health care benefits. The pre-65 rate was assumed to decrease gradually to 4.5% (1.8% post-65) in 2029 and remain at that level thereafter. For purposes of measuring the 2021 post-retirement health care costs, the company assumed a 6.0% pre-65 (2.3% post-65) annual rate of increase in the per capita cost of covered health care benefits. The pre-65 rate was assumed to decrease gradually to 4.5% (2.0% post-65) for 2029 and remain at that level thereafter.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 84 |
Defined Benefit Pension Plan Assets | | | | | | | | | | | | | | | | | | | | | | | |
| | | Basis of fair value measurement |
as of December 31 (in millions) | 2021 | | Quoted prices in active markets for identical assets (Level 1) | | Significant other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
Equities | | | | | | | |
U.S. large cap(a) | $ | 1,428 | | | $ | 1,428 | | | $ | — | | | $ | — | |
U.S. mid cap(b) | 198 | | | 198 | | | — | | | — | |
International(c) | 458 | | | 458 | | | — | | | — | |
Fixed income securities | | | | | | | |
U.S. government securities(d) | 228 | | | 95 | | | 133 | | | — | |
Corporate debt instruments(d) | 945 | | | 179 | | | 766 | | | — | |
Non-U.S. government securities(d) | 602 | | | 445 | | | 157 | | | — | |
Other(d) | 273 | | | 268 | | | 5 | | | — | |
Absolute return funds(e) | 100 | | | 5 | | | 95 | | | — | |
Real assets | 10 | | | 10 | | | — | | | — | |
Other(f) | 261 | | | 216 | | | 45 | | | — | |
Total | $ | 4,503 | | | $ | 3,302 | | | $ | 1,201 | | | $ | — | |
Total assets measured at NAV | 6,152 | | | | | | | |
Fair value of plan assets | $ | 10,655 | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | Basis of fair value measurement |
as of December 31 (in millions) | 2020 | | Quoted prices in active markets for identical assets (Level 1) | | Significant other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
Equities | | | | | | | |
U.S. large cap(a) | $ | 1,143 | | | $ | 1,143 | | | $ | — | | | $ | — | |
U.S. mid cap(b) | 164 | | | 164 | | | — | | | — | |
International(c) | 524 | | | 524 | | | — | | | — | |
Fixed income securities | | | | | | | |
U.S. government securities(d) | 132 | | | 18 | | | 114 | | | — | |
Corporate debt instruments(d) | 854 | | | 178 | | | 676 | | | — | |
Non-U.S. government securities(d) | 544 | | | 397 | | | 147 | | | — | |
Other(d) | 297 | | | 294 | | | 3 | | | — | |
Absolute return funds(e) | 310 | | | 4 | | | 306 | | | — | |
Real assets | 10 | | | 10 | | | — | | | — | |
Other(f) | 252 | | | 250 | | | 2 | | | — | |
Total | $ | 4,230 | | | $ | 2,982 | | | $ | 1,248 | | | $ | — | |
Total assets measured at NAV | 5,472 | | | | | | | |
Fair value of plan assets | $ | 9,702 | | | | | | | |
(a)A mix of index funds and actively managed equity accounts that are benchmarked to various large cap indices.
(b)A mix of index funds and actively managed equity accounts that are benchmarked to various mid cap indices.
(c)A mix of index funds and actively managed equity accounts that are benchmarked to various non-U.S. equity indices in both developed and emerging markets.
(d)Securities held by actively managed accounts, index funds and mutual funds.
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85 | | 2021 Form 10-K | | |
(e)Primarily funds having global mandates with the flexibility to allocate capital broadly across a wide range of asset classes and strategies, including but not limited to equities, fixed income, commodities, financial futures, currencies and other securities, with objectives to outperform agreed upon benchmarks of specific return and volatility targets.
(f)Investments in cash and cash equivalents.
Equities and registered investment companies having quoted prices are valued at the published market prices. Fixed income securities that are valued using significant other observable inputs are quoted at prices obtained from independent financial service industry-recognized vendors. Investments held in pooled investment funds, common collective trusts or limited partnerships are valued at the net asset value (NAV) practical expedient to estimate fair value. The NAV is provided by the fund administrator and is based on the value of the underlying assets owned by the fund minus its liabilities.
The investment mix of equity securities, fixed income and other asset allocation strategies is based upon achieving a desired return, balancing higher return, more volatile equity securities and lower return, less volatile fixed income securities. Investment allocations are established for each plan and are generally made across a range of markets, industry sectors, capitalization sizes and in the case of fixed income securities, maturities and credit quality. The 2021 target investment allocation for the AbbVie Pension Plan was 62.5% in equity securities, 22.5% in fixed income securities and 15% in asset allocation strategies and other holdings. There are no known significant concentrations of risk in the plan assets of the AbbVie Pension Plan or of any other plans.
The expected return on plan assets assumption for each plan is based on management's expectations of long-term average rates of return to be achieved by the underlying investment portfolio. In establishing this assumption, management considers historical and expected returns for the asset classes in which the plans are invested, as well as current economic and capital market conditions.
Expected Benefit Payments
The following table summarizes total benefit payments expected to be paid to plan participants including payments funded from both plan and company assets: | | | | | | | | | | | |
years ending December 31 (in millions) | Defined benefit plans | | Other post-employment plans |
2022 | $ | 293 | | | $ | 27 | |
2023 | 312 | | | 30 | |
2024 | 334 | | | 31 | |
2025 | 356 | | | 34 | |
2026 | 379 | | | 36 | |
2027 to 2031 | 2,291 | | | 224 | |
Defined Contribution Plan
AbbVie maintains defined contribution savings plans for the benefit of its eligible employees. The expense recognized for these plans was $267 million in 2021, $191 million in 2020 and $102 million in 2019. AbbVie provides certain other post-employment benefits, primarily salary continuation arrangements, to qualifying employees and accrues for the related cost over the service lives of the employees.
Stock-Based Compensation
In May 2021, stockholders of the company approved the AbbVie Amended and Restated 2013 Incentive Stock Program (the Amended Plan), which amends and restates the AbbVie 2013 Incentive Stock Program (2013 ISP). AbbVie grants stock-based awards to eligible employees pursuant to the Amended Plan, which provides for several different forms of benefits, including non-qualified stock options, RSUs and various performance-based awards. Under the Amended Plan, a total of 144 million shares of AbbVie common stock have been reserved for issuance as awards to AbbVie employees. The 2013 ISP also facilitated the assumption of certain awards granted under Abbott’s incentive stock program, which were adjusted and converted into Abbott and AbbVie stock-based awards as a result of AbbVie's separation from Abbott.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 86 |
AbbVie measures compensation expense for stock-based awards based on the grant date fair value of the awards and the estimated number of awards that are expected to vest. Forfeitures are estimated based on historical experience at the time of grant and are revised in subsequent periods if actual forfeitures differ from those estimates. Compensation cost for stock-based awards is amortized over the service period, which could be shorter than the vesting period if an employee is retirement eligible. Retirement eligible employees generally are those who are age 55 or older and have at least 10 years of service.
Stock-based compensation expense is principally related to awards issued pursuant to the 2013 ISP and the Amended Plan and is summarized as follows: | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Cost of products sold | $ | 46 | | | $ | 47 | | | $ | 29 | |
Research and development | 226 | | | 247 | | | 171 | |
Selling, general and administrative | 420 | | | 459 | | | 230 | |
Pre-tax compensation expense | 692 | | | 753 | | | 430 | |
Tax benefit | 126 | | | 131 | | | 80 | |
After-tax compensation expense | $ | 566 | | | $ | 622 | | | $ | 350 | |
Realized excess tax benefits associated with stock-based compensation totaled $50 million in 2021, $34 million in 2020 and $15 million in 2019.
Stock Options
Stock options awarded to employees typically have a contractual term of 10 years and generally vest in one-third increments over a three-year period. The exercise price is equal to at least 100% of the market value on the date of grant. The fair value is determined using the Black-Scholes model. The weighted-average grant-date fair values of stock options granted were $16.28 in 2021, $12.14 in 2020 and $12.54 in 2019.
In connection with the Allergan acquisition, during the second quarter of 2020, AbbVie issued 11.2 million stock options to holders of Allergan options as a result of the conversion of such options. These options were fair-valued using a lattice valuation model. Refer to Note 5 for additional information regarding the Allergan acquisition.
The following table summarizes AbbVie stock option activity in 2021: | | | | | | | | | | | | | | | | | | | | | | | |
(options in thousands, aggregate intrinsic value in millions) | Options | | Weighted- average exercise price | | Weighted-average remaining life (in years) | | Aggregate intrinsic value |
Outstanding at December 31, 2020 | 15,691 | | | $ | 73.90 | | | 4.7 | | $ | 559 | |
Granted | 1,147 | | | 105.94 | | | | | |
Exercised | (4,278) | | | 57.77 | | | | | |
Lapsed and forfeited | (186) | | | 105.28 | | | | | |
Outstanding at December 31, 2021 | 12,374 | | | $ | 81.98 | | | 4.7 | | $ | 661 | |
Exercisable at December 31, 2021 | 9,424 | | | $ | 78.03 | | | 3.6 | | $ | 541 | |
The total intrinsic value of options exercised was $239 million in 2021, $186 million in 2020 and $22 million in 2019. The total fair value of options vested during 2021 was $21 million. As of December 31, 2021, $10 million of unrecognized compensation cost related to stock options is expected to be recognized as expense over approximately the next two years.
RSUs and Performance Shares
RSUs awarded to employees other than senior executives and other key employees generally vest in ratable increments over a three or four-year period. Recipients of these RSUs are entitled to receive dividend equivalents as dividends are declared and paid during the RSU vesting period.
The majority of the equity awards AbbVie grants to its senior executives and other key employees are performance-based. Equity awards granted to senior executives and other key employees consist of a combination of performance-vested RSUs and performance shares as well as non-qualified stock options described above. The performance-vested RSUs have the potential to vest in one-third increments during a three-year performance period. For awards granted in 2021 and 2020, performance is based on AbbVie's return on invested capital relative to a defined peer group of pharmaceutical, biotech and life science companies. For awards granted in 2019, the tranches tied to 2021 performance are based on AbbVie’s return on
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87 | | 2021 Form 10-K | | |
equity relative to a defined peer group of pharmaceutical, biotech and life sciences companies. The recipient may receive one share of AbbVie common stock for each vested award. The performance shares have the potential to vest over a three-year performance period and may be earned based on AbbVie’s EPS achievement and AbbVie’s total stockholder return (TSR) (a market condition) relative to a defined peer group of pharmaceutical, biotech and life sciences companies. Dividend equivalents on performance-vested RSUs and performance shares accrue during the performance period and are payable at vesting only to the extent that shares are earned.
The weighted-average grant-date fair value of RSUs and performance shares generally is determined based on the number of shares/units granted and the quoted price of AbbVie’s common stock on the date of grant. The weighted-average grant-date fair values of performance shares with a TSR market condition are determined using the Monte Carlo simulation model.
The following table summarizes AbbVie RSU and performance share activity for 2021: | | | | | | | | | | | |
(share units in thousands) | Share units | | Weighted-average grant date fair value |
Outstanding at December 31, 2020 | 15,918 | | | $ | 87.03 | |
Granted | 7,556 | | | 105.79 | |
Vested | (6,735) | | | 91.63 | |
Forfeited | (1,849) | | | 83.35 | |
Outstanding at December 31, 2021 | 14,890 | | | $ | 94.93 | |
The fair market value of RSUs and performance shares (as applicable) vested was $718 million in 2021, $618 million in 2020 and $371 million in 2019.
In connection with the Allergan acquisition, during the second quarter of 2020, AbbVie issued 8.2 million RSUs to holders of Allergan equity awards based on a conversion factor described in the transaction agreement. Refer to Note 5 for additional information regarding the Allergan acquisition.
As of December 31, 2021, $592 million of unrecognized compensation cost related to RSUs and performance shares is expected to be recognized as expense over approximately the next two years.
Cash Dividends
Cash dividends declared per common share totaled $5.31 in 2021, $4.84 in 2020 and $4.39 in 2019. The following table summarizes quarterly cash dividends declared during 2021, 2020 and 2019: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
2021 | | 2020 | | 2019 |
Date Declared | | Payment Date | | Dividend Per Share | | Date Declared | | Payment Date | | Dividend Per Share | | Date Declared | | Payment Date | | Dividend Per Share |
10/29/21 | | 02/15/22 | | $1.41 | | 10/30/20 | | 02/16/21 | | $1.30 | | 11/01/19 | | 02/14/20 | | $1.18 |
09/10/21 | | 11/15/21 | | $1.30 | | 09/11/20 | | 11/16/20 | | $1.18 | | 09/06/19 | | 11/15/19 | | $1.07 |
06/17/21 | | 08/16/21 | | $1.30 | | 06/17/20 | | 08/14/20 | | $1.18 | | 06/20/19 | | 08/15/19 | | $1.07 |
02/18/21 | | 05/14/21 | | $1.30 | | 02/20/20 | | 05/15/20 | | $1.18 | | 02/21/19 | | 05/15/19 | | $1.07 |
Stock Repurchase Program
The company's stock repurchase authorization permits purchases of AbbVie shares from time to time in open-market or private transactions at management’s discretion. The program has no time limit and can be discontinued at any time. Shares repurchased under these programs are recorded at acquisition cost, including related expenses and are available for general corporate purposes.
AbbVie repurchased 6 million shares for $670 million in 2021, 8 million shares for $757 million in 2020 and 4 million shares for $300 million in 2019. AbbVie's remaining stock repurchase authorization was $2.5 billion as of December 31, 2021.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 88 |
Accumulated Other Comprehensive Loss
The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for 2021, 2020 and 2019: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(in millions) (brackets denote losses) | Foreign currency translation adjustments | | Net investment hedging activities | | Pension and post-employment benefits | | Marketable security activities | | Cash flow hedging activities | | Total |
Balance as of December 31, 2018 | $ | (830) | | | $ | (65) | | | $ | (1,722) | | | $ | (10) | | | $ | 147 | | | $ | (2,480) | |
Other comprehensive income (loss) before reclassifications | (98) | | | 95 | | | (1,330) | | | 12 | | | 298 | | | (1,023) | |
Net losses (gains) reclassified from accumulated other comprehensive loss | — | | | (21) | | | 87 | | | (2) | | | (157) | | | (93) | |
Net current-period other comprehensive income (loss) | (98) | | | 74 | | | (1,243) | | | 10 | | | 141 | | | (1,116) | |
Balance as of December 31, 2019 | (928) | | | 9 | | | (2,965) | | | — | | | 288 | | | (3,596) | |
Other comprehensive income (loss) before reclassifications | 1,511 | | | (785) | | | (300) | | | — | | | (108) | | | 318 | |
Net losses (gains) reclassified from accumulated other comprehensive loss | — | | | (14) | | | 198 | | | — | | | (23) | | | 161 | |
Net current-period other comprehensive income (loss) | 1,511 | | | (799) | | | (102) | | | — | | | (131) | | | 479 | |
Balance as of December 31, 2020 | 583 | | | (790) | | | (3,067) | | | — | | | 157 | | | (3,117) | |
Other comprehensive income (loss) before reclassifications | (1,153) | | | 720 | | | 298 | | | — | | | 76 | | | (59) | |
Net losses (gains) reclassified from accumulated other comprehensive loss | — | | | (21) | | | 223 | | | — | | | 75 | | | 277 | |
Net current-period other comprehensive income (loss) | (1,153) | | | 699 | | | 521 | | | — | | | 151 | | | 218 | |
Balance as of December 31, 2021 | $ | (570) | | | $ | (91) | | | $ | (2,546) | | | $ | — | | | $ | 308 | | | $ | (2,899) | |
Other comprehensive income (loss) for 2021 included foreign currency translation adjustments totaling losses of $1.2 billion and the offsetting impact of net investment hedging activities totaling gains of $699 million, which were principally due to the impact of the weakening of the Euro on the translation of the company’s Euro-denominated assets. Other comprehensive income (loss) for 2020 included foreign currency translation adjustments totaling gains of $1.5 billion and the offsetting impact of net investment hedging activities totaling losses of $799 million, which were principally due to the impact of the strengthening of the Euro on the translation of the company's Euro-denominated assets.
Other comprehensive income (loss) for 2019 included pension and post-employment benefit plan losses of $1.2 billion primarily due to an actuarial loss driven by lower discount rates. See Note 12 for additional information.
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89 | | 2021 Form 10-K | | |
The table below presents the impact on AbbVie's consolidated statements of earnings for significant amounts reclassified out of each component of accumulated other comprehensive loss: | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) (brackets denote gains) | 2021 | | 2020 | | 2019 |
Net investment hedging activities | | | | | |
Gains on derivative amount excluded from effectiveness testing(a) | $ | (26) | | | $ | (18) | | | $ | (27) | |
Tax expense | 5 | | | 4 | | | 6 | |
Total reclassifications, net of tax | $ | (21) | | | $ | (14) | | | $ | (21) | |
Pension and post-employment benefits | | | | | |
Amortization of actuarial losses and other(b) | $ | 283 | | | $ | 251 | | | $ | 110 | |
Tax benefit | (60) | | | (53) | | | (23) | |
Total reclassifications, net of tax | $ | 223 | | | $ | 198 | | | $ | 87 | |
Cash flow hedging activities | | | | | |
Losses (gains) on foreign currency forward exchange contracts(c) | $ | 87 | | | $ | (23) | | | $ | (167) | |
Gains on treasury rate lock agreements(a) | (24) | | | (24) | | | (3) | |
Losses (gains) on interest rate swap contracts(a) | 24 | | | 17 | | | (1) | |
Tax expense (benefit) | (12) | | | 7 | | | 14 | |
Total reclassifications, net of tax | $ | 75 | | | $ | (23) | | | $ | (157) | |
(a)Amounts are included in interest expense, net (see Note 11).
(b)Amounts are included in the computation of net periodic benefit cost (see Note 12).
(c)Amounts are included in cost of products sold (see Note 11).
Other
In addition to common stock, AbbVie's authorized capital includes 200 million shares of preferred stock, par value $0.01. As of December 31, 2021, no shares of preferred stock were issued or outstanding.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 90 |
Earnings Before Income Tax Expense | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Domestic | $ | (1,644) | | | $ | (4,467) | | | $ | (2,784) | |
Foreign | 14,633 | | | 7,865 | | | 11,210 | |
Total earnings before income tax expense | $ | 12,989 | | | $ | 3,398 | | | $ | 8,426 | |
Income Tax Expense | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Current | | | | | |
Domestic | $ | 1,987 | | | $ | 907 | | | $ | 102 | |
Foreign | 351 | | | 194 | | | 320 | |
Total current taxes | $ | 2,338 | | | $ | 1,101 | | | $ | 422 | |
Deferred | | | | | |
Domestic | $ | (839) | | | $ | (58) | | | $ | (137) | |
Foreign | (59) | | | (2,267) | | | 259 | |
Total deferred taxes | $ | (898) | | | $ | (2,325) | | | $ | 122 | |
Total income tax expense (benefit) | $ | 1,440 | | | $ | (1,224) | | | $ | 544 | |
Effective Tax Rate Reconciliation | | | | | | | | | | | | | | | | | |
years ended December 31 | 2021 | | 2020 | | 2019 |
Statutory tax rate | 21.0 | % | | 21.0 | % | | 21.0 | % |
Effect of foreign operations | (5.4) | | | 2.4 | | | (8.4) | |
U.S. tax credits | (2.8) | | | (10.6) | | | (3.3) | |
Impacts related to U.S. tax reform | — | | | (1.1) | | | (1.6) | |
Non-deductible expenses | 0.3 | | | 7.2 | | | 1.0 | |
Tax law changes and related restructuring | (2.0) | | | (48.5) | | | 3.1 | |
Tax audit settlements | (0.4) | | | (5.1) | | | (4.7) | |
| | | | | |
All other, net | 0.4 | | | (1.3) | | | (0.6) | |
Effective tax rate | 11.1 | % | | (36.0 | %) | | 6.5 | % |
The effective income tax rate fluctuates year to year due to the allocation of the company's taxable earnings among jurisdictions, as well as certain discrete factors and events in each year, including changes in tax law, acquisitions and collaborations. The effective income tax rates in 2021, 2020 and 2019 differed from the statutory tax rate principally due to the impact of foreign operations which reflects the impact of lower income tax rates in locations outside the United States, tax incentives in Puerto Rico and other foreign tax jurisdictions, business development activities, changes in enacted tax rates and laws and related restructuring, tax audit settlements and accretion on contingent consideration. The 2020 effective income tax rate included the recognition of a net tax benefit of $1.7 billion related to changes in tax laws and related restructuring, including certain intra-group transfers of intellectual property and deferred tax remeasurement. The effective tax rates for these periods also reflected the benefit from U.S. tax credits principally related to research and development credits, the orphan drug tax credit and Puerto Rico excise tax credits. The Puerto Rico excise tax credits relate to legislation enacted by Puerto Rico that assesses an excise tax on certain products manufactured in Puerto Rico. The tax is levied on gross inventory purchases from entities in Puerto Rico and is included in cost of products sold in the consolidated statements of earnings. The majority of the tax is creditable for U.S. income tax purposes.
The effective income tax rate in 2020 and 2019 included impacts related to U.S. tax reform. The Tax Cuts and Jobs Act (the Act) was signed into law in December 2017, resulting in significant changes to the U.S. corporate tax system, including a one-time transition tax on a mandatory deemed repatriation of earnings of certain foreign subsidiaries that were previously untaxed. The Act also created a minimum tax on certain foreign sourced earnings. The company’s accounting policy for the minimum tax on foreign sourced earnings is to report the tax effects on the basis that the minimum tax will be recognized in tax expense in the year it is incurred as a period expense. The effective income tax rates for 2019 also included the effects of Stemcentrx impairment related expenses.
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91 | | 2021 Form 10-K | | |
Deferred Tax Assets and Liabilities | | | | | | | | | | | |
as of December 31 (in millions) | 2021 | | 2020 |
Deferred tax assets | | | |
Compensation and employee benefits | $ | 937 | | | $ | 1,109 | |
Accruals and reserves | 667 | | | 438 | |
Chargebacks and rebates | 837 | | | 555 | |
Advance payments | 809 | | | 324 | |
Net operating losses and other credit carryforwards | 10,095 | | | 2,765 | |
Other | 1,234 | | | 1,371 | |
Total deferred tax assets | 14,579 | | | 6,562 | |
Valuation allowances | (9,391) | | | (1,203) | |
Total net deferred tax assets | 5,188 | | | 5,359 | |
Deferred tax liabilities | | | |
Excess of book basis over tax basis of intangible assets | (4,711) | | | (5,274) | |
Excess of book basis over tax basis in investments | (308) | | | (335) | |
Other | (904) | | | (982) | |
Total deferred tax liabilities | (5,923) | | | (6,591) | |
Net deferred tax liabilities | $ | (735) | | | $ | (1,232) | |
The decrease in net deferred tax assets is primarily related to the utilization of net operating losses and other carryforwards offset by an increase in advance payments. The decrease in deferred tax liabilities is primarily related to amortization of intangible assets.
In connection with the Allergan acquisition, the company recorded adjustments within the measurement period in 2021 related to foreign net operating losses and other credit carryforwards that are not expected to be realized. The adjustments reflected an increase of $8.2 billion to deferred tax assets and an offsetting increase to valuation allowances, resulting in no net impact to deferred tax assets.
The company had valuation allowances of $9.4 billion as of December 31, 2021 and $1.2 billion as of December 31, 2020. These were principally related to foreign and state net operating losses and other credit carryforwards that are not expected to be realized.
As of December 31, 2021, the company had U.S. federal and state credit carryforwards of $214 million as well as U.S. federal, state and foreign net operating loss carryforwards of $34.4 billion, which will expire at various times through 2041. The remaining U.S. federal and foreign loss carryforwards of $3.2 billion have no expiration.
The Act significantly changed the timing and manner in which earnings of foreign subsidiaries are subject to U.S. tax. Therefore, unremitted foreign earnings subject to the Act’s transition tax are not considered indefinitely reinvested. Post-2017 earnings subject to the U.S. minimum tax on foreign sourced earnings or eligible for the 100 percent foreign dividends received deduction are also not considered indefinitely reinvested earnings. However, the company generally considers instances of outside basis differences in foreign subsidiaries that would incur additional U.S. tax upon reversal (e.g., capital gain distribution) to be permanent in duration. The unrecognized tax liability is not practicable to determine.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 92 |
Unrecognized Tax Benefits | | | | | | | | | | | | | | | | | |
years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Beginning balance | $ | 5,264 | | | $ | 2,661 | | | $ | 2,852 | |
Increase due to acquisition | — | | | 2,674 | | | — | |
Increase due to current year tax positions | 208 | | | 91 | | | 113 | |
Increase due to prior year tax positions | 137 | | | 59 | | | 499 | |
Decrease due to prior year tax positions | (62) | | | (7) | | | (21) | |
Settlements | (24) | | | (141) | | | (749) | |
Lapse of statutes of limitations | (34) | | | (73) | | | (33) | |
Ending balance | $ | 5,489 | | | $ | 5,264 | | | $ | 2,661 | |
If recognized, the net amount of potential tax benefits that would impact the company's effective tax rate is $5.2 billion in 2021 and $5.0 billion in 2020. Of the unrecognized tax benefits recorded in the table above as of December 31, 2021, AbbVie would be indemnified for approximately $79 million. The "Increase due to current year tax positions" and "Increase due to prior year tax positions" in the table above include amounts related to federal, state and international tax items. "Increase due to acquisition" in the table above includes amounts related to federal, state and international tax items recorded in acquisition accounting related to the Allergan acquisition.
AbbVie recognizes interest and penalties related to income tax matters in income tax expense in the consolidated statements of earnings. AbbVie recognized gross income tax expense of $161 million in 2021, $142 million in 2020 and $51 million in 2019, for interest and penalties related to income tax matters. AbbVie had an accrual for the payment of gross interest and penalties of $803 million at December 31, 2021, $642 million at December 31, 2020 and $191 million at December 31, 2019.
The company is routinely audited by the tax authorities in significant jurisdictions and a number of audits are currently underway. It is reasonably possible during the next 12 months that uncertain tax positions may be settled, which could result in a decrease in the gross amount of unrecognized tax benefits. Due to the potential for resolution of federal, state and foreign examinations and the expiration of various statutes of limitation, the company's gross unrecognized tax benefits balance may change within the next 12 months up to $225 million. All significant federal, state, local and international matters have been concluded for years through 2008. The company believes adequate provision has been made for all income tax uncertainties.
Note 15 Legal Proceedings and Contingencies AbbVie is subject to contingencies, such as various claims, legal proceedings and investigations regarding product liability, intellectual property, commercial, securities and other matters that arise in the normal course of business. The most significant matters are described below. Loss contingency provisions are recorded for probable losses at management’s best estimate of a loss, or when a best estimate cannot be made, a minimum loss contingency amount within a probable range is recorded. For litigation 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, if any, beyond the amounts accrued. Initiation of new legal proceedings or a change in the status of existing proceedings may result in a change in the estimated loss accrued by AbbVie. While it is not feasible to predict the outcome of all proceedings and exposures with certainty, management believes that their ultimate disposition should not have a material adverse effect on AbbVie’s consolidated financial position, results of operations or cash flows.
Subject to certain exceptions specified in the separation agreement by and between Abbott and AbbVie, AbbVie assumed the liability for, and control of, all pending and threatened legal matters related to its business, including liabilities for any claims or legal proceedings related to products that had been part of its business, but were discontinued prior to the distribution, as well as assumed or retained liabilities, and will indemnify Abbott for any liability arising out of or resulting from such assumed legal matters.
Antitrust Litigation
Lawsuits are pending against AbbVie and others generally alleging that the 2005 patent litigation settlement involving Niaspan entered into between Kos Pharmaceuticals, Inc. (a company acquired by Abbott in 2006 and presently a subsidiary of AbbVie) and a generic company violates federal and state antitrust laws and state unfair and deceptive trade practices and unjust enrichment laws. Plaintiffs generally seek monetary damages and/or injunctive relief and attorneys' fees. The lawsuits
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93 | | 2021 Form 10-K | | |
pending in federal court consist of four individual plaintiff lawsuits and two consolidated purported class actions: one brought by Niaspan direct purchasers and one brought by Niaspan end-payors. The cases are pending in the United States District Court for the Eastern District of Pennsylvania for coordinated or consolidated pre-trial proceedings under the MDL Rules as In re: Niaspan Antitrust Litigation, MDL No. 2460. In August 2019, the court certified a class of direct purchasers of Niaspan. In June 2020 and August 2021, the court denied the end-payors' motion to certify a class. In October 2016, the Orange County, California District Attorney’s Office filed a lawsuit on behalf of the State of California regarding the Niaspan patent litigation settlement in Orange County Superior Court, asserting a claim under the unfair competition provision of the California Business and Professions Code seeking injunctive relief, restitution, civil penalties and attorneys’ fees.
In August 2019, direct purchasers of AndroGel filed a lawsuit, King Drug Co. of Florence, Inc., et al. v. AbbVie Inc., et al., against AbbVie and others in the United States District Court for the Eastern District of Pennsylvania, alleging that 2006 patent litigation settlements and related agreements by Solvay Pharmaceuticals, Inc. (a company Abbott acquired in February 2010 and now known as AbbVie Products LLC) with three generic companies violated federal antitrust law, and also alleging that 2011 patent litigation by Abbott with two generic companies regarding AndroGel was sham litigation and the settlements of those litigations violated federal antitrust law. In May 2020, Perrigo Company and related entities filed a lawsuit against AbbVie and others in the United States District Court for the Eastern District of Pennsylvania, alleging that Abbott's 2011 AndroGel patent lawsuit filed against Perrigo was sham litigation. In October 2020, the Perrigo lawsuit was transferred to the United States District Court for New Jersey. In September 2021, the New Jersey court granted AbbVie's motion for judgment on the pleadings in the Perrigo lawsuit, dismissing it with prejudice. Perrigo has appealed the dismissal.
Between March and May 2019, 12 putative class action lawsuits were filed in the United States District Court for the Northern District of Illinois by indirect Humira purchasers, alleging that AbbVie’s settlements with biosimilar manufacturers and AbbVie’s Humira patent portfolio violated state and federal antitrust laws. The court consolidated these lawsuits as In re: Humira (Adalimumab) Antitrust Litigation. In June 2020, the court dismissed the consolidated litigation with prejudice. The plaintiffs have appealed the dismissal.
Lawsuits are pending against Forest Laboratories, LLC and others generally alleging that 2009 and 2010 patent litigation settlements involving Namenda entered into between Forest and generic companies and other conduct by Forest involving Namenda, violated state antitrust, unfair and deceptive trade practices, and unjust enrichment laws. Plaintiffs generally seek monetary damages, injunctive relief and attorneys’ fees. The lawsuits, purported class actions filed by indirect purchasers of Namenda, are consolidated as In re: Namenda Indirect Purchaser Antitrust Litigation in the United States District Court for the Southern District of New York.
Lawsuits are pending against Allergan Inc. generally alleging that Allergan’s petitioning to the U.S. Patent Office and Food and Drug Administration and other conduct by Allergan involving Restasis violated federal and state antitrust laws and state unfair and deceptive trade practices and unjust enrichment laws. Plaintiffs generally seek monetary damages, injunctive relief and attorneys’ fees. The lawsuits, certified as a class action filed on behalf of indirect purchasers of Restasis, are consolidated for pre-trial purposes in the United States District Court for the Eastern District of New York under the MDL Rules as In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, MDL No. 2819. In May 2021, the parties reached an agreement to settle this matter that is subject to final court approval.
Lawsuits are pending against Forest Laboratories, LLC and others generally alleging that 2012 and 2013 patent litigation settlements involving Bystolic with six generic manufacturers violated federal and state antitrust laws and state unfair and deceptive trade practices and unjust enrichment laws. Plaintiffs generally seek monetary damages, injunctive relief, and attorneys’ fees. The lawsuits, purported class actions filed on behalf of direct and indirect purchasers of Bystolic, are consolidated as In re: Bystolic Antitrust Litigation in the United States District Court for the Southern District of New York.
Government Proceedings
Lawsuits are pending against Allergan and several other manufacturers generally alleging that they improperly promoted and sold prescription opioid products. Approximately 3,130 matters are pending against Allergan. The federal court cases are consolidated for pre-trial purposes in the United States District Court for the Northern District of Ohio under the MDL rules as In re: National Prescription Opiate Litigation, MDL No. 2804. Approximately 251 of the claims are pending in various state courts. The plaintiffs in these cases, which include states, counties, cities, other municipal entities, Native American tribes, union trust funds and other third-party payors, private hospitals, and personal injury claimants, generally seek compensatory and punitive damages. In December 2021, a California state court reached a judgment for Allergan and other defendants in the trial of an opioid lawsuit by Orange, Los Angeles, and Santa Clara Counties and the City of Oakland. In December 2021, Allergan reached an agreement to settle a lawsuit brought by the State of New York and two New York counties, which also provides all other New York counties and political subdivisions the opportunity to participate in the settlement.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 94 |
In July 2019, the New Mexico Attorney General filed a lawsuit, State of New Mexico ex rel. Balderas v. AbbVie Inc., et al., in New Mexico District Court for Santa Fe County against AbbVie and other companies alleging their marketing of AndroGel violated New Mexico’s Unfair Practices Act. In October 2020, the state added a claim under the New Mexico False Advertising Act.
Shareholder and Securities Litigation
In June 2016, a lawsuit, Elliott Associates, L.P., et al. v. AbbVie Inc., was filed by five investment funds against AbbVie in the Cook County, Illinois Circuit Court alleging that AbbVie made misrepresentations and omissions in connection with its proposed transaction with Shire. Similar lawsuits were filed between July 2017 and October 2019 against AbbVie and in some instances its chief executive officer in the same court by additional investment funds. The court granted motions dismissing the claims of three investment-fund plaintiffs, which they appealed. In March 2021, in the first of those appeals, the dismissal was affirmed. One of these plaintiffs refiled its lawsuit in New York state court in June 2020 while the appeal of its dismissal in Illinois is pending. In November 2020, the New York Supreme Court for the County of New York dismissed that lawsuit, which is being appealed. In September 2021, the Illinois court granted AbbVie's motion for summary judgment against all remaining plaintiffs on all the remaining claims, dismissing them with prejudice. The plaintiffs have appealed the dismissals.
In October 2018, a federal securities lawsuit, Holwill v. AbbVie Inc., et al., was filed in the United States District Court for the Northern District of Illinois) against AbbVie, its chief executive officer and former chief financial officer, alleging that reasons stated for Humira sales growth in financial filings between 2013 and 2017 were misleading because they omitted alleged misconduct in connection with Humira patient and reimbursement support services and other services and items of value that allegedly induced Humira prescriptions. In September 2021, the court granted plaintiffs' motion to certify a class.
Lawsuits are pending against Allergan and certain of its current and former officers alleging they made misrepresentations and omissions regarding Allergan's textured breast implants. The lawsuits, which were filed by Allergan shareholders, have been consolidated in the United States District Court for the Southern District of New York as In re: Allergan plc Securities Litigation. The plaintiffs generally seek compensatory damages and attorneys’ fees. In September 2019, the court partially granted Allergan's motion to dismiss. In September 2021, the court granted plaintiffs' motion to certify a class.
Lawsuits are pending against Allergan and certain of its current and former officers alleging they made misrepresentations and omissions regarding Allergan’s former Actavis generics unit and its alleged anticompetitive conduct with other generic drug companies. The lawsuits were filed by Allergan shareholders and consist of three purported class actions and one individual action that have been consolidated in the U.S. District Court for the District of New Jersey as In re: Allergan Generic Drug Pricing Securities Litigation. In July 2021, the parties reached an agreement to settle the class action lawsuits, which received court approval in November 2021.
Product Liability and General Litigation
In 2018, a qui tam lawsuit, U.S. ex rel. Silbersher v. Allergan Inc., et al., was filed in the United States District Court for the Northern District of California against several Allergan entities and others, alleging that their conduct before the U.S. Patent Office resulted in false claims for payment being made to federal and state healthcare payors for Namenda XR and Namzaric. The plaintiff-relator seeks damages and attorneys' fees under the federal False Claims Act and state law analogues. The federal government and state governments declined to intervene in the lawsuit.
Intellectual Property Litigation
AbbVie Inc. and AbbVie Biotechnology Ltd are seeking to enforce their patent rights relating to adalimumab (a drug AbbVie sells under the trademark Humira). In April 2021 and May 2021, cases were filed in the United States District Court for the Northern District of Illinois against Alvotech hf. AbbVie alleges defendant’s proposed biosimilar adalimumab product infringes certain AbbVie patents and seeks declaratory and injunctive relief. In August 2021, the court denied Defendant’s motion to dismiss on jurisdictional grounds in the first case; a motion in the second case remains pending. The court has set a trial on a subset of patents for August 2022. The court order provides that Alvotech will stay off the market until that decision. Litigation on the remaining patents is stayed. In October 2021, the May 2021 declaratory judgment action filed by Alvotech hf. and its U.S. subsidiary Alvotech USA, Inc. in the United States Eastern District of Virginia was transferred to the Northern District of Illinois and subsequently dismissed.
Pharmacyclics LLC, a wholly owned subsidiary of AbbVie, is seeking to enforce its patent rights relating to ibrutinib tablets (a drug Pharmacyclics sells under the trademark Imbruvica). Cases were filed in the United States District Court for the District of Delaware in March 2019 against Alvogen Pine Brook LLC and Natco Pharma Ltd.. In August 2021, the court issued a decision holding all asserted patents infringed and valid. The judgment precludes Defendants from obtaining regulatory approval and launching until the last patent expires in 2036. Janssen Biotech, Inc. which is in a global collaboration with Pharmacyclics concerning the development and marketing of Imbruvica, is the co-plaintiff in these suits.
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95 | | 2021 Form 10-K | | |
Allergan USA, Inc., Allergan Sales, LLC, and Forest Laboratories Holdings Limited, wholly owned subsidiaries of AbbVie, are seeking to enforce patent rights relating to cariprazine (a drug sold under the trademark Vraylar). Litigation was filed in the United States District Court for the District of Delaware in December 2019 against Sun Pharmaceutical Industries Limited and Sun Pharma Global FZE; Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc.; and Zydus Pharmaceuticals (USA), Inc. and Cadila Healthcare Limited. Allergan alleges defendants' proposed generic cariprazine products infringe certain patents and seeks declaratory and injunctive relief. Gedeon Richter Plc, Inc. which is in a global collaboration with Allergan concerning the development and marketing of Vraylar, is the co-plaintiff in this suit.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 96 |
Note 16 Segment and Geographic Area Information AbbVie operates as a single global business segment dedicated to the research and development, manufacturing, commercialization and sale of innovative medicines and therapies. This operating structure enables the Chief Executive Officer, as chief operating decision maker (CODM), to allocate resources and assess business performance on a global basis in order to achieve established long-term strategic goals. Consistent with this structure, a global research and development and supply chain organization is responsible for the discovery, manufacturing and supply of products. Commercial efforts that coordinate the marketing, sales and distribution of these products are organized by geographic region or therapeutic area. All of these activities are supported by a global corporate administrative staff. The determination of a single business segment is consistent with the consolidated financial information regularly reviewed by the CODM for purposes of assessing performance, allocating resources and planning and forecasting future periods.
Substantially all of AbbVie's net revenues in the United States are to three wholesalers. Outside the United States, products are sold primarily to health care providers or through distributors, depending on the market served. The following tables detail AbbVie's worldwide net revenues:
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years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Immunology | | | | | |
Humira | United States | $ | 17,330 | | | $ | 16,112 | | | $ | 14,864 | |
| International | 3,364 | | | 3,720 | | | 4,305 | |
| Total | $ | 20,694 | | | $ | 19,832 | | | $ | 19,169 | |
Skyrizi | United States | $ | 2,486 | | | $ | 1,385 | | | $ | 311 | |
| International | 453 | | | 205 | | | 44 | |
| Total | $ | 2,939 | | | $ | 1,590 | | | $ | 355 | |
Rinvoq | United States | $ | 1,271 | | | $ | 653 | | | $ | 47 | |
| International | 380 | | | 78 | | | — | |
| Total | $ | 1,651 | | | $ | 731 | | | $ | 47 | |
Hematologic Oncology | | | | | |
Imbruvica | United States | $ | 4,321 | | | $ | 4,305 | | | $ | 3,830 | |
| Collaboration revenues | 1,087 | | | 1,009 | | | 844 | |
| Total | $ | 5,408 | | | $ | 5,314 | | | $ | 4,674 | |
Venclexta | United States | $ | 934 | | | $ | 804 | | | $ | 521 | |
| International | 886 | | | 533 | | | 271 | |
| Total | $ | 1,820 | | | $ | 1,337 | | | $ | 792 | |
Aesthetics | | | | | |
Botox Cosmetic (a) | United States | $ | 1,424 | | | $ | 687 | | | $ | — | |
| International | 808 | | | 425 | | | — | |
| Total | $ | 2,232 | | | $ | 1,112 | | | $ | — | |
Juvederm Collection (a) | United States | $ | 658 | | | $ | 318 | | | $ | — | |
| International | 877 | | | 400 | | | — | |
| Total | $ | 1,535 | | | $ | 718 | | | $ | — | |
Other Aesthetics (a) | United States | $ | 1,268 | | | $ | 666 | | | $ | — | |
| International | 198 | | | 94 | | | — | |
| Total | $ | 1,466 | | | $ | 760 | | | $ | — | |
Neuroscience | | | | | |
Botox Therapeutic (a) | United States | $ | 2,012 | | | $ | 1,155 | | | $ | — | |
| International | 439 | | | 232 | | | — | |
| Total | $ | 2,451 | | | $ | 1,387 | | | $ | — | |
Vraylar (a) | United States | $ | 1,728 | | | $ | 951 | | | $ | — | |
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Duodopa | United States | $ | 102 | | | $ | 103 | | | $ | 97 | |
| International | 409 | | | 391 | | | 364 | |
| Total | $ | 511 | | | $ | 494 | | | $ | 461 | |
Ubrelvy (a) | United States | $ | 552 | | | $ | 125 | | | $ | — | |
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Other Neuroscience (a) | United States | $ | 667 | | | $ | 528 | | | $ | — | |
| International | 18 | | | 11 | | | — | |
| Total | $ | 685 | | | $ | 539 | | | $ | — | |
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97 | | 2021 Form 10-K | | |
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years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
Eye Care | | | | | |
Lumigan/Ganfort (a) | United States | $ | 273 | | | $ | 165 | | | $ | — | |
| International | 306 | | | 213 | | | — | |
| Total | $ | 579 | | | $ | 378 | | | $ | — | |
Alphagan/Combigan (a) | United States | $ | 373 | | | $ | 223 | | | $ | — | |
| International | 156 | | | 103 | | | — | |
| Total | $ | 529 | | | $ | 326 | | | $ | — | |
Restasis (a) | United States | $ | 1,234 | | | $ | 755 | | | $ | — | |
| International | 56 | | | 32 | | | — | |
| Total | $ | 1,290 | | | $ | 787 | | | $ | — | |
Other Eye Care (a) | United States | $ | 523 | | | $ | 305 | | | $ | — | |
| International | 646 | | | 388 | | | — | |
| Total | $ | 1,169 | | | $ | 693 | | | $ | — | |
Women's Health | | | | | |
Lo Loestrin (a) | United States | $ | 423 | | | $ | 346 | | | $ | — | |
| International | 14 | | | 10 | | | — | |
| Total | $ | 437 | | | $ | 356 | | | $ | — | |
Orilissa/Oriahnn | United States | $ | 139 | | | $ | 121 | | | $ | 91 | |
| International | 6 | | | 4 | | | 2 | |
| Total | $ | 145 | | | $ | 125 | | | $ | 93 | |
Other Women's Health (a) | United States | $ | 209 | | | $ | 181 | | | $ | — | |
| International | 5 | | | 11 | | | — | |
| Total | $ | 214 | | | $ | 192 | | | $ | — | |
Other Key Products | | | | | |
Mavyret | United States | $ | 754 | | | $ | 785 | | | $ | 1,473 | |
| International | 956 | | | 1,045 | | | 1,420 | |
| Total | $ | 1,710 | | | $ | 1,830 | | | $ | 2,893 | |
Creon | United States | $ | 1,191 | | | $ | 1,114 | | | $ | 1,041 | |
Lupron | United States | $ | 604 | | | $ | 600 | | | $ | 720 | |
| International | 179 | | | 152 | | | 167 | |
| Total | $ | 783 | | | $ | 752 | | | $ | 887 | |
Linzess/Constella (a) | United States | $ | 1,006 | | | $ | 649 | | | $ | — | |
| International | 32 | | | 18 | | | — | |
| Total | $ | 1,038 | | | $ | 667 | | | $ | — | |
Synthroid | United States | $ | 767 | | | $ | 771 | | | $ | 786 | |
All other | | $ | 2,673 | | | $ | 2,923 | | | $ | 2,068 | |
Total net revenues | $ | 56,197 | | | $ | 45,804 | | | $ | 33,266 | |
(a)Net revenues include Allergan product revenues after the acquisition closing date of May 8, 2020.
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| | 2021 Form 10-K | ![abbv-20211231_g2.gif](https://content.edgar-online.com/edgar_conv_img/2022/02/18/0001551152-22-000007_abbv-20211231_g2.gif) | 98 |
Net revenues to external customers by geographic area, based on product shipment destination, were as follows:
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years ended December 31 (in millions) | 2021 | | 2020 | | 2019 |
United States | $ | 43,510 | | | $ | 34,879 | | | $ | 23,907 | |
Canada | 1,397 | | | 1,159 | | | 813 | |
Germany | 1,223 | | | 1,049 | | | 909 | |
Japan | 1,090 | | | 1,198 | | | 1,211 | |
France | 936 | | | 797 | | | 695 | |
China | 857 | | | 471 | | | 195 | |
Australia | 533 | | | 527 | | | 395 | |
Spain | 519 | | | 453 | | | 472 | |
Italy | 506 | | | 379 | | | 372 | |
United Kingdom | 497 | | | 509 | | | 372 | |
Brazil | 368 | | | 406 | | | 359 | |
All other countries | 4,761 | | | 3,977 | | | 3,566 | |
Total net revenues | $ | 56,197 | | | $ | 45,804 | | | $ | 33,266 | |
Long-lived assets, primarily net property and equipment, by geographic area were as follows:
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as of December 31 (in millions) | 2021 | | 2020 |
United States and Puerto Rico | $ | 3,369 | | | $ | 3,354 | |
Europe | 1,400 | | | 1,534 | |
All other | 341 | | | 360 | |
Total long-lived assets | $ | 5,110 | | | $ | 5,248 | |
Note 17 Fourth Quarter Financial Results (unaudited) | | | | | | | |
quarter ended December 31 (in millions except per share data) | 2021 | | |
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Net revenues | $ | 14,886 | | | |
Gross margin | 10,566 | | | |
Net earnings attributable to AbbVie Inc. | 4,044 | | | |
Basic earnings per share attributable to AbbVie Inc. | $ | 2.27 | | | |
Diluted earnings per share attributable to AbbVie Inc. | $ | 2.26 | | | |
Cash dividends declared per common share | $ | 1.41 | | | |
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99 | | 2021 Form 10-K | | |