AbbVie (ABBV) 10-K risk factor changes: FY2022 vs FY2021

The [removed: continuing] pandemic caused by the novel strain of coronavirus (COVID-19) [removed: has] caused many countries, including the United States, to declare national emergencies and implement preventive measures such as travel bans and shelter in place or total lock-down [removed: orders, some of which have eased.][added: orders.]

The COVID-19 pandemic [removed: has] caused AbbVie to modify [added: certain of] its business [removed: practices (including instituting remote work for many of AbbVie’s employees),] [added: practices,] and AbbVie may take further actions as may be required by government authorities or as AbbVie determines are in the best interests of AbbVie’s employees, patients, customers and business partners.

While the impact of COVID-19 on AbbVie’s operations, including, among others, its manufacturing and supply chain, sales and marketing, commercial and clinical trial operations, to date [removed: has] [added: was] not [removed: been] material, AbbVie [removed: has] experienced lower new patient starts in certain products and markets.

The impact of COVID-19 [added: and other public health outbreaks] on AbbVie over the long-term is uncertain and cannot be predicted with confidence.

The extent of the adverse impact of COVID-19 [added: or any other public health outbreak] on AbbVie’s operations will depend on the extent and severity of the continued spread of [removed: COVID-19] [added: the disease] globally, the timing and nature of actions taken to respond to [removed: COVID-19] [added: it] and the resulting economic consequences.

Ultimately, efforts to mitigate the impact of COVID-19 [added: or any other public health outbreak] may not completely prevent AbbVie's business from being adversely affected and future impacts remain uncertain.

The expiration or loss of patent protection and [removed: licenses] [added: licenses, including the loss of exclusivity for Humira and increased competition from biosimilars,] may adversely affect AbbVie's [removed: future] revenues and operating earnings.

As patents for certain of its products expire, AbbVie [removed: will or] could face competition from lower priced generic or biosimilar products.

AbbVie's principal patents and trademarks are described in greater detail in Item 1, "Business—Intellectual Property Protection and Regulatory Exclusivity" and Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations," and litigation regarding these patents is described in Item 3, "Legal Proceedings." [removed: The United States composition of matter patent for Humira, which is AbbVie's largest product and had worldwide net revenues of approximately $20.7 billion in 2021, expired in December 2016, and the equivalent European Union patent expired in the majority of European Union countries in October 2018.]

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AbbVie's major products could lose patent protection earlier than expected, which could adversely affect AbbVie's [removed: future] revenues and operating earnings.

In addition, petitioners have filed, and may continue to file, challenges to the validity of [removed: AbbVie] [added: AbbVie's] patents under the 2011 Leahy-Smith America Invents Act, which created *inter partes* review and post grant review procedures for challenging patent validity in administrative proceedings at the United States Patent and Trademark Office.

If triggered, compulsory licenses [removed: could] [added: may] diminish or eliminate sales and profits from those jurisdictions and negatively affect AbbVie's results of operations.

[removed: To the extent AbbVie's intellectual property is] successfully challenged, circumvented or weakened, or to the extent such intellectual property does not allow AbbVie to compete effectively, AbbVie's business will suffer.

To the extent that countries do not enforce AbbVie's intellectual property rights or require compulsory licensing of AbbVie's intellectual property, AbbVie's [removed: future] revenues and operating earnings will be reduced.

A third party's intellectual property may prevent AbbVie from selling its products or have a material adverse effect on AbbVie's [removed: future] profitability and financial condition.

Resolving an intellectual property infringement [added: or other] claim can be costly and time consuming and may require AbbVie to enter into license agreements.

[added: For example,] Humira accounted for approximately 37% of AbbVie's total net revenues in [removed: 2021.][added: 2022.]

[removed: To remain competitive, AbbVie must continue to launch new products and new indications and/or brand extensions for existing products, and such] [added: Such] launches must generate revenue sufficient both to cover its substantial research and development costs and to replace revenues of profitable products that are lost to or displaced by competing products or therapies.

Accordingly, AbbVie commits substantial effort, [removed: funds,] [added: funds] and other resources to research and development and must make ongoing substantial expenditures without any assurance that its efforts will be commercially successful.

Products that appear promising in development may fail to reach the market for numerous reasons, including failure to demonstrate effectiveness, safety concerns, superior safety or efficacy of competing therapies, failure to achieve positive clinical or pre-clinical outcomes beyond the current standards of care, [added: inability to obtain necessary regulatory approvals or delays in the approval of new products and new indications, limited scope of approved uses, excessive costs to manufacture or the failure to obtain or maintain intellectual property rights, or infringement of the intellectual property rights of others.]

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More detailed studies may demonstrate additional benefits that can help in the marketing, but they also consume time and resources and may delay submitting the pharmaceutical product candidate for [added: regulatory] approval.

AbbVie cannot guarantee that a proper balance of speed and testing will be made with respect to each pharmaceutical product candidate or that decisions in this area would not adversely affect AbbVie's [removed: future] results of operations.

This could result in the loss of intellectual property rights or protection, delay the development and sale of potential pharmaceutical [added: products, affect the effective sale and delivery of AbbVie's commercialized] products and lead to lengthy and expensive litigation, administrative proceedings or arbitration.

Biologics carry unique risks and uncertainties, which could have a negative impact on [removed: future] [added: AbbVie's business and] results of operations.

For example, access to and supply of necessary biological materials, such as cell lines, may be limited and [added: current] governmental regulations restrict access to and regulate the transport and use of such materials.

[removed: Manufacturing] [added: As a result, manufacturing] biologics, especially in large quantities, is often complex and may require the use of innovative technologies.

Failure to successfully discover, develop, manufacture and sell biologics—including [removed: Humira—could adversely] [added: Humira and Skyrizi —could have a negative] impact [added: on] AbbVie's business and results of operations.

[removed: In addition, companies] [added: Companies have developed and] are developing biosimilars [removed: in other countries] that [removed: could and do] compete with AbbVie’s biologic products, including Humira.

Expiration [added: of] or successful [removed: challenge of] [added: challenges to] AbbVie’s applicable patent rights could also trigger competition from other products, assuming any relevant exclusivity period has expired.

As a result, AbbVie could face [removed: more] [added: increased] litigation and administrative proceedings with respect to the validity and/or scope of patents relating to its biologic products.

AbbVie competes with other research-based pharmaceutical and biotechnology companies that [removed: discover,] [added: research, develop,] manufacture, market and sell proprietary pharmaceutical products and biologics.

For example, Humira competes with [removed: anti-TNF products][added: anti-]

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[added: TNF products] and other competitive products intended to treat a number of disease states and Mavyret/Maviret competes with other available hepatitis C treatment options.

All of these competitors may introduce new products or develop technological advances that compete with AbbVie’s products in therapeutic areas such as immunology, hematologic oncology, aesthetics, [removed: neuroscience, eye care] [added: neuroscience] and [removed: women's health.][added: eye care.]

Such competing products may be safer, more effective, more effectively marketed or sold, [removed: or] have lower prices or [added: better insurance coverage or reimbursement levels, or have] superior performance features than AbbVie’s products, and this [removed: could] [added: may] negatively impact AbbVie’s business and results of operations.

If problems arise during the production of a batch of product, [removed: that] [added: such] batch of product may have to be discarded and AbbVie may experience product shortages or incur added expenses.

AbbVie uses [removed: a number of products] [added: raw materials and components] in its pharmaceutical and biologic manufacturing [removed: processes that are] [added: processes, including those] sourced from single suppliers, and an interruption in the supply of those [removed: products] [added: raw materials and components] could adversely affect AbbVie's business and results of operations.

Large pharmaceutical companies and generics manufacturers of pharmaceutical products continue to expand into the biotechnology field and form partnerships to pursue biosimilars.

Humira is facing competition from biosimilar products in the United States beginning in 2023 due to the loss of exclusivity, which AbbVie anticipates will cause a significant decline in Humira's revenue and could adversely affect AbbVie’s revenues and operating earnings.

A significant portion of AbbVie's revenue and operating earnings are derived from several major products.

To the extent AbbVie's intellectual property is

In addition, in its pursuit of valid business opportunities, AbbVie may be required to challenge intellectual property rights held by others that it believes were improperly granted.

To remain competitive, AbbVie must continue to launch new products and new indications and/or brand extensions for existing products.

In particular, the Inflation Reduction Act of

2022 requires (i) the government to negotiate prices for select high expenditure Medicare Part D drugs (prices effective beginning in 2026) and Part B drugs (prices effective beginning in 2028), (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices for those drugs increase faster than inflation beginning in 2022 for Part D and 2023 for Part B, and (iii) a Medicare Part D redesign replacing the current coverage gap provisions and establishing a $2,000 cap for out-of-pocket costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.

The Inflation Reduction Act is to be implemented through forthcoming agency action, the outcome of which cannot be reasonably determined with certainty.

Additionally, changes to U.S. tax laws now require (i) a 15% minimum tax generally applied to U.S. corporations on adjusted financial statement income beginning in 2023 and (ii) a non-deductible 1% excise tax provision on net stock repurchases, to be applied to repurchases beginning in 2023.

AbbVie continues to evaluate the impact that the Inflation Reduction Act may have on the company.

In addition, as AbbVie products lose exclusivity, competition surrounding such products will increase and generic and biosimilar products will increasingly penetrate the markets.

Increases in demand on any of AbbVie's suppliers could result in delays and disruptions in the manufacturing, distribution and sale of its products and/or product shortages, leading to lost revenue.

Business interruption insurance may not provide adequate compensation in the case of a failure by a supplier.

Additional, and perhaps more extensive, studies may also be conducted, which may be sponsored by AbbVie but could also be sponsored by competitors, insurance companies, government institutions, scientists, investigators or other interested parties.

the conditions of use for a product.

AbbVie evaluates its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and, as such, AbbVie's product liability losses are self-insured.

Allergan recently agreed to a nationwide settlement to resolve such matters, which will provide for up to $2.02 billion to help support state and local efforts to address opioid-related issues in the United States, among other things.

However, AbbVie cannot guarantee that the conditions to such settlement will be satisfied, or that additional suits will not be filed.

The U.S. healthcare industry, in particular, is highly regulated and subject to frequent and substantial regulatory changes.

It is expected that the U.S. healthcare industry will continue to be subject to increasing regulation as well as political and legal action, as future proposals to reform the healthcare system are considered by the executive branch, Congress and state legislatures.

AbbVie cannot predict with certainty when additional changes in the healthcare industry in general, or the pharmaceutical industry in particular, will occur, or what the impact of such changes may be.

For example, the Inflation Reduction Act is to be implemented through forthcoming agency action, the outcome of which cannot be reasonably determined with certainty.

Such violations may also lead to product recalls and seizures, interruption of production leading to product shortages, import bans or denials of import certifications, delays or denials in the approvals of new products or supplemental approvals of current products pending resolution of the issues, and reputational harm, any of which would adversely affect AbbVie's business.

In particular, in February 2022, armed conflict escalated between Russia and Ukraine.

In response thereto, the United States and other North Atlantic Treaty Organizations member states, as well as certain non-member states, announced targeted economic sanctions, embargoes and export controls on Russia and Belarus.

Although AbbVie is continuing to supply essential pharmaceutical products in Russia for humanitarian reasons while working to maintain compliance with evolving international sanctions, it has suspended operations for all aesthetics products in Russia.

AbbVie's operations in Russia, Belarus and Ukraine are not significant.

However, it is not possible to predict with certainty the continued consequences of this conflict, which, in addition to sanctions, have included regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, currency exchange rates and financial markets.

Any such consequences could have an adverse impact on AbbVie's business and results of operations.

greater than expected costs, may take longer than expected to complete or encounter other difficulties, including the need for regulatory approval where appropriate.

AbbVie may need additional financing in the future to meet its capital needs or to make opportunistic acquisitions.

The capital and credit markets may experience extreme volatility and disruption, which may lead to uncertainty and liquidity issues for both borrowers and investors, and AbbVie may be unable to obtain any desired additional financing on terms favorable to it, if at all.

In addition, while AbbVie maintains cyber insurance, it cannot guarantee that such insurance will be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of AbbVie systems.

useful lives and cash flows of the acquired products.

For IPR&D assets, the risk of failure is significant, and there can be no certainty that these assets ultimately will yield successful products.

AbbVie's ability to realize value on these significant investments is often contingent upon, among other things, regulatory approvals and market conditions.

As such, IPR&D assets may become impaired and/or be written off at some point in the future if the associated research and development effort is abandoned or is curtailed.

The illegal distribution and sale by third parties of counterfeit or unregistered versions of AbbVie products could have a material adverse impact on its reputation, business and results of operations.

Third parties may illegally obtain, distribute, and sell counterfeit or illegally diverted from their intended market versions of AbbVie products.

Any significant event that adversely affects Humira revenues could have a material and negative impact on AbbVie's results of operations and cash flows.

Any significant event that adversely affects Humira's revenues could have a material adverse impact on AbbVie's results of operations and cash flows.

These events could include loss of patent protection for Humira (as described further in “—*The expiration or loss of patent protection and licenses may adversely affect AbbVie’s future revenues and operating earnings*” above), the commercialization of biosimilars of Humira, the discovery of previously unknown side effects or impaired efficacy, increased competition from the introduction of new, more effective or less expensive treatments and discontinuation or removal from the market of Humira for any reason.

inability to obtain necessary regulatory approvals or delays in the approval of new products and new indications, limited scope of approved uses, excessive costs to manufacture, the failure to obtain or maintain intellectual property rights, or infringement of the intellectual property rights of others.

AbbVie's biologic products are subject to competition from biosimilars.

The Biologics Price Competition and Innovation Act creates a framework for the approval of biosimilars in the United States and could allow competitors to reference data from biologic products already approved.

In Europe, the European Commission has granted marketing authorizations for several biosimilars pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years.

AbbVie does, however, carry business interruption insurance, which provides a degree of protection in the case of a failure by a single-source supplier.

Investigators may also conduct additional, and perhaps more extensive, studies.

taken by such regulatory authorities.

Product liability losses are self-insured.

Events contemplated by these risks may, individually or in the aggregate, have a material adverse effect on AbbVie's revenues and profitability.

In particular, AbbVie incurred significant debt in connection with its acquisition of Allergan.

AbbVie’s substantially increased indebtedness and higher debt to equity ratio as a result of the acquisition may exacerbate these risks and have the effect of, among other things, reducing its flexibility to respond to changing business and economic conditions and/or lowering its credit ratings.

AbbVie may need to seek additional financing for its general corporate purposes.

AbbVie may be unable to obtain any desired additional financing on terms favorable to it, if at all.

These systems are potentially vulnerable to malicious intrusion, random attack, loss of data privacy, disruption, degradation or breakdown.

In connection with the acquisition of Allergan, AbbVie’s balances of intangible assets, including developed product rights and goodwill acquired, have increased significantly.

This commentary should be read in conjunction with the Consolidated Financial Statements and accompanying notes appearing in Item 8, "Financial Statements and Supplementary Data." This section of [removed: this] Form 10-K generally discusses [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] items and year-to-year comparisons between [removed: 2021] [added: 2022] and [removed: 2020.][added: 2021.]

Discussions of [removed: 2019] [added: 2020] items and year-to-year comparisons between [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] that are not included in this Form 10-K can be found in “Management's Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2020.][added: 2021.]

AbbVie is a global, diversified research-based biopharmaceutical company positioned for success with a comprehensive product portfolio that has leadership positions across immunology, [removed: hematologic] oncology, [removed: neuroscience, aesthetics] [added: aesthetics, neuroscience] and eye care.

Outside the United States, AbbVie sells products primarily to [removed: customers] [added: wholesalers] or through distributors, [added: and] depending on the market [removed: served.][added: works through largely centralized national payers system to agree on reimbursement terms.]

AbbVie [added: operates as a single global business segment and] has approximately 50,000 employees.

[removed: 2021] [added: 2022] Financial Results

The company's financial performance in [removed: 2021] [added: 2022] included delivering worldwide net revenues of [removed: $56.2] [added: $58.1] billion, operating earnings of [removed: $17.9] [added: $18.1] billion, diluted earnings per share of [removed: $6.45] [added: $6.63] and cash flows from operations of [removed: $22.8] [added: $24.9] billion.

Worldwide net revenues increased by [removed: 23%] [added: 3%] on a reported basis and [removed: 22%] [added: 5%] on a constant currency basis, reflecting growth across its immunology, [removed: hematologic oncology, neuroscience, aesthetics] [added: neuroscience] and [removed: eye care portfolios as well as a full period of Allergan results in 2021 compared to the prior year.][added: aesthetics portfolios.]

Diluted earnings per share in [removed: 2021] [added: 2022] was [removed: $6.45] [added: $6.63] and included the following after-tax costs: (i) $6.4 billion related to the amortization of intangible assets; (ii) [removed: $2.7] [added: $2.8] billion for the change in fair value of contingent consideration liabilities; (iii) [removed: $948 million for acquired in-process research and development (IPR&D); (iv) $500 million as a result of a collaboration agreement extension with Calico Life Sciences LLC; (v) $307 million for milestones and other research and development (R&D) expenses; (vi) $253 million] [added: $2.0 billion] for charges related to litigation matters; [removed: and (vii) $215] [added: (iv) $766] million of acquisition and integration [removed: expenses.][added: expenses; and (v) $604 million related to intangible asset impairment.]

[removed: In] [added: On] October [removed: 2021, AbbVie's] [added: 28, 2022, AbbVie announced that its] board of directors declared [removed: a] [added: an increase in the] quarterly cash dividend [removed: of] [added: from] $1.41 per share [removed: of common stock] [added: to $1.48 per share beginning with the dividend] payable [removed: in] [added: on] February [removed: 2022.][added: 15, 2023, to stockholders of record as of January 13, 2023.]

This reflects an increase of approximately [removed: 8.5%] [added: 5.0%] over the previous quarterly [removed: dividend of $1.30 per share of common stock.][added: rate.]

Following the closing of the Allergan [removed: acquisition,] [added: acquisition in 2020,] AbbVie implemented an integration plan designed to reduce costs, integrate and optimize the combined organization.

[removed: The] [added: As a result of the successful execution of the] integration [removed: plan is expected to realize approximately] [added: plan, AbbVie realized] $2.5 billion of annual cost synergies in 2022.

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To achieve these integration objectives, AbbVie [removed: expects to incur] [added: incurred] total cumulative charges of [removed: approximately $2] [added: $2.3] billion through 2022.

These costs [removed: consist] [added: consisted] 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.

[added: In response to COVID-19,] AbbVie [removed: also] continues to closely manage manufacturing and supply chain resources around the world to help ensure that patients continue to receive an uninterrupted supply of their medicines.

The extent to which COVID-19 may impact AbbVie's financial condition and results of operations remains uncertain and is dependent on numerous evolving factors, including the measures being taken by authorities to mitigate against the spread of COVID-19, the emergence of new variants and the [removed: availability and successful administration] [added: effectiveness] of [removed: effective vaccines.][added: vaccines and therapeutics.]

[removed: 2022] [added: 2023] Strategic Objectives

AbbVie intends to [removed: continue to] [added: execute its strategy and] advance its mission in a number of ways, including: (i) maximizing the benefits of a diversified revenue base with multiple long-term growth drivers; (ii) [removed: growing revenues by] leveraging AbbVie's commercial strength and international infrastructure across therapeutic areas and ensuring strong commercial execution of new product launches; (iii) continuing to invest in and expand its pipeline in support of opportunities in immunology, oncology, aesthetics, neuroscience and eye care as well as continued investment in key on-market products; (iv) [removed: expanding] [added: generating substantial] operating [removed: margins;] [added: cash flows to support investment in innovative research] and [removed: (v) returning] [added: development, and return] cash to shareholders via a strong and growing dividend while also reducing debt.

- [removed: Immunology] [added: Skyrizi and Rinvoq] revenue growth driven by increasing market share and indication [removed: expansion of Skyrizi and Rinvoq, as well as Humira U.S. sales growth.][added: expansion.]

- [removed: Aesthetics revenue growth driven by] [added: Continuing investment in the] global expansion [added: of aesthetics] and increasing market penetration of Botox and Juvederm Collection.

- Neuroscience revenue growth driven by Vraylar, Botox Therapeutic, Ubrelvy and [removed: recently launched] Qulipta.

- [removed: Sustaining eye care leadership by maximizing] [added: Maximizing] AbbVie's [removed: current] [added: existing] eye care portfolio.

- The favorable impact of pipeline products and indications recently approved or currently under regulatory review where approval is expected in [removed: 2022.][added: 2023.]

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AbbVie's pipeline currently includes [removed: approximately 90] [added: over 80] compounds, devices or indications in development individually or under collaboration or license agreements and is focused on such important specialties as immunology, oncology, aesthetics, neuroscience and eye care.

Of these programs, [removed: more than] [added: approximately] 50 are in mid- and late-stage development.

- In [removed: January 2021,] [added: February 2022,] AbbVie announced top-line results from its [added: second] Phase 3 [removed: ADVANCE and MOTIVATE] induction [removed: studies of Skyrizi] [added: study, U-Excel, for Rinvoq] in patients with [added: moderate to severe] Crohn’s disease [added: who had an inadequate response or were intolerant to conventional or biologic therapy] met the primary and [added: most] key secondary endpoints.

- In [removed: September 2021,] [added: July 2022,] AbbVie [removed: submitted] [added: announced its submission of] a supplemental New Drug Application (sNDA) to the FDA [added: and a marketing authorization application (MAA) to the EMA] for [removed: Skyrizi] [added: Rinvoq] for the treatment of [added: adult] patients [removed: 16 years and older] with [removed: moderate] [added: moderately] to [removed: severe] [added: severely active] Crohn’s disease.

- In November [removed: 2021,] [added: 2022,] AbbVie [removed: submitted a marketing authorization application (MAA) to] [added: announced that] the European [removed: Medicines Agency (EMA) for] [added: Commission (EC) approved] Skyrizi for the treatment of [removed: patients 16 years or older] [added: adults] with [removed: moderate] [added: moderately] to [removed: severe] [added: severely] active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

- In [removed: November 2021,] [added: April 2022,] AbbVie announced that the [removed: European Commission (EC)] [added: FDA] approved [removed: Skyrizi alone or in combination with methotrexate] [added: Rinvoq] for the treatment of [removed: active PsA in] adults [added: with active ankylosing spondylitis] who have had an inadequate response or [removed: who have been intolerant] [added: intolerance] to one or more [removed: disease-modifying antirheumatic drugs.][added: TNF blockers.]

- In [removed: January] [added: June] 2022, AbbVie announced that the FDA approved Skyrizi for the treatment of adults with [added: moderately to severely] active [removed: PsA.][added: Crohn’s disease.]

- In January [removed: 2021,] [added: 2022,] AbbVie announced that the [removed: EC] [added: U.S. Food and Drug Administration (FDA)] approved [removed: Rinvoq] [added: Skyrizi] for the treatment of adults with active [removed: PsA and ankylosing spondylitis (AS).][added: psoriatic arthritis.]

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[removed: *•*In December 2021,] [added: - In May 2022,] AbbVie announced [added: positive] top-line results from [removed: its] [added: U-ENDURE, a] Phase 3 [removed: U-EXCEED induction] [added: maintenance] study for Rinvoq in [added: adult] patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to [added: a conventional or] biologic [removed: therapy met the primary and key secondary endpoints.][added: therapy.]

[removed: The indication has also been updated to be indicated] [added: - In March 2022, AbbVie announced that the FDA approved Rinvoq] for the treatment of adults with moderately to severely active [removed: RA] [added: ulcerative colitis (UC)] who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

- In [removed: December 2021,] [added: October 2022,] AbbVie announced that the FDA approved Rinvoq for the treatment of adults with active [removed: PsA] [added: nr-axSpA with objective signs of inflammation] who have had an inadequate response or intolerance to [removed: one or more] TNF [removed: blockers.][added: blocker therapy.]

[removed: *•*In] [added: - In] January 2022, AbbVie announced that the FDA approved Rinvoq for the treatment of moderate to severe [removed: AD] [added: atopic dermatitis] in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.

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These costs were partially offset by an after-tax gain of $126 million related to the divestiture of Pylera and a benefit of $26 million related to certain tax items.

Recent Global Events

Russia/Ukraine

In response to the military conflict between Russia and Ukraine, the United States and other North Atlantic Treaty Organization member states, as well as certain non-member states, announced targeted economic sanctions and export controls on Russia and Belarus.

These include restrictions on the export and transfer of products containing certain toxins, including Botox, to Russia and Belarus.

However, AbbVie is not prohibited to continue the sale of essential pharmaceutical products to help ensure patients receive an uninterrupted supply of their medicines.

In March 2022, AbbVie announced the suspension of operations for all aesthetics products in Russia.

In April 2022, AbbVie also announced that all profits from the sales of essential medicines in Russia will be donated to support direct humanitarian relief efforts in Ukraine.

While the company’s operations in Russia, Belarus and Ukraine are not significant, if the conflict escalates and results in broader economic and political concerns, AbbVie’s business could be adversely impacted.

- Advancing our hematologic oncology portfolio by increasing Venclexta market share and new indications, strong commercial execution of new product launches and effectively managing market and competitive challenges impacting Imbruvica.

- Effectively managing the impact of Humira biosimilar erosion.

The results showed that more patients treated with Rinvoq achieved the co-primary and secondary endpoints at one year compared to placebo.

- In July 2022, AbbVie announced that the EC approved Rinvoq for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

- In July 2022, AbbVie announced that the EC approved Rinvoq for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

- In November 2022, AbbVie announced that the EMA's Committee for Medical Products for Human Use (CHMP) adopted an opinion following a review of the benefit-risk of medicines within the JAK inhibitor class for the treatment of inflammatory diseases, including Rinvoq.

Confirming the recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC), the CHMP did not recommend changes to the current Rinvoq indication statements and recommended updates to dosage and special warnings for all JAK inhibitor products indicated for the treatment of inflammatory diseases.

These recommendations will be forwarded to the EC, which is expected to issue a final decision.

- In May 2022, AbbVie initiated a Phase 3 clinical trial to evaluate Teliso-V versus docetaxel for the treatment of patients with previously treated c-Met overexpressing, epidermal growth factor receptor wild type, advanced/metastatic non-squamous non-small cell lung cancer.

Epcoritamab

- In March 2022, Genmab A/S (Genmab) announced that the FDA granted orphan-drug designation to the investigational medicine, epcoritamab (DuoBody-CD3xCD20), for the treatment of follicular lymphoma.

Genmab and AbbVie are co-developing epcoritamab and will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

- In June 2022, AbbVie and Genmab announced primary results from the large B-cell lymphoma expansion cohort in the EPCORE NHL-1 phase 2 clinical trial evaluating epcoritamab, an investigational subcutaneous bispecific antibody.

In this study, epcoritamab demonstrated efficacy with durable responses in patients who had previously received at least two prior lines of anti-lymphoma therapy including chimeric antigen receptor T-cell therapy.

- In September 2022, AbbVie and Genmab submitted a biological license application (BLA) to the FDA for epcoritamab for the treatment of patients with relapsed/refractory large B-cell lymphoma.

- In October 2022, AbbVie and Genmab submitted an MAA to the EMA for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.

- In October 2022, AbbVie initiated a Phase 3 clinical trial to evaluate epcoritamab in combination with rituximab and lenalidomide compared to rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma.

- In November 2022, AbbVie announced that the FDA has accepted for priority review the BLA for epcoritamab for the treatment of relapsed/refractory large B-cell lymphoma.

- In August 2022, AbbVie announced that the FDA approved the use of Imbruvica for the treatment of pediatric patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic therapy.

- In August 2022, the National Comprehensive Cancer Network (NCCN) in the United States issued updated guidelines for the management of chronic lymphocytic leukemia (CLL) re-categorizing Imbruvica from “Preferred Regimen” to “Other Recommended Regimen”.

*Aesthetics*

Juvederm Collection

- In February 2022, AbbVie announced that the FDA approved Juvederm Volbella XC for improvement of infraorbital hollows in adults over the age of 21.

- In August 2022, AbbVie announced that the FDA approved Juvederm Volux XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.

BoNTE

- In March 2022, AbbVie initiated three Phase 3 clinical trials to evaluate the efficacy and safety of BoNTE (AGN-151586) for the treatment of glabellar lines.

- In December 2022, AbbVie announced that the FDA approved Vraylar as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults.

- In March 2022, AbbVie announced results from the Phase 3 PROGRESS trial for Qulipta in the preventive treatment of chronic migraine in adults met the primary endpoint and resulted in significant improvements in all secondary endpoints after adjustment for multiple comparisons.

- In June 2022, AbbVie submitted an sNDA to the FDA for Qulipta for the preventative treatment of chronic migraine in adults.

- In July 2022, AbbVie submitted an MAA to the EMA for Qulipta for the prophylactic treatment of migraine in adult patients who have at least four migraine days per month.

- In May 2022, AbbVie submitted a New Drug Application to the FDA for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson's disease.

AbbVie operates as a single global business segment.

These costs were partially offset by $265 million of certain tax benefits.

In response to the ongoing public health crisis posed by COVID-19, AbbVie continues to focus on ensuring the safety of employees.

Throughout the pandemic, AbbVie has followed health and safety guidance from state and local health authorities and implemented safety measures for those employees who are returning to the workplace.

- Hematologic oncology revenue growth driven by increasing market share and indication expansion of Venclexta, as well as maintaining the strong leadership position of Imbruvica.

AbbVie remains committed to driving continued expansion of operating margins and expects to achieve this objective through continued realization of expense synergies from the Allergan acquisition, leverage from revenue growth, productivity initiatives in supply chain and ongoing efficiency programs to optimize manufacturing, commercial infrastructure, administrative costs and general corporate expenses.

- In January 2021, AbbVie announced top-line results from its Phase 3 KEEPsAKE-1 and KEEPsAKE-2 clinical trials of Skyrizi in adults with active psoriatic arthritis (PsA) met the primary and ranked secondary endpoints.

- In April 2021, AbbVie received U.S. Food and Drug Administration (FDA) approval of Skyrizi in a single dose pre-filled syringe and pre-filled pen.

This approval will reduce the number of injections administered per treatment.

- In June 2021, AbbVie announced top-line results from its Phase 3 FORTIFY study for Skyrizi in patients with moderate to severe Crohn’s disease met the co-primary endpoints.

- In February 2021, AbbVie announced its Phase 3 U-ACCOMPLISH induction study of Rinvoq for the treatment of adult patients with moderate to severe ulcerative colitis (UC) met the primary and all ranked secondary endpoints.

- In June 2021, AbbVie announced the FDA will not meet the Prescription Drug User Fee Act action dates for the sNDA of Rinvoq for the treatment of adults with active AS.

No formal regulatory action has been taken on the sNDA for Rinvoq in AS.

- In June 2021, AbbVie announced the results from its Phase 3 maintenance study of Rinvoq in patients with UC met the primary and all secondary endpoints.

*•*In August 2021, AbbVie announced that the EC approved Rinvoq for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

- In September 2021, AbbVie submitted an sNDA to the FDA and an MAA to the EMA for Rinvoq for the treatment of adults with moderately to severely active UC.

- In October 2021, AbbVie announced the results from Study 1 of the Phase 3 SELECT-AXIS 2 clinical trial for Rinvoq in patients with active AS and inadequate response to biologic disease-modifying antirheumatic drugs met the primary and all ranked secondary endpoints.

*•*In October 2021, AbbVie announced the results from Study 2 of the Phase 3 SELECT-AXIS 2 clinical trial for Rinvoq in adults with non-radiographic axial spondyloarthritis met the primary and 12 of 14 ranked secondary endpoints.

- In December 2021, AbbVie announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq for the treatment of adults with moderate to severe rheumatoid arthritis (RA).

This update follows a Drug Safety Communication (DSC) issued by the FDA in September 2021 based on its final review of the post-marketing study evaluating another JAK inhibitor (tofacitinib) in patients with RA.

The DSC and this label update apply to the class of systematically administered FDA-approved JAK inhibitors for the treatment of RA and other inflammatory diseases.

Based on this class-wide update, the U.S. label for Rinvoq will now include additional information about risks within the Boxed Warnings and Warnings Precautions sections.

*•*In January 2022, AbbVie announced its submission of an sNDA to the FDA and an MAA to the EMA for Rinvoq for the treatment of adults with active nr-axSpA with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs.

- In February 2022, AbbVie was notified that the EC is requesting the EMA to assess safety concerns associated with JAK inhibitor products authorized in inflammatory diseases and to evaluate the impact of these events on their benefit-risk balance.

The assessment covers all JAK inhibitors approved for use in inflammatory diseases.

The request is for an opinion from the EMA by September 30, 2022.

- In June 2021, AbbVie announced results from its Phase 3 GLOW study comparing the efficacy and safety of Imbruvica in combination with Venclexta versus chlorambucil plus obinutuzumab for first-line treatment in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma met its primary endpoint.

Venclexta

- In May 2021, AbbVie received European Commission approval for Venclyxto in combination with a hypomethylating agent for patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

- In July 2021, AbbVie announced that the FDA granted Breakthrough Therapy Designation to Venclexta in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes.

Botox Therapeutic

- In February 2021, AbbVie received FDA approval of Botox for the treatment of detrusor overactivity associated with a neurological condition in certain pediatric patients 5 years of age and older.

- In September 2021, AbbVie announced that the FDA approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults.

- In October 2021, AbbVie announced top-line results from two Phase 3 clinical trials, Study 3111-301-001 and Study 3111-302-001, evaluating the efficacy and safety of cariprazine (Vraylar) as an adjunctive treatment for patients with major depressive disorder (MDD).

In Study 3111-301-001, Vraylar met its primary endpoint demonstrating statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo in patients with MDD.

In Study 3111-302-001, Vraylar demonstrated numerical improvement in depressive symptoms from baseline to week six in MADRS total score compared with placebo but did not achieve statistical significance.

Safety data were consistent with the established safety profile of Vraylar across indications with no new safety signals identified.

- In October 2021, AbbVie announced that results from its pivotal Phase 3 M15-736 study of ABBV-951 (foslevodopa/foscarbidopa) in patients with advanced Parkinson’s disease met its primary endpoint in a 12-week study.

*Eye Care*

Vuity

The following table reflects the total foreign currency forward exchange contracts outstanding at December 31, [removed: 2021] [added: 2022] and [removed: 2020:][added: 2021:]

| Euro | | | $ | [removed: 10,253] [added: 8,507] | | | | | [removed: 1.155] [added: 1.071] | | | | | | $ | [removed: 195] [added: 9] | | | | | $ | [removed: 7,818] [added: 10,253] | | | | | [removed: 1.213] [added: 1.155] | | | | | | $ | [removed: (39)] [added: 195] | |

| Chinese yuan | | | [removed: 673] [added: 596] | | | | | | [removed: 6.400] [added: 7.024] | | | | | | [removed: (1)] [added: (5)] | | | | | | [removed: 247] [added: 673] | | | | | | [removed: 6.584] [added: 6.400] | | | | | | (1) | | |

| British pound | | | [removed: 605] [added: 772] | | | | | | [removed: 1.331] [added: 1.234] | | | | | | [removed: 9] [added: (8)] | | | | | | [removed: 275] [added: 605] | | | | | | [removed: 1.341] [added: 1.331] | | | | | | [removed: 3] [added: 9] | | |

| Japanese yen | | | [removed: 602] [added: 567] | | | | | | [removed: 113.3] [added: 133.3] | | | | | | [removed: 9] [added: (3)] | | | | | | [removed: 837] [added: 602] | | | | | | [removed: 103.9] [added: 113.3] | | | | | | [removed: (7)] [added: 9] | | |

| Canadian dollar | | | [removed: 571] [added: 1,302] | | | | | | [removed: 1.258] [added: 1.312] | | | | | | [removed: 9] [added: 40] | | | | | | [removed: 591] [added: 571] | | | | | | [removed: 1.328] [added: 1.258] | | | | | | [removed: (23)] [added: 9] | | |

| All other currencies | | | [removed: 1,549] [added: 1,954] | | | | | | n/a | | | | | | [removed: 5] [added: (2)] | | | | | | [removed: 1,459] [added: 1,549] | | | | | | n/a | | | | | | [removed: (14)] [added: 5] | | |

| Total | | | $ | [removed: 14,253] [added: 13,698] | | | | | | | | | | | $ | [removed: 226] [added: 31] | | | | | $ | [removed: 11,227] [added: 14,253] | | | | | | | | | | | $ | [removed: (81)] [added: 226] | |

The company estimates that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar, with all other variables held constant, would decrease the fair value of foreign exchange forward contracts by $1.4 billion at December 31, [removed: 2021.][added: 2022.]

As of December 31, [removed: 2021,] [added: 2022,] the company has €5.9 billion aggregate principal amount of unsecured senior Euro notes outstanding, which are exposed to foreign currency risk.

See Note 10 to the Consolidated Financial Statements for additional information regarding [removed: to] the senior Euro notes and Note 11 to the Consolidated Financial Statements for additional information regarding [removed: to] the net investment hedging program.

The company estimates that an increase in interest rates of 100 basis points would adversely impact the fair value of AbbVie's interest rate swap contracts by approximately [removed: $244] [added: $155] million at December 31, [removed: 2021.][added: 2022.]

The company estimates that an increase of 100 basis points in long-term interest rates would decrease the fair value of long-term debt by [removed: $5.0] [added: $4.2] billion at December 31, [removed: 2021.][added: 2022.]

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 48 | | |

| | | | 2022 | | | | | | | | | | | | | | | | | | 2021 | | | | | | | | | | | | | | |

| | | | 2021 | | | | | | | | | | | | | | | | | | 2020 | | | | | | | | | | | | | | |

[removed: AbbVie(1)] [added: AbbVie] is a global, diversified research-based biopharmaceutical company positioned for success with a comprehensive product portfolio that has leadership positions across immunology, [removed: hematologic] oncology, [removed: neuroscience, aesthetics] [added: aesthetics, neuroscience] and eye care.

[removed: (1)As used throughout the text of this report on Form 10-K, the terms "AbbVie"] [added: AbbVie] or "the company" refer to AbbVie Inc., [removed: a Delaware corporation,] or AbbVie Inc. and its consolidated subsidiaries, as the context requires.

| 1 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

Humira is sold in numerous other markets worldwide, including Japan, China, Brazil and Australia, and accounted for approximately 37% of AbbVie's total net revenues in [removed: 2021.][added: 2022.]

[removed: It] [added: In psoriatic disease (psoriasis or psoriatic arthritis) Skyrizi] is [removed: a biologic therapy] administered as a quarterly subcutaneous injection following two induction doses.

Skyrizi is approved in [added: multiple countries globally, including] the United States, [removed: Canada, Mexico] [added: Canada] and the European [removed: Union and is indicated] [added: Union,] for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

In the [removed: United States and the] European Union, [removed: Skyrizi] [added: Rinvoq] is [removed: additionally approved] [added: indicated] for the treatment of [added: moderate to severe rheumatoid arthritis in adults, for] active psoriatic arthritis in [removed: adult patients] [added: adults] who have an inadequate response or intolerance to disease-modifying [removed: antirheumatic drugs (DMARDs).][added: anti-rheumatic medicines (DMARDs), and for active axial spondyloarthritis in adults.]

[removed: In Japan,] Skyrizi is [added: also] approved [added: in Japan] for the treatment of plaque psoriasis, [removed: generalized pustular psoriasis,] [added: psoriatic arthritis,] erythrodermic psoriasis [removed: and psoriatic arthritis] in [removed: adult] patients who have an inadequate response to conventional [removed: therapies.][added: therapies, and for induction and maintenance in moderately to severely active Crohn's disease.]

Rinvoq (upadacitinib) is an oral, once-daily selective and reversible JAK inhibitor that is approved to treat the following inflammatory diseases in North America, [removed: Japan and] the European [removed: Union:][added: Union and Japan:]

| Ankylosing spondylitis | | | | | | [added: U.S.,] European Union | | |

In the United States, Rinvoq is indicated for both the treatment of moderate to severe active rheumatoid arthritis, [removed: and] for active psoriatic arthritis, [added: for moderately to severely active ulcerative colitis, for active ankylosing spondylitis and for active non-radiographic axial spondyloarthritis] in adult patients who have an inadequate response or intolerance to one or more TNF blockers.

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 2 | | |

Venclexta is approved by the FDA for adults with CLL or [removed: SLL.][added: small lymphocytic lymphoma.]

[removed: In addition, Venclexta] is approved in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia who are 75 years of age or older or have other medical conditions that prevent the use of standard chemotherapy.

Having received its initial FDA approval in 2002, Botox Cosmetic is now approved for use in all major markets around the [removed: world and has become one of the world’s most recognized and iconic brands.][added: world.]

*Other aesthetics.* Other aesthetics products include, but are not limited to, [removed: Coolsculpting body contouring technology,] Alloderm regenerative dermal tissue, [added: Coolsculpting body contouring technology,] Natrelle breast implants, the SkinMedica skincare [removed: line] [added: line, Latisse eyelash solution] and DiamondGlow dermabrasion technology.

*Botox Therapeutic.* Botox Therapeutic (onabotulinumtoxinA injection) is [added: an acetylcholine release inhibitor and] a neuromuscular blocking agent that is injected into muscle [removed: tissue in treatment for the following indications in the United States:][added: tissue.]

[removed: - Urinary] [added: In the United States, it is approved to treat numerous indications, including chronic migraine, overactive bladder in adults who have an inadequate response to an anticholinergic medication, and urinary] incontinence due to detrusor overactivity associated with a neurologic condition [removed: (e.g., spinal cord injury, multiple sclerosis)] in adults who have an inadequate response to [removed: or are intolerant of] an anticholinergic medication.

[removed: Licenses] [added: Botox is marketed in other countries] around the world [added: and licenses will] vary.

| 3 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

Vraylar is indicated for acute and maintenance treatment of schizophrenia in adults, acute treatment of manic or mixed episodes associated with bipolar disorder in [removed: adults and] [added: adults,] acute treatment of depressive episodes associated with bipolar I disorder in [removed: adults.][added: adults and as an adjunctive treatment in major depressive disorder.]

*Ubrelvy.* Ubrelvy (ubrogepant) is [added: a calcitonin gene-related peptide receptor antagonist] indicated for the acute treatment of migraine with or without aura in [removed: adults and is only commercialized in the United States.][added: adults.]

*Other eye care.* Other eye care products include [removed: Xen, Durysta,] Ozurdex, [removed: Refresh/Optive] [added: Refresh/Optive, Xen] and [removed: Vuity.][added: Durysta.]

Other key products. AbbVie’s other key products include, among other things, treatments for patients with hepatitis C virus (HCV), metabolic and hormone products that target a number of conditions, including exocrine pancreatic insufficiency and hypothyroidism, as well as endocrinology products for the palliative treatment of advanced prostate [added: cancer, treatment of endometriosis and central precocious puberty and for the preoperative treatment of patients with anemia caused by uterine fibroids.]

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 4 | | |

*Linzess/Constella.* Linzess (linaclotide) is a once-daily guanylate cyclase-C agonist used in adults to treat irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic [removed: constipation (CIC).][added: constipation.]

AbbVie directs its primary marketing efforts toward securing the prescription, or recommendation, of its brand of products by physicians, [removed: key opinion leaders] [added: external experts] and other health care providers.

Managed care providers (for example, health maintenance organizations and pharmacy benefit managers), hospitals and state and federal government agencies (for example, [added: State Medicaid programs,] the United States Department of Veterans Affairs and the United States Department of Defense) are also important customers.

Outside of the United States, AbbVie focuses its promotional and market access efforts on [removed: key opinion leaders,] [added: external experts,] payers, physicians and health systems.

In [removed: 2021,] [added: 2022,] three wholesale distributors (McKesson Corporation, Cardinal Health, Inc. and AmerisourceBergen Corporation) accounted for substantially all of AbbVie's pharmaceutical product sales in the United States.

No individual wholesaler accounted for greater than [removed: 37%] [added: 39%] of AbbVie's [removed: 2021] [added: 2022] gross revenues in the United States.

Outside the United States, AbbVie sells products primarily to [removed: customers] [added: wholesalers] or through distributors, [added: and] depending on the market [removed: served.][added: works through largely centralized national payers system to agree on reimbursement terms.]

AbbVie competes with other research-based pharmaceuticals and biotechnology companies that discover, manufacture, market and sell proprietary pharmaceutical products, therapies [added: and biologics.]

| 5 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

For example, [removed: Humira competes] [added: AbbVie's immunology products compete] with anti-TNF products, JAK inhibitors and other competitive products intended to treat a number of disease [removed: states] [added: states,] and [removed: Mavyret/Maviret competes] [added: AbbVie's oncology products compete] with [removed: other available HCV treatment options.][added: BTK inhibitors.]

In addition, the substitution of generic [added: and biosimilar] pharmaceutical products for branded [removed: conventional (small-molecule)] pharmaceutical products creates competitive pressures on AbbVie's products that do not have patent protection.

Humira is now facing direct biosimilar competition in [removed: Europe] [added: Europe, the United States] and other countries, and AbbVie will continue to face competitive pressure from these biologics and from orally administered products.

The length of the patent extension is roughly based on 50 percent of the period of time from the filing of an Investigational New Drug Application (NDA) for a [removed: compound to the submission of the NDA for such compound, plus 100 percent of the time period from NDA submission to regulatory approval.]

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 6 | | |

[added: Specific conditions of use approved for] individual products may also be entitled to three years of exclusivity if approval was based on the FDA’s reliance on new clinical studies essential to approval submitted by the NDA applicant.

It is a biologic therapy approved to treat the following autoimmune diseases in North America, the European Union and Japan:

| Plaque psoriasis (moderate to severe) | | | | | | North America, European Union, Japan | | |

| Psoriatic arthritis | | | | | | U.S., European Union | | |

| Adult Crohn's disease (moderate to severe) | | | | | | U.S., Canada, European Union | | |

When administered for Crohn’s disease, Skyrizi is given in three induction doses via IV infusion, followed by subcutaneous injection via an on-body injector every eight weeks.

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Condition | | | | | | Principal Markets | | |

| Axial spondyloarthropathy | | | | | | U.S., European Union | | |

| Ulcerative colitis | | | | | | U.S., European Union | | |

It is also indicated for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older, and for moderately to severely active ulcerative colitis in adults.

Imbruvica is approved in adult and pediatric patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic therapy.

In addition, Venclexta

In addition, Botox Therapeutic is approved to treat spasticity in patients two years of age and older, cervical dystonia in adults, as well as other conditions.

Botox Therapeutic is marketed by GSK in Japan.

Ubrelvy is commercialized in the United States, Israel, Saudi Arabia, United Arab Emirates and has been approved in Canada.

*Qulipta.* Qulipta (atogepant) is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of episodic migraine in adults.

Qulipta is commercialized in the United States and has recently been approved for use in Canada.

compound to the submission of the NDA for such compound, plus 100 percent of the time period from NDA submission to regulatory approval.

However, no generic entry for any ibrutinib product is expected prior to March 30, 2032.

And the United States composition of matter patent covering upadacitinib is expected to expire in 2033.

contractors and collaborators.

The Veterans Health Care

AbbVie has also invested in integrated inclusive practices across the end-to-end hiring process and introduced Inclusive Recruitment Live Trainings, as a requirement for all people leaders and recruiters.

In 2022, AbbVie launched on-site health care clinics at certain locations, offering convenient and affordable access to quality healthcare, flu shots and vaccines.

In 2022, we implemented "Where We Work", AbbVie's hybrid work model, offering eligible employees predictable flexibility.

Impact of the Coronavirus Disease 2019 (COVID-19)

The novel coronavirus (COVID-19) pandemic continues to spread throughout the United States and around the world.

As COVID-19 continues to have an impact worldwide, AbbVie is focused on the health and safety of its employees, health care professionals and patients and communities.

In the continued operation of its business, AbbVie has followed health and safety guidance from relevant health authorities, managed manufacturing and supply chain resources and monitored closely its clinical trial sites.

See Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations—Impact of the Coronavirus Disease 2019 (COVID-19)."

_______________________________________________________________________________

| | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

- Prophylaxis of headaches in adult patients with chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).

- Overactive bladder with symptoms of urge urinary incontinence, urgency and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

- Spasticity in patients 2 years of age and older.

- Cervical dystonia in adults to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

- Strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and older.

- Severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

- Focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant pediatric cerebral palsy patients 2 years of age or older.

- Focal spasticity of the wrist and hand in adult post stroke patients.

- Focal spasticity of the ankle and foot in adult post stroke patients.

Its D3 binding profile may be linked to observed improvements in the negative symptoms of schizophrenia and to antidepressant effects in bipolar I disorder (bipolar depression).

*Other neuroscience.* Other neuroscience products include Qulipta (atogepant), which is indicated for preventive treatment of episodic migraine in adults.

Women's health products. AbbVie’s women's health products are:

*Lo Loestrin*.

Lo Loestrin Fe is an oral contraceptive.

It is indicated for prevention of pregnancy with the lowest dose of estrogen with only 10mcg and is dispensed in a unique 24/2/2 regimen with a two-day hormone-free interval.

It is marketed in the U.S. as Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) and in select markets outside the U.S. as Lolo.

*Orilissa/Oriahnn.* Orilissa (elagolix) is the first and only orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain.

It represents the first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade.

Orilissa inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland.

Administration results in dose-dependent suppression of luteinizing hormone and follicle-stimulating hormone, leading to decreased blood concentrations of ovarian sex hormones, estradiol and progesterone.

Outside the United States, Orilissa is also launched in Canada.

Oriahnn (elagolix, estradiol and norethindrone acetate capsules; elagolix capsules) is a combination prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause.

*Other women's health.* Other women's health includes Liletta, a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to six years.

cancer, treatment of endometriosis and central precocious puberty and for the preoperative treatment of patients with anemia caused by uterine fibroids.

Throughout the COVID-19 pandemic AbbVie has maintained its promotional activities with key stakeholders by leveraging digital engagement where permitted and in compliance with the locally applicable government guidance.

and biologics.

Specific conditions of use approved for

The United States composition of matter (that is, compound) patent covering adalimumab expired in December 2016, and the equivalent European Union patent expired in October 2018 in the majority of European Union countries.

In the United States, non-composition of matter patents covering adalimumab expire no earlier than 2022.

In

AbbVie expects debate to continue during 2022 at all government levels worldwide over the marketing, availability, method of delivery and payment for health care products and services.

AbbVie believes that future legislation and regulation in the markets it serves could affect access to health care products and services, increase rebates, reduce prices or the rate of price increases for health care products and services, change health care delivery systems, create new fees and obligations for the pharmaceuticals industry, or require additional reporting and disclosure.

For the fiscal year ended December 31, [removed: 2021][added: 2022]

[removed: ][added: ]

The aggregate market value of the [removed: 1,751,117,802] [added: 1,751,453,358] shares of voting stock held by non-affiliates of the registrant, computed by reference to the closing price as reported on the New York Stock Exchange, as of the last business day of AbbVie Inc.'s most recently completed second fiscal quarter (June 30, [removed: 2021),] [added: 2022),] was [removed: $197,245,909,217.][added: $268,252,598,311.]

Portions of the [removed: 2022] [added: 2023] AbbVie Inc. Proxy Statement are incorporated by reference into Part III.

The Definitive Proxy Statement will be filed on or about March [removed: 21, 2022.][added: 20, 2023.]

FOR THE YEAR ENDED DECEMBER 31, [removed: 2021][added: 2022]

| [removed: Item 1.] [added: [Item 1.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_13)] | | | [removed: [BUSINESS](#i1293eb1bca8b4a9faecfc0731a3b171e_13)] [added: [BUSINESS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_13)] | | | [removed: [1](#i1293eb1bca8b4a9faecfc0731a3b171e_13)] [added: [1](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_13)] | | |

| [removed: Item 1A.] [added: [Item 1A.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_16)] | | | [RISK [removed: FACTORS](#i1293eb1bca8b4a9faecfc0731a3b171e_16)] [added: FACTORS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_16)] | | | [removed: [15](#i1293eb1bca8b4a9faecfc0731a3b171e_16)] [added: [13](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_16)] | | |

| [removed: Item 1B.] [added: [Item 1B.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_22)] | | | [UNRESOLVED STAFF [removed: COMMENTS](#i1293eb1bca8b4a9faecfc0731a3b171e_22)] [added: COMMENTS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_22)] | | | [removed: [25](#i1293eb1bca8b4a9faecfc0731a3b171e_22)] [added: [25](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_22)] | | |

| [removed: Item 2.] [added: [Item 2.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_25)] | | | [removed: [PROPERTIES](#i1293eb1bca8b4a9faecfc0731a3b171e_25)] [added: [PROPERTIES](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_25)] | | | [removed: [25](#i1293eb1bca8b4a9faecfc0731a3b171e_25)] [added: [25](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_25)] | | |

| [removed: Item 3.] [added: [Item 3.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_31)] | | | [LEGAL [removed: PROCEEDINGS](#i1293eb1bca8b4a9faecfc0731a3b171e_28)] [added: PROCEEDINGS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_31)] | | | [removed: [26](#i1293eb1bca8b4a9faecfc0731a3b171e_28)] [added: [26](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_31)] | | |

| [removed: Item 4.] [added: [Item 4.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_34)] | | | [MINE SAFETY [removed: DISCLOSURES](#i1293eb1bca8b4a9faecfc0731a3b171e_31)] [added: DISCLOSURES](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_34)] | | | [removed: [26](#i1293eb1bca8b4a9faecfc0731a3b171e_31)] [added: [26](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_34)] | | |

| | | | [INFORMATION ABOUT OUR EXECUTIVE [removed: OFFICERS](#i1293eb1bca8b4a9faecfc0731a3b171e_34)] [added: OFFICERS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_37)] | | | [removed: [27](#i1293eb1bca8b4a9faecfc0731a3b171e_34)] [added: [27](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_37)] | | |

| [removed: Item 5.] [added: [Item 5.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_43)] | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i1293eb1bca8b4a9faecfc0731a3b171e_40)] [added: SECURITIES](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_43)] | | | [removed: [29](#i1293eb1bca8b4a9faecfc0731a3b171e_40)] [added: [29](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_43)] | | |

| [removed: Item 6.] [added: [Item 6.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_46)] | | | [removed: [\[RESERVED\]](#i1293eb1bca8b4a9faecfc0731a3b171e_43)] [added: [\[RESERVED\]](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_46)] | | | [removed: [31](#i1293eb1bca8b4a9faecfc0731a3b171e_43)] [added: [31](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_46)] | | |

| [removed: Item 7.] [added: [Item 7.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_49)] | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i1293eb1bca8b4a9faecfc0731a3b171e_49)] [added: OPERATIONS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_49)] | | | [removed: [32](#i1293eb1bca8b4a9faecfc0731a3b171e_49)] [added: [32](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_49)] | | |

| [removed: Item 7A.] [added: [Item 7A.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_94)] | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i1293eb1bca8b4a9faecfc0731a3b171e_91)] [added: RISK](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_94)] | | | [removed: [48](#i1293eb1bca8b4a9faecfc0731a3b171e_91)] [added: [48](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_94)] | | |

| [removed: Item 8.] [added: [Item 8.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_97)] | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i1293eb1bca8b4a9faecfc0731a3b171e_94)] [added: DATA](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_97)] | | | [removed: [49](#i1293eb1bca8b4a9faecfc0731a3b171e_94)] [added: [49](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_97)] | | |

| [removed: Item 9.] [added: [Item 9.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_199)] | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i1293eb1bca8b4a9faecfc0731a3b171e_193)] [added: DISCLOSURE](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_199)] | | | [removed: [103](#i1293eb1bca8b4a9faecfc0731a3b171e_193)] [added: [101](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_199)] | | |

| [removed: Item 9A.] [added: [Item 9A.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_202)] | | | [CONTROLS AND [removed: PROCEDURES](#i1293eb1bca8b4a9faecfc0731a3b171e_196)] [added: PROCEDURES](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_202)] | | | [removed: [103](#i1293eb1bca8b4a9faecfc0731a3b171e_196)] [added: [101](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_202)] | | |

| [removed: Item 9B.] [added: [Item 9B.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_208)] | | | [OTHER [removed: INFORMATION](#i1293eb1bca8b4a9faecfc0731a3b171e_202)] [added: INFORMATION](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_208)] | | | [removed: [105](#i1293eb1bca8b4a9faecfc0731a3b171e_202)] [added: [103](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_208)] | | |

| [removed: Item 10.] [added: [Item 10.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_214)] | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i1293eb1bca8b4a9faecfc0731a3b171e_208)] [added: GOVERNANCE](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_214)] | | | [removed: [106](#i1293eb1bca8b4a9faecfc0731a3b171e_208)] [added: [104](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_214)] | | |

| [removed: Item 11.] [added: [Item 11.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_217)] | | | [EXECUTIVE [removed: COMPENSATION](#i1293eb1bca8b4a9faecfc0731a3b171e_211)] [added: COMPENSATION](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_217)] | | | [removed: [106](#i1293eb1bca8b4a9faecfc0731a3b171e_211)] [added: [104](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_217)] | | |

| [removed: Item 12.] [added: [Item 12.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_220)] | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i1293eb1bca8b4a9faecfc0731a3b171e_214)] [added: MATTERS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_220)] | | | [removed: [107](#i1293eb1bca8b4a9faecfc0731a3b171e_214)] [added: [105](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_220)] | | |

| [removed: Item 13.] [added: [Item 13.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_223)] | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR [removed: INDEPENDENCE](#i1293eb1bca8b4a9faecfc0731a3b171e_217)] [added: INDEPENDENCE](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_223)] | | | [removed: [107](#i1293eb1bca8b4a9faecfc0731a3b171e_217)] [added: [105](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_223)] | | |

| [removed: Item 14.] [added: [Item 14.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_226)] | | | [PRINCIPAL ACCOUNTING FEES AND [removed: SERVICES](#i1293eb1bca8b4a9faecfc0731a3b171e_220)] [added: SERVICES](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_226)] | | | [removed: [107](#i1293eb1bca8b4a9faecfc0731a3b171e_220)] [added: [105](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_226)] | | |

| [removed: Item 15.] [added: [Item 15.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_232)] | | | [EXHIBITS, FINANCIAL STATEMENT [removed: SCHEDULES](#i1293eb1bca8b4a9faecfc0731a3b171e_226)] [added: SCHEDULES](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_232)] | | | [removed: [108](#i1293eb1bca8b4a9faecfc0731a3b171e_226)] [added: [106](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_232)] | | |

| [removed: Item 16.] [added: [Item 16.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_235)] | | | [FORM 10-K [removed: SUMMARY](#i1293eb1bca8b4a9faecfc0731a3b171e_229)] [added: SUMMARY](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_235)] | | | [removed: [112](#i1293eb1bca8b4a9faecfc0731a3b171e_229)] [added: [110](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_235)] | | |

If securities are registered pursuant to Section 12(b) of the Act, indicate by checkmark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

Number of common shares outstanding as of January 31, 2023: 1,769,399,971

| [PART I](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_10) | | | | | | | | |

| [PART II](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_40) | | | | | | | | |

| [Item 9C.](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_2319) | | | [DISCLOSURE REGARDING FOREIGN JURISDICTION](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_2319)[S](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_2319) [THAT PREVENT INSPECTIONS](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_2319) | | | [103](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_2319) | | |

| [PART III](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_211) | | | | | | | | |

| [PART IV](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_229) | | | | | | | | |

| | | | [SIGNATURES](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_238) | | | [111](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_238) | | |

Number of common shares outstanding as of January 31, 2022: 1,768,753,829

| [PART I](#i1293eb1bca8b4a9faecfc0731a3b171e_10) | | | | | | | | |

| [PART II](#i1293eb1bca8b4a9faecfc0731a3b171e_37) | | | | | | | | |

| [PART III](#i1293eb1bca8b4a9faecfc0731a3b171e_205) | | | | | | | | |

| [PART IV](#i1293eb1bca8b4a9faecfc0731a3b171e_223) | | | | | | | | |

| | | | [SIGNATURES](#i1293eb1bca8b4a9faecfc0731a3b171e_232) | | | [113](#i1293eb1bca8b4a9faecfc0731a3b171e_232) | | |

As of December 31, [removed: 2021,] [added: 2022,] AbbVie owns or leases approximately [removed: 645] [added: 637] facilities worldwide, containing an aggregate of approximately [removed: 20] [added: 19] million square feet of floor space dedicated to production, [removed: distribution,] [added: distribution] and administration.

| 25 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 26 | | |

| Richard A. Gonzalez | | | | | | [removed: 68] [added: 69] | | | | | | Chairman of the Board and Chief Executive Officer | | |

| Robert A. Michael | | | | | | [removed: 51] [added: 52] | | | | | | Vice [removed: Chairman, Finance and Commercial Operations] [added: Chairman] and [removed: Chief Financial Officer] [added: President] | | |

[removed: |] [added: Mr.] Michael [removed: E. Severino, M.D. | | | | | | 56 | | | | | |] [added: is AbbVie’s] Vice Chairman and [removed: President | | |][added: President.]

| [removed: Henry O. Gosebruch] [added: Scott T. Reents] | | | | | | [removed: 49] [added: 55] | | | | | | Executive Vice President, Chief [removed: Strategy] [added: Financial] Officer | | |

| Timothy J. Richmond | | | | | | [removed: 55] [added: 56] | | | | | | Executive Vice President, Chief Human Resources Officer | | |

| Azita Saleki-Gerhardt, Ph.D. | | | | | | [removed: 58] [added: 59] | | | | | | Executive Vice President, Operations | | |

| Jeffrey R. Stewart | | | | | | [removed: 53] [added: 54] | | | | | | Executive Vice President, Chief Commercial Officer | | |

| Thomas J. Hudson, M.D. | | | | | | [removed: 60] [added: 61] | | | | | | Senior Vice President, Research & Development and Chief Scientific Officer | | |

| Elaine K. Sorg | | | | | | [removed: 55] [added: 56] | | | | | | Senior Vice President, [added: AbbVie and President,] U.S. Commercial Operations | | |

| Carrie Strom | | | | | | [removed: 44] [added: 45] | | | | | | Senior Vice President, AbbVie and President, Global Allergan Aesthetics | | |

| Brian L. Durkin | | | | | | [removed: 61] [added: 62] | | | | | | Vice President, Controller | | |

He served as Abbott’s Executive Vice President of the Pharmaceutical Products Group from July 2010 to December 2012, and was responsible for Abbott’s worldwide pharmaceutical business, including commercial operations, research and [removed: development,] [added: development] and manufacturing.

Mr. [removed: Michael] [added: Reents] is AbbVie’s [added: Executive] Vice [removed: Chairman, Finance and Commercial Operations and] [added: President,] Chief Financial Officer.

Mr. Michael previously served as [added: Vice Chairman, Finance and Commercial Operations and Chief Financial Officer from June 2021 to June 2022, as] Executive Vice President, Chief Financial Officer from 2019 to 2021, as Senior Vice President, Chief Financial Officer from 2018 to [removed: 2019,] [added: 2019] and as Vice President, Controller from 2017 to 2018.

Mr. Michael joined Abbott in 1993 and was first appointed as an AbbVie corporate officer in [removed: December 2015.][added: March 2017.]

[removed: Prior to her current appointment in 2018, she served as] [added: Mr. Siatis is] AbbVie’s Executive Vice President, [removed: External Affairs,] General Counsel and [removed: Corporate] Secretary.

[removed: He] [added: Mr. Reents] joined [removed: AbbVie] [added: Abbott] in [removed: 2014] [added: 2008] and was first appointed as an AbbVie corporate officer in June [removed: 2014.][added: 2022.]

Mr. [removed: Gosebruch] [added: Siatis] joined [removed: AbbVie] [added: Abbott] in [removed: 2015] [added: 2005] and was first appointed as an AbbVie corporate officer in [removed: December 2015.][added: October 2022.]

Mr. Richmond served as Abbott’s Divisional Vice President of Compensation & Benefits from 2008 to 2012, as Group Vice President of Talent and Rewards from 2007 to [removed: 2008,] [added: 2008] and as Divisional Vice President of [added: Talent Acquisition from 2006 to 2007.]

| 27 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

He previously served as Senior Vice President, U.S. Commercial Operations from 2018 to 2020 and as AbbVie’s President, Commercial Operations from 2013 to [removed: 2018.]

Ms. Sorg is AbbVie’s Senior Vice President, [added: AbbVie, and President] U.S. Commercial Operations.

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 28 | | |

| Perry C. Siatis | | | | | | 48 | | | | | | Executive Vice President, General Counsel and Secretary | | |

He previously served as Senior Vice President, Chief Financial Officer from June 2022 to November 2022, as Vice President, Tax and Treasury from 2019 to June 2022, and as Vice President, Tax from 2013 to 2019.

Mr. Siatis previously served as Senior Vice President, Deputy General Counsel from September 2021 until October 2022.

From 2013 until 2021, Mr. Siatis also served in various roles including as Senior Vice President, Legal and Chief Ethics and Compliance Officer; Senior Vice President of Legal Transactions and R&D/Alliance Management and Chief Ethics and Compliance Officer; and Vice President, Biologic Strategic Development and Legal Regulatory.

2018.

| Laura J. Schumacher | | | | | | 58 | | | | | | Vice Chairman, External Affairs and Chief Legal Officer | | |

Ms. Schumacher is AbbVie’s Vice Chairman, External Affairs and Chief Legal Officer, responsible for global legal, health economics outcomes research, corporate responsibility, brand and communications and government affairs.

Prior to AbbVie’s separation from Abbott, Ms. Schumacher served as Executive Vice President, General Counsel from 2007 to 2012.

Both at Abbott and AbbVie, Ms. Schumacher also led Business Development and Ventures and Early Stage Collaborations.

Ms. Schumacher was first appointed as an AbbVie corporate officer in December 2012.

She serves on the board of General Dynamics Corporation and CrowdStrike Holdings, Inc.

Dr. Severino is AbbVie’s Vice Chairman and President, responsible for research and development and the corporate strategy office.

He served as Executive Vice President, Research and Development and Chief Scientific Officer from 2014 to 2018.

Dr. Severino served at Amgen Inc. as Senior Vice President, Global Development and Corporate Chief Medical Officer from 2012 to 2014, as Vice President, Global Development from 2010 to 2012 and as Vice President, Therapeutic Area Head, General Medicine and Inflammation Global Clinical Development from 2007 to 2012.

Dr. Severino also serves on the board of Avantor, Inc.

Mr. Gosebruch is AbbVie's Executive Vice President, Chief Strategy Officer.

He worked for more than 20 years in the Mergers & Acquisitions Group at J.P. Morgan Securities LLC, serving as Managing Director since 2007 and as Co-Head of M&A North America during 2015.

He serves on the board of Aptinyx Inc.

Talent Acquisition from 2006 to 2007.

There were [removed: 46,139] [added: 44,487] stockholders of record of AbbVie common stock as of January 31, [removed: 2022.][added: 2023.]

The following graph compares the cumulative total returns of AbbVie, the S&P 500 Index and the NYSE Arca Pharmaceuticals Index for the period from December 31, [removed: 2016] [added: 2017] through December 31, [removed: 2021.][added: 2022.]

This graph assumes $100 was invested in AbbVie common stock and each index on December 31, [removed: 2016] [added: 2017] and also assumes the reinvestment of dividends.

[removed: ][added: ]

| 29 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

On October [removed: 29, 2021,] [added: 28, 2022,] AbbVie's board of directors declared an increase in the quarterly cash dividend from [removed: $1.30] [added: $1.41] per share to [removed: $1.41] [added: $1.48] per share, payable on February 15, [removed: 2022] [added: 2023,] to stockholders of record as of January [removed: 14, 2022.][added: 13, 2023.]

| Period | | | [removed: (a) Total] [added: Total] Number of Shares (or Units) Purchased | | | | | | [removed: (b) Average] [added: Average] Price Paid per Share (or Unit) | | | | | | [removed: (c) Total] [added: Total] Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs | | | | | | [removed: (d) Maximum] [added: Maximum] Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs | | | | | |

In addition to AbbVie shares repurchased on the open market under a publicly announced program, if any, these shares also included the shares purchased on the open market for the benefit of participants in the AbbVie Employee Stock Purchase Plan – [removed: 3,808] [added: 926] in October; [removed: 845] [added: 940] in November; and [removed: 24,473] [added: 26,019] in December.

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 30 | | |

| October 1, 2022 - October 31, 2022 | | | 926 | | | (1) | | | $ | 141.34 | | (1) | | | — | | | | | | $ | 1,393,714,917 | | | | |

| November 1, 2022 - November 30, 2022 | | | 940 | | | (1) | | | $ | 146.61 | | (1) | | | — | | | | | | $ | 1,393,714,917 | | | | |

| December 1, 2022 - December 31, 2022 | | | 26,019 | | | (1) | | | $ | 161.87 | | (1) | | | — | | | | | | $ | 1,393,714,917 | | | | |

| Total | | | 27,885 | | | (1) | | | $ | 160.67 | | (1) | | | — | | | | | | $ | 1,393,714,917 | | | | |

| October 1, 2021 - October 31, 2021 | | | 3,808 | | | (1) | | | $ | 108.90 | | (1) | | | — | | | | | | $ | 2,643,316,927 | | | | |

| November 1, 2021 - November 30, 2021 | | | 845 | | | (1) | | | $ | 116.08 | | (1) | | | — | | | | | | $ | 2,643,316,927 | | | | |

| December 1, 2021 - December 31, 2021 | | | 904,176 | | | (1) | | | $ | 136.23 | | (1) | | | 879,703 | | | | | | $ | 2,523,316,993 | | | | |

| Total | | | 908,829 | | | (1) | | | $ | 136.10 | | (1) | | | 879,703 | | | | | | $ | 2,523,316,993 | | | | |

| 31 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

| [Consolidated Statements of [removed: Earnings](#i1293eb1bca8b4a9faecfc0731a3b171e_97)] [added: Earnings](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_100)] | | | [removed: [50](#i1293eb1bca8b4a9faecfc0731a3b171e_97)] [added: [50](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_100)] | | |

| [Consolidated Statements of Comprehensive [removed: Income](#i1293eb1bca8b4a9faecfc0731a3b171e_100)] [added: Income](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_103)] | | | [removed: [51](#i1293eb1bca8b4a9faecfc0731a3b171e_100)] [added: [51](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_103)] | | |

| [Consolidated Balance [removed: Sheets](#i1293eb1bca8b4a9faecfc0731a3b171e_103)] [added: Sheets](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_106)] | | | [removed: [52](#i1293eb1bca8b4a9faecfc0731a3b171e_103)] [added: [52](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_106)] | | |

| [Consolidated Statements of [removed: Equity](#i1293eb1bca8b4a9faecfc0731a3b171e_106)] [added: Equity](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_109)] | | | [removed: [53](#i1293eb1bca8b4a9faecfc0731a3b171e_106)] [added: [53](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_109)] | | |

| [Consolidated Statements of Cash [removed: Flows](#i1293eb1bca8b4a9faecfc0731a3b171e_109)] [added: Flows](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_112)] | | | [removed: [54](#i1293eb1bca8b4a9faecfc0731a3b171e_109)] [added: [54](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_112)] | | |

| [removed: [Notes] [added: Notes] to Consolidated Financial [removed: Statements](#i1293eb1bca8b4a9faecfc0731a3b171e_112)] [added: Statements] | | | [removed: [55](#i1293eb1bca8b4a9faecfc0731a3b171e_112)] | | |

| 49 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

| years ended December 31 (in millions, except per share data) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Net revenues | | | $ | [removed: 56,197] [added: 58,054] | | | | | $ | [removed: 45,804] [added: 56,197] | | | | | $ | [removed: 33,266] [added: 45,804] | |

| Cost of products sold | | | [removed: 17,446] [added: 17,414] | | | | | | [removed: 15,387] [added: 17,446] | | | | | | [removed: 7,439] [added: 15,387] | | |

| Selling, general and administrative | | | [removed: 12,349] [added: 15,260] | | | | | | [removed: 11,299] [added: 12,349] | | | | | | [removed: 6,942] [added: 11,299] | | |

| Other operating [removed: expense (income),] [added: expense,] net | | | [removed: 432] [added: 56] | | | | | | [removed: —] [added: 432] | | | | | | [removed: (890)] [added: —] | | |

| Total operating costs and expenses | | | [removed: 38,273] [added: 39,937] | | | | | | [removed: 34,441] [added: 38,273] | | | | | | [removed: 20,283] [added: 34,441] | | |

| Operating earnings | | | [removed: 17,924] [added: 18,117] | | | | | | [removed: 11,363] [added: 17,924] | | | | | | [removed: 12,983] [added: 11,363] | | |

| Interest expense, net | | | [removed: 2,384] [added: 2,044] | | | | | | [removed: 2,280] [added: 2,384] | | | | | | [removed: 1,509] [added: 2,280] | | |

| Net foreign exchange loss | | | [removed: 51] [added: 148] | | | | | | [removed: 71] [added: 51] | | | | | | [removed: 42] [added: 71] | | |

| Other expense, net | | | [removed: 2,500] [added: 2,448] | | | | | | [removed: 5,614] [added: 2,500] | | | | | | [removed: 3,006] [added: 5,614] | | |

| Earnings before income tax expense | | | [removed: 12,989] [added: 13,477] | | | | | | [removed: 3,398] [added: 12,989] | | | | | | [removed: 8,426] [added: 3,398] | | |

| Income tax expense (benefit) | | | [removed: 1,440] [added: 1,632] | | | | | | [removed: (1,224)] [added: 1,440] | | | | | | [removed: 544] [added: (1,224)] | | |

| Net earnings | | | [removed: 11,549] [added: 11,845] | | | | | | [removed: 4,622] [added: 11,549] | | | | | | [removed: 7,882] [added: 4,622] | | |

| Net earnings attributable to noncontrolling interest | | | [removed: 7] [added: 9] | | | | | | [removed: 6] [added: 7] | | | | | | [removed: —] [added: 6] | | |

| Net earnings attributable to AbbVie Inc. | | | $ | [removed: 11,542] [added: 11,836] | | | | | $ | [removed: 4,616] [added: 11,542] | | | | | $ | [removed: 7,882] [added: 4,616] | |

| Basic earnings per share attributable to AbbVie Inc. | | | $ | [removed: 6.48] [added: 6.65] | | | | | $ | [removed: 2.73] [added: 6.48] | | | | | $ | [removed: 5.30] [added: 2.73] | |

| Diluted earnings per share attributable to AbbVie Inc. | | | $ | [removed: 6.45] [added: 6.63] | | | | | $ | [removed: 2.72] [added: 6.45] | | | | | $ | [removed: 5.28] [added: 2.72] | |

| Weighted-average basic shares outstanding | | | [removed: 1,770] [added: 1,771] | | | | | | [removed: 1,667] [added: 1,770] | | | | | | [removed: 1,481] [added: 1,667] | | |

| Weighted-average diluted shares outstanding | | | [removed: 1,777] [added: 1,778] | | | | | | [removed: 1,673] [added: 1,777] | | | | | | [removed: 1,484] [added: 1,673] | | |

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 50 | | |

| years ended December 31 (in millions) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Net earnings | | | $ | [removed: 11,549] [added: 11,845] | | | | | $ | [removed: 4,622] [added: 11,549] | | | | | $ | [removed: 7,882] [added: 4,622] | |

| Foreign currency translation adjustments, net of tax expense (benefit) of [added: $(10) in 2022,] $(35) in [removed: 2021,] [added: 2021 and] $28 in 2020 [removed: and $(4) in 2019] | | | [removed: (1,153)] [added: (943)] | | | | | | [removed: 1,511] [added: (1,153)] | | | | | | [removed: (98)] [added: 1,511] | | |

| Net investment hedging activities, net of tax expense (benefit) of [added: $152 in 2022,] $193 in [removed: 2021,] [added: 2021 and] $(221) in 2020 [removed: and $22 in 2019] | | | [removed: 699] [added: 555] | | | | | | [removed: (799)] [added: 699] | | | | | | [removed: 74] [added: (799)] | | |

| Pension and post-employment benefits, net of tax expense (benefit) of [added: $272 in 2022,] $124 in [removed: 2021,] [added: 2021 and] $(47) in 2020 [removed: and $(323) in 2019] | | | [removed: 521] [added: 1,088] | | | | | | [removed: (102)] [added: 521] | | | | | | [removed: (1,243)] [added: (102)] | | |

| [removed: Marketable security] [added: Cash flow hedging] activities, net of tax expense (benefit) of [removed: $—] [added: $5] in [removed: 2021, $—] [added: 2022, $20] in [removed: 2020] [added: 2021] and [removed: $—] [added: $(23)] in [removed: 2019] [added: 2020] | | | — | | | | | | [removed: —] [added: 151] | | | | | | [removed: 10] [added: (131)] | | |

| Other comprehensive income [removed: (loss)] | | | $ | [removed: 218] [added: 700] | | | | | $ | [removed: 479] [added: 218] | | | | | $ | [removed: (1,116)] [added: 479] | |

| Comprehensive income | | | [removed: 11,767] [added: 12,545] | | | | | | [removed: 5,101] [added: 11,767] | | | | | | [removed: 6,766] [added: 5,101] | | |

| Comprehensive income attributable to noncontrolling interest | | | [removed: 7] [added: 9] | | | | | | [removed: 6] [added: 7] | | | | | | [removed: —] [added: 6] | | |

| Comprehensive income attributable to AbbVie Inc. | | | $ | [removed: 11,760] [added: 12,536] | | | | | $ | [removed: 5,095] [added: 11,760] | | | | | $ | [removed: 6,766] [added: 5,095] | |

| 51 | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

| as of December 31 (in millions, except share data) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Cash and equivalents | | | $ | [removed: 9,746] [added: 9,201] | | | | | $ | [removed: 8,449] [added: 9,746] | |

| [Note 1](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_118) | | | [Background](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_118) | | | [55](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_118) | | |

| [Note 2](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_121) | | | [Summary of Significant Accounting Policies](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_121) | | | [55](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_121) | | |

| [Note 3](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_127) | | | [Supplemental Financial Information](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_127) | | | [60](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_127) | | |

| [Note 4](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_130) | | | [Earnings Per Share](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_130) | | | [61](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_130) | | |

| [Note 5](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_133) | | | [Licensing, Acquisitions and Other Arrangements](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_133) | | | [62](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_133) | | |

| [Note 6](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_139) | | | [Collaborations](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_139) | | | [66](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_139) | | |

| [Note 7](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_142) | | | [Goodwill and Intangible Assets](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_142) | | | [68](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_142) | | |

| [Note 8](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_145) | | | [Integration and Restructuring Plans](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_145) | | | [69](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_145) | | |

| [Note 9](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_148) | | | [Leases](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_148) | | | [70](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_148) | | |

| [Note 10](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_4398046513320) | | | [Debit, Credit Facilities](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_4398046513320) [and Commitments and Contingencies](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_4398046513320) | | | [72](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_4398046513320) | | |

| [Note 11](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_163) | | | [Financial Instruments and Fair Value Measures](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_163) | | | [74](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_163) | | |

| [Note 12](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_169) | | | [Post-Employment Benefits](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_169) | | | [80](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_169) | | |

| [Note 13](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_175) | | | [Equity](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_175) | | | [85](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_175) | | |

| [Note 14](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_181) | | | [Income Taxes](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_181) | | | [90](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_181) | | |

| [Note 15](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_184) | | | [Legal](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_184) [P](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_184)[roceedings and Contingencies](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_184) | | | [92](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_184) | | |

| [Note 16](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_187) | | | [Segment and Geographic Area Information](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_187) | | | [94](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_187) | | |

| [Note 17](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_193) | | | [Fourth Quarter Financial Results (](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_193)[unaudited](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_193)[)](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_193) | | | [97](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_193) | | |

| [Report](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196) [of Independent Registered Public Account](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196)[ing](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196) [Firm](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196) [](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196)[(PCA](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196)[OB ID:](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196) 42[)](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196) | | | [98](#i8aa2d13e9ab74474a8ce0ca02e5f47bc_196) | | |

| Research and development | | | 6,510 | | | | | | 6,922 | | | | | | 6,379 | | |

| Acquired IPR&D and milestones | | | 697 | | | | | | 1,124 | | | | | | 1,376 | | |

| Change in noncontrolling interest | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 5 | | | | | | 5 | | |

| Balance at December 31, 2022 | | | 1,769 | | | | | | $ | 18 | | | | | $ | (4,594) | | | | | $ | 19,245 | | | | | $ | 4,784 | | | | | $ | (2,199) | | | | | $ | 33 | | | | | $ | 17,287 | |

| Acquired IPR&D and milestones | | | 697 | | | | | | 1,124 | | | | | | 1,376 | | |

| Other charges related to collaborations | | | — | | | | | | 500 | | | | | | — | | |

| Non-cash litigation reserve adjustments, net of cash payments | | | 2,243 | | | | | | 163 | | | | | | (31) | | |

| Impairment of intangible assets | | | 770 | | | | | | 50 | | | | | | — | | |

| Other, net | | | (150) | | | | | | (213) | | | | | | 863 | | |

During 2022, AbbVie revised its classification of development milestone expense associated with licensing and collaboration arrangements in the consolidated statements of earnings.

Milestone payments incurred prior to regulatory approval, which were previously included in research and development (R&D) expense, are now presented as acquired IPR&D and milestones expense in the consolidated statements of earnings.

The reclassification decreased R&D expense and increased acquired IPR&D and milestones expense by $162 million in 2021 and $178 million in 2020.

The company believes this presentation assists users of the financial statements to better understand the total upfront and subsequent development milestone payments incurred to acquire in-process research and development projects.

Prior periods have been reclassified to conform to the current period presentation.

The company recognizes shipping and handling costs as an

Acquired IPR&D and Milestones Expenses

| as of December 31 (in millions) | | | 2022 | | | | | | 2021 | | |

If the undiscounted cash

Future changes to these estimates and assumptions could have a material impact on the company's results of operations.

| as of December 31 (in millions) | | | 2022 | | | | | | 2021 | | |

| Current portion of contingent consideration liabilities | | | 1,469 | | | | | | 1,249 | | |

| Other | | | 5,819 | | | | | | 5,325 | | |

| [Report of Independent Registered Public Accounting Firm (PC](#i1293eb1bca8b4a9faecfc0731a3b171e_190)[AOB ID:](#i1293eb1bca8b4a9faecfc0731a3b171e_190) [](#i1293eb1bca8b4a9faecfc0731a3b171e_190)42) | | | [100](#i1293eb1bca8b4a9faecfc0731a3b171e_190) | | |

| | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | | | | | | | | | | | | |

| Research and development | | | 7,084 | | | | | | 6,557 | | | | | | 6,407 | | |

| Acquired in-process research and development | | | 962 | | | | | | 1,198 | | | | | | 385 | | |

| Cash flow hedging activities, net of tax expense (benefit) of $20 in 2021, $(23) in 2020 and $70 in 2019 | | | 151 | | | | | | (131) | | | | | | 141 | | |

| Balance at December 31, 2018 | | | 1,479 | | | | | | $ | 18 | | | | | $ | (24,108) | | | | | $ | 14,756 | | | | | $ | 3,368 | | | | | $ | (2,480) | | | | | $ | — | | | | | $ | (8,446) | |

| Upfront costs and milestones related to collaborations | | | 1,624 | | | | | | 1,376 | | | | | | 490 | | |

| Stemcentrx impairment | | | — | | | | | | — | | | | | | 1,030 | | |

| Net change in commercial paper borrowings | | | — | | | | | | — | | | | | | (699) | | |

Rebate amounts are

Sales incentives to customers are insignificant.

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.

the estimated fair value of the assets and potentially result in different impacts to the company's results of operations.

Acquired In-Process Research and Development

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.

| Other | | | 6,574 | | | | | | 6,208 | | |

| | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

product rights.

AbbVie recorded acquired IPR&D charges of $962 million in 2021, $1.2 billion in 2020 and $385 million in 2019.

commercial milestones, and AbbVie will pay tiered royalties from low-to-mid teen percentages on global net revenues outside of greater China.

*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.

| Indefinite-lived research and development | | | 670 | | | | | | — | | | | | | 670 | | | | | | 1,877 | | | | | | — | | | | | | 1,877 | | |

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.

Gonzalez, and the Chief Financial Officer, [removed: Robert A.][added: Scott T.]

[removed: Michael,] [added: Reents,] evaluated the effectiveness of AbbVie's disclosure controls and procedures as of the end of the period covered by this report, and concluded that AbbVie's disclosure controls and procedures were effective to ensure that information AbbVie is required to disclose in the reports that it files or submits with the Securities and Exchange Commission under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Commission's rules and forms, and to ensure that information required to be disclosed by AbbVie in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to AbbVie's management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in internal control over financial reporting. There were no changes in AbbVie's internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934) that have materially affected, or are reasonably likely to materially affect, AbbVie's internal control over financial reporting during the quarter ended December 31, [removed: 2021.][added: 2022.]

Management assessed the effectiveness of AbbVie's internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]

Based on that assessment, management concluded that AbbVie maintained effective internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on the COSO criteria.

The effectiveness of AbbVie's internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their attestation report below, which expresses an unqualified opinion on the effectiveness of AbbVie's internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]

| [removed: 103] [added: 101] | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

We have audited AbbVie Inc. and subsidiaries' internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, AbbVie Inc. and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of AbbVie Inc. and subsidiaries as of December 31, [removed: 2021 and 2020,] [added: 2022] and [added: 2021,] the related consolidated statements of earnings, comprehensive income, equity and cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] and the related notes and our report dated February [removed: 18, 2022] [added: 17, 2023] expressed an unqualified opinion thereon.

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | [removed: 104] [added: 102] | | |

February 17, 2023

February 18, 2022

| | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| 105 | | |  \| *2021 Form 10-K* | | | | | | | | |

PART III

Not Applicable.

| | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| 103 | | |  \| *2022 Form 10-K* | | | | | | | | |

PART III

Incorporated herein by reference are "Information Concerning Director Nominees," "The Board of Directors and its Committees—Committees of the Board of Directors," [removed: and "Procedure for Recommendation and Nomination] [added: "Communicating with the Board] of [removed: Directors] [added: Directors,"] and [removed: Transaction] [added: "Deadlines for Notice] of [removed: Business] [added: Stockholder Actions to be Considered] at [added: the 2024] Annual [removed: Meeting"] [added: Meeting of Stockholders"] to be included in the [removed: 2022] [added: 2023] AbbVie Inc. Proxy Statement.

The [removed: 2022] [added: 2023] Definitive Proxy Statement will be filed on or about March [removed: 21, 2022.][added: 20, 2023.]

AbbVie has a chief ethics and compliance officer who reports to the [added: Executive] Vice [removed: Chairman, External Affairs] [added: President, General Counsel] and [removed: Chief Legal Officer] [added: Secretary] and to the public policy committee.

The material to be included in the [removed: 2022] [added: 2023] AbbVie Inc. Proxy Statement under the headings "Director Compensation," "Executive Compensation," and "Compensation Committee Report" is incorporated herein by reference.

The [removed: 2022] [added: 2023] Definitive Proxy Statement will be filed on or about March [removed: 21, 2022.][added: 20, 2023.]

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | [removed: 106] [added: 104] | | |

The following table presents information as of December 31, [removed: 2021] [added: 2022] about AbbVie's equity compensation plans under which AbbVie common stock has been authorized for issuance:

(1)Includes [removed: 138,085] [added: 34,879] shares issuable under AbbVie's Incentive Stock Program pursuant to awards granted by Abbott and adjusted into AbbVie awards in connection with AbbVie's separation from Abbott.

(3)Excludes shares issuable upon the exercise of stock options and pursuant to other rights granted under the Stemcentrx 2011 Equity Incentive Plan, which was assumed by AbbVie upon the consummation of its acquisition of Stemcentrx, Inc. As of December 31, [removed: 2021, 44,912] [added: 2022, 41,212] options remained outstanding under this plan.

The options have a weighted-average exercise price of [removed: $17.63.][added: $18.02.]

*(b)Information Concerning Security Ownership.* Incorporated herein by reference is the material under the heading "Securities Ownership—Securities Ownership of Executive Officers and Directors" in the [removed: 2022] [added: 2023] AbbVie Inc. Proxy Statement.

The [removed: 2022] [added: 2023] Definitive Proxy Statement will be filed on or about March [removed: 21, 2022.][added: 20, 2023.]

| Equity compensation plans approved by security holders | | | 22,351,655 | | | | | | $ | 91.84 | | | | | 67,365,289 | | |

| Total | | | 22,351,655 | | | | | | $ | 91.84 | | | | | 67,365,289 | | |

| Equity compensation plans approved by security holders | | | 27,264,327 | | | | | | $ | 81.98 | | | | | 74,075,427 | | |

| Total | | | 27,264,327 | | | | | | $ | 81.98 | | | | | 74,075,427 | | |

The material to be included in the [removed: 2022] [added: 2023] AbbVie Inc. Proxy Statement under the headings "The Board of Directors and its Committees," "Corporate Governance Materials," and "Procedures for Approval of Related Person Transactions" is incorporated herein by reference.

The [removed: 2022] [added: 2023] Definitive Proxy Statement will be filed on or about March [removed: 21, 2022.][added: 20, 2023.]

The material to be included in the [removed: 2022] [added: 2023] AbbVie Inc. Proxy Statement under the headings "Audit Fees and Non-Audit Fees" and "Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of the Independent Registered Public Accounting Firm" is incorporated herein by reference.

The [removed: 2022] [added: 2023] Definitive Proxy Statement will be filed on or about March [removed: 21, 2022.][added: 20, 2023.]

| [removed: 107] [added: 105] | | | [removed: ] [added: ] \| [removed: *2021] [added: *2022] Form 10-K* | | | | | | | | |

*(1)Financial Statements:* See Item 8, "Financial Statements and Supplementary [removed: Data," on page 48 hereof,] [added: Data"] for a list of financial statements.

| [removed: [3.2](http://www.sec.gov/Archives/edgar/data/1551152/000110465919055567/tm19205582_ex3-1.htm)] [added: [3.2](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm)] | | | | | | [removed: [*Amended] [added: [*](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm)[Second](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm) [Amended] and Restated By-Laws of AbbVie Inc. (incorporated by reference to Exhibit 3.1 of the company's Current Report on Form 8-K filed on [removed: October 22, 2019).](http://www.sec.gov/Archives/edgar/data/1551152/000110465919055567/tm19205582_ex3-1.htm)] [added: October](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm) [14](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm)[, 20](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm)[22](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm)[).](https://www.sec.gov/Archives/edgar/data/1551152/000110465922108910/tm2228135d1_ex3-1.htm)] | | | | | |

| [removed: [4.1](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex41.htm)] [added: [4.1](https://www.sec.gov/Archives/edgar/data/1551152/000155115223000011/abbv-20221231xex41.htm)] | | | | | | [Description of the company’s securities registered pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex41.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/1551152/000155115223000011/abbv-20221231xex41.htm)] | | | | | |

| | | | | | | [removed: *2021] [added: *2022] Form 10-K* \| [removed: ] [added: ] | | | 108 | | |

| [10.2](https://www.sec.gov/Archives/edgar/data/1551152/000155837021003318/tmb-20210507xdef14a.htm) | | | | | | [*AbbVie 2013 Amended and Restated Incentive Stock Program (incorporated by reference to Appendix C to the AbbVie Inc. Definitive Proxy Statement on Schedule 14A dated March 22, [removed: 2021).](https://www.sec.gov/Archives/edgar/data/1551152/000155837021003318/tmb-20210507xdef14a.htm)[*](https://www.sec.gov/Archives/edgar/data/1551152/000155837021003318/tmb-20210507xdef14a.htm)[*](https://www.sec.gov/Archives/edgar/data/1551152/000155837021003318/tmb-20210507xdef14a.htm)] [added: 2021).](https://www.sec.gov/Archives/edgar/data/1551152/000155837021003318/tmb-20210507xdef14a.htm)] | | | | | |

| [removed: [10.3](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)] [added: [10.27](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)] | | | | | | [removed: [AbbVie] [added: *[AbbVie] Performance Incentive Plan, as amended and restated](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm) [removed: [.](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)] [added: [(](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)[incorporated by reference to Exhibit 10.](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)[3 of the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)[)](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)[.](https://www.sec.gov/Archives/edgar/data/1551152/000155115222000007/abbv-20211231xex103.htm)] | | | | | |