AbbVie (ABBV) 10-K risk factor changes: FY2019 vs FY2018

[removed: You] [added: *You] should carefully consider the following risks and other information in this Form 10-K in evaluating AbbVie and AbbVie's common stock.

The risk factors generally have been separated into [removed: two] [added: three] groups: risks related to AbbVie's [removed: business] [added: business, risks related to AbbVie's proposed acquisition of Allergan (the "Acquisition")] and [added: the combined company upon completion of the Acquisition, and] risks related to AbbVie's common stock.

In addition, past financial performance may not be a reliable indicator of future performance and historical trends should not be used to anticipate results or trends in future [removed: periods.][added: periods.*]

[removed: If] [added: *If] any of the following risks and uncertainties develops into actual events, these events could have a material adverse effect on AbbVie's business, results of operations, financial condition or cash flows.

In such case, the trading price of AbbVie's common stock could [removed: decline.][added: decline.*]

[removed: Risks] [added: Risks] Related to AbbVie's [removed: Business][added: Business]

[removed: The] [added: The] expiration or loss of patent protection and licenses may adversely affect AbbVie's future revenues and operating [removed: earnings.][added: earnings.]

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." The United States composition of matter patent for HUMIRA, which is AbbVie's largest product and had worldwide net revenues of approximately [removed: $19.9] [added: $19.2] billion in [removed: 2018,] [added: 2019,] expired in December 2016, and the equivalent European Union patent expired in the majority of European Union countries in October 2018.

| [removed: 10  \| 2018] [added: 10  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

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

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

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

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

[removed: Any] [added: Any] significant event that adversely affects HUMIRA revenues could have a material and negative impact on AbbVie's results of operations and cash [removed: flows.][added: flows.]

HUMIRA accounted for approximately [removed: 61%] [added: 58%] of AbbVie's total net revenues in [removed: 2018.][added: 2019.]

These events could include loss of patent protection for [removed: HUMIRA,] [added: 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.

[removed: AbbVie's] [added: AbbVie's] research and development efforts may not succeed in developing and marketing commercially successful products and technologies, which may cause its revenues and profitability to [removed: decline.][added: decline.]

A high rate of failure in the biopharmaceutical industry is inherent in the research and development of new products, and failure can occur at any point in the research and development process, [removed: including after significant funds have been invested.]

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  11] [added: 10-K* \|  11] |

[added: 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, 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.

[removed: A] [added: A] portion of AbbVie's near-term pharmaceutical pipeline relies on collaborations with third parties, which may adversely affect the development and sale of its [removed: products.][added: products.]

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

[removed: AbbVie's] [added: AbbVie's] biologic products are subject to competition from [removed: biosimilars.][added: biosimilars.]

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

| [removed: 12  \| 2018] [added: 12  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

[removed: New] [added: New] products and technological advances by AbbVie's competitors may negatively affect AbbVie's results of [removed: operations.][added: operations.]

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

[removed: The] [added: The] manufacture of many of AbbVie's products is a highly exacting and complex process, and if AbbVie or one of its suppliers encounters problems manufacturing AbbVie's products, AbbVie's business could [removed: suffer.][added: suffer.]

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

[removed: Significant] [added: Significant] safety or efficacy issues could arise for AbbVie's products, which could have a material adverse effect on AbbVie's revenues and financial [removed: condition.][added: condition.]

If safety or efficacy issues with an AbbVie product arise, sales of the product could be halted by AbbVie or by regulatory [removed: authorities.][added: authorities and regulatory action could be taken]

New data about AbbVie's products, or products similar to its products, could negatively impact demand for AbbVie's products due to real or perceived safety issues or uncertainty regarding efficacy and, in some cases, could result in product [added: withdrawal.]

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  13] [added: 10-K* \|  13] |

[removed: AbbVie] [added: AbbVie] is subject to product liability claims and [added: other] lawsuits that may adversely affect its business and results of [removed: operations.][added: operations.]

[removed: AbbVie] [added: AbbVie] is subject to cost-containment efforts and pricing pressures that could cause a reduction in future revenues and operating earnings, and changes in the terms of rebate and chargeback programs, which are common in the pharmaceuticals industry, could have a material adverse effect on AbbVie's [removed: operations.][added: operations.]

[removed: AbbVie] [added: AbbVie] is subject to numerous governmental regulations, and it can be costly to comply with these regulations and to develop compliant products and [removed: processes.][added: processes.]

These requirements include, among other things, regulations regarding manufacturing practices, product labeling and advertising and post-marketing reporting, including adverse event reports and [added: field alerts due to manufacturing quality concerns.]

| [removed: 14  \| 2018] [added: 14  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

Possible regulatory actions could result in substantial modifications to AbbVie's business practices and operations; refunds, [removed: recalls,] [added: recalls] or seizures of AbbVie's products; a total or partial shutdown of production in one or more of AbbVie's or its suppliers' facilities while AbbVie or its supplier remedies the alleged violation; the inability to obtain future approvals; and withdrawals or suspensions of current products from the market.

[removed: Laws] [added: Laws] and regulations affecting government benefit programs could impose new obligations on AbbVie, require it to change its business practices, and restrict its operations in the [removed: future.][added: future.]

including after significant funds have been invested.

exclusivity period has expired.

by such regulatory authorities.

AbbVie is also the subject of other claims, legal proceedings and investigations in the ordinary course of business, which relate to the intellectual property, commercial, securities and other matters.

Adverse outcomes in such claims, legal proceedings and investigations may also adversely affect AbbVie’s business and results of operations.

| • | international trade disruptions or disputes, including in connection with the ongoing trade negotiations between the United States and China; |

| • | political and economic instability, including the United Kingdom’s exit from the European Union; |

| • | sovereign debt issues; |

Failure to attract and retain highly qualified personnel could affect AbbVie’s ability to successfully develop and commercialize products.

AbbVie’s success is largely dependent on its continued ability to attract and retain highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical R&D, governmental regulation and commercialization.

Competition for qualified personnel in the biopharmaceutical field is intense.

AbbVie cannot be sure that it will be able to attract and retain quality personnel or that the costs of doing so will not materially increase.

Risks Related to the Acquisition and the Combined Company Upon Completion of the Acquisition

The pending acquisition of Allergan may not be completed on the currently contemplated timeline or terms, or at all, and may not achieve the intended benefits.

Consummation of the Acquisition is conditioned on, among other things, obtaining necessary governmental and regulatory approvals.

If any of the conditions to the Acquisition is not satisfied, it could delay or prevent the Acquisition from occurring, which could negatively impact AbbVie’s share price and future business and financial results.

Further, as a condition to their approval of the Acquisition, agencies may impose requirements, limitations or costs or require divestitures or place restrictions on the conduct of the AbbVie’s business after the closing.

These requirements, limitations, costs, divestitures or restrictions could jeopardize or delay the consummation of the Acquisition or may reduce the anticipated benefits of the transaction.

In addition, changes in laws and regulations, including Irish legislation implementing a tax increase payable upon completion of the Acquisition, could adversely impact AbbVie’s post-Acquisition profitability and financial results.

Following the Acquisition, AbbVie may not realize the Acquisition’s intended benefits within the expected timeframe or at all.

The indebtedness of the combined company following the consummation of the Acquisition will be substantially greater than AbbVie’s indebtedness on a standalone basis and greater than the combined indebtedness of AbbVie and Allergan prior to the announcement of the acquisition.

This increased level of indebtedness could adversely affect the combined company’s business flexibility and increase its borrowing costs.

AbbVie expects that the cash consideration due to Allergan’s shareholders under the transaction agreement and related fees and expenses will be approximately $41 billion.

In addition to using cash on hand, AbbVie has incurred significant Acquisition-related debt financing, including unsecured term loans and senior notes.

For more information, see Note 10“Debt, Credit Facilities and Commitments and Contingencies,” to the Consolidated Financial Statements included under Item 8, “Financial Statements and Supplementary Data.” AbbVie also intends to assume all the existing indebtedness of Allergan and its subsidiaries.

AbbVie’s substantially increased indebtedness and higher debt to equity ratio following the consummation of the Acquisition may have the effect of, among other things, reducing its flexibility to respond to changing business and economic conditions, lowering its credit ratings, increasing its borrowing costs and/or requiring it to reduce or delay investments, strategic acquisitions and capital expenditures or to seek additional capital or restructure or refinance its indebtedness.

(including AbbVie's pending acquisition of Allergan), or other purposes.

| | |

| --- | --- |

| | |

| --- | --- |

| | | | |

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

| | | | |

| | | *2019 Form 10-K* \|  19 |

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

withdrawal.

field alerts due to manufacturing quality concerns.

| • | political and economic instability, including sovereign debt issues; |

If AbbVie loses its investment grade credit rating or adequate

The following is a discussion and analysis of the financial condition of AbbVie Inc. (AbbVie or the company) as of December 31, [removed: 2018] [added: 2019] and [removed: 2017] [added: 2018] and results of operations for each of the three years in the period ended December 31, [removed: 2018.][added: 2019.]

[removed: EXECUTIVE OVERVIEW][added: EXECUTIVE OVERVIEW]

[removed: Company Overview][added: Company Overview]

Outside the United States, [added: AbbVie sells] products [removed: are sold] primarily to customers or through distributors, depending on the market served.

[removed: 2018 Financial Results][added: 2019 Financial Results]

The company's financial performance in [removed: 2018] [added: 2019] included delivering worldwide net revenues of [removed: $32.8] [added: $33.3] billion, operating earnings of [removed: $6.4] [added: $13.0] billion, diluted earnings per share of [removed: $3.66] [added: $5.28] and cash flows from operations of [removed: $13.4] [added: $13.3] billion.

Worldwide net revenues grew by [removed: 16%, or 15%] [added: 3%] on a constant currency basis, [removed: driven] primarily [added: driven] by revenue growth related to [removed: MAVYRET,] IMBRUVICA and [removed: VENCLEXTA, and] [added: VENCLEXTA as well as] the continued strength of [removed: HUMIRA.][added: HUMIRA in the U.S. and newly launched immunology assets SKYRIZI and RINVOQ, offset by international HUMIRA biosimilar competition.]

Additionally, financial results reflected continued [removed: added] funding to support all stages of AbbVie’s emerging pipeline assets and continued investment in AbbVie’s [removed: growth] [added: on-market] brands.

In November [removed: 2018,] [added: 2019,] AbbVie's board of directors declared a quarterly cash dividend of [removed: $1.07] [added: $1.18] per share of common stock payable in February [removed: 2019.][added: 2020.]

This [removed: reflected] [added: reflects] an increase of approximately [removed: 11.5%] [added: 10.3%] over the previous quarterly dividend of [removed: $0.96] [added: $1.07] per share of common stock.

| [removed: 26  \| 2018] [added: 26  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

[removed: 2019 Strategic Objectives][added: 2020 Strategic Objectives]

AbbVie intends to continue to advance its mission in a number of ways, including: (i) growing revenues by diversifying revenue streams, [removed: driving late-stage pipeline assets to the market and] ensuring strong commercial execution of new product [removed: launches;] [added: launches and driving late-stage pipeline assets to the market;] (ii) [removed: continued investment] [added: continuing to invest] and [removed: expansion in] [added: expand] its pipeline in support of opportunities in immunology, oncology and neuroscience, with additional targeted investment in cystic fibrosis and women's health as well as continued investment in key on-market products; (iii) expanding operating margins; and (iv) returning cash to shareholders via [removed: dividends] [added: a strong] and [removed: share repurchases.][added: growing dividend while also reducing incremental debt.]

In addition, AbbVie anticipates several regulatory submissions and key data readouts from key clinical trials in the next [removed: twelve] [added: 12] months.

| • | The favorable impact of pipeline products and indications recently approved or currently under regulatory review where approval is expected in [removed: 2019.] [added: 2020.] These products are described in greater detail in the section labeled "Research and Development" included as part of this Item 7. |

AbbVie remains committed to driving continued expansion of operating margins and expects to achieve this objective through continued leverage from revenue growth, [removed: the reduction of HUMIRA royalty expense,] productivity initiatives in supply chain and ongoing efficiency programs to optimize manufacturing, commercial infrastructure, administrative costs and general corporate expenses.

[removed: Research] [added: Research] and [removed: Development][added: Development]

AbbVie's pipeline currently includes [removed: more than] [added: approximately] 60 compounds or indications in clinical development individually or under collaboration or license agreements and is focused on such important medical specialties as immunology, oncology and neuroscience along with targeted investments in cystic fibrosis and women's health.

Of these programs, [removed: more than] [added: approximately] 30 are in mid- and late-stage development.

AbbVie expects multiple Phase 2 programs to transition into Phase 3 programs in the next [removed: twelve] [added: 12] months.

[removed: Significant] [added: Significant] Programs and [removed: Developments][added: Developments]

[removed: Immunology][added: *Immunology*]

| • | In [removed: January 2018,] [added: February 2019,] the U.S. Food and Drug Administration (FDA) [removed: granted breakthrough therapy designation] [added: accepted] for [added: priority review AbbVie's New Drug Application (NDA) for] upadacitinib, an investigational oral JAK1-selective inhibitor, [removed: in] [added: for the treatment of] adult patients with moderate to severe [removed: atopic dermatitis who are candidates for systemic therapy.] [added: rheumatoid arthritis (RA).] |

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  27] [added: 10-K* \|  27] |

| • | In [removed: July 2018,] [added: March 2019,] AbbVie initiated two Phase 3 clinical trials to evaluate the efficacy and safety of [removed: upadacitinib] [added: risankizumab, an investigational interleukin-23 (IL-23) inhibitor,] in subjects with [removed: moderate to severe atopic dermatitis.] [added: psoriatic arthritis.] |

| • | In [removed: September 2018,] [added: February 2019,] AbbVie initiated a Phase 3 clinical trial to evaluate the efficacy and safety of upadacitinib in subjects with [removed: moderate to severe ulcerative colitis.] [added: giant cell arteritis.] |

[removed: Oncology][added: *Oncology*]

| [removed: 28  \| 2018] [added: 28  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

| • | In January 2019, the FDA approved IMBRUVICA, in combination with [removed: GAZYVA,] [added: GAZYVA (obinutuzumab),] for adult patients with previously untreated [removed: CLL/SLL.] [added: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).] |

[removed: Other][added: *Other*]

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  29] [added: 10-K* \|  29] |

[removed: Virology/Liver Disease][added: *Virology/Liver Disease*]

[removed: Neuroscience][added: *Neuroscience*]

[removed: RESULTS] [added: RESULTS] OF [removed: OPERATIONS][added: OPERATIONS]

[removed: Net Revenues][added: Net Revenues]

| | | | | | | | | | | | | | [removed: Percent change] [added: Percent change] | | | | | | | | | | |

| | | | | | | | | | | | | | [removed: At] [added: At] actual currency [removed: rates] [added: rates] | | | | | | [removed: At] [added: At] constant currency [removed: rates] [added: rates] | | | | |

| [removed: for the years] [added: years] ended (dollars in [removed: millions)] [added: millions)] | [removed: 2018] [added: 2019] | | | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2018] [added: 2019] | | | [removed: 2017] [added: 2018] | | | [removed: 2018] [added: 2019] | | | [removed: 2017] [added: 2018] | |

| United States | $ | [removed: 21,524] [added: 23,907] | | | $ | [removed: 18,251] [added: 21,524] | | | $ | [removed: 15,947] [added: 18,251] | | | [removed: 17.9] [added: 11.1] | % | | [removed: 14.4] [added: 17.9] | % | | [removed: 17.9] [added: 11.1] | % | | [removed: 14.4] [added: 17.9] | % |

| International | [removed: 11,229] [added: 9,359] | | | | [removed: 9,965] [added: 11,229] | | | | [removed: 9,691] [added: 9,965] | | | | [removed: 12.8] [added: (16.7] | [removed: %] [added: )%] | | [removed: 2.8] [added: 12.8] | % | | [removed: 10.4] [added: (13.6] | [removed: %] [added: )%] | | [removed: 2.1] [added: 10.4] | % |

On June 25, 2019, AbbVie announced that it entered into a definitive transaction agreement under which AbbVie will acquire Allergan plc (Allergan).

Diluted earnings per share in 2019 was $5.28 and included the following after-tax costs: (i) $3.2 billion for the change in fair value of contingent consideration liabilities; (ii) $1.3 billion related to the amortization of intangible assets; (iii) a Stemcentrx-related impairment charge of $823 million net of the related fair value adjustment to contingent consideration liabilities; (iv) $364 million for acquired in-process research and development (IPR&D); and (v) $338 million of expenses related to the proposed Allergan acquisition.

These costs were partially offset by the following after-tax benefits: (i) $414 million from litigation matters primarily due to the settlement of an intellectual property dispute with a third party; (ii) $400 million due to the favorable resolution of various tax positions; and (iii) $297 million from an amended and restated license agreement between AbbVie and Reata Pharmaceuticals, Inc. (Reata).

| • | Completion and successful integration of the proposed Allergan acquisition. |

| • | Immunology revenue growth driven by successful commercial launches of SKYRIZI and RINVOQ, as well as HUMIRA U.S. sales growth. |

The combination of AbbVie and Allergan will create a diverse entity with leadership positions across immunology, hematologic oncology, aesthetics, neuroscience, women's health, eye care and virology.

AbbVie's existing product portfolio and pipeline will be enhanced with numerous Allergan assets and Allergan's product portfolio will benefit from AbbVie's commercial strength, expertise and international infrastructure.

RINVOQ

| • | In August 2019, the FDA approved RINVOQ (upadacitinib) for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. |

| • | In October 2019, AbbVie announced top-line results from its first Phase 3 clinical trial of RINVOQ in adult patients with active psoriatic arthritis (PsA). Results from the SELECT-PsA 2 study, which evaluated RINVOQ versus placebo in patients who did not adequately respond to treatment with one or more biologic DMARDs, showed that both doses of RINVOQ (15 mg and 30 mg) met the primary and key secondary endpoints at week 12. The safety profile was consistent with that of previous studies across indications, with no new safety risks detected. |

| • | In November 2019, AbbVie announced data from the Phase 2/3 SELECT-AXIS 1 trial in which twice as many adult patients with ankylosing spondylitis treated with RINVOQ achieved the primary endpoint at week 14 versus placebo. The safety profile was consistent with that of previous studies across indications, with no new safety risks detected. |

| • | In November 2019, AbbVie initiated a Phase 3 clinical trial to evaluate the efficacy and safety of RINVOQ in adult patients with axial spondyloarthritis. |

| • | In December 2019, the European Commission (EC) granted marketing authorization for RINVOQ for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to one or more DMARDs. |

| • | In February 2020, AbbVie announced top-line results from its second Phase 3 clinical trial of RINVOQ in adult patients with active PsA. Results from the SELECT-PsA 1 study, which evaluated RINVOQ versus placebo in patients who did not adequately respond to treatment with one or more non-biologic DMARDs, showed that both doses of RINVOQ (15 mg and 30 mg) met the primary and key secondary endpoints. The safety profile was consistent with that of previous studies across indications, with no new safety risks detected. |

SKYRIZI

| • | In April 2019, the FDA approved SKYRIZI (risankizumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. |

| • | In April 2019, the EC granted marketing authorization for SKYRIZI for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. |

| • | In June 2019, AbbVie announced results from the Phase 3 CLL12 trial, evaluating IMBRUVICA in patients with previously untreated CLL, which demonstrated that IMBRUVICA significantly improved event- and progression-free survival. |

| • | In November 2019, AbbVie submitted a supplemental New Drug Application (sNDA) to the FDA for IMBRUVICA in combination with rituximab for the first-line treatment of younger patients with CLL or SLL. |

| • | In March 2019, AbbVie announced that the FDA placed a partial clinical hold on all clinical trials evaluating VENCLEXTA for the investigational treatment of multiple myeloma (MM). The partial clinical hold followed a review of data from the ongoing Phase 3 BELLINI trial, a study in relapsed/refractory MM, in which a higher proportion of deaths was observed in the VENCLEXTA arm compared to the control arm of the trial. In June 2019, AbbVie announced that the FDA lifted the partial clinical hold placed on the Phase 3 CANOVA trial, evaluating VENCLEXTA for the investigational treatment of relapsed/refractory MM positive for the translocation (11;14) abnormality, based upon agreement on revisions to the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria. This action does not impact any of the approved indications for VENCLEXTA, such as CLL or acute myeloid leukemia (AML). |

| • | In May 2019, the FDA approved VENCLEXTA, in combination with obinutuzumab, for adult patients with previously untreated CLL/SLL. The approval was based on data from the Phase 3 CLL14 trial, evaluating the efficacy and safety of VENCLEXTA plus obinutuzumab versus obinutuzumab plus chlorambucil in previously untreated patients with CLL, which demonstrated that VENCLEXTA plus obinutuzumab prolonged progression-free survival and achieved higher rates of complete response and minimal residual disease-negativity compared to commonly used standard of care obinutuzumab plus chlorambucil. |

| • | In January 2020, AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for VENCLYXTO in combination with obinutuzumab for patients with previously untreated CLL. |

Depatux-M

| • | In May 2019, AbbVie announced the decision to discontinue the Phase 3 INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) in patients with newly diagnosed glioblastoma, whose tumors have EGFR (epidermal growth factor receptor) amplification, at an interim analysis. An Independent Data Monitoring Committee recommended stopping enrollment in INTELLANCE-1 due to lack of survival benefit for patients receiving Depatux-M compared with placebo when added to the standard regimen of radiation and temozolomide. Enrollment has been halted in all ongoing Depatux-M studies. |

Veliparib

| • | In July 2019, AbbVie announced that top-line results from the Phase 3 BROCADE3 study evaluating veliparib, an investigational, oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, in combination with carboplatin and paclitaxel met its primary endpoint of progression-free survival in patients with HER2 negative germline BRCA-mutated advanced breast cancer. |

| • | In July 2019, AbbVie announced that top-line results from the Phase 3 VELIA study, conducted in collaboration with the GOG Foundation, Inc., evaluating veliparib with carboplatin and paclitaxel followed by veliparib maintenance therapy met its primary endpoint of progression-free survival in patients with newly diagnosed ovarian cancer, regardless of biomarker status. |

| • | In August 2019, AbbVie announced the decision to terminate the MERU trial, a Phase 3 study evaluating rovalpituzumab tesirine (Rova-T) as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee recommended terminating the study after results demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. With the closing of the MERU trial, AbbVie announced the termination of the Rova-T research and development program. |

| • | In August 2019, the EC granted marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic HCV patients with genotype (GT)1, 2, 4, 5 and 6 infection. |

| • | In September 2019, the FDA approved MAVYRET (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic HCV patients across all genotypes (GT1-6). |

| • | In January 2020, AbbVie announced that the CHMP of the EMA has recommended a change to the marketing authorization for MAVIRET to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic HCV patients with GT 3 infection. |

| • | In May 2019, AbbVie initiated a Phase 3 clinical trial to evaluate the safety and tolerability of ABBV-951, a subcutaneous levodopa/carbidopa delivery system, in subjects with Parkinson's disease. |

| • | In July 2019, AbbVie announced the decision to discontinue the Phase 2 ARISE study evaluating ABBV-8E12, an investigational anti-tau antibody, in patients with progressive supranuclear palsy, after an Independent Data |

Monitoring Committee recommended stopping the trial for futility after the trial showed that ABBV-8E12 did not provide efficacy.

| • | In July 2019, AbbVie submitted an NDA to the FDA for elagolix in combination with estradiol/norethindrone acetate (E2/NETA) daily add-back therapy for the management of heavy menstrual bleeding associated with uterine fibroids. |

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

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

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

| | | | | | | | | | | | | | | | At actual currency rates | | | | | | At constant currency rates | | | | |

| SKYRIZI | United States | | $ | 311 | | | $ | — | | | $ | — | | | n/m | | | n/m | | | n/m | | | n/m | |

Diluted earnings per share in 2018 was $3.66 and included the following after-tax costs: (i) a Stemcentrx-related impairment charge of $4.1 billion net of the related fair value adjustment to contingent consideration liabilities; (ii) $1.1 billion of intangible asset amortization; (iii) $500 million as a result of a collaboration agreement extension with Calico Life Sciences LLC (Calico); (iv) $424 million for acquired in-process research and development (IPR&D); (v) $478 million for the change in fair value of contingent consideration liabilities excluding the fair value adjustment associated with the Stemcentrx-related impairment; (vi) litigation reserve charges of $282 million; (vii) charitable contributions of $271 million as part of AbbVie's previously announced plan to make contributions to U.S. not-for-profit organizations in 2018; and (viii) milestone payments of $137 million.

2018 financial results were also impacted by U.S. tax reform and the timing of the new legislation's phase in on certain subsidiaries.

| | |

| --- | --- |

| • | The strong execution of new product launches across multiple therapeutic areas. |

| • | HUMIRA U.S. sales growth by driving biologic penetration across disease categories and maintaining market leadership. |

Upadacitinib

| • | In April 2018, AbbVie announced that top-line results from the Phase 3 SELECT-COMPARE clinical trial evaluating upadacitinib met all primary and ranked secondary endpoints in patients with moderate to severe rheumatoid arthritis (RA) who are on a stable background of methotrexate and who have an inadequate response. The safety profile of upadacitinib was consistent with previously reported clinical trials and no new safety signals were detected. |

| • | In June 2018, AbbVie announced that top-line results from the Phase 3 SELECT-EARLY clinical trial evaluating upadacitinib versus methotrexate in adult patients with moderate to severe RA who were methotrexate-naïve met all primary and ranked secondary endpoints. The safety profile of upadacitinib was consistent with previously reported clinical trials and no new safety signals were detected. |

| • | In December 2018, AbbVie submitted a New Drug Application (NDA) to the FDA and a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for upadacitinib for the treatment of adult patients with moderate to severe RA. |

Risankizumab

| • | In January 2018, AbbVie initiated two Phase 3 clinical trials to evaluate the efficacy and safety of risankizumab, an investigational interleukin-23 (IL-23) inhibitor, versus placebo during induction therapy in subjects with moderately to severely active Crohn’s disease. |

| • | In February 2018, AbbVie announced that top-line results from two Phase 3 clinical trials evaluating risankizumab with 12-week dosing compared to ustekinumab met ranked additional secondary endpoints for the treatment of patients with moderate to severe chronic plaque psoriasis. The initial results from these clinical trials were previously announced in October 2017. The safety profile was consistent with all previously reported studies, and there were no new safety signals detected across the two studies. |

| • | In April 2018, AbbVie submitted a Biologics License Application (BLA) to the FDA and an MAA to the EMA for risankizumab for the treatment of plaque psoriasis in adults. |

| • | In May 2018, AbbVie initiated a Phase 2b/3 clinical trial to evaluate the efficacy and safety of risankizumab versus placebo in subjects with moderately to severely active ulcerative colitis. |

| • | In April 2018, AbbVie initiated a Phase 3 clinical trial to evaluate the safety and efficacy of IMBRUVICA in combination with VENCLEXTA versus chlorambucil plus GAZYVA (obinutuzumab) for the first-line treatment of subjects with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). |

| • | In May 2018, AbbVie announced that results from the Phase 3 iLLUMINATE study evaluating IMBRUVICA in combination with GAZYVA in previously untreated CLL/SLL met its primary endpoint. In December 2018, AbbVie announced additional results from the Phase 3 iLLUMINATE study that demonstrated significantly prolonged progression-free survival (PFS). |

| • | In June 2018, AbbVie announced that results from an interim analysis of the Phase 3 iNNOVATE study evaluating IMBRUVICA plus Rituxan (rituximab) in previously untreated and relapsed/refractory (R/R) patients with Waldenström’s macroglobulinemia (WM) met its primary endpoint. |

| • | In July 2018, AbbVie announced that results from a Phase 3 study evaluating the addition of IMBRUVICA to a chemotherapy regimen consisting of five different agents used in combination did not meet its primary endpoint in a subset of untreated diffuse large B-cell lymphoma patients identified to have the non-germinal center B-cell or activated B-cell subtypes of this disease. |

| • | In August 2018, the FDA approved IMBRUVICA, in combination with Rituxan, for the treatment of adult patients with WM. |

| • | In December 2018, AbbVie announced that results from an interim analysis of the Phase 3 ECOG1912E study evaluating IMBRUVICA in combination with Rituxan versus the chemoimmunotherapy FCR (fludarabine, cyclophosphamide and rituximab) in previously untreated and younger CLL patients met its primary endpoint. |

| • | In January 2019, AbbVie announced an update on the Phase 3 RESOLVE study evaluating IMBRUVICA in combination with nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine combination in patients |

with metastatic pancreatic adenocarcinoma.

Results showed the study did not meet its primary endpoint of improving PFS or overall survival (OS) benefit among the study population.

Safety data collected from the study were consistent with the existing safety information for the study therapies.

| • | In January 2018, AbbVie submitted an sNDA to the FDA for VENCLEXTA monotherapy in patients with CLL who are refractory to or have relapsed B-cell receptor pathway inhibitors. |

| • | In June 2018, the FDA approved VENCLEXTA in combination with Rituxan for the treatment of patients with CLL/SLL, with or without 17p deletion, who have received at least one prior therapy. VENCLEXTA plus Rituxan is the first oral-based, chemotherapy-free combination in CLL that allows patients an option for fixed treatment duration. |

| • | In September 2018, the FDA expanded the label for VENCLEXTA in combination with Rituxan to include information about patients with previously-treated CLL who achieved minimal residual disease (MRD)-negativity in the Phase 3 MURANO trial. |

| • | In October 2018, the European Commission approved the type-II variation application for VENCLYXTO in combination with Rituxan for the treatment of patients with R/R CLL who have received at least one prior therapy. In November, AbbVie received notification from the European Commission that conditions of the original conditional marketing authorisation have been fulfilled, granting VENCLYXTO official receipt of approval. |

| • | In October 2018, AbbVie announced that the results from the Phase 3 CLL14 study comparing the efficacy and safety of VENCLEXTA plus obinutuzumab versus obinutuzumab plus chlorambucil in previously untreated patients with CLL and coexisting medical conditions met its primary endpoint. |

| • | In November 2018, the FDA granted accelerated approval for VENCLEXTA in combination with azacitidine, or decitabine, or low dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |

| • | In March 2018, AbbVie announced top-line results from the Phase 2 TRINITY study evaluating rovalpituzumab tesirine (Rova-T) for third-line R/R small cell lung cancer (SCLC). Although Rova-T demonstrated single agent responses in advanced SCLC patients, after consulting with the FDA, based on the magnitude of effect across multiple parameters in this single-arm study, the company will not seek accelerated approval for Rova-T in third-line R/R SCLC. |

| • | In December 2018, AbbVie announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rova-T as a second-line therapy for advanced SCLC. An Independent Data Monitoring Committee recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. AbbVie will continue its ongoing Phase 3 study of Rova-T in first-line SCLC. |

| • | In November 2018, Bristol-Myers Squibb Company (BMS) announced that the FDA expanded the label for Empliciti in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies. BMS and AbbVie are co-developing Empliciti, with BMS solely responsible for commercial activities. |

| • | In November 2018, AbbVie presented EXPEDITION 8 data at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), in which 8 weeks of MAVYRET in treatment naïve, cirrhotic patients was safe and effective with no virologic failures reported. |

| • | In March 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal of marketing authorizations for ZINBRYTA, a prescription medicine used to treat adults with relapsing forms of multiple sclerosis. |

| • | In February 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-I study evaluating elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated in combination with low-dose hormone (add-back) therapy for uterine fibroids met its primary efficacy endpoint and all ranked secondary endpoints. |

| • | In March 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-II study evaluating elagolix in combination with low-dose hormone (add-back) therapy for uterine fibroids met its primary efficacy endpoint and all ranked secondary endpoints. |

| • | In July 2018, the FDA approved ORILISSA (elagolix) for the management of moderate to severe pain associated with endometriosis. |

| • | In August 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-EXTEND study evaluating elagolix in combination with low-dose hormone (add-back) therapy for uterine fibroids were consistent with findings observed in the ELARIS UF-I and ELARIS UF-II Phase 3 studies. |

See Note [removed: 10] [added: 11] to the Consolidated Financial Statements for additional information regarding the company's financial instruments and hedging strategies.

[removed: Foreign] [added: Foreign] Currency [removed: Risk][added: Risk]

AbbVie's primary net foreign currency exposures are the Euro, Japanese [removed: yen] [added: yen, Canadian dollar] and British pound.

The following table reflects the total foreign currency forward exchange contracts outstanding at December 31, [removed: 2018] [added: 2019] and [removed: 2017:][added: 2018:]

| [removed: (in millions)] [added: (in millions)] | [removed: Contract amount] [added: Contract amount] | | | | [removed: Weighted average exchange rate] [added: Weighted average exchange rate] | | | [removed: Fair and carrying value receivable/(payable)] [added: Fair and carrying value receivable/(payable)] | | | | [removed: Contract amount] [added: Contract amount] | | | | [removed: Weighted average exchange rate] [added: Weighted average exchange rate] | | | [removed: Fair and carrying value receivable/(payable)] [added: Fair and carrying value receivable/(payable)] | | |

| Euro | $ | [removed: 6,660] [added: 6,217] | | | [removed: 1.157] [added: 1.116] | | | $ | [removed: 68] [added: (12] | [added: )] | | $ | [removed: 6,366] [added: 6,660] | | | [removed: 1.175] [added: 1.157] | | | $ | [removed: (88] [added: 68] | [removed: )] |

| Japanese yen | [removed: 1,076] [added: 820] | | | | [removed: 111.5] [added: 108.7] | | | [removed: (12] [added: —] | | [removed: )] | | [removed: 940] [added: 1,076] | | | | [removed: 112.4] [added: 111.5] | | | [removed: 2] [added: (12] | | [added: )] |

| British pound | [removed: 499] [added: 427] | | | | [removed: 1.328] [added: 1.305] | | | [removed: 21] [added: (6] | | [added: )] | | [removed: 760] [added: 499] | | | | [removed: 1.310] [added: 1.328] | | | [removed: (22] [added: 21] | | [removed: )] |

| All other currencies | [removed: 1,776] [added: 1,508] | | | | n/a | | | [removed: 29] [added: (10] | | [added: )] | | [removed: 1,877] [added: 1,370] | | | | n/a | | | [removed: (18] [added: 15] | | [removed: )] |

| Total | $ | [removed: 10,011] [added: 9,476] | | | | | | $ | [removed: 106] [added: (34] | [added: )] | | $ | [removed: 9,943] [added: 10,011] | | | | | | $ | [removed: (126] [added: 106] | [removed: )] |

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 [removed: $1.0 billion] [added: $942 million] at December 31, [removed: 2018.][added: 2019.]

[removed: In November 2016,] [added: As of December 31, 2019,] the company [removed: issued] [added: has] €3.6 billion aggregate principal amount of unsecured senior Euro [removed: notes,] [added: notes outstanding,] which are exposed to foreign currency risk.

The company [removed: has] designated these foreign currency denominated notes as hedges of its net investments in certain foreign subsidiaries and affiliates.

See Note [removed: 9] [added: 10] to the Consolidated Financial Statements for additional information [removed: related] [added: regarding] to the senior Euro [removed: note issuance] [added: notes] and Note [removed: 10] [added: 11] to the Consolidated Financial Statements for additional information [removed: related] [added: regarding] to the net investment hedging program.

[removed: Interest] [added: Interest] Rate [removed: Risk][added: Risk]

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: $403] [added: $280] million at December 31, [removed: 2018.][added: 2019.]

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: $2.4] [added: $5.0] billion at December 31, [removed: 2018.][added: 2019.]

| [added: 42  \| *2019 Form 10-K*] | | [removed: 2018 Form 10-K \|  41] |

| | 2019 | | | | | | | | | | | 2018 | | | | | | | | | |

| Canadian dollar | 504 | | | | 1.324 | | | (6 | | ) | | 406 | | | | 1.314 | | | 14 | | |

| | 2018 | | | | | | | | | | | 2017 | | | | | | | | | |

Market Price Risk

AbbVie’s debt securities investment portfolio (the portfolio) is its main exposure to market price risk.

The portfolio is subject to changes in fair value as a result of interest rate fluctuations and other market factors.

It is AbbVie’s policy to mitigate market price risk by maintaining a diversified portfolio that limits the amount of exposure to a particular issuer and security type while placing limits on the amount of time to maturity.

AbbVie’s investment policy limits investments to investment grade credit ratings.

The company estimates that an increase in interest rates of 100 basis points would decrease the fair value of the portfolio by approximately $16 million as of December 31, 2018.

If the portfolio were to be liquidated, the fair value reduction would affect the statement of earnings in the period sold.

[removed: Overview][added: Overview]

[removed: Segments][added: Segments]

See Note [removed: 15] [added: 16] to the Consolidated Financial Statements and the sales information related to HUMIRA, IMBRUVICA and MAVYRET included under Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations."

[removed: Products][added: Products]

[added: *HUMIRA.*] HUMIRA (adalimumab) is a biologic therapy administered as a subcutaneous injection.

| [removed: Condition] [added: Condition] | | [removed: Principal Markets] [added: Principal Markets] |

HUMIRA is sold in numerous other markets worldwide, including Japan, China, Brazil and Australia, and accounted for approximately [removed: 61%] [added: 58%] of AbbVie's total net revenues in [removed: 2018.][added: 2019.]

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  1] [added: 10-K* \|  1] |

[added: Oncology products.] AbbVie’s oncology products target some of the most complex and difficult-to-treat cancers.

[added: *IMBRUVICA.*] IMBRUVICA (ibrutinib) is an oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).

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

[added: Virology Products.] AbbVie's virology products address unmet needs for patients living with HCV and HIV.

[added: HCV products. AbbVie's] HCV [removed: products.][added: products are:]

[removed: AbbVie's HCV] [added: These] products are:

[added: *MAVYRET/MAVIRET.*] MAVYRET (glecaprevir/pibrentasvir) is approved in the United States and European Union (MAVIRET) for the treatment of patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A).

It is an 8-week, pan-genotypic treatment for patients without cirrhosis and [added: following the EXPEDITION-8 study, also in patients with compensated cirrhosis] who are new to treatment.

[added: *VIEKIRA PAK AND TECHNIVIE.*] VIEKIRA PAK (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets) is an all-oral, short-course, interferon-free therapy, with or without ribavirin, for the treatment of adult patients with genotype 1 chronic HCV, including those with compensated cirrhosis.

[removed: AbbVie's TECHNIVIE (ombitasvir, paritaprevir and] ritonavir) is FDA-approved for use in combination with ribavirin for the treatment of adults with genotype 4 HCV infection in the United States.

[removed: Additional] [added: Additional] Virology [removed: products.][added: products. AbbVie's additional virology products include:]

[added: Other products.] AbbVie's [removed: additional virology] [added: other] products include:

[added: *SYNAGIS.*] SYNAGIS (palivizumab) is a product marketed by AbbVie outside of the United States that protects at-risk infants from severe respiratory disease caused by respiratory syncytial virus (RSV).

[added: *KALETRA.*] KALETRA (lopinavir/ritonavir), which is also marketed as [removed: Aluvia] [added: ALUVIA] in emerging markets, is a prescription anti-HIV-1 medicine that contains two protease inhibitors: lopinavir and ritonavir.

| [removed: 2  \| 2018] [added: 2  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

[added: Metabolics/Hormones products.] Metabolic and hormone products target a number of conditions, including testosterone deficiency due to certain underlying conditions, exocrine pancreatic insufficiency and hypothyroidism.

[added: *CREON.*] CREON (pancrelipase) is a pancreatic enzyme therapy for exocrine pancreatic insufficiency, a condition that occurs in patients with cystic fibrosis, chronic pancreatitis and several other conditions.

[added: *Synthroid.*] Synthroid (levothyroxine sodium tablets, USP) is used in the treatment of hypothyroidism.

[added: *AndroGel.*] AndroGel (testosterone gel) is a testosterone replacement therapy for males diagnosed with symptomatic low testosterone due to certain underlying conditions.

[added: Endocrinology products.] Lupron (leuprolide acetate), which is also marketed as Lucrin and LUPRON DEPOT, is a product for the palliative treatment of advanced prostate cancer, treatment of endometriosis and central precocious puberty and for the preoperative treatment of patients with anemia caused by uterine fibroids.

[added: *ORILISSA.*] 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.

[removed: Duopa] [added: *Duopa] and [removed: Duodopa] [added: Duodopa*] (carbidopa and levodopa).

[added: *Sevoflurane.*] Sevoflurane (sold under the trademarks Ultane and Sevorane) is an anesthesia product that AbbVie sells worldwide for human use.

[removed: Marketing,] [added: Marketing,] Sales and Distribution [removed: Capabilities][added: Capabilities]

In [removed: 2018,] [added: 2019,] three wholesale distributors (McKesson Corporation, Cardinal Health, Inc. and AmerisourceBergen Corporation) accounted for substantially all of AbbVie's sales in the United States.

No individual wholesaler accounted for greater than 42% of AbbVie's [removed: 2018] [added: 2019] gross revenues in the United States.

Outside the United States, [added: AbbVie sells] products [removed: are sold] primarily to customers or through distributors, depending on the market served.

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  3] [added: 10-K* \|  3] |

[added: No material portion of AbbVie's] business is subject to renegotiation of profits or termination of contracts at the election of the government.

[removed: Competition][added: Competition]

[added: Biosimilars.] Competition for AbbVie’s biologic products is affected by the approval of follow-on biologics, also known as “biosimilars.” Biologics have added major therapeutic options for the treatment of many diseases, including some for which therapies were unavailable or inadequate.

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

In June 2019, AbbVie announced that it entered into a definitive transaction agreement under which AbbVie will acquire Allergan plc (Allergan).

Allergan is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of brands and products primarily focused on key therapeutic areas including aesthetics, eye care, neuroscience, gastroenterology and women's health.

See Note 5 to the Consolidated Financial Statements for additional information regarding the proposed acquisition.

Immunology products. AbbVie maintains an extensive immunology portfolio across rheumatology, dermatology and gastroenterology.

AbbVie's immunology products address unmet needs for patients with autoimmune diseases.

*SKYRIZI.* SKYRIZI (risankizumab) is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.

It is a biologic therapy administered as a quarterly subcutaneous injection following an induction dose.

SKYRIZI is approved in the United States, Canada and the European Union and is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

In Japan, SKYRIZI is approved for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.

*RINVOQ*.

RINVOQ (upadacitinib) is a once-daily oral selective and reversible JAK inhibitor and is approved in the United States, Canada and the European Union.

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).

RINVOQ may be used as monotherapy or in combination with methotrexate.

*VENCLEXTA/VENCLYXTO.

VENCLEXTA* (venetoclax) is a BCL-2 inhibitor used to treat hematological malignancies.

VENCLEXTA is approved by the FDA for adults with CLL or SLL.

VENCLYXTO is approved in Europe for CLL in combination with rituximab in patients who have received at least one previous treatment.

MAVIRET is now also indicated for the treatment of HCV genotypes 1-6 in children between 12-18 years.

AbbVie's TECHNIVIE (ombitasvir, paritaprevir and

The use of VIEKIRA in the United States, Europe and Japan is currently limited given the significant use of pangenotypic regimens, including MAVIRET.

Outside the United States, ORILISSA is also launched in Canada and Puerto Rico.

patents on products (or processes for making the product) regulated by the Federal Food, Drug, and Cosmetic Act.

AbbVie has entered into settlement and license agreements with several adalimumab biosimilar manufactures.

Under the agreements, the license in the United States will begin in 2023 and the license in Europe began in 2018.

discovered by competitors.

The acquisitions and option-to-acquire agreements typically include, among other terms and conditions, non-refundable purchase price payments or option fees, option exercise payments, milestones or earn-outs, and other customary terms and obligations.

procedures, clinical investigations, product approvals and manufacturing, labeling, packaging, marketing and promotion, pricing and reimbursement, sampling, distribution, quality control, post-marketing surveillance, record keeping, storage and disposal practices.

teaching hospitals and to report this data to the Centers for Medicare and Medicaid Services for subsequent public disclosure.

HUMIRA.

Oncology products.

IMBRUVICA.

VENCLEXTA.

VENCLEXTA (venetoclax) is a BCL-2 inhibitor used to treat adults with CLL or SLL, with or without 17p deletion, who have received at least one prior treatment.

Virology Products.

MAVYRET/MAVIRET.

VIEKIRA PAK AND TECHNIVIE.

SYNAGIS.

KALETRA.

NORVIR.

NORVIR (ritonavir) is a protease inhibitor that is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Metabolics/Hormones products.

CREON.

Synthroid.

AndroGel.

Endocrinology products.

Other products.

AbbVie's other products include:

ORILISSA.

Sevoflurane.

No material portion of AbbVie's

Biosimilars.

HUMIRA is now facing direct biosimilar competition in Europe and other countries, which represent approximately 75% of AbbVie's international HUMIRA business or approximately 25% of total global HUMIRA revenues.

regulatory approval cannot exceed 14 years.

United States.

Outside the United States.

AbbVie's operations are also affected by trade regulations in many countries that limit the import of raw

countries worldwide either have adopted or are considering similar laws requiring disclosure of interactions with health care professionals.

European Union.

Japan.

Emerging Markets.

Information pertaining to legal proceedings is provided in Note [removed: 14,] [added: 15,] "Legal Proceedings and Contingencies" to the Consolidated Financial Statements included under Item 8, "Financial Statements and Supplementary Data," and is incorporated by reference herein.

[removed: UNITED STATES][added: UNITED STATES]

[removed: SECURITIES] [added: SECURITIES] AND EXCHANGE [removed: COMMISSION][added: COMMISSION]

[removed: WASHINGTON,] [added: WASHINGTON,] D. C. [removed: 20549][added: 20549]

[removed: FORM 10-K][added: FORM 10-K]

| [removed: (MARK ONE)] [added: (MARK ONE)] | | |

| [removed: x] [added: ☒] | | [removed: ANNUAL] [added: ANNUAL] REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF [removed: 1934] [added: 1934] |

| [removed: o] [added: ☐] | | [removed: TRANSITION] [added: TRANSITION] REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF [removed: 1934] [added: 1934] |

[removed: |] For the fiscal year ended December 31, [removed: 2018 | | |][added: 2019]

[removed: Commission] [added: Commission] file [removed: number 001-35565][added: number 001-35565]

[removed: ][added: ]

[removed: AbbVie Inc.][added: AbbVie Inc.]

| [removed: Delaware] (State or other jurisdiction of incorporation or organization) | | [removed: 32-0375147] (I.R.S. employer identification number) |

[removed: | 1 North Waukegan Road North Chicago, Illinois 60064-6400 (Address] [added: (Address, including zip code, and telephone number] of principal executive offices) [removed: (Zip Code) | | (847) 932-7900 (Telephone number) |]

| [removed: Title] [added: Title] of Each [removed: Class] [added: Class] | | [removed: Name] [added: Trading Symbol(s) | | Name] of Each Exchange on Which [removed: Registered] [added: Registered] |

| Common Stock, par value $0.01 per share | | [added: ABBV | |] New York Stock Exchange [removed: Chicago Stock Exchange] |

Yes [removed: x] [added: ☒] No [removed: o][added: ☐]

Yes [removed: o] [added: ☐] No [removed: x][added: ☒]

| Large Accelerated Filer [removed: x] | [added: ☒] | Accelerated Filer [removed: o] | [removed: | Non-accelerated Filer o] [added: ☐] |

| [removed: Smaller Reporting Company o] | | Emerging [removed: Growth Company o |] [added: growth company] | [added: ☐] |

The aggregate market value of the [removed: 1,498,817,459] [added: 1,462,630,048] 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: 2018),] [added: 2019),] was [removed: $138,865,437,576.][added: $106,362,457,090.]

[removed: DOCUMENTS] [added: DOCUMENTS] INCORPORATED BY [removed: REFERENCE][added: REFERENCE]

Portions of the [removed: 2019] [added: 2020] AbbVie Inc. Proxy Statement are incorporated by reference into Part III.

The Definitive Proxy Statement will be filed on or about March [removed: 22, 2019.][added: 19, 2020.]

[removed: FOR] [added: FOR] THE YEAR ENDED DECEMBER [removed: 31, 2018][added: 31, 2019]

[removed: TABLE] [added: TABLE] OF [removed: CONTENTS][added: CONTENTS]

[removed: | [PART I](#sD856D38DAB43575D9B1C10440B543DCA) | | |][added: PART I]

| Item 1. | [removed: [BUSINESS](#sF1227EA780A651FDBEFF6402264B224F)] [added: [BUSINESS](#sB3F1D163C2DA512BA1C6B355E6FC8B05)] | [removed: [1](#sF1227EA780A651FDBEFF6402264B224F)] [added: [1](#sB3F1D163C2DA512BA1C6B355E6FC8B05)] |

| Item 1A. | [RISK [removed: FACTORS](#sC6A3B0BAB29253B2807E5CC3F72250FE)] [added: FACTORS](#s3DA4D32DE2185DDFA39441C9603DDC6E)] | [removed: [10](#sC6A3B0BAB29253B2807E5CC3F72250FE)] [added: [10](#s3DA4D32DE2185DDFA39441C9603DDC6E)] |

| Item 1B. | [UNRESOLVED STAFF [removed: COMMENTS](#s5C10E6E151A3583EB8C59C6F0A5969A2)] [added: COMMENTS](#s6A68780BE3FD55C8807FAB2F36879D76)] | [removed: [19](#s5C10E6E151A3583EB8C59C6F0A5969A2)] [added: [20](#s6A68780BE3FD55C8807FAB2F36879D76)] |

| Item 2. | [removed: [PROPERTIES](#sDF9654B70E8E5B8288C82C858258B8BE)] [added: [PROPERTIES](#s5CD8FA9864D75E7BBEAF9F38B4B51CA0)] | [removed: [19](#sDF9654B70E8E5B8288C82C858258B8BE)] [added: [20](#s5CD8FA9864D75E7BBEAF9F38B4B51CA0)] |

| Item 3. | [LEGAL [removed: PROCEEDINGS](#s90954B5165295721A77216184C0F0181)] [added: PROCEEDINGS](#s924472A5E7AA5CC2ACD6C5E2092D02A5)] | [removed: [20](#s90954B5165295721A77216184C0F0181)] [added: [20](#s924472A5E7AA5CC2ACD6C5E2092D02A5)] |

| Item 4. | [MINE SAFETY [removed: DISCLOSURES](#sFD0D632700A459779A6746190A363F90)] [added: DISCLOSURES](#s14A6C869CCE55EF8AFFA1066A9439B3A)] | [removed: [20](#sFD0D632700A459779A6746190A363F90)] [added: [20](#s14A6C869CCE55EF8AFFA1066A9439B3A)] |

| Item 5. | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#sC710CEF9D05F5F7DA40FB449D2DC16EA)] [added: SECURITIES](#sAAAF96B4756B5E738319EEB934C41775)] | [removed: [23](#sC710CEF9D05F5F7DA40FB449D2DC16EA)] [added: [23](#sAAAF96B4756B5E738319EEB934C41775)] |

| Item 6. | [SELECTED FINANCIAL [removed: DATA](#sA8A36F3AF78F5F988DCBB6506F9F6438)] [added: DATA](#s88BFE731126A543B927FE937A6587474)] | [removed: [25](#sA8A36F3AF78F5F988DCBB6506F9F6438)] [added: [25](#s88BFE731126A543B927FE937A6587474)] |

| Item 7. | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#s5A7A5468FD435DA79D3512C4B961A4EA)] [added: OPERATIONS](#s688F207CD30B549FAE799907E39F2C28)] | [removed: [26](#s5A7A5468FD435DA79D3512C4B961A4EA)] [added: [26](#s688F207CD30B549FAE799907E39F2C28)] |

| Item 7A. | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#s45400DEFF7585A0B84D0FA90D37E22CA)] [added: RISK](#s94D547A3A14C5540A3E5EED69FAB64AB)] | [removed: [41](#s45400DEFF7585A0B84D0FA90D37E22CA)] [added: [42](#s94D547A3A14C5540A3E5EED69FAB64AB)] |

| Item 8. | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#s34F90B471E8D5D7C9D8811B7213ED33A)] [added: DATA](#sAADFB6281AFB5465B725D1C94781050C)] | [removed: [42](#s34F90B471E8D5D7C9D8811B7213ED33A)] [added: [43](#sAADFB6281AFB5465B725D1C94781050C)] |

| Item 9. | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#s1FCADB9452145B539151BA7467B4A718)] [added: DISCLOSURE](#s346C49594F5955EEA86EF61FC029E707)] | [removed: [89](#s1FCADB9452145B539151BA7467B4A718)] [added: [91](#s346C49594F5955EEA86EF61FC029E707)] |

| Item 9A. | [CONTROLS AND [removed: PROCEDURES](#s0856457CD20853F191B392515C2E69F5)] [added: PROCEDURES](#sA34D437D5B7557D7A2B8ABE04B13799F)] | [removed: [89](#s0856457CD20853F191B392515C2E69F5)] [added: [91](#sA34D437D5B7557D7A2B8ABE04B13799F)] |

| Item 9B. | [OTHER [removed: INFORMATION](#s23427E6D76345BCF87906FD5FBA98BD0)] [added: INFORMATION](#s4DE4C370572F554AA25D4FC6D9E11EB4)] | [removed: [92](#s23427E6D76345BCF87906FD5FBA98BD0)] [added: [94](#s4DE4C370572F554AA25D4FC6D9E11EB4)] |

OR

For the transition period from to

| Delaware | | 32-0375147 |

1 North Waukegan Road

North Chicago, Illinois 60064-6400

(847) 932-7900

| | | | | Chicago Stock Exchange |

| 1.375% Senior Notes due 2024 | | ABBV24 | | New York Stock Exchange |

| 0.750% Senior Notes due 2027 | | ABBV27 | | New York Stock Exchange |

| 2.125% Senior Notes due 2028 | | ABBV28 | | New York Stock Exchange |

| 1.250% Senior Notes due 2031 | | ABBV31 | | New York Stock Exchange |

Yes ☒ No ☐

Yes ☒ No ☐

| | | | |

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

| | | | |

| Non-Accelerated Filer | ☐ | Smaller reporting company | ☐ |

Yes ☐ No ☒

Number of common shares outstanding as of January 31, 2020: 1,479,156,683

ABBVIE INC.

FORM 10-K

| | [INFORMATION ABOUT OUR EXECUTIVE OFFICERS](#sD1AAE77B70F855E3B70FF04F9E1494EC) | [21](#sD1AAE77B70F855E3B70FF04F9E1494EC) |

| [PART II](#s6BFE6E2B67505511B1B9EF7C84CA6594) | | |

| [PART IV](#sD396DBDDB75C5792B2E4EF777FF9F32E) | | |

| | [SIGNATURES](#s4C2B6C21D4E159FF970D43BF1C463841) | [102](#s4C2B6C21D4E159FF970D43BF1C463841) |

10-K 1 abbv-20181231x10k.htm 10-K

| | | |

| OR | | |

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x

Number of common shares outstanding as of February 8, 2019: 1,475,083,514

| | [EXECUTIVE OFFICERS OF THE REGISTRANT](#s5486FFA5844E589E89B7DEC0EF9AF3A9) | [21](#s5486FFA5844E589E89B7DEC0EF9AF3A9) |

| [PART II](#s686B47EE396E5B92806A10150D4D94F2) | | |

| [PART IV](#s21C1EDC8883B5AF89BBDFFA08E9B7A75) | | |

| | [SIGNATURES](#s6391FF5887265C0FB0C9A246BDE8803A) | [100](#s6391FF5887265C0FB0C9A246BDE8803A) |

| [removed: United States] [added: United States] | | [removed: Outside] [added: Outside] the United [removed: States] [added: States] |

| North Chicago, Illinois | | [removed: Singapore*] [added: Ludwigshafen, Germany] |

| Worcester, Massachusetts* | | [removed: Sligo, Ireland] [added: Singapore*] |

| Wyandotte, Michigan* | | [added: Sligo, Ireland] |

| Jayuya, Puerto Rico | | Ludwigshafen, Germany |

| | | | |

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

| | | 2018 Form 10-K \|  19 |

| [removed: 20  \| 2018] [added: 20  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

| [removed: Name] [added: Name] | | [removed: Age] [added: Age] | | [removed: Position] [added: Position] |

| Richard A. Gonzalez | | [removed: 65] [added: 66] | | Chairman of the Board and Chief Executive Officer |

| Carlos Alban | | [removed: 56] [added: 57] | | Vice Chairman, Chief Commercial Officer |

| Laura J. Schumacher | | [removed: 55] [added: 56] | | Vice Chairman, External Affairs and Chief Legal Officer |

| Michael E. Severino, M.D.* | | [removed: 53] [added: 54] | | Vice Chairman and President |

| Henry O. Gosebruch* | | [removed: 46] [added: 47] | | Executive Vice President and Chief Strategy Officer |

| Timothy J. Richmond | | [removed: 52] [added: 53] | | Executive Vice President, Chief Human Resources Officer |

| Azita Saleki-Gerhardt, Ph.D. | | [removed: 55] [added: 56] | | Executive Vice President, Operations |

| Nicholas Donoghoe, M.D.* | | [removed: 38] [added: 39] | | Senior Vice President, Enterprise Innovation |

| Robert A. Michael* | | [removed: 48] [added: 49] | | [removed: Senior] [added: Executive] Vice President, Chief Financial Officer |

| Jeffrey R. Stewart* | | [removed: 50] [added: 51] | | Senior Vice President, U.S. Commercial Operations |

| Brian L. Durkin* | | [removed: 58] [added: 59] | | Vice President, Controller |

| * | Dr. Severino was first appointed as a corporate officer in June 2014; Mr. Gosebruch was first appointed as a corporate officer in December 2015; Dr. Donoghoe was first appointed as a corporate officer in January 2019; Mr. Michael was first appointed as a corporate officer in December 2015; [added: Dr. Hudson was first appointed as a corporate officer in July 2019;] Mr. Stewart was first appointed as a corporate officer in December 2018; and Mr. Durkin was first appointed as a corporate officer in October 2018. |

Ms. Schumacher is AbbVie’s Vice Chairman, External Affairs and Chief Legal Officer, responsible for [added: global] legal, [removed: ethics and compliance, corporate governance, corporate aviation, and all externally-facing functions including] health economics outcomes research, [removed: government affairs,] corporate responsibility, brand and [removed: communications.][added: communications and government affairs.]

Prior to AbbVie’s separation from Abbott, Ms. Schumacher served as Executive Vice President, General Counsel [removed: and Corporate Secretary] from 2007 to 2012.

Both at Abbott and AbbVie, Ms. Schumacher also led [removed: Licensing and Acquisition] [added: Business Development] and Ventures and Early Stage Collaborations.

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  21] [added: 10-K* \|  21] |

[removed: He] [added: Mr. Michael] previously served as [removed: Executive] [added: Senior] Vice President, Chief Financial Officer from [removed: 2013] [added: October 2018] to [added: July 2019, and as Vice President, Controller from March 2017 to October] 2018.

Mr. Michael is AbbVie’s [removed: Senior] [added: Executive] Vice President, Chief Financial Officer.

He [removed: became an AbbVie officer in 2015 and] served as AbbVie’s Vice President, Treasurer from 2015 to 2016, as Vice President, Controller, Commercial Operations from 2013 to 2015 and Vice President, Financial Planning and Analysis from 2012 to 2013.

| [removed: 22  \| 2018] [added: 22  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

[removed: PART II][added: PART II]

INFORMATION ABOUT OUR EXECUTIVE OFFICERS

| Thomas J. Hudson, M.D.* | | 58 | | Senior Vice President, Research & Development and Chief Scientific Officer |

He serves on the board of Aptinyx Inc.

Dr. Hudson is AbbVie's Senior Vice President, Research & Development and Chief Scientific Officer.

He previously served as Vice President, Head of Oncology Discovery and Early Development from 2016 to 2019.

Prior to joining AbbVie, Dr. Hudson served at the Ontario Institute for Cancer Research as President and Scientific Director.

He also previously served as Founder and Director of the McGill University and Genome Quebec Innovation Centre and Assistant Director of the Whitehead/MIT Center for Genome Research.

EXECUTIVE OFFICERS OF THE REGISTRANT

| William J. Chase | | 51 | | Executive Vice President, Finance and Administration |

At Abbott, Ms. Schumacher was also responsible for its Office of Ethics and Compliance.

Mr. Chase is AbbVie’s Executive Vice President, Finance and Administration, responsible for all financial and administrative functions of the company.

He served as Abbott’s Vice President, Licensing and Acquisitions from 2010 to 2012, as Vice President, Treasurer from 2007 to 2010, and as Divisional Vice President, Controller of Abbott International from 2004 to 2007.

Mr. Chase joined Abbott in 1989.

Mr. Michael previously served as Vice President, Controller from March 2017 to October 2018.

[removed: Principal Market][added: Principal Market]

[removed: Stockholders][added: Stockholders]

There were [removed: 48,516] [added: 46,544] stockholders of record of AbbVie common stock as of January 31, [removed: 2019.][added: 2020.]

[removed: Dividends][added: Dividends]

On November [removed: 2, 2018,] [added: 1, 2019,] AbbVie's board of directors declared an increase in the quarterly cash dividend from [removed: $0.96] [added: $1.07] per share to [removed: $1.07] [added: $1.18] per share, payable on February [removed: 15, 2019] [added: 14, 2020] to stockholders of record as of January 15, [removed: 2019.][added: 2020.]

[removed: Performance Graph][added: Performance Graph]

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: 2013] [added: 2014] through December 31, [removed: 2018.][added: 2019.]

This graph assumes $100 was invested in AbbVie common stock and each index on December 31, [removed: 2013] [added: 2014] and also assumes the reinvestment of dividends.

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  23] [added: 10-K* \|  23] |

[removed: ][added: ]

[removed: Issuer] [added: Issuer] Purchases of Equity [removed: Securities][added: Securities]

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

| 1. | 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: 4,246] [added: 4,293] in October; [removed: 1,331] [added: 1,086] in November; and [removed: 13,443] [added: 1,016] in December. |

| [removed: 24  \| 2018] [added: 24  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

| October 1, 2019 - October 31, 2019 | 4,293 | | (1) | $ | 77.19 | | (1) | — | | | $ | 3,950,021,071 | | |

| November 1, 2019 - November 30, 2019 | 1,086 | | (1) | $ | 80.53 | | (1) | — | | | $ | 3,950,021,071 | | |

| December 1, 2019 - December 31, 2019 | 1,016 | | (1) | $ | 87.39 | | (1) | — | | | $ | 3,950,021,071 | | |

| Total | 6,395 | | (1) | $ | 79.38 | | (1) | — | | | $ | 3,950,021,071 | | |

| October 1, 2018 - October 31, 2018 | 4,246 | | (1) | $ | 88.24 | | (1) | — | | | $ | 1,500,000,050 | | |

| November 1, 2018 - November 30, 2018 | 17,119,956 | | (1) | $ | 87.62 | | (1) | 17,118,625 | | | $ | 8,924 | | |

| December 1, 2018 - December 31, 2018 | 8,546,698 | | (1) | $ | 87.89 | | (1) | 8,533,255 | | | $ | 4,250,016,122 | | (2) |

| Total | 25,670,900 | | (1) | $ | 87.71 | | (1) | 25,651,880 | | | $ | 4,250,016,122 | | (2) |

| | |

| --- | --- |

| 2. | On December 13, 2018, AbbVie's board of directors authorized a $5.0 billion increase to the existing stock repurchase program. The company's stock repurchase authorization permits purchases of AbbVie shares from time to time in open-market or private transactions at management’s discretion. The program has no time limit and can be discontinued at any time. |

| [removed: as] [added: as] of and for the years ended December 31 (in millions, except per share [removed: data)] [added: data)] | [removed: 2018] [added: 2019] | | | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2015] [added: 2016] | | | | [removed: 2014] [added: 2015] | | |

| [removed: Statement] [added: Statement] of earnings [removed: data] [added: data] | | | | | | | | | | | | | | | | | | | |

| Net revenues | $ | [removed: 32,753] [added: 33,266] | | | $ | [removed: 28,216] [added: 32,753] | | | $ | [removed: 25,638] [added: 28,216] | | | $ | [removed: 22,859] [added: 25,638] | | | $ | [removed: 19,960] [added: 22,859] | |

| Net earnings | [removed: 5,687] [added: 7,882] | | | | [removed: 5,309] [added: 5,687] | | | | [removed: 5,953] [added: 5,309] | | | | [removed: 5,144] [added: 5,953] | | | | [removed: 1,774] [added: 5,144] | | |

| Basic earnings per share | $ | [removed: 3.67] [added: 5.30] | | | $ | [removed: 3.31] [added: 3.67] | | | $ | [removed: 3.65] [added: 3.31] | | | $ | [removed: 3.15] [added: 3.65] | | | $ | [removed: 1.11] [added: 3.15] | |

| Diluted earnings per share | $ | [removed: 3.66] [added: 5.28] | | | $ | [removed: 3.30] [added: 3.66] | | | $ | [removed: 3.63] [added: 3.30] | | | $ | [removed: 3.13] [added: 3.63] | | | $ | [removed: 1.10] [added: 3.13] | |

| Cash dividends declared per common share | $ | [removed: 3.95] [added: 4.39] | | | $ | [removed: 2.63] [added: 3.95] | | | $ | [removed: 2.35] [added: 2.63] | | | $ | [removed: 2.10] [added: 2.35] | | | $ | [removed: 1.75] [added: 2.10] | |

| Weighted-average basic shares outstanding | [removed: 1,541] [added: 1,481] | | | | [removed: 1,596] [added: 1,541] | | | | [removed: 1,622] [added: 1,596] | | | | [removed: 1,625] [added: 1,622] | | | | [removed: 1,595] [added: 1,625] | | |

| Weighted-average diluted shares outstanding | [removed: 1,546] [added: 1,484] | | | | [removed: 1,603] [added: 1,546] | | | | [removed: 1,631] [added: 1,603] | | | | [removed: 1,637] [added: 1,631] | | | | [removed: 1,610] [added: 1,637] | | |

| [removed: Balance] [added: Balance] sheet [removed: data] [added: data] | | | | | | | | | | | | | | | | | | | |

| Total assets [removed: (a)(b)] [added: (a)] | $ | [removed: 59,352] [added: 89,115] | | | $ | [removed: 70,786] [added: 59,352] | | | $ | [removed: 66,099] [added: 70,786] | | | $ | [removed: 53,050] [added: 66,099] | | | $ | [removed: 27,513] [added: 53,050] | |

| Long-term debt and [added: finance] lease obligations [removed: (a)(b)(c)] [added: (a)(b)] | [removed: 36,611] [added: 66,728] | | | | [removed: 36,968] [added: 36,611] | | | | [removed: 36,465] [added: 36,968] | | | | [removed: 31,265] [added: 36,465] | | | | [removed: 14,552] [added: 31,265] | | |

| [removed: (c)] [added: (b)] | Includes current portion of both long-term debt and [added: finance] lease obligations. |

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  25] [added: 10-K* \|  25] |

| (a) | In November 2019, AbbVie issued $30.0 billion aggregate principal amount of floating rate and fixed rate unsecured senior notes at maturities ranging from 18 months to 30 years. AbbVie expects to use the net proceeds to fund a portion of the aggregate cash consideration due to Allergan shareholders in connection with the proposed acquisition and to pay related fees and expenses. See Note 5 to the Consolidated Financial Statements for information regarding the proposed acquisition and Note 10 for information on the senior notes. |

| | |

| --- | --- |

| (a) | In May 2015, AbbVie acquired Pharmacyclics for approximately $20.8 billion, including cash consideration of $12.4 billion and equity consideration of approximately 128 million shares of AbbVie common stock valued at $8.4 billion. In connection with the acquisition, AbbVie issued $16.7 billion aggregate principal amount of unsecured senior notes, of which approximately $11.5 billion was used to finance the acquisition and approximately $5.0 billion was used to finance an accelerated share repurchase (ASR) program. |

| (b) | In June 2016, AbbVie acquired Stemcentrx for approximately $6.4 billion, including cash consideration of $1.9 billion, equity consideration of approximately 62.4 million shares of AbbVie common stock valued at $3.9 billion and contingent consideration of approximately $620 million. In connection with the acquisition, AbbVie issued $7.8 billion aggregate principal amount of unsecured senior notes. Of the $7.7 billion net proceeds, approximately $1.9 billion was used to finance the acquisition, approximately $3.8 billion was used to finance an ASR and approximately $2.0 billion was used to repay the company's outstanding term loan that was due to mature in November 2016. See Note 5 to the Consolidated Financial Statements for information regarding the acquisition of Stemcentrx, Note 9 for information on the senior notes and Note 12 for information on the ASR. |

| | [removed: Page] [added: Page] |

| [removed: Consolidated] [added: Consolidated] Financial [removed: Statements] [added: Statements] | |

[removed: | [Consolidated] [added: Consolidated] Statements of [removed: Earnings](#s76C37AFEFB475716AF8B22B34D33E4D9) | [43](#s76C37AFEFB475716AF8B22B34D33E4D9) |][added: Earnings]

[removed: | [Consolidated] [added: Consolidated] Statements of Comprehensive [removed: Income](#s7145A93ACD9B59E2B0F6715D41534619) | [44](#s7145A93ACD9B59E2B0F6715D41534619) |][added: Income]

[removed: | [Consolidated] [added: Consolidated] Balance [removed: Sheets](#s71E05AF9910356549D8668CC72F6EF17) | [45](#s71E05AF9910356549D8668CC72F6EF17) |][added: Sheets]

[removed: | [Consolidated] [added: Consolidated] Statements of [removed: Equity](#s8F4A1D5A184355D68F80E6670C37FE68) | [46](#s8F4A1D5A184355D68F80E6670C37FE68) |][added: Equity]

[removed: | [Consolidated] [added: Consolidated] Statements of Cash [removed: Flows](#s697E68C309115EA9BE6BB031F1500623) | [47](#s697E68C309115EA9BE6BB031F1500623) |][added: Flows]

[removed: | [Notes] [added: Notes] to Consolidated Financial [removed: Statements](#s7ED162C621ED5E378EF1E810D4EB20AD) | [48](#s7ED162C621ED5E378EF1E810D4EB20AD) |][added: Statements]

[removed: | [Report] [added: Report] of Independent Registered Public Accounting [removed: Firm](#s8F5B70D79A175A72A81BF955B6B04109) | [88](#s8F5B70D79A175A72A81BF955B6B04109) |][added: Firm]

| [removed: 42  \| 2018 Form 10-K] | | [added: *2019 Form 10-K* \|  43] |

[removed: AbbVie] [added: AbbVie] Inc. and [removed: Subsidiaries][added: Subsidiaries]

[removed: Consolidated] [added: | [Consolidated] Statements of [removed: Earnings][added: Earnings](#s1A5C13CF39625F559F9C1D6032DD6E5B) | [44](#s1A5C13CF39625F559F9C1D6032DD6E5B) |]

| [removed: years] [added: years] ended December 31 (in millions, except per share [removed: data)] [added: data)] | [removed: 2018] [added: 2019] | | | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | |

| [removed: Net revenues] [added: Net revenues] | $ | [removed: 32,753] [added: 33,266] | | | $ | [removed: 28,216] [added: 32,753] | | | $ | [removed: 25,638] [added: 28,216] | |

| Cost of products sold | [removed: 7,718] [added: 7,439] | | | | [removed: 7,042] [added: 7,718] | | | | [removed: 5,832] [added: 7,042] | | |

| Selling, general and administrative | [removed: 7,399] [added: 6,942] | | | | [removed: 6,295] [added: 7,399] | | | | [removed: 5,881] [added: 6,295] | | |

| Research and development | [removed: 10,329] [added: 6,407] | | | | [removed: 5,007] [added: 10,329] | | | | [removed: 4,385] [added: 5,007] | | |

| Acquired in-process research and development | [removed: 424] [added: 385] | | | | [removed: 327] [added: 424] | | | | [removed: 200] [added: 327] | | |

| Other [added: operating] expense [added: (income)] | [removed: 500] [added: (890] | | [added: )] | | [removed: —] [added: 500] | | | | — | | |

| Total operating costs and expenses | [removed: 26,370] [added: 20,283] | | | | [removed: 18,671] [added: 26,370] | | | | [removed: 16,298] [added: 18,671] | | |

| Operating earnings | [removed: 6,383] [added: 12,983] | | | | [removed: 9,545] [added: 6,383] | | | | [removed: 9,340] [added: 9,545] | | |

| Interest expense, net | [removed: 1,144] [added: 1,509] | | | | [removed: 1,004] [added: 1,144] | | | | [removed: 965] [added: 1,004] | | |

| Net foreign exchange loss | [removed: 24] [added: 42] | | | | [removed: 348] [added: 24] | | | | [removed: 303] [added: 348] | | |

| Other expense, net | [removed: 18] [added: 3,006] | | | | [removed: 466] [added: 18] | | | | [removed: 188] [added: 466] | | |

| Earnings before income [removed: taxes] [added: tax] | [removed: 5,197] [added: 8,426] | | | | [removed: 7,727] [added: 5,197] | | | | [removed: 7,884] [added: 7,727] | | |

| Income tax expense (benefit) | [removed: (490] [added: 544] | | [removed: )] | | [removed: 2,418] [added: (490] | | [added: )] | | [removed: 1,931] [added: 2,418] | | |

| [removed: Net earnings] [added: Net earnings] | $ | [removed: 5,687] [added: 7,882] | | | $ | [removed: 5,309] [added: 5,687] | | | $ | [removed: 5,953] [added: 5,309] | |

| [removed: Per] [added: Per] share [removed: data] [added: data] | | | | | | | | | | | |

| Basic earnings per share | $ | [removed: 3.67] [added: 5.30] | | | $ | [removed: 3.31] [added: 3.67] | | | $ | [removed: 3.65] [added: 3.31] | |

| Diluted earnings per share | $ | [removed: 3.66] [added: 5.28] | | | $ | [removed: 3.30] [added: 3.66] | | | $ | [removed: 3.63] [added: 3.30] | |

| Weighted-average basic shares outstanding | [removed: 1,541] [added: 1,481] | | | | [removed: 1,596] [added: 1,541] | | | | [removed: 1,622] [added: 1,596] | | |

| Weighted-average diluted shares outstanding | [removed: 1,546] [added: 1,484] | | | | [removed: 1,603] [added: 1,546] | | | | [removed: 1,631] [added: 1,603] | | |

| [added: 44  \| *2019 Form 10-K*] | | [removed: 2018 Form 10-K \|  43] |

[removed: Consolidated] [added: | [Consolidated] Statements of Comprehensive [removed: Income][added: Income](#s0194478B63435CBD8A68F4FCC42D29F2) | [45](#s0194478B63435CBD8A68F4FCC42D29F2) |]

| [removed: years] [added: years] ended December 31 (in [removed: millions)] [added: millions)] | [removed: 2018] [added: 2019] | | | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | |

| Foreign currency translation adjustments, net of tax expense (benefit) of [added: $(4) in 2019,] $(18) in [removed: 2018,] [added: 2018 and] $34 in 2017 [removed: and $(31) in 2016] | [removed: (391] [added: (98] | | ) | | [removed: 996] [added: (391] | | [added: )] | | [removed: (165] [added: 996] | | [removed: )] |

| Net investment hedging activities, net of tax expense (benefit) of [added: $22 in 2019,] $40 in [removed: 2018,] [added: 2018 and] $(194) in 2017 [removed: and $79 in 2016] | [removed: 138] [added: 74] | | | | [removed: (343] [added: 138] | | [removed: )] | | [removed: 140] [added: (343] | | [added: )] |

| Pension and post-employment benefits, net of tax expense (benefit) of [added: $(323) in 2019,] $35 in [removed: 2018,] [added: 2018 and] $(94) in 2017 [removed: and $(75) in 2016] | [removed: 197] [added: (1,243] | | [added: )] | | [removed: (406] [added: 197] | | [removed: )] | | [removed: (135] [added: (406] | | ) |

| Marketable security activities, net of tax expense (benefit) of $— in [removed: 2018, $(8)] [added: 2019, $—] in [removed: 2017] [added: 2018] and [removed: $(11)] [added: $(8)] in [removed: 2016] [added: 2017] | [removed: (10] [added: 10] | | [removed: )] | | [removed: (46] [added: (10] | | ) | | [removed: (1] [added: (46] | | ) |

| Cash flow hedging activities, net of tax expense (benefit) of [added: $70 in 2019,] $23 in [removed: 2018,] [added: 2018 and] $(26) in 2017 [removed: and $18 in 2016] | [removed: 313] [added: 141] | | | | [removed: (342] [added: 313] | | [removed: )] | | [removed: 136] [added: (342] | | [added: )] |

AbbVie Inc. and Subsidiaries

AbbVie Inc. and Subsidiaries

AbbVie Inc. and Subsidiaries

| Balance at December 31, 2019 | 1,479 | | | $ | 18 | | | $ | (24,504 | ) | | $ | 15,193 | | | $ | 4,717 | | | $ | (3,596 | ) | | $ | (8,172 | ) |

AbbVie Inc. and Subsidiaries

| Net earnings | $ | 7,882 | | | $ | 5,687 | | | $ | 5,309 | |

| Gain on divestitures | (330 | | ) | | — | | | | — | | |

AbbVie Inc. and Subsidiaries

On June 25, 2019, AbbVie announced that it entered into a definitive transaction agreement under which AbbVie will acquire Allergan plc (Allergan).

Investments in marketable debt securities are classified as available-for-sale and are recorded at fair value with any

| as of December 31 (in millions) | 2019 | | | | 2018 | | |

Leases

Short-term leases with a term of 12 months or less are not recorded on the balance sheet.

For leases commencing or modified in 2019 or later, AbbVie does not separate lease components from non-lease components.

The company records lease liabilities based on the present value of lease payments over the lease term.

AbbVie generally uses an incremental borrowing rate to discount its lease liabilities, as the rate implicit in the lease is typically not readily determinable.

Certain lease agreements include renewal options that are under the company's control.

AbbVie includes optional renewal periods in the lease term only when it is reasonably certain that AbbVie will exercise its option.

Variable lease payments include payments to lessors for taxes, maintenance, insurance and other operating costs as well as payments that are adjusted based on an index or rate.

The company's lease agreements do not contain any significant residual value guarantees or restrictive covenants.

The use of alternative estimates and assumptions could increase or decrease

Under the new standard, on January 1, 2019, the company recognized a cumulative-effect adjustment to its consolidated balance sheet primarily related to the recognition of liabilities and corresponding right-of-use assets for operating leases.

Upon adoption, the company made an election to not reclassify the income tax effects of the Act from AOCI to retained earnings.

Therefore, the adoption of the standard had no impact on AbbVie's consolidated financial statements.

AbbVie has completed its assessment of the new standard as of December 31, 2019 and concluded that the adoption will not have a material impact on its consolidated financial statements based on the company's current portfolio of financial assets.

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.

| as of December 31 (in millions) | 2019 | | | | 2018 | | |

| as of December 31 (in millions) | 2019 | | | | 2018 | | |

| Net earnings | $ | 7,882 | | | $ | 5,687 | | | $ | 5,309 | |

| Weighted-average basic shares outstanding | 1,481 | | | | 1,541 | | | | 1,596 | | |

| Net earnings | $ | 7,882 | | | $ | 5,687 | | | $ | 5,309 | |

| Earnings allocated to participating securities | 40 | | | | 30 | | | | 26 | | |

| Earnings available to common shareholders | $ | 7,842 | | | $ | 5,657 | | | $ | 5,283 | |

| Weighted-average diluted shares outstanding | 1,484 | | | | 1,546 | | | | 1,603 | | |

Proposed Acquisition of Allergan plc

On June 25, 2019, AbbVie announced that it entered into a definitive transaction agreement under which AbbVie will acquire Allergan plc (Allergan) in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie’s common stock of $78.45 on June 24, 2019.

Under the terms of the transaction agreement, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share.

On October 14, 2019, Allergan shareholders approved the proposed transaction.

| | | | |

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

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

| Balance at December 31, 2015 | 1,610 | | | $ | 17 | | | $ | (8,839 | ) | | $ | 13,080 | | | $ | 2,248 | | | $ | (2,561 | ) | | $ | 3,945 | |

| Common shares issued to Stemcentrx stockholders | 63 | | | — | | | | 3,958 | | | | (35 | | ) | | — | | | | — | | | | 3,923 | | |

| Devaluation loss related to Venezuela | — | | | | — | | | | 298 | | |

| Acquisition of businesses, net of cash acquired | — | | | | — | | | | (2,495 | | ) |

| Supplemental schedule of non-cash investing and financing activities | | | | | | | | | | | |

| Issuance of common shares associated with acquisitions of businesses | — | | | | — | | | | 3,923 | | |

Held-to-

Assets related to capital leases were insignificant at December 31, 2018 and 2017.

becomes available.

remeasured as if the functional currency were the reporting currency.

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers (Topic 606) and Other Assets and Deferred Costs - Contracts with Customers (Subtopic 340-40).

The amendments in this standard superseded most existing revenue recognition requirements.

The core principle of the new guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.

There were no significant changes to the amounts or timing of revenue recognition for product sales, the company's primary revenue stream.

For certain licensing arrangements where revenue was previously deferred and recognized over time, revenue is now recognized at the point in time when the license is granted.

Additionally, for certain contract manufacturing arrangements where revenue was previously recognized at a point in time at the end of the manufacturing process, revenue is now recognized over time throughout the manufacturing process.

Under the new standard, on January 1, 2018, the company recognized a cumulative-effect adjustment to retained earnings primarily related to certain deferred license revenues that were originally expected to be recognized through early 2020.

The impact of adoption on the company’s consolidated statements of earnings in 2018 was as follows:

| year ended December 31, 2018 (in millions, except per share data) | | As Reported | | | | Balances Without Adoption of ASU 2014-09 | | | | Effect of Change Higher/(Lower) | | |

As of December 31, 2018, due to the impact of the adoption of ASU 2014-09, prepaid expenses and other were $40 million higher, inventories were $27 million lower, accounts payable and accrued liabilities were $53 million lower, other long-term liabilities were $18 million lower, deferred income taxes were $11 million higher and retained earnings were $80 million higher on the company’s consolidated balance sheet than they would have been had ASU 2014-09 not been adopted.

Other impacts to the consolidated balance sheet were insignificant.

ASU No. 2016-01

In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities.

The standard requires several targeted changes including that equity investments (except those accounted for under the equity method of accounting, or those that result in consolidation of the investee) be measured at fair value with changes in fair value recognized in net earnings.

The adoption did not impact the accounting for AbbVie's investments in debt securities and did not have a material impact on the company's consolidated financial statements.

ASU No. 2016-16

The standard requires entities to recognize the income tax consequences of an intercompany transfer of an asset other than inventory when the transfer occurs.

Under previous U.S. GAAP, the income tax consequences of these intercompany asset transfers were deferred until the asset was sold to a third party or otherwise recovered through use.

As a result, on January 1, 2018, the company recorded a cumulative-effect adjustment to its consolidated balance sheet that included a $1.9 billion decrease to retained earnings, a $1.4 billion decrease to prepaid expenses and other and a $0.5 billion decrease to other assets.

ASU No. 2017-07

In March 2017, the FASB issued ASU No. 2017-07, Compensation - Retirement Benefits (Topic 715): Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost.

The standard requires that an employer continue to report the service cost component of net periodic benefit cost in the same income statement line item or items as other employee compensation costs arising from services rendered during the period.

The other components of net periodic benefit cost are required to be presented separately outside of income from operations and are not eligible for capitalization.

AbbVie adopted the standard in the first quarter of 2018 and applied the income statement classification provisions of this standard retrospectively.

As a result, the company reclassified income of $47 million from operating earnings to non-operating income in 2017 and $44 million in 2016.

Additionally, the company recorded approximately $34 million of non-operating income in 2018 which would have been recorded in operating earnings under the previous guidance.

ASU No. 2017-12

[removed: Disclosure] [added: Disclosure] Controls and Procedures; Internal Control Over Financial [removed: Reporting][added: Reporting]

[removed: Evaluation] [added: Evaluation] of disclosure controls and [removed: procedures.][added: procedures. The Chief Executive Officer, Richard A.]

[removed: Changes in internal control] [added: Opinion on Internal Control] over [removed: financial reporting.][added: Financial Reporting]

[added: 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: 2018.][added: 2019.]

[added: Inherent limitations on effectiveness of controls.] AbbVie's management, including its Chief Executive Officer and its Chief Financial Officer, do not expect that AbbVie's disclosure controls or internal control over financial reporting will prevent or detect all errors and all fraud.

[added: Management's annual report on internal control over financial reporting.] Management of AbbVie is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Securities Exchange Act of 1934.

Management assessed the effectiveness of AbbVie's internal control over financial reporting as of December 31, [removed: 2018.][added: 2019.]

In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in [removed: Internal] [added: *Internal] Control-Integrated [removed: Framework] [added: Framework*] (2013 framework).

Based on that assessment, management concluded that AbbVie maintained effective internal control over financial reporting as of December 31, [removed: 2018,] [added: 2019,] based on the COSO criteria.

The effectiveness of AbbVie's internal control over financial reporting as of December 31, [removed: 2018] [added: 2019] 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: 2018.][added: 2019.]

| | | [removed: 2018] [added: *2019] Form [removed: 10-K \|  89] [added: 10-K* \|  91] |

[removed: Report] [added: Report] of [removed: independent registered public accounting firm.][added: Independent Registered Public Accounting Firm]

[added: Report of independent registered public accounting firm.] The report of AbbVie's independent registered public accounting firm related to its assessment of the effectiveness of internal control over financial reporting is included below.

| [removed: 90  \| 2018] [added: 92  \| *2019] Form [removed: 10-K] [added: 10-K*] | | |

[removed: Opinion] [added: Definition and Limitations] on Internal Control [removed: over] [added: Over] Financial [removed: Reporting][added: Reporting]

We have audited AbbVie Inc. and subsidiaries' internal control over financial reporting as of December 31, [removed: 2018,] [added: 2019,] 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: 2018,] [added: 2019,] 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: 2018] [added: 2019] and [removed: 2017,] [added: 2018,] and 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: 2018,] [added: 2019,] and the related notes and our report dated February [removed: 27, 2019] [added: 21, 2020] expressed an unqualified opinion thereon.