ACO 413 - PROJECT –AUDIT REPORT ANALYSIS AND BUSINESS FAILURE PREDICTION The project should be submitted as a soft copy and should follow the below structure: 1. Brief Introduction of the company. 2....

1. Reports Attached at PDF below:
2. Brief Introduction of the company
AbbVie is a global, research-based biopharmaceutical company. AbbVie develops and markets advanced therapies that address some of the world's most complex and serious diseases. AbbVie's products are focused on treating conditions such as chronic autoimmune diseases in rheumatology, gastroenterology and dermatology; oncology, including blood cancers; virology, including hepatitis C virus (HCV) and human immunodeficiency virus (HIV); neurological disorders, such as Parkinson's disease; metabolic diseases, including thyroid disease and complications associated with cystic fibrosis; pain associated with endometriosis; as well as other serious health conditions. AbbVie also has a pipeline of promising new medicines in clinical development across such important medical specialties as immunology, oncology and neuroscience, with additional targeted investment in cystic fibrosis and women's health.
AbbVie was incorporated in Delaware on April 10, 2012. On January 1, 2013, AbbVie became an independent, publicly-traded company as a result of the distribution by Abbott Laboratories (Abbott) of 100% of the outstanding common stock of AbbVie to Abbott's shareholders.
AbbVie's portfolio of products includes a broad line of therapies that address some of the world's most complex and serious diseases. 
3. List All financial statements included
· Consolidated statement of earnings
· Consolidated Statements of Comprehensive Income
· Consolidated Balance Sheets
· Consolidated Statements of Equity
· Consolidated Statements of Cash Flows
· Notes to Consolidated Financial Statements
· Report of Independent Registered Public Accounting Firm
4. List of Directors who have signed the report
· RICHARD A. GONZALEZ
· ROBERT A. MICHAEL
· BRIAN L. DURKIN
· ROBERT J. ALPERN, M.D
· ROXANNE S. AUSTIN
· WILLIAM H.L. BURNSIDE
· BRETT J. HART
· EDWARD M. LIDDY
· MELODY B. MEYER
· EDWARD J. RAPP
· REBECCA B. ROBERTS
· GLENN F. TILTON
· FREDERICK H. WADDELL
5. Name of Auditor
· Ernst & Young LLP
6. Main Responsibilities highlighted in Management Report
· Preparation and fair presentation of the financial statements in accordance with GAAP/IFRS.
· Internal Control as management determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
· Assessing the company’s ability to continue as a going concern, and whether the use of the going concern basis of accounting is appropriate, as well as disclosing matters related to going concern.
7. Main components of the Auditor’s report, its type and main reason for its qualification
· Main Components of Auditor’s report – Opinion on Financial Statements, Basis for the opinion, Critical Audit matters, Auditor Signature and Name, Date.
· Type – Unqualified Audit report
· Reason – Audits were conducted in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures to respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
8. Is the company providing GAAP versus Non GAAP view of its financial statements? Why?
    Yes the company is providing GAAP versus Non GAAP view of its financial statements.
This is because GAAP is a standardized set of principles that public companies in US must follow. However, investment research requires an assessment of both GAAP & Non- GAAP results, because there are instances in which GAAP reporting fails to accurately portray the operations of the business. Companies are allowed to display their own accounting figures, as long as they provide reconciliation of Non-GAAP and GAAP results. Non-GAAP figures generally exclude irregular or non-cash expenses or one-time balance sheet adjustments. Such things provide a clearer picture of the on-going business.
9. Materiality of Research and Development Cost (If any) and the effect of such investment.
AbbVie is a pharmaceutical company which expense a lot on its research and development activities and has numerous compounds in clinical development, including potential treatments for complex, life-threatening diseases. AbbVie’s ability to discover and develop new compounds is enhanced by the company’s use of integrated discovery and development project teams, which include chemists, biologists, physicians and pharmacologists who work on the same compounds as a team. AbbVie also partners with third parties, such as biotechnology companies, other pharmaceutical companies and academic institutions to identify and prioritize promising new treatments that complement and enhance AbbVie’s existing portfolio.
In 2019, the company spent $6,407 million dollars on R&D which is 19% of its net revenues.
According to International Standard of Auditing (ISA) 320 Para 10:
“Factors that may indicate the existence of one or more particular classes of transactions, account balances or disclosures for which misstatements of lesser amounts than materiality for the financial statements as a whole could reasonably be expected to influence the economic decisions of users taken on the basis of the financial statements include the following:
· Whether law, regulation or the applicable financial reporting framework affect users’ expectations regarding the measurement or disclosure of certain items (for example, related party transactions, and the remuneration of management and those charged with governance).
· The key disclosures in relation to the industry in which the entity operates (for example, research and development costs for a pharmaceutical company).
· Whether attention is focused on a particular aspect of the entity’s business that is separately disclosed in the financial statements (for example, a newly acquired business).
The impact of such investment is obviously huge on the financial statements of the company, but without expenditure on this area, no new drug or molecule can be studied and no new medicine/vaccine can be made. This area is the most important and critical for AbbVie as the future sales depends majorly on how the drug developed is thoroughly researched and developed by the company.
10. Materiality of Restructuring Cost (If any) and the effect of such investment.
Pharmaceutical companies also spend on acquiring various businesses or collaborating with other companies for drug development.
AbbVie may acquire other businesses, license rights to technologies or products, form alliances, or dispose of assets, which could cause it to incur significant expenses and could negatively affect profitability.
AbbVie continuously evaluates its operations to identify opportunities to optimize its manufacturing and R&D operations, commercial infrastructure and administrative costs and to respond to changes in its business environment. As a result, AbbVie management periodically approves individual restructuring plans to achieve these objectives.
In 2019, $234 million were spent on restructuring costs which turn out to be non-material for the company as its major focus is on new research & development.
11. Assess Going Concern Risk.
In 2019, AbbVie achieved several new product approvals and continued to advance its robust mid-and late-stage pipeline. Collectively, the new medicines that AbbVie has introduced since inception—including new therapies in rheumatoid arthritis, psoriasis, hematologic oncology and hepatitis C virus— represented more than a quarter of AbbVie’s total sales in 2019 and will be important contributors in 2020 and beyond. AbbVie delivered another year of outstanding performance in 2019, which reflects the continued strength of its execution across business priorities.
In June 2019, AbbVie announced that it entered into a definitive transaction agreement under which AbbVie will acquire Allergan plc. (AGN). 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.
With approximately 30 programs in mid and late stage development, AbbVie made significant pipeline advancements in 2019. Also, the internal control systems have been thoroughly verified and it follows all the standards as prescribed which gives suitable impression of going concern.
Keeping in mind the 2019 performance and the management decisions regarding future operations, increased R&D, acquisition of Allergan, it is being decided that the company is a going concern.
12. Assess any other risk factor.
    Below are some other risk factors:
· The expiration or loss of patent protection and licenses may adversely affect AbbVie’s future revenues and operating earnings.
· AbbVie’s major products could lose patent protection earlier than expected, which could adversely affect AbbVie’s future revenues and operating earnings.
· Any significant event that adversely affects HUMIRA revenues could have a material and negative impact on AbbVie’s results of operations and cash flows
· 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 decline.
· 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 suffer.
· 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 operations.
· 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 future.
Although the company has placed and effective internal control and follows standards as prescribed. However a control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
13. Predict business failure:
    Cash Ratios:
    Particulars
    Calculation
    Ratio
    CFO/CL
    13,324/15,585
    0.85
    CFO/TL
    13324/97287
    0.14
    CFO/TA
    13324/89115
    0.15
    C/TA
    39924/89115
    0.45
    CFOIT/INT
    16565/1794
    9.23
    CFO/S
    13324/33266
    0.40
Accrual Ratios:
    
    Particulars
    Calculation
    Ratio
    CA/CL
    49519/15585
    3.18
    NI/TA
    7882/89115
    0.09
    Quick Ratio
    87302/97287
    0.90
    WC/TA
    33934/89115
    0.38
    EBIT/TA
    9935/89115
    0.11
    S/TA
    33266/89115
    0.37
    Ratio Analysis:
· Cash ratios – Most of the Cash flow from operations ratios are not up to the benchmark values such as CFO/CL is at 0.85:1 and CFO/TL being 0.14:1. Such ratios is far below but taken into consideration the nature of the industry, i.e. Pharmaceutical industry in which major part of the cash is capitalized in the form of Research and development expenditure, cash left over is less. However cash flow interest coverage ratio is far more than the favourable benchmark which makes it sufficient to pay its interest obligations.
· Accrual Ratios – Most of the accrual ratios are very favourable for the company with its ability to pay of current liabilities. S/TA ratio is little bit less as a lot of expense goes into R&D which in turn generates income/sales revenue for the company. NI/TA is good as its more than 5% keeping in mind the competition in the pharma market with new technologies coming in every day.
If we combine both the ratios, a favourable position of the company comes into picture with no chance of business failure; however company must work towards generating more cash from the operations so that there is no difficulty in paying to current liabilities and other immediate payments.
Apart from above ratios, R&D/Cash and R&D/TA ratio must also be calculated to check how much expenditure is being done for R&D as its shows whether excess or non-essential expenditure has been done or not.
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 1/104
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 10-K
(MARK ONE)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2019
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transi�on period from to
Commission file number 001-35565
AbbVie Inc.
(Exact name of registrant as specified in its charter)
Delaware 32-0375147
(State or other jurisdic�on of
incorpora�on or organiza�on)
(I.R.S. employer
iden�fica�on number)
1 North Waukegan Road
North Chicago, Illinois 60064-6400
(847) 932-7900
(Address, including zip code, and telephone number of principal execu�ve offices)
Securi�es Registered Pursuant to Sec�on 12(b) of the Act:
Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered
Common Stock, par value $0.01 per share ABBV New York Stock Exchange
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
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securi�es Act.
Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Sec�on 13 or 15(d) of the Act.
Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Sec�on 13 or 15(d) of the Securi�es Exchange Act of 1934 during the preceding 12 months (or for such shorter period that
the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submi�ed electronically every Interac�ve Data File required to be submi�ed pursuant to Rule 405 of Regula�on S-T during the preceding 12 months (or for such
shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller repor�ng company. See the defini�ons of "large accelerated filer," "accelerated filer"
and "smaller repor�ng company" in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer ☒ Accelerated Filer ☐
Non-Accelerated Filer ☐ Smaller repor�ng company ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transi�on period for complying with any new or revised financial accoun�ng standards provided pursuant
to Sec�on 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐ No ☒
The aggregate market value of the 1,462,630,048 shares of vo�ng 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, 2019), was $106,362,457,090. AbbVie has no non-vo�ng common equity.
Number of common shares outstanding as of January 31, 2020: 1,479,156,683
DOCUMENTS INCORPORATED BY REFERENCE
Por�ons of the 2020 AbbVie Inc. Proxy Statement are incorporated by reference into Part III. The Defini�ve Proxy Statement will be filed on or about March 19, 2020.
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 2/104
ABBVIE INC.
FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2019
TABLE OF CONTENTS
Page No.
PART I
Item 1. BUSINESS 1
Item 1A. RISK FACTORS 10
Item 1B. UNRESOLVED STAFF COMMENTS 20
Item 2. PROPERTIES 20
Item 3. LEGAL PROCEEDINGS 20
Item 4. MINE SAFETY DISCLOSURES 20
INFORMATION ABOUT OUR EXECUTIVE OFFICERS 21

PART II
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 23
Item 6. SELECTED FINANCIAL DATA 25
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 26
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 42
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 43
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 91
Item 9A. CONTROLS AND PROCEDURES 91
Item 9B. OTHER INFORMATION 94

PART III
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 95
Item 11. EXECUTIVE COMPENSATION 95
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 96
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 96
Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 96

PART IV
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 97
Item 16. FORM 10-K SUMMARY 101
SIGNATURES 102
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 3/104
PART I
ITEM 1. BUSINESS
Overview
AbbVie(1) is a global, research-based biopharmaceu�cal company. AbbVie develops and markets advanced therapies that address some of the world's most complex and serious diseases. AbbVie's products are
focused on trea�ng condi�ons such as chronic autoimmune diseases in rheumatology, gastroenterology and dermatology; oncology, including blood cancers; virology, including hepa��s C virus (HCV) and human
immunodeficiency virus (HIV); neurological disorders, such as Parkinson's disease; metabolic diseases, including thyroid disease and complica�ons associated with cys�c fibrosis; pain associated with endometriosis; as well
as other serious health condi�ons. AbbVie also has a pipeline of promising new medicines in clinical development across such important medical special�es as immunology, oncology and neuroscience, with addi�onal
targeted investment in cys�c fibrosis and women's health.
In June 2019, AbbVie announced that it entered into a defini�ve transac�on agreement under which AbbVie will acquire Allergan plc (Allergan). Allergan is a global pharmaceu�cal leader focused on developing,
manufacturing and commercializing branded pharmaceu�cal, device, biologic, surgical and regenera�ve medicine products for pa�ents around the world. Allergan markets a por�olio of brands and products primarily
focused on key therapeu�c areas including aesthe�cs, eye care, neuroscience, gastroenterology and women's health. See Note 5 to the Consolidated Financial Statements for addi�onal informa�on regarding the proposed
acquisi�on.
AbbVie was incorporated in Delaware on April 10, 2012. On January 1, 2013, AbbVie became an independent, publicly-traded company as a result of the distribu�on by Abbo� Laboratories (Abbo�) of 100% of the
outstanding common stock of AbbVie to Abbo�'s shareholders.
Segments
AbbVie operates in one business segment—pharmaceu�cal products. See Note 16 to the Consolidated Financial Statements and the sales informa�on related to HUMIRA, IMBRUVICA and MAVYRET included under
Item 7, "Management's Discussion and Analysis of Financial Condi�on and Results of Opera�ons."
Products
AbbVie's por�olio of products includes a broad line of therapies that address some of the world's most complex and serious diseases.
Immunology products. AbbVie maintains an extensive immunology por�olio across rheumatology, dermatology and gastroenterology. AbbVie's immunology products address unmet needs for pa�ents with
autoimmune diseases. These products are:
HUMIRA. HUMIRA (adalimumab) is a biologic therapy administered as a subcutaneous injec�on. It is approved to treat the following autoimmune diseases in the United States, Canada and Mexico (collec�vely,
North America) and in the European Union:
Condi�on Principal Markets
Rheumatoid arthri�s (moderate to severe) North America, European Union
Psoria�c arthri�s North America, European Union
Ankylosing spondyli�s North America, European Union
Adult Crohn's disease (moderate to severe) North America, European Union
Plaque psoriasis (moderate to severe chronic) North America, European Union
Juvenile idiopathic arthri�s (moderate to severe polyar�cular) North America, European Union
Ulcera�ve coli�s (moderate to severe) North America, European Union
Axial spondyloarthropathy European Union
Pediatric Crohn's disease (moderate to severe) North America, European Union
Hidradeni�s Suppura�va (moderate to severe) North America, European Union
Pediatric enthesi�s-related arthri�s European Union
Non-infec�ous intermediate, posterior and panuvei�s North America, European Union
_______________________________________________________________________________
(1) As used throughout the text of this report on Form 10-K, the terms "AbbVie" or "the company" refer to AbbVie Inc., a Delaware corpora�on, or AbbVie Inc. and its consolidated subsidiaries, as the context requires.

2019 Form 10-K | 1
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 4/104
HUMIRA is also approved in Japan for the treatment of intes�nal Behçet's disease.
HUMIRA is sold in numerous other markets worldwide, including Japan, China, Brazil and Australia, and accounted for approximately 58% of AbbVie's total net revenues in 2019.
SKYRIZI. SKYRIZI (risankizumab) is an interleukin-23 (IL-23) inhibitor that selec�vely blocks IL-23 by binding to its p19 subunit. It is a biologic therapy administered as a quarterly subcutaneous injec�on following
an induc�on 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 psoria�c arthri�s in adult pa�ents who have an inadequate response to
conven�onal therapies.
RINVOQ. RINVOQ (upadaci�nib) is a once-daily oral selec�ve 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 ac�ve rheumatoid arthri�s in adult pa�ents who have responded inadequately to, or who are intolerant to one or more disease-modifying an�-rheuma�c drugs (DMARDs). RINVOQ may be used as
monotherapy or in combina�on with methotrexate.
Oncology products. AbbVie’s oncology products target some of the most complex and difficult-to-treat cancers. These products are:
IMBRUVICA. IMBRUVICA (ibru�nib) is an oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). IMBRUVICA was one of the first medicines to receive a United States Food and Drug
Administra�on (FDA) approval a�er being granted a Breakthrough Therapy Designa�on and is one of the few therapies to receive four separate designa�ons. IMBRUVICA currently is approved for the treatment of adult
pa�ents with:
• Chronic lymphocy�c leukemia (CLL)/Small lymphocy�c lymphoma (SLL) and CLL/SLL with 17p dele�on;
• Mantle cell lymphoma (MCL) who have received at least one prior therapy*;
• Waldenström’s macroglobulinemia (WM);
• Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior an�-CD20-based therapy*; and
• Chronic gra� versus host disease (cGVHD) a�er failure of one or more lines of systemic therapy.
_______________________________________________________________________________
* Accelerated approval was granted for this indica�on based on overall response rate. Con�nued approval for this indica�on may be con�ngent upon verifica�on of clinical benefit in confirmatory trials.
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. In addi�on, VENCLEXTA is
approved in combina�on with azaci�dine, 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 condi�ons
that prevent the use of standard chemotherapy. VENCLYXTO is approved in Europe for CLL in combina�on with rituximab in pa�ents who have received at least one previous treatment.
Virology Products. AbbVie's virology products address unmet needs for pa�ents living with HCV and HIV.
HCV products. AbbVie's HCV products are:
MAVYRET/MAVIRET. MAVYRET (glecaprevir/pibrentasvir) is approved in the United States and European Union (MAVIRET) for the treatment of pa�ents with chronic HCV genotype 1-6 infec�on without cirrhosis and
with compensated cirrhosis (Child-Pugh A). It is also indicated for the treatment of adult pa�ents with HCV genotype 1 infec�on, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an
NS3/4A protease inhibitor, but not both. It is an 8-week, pan-genotypic treatment for pa�ents without cirrhosis and following the EXPEDITION-8 study, also in pa�ents with compensated cirrhosis who are new to
treatment. MAVIRET is now also indicated for the treatment of HCV genotypes 1-6 in children between 12-18 years.
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
pa�ents with genotype 1 chronic HCV, including those with compensated cirrhosis. In Europe, VIEKIRA PAK is marketed as VIEKIRAX + EXVIERA and is approved for use in pa�ents with genotype 1 and genotype 4 HCV.
AbbVie's TECHNIVIE (ombitasvir, paritaprevir and
2 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 5/104
ritonavir) is FDA-approved for use in combina�on with ribavirin for the treatment of adults with genotype 4 HCV infec�on in the United States. The use of VIEKIRA in the United States, Europe and Japan is currently
limited given the significant use of pangenotypic regimens, including MAVIRET.
Addi�onal Virology products. AbbVie's addi�onal virology products include:
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 syncy�al virus (RSV).
KALETRA. KALETRA (lopinavir/ritonavir), which is also marketed as ALUVIA in emerging markets, is a prescrip�on an�-HIV-1 medicine that contains two protease inhibitors: lopinavir and ritonavir. KALETRA is used
with other an�-HIV-1 medica�ons as a treatment that maintains viral suppression in people with HIV-1.
Metabolics/Hormones products. Metabolic and hormone products target a number of condi�ons, including testosterone deficiency due to certain underlying condi�ons, exocrine pancrea�c insufficiency and
hypothyroidism. These products include:
CREON. CREON (pancrelipase) is a pancrea�c enzyme therapy for exocrine pancrea�c insufficiency, a condi�on that occurs in pa�ents with cys�c fibrosis, chronic pancrea��s and several other condi�ons.
Synthroid. Synthroid (levothyroxine sodium tablets, USP) is used in the treatment of hypothyroidism.
AndroGel. AndroGel (testosterone gel) is a testosterone replacement therapy for males diagnosed with symptoma�c low testosterone due to certain underlying condi�ons.
AbbVie has the rights to sell AndroGel, CREON and Synthroid only in the United States.
Endocrinology products. Lupron (leuprolide acetate), which is also marketed as Lucrin and LUPRON DEPOT, is a product for the pallia�ve treatment of advanced prostate cancer, treatment of endometriosis and central
precocious puberty and for the preopera�ve treatment of pa�ents with anemia caused by uterine fibroids. Lupron is approved for daily subcutaneous injec�on and one-month, three-month, four-month and six-month
intramuscular injec�on.
Other products. AbbVie's other products include:
ORILISSA. ORILISSA (elagolix) is the first and only orally-administered, nonpep�de small molecule gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe
endometriosis pain. The FDA approved ORILISSA under priority review. It represents the first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a
decade. ORILISSA inhibits endogenous GnRH signaling by binding compe��vely to GnRH receptors in the pituitary gland. Administra�on results in dose-dependent suppression of luteinizing hormone and follicle-
s�mula�ng hormone, leading to decreased blood concentra�ons of ovarian sex hormones, estradiol and progesterone. Outside the United States, ORILISSA is also launched in Canada and Puerto Rico.
Duopa and Duodopa (carbidopa and levodopa). AbbVie's levodopa-carbidopa intes�nal gel for the treatment of advanced Parkinson's disease is marketed as Duopa in the United States and as Duodopa outside of
the United States.
Sevoflurane. Sevoflurane (sold under the trademarks Ultane and Sevorane) is an anesthesia product that AbbVie sells worldwide for human use.
Marke�ng, Sales and Distribu�on Capabili�es
AbbVie u�lizes a combina�on of dedicated commercial resources, regional commercial resources and distributorships to market, sell and distribute its products worldwide. AbbVie directs its primary marke�ng efforts
toward securing the prescrip�on, or recommenda�on, of its brand of products by physicians, key opinion leaders and other health care providers. Managed care providers (for example, health maintenance organiza�ons
and pharmacy benefit managers), hospitals and state and federal government agencies (for example, the United States Department of Veterans Affairs and the United States Department of Defense) are also important
customers. AbbVie also markets directly to consumers themselves, although in the United States all of the company's products must be sold pursuant to a prescrip�on. Outside of the United States, AbbVie focuses its
marke�ng efforts on key opinion leaders, payers, physicians and country regulatory bodies. AbbVie also provides pa�ent support programs closely related to its products.
AbbVie's products are generally sold worldwide directly to wholesalers, distributors, government agencies, health care facili�es, specialty pharmacies and independent retailers from AbbVie-owned distribu�on
centers and public warehouses. Although AbbVie's business does not have significant seasonality, AbbVie's product revenues may be affected by end customer and retail buying pa�erns, fluctua�ons in wholesaler inventory
levels and other factors.

2019 Form 10-K | 3
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 6/104
In the United States, AbbVie distributes pharmaceu�cal products principally through independent wholesale distributors, with some sales directly to pharmacies and pa�ents. In 2019, three wholesale distributors
(McKesson Corpora�on, Cardinal Health, Inc. and AmerisourceBergen Corpora�on) accounted for substan�ally all of AbbVie's sales in the United States. No individual wholesaler accounted for greater than 42% of AbbVie's
2019 gross revenues in the United States. Outside the United States, AbbVie sells products primarily to customers or through distributors, depending on the market served. These wholesalers purchase product from AbbVie
under standard terms and condi�ons of sale.
Certain products are co-marketed or co-promoted with other companies. AbbVie has no single customer that, if the customer were lost, would have a material adverse effect on the company's business. No material
por�on of AbbVie's business is subject to renego�a�on of profits or termina�on of contracts at the elec�on of the government. Orders are generally filled on a current basis and order backlog is not material to AbbVie's
business.
Compe��on
The markets for AbbVie's products are highly compe��ve. AbbVie competes with other research-based pharmaceu�cals and biotechnology companies that discover, manufacture, market and sell proprietary
pharmaceu�cal products and biologics. For example, HUMIRA competes with an�-TNF products and other compe��ve products intended to treat a number of disease states and AbbVie's virology products compete with
other available HCV treatment op�ons. The search for technological innova�ons in pharmaceu�cal products is a significant aspect of compe��on. The introduc�on of new products by compe�tors and changes in medical
prac�ces and procedures can result in product obsolescence. Price is also a compe��ve factor. In addi�on, the subs�tu�on of generic pharmaceu�cal products for branded pharmaceu�cal products creates compe��ve
pressures on AbbVie's products that do not have patent protec�on. New products or treatments brought to market by AbbVie’s compe�tors could cause revenues for AbbVie’s products to decrease due to price reduc�ons
and sales volume decreases.
Biosimilars. Compe��on for AbbVie’s biologic products is affected by the approval of follow-on biologics, also known as “biosimilars.” Biologics have added major therapeu�c op�ons for the treatment of many
diseases, including some for which therapies were unavailable or inadequate. The cost of developing and producing biologic therapies is typically drama�cally higher than for conven�onal (small molecule) medica�ons, and
many biologic medica�ons are used for ongoing treatment of chronic diseases, such as rheumatoid arthri�s or inflammatory bowel disease, or for the treatment of previously untreatable cancer. Significant investments in
biologics infrastructure and manufacturing are necessary to produce biologic products.
HUMIRA is now facing direct biosimilar compe��on in Europe and other countries, and AbbVie will con�nue to face compe��ve pressure from these biologics and from orally administered products.
In the United States, the FDA regulates biologics under the Federal Food, Drug and Cosme�c Act, the Public Health Service Act and implemen�ng regula�ons. The enactment of federal health care reform legisla�on in
March 2010 provided a pathway for approval of biosimilars under the Public Health Service Act, but the approval process for, and science behind, biosimilars is complex. Approval by the FDA is dependent upon many
factors, including a showing that the biosimilar is "highly similar" to the original product and has no clinically meaningful differences from the original product in terms of safety, purity and potency. The types of data that
could ordinarily be required in an applica�on to show similarity may include analy�cal data, bioequivalence studies and studies to demonstrate chemical similarity, animal studies (including toxicity studies) and clinical
studies.
Furthermore, the law provides that only a biosimilar product that is determined to be "interchangeable" will be considered subs�tutable for the original biologic product without the interven�on of the health care
provider who prescribed the original biologic product. To prove that a biosimilar product is interchangeable, the applicant must demonstrate that the product can be expected to produce the same clinical results as the
original biologic product in any given pa�ent, and if the product is administered more than once in a pa�ent, that safety risks and poten�al for diminished efficacy of alterna�ng or switching between the use of the
interchangeable biosimilar biologic product and the original biologic product is no greater than the risk of using the original biologic product without switching. The law con�nues to be interpreted and implemented by the
FDA. As a result, its ul�mate impact, implementa�on and meaning remains subject to substan�al uncertainty.
Intellectual Property Protec�on and Regulatory Exclusivity
Generally, upon approval, products may be en�tled to certain kinds of exclusivity under applicable intellectual property and regulatory regimes. AbbVie’s intellectual property is materially valuable to the company, and
AbbVie seeks patent protec�on, where available, in all significant markets and/or countries for each product in development. In the United States, the expira�on date for patents is 20 years a�er the filing date. Given that
patents rela�ng to pharmaceu�cal products are o�en obtained early in the development process and given the amount of �me needed to complete clinical trials and other development ac�vi�es required for regulatory
approval, the length of �me between product launch and patent expira�on is significantly less than 20 years. The Drug Price Compe��on and Patent Term Restora�on Act of 1984 (commonly known as the Hatch-Waxman
Act) permits a patent holder to seek a patent extension, commonly called a “patent term restora�on,” for
4 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 7/104
patents on products (or processes for making the product) regulated by the Federal Food, Drug, and Cosme�c Act. The length of the patent extension is roughly based on 50 percent of the period of �me from the filing of
an Inves�ga�onal New Drug Applica�on (NDA) for a compound to the submission of the NDA for such compound, plus 100 percent of the �me period from NDA submission to regulatory approval. The extension, however,
cannot exceed five years and the patent term remaining a�er regulatory approval cannot exceed 14 years. Biological products licensed under the Public Health Service Act are similarly eligible for terms of patent
restora�on.
Pharmaceu�cal products may be en�tled to other forms of legal or regulatory exclusivity upon approval. The scope, length, and requirements for each of these exclusivi�es vary both in the United States and in other
jurisdic�ons. In the United States, if the FDA approves a drug product that contains an ac�ve ingredient not previously approved, the product is typically en�tled to five years of non-patent regulatory exclusivity. Other
products may be en�tled to three years of exclusivity if approval was based on the FDA’s reliance on new clinical studies essen�al to approval submi�ed by the NDA applicant. If the NDA applicant studies the product for use
by children, the FDA may grant pediatric exclusivity, which extends by 180 days all exis�ng exclusivi�es (patent and regulatory) related to the product. For products that are either used to treat condi�ons that afflict a
rela�vely small popula�on or for which there is not a reasonable expecta�on that the research and development costs will be recovered, the FDA may designate the pharmaceu�cal as an orphan drug and grant it seven
years of market exclusivity.
Applicable laws and regula�ons dictate the scope of any exclusivity to which a product or par�cular characteris�cs of a product is en�tled upon approval in any par�cular country. In certain instances, regulatory
exclusivity may offer protec�on where patent protec�on is no longer available or for a period of �me in excess of patent protec�on. It is not possible to es�mate for each product in development the total period and scope
of exclusivity to which it may become en�tled un�l regulatory approval is obtained. However, given the length of �me required to complete clinical development of a pharmaceu�cal product, the periods of exclusivity that
might be achieved in any individual case would not be expected to exceed a minimum of three years and a maximum of 14 years. These es�mates do not consider other factors, such as the difficulty of recrea�ng the
manufacturing process for a par�cular product or other proprietary knowledge that may delay the introduc�on of a generic or other follow-on product a�er the expira�on of applicable patent and other regulatory
exclusivity periods.
Biologics may be en�tled to exclusivity under the Biologics Price Compe��on and Innova�on Act, which was passed on March 23, 2010 as Title VII to the Pa�ent Protec�on and Affordable Care Act. The law provides a
pathway for approval of biosimilars following the expira�on of 12 years of regulatory exclusivity for the innovator biologic and a poten�al addi�onal 180 day-extension term for conduc�ng pediatric studies. Biologics are
also eligible for orphan drug exclusivity, as discussed above. The law also includes an extensive process for the innovator biologic and biosimilar manufacturer to li�gate patent infringement, validity, and enforceability. The
European Union has also created a pathway for approval of biosimilars and has published guidelines for approval of certain biosimilar products. The more complex nature of biologics and biosimilar products has led to close
regulatory scru�ny over follow-on biosimilar products, which can reduce the effect of biosimilars on sales of the innovator biologic as compared to the sales erosion caused by generic versions of small molecule
pharmaceu�cal products.
AbbVie owns or has licensed rights to a substan�al number of patents and patent applica�ons. AbbVie licenses or owns a patent por�olio of thousands of patent families, each of which includes United States patent
applica�ons and/or issued patents and may also contain the non-United States counterparts to these patents and applica�ons.
These patents and applica�ons, including various patents that expire during the period 2020 to the late 2030s, in aggregate are believed to be of material importance in the opera�on of AbbVie’s business. However,
AbbVie believes that no single patent, license, trademark (or related group of patents, licenses, or trademarks), except for those related to adalimumab (which is sold under the trademark HUMIRA), are material in rela�on
to the company’s business as a whole. The United States composi�on of ma�er (that is, compound) patent covering adalimumab expired in December 2016, and the equivalent European Union patent expired in October
2018 in the majority of European Union countries. In the United States, non-composi�on of ma�er patents covering adalimumab expire no earlier than 2022. AbbVie has entered into se�lement 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.
In addi�on, the following patents, licenses, and trademarks are significant: those related to ibru�nib (which is sold under the trademark IMBRUVICA) and those related to glecaprevir and pibrentasvir (which are sold
under the trademarks MAVYRET and MAVIRET). The United States composi�on of ma�er patent covering ibru�nib is expected to expire in 2027. The United States composi�on of ma�er patents covering glecaprevir and
pibrentasvir are expected to expire in 2032.
AbbVie may rely, in some circumstances, on trade secrets to protect its technology. However, trade secrets are difficult to protect. AbbVie seeks to protect its technology and product candidates, in part, by
confiden�ality agreements with its employees, consultants, advisors, contractors, and collaborators. These agreements may be breached and AbbVie may not have adequate remedies for any breach. In addi�on, AbbVie’s
trade secrets may otherwise become known or be independently

2019 Form 10-K | 5
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 8/104
discovered by compe�tors. To the extent that AbbVie’s employees, consultants, advisors, contractors, and collaborators use intellectual property owned by others in their work for the company, disputes may arise as to the
rights in related or resul�ng know-how and inven�ons.
Licensing, Acquisi�ons and Other Arrangements
In addi�on to its independent efforts to develop and market products, AbbVie enters into arrangements such as acquisi�ons, op�on-to-acquire agreements, licensing arrangements, op�on-to-license arrangements,
strategic alliances, co-promo�on arrangements, co-development and co-marke�ng agreements, and joint ventures. The acquisi�ons and op�on-to-acquire agreements typically include, among other terms and condi�ons,
non-refundable purchase price payments or op�on fees, op�on exercise payments, milestones or earn-outs, and other customary terms and obliga�ons. The licensing and other arrangements typically include, among other
terms and condi�ons, non-refundable upfront license fees, op�on fees and op�on exercise payments, milestone payments and royalty and/or profit sharing obliga�ons. See Note 5, "Licensing, Acquisi�ons and Other
Arrangements—Other Licensing & Acquisi�ons Ac�vity," to the Consolidated Financial Statements included under Item 8, "Financial Statements and Supplementary Data."
Third Party Agreements
AbbVie has agreements with third par�es for process development, product distribu�on, analy�cal services and manufacturing of certain products. AbbVie procures certain products and services from a limited
number of suppliers and, in some cases, a single supply source. In addi�on, AbbVie has agreements with third par�es for ac�ve pharmaceu�cal ingredient and product manufacturing, formula�on and development
services, fill, finish and packaging services, transporta�on and distribu�on and logis�cs services for certain products. AbbVie does not believe that these manufacturing related agreements are material because AbbVie's
business is not substan�ally dependent on any individual agreement. In most cases, AbbVie maintains alternate supply rela�onships that it can u�lize without undue disrup�on of its manufacturing processes if a third party
fails to perform its contractual obliga�ons. AbbVie also maintains sufficient inventory of product to minimize the impact of any supply disrup�on.
AbbVie is also party to certain collabora�ons and other arrangements, as discussed in Note 5, "Licensing, Acquisi�ons and Other Arrangements—Other Licensing & Acquisi�ons Ac�vity," to the Consolidated Financial
Statements included under Item 8, "Financial Statements and Supplementary Data."
Sources and Availability of Raw Materials
AbbVie purchases, in the ordinary course of business, raw materials and supplies essen�al to its opera�ons from numerous suppliers around the world. In addi�on, certain medical devices and components necessary
for the manufacture of AbbVie products are provided by unaffiliated third party suppliers. AbbVie has not experienced any recent significant availability problems or supply shortages that impacted fulfillment of product
demand.
Research and Development Ac�vi�es
AbbVie makes a significant investment in research and development and has numerous compounds in clinical development, including poten�al treatments for complex, life-threatening diseases. AbbVie's ability to
discover and develop new compounds is enhanced by the company's use of integrated discovery and development project teams, which include chemists, biologists, physicians and pharmacologists who work on the same
compounds as a team. AbbVie also partners with third par�es, such as biotechnology companies, other pharmaceu�cal companies and academic ins�tu�ons to iden�fy and priori�ze promising new treatments that
complement and enhance AbbVie’s exis�ng por�olio.
The research and development process generally begins with discovery research which focuses on the iden�fica�on of a molecule that has a desired effect against a given disease. If preclinical tes�ng of an iden�fied
compound proves successful, the compound moves into clinical development which generally includes the following phases:
• Phase 1—involves the first human tests in a small number of healthy volunteers or pa�ents to assess safety, tolerability and poten�al dosing.
• Phase 2—tests the drug's efficacy against the disease in a rela�vely small group of pa�ents.
• Phase 3—tests a drug that demonstrates favorable results in the earlier phases in a significantly larger pa�ent popula�on to further demonstrate efficacy and safety based on regulatory criteria.
The clinical trials from all of the development phases provide the data required to prepare and submit an NDA, a Biological License Applica�on (BLA) or other submission for regulatory approval to the FDA or similar
government agencies outside the United States. The specific requirements (e.g., scope of clinical trials) for obtaining regulatory approval vary across different countries and geographic regions.
6 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 9/104
The research and development process from discovery through a new drug launch typically takes 8 to 12 years and can be even longer. The research and development of new pharmaceu�cal products has a significant
amount of inherent uncertainty. There is no guarantee when, or if, a molecule will receive the regulatory approval required to launch a new drug or indica�on.
In addi�on to the development of new products and new formula�ons, research and development projects also may include Phase 4 trials, some�mes called post-marke�ng studies. For such projects, clinical trials are
designed and conducted to collect addi�onal data regarding, among other parameters, the benefits and risks of an approved drug.
Regula�on—Discovery and Clinical Development
United States. Securing approval to market a new pharmaceu�cal product in the United States requires substan�al effort and financial resources and takes several years to complete. The applicant must complete
preclinical tests and submit protocols to the FDA before commencing clinical trials. Clinical trials are intended to establish the safety and efficacy of the pharmaceu�cal product and typically are conducted in sequen�al
phases, although the phases may overlap or be combined. If the required clinical tes�ng is successful, the results are submi�ed to the FDA in the form of an NDA or BLA reques�ng approval to market the product for one or
more indica�ons. The FDA reviews an NDA or BLA to determine whether a product is safe and effec�ve for its intended use and whether its manufacturing is compliant with current Good Manufacturing Prac�ces (cGMP).
Even if an NDA or a BLA receives approval, the applicant must comply with post-approval requirements. For example, holders of an approval must report adverse reac�ons, provide updated safety and efficacy
informa�on and comply with requirements concerning adver�sing and promo�onal materials and ac�vi�es. Also, quality control and manufacturing procedures must con�nue to conform to cGMP a�er approval, and
certain changes to the manufacturing procedures and finished product must be included in the NDA or BLA and approved by the FDA prior to implementa�on. The FDA periodically inspects manufacturing facili�es to assess
compliance with cGMP, which imposes extensive procedural and record keeping requirements. In addi�on, as a condi�on of approval, the FDA may require post-marke�ng tes�ng and surveillance to further assess and
monitor the product's safety or efficacy a�er commercializa�on, which may require addi�onal clinical trials, pa�ent registries, observa�onal data or addi�onal work on chemistry, manufacturing and controls. Any post-
approval regulatory obliga�ons, and the cost of complying with such obliga�ons, could expand in the future.
Outside the United States. AbbVie is subject to similar regulatory requirements outside the United States for approval and marke�ng of pharmaceu�cal products. AbbVie must obtain approval of a clinical trial
applica�on or product from the applicable regulatory authori�es before it can commence clinical trials or marke�ng of the product. The approval requirements and process for each country can vary, and the �me required
to obtain approval may be longer or shorter than that required for FDA approval in the United States. For example, AbbVie may submit marke�ng authoriza�ons in the European Union under either a centralized or
decentralized procedure. The centralized procedure is mandatory for the approval of biotechnology products and many pharmaceu�cal products and provides for a single marke�ng authoriza�on that is valid for all
European Union member states. Under the centralized procedure, a single marke�ng authoriza�on applica�on is submi�ed to the European Medicines Agency (EMA). A�er the agency evaluates the applica�on, it makes a
recommenda�on to the European Commission, which then makes the final determina�on on whether to approve the applica�on. The decentralized procedure provides for mutual recogni�on of individual na�onal approval
decisions and is available for products that are not subject to the centralized procedure.
In Japan, applica�ons for approval of a new product are made through the Pharmaceu�cal and Medical Devices Agency (PMDA). Bridging studies to demonstrate that the non-Japanese clinical data applies to Japanese
pa�ents may be required. A�er comple�ng a comprehensive review, the PMDA reports to the Ministry of Health, Labour and Welfare, which then approves or denies the applica�on.
The regulatory process in many emerging markets con�nues to evolve. Many emerging markets, including those in Asia, generally require regulatory approval to have been obtained in a large developed market (such
as the United States or Europe) before the country will begin or complete its regulatory review process. Some countries also require that local clinical studies be conducted in order to obtain regulatory approval in the
country.
The requirements governing the conduct of clinical trials and product licensing also vary. In addi�on, post-approval regulatory obliga�ons such as adverse event repor�ng and cGMP compliance generally apply and
may vary by country. For example, a�er a marke�ng authoriza�on has been granted in the European Union, periodic safety reports must be submi�ed and other pharmacovigilance measures may be required (such as Risk
Management Plans).
Regula�on—Commercializa�on, Distribu�on and Manufacturing
The manufacture, marke�ng, sale, promo�on and distribu�on of AbbVie's products are subject to comprehensive government regula�on. Government regula�on by various na�onal, regional, federal, state and local
agencies, both in the United States and other countries, addresses (among other ma�ers) inspec�on of, and controls over, research and laboratory

2019 Form 10-K | 7
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 10/104
procedures, clinical inves�ga�ons, product approvals and manufacturing, labeling, packaging, marke�ng and promo�on, pricing and reimbursement, sampling, distribu�on, quality control, post-marke�ng surveillance,
record keeping, storage and disposal prac�ces. AbbVie's opera�ons are also affected by trade regula�ons in many countries that limit the import of raw materials and finished products and by laws and regula�ons that seek
to prevent corrup�on and bribery in the marketplace (including the United States Foreign Corrupt Prac�ces Act and the United Kingdom Bribery Act, which provide guidance on corporate interac�ons with government
officials) and require safeguards for the protec�on of personal data. In addi�on, AbbVie is subject to laws and regula�ons pertaining to health care fraud and abuse, including state and federal an�-kickback and false claims
laws in the United States. Prescrip�on drug manufacturers such as AbbVie are also subject to taxes, as well as applica�on, product, user and other fees.
Compliance with these laws and regula�ons is costly and materially affects AbbVie's business. Among other effects, health care regula�ons substan�ally increase the �me, difficulty and costs incurred in obtaining and
maintaining approval to market newly developed and exis�ng products. AbbVie expects compliance with these regula�ons to con�nue to require significant technical exper�se and capital investment to ensure compliance.
Failure to comply can delay the release of a new product or result in regulatory and enforcement ac�ons, the seizure or recall of a product, the suspension or revoca�on of the authority necessary for a product's produc�on
and sale and other civil or criminal sanc�ons, including fines and penal�es.
In addi�on to regulatory ini�a�ves, AbbVie's business can be affected by ongoing studies of the u�liza�on, safety, efficacy and outcomes of health care products and their components that are regularly conducted by
industry par�cipants, government agencies and others. These studies can call into ques�on the u�liza�on, safety and efficacy of previously marketed products. In some cases, these studies have resulted, and may in the
future result, in the discon�nuance of, or limita�ons on, marke�ng of such products domes�cally or worldwide, and may give rise to claims for damages from persons who believe they have been injured as a result of their
use.
Access to human health care products con�nues to be a subject of oversight, inves�ga�on and ac�on by governmental agencies, legisla�ve bodies and private organiza�ons in the United States and other countries. A
major focus is cost containment. Efforts to reduce health care costs are also being made in the private sector, notably by health care payers and providers, which have ins�tuted various cost reduc�on and containment
measures. AbbVie expects insurers and providers to con�nue a�empts to reduce the cost of health care products. Outside the United States, many countries control the price of health care products directly or indirectly,
through reimbursement, payment, pricing, coverage limita�ons, or compulsory licensing. Poli�cal and budgetary pressures in the United States and in other countries may also heighten the scope and severity of pricing
pressures on AbbVie's products for the foreseeable future.
United States. Specifically, U.S. federal laws require pharmaceu�cal manufacturers to pay certain statutorily-prescribed rebates to state Medicaid programs on prescrip�on drugs reimbursed under state Medicaid
plans, and the efforts by states to seek addi�onal rebates affect AbbVie's business. Similarly, the Veterans Health Care Act of 1992, as a prerequisite to par�cipa�on in Medicaid and other federal health care programs,
requires that manufacturers extend addi�onal discounts on pharmaceu�cal products to various federal agencies, including the United States Department of Veterans Affairs, Department of Defense and Public Health
Service en��es and ins�tu�ons. In addi�on, recent legisla�ve changes would require similarly discounted prices to be offered to TRICARE program beneficiaries. The Veterans Health Care Act of 1992 also established the
340B drug discount program, which requires pharmaceu�cal manufacturers to provide products at reduced prices to various designated health care en��es and facili�es.
In the United States, most states also have generic subs�tu�on legisla�on requiring or permi�ng a dispensing pharmacist to subs�tute a different manufacturer's generic version of a pharmaceu�cal product for the
one prescribed. In addi�on, the federal government follows a diagnosis-related group (DRG) payment system for certain ins�tu�onal services provided under Medicare or Medicaid and has implemented a prospec�ve
payment system (PPS) for services delivered in hospital outpa�ent, nursing home and home health se�ngs. DRG and PPS en�tle a health care facility to a fixed reimbursement based on the diagnosis and/or procedure
rather than actual costs incurred in pa�ent treatment, thereby increasing the incen�ve for the facility to limit or control expenditures for many health care products. Medicare reimburses Part B drugs based on average sales
price plus a certain percentage to account for physician administra�on costs, which have been reduced in the hospital outpa�ent se�ng. Medicare enters into contracts with private plans to nego�ate prices for most
pa�ent-administered medicine delivered under Part D.
Under the Pa�ent Protec�on and Affordable Care Act and the Health Care and Educa�on Reconcilia�on Act (together, the Affordable Care Act), AbbVie pays a fee related to its pharmaceu�cals sales to government
programs. In addi�on, AbbVie provides a discount of 50% for branded prescrip�on drugs sold to pa�ents who fall into the Medicare Part D coverage gap, or "donut hole."
The Affordable Care Act also includes provisions known as the Physician Payments Sunshine Act, which require manufacturers of drugs and biologics covered under Medicare and Medicaid to record any transfers of
value to physicians and
8 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 11/104
teaching hospitals and to report this data to the Centers for Medicare and Medicaid Services for subsequent public disclosure. Similar repor�ng requirements have also been enacted on the state level in the United States,
and an increasing number of countries worldwide either have adopted or are considering similar laws requiring disclosure of interac�ons with health care professionals. Failure to report appropriate data may result in civil
or criminal fines and/or penal�es.
AbbVie expects debate to con�nue during 2020 at all government levels worldwide over the marke�ng, availability, method of delivery and payment for health care products and services. AbbVie believes that future
legisla�on and regula�on in the markets it serves could affect access to health care products and services, increase rebates, reduce prices or the rate of price increases for health care products and services, change health
care delivery systems, create new fees and obliga�ons for the pharmaceu�cals industry, or require addi�onal repor�ng and disclosure. It is not possible to predict the extent to which AbbVie or the health care industry in
general might be affected by the ma�ers discussed above.
European Union. The European Union has adopted direc�ves and other legisla�on governing labeling, adver�sing, distribu�on, supply, pharmacovigilance and marke�ng of pharmaceu�cal products. Such legisla�on
provides mandatory standards throughout the European Union and permits member states to supplement these standards with addi�onal regula�ons. European governments also regulate pharmaceu�cal product prices
through their control of na�onal health care systems that fund a large part of the cost of such products to consumers. As a result, pa�ents are unlikely to use a pharmaceu�cal product that is not reimbursed by the
government. In many European countries, the government either regulates the pricing of a new product at launch or subsequent to launch through direct price controls or reference pricing. In recent years, many countries
have also imposed new or addi�onal cost containment measures on pharmaceu�cal products. Differences between na�onal pricing regimes create price differen�als within the European Union that can lead to significant
parallel trade in pharmaceu�cal products.
Most governments also promote generic subs�tu�on by manda�ng or permi�ng a pharmacist to subs�tute a different manufacturer's generic version of a pharmaceu�cal product for the one prescribed and by
permi�ng or manda�ng that health care professionals prescribe generic versions in certain circumstances. Many governments are also following a similar path for biosimilar therapies. In addi�on, governments use
reimbursement lists to limit the pharmaceu�cal products that are eligible for reimbursement by na�onal health care systems.
Japan. In Japan, the Na�onal Health Insurance system maintains a Drug Price List specifying which pharmaceu�cal products are eligible for reimbursement, and the Ministry of Health, Labour and Welfare sets the
prices of the products on this list. The government generally introduces price cut rounds every other year and also mandates price decreases for specific products. New products judged innova�ve or useful, that are
indicated for pediatric use, or that target orphan or small popula�on diseases, however, may be eligible for a pricing premium. The government has also promoted the use of generics, where available.
Emerging Markets. Many emerging markets take steps to reduce pharmaceu�cal product prices, in some cases through direct price controls and in others through the promo�on of generic/biosimilar alterna�ves to
branded pharmaceu�cals.
Since AbbVie markets its products worldwide, certain products of a local nature and varia�ons of product lines must also meet other local regulatory requirements. Certain addi�onal risks are inherent in conduc�ng
business outside the United States, including price and currency exchange controls, changes in currency exchange rates, limita�ons on par�cipa�on in local enterprises, expropria�on, na�onaliza�on and other
governmental ac�on.
Environmental Ma�ers
AbbVie believes that its opera�ons comply in all material respects with applicable laws and regula�ons concerning environmental protec�on. Regula�ons under federal and state environmental laws impose stringent
limita�ons on emissions and discharges to the environment from various manufacturing opera�ons. AbbVie's capital expenditures for pollu�on control in 2019 were approximately $29 million and opera�ng expenditures
were approximately $34 million. In 2020, capital expenditures for pollu�on control are es�mated to be approximately $5 million and opera�ng expenditures are es�mated to be approximately $35 million.
Abbo� was iden�fied as one of many poten�ally responsible par�es in inves�ga�ons and/or remedia�ons at several loca�ons in the United States, including Puerto Rico, under the Comprehensive Environmental
Response, Compensa�on and Liability Act, commonly known as Superfund. Some of these loca�ons were transferred to AbbVie in connec�on with the separa�on and distribu�on, and AbbVie has become a party to these
inves�ga�ons and remedia�ons. Abbo� was also engaged in remedia�on at several other sites, some of which have been transferred to AbbVie in connec�on with the separa�on and distribu�on, in coopera�on with the
Environmental Protec�on Agency or similar agencies. While it is not feasible to predict with certainty the final costs related to those inves�ga�ons and remedia�on ac�vi�es, AbbVie believes that such costs, together with
other expenditures to maintain compliance with applicable laws and regula�ons concerning environmental protec�on, should not have a material adverse effect on the company's financial posi�on, cash flows, or results of
opera�ons.

2019 Form 10-K | 9
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 12/104
Employees
AbbVie employed approximately 30,000 persons as of January 31, 2020. Outside the United States, some of AbbVie's employees are represented by unions or works councils. AbbVie believes that it has good rela�ons
with its employees.
Internet Informa�on
Copies of AbbVie's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Sec�on 13(a) or 15(d) of the Securi�es
Exchange Act of 1934 are available free of charge through AbbVie's investor rela�ons website (www.abbvieinvestor.com) as soon as reasonably prac�cable a�er AbbVie electronically files the material with, or furnishes it to,
the Securi�es and Exchange Commission (SEC).
AbbVie's corporate governance guidelines, outline of directorship qualifica�ons, code of business conduct and the charters of AbbVie's audit commi�ee, compensa�on commi�ee, nomina�ons and governance
commi�ee and public policy commi�ee are all available on AbbVie's investor rela�ons website (www.abbvieinvestor.com).
ITEM 1A. RISK FACTORS
You should carefully consider the following risks and other informa�on in this Form 10-K in evalua�ng AbbVie and AbbVie's common stock. Any of the following risks could materially and adversely affect AbbVie's
results of opera�ons, financial condi�on or cash flows. The risk factors generally have been separated into three groups: risks related to AbbVie's business, risks related to AbbVie's proposed acquisi�on of Allergan (the
"Acquisi�on") and the combined company upon comple�on of the Acquisi�on, and risks related to AbbVie's common stock. Based on the informa�on currently known to it, AbbVie believes that the following informa�on
iden�fies the most significant risk factors affec�ng it in each of these categories of risks. However, the risks and uncertain�es AbbVie faces are not limited to those set forth in the risk factors described below and may not be
in order of importance or probability of occurrence. Addi�onal risks and uncertain�es not presently known to AbbVie or that AbbVie currently believes to be immaterial may also adversely affect its business. In addi�on, past
financial performance may not be a reliable indicator of future performance and historical trends should not be used to an�cipate results or trends in future periods.
If any of the following risks and uncertain�es develops into actual events, these events could have a material adverse effect on AbbVie's business, results of opera�ons, financial condi�on or cash flows. In such case, the
trading price of AbbVie's common stock could decline.
Risks Related to AbbVie's Business
The expira�on or loss of patent protec�on and licenses may adversely affect AbbVie's future revenues and opera�ng earnings.
AbbVie relies on patent, trademark and other intellectual property protec�on in the discovery, development, manufacturing and sale of its products. In par�cular, patent protec�on is, in the aggregate, important in
AbbVie's marke�ng of pharmaceu�cal products in the United States and most major markets outside of the United States. Patents covering AbbVie products normally provide market exclusivity, which is important for the
profitability of many of AbbVie's products.
As patents for certain of its products expire, AbbVie will or could face compe��on from lower priced generic or biosimilar products. The expira�on or loss of patent protec�on for a product typically is followed
promptly by subs�tutes that may significantly reduce sales for that product in a short amount of �me. If AbbVie's compe��ve posi�on is compromised because of generics, biosimilars or otherwise, it could have a material
adverse effect on AbbVie's business and results of opera�ons. In addi�on, proposals emerge from �me to �me for legisla�on to further encourage the early and rapid approval of generic drugs or biosimilars. Any such
proposals that are enacted into law could increase the impact of generic compe��on.
AbbVie's principal patents and trademarks are described in greater detail in Item 1, "Business—Intellectual Property Protec�on and Regulatory Exclusivity" and Item 7, "Management's Discussion and Analysis of
Financial Condi�on and Results of Opera�ons—Results of Opera�ons," and li�ga�on regarding these patents is described in Item 3, "Legal Proceedings." The United States composi�on of ma�er patent for HUMIRA, which is
AbbVie's largest product and had worldwide net revenues of approximately $19.2 billion in 2019, expired in December 2016, and the equivalent European Union patent expired in the majority of European Union countries
in October 2018.
10 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 13/104
AbbVie's major products could lose patent protec�on earlier than expected, which could adversely affect AbbVie's future revenues and opera�ng earnings.
Third par�es or government authori�es may challenge or seek to invalidate or circumvent AbbVie's patents and patent applica�ons. For example, manufacturers of generic pharmaceu�cal products file, and may
con�nue to file, Abbreviated New Drug Applica�ons with the FDA seeking to market generic forms of AbbVie's products prior to the expira�on of relevant patents owned or licensed by AbbVie by asser�ng that the patents
are invalid, unenforceable and/or not infringed. In addi�on, pe��oners have filed, and may con�nue to file, challenges to the validity of AbbVie patents under the 2011 Leahy-Smith America Invents Act, which created inter
partes review and post grant review procedures for challenging patent validity in administra�ve proceedings at the United States Patent and Trademark Office.
Although most of the challenges to AbbVie's intellectual property have come from other businesses, governments may also challenge intellectual property rights. For example, court decisions and poten�al legisla�on
rela�ng to patents, such as legisla�on regarding biosimilars, and other regulatory ini�a�ves may result in further erosion of intellectual property protec�on. In addi�on, certain governments outside the United States have
indicated that compulsory licenses to patents may be sought to further their domes�c policies or on the basis of na�onal emergencies, such as HIV/AIDS. If triggered, compulsory licenses could diminish or eliminate sales
and profits from those jurisdic�ons and nega�vely affect AbbVie's results of opera�ons.
AbbVie normally responds to challenges by vigorously defending its patents, including by filing patent infringement lawsuits. Patent li�ga�on, administra�ve proceedings and other challenges to AbbVie's patents are
costly and unpredictable and may deprive AbbVie of market exclusivity for a patented product. To the extent AbbVie's intellectual property is successfully challenged, circumvented or weakened, or to the extent such
intellectual property does not allow AbbVie to compete effec�vely, AbbVie's business will suffer. To the extent that countries do not enforce AbbVie's intellectual property rights or require compulsory licensing of AbbVie's
intellectual property, AbbVie's future revenues and opera�ng earnings will be reduced.

A third party's intellectual property may prevent AbbVie from selling its products or have a material adverse effect on AbbVie's future profitability and financial condi�on.
Third par�es may claim that an AbbVie product infringes upon their intellectual property. Resolving an intellectual property infringement claim can be costly and �me consuming and may require AbbVie to enter into
license agreements. AbbVie cannot guarantee that it would be able to obtain license agreements on commercially reasonable terms. A successful claim of patent or other intellectual property infringement could subject
AbbVie to significant damages or an injunc�on preven�ng the manufacture, sale, or use of the affected AbbVie product or products. Any of these events could have a material adverse effect on AbbVie's profitability and
financial condi�on.

Any significant event that adversely affects HUMIRA revenues could have a material and nega�ve impact on AbbVie's results of opera�ons and cash flows.
HUMIRA accounted for approximately 58% of AbbVie's total net revenues in 2019. Any significant event that adversely affects HUMIRA's revenues could have a material adverse impact on AbbVie's results of
opera�ons and cash flows. These events could include loss of patent protec�on for HUMIRA (as described further in “—The expira�on or loss of patent protec�on and licenses may adversely affect AbbVie’s future revenues
and opera�ng earnings” above), the commercializa�on of biosimilars of HUMIRA, the discovery of previously unknown side effects or impaired efficacy, increased compe��on from the introduc�on of new, more effec�ve or
less expensive treatments and discon�nua�on or removal from the market of HUMIRA for any reason.

AbbVie's research and development efforts may not succeed in developing and marke�ng commercially successful products and technologies, which may cause its revenues and profitability to decline.
To remain compe��ve, AbbVie must con�nue to launch new products and new indica�ons and/or brand extensions for exis�ng products, and such launches must generate revenue sufficient both to cover its
substan�al research and development costs and to replace revenues of profitable products that are lost to or displaced by compe�ng products or therapies. Failure to do so would have a material adverse effect on AbbVie's
revenue and profitability. Accordingly, AbbVie commits substan�al effort, funds, and other resources to research and development and must make ongoing substan�al expenditures without any assurance that its efforts will
be commercially successful. A high rate of failure in the biopharmaceu�cal industry is inherent in the research and development of new products, and failure can occur at any point in the research and development process,

2019 Form 10-K | 11
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 14/104
including a�er significant funds have been invested. Products that appear promising in development may fail to reach the market for numerous reasons, including failure to demonstrate effec�veness, safety concerns,
superior safety or efficacy of compe�ng therapies, failure to achieve posi�ve 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 indica�ons, 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.
Decisions about research studies made early in the development process of a pharmaceu�cal product candidate can affect the marke�ng strategy once such candidate receives approval. More detailed studies may
demonstrate addi�onal benefits that can help in the marke�ng, but they also consume �me and resources and may delay submi�ng the pharmaceu�cal product candidate for approval. AbbVie cannot guarantee that a
proper balance of speed and tes�ng will be made with respect to each pharmaceu�cal product candidate or that decisions in this area would not adversely affect AbbVie's future results of opera�ons.
Even if AbbVie successfully develops and markets new products or enhancements to its exis�ng products, they may be quickly rendered obsolete by changing clinical preferences, changing industry standards, or
compe�tors' innova�ons. AbbVie's innova�ons may not be accepted quickly in the marketplace because of exis�ng clinical prac�ces or uncertainty over third-party reimbursement. AbbVie cannot state with certainty when
or whether any of its products under development will be launched, whether it will be able to develop, license, or otherwise acquire compounds or products, or whether any products will be commercially successful.
Failure to launch successful new products or new indica�ons for exis�ng products may cause AbbVie's products to become obsolete, causing AbbVie's revenues and opera�ng results to suffer.

A por�on of AbbVie's near-term pharmaceu�cal pipeline relies on collabora�ons with third par�es, which may adversely affect the development and sale of its products.
AbbVie depends on alliances with pharmaceu�cal and biotechnology companies for a por�on of the products in its near-term pharmaceu�cal pipeline. Failures by these par�es to meet their contractual, regulatory, or
other obliga�ons to AbbVie, or any disrup�on in the rela�onships between AbbVie and these third par�es, could have an adverse effect on AbbVie's pharmaceu�cal pipeline and business. In addi�on, AbbVie's collabora�ve
rela�onships for research and development extend for many years and may give rise to disputes regarding the rela�ve rights, obliga�ons and revenues of AbbVie and its collabora�on partners, including the ownership of
intellectual property and associated rights and obliga�ons. This could result in the loss of intellectual property rights or protec�on, delay the development and sale of poten�al pharmaceu�cal products and lead to lengthy
and expensive li�ga�on, administra�ve proceedings or arbitra�on.

Biologics carry unique risks and uncertain�es, which could have a nega�ve impact on future results of opera�ons.
The successful discovery, development, manufacturing and sale of biologics is a long, expensive and uncertain process. There are unique risks and uncertain�es with biologics. For example, access to and supply of
necessary biological materials, such as cell lines, may be limited and governmental regula�ons restrict access to and regulate the transport and use of such materials. In addi�on, the development, manufacturing and sale of
biologics is subject to regula�ons that are o�en more complex and extensive than the regula�ons applicable to other pharmaceu�cal products. Manufacturing biologics, especially in large quan��es, is o�en complex and
may require the use of innova�ve technologies. Such manufacturing also requires facili�es specifically designed and validated for this purpose and sophis�cated quality assurance and quality control procedures. Biologics
are also frequently costly to manufacture because produc�on inputs are derived from living animal or plant material, and some biologics cannot be made synthe�cally. Failure to successfully discover, develop, manufacture
and sell biologics—including HUMIRA—could adversely impact AbbVie's business and results of opera�ons.

AbbVie's biologic products are subject to compe��on from biosimilars.
The Biologics Price Compe��on and Innova�on Act creates a framework for the approval of biosimilars in the United States and could allow compe�tors to reference data from biologic products already approved. In
Europe, the European Commission has granted marke�ng authoriza�ons for several biosimilars pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In
addi�on, companies are developing biosimilars in other countries that could and do compete with AbbVie’s biologic products, including HUMIRA. As compe�tors obtain marke�ng approval for biosimilars referencing
AbbVie’s biologic products, AbbVie’s products may become subject to compe��on from such biosimilars, with the a�endant compe��ve pressure and consequences. Expira�on or successful challenge of AbbVie’s applicable
patent rights could also trigger compe��on from other products, assuming any relevant
12 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 15/104
exclusivity period has expired. As a result, AbbVie could face more li�ga�on and administra�ve proceedings with respect to the validity and/or scope of patents rela�ng to its biologic products.

New products and technological advances by AbbVie's compe�tors may nega�vely affect AbbVie's results of opera�ons.
AbbVie competes with other research-based pharmaceu�cal and biotechnology companies that discover, manufacture, market and sell proprietary pharmaceu�cal products and biologics. For example, HUMIRA
competes with an�-TNF products and other compe��ve products intended to treat a number of disease states and AbbVie’s virology products compete with other available hepa��s C treatment op�ons. These compe�tors
may introduce new products or develop technological advances that compete with AbbVie’s products in therapeu�c areas such as immunology, virology/liver disease, oncology and neuroscience. AbbVie cannot predict with
certainty the �ming or impact of the introduc�on by compe�tors of new products or technological advances. Such compe�ng products may be safer, more effec�ve, more effec�vely marketed or sold, or have lower prices
or superior performance features than AbbVie’s products, and this could nega�vely impact AbbVie’s business and results of opera�ons.

The manufacture of many of AbbVie's products is a highly exac�ng and complex process, and if AbbVie or one of its suppliers encounters problems manufacturing AbbVie's products, AbbVie's business could suffer.
The manufacture of many of AbbVie's products is a highly exac�ng and complex process, due in part to strict regulatory requirements. Problems may arise during manufacturing for a variety of reasons, including
equipment malfunc�on, failure to follow specific protocols and procedures, problems with raw materials, delays related to the construc�on of new facili�es or the expansion of exis�ng facili�es, including those intended to
support future demand for AbbVie's products, changes in manufacturing produc�on sites and limits to manufacturing capacity due to regulatory requirements, changes in the types of products produced, physical
limita�ons that could inhibit con�nuous supply, man-made or natural disasters and environmental factors. If problems arise during the produc�on of a batch of product, that batch of product may have to be discarded and
AbbVie may experience product shortages or incur added expenses. This could, among other things, lead to increased costs, lost revenue, damage to customer rela�ons, �me and expense spent inves�ga�ng the cause and,
depending on the cause, similar losses with respect to other batches or products. If problems are not discovered before the product is released to the market, recall and product liability costs may also be incurred.

AbbVie uses a number of products in its pharmaceu�cal and biologic manufacturing processes that are sourced from single suppliers, and an interrup�on in the supply of those products could adversely affect
AbbVie's business and results of opera�ons.
AbbVie uses a number of products in its pharmaceu�cal and biologic manufacturing processes that are sourced from single suppliers. The failure of these single-source suppliers to fulfill their contractual obliga�ons in
a �mely manner or as a result of regulatory noncompliance or physical disrup�on at a manufacturing site may impair AbbVie's ability to deliver its products to customers on a �mely and compe��ve basis, which could
adversely affect AbbVie's business and results of opera�ons. Finding an alterna�ve supplier could take a significant amount of �me and involve significant expense due to the nature of the products and the need to obtain
regulatory approvals. AbbVie cannot guarantee that it will be able to reach agreement with alterna�ve providers or that regulatory authori�es would approve AbbVie's use of such alterna�ves. AbbVie does, however, carry
business interrup�on insurance, which provides a degree of protec�on in the case of a failure by a single-source supplier.

Significant safety or efficacy issues could arise for AbbVie's products, which could have a material adverse effect on AbbVie's revenues and financial condi�on.
Pharmaceu�cal products receive regulatory approval based on data obtained in controlled clinical trials of limited dura�on. Following regulatory approval, these products will be used over longer periods of �me in
many pa�ents. Inves�gators may also conduct addi�onal, and perhaps more extensive, studies. If new safety or efficacy issues are reported or if new scien�fic informa�on becomes available (including results of post-
marke�ng Phase 4 trials), or if governments change standards regarding safety, efficacy or labeling, AbbVie may be required to amend the condi�ons of use for a product. For example, AbbVie may voluntarily provide or be
required to provide updated informa�on on a product's label or narrow its approved indica�on, either of which could reduce the product's market acceptance. If safety or efficacy issues with an AbbVie product arise, sales
of the product could be halted by AbbVie or by regulatory authori�es and regulatory ac�on could be taken

2019 Form 10-K | 13
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 16/104
by such regulatory authori�es. Safety or efficacy issues affec�ng suppliers' or compe�tors' products also may reduce the market acceptance of AbbVie's products.
New data about AbbVie's products, or products similar to its products, could nega�vely 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 withdrawal. Furthermore, new data and informa�on, including informa�on about product misuse, may lead government agencies, professional socie�es, prac�ce management groups or
organiza�ons involved with various diseases to publish guidelines or recommenda�ons related to the use of AbbVie's products or the use of related therapies or place restric�ons on sales. Such guidelines or
recommenda�ons may lead to lower sales of AbbVie's products.

AbbVie is subject to product liability claims and other lawsuits that may adversely affect its business and results of opera�ons.
In the ordinary course of business, AbbVie is the subject of product liability claims and lawsuits alleging that AbbVie's products or the products of other companies that it promotes have resulted or could result in an
unsafe condi�on for or injury to pa�ents. Product liability claims and lawsuits and safety alerts or product recalls, regardless of their ul�mate outcome, may have a material adverse effect on AbbVie's business, results of
opera�ons and reputa�on and on its ability to a�ract and retain customers. Consequences may also include addi�onal costs, a decrease in market share for the product in ques�on, lower income and exposure to other
claims. Product liability losses are self-insured.
AbbVie is also the subject of other claims, legal proceedings and inves�ga�ons in the ordinary course of business, which relate to the intellectual property, commercial, securi�es and other ma�ers. Adverse outcomes
in such claims, legal proceedings and inves�ga�ons may also adversely affect AbbVie’s business and results of opera�ons.

AbbVie is subject to cost-containment efforts and pricing pressures that could cause a reduc�on in future revenues and opera�ng earnings, and changes in the terms of rebate and chargeback programs, which are
common in the pharmaceu�cals industry, could have a material adverse effect on AbbVie's opera�ons.
Cost-containment efforts by governments and private organiza�ons are described in greater detail in Item 1, "Business—Regula�on—Commercializa�on, Distribu�on and Manufacturing." To the extent these cost
containment efforts are not offset by greater demand, increased pa�ent access to health care, or other factors, AbbVie's future revenues and opera�ng earnings will be reduced. In the United States, the European Union
and other countries, AbbVie's business has experienced downward pressure on product pricing, and this pressure could increase in the future.
AbbVie is subject to increasing public and legisla�ve pressure with respect to pharmaceu�cal pricing. In the United States, prac�ces of managed care groups, and ins�tu�onal and governmental purchasers, and United
States federal laws and regula�ons related to Medicare and Medicaid, including the Medicare Prescrip�on Drug Improvement and Moderniza�on Act of 2003 and the Pa�ent Protec�on and Affordable Care Act, contribute
to pricing pressures. The poten�al for con�nuing changes to the health care system in the United States and the increased purchasing power of en��es that nego�ate on behalf of Medicare, Medicaid and private sector
beneficiaries could result in addi�onal pricing pressures.
In numerous major markets worldwide, the government plays a significant role in funding health care services and determining the pricing and reimbursement of pharmaceu�cal products. Consequently, in those
markets, AbbVie is subject to government decision-making and budgetary ac�ons with respect to its products. In par�cular, many European countries have ongoing government-mandated price reduc�ons for many
pharmaceu�cal products, and AbbVie an�cipates con�nuing pricing pressures in Europe. Differences between countries in pricing regula�ons could lead to third-party cross-border trading in AbbVie's products that results
in a reduc�on in future revenues and opera�ng earnings.
Rebates related to government programs, such as fee-for-service Medicaid or Medicaid managed care programs, arise from laws and regula�ons. AbbVie cannot predict if addi�onal government ini�a�ves to contain
health care costs or other factors could lead to new or modified regulatory requirements that include higher or incremental rebates or discounts. Other rebate and discount programs arise from contractual agreements with
private payers. Various factors, including market factors and the ability of private payers to control pa�ent access to products, may provide payers the leverage to nego�ate higher or addi�onal rebates or discounts that
could have a material adverse effect on AbbVie's opera�ons.

14 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 17/104
AbbVie is subject to numerous governmental regula�ons, and it can be costly to comply with these regula�ons and to develop compliant products and processes.
AbbVie's products are subject to rigorous regula�on by numerous interna�onal, suprana�onal, federal and state authori�es, as described in Item 1, "Business—Regula�on—Discovery and Clinical Development." The
process of obtaining regulatory approvals to market a pharmaceu�cal product can be costly and �me consuming, and approvals might not be granted for future products, or addi�onal indica�ons or uses of exis�ng
products, on a �mely basis, if at all. Delays in the receipt of, or failure to obtain approvals for, future products, or new indica�ons and uses, could result in delayed realiza�on of product revenues, reduc�on in revenues and
substan�al addi�onal costs.
In addi�on, AbbVie cannot guarantee that it will remain compliant with applicable regulatory requirements once approval has been obtained for a product. These requirements include, among other things,
regula�ons regarding manufacturing prac�ces, product labeling and adver�sing and post-marke�ng repor�ng, including adverse event reports and field alerts due to manufacturing quality concerns. AbbVie must incur
expense and spend �me and effort to ensure compliance with these complex regula�ons.
Possible regulatory ac�ons could result in substan�al modifica�ons to AbbVie's business prac�ces and opera�ons; refunds, recalls or seizures of AbbVie's products; a total or par�al shutdown of produc�on in one or
more of AbbVie's or its suppliers' facili�es while AbbVie or its supplier remedies the alleged viola�on; the inability to obtain future approvals; and withdrawals or suspensions of current products from the market. Any of
these events could disrupt AbbVie's business and have a material adverse effect on its business and results of opera�ons.

Laws and regula�ons affec�ng government benefit programs could impose new obliga�ons on AbbVie, require it to change its business prac�ces, and restrict its opera�ons in the future.
The health care industry is subject to various federal, state and interna�onal laws and regula�ons pertaining to government benefit programs reimbursement, rebates, price repor�ng and regula�on and health care
fraud and abuse. In the United States, these laws include an�-kickback and false claims laws, the Medicaid Rebate Statute, the Veterans Health Care Act and individual state laws rela�ng to pricing and sales and marke�ng
prac�ces. Viola�ons of these laws may be punishable by criminal and/or civil sanc�ons, including, in some instances, substan�al fines, imprisonment and exclusion from par�cipa�on in federal and state health care
programs, including Medicare, Medicaid and Veterans Administra�on health programs. These laws and regula�ons are broad in scope and they are subject to change and evolving interpreta�ons, which could require
AbbVie to incur substan�al costs associated with compliance or to alter one or more of its sales or marke�ng prac�ces. In addi�on, viola�ons of these laws, or allega�ons of such viola�ons, could disrupt AbbVie's business
and result in a material adverse effect on its business and results of opera�ons.

The interna�onal nature of AbbVie's business subjects it to addi�onal business risks that may cause its revenue and profitability to decline.
AbbVie's business is subject to risks associated with doing business interna�onally, including in emerging markets. Net revenues outside of the United States made up approximately 28% of AbbVie's total net revenues
in 2019. The risks associated with AbbVie's opera�ons outside the United States include:
• fluctua�ons in currency exchange rates;
• changes in medical reimbursement policies and programs;
• mul�ple legal and regulatory requirements that are subject to change and that could restrict AbbVie's ability to manufacture, market and sell its products;
• differing local product preferences and product requirements;
• trade protec�on measures and import or export licensing requirements;
• interna�onal trade disrup�ons or disputes, including in connec�on with the ongoing trade nego�a�ons between the United States and China;
• difficulty in establishing, staffing and managing opera�ons;
• differing labor regula�ons;
• poten�ally nega�ve consequences from changes in or interpreta�ons of tax laws;

2019 Form 10-K | 15
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 18/104
• poli�cal and economic instability, including the United Kingdom’s exit from the European Union;
• sovereign debt issues;
• price and currency exchange controls, limita�ons on par�cipa�on in local enterprises, expropria�on, na�onaliza�on and other governmental ac�on;
• infla�on, recession and fluctua�ons in interest rates;
• poten�al deteriora�on in the economic posi�on and credit quality of certain non-U.S. countries, including in Europe and La�n America; and
• poten�al penal�es or other adverse consequences for viola�ons of an�-corrup�on, an�-bribery and other similar laws and regula�ons, including the United States Foreign Corrupt Prac�ces Act and the United
Kingdom Bribery Act.
Events contemplated by these risks may, individually or in the aggregate, have a material adverse effect on AbbVie's revenues and profitability.

If AbbVie does not effec�vely and profitably commercialize its products, AbbVie's revenues and financial condi�on could be adversely affected.
AbbVie must effec�vely and profitably commercialize its principal products by crea�ng and mee�ng con�nued market demand; achieving market acceptance and genera�ng product sales; ensuring that the ac�ve
pharmaceu�cal ingredient(s) for a product and the finished product are manufactured in sufficient quan��es and in compliance with requirements of the FDA and similar foreign regulatory agencies and with acceptable
quality and pricing to meet commercial demand; and ensuring that the en�re supply chain efficiently and consistently delivers AbbVie's products to its customers. The commercializa�on of AbbVie products may not be
successful due to, among other things, unexpected challenges from compe�tors, new safety issues or concerns being reported that may impact or narrow approved indica�ons, the rela�ve price of AbbVie's product as
compared to alterna�ve treatment op�ons and changes to a product's label that further restrict its marke�ng. If the commercializa�on of AbbVie's principal products is unsuccessful, AbbVie's ability to generate revenue
from product sales will be adversely affected.

AbbVie may acquire other businesses, license rights to technologies or products, form alliances, or dispose of assets, which could cause it to incur significant expenses and could nega�vely affect profitability.
AbbVie may pursue acquisi�ons (such as the pending acquisi�on of Allergan), technology licensing arrangements, and strategic alliances, or dispose of some of its assets, as part of its business strategy. AbbVie may
not complete these transac�ons in a �mely manner, on a cost-effec�ve basis, or at all, and may not realize the expected benefits. If AbbVie is successful in making an acquisi�on, the products and technologies that are
acquired may not be successful or may require significantly greater resources and investments than originally an�cipated. AbbVie may not be able to integrate acquisi�ons successfully into its exis�ng business and could
incur or assume significant debt and unknown or con�ngent liabili�es. AbbVie could also experience nega�ve effects on its reported results of opera�ons from acquisi�on or disposi�on-related charges, amor�za�on of
expenses related to intangibles and charges for impairment of long-term assets. These effects could cause a deteriora�on of AbbVie's credit ra�ng and result in increased borrowing costs and interest expense.
Addi�onally, changes in AbbVie's structure, opera�ons, revenues, costs, or efficiency resul�ng from major transac�ons such as acquisi�ons, dives�tures, mergers, alliances, restructurings or other strategic ini�a�ves,
may result in greater than expected costs, may take longer than expected to complete or encounter other difficul�es, including the need for regulatory approval where appropriate.

AbbVie is dependent on wholesale distributors for distribu�on of its products in the United States and, accordingly, its results of opera�ons could be adversely affected if they encounter financial difficul�es.
In 2019, three wholesale distributors (McKesson Corpora�on, Cardinal Health, Inc. and AmerisourceBergen Corpora�on) accounted for substan�ally all of AbbVie's sales in the United States. If one of its significant
wholesale distributors encounters financial or other difficul�es, such distributor may decrease the amount of business that it does with AbbVie, and AbbVie may be unable to collect all the amounts that the distributor
owes it on a �mely basis or at all, which could nega�vely impact AbbVie's business and results of opera�ons.
16 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 19/104
AbbVie has debt obliga�ons that could adversely affect its business and its ability to meet its obliga�ons.
The amount of debt that AbbVie has incurred and intends to incur could have important consequences to AbbVie and its investors. These consequences include, among other things, requiring a por�on of AbbVie's
cash flow from opera�ons to make interest payments on this debt and reducing the cash flow available to fund capital expenditures and other corporate purposes and to grow AbbVie's business. To the extent AbbVie incurs
addi�onal indebtedness or interest rates increase, these risks could increase. In addi�on, AbbVie's cash flow from opera�ons may not be sufficient to repay all of the outstanding debt as it becomes due, and AbbVie may
not be able to borrow money, sell assets, or otherwise raise funds on acceptable terms, or at all, to refinance its debt.

AbbVie may need addi�onal financing in the future to meet its capital needs or to make opportunis�c acquisi�ons, and such financing may not be available on favorable terms, if at all.
AbbVie may need to seek addi�onal financing for its general corporate purposes. For example, it may need to increase its investment in research and development ac�vi�es or need funds to make acquisi�ons. AbbVie
may be unable to obtain any desired addi�onal financing on terms favorable to it, if at all. If AbbVie loses its investment grade credit ra�ng or adequate funds are not available on acceptable terms, AbbVie may be unable to
fund its expansion, successfully develop or enhance products, or respond to compe��ve pressures, any of which could nega�vely affect AbbVie's business. If AbbVie raises addi�onal funds by issuing debt or entering into
credit facili�es, it may be subject to limita�ons on its opera�ons due to restric�ve covenants. Failure to comply with these covenants could adversely affect AbbVie's business.

AbbVie depends on informa�on technology and a failure of those systems could adversely affect AbbVie's business.
AbbVie relies on sophis�cated so�ware applica�ons and complex informa�on technology systems to operate its business. These systems are poten�ally vulnerable to malicious intrusion, random a�ack, loss of data
privacy, disrup�on, degrada�on or breakdown. Data privacy or security breaches by employees or others may result in the failure of cri�cal business opera�ons or may cause sensi�ve data, including intellectual property,
trade secrets or personal informa�on belonging to AbbVie, its pa�ents, customers or business partners, to be exposed to unauthorized persons or to the public. Although AbbVie has invested in the protec�on of its data
and informa�on technology and also monitors its systems on an ongoing basis, there can be no assurance that these efforts will prevent breakdowns or breaches in AbbVie's informa�on technology systems that could
adversely affect AbbVie's business. Such adverse consequences could include loss of revenue, or the loss of cri�cal or sensi�ve informa�on from AbbVie’s or third-party providers’ databases or IT systems and could also
result in legal, financial, reputa�onal or business harm to AbbVie and poten�ally substan�al remedia�on costs.
Failure to a�ract and retain highly qualified personnel could affect AbbVie’s ability to successfully develop and commercialize products.
AbbVie’s success is largely dependent on its con�nued ability to a�ract and retain highly qualified scien�fic, technical and management personnel, as well as personnel with exper�se in clinical R&D, governmental
regula�on and commercializa�on. Compe��on for qualified personnel in the biopharmaceu�cal field is intense. AbbVie cannot be sure that it will be able to a�ract and retain quality personnel or that the costs of doing so
will not materially increase.

Other factors can have a material adverse effect on AbbVie's profitability and financial condi�on.
Many other factors can affect AbbVie's results of opera�ons, cash flows and financial condi�on, including:
• changes in or interpreta�ons of laws and regula�ons, including changes in accoun�ng standards, taxa�on requirements, product marke�ng applica�on standards, data privacy laws and environmental laws;
• differences between the fair value measurement of assets and liabili�es and their actual value, par�cularly for pension and post-employment benefits, stock-based compensa�on, intangibles and goodwill; and
for con�ngent liabili�es such as li�ga�on and con�ngent considera�on, the absence of a recorded amount, or an amount recorded at the minimum, compared to the actual amount;
• changes in the rate of infla�on (including the cost of raw materials, commodi�es and supplies), interest rates, market value of AbbVie's equity investments and the performance of investments held by it or its
employee benefit trusts;

2019 Form 10-K | 17
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 20/104
• changes in the creditworthiness of counterpar�es that transact business with or provide services to AbbVie or its employee benefit trusts;
• changes in the ability of third par�es that provide informa�on technology, accoun�ng, human resources, payroll and other outsourced services to AbbVie to meet their contractual obliga�ons to AbbVie; and
• changes in business, economic and poli�cal condi�ons, including: war, poli�cal instability, terrorist a�acks, the threat of future terrorist ac�vity and related military ac�on; natural disasters; the cost and
availability of insurance due to any of the foregoing events; labor disputes, strikes, slow-downs, or other forms of labor or union ac�vity; and pressure from third-party interest groups.

Risks Related to the Acquisi�on and the Combined Company Upon Comple�on of the Acquisi�on
The pending acquisi�on of Allergan may not be completed on the currently contemplated �meline or terms, or at all, and may not achieve the intended benefits.
Consumma�on of the Acquisi�on is condi�oned on, among other things, obtaining necessary governmental and regulatory approvals. If any of the condi�ons to the Acquisi�on is not sa�sfied, it could delay or prevent
the Acquisi�on from occurring, which could nega�vely impact AbbVie’s share price and future business and financial results. Further, as a condi�on to their approval of the Acquisi�on, agencies may impose requirements,
limita�ons or costs or require dives�tures or place restric�ons on the conduct of the AbbVie’s business a�er the closing. These requirements, limita�ons, costs, dives�tures or restric�ons could jeopardize or delay the
consumma�on of the Acquisi�on or may reduce the an�cipated benefits of the transac�on. In addi�on, changes in laws and regula�ons, including Irish legisla�on implemen�ng a tax increase payable upon comple�on of
the Acquisi�on, could adversely impact AbbVie’s post-Acquisi�on profitability and financial results. Following the Acquisi�on, AbbVie may not realize the Acquisi�on’s intended benefits within the expected �meframe or at
all.

The indebtedness of the combined company following the consumma�on of the Acquisi�on will be substan�ally 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 acquisi�on. This increased level of indebtedness could adversely affect the combined company’s business flexibility and increase its
borrowing costs.
AbbVie expects that the cash considera�on due to Allergan’s shareholders under the transac�on agreement and related fees and expenses will be approximately $41 billion. In addi�on to using cash on hand, AbbVie
has incurred significant Acquisi�on-related debt financing, including unsecured term loans and senior notes. For more informa�on, see Note 10“Debt, Credit Facili�es and Commitments and Con�ngencies,” to the
Consolidated Financial Statements included under Item 8, “Financial Statements and Supplementary Data.” AbbVie also intends to assume all the exis�ng indebtedness of Allergan and its subsidiaries. AbbVie’s substan�ally
increased indebtedness and higher debt to equity ra�o following the consumma�on of the Acquisi�on may have the effect of, among other things, reducing its flexibility to respond to changing business and economic
condi�ons, lowering its credit ra�ngs, increasing its borrowing costs and/or requiring it to reduce or delay investments, strategic acquisi�ons and capital expenditures or to seek addi�onal capital or restructure or refinance
its indebtedness.

Risks Related to AbbVie's Common Stock

AbbVie cannot guarantee the �ming, amount, or payment of dividends on its common stock.
Although AbbVie expects to pay regular cash dividends, the �ming, declara�on, amount and payment of future dividends to stockholders will fall within the discre�on of AbbVie's board of directors. The board's
decisions regarding the payment of dividends will depend on many factors, such as AbbVie's financial condi�on, earnings, capital requirements, debt service obliga�ons, industry prac�ce, legal requirements, regulatory
constraints and other factors that the board deems relevant. For more informa�on, see Item 5, "Market for Registrant's Common Equity, Related Stockholder Ma�ers and Issuer Purchases of Equity Securi�es." AbbVie's
ability to pay dividends will depend on its ongoing ability to generate cash from opera�ons and access capital markets. AbbVie cannot guarantee that it will con�nue to pay a dividend in the future.

An AbbVie stockholder's percentage of ownership in AbbVie may be diluted in the future.
In the future, a stockholder's percentage ownership in AbbVie may be diluted because of equity issuances for capital market transac�ons, equity awards that AbbVie will be gran�ng to AbbVie's directors, officers and
employees, acquisi�ons
18 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 21/104
(including AbbVie's pending acquisi�on of Allergan), or other purposes. AbbVie's employees have op�ons to purchase shares of its common stock as a result of conversion of their Abbo� stock op�ons (in whole or in part)
to AbbVie stock op�ons. AbbVie an�cipates its compensa�on commi�ee will grant addi�onal stock op�ons or other stock-based awards to its employees. Such awards will have a dilu�ve effect on AbbVie's earnings per
share, which could adversely affect the market price of AbbVie's common stock. From �me to �me, AbbVie will issue addi�onal op�ons or other stock-based awards to its employees under AbbVie's employee benefits
plans.
In addi�on, AbbVie's amended and restated cer�ficate of incorpora�on authorizes AbbVie to issue, without the approval of AbbVie's stockholders, one or more classes or series of preferred stock having such
designa�on, powers, preferences and rela�ve, par�cipa�ng, op�onal and other special rights, including preferences over AbbVie's common stock respec�ng dividends and distribu�ons, as AbbVie's board of directors
generally may determine. The terms of one or more classes or series of preferred stock could dilute the vo�ng power or reduce the value of AbbVie's common stock. For example, AbbVie could grant the holders of
preferred stock the right to elect some number of AbbVie's directors in all events or on the happening of specified events or the right to veto specified transac�ons. Similarly, the repurchase or redemp�on rights or
liquida�on preferences AbbVie could assign to holders of preferred stock could affect the residual value of the common stock.

Certain provisions in AbbVie's amended and restated cer�ficate of incorpora�on and amended and restated by-laws, and of Delaware law, may prevent or delay an acquisi�on of AbbVie, which could decrease the
trading price of AbbVie's common stock.
AbbVie's amended and restated cer�ficate of incorpora�on and amended and restated by-laws contain, and Delaware law contains, provisions that are intended to deter coercive takeover prac�ces and inadequate
takeover bids by encouraging prospec�ve acquirors to nego�ate with AbbVie's board of directors rather than to a�empt a hos�le takeover. These provisions include, among others:
• the inability of AbbVie's stockholders to call a special mee�ng;
• the division of AbbVie's board of directors into three classes of directors, with each class serving a staggered three-year term;
• a provision that stockholders may only remove directors for cause;
• the ability of AbbVie's directors, and not stockholders, to fill vacancies on AbbVie's board of directors; and
• the requirement that the affirma�ve vote of stockholders holding at least 80% of AbbVie's vo�ng stock is required to amend certain provisions in AbbVie's amended and restated cer�ficate of incorpora�on and
AbbVie's amended and restated by-laws rela�ng to the number, term and elec�on of AbbVie's directors, the filling of board vacancies, the calling of special mee�ngs of stockholders and director and officer
indemnifica�on provisions.
In addi�on, Sec�on 203 of the Delaware General Corpora�on Law provides that, subject to limited excep�ons, persons that acquire, or are affiliated with a person that acquires, more than 15% of the outstanding
vo�ng stock of a Delaware corpora�on shall not engage in any business combina�on with that corpora�on, including by merger, consolida�on or acquisi�ons of addi�onal shares, for a three-year period following the date
on which that person or its affiliates becomes the holder of more than 15% of the corpora�on's outstanding vo�ng stock.
AbbVie believes these provisions protect its stockholders from coercive or otherwise unfair takeover tac�cs by requiring poten�al acquirors to nego�ate with AbbVie's board of directors and by providing AbbVie's
board of directors with more �me to assess any acquisi�on proposal. These provisions are not intended to make the company immune from takeovers. However, these provisions apply even if the offer may be considered
beneficial by some stockholders and could delay or prevent an acquisi�on that AbbVie's board of directors determines is not in the best interests of AbbVie and AbbVie's stockholders. These provisions may also prevent or
discourage a�empts to remove and replace incumbent directors.

2019 Form 10-K | 19
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 22/104
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains certain forward looking statements regarding business strategies, market poten�al, future financial performance and other ma�ers. The words "believe," "expect,"
"an�cipate," "project" and similar expressions, among others, generally iden�fy "forward looking statements," which speak only as of the date the statements were made. The ma�ers discussed in these forward looking
statements are subject to risks, uncertain�es and other factors that could cause actual results to differ materially from those projected, an�cipated or implied in the forward looking statements. In par�cular, informa�on
included under Item 1, "Business," Item 1A, "Risk Factors," and Item 7, "Management's Discussion and Analysis of Financial Condi�on and Results of Opera�ons" contain forward looking statements. Where, in any forward
looking statement, an expecta�on or belief as to future results or events is expressed, such expecta�on or belief is based on the current plans and expecta�ons of AbbVie management and expressed in good faith and
believed to have a reasonable basis, but there can be no assurance that the expecta�on or belief will result or be achieved or accomplished. Factors that could cause actual results or events to differ materially from those
an�cipated include the ma�ers described under Item 1A, "Risk Factors" and Item 7, "Management's Discussion and Analysis of Financial Condi�on and Results of Opera�ons." AbbVie does not undertake any obliga�on to
update the forward-looking statements included in this Annual Report on Form 10-K to reflect events or circumstances a�er the date hereof, unless AbbVie is required by applicable securi�es law to do so.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
AbbVie's corporate offices are located at 1 North Waukegan Road, North Chicago, Illinois 60064-6400. AbbVie's manufacturing facili�es are in the following loca�ons:
United States Outside the United States
Abbo� Park, Illinois* Campoverde di Aprilia, Italy
Barceloneta, Puerto Rico Cork, Ireland
North Chicago, Illinois Ludwigshafen, Germany
Worcester, Massachuse�s* Singapore*
Wyando�e, Michigan* Sligo, Ireland
_______________________________________________________________________________
* Leased property.
In addi�on to the above, AbbVie has other manufacturing facili�es worldwide. AbbVie believes its facili�es are suitable and provide adequate produc�on capacity. There are no material encumbrances on AbbVie's
owned proper�es.
In the United States, including Puerto Rico, AbbVie has one distribu�on center. AbbVie also has research and development facili�es in the United States located at: Abbo� Park, Illinois; North Chicago, Illinois; Redwood
City, California; South San Francisco, California; Sunnyvale, California; Cambridge, Massachuse�s; and Worcester, Massachuse�s. Outside the United States, AbbVie's principal research and development facili�es are located
in Ludwigshafen, Germany.
ITEM 3. LEGAL PROCEEDINGS
Informa�on pertaining to legal proceedings is provided in Note 15, "Legal Proceedings and Con�ngencies" to the Consolidated Financial Statements included under Item 8, "Financial Statements and Supplementary
Data," and is incorporated by reference herein.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
20 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 23/104
INFORMATION ABOUT OUR EXECUTIVE OFFICERS
The following table lists AbbVie's execu�ve officers, each of whom was first appointed as an AbbVie corporate officer in December 2012, except as otherwise indicated:
Name Age Posi�on
Richard A. Gonzalez 66 Chairman of the Board and Chief Execu�ve Officer
Michael E. Severino, M.D.* 54 Vice Chairman and President
Laura J. Schumacher 56 Vice Chairman, External Affairs and Chief Legal Officer
Carlos Alban 57 Vice Chairman, Chief Commercial Officer
Henry O. Gosebruch* 47 Execu�ve Vice President and Chief Strategy Officer
Robert A. Michael* 49 Execu�ve Vice President, Chief Financial Officer
Timothy J. Richmond 53 Execu�ve Vice President, Chief Human Resources Officer
Azita Saleki-Gerhardt, Ph.D. 56 Execu�ve Vice President, Opera�ons
Nicholas Donoghoe, M.D.* 39 Senior Vice President, Enterprise Innova�on
Thomas J. Hudson, M.D.* 58 Senior Vice President, Research & Development and Chief Scien�fic Officer
Jeffrey R. Stewart* 51 Senior Vice President, U.S. Commercial Opera�ons
Brian L. Durkin* 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; 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.
Mr. Gonzalez is the Chairman and Chief Execu�ve Officer of AbbVie. He served as Abbo�’s Execu�ve Vice President of the Pharmaceu�cal Products Group from July 2010 to December 2012, and was responsible for
Abbo�’s worldwide pharmaceu�cal business, including commercial opera�ons, research and development, and manufacturing. He also served as President, Abbo� Ventures Inc., Abbo�’s medical technology investment
arm, from 2009 to 2011. Mr. Gonzalez joined Abbo� in 1977 and held various management posi�ons.
Dr. Severino is AbbVie’s Vice Chairman and President, responsible for research and development, human resources, opera�ons, and the corporate strategy office. He served as Execu�ve Vice President, Research and
Development and Chief Scien�fic Officer from 2014 to 2018. Dr. Severino served at Amgen Inc. as Senior Vice President, Global Development and Corporate Chief Medical Officer from 2012 to 2014, as Vice President, Global
Development from 2010 to 2012 and as Vice President, Therapeu�c Area Head, General Medicine and Inflamma�on Global Clinical Development from 2007 to 2012. He joined AbbVie in 2014.
Ms. Schumacher is AbbVie’s Vice Chairman, External Affairs and Chief Legal Officer, responsible for global legal, health economics outcomes research, corporate responsibility, brand and communica�ons and
government affairs. Prior to her current appointment in 2018, she served as AbbVie’s Execu�ve Vice President, External Affairs, General Counsel and Corporate Secretary. Prior to AbbVie’s separa�on from Abbo�, Ms.
Schumacher served as Execu�ve Vice President, General Counsel from 2007 to 2012. Both at Abbo� and AbbVie, Ms. Schumacher also led Business Development and Ventures and Early Stage Collabora�ons. Ms.
Schumacher joined Abbo� in 1990. She serves on the board of General Dynamics Corpora�on.
Mr. Alban is AbbVie’s Vice Chairman, Chief Commercial Officer, responsible for global commercial opera�ons of the company, including the Pharmacyclics commercial func�ons. He previously served as Execu�ve Vice
President, Commercial Opera�ons from 2013 to 2018. He served as Abbo�’s Senior Vice President, Proprietary Pharmaceu�cal Products, Global Commercial Opera�ons from 2011 to 2012, as Senior Vice President,
Interna�onal Pharmaceu�cals from 2009 to 2011, as Vice President, Western Europe and Canada from 2007 to 2009, and as Vice President, European Opera�ons from 2006 to 2007. Mr. Alban joined Abbo� in 1986.
Mr. Gosebruch is AbbVie's Execu�ve Vice President and Chief Strategy Officer. He worked for more than 20 years in the Mergers & Acquisi�ons Group at J.P. Morgan Securi�es LLC, serving as Managing Director since
2007 and as Co-Head of M&A North America during 2015. Mr. Gosebruch joined AbbVie in 2015. He serves on the board of Ap�nyx Inc.

2019 Form 10-K | 21
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 24/104
Mr. Michael is AbbVie’s Execu�ve Vice President, Chief Financial Officer. Mr. Michael previously served as Senior Vice President, Chief Financial Officer from October 2018 to July 2019, and as Vice President, Controller
from March 2017 to October 2018. He served as AbbVie’s Vice President, Treasurer from 2015 to 2016, as Vice President, Controller, Commercial Opera�ons from 2013 to 2015 and Vice President, Financial Planning and
Analysis from 2012 to 2013. At Abbo�, Mr. Michael served as Division Controller, Nutri�on Supply Chain from 2010 to 2012. Mr. Michael joined Abbo� in 1993.
Mr. Richmond is AbbVie’s Execu�ve Vice President, Chief Human Resources Officer. He served as Senior Vice President, Human Resources from 2013 to 2018. Mr. Richmond served as Abbo�’s Divisional Vice President
of Compensa�on & Benefits from 2008 to 2012, as Group Vice President of Talent and Rewards from 2007 to 2008, and as Divisional Vice President of Talent Acquisi�on from 2006 to 2007. Mr. Richmond joined Abbo� in
2006.
Dr. Saleki-Gerhardt is AbbVie’s Execu�ve Vice President, Opera�ons. She served as Senior Vice President, Opera�ons from 2013 to 2018. Dr. Saleki-Gerhardt served as Abbo�’s Vice President, Pharmaceu�cals
Manufacturing and Supply from 2011 to 2012, and as Divisional Vice President, Quality Assurance, Global Pharmaceu�cal Opera�ons from 2008 to 2011. Dr. Saleki-Gerhardt joined Abbo� in 1993. She serves on the board
of Entegris Inc.
Dr. Donoghoe is AbbVie's Senior Vice President, Enterprise Innova�on. He previously served as a Partner at McKinsey & Company, leading the firm's West Coast pharma and biotechnology prac�ce. Dr. Donoghoe
joined the firm in 2007 and supported mul�ple successful launches in therapeu�c areas such as oncology, immunology, and primary care. He joined AbbVie in 2019.
Dr. Hudson is AbbVie's Senior Vice President, Research & Development and Chief Scien�fic 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 Ins�tute for Cancer Research as President and Scien�fic Director. He also previously served as Founder and Director of the McGill University and Genome Quebec
Innova�on Centre and Assistant Director of the Whitehead/MIT Center for Genome Research.
Mr. Stewart is AbbVie’s Senior Vice President, U.S. Commercial Opera�ons. Mr. Stewart previously served as AbbVie’s President, Commercial Opera�ons from 2013 to 2018. Prior to AbbVie’s separa�on from Abbo�,
he served as Vice President, Abbo� Proprietary Pharmaceu�cal Division, United States. Mr. Stewart joined Abbo� in 1992.
Mr. Durkin is AbbVie’s Vice President, Controller. Mr. Durkin previously served as Vice President, Internal Audit from 2016 to 2018. Prior to joining AbbVie, he served as Vice President of Finance and Division Controller
for Abbo�’s Vision Care business from 2009 to 2016 and Controller Pharmaceu�cal Research and Development from 2005 to 2009. Mr. Durkin joined Abbo� in 1986.
The execu�ve officers of AbbVie are elected annually by the board of directors. All other officers are elected by the board or appointed by the Chairman of the Board. All officers are either elected at the first mee�ng
of the board of directors held a�er the annual stockholder mee�ng or appointed by the Chairman of the Board a�er that board mee�ng. Each officer holds office un�l a successor has been duly elected or appointed and
qualified or un�l the officer's death, resigna�on, or removal. There are no family rela�onships between any of the execu�ve officers listed above.
22 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 25/104
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Principal Market
The principal market for AbbVie's common stock is the New York Stock Exchange (Symbol: ABBV). AbbVie's common stock is also listed on the Chicago Stock Exchange and traded on various regional and electronic
exchanges.
Stockholders
There were 46,544 stockholders of record of AbbVie common stock as of January 31, 2020.
Performance Graph
The following graph compares the cumula�ve total returns of AbbVie, the S&P 500 Index and the NYSE Arca Pharmaceu�cals Index for the period from December 31, 2014 through December 31, 2019. This graph
assumes $100 was invested in AbbVie common stock and each index on December 31, 2014 and also assumes the reinvestment of dividends. The stock price performance on the following graph is not necessarily indica�ve
of future stock price performance.
This performance graph is furnished and shall not be deemed "filed" with the SEC or subject to Sec�on 18 of the Securi�es Exchange Act of 1934, nor shall it be deemed incorporated by reference in any of AbbVie's
filings under the Securi�es Act of 1933, as amended.

2019 Form 10-K | 23
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 26/104
Dividends
On November 1, 2019, AbbVie's board of directors declared an increase in the quarterly cash dividend from $1.07 per share to $1.18 per share, payable on February 14, 2020 to stockholders of record as of January 15,
2020. The �ming, declara�on, amount of and payment of any dividends by AbbVie in the future is within the discre�on of its board of directors and will depend upon many factors, including AbbVie's financial condi�on,
earnings, capital requirements of its opera�ng subsidiaries, covenants associated with certain of AbbVie's debt service obliga�ons, legal requirements, regulatory constraints, industry prac�ce, ability to access capital
markets and other factors deemed relevant by its board of directors. Moreover, if AbbVie determines to pay any dividend in the future, there can be no assurance that it will con�nue to pay such dividends or the amount of
such dividends.
Issuer Purchases of Equity Securi�es
Period
(a) Total
Number
of Shares
(or Units)
Purchased
(b) Average
Price
Paid per Share
(or Unit)
(c) Total
Number of
Shares (or Units)
Purchased as Part
of Publicly
Announced
Plans or
Programs
(d) Maximum Number (or
Approximate Dollar Value) of
Shares (or Units) that May
Yet Be Purchased Under the
Plans or Programs
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
1. In addi�on 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 par�cipants in the
AbbVie Employee Stock Purchase Plan – 4,293 in October; 1,086 in November; and 1,016 in December.
These shares do not include the shares surrendered to AbbVie to sa�sfy minimum tax withholding obliga�ons in connec�on with the ves�ng or exercise of stock-based awards.
24 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 27/104
ITEM 6. SELECTED FINANCIAL DATA
The selected financial informa�on should be read in conjunc�on with the financial statements and accompanying notes included under Item 8, "Financial Statements and Supplementary Data" and Item 7,
"Management's Discussion and Analysis of Financial Condi�on and Results of Opera�ons."
as of and for the years ended December 31 (in millions, except per share data) 2019 2018 2017 2016 2015
Statement of earnings data
Net revenues $ 33,266 $ 32,753 $ 28,216 $ 25,638 $ 22,859
Net earnings 7,882 5,687 5,309 5,953 5,144
Basic earnings per share $ 5.30 $ 3.67 $ 3.31 $ 3.65 $ 3.15
Diluted earnings per share $ 5.28 $ 3.66 $ 3.30 $ 3.63 $ 3.13
Cash dividends declared per common share $ 4.39 $ 3.95 $ 2.63 $ 2.35 $ 2.10
Weighted-average basic shares outstanding 1,481 1,541 1,596 1,622 1,625
Weighted-average diluted shares outstanding 1,484 1,546 1,603 1,631 1,637
Balance sheet data
Total assets (a) $ 89,115 $ 59,352 $ 70,786 $ 66,099 $ 53,050
Long-term debt and finance lease obliga�ons (a)(b) 66,728 36,611 36,968 36,465 31,265
(a) In November 2019, AbbVie issued $30.0 billion aggregate principal amount of floa�ng rate and fixed rate unsecured senior notes at maturi�es ranging from 18 months to 30 years. AbbVie expects to use the net
proceeds to fund a por�on of the aggregate cash considera�on due to Allergan shareholders in connec�on with the proposed acquisi�on and to pay related fees and expenses. See Note 5 to the Consolidated
Financial Statements for informa�on regarding the proposed acquisi�on and Note 10 for informa�on on the senior notes.
(b) Includes current por�on of both long-term debt and finance lease obliga�ons.

2019 Form 10-K | 25
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 28/104
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following is a discussion and analysis of the financial condi�on of AbbVie Inc. (AbbVie or the company) as of December 31, 2019 and 2018 and results of opera�ons for each of the three years in the period ended
December 31, 2019. This commentary should be read in conjunc�on with the consolidated financial statements and accompanying notes appearing in Item 8, "Financial Statements and Supplementary Data."
EXECUTIVE OVERVIEW
Company Overview
AbbVie is a global, research-based biopharmaceu�cal company formed in 2013 following separa�on from Abbo� Laboratories (Abbo�). AbbVie uses its exper�se, dedicated people and unique approach to innova�on
to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie's products are focused on trea�ng condi�ons such as chronic autoimmune diseases in rheumatology,
gastroenterology and dermatology; oncology, including blood cancers; virology, including hepa��s C virus (HCV) and human immunodeficiency virus (HIV); neurological disorders, such as Parkinson's disease; metabolic
diseases, including thyroid disease and complica�ons associated with cys�c fibrosis; pain associated with endometriosis; as well as other serious health condi�ons. AbbVie also has a pipeline of promising new medicines in
clinical development across such important medical special�es as immunology, oncology and neuroscience, with addi�onal targeted investment in cys�c fibrosis and women's health.
AbbVie's products are generally sold worldwide directly to wholesalers, distributors, government agencies, health care facili�es, specialty pharmacies and independent retailers from AbbVie-owned distribu�on
centers and public warehouses. In the United States, AbbVie distributes pharmaceu�cal products principally through independent wholesale distributors, with some sales directly to pharmacies and pa�ents. Outside the
United States, AbbVie sells products primarily to customers or through distributors, depending on the market served. Certain products are co-marketed or co-promoted with other companies. AbbVie has approximately
30,000 employees. AbbVie operates in one business segment—pharmaceu�cal products.
On June 25, 2019, AbbVie announced that it entered into a defini�ve transac�on agreement under which AbbVie will acquire Allergan plc (Allergan). See Note 5 to the Consolidated Financial Statements for addi�onal
informa�on regarding the proposed acquisi�on.
2019 Financial Results
AbbVie's strategy has focused on delivering strong financial results, advancing and inves�ng in its pipeline and returning value to shareholders while ensuring a strong, sustainable growth business over the long term.
The company's financial performance in 2019 included delivering worldwide net revenues of $33.3 billion, opera�ng earnings of $13.0 billion, diluted earnings per share of $5.28 and cash flows from opera�ons of $13.3
billion. Worldwide net revenues grew by 3% on a constant currency basis, primarily driven by revenue growth related to IMBRUVICA and VENCLEXTA as well as the con�nued strength of HUMIRA in the U.S. and newly
launched immunology assets SKYRIZI and RINVOQ, offset by interna�onal HUMIRA biosimilar compe��on.
Diluted earnings per share in 2019 was $5.28 and included the following a�er-tax costs: (i) $3.2 billion for the change in fair value of con�ngent considera�on liabili�es; (ii) $1.3 billion related to the amor�za�on of
intangible assets; (iii) a Stemcentrx-related impairment charge of $823 million net of the related fair value adjustment to con�ngent considera�on liabili�es; (iv) $364 million for acquired in-process research and
development (IPR&D); and (v) $338 million of expenses related to the proposed Allergan acquisi�on. These costs were par�ally offset by the following a�er-tax benefits: (i) $414 million from li�ga�on ma�ers primarily due
to the se�lement of an intellectual property dispute with a third party; (ii) $400 million due to the favorable resolu�on of various tax posi�ons; and (iii) $297 million from an amended and restated license agreement
between AbbVie and Reata Pharmaceu�cals, Inc. (Reata). Addi�onally, financial results reflected con�nued funding to support all stages of AbbVie’s emerging pipeline assets and con�nued investment in AbbVie’s on-market
brands.
In November 2019, AbbVie's board of directors declared a quarterly cash dividend of $1.18 per share of common stock payable in February 2020. This reflects an increase of approximately 10.3% over the previous
quarterly dividend of $1.07 per share of common stock.
26 | 2019 Form 10-K

5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 29/104
2020 Strategic Objec�ves
AbbVie's mission is to be an innova�on-driven, pa�ent-focused specialty biopharmaceu�cal company capable of achieving top-�er financial performance through outstanding execu�on and a consistent stream of
innova�ve new medicines. AbbVie intends to con�nue to advance its mission in a number of ways, including: (i) growing revenues by diversifying revenue streams, ensuring strong commercial execu�on of new product
launches and driving late-stage pipeline assets to the market; (ii) con�nuing to invest and expand its pipeline in support of opportuni�es in immunology, oncology and neuroscience, with addi�onal targeted investment in
cys�c fibrosis and women's health as well as con�nued investment in key on-market products; (iii) expanding opera�ng margins; and (iv) returning cash to shareholders via a strong and growing dividend while also reducing
incremental debt. In addi�on, AbbVie an�cipates several regulatory submissions and key data readouts from key clinical trials in the next 12 months.
AbbVie expects to achieve its strategic objec�ves through:
• Comple�on and successful integra�on of the proposed Allergan acquisi�on.
• Hematologic oncology revenue growth from both IMBRUVICA and VENCLEXTA.
• Immunology revenue growth driven by successful commercial launches of SKYRIZI and RINVOQ, as well as HUMIRA U.S. sales growth.
• Effec�ve management of HUMIRA interna�onal biosimilar erosion.
• The favorable impact of pipeline products and indica�ons recently approved or currently under regulatory review where approval is expected in 2020. These products are described in greater detail in the
sec�on labeled "Research and Development" included as part of this Item 7.
AbbVie remains commi�ed to driving con�nued expansion of opera�ng margins and expects to achieve this objec�ve through con�nued leverage from revenue growth, produc�vity ini�a�ves in supply chain and
ongoing efficiency programs to op�mize manufacturing, commercial infrastructure, administra�ve costs and general corporate expenses.
The combina�on of AbbVie and Allergan will create a diverse en�ty with leadership posi�ons across immunology, hematologic oncology, aesthe�cs, neuroscience, women's health, eye care and virology. AbbVie's
exis�ng product por�olio and pipeline will be enhanced with numerous Allergan assets and Allergan's product por�olio will benefit from AbbVie's commercial strength, exper�se and interna�onal infrastructure.
Research and Development
Research and innova�on are the cornerstones of AbbVie's business as a global biopharmaceu�cal company. AbbVie's long-term success depends to a great extent on its ability to con�nue to discover and develop
innova�ve pharmaceu�cal products and acquire or collaborate on compounds currently in development by other biotechnology or pharmaceu�cal companies.
AbbVie's pipeline currently includes approximately 60 compounds or indica�ons in clinical development individually or under collabora�on or license agreements and is focused on such important medical special�es
as immunology, oncology and neuroscience along with targeted investments in cys�c fibrosis and women's health. Of these programs, approximately 30 are in mid- and late-stage development.
The following sec�ons summarize transi�ons of significant programs from Phase 2 development to Phase 3 development as well as developments in significant Phase 3 and registra�on programs. AbbVie expects
mul�ple Phase 2 programs to transi�on into Phase 3 programs in the next 12 months.
Significant Programs and Developments
Immunology
RINVOQ
• In February 2019, the U.S. Food and Drug Administra�on (FDA) accepted for priority review AbbVie's New Drug Applica�on (NDA) for upadaci�nib, an inves�ga�onal oral JAK1-selec�ve inhibitor, for the
treatment of adult pa�ents with moderate to severe rheumatoid arthri�s (RA).
• In February 2019, AbbVie ini�ated a Phase 3 clinical trial to evaluate the efficacy and safety of upadaci�nib in subjects with giant cell arteri�s.

2019 Form 10-K | 27
5/2/2020 Document
https://www.sec.gov/Archives/edgar/data/1551152/000155115220000007/abbv-20191231x10k.htm 30/104
• In August 2019, the FDA approved RINVOQ (upadaci�nib) for the treatment of adults with moderately to severely ac�ve 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 pa�ents with ac�ve psoria�c arthri�s (PsA). Results from the SELECT-PsA 2 study, which evaluated
RINVOQ versus placebo in pa�ents 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 indica�ons, 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 pa�ents with ankylosing spondyli�s treated with RINVOQ achieved the primary endpoint at
week 14 versus placebo. The safety profile was consistent with that of previous studies across indica�ons, with no new safety risks detected.
• In November 2019, AbbVie ini�ated a Phase 3 clinical trial to evaluate the efficacy and safety of RINVOQ in adult pa�ents with axial spondyloarthri�s.
• In December 2019, the European Commission (EC) granted marke�ng authoriza�on for RINVOQ for the treatment of adult pa�ents with moderate to severe ac�ve rheumatoid arthri�s 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 pa�ents with ac�ve PsA. Results from the SELECT-PsA 1 study, which evaluated RINVOQ versus
placebo in pa�ents 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 indica�ons, with no new safety risks detected.
SKYRIZI
• In March 2019, AbbVie ini�ated two Phase 3 clinical trials to evaluate the efficacy and safety of risankizumab, an inves�ga�onal interleukin-23 (IL-23) inhibitor, in subjects with psoria�c arthri�s.
• 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 marke�ng authoriza�on for SKYRIZI for the treatment of moderate to severe plaque psoriasis in adult pa�ents who are candidates for systemic therapy.
Oncology
IMBRUVICA
• In January 2019, the FDA approved IMBRUVICA, in combina�on with GAZYVA (obinutuzumab), for adult pa�ents with previously untreated chronic lymphocy�c leukemia (CLL)/small lymphocy�c lymphoma
(SLL).
• In June 2019, AbbVie announced results from the Phase 3 CLL12 trial, evalua�ng IMBRUVICA in pa�ents with previously untreated CLL, which demonstrated that IMBRUVICA significantly improved event- and
progression-free survival.
• In November 2019, AbbVie submi�ed a supplemental New Drug Applica�on (sNDA) to the FDA for IMBRUVICA in combina�on with rituximab for the first-line treatment of younger pa�ents with CLL or SLL.
VENCLEXTA
• In March 2019, AbbVie announced that the FDA placed a par�al clinical hold on all clinical trials evalua�ng VENCLEXTA for the inves�ga�onal treatment of mul�ple myeloma (MM). The par�al clinical hold
followed a review of data from the ongoing Phase 3 BELLINI trial, a study in relapsed/refractory MM, in which a higher propor�on of deaths was observed in the VENCLEXTA arm compared to the control arm of
the trial. In June 2019, AbbVie announced that the FDA li�ed the par�al clinical hold placed on the Phase 3 CANOVA trial, evalua�ng VENCLEXTA for the inves�ga�onal treatment of relapsed/refractory MM
posi�ve for the transloca�on (11;14) abnormality, based upon agreement on revisions to the CANOVA study protocol, including new risk mi�ga�on measures,...