What changed in this filing

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Item 1. Business

2024-02-20 compared with 2023-02-17 · 74 added, 60 removed, 396 unchanged (25% of the section changed)

44 unchanged sentences

U.S., European Union

Adult Crohn's disease (moderate to severe)

Crohn's disease (moderate to severe)

U.S., Canada, European Union

10 unchanged sentences

Axial spondyloarthropathy U.S., European Union

Ulcerative colitis U.S., European Union

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

It is also indicated for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

Ulcerative colitis (moderate to severe)

U.S., European Union

Crohn's disease (moderate to severe)

U.S., European Union

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

It is also indicated for the treatment of Crohn's disease in adult patients who have an inadequate response or intolerance to one or more TNF blockers and for moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

In the European Union, Rinvoq is indicated for the treatment of moderate to severe rheumatoid arthritis in adults, for active psoriatic arthritis in adults who have an inadequate response or intolerance to disease-modifying anti-rheumatic medicines (DMARDs), and for active axial spondyloarthritis in adults.

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

It is also indicated for the treatment of Crohn's disease in adult patients who have an inadequate response or intolerance to one or more TNF blockers and for moderate to severe atopic dermatitis in adults and children 12 years of age and older, and for moderately to severely active ulcerative colitis in adults.

2023 Form 10-K |

Oncology products.

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Venclexta/Venclyxto.

Venclexta (venetoclax) is a B-cell lymphoma 2 (BCL-2) inhibitor used to treat hematological malignancies.

Venclexta (venetoclax) is a B-cell lymphoma 2 (BCL-2) inhibitor used to treat blood cancers.

Venclexta is approved by the FDA for adults with CLL or small lymphocytic lymphoma.

In addition, Venclexta

2022 Form 10-K |

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

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

Epkinly (epcoritimab) is a product used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has recurred or that does not respond to previous treatment after receiving two or more treatments.

Epkinly is administered as a subcutaneous injection.

Elahere (mirvetuximab soravtansine-gynx) is an antibody-drug conjugate (ADC) used to treat certain types of cancer.

On November 14, 2022, the FDA granted accelerated approval for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Aesthetics products.

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AbbVie's levodopa-carbidopa intestinal 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.

| 2023 Form 10-K

Ubrelvy (ubrogepant) is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.

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

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

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

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

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

Qulipta is commercialized in the United States and Canada and is approved in the European Union under the brand name Aquipta.

Eye care products.

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These products are:

Ozurdex (dexamethasone intravitreal implant) is a corticosteroid implant that slowly releases medication over time.

Injected directly into the back of the eye, it dissolves naturally and does not need to be removed.

Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME), adult patients with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) and patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis.

Ozurdex® is commercially available in the United States and numerous markets around the world.

Lumigan/Ganfort.

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Both Alphagan and Combigan are available for sale in the United States and numerous markets around the world.

| 2022 Form 10-K

Restasis is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

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Other eye care.

Other eye care products include Ozurdex, Refresh/Optive, Xen and Durysta.

Other eye care products include Refresh/Optive, Xen and Durysta.

Other key products.

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It is also indicated for the treatment of adult and pediatric patients (12 years and older or weighing at least 45 kilograms) with HCV genotype 1 infection, 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 patients without cirrhosis and following the EXPEDITION-8 study, also in patients with compensated cirrhosis who are new to treatment.

Creon (pancrelipase) is a pancreatic enzyme therapy for exocrine pancreatic insufficiency, a condition that occurs in patients with cystic fibrosis, chronic pancreatitis and several other conditions.

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AbbVie has the rights to sell Creon and Synthroid only in the United States.

2023 Form 10-K |

Marketing, Sales and Distribution Capabilities

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No individual wholesaler accounted for greater than 39% of AbbVie's 2023 gross revenues in the United States.

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

2022 Form 10-K |

Certain products are co-marketed or co-promoted with other companies.

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

For example, AbbVie's immunology products compete with anti-TNF products, JAK inhibitors and other competitive products intended to treat a number of disease states, and AbbVie's oncology products compete with BTK inhibitors.

In addition, in the past few years, a number of other companies have started to develop, have successfully developed and/or are currently marketing products that are being positioned as competitors to Botox.

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Significant investments in biologics infrastructure and manufacturing are necessary to produce biologic products.

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

Humira is facing direct biosimilar competition globally, and AbbVie will continue to face competitive pressure from these biologics and from orally administered products.

In the United States, the FDA regulates biologics under the Federal Food, Drug, and Cosmetic Act (the FFDCA), the Public Health Service Act (PHSA) and the regulations implementing these statutes.

The enactment of federal health care reform legislation in March 2010 provided a pathway for approval of biosimilars under the PHSA, 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.

| 2023 Form 10-K

terms of safety, purity and potency.

The types of data that could ordinarily be required in an application to show similarity may include analytical data, bioequivalence studies and studies to demonstrate chemical similarity, animal studies (including toxicity studies) and clinical studies.

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The Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman Act) permits a patent holder to seek a patent extension, commonly called a “patent term restoration,” for patents on products (or processes for making the product) regulated by the FFDCA.

The length of the patent extension is roughly based on 50 percent of the period of time from the filing of an Investigational New Drug Application (NDA) for a

| 2022 Form 10-K

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

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

The extension, however, cannot exceed five years and the patent term remaining after regulatory approval cannot exceed 14 years.

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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 litigate patent infringement, validity and enforceability.

The law also includes an extensive process for the innovator biologic and biosimilar manufacturer to litigate patent

2023 Form 10-K |

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.

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AbbVie licenses or owns a patent portfolio of thousands of patent families, each of which includes United States patent applications and/or issued patents and may also contain the non-United States counterparts to these patents and applications.

These patents and applications, including various patents that expire during the period 2023 to the early 2040s, in aggregate are believed to be of material importance in the operation 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 relation to the company’s business as a whole.

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

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

These patents and applications, including various patents that expire during the period 2024 to the mid 2040s, in aggregate are believed to be of material importance in the operation of AbbVie’s business.

However, AbbVie believes that no single patent, license, trademark (or related group of patents, licenses, or trademarks), are material in relation to the company’s business as a whole.

In addition, the following patents, licenses and trademarks are significant:

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AbbVie may rely, in some circumstances, on trade secrets to protect its technology.

AbbVie seeks to protect its technology and product candidates, in part, by confidentiality agreements with its employees, consultants, advisors,

2022 Form 10-K |

contractors and collaborators.

AbbVie seeks to protect its technology and product candidates, in part, by confidentiality agreements with its employees, consultants, advisors, contractors and collaborators.

These agreements may be breached and AbbVie may not have adequate remedies for any breach.

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AbbVie purchases, in the ordinary course of business, raw materials and supplies essential to its operations from numerous suppliers around the world.

In addition, certain medical devices and components necessary for the manufacture of AbbVie products are provided by unaffiliated third party suppliers.

Despite the disruption to the global supply chain caused by COVID-19, AbbVie has continued to supply patients with no material supply impact, except for the previously-disclosed supply issues impacting Lupron.

Given the general increased global volatility due to the pandemic, AbbVie is monitoring and taking actions to mitigate potential supply shortages which may impact the fulfillment of product demand.

In addition, certain medical devices and components necessary for the manufacture of

| 2023 Form 10-K

AbbVie products are provided by unaffiliated third party suppliers.

AbbVie has robust business continuity and supplier monitoring programs.

Research and Development Activities

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• Phase 3— tests a drug that demonstrates favorable results in the earlier phases in a significantly larger patient population to further demonstrate efficacy and safety in order to meet requirements to enable global approval.

| 2022 Form 10-K

Preclinical data and clinical trials from all of the development phases provide the data required to prepare and submit an NDA, a Biological License Application (BLA) or other submission for regulatory approval to the FDA or similar government agencies outside the United States.

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The FDA periodically inspects manufacturing facilities to assess compliance with cGMP, which imposes extensive procedural and record keeping requirements.

In addition, as a condition of approval, the FDA may require post-marketing testing and surveillance to further assess and monitor the product's safety or efficacy after commercialization, which may require additional clinical trials, patient registries, observational data or additional work on chemistry, manufacturing and controls.

In addition, as a condition of approval, the FDA may require post-marketing testing and surveillance to further

2023 Form 10-K |

assess and monitor the product's safety or efficacy after commercialization, which may require additional clinical trials, patient registries, observational data or additional work on chemistry, manufacturing and controls.

Any post-approval regulatory obligations, and the cost of complying with such obligations, could expand in the future.

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In Japan, applications for approval of a new product are made through the Pharmaceutical and Medical Devices Agency (PMDA).

Japan-specific trials and/or bridging studies to demonstrate that the non-Japanese clinical data applies to Japanese patients may be required.

Japan-specific trials and/or bridging studies to demonstrate that the non-Japanese clinical data applies to Japanese patients are usually required.

After completing a comprehensive review, the PMDA reports to the Ministry of Health, Labour and Welfare, which then approves or denies the application.

2022 Form 10-K |

Similarly, applications for a new product in China are submitted to the Center for Drug Evaluation of the National Medical Products Administration for technical review and approval of a product for marketing in China.

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Failure to comply can delay the release of a new product or result in regulatory and enforcement actions, the seizure or recall of a product, the suspension or revocation of the authority necessary for a product's production and sale and other civil or criminal sanctions, including fines and penalties.

| 2023 Form 10-K

In addition to regulatory initiatives, AbbVie's business can be affected by ongoing studies of the utilization, safety, efficacy and outcomes of health care products and their components that are regularly conducted by industry participants, government agencies and others.

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In addition, recent legislative changes would require similarly discounted prices to be offered to TRICARE program beneficiaries.

The Veterans Health Care

| 2022 Form 10-K

Act of 1992 also established the 340B drug discount program, which requires pharmaceutical manufacturers to provide products at reduced prices to various designated health care entities and facilities.

The Veterans Health Care Act of 1992 also established the 340B drug discount program, which requires pharmaceutical manufacturers to provide products at reduced prices to various designated health care entities and facilities.

In the United States, most states also have generic substitution legislation requiring or permitting a dispensing pharmacist to substitute a different manufacturer's generic version of a pharmaceutical product for the one prescribed.

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Failure to report appropriate data may result in civil or criminal fines and/or penalties.

The Inflation Reduction Act of 2022 (the IRA) requires:

(i) the government to set prices for select high expenditure Medicare Part D drugs (prices effective beginning in 2026) and Part B drugs (prices effective beginning in 2028) that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices for those drugs increase faster than inflation beginning in 2022 for Part D and 2023 for Part B, and (iii) a Medicare Part D redesign replacing the current coverage gap provisions and establishing a $2,000 cap for out-of-pocket costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.

In August 2023, the U.S.

Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (the CMS), selected Imbruvica as one of the first 10 medicines subject to government-set prices beginning in 2026.

The price-setting process will conclude by August 1, 2024, and on September 1, 2024, the CMS will publish prices that will be applicable to the 10 drugs in the Medicare program beginning January 1, 2026.

It is possible that more of our products, including products that generate substantial revenues,

2023 Form 10-K |

could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiration of intellectual property protections.

The effect of reducing prices and reimbursement would significantly impact revenues for certain of our products.

European Union.

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Certain additional risks are inherent in conducting business outside the United States, including price and currency exchange controls, changes in currency exchange rates, limitations on participation in local enterprises, expropriation, nationalization and other governmental action.

2022 Form 10-K |

Regulation – Medical Devices

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The majority of AbbVie’s medical device products, including AbbVie’s breast implants, are regulated as Class III medical devices.

A Class III device may have significant additional obligations imposed in its conditions of approval, and the time in which it takes to obtain approval can be long.

A Class III device may have significant additional obligations imposed in its conditions of approval, and the time in which it takes

| 2023 Form 10-K

to obtain approval can be long.

Compliance with regulatory requirements is assured through periodic, unannounced facility inspections by the FDA and other regulatory authorities, and these inspections may include the manufacturing facilities of AbbVie’s subcontractors or other third-party manufacturers.

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Failure to comply with these domestic and international regulatory requirements could affect AbbVie’s ability to market and sell AbbVie’s products in these countries.

| 2022 Form 10-K

Environmental Matters

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AbbVie believes that it has good relations with its employees.

2023 Form 10-K |

Human Capital Management

Attracting, retaining and providing meaningful growth and development opportunities to AbbVie's employees is critical to the company's success in making a remarkable impact on people’s lives around the world.

AbbVie leverages numerous resources to identify and enhance strategic and leadership capability, foster employee engagement and create a culture where diverse talent is productive and engaged.

AbbVie leverages numerous resources to identify and enhance strategic and leadership capability, foster employee engagement and create a culture where talent is productive and engaged.

AbbVie invests in its employees through competitive compensation, benefits and employee support programs and offers best-in-class development and leadership opportunities.

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AbbVie implements detailed talent attraction strategies, with an emphasis on STEM skill sets, a diverse talent base and other critical skillsets, including drug discovery, clinical development, market access and business development.

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

AbbVie also invests in competitive compensation and benefits programs.

In addition to offering a comprehensive suite of benefits ranging from medical and dental coverage to retirement, disability and life insurance programs, AbbVie also provides health promotion programs, mental health awareness campaigns and employee assistance programs in several countries, financial wellness support, on-site health screenings and immunizations in several countries and on-site fitness and rehabilitation centers.

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

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

In addition, the AbbVie Employee Assistance Fund (a part of the AbbVie Foundation) supports two programs for global employees:

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the death of a spouse).

Finally, AbbVie empowers managers and their teams with tools, tips and guidelines on effectively managing workloads, managing teams from a distance and supporting flexible work practices.

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

Finally, AbbVie empowers managers and their teams with tools, tips and guidelines on effectively managing workloads, managing teams from a distance and supporting flexible work practices, including "Where We Work", AbbVie's hybrid work model, offering eligible employees predictable flexibility.

New AbbVie employees are given a tailored onboarding experience for faster integration and to support performance.

One of AbbVie's mentorship programs allows employees to self-nominate as mentors or mentees and facilitates meaningful relationships supporting employees’ career and development goals.

2022 Form 10-K |

AbbVie also provides structured, broad-based development opportunities, focusing on high-performance skills and leadership training.

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In addition, a foundational success factor to AbbVie's leadership pipeline is the company's Professional Development Programs, which attract graduates, postgraduates and post-doctoral talent to participate in formal development programs lasting up to three years, with the objective of strengthening functional and leadership capabilities.

AbbVie’s shared values of transforming lives, acting with integrity, driving innovation, embracing diversity and inclusion and serving the community form the core of the company's culture.

AbbVie’s shared principles of transforming lives, acting with integrity, driving innovation, embracing diversity and inclusion and serving the community form the core of the company's culture.

AbbVie articulates the behaviors associated with these values in the Ways We Work, a core set of working behaviors that emphasize how the company achieves results is equally as important as achieving them.

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A cornerstone of AbbVie’s human capital management approach is to prioritize fostering an inclusive and diverse workforce.

Recently, AbbVie adopted a five-year Equality, Diversity & Inclusion roadmap that defines key global focus areas, objectives and associated initiatives, and includes implementation plans organized by business function and geography.

AbbVie's Equity, Equality, Diversity & Inclusion roadmap defines key global focus areas, objectives and associated initiatives, and includes implementation plans organized by business function and geography.

AbbVie’s senior leaders have adopted formal goals aligned with executing this strategy.

In recent years, AbbVie's board of directors has prioritized oversight of AbbVie's response to the U.S.

racial justice movement, including overseeing internal programs designed to ensure that AbbVie is attracting, retaining and developing diverse talent.

Through December 2022, women represented 52 percent of management positions globally and in the United States, 37 percent of AbbVie's workforce was comprised of members of historically underrepresented populations, an increase from 2021.

Through December 2023, women represented 52 percent of management positions globally and in the United States, 37 percent of AbbVie's workforce was comprised of members of historically underrepresented populations, consistent with 2022.

Further, AbbVie is committed to pay equity and conducts pay equity analyses annually.

A critical component of AbbVie's strategy is to instill an inclusive mindset in all AbbVie leaders and employees, so the company continues to realize the full value of its diverse workforce from recruitment through retirement.

AbbVie's Employee Resource Groups also help the company nurture an inclusive culture by building community and creating connections and opportunities for mentoring, professional development, talent attraction and networking.

In 2021, AbbVie reiterated its commitment to racial equality and social justice by, among other things, expanding its employee matching program to $3-to-$1 for donations to civil rights nonprofits fostering racial equity and by reaffirming its commitment to clinical trial diversity.

Additional information about AbbVie's efforts on racial equality and social justice is provided on the company's website at:

https://abbvie.com/our-company/equality-inclusion-diversity/our-commitment-to-racial-justice.html.

A critical component of AbbVie's strategy is to instill an inclusive mindset in all AbbVie leaders and employees, so the company continues to realize the full value of its workforce from recruitment through retirement.

AbbVie's Employee Resource Groups also help the company nurture an inclusive culture by building community and creating connections.

Additional information about AbbVie's Equity, Equality, Diversity and

| 2023 Form 10-K

Inclusion efforts can be found on the company's website at:

https://www.abbvie.com/who-we-are/equity-equality-inclusion-diversity.html.

Internet Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business