What changed in this filing

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Item 1. Business

2025-02-14 compared with 2024-02-20 · 62 added, 63 removed, 407 unchanged (23% of the section changed)

23 unchanged sentences

Ankylosing spondylitis North America, European Union

Adult Crohn's disease (moderate to severe) North America, European Union

Crohn's disease (moderate to severe)

North America, European Union

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

1 unchanged sentence

Ulcerative colitis (moderate to severe) North America, European Union

Axial spondyloarthropathy European Union

Non-radiographic axial spondyloarthritis

European Union

Pediatric Crohn's disease (moderate to severe) North America, European Union

2 unchanged sentences

Non-infectious intermediate, posterior and panuveitis North America, European Union

Pediatric ulcerative colitis (moderate to severe) U.S., Canada, European Union

Pediatric ulcerative colitis (moderate to severe) North America, European Union

Pediatric uveitis North America, European Union

| 2024 Form 10-K

Humira is also approved in Japan for the treatment of intestinal Behçet's disease and pyoderma gangrenosum.

Humira is sold in numerous other markets worldwide, including Japan, China, Brazil and Australia, and accounted for approximately 27% of AbbVie's total net revenues in 2023.

Humira is also approved in Japan for the treatment of intestinal Behçet's disease, generalized pustular psoriasis, and pyoderma gangrenosum.

Humira is sold in numerous other markets worldwide, including Japan, China, Brazil and Australia.

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

4 unchanged sentences

Psoriatic arthritis

U.S., European Union

North America, European Union, Japan

Crohn's disease (moderate to severe)

U.S., Canada, European Union

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

North America, European Union, Japan

Ulcerative colitis (moderate to severe)

U.S., Canada, European Union, Japan

Skyrizi is also approved in Japan for the treatment of erythrodermic psoriasis in patients who have an inadequate response to conventional therapies, for generalized pustular psoriasis, and for palmoplantar pustulosis in patients who have an inadequate response to conventional therapies.

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

In psoriatic disease (psoriasis or psoriatic arthritis), Skyrizi is administered as a quarterly subcutaneous injection following two induction doses.

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

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

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

1 unchanged sentence

Rheumatoid arthritis (moderate to severe) North America, European Union, Japan

Psoriatic arthritis U.S., Canada, European Union, Japan

Ankylosing spondylitis U.S., European Union

Atopic dermatitis (moderate to severe) U.S., Canada, European Union, Japan

Axial spondyloarthropathy U.S., European Union

Psoriatic arthritis North America, European Union, Japan

Ankylosing spondylitis North America, European Union, Japan

Atopic dermatitis (moderate to severe) North America, European Union, Japan

Non-radiographic axial spondyloarthritis

U.S., Canada, European Union, Japan

Ulcerative colitis (moderate to severe)

U.S., European Union

North America, European Union, Japan

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.

U.S., Canada, European Union, Japan

Active polyarticular juvenile idiopathic arthritis

In the United States, Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis, for active psoriatic arthritis in adults and children 2 years of age and older, 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.

1 unchanged sentence

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.

RINVOQ is sold in numerous other markets worldwide, including China, Brazil, and Australia.

In the United States, a liquid formulation (RINVOQ LQ) is also approved for use in pediatric patients with psoriatic arthritis and polyarticular juvenile idiopathic arthritis.

2024 Form 10-K |

10 unchanged sentences

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.

Elahere is approved in both the United States and the European Union 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.

Epkinly (epcoritamab) 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.

Epkinly is also approved to treat adults with relapsed or refractory follicular lymphoma.

Aesthetics products.

3 unchanged sentences

Botox Cosmetic.

Botox Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for treatment in three areas:

temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows), moderate to severe crow's feet and moderate to severe forehead lines in adults.

Having received its initial FDA approval in 2002, Botox Cosmetic is now approved for use in all major markets around the world.

Botox Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for treatment in four areas:

temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows), moderate to severe crow's feet, moderate to severe forehead lines in adults and moderate to severe platysma bands.

Botox Cosmetic is approved for use in all major markets around the world and is approved for the treatment of masseter muscle prominence in China.

The Juvederm Collection of Fillers.

The Juvederm Collection of Fillers is a portfolio of hyaluronic acid-based dermal fillers with a variety of approved indications in the U.S.

and in other major markets around the world to augment or treat volume loss in the cheeks, chin, lips and lower face.

and in other major markets around the world to augment or treat volume loss in the temples, undereye, cheeks, chin, lips and lower face.

Other aesthetics.

18 unchanged sentences

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

Other neuroscience.

Other neuroscience products include Vyalev/Produodopa, a subcutaneous 24-hour infusion of levodopa-based therapy approved for the treatment of motor fluctuations in adults with advanced Parkinson's disease, as well as other products.

Eye care products.

24 unchanged sentences

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.

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

Lupron is approved for daily subcutaneous injection and one-month, three-month, four-month and six-month intramuscular injection.

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

Linzess/Constella.

1 unchanged sentence

The product is marketed as Linzess in the United States and as Constella outside of the United States.

Synthroid (levothyroxine sodium tablets, USP) is used in the treatment of hypothyroidism.

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

2024 Form 10-K |

11 unchanged sentences

In 2024, three wholesale distributors (McKesson Corporation, Cardinal Health, Inc.

and AmerisourceBergen Corporation) accounted for substantially all of AbbVie's pharmaceutical product sales in the United States.

and Cencora, Inc.) accounted for substantially all of AbbVie's pharmaceutical product sales in the United States.

No individual wholesaler accounted for greater than 39% of AbbVie's 2024 gross revenues in the United States.

16 unchanged sentences

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

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

Humira faces 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.

42 unchanged sentences

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

those related to ibrutinib (which is sold under the trademark Imbruvica), those related to risankizumab (which is sold under the trademark Skyrizi) and those related to upadacitinib (which is sold under the trademark Rinvoq).

The United States composition of matter patent covering ibrutinib is expected to expire in 2027, with pediatric regulatory exclusivity then extending until May 2028.

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

The United States composition of matter patent covering risankizumab is expected to expire in 2033.

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

those related to risankizumab (which is sold under the trademark Skyrizi) and those related to upadacitinib (which is sold under the trademark Rinvoq).

The United States composition of matter patents covering risankizumab and upadacitinib are expected to expire in 2033.

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

18 unchanged sentences

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

| 2023 Form 10-K

AbbVie products are provided by unaffiliated third party suppliers.

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

AbbVie has robust business continuity and supplier monitoring programs.

| 2024 Form 10-K

Research and Development Activities

28 unchanged sentences

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

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.

Any post-approval

2024 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.

regulatory obligations, and the cost of complying with such obligations, could expand in the future.

Further, the FDA continues to regulate product labeling, and prohibits the promotion of products for unapproved or “off-label” uses along with other labeling restrictions.

51 unchanged sentences

Under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (together, the Affordable Care Act), AbbVie pays a fee related to its pharmaceuticals sales to government programs.

In addition, AbbVie provides a discount of 70% for branded prescription drugs sold to patients who fall into the Medicare Part D coverage gap, or "donut hole."

In addition, through the end of 2024 AbbVie provided a discount of 70% for branded prescription drugs sold to patients who fell 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 teaching hospitals and to report this data to the Centers for Medicare and Medicaid Services for subsequent public disclosure.

4 unchanged sentences

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,

Department of Health and Human Services (HHS), 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.

In August 2024, the CMS published Medicare Part D prices that will be applicable to these medicines, including Imbruvica, beginning January 1, 2026.

In January 2025, HHS, through the CMS, selected Vraylar and Linzess as two of the 15 medicines subject to government-set prices

2024 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.

beginning in 2027.

It is possible that more of our products, including products that generate substantial revenues, 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 could significantly impact revenues for certain of our products.

European Union.

32 unchanged sentences

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

| 2024 Form 10-K

to obtain approval can be long.

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.

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.

38 unchanged sentences

AbbVie has developed a deep talent base through ongoing investment in functional and leadership training and by sourcing world-class external talent, ensuring a sustainable talent pipeline.

AbbVie continuously cultivates and enhances its working culture and embraces equality, diversity and inclusion as fundamental to the company's mission.

Attracting and Developing Talent.

Attracting and developing high-performing talent is essential to AbbVie’s continued success.

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

AbbVie seeks candidates with diverse backgrounds, experiences, and perspectives to enhance innovation and problem-solving.

AbbVie also invests in competitive compensation and benefits programs.

7 unchanged sentences

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, including "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 and managing teams from a distance.

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

9 unchanged sentences

AbbVie believes its culture creates strong engagement, which is measured regularly through a confidential, third-party all-employee survey, and this engagement supports AbbVie’s mission of making a remarkable impact on people’s lives.

Equity, Equality, Diversity & Inclusion (EED&I).

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

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.

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.

Diversity & Inclusion.

A cornerstone of AbbVie’s human capital management approach is to prioritize fostering an inclusive workforce where all employees have equal opportunity to succeed.

AbbVie is committed to equal employment opportunity and non-discrimination in all aspects of employment.

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

1 unchanged sentence

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

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 Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available free of charge through AbbVie's investor relations website ( investors.abbvie.com ) as soon as reasonably practicable after AbbVie electronically files the material with, or furnishes it to, the Securities and Exchange Commission (SEC).

AbbVie's corporate governance guidelines, outline of directorship qualifications, code of business conduct and the charters of AbbVie's audit committee, compensation committee, nominations and governance committee and public policy committee are all available on AbbVie's investor relations website ( investors.abbvie.com ).

| 2024 Form 10-K

available free of charge through AbbVie's investor relations website ( investors.abbvie.com ) as soon as reasonably practicable after AbbVie electronically files the material with, or furnishes it to, the Securities and Exchange Commission (SEC).

AbbVie's corporate governance guidelines, outline of directorship qualifications, code of business conduct and the charters of AbbVie's audit committee, compensation committee, nominations and governance committee and public policy and sustainability committee are all available on AbbVie's investor relations website ( investors.abbvie.com ).

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