What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-02-20 compared with 2025-02-14 · 120 added, 121 removed, 348 unchanged (41% of the section changed)

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and its consolidated subsidiaries, as the context requires.

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

AbbVie uses its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases.

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These products are:

Humira (adalimumab) is a biologic therapy administered as a subcutaneous injection.

It is approved to treat the following autoimmune diseases in the United States, Canada and Mexico (collectively, North America) and in the European Union:

Condition Principal Markets

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

Psoriatic arthritis North America, European Union

Ankylosing spondylitis North America, European Union

Crohn's disease (moderate to severe)

North America, European Union

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

Juvenile idiopathic arthritis (moderate to severe polyarticular) North America, European Union

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

Non-radiographic axial spondyloarthritis

European Union

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

Hidradenitis suppurativa (moderate to severe) North America, European Union

Pediatric enthesitis-related arthritis European Union

Non-infectious intermediate, posterior and panuveitis North America, 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, 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.

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

It is a biologic therapy approved to treat the following autoimmune diseases in the United States, Canada and Mexico (collectively, North America), the European Union and Japan:

Principal Markets

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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 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.

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

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

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

Skyrizi is sold in numerous other markets worldwide.

| 2025 Form 10-K

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:

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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)

North America, European Union, Japan

Non-radiographic axial spondyloarthritis North America, European Union, Japan

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

Crohn's disease (moderate to severe)

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.

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 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.

Giant cell arteritis U.S., Canada, European Union, Japan

Active polyarticular juvenile idiopathic arthritis U.S.

In the United States, Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis, moderate to severe ulcerative colitis and moderate to severe active Crohn's disease in adult patients who have an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

For Crohn's disease and ulcerative colitis, it is additionally approved prior to the use of TNF blockers in patients for whom the use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy.

It is also indicated for the treatment of adult and pediatric patients two years of age and older with active psoriatic arthritis and for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

It is also indicated for the treatment of adults and adolescents 12 years of age and older with moderate to severe atopic dermatitis 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 active rheumatoid arthritis and active psoriatic arthritis in adult patients who have an inadequate response or intolerance to disease-modifying anti-rheumatic medicines (DMARDs).

It is also indicated for the treatment of moderate to severe active ulcerative colitis and Crohn's disease in adult patients who have an inadequate response or were intolerant to either conventional therapy or a biologic agent.

It is also indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs) and for ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Additionally, it is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years of age and older who are candidates for systemic therapy.

Rinvoq is sold in numerous other markets worldwide.

2025 Form 10-K |

Humira (adalimumab) is a biologic therapy administered as a subcutaneous injection.

It is approved to treat the following autoimmune diseases in North America and in the European Union:

Condition Principal Markets

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

Psoriatic arthritis North America, European Union

Ankylosing spondylitis North America, European Union

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

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

Juvenile idiopathic arthritis (moderate to severe polyarticular) North America, European Union

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

Non-radiographic axial spondyloarthritis European Union

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

Hidradenitis suppurativa (moderate to severe) North America, European Union

Pediatric enthesitis-related arthritis European Union

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

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

Pediatric uveitis North America, European Union

Neuroscience products.

AbbVie’s neuroscience products address some of the most difficult-to-treat neurologic diseases.

These products are:

Vraylar (cariprazine) is a dopamine D3-preferring D3/D2 receptor partial agonist and a 5-HT1A receptor partial agonist.

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

Botox Therapeutic.

Botox Therapeutic (onabotulinumtoxinA) is an injectable product, an acetylcholine release inhibitor and a neuromuscular blocking agent.

In the United States, it is approved to treat numerous indications, including chronic migraine, overactive bladder in adults who have an inadequate response to an anticholinergic medication and urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to an anticholinergic medication.

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

Botox is marketed in other countries around the world and licenses will vary.

Botox Therapeutic is marketed by GSK in Japan.

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 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.

Vyalev (foscarbidopa and foslevodopa) is a subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

Vyalev is commercialized in the United States and in many other markets primarily as Produodopa though brand names vary by region.

Duodopa (carbidopa and levodopa) is a levodopa-carbidopa intestinal gel for the treatment of advanced Parkinson's disease is marketed as Duopa in the United States and primarily as Duodopa outside of the United States.

| 2025 Form 10-K

Oncology products.

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

Venclexta/Venclyxto.

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

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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.

It is marketed as Venclexta in the United States and primarily as Venclyxto outside of the United States.

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

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

It is marketed as Epkinly in the United States and primarily as Tepkinly outside of the United States.

Other oncology.

Other oncology products include Emrelis, an ADC used for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression who have received prior systemic therapy.

Aesthetics products.

AbbVie’s Aesthetics portfolio consists of facial injectables, plastics and regenerative medicine, body contouring and skincare products, which hold market-leading positions in the U.S.

and in key markets around the world.

AbbVie’s Aesthetics portfolio consists of facial injectables, plastics and regenerative medicine, body contouring and skincare products, which hold market-leading positions in the United States and in key markets around the world.

These products are:

Botox Cosmetic.

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

Botox Cosmetic (onabotulinumtoxinA) 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.

Juvederm Collection.

Juvederm Collection 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 temples, undereye, cheeks, chin, lips and lower face.

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Other aesthetics products include, but are not limited to, Alloderm regenerative dermal tissue, CoolSculpting body contouring technology, Natrelle breast implants, the SkinMedica skincare line, Latisse eyelash solution and DiamondGlow dermabrasion technology.

Neuroscience products.

AbbVie’s neuroscience products address some of the most difficult-to-treat neurologic diseases.

These products are:

Botox Therapeutic.

Botox Therapeutic (onabotulinumtoxinA injection) is an acetylcholine release inhibitor and a neuromuscular blocking agent that is injected into muscle tissue.

In the United States, it is approved to treat numerous indications, including chronic migraine, overactive bladder in adults who have an inadequate response to an anticholinergic medication, and urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to an anticholinergic medication.

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

Botox is marketed in other countries around the world and licenses will vary.

Botox Therapeutic is marketed by GSK in Japan.

Vraylar (cariprazine) is a dopamine D3-preferring D3/D2 receptor partial agonist and a 5-HT1A receptor partial agonist.

Duopa and Duodopa (carbidopa and levodopa).

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.

| 2024 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 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.

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.

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Lumigan (bimatoprost ophthalmic solution) 0.01% is a once daily, topical prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

Ganfort is a once daily topical fixed combination of bimatoprost 0.03% and timolol 0.5% for the reduction of IOP in adult patients with OAG or OHT.

Ganfort is a once daily topical fixed combination of bimatoprost 0.03% and timolol 0.5% for the reduction

2025 Form 10-K |

of IOP in adult patients with OAG or OHT.

Lumigan is sold in the United States and numerous markets around the world, while Ganfort is approved in the European Union and some markets in South America, the Middle East and Asia.

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

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.

Restasis is approved in the United States and a number of other markets in South America, the Middle East and Asia.

Other eye care.

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

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

Other key products.

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

AbbVie’s other key products include, among other things, treatments for patients with hepatitis C virus (HCV), exocrine pancreatic insufficiency, hypothyroidism, irritable bowel syndrome with constipation and chronic idiopathic constipation.

These products are:

Mavyret/Maviret.

Mavyret (glecaprevir/pibrentasvir) is approved in the United States and European Union (Maviret) for the treatment of adult and pediatric patients (12 years and older or weighing at least 45 kilograms) with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A).

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.

Mavyret is also approved in the United States for the treatment of adults and pediatric patients 3 years and older with acute or chronic hepatitis C virus infection.

It is marketed as Mavyret in the United States and primarily as Maviret outside of the United States.

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

2024 Form 10-K |

Marketing, Sales and Distribution Capabilities

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AbbVie has no single customer that, if the customer were lost, would have a material adverse effect on the company's business.

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

Orders are generally filled on a current basis and order backlog is not material to AbbVie's business.

| 2025 Form 10-K

The markets for AbbVie's products are highly competitive.

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 and other competitive products intended to treat certain cancers.

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.

For example, AbbVie's immunology products compete with IL-23 inhibitors, IL-17 inhibitors, JAK inhibitors, biosimilars and other competitive products intended to treat a number of disease states, and AbbVie's oncology products compete with targeted therapies including BTK inhibitors, ADCs, cell therapies and other competitive products intended to treat certain cancers.

In addition, a number of other companies have successfully developed and market products that are being positioned as competitors to Botox.

The search for technological innovations in pharmaceutical products is a significant aspect of competition.

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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.

In the United States, the FDA regulates biologics under the Federal Food, Drug, and Cosmetic Act (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

| 2024 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 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% 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% 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.

Biological products licensed under the PHSA are similarly eligible for terms of patent restoration.

2025 Form 10-K |

Pharmaceutical products may be entitled to other forms of legal or regulatory exclusivity upon approval.

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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

2024 Form 10-K |

infringement, validity and enforceability.

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

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These patents and applications, including various patents that expire during the period 2026 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:

The following patents, licenses and trademarks are significant:

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.

In September 2025, AbbVie settled litigation with all generic manufacturers that filed abbreviated new drug applications with the U.S.

FDA for generic versions of upadacitinib tablets.

Given the settlement and license agreements, which are subject to standard acceleration provisions, assuming pediatric exclusivity is granted, no generic entry for Rinvoq tablets is expected prior to April 2037 in the United States.

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

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

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Licensing, Acquisitions and Other Arrangements

In addition to its independent efforts to develop and market products, AbbVie enters into arrangements such as acquisitions, option-to-acquire agreements, licensing arrangements, option-to-license arrangements, strategic alliances, co-promotion arrangements, co-development and co-marketing agreements and joint ventures.

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

The licensing and other arrangements typically include, among other terms and conditions, non-refundable upfront license fees, option fees and option exercise payments, milestone payments and royalty and/or profit sharing obligations.

| 2025 Form 10-K

promotion arrangements, co-development and co-marketing agreements and joint ventures.

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

The licensing and other arrangements typically include, among other terms and conditions, upfront license fees, option fees and option exercise payments, milestone payments and royalty and/or profit sharing obligations.

See Note 5, "Licensing, Acquisitions and Other Arrangements—Other Licensing & Acquisitions Activity," to the Consolidated Financial Statements included under Item 8, "Financial Statements and Supplementary Data."

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AbbVie has robust business continuity and supplier monitoring programs.

| 2024 Form 10-K

Research and Development Activities

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• Phase 2— tests different doses of the drug in a disease state in order to assess efficacy.

• 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.

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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There is no guarantee when, or if, a molecule will receive the regulatory approval required to launch a new drug or indication.

2025 Form 10-K |

In addition to the development of new products, delivery devices and new formulations, research and development projects also may include Phase 4 trials, sometimes called post-marketing studies.

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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 |

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

Any post-approval 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.

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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.

Similar to the requirements in Japan and China, certain countries (notably South Korea, Taiwan, India and Russia) also generally require that clinical studies that include data from patients in those countries be conducted in order to support local regulatory approval.

Similar to the requirements in Japan and

| 2025 Form 10-K

China, certain countries (notably South Korea, Taiwan, India and Russia) also generally require that clinical studies that include data from patients in those countries be conducted in order to support local regulatory approval.

The requirements governing the conduct of clinical trials and product licensing also vary.

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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.

| 2024 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, the federal government follows a diagnosis-related group (DRG) payment system for certain institutional services provided under Medicare or Medicaid and has implemented a prospective payment system (PPS) for services delivered in hospital outpatient, nursing home and home health settings.

DRG and PPS entitle a health care facility to a fixed reimbursement based on the diagnosis and/or procedure rather than actual costs incurred in patient treatment, thereby increasing the incentive for the facility to limit or control expenditures for many health care products.

DRG and PPS entitle a health care facility to a fixed

2025 Form 10-K |

reimbursement based on the diagnosis and/or procedure rather than actual costs incurred in patient treatment, thereby increasing the incentive 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 administration costs, which have been reduced in the hospital outpatient setting.

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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.

Similar reporting 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 interactions with health care professionals.

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

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

The Inflation Reduction Act of 2022 (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 (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 |

beginning in 2027.

Department of Health and Human Services (HHS), through CMS, selected Imbruvica as one of 10 medicines subject to government-set prices in Medicare Part D beginning January 1, 2026, and in January 2025, selected Vraylar and Linzess as two of 15 medicines subject to government-set prices in Medicare Part D beginning January 1, 2027.

In January 2026, Botox was selected as one of 15 medicines subject to government-set prices in Medicare Parts B and D beginning January 1, 2028.

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.

17 unchanged sentences

Many emerging markets take steps to reduce pharmaceutical product prices, in some cases through direct price controls and in others through the promotion of generic/biosimilar alternatives to branded pharmaceuticals.

| 2025 Form 10-K

Since AbbVie markets its products worldwide, certain products of a local nature and variations of product lines must also meet other local regulatory requirements.

15 unchanged sentences

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

| 2024 Form 10-K

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 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.

16 unchanged sentences

European Union.

Medical device products that are marketed in the European Union must comply with the requirements of the Medical Device Regulation (the MDR), which came into effect in May 2021.

Medical device products that are marketed in the European Union must comply with the requirements of the Medical Device Regulation (MDR), which came into effect in May 2021.

The MDR provides for regulatory oversight with respect to the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices to ensure that medical devices marketed in the European Union are safe and effective for their intended uses.

Medical devices that comply with the MDR are entitled to bear a Conformité Européenne marking evidencing such compliance and may be marketed in the European Union.

Medical devices that comply with the MDR are entitled to bear a Conformité Européenne marking evidencing such compliance and may be

2025 Form 10-K |

marketed in the European Union.

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.

8 unchanged sentences

While it is not feasible to predict with certainty the final costs related to those investigations and remediation activities, AbbVie believes that such costs, together with other expenditures to maintain compliance with applicable laws and regulations concerning environmental protection, should not have a material adverse effect on the company's financial position, cash flows, or results of operations.

AbbVie employed approximately 55,000 employees in over 70 countries as of January 31, 2025.

AbbVie employed approximately 57,000 employees in over 70 countries as of December 31, 2025.

Outside the United States, some of AbbVie's employees are represented by unions or works councils.

AbbVie believes that it has good relations with its employees.

2024 Form 10-K |

Human Capital Management

5 unchanged sentences

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 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 skill sets, 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.

4 unchanged sentences

the AbbVie Possibilities Scholarship for children of employees, which is an annual merit-based scholarship for use at accredited colleges, universities or vocational-technical schools;

and the Employee Relief Program, which is financial assistance to support short term needs of employees when faced with large-scale disasters (e.g.

a hurricane), individual disasters (e.g.

a home fire) or financial hardship (e.g.

the death of a spouse).

and the Employee Relief Program, which is financial assistance to support short term needs of employees when faced with large-scale disasters (e.g., a hurricane), individual disasters (e.g., a home fire) or financial hardship (e.g., the death of a spouse).

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

2 unchanged sentences

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

AbbVie has invested significantly in equipping employees with foundational artificial intelligence (AI) skills,

| 2025 Form 10-K

reflecting both the opportunities AI presents and its commitment to supporting employees as work evolves.

AbbVie's talent philosophy holds leaders accountable for building a high-performing organization, and the company provides development opportunities for all levels of leadership.

5 unchanged sentences

AbbVie integrates the Ways We Work into all talent processes, forming the basis for assessing performance, prioritizing development and ultimately rewarding employees.

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.

AbbVie believes its culture creates strong engagement, which is measured regularly through a confidential, third-party all-employee survey.

Employee engagement consistently remains strong, with survey results holding steady or improving across all measured categories.

AbbVie continues to be recognized among the world’s top places to work.

This engagement supports AbbVie’s mission of making a remarkable impact on people’s lives.

Diversity & Inclusion.

3 unchanged sentences

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.

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

Internet Information

| 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).

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 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