What changed in this filing

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Item 1. Business

2023-02-17 compared with 2022-02-18 · 47 added, 45 removed, 184 unchanged (33% of the section changed)

7 unchanged sentences

These products include a broad line of branded generic pharmaceuticals manufactured worldwide and marketed and sold outside the United States in emerging markets.

These products are generally sold directly to wholesalers, distributors, government agencies, health care facilities, pharmacies, and independent retailers from Abbott-owned distribution centers and public warehouses, depending on the market served.

These products are generally sold directly to wholesalers, distributors, government agencies, health care facilities, pharmacies, and independent retailers from Abbott-owned distribution centers or public warehouses, depending on the market served.

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

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In addition, the substitution of generic drugs for the brand prescribed and introduction of additional forms of already marketed established products by generic or branded competitors may increase competitive pressures.

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* As used throughout the text of this report on Form 10-K, the term “Abbott” refers to Abbott Laboratories, an Illinois corporation, or Abbott Laboratories and its consolidated subsidiaries, as the context requires.

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The principal products included in the Diagnostic Products segment are:

● core laboratory systems in the areas of immunoassay, clinical chemistry, hematology, and transfusion medicine, including the Alinity ® family of instruments, ARCHITECT ® , ABBOTT PRISM ® , and Cell-Dyn ® , with assays used for screening and/or diagnosis for cancer, cardiac, metabolics, drugs of abuse, fertility, general chemistries, infectious diseases such as hepatitis and HIV, therapeutic drug monitoring, and a suite of SARS-CoV-2 serology assays;

● molecular diagnostics polymerase chain reaction (PCR) instrument systems, including Alinity ® m and m2000 ® that automate the extraction, purification, and preparation of DNA and RNA from patient samples, and detect and measure infectious agents including HIV, hepatitis, HPV, sexually transmitted infections, SARS-CoV-2 and influenza A & B, and respiratory syncytial virus (RSV);and products for oncology with the Vysis ® FISH product line of genomic-based tests;

• core laboratory and transfusion medicine systems in the areas of immunoassay, clinical chemistry, hematology, and transfusion serology testing, including the Alinity ® family of instruments along with the ARCHITECT ® and Cell-Dyn ® systems.

These systems are used for screening and/or diagnosis for cancer, cardiac and metabolic disorders, drugs of abuse, thyroid function, fertility, neurologic and general chemistries, infectious diseases such as hepatitis and HIV, therapeutic drug monitoring, and a suite of SARS-CoV-2 serology assays;

• molecular diagnostics polymerase chain reaction (PCR) instrument systems, including Alinity ® m and m2000™ that automate the extraction, purification, and preparation of DNA and RNA from patient samples, and detect and measure infectious agents including HIV, hepatitis, HPV, sexually transmitted infections, SARS-CoV-2 and influenza A & B, and respiratory syncytial virus (RSV);

and products for oncology with the Vysis ® FISH product line of genomic-based tests;

• point of care systems, including the i-STAT ® and next-generation i-STAT ® Alinity ® and cartridges for testing blood gas, chemistry, electrolytes, coagulation and immunoassay;

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a toxicology business for drug and alcohol testing;

and remote patient monitoring and consumer self-testing;

● informatics and automation solutions for use in laboratories, including laboratory automation systems such as the GLP track system,the RALS ® point of care solution, and AlinIQ ® , a suite of informatics tools and professional services.

and consumer self-testing;

• informatics and automation solutions for use in laboratories, including laboratory automation systems such as the GLP systems track™, the RALS ® point of care solution, and AlinIQ ® , a suite of informatics tools and professional services.

The Diagnostic Products segment’s products are subject to competition in technological innovation, price, convenience of use, service, instrument warranty provisions, product performance, laboratory efficiency, long-term supply contracts, and product potential for overall cost-effectiveness and productivity gains.

5 unchanged sentences

The principal products included in the Nutritional Products segment are:

● various forms of infant formula and follow-on formula, including Similac ® , Similac® 360 Total Care®, Similac Pro-Advance ® , Similac ® Advance ® , Similac ® Advance ® Non-GMO, Similac Pro-Sensitive ® , Similac Sensitive ® , Similac Sensitive ® Non-GMO, Go&Grow by Similac ® , Similac ® NeoSure ® , Similac ® Organic, Similac ® Special Care ® , Similac Total Comfort ® , Similac ® For Supplementation, Isomil ® Advance ® , Isomil ® , Alimentum ® , Gain™, Grow™, Similac En Mei Li™, and Eleva™;

● adult and other pediatric nutritional products, including Ensure ® , Ensure Plus ® , Ensure ® Enlive ® , Ensure ® (with NutriVigor ® ), Ensure ® Max Protein, Ensure ® High Protein, Glucerna ® , Glucerna Hunger Smart ® , ProSure™, PediaSure ® , PediaSure SideKicks ® , PediaSure ® Peptide, EleCare ® , Juven ® , Abound™, Pedialyte ® and Zone Perfect ® ;

• various forms of infant formula and follow-on formula, including Similac ® , Similac ® 360 Total Care ® , Similac Pro-Advance ® , Similac ® Advance ® , Similac ® 360 Total Care ® Sensitive, Similac Pro-Sensitive ® , Similac Sensitive ® , Go & Grow by Similac ® , Similac ® NeoSure ® , Similac ® Organic, Similac ® Special Care ® , Similac Total Comfort ® , Similac ® Soy Isomil ® , Similac ® Alimentum ® , EleCare ® , Gain™, and Grow™;

• adult and other pediatric nutritional products, including Ensure ® , Ensure Plus ® , Ensure ® Enlive ® , Ensure ® (with NutriVigor ® ), Ensure ® Max Protein, Ensure ® High Protein, Glucerna ® , Glucerna Hunger Smart ® , ProSure™, PediaSure ® , PediaSure SideKicks ® , PediaSure ® Peptide, Juven ® , Abound™, Pedialyte ® and Zone Perfect ® ;

• nutritional products used in enteral feeding in health care institutions, including Jevity ® , Glucerna ® 1.2 Cal, Glucerna ® 1.5 Cal, Osmolite ® , Oxepa ® , Freego™ (Enteral Pump) and Freego™ sets, Nepro ® , and Vital ® .

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The principal products included in the Medical Devices segment are:

● rhythm management products, including Assurity MRI ® and Endurity MRI ® pacemaker systems;

• rhythm management products, including Assurity MRI ® and Endurity MRI ® pacemaker systems, and Aveir ® VR single-chamber VR leadless pacemaker system;

Ellipse ® , Fortify Assura ® , and Gallant ® implantable cardioverter defibrillators and Gallant and Quadra Assura MP ® implantable cardioverter defibrillator with cardiac resynchronization therapy and MultiPoint™ Pacing technology;

and Confirm Rx ® and Jot Dx ® implantable cardiac monitors;

● electrophysiology products, including the TactiCath ® family of ablation catheters and FlexAbility ® irrigated ablation catheters;

Ampere ® RF ablation generator;

• electrophysiology products, including the TactiFlex™ and TactiCath ® families of ablation catheters, and FlexAbility ® irrigated ablation catheters;

EnSite ® family of cardiac mapping systems;

Agilis™ NxT Steerable Introducer;

Agilis ® NxT and Swartz™ introducer catheters;

the Advisor ® HD Grid mapping catheter;

ViewFlex™ family of intracardiac echocardiography catheters;

and ViewMate™ Ultrasound System;

● heart failure related products, including the HeartMate ® left ventricular device family, the CardioMEMS ® HF System pulmonary artery sensor, a heart failure monitoring system, and the CentriMag ® System, an acute circulatory support system;

and ViewFlex™ family of intracardiac echocardiography catheters;

• heart failure related products, including the HeartMate ® left ventricular assist device family, the CardioMEMS ® HF System pulmonary artery sensor, a heart failure monitoring system, and the CentriMag ® System, an acute mechanical circulatory support system;

• vascular products, including the XIENCE ® family of drug-eluting coronary stent systems developed on the Multi-Link Vision ® platform;

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and the JETi ® peripheral thrombectomy systems for clot removal;

● structural heart products, including MitraClip ® , a transcatheter mitral valve repair system;

Trifecta ® Valve with Glide™ Technology, a surgical tissue heart valve;

• structural heart products, including MitraClip ® , a mitral valve transcatheter edge-to-edge repair system;

TriClip ® , a tricuspid valve transcatheter edge-to-edge repair system;

Epic ® , a surgical family of aortic valve and mitral valve replacement devices;

Portico ® and Navitor™ transcatheter aortic heart valves;

Regent™ mechanical heart valve s ;

Regent™ and Masters Series™ mechanical heart valves;

Amplatzer ® PFO occluders;

Amplatzer Amulet ® occluder devices;

the Tendyne ® Transcatheter Mitral Valve Implantation (TMVI) system;

and the TriClip ® Transcatheter Tricuspid Valve Repair System;

● continuous glucose and blood glucose monitoring systems, including test strips, sensors, data management decision software, and accessories for people with diabetes, under the FreeStyle ® brand such as the FreeStyle Libre ® system;

and the Tendyne ® transcatheter mitral valve replacement system;

• continuous glucose and blood glucose monitoring systems under the FreeStyle ® brand such as the FreeStyle Libre ® system, including sensors, data management decision software, test strips, and accessories for people with diabetes;

• neuromodulation products, including spinal cord stimulators Proclaim ® Elite and Proclaim ® XR Recharge-free implantable pulse generators (IPG) and Prodigy MRI ® IPG, each with BurstDR ® stimulation, and Proclaim ® DRG IPG, a neurostimulation device designed for dorsal root ganglion therapy, for the treatment of chronic pain disorders;

6 unchanged sentences

Abbott purchases, in the ordinary course of business, raw materials and supplies essential to Abbott’s operations from numerous suppliers in the United States and around the world.

Due to disruptions to the global supply chain caused in part by the COVID-19 pandemic, Abbott has experienced availability issues with some materials and electronic components.

Due to disruptions to the global supply chain caused in part by the COVID-19 pandemic and macroeconomic conditions such as inflationary pressures and labor shortages, Abbott has experienced availability issues with some materials and electronic components.

To date, Abbott has been able to manage these challenges without significant supply disruptions or shortages for raw materials and supplies.

A more detailed discussion on the COVID-19 pandemic’s disruption of the global supply chain and its resulting impact on Abbott’s business is contained in “ Abbott is subject to risks related to public health crises, such as widespread outbreaks of infectious diseases like the COVID-19 pandemic.

” in “Economic and Industry Risk” under “Item 1A.

Risk Factors.”

A more detailed discussion on the global supply chain disruptions and its resulting impact on Abbott’s business is contained in Item 1A.

Risk Factors and in the "Financial Review” section in Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Patents, Trademarks, and Licenses

22 unchanged sentences

workforce, 46% of its global workforce, and 41% of its managers.

Health and Safety

The health, safety and wellness of its employees is an Abbott priority embedded at every level of its business.

Abbott’s integrated Environmental, Health and Safety organization governs health, safety and wellness at Abbott’s facilities.

Abbott also maintains global policies and standards for managing employee health and safety.

Abbott takes a holistic approach to employee well-being.

Abbott’s global wellness programs are designed to meet the unique needs of employees across businesses and geographies and offer a wide range of programs, including supporting the mental, financial and physical health of employees and their families.

For example, for over 20 years, Abbott has annually offered Exercise Across Abbott, which is a four-week physical wellness program that encourages employees to team up with colleagues and track how many minutes they exercise each day.

Over 21,000 Abbott employees across 73 countries took part in 2021.

During the COVID-19 pandemic, Abbott has taken aggressive steps to limit exposure and enhance the safety of facilities for its employees, including providing and requiring the use of personal protective equipment and at many facilities, providing vaccinations, providing and requiring onsite COVID-19 testing, and implementing social distancing.

In some locations, employees also have received free over-the-counter COVID-19 tests for at-home use.

Talent Management

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The board of directors conducts an annual Talent Management Review, focusing on development of talent, diversity, and succession planning for critical positions.

Similar reviews take place at every level of Abbott to develop talent and diversity across the organization.

Similar reviews take place across Abbott to develop talent and diversity across the organization.

Diversity and Inclusion

1 unchanged sentence

Abbott ties executive compensation to human capital management, including diversity outcomes, to sustain an inclusive culture and the fair and balanced treatment of Abbott’s employees.

In 2021, Abbott issued its first-ever diversity, equity, and inclusion report, which describes Abbott’s plans, strategies, and actions to fulfill its commitment to develop an inclusive workplace.

In 2022, Abbott released the second edition of its diversity, equity, and inclusion report, providing an update on Abbott’s plans, strategies, and actions to fulfill its commitment to develop an inclusive workplace.

Abbott’s employee networks play an important role in building an inclusive culture across all Abbott operations.

A member of Abbott’s senior management serves as a sponsor for each of these networks, helping to align their objectives with Abbott’s business strategies.

A corporate officer serves as a sponsor for each of these networks, helping to align their objectives with Abbott’s business strategies.

Abbott has ten such networks, which are:

Advancing Professionals Network (supporting early career employees), Asian Leadership and Cultural Network, Black Business Network, Flex Network (supporting employees with part-time and flexible schedules), LA VOICE Network (supporting Hispanic and Latino employees), disABILITY Network (supporting people with disabilities), PRIDE (supporting LGBTQ employees), Veterans Network, Women Leaders of Abbott, and Women in STEM.

All Abbott employees are encouraged to join any of the employee networks.

Early Career Network (supporting early career employees), Asian Leadership and Cultural Network, Black Business Network, Flex Network (supporting employees with part-time and flexible schedules), LA VOICE Network (supporting Hispanic and Latino employees), disABILITY Network (supporting employees with disabilities), PRIDE (supporting LGBTQ employees), Veterans Network, Women Leaders of Abbott, and Women in STEM.

All networks are open to all Abbott employees.

Abbott offers professional development programs, which provide recent college graduates the opportunity to rotate through different areas of Abbott, often with the chance to work outside their home country.

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Further, Abbott has offered a STEM internship program for high school students in the U.S.

since 2012 and beginning in 2021, students who complete the program are eligible to receive college credit for their experience.

since 2012 and since 2021, students who complete the program receive a college credit recommendation from the American Council on Education.

The program’s objective is to increase the number of students pursuing STEM-related careers and contribute to a more diverse talent pipeline for Abbott.

In 2022, 69% of the STEM interns were women and 78% were minorities.

Health and Safety

The health, safety and wellness of its employees is an Abbott priority embedded at every level of its business.

Abbott’s integrated Environmental, Health and Safety organization governs health, safety and wellness at Abbott’s facilities.

Abbott also maintains global policies and standards for managing employee health and safety.

Abbott takes a holistic approach to employee well-being.

Over 21,000 Abbott employees across 74 countries took part in 2022.

Compensation and Benefits

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Examples include expansion of telehealth coverages and increased reimbursements for diagnostic testing.

It is uncertain when the public health emergency will end and to what extent these policies will continue or revert back to previous policies.

On January 30, 2023, the U.S.

announced that it plans to end the public health emergency on May 11, 2023.

Abbott is evaluating the potential impacts of the end of the public health emergency, and it will continue to monitor further regulatory actions from relevant U.S.

government agencies and assess potential impacts on pandemic-related government policies and product authorizations.

Abbott’s international operations are also affected by trade and investment regulations in many countries.

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Compliance with these laws and regulations is costly and materially affects Abbott’s business.

Among other effects, health care regulations and significant changes thereto (such as the introduction of the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation in the European Union) substantially increase the time, difficulty, and costs incurred in developing, obtaining and maintaining approval to market, and marketing newly developed and existing products.

Among other effects, health care regulations and significant changes thereto (such as the introduction of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation in the European Union) substantially increase the time, difficulty, and costs incurred in developing, obtaining and maintaining approval to market, and marketing newly developed and existing products.

Abbott expects this regulatory environment will continue to require significant technical expertise and investment to ensure compliance.

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Additionally, the Protecting Access to Medicare Act established a new payment system for clinical laboratory tests in 2018.

Governmental cost containment efforts also affect Abbott’s nutritional products business.

In the United States, for example, under regulations governing the federally funded Special Supplemental Nutrition Program for Women, Infants, and Children, all states must have a cost containment program for infant formula.

As a result, through competitive bidding states obtain rebates from manufacturers of infant formula whose products are used in the program.

The Patient Protection and Affordable Care Act (the Affordable Care Act) includes provisions known as the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, and medical supplies 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 & Medicaid Services for subsequent public disclosure.

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Transferring and managing protected information will become more challenging as laws and regulations are enacted or amended, and Abbott expects there will be increasing complexity in this area.

Governmental cost containment efforts also affect Abbott’s nutritional products business.

As a result, through competitive bidding states obtain rebates from manufacturers of infant formula whose products are used in the program.

Abbott expects debate to continue at all government levels worldwide over the manufacture, quality assurance requirements, marketing authorization processes, post-market surveillance requirements, availability, method of delivery, and payment for health care products and services, as well as data privacy and security.

6 unchanged sentences

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