Abbott Laboratories (ABT) 10-K risk factor changes: FY2021 vs FY2020
The 2021-12-31 10-K against the 2020-12-31 one, compared heading by heading and sentence by sentence.
Item 1A16 rewritten9 added2 removed165 unchanged
All filing items825 rewritten324 added267 removed1,864 unchanged
Summary
counted, not written
- Item 1A lists 18 risk factor headings: 0 new, 2 reworded and 16 unchanged since FY2020. 0 headings from FY2020 no longer appear.
- Sentence by sentence, 324 added, 267 removed, 825 rewritten and 1,864 unchanged across 20 items that differ.
- New this year: Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
New Item 1A headings (0)
No risk factor heading in this filing is absent from FY2020.
Removed Item 1A headings (0)
Every FY2020 risk factor heading is still here, word for word or reworded.
Reworded Item 1A headings (2)
- The expiration or loss of
[removed: patent][added: intellectual property] protection and licenses may affect Abbott’s future revenues and operating income. - Fluctuation in foreign currency exchange rates may adversely affect
[removed: our][added: Abbott’s] financial statements and[removed: Abbott’s][added: its] ability to realize projected sales and earnings.
A heading is new when no FY2020 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
22 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2021; struck-through words were in FY2020. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
16 rewritten, 9 added, 2 removed, 165 unchanged
A significant attack or other disruption could result in adverse consequences, including increased costs and expenses, manufacturing challenges or disruption, problems with product functionality, damage to customer relations, [added: reputational damage,] lost revenue, and legal or regulatory penalties.
Abbott invests in its systems and technology and in the protection of its products and data to reduce the risk of an attack or other significant disruption, and monitors its systems on an ongoing basis for any current or potential threats [added: or vulnerabilities] and for changes in technology and the regulatory environment.
Problems may arise during manufacturing for a variety of reasons, including equipment malfunction, failure to follow specific protocols and procedures, problems with raw [removed: materials,] [added: materials or the global supply chain, cyber attacks,] natural disasters, and environmental factors.
As of December 31, [removed: 2020,] [added: 2021,] Abbott's consolidated indebtedness was approximately [removed: $18.7] [added: $18.1] billion.
The process of obtaining regulatory approvals to market a drug, medical device, [removed: or] diagnostic [added: product, or nutritional] product can be costly and time-consuming, and approvals might not be granted for future products, or additional indications or uses of existing products, on a timely basis, if at all.
The expiration or loss of [removed: patent] [added: intellectual property] protection and licenses may affect Abbott’s future revenues and operating income.
Health concerns and significant changes in political or economic conditions caused by such outbreaks can cause significant reductions in demand for [removed: routine diagnostic testing and medical device procedures or] [added: certain products,] increased difficulty in serving customers, disrupt manufacturing and supply chains, and negatively affect [removed: our] [added: Abbott’s] operations as well as the operations of [removed: our] [added: its] suppliers, distributors and other third-party partners.
With regard to [removed: the] COVID-19 [removed: pandemic,] [added: diagnostic testing,] the FDA issued Emergency Use Authorizations (EUAs) for several COVID-19 related products in [removed: 2020,] [added: 2020 and 2021,] including Abbott diagnostic tests.
Abbott is actively pursuing the FDA’s customary regulatory approval process for [removed: these] [added: various COVID-19] diagnostic tests which has uncertainty as discussed in “_Abbott is subject to numerous governmental regulations and it can be costly to comply with these regulations and to develop compliant products and processes._” in “Legal and Regulatory Risks” under “Item 1A.
Fluctuation in foreign currency exchange rates may adversely affect [removed: our] [added: Abbott’s] financial statements and [removed: Abbott’s] [added: its] ability to realize projected sales and earnings.
Sales outside of the United States in [removed: 2020] [added: 2021] made up approximately [removed: 62] [added: 61] percent of Abbott’s net sales.
A discussion of the steps taken to mitigate the impact of foreign exchange is contained in Item 7A, Quantitative and Qualitative Disclosures about Market Risk in Abbott’s [removed: 2020] [added: 2021] Form 10-K.
Information on Abbott’s hedging arrangements is contained in Note [removed: 12] [added: 11] to the consolidated financial statements in this report.
| | ● | trade protection measures, including tariffs, import or export licensing requirements, [added: other governmental restrictions,] and changes to international trade agreements; |
| | ● | changes in business, economic, and political conditions, including: war, political instability, terrorist attacks, the threat of future terrorist activity and related military action; global [removed: climate,] [added: climate change,] extreme weather and natural disasters; the cost and availability of insurance due to any of the foregoing events; labor disputes, strikes, slow-downs, or other forms of labor or union activity; and pressure from third-party interest groups; |
| | ● | changes in the buying patterns of a major distributor, [removed: retailer,] [added: retailer,wholesaler,] or [removed: wholesale] [added: other] customer resulting from buyer purchasing decisions, pricing, seasonality, or other factors, or other problems with licensors, suppliers, distributors, and business partners; and |
To date, the COVID-19 pandemic has affected Abbott's diversified health care business in various ways, with some businesses performing at the levels required to successfully meet new demands, other having faced challenges during periods when the number of COVID-19 cases significantly increased, and still others being relatively less impacted by the pandemic.
Risk Factors.” Further, the demand for COVID-19 tests has been, and Abbott expects it to continue to be, highly volatile, primarily driven by the emergence and severity of new variants, which are unpredictable.
In addition, the COVID-19 pandemic has contributed to global supply chain disruptions, which has adversely impacted the cost and availability of certain raw materials, supplies, and services.
While Abbott has taken actions to offset some of these inflationary pressures in its supply chain, Abbott may not be able to completely offset all the increases in its operational costs.
Further, Abbott has experienced, and may continue to experience, availability issues with some services and materials used in its products.
To date, Abbott has been able to manage these challenges without significant supply disruption or shortage for services, raw materials and supplies, however, no assurance can be given that these efforts will continue to be successful.
Significant disruptions or shortages may result in Abbott’s inability to meet customer demand for certain of its products.
In the ordinary course of business, Abbott is the subject of patent litigation, such as competitor claims that an Abbott product infringes their intellectual property.
Sales outside of the United States in 2021 made up approximately 61 percent of Abbott’s net sales.
Risk Factors.”
Competitors may claim that an Abbott product infringes their intellectual property.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
138 rewritten, 108 added, 116 removed, 302 unchanged
Patent protection and licenses, technological and performance features, and inclusion of Abbott’s products under a contract most impact which products are sold; price controls, competition and rebates most impact the net selling prices of products; and [removed: foreign currency translation impacts] the measurement of net sales and [removed: costs.][added: costs is impacted by foreign currency translation.]
Sales in international markets comprise approximately [removed: 62] [added: 61] percent of consolidated net sales.
In [removed: 2020,] [added: 2020 and 2021,] the coronavirus (COVID-19) pandemic affected Abbott’s diversified health care businesses in various ways.
As is further described below, some businesses have performed at the levels required to successfully meet new demands, others have faced [removed: challenges,] [added: challenges during periods when the number of COVID-19 cases significantly increased,] and still others have been relatively less impacted by the pandemic.
[added: In 2020 and 2021,] Abbott mobilized its teams across multiple fronts to develop and launch [removed: the following] [added: various] new diagnostic tests for [removed: COVID-19 in 2020:][added: COVID-19.]
[removed: | | ● |] In [removed: March, Abbott] [added: 2020, Molecular Diagnostics developed and] launched [removed: a] molecular [removed: test] [added: tests to detect COVID-19] using polymerase chain reaction (PCR) methods on its [removed: _m_2000™] [added: m2000®] RealTi_m_e lab-based platform [removed: to detect COVID-19] [added: and its Alinity® m system] pursuant to [removed: an Emergency Use Authorization (EUA)] [added: EUAs] in the U.S. and CE [removed: Mark. |][added: Marks.]
[removed: | | ● |] In [removed: March, Abbott also] [added: March 2020, Rapid Diagnostics] launched a molecular test to detect COVID-19 on its ID [removed: NOW™] [added: NOW®] rapid point-of-care platform in the U.S. pursuant to an [removed: EUA. |][added: Emergency Use Authorization (EUA).]
[removed: | | ● |] In [removed: April, Abbott] [added: 2020 and 2021, Core Laboratory Diagnostics developed and] launched [removed: an IgG (Immunoglobulin G)] [added: various] lab-based serology blood [removed: test] [added: tests] on its ARCHITECT® [removed: i1000SR] [added: i1000SR®] and [added: ARCHITECT] i2000SR® laboratory instruments [added: and on its Alinity i system] for the detection of an antibody to determine if someone was previously infected with the virus. [removed: The serology test was granted an EUA in the U.S. and CE Mark in April. |]
[removed: | | ● |] In [removed: August,] [added: August 2020,] Abbott launched its [removed: BinaxNOW™] [added: BinaxNOW®] COVID-19 Ag Card test, a portable, lateral flow rapid test to detect COVID-19 pursuant to an EUA in the U.S. [removed: |][added: In December 2020, Abbott received an EUA in the U.S. for virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test and launched the product for at-home use.]
[removed: | | ● |] In [removed: September, Abbott launched its Panbio rapid antigen test to detect COVID-19 pursuant to a CE Mark. In October,] [added: October 2020,] Abbott received approval by the World Health Organization for emergency use listing for the Panbio antigen test. [removed: |]
[removed: | | ● | In December, Abbott] [added: Molecular Diagnostics also developed and] launched its multiplex molecular test on its Alinity m system to detect COVID-19, [removed: flu] [added: influenza] A, [removed: flu] [added: influenza] B, and respiratory syncytial virus (RSV) [removed: pursuant to a CE Mark. |][added: in one test.]
In [removed: 2020,] [added: 2020 and 2021,] Abbott’s COVID-19 [removed: testing related] [added: testing-related] sales totaled approximately [removed: $3.884] [added: $3.9 billion and $7.7] billion, [added: respectively,] led by sales related to Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.
In [added: 2020, in] addition to negatively impacting routine core diagnostic testing volumes, the pandemic negatively affected the number of cardiovascular and neuromodulation procedures performed by health care providers globally, thereby reducing the demand for Abbott’s cardiovascular and neuromodulation devices and routine diagnostic [removed: tests in 2020.][added: tests.]
The decrease began in February [added: 2020] in China as that country implemented quarantine restrictions and postponed non-emergency health care activities.
The extent of the impact and the timing of a recovery in the number of procedures and routine testing in a particular country or geographic region depended upon the progression of COVID-19 cases in [removed: the] [added: that] country or [removed: region.][added: region as well as the actions taken by the government in that country related to COVID-19.]
[removed: The] [added: In 2020, the] recovery in procedures and routine testing volumes in China began in [removed: March.][added: March 2020.]
However, in the fourth [removed: quarter,] [added: quarter of 2020,] the improving trends in the demand for procedures and routine testing flattened or were negatively impacted depending upon the business and the region as many [removed: countries] [added: countries, including the U.S.,] experienced an increase in the number of COVID-19 cases and hospitalizations.
[added: While] Abbott’s branded generic pharmaceuticals business was also negatively affected by the pandemic in 2020 as COVID-19 spread across emerging market countries in the second and third quarters of [removed: 2020.][added: 2020, volumes recovered and grew in 2021.]
Abbott has taken aggressive steps to limit exposure [added: to COVID-19] and enhance the safety of facilities for its employees.
Due to the unpredictability of the duration and impact of the [removed: current] COVID-19 pandemic, the extent to which the [removed: COVID-19] pandemic will have a material effect on [removed: its] [added: Abbott’s] business, financial condition or results of operations is uncertain.
While Abbott’s [added: 2021 and] 2020 sales were most significantly affected by the COVID-19 pandemic, the increase in total sales over the last three years also reflects [removed: volume growth due to] the introduction of new products across various businesses as well as higher sales of various existing products.
Sales in emerging markets, which represent approximately [removed: 37] [added: 35] percent of total company sales, increased [removed: 2.0] [added: 19.6] percent in [removed: 2020] [added: 2021] and [removed: 8.2] [added: 2.0] percent in [removed: 2019,] [added: 2020,] excluding the impact of foreign exchange.
Over the last three years, Abbott’s operating margin as a percentage of sales increased from [removed: 11.9] [added: 14.2] percent in [removed: 2018] [added: 2019] to [removed: 14.2] [added: 15.5] percent in [removed: 2019] [added: 2020] and [removed: 15.5] [added: 19.6] percent in [removed: 2020.][added: 2021.]
In addition, a reduction in the costs associated with business acquisitions and restructuring activities drove an improvement in operating margins from [removed: 2018] [added: 2019] to 2020.
With respect to the performance of each reportable segment over the last three years, sales in the Medical Devices [removed: segment] [added: segment,] excluding the impact of foreign [removed: exchange decreased 3.8] [added: exchange, increased 19.4] percent in [removed: 2020] [added: 2021] and [removed: increased 10.5] [added: decreased 3.8] percent in [removed: 2019.][added: 2020.]
In [removed: 2020,] [added: 2021,] operating earnings for the Medical Devices segment [removed: decreased 19.4] [added: increased 48.6] percent.
[removed: The operating margin profile decreased from 30.8 percent of sales in 2019 to 25.8 percent in 2020 primarily due to lower sales and manufacturing volumes as a result of the pandemic and] [added: This growth was partially offset by] pricing pressures on drug eluting stents (DES) as a result of market competition in the U.S. and other major markets.
In [removed: 2020,] [added: 2021,] key product approvals in the Medical Devices segment included:
[removed: | | ● | CE Mark for Abbott’s TriClip® heart valve repair system,] [added: The growth in Structural Heart during 2021 was broad-based across several areas of] the [added: business, including MitraClip and TriClip®, the] world’s first minimally invasive, clip-based device for repair of a leaky tricuspid heart [removed: valve, |][added: valve which was launched in Europe in May 2020.]
In Abbott’s worldwide diagnostics business, sales increased [removed: 40.6] [added: 42.7] percent in [removed: 2020] [added: 2021] and [removed: 5.9] [added: 40.6] percent in [removed: 2019,] [added: 2020,] excluding the impact of foreign exchange.
[removed: As was discussed above, sales growth] [added: Growth] in 2020 was driven by demand for Abbott's portfolio of COVID-19 diagnostics tests across its rapid and lab-based platforms, partially offset by lower volumes of routine laboratory testing due to the pandemic.
Abbott has also obtained regulatory approvals in the [removed: U.S. and] [added: U.S.,] Europe [added: and other markets] for the “Alinity s” (blood screening) and “Alinity m” (molecular) instruments and several testing assays.
In [removed: 2020,] [added: 2021,] operating earnings for the Diagnostics segment increased [removed: 94.8] [added: 68.0] percent.
The operating margin profile increased from [removed: 24.9] [added: 24.8] percent of sales in [removed: 2018] [added: 2019] to [removed: 34.5] [added: 40.0] percent in [removed: 2020] [added: 2021] primarily due to higher sales in [removed: 2020 in] Rapid Diagnostics [added: in 2020] and [removed: Molecular Diagnostics, partially offset by lower volumes of] [added: 2021 and increased] routine [added: diagnostics] testing in [added: 2021 in] Core [removed: Laboratory.][added: Laboratory Diagnostics.]
In Abbott’s worldwide nutritional products business, sales over the last three years were positively impacted by numerous new product introductions, including the roll-outs of human milk oligosaccharide, or HMO, in infant [removed: formula and of high-protein Ensure®,] [added: formula,] that leveraged Abbott’s strong brands.
Excluding the impact of foreign exchange, total adult nutrition sales increased [removed: 10.3] [added: 12.8] percent in [removed: 2020] [added: 2021] and [removed: 6.6] [added: 10.3] percent in [removed: 2019] [added: 2020,] led by the continued growth of [removed: Ensure,] [added: Ensure®,] Abbott’s market-leading complete and balanced nutrition brand, and Glucerna®, Abbott’s market-leading diabetes-specific nutrition brand, across several countries.
[removed: The 2019 sales growth was partially offset by the unfavorable impact of the discontinuation of a non-core product line in the U.S.] Excluding the impact of foreign exchange, total pediatric nutrition sales increased [removed: 0.3] [added: 3.3] percent in [removed: 2020] [added: 2021] and [removed: 3.4] [added: 0.3] percent in [removed: 2019] [added: 2020] driven by the [added: Pedialyte®,] PediaSure® and [removed: Pedialyte®] [added: Similac®] brands in the U.S. as well as infant and toddler product growth across several [removed: markets in Asia and Latin America,] [added: international markets,] partially offset by challenging market dynamics in the infant category in Greater China.
Excluding the impact of foreign exchange, Established Pharmaceutical sales increased [removed: 1.9] [added: 10.4] percent in [removed: 2020] [added: 2021] and [removed: 7.3] [added: 1.9] percent in [removed: 2019.][added: 2020.]
The sales increases in [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] reflect higher sales in several geographies including India, China, Brazil and Russia.
Operating margins decreased from [removed: 20.2] [added: 20.1] percent of sales in [removed: 2018] [added: 2019] to [removed: 18.5] [added: 18.8] percent in [removed: 2020] [added: 2021] primarily due to the unfavorable impact of foreign exchange, [added: higher] product [removed: mix] [added: costs] and [removed: lower] [added: product mix, partially offset by the impact of] gross [removed: margins.][added: margin improvement initiatives.]
Abbott’s Diagnostics segment experienced the most significant change in sales from 2019 to 2021 as a result of the COVID-19 pandemic.
In March 2021, Abbott announced that it had received an EUA in the U.S. for its over-the-counter, non-prescription BinaxNOW COVID-19 Ag Self Test for individuals with or without symptoms.
In the first quarter of 2021, Abbott also received EUAs in the U.S. that allow the non-prescription use of the BinaxNOW COVID-19 Ag Card Home Test and the BinaxNOW COVID-19 Ag Card test for professional use for individuals with or without symptoms.
Outside the U.S., in September 2020, Rapid Diagnostics launched its Panbio® rapid antigen test to detect COVID-19 pursuant to a CE Mark.
In January 2021, Abbott received CE Mark for two new uses of its Panbio rapid antigen test: asymptomatic testing and self-swabbing under the supervision of a healthcare worker.
In June 2021, Abbott announced that it had received CE Mark for its over-the-counter Panbio COVID-19 Antigen Self-Test for individuals with or without symptoms.
This multiplex molecular test was launched pursuant to a CE Mark in December 2020 and an EUA in the U.S. in March 2021.
The tests were launched under EUAs in the U.S. and CE Marks.
2021 volumes were affected by fluctuations in the number of COVID-19 cases, especially in the U.S., over the course of the year.
In the second quarter of 2021, demand for COVID-19 tests decreased from the previous quarter as COVID-19 vaccines were administered, COVID-19 cases and hospitalizations declined, and the U.S. health authority updated its guidance on testing for fully vaccinated individuals.
However, in the second half of 2021, as the Delta and Omicron variants of COVID-19 spread and the number of new COVID-19 cases increased, demand for rapid COVID-19 tests increased significantly.
With respect to other products sold by the Diagnostics segment, demand for routine diagnostic testing generally fluctuated as the number of COVID-19 cases changed in various geographic regions throughout the two-year period.
While routine diagnostic testing and cardiovascular and neuromodulation procedure volumes were negatively impacted early in 2021 by elevated COVID-19 case rates, overall volumes improved over the course of the year until the latter part of 2021 when demand softened in several geographies with the emergence of another variant.
Abbott is continually monitoring the effects of the pandemic on its operations.
Throughout the pandemic, Abbott has continued to ensure that its operations throughout the world are aligned with the specific governmental orders and guidelines affecting each location.
The demand for COVID-19 tests has been highly volatile.
Abbott expects this volatility to continue as the possible emergence and severity of new variants are unpredictable.
The increase in 2021 from 2020 reflects the impact of sales volume increases for COVID-19 tests in Rapid Diagnostics and growth across virtually all of Abbott’s businesses due, in part, to recovery from the COVID-19 pandemic, partially offset by the impact of inflation and supply chain challenges on various manufacturing inputs and transportation costs, an increase in restructuring costs, and the unfavorable effect of foreign exchange.
In 2021, Abbott experienced availability issues with some services and materials used in its products.
To date, Abbott has been able to manage the various supply chain challenges without significant supply disruption or shortage for services, raw materials and supplies.
While Abbott expects inflationary pressures on various raw materials, packaging materials and transportation costs to continue in 2022, the impact of such cost increases is expected to be at least partially mitigated by price increases in certain businesses and the impact of continued gross margin improvement initiatives.
To the extent that supply chain challenges in the industries in which Abbott operates normalize over time, this may lessen inflationary pressures.
The sales increase in 2021 was driven by double-digit growth across all of Abbott’s Medical Devices divisions, led by Diabetes Care, Structural Heart and Electrophysiology.
The operating margin profile increased from 30.8 percent of sales in 2019 to 31.4 percent in 2021 primarily due to higher sales volumes in Diabetes Care and Abbott’s cardiovascular and neuromodulation businesses.
| | ● | CE Mark in Europe for Navitor™, Abbott’s latest-generation transcatheter aortic valve implantation (TAVI) system for patients with severe aortic stenosis who are at high or extreme surgical risk, |
| | ● | U.S. Food and Drug Administration (FDA) approval of the Amplatzer® Amulet® Left Atrial Appendage Occluder, which offers immediate closure of the left atrial appendage, an area in the heart where blood clots can form, |
| | ● | FDA approval of the Portico® with FlexNav® TAVI system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open heart surgery, and |
| | ● | FDA approval of the Amplatzer Talisman™ PFO Occlusion System to treat people with a patent foramen ovale – a small opening between the upper chambers of the heart – who are at risk of recurrent ischemic stroke. |
As was discussed above, sales growth in 2021 was driven by demand for Abbott's portfolio of rapid diagnostics tests for COVID-19 and higher routine diagnostics testing in the core laboratory business, partially offset by lower demand for Abbott’s laboratory-based tests for COVID-19 in the molecular diagnostics business.
Sales over the last two years were also positively impacted by consumers’ interest in nutrients that help support their immune systems.
Operating margins for the worldwide nutritional products business decreased from 23.0 percent in 2019 to 21.3 percent in 2021.
The decrease was driven by higher manufacturing and distribution costs, including commodity prices, partially offset by the impact of gross margin improvement initiatives.
In December 2021, Abbott increased the company’s quarterly dividend by 4.4 percent to $0.47 per share from $0.45 per share, effective with the dividend paid in February 2022.
The impact of higher interest rates and improved asset returns during 2021 significantly decreased the net actuarial losses for these plans.
| 2021 vs. 2020 | | 24.5 | | (1.5) | | 24.4 | | 1.6 |
| 2021 vs. 2020 | | 27.8 | | (1.9) | | 29.7 | | — |
| 2021 vs. 2020 | | 22.5 | | (1.3) | | 21.2 | | 2.6 |
| 2021 vs. 2020 | | 9.6 | | 4.2 | | 6.2 | | (0.8) |
| 2021 vs. 2020 | | 8.5 | | 1.0 | | 6.7 | | 0.8 |
| 2021 vs. 2020 | | 44.8 | | (6.2) | | 48.9 | | 2.1 |
Abbott’s Diagnostics business experienced the most significant change in sales from 2019 to 2020 as sales from new tests and other related products to detect COVID-19 more than outweighed the negative impact of COVID-19 on routine diagnostic testing volumes.
| --- | --- | --- |
| | ● | In May, Abbott launched a lab-based serology blood test on its Alinity® i system pursuant to an EUA in the U.S. and CE Mark. |
| | ● | In May, Abbott also launched a molecular PCR test on its Alinity m system to detect COVID-19 pursuant to an EUA in the U.S. Abbott received CE Mark for this test in June. |
| | ● | In June, Abbott launched a lateral flow COVID-19 rapid antibody test on its Panbio™ system in select countries pursuant to a CE Mark. This serology test detects an antibody to determine if someone was previously infected with the virus. |
| | ● | In August, Abbott launched its AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on its ARCHITECT and Alinity platforms pursuant to a CE Mark. Abbott was granted an EUA in the U.S. for this test in October. |
| | ● | In December, Abbott received CE Mark and launched its SARS-CoV-2-IgG II quantitative lab-based serology blood test for use on its ARCHITECT and Alinity i platforms. |
| | ● | In December, Abbott received an EUA in the U.S. for virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test to detect COVID-19 and launched the product for at-home use. |
Abbott is continually implementing business continuity plans in the face of the pandemic.
Due to the critical nature of its products and services, Abbott was generally exempt from governmental orders issued during the first quarter of 2020 in the U.S. and other countries requiring businesses to cease operations.
The majority of its office-based work was conducted remotely during the period of such governmental orders and the company implemented strict travel restrictions.
As some governmental orders were lifted in May and June 2020, Abbott entered a new phase in its operations whereby some office-based employees started working at Abbott’s offices on a rotational basis.
As various governmental orders and guidelines were modified in the fourth quarter to put in place new restrictions, Abbott continued to ensure that its guidance was aligned with such restrictions.
In 2019, the increase in Abbott’s operating margin also reflects margin improvement in various businesses and lower intangible amortization expense compared to 2018.
The sales increase in 2019 was driven primarily by higher Diabetes Care, Structural Heart, Electrophysiology and Heart Failure sales.
| | ● | CE Mark for Abbott’s Tendyne™ Transcatheter Mitral Valve Implantation system for the treatment of significant mitral regurgitation (MR) in patients requiring a heart valve replacement who are not candidates for open-heart surgery or transcatheter mitral valve repair, |
| | ● | U.S. Food and Drug Administration (FDA) clearance of FreeStyle® Libre 2 as an integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes, |
| | ● | CE Mark for Abbott’s FreeStyle Libre 3 system, which automatically delivers real time, up-to-the-minute glucose readings, 14-day accuracy and real-time glucose alarms, |
| | ● | CE Mark for the Libre Sense™ Glucose Sport Biosensor that provides continuous glucose monitoring to help athletes better understand the efficacy of their nutrition choices on training and athletic performance, |
| | ● | U.S. FDA approval of the next-generation Gallant™ implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator devices which help manage heart rhythm disorders and offer Bluetooth technology and a new patient smartphone app for improved remote monitoring and enhanced patient-physician engagement, |
| | ● | CE Mark for MitraClip® G4, Abbott’s next-generation MitraClip mitral valve repair device, |
| | ● | CE Mark of EnSite™ X EP System, a next-generation 3D cardiac mapping platform used for ablation therapy to treat abnormal heart rhythms, |
| | ● | U.S. FDA clearance and CE Mark of the IonicRF™ Generator, a non-surgical, minimally invasive device that uses heat to target specific nerves for the management of chronic pain, and |
| | ● | U.S. FDA approval of updated labeling to allow Abbott’s HeartMate 3™ heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure. |
Growth in 2019 reflected continued market penetration by the core laboratory business in the U.S. and internationally.
The 2019 growth included the continued adoption by customers of Alinity, which is Abbott’s integrated family of next-generation diagnostic systems and solutions that are designed to increase efficiency by running more tests in less space, generating test results faster and minimizing human errors while continuing to provide quality results.
Sales were also positively affected by demographics such as an aging population and an increasing rate of chronic disease in developed markets and the rise of a middle class in many emerging markets.
The 2020 increase was also driven by higher Similac® sales in the U.S.
Low interest rates have significantly increased actuarial losses for these plans.
| 2019 vs. 2018 | | 4.3 | | 0.2 | | 7.3 | | (3.2) |
| 2019 vs. 2018 | | 5.2 | | (0.4) | | 5.6 | | — |
| 2019 vs. 2018 | | 3.9 | | 0.5 | | 8.3 | | (4.9) |
| 2019 vs. 2018 | | 1.4 | | 3.0 | | 4.3 | | (5.9) |
| 2019 vs. 2018 | | 2.5 | | 0.9 | | 3.9 | | (2.3) |
| 2019 vs. 2018 | | 2.9 | | (0.5) | | 6.4 | | (3.0) |
| 2019 vs. 2018 | | 7.6 | | (0.9) | | 11.4 | | (2.9) |
| | | | | | | | | | | | | | |
| (a) Vascular Product Lines: | | | | | | | | | | | | | |
| Coronary and Endovascular | | | 2,263 | | | 2,740 | | (17) | | — | | (17) | |
| Core Laboratory | | | 4,656 | | | 4,386 | | 6 | | (4) | | 10 | |
An excerpt. Shown here: 40 of 138 rewritten, 40 of 108 added and 40 of 116 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS in the FY2021 filing and the FY2020 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
18 rewritten, 1 added, 1 removed, 29 unchanged
The fair value of equity securities held by Abbott with a readily determinable fair value was approximately [removed: $20] [added: $11] million and [removed: $11] [added: $20] million as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.
A hypothetical 20 percent decrease in the share prices of these investments would decrease their fair value at December 31, [removed: 2020] [added: 2021] by approximately [removed: $4] [added: $2] million.
The fair value of investments in mutual funds that are held in a rabbi trust for the purpose of paying benefits under a deferred compensation plan was approximately [removed: $366] [added: $391] million and [removed: $346] [added: $366] million as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.
The carrying value of these investments was [removed: $113] [added: $90] million and [removed: $158] [added: $113] million as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.
At December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] Abbott had interest rate hedge contracts totaling $2.9 billion to manage its exposure to changes in the fair value of debt.
The fair value of long-term debt at December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] amounted to [removed: $22.8] [added: $21.2] billion and [removed: $20.8] [added: $22.8] billion, respectively (average interest rates of [added: 3.4% and] 3.3% as of December 31, [removed: 2020] [added: 2021] and [removed: 2019)] [added: 2020, respectively)] with maturities through 2046.
At December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] the fair value of current and long-term investment securities amounted to approximately [removed: $1.1] [added: $1.3] billion and [removed: $1.2] [added: $1.1] billion, respectively.
At December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] Abbott held [removed: $8.1] [added: $8.6] billion and [removed: $6.8] [added: $8.1] billion, respectively, of such contracts.
Contracts held at December 31, 2020 [removed: will mature] [added: matured] in 2021 or [added: will mature in] 2022 depending upon the contract.
Contracts held at December 31, [removed: 2019 matured in 2020 or] [added: 2021] will mature in [removed: 2021] [added: 2022 or 2023] depending upon the contract.
At December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] Abbott held [removed: $11.0] [added: $12.2] billion and [removed: $9.1] [added: $11.0] billion, respectively, of such contracts, which mature in the next 13 months.
The value of this long-term debt was approximately [removed: $577] [added: $521] million and [removed: $546] [added: $577] million as of December 31, [removed: 2020] [added: 2021] and December 31, [removed: 2019,] [added: 2020,] respectively.
The following table reflects the total foreign currency forward exchange contracts outstanding at December 31, [removed: 2020] [added: 2021] and [removed: 2019:][added: 2020:]
| Euro | | $ | [removed: 7,781] [added: 8,698] | | [removed: 1.1821] [added: 1.1360] | | $ | [removed: (91)] [added: 90] | | $ | [removed: 7,085] [added: 7,781] | | [removed: 1.1189] [added: 1.1821] | | $ | [removed: 65] [added: (91)] |
| Chinese Yuan | | | [removed: 2,401] [added: 2,148] | | [removed: 6.4900] [added: 6.5744] | | | [removed: (99)] [added: (35)] | | | [removed: 2,177] [added: 2,401] | | [removed: 7.0216] [added: 6.4900] | | | [removed: 4] [added: (99)] |
| Japanese Yen | | | [removed: 1,589] [added: 1,497] | | [removed: 105.3861] [added: 111.7260] | | | [removed: (20)] [added: 31] | | | [removed: 1,092] [added: 1,589] | | [removed: 106.8530] [added: 105.3861] | | | [removed: 13] [added: (20)] |
| All other currencies | | | [removed: 7,369] [added: 8,426] | | n/a | | | [removed: (198)] [added: 109] | | | [removed: 5,532] [added: 7,369] | | n/a | | | [removed: (23)] [added: (198)] |
| Total | | $ | [removed: 19,140] [added: 20,769] | | | | $ | [removed: (408)] [added: 195] | | $ | [removed: 15,886] [added: 19,140] | | | | $ | [removed: 59] [added: (408)] |
| | | 2021 | | | | | | | | 2020 | | | | | | |
| | | 2020 | | | | | | | | 2019 | | | | | | |
Item 1. BUSINESS
27 rewritten, 9 added, 2 removed, 170 unchanged
| | ● | molecular diagnostics polymerase chain reaction (PCR) instrument systems, including Alinity® m and [removed: m2000™] [added: 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, [added: SARS-CoV-2] and [removed: SARS-CoV-2;] [added: influenza A & B,] and [added: respiratory syncytial virus (RSV);and] products for oncology with the Vysis® FISH product line of genomic-based tests; |
| | ● | rapid diagnostics lateral flow testing products in the area of infectious [removed: diseases, including respiratory viruses] [added: diseases] such as [removed: SARS-CoV-2] [added: SARS-CoV-2, including the BinaxNOW®] and [added: Panbio® rapid testing platforms,] influenza, HIV, hepatitis, and tropical diseases such as malaria and dengue fever; molecular point-of-care testing for HIV, including the m-PIMA® HIV-1/2 Viral Load Test, and for SARS-CoV-2 and influenza A & B, RSV and strep A, including the ID NOW® rapid molecular system; cardiometabolic testing, including Afinion® and [removed: Cholestech™] [added: Cholestech LDX®] platforms and tests; a toxicology business for drug and alcohol testing; and remote patient monitoring and consumer self-testing; and |
| | ● | informatics and automation solutions for use in laboratories, including laboratory automation [removed: systems,] [added: systems such as] the [added: GLP track system,the] RALS® point of care solution, and AlinIQ®, a suite of informatics tools and professional services. |
| | ● | various forms of [removed: prepared] infant formula and follow-on formula, including [removed: Similac®*,] [added: Similac®, Similac® 360 Total Care®,] Similac [removed: Pro-Advance®*,] [added: Pro-Advance®,] Similac® Advance®, Similac® Advance® Non-GMO, Similac [removed: Pro-Sensitive®*,] [added: Pro-Sensitive®,] Similac Sensitive®, Similac Sensitive® Non-GMO, Go&Grow by [removed: Similac®*,] [added: Similac®,] Similac® NeoSure®, Similac® Organic, Similac® Special Care®, Similac Total [removed: Comfort®*,] [added: Comfort®,] Similac® For Supplementation, Isomil® Advance®, Isomil®, Alimentum®, Gain™, Grow™, Similac En Mei Li™, and Eleva™; |
In addition, [removed: certain] nutritional products [removed: sold as Similac®, Gain™, Grow™, Eleva™, PediaSure®, PediaSure SideKicks®, Pedialyte®, Ensure®, Zone Perfect®, and Glucerna®] are also promoted directly to the public by consumer marketing efforts in [removed: select] markets where [removed: appropriate.][added: permitted.]
| | ● | rhythm management products, including Assurity MRI® and Endurity MRI® pacemaker systems; 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® [added: and Jot Dx™] implantable cardiac [removed: monitor;] [added: monitors;] |
| | ● | electrophysiology products, including the TactiCath® family of ablation catheters and FlexAbility® irrigated ablation catheters; Ampere® RF ablation generator; EnSite® family of cardiac mapping systems; [removed: and] [added: Agilis™ NxT Steerable Introducer;] the Advisor® HD Grid mapping catheter; [added: ViewFlex™ family of intracardiac echocardiography catheters; and ViewMate™ Ultrasound System;] |
| | ● | heart failure related products, including the [removed: HeartMate™] [added: HeartMate®] left ventricular device [removed: family and] [added: family,] the CardioMEMS® HF System pulmonary artery sensor, a heart failure monitoring [added: system, and the CentriMag® System, an acute circulatory support] system; |
| | ● | vascular products, including the [removed: XIENCE™] [added: XIENCE®] family of drug-eluting coronary stent systems developed on the Multi-Link Vision® platform; StarClose [removed: SE® and] [added: SE®,] Perclose ProGlide® [added: and Perclose ProStyle®] vessel closure devices, TREK® coronary balloon dilatation products, Hi-Torque Balance Middleweight Universal II® guidewires, Supera® Peripheral Stent System, a peripheral vascular stent system; Acculink®/Accunet® and Xact®/Emboshield NAV6®, carotid stent systems; [removed: and] the OPTIS® integrated [removed: system] [added: systems] with [added: Ultreon™ 1.0 Software, compatible with] the Dragonfly OPTIS® imaging catheter and PressureWire® fractional flow reserve measurement systems; [added: and the JETi™ peripheral thrombectomy systems for clot removal;] |
| | ● | structural heart products, including MitraClip®, a [removed: percutaneous] [added: transcatheter] mitral valve repair system; Trifecta® Valve with Glide™ Technology, a surgical tissue heart valve; Portico® [added: and Navitor™] transcatheter aortic heart [removed: valve;] [added: valves;] Regent™ mechanical heart [removed: valve;] [added: valves;] Amplatzer® PFO occluders; Amplatzer Amulet® occluder devices; the Tendyne® Transcatheter Mitral Valve Implantation (TMVI) system; and the TriClip® Transcatheter Tricuspid Valve Repair System; |
Principal trademarks and the products they cover are discussed in the Narrative Description of Business on pages 1 through [removed: 4.][added: 3.]
These, and various patents which expire during the period [removed: 2021] [added: 2022] to [removed: 2041,] [added: 2042,] in the aggregate, are believed to be of material importance in the operation of Abbott’s business.
Regulations under [removed: federal] [added: federal, state,] and [removed: state] [added: various other countries’] environmental laws impose stringent limitations on emissions and discharges to the environment from various manufacturing operations.
Abbott’s capital and operating expenditures for pollution control in [removed: 2020] [added: 2021] were not material and are not expected to be material in [removed: 2021.][added: 2022.]
As of December 31, [removed: 2020,] [added: 2021,] Abbott employed approximately [removed: 109,000] [added: 113,000] people, 70% of whom were employed outside of the U.S. Women represented 47% of Abbott’s U.S. workforce, 45% of its global workforce, and [removed: 39%] [added: 40%] of its managers.
Over [removed: 22,000] [added: 21,000] Abbott employees across [removed: 72] [added: 73] countries took part in [removed: 2020.][added: 2021.]
During the COVID-19 pandemic, Abbott has taken aggressive steps to limit exposure and enhance the safety of facilities for its employees, including [removed: implementing mandatory temperature screening and social distancing,] providing and requiring the use of personal protective [removed: equipment,] [added: equipment] and at [removed: most U.S.] [added: many] facilities, [added: providing vaccinations, providing and requiring] onsite COVID-19 [removed: testing.][added: testing, and implementing social distancing.]
Abbott has ten such networks, which are: Advancing Professionals Network (supporting early career employees), Asian Leadership and Cultural Network, Black Business Network, Flex Network [removed: (employees] [added: (supporting employees] with part-time and flexible schedules), LA VOICE Network (supporting Hispanic and Latino employees), [removed: People] [added: disABILITY Network (supporting people] with [removed: Disabilities Network,] [added: disabilities),] PRIDE (supporting LGBTQ employees), Veterans Network, Women Leaders of Abbott, and Women in STEM.
In [removed: 2020, 52%] [added: 2021, 50%] of the participants were women.
In [removed: 2020, 55%] [added: 2021, 58%] of the U.S. interns were women and [removed: 39%] [added: 48%] were minorities.
Further, Abbott has [removed: operated] [added: offered] a STEM internship program for high school students in the U.S. since [removed: 2012.][added: 2012 and beginning in 2021, students who complete the program are eligible to receive college credit for their experience.]
In [removed: 2020, 58%] [added: 2021, 62%] of the STEM interns were women and [removed: 71%] [added: 68%] were minorities.
To that end, Abbott provides market competitive compensation, healthcare benefits, [added: continuing education benefits,] pension and/or retirement savings plans, [added: financial support for employees with student loan debt,] and several programs to facilitate employees building an ownership stake in Abbott, including a global long-term incentive program for employees generally beginning at the manager level.
Abbott also has procedures and processes focused on [removed: providing] [added: ensuring] employees [added: receive] equitable compensation, regardless of race or gender or other personal characteristics.
Abbott’s laboratory [removed: facilities and] [added: facilities,] home monitoring [removed: services,] [added: services,and durable medical equipment suppliers,] which provide services, related products and medical devices to consumers, are subject to additional laws and regulations applicable to health care providers and suppliers that submit claims for reimbursement to third-party payors.
For example, the European Union, [added: China,] various other countries, and various U.S. states (e.g., [removed: California)] [added: California, Virginia, and Colorado)] have enacted [removed: stricter] data protection laws that contain [removed: enhanced] [added: significant compliance obligations and] financial penalties for noncompliance.
[removed: Similarly,] [added: For example,] the U.S. Department of Health and Human Services has issued rules governing the use, disclosure, and security of protected health information, and the FDA has issued further guidance concerning cybersecurity for medical devices.
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.
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.”
In some locations, employees also have received free over-the-counter COVID-19 tests for at-home use.
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.
All Abbott employees are encouraged to join any of the employee networks.
In addition, regulators with general consumer protection authority, such as the Federal Trade Commission and U.S. states Attorneys General, are focused on how consumer data is used by entities in the health care industry.
Further, there are regulations of data privacy and security that are specific to health care companies.
* These products are available with 2'‐FL HMO (Human Milk Oligosaccharide) in several markets.
There have been no recent significant availability problems or supply shortages for raw materials or supplies.
Item 3. LEGAL PROCEEDINGS
2 rewritten, 14 added, 0 removed, 0 unchanged
Abbott is involved in various claims, legal [removed: proceedings] [added: proceedings,] and [removed: investigations.][added: investigations, including (as of January 31, 2022) those described below.]
While it is not feasible to predict the outcome of such pending claims, [removed: proceedings] [added: proceedings,] and investigations with certainty, management is of the opinion that their ultimate resolution should not have a material adverse effect on Abbott’s financial position, cash flows, or results of operations.
Abbott is a defendant in numerous lawsuits involving certain of its specialty infant formula products administered to preterm infants.
The lawsuits allege that preterm infants developed necrotizing enterocolitis as a result of being administered a cow’s milk-based preterm infant formula product, which resulted in personal injuries or death.
As of January 31, 2022, there were 68 lawsuits pending in federal and state courts in which Abbott is a party.
The plaintiffs seek various damages, including punitive damages.
In January 2022, the U.S. Judicial Panel on Multidistrict Litigation was asked to consolidate the federal court cases for pretrial purposes.
In addition, on December 15, 2021, a purported class of Canadian preterm infants filed suit in British Columbia making similar allegations against Abbott.
These plaintiffs seek various damages, including punitive damages.
Many of the lawsuits name another infant formula manufacturer as a co-defendant.
In June and July 2021, DexCom, Inc. (DexCom) initiated patent infringement litigation against Abbott over certain of Abbott’s continuous glucose monitoring products, including those under the FreeStyle brand, in the U.S. District Court for the Eastern District of Texas and in the Regional Court of Mannheim in Germany.
In both jurisdictions, DexCom seeks injunctive relief and monetary damages.
In all cases, Abbott asserts that it has a license to each of Dexcom’s asserted patents and that the patents are invalid and not infringed.
In July 2021, Abbott sued DexCom for patent infringement over certain of DexCom’s continuous glucose monitoring products in the U.S. District Court for the District of Delaware, the Regional Courts of Mannheim and Dusseldorf in Germany, and the High Court of Justice in the United Kingdom.
Abbott seeks injunctive relief and monetary damages.
In December 2021, Abbott filed a breach of contract suit against DexCom in the U.S. District Court for the District of Delaware alleging that DexCom breached the parties’ 2014 Settlement and License Agreement by asserting infringement of patents against Abbott that DexCom previously licensed to Abbott.
Cover and table of contents
4 rewritten, 2 added, 1 removed, 49 unchanged
| For the fiscal year ended December 31, [removed: 2020] [added: 2021] | Commission file number 1-2189 |
The aggregate market value of the [removed: 1,727,625,764] [added: 1,730,623,501] shares of voting stock held by nonaffiliates of the registrant, computed by reference to the closing price as reported on the New York Stock Exchange, as of the last business day of Abbott Laboratories’ most recently completed second fiscal quarter (June 30, [removed: 2020),] [added: 2021),] was [removed: $157,956,823,602.][added: $200,631,182,471.]
Portions of the [removed: 2021] [added: 2022] Abbott Laboratories Proxy Statement are incorporated by reference into Part III.
The [removed: Definitive] Proxy Statement will be filed on or about March [removed: 12, 2021.][added: 18, 2022.]
Number of common shares outstanding as of January 31, 2022: 1,763,482,267
Number of common shares outstanding as of January 31, 2021: 1,771,529,358
Item 2. PROPERTIES
4 rewritten, 0 added, 0 removed, 13 unchanged
As of December 31, [removed: 2020,] [added: 2021,] Abbott owned or leased properties totaling approximately 43 million square feet, of which approximately 65% is owned by Abbott.
Abbott operates [removed: 93] [added: 90] manufacturing facilities globally.
| Established Pharmaceutical Products | | [removed: 28] [added: 25] |
| Worldwide Total | | [removed: 93] [added: 90] |
Item 4. MINE SAFETY DISCLOSURES
30 rewritten, 20 added, 14 removed, 82 unchanged
Abbott’s executive officers, their ages as of February [removed: 19, 2021,] [added: 18, 2022,] and the dates of their first election as officers of Abbott are listed below.
[removed: 2020] [added: 2021] to present — [removed: Executive] Chairman [added: of the Board] and [added: Chief Executive Officer, and] Director.
[removed: 1999 to] 2020 [added: to 2021] — [removed: Chairman of the Board] [added: President] and Chief Executive Officer, and Director.
Elected Corporate Officer — [removed: 1993.][added: 2021.]
Ford, [removed: 47][added: 48]
Allen, [removed: 55][added: 56]
Capek, [removed: 59][added: 60]
Earnhardt, [removed: 51][added: 52]
Funck, Jr., [removed: 59][added: 60]
Ginascol, [removed: 62][added: 63]
2017 to [removed: present] [added: 2021] — Executive Vice President, [removed: Established Pharmaceuticals.][added: Nutritional Products.]
Elected Corporate Officer — [removed: 2015.][added: 2021.]
Moreland, [removed: 54][added: 55]
Daniel Salvadori, [removed: 42][added: 43]
[removed: 2017] [added: 2021] to present — Executive Vice President, Nutritional Products.
Andrea Wainer, [removed: 52][added: 53]
Ahlberg, [removed: 54][added: 55]
[removed: 2015] [added: 2021] to present — Senior Vice President, U.S. Nutrition.
[removed: 2017] [added: 2021] to present — Senior Vice President, Abbott Vascular.
Dale, [removed: 61][added: 62]
Sammy Karam, [removed: 59][added: 60]
Joseph Manning, [removed: 52][added: 53]
2017 to [removed: present] [added: 2021] — Senior Vice President, International Nutrition.
Pederson, [removed: 59][added: 60]
2019 to [removed: present] [added: 2021] — Senior Vice President, Electrophysiology and Heart Failure.
[removed: 2019] [added: 2021] to present — Senior Vice President, Rapid Diagnostics.
Watkin, [removed: 53][added: 54]
Wellisch, [removed: 46][added: 47]
Woodgrift, [removed: 59][added: 60]
Boudreau, [removed: 48][added: 49]
2021 to present — Executive Vice President and Group President, Established Pharmaceuticals and Nutritional Products.
Calamari, 51
2017 to 2021 — Vice President, Pediatric Nutrition.
2014 to 2017 — Divisional Vice President and General Manager, Pediatric Nutrition.
Fernando Mateus, 47
2021 to present — Senior Vice President, International Nutrition.
2018 to 2021 — Divisional Vice President, EURISA, Abbott International Nutrition.
2016 to 2018 — Chief Executive Officer, Exeltis USA, Inc. (a subsidiary of Exeltis, a women’s health company focused on respiratory, dermatology, and endocrinology).
Louis H.
Morrone, 45
2017 to 2021 — Vice President, Transfusion Medicine.
2015 to 2017 — Divisional Vice President and General Manager, Transfusion Medicine, ADD.
2021 to present — Senior Vice President, Electrophysiology
Julie L.
Tyler, 52
April 2021 to July 2021 — Divisional Vice President, U.S. Commercial, ADC.
2019 to 2021 — Divisional Vice President, Global Marketing, AVD.
2017 to 2019 — Divisional Vice President, U.S. Sales and Marketing Endovascular, AVD.
Elected Corporate Officer — 2017.
Miles D.
White, 65
2020 to present — President and Chief Executive Officer, and Director.
Andrew H.
Lane, 50
2015 to 2017 — Senior Vice President, Established Pharmaceuticals, Emerging Markets.
Roger M.
Bird, 64
Charles R.
Brynelsen, 64
2016 to 2017 — Managing Director, CB Business Advisors, Inc. (a medical device consulting firm).
2015 to 2016 — Senior Vice President and President, Medtronic Early Technologies, Medtronic plc (a global medical device company).
Scoggins, 51
2015 to 2019 — Vice President, Diabetes Care, Commercial Operations.
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
9 rewritten, 5 added, 4 removed, 14 unchanged
There were [removed: 37,450] [added: 35,926] shareholders of record of Abbott common shares as of December 31, [removed: 2020.][added: 2021.]
Abbott certified that the HIB requirements were met for the calendar year ending December 31, [removed: 2020.][added: 2021.]
| | | | | [removed: ] [added: ] | | | (c) Total Number of | | (d) Maximum Number (or | | |
| | [removed: ] [added: ] | (a) Total Number | [removed: ] [added: ] | [removed: ] [added: ] | | [removed: ] [added: ] | Shares (or Units) | [removed: ] [added: ] | Approximate Dollar Value) of | | |
| | [removed: ] [added: ] | of Shares | [removed: ] [added: ] | (b) Average Price | | [removed: ] [added: ] | Purchased as Part of | [removed: ] [added: ] | Shares (or Units) that May | | |
| | [removed: ] [added: ] | (or Units) | [removed: ] [added: ] | Paid per Share | | [removed: ] [added: ] | Publicly Announced | [removed: ] [added: ] | Yet Be Purchased Under the | | |
| Period | [removed: ] [added: ] | Purchased | [removed: ] [added: ] | (or Unit) | | [removed: ] [added: ] | Plans or Programs | [removed: ] [added: ] | Plans or Programs | | |
[removed: | (1) |] These shares do not include the shares surrendered to Abbott to satisfy tax withholding obligations in connection with the vesting of restricted stock or restricted stock units. [removed: |]
| (2) | On [removed: September] [added: October] 11, [removed: 2014,] [added: 2019,] the board of directors authorized the repurchase of up to $3 billion of [removed: its] [added: Abbott] common shares, from time to time (the [removed: “2014] [added: “2019] Plan”). On [removed: October 11, 2019,] [added: December 10, 2021,] the board of directors authorized the repurchase of up to [removed: $3] [added: $5] billion of Abbott common shares, from time to time (the [removed: “2019] [added: “2021] Plan”). The [removed: 2019] [added: 2021] Plan is in addition to the unused portion of the [removed: 2014] [added: 2019] Plan. |
| October 1, 2021 — October 31, 2021 | | 1,767,000 | (1) | $ | 127.811 | | 1,750,000 | | $ | 1,686,728,997 | (2) |
| November 1, 2021 — November 30, 2021 | | 4,750,000 | (1) | $ | 127.486 | | 4,750,000 | | $ | 1,081,169,672 | (2) |
| December 1, 2021 — December 31, 2021 | | 135 | (1) | $ | 141.000 | | 0 | | $ | 6,081,169,672 | (2) |
| Total | | 6,517,135 | (1) | $ | 127.575 | | 6,500,000 | | $ | 6,081,169,672 | (2) |
| (1) | These shares include the shares deemed surrendered to Abbott to pay the exercise price in connection with the exercise of employee stock options – 17,000 in October, 0 in November, and 135 in December. |
| October 1, 2020 — October 31, 2020 | | 0 | (1) | $ | 0 | | 0 | | $ | 3,270,234,923 | (2) |
| November 1, 2020 — November 30, 2020 | | 0 | (1) | $ | 0 | | 0 | | $ | 3,270,234,923 | (2) |
| December 1, 2020 — December 31, 2020 | | 1,600,411 | (1) | $ | 107.999 | | 1,600,411 | | $ | 3,097,391,913 | (2) |
| Total | | 1,600,411 | (1) | $ | 107.999 | | 1,600,411 | | $ | 3,097,391,913 | (2) |
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
513 rewritten, 141 added, 109 removed, 682 unchanged
| [Consolidated Statement of Earnings](#ConsolidatedStatementofEarnings_756832) | | [removed: 43] [added: 41] |
| [Consolidated Statement of Comprehensive Income](#ComprehensiveIncome_527351) | | [removed: 44] [added: 42] |
| [Consolidated Statement of Cash Flows](#CashFlows_598485) | | [removed: 45] [added: 43] |
| [Consolidated Balance Sheet](#ConsolidatedBalanceSheet_69561) | | [removed: 46] [added: 44] |
| [Consolidated Statement of Shareholders’ Investment](#ShareholdersInvestment_387504) | | [removed: 48] [added: 46] |
| [Notes to Consolidated Financial [removed: Statements](#Note1SummaryofSignificant_734166)] [added: Statements](#Note1SummaryofSignificantAccountingPolic)] | | [removed: 49] [added: 47] |
| [Management Report on Internal Control Over Financial Reporting](#ManagementReportonInternal_357767) | | [removed: 81] [added: 75] |
| [Report of Independent Registered Public Accounting Firm](#ReportofIndependent_5199) [added: (PCAOB ID: 42)] | | [removed: 82] [added: 76] |
| [Report of Independent Registered Public Accounting Firm](#PublicAccountingFirm_660147) | | [removed: 84] [added: 78] |
| | | [removed: 2020] [added: 2021] | | | [removed: 2019] [added: 2020] | | | [removed: 2018] [added: 2019] | |
| Net Sales | | $ | [removed: 34,608] [added: 43,075] | | $ | [removed: 31,904] [added: 34,608] | | $ | [removed: 30,578] [added: 31,904] |
| Cost of products sold, excluding amortization of intangible assets | | | [removed: 15,003] [added: 18,537] | | | [removed: 13,231] [added: 15,003] | | | [removed: 12,706] [added: 13,231] |
| Amortization of intangible assets | | | [removed: 2,132] [added: 2,047] | | | [removed: 1,936] [added: 2,132] | | | [removed: 2,178] [added: 1,936] |
| Research and development | | | [removed: 2,420] [added: 2,742] | | | [removed: 2,440] [added: 2,420] | | | [removed: 2,300] [added: 2,440] |
| Selling, general and administrative | | | [removed: 9,696] [added: 11,324] | | | [removed: 9,765] [added: 9,696] | | | [removed: 9,744] [added: 9,765] |
| Total Operating Cost and Expenses | | | [removed: 29,251] [added: 34,650] | | | [removed: 27,372] [added: 29,251] | | | [removed: 26,928] [added: 27,372] |
| Operating Earnings | | | [removed: 5,357] [added: 8,425] | | | [removed: 4,532] [added: 5,357] | | | [removed: 3,650] [added: 4,532] |
| Interest expense | | | [removed: 546] [added: 533] | | | [removed: 670] [added: 546] | | | [removed: 826] [added: 670] |
| Interest income | | | [removed: (46)] [added: (43)] | | | [removed: (94)] [added: (46)] | | | [removed: (105)] [added: (94)] |
| Net foreign exchange (gain) loss | | | [removed: (8)] [added: 1] | | | [removed: 7] [added: (8)] | | | [removed: 28] [added: 7] |
| Debt extinguishment costs | | | — | | | [removed: 63] [added: —] | | | [removed: 167] [added: 63] |
| Other (income) expense, net | | | [removed: (103)] [added: (277)] | | | [removed: (191)] [added: (103)] | | | [removed: (139)] [added: (191)] |
| Earnings from Continuing Operations Before Taxes | | | [removed: 4,968] [added: 8,211] | | | [removed: 4,077] [added: 4,968] | | | [removed: 2,873] [added: 4,077] |
| Taxes on Earnings from Continuing Operations | | | [removed: 497] [added: 1,140] | | | [removed: 390] [added: 497] | | | [removed: 539] [added: 390] |
| Earnings from Continuing Operations | | | [removed: 4,471] [added: 7,071] | | | [removed: 3,687] [added: 4,471] | | | [removed: 2,334] [added: 3,687] |
| Net Earnings from Discontinued Operations, net of taxes | | | [removed: 24] [added: —] | | | [removed: —] [added: 24] | | | [removed: 34] [added: —] |
| Net Earnings | | $ | [removed: 4,495] [added: 7,071] | | $ | [removed: 3,687] [added: 4,495] | | $ | [removed: 2,368] [added: 3,687] |
| Continuing Operations | | $ | [removed: 2.51] [added: 3.97] | | $ | [removed: 2.07] [added: 2.51] | | $ | [removed: 1.32] [added: 2.07] |
| Discontinued Operations | | | [removed: 0.01] [added: —] | | | [removed: —] [added: 0.01] | | | [removed: 0.02] [added: —] |
| Net Earnings | | $ | [removed: 2.52] [added: 3.97] | | $ | [removed: 2.07] [added: 2.52] | | $ | [removed: 1.34] [added: 2.07] |
| Continuing Operations | | $ | [removed: 2.49] [added: 3.94] | | $ | [removed: 2.06] [added: 2.49] | | $ | [removed: 1.31] [added: 2.06] |
| Net Earnings | | $ | [removed: 2.50] [added: 3.94] | | $ | [removed: 2.06] [added: 2.50] | | $ | [removed: 1.33] [added: 2.06] |
| Average Number of Common Shares Outstanding Used for Basic Earnings Per Common Share | | | [removed: 1,773] [added: 1,775] | | | [removed: 1,768] [added: 1,773] | | | [removed: 1,758] [added: 1,768] |
| Dilutive Common Stock Options | | | [removed: 13] [added: 14] | | | 13 | | | [removed: 12] [added: 13] |
| Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options | | | [removed: 1,786] [added: 1,789] | | | [removed: 1,781] [added: 1,786] | | | [removed: 1,770] [added: 1,781] |
| Outstanding Common Stock Options Having No Dilutive Effect | | | [removed: 9] [added: —] | | | [removed: 61] [added: 9] | | | [removed: —] [added: 61] |
| | | [removed: 2020] [added: 2021] | | | [removed: 2019] [added: 2020] | | | [removed: 2018] [added: 2019] | |
| Foreign currency translation gain (loss) adjustments | | | [removed: 65] [added: (980)] | | | [removed: (12)] [added: 65] | | | [removed: (1,460)] [added: (12)] |
| Net actuarial gains (losses) and prior service cost and credits and amortization of net actuarial losses and prior service cost and credits, net of taxes of [added: $340 in 2021,] $(79) in [removed: 2020,] [added: 2020 and] $(238) in 2019 [removed: and $47 in 2018] | | | [removed: (331)] [added: 1,201] | | | [removed: (814)] [added: (331)] | | | [removed: 132] [added: (814)] |
| Net [removed: (losses)] gains [added: (losses)] on derivative instruments designated as cash flow hedges, net of taxes of [added: $63 in 2021,] $(87) in [removed: 2020,] [added: 2020 and] $(17) in 2019 [removed: and $50 in 2018] | | | [removed: (215)] [added: 351] | | | [removed: (53)] [added: (215)] | | | [removed: 136] [added: (53)] |
| Discontinued Operations | | | — | | | 0.01 | | | — |
| Net earnings | | $ | 7,071 | | $ | 4,495 | | $ | 3,687 |
| | | 2021 | | | 2020 | |
| | | | 19,364 | | | 18,793 |
| | | $ | 75,196 | | $ | 72,548 |
| | | 2021 | | | 2020 | |
| Common shares held in treasury, at cost — Shares: 2021: 221,191,228; 2020: 209,926,622 | | | (11,822) | | | (10,042) |
| | | $ | 75,196 | | $ | 72,548 |
| Net earnings | | | 7,071 | | | 4,495 | | | 3,687 |
| Other comprehensive income (loss) | | | 572 | | | (481) | | | (879) |
Abbott adopted the standard on January 1, 2021.
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The amounts as of December 31, 2021 and 2020 were not significant.
| Balance at December 31, 2021 | | $ | 520 |
| Provisions/charges to income | | | 51 |
| Amounts charged off and other deductions | | | (26) |
| Balance at December 31, 2021 | | $ | 313 |
| (in millions) | | 2021 | | | 2020 | |
The decrease in Abbott’s long-term investments as of December 31, 2021 versus the balance as of December 31, 2020 primarily relates to the sale of an equity method investment partially offset by the acquisition of additional investments.
In September 2021, Abbott acquired 100 percent of Walk Vascular, LLC (Walk Vascular), a commercial-stage medical device company with a minimally invasive thrombectomy system designed to remove peripheral blood clots.
Walk Vascular’s peripheral thrombectomy system will be incorporated into Abbott’s existing endovascular portfolio.
The purchase price, the allocation of acquired assets and liabilities, and the revenue and net income contributed by Walk Vascular since the date of acquisition are not material to Abbott’s consolidated financial statements.
| (in millions) | | 2021 | | | 2020 | |
| (in millions) | | 2021 | | | 2020 | |
| Balance at December 31, 2021 | | $ | (5,839) | | $ | (2,670) | | $ | 135 | | $ | (8,374) |
There were no reductions of goodwill relating to impairments in 2021 and 2020.
The decrease is due to IPR&D assets primarily related to the Medical Devices segment that became amortizable in 2021, partially offset by an increase of approximately $80 million related to a recent acquisition.
Amortizable intangible assets increased by approximately $120 million as a result of a recent acquisition and the additional assets are being amortized over 9 years.
In 2021, asset impairments related to the Established Pharmaceutical Products segment decreased intangible assets by $14 million.
On May 27, 2021, Abbott management approved a restructuring plan related to its Diagnostic Products segment to align its manufacturing network for COVID-19 diagnostic tests with changes in the second quarter in projected testing demand driven by several factors, including significant reductions in cases in the U.S. and other major developed countries, the accelerated rollout of COVID-19 vaccines globally and the U.S. health authority’s updated guidance on testing for fully vaccinated individuals.
In the second quarter of 2021, Abbott recorded charges of $499 million under this plan in Cost of products sold.
The charge recognized in the second quarter included fixed asset write-downs of $80 million, inventory-related charges of $248 million, and other exit costs, which included contract cancellations and employee-related costs of $171 million.
In the second half of 2021, as the Delta and Omicron variants of COVID-19 spread and the number of new COVID-19 cases increased significantly, particularly in the U.S., demand for rapid COVID-19 tests increased significantly.
As a result, in the second half of 2021, Abbott sold approximately $181 million of inventory that was previously estimated to have no net realizable value under the second quarter restructuring action.
| | | |
| --- | --- | --- |
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Abbott Laboratories and Subsidiaries
| Amortization of inventory step-up | | | — | | | — | | | 32 |
| | | | 18,793 | | | 16,799 |
| | | $ | 72,548 | | $ | 67,887 |
| Shares: 2020: 214,351,838; 2019: 215,570,043; 2018: 222,305,719 | | $ | (10,147) | | $ | (9,962) | | $ | (10,225) |
Notes to Consolidated Financial Statements (Continued)
Investments in debt securities are classified as held-to-maturity, as management has both the intent and ability to hold these securities to maturity, and are reported at cost, net of any unamortized premium or discount.
Income relating to these securities is reported as interest income.
Note 2 – New Accounting Standards
In February 2018, the FASB issued Accounting Standards Update (ASU) 2018-02, _Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income_, which allows companies to reclassify stranded tax effects resulting from the 2017 Tax Cuts and Jobs Act, from Accumulated other comprehensive income (loss) to retained earnings (Earnings employed in the business).
Abbott adopted the new standard at the beginning of the fourth quarter of 2018.
As a result of the adoption of the new standard, approximately $337 million of stranded tax effects were reclassified from Accumulated other comprehensive income (loss) to Earnings employed in the business.
Note 2 — New Accounting Standards (Continued)
In October 2016, the FASB issued ASU 2016-16, _Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory_, which requires the recognition of the income tax effects of intercompany sales and transfers of assets, other than inventory, in the period in which the transfer occurs.
Abbott adopted the standard on January 1, 2018, using a modified retrospective approach and recorded a cumulative catch-up adjustment to Earnings employed in the business in the Consolidated Balance Sheet that was not significant.
Recent Accounting Standards Not Yet Adopted
The standard becomes effective for Abbott in the first quarter of 2021.
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| Balance at December 31, 2018 | | $ | 259 |
Note 4 — Discontinued Operations and Business Dispositions
The net earnings of discontinued operations include income tax benefits of $24 million in 2020 and $39 million in 2018.
The 2020 tax benefits primarily relate to the resolution of various tax positions related to Abbott’s developed markets branded generic pharmaceuticals business which was sold to Mylan Inc. (Mylan) in 2015.
The tax positions relate to years prior to the sale to Mylan.
The 2018 tax benefits primarily relate to the resolution of various tax positions related to the operations of AbbVie Inc. (AbbVie) for years prior to the separation.
Abbott completed the separation of AbbVie, which was formed to hold Abbott’s research-based proprietary pharmaceuticals business, in January 2013.
Abbott retained all liabilities for all U.S. federal and foreign income taxes on income prior to the separation.
Abbott’s long-term investments as of December 31, 2020 declined versus the balance as of December 31, 2019 due primarily to investment impairments totaling approximately $115 million, recorded in Other (income) expense, net within the Consolidated Statement of Earnings, which was partially offset by approximately $35 million of additional investments during 2020.
| Balance at December 31, 2018 | | $ | (4,912) | | $ | (2,726) | | $ | 52 | | $ | (7,586) |
There was no reduction of goodwill relating to impairments in 2020 and 2019.
| Restructuring charges | | | 66 |
| Payments and other adjustments | | | (57) |
| Accrued balance at December 31, 2019 | | | 79 |
| Restructuring charges | | | 36 |
| Payments and other adjustments | | | (45) |
| Accrued balance at December 31, 2020 | | $ | 70 |
An excerpt. Shown here: 40 of 513 rewritten, 40 of 141 added and 40 of 109 removed. The counts are complete. For every sentence, read Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA in the FY2021 filing and the FY2020 filing.
Item 9A. CONTROLS AND PROCEDURES
3 rewritten, 0 added, 0 removed, 5 unchanged
_Management’s annual report on internal control over financial reporting._ Management’s report on Abbott’s internal control over financial reporting is included on page [removed: 81] [added: 75] hereof.
The report of Abbott’s independent registered public accounting firm related to their assessment of the effectiveness of internal control over financial reporting is included on page [removed: 84] [added: 78] hereof.
_Changes in internal control over financial reporting._ During the quarter ended December 31, [removed: 2020,] [added: 2021,] there were no changes in Abbott’s internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that have materially affected, or are reasonably likely to materially affect, Abbott’s internal control over financial reporting.
Item 9B. OTHER INFORMATION
0 rewritten, 0 added, 2 removed, 1 unchanged
PART III
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
0 rewritten, 3 added, 0 removed, 0 unchanged
New section this year
Not applicable.
PART III
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
3 rewritten, 0 added, 0 removed, 3 unchanged
Incorporated herein by reference are “Nominees for Election as Directors,” “Committees of the Board of Directors,” and “Procedure for Recommendation and Nomination of Directors and Transaction of Business at Annual Meeting” to be included in the [removed: 2021] [added: 2022] Abbott Laboratories Proxy Statement.
The [removed: 2021 Definitive] [added: 2022] Proxy Statement will be filed on or about March [removed: 12, 2021.][added: 18, 2022.]
Also incorporated herein by reference is the text found under the caption, “Information About Our Executive Officers” on pages [removed: 16] [added: 17] through [removed: 19] [added: 20] hereof.
Item 11. EXECUTIVE COMPENSATION
2 rewritten, 0 added, 0 removed, 0 unchanged
The material to be included in the [removed: 2021] [added: 2022] Proxy Statement under the headings [removed: “2020 Director] [added: “Director] Compensation” and “Executive Compensation” is incorporated herein by reference.
The [removed: 2021 Definitive] [added: 2022] Proxy Statement will be filed on or about March [removed: 12, 2021.][added: 18, 2022.]
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
6 rewritten, 2 added, 2 removed, 33 unchanged
The following table presents information as of December 31, [removed: 2020] [added: 2021] about our compensation plans under which Abbott common shares have been authorized for issuance.
| | | Purchase cycles are generally six months long and usually begin on August 1 and February 1. On the last day of each purchase cycle, Abbott uses participant contributions to acquire Abbott common shares. The shares may be either authorized but unissued shares, treasury shares, or shares acquired on the open market. The purchase price is typically 85% of the lower of the fair market value of the shares on the purchase date or on the first day of that purchase cycle. As the number of shares subject to outstanding options is indeterminable, columns (a) and (b) of the above table do not include information on the Employee Stock Purchase Plan. As of December 31, [removed: 2020,] [added: 2021,] an aggregate of [removed: 11,611,818] [added: 10,638,639] common shares were available for future issuance under the Employee Stock Purchase Plan, including shares subject to purchase during the current purchase cycle. |
| (2) | | Not included in the table: _St. Jude Medical, Inc. Plans_. In 2017, in connection with the acquisition of St. Jude Medical, Inc., options outstanding under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, as Amended and Restated (2014) were assumed by Abbott and converted into Abbott options of substantially equivalent value. As of December 31, [removed: 2020, 885,521] [added: 2021, 589,916] options remained outstanding under these plans. These options have a weighted average purchase price of [removed: $30.46.] [added: $30.61.] No further awards will be granted under these plans. |
For additional information concerning the Abbott Laboratories 2009 Incentive Stock Program, the Abbott Laboratories 2017 Incentive Stock Program, and the Abbott Laboratories 2017 Employee Stock Purchase Plan for Non-U.S. Employees, see the discussion in Note [removed: 9] [added: 8] entitled “Incentive Stock Program” of the Notes to Consolidated Financial Statements included under Item 8, “Financial Statements and Supplementary Data.”
Incorporated herein by reference is the material under the heading “Security Ownership of Executive Officers and Directors” and “Information Concerning Security Ownership” in the [removed: 2021] [added: 2022] Proxy Statement.
The [removed: 2021 Definitive] [added: 2022] Proxy Statement will be filed on or about March [removed: 12, 2021.][added: 18, 2022.]
| Equity compensation plans approved by security holders (1) | | 26,609,935 | | $ | 65.93 | | 90,958,732 |
| Total (1)(2) | | 26,609,935 | | $ | 65.93 | | 90,958,732 |
| Equity compensation plans approved by security holders (1) | | 28,034,365 | | $ | 56.45 | | 124,762,755 |
| Total (1)(2) | | 28,034,365 | | $ | 56.45 | | 124,762,755 |
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
2 rewritten, 0 added, 0 removed, 0 unchanged
The material to be included in the [removed: 2021] [added: 2022] Proxy Statement under the headings “The Board of Directors,” “Committees of the Board of Directors,” and “Approval Process for Related Person Transactions” is incorporated herein by reference.
The [removed: 2021 Definitive] [added: 2022] Proxy Statement will be filed on or about March [removed: 12, 2021.][added: 18, 2022.]
Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
2 rewritten, 0 added, 0 removed, 1 unchanged
The material to be included in the [removed: 2021] [added: 2022] Proxy Statement under the headings “Audit Fees and Non-Audit Fees” and “Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of the Independent Auditor” is incorporated herein by reference.
The [removed: 2021 Definitive] [added: 2022] Proxy Statement will be filed on or about March [removed: 12, 2021.][added: 18, 2022.]
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
33 rewritten, 2 added, 4 removed, 258 unchanged
(1) _Financial Statements:_ See Item 8, “Financial Statements and Supplementary Data,” on page [removed: 42] [added: 40] hereof, for a list of financial statements.
| [Valuation and Qualifying Accounts (Schedule II)](#SCHEDULEIIVALUATION_950279) | | [removed: 101] [added: 94] |
| [Report of Independent Registered Public Accounting Firm](#ReportofIndependentRegistered_669574) | | [removed: 102] [added: 95] |
| 3.1 | * | [removed: [Articles] [added: [Amended and Restated Articles] of [removed: Incorporation,] [added: Incorporation of] Abbott Laboratories, filed as Exhibit 3.1 to the Abbott Laboratories [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q for the quarter ended March 31, 1998.](https://www.sec.gov/Archives/edgar/data/1800/0001047469-98-020300-index.html)] [added: 8-K filed on April 26, 2021.](https://www.sec.gov/Archives/edgar/data/1800/000110465921054917/tm2114110d1_ex3-1.htm)] | |
| 3.2 | * | [By-Laws of Abbott Laboratories, as amended and restated effective [removed: April 24, 2020,] [added: December 10,2021,] filed as Exhibit 3.1 to the Abbott Laboratories Current Report on Form 8-K [removed: dated February 21, 2020.](https://www.sec.gov/Archives/edgar/data/1800/000110465920026170/tm2011078d1_ex3-1.htm)] [added: filed on December 10,2021.](https://www.sec.gov/Archives/edgar/data/1800/000110465921148608/tm2134920d1_ex3-1.htm)] | |
| 4.29 | * | [Form of 0.875% Note due 2023 (included in Exhibit 4.2 to the Abbott Laboratories Current Report on Form 8-K dated September 27, [removed: 2018).](https://www.sec.gov/Archives/edgar/data/1800/000110465918059457/a18-36079_1ex4d2.htm)] [added: 2018).](https://www.sec.gov/Archives/edgar/data/1800/000110465918059457/a18-36079_1ex4d2.htm#Exhibit4_2_033809)] | |
| 4.30 | * | [Form of 1.500% Note due 2026 (included in Exhibit 4.2 to the Abbott Laboratories Current Report on Form 8-K dated September 27, [removed: 2018).](https://www.sec.gov/Archives/edgar/data/1800/000110465918059457/a18-36079_1ex4d2.htm)] [added: 2018).](https://www.sec.gov/Archives/edgar/data/1800/000110465918059457/a18-36079_1ex4d2.htm#Exhibit4_2_033809)] | |
| [removed: 4.36] [added: 10.72] | * | [removed: [Description of Registrant's Securities,] [added: [Management Savings Plan, as amended and restated,] filed as Exhibit [removed: 4.34] [added: 10.75] to the 2019 Abbott Laboratories Annual Report on Form [removed: 10-K).](https://www.sec.gov/Archives/edgar/data/1800/000110465920023904/ex-4d34.htm)] [added: 10-K).](https://www.sec.gov/Archives/edgar/data/1800/000110465920023904/ex-10d75.htm)] | |
| 10.56 | [removed: ] [added: *] | [Form of Performance Restricted Stock Unit Agreement for foreign employees (annual performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d56.htm)] [added: Program, filed as Exhibit 10.56 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d56.htm)] | |
| 10.57 | [removed: ] [added: *] | [Form of Performance Restricted Stock Unit Agreement for foreign employees (interim performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d57.htm)] [added: Program, filed as Exhibit 10.57 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d57.htm)] | |
| 10.58 | [removed: ] [added: *] | [Form of Performance Restricted Stock Agreement (annual performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d58.htm)] [added: Program , filed as Exhibit 10.58 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d58.htm)] | |
| 10.59 | [removed: ] [added: *] | [Form of Performance Restricted Stock Agreement (interim performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d59.htm)] [added: Program, filed as Exhibit 10.59 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d59.htm)] | |
| 10.60 | [removed: ] [added: *] | [Form of Performance Restricted Stock Unit Agreement for foreign executive officers (annual performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d60.htm)] [added: Program, filed as Exhibit 10.60 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d60.htm)] | |
| 10.61 | [removed: ] [added: *] | [Form of Performance Restricted Stock Unit Agreement for foreign executive officers (interim performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d61.htm)] [added: Program, filed as Exhibit 10.61 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d61.htm)] | |
| 10.62 | [removed: ] [added: *] | [Form of Performance Restricted Stock Agreement for executive officers (annual performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d62.htm)] [added: Program, filed as Exhibit 10.62 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d62.htm)] | |
| 10.63 | [removed: ] [added: *] | [Form of Performance Restricted Stock Agreement for executive officers (interim performance based) under the Abbott Laboratories 2017 Incentive Stock [removed: Program.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d63.htm)] [added: Program, filed as Exhibit 10.63 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d63.htm)] | |
| 10.65 | * | [Form of Extension of Agreement Regarding Change in Control by and between Abbott Laboratories and its named executive officers (other than Mr. White), extending the agreement term to December 31, [removed: 2020,] [added: 2022,] filed as Exhibit [removed: 10.74] [added: 10.66] to the [removed: 2018] [added: 2020] Abbott Laboratories Annual Report on Form [removed: 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000104746919000624/a2237733zex-10_74.htm)] [added: 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d66.htm)] | |
| [removed: 10.67] [added: 10.66] | * | [Form of Time Sharing Agreement between Abbott Laboratories Inc. and M.D. White, filed as Exhibit 10.6 to the Abbott Laboratories Quarterly Report on Form 10-Q for the quarter ended June 30, 2006.](https://www.sec.gov/Archives/edgar/data/1800/000110465906052230/a06-14795_1ex10d6.htm) | |
| [removed: 10.68] [added: 10.67] | [removed: ] [added: *] | [Form of Time Sharing Agreement between Abbott Laboratories Inc. and Robert B. [removed: Ford.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d68.htm)] [added: Ford, filed as Exhibit 10.68 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d68.htm)] | |
| [removed: 10.69] [added: 10.68] | † | [St. Jude Medical, Inc. 2007 Stock Incentive Plan, as amended and restated (2014), filed as Exhibit 10.22 to St. Jude Medical, Inc. Annual Report on Form 10-K for the year ended January 3, 2015 dated February 26, 2015.](https://www.sec.gov/Archives/edgar/data/203077/000020307715000003/exhibit102201032015.htm) | |
| [removed: 10.70] [added: 10.69] | † | [Form of Non-Qualified Stock Option Agreement (Global) and related Notice of Non-Qualified Stock Option Grant for stock options granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, filed as Exhibit 10.24 to the St. Jude Medical, Inc. Annual Report on Form 10-K for the year ended December 29, 2012 dated February 26, 2013.](https://www.sec.gov/Archives/edgar/data/203077/000020307713000003/exhibit102412292012.htm) | |
| [removed: 10.71] [added: 10.70] | † | [Form of Non-Qualified Stock Option Agreement for Non-Employee Directors and related Notice of Non-Qualified Stock Option Grant for stock options granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, filed as Exhibit 10.25 to the St. Jude Medical, Inc. Annual Report on Form 10-K for the year ended December 29, 2012, dated February 26, 2013.](https://www.sec.gov/Archives/edgar/data/203077/000020307713000003/exhibit102512292012.htm) | |
| [removed: 10.72] [added: 10.71] | † | [Form of Restricted Stock Units Award Agreement (Global) and related Restricted Stock Units Award Certificate for restricted stock units granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, filed as Exhibit 10.27 to the St. Jude Medical, Inc. Annual Report on Form 10-K for the year ended December 29, 2012, dated February 26, 2013.](https://www.sec.gov/Archives/edgar/data/203077/000020307713000003/exhibit102712292012.htm) | |
| 10.73 | * | [removed: [Management Savings] [added: [Abbott Overseas Managers Pension] Plan, as amended and restated, filed as Exhibit [removed: 10.75] [added: 10.74] to the [removed: 2019] [added: 2020] Abbott Laboratories Annual Report on Form [removed: 10-K).](https://www.sec.gov/Archives/edgar/data/1800/000110465920023904/ex-10d75.htm)] [added: 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d74.htm)] | |
| [removed: 10.75] [added: 10.74] | [removed: ] [added: *] | [Five Year Credit Agreement, dated as of November 12, 2020, among Abbott Laboratories, as borrower, various financial institutions, as lenders, and JPMorgan Chase Bank, N.A., as administrative [removed: agent.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d75.htm)] [added: agent, filed as Exhibit 10.75 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d75.htm)] | |
| 21 | | [Subsidiaries of Abbott [removed: Laboratories.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex21.htm)] [added: Laboratories.](https://www.sec.gov/Archives/edgar/data/1800/000110465922025141/abt-20211231xex21d1.htm)] | |
| 23.1 | | [Consent of Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex23d1.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/1800/000110465922025141/abt-20211231xex23d1.htm)] | |
| 31.1 | | [Certification of Chief Executive Officer Required by Rule 13a-14(a) (17 CFR [removed: 240.13a-14(a)).](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex31d1.htm)] [added: 240.13a-14(a)).](https://www.sec.gov/Archives/edgar/data/1800/000110465922025141/abt-20211231xex31d1.htm)] | |
| 31.2 | | [Certification of Chief Financial Officer Required by Rule 13a-14(a) (17 CFR [removed: 240.13a-14(a)).](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex31d2.htm)] [added: 240.13a-14(a)).](https://www.sec.gov/Archives/edgar/data/1800/000110465922025141/abt-20211231xex31d2.htm)] | |
| 32.1 | | [Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex32d1.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/1800/000110465922025141/abt-20211231xex32d1.htm)] | |
| 32.2 | | [Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex32d2.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/1800/000110465922025141/abt-20211231xex32d2.htm)] | |
| 101 | | The following financial statements and notes from the Abbott Laboratories Annual Report on Form 10-K for the year ended December 31, [removed: 2020] [added: 2021] filed on February [removed: 19, 2021,] [added: 18, 2022,] formatted in Inline XBRL: (i) Consolidated Statement of Earnings; (ii) Consolidated Statement of Comprehensive Income; (iii) Consolidated Statement of Cash Flows; (iv) Consolidated Balance Sheet; (v) Consolidated Statement of Shareholders’ Investment; and (vi) the notes to the consolidated financial statements. | |
_(c) Financial Statement Schedule filed [removed: (page_ 101_)._][added: (page 94)._]
| 4.36 | | [Description of Registrant’s Securities.](https://www.sec.gov/Archives/edgar/data/1800/000110465922025141/abt-20211231xex4d36.htm) | |
| 10.2 | * | [Abbott Laboratories Deferred Compensation Plan, as amended, filed as Exhibit 10.2 to the 2020 Abbott Laboratories Annual Report on Form 10-K.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d2.htm) | |
| | | | |
| 10.2 | | [Abbott Laboratories Deferred Compensation Plan, as amended.](http://www.sec.gov/Archives/edgar/data/1800/000104746918000856/a2234264zex-10_2.htm) | |
| 10.66 | | [Form of Extension of Agreement Regarding Change in Control by and between Abbott Laboratories and its named executive officers (other than Mr. White), extending the agreement term to December 31, 2022.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d66.htm) | |
| 10.74 | | [Abbott Overseas Managers Pension Plan, as amended and restated.](https://www.sec.gov/Archives/edgar/data/1800/000110465921025751/abt-20201231xex10d74.htm) | |
Item 16. FORM 10-K SUMMARY
13 rewritten, 8 added, 10 removed, 55 unchanged
| | | Robert B. Ford [removed: President] [added: Chairman of the Board] and Chief Executive Officer |
| | Date: | February [removed: 19, 2021] [added: 18, 2022] |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of Abbott Laboratories on February [removed: 19, 2021] [added: 18, 2022] in the capacities indicated below.
| [removed: President] [added: Chairman of the Board] and Chief Executive Officer, and Director of Abbott Laboratories (principal executive officer) | | Executive Vice President, Finance and Chief Financial Officer (principal financial officer) |
| /s/ PHILIP P. BOUDREAU | | [removed: /s/ MILES D. WHITE] [added: ] |
| Philip P. Boudreau | | [removed: Miles D. White] [added: ] |
| Vice President, Finance and Controller (principal accounting officer) | | [removed: Executive Chairman of the Board] [added: ] |
| Sally E. Blount, Ph.D. | | [removed: Michelle A. Kumbier] [added: Paola Gonzalez] |
| [removed: Edward M. Liddy] [added: Michelle A. Kumbier] Director of Abbott Laboratories | | Darren W. McDew Director of Abbott Laboratories |
FOR THE YEARS ENDED DECEMBER 31, [removed: 2020, 2019] [added: 2021, 2020] AND [removed: 2018][added: 2019]
| 2020 | | [removed: $] [added: ] | 384 | | [removed: $] [added: ] | 187 | | [removed: $] [added: ] | (111) | | [removed: $] [added: ] | 460 |
| 2019 | | [removed: ] | 314 | | | 137 | | | (68) | | | 384 |
We have audited the consolidated financial statements of Abbott Laboratories and subsidiaries (the Company) as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] and have issued our report thereon dated February [removed: 19, 2021] [added: 18, 2022] (included elsewhere in this Annual Report on Form 10-K).
| /s/ SALLY E. BLOUNT | | /s/ PAOLA GONZALEZ |
| /s/ MICHELLE A. KUMBIER | | /s/ DARREN W. MCDEW |
| /s/ NANCY MCKINSTRY | | /s/ WILLIAM A. OSBORN |
| Nancy McKinstry | | William A. Osborn |
| /s/ MICHAEL F. ROMAN | | /s/ DANIEL J. STARKS |
| Michael F. Roman | | Daniel J. Starks |
| 2021 | | $ | 460 | | $ | 145 | | $ | (86) | | $ | 519 |
February 18, 2022
| --- | --- | --- |
| /s/ SALLY E. BLOUNT | | /s/ MICHELLE A. KUMBIER |
| /s/ EDWARD M. LIDDY | | /s/ DARREN W. MCDEW |
| /s/ NANCY MCKINSTRY | | /s/ PHEBE N. NOVAKOVIC |
| Nancy McKinstry | | Phebe N. Novakovic |
| /s/ WILLIAM A. OSBORN | | /s/ DANIEL J. STARKS |
| William A. Osborn | | Daniel J. Starks |
| 2018 | | | 294 | | | 110 | | | (90) | | | 314 |
February 19, 2021