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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM  10-Q

(Mark One)

          QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2020

OR

           TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                   to                  

Commission File No.  1-2189

ABBOTT LABORATORIES

An Illinois Corporation

    

I.R.S. Employer Identification No.

36-0698440

100 Abbott Park Road

Abbott Park Illinois 60064-6400

Telephone:   ( 224 ) 667-6100

Securities Registered Pursuant to Section 12(b) of the Act:

Title of Each Class

    

Trading Symbol(s)

    

Name of Each Exchange on Which Registered

Common Shares, Without Par Value

ABT

New York Stock Exchange
Chicago Stock Exchange, Inc.

Indicate by check mark whether the registrant: (l) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of l934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)  has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer

Accelerated Filer

Non-Accelerated Filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule  12b-2 of the Exchange Act). Yes No

As of March 31, 2020, Abbott Laboratories had 1,768,845,326 common shares without par value outstanding.

Table of Contents

Abbott Laboratories

Table of Contents

Part I - Financial Information

Page

Item 1. Financial Statements and Supplementary Data

Condensed Consolidated Statement of Earnings

3

Condensed Consolidated Statement of Comprehensive Income

4

Condensed Consolidated Balance Sheet

5

Condensed Consolidated Statement of Shareholders’ Investment

6

Condensed Consolidated Statement of Cash Flows

7

Notes to the Condensed Consolidated Financial Statements

8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

Item 4. Controls and Procedures

22

Part II - Other Information

Item 1. Legal Proceedings

22

Item 1A. Risk Factors

22

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

23

Item 6. Exhibits

24

Signature

25

2

Table of Contents

Abbott Laboratories and Subsidiaries

Condensed Consolidated Statement of Earnings

(Unaudited)

(dollars in millions except per share data; shares in thousands)

Three Months Ended March 31

    

2020

    

2019

Net sales

$

7,726

$

7,535

Cost of products sold, excluding amortization of intangible assets

 

3,281

 

3,160

Amortization of intangible assets

 

561

 

486

Research and development

 

578

 

672

Selling, general and administrative

 

2,548

 

2,478

Total operating cost and expenses

 

6,968

 

6,796

Operating earnings

 

758

 

739

Interest expense

 

139

 

171

Interest (income)

 

( 18 )

 

( 23 )

Net foreign exchange (gain) loss

 

5

 

6

Other (income) expense, net

 

( 1 )

 

( 47 )

Earnings from continuing operations before tax

 

633

 

632

Tax expense (benefit) on earnings from continuing operations

 

89

 

( 40 )

Earnings from continuing operations

 

544

 

672

Earnings from discontinued operations, net of tax

20

Net Earnings

 

$

564

 

$

672

Basic Earnings Per Common Share —

Continuing operations

 

$

0.31

 

$

0.38

Discontinued operations

0.01

 

Net earnings

 

$

0.32

 

$

0.38

Diluted Earnings Per Common Share —

Continuing operations

 

$

0.30

 

$

0.38

Discontinued operations

 

0.01

 

Net earnings

 

$

0.31

 

$

0.38

Average Number of Common Shares Outstanding Used for Basic Earnings Per Common Share

 

1,768,901

 

1,763,278

Dilutive Common Stock Options

 

11,677

 

13,295

Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options

 

1,780,578

 

1,776,573

Outstanding Common Stock Options Having No Dilutive Effect

 

4,035

 

4,011

The accompanying notes to the condensed consolidated financial statements are an integral part of this statement.

3

Table of Contents

Abbott Laboratories and Subsidiaries

Condensed Consolidated Statement of Comprehensive Income

(Unaudited)

(dollars in millions)

Three Months Ended March 31

    

2020

    

2019

Net Earnings

$

564

$

672

Foreign currency translation gain (loss) adjustments

 

( 1,144 )

 

122

Net actuarial gains (losses) and amortization of net actuarial (losses) and prior service (cost) and credits, net of taxes of $ 15 in 2020 and $ 7 in 2019

 

57

 

23

Net gains (losses) for derivative instruments designated as cash flow hedges, net of taxes of $ 48 in 2020 and $( 8 ) in 2019

 

166

 

( 29 )

Other comprehensive income (loss)

 

( 921 )

 

116

Comprehensive Income (Loss)

 

$

( 357 )

 

$

788

March 31, 

December 31, 

    

2020

    

2019

Supplemental Accumulated Other Comprehensive Income (Loss) Information, net of tax:

Cumulative foreign currency translation (loss) adjustments

$

( 6,068 )

$

( 4,924 )

Net actuarial (losses) and prior service (cost) and credits

 

( 3,483 )

 

( 3,540 )

Cumulative gains (losses) on derivative instruments designated as cash flow hedges

 

165

 

( 1 )

Accumulated Other Comprehensive Income (Loss)

$

( 9,386 )

$

( 8,465 )

The accompanying notes to the condensed consolidated financial statements are an integral part of this statement.

4

Table of Contents

Abbott Laboratories and Subsidiaries

Condensed Consolidated Balance Sheet

(Unaudited)

(dollars in millions)

March 31, 

December 31, 

    

2020

    

2019

Assets

Current Assets:

Cash and cash equivalents

$

3,377

$

3,860

Short-term investments

 

291

 

280

Trade receivables, less allowances of $ 389 in 2020 and $ 384 in 2019

 

5,292

 

5,425

Inventories:

Finished products

 

2,873

 

2,784

Work in process

 

615

 

560

Materials

 

1,080

 

972

Total inventories

 

4,568

 

4,316

Prepaid expenses and other receivables

 

1,970

 

1,786

Total Current Assets

 

15,498

 

15,667

Investments

 

790

 

883

Property and equipment, at cost

 

16,707

 

16,799

Less: accumulated depreciation and amortization

 

8,800

 

8,761

Net property and equipment

 

7,907

 

8,038

Intangible assets, net of amortization

 

16,265

 

17,025

Goodwill

 

22,927

 

23,195

Deferred income taxes and other assets

 

3,390

 

3,079

 

$

66,777

 

$

67,887

Liabilities and Shareholders’ Investment

Current Liabilities:

Short-term borrowings

 

$

204

$

201

Trade accounts payable

 

3,181

 

3,252

Salaries, wages and commissions

 

949

 

1,237

Other accrued liabilities

 

4,408

 

4,035

Dividends payable

 

637

 

635

Income taxes payable

 

165

 

226

Current portion of long-term debt

 

1,264

 

1,277

Total Current Liabilities

 

10,808

 

10,863

Long-term debt

 

16,804

 

16,661

Post-employment obligations, deferred income taxes and other long-term liabilities

 

8,738

 

9,062

Commitments and Contingencies

Shareholders’ Investment:

Preferred shares, one dollar par value Authorized — 1,000,000 shares, none issued

 

 

Common shares, without par value Authorized — 2,400,000,000 shares
Issued at stated capital amount — Shares: 2020: 1,978,112,501 ; 2019: 1,976,855,085

 

23,731

 

23,853

Common shares held in treasury, at cost — Shares: 2020: 209,267,175 ; 2019: 214,351,838

 

( 9,913 )

 

( 10,147 )

Earnings employed in the business

 

25,786

 

25,847

Accumulated other comprehensive income (loss)

 

( 9,386 )

 

( 8,465 )

Total Abbott Shareholders’ Investment

 

30,218

 

31,088

Noncontrolling Interests in Subsidiaries

 

209

 

213

Total Shareholders’ Investment

 

30,427

 

31,301

 

$

66,777

$

67,887

The accompanying notes to the condensed consolidated financial statements are an integral part of this statement.

5

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Abbott Laboratories and Subsidiaries

Condensed Consolidated Statement of Shareholders’ Investment

(Unaudited)

(in millions except shares and per share data)

Three Months Ended March 31

    

2020

    

2019

Common Shares:

 

  

 

  

Balance at January 1

 

  

 

  

Shares: 2020: 1,976,855,085 ; 2019: 1,971,189,465

$

23,853

$

23,512

Issued under incentive stock programs

 

  

 

  

Shares: 2020: 1,257,416 ; 2019: 2,283,041

 

53

 

76

Share-based compensation

 

245

 

237

Issuance of restricted stock awards

 

( 420 )

 

( 364 )

Balance at March 31

Shares: 2020: 1,978,112,501 ; 2019: 1,973,472,506

$

23,731

$

23,461

Common Shares Held in Treasury:

 

  

 

  

Balance at January 1

Shares: 2020: 214,351,838 ; 2019: 215,570,043

$

( 10,147 )

$

( 9,962 )

Issued under incentive stock programs

Shares: 2020: 5,333,626 ; 2019: 6,544,927

 

253

 

303

Purchased

Shares: 2020: 248,963 ; 2019: 266,128

 

( 19 )

 

( 20 )

Balance at March 31

Shares: 2020: 209,267,175 ; 2019: 209,291,244

$

( 9,913 )

$

( 9,679 )

Earnings Employed in the Business:

 

  

 

  

Balance at January 1

$

25,847

$

24,560

Impact of adoption of new accounting standard

( 5 )

Net earnings

 

564

 

672

Cash dividends declared on common shares (per share — 2020: $ 0.36 ; 2019: $ 0.32 )

 

( 641 )

 

( 568 )

Effect of common and treasury share transactions

 

21

 

( 51 )

Balance at March 31

$

25,786

$

24,613

Accumulated Other Comprehensive Income (Loss):

 

  

 

  

Balance at January 1

$

( 8,465 )

$

( 7,586 )

Other comprehensive income (loss)

 

( 921 )

 

116

Balance at March 31

$

( 9,386 )

$

( 7,470 )

Noncontrolling Interests in Subsidiaries:

 

  

 

  

Balance at January 1

$

213

$

198

Noncontrolling Interests’ share of income, business combinations, net of distributions
and share repurchases

 

( 4 )

 

6

Balance at March 31

$

209

$

204

The accompanying notes to condensed consolidated financial statements are an integral part of this statement.

6

Table of Contents

Abbott Laboratories and Subsidiaries

Condensed Consolidated Statement of Cash Flows

(Unaudited)

(dollars in millions)

Three Months Ended March 31

    

2020

    

2019

Cash Flow From (Used in) Operating Activities:

Net earnings

$

564

$

672

Adjustments to reconcile net earnings to net cash from operating activities -

Depreciation

 

267

 

267

Amortization of intangible assets

 

561

 

486

Share-based compensation

233

226

Trade receivables

 

( 104 )

 

( 170 )

Inventories

 

( 437 )

 

( 286 )

Other, net

 

( 369 )

 

( 483 )

Net Cash From Operating Activities

 

715

 

712

Cash Flow From (Used in) Investing Activities:

Acquisitions of property and equipment

 

( 360 )

 

( 335 )

Acquisitions of businesses and technologies, net of cash acquired

( 78 )

Sales (purchases) of other investment securities, net

 

( 36 )

 

2

Other

 

3

 

15

Net Cash (Used in) Investing Activities

 

( 393 )

 

( 396 )

Cash Flow From (Used in) Financing Activities:

Net borrowings (repayments) of short-term debt and other

 

51

 

13

Repayments of long-term debt

 

( 1 )

 

( 500 )

Purchases of common shares

 

( 236 )

 

( 217 )

Proceeds from stock options exercised

 

89

 

127

Dividends paid

 

( 638 )

 

( 565 )

Net Cash (Used in) Financing Activities

 

( 735 )

 

( 1,142 )

Effect of exchange rate changes on cash and cash equivalents

 

( 70 )

 

4

Net Decrease in Cash and Cash Equivalents

 

( 483 )

 

( 822 )

Cash and Cash Equivalents, Beginning of Year

 

3,860

 

3,844

Cash and Cash Equivalents, End of Period

 

$

3,377

 

$

3,022

The accompanying notes to the condensed consolidated financial statements are an integral part of this statement.

7

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

Note 1 — Basis of Presentation

The accompanying unaudited, condensed consolidated financial statements have been prepared pursuant to rules and regulations of the Securities and Exchange Commission and, therefore, do not include all information and footnote disclosures normally included in audited financial statements.  However, in the opinion of management, all adjustments (which include only normal adjustments) necessary to present fairly the results of operations, financial position and cash flows have been made.  It is suggested that these statements be read in conjunction with the financial statements included in Abbott’s Annual Report on Form 10-K for the year ended December 31, 2019.  The condensed consolidated financial statements include the accounts of the parent company and subsidiaries, after elimination of intercompany transactions.

Note 2 — New Accounting Standards

Recently Adopted Accounting Standards

In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-13, Financial Instruments – Credit Losses , which changes the methodology to be used to measure credit losses for certain financial instruments and financial assets, including trade receivables.  The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to be incurred over the life of the financial asset.  Abbott adopted the standard on January 1, 2020 and recorded a cumulative adjustment that was not significant to Earnings employed in the business in the Condensed Consolidated Balance Sheet.

Recent Accounting Standards Not Yet Adopted

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , which among other things, eliminates certain exceptions in the current rules regarding the approach for intraperiod tax allocations and the methodology for calculating income taxes in an interim period, and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill.  The standard becomes effective for Abbott  in the first quarter of 2021 and early adoption is permitted.  Abbott does not expect adoption of this new standard to have a material impact on its condensed consolidated financial statements.

Note 3 — Revenue

Abbott’s revenues are derived primarily from the sale of a broad line of health care products under short-term receivable arrangements.  Abbott has four reportable segments: Established Pharmaceutical Products, Diagnostic Products, Nutritional Products, and Medical Devices.

8

Table of Contents

Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

The following table provides revenues by sales category:

Three Months Ended March 31, 2020

Three Months Ended March 31, 2019

(in millions)

    

U.S.

    

Int’l

    

Total

    

U.S.

    

Int’l

    

Total

Established Pharmaceutical Products —

 

  

 

  

 

  

 

  

 

  

 

  

Key Emerging Markets

$

$

813

$

813

$

$

752

$

752

Other

 

 

231

 

231

 

 

240

240

Total

 

 

1,044

 

1,044

 

 

992

 

992

Nutritionals —

 

  

 

  

 

  

 

  

 

  

 

  

Pediatric Nutritionals

 

518

 

571

 

1,089

 

453

 

576

 

1,029

Adult Nutritionals

 

294

 

521

 

815

 

294

 

469

 

763

Total

 

812

 

1,092

 

1,904

 

747

 

1,045

 

1,792

Diagnostics —

 

  

 

  

 

  

 

  

 

  

 

  

Core Laboratory

 

267

 

722

 

989

 

249

 

812

 

1,061

Molecular

 

65

 

74

 

139

 

40

 

68

 

108

Point of Care

 

103

 

35

 

138

 

109

 

26

 

135

Rapid Diagnostics

 

368

 

192

 

560

 

326

 

211

 

537

Total

 

803

 

1,023

 

1,826

 

724

 

1,117

 

1,841

Medical Devices -

 

  

 

  

 

  

 

  

 

  

 

  

Rhythm Management

 

228

 

246

 

474

 

252

 

262

 

514

Electrophysiology

 

164

 

224

 

388

 

174

 

231

 

405

Heart Failure

 

152

 

51

 

203

 

143

 

41

 

184

Vascular

 

230

 

395

 

625

 

266

 

443

 

709

Structural Heart

 

136

 

182

 

318

 

136

 

188

 

324

Neuromodulation

 

137

 

40

 

177

 

152

 

41

 

193

Diabetes Care

186

566

752

152

414

566

Total

 

1,233

 

1,704

 

2,937

 

1,275

 

1,620

 

2,895

Other

 

8

 

7

 

15

 

8

 

7

 

15

Total

$

2,856

$

4,870

$

7,726

$

2,754

$

4,781

$

7,535

Remaining Performance Obligations

As of March 31, 2020, the estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied (or partially unsatisfied) was approximately $ 3.4 billion in the Diagnostics segment and approximately $ 400 million in the Medical Devices segment.  Abbott expects to recognize revenue on approximately 60 percent of these remaining performance obligations over the next 24 months , approximately 17 percent over the subsequent 12 months and the remainder thereafter.  

These performance obligations primarily reflect the future sale of reagents/consumables in contracts with minimum purchase obligations, extended warranty or service obligations related to previously sold equipment, and remote monitoring services related to previously implanted devices.  Abbott has applied the practical expedient described in Accounting Standards Codification (ASC) 606-10-50-14 and has not included remaining performance obligations related to contracts with original expected durations of one year or less in the amounts above.

Other Contract Assets and Liabilities

Abbott discloses Trade receivables separately in the Condensed Consolidated Balance Sheet at the net amount expected to be collected.  Contract assets primarily relate to Abbott’s conditional right to consideration for work completed but not billed at the reporting date. Contract assets at the beginning and end of the period, as well as the changes in the balance, were not significant.

Contract liabilities primarily relate to payments received from customers in advance of performance under the contract. Abbott’s contract liabilities arise primarily in the Medical Devices reportable segment when payment is received upfront for various multi-period extended service arrangements.

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

Changes in the contract liabilities during the period are as follows:

(in millions)

    

Contract Liabilities

Balance at December 31, 2019

$

294

Unearned revenue from cash received during the period

 

105

Revenue recognized related to contract liability balance

 

( 94 )

Balance at March 31, 2020

$

305

Note 4 — Supplemental Financial Information

Shares of unvested restricted stock that contain non-forfeitable rights to dividends are treated as participating securities and are included in the computation of earnings per share under the two-class method.  Under the two-class method, net earnings are allocated between common shares and participating securities. Earnings from Continuing Operations allocated to common shares for the three months ended March 31, 2020 and 2019 were $ 541 million and $ 668 million, respectively. Net earnings allocated to common shares for the three months ended March 31, 2020 and 2019 were $ 561 million and $ 668 million, respectively.

Other, net in Net cash from operating activities in the Condensed Consolidated Statement of Cash Flows for the first three months of 2020 includes $ 320 million of pension contributions and the payment of cash taxes of approximately $ 125 million.  The first three months of 2019 includes $ 313 million of pension contributions and the payment of cash taxes of approximately $ 185 million.

Earnings from discontinued operations, net of tax, in the first quarter of 2020 include the recognition of $ 20 million of tax benefits as a result of the resolution of various tax positions related to the previous sale of a business that was reported as a discontinued operation.

The following summarizes the activity for the first three months of 2020 related to the allowance for doubtful accounts as of March 31, 2020:

(in millions)

Allowance for Doubtful Accounts

Balance at December 31, 2019

$

228

Impact of adopting ASU 2016-13

 

7

Provisions/charges to income

21

Amounts charged off and other deductions

 

( 15 )

Balance at March 31, 2020

$

241

The allowance for doubtful accounts reflects the current estimate of credit losses expected to be incurred over the life of the accounts receivables. Abbott considers various factors in establishing, monitoring, and adjusting its allowance for doubtful accounts including the aging of the accounts and aging trends, the historical level of charge-offs, and specific exposures related to particular customers.  Abbott also monitors other risk factors and forward-looking information, such as country risk, when determining credit limits for customers and establishing adequate allowances.

The components of long-term investments as of March 31, 2020 and December 31, 2019 are as follows:

March 31, 

December 31, 

(in millions)

    

2020

    

2019

Long-term Investments

Equity securities

$

741

$

836

Other

49

47

Total

 

$

790

 

$

883

Abbott’s long-term investments as of March 31, 2020, declined versus the balance as of December 31, 2019, due in part to the impairment of an investment for approximately $ 50 million.

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

Abbott's equity securities as of March 31, 2020, include approximately $ 289 million of investments in mutual funds that are held in a rabbi trust and were acquired as part of the St. Jude Medical, Inc. (St. Jude Medical) business acquisition. These investments, which are specifically designated as available for the purpose of paying benefits under a deferred compensation plan, are not available for general corporate purposes and are subject to creditor claims in the event of insolvency.

Abbott also holds certain investments as of March 31, 2020 with a carrying value of approximately $ 275 million that are accounted for under the equity method of accounting and other equity investments with a carrying value of approximately $ 162 million that do not have a readily determinable fair value. The $ 162 million carrying value includes cumulative unrealized gains of approximately $ 50 million.

In the first quarter of 2019, in conjunction with the acquisition of Cephea Valve Technologies, Inc., Abbott acquired a research & development (R&D) asset valued at $ 102 million, which was immediately expensed. The $ 102 million of expense was recorded in the R&D line of Abbott's Condensed Consolidated Statement of Earnings.

Note 5 — Changes in Accumulated Other Comprehensive Income (Loss)

The changes in accumulated other comprehensive income (loss), net of income taxes, are as follows:

Three Months Ended March 31

Cumulative Gains

(Losses) on

Net Actuarial

Derivative

Cumulative   Foreign

(Losses) and Prior

Instruments

Currency Translation

Service (Costs)

Designated as

Adjustments

and Credits

Cash Flow Hedges

(in millions)

    

2020

    

2019

    

2020

    

2019

    

2020

    

2019

Balance at January 1

$

( 4,924 )

$

( 4,912 )

$

( 3,540 )

$

( 2,726 )

$

( 1 )

$

52

Other comprehensive income (loss) before reclassifications

 

( 1,144 )

 

122

7

 

( 1 )

 

176

 

( 17 )

Amounts reclassified from accumulated other comprehensive income

 

 

 

50

 

24

 

( 10 )

 

( 12 )

Net current period comprehensive income (loss)

 

( 1,144 )

 

122

 

57

 

23

 

166

 

( 29 )

Balance at March 31

$

( 6,068 )

$

( 4,790 )

$

( 3,483 )

$

( 2,703 )

$

165

$

23

Reclassified amounts for foreign currency translation are recorded in the Condensed Consolidated Statement of Earnings as Net foreign exchange (gain) loss; and amounts for cash flow hedges are recorded as Cost of products sold.  Net actuarial losses and prior service cost are included as a component of net periodic benefit costs; see Note 12 for additional details.

Note 6 — Goodwill and Intangible Assets

The total amount of goodwill reported was $ 22.9 billion at March 31, 2020 and $ 23.2 billion at December 31, 2019. Foreign currency translation adjustments decreased goodwill by approximately $ 268 million in the first three months of 2020. The amount of goodwill related to reportable segments at March 31, 2020 was $ 2.8 billion for the Established Pharmaceutical Products segment, $ 286 million for the Nutritional Products segment, $ 3.6 billion for the Diagnostic Products segment, and $ 16.1 billion for the Medical Devices segment.  There was no reduction of goodwill relating to impairments in the first three months of 2020.

The gross amount of amortizable intangible assets, primarily product rights and technology was $ 27.3 billion as of March 31, 2020 and $ 27.6 billion as of December 31, 2019, and accumulated amortization was $ 12.3 billion as of March 31, 2020 and $ 11.9 billion as of December 31, 2019. Foreign currency translation adjustments decreased intangible assets by $ 204 million for the first three months of 2020. Abbott’s estimated annual amortization expense for intangible assets is approximately $ 2.1 billion in 2020, $ 2.0 billion in 2021, 2022 , and 2023 and $ 1.9 billion in 2024.

Indefinite-lived intangible assets, which relate to in-process R&D acquired in a business combination, were approximately $ 1.2 billion and $ 1.3 billion as of March 31, 2020 and December 31, 2019, respectively .

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

Note 7 — Restructuring Plans

From 2017 to 2020, Abbott management approved restructuring plans as part of the integration of the acquisitions of St. Jude Medical into the Medical Devices segment, and Alere Inc. (Alere) into the Diagnostic Products segment, in order to leverage economies of scale and reduce costs. In the first three months of 2020, charges of $ 9 million were recognized, of which $ 3 million is recorded in Cost of products sold, $ 1 million is recorded in Research and development and $ 5 million as Selling, general and administrative expense.  The following summarizes the activity for the first three months of 2020 related to these actions and the status of the related accrual as of March 31, 2020:

(in millions)

    

Accrued balance at December 31, 2019

$

46

Restructuring charges recorded in 2020

9

Payments and other adjustments

( 18 )

Accrued balance at March 31, 2020

$

37

From 2017 to 2020, Abbott management approved plans to streamline operations in order to reduce costs and improve efficiencies in various Abbott businesses including the nutritional, established pharmaceuticals and vascular businesses. In the first three months of 2020, charges of $ 23 million were recognized, of which $ 1 million is recorded in Cost of products sold, $ 1 million is recorded in Research and development and $ 21 million as Selling, general and administrative expense.  The following summarizes the activity for the first three months of 2020 related to these restructuring actions and the status of the related accrual as of March 31, 2020:

(in millions)

    

Accrued balance at December 31, 2019

$

79

Restructuring charges recorded in 2020

23

Payments and other adjustments

( 8 )

Accrued balance at March 31, 2020

$

94

Note 8 — Incentive Stock Program

In the first three months of 2020, Abbott granted 3,956,637 stock options, 568,471 restricted stock awards and 5,042,550 restricted stock units under its incentive stock program. At March 31, 2020, approximately 112 million shares were reserved for future grants. Information regarding the number of options outstanding and exercisable at March 31, 2020 is as follows:

    

Outstanding

    

Exercisable

Number of shares

 

 

32,412,976

 

23,330,203

Weighted average remaining life ( years )

 

 

6.5

 

5.5

Weighted average exercise price

 

$

53.83

$

44.69

Aggregate intrinsic value ( in millions )

 

$

849

$

798

The total unrecognized share-based compensation cost at March 31, 2020 amounted to approximately $ 687 million which is expected to be recognized over the next three years .

Note 9 — Debt and Lines of Credit

On February 24, 2019, Abbott redeemed the $ 500 million outstanding principal amount of its 2.80 % Notes due 2020.

Note 10 — Financial Instruments, Derivatives and Fair Value Measures

Certain Abbott foreign subsidiaries enter into foreign currency forward exchange contracts to manage exposures to changes in foreign exchange rates primarily for anticipated intercompany purchases by those subsidiaries whose functional currencies are not the U.S. dollar.  These contracts, with gross notional amounts totaling $ 7.0 billion at March 31, 2020 and $ 6.8 billion at December 31, 2019 are designated as cash flow hedges of the variability of the cash flows due to changes in foreign exchange rates and are recorded at fair value. Accumulated gains and losses as of March 31, 2020 will be included in Cost of products sold at the time the products are sold, generally through the next twelve to eighteen months .

Abbott enters into foreign currency forward exchange contracts to manage currency exposures for foreign currency denominated third-party trade payables and receivables, and for intercompany loans and trade accounts payable where the receivable or payable is denominated in a currency other than the functional currency of the entity.  For intercompany loans, the contracts require Abbott to sell or buy foreign currencies, primarily European currencies, in exchange for primarily U.S. dollars and other European currencies.  For intercompany and trade payables and receivables, the currency exposures are primarily the U.S. dollar and European currencies.  At March 31, 2020 and December 31, 2019, Abbott held the gross notional amount of $ 9.5 billion and $ 9.1 billion, respectively, of such foreign currency forward exchange contracts.

Abbott has designated a yen-denominated, 5-year term loan of approximately $ 554 million and $ 546 million as of March 31, 2020 and December 31, 2019, respectively, as a hedge of the net investment in certain foreign subsidiaries.  The change in the value of the debt, which is due to changes in foreign exchange rates, is recorded in Accumulated other comprehensive income (loss), net of tax.

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

Abbott is a party to interest rate hedge contracts totaling approximately $ 2.9 billion at March 31, 2020 and December 31, 2019 to manage its exposure to changes in the fair value of fixed-rate debt. These contracts are designated as fair value hedges of the variability of the fair value of fixed-rate debt due to changes in the long-term benchmark interest rates.  The effect of the hedge is to change a fixed-rate interest obligation to a variable rate for that portion of the debt. Abbott records the contracts at fair value and adjusts the carrying amount of the fixed-rate debt by an offsetting amount.

The following table summarizes the amounts and location of certain derivative financial instruments as of March 31, 2020 and December 31, 2019:

Fair Value - Assets

Fair Value - Liabilities

March 31,

Dec. 31,

March 31,

Dec. 31,

(in millions)

    

2020

    

2019

    

Balance Sheet Caption

    

2020

    

2019

    

Balance Sheet Caption

Interest rate swaps designated as fair value hedges

 

$

216

 

$

48

 

Deferred income taxes and other assets

 

$

 

$

 

Post-employment obligations, deferred income taxes and other long-term liabilities

Foreign currency forward exchange contracts:

Hedging instruments

 

247

 

110

 

Prepaid expenses and other receivables

 

92

 

56

 

Other accrued liabilities

Others not designated as hedges

 

117

 

38

 

Prepaid expenses and other receivables

 

97

 

33

 

Other accrued liabilities

Debt designated as a hedge of net investment in a foreign subsidiary

n/a

554

546

Long-term debt

 

$

580

 

$

196

 

$

743

 

$

635

The following table summarizes the activity for foreign currency forward exchange contracts designated as cash flow hedges, debt designated as a hedge of net investment in a foreign subsidiary and certain other derivative financial instruments, as well as the amounts and location of income (expense) and gain (loss) reclassified into income for the three months ended March 31, 2020 and 2019.

Gain (loss) Recognized in Other

Income (expense) and Gain (loss)

Comprehensive Income (loss)

Reclassified into Income

(in millions)

    

2020

    

2019

    

2020

    

2019

    

Income Statement Caption

Foreign currency forward exchange contracts designated as cash flow hedges

$

227

$

( 19 )

$

11

$

15

Cost of products sold

Debt designated as a hedge of net investment in a foreign subsidiary

( 8 )

n/a

Interest rate swaps designated as fair value hedges

 

n/a

 

n/a

 

168

 

43

Interest expense

Losses of $ 165 million and gains of $ 49 million were recognized in the three months ended March 31, 2020 and 2019, respectively, related to foreign currency forward exchange contracts not designated as a hedge.  These amounts are reported in the Condensed Consolidated Statement of Earnings on the Net foreign exchange (gain) loss line.

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

The carrying values and fair values of certain financial instruments as of March 31, 2020 and December 31, 2019 are shown in the following table.  The carrying values of all other financial instruments approximate their estimated fair values.  The counterparties to financial instruments consist of select major international financial institutions.  Abbott does not expect any losses from non-performance by these counterparties.

March 31, 2020

December 31, 2019

Carrying

Fair

Carrying

Fair

(in millions)

    

Value

    

Value

    

Value

    

Value

Long-term Investment Securities:

Equity securities

 

$

741

 

$

741

$

836

 

$

836

Other

 

49

 

49

 

47

 

47

Total Long-term Debt

 

( 18,068 )

 

( 20,998 )

 

( 17,938 )

 

( 20,772 )

Foreign Currency Forward Exchange Contracts:

Receivable position

 

364

 

364

 

148

 

148

(Payable) position

 

( 189 )

 

( 189 )

 

( 89 )

 

( 89 )

Interest Rate Hedge Contracts:

Receivable position

216

216

48

48

The fair value of the debt was determined based on significant other observable inputs, including current interest rates.

The following table summarizes the bases used to measure certain assets and liabilities at fair value on a recurring basis in the balance sheet:

Basis of Fair Value Measurement

Quoted

Significant

Prices in

Other

Significant

Outstanding

Active

Observable

Unobservable

(in millions)

    

Balances

    

Markets

    

Inputs

    

Inputs

March 31, 2020:

Equity securities

 

$

304

$

304

 

$

 

$

Interest rate swap derivative financial instruments

 

216

 

 

216

 

Foreign currency forward exchange contracts

 

364

 

 

364

 

Total Assets

 

$

884

 

$

304

 

$

580

 

$

Fair value of hedged long-term debt

 

$

3,064

$

 

$

3,064

 

$

Foreign currency forward exchange contracts

189

189

Contingent consideration related to business combinations

 

67

 

 

 

67

Total Liabilities

 

$

3,320

 

$

 

$

3,253

$

67

December 31, 2019:

Equity securities

 

$

357

 

$

357

 

$

 

$

Interest rate swap derivative financial instruments

 

48

 

 

48

 

Foreign currency forward exchange contracts

 

148

 

 

148

 

Total Assets

 

$

553

 

$

357

 

$

196

 

$

Fair value of hedged long-term debt

 

$

2,890

 

$

 

$

2,890

 

$

Foreign currency forward exchange contracts

 

89

 

 

89

 

Contingent consideration related to business combinations

 

68

 

 

 

68

Total Liabilities

 

$

3,047

 

$

 

$

2,979

 

$

68

The fair value of foreign currency forward exchange contracts is determined using a market approach, which utilizes values for comparable derivative instruments.  The fair value of debt was determined based on the face value of the debt adjusted for the fair value of the interest rate swaps, which is based on a discounted cash flow analysis using significant other observable inputs.  The fair value of the contingent consideration was determined based on independent appraisals at the time of acquisition, adjusted for the time value of money and other changes in fair value.

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

Note 11 — Litigation and Environmental Matters

Abbott has been identified as a potentially responsible party for investigation and cleanup costs at a number of locations in the United States and Puerto Rico under federal and state remediation laws and is investigating potential contamination at a number of company-owned locations. Abbott has recorded an estimated cleanup cost for each site for which management believes Abbott has a probable loss exposure. No individual site cleanup exposure is expected to exceed $ 4  million, and the aggregate cleanup exposure is not expected to exceed $ 10  million.

Abbott is involved in various claims and legal proceedings, and Abbott estimates the range of possible loss for its legal proceedings and environmental exposures to be from approximately $ 90  million to $ 125  million. The recorded accrual balance at March 31, 2020 for these proceedings and exposures was approximately $ 110  million. This accrual represents management’s best estimate of probable loss, as defined by FASB ASC No. 450, “Contingencies.” Within the next year, legal proceedings may occur that may result in a change in the estimated loss accrued by Abbott. While it is not feasible to predict the outcome of all such proceedings and exposures with certainty, management believes that their ultimate disposition should not have a material adverse effect on Abbott’s financial position, cash flows, or results of operations.

Note 12 — Post-Employment Benefits

Retirement plans consist of defined benefit, defined contribution, and medical and dental plans. Net periodic benefit costs, other than service costs, are recognized in the Other (income) expense, net line of the Condensed Consolidated Statement of Earnings. Net cost recognized in continuing operations for the three months ended March 31 for Abbott’s major defined benefit plans and post-employment medical and dental benefit plans is as follows:

 

Defined Benefit Plans

Medical and Dental Plans

March 31, 

March 31, 

March 31, 

March 31, 

(in millions)

    

2020

    

2019

    

2020

    

2019

Service cost - benefits earned during the period

$

85

$

64

$

12

$

6

Interest cost on projected benefit obligations

 

75

 

84

 

12

 

13

Expected return on plan assets

 

( 192 )

 

( 178 )

 

( 7 )

 

( 7 )

Net amortization of:

 

 

 

 

Actuarial loss, net

 

63

 

33

 

8

 

6

Prior service cost (credit)

 

 

 

( 7 )

 

( 8 )

Net cost - continuing operations

$

31

$

3

$

18

$

10

Abbott funds its domestic defined benefit plans according to IRS funding limitations.  International pension plans are funded according to similar regulations.  In the first three months of 2020 and 2019, $ 320 million and $ 313 million, respectively, were contributed to defined benefit plans and $ 11 million was contributed to the post-employment medical and dental benefit plans in each year.

Note 13 — Taxes on Earnings

Taxes on earnings from continuing operations reflect the estimated annual effective rates and include charges for interest and penalties.  In the first three months of 2020, taxes on earnings from continuing operations include approximately $ 47 million in excess tax benefits associated with share-based compensation. Earnings from discontinued operations, net of tax, in the first three months of 2020 reflect the recognition of $ 20 million of net tax benefits primarily as a result of the resolution of various tax positions related to prior years. In the first three months of 2019, taxes on earnings from continuing operations include a $ 78 million reduction to the transition tax related to the Tax Cut and Jobs Act (TCJA) and approximately $ 65 million in excess tax benefits associated with share-based compensation.

Tax authorities in various jurisdictions regularly review Abbott’s income tax filings.  Abbott believes that it is reasonably possible that the recorded amount of gross unrecognized tax benefits may decrease between $ 230 million and $ 520 million, including cash adjustments, within the next twelve months as a result of concluding various domestic and international tax matters. In the U.S., Abbott’s federal income tax returns through 2016 are settled except for the federal income tax returns of the former Alere consolidated group which are settled through 2015 and the former St. Jude Medical consolidated group which are settled through 2013.

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Abbott Laboratories and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2020

(Unaudited)

Note 14 — Segment Information

Abbott’s principal business is the discovery, development, manufacture and sale of a broad line of health care products.  Abbott’s products are generally sold directly to retailers, wholesalers, hospitals, health care facilities, laboratories, physicians’ offices and government agencies throughout the world.

Abbott’s reportable segments are as follows:

Established Pharmaceutical Products — International sales of a broad line of branded generic pharmaceutical products.

Nutritional Products — Worldwide sales of a broad line of adult and pediatric nutritional products.

Diagnostic Products — Worldwide sales of diagnostic systems and tests for blood banks, hospitals, commercial laboratories, physician offices and alternate-care testing sites. For segment reporting purposes, the Core Laboratories Diagnostics, Rapid Diagnostics, Molecular Diagnostics and Point of Care Diagnostics divisions are aggregated and reported as the Diagnostic Products segment.

Medical Devices — Worldwide sales of rhythm management, electrophysiology, heart failure, vascular, structural heart, neuromodulation and diabetes care products.  For segment reporting purposes, the Cardiac Rhythm Management, Electrophysiology and Heart Failure, Vascular, Neuromodulation, Structural Heart and Diabetes Care divisions are aggregated and reported as the Medical Devices segment.

Abbott’s underlying accounting records are maintained on a legal entity basis for government and public reporting requirements.  Segment disclosures are on a performance basis consistent with internal management reporting.  Intersegment transfers of inventory are recorded at standard cost and are not a measure of segment operating earnings.  The cost of some corporate functions and the cost of certain employee benefits are charged to segments at predetermined rates that approximate cost.  Remaining costs, if any, are not allocated to segments.  In addition, intangible asset amortization is not allocated to operating segments, and intangible assets and goodwill are not included in the measure of each segment’s assets.

The following segment information has been prepared in accordance with the internal accounting policies of Abbott, as described above, and is not presented in accordance with generally accepted accounting principles applied to the consolidated financial statements.

Three Months Ended March 31

Net Sales to

Operating

External Customers

Earnings

(in millions)

    

2020

    

2019

    

2020

    

2019

Established Pharmaceutical Products

$

1,044

$

992

$

181

$

159

Nutritional Products

 

1,904

 

1,792

 

459

 

380

Diagnostic Products

 

1,826

 

1,841

 

405

 

434

Medical Devices

 

2,937

 

2,895

 

803

 

847

Total Reportable Segments

 

7,711

 

7,520

 

1,848

 

1,820

Other

 

15

 

15

Net sales

$

7,726

$

7,535

Corporate functions and benefit plans costs

( 132 )

( 102 )

Net interest expense

( 121 )

( 148 )

Share-based compensation (a)

( 233 )

( 226 )

Amortization of intangible assets

( 561 )

( 486 )

Other, net (b)

( 168 )

( 226 )

Earnings from continuing operations before taxes

$

633

$

632

(a) Approximately 50 percent of the annual net cost of share-based awards will typically be recognized in the first quarter due to the timing of the granting of share-based awards.
(b) Other, net includes integration costs associated with the acquisition of St. Jude Medical and Alere, and restructuring charges.  Other, net for the three months ended March 31, 2019 also includes a charge associated with an R&D asset acquired and immediately expensed.

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Table of Contents

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Financial Review - Results of Operations

Abbott’s revenues are derived primarily from the sale of a broad line of health care products under short-term receivable arrangements.  Patent protection and licenses, technological and performance features, and inclusion of Abbott’s products under a contract impact which products are sold; price controls, competition and rebates impact the net selling prices of products; and foreign currency translation impacts the measurement of net sales and costs.  Abbott’s primary products are medical devices, diagnostic testing products, nutritional products and branded generic pharmaceuticals.

During the first quarter of 2020, the coronavirus (COVID-19) pandemic affected Abbott’s diversified health care businesses in various ways.  As is further described below, some businesses faced challenges, others have been relatively stable, and still others are performing at the levels required to successfully meet new demands. Beginning in February, cardiovascular and neuromodulation procedures and routine core laboratory diagnostic testing volumes declined in China as that country implemented quarantine restrictions and postponed non-emergency health care activities. As March progressed, procedures and routine testing volumes in China steadily improved from the low levels seen in February. As COVID-19 spread geographically, the impact initially expanded to certain countries in Asia and Europe beginning in late February, and more broadly across Europe and the U.S. during the last few weeks of March.  As the health care industry in these countries shifted their focus to fighting COVID-19, the impact on cardiovascular and neuromodulation device procedures and routine diagnostic testing volumes was similar to what was experienced in China in February. Due to the critical nature of these products, Abbott anticipates increased demand when health care services return to more normal levels.

Abbott has mobilized its teams across multiple fronts to develop and launch three new diagnostic tests for COVID-19. In March, Abbott launched a molecular test to detect COVID-19 on its ID NOW™ rapid point-of-care platform in the U.S. pursuant to an Emergency Use Authorization (EUA). Abbott also launched a molecular test on its m 2000™ RealTi m e lab-based platform to detect COVID-19 pursuant to an EUA in the U.S. and CE Mark.  In April, Abbott launched a serology blood test on its ARCHITECT ® i1000SR and i2000SR laboratory instruments for the detection of an antibody to determine if someone was previously infected.  The serology test was granted an EUA in the U.S. on April 26, 2020 and CE Mark on April 24, 2020.

Abbott is continually implementing business continuity plans in the face of the global crisis.  Due to the critical nature of its products and services, Abbott is generally exempt from governmental orders in the U.S. and other countries requiring businesses to cease operations. To protect its employees, the majority of its office-based work is being conducted remotely and the company has implemented strict travel restrictions.  Abbott has taken aggressive steps to limit exposure and enhance the safety of its facilities for employees working to continue to supply healthcare products to hospital and other customers.

With respect to Abbott’s financial position, at the end of the first quarter of 2020, Abbott’s cash and cash equivalents and short-term investments totaled approximately $3.7 billion and existing credit agreements are in place that would provide additional access to $5 billion, if needed.

Due to uncertainties regarding the duration and impact of the current COVID-19 pandemic, Abbott is unable to predict the extent to which the COVID-19 pandemic may have a material effect on its business, financial condition or results of operations.

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Table of Contents

The following table details sales by reportable segment for the three months ended March 31. Percent changes are versus the prior year and are based on unrounded numbers.

Net Sales to External Customers

 

    

Three Months

    

Three Months

    

    

    

 

Ended

Ended

Impact of

Total Change

 

March 31, 

March 31, 

Total

Foreign

Excl. Foreign

 

(in millions)

2020

2019

Change

Exchange

Exchange

 

Established Pharmaceutical Products

$

1,044

$

992

 

5.2

%  

(4.1)

%  

9.3

%

Nutritional Products

 

1,904

 

1,792

 

6.3

 

(1.0)

 

7.3

Diagnostic Products

 

1,826

 

1,841

 

(0.8)

 

(1.5)

 

0.7

Medical Devices

 

2,937

 

2,895

 

1.4

 

(1.5)

 

2.9

Total Reportable Segments

 

7,711

 

7,520

 

2.5

 

(1.8)

 

4.3

Other

 

15

 

15

 

5.3

 

(1.1)

 

6.4

Net sales

$

7,726

$

7,535

 

2.5

 

(1.8)

 

4.3

Total U.S.

$

2,856

$

2,754

 

3.7

 

 

3.7

Total International

$

4,870

$

4,781

 

1.8

 

(2.8)

 

4.6

Note: In order to compute results excluding the impact of foreign exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Net sales growth in 2020, excluding the impact of foreign exchange, was driven by growth in the Established Pharmaceuticals and Nutritional Products reportable segments.

Excluding the impact of foreign exchange, total net sales increased 4.3 percent in the first quarter of 2020.  Abbott’s net sales were unfavorably impacted by changes in foreign exchange rates in the first quarter as the relatively stronger U.S. dollar decreased total international sales by 2.8 percent and total sales by 1.8 percent.

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Table of Contents

The table below provides detail by sales category for the three months ended March 31. Percent changes are versus the prior year and are based on unrounded numbers.

    

    

    

    

Impact of

    

Total Change

 

March 31, 

March 31, 

Total

Foreign

Excl. Foreign

 

(in millions)

2020

2019

Change

Exchange

Exchange

 

Established Pharmaceutical Products —

 

  

 

  

 

  

 

  

 

  

Key Emerging Markets

$

813

$

752

 

8.1

%  

(5.0)

%  

13.1

%

Other Emerging Markets

 

231

 

240

 

(3.7)

 

(1.0)

 

(2.7)

Nutritionals —

 

 

 

 

 

International Pediatric Nutritionals

 

571

 

576

 

(0.8)

 

(1.0)

 

0.2

U.S. Pediatric Nutritionals

 

518

 

453

 

14.3

 

 

14.3

International Adult Nutritionals

 

521

 

469

 

11.2

 

(2.6)

 

13.8

U.S. Adult Nutritionals

 

294

 

294

 

0.1

 

 

0.1

Diagnostics —

 

 

 

 

 

Core Laboratory

 

989

 

1,061

 

(6.8)

 

(1.9)

 

(4.9)

Molecular

 

139

 

108

 

29.1

 

(1.2)

 

30.3

Point of Care

 

138

 

135

 

2.4

 

(0.3)

 

2.7

Rapid Diagnostics

 

560

 

537

 

4.3

 

(1.1)

 

5.4

Medical Devices -

 

 

 

 

 

Rhythm Management

 

474

 

514

 

(7.9)

 

(1.4)

 

(6.5)

Electrophysiology

 

388

 

405

 

(4.0)

 

(1.1)

 

(2.9)

Heart Failure

 

203

 

184

 

9.9

 

(0.7)

 

10.6

Vascular (a)

 

625

 

709

 

(11.9)

 

(1.1)

 

(10.8)

Structural Heart

 

318

 

324

 

(1.8)

 

(1.6)

 

(0.2)

Neuromodulation

 

177

 

193

 

(8.7)

 

(0.9)

 

(7.8)

Diabetes Care

752

566

32.9

(2.7)

35.6

(a) Vascular Product Lines:

Coronary and Endovascular

603

675

(10.7)

(1.2)

(9.5)

Key Emerging Markets for the Established Pharmaceutical Products business include India, Russia, Brazil and China, along with several other markets that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio.  Excluding the unfavorable effect of foreign exchange, sales in the Key Emerging Markets increased 13.1 percent compared to the first three months of 2019 led by growth in Russia and various countries in Latin America and southeast Asia.  Other Emerging Markets, excluding the effect of foreign exchange, decreased by 2.7 percent in the first three months of 2020.

International Pediatric Nutritional sales, excluding the effect of foreign exchange, were relatively flat in the first three months of 2020 versus the comparable 2019 period.  Growth across Abbott’s pediatric products in various countries in Asia and Latin America along with higher consumer purchases in several countries in advance of shelter in place restrictions related to the COVID-19 pandemic were offset by challenging market dynamics in the Greater China infant category, including the unfavorable impact of COVID-19.  U.S. Pediatric Nutritional sales increased 14.3 percent primarily due to increased demand in late March in advance of shelter in place restrictions related to the COVID-19 pandemic.  The 13.8 percent increase in International Adult Nutritional sales, excluding the effect of foreign exchange, reflects continued growth of the Glucerna ® and Ensure ® brands in several countries.  U.S. Adult Nutritional sales were relatively flat due to the timing of retailer stocking for promotional programs.

In the Diagnostics segment, Core Laboratory sales decreased 4.9 percent, excluding the effect of foreign exchange, as the volume of routine testing performed in hospital and other laboratories was negatively impacted by COVID-19.  In April 2020, Abbott launched a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person was previously infected with COVID-19.  The 30.3 percent increase in Molecular Diagnostics sales, excluding the effect of foreign exchange, reflects higher volumes due to the launch in March 2020 of Abbott’s RealTi me SARS-CoV-2  test for use on Abbott’s m 2000 RealTi me System to detect COVID-19.

In Rapid Diagnostics, sales increased 5.4 percent, excluding the effect of foreign exchange, as increased testing for flu in the U.S. was partially offset by the unfavorable impact of COVID-19 on routine diagnostic testing performed in various countries outside of the U.S.  In late March, Abbott launched a molecular test for the detection of COVID-19 that is run on Abbott’s point-of-care ID NOW instruments.

Excluding the effect of foreign exchange, total Medical Devices sales grew 2.9 percent; the increase was driven by double-digit growth in Diabetes Care and Heart Failure partially offset by the impact of the COVID-19 pandemic on Abbott’s other medical device businesses.  Growth in Diabetes Care sales was driven by continued growth of FreeStyle Libre ® , Abbott’s continuous glucose monitoring system, internationally and in the U.S.  FreeStyle Libre sales totaled $604 million in the first quarter of 2020, which reflected a 62.5 percent increase, excluding the effect of foreign exchange, over the first three months of 2019 when Libre sales totaled $379 million.

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In Heart Failure, sales growth was driven by continued market adoption of Abbott's HeartMate 3 ® Left Ventricular Assist Device (LVAD) for people living with advanced heart failure as well as increased sales of Abbott’s CentriMag™ circulatory support system for use in acute hospital care.  In Abbott’s other cardiovascular and neuromodulation businesses, revenues were negatively impacted by reduced procedure volumes due to the COVID-19 pandemic.

In April 2017, Abbott received a warning letter from the U.S. Food and Drug Administration (FDA) related to its manufacturing facility in Sylmar, CA which was acquired by Abbott on January 4, 2017 as part of the acquisition of St. Jude Medical. This facility manufactures implantable cardioverter defibrillators, cardiac resynchronization therapy defibrillators, and monitors. Abbott prepared and executed a comprehensive plan of corrective actions. On April 28, 2020, Abbott received a letter from the FDA indicating that, based on the FDA’s evaluation, it appeared that Abbott had addressed the items in the warning letter. As a result, the warning letter is considered closed.

The gross profit margin percentage was 50.3 percent for the first quarter of 2020 compared to 51.6 percent for the first quarter of 2019.  The decrease primarily reflects the increase in intangible amortization expense and the unfavorable effect of foreign exchange on gross margin in 2020.

Research and development expenses decreased $94 million, or 14.1 percent, in the first quarter of 2020.  The 2020 decrease in R&D expense was primarily driven by the immediate expensing of an R&D asset valued at $102 million in the first quarter of 2019, in conjunction with the acquisition of Cephea Valve Technologies, Inc.  For the three months ended March 31, 2020, research and development expenditures totaled $309 million for the Medical Devices segment, $134 million for the Diagnostic Products segment, $46 million for the Nutritional Products segment and $43 million for the Established Pharmaceutical Products segment.

Selling, general and administrative (SG&A) expenses for the first quarter of 2020 increased 2.8 percent due primarily to higher selling and marketing costs to drive growth across various businesses.

Restructuring Plans

The results for the first three months of 2020 reflect charges under approved restructuring plans as part of the integration of the acquisitions of St. Jude Medical and Alere or as a part of various cost reduction programs.  Abbott recorded employee related severance and other charges of $32 million in the first three months of 2020 related to these initiatives, of which $4 million is recognized in Cost of products sold, $2 million is recognized in Research and development and $26 million is recognized in SG&A. See Note 7 to the financial statements, “Restructuring Plans,” for additional information regarding these charges.

Other (Income) Expense, net

Other (income) expense, net decreased $46 million in the first quarter of 2020 from $47 million of income in 2019 to $1 million in 2020. The decrease in income in the first quarter of 2020 as compared to 2019 was due to an impairment of an equity investment of approximately $50 million in 2020.

Interest Expense, net

Interest expense, net decreased $27 million in the first quarter of 2020 due to a reduction in interest expense resulting from the favorable impact of the euro debt financing in November of 2019 and the repayment of debt in 2019.

Taxes on Earnings

Taxes on earnings from continuing operations reflect the estimated annual effective rates and include charges for interest and penalties.  In the first three months of 2020, taxes on earnings from continuing operations include approximately $47 million in excess tax benefits associated with share-based compensation.  Earnings from discontinued operations, net of tax, in the first three months of 2020 reflect the recognition of $20 million of net tax benefits primarily as a result of the resolution of various tax positions related to prior years.  In the first three months of 2019, taxes on earnings from continuing operations include a $78 million reduction to the transition tax related to the Tax Cut and Jobs Act (TCJA) and approximately $65 million in excess tax benefits associated with share-based compensation.

Tax authorities in various jurisdictions regularly review Abbott’s income tax filings.  Abbott believes that it is reasonably possible that the recorded amount of gross unrecognized tax benefits may decrease between $230 million and $520 million, including cash adjustments, within the next twelve months as a result of concluding various domestic and international tax matters.  In the U.S., Abbott's federal income tax returns through 2016 are settled except for the federal income tax returns of the former Alere consolidated group which are settled through 2015 and the former St. Jude Medical consolidated group which are settled through 2013.

Liquidity and Capital Resources March 31, 2020 Compared with December 31, 2019

The reduction of cash and cash equivalents from $3.9 billion at December 31, 2019 to $3.4 billion at March 31, 2020 primarily reflects the payment of dividends and capital expenditures, partially offset by cash generated from operations in the first three months of 2020.  Working capital was $4.7 billion at March 31, 2020 and $4.8 billion at December 31, 2019.  The decrease in working capital in 2020 primarily reflects the decrease in cash and cash equivalents partially offset by an increase in inventory.

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In the Condensed Consolidated Statement of Cash Flows, Net cash from operating activities for the first three months of 2020 totaled $715 million, an increase of $3 million over the prior year as the negative impact of an increased investment in working capital was offset by lower cash taxes paid and higher operating earnings.  Other, net in Net cash from operating activities for the first three months of 2020 was a use of $369 million and includes $320 million of pension contributions and the payment of cash taxes of approximately $125 million.  Other, net in Net cash from operating activities for the first three months of 2019 was a use of $483 million and includes $313 million of pension contributions and the payment of cash taxes of approximately $185 million.

In September 2019, the board of directors authorized the early redemption of up to $5 billion of outstanding long-term notes.  This bond redemption authorization superseded the board’s previous authorization under which $700 million had not yet been redeemed.  In December 2019, Abbott redeemed $2.850 billion of debt.  After this redemption, $2.15 billion of the $5 billion debt redemption authorization remains available.

At March 31, 2020, Abbott’s long-term debt rating was A- by Standard & Poor’s Corporation and A3 by Moody’s Investors Service.  Abbott expects to maintain an investment grade rating.  Abbott has readily available financial resources, including lines of credit of $5.0 billion which expire in 2023.

In October 2019, the board of directors authorized the repurchase of up to $3 billion of Abbott’s common shares from time to time.  The new authorization is in addition to the $270 million unused portion of the share repurchase program authorized in 2014.

On April 27, 2016, the board of directors authorized the issuance and sale for general corporate purposes of up to 75 million common shares that would result in proceeds of up to $3 billion.  No shares have been issued under this authorization.

In the first quarter of 2020, Abbott declared a quarterly dividend of $0.36 per share on its common shares, which represents an increase of approximately 12.5 percent over the $0.32 per share dividend declared in the first quarter of 2019.

Recently Adopted Accounting Standards

In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-13, Financial Instruments – Credit Losses, which changes the methodology to be used to measure credit losses for certain financial instruments and financial assets, including trade receivables.  The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to be incurred over the life of the financial asset.  Abbott adopted the standard on January 1, 2020 and recorded a cumulative adjustment that was not significant to Earnings employed in the business in the Condensed Consolidated Balance Sheet.

Recently Issued Accounting Standards Not Yet Adopted

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which among other things, eliminates certain exceptions in the current rules regarding the approach for intraperiod tax allocations and the methodology for calculating income taxes in an interim period, and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill.  The standard becomes effective for Abbott  in the first quarter of 2021 and early adoption is permitted.  Abbott does not expect adoption of this new standard to have a material impact on its condensed consolidated financial statements.

Legislative Issues

Abbott’s primary markets are highly competitive and subject to substantial government regulations throughout the world.  Abbott expects debate to continue over the availability, method of delivery, and payment for health care products and services.  It is not possible to predict the extent to which Abbott or the health care industry in general might be adversely affected by these factors in the future.  A more complete discussion of these factors is contained in Item 1, Business, and Item 1A, Risk Factors, in the 2019 Annual Report on Form 10-K.

Private Securities Litigation Reform Act of 1995 — A Caution Concerning Forward-Looking Statements

Under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Abbott cautions that any forward-looking statements made by Abbott are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on Abbott's operations and financial results, that may cause actual results to differ materially from those indicated in the forward-looking statements.  Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors'', in the 2019 Annual Report on Form 10-K and in Item 1A, “Risk Factors”, in the quarterly report for the quarter ended March 31, 2020.  Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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PART I.    FINANCIAL INFORMATION

Item 4. Controls and Procedures

(a)

Evaluation of disclosure controls and procedures.  The President and Chief Executive Officer, Robert B. Ford, and Chief Financial Officer, Robert E. Funck, Jr., evaluated the effectiveness of Abbott Laboratories’ disclosure controls and procedures as of the end of the period covered by this report, and concluded that Abbott Laboratories’ disclosure controls and procedures were effective to ensure that information Abbott is required to disclose in the reports that it files or submits with the Securities and Exchange Commission (the “Commission”) under the Securities Exchange Act of 1934 (the “Exchange Act”) is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms, and to ensure that information required to be disclosed by Abbott in the reports that it files or submits under the Exchange Act is accumulated and communicated to Abbott’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

(b)

Changes in internal control over financial reporting. During the quarter ended March 31, 2020, 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.

PART II.    OTHER INFORMATION

Item 1. Legal Proceedings

Abbott is involved in various claims, legal proceedings and investigations, including those described in our Annual Report on Form 10-K for the year ended December 31, 2019.

Item 1A.    Risk Factors

There have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019, except for the following:

Abbott is subject to risks related to public health crises, such as widespread outbreaks of infectious diseases like the COVID-19 pandemic.

As a global healthcare company, public health crises, such as the widespread outbreaks of infectious diseases like the COVID-19 pandemic, may negatively impact Abbott's operations. Health concerns and significant changes in political or economic conditions caused by such outbreaks can cause significant reductions in demand for routine diagnostic testing and medical device procedures or increased difficulty in serving customers, disrupt manufacturing and supply chains, and negatively affect our operations as well as the operations of our suppliers, distributors and other third-party partners. Furthermore, such widespread outbreaks may impact the broader economies of affected countries, including negatively impacting economic growth, the proper functioning of financial and capital markets, foreign currency exchange rates, and interest rates. Due to uncertainties regarding the duration and impact of the current COVID-19 pandemic, Abbott is unable to predict the extent to which the COVID-19 pandemic may have a material effect on its business, financial condition or results of operations.

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Item 2.      Unregistered Sales of Equity Securities and Use of Proceeds

(c)    Issuer Purchases of Equity Securities

    

    

    

    

(d) Maximum

 

Number (or

 

(c) Total Number

Approximate

 

of Shares (or

Dollar Value) of

 

(a) Total

Units) Purchased

Shares (or Units)

 

Number of

(b) Average

as Part of

that May Yet Be

 

Shares (or

Price Paid per

Publicly

Purchased Under

 

Units)

Share (or

Announced Plans

the Plans or

 

Period

Purchased

Unit)

or Programs

Programs

 

January 1, 2020 - January 31, 2020

 

2,957

(1)

$

85.89

 

0

$

3,270,234,923

(2)

February 1, 2020 - February 29, 2020

 

0

(1)

$

0

 

0

$

3,270,234,923

(2)

March 1, 2020 - March 31, 2020

 

0

(1)

$

0

 

0

$

3,270,234,923

(2)

Total

 

2,957

(1)

$

85.89

 

0

$

3,270,234,923

(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 – 2,957 in January, 0 in February, and 0 in March.

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.

(2)   On September 11, 2014, the board of directors authorized the repurchase of up to $3 billion of Abbott common shares, from time to time (the “2014 Plan”).  On October 11, 2019, the board of directors authorized the repurchase of up to $3 billion of Abbott common shares, from time to time (the “2019 Plan”).  The 2019 Plan is in addition to the unused portion of the 2014 Plan.

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Item 6.      Exhibits

Exhibit No.

    

Exhibit

3.1

By-Laws of Abbott Laboratories, as amended and restated, effective April 24, 2020, filed as Exhibit 3.1 to the Abbott Laboratories Current Report on Form 8-K filed on February 27, 2020.

31.1

Certification of Chief Executive Officer Required by Rule 13a-14(a) (17 CFR 240.13a-14(a)).

31.2

Certification of Chief Financial Officer Required by Rule 13a-14(a) (17 CFR 240.13a-14(a)).

Exhibits 32.1 and 32.2 are furnished herewith and should not be deemed to be “filed” under the Securities Exchange Act of 1934.

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 2002.

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 2002.

101

The following financial statements and notes from the Abbott Laboratories Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, formatted in Inline XBRL: (i) Condensed Consolidated Statement of Earnings; (ii) Condensed Consolidated Statement of Comprehensive Income; (iii) Condensed Consolidated Balance Sheet; (iv) Condensed Consolidated Statement of Shareholders' Investment; (v) Condensed Consolidated Statement of Cash Flows; and (vi) Notes to the Condensed Consolidated Financial Statements.

104

Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document and included in Exhibit 101).

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

ABBOTT LABORATORIES

By:

/ s/ Robert E. Funck, Jr.

Robert E. Funck, Jr.

Executive Vice President, Finance
and Chief Financial Officer

Date: April 29, 2020

25

abt_Ex31_1

Exhibit 31.1

 

Certification of Chief Executive Officer

Required by Rule 13a-14(a) (17 CFR 240.13a-14(a))

 

I, Robert B. Ford, certify that:

 

1.            I have reviewed this quarterly report on Form 10-Q of Abbott Laboratories;

 

2.            Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.            Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of Abbott as of, and for, the periods presented in this report;

 

4.            Abbott’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for Abbott and have:

 

a)    Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to Abbott, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)    Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)    Evaluated the effectiveness of Abbott’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)    Disclosed in this report any change in Abbott’s internal control over financial reporting that occurred during Abbott’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, Abbott’s internal control over financial reporting; and

 

5.            Abbott’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to Abbott’s auditors and the audit committee of Abbott’s board of directors:

 

a)    All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect Abbott’s ability to record, process, summarize and report financial information; and

 

b)    Any fraud, whether or not material, that involves management or other employees who have a significant role in Abbott’s internal control over financial reporting.

 

Date: April 29, 2020

/s/ Robert B. Ford

 

Robert B. Ford

President and

Chief Executive Officer

 

abt_Ex31_2

Exhibit 31.2

 

Certification of Chief Financial Officer

Required by Rule 13a-14(a) (17 CFR 240.13a-14(a))

 

I, Robert E. Funck, Jr., certify that:

 

1.            I have reviewed this quarterly report on Form 10-Q of Abbott Laboratories;

 

2.            Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.            Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of Abbott as of, and for, the periods presented in this report;

 

4.            Abbott’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for Abbott and have:

 

a)    Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to Abbott, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)    Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)    Evaluated the effectiveness of Abbott’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)    Disclosed in this report any change in Abbott’s internal control over financial reporting that occurred during Abbott’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, Abbott’s internal control over financial reporting; and

 

5.            Abbott’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to Abbott’s auditors and the audit committee of Abbott’s board of directors:

 

a)    All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect Abbott’s ability to record, process, summarize and report financial information; and

 

b)    Any fraud, whether or not material, that involves management or other employees who have a significant role in Abbott’s internal control over financial reporting.

 

Date: April 29, 2020

/s/ Robert E. Funck, Jr.

 

Robert E. Funck, Jr.

Executive Vice President, Finance

and Chief Financial Officer

 

abt_Ex32_1

Exhibit 32.1

 

Certification Pursuant To

18 U.S.C. Section 1350

As Adopted Pursuant To

Section 906 of the Sarbanes-Oxley Act of 2002

 

In connection with the Quarterly Report of Abbott Laboratories (the “Company”) on Form 10-Q for the period ended March 31, 2020 as filed with the Securities and Exchange Commission (the “Report”), I, Robert B. Ford, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Robert B. Ford

 

Robert B. Ford

 

President and

 

Chief Executive Officer

 

April 29, 2020

 

 

A signed original of this written statement required by Section 906 has been provided to Abbott Laboratories and will be retained by Abbott Laboratories and furnished to the Securities and Exchange Commission or its staff upon request.

abt_Ex32_2

Exhibit 32.2

 

Certification Pursuant To

18 U.S.C. Section 1350

As Adopted Pursuant To

Section 906 of the Sarbanes-Oxley Act of 2002

 

In connection with the Quarterly Report of Abbott Laboratories (the “Company”) on Form 10-Q for the period ended March 31, 2020 as filed with the Securities and Exchange Commission (the “Report”), I, Robert E. Funck, Jr., Executive Vice President, Finance and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)   The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)   The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Robert E. Funck, Jr.

 

Robert E. Funck, Jr.

 

Executive Vice President, Finance

 

and Chief Financial Officer

 

April 29, 2020

 

 

A signed original of this written statement required by Section 906 has been provided to Abbott Laboratories and will be retained by Abbott Laboratories and furnished to the Securities and Exchange Commission or its staff upon request.