10-Q 1 q12019form10-q.htm 10-Q Q1 2019 Document

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
þ
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2019
OR
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File No. 1-11083
BOSTON SCIENTIFIC CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE
04-2695240
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
300 BOSTON SCIENTIFIC WAY, MARLBOROUGH, MASSACHUSETTS 01752-1234
(Address of principal executive offices) (zip code)
(508) 683-4000
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 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 þ No o
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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes þ No o
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 þ
Accelerated filer o
Non-Accelerated filer o
Smaller reporting company o
 
Emerging growth company o
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. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
 
 
Shares outstanding
Class
 
as of April 23, 2019
Common Stock, $0.01 par value
 
1,390,652,506



TABLE OF CONTENTS

 
 
Page No.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2


PART I
FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

 
Three Months Ended March 31,
(in millions, except per share data)
2019
 
2018
Net sales
$
2,493

 
$
2,379

Cost of products sold
730

 
672

Gross profit
1,763

 
1,707

 
 
 
 
Operating expenses:
 
 
 
Selling, general and administrative expenses
869

 
860

Research and development expenses
280

 
261

Royalty expense
16

 
18

Amortization expense
160

 
141

Intangible asset impairment charges
67

 
1

Contingent consideration expense (benefit)
(28
)
 
5

Restructuring charges (credits)
6

 
13

Litigation-related net charges (credits)
(148
)
 

 
1,222

 
1,300

Operating income (loss)
541

 
407

 
 
 
 
Other income (expense):
 
 
 
Interest expense
(109
)
 
(61
)
Other, net
25

 
(23
)
Income (loss) before income taxes
457

 
323

Income tax expense (benefit)
33

 
26

Net income (loss)
$
424

 
$
298

 
 
 
 
Net income (loss) per common share — basic
$
0.31

 
$
0.22

Net income (loss) per common share — assuming dilution
$
0.30

 
$
0.21

 
 
 
 
Weighted-average shares outstanding
 
 
 
Basic
1,387.7

 
1,376.5

Assuming dilution
1,408.4

 
1,396.8










See notes to the unaudited condensed consolidated financial statements.

3


BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED)

 
Three Months Ended March 31,
(in millions)
2019
 
2018
Net income (loss)
$
424

 
$
298

Other comprehensive income (loss), net of tax:
 
 
 
Foreign currency translation adjustment
6

 
10

Net change in derivative financial instruments
49

 
(80
)
Net change in defined benefit pensions and other items
(1
)
 

Total other comprehensive income (loss)
54

 
(69
)
Total comprehensive income (loss)
$
479

 
$
228










































See notes to the unaudited condensed consolidated financial statements.

4


BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
 
As of
(in millions, except share and per share data)
March 31, 2019
 
December 31, 2018
 
(unaudited)
 
 
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
139

 
$
146

Trade accounts receivable, net
1,621

 
1,608

Inventories
1,228

 
1,166

Prepaid income taxes
163

 
161

Other current assets
3,083

 
921

Total current assets
6,234

 
4,003

Property, plant and equipment, net
1,782

 
1,782

Goodwill
8,179

 
7,911

Other intangible assets, net
6,448

 
6,372

Other long-term assets
1,158

 
932

TOTAL ASSETS
$
23,802

 
$
20,999

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Current debt obligations
$
1,638

 
$
2,253

Accounts payable
498

 
349

Accrued expenses
1,963

 
2,246

Other current liabilities
380

 
412

Total current liabilities
4,479

 
5,260

Long-term debt
7,590

 
4,803

Deferred income taxes
441

 
328

Other long-term liabilities
2,059

 
1,882

 
 
 
 
Commitments and contingencies

 

 
 
 
 
Stockholders’ equity
 
 
 
Preferred stock, $0.01 par value - authorized 50,000,000 shares, none issued and outstanding


 


Common stock, $0.01 par value - authorized 2,000,000,000 shares - issued 1,638,149,373 shares as of March 31, 2019 and 1,632,148,030 shares as of December 31, 2018
16

 
16

Treasury stock, at cost - 247,566,270 shares as of March 31, 2019 and December 31, 2018
(1,717
)
 
(1,717
)
Additional paid-in capital
17,374

 
17,346

Accumulated deficit
(6,528
)
 
(6,953
)
Accumulated other comprehensive income (loss), net of tax
87

 
33

Total stockholders’ equity
9,233

 
8,726

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$
23,802

 
$
20,999





See notes to the unaudited condensed consolidated financial statements.

5


BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED)
 
Common Stock
 
Treasury Stock
 
Additional Paid-In Capital
 
Accumulated Deficit
 
Accumulated Other Comprehensive Income (Loss), Net of Tax
(in millions, except share data)
Shares Issued
 
Par Value
 
 
 
 
Balance as of December 31, 2017
1,621,062,898

 
$
16

 
$
(1,717
)
 
$
17,161

 
$
(8,390
)
 
$
(59
)
Net income (loss)
 
 
 
 
 
 
 
 
298

 
 
Cumulative effect adjustments for ASC Update Adoptions(1)
 
 
 
 
 
 
 
 
(233
)
 
 
Changes in other comprehensive income (loss), net of tax:
 
 
 
 
 
 
 
 
 
 
 
Foreign currency translation adjustment
 
 
 
 
 
 
 
 
 
 
10

Derivative financial instruments
 
 
 
 
 
 
 
 
 
 
(80
)
Impact of stock-based compensation plans, net of tax
6,125,111

 

 

 
23

 
 
 
 
Balance as of March 31, 2018
1,627,188,009

 
$
16

 
$
(1,717
)
 
$
17,184

 
$
(8,326
)
 
$
(128
)
 
 
 
 
 
 
 
 
 
 
 
 
Balance as of December 31, 2018
1,632,148,030

 
$
16

 
$
(1,717
)
 
$
17,346

 
$
(6,953
)
 
$
33

Net income (loss)
 

 
 

 
 
 
 

 
424

 
 

Changes in other comprehensive income (loss), net of tax:
 

 
 

 
 
 
 

 
 
 
 

Foreign currency translation adjustment
 

 
 

 
 
 
 

 
 

 
6

Derivative financial instruments
 

 
 

 
 
 
 

 
 

 
49

Defined benefit pensions and other items
 
 
 
 
 
 
 
 

 
(1
)
Impact of stock-based compensation plans, net of tax
6,001,343

 

 

 
28

 
 
 
 
Balance as of March 31, 2019
1,638,149,373

 
$
16

 
$
(1,717
)
 
$
17,374

 
$
(6,528
)
 
$
87

(1) In 2018, we recorded cumulative effect adjustments to retained earnings to reflect the adoption of Accounting Standards Codification (ASC) Update No. 2014-09, Update No. 2016-16 and Update No. 2016-01. Please refer to Note A – Significant Accounting Policies included in Item 8 of our most recent Annual Report on Form 10-K for more information.






















See notes to the unaudited condensed consolidated financial statements.

6


BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
 
Three Months Ended March 31,
(in millions)
2019
 
2018
Cash provided by (used for) operating activities
$
350

 
$
193

 
 
 
 
Investing activities:
 
 
 
Purchases of property, plant and equipment
(63
)
 
(60
)
Proceeds from sale of property, plant and equipment
2

 

Payments for acquisitions of businesses, net of cash acquired
(321
)
 
(9
)
Payments for investments and acquisitions of certain technologies
(28
)
 
(103
)
Cash provided by (used for) investing activities
(410
)
 
(173
)
 
 
 
 
Financing activities:
 
 
 
Payment of contingent consideration amounts previously established in purchase accounting
(7
)
 

Payments on short-term borrowings
(1,000
)
 

Net increase (decrease) in commercial paper
370

 
(316
)
Proceeds from borrowings on credit facilities

 
70

Payments on long-term borrowings and debt extinguishment costs
(1,472
)
 
(602
)
Proceeds from long-term borrowings, net of debt issuance costs
4,243

 
990

Cash used to net share settle employee equity awards
(60
)
 
(50
)
Proceeds from issuances of shares of common stock
53

 
38

Cash provided by (used for) financing activities
2,127

 
130

 
 
 
 
Effect of foreign exchange rates on cash

 
1

 
 
 
 
Net increase (decrease) in cash, cash equivalents, restricted cash and restricted cash equivalents
2,067

 
151

Cash, cash equivalents, restricted cash and restricted cash equivalents at beginning of period
829

 
1,017

Cash, cash equivalents, restricted cash and restricted cash equivalents at end of period
$
2,896

 
$
1,168

 
 
 
 
Supplemental Information
 
 
 
Stock-based compensation expense
$
36

 
$
36

Fair value of contingent consideration recorded in purchase accounting
87

 


 
As of March 31,
Reconciliation to amounts within the unaudited condensed consolidated balance sheets:
2019
 
2018
Cash and cash equivalents
$
139

 
$
287

Restricted cash and restricted cash equivalents included in Other current assets
2,724

 
850

Restricted cash equivalents included in Other long-term assets
33

 
31

Cash, cash equivalents, restricted cash and restricted cash equivalents at end of period
$
2,896

 
$
1,168








See notes to the unaudited condensed consolidated financial statements.

7


NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE A – BASIS OF PRESENTATION

The accompanying unaudited condensed consolidated financial statements of Boston Scientific Corporation have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. When used in this report, the terms, "we," "us," "our," and "the Company" mean Boston Scientific Corporation and its divisions and subsidiaries. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for fair presentation have been included. Operating results for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. For further information, refer to the consolidated financial statements and footnotes thereto included in Item 8 of our most recent Annual Report on Form 10-K.

Amounts reported in millions within this report are computed based on the amounts in thousands. As a result, the sum of the components reported in millions may not equal the total amount reported in millions due to rounding. Certain columns and rows within tables may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying numbers in dollars.

Revision of Emerging Markets

We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Periodically, we assess our list of Emerging Markets; effective January 1, 2019, we updated our list of Emerging Market countries. Our current list is comprised of the following countries: Argentina, Brazil, Chile, China, Colombia, Czech Republic, India, Indonesia, Malaysia, Mexico, Philippines, Poland, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey and Vietnam. We have revised prior year amounts to the current year’s presentation (as denoted with † throughout). The revision had an immaterial impact on prior year sales.

Subsequent Events

We evaluate events occurring after the date of our most recent accompanying unaudited condensed consolidated balance sheet for potential recognition or disclosure in our financial statements. On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered that all manufacturers of surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse stop selling and distributing their products in the United States immediately, stemming from the FDA’s 2016 reclassification of these devices to class III (high risk) devices. As a result, we recognized a subsequent event to our unaudited condensed consolidated financial statements for the three months ended March 31, 2019 and recorded approximately $25 million in total pre-tax charges primarily related to inventory, intangible asset write-offs and sales returns reserves.

In addition, those items requiring disclosure (nonrecognized subsequent events) in the financial statements have been disclosed accordingly. Refer to Note I – Commitments and Contingencies for more information.

Accounting Standards Implemented Since December 31, 2018

ASC Update No. 2016-02

In February 2016, the Financial Accounting Standards Board (FASB) issued ASC Update No. 2016-02, Leases (FASB ASC Topic 842, Leases). We adopted the standard as of January 1, 2019, using the modified retrospective approach and the transition method provided by ASC Update No. 2018-11, Leases (Topic 842): Targeted Improvements. Under this method, we applied the new leasing rules on the date of adoption and recognized the cumulative effect of initially applying the standard as an adjustment to our opening balance sheet, rather than at the earliest comparative period presented in the financial statements. Prior periods presented are in accordance with the previous lease guidance under FASB ASC Topic 840, Leases.

In addition, we applied the package of practical expedients permitted under FASB ASC Topic 842 transition guidance to our entire lease portfolio at January 1, 2019. As a result, we were not required to reassess (i) whether any expired or existing contracts are or contain leases, (ii) the classification of any expired or existing leases and (iii) the treatment of initial direct costs for any existing leases. Furthermore, we elected not to separate lease and non-lease components for the majority of our leases. Instead, for all applicable classes of underlying assets, we accounted for each separate lease component and the non-lease components associated with that lease component, as a single lease component.


8


As a result of adopting FASB ASC Topic 842 on January 1, 2019, we recognized right-of-use assets of $271 million and corresponding liabilities of $278 million for our existing operating lease portfolio on our unaudited condensed consolidated balance sheet. Operating lease right-of-use assets are presented within Other long-term assets and corresponding liabilities are presented within Other current liabilities and Other long-term liabilities on our unaudited condensed consolidated balance sheets. Finance leases are immaterial to our unaudited condensed consolidated financial statements. Refer to Note E – Borrowings and Credit Arrangements for additional information. There was no material impact to our unaudited condensed consolidated statements of operations or unaudited condensed consolidated statements of cash flows. Please refer to Note G – Leases for information regarding our lease portfolio as of March 31, 2019 as accounted for under FASB ASC Topic 842.

To meet the reporting and disclosure requirements of FASB ASC Topic 842, we implemented a new lease administration and lease accounting system in 2018 that tracks all of our material leasing arrangements. In addition, we designed and implemented new processes and internal controls during the first quarter of 2019 to ensure the completeness and accuracy of the transition adjustment and subsequent financial reporting under FASB ASC Topic 842. We also established monitoring controls to ensure we have appropriate mechanisms in place to identify material leases timely, particularly contracts that may contain embedded lease features.

NOTE B – ACQUISITIONS AND STRATEGIC INVESTMENTS

Our unaudited condensed consolidated financial statements include the operating results for acquired entities from the respective date of acquisition. We have not presented pro forma financial information for acquisitions given their results are not material to our unaudited condensed consolidated financial statements. Transaction costs associated with these acquisitions were expensed as incurred and are not material for the first quarter of 2019 and 2018.

Proposed BTG Acquisition

On November 20, 2018, our board of directors and the board of directors of our wholly owned indirect subsidiary, Bravo Bidco Limited (Bidco), and BTG plc (BTG), a public company organized under the laws of England and Wales, issued an announcement (the Rule 2.7 Announcement) under Rule 2.7 of the United Kingdom City Code on Takeovers and Mergers, disclosing the terms of a recommended cash offer to be made by Bidco for the entire issued and to be issued ordinary share capital of BTG (the proposed BTG Acquisition). In connection with the proposed BTG Acquisition, (i) we entered into a co-operation agreement with Bidco and BTG, (ii) certain shareholders and each BTG director owning shares of BTG delivered deeds of irrevocable undertakings to Bidco and (iii) we entered into a bridge credit agreement (Bridge Facility) that we terminated in February 2019 upon the closing of our senior notes offering. Refer to Note E – Borrowings and Credit Arrangements for further details. On February 14, 2019, each of the Company and BTG received a request for additional information and documentary material from the United States Federal Trade Commission in connection with the proposed BTG Acquisition.

On January 24, 2019, Bidco made such offer on the terms and subject to the conditions of the scheme document published on the same date. On February 28, 2019, a majority in number of BTG shareholders approved the scheme document published on January 24, 2019.

Under the terms of the proposed BTG Acquisition, BTG shareholders will receive 840 pence in cash for each BTG share, which values BTG’s existing issued and to be issued ordinary share capital at approximately £3.311 billion (or approximately $4.317 billion based on the exchange rate of U.S. $1.30: £1.00 as of March 29, 2019). We intend to implement the proposed BTG Acquisition by way of a court-sanctioned scheme of arrangement under Part 26 of the United Kingdom Companies Act 2006, as amended. Subject to the satisfaction or waiver of all relevant conditions, we expect the proposed BTG Acquisition to be effective in mid-year 2019. BTG develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases, as well as acute care pharmaceuticals.


9


2019 Acquisitions

Millipede, Inc.

On January 29, 2019, we announced the closing of our acquisition of Millipede, Inc. (Millipede), a privately-held company that has developed the IRIS Transcatheter Annuloplasty Ring System for the treatment of severe mitral regurgitation. We have been an investor in Millipede since the first quarter of 2018 as part of an investment and acquisition option agreement, whereby we purchased a portion of the outstanding shares of Millipede along with newly issued shares of the company for an upfront cash payment of $90 million. In the fourth quarter of 2018, upon the recent successful completion of a first-in-human clinical study, we exercised our option to acquire the remaining shares of Millipede. We held an interest of approximately 20 percent immediately prior to the acquisition date. We remeasured the fair value of our previously-held investment based on the implied enterprise value and allocation of purchase price consideration according to priority of equity interests. The transaction price for the remaining stake consists of an upfront cash payment of $325 million and up to an additional $125 million payment upon achievement of a commercial milestone. Millipede is part of our Interventional Cardiology business.

Purchase Price Allocation

We accounted for the acquisition of Millipede as a business combination, and in accordance with FASB ASC Topic 805, Business Combinations, we recorded the assets acquired and liabilities assumed at their respective fair values as of the acquisition date. The preliminary purchase price was comprised of the following components:
(in millions)
 
Payment for acquisition, net of cash acquired
$
321

Fair value of contingent consideration
87

Fair value of prior interest
103

 
$
510


The following summarizes the preliminary purchase price allocation for the Millipede acquisition as of March 31, 2019:
(in millions)
 
Goodwill
$
271

Indefinite-lived intangible assets
295

Other assets acquired
2

Liabilities assumed
(1
)
Net deferred tax liabilities
(57
)
 
$
510


We allocated a portion of the preliminary purchase price to the specific intangible asset category as follows:
 
Amount Assigned
(in millions)
 
Amortization Period
(in years)
 
Risk-Adjusted Discount
Rates used in Purchase Price Allocation
Indefinite-lived intangible assets:
 
 
 
 
 
In-process research and development (IPR&D)
$
295

 
N/A
 
20%

2018 Acquisitions

We did not close any material acquisitions during the first quarter of 2018, nor did we record any material purchase price adjustments to the preliminary purchase price allocations of the 2018 acquisitions in the first quarter of 2019.

Goodwill was primarily established due to synergies expected to be gained from leveraging our existing operations as well as revenue and cash flow projections associated with future technologies and has been allocated to our reportable segments based on the relative expected benefit. Based on preliminary estimates updated for applicable regulatory changes, the goodwill recorded relating to our 2019 acquisition is not deductible for tax purposes.

10



Contingent Consideration

Changes in the fair value of our contingent consideration liability were as follows:
(in millions)
 
Balance as of December 31, 2018
$
347

Amount recorded related to current year acquisition
87

Contingent consideration expense (benefit)
(28
)
Contingent consideration payments
(11
)
Balance as of March 31, 2019
$
394


As of March 31, 2019, the maximum amount of future contingent consideration (undiscounted) that we could be required to pay was approximately $914 million.

The recurring Level 3 fair value measurements of our contingent consideration liability include the following significant unobservable inputs:
Contingent Consideration Liability
Fair Value as of March 31, 2019
Valuation Technique
Unobservable Input
Range
R&D, Regulatory and Commercialization-based Milestones
$276 million
Discounted Cash Flow
Discount Rate
3
%
-
4%
Probability of Payment
17
%
-
99%
Projected Year of Payment
2019

-
2027
Revenue-based Payments
$119 million
Discounted Cash Flow
Discount Rate
11
%
-
15%
Probability of Payment
60
%
-
100%
Projected Year of Payment
2019

-
2026

Projected contingent payment amounts related to some of our research and development (R&D), commercialization-based and revenue-based milestones are discounted back to the current period using a discounted cash flow model. Projected revenues are based on our most recent internal operational budgets and strategic plans. Increases or decreases in projected revenues, probabilities of payment, discount rates or the time until payment is made may result in significantly lower or higher fair value measurements.

Strategic Investments

The aggregate carrying amount of our strategic investments were comprised of the following categories:


As of
(in millions)
March 31, 2019
 
December 31, 2018
Equity method investments
$
199

 
$
303

Measurement alternative investments (1)
112

 
94

Publicly-held equity securities (2)
1

 

Notes receivable
31

 
26

 
$
342

 
$
424

(1)
Measurement alternative investments are privately-held equity securities without readily determinable fair values that are measured at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
(2)
Publicly-held equity securities are measured at fair value with changes in fair value recognized currently in Net income (loss).

These investments are classified as Other long-term assets within our accompanying unaudited condensed consolidated balance sheets, in accordance with U.S. GAAP and our accounting policies.

As of March 31, 2019, the cost of our aggregated equity method investments exceeded our share of the underlying equity in net assets by approximately $226 million, which represents amortizable intangible assets, IPR&D, goodwill and deferred tax liabilities.


11


NOTE C – GOODWILL AND OTHER INTANGIBLE ASSETS

The gross carrying amount of goodwill and other intangible assets and the related accumulated amortization for intangible assets subject to amortization and accumulated write-offs of goodwill are as follows:
 
As of March 31, 2019
 
As of December 31, 2018
(in millions)
Gross Carrying Amount
 
Accumulated Amortization/ Write-offs
 
Gross Carrying Amount
 
Accumulated Amortization/ Write-offs
Amortizable intangible assets
 
 
 
 
 
 
 
Technology-related
$
10,081

 
$
(5,327
)
 
$
10,197

 
$
(5,266
)
Patents
521

 
(397
)
 
520

 
(393
)
Other intangible assets
1,656

 
(987
)
 
1,666

 
(958
)
 
$
12,258

 
$
(6,711
)
 
$
12,383

 
$
(6,617
)
Indefinite-lived intangible assets
 
 
 
 
 
 
 
Goodwill
$
18,079

 
$
(9,900
)
 
$
17,811

 
$
(9,900
)
IPR&D
781

 

 
486

 

Technology-related
120

 

 
120

 

 
$
18,980

 
$
(9,900
)
 
$
18,417

 
$
(9,900
)

The following represents our goodwill balance by global reportable segment:
(in millions)
MedSurg
 
Rhythm and Neuro
 
Cardiovascular
 
Total
Balance as of December 31, 2018
$
2,063

 
$
1,924

 
$
3,925

 
$
7,911

Impact of foreign currency fluctuations and other changes in carrying amount
(2
)
 

 
(1
)
 
(2
)
Goodwill acquired

 

 
271

 
271

Balance as of March 31, 2019
$
2,061

 
$
1,924

 
$
4,195

 
$
8,179


Refer to Critical Accounting Policies and Estimates within Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations contained in our most recent Annual Report on Form 10-K for discussion of our annual goodwill and indefinite-lived intangible asset impairment testing.

NOTE D – HEDGING ACTIVITIES AND FAIR VALUE MEASUREMENTS

Derivative Instruments and Hedging Activities

We address market risk from changes in foreign currency exchange rates and interest rates through risk management programs which include the use of derivative financial instruments. We operate these programs pursuant to documented corporate risk management policies and do not enter into derivative transactions for speculative purposes. Our derivative instruments do not subject our earnings to material risk, as the gains or losses on these derivatives generally offset losses or gains recognized on the hedged item.

We manage concentration of counterparty credit risk by limiting acceptable counterparties to major financial institutions with investment grade credit ratings, limiting the amount of credit exposure to individual counterparties and by actively monitoring counterparty credit ratings and the amount of individual credit exposure. We also employ master netting arrangements that limit the risk of counterparty non-payment on a particular settlement date to the net gain that would have otherwise been received from the counterparty. Although not completely eliminated, we do not consider the risk of counterparty default to be significant as a result of these protections. Further, none of our derivative instruments are subject to collateral or other security arrangements, nor do they contain provisions that are dependent on our credit ratings from any credit rating agency.


12


Currency Derivative Instruments
Risk Management Strategy
Our risk from changes in currency exchange rates consists primarily of monetary assets and liabilities, forecast intercompany and third-party transactions and net investments in certain subsidiaries. We manage currency exchange rate risk at a consolidated level to reduce the cost of hedging by taking advantage of offsetting transactions. We employ derivative instruments, primarily forward currency contracts, to reduce the risk to our earnings and cash flows associated with changes in currency exchange rates.

The success of our currency risk management program depends, in part, on forecast transactions denominated primarily in British pound sterling, Euro and Japanese yen. We may experience unanticipated currency exchange gains or losses to the extent the actual activity is different than forecast. In addition, changes in currency exchange rates related to any unhedged transactions may impact our earnings and cash flows.

Derivative Designations and Hedging Relationships

Certain of our currency derivative instruments are designated as cash flow hedges under FASB ASC Topic 815, Derivatives and Hedging, and are intended to protect the U.S. dollar value of forecasted transactions. The gain or loss on a derivative instrument designated as a cash flow hedge is recorded in the Net change in derivative financial instruments component of Other comprehensive income (loss), net of tax (OCI) on our unaudited condensed consolidated statements of comprehensive income (loss) until the underlying third-party transaction occurs. When the underlying third-party transaction occurs, we recognize the gain or loss in earnings within the Cost of products sold caption of our unaudited condensed consolidated statements of operations. In the event the hedging relationship is no longer effective, or if the hedged forecast transaction becomes no longer probable of occurring, we reclassify the gains or losses within Accumulated other comprehensive income (loss), net of tax (AOCI) to earnings at that time.

We also designate certain forward currency contracts as net investment hedges to hedge a portion of our net investments in certain of our entities with functional currencies denominated in the Euro, Swiss franc, and Japanese yen. We have elected to use the spot method to assess effectiveness for our derivatives that are designated as net investment hedges. Under the spot method, the change in fair value attributable to changes in the spot rate is recorded in the Foreign currency translation adjustment (CTA) component of OCI. We have elected to exclude the spot-forward difference from the assessment of hedge effectiveness and are amortizing this amount separately, as calculated at the date of designation, on a straight-line basis over the term of the currency forward contracts. Amortization of the spot-forward difference is then reclassified from AOCI to current period earnings as a reduction to Interest expense on our unaudited condensed consolidated statements of operations.

We also use forward currency contracts that are not part of designated hedging relationships under FASB ASC Topic 815 as a part of our strategy to manage our exposure to currency exchange rate risk related to monetary assets and liabilities and related forecast transactions. These non-designated currency forward contracts have an original time to maturity consistent with the hedged currency transaction exposures, generally less than one year, and are marked-to-market with changes in fair value recorded to earnings within the Other, net caption of our unaudited condensed consolidated statements of operations.

Certain of our non-designated forward currency contracts were entered into for the purpose of managing our exposure to currency exchange rate risk related to the purchase price of the proposed BTG Acquisition. As of March 31, 2019, we have entered into £3.311 billion in aggregate notional amount of forward and deal-contingent forward currency contracts and have hedged the full purchase price. As of December 31, 2018, we had entered into £2.000 billion in aggregate notional amount of these contracts. In the first quarter of 2019, we recognized immaterial gains due to changes in fair value of the contracts in Other, net, and we will continue to recognize changes in fair value in earnings until contract settlement.

Interest Rate Derivative Instruments
Risk Management Strategy

Our interest rate risk relates primarily to U.S. dollar borrowings partially offset by U.S. dollar cash investments. We use interest rate derivative instruments to manage our earnings and cash flow exposure to changes in interest rates. Under these agreements we and the counterparty, at specified intervals, exchange the difference between fixed and floating interest amounts calculated by reference to an agreed-upon notional principal amount. We designate these derivative instruments either as fair value or cash flow hedges in accordance with FASB ASC Topic 815.


13


Derivative Designations and Hedging Relationships

We had no interest rate derivative instruments designated as cash flow hedges outstanding as of March 31, 2019 and $1.000 billion outstanding as of December 31, 2018, which were intended to manage our earnings and cash flow exposure to changes in the benchmark interest rate in connection with the forecasted issuance of fixed-rate debt. For outstanding designated cash flow hedges, we record the changes in the fair value of the derivatives within OCI until the underlying hedged transaction occurs, at which time we recognize the gain or loss within Interest expense over the same period that the hedged items affect earnings, so long as the hedge relationship remains effective. If we determine the hedging relationship is no longer effective, or if the hedged forecast transaction becomes no longer probable of occurring, we reclassify the amount of gains or losses from AOCI to earnings at that time.

During the fourth quarter of 2018, we entered into interest rate derivative contracts designated as cash flow hedges having a notional amount of $1.000 billion to hedge interest rate risk. In the first quarter of 2019, we terminated these instruments in connection with our senior notes issuance in the first quarter of 2019 as discussed in Note E – Borrowings and Credit Arrangements. We recognized an immaterial loss within OCI in the first quarter of 2019 and are reclassifying the amortization of the loss from AOCI into earnings as a component of Interest expense over the same period that the hedged item affects earnings, so long as the hedge relationship remains effective. We are also continuing to reclassify the amortization of the gains or losses of our other previously terminated interest rate derivative instruments that were designated as cash flow hedges in a similar manner. The balance of the deferred loss on our terminated cash flow hedges within AOCI was immaterial as of March 31, 2019 and December 31, 2018. We recognized immaterial gains and losses in Interest expense relating to the amortization of our terminated cash flow hedges in the current and prior periods.

We had no interest rate derivative instruments designated as fair value hedges outstanding as of March 31, 2019 and December 31, 2018. Prior to 2018, we previously terminated interest rate derivative instruments that were designated as fair value hedges and are continuing to recognize the amortization of the gains or losses originally recorded within the Long-term debt caption on our unaudited condensed consolidated balance sheets into earnings as a component of Interest expense over the same period that the discount or premium associated with the hedged items affect earnings. In the event that we designate outstanding interest rate derivative instruments as fair value hedges, we record the changes in the fair values of interest rate derivatives designated as fair value hedges and of the underlying hedged debt instruments in Interest expense, which generally offset. The balance of the deferred gains on our terminated fair value hedges within Long-term debt was immaterial as of March 31, 2019 and December 31, 2018. We recognized immaterial gains in Interest expense relating to the amortization of the terminated fair value hedges in the current and prior periods.

The following table presents the contractual amounts of our derivative instruments outstanding:
(in millions)
 
FASB ASC Topic 815 Designation
 
As of
 
March 31, 2019
 
December 31, 2018
Forward currency contracts
 
Cash flow hedge
 
$
4,142

 
$
3,962

Forward currency contracts
 
Net investment hedge
 
1,517

 
1,483

Forward currency contracts
 
Non-designated
 
7,393

 
5,880

Interest rate derivative contracts
 
Cash flow hedge
 

 
1,000

Total Notional Outstanding
 
 
 
$
13,052

 
$
12,326


The remaining time to maturity as of March 31, 2019 is within 60 months for all designated forward currency contracts and generally less than one year for all non-designated forward currency contracts.


14


The following presents the effect of our derivative instruments designated as cash flow and net investment hedges under FASB ASC Topic 815 on our accompanying unaudited condensed consolidated statements of operations. Refer to Note M – Changes in Other Comprehensive Income for the total amounts relating to derivative instruments presented within the unaudited condensed consolidated statements of comprehensive income (loss).
 
Effect of Hedging Relationships on Accumulated Other Comprehensive Income
 
Amount Recognized in OCI on Derivative
 
Unaudited Condensed Consolidated Statements of Operations (1)
 
Amount Reclassified from AOCI into Earnings
(in millions)
Pre-Tax Gain (Loss)
Tax Benefit (Expense)
Gain (Loss) Net of Tax
 
Location of Amount Reclassified
Total Amount of Line Item Presented
 
Pre-Tax (Gain) Loss
Tax (Benefit) Expense
(Gain) Loss Net of Tax
Three Months Ended March 31, 2019
Forward currency contracts
 
 
 
 
 
 
 
 
Cash flow hedges
$
72

$
(16
)
$
56

 
Cost of products sold
$
730

 
$
(9
)
$
2

$
(7
)
Net investment hedges (2)
33

(7
)
26

 
Interest expense
109

 
(10
)
2

(8
)
Three Months Ended March 31, 2018
Forward currency contracts
 
 
 
 
 
 
 
 
Cash flow hedges
$
(118
)
$
27

$
(91
)
 
Cost of products sold
$
672

 
$
15

$
(3
)
$
12

(1)
In all periods presented in the table above, the pre-tax (gain) loss amounts reclassified from AOCI to earnings represent the effect of the hedging relationships on earnings. All other amounts included in earnings related to hedging relationships were immaterial.
(2)
For our outstanding net investment hedges, the net gain or loss reclassified from AOCI to earnings as a reduction of Interest expense represents the straight-line amortization of the excluded component as calculated at the date of designation. This initial value of the excluded component has been excluded from the assessment of effectiveness in accordance with FASB ASC Topic 815. In the current period, we did not recognize any gains or losses on the components included in the assessment of hedge effectiveness in AOCI or earnings.

As of March 31, 2019, pre-tax net gains or losses for our derivative instruments designated, or previously designated, as cash flow and net investment hedges under FASB ASC Topic 815 that may be reclassified from AOCI to earnings within the next twelve months are presented below (in millions):
Designated Derivative Instrument
 
FASB ASC Topic 815 Designation
 
Location on Unaudited Condensed Consolidated Statements of Operations
 
Amount of Pre-Tax Gain (Loss) that may be Reclassified to Earnings
Forward currency contracts
 
Cash flow hedge
 
Cost of products sold
 
71

Forward currency contracts
 
Net investment hedge
 
Interest expense
 
41

Interest rate derivative contracts
 
Cash flow hedge
 
Interest expense
 
(5
)

Net gains and losses on currency hedge contracts not designated as hedging instruments offset by net gains and losses from currency transaction exposures are presented below:
 
 
Location on Unaudited Condensed Consolidated Statements of Operations
 
Three Months Ended March 31,
(in millions)
 
 
2019
 
2018
Net gain (loss) on currency hedge contracts
 
Other, net
 
$
22

 
$
(23
)
Net gain (loss) on currency transaction exposures
 
Other, net
 
6

 
16

Net currency exchange gain (loss)
 
 
 
$
28

 
$
(8
)

15



Fair Value Measurements

FASB ASC Topic 815 requires all derivative instruments to be recognized at their fair values as either assets or liabilities on the balance sheet. We determine the fair value of our derivative instruments using the framework prescribed by FASB ASC Topic 820, Fair Value Measurements and Disclosures and considering the estimated amount we would receive or pay to transfer these instruments at the reporting date with respect to current currency exchange rates, interest rates, the creditworthiness of the counterparty for unrealized gain positions and our own creditworthiness for unrealized loss positions. In certain instances, we may utilize financial models to measure fair value of our derivative instruments. In doing so, we use inputs that include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, other observable inputs for the asset or liability and inputs derived principally from, or corroborated by, observable market data by correlation or other means. The following are the balances of our derivative assets and liabilities:
 
 
Location on Unaudited Condensed Consolidated Balance Sheets (1)
 
As of
(in millions)
 
 
March 31, 2019
 
December 31, 2018
Derivative Assets:
 
 
 
 
 
 
Designated Derivative Instruments
 
 
 
 
 
 
Forward currency contracts
 
Other current assets
 
$
70

 
$
55

Forward currency contracts
 
Other long-term assets
 
265

 
183

 
 
 
 
335

 
237

Non-Designated Derivative Instruments
 
 
 
 
 
 
Forward currency contracts
 
Other current assets
 
101

 
67

Total Derivative Assets
 
 
 
$
436

 
$
304

 
 
 
 
 
 
 
Derivative Liabilities:
 
 
 
 
 
 
Designated Derivative Instruments
 
 
 
 
 
 
Forward currency contracts
 
Other current liabilities
 
$
3

 
$
2

Forward currency contracts
 
Other long-term liabilities
 
3

 
3

Interest rate contracts
 
Other current liabilities
 

 
44

 
 
 
 
6

 
49

Non-Designated Derivative Instruments
 
 
 
 
 
 
Forward currency contracts
 
Other current liabilities
 
42

 
31

Total Derivative Liabilities
 
 
 
$
48

 
$
80

(1)
We classify derivative assets and liabilities as current when the settlement date of the derivative contract is one year or less.
Recurring Fair Value Measurements
On a recurring basis, we measure certain financial assets and financial liabilities at fair value based upon quoted market prices. Where quoted market prices or other observable inputs are not available, we apply valuation techniques to estimate fair value. FASB ASC Topic 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. The category of a financial asset or a financial liability within the valuation hierarchy is based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows:
Level 1 – Inputs to the valuation methodology are quoted market prices for identical assets or liabilities.
Level 2 – Inputs to the valuation methodology are other observable inputs, including quoted market prices for similar assets or liabilities and market-corroborated inputs.
Level 3 – Inputs to the valuation methodology are unobservable inputs based on management’s best estimate of inputs market participants would use in pricing the asset or liability at the measurement date, including assumptions about risk.

16


Assets and liabilities measured at fair value on a recurring basis consist of the following:
 
As of
 
March 31, 2019
 
December 31, 2018
(in millions)
Level 1
 
Level 2
 
Level 3
 
Total
 
Level 1
 
Level 2
 
Level 3
 
Total
Assets
 
 
 

 
 
 
 
 
 
 
 

 
 
 
 
Money market and government funds
$
25

 
$

 
$

 
$
25

 
$
13

 
$

 
$

 
$
13

Publicly-held equity securities
1

 

 

 
1

 

 

 

 

Derivative instruments

 
436

 

 
436

 

 
304

 

 
304

 
$
26

 
$
436

 
$

 
$
462

 
$
14

 
$
304

 
$

 
$
318

Liabilities
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Derivative instruments
$

 
$
48

 
$

 
$
48

 
$

 
$
80

 
$

 
$
80

Contingent consideration

 

 
394

 
394

 

 

 
347

 
347

 
$

 
$
48

 
$
394

 
$
442

 
$

 
$
80

 
$
347

 
$
427


Our investments in money market and government funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. These investments are classified as Cash and cash equivalents within our accompanying unaudited condensed consolidated balance sheets, in accordance with U.S. GAAP and our accounting policies. In addition to $25 million invested in money market and government funds as of March 31, 2019, we had $114 million in interest bearing and non-interest-bearing bank accounts. In addition to $13 million invested in money market and government funds as of December 31, 2018, we had $133 million in interest bearing and non-interest-bearing bank accounts.

Our recurring fair value measurements using Level 3 inputs relate solely to our contingent consideration liability. Refer to Note B – Acquisitions and Strategic Investments for a discussion of the changes in the fair value of our contingent consideration liability.
Non-Recurring Fair Value Measurements

We hold certain assets and liabilities that are measured at fair value on a non-recurring basis in periods after initial recognition. The fair value of a measurement alternative investment is not estimated if there are no identified events or changes in circumstances that may have a significant adverse effect on the fair value of the investment. Refer to Note B – Acquisitions and Strategic Investments for a discussion of our strategic investments.

Refer to Note C – Goodwill and Other Intangible Assets for a discussion of the fair values.

The fair value of our outstanding debt obligations was $9.750 billion as of March 31, 2019 and $7.239 billion as of December 31, 2018. We determined fair value by using quoted market prices for our publicly registered senior notes, classified as Level 1 within the fair value hierarchy, amortized cost for commercial paper and face value for term loans and credit facility borrowings outstanding. Refer to Note E – Borrowings and Credit Arrangements for a discussion of our debt obligations.


17


NOTE E – BORROWINGS AND CREDIT ARRANGEMENTS

We had total debt of $9.228 billion as of March 31, 2019 and $7.056 billion as of December 31, 2018. The debt maturity schedule for our long-term debt obligations is presented below:
(in millions, except interest rates)
 
Issuance Date
 
Maturity Date
 
As of
 
Semi-annual Coupon Rate
 
March 31, 2019
 
December 31, 2018
 
January 2020 Notes
 
December 2009
 
January 2020
 
$

 
$
850

 
6.000%
May 2020 Notes
 
May 2015
 
May 2020
 

 
600

 
2.850%
May 2022 Notes
 
May 2015
 
May 2022
 
500

 
500

 
3.375%
October 2023 Notes
 
August 2013
 
October 2023
 
450

 
450

 
4.125%
March 2024 Notes
 
February 2019
 
March 2024
 
850

 

 
3.450%
May 2025 Notes
 
May 2015
 
May 2025
 
750

 
750

 
3.850%
March 2026 Notes
 
February 2019
 
March 2026
 
850

 

 
3.750%
March 2028 Notes
 
February 2018
 
March 2028
 
1,000

 
1,000

 
4.000%
March 2029 Notes
 
February 2019
 
March 2029
 
850

 

 
4.000%
November 2035 Notes
 
November 2005
 
November 2035
 
350

 
350

 
7.000%
March 2039 Notes
 
February 2019
 
March 2039
 
750

 

 
4.550%
January 2040 Notes
 
December 2009
 
January 2040
 
300

 
300

 
7.375%
March 2049 Notes
 
February 2019
 
March 2049
 
1,000

 

 
4.700%
Unamortized Debt Issuance Discount
and Deferred Financing Costs
 
 
 
2020 - 2049
 
(82
)
 
(29
)
 
 
Unamortized Gain on Fair Value Hedges
 
 
 
2020 - 2023
 
16

 
26

 
 
Finance Lease Obligation (1)
 
 
 
Various
 
6

 
6

 
 
Long-term debt
 
 
 
 
 
$
7,590

 
$
4,803

 
 
Note: The table above does not include unamortized amounts related to interest rate contracts designated as cash flow hedges.
(1)    Effective January 1, 2019, we adopted FASB ASC Topic 842 and recognize finance lease obligations in our unaudited condensed consolidated balance sheet as of March 31, 2019. As of December 31, 2018, these leases were referred to as capital lease obligations in accordance with FASB ASC Topic 840. Please refer to Note A – Basis of Presentation for additional information.

Revolving Credit Facility

As of March 31, 2019 and December 31, 2018, we maintained a $2.750 billion revolving credit facility (2018 Facility) with a global syndicate of commercial banks that matures on December 19, 2023 with one-year extension options subject to certain conditions. This facility provides backing for the commercial paper program. The 2018 Credit Agreement requires that we comply with certain covenants, including financial covenants as described within Debt Covenants below. There were no amounts outstanding under our revolving credit facility as of March 31, 2019 and December 31, 2018.

Term Loans

On February 25, 2019, upon the closing of our senior notes offering in aggregate principal amount of $4.300 billion described below, we terminated the $1.000 billion Term Loan Credit Agreement, entered into on August 20, 2018 and amended on December 19, 2018 (August 2019 Term Loan). The August 2019 Term Loan was scheduled to mature on August 19, 2019. As of December 31, 2018, we had $1.000 billion outstanding under our August 2019 Term Loan, which was presented within Current debt obligations on our accompanying unaudited condensed consolidated balance sheets.

On December 19, 2018, we entered into a $2.000 billion senior unsecured delayed-draw term loan facility consisting of a $1.000 billion two-year delayed draw term loan credit facility maturing in two years from the date of the closing of the proposed BTG Acquisition (Two-Year Delayed Draw Term Loan) and a $1.000 billion three-year delayed draw term loan credit facility maturing in three years from the date of the closing of the proposed BTG Acquisition (Three-Year Delayed Draw Term Loan). Borrowings are available in U.S. dollars and bear interest at LIBOR or a base rate, in each case plus an applicable margin based on our public debt ratings. We are required to pay customary ticking fees on the average daily unused commitments based on our public debt ratings. The facilities contain customary representations and covenants, as described within Debt Covenants below. The facilities

18


contain customary events of default, which may result in the acceleration of any outstanding commitments, and also contain customary U.K. certain funds provisions. Any proceeds from the facilities will be available to finance the proposed BTG Acquisition and pay related transaction costs, as defined by the facilities. As of March 31, 2019 and December 31, 2018, we had no amounts borrowed under the Two-Year Delayed Draw Term Loan or the Three-Year Delayed Draw Term Loan.

Debt Covenants

As of and through March 31, 2019, we were in compliance with all the required covenants related to our debt obligations. For additional information regarding the terms of our debt agreements, refer to Note E – Borrowings and Credit Arrangements to our consolidated financial statements in our most recent Annual Report on Form 10-K.

All existing credit arrangements described above require that we maintain certain financial covenants, as follows:
 
 
Covenant Requirement
 
Actual
 
 
as of March 31, 2019
 
as of March 31, 2019
Maximum leverage ratio (1)
 
3.75 times
 
2.49 times
(1)
Ratio of total debt to consolidated EBITDA, as defined by the agreements, for the preceding four consecutive fiscal quarters.

Our covenants require that we maintain a maximum leverage ratio of 3.75 times, provided, however, that for the two consecutive fiscal quarters ended immediately following the consummation of a Qualified Acquisition, as defined by each agreement, the maximum leverage ratio shall be 4.75 times, and then subject to a step-down for each succeeding fiscal quarter end to 4.50 times, 4.25 times, 4.00 times and then back to 3.75 times for each fiscal quarter end thereafter. Our covenants provide for an exclusion from the calculation of consolidated EBITDA, as defined by the agreements, through maturity, of any non-cash charges and up to $500 million in restructuring charges and restructuring-related expenses related to our current or future restructuring plans. As of March 31, 2019, we had $338 million of the restructuring charge exclusion remaining. In addition, any cash litigation payments (net of any cash litigation receipts), as defined by the agreements, are excluded from the calculation of consolidated EBITDA, as defined by the agreements, provided that the sum of any excluded net cash litigation payments do not exceed $2.624 billion in the aggregate. As of March 31, 2019, we had $1.366 billion of the litigation exclusion remaining. Our covenants also provide for an exclusion of any debt incurred to prefund a Qualified Acquisition, as defined by each agreement, until the earlier of the acquisition close date or date of abandonment, termination or expiration of the acquisition agreement. As of March 31, 2019, we excluded $2.298 billion of debt incurred from our leverage ratio calculation in connection with the proposed BTG Acquisition.

Any inability to maintain compliance with these covenants could require us to seek to renegotiate the terms of our credit facility or seek waivers from compliance with these covenants, both of which could result in additional borrowing costs. Further, there can be no assurance that our lenders would agree to such new terms or grant such waivers on terms acceptable to us. In this case, all credit facility commitments would terminate, and any amounts borrowed under the facility would become immediately due and payable. Furthermore, any termination of our credit facility may negatively impact the credit ratings assigned to our commercial paper program which may impact our ability to refinance any then outstanding commercial paper as it becomes due and payable.
Commercial Paper
 
As of
(in millions, except maturity and yield)
March 31, 2019
 
December 31, 2018
Commercial paper outstanding
$
1,630

 
$
1,248

Maximum borrowing capacity
2,750

 
2,750

Borrowing capacity available
1,120

 
1,502

Weighted average maturity
51 days

 
27 days

Weighted average yield
3.01
%
 
3.04
%

Senior Notes

We had senior notes outstanding of $7.650 billion as of March 31, 2019 and $4.800 billion as of December 31, 2018.


19


In February 2019, we completed an offering of $4.300 billion in aggregate principal amount of senior notes comprised of $850 million of 3.450% senior notes due March 2024, $850 million of 3.750% senior notes due March 2026, $850 million of 4.000% senior notes due March 2029, $750 million of 4.550% senior notes due March 2039 and $1.000 billion of 4.700% senior notes due March 2049. We used a portion of the net proceeds from the offering to repay the $850 million plus accrued interest and premium of our 6.000% senior notes due in January 2020, the $600 million plus accrued interest and premium of our 2.850% senior notes due in May 2020 and the $1.000 billion plus accrued interest of our August 2019 Term Loan. The remaining proceeds are intended to be used to finance a portion of the proposed BTG Acquisition and are included in our restricted cash in Other current assets until the proposed BTG Acquisition closes. As of March 31, 2019, the balance of our restricted cash in Other current assets relating to the proposed BTG Acquisition was $2.302 billion.

In the event that the proposed BTG Acquisition, in accordance with its terms, has not become effective on or prior to August 20, 2019 or such later date (Long Stop Date) or if, prior to becoming effective, the proposed BTG Acquisition lapses, is withdrawn or terminates, then we will be required to redeem all outstanding March 2024 Notes and March 2026 Notes on the special mandatory redemption date, as defined below, at a special mandatory redemption price equal to 101 percent of the principal amount, plus any accrued and unpaid interest. The special mandatory redemption date is defined as 30 days, or first business day thereafter, following the earlier of the Long Stop Date or the lapse, withdrawal or termination of the proposed BTG Acquisition in accordance with its terms.

Our senior notes were issued in public offerings, are redeemable prior to maturity and are not subject to sinking fund requirements. Our senior notes are unsecured, unsubordinated obligations and rank on parity with each other. These notes are effectively junior to liabilities of our subsidiaries (see Other Arrangements below).

Bridge Facility

On February 25, 2019, upon the closing of our senior notes offering in aggregate principal amount of $4.300 billion described above, we terminated the Bridge Facility entered into on November 20, 2018. The termination was pursuant to the terms of the Bridge Facility, which required full termination upon the refinancing of the January 2020 Notes and May 2020 Notes discussed above. There were no amounts borrowed under the Bridge Facility as of December 31, 2018.

Other Arrangements

We have accounts receivable factoring programs in certain European countries and with commercial banks in Japan which include promissory notes discounting programs. We account for our factoring programs as sales under FASB ASC Topic 860, Transfers and Servicing. We have no retained interest in the transferred receivables, other than collection and administration, and once sold, the accounts receivable are no longer available to satisfy creditors in the event of bankruptcy. Amounts de-recognized for accounts and notes receivable, which are excluded from Trade accounts receivable, net in the accompanying unaudited condensed consolidated balance sheets, are aggregated by contract denominated currency below (in millions):
Factoring Arrangements
As of March 31, 2019
 
As of December 31, 2018
Amount
De-recognized
 
Average Interest Rate
 
Amount
De-recognized
 
Average Interest Rate
Euro denominated
$
167

 
1.8
%
 
$
165

 
2.7
%
Yen denominated
198

 
0.6
%
 
195

 
0.9
%

Refer to Note E – Borrowing and Credit Arrangements to our audited financial statements contained in Item 8 of our most recent Annual Report on Form 10-K for additional information on our borrowings and credit agreements.


20


NOTE F – SUPPLEMENTAL BALANCE SHEET INFORMATION

Components of selected captions in our accompanying unaudited condensed consolidated balance sheets are as follows:

Cash, cash equivalents, restricted cash and restricted cash equivalents
 
As of
(in millions)
March 31, 2019
 
December 31, 2018
Cash and cash equivalents
$
139

 
$
146

Restricted cash and restricted cash equivalents in Other current assets:
 
 
 
Restricted cash related to the proposed BTG Acquisition (1)
2,302

 

Other restricted cash and restricted cash equivalents
422

 
655

 
2,724

 
655

Restricted cash equivalents in Other long-term assets
33

 
27

 
$
2,896

 
$
829

(1)
Refer to Note B – Acquisitions and Strategic Investments and Note E – Borrowings and Credit Arrangements for additional information regarding the proposed BTG Acquisition.

Trade accounts receivable, net
 
As of
(in millions)
March 31, 2019
 
December 31, 2018
Accounts receivable
$
1,693

 
$
1,676

Allowance for doubtful accounts
(72
)
 
(68
)
 
$
1,621

 
$
1,608


The following is a rollforward of our allowance for doubtful accounts:
 
Three Months Ended March 31,
(in millions)
2019
 
2018
Beginning balance
$
68

 
$
68

Net charges to expenses
7

 
4

Utilization of allowances
(2
)
 
(5
)
Ending balance
$
72

 
$
67


Inventories
 
As of
(in millions)
March 31, 2019
 
December 31, 2018
Finished goods
$
785

 
$
760

Work-in-process
107

 
100

Raw materials
337

 
306

 
$
1,228

 
$
1,166



21


Property, plant and equipment, net
 
As of
(in millions)
March 31, 2019
 
December 31, 2018
Land
$
96

 
$
97

Buildings and improvements
1,112

 
1,100

Equipment, furniture and fixtures
3,276

 
3,224

Capital in progress
292

 
319

 
4,777

 
4,740

Less: accumulated depreciation
2,994

 
2,958

 
$
1,782

 
$
1,782


Depreciation expense was $69 million for the first quarter of 2019 and $68 million for the first quarter of 2018.

Accrued expenses
 
As of
(in millions)
March 31, 2019
 
December 31, 2018
Legal reserves
$
527

 
$
712

Payroll and related liabilities
530

 
630

Rebates
232

 
229

Contingent consideration
159

 
138

Other
515

 
538

 
$
1,963

 
$
2,246


Other long-term liabilities
 
As of
(in millions)
March 31, 2019
 
December 31, 2018
Income taxes
$
747

 
$
739

Legal reserves
172

 
217

Contingent consideration
236

 
209

Other
905

 
717

 
$
2,059

 
$
1,882


NOTE G – LEASES

We have operating and finance leases for real estate including corporate offices, land, warehouse space, vehicles and certain equipment. Leases with an initial term of 12 months or less are generally not recorded on the balance sheet, unless the arrangement includes an option to purchase the underlying asset, or an option to renew the arrangement, that we are reasonably certain to exercise (short-term leases). We recognize lease expense on a straight-line basis over the lease term for short-term leases that we do not record on our balance sheet. If there is a change in our assessment of the lease term, and as a result, the remaining lease term extends more than 12 months from the end of the previously determined lease term, or we subsequently become reasonably certain that we will exercise an option to purchase the underlying asset, the lease no longer meets the definition of a short-term lease and is accounted for as either an operating or finance lease and recognized on the balance sheet. For leases executed in 2019 and later, we account for the lease components and the non-lease components as a single lease component, with the exception of our warehouse leases. Our leases have remaining lease terms of less than 1 year to approximately 60 years, some of which may include options to extend the leases for up to 10 years. If we are reasonably certain we will exercise an option to extend the lease, the time period covered by the extension option is included in the lease term.

We determine whether an arrangement is or contains a lease based on the unique facts and circumstances present at the inception of an arrangement. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, we utilize the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over

22


a similar term at an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.

The following table presents supplemental balance sheet information related to our operating leases:
(in millions)
As of March 31, 2019
Assets
 
Operating lease right-of-use assets in Other long-term assets
$
257

Liabilities
 
Operating lease liabilities in Other current liabilities
$
55

Operating lease liabilities in Other long-term liabilities 
211


The following table presents the weighted average remaining lease term and discount rate information related to our operating leases:
 
As of March 31, 2019
Weighted average remaining lease term
5.28 years
Weighted average discount rate
3.61%

Our operating lease cost was $18 million in the first quarter of 2019.

The following table presents supplemental cash flow information related to our operating leases:
(in millions)
Three Months Ended March 31, 2019
Cash paid for amounts included in the measurement of operating lease liabilities
 
Operating cash flows from operating leases
$
17


Right-of-use assets obtained in exchange for operating lease obligations were immaterial as of March 31, 2019.

The following table presents the maturities of our operating lease liabilities as of March 31, 2019:
Fiscal year (in millions)
Operating Leases
2019 (excluding the first quarter of 2019)
$
54

2020
60

2021
48

2022
39

2023
30

Thereafter
65

Total future minimum operating lease payments
297

Less: imputed interest
31

Present value of operating lease liabilities
$
266


As of March 31, 2019, we have additional leases for office space and R&D space, that have not yet commenced, of approximately $63 million. These leases will commence during 2019 and 2020, with lease terms of 6 months to 15 years.


23


NOTE H – INCOME TAXES

Our effective tax rate from continuing operations is presented below:
 
Three Months Ended March 31,
2019
 
2018
Effective tax rate from continuing operations
7.1
%
 
8.0
%

The change in our reported tax rates for the first quarter of 2019, as compared to the same period in 2018, relates primarily to the impact of certain receipts and charges that are taxed at different rates than our effective tax rate. These receipts and charges include intangible asset impairment charges, acquisition-related items, restructuring items, litigation-related items, as well as certain discrete tax items, primarily related to share-based payments.

We have immaterial changes to our overall uncertain tax benefits as of March 31, 2019 as compared to December 31, 2018.

NOTE I – COMMITMENTS AND CONTINGENCIES

The medical device market in which we primarily participate is largely technology driven. As a result, intellectual property rights, particularly patents and trade secrets, play a significant role in product development and differentiation. Over the years, there has been litigation initiated against us by others, including our competitors, claiming that our current or former product offerings infringe patents owned or licensed by them. Intellectual property litigation is inherently complex and unpredictable. In addition, competing parties frequently file multiple suits to leverage patent portfolios across product lines, technologies and geographies and to balance risk and exposure between the parties. In some cases, several competitors are parties in the same proceeding, or in a series of related proceedings, or litigate multiple features of a single class of devices. These forces frequently drive settlement not only for individual cases, but also for a series of pending and potentially related and unrelated cases. Although monetary and injunctive relief is typically sought, remedies and restitution are generally not determined until the conclusion of the trial court proceedings and can be modified on appeal. Accordingly, the outcomes of individual cases are difficult to time, predict or quantify and are often dependent upon the outcomes of other cases in other geographies.

During recent years, we successfully negotiated closure of several long-standing legal matters and have received favorable rulings in several other matters; however, there continues to be outstanding intellectual property litigation. Adverse outcomes in one or more of these matters could have a material adverse effect on our ability to sell certain products and on our operating margins, financial position, results of operations and/or liquidity.

In the normal course of business, product liability, securities and commercial claims are asserted against us. Similar claims may be asserted against us in the future related to events not known to management at the present time. We maintain an insurance policy providing limited coverage against securities claims and we are substantially self-insured with respect to product liability claims and fully self-insured with respect to intellectual property infringement claims. The absence of significant third-party insurance coverage increases our potential exposure to unanticipated claims or adverse decisions. Product liability claims, securities and commercial litigation and other legal proceedings in the future, regardless of their outcome, could have a material adverse effect on our financial position, results of operations and/or liquidity.

In addition, like other companies in the medical device industry, we are subject to extensive regulation by national, state and local government agencies in the U.S. and other countries in which we operate. From time to time we are the subject of qui tam actions and governmental investigations often involving regulatory, marketing and other business practices. These qui tam actions and governmental investigations could result in the commencement of civil and criminal proceedings, substantial fines, penalties and administrative remedies and have a material adverse effect on our financial position, results of operations and/or liquidity.

In accordance with FASB ASC Topic 450, Contingencies, we accrue anticipated costs of settlement, damages, losses for product liability claims and, under certain conditions, costs of defense, based on historical experience or to the extent specific losses are probable and estimable. Otherwise, we expense these costs as incurred. If the estimate of a probable loss is a range and no amount within the range is more likely, we accrue the minimum amount of the range.


24


Our accrual for legal matters that are probable and estimable was $699 million as of March 31, 2019 and $929 million as of December 31, 2018 and includes certain estimated costs of settlement, damages and defense. The decrease in our legal accrual was primarily due to settlement payments, authorized for payment in the first quarter of 2019 and funded in a prior period, associated with product liability cases or claims related to transvaginal surgical mesh products. A portion of our legal accrual is already funded through our qualified settlement fund (QSF), which is included in other restricted cash and restricted cash equivalents balance of $422 million as of March 31, 2019 and $655 million as of December 31, 2018. Refer to Note F – Supplemental Balance Sheet Information for additional information.

In the first quarter of 2019, we recorded $148 million of the total $180 million one-time settlement payment received from Edwards Lifesciences Corporation in January 2019 to Litigation-related charges (credits) on our unaudited condensed consolidated financial statements. We record certain legal and product liability charges, credits and costs of defense, which we consider to be unusual or infrequent and significant as Litigation-related net charges (credits) in our unaudited condensed consolidated financial statements. All other legal and product liability charges, credits and costs are recorded within Selling, general and administrative expenses. As such, a portion of the related gain from this settlement was recorded in Selling, general and administrative expenses on our unaudited condensed consolidated statements of operations. Our litigation-related net charges were immaterial in the first quarter of 2018. We continue to assess certain litigation and claims to determine the amounts, if any, that management believes will be paid as a result of such claims and litigation and, therefore, additional losses may be accrued and paid in the future, which could materially adversely impact our operating results, cash flows and/or our ability to comply with our debt covenants.

In management's opinion, we are not currently involved in any legal proceedings other than those disclosed in our most recent Annual Report on Form 10-K and those specifically identified below, which, individually or in the aggregate, could have a material adverse effect on our financial condition, operations and/or cash flows. Unless included in our legal accrual or otherwise indicated below, a range of loss associated with any individual material legal proceeding cannot be estimated.

Product Liability Litigation

As of April 23, 2019, approximately 53,000 product liability cases or claims related to transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse have been asserted against us. On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered that all manufacturers of surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse stop selling and distributing their products in the United States immediately, stemming from the FDA’s 2016 reclassification of these devices to class III (high risk) devices, and as a result, the Company ceased global sales and distribution of surgical mesh products indicated for transvaginal pelvic organ prolapse. The pending cases are in various federal and state courts in the U.S. and include eight putative class actions. There were also fewer than 25 cases in Canada, inclusive of one certified and three putative class actions and fewer than 25 claims in the United Kingdom. Generally, the plaintiffs allege personal injury associated with use of our transvaginal surgical mesh products. The plaintiffs assert design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims. Over 3,100 of the cases have been specially assigned to one judge in state court in Massachusetts. On February 7, 2012, the Judicial Panel on Multi-District Litigation (MDL) established MDL-2326 in the U.S. District Court for the Southern District of West Virginia and transferred the federal court transvaginal surgical mesh cases to MDL-2326 for coordinated pretrial proceedings. During the fourth quarter of 2013, we received written discovery requests from certain state attorneys general offices regarding our transvaginal surgical mesh products. We have responded to those requests. As of April 23, 2019, we have entered into master settlement agreements in principle or are in the final stages of entering one with certain plaintiffs' counsel to resolve an aggregate of approximately 51,000 cases and claims. These master settlement agreements provide that the settlement and distribution of settlement funds to participating claimants are conditional upon, among other things, achieving minimum required claimant participation thresholds. Of the approximately 51,000 cases and claims, approximately 41,000 have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.

We have established a product liability accrual for known and estimated future cases and claims asserted against us as well as with respect to the actions that have resulted in verdicts against us and the costs of defense thereof associated with our transvaginal surgical mesh products. While we believe that our accrual associated with this matter is adequate, changes to this accrual may be required in the future as additional information becomes available. While we continue to engage in discussions with plaintiffs’ counsel regarding potential resolution of pending cases and claims and intend to vigorously contest the cases and claims asserted against us, that do not settle, the final resolution of the cases and claims is uncertain and could have a material impact on our results of operations, financial condition and/or liquidity. Initial trials involving our transvaginal surgical mesh products have resulted in both favorable and unfavorable judgments for us. We do not believe that the judgment in any one trial is representative of potential outcomes of all cases or claims related to our transvaginal surgical mesh products.


25


Other Proceedings

On November 1, 2017 we entered into a definitive agreement with Channel Medsystems, Inc. (Channel) where we could have been obligated to pay $145 million in cash up-front and a maximum of $130 million in contingent payments to acquire Channel. The agreement contained a provision allowing Channel to sell the remaining equity interests of the company to us upon achievement of a regulatory milestone and an option allowing us to acquire the remaining equity interests. We sent a notice of termination of that agreement to Channel in the second quarter of 2018. On September 12, 2018, Channel filed a complaint in Delaware Chancery Court against us for alleged breach of the agreement. Channel alleges that we breached the agreement by terminating it. We have answered the complaint, denied the claims by Channel and have counterclaimed to recover part of our investment in Channel, alleging fraud in the inducement. On April 2, 2019, Channel announced its receipt of FDA approval of the Cerene® Cryotherapy Device. Trial testimony was taken from April 15th through April 18th, and post-hearing briefs will be prepared and briefing will be completed by June 11, 2019.

On April 24, 2019, a class action complaint was filed in the U.S. District Court for the Southern District of New York against Boston Scientific Corporation, Michael F. Mahoney, our Chief Executive Officer, and Daniel J. Brennan, our Chief Financial Officer. The complaint alleges violations of federal securities laws based on false and/or misleading statements and failure to disclose facts related to the Company’s transvaginal surgical mesh products. We have reviewed the allegations and believe the suit is without merit. We will defend vigorously.

Proposed Acquisition

Refer to Note B – Acquisitions and Strategic Investments, Note D – Hedging Activities and Fair Value Measurements and Note E – Borrowings and Credit Arrangements for information regarding the proposed BTG Acquisition.

Matters Concluded Since December 31, 2018

On January 15, 2019, we announced that we reached an agreement with Edwards Lifesciences Corporation (Edwards) to settle all outstanding patent disputes between us and Edwards in all venues around the world. All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted. Under the terms of the agreement, Edwards made a one-time payment to us of $180 million. No further royalties will be owed by either party under the agreement. All other terms remain confidential. The previously disclosed matters that have been resolved as a result of this settlement include:

On October 30, 2015, a subsidiary of Boston Scientific filed suit against Edwards Lifesciences Corporation and Edwards Lifesciences Services GmbH in Düsseldorf District Court in Germany for patent infringement. We allege that Edwards’ SAPIEN 3™ Heart Valve infringes our patent related to adaptive sealing technology. On February 25, 2016, we extended the action to allege infringement of a second patent related to adaptive sealing technology. The trial began on February 7, 2017. On March 9, 2017, the court found that Edwards infringed both patents and Edwards appealed.

On November 9, 2015, Edwards Lifesciences, LLC filed an invalidity claim against one of our subsidiaries, Sadra Medical, Inc. (Sadra), in the High Court of Justice, Chancery Division Patents Court in the United Kingdom, alleging that a European patent owned by Sadra relating to a repositionable heart valve is invalid. On January 15, 2016, we filed our defense and counterclaim for a declaration that our European patent is valid and infringed by Edwards. On February 25, 2016, we amended our counterclaim to allege infringement of a second patent related to adaptive sealing technology. A trial was held from January 18 to January 27, 2017. On March 3, 2017, the court found one of our patents valid and infringed and some claims of the second patent invalid and the remaining claims not infringed. Both parties have filed an appeal. On March 28, 2018, the Court of Appeals affirmed the decision of the High Court.

On November 23, 2015, Edwards Lifesciences PVT, Inc. filed a patent infringement action against us and one of our subsidiaries, Boston Scientific Medizintechnik GmbH, in the District Court of Düsseldorf, Germany alleging a European patent (Spenser '672) owned by Edwards is infringed by our Lotus™ Valve System. The trial began on February 7, 2017. On March 9, 2017, the court found that we did not infringe the Spenser '672 patent. Edwards filed an appeal.

On November 23, 2015, Edwards Lifesciences Corporation filed a patent infringement action against us and Boston Scientific Medizintechnik GmbH in the District Court of Düsseldorf, Germany alleging an European patent (Bourang) owned by Edwards is infringed by our Lotus Valve System. The trial began on February 7, 2017. On March 28, 2017, the European Patent Office revoked the Bourang patent and on April 3, 2017, the court suspended the infringement action pending Edwards' appeal of the revocation of the patent at the European Patent Office.

26



On April 19, 2016, a subsidiary of Boston Scientific filed suit against Edwards Lifesciences Corporation (Edwards) in the U.S. District Court for the District of Delaware for patent infringement. We allege that Edwards’ SAPIEN 3™ Valve infringes a patent related to adaptive sealing technology. On June 9, 2016, Edwards filed a counterclaim alleging that our Lotus™ Valve System infringes three patents owned by Edwards. On October 12, 2016, Edwards filed a petition for inter partes review of our patent with the U.S. Patent and Trademark Office (USPTO), Patent Trial and Appeal Board. On March 29, 2017, the USPTO granted the inter partes review request. On April 18, 2017, Edwards filed a second petition for inter partes review of our patent with the USPTO. On March 23, 2018, the USPTO found our patent invalid. The Company filed an appeal before the United States Court of Appeals for the Federal Circuit on May 24, 2018.

On April 19, 2016, a subsidiary of Boston Scientific filed suit against Edwards Lifesciences Corporation in the U.S. District Court for the Central District of California for patent infringement. We allege that Edwards’ aortic valve delivery systems infringe eight of our catheter related patents. On October 13, 2016, Edwards filed a petition for inter partes review of one asserted patent with the USPTO, Patent Trial and Appeal Board. On April 21, 2017, the USPTO denied the petition. On April 19 and 20, 2017, Edwards filed multiple inter partes review petitions against the patents in suit. On September 8, 2017, the court granted a stay of the action pending an inter partes review of the patents in suit.

On April 26, 2016, Edwards Lifesciences PVT, Inc. filed a patent infringement action against us and one of our subsidiaries, Boston Scientific Medizintechnik GmbH, in the District Court of Düsseldorf, Germany alleging a European patent (Spenser '550) owned by Edwards is infringed by our Lotus Transcatheter Heart Valve System. The trial began on February 7, 2017. On March 9, 2017, the court found that we infringed the Spenser '550 patent. The Company filed an appeal. On April 13, 2018, the ‘550 patent was revoked by the European Patent Office.

On October 27, 2016, Edwards Lifesciences PVT, Inc. filed a patent infringement action against us and one of our subsidiaries, Boston Scientific, LTD, in the Federal Court of Canada alleging that three Canadian patents (Spenser) owned by Edwards are infringed by our Lotus Transcatheter Heart Valve System.

On December 22, 2016, Edwards Lifesciences PVT, Inc. and Edwards Lifesciences SA (AG) filed a plenary summons against Boston Scientific Limited and Boston Scientific Group Public Company in the High Court of Ireland alleging that a European patent (Spenser) owned by Edwards is infringed by our Lotus Valve System. On April 13, 2018, the ‘550 patent was revoked by the European Patent Office.

On August 1, 2018, the Company filed a patent infringement action on the merits in Dusseldorf, Germany against Edwards Lifesciences Corporation and Edwards Lifesciences GmbH (collectively Edwards) alleging that the Sapien 3 Device and Sapien 3 Ultra Device infringed a patent owned by the Company.

On August 3, 2018, the Company filed a preliminary injunction request in Dusseldorf, Germany against Edwards Lifesciences Corporation and Edwards Lifesciences GmbH (collectively Edwards) alleging that the Sapien 3 Ultra Device infringed a patent owned by the Company. On October 23, 2018, the court found that the Sapien 3 Ultra Device infringed the patent. Edwards had the right to appeal.

On August 22, 2018, Edwards Lifesciences LLC filed a patent infringement action against Boston Scientific Corporation, in the U. S. District Court of Delaware, alleging that two U.S. patents (Schweich) owned by them are infringed by our Watchman™ Left Atrial Appendage Closure Device, Watchman Delivery System and Watchman Access System.

On December 14, 2016, we learned that the Associacao Brasileira de Medicina de Grupo d/b/a ABRAMGE filed a complaint against us, Arthrex and Zimmer Biomet Holdings, in the U.S. District Court for the District of Delaware. This complaint, which ABRAMGE never served against us, alleges that the defendants or their agents paid kickbacks to health care providers in order to increase sales and prices and are liable under a variety of common law theories. On February 6, 2017, ABRAMGE filed and served an amended complaint on us and the other defendants. The amended complaint does not contain any material changes in the allegations against us. Subsequently, on March 2, 2017, ABRAMGE filed a motion to consolidate this lawsuit with two other similar suits that it had brought against Stryker and Abbott Laboratories, in a multidistrict litigation proceeding. On April 13, 2017, we filed a motion to dismiss the amended complaint, as well as a separate opposition to the multidistrict litigation motion and on May 31, 2017, the Joint Panel on Multi-District Litigation denied ABRAMGE’s motion for the multidistrict litigation. On September 1, 2017, ABRAMGE filed a motion for leave to file a Second Amended Complaint, while our motion to dismiss the Amended Complaint remained pending. On September 15, 2017, we filed an opposition to the motion seeking leave to amend. Both our motion to dismiss and the motion seeking leave to amend remain pending. On November 8, 2018, the Court granted ABRAMGE’s motion for leave to file a Second Amended Complaint, while also granting us leave to renew our motion to dismiss. We filed our

27


motion to dismiss the Second Amended Complaint on January 18, 2019. On February 28, 2019, ABRAMGE dismissed its Second Amended Complaint, concluding the lawsuit.

NOTE J – WEIGHTED AVERAGE SHARES OUTSTANDING
 
Three Months Ended March 31,
(in millions)
2019

2018
Weighted average shares outstanding - basic
1,387.7

 
1,376.5

Net effect of common stock equivalents
20.7

 
20.2

Weighted average shares outstanding - assuming dilution
1,408.4

 
1,396.8


In the first quarter of 2019 and the first quarter of 2018, the impact of stock options outstanding with exercise prices greater than the average fair market value of our common stock was immaterial.

We issued approximately six million shares of our common stock in the first quarter of 2019 and in the first quarter of 2018, following the exercise of stock options, vesting of deferred stock units or purchases under our employee stock purchase plan. We did not repurchase any shares of our common stock in the first three months of 2019 or 2018.

NOTE K – SEGMENT REPORTING

We have three reportable segments comprised of MedSurg, Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments.
Each of our reportable segments generates revenues from the sale of medical devices. We measure and evaluate our reportable segments based on reportable segment net sales, operating income of reportable segments, excluding intersegment profits, and reportable segment operating income as a percentage of reportable segment net sales. Reportable segment operating income as a percentage of reportable segment net sales is defined as operating income of reportable segments divided by reportable segment net sales. Our presentation of reportable segment net sales and operating income of reportable segments includes the impact of foreign currency fluctuations, since our chief operating decision maker (CODM) reviews operating results both including and excluding the impact of foreign currency fluctuations, and the following presentation more closely aligns to our unaudited condensed consolidated financial statements. We exclude from operating income of reportable segments certain corporate-related expenses and certain transactions or adjustments that our CODM considers to be non-operational, such as amounts related to amortization expense, intangible asset impairment charges, acquisition-related items, restructuring and restructuring-related items and litigation-related items. Although we exclude these amounts from operating income of reportable segments, they are included in Income (loss) before income taxes on the unaudited condensed consolidated statements of operations and are included in the reconciliation below.

28



A reconciliation of the totals reported for the reportable segments to the applicable line items in our accompanying unaudited condensed consolidated statements of operations is as follows (in millions, except percentages):
 
Three Months Ended March 31,
 
2019
 
2018
 
 
 
 
Net sales
 
 
 
MedSurg
$
766

 
$
711

Rhythm and Neuro
757

 
736

Cardiovascular
972

 
933

 
$
2,493

 
$
2,379

 
 
 
 
 
 
 
 
 
Three Months Ended March 31,
 
2019
 
2018
 
 
 
 
Income (loss) before income taxes
 
 
 
MedSurg
$
256

 
$
259

Rhythm and Neuro
155

 
153

Cardiovascular
275

 
290

Operating income of reportable segments
686

 
703

Corporate expenses, including hedging activities
(48
)
 
(100
)
Intangible asset impairment charges, acquisition-related, restructuring- and restructuring-related and litigation-related net (charges) credits
63

 
(54
)
Amortization expense
(160
)
 
(141
)
Operating income (loss)
541

 
407

Other expense, net
(84
)
 
(84
)
Income (loss) before income taxes
$
457

 
$
323

 
 
 
 
 
 
 
 
 
Three Months Ended March 31,
 
2019
 
2018
 
 
 
 
Reportable segment operating income as a percentage of reportable segment net sales
MedSurg
33.4
%
 
36.4
%
Rhythm and Neuro
20.5
%
 
20.8
%
Cardiovascular
28.3
%
 
31.1
%


29


NOTE L – REVENUE

We generate revenue primarily from the sale of single-use medical devices and present revenue net of sales taxes in our unaudited condensed consolidated statements of operations. The following tables disaggregate our revenue from contracts with customers by business and geographic region (in millions):
 
Three Months Ended March 31,
Businesses
2019
 
2018
Endoscopy
 
 
 
U.S.
$
253

 
$
231

International
187

 
187

Worldwide
440

 
418

 
 
 
 
Urology and Pelvic Health
 
 
 
U.S.
231

 
197

International
94

 
96

Worldwide
326

 
293

 
 
 
 
Cardiac Rhythm Management
 
 
 
U.S.
288

 
290

International
203

 
203

Worldwide
491

 
493

 
 
 
 
Electrophysiology
 
 
 
U.S.
36

 
35

International
43

 
39

Worldwide
79

 
75

 
 
 
 
Neuromodulation
 
 
 
U.S.
144

 
131

International
42

 
38

Worldwide
186

 
169

 
 
 
 
Interventional Cardiology
 
 
 
U.S.
296

 
281

International
365

 
364

Worldwide
661

 
645

 
 
 
 
Peripheral Interventions
 
 
 
U.S.
156

 
145

International
155

 
142

Worldwide
311

 
288

 
 
 
 
Total Company
 
 
 
U.S.
1,403

 
1,310

International
1,090

 
1,069

Net Sales
$
2,493

 
$
2,379



30


 
Three Months Ended March 31,
Geographic Regions
2019
 
2018
U.S.
$
1,403

 
$
1,310

EMEA (Europe, Middle East and Africa)
561

 
563

APAC (Asia-Pacific)
437

 
415

Latin America and Canada
92

 
91

 
$
2,493

 
$
2,379

 
 
 
 
Emerging Markets
$
297

 
$
262

We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Refer to Note A – Basis of Presentation for additional information.

Deferred Revenue

Contract liabilities are classified within Other current liabilities and Other long-term liabilities on our accompanying unaudited condensed consolidated balance sheets. Our deferred revenue balance was $369 million as of March 31, 2019 and $373 million as of December 31, 2018. Our contractual liabilities are primarily composed of deferred revenue related to the LATITUDE™ Patient Management System. Revenue is recognized over the average service period which is based on device and patient longevity. We recognized revenue of $36 million in the first quarter of 2019 that was included in the above December 31, 2018 contract liability balance. We have elected not to disclose the transaction price allocated to unsatisfied performance obligations when the original expected contract duration is one year or less. In addition, we have not identified material unfulfilled performance obligations for which revenue is not currently deferred.

Variable Consideration

We generally allow our customers to return defective, damaged and, in certain cases, expired products for credit and record the amount for estimated sales returns as a reduction to revenue when we sell the initial product. In addition, we may allow customers to return previously purchased products for next-generation product offerings. For these transactions, we defer recognition of revenue on the sale of the earlier generation product based upon an estimate of the amount of product to be returned when the next-generation products are shipped to the customer.

We also offer sales rebates and discounts to certain customers. We treat sales rebates and discounts as a reduction of revenue and classify the corresponding liability as current. If we are unable to reasonably estimate the expected rebates, we record a liability for the maximum rebate percentage offered. We have entered certain agreements with group purchasing organizations to sell our products to participating hospitals at negotiated prices. We recognize revenue from these agreements following the same revenue recognition criteria discussed above.

NOTE M – CHANGES IN OTHER COMPREHENSIVE INCOME

The following tables provide the reclassifications out of Other comprehensive income (loss), net of tax:
(in millions)
Foreign Currency Translation Adjustments
 
Net Change in Derivative Financial Instruments
 
Net Change in Available-for-Sale Securities
 
Net Change in Defined Benefit Pensions and Other Items
 
Total
Balance as of December 31, 2018
$
(53
)
 
$
111

 
$

 
$
(25
)
 
$
33

Other comprehensive income (loss) before reclassifications
14

 
56

 

 
(1
)
 
69

(Income) loss amounts reclassified from accumulated other comprehensive income
(8
)
 
(7
)
 

 

 
(15
)
Total other comprehensive income (loss)
6

 
49

 

 
(1
)
 
54

Balance as of March 31, 2019
$
(46
)
 
$
160

 
$

 
$
(26
)
 
$
87



31


(in millions)
Foreign Currency Translation Adjustments
 
Net Change in Derivative Financial Instruments
 
Net Change in Available-for-Sale Securities
 
Net Change in Defined Benefit Pensions and Other Items
 
Total
Balance as of December 31, 2017
$
(32
)
 
$
1

 
$
(1
)
 
$
(27
)
 
$
(59
)
Other comprehensive income (loss) before reclassifications
10

 
(91
)
 

 

 
(81
)
(Income) loss amounts reclassified from accumulated other comprehensive income