UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED SEPTEMBERJUNE 30, 20172019

Commission File Number 001-16407

 

ZIMMER BIOMET HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

13-4151777

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

 

345 East Main Street, Warsaw, IN  46580

(Address of principal executive offices)

Telephone:  (574) 267-6131

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.01 par value

ZBH

New York Stock Exchange

1.414% Notes due 2022

ZBH 22A

New York Stock Exchange

2.425% Notes due 2026

ZBH 26

New York Stock Exchange

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.YesNo

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).     Yes      No  

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

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

Non-accelerated filer

  (Do not check if a smaller reporting company)

Smaller reporting company

 

 

 

 

Emerging growth company

 

 

 

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

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

As of October 27, 2017, 202,473,076August 1, 2019, 205,314,527 shares of the registrant’s $.01 par value common stock were outstanding.


ZIMMER BIOMET HOLDINGS, INC.

INDEX TO FORM 10-Q

SeptemberJune 30, 20172019

 

 

 

 

 

Page

 

 

 

Part I - Financial Information

Item 1.

Financial Statements (unaudited)

3

Condensed Consolidated Statements of Earnings for the Three and Six Months Ended June 30, 2019 and 2018

3

Condensed Consolidated Statements of Comprehensive Income for the Three and Six Months Ended June 30, 2019 and 2018

4

Condensed Consolidated Balance Sheets as of June 30, 2019 and December 31, 2018

5

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2019 and 2018

6

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2019 and 2018

7

Notes to Interim Condensed Consolidated Financial Statements

8

Item 2.

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

29

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

40

Item 4.

Controls and Procedures

40

Part II - Other Information

 

 

 

 

 

 

 

Item 1.

 

Financial Statements (unaudited)Legal Proceedings

 

342

 

 

Condensed Consolidated Statements of Earnings for the Three and Nine Month Periods Ended September 30, 2017 and 2016

3

 

 

Condensed Consolidated Statements of Comprehensive Income for the Three and Nine Month Periods Ended September 30, 2017 and 2016

4

Item 1A.

 

Condensed Consolidated Balance Sheets as of September 30, 2017 and December 31, 2016Risk Factors

 

5

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2017 and 2016

6

Notes to Interim Condensed Consolidated Financial Statements

742

 

 

 

 

 

Item 2.

 

Management’s DiscussionUnregistered Sales of Equity Securities and AnalysisUse of Financial Condition and Results of OperationsProceeds

 

2842

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market RiskDefaults Upon Senior Securities

 

3842

 

 

 

 

 

Item 4.

 

Controls and ProceduresMine Safety Disclosures

 

38

Part II - Other Information

Item 1.

Legal Proceedings

40

Item 1A.

Risk Factors

40

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

40

Item 3.

Defaults Upon Senior Securities

40

Item 4.

Mine Safety Disclosures

4043

 

 

 

 

 

Item 5.

 

Other Information

 

4043

 

 

 

 

 

Item 6.

 

Exhibits

 

4144

 

 

 

Signatures

 

4245

 

2


Part I – FinancialFinancial Information

Item 1.  Financial  Statements

ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS

(in millions, except per share amounts, unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

September 30,

 

 

September 30,

 

 

June 30,

 

 

June 30,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net Sales

 

$

1,818.1

 

 

$

1,832.8

 

 

$

5,749.8

 

 

$

5,670.8

 

 

$

1,988.6

 

 

$

2,007.6

 

 

$

3,964.1

 

 

$

4,025.2

 

Cost of products sold, excluding intangible asset amortization

 

 

500.9

 

 

 

479.3

 

 

 

1,541.5

 

 

 

1,760.0

 

 

 

581.3

 

 

 

583.7

 

 

 

1,134.7

 

 

 

1,159.5

 

Intangible asset amortization

 

 

152.7

 

 

 

164.3

 

 

 

452.4

 

 

 

424.7

 

 

 

146.9

 

 

 

149.5

 

 

 

290.3

 

 

 

300.3

 

Research and development

 

 

91.2

 

 

 

95.6

 

 

 

272.4

 

 

 

269.9

 

 

 

112.1

 

 

 

99.1

 

 

 

213.8

 

 

 

194.8

 

Selling, general and administrative

 

 

694.5

 

 

 

727.7

 

 

 

2,203.3

 

 

 

2,176.6

 

 

 

840.3

 

 

 

791.3

 

 

 

1,636.7

 

 

 

1,593.0

 

Special items (Note 2)

 

 

165.4

 

 

 

170.4

 

 

 

434.1

 

 

 

397.0

 

Intangible asset impairment

 

 

70.1

 

 

 

-

 

 

 

70.1

 

 

 

-

 

Acquisition, integration and related

 

 

10.5

 

 

 

50.5

 

 

 

21.2

 

 

 

96.5

 

Quality remediation

 

 

22.7

 

 

 

37.5

 

 

 

42.4

 

 

 

80.1

 

Operating expenses

 

 

1,604.7

 

 

 

1,637.3

 

 

 

4,903.7

 

 

 

5,028.2

 

 

 

1,783.9

 

 

 

1,711.6

 

 

 

3,409.2

 

 

 

3,424.2

 

Operating Profit

 

 

213.4

 

 

 

195.5

 

 

 

846.1

 

 

 

642.6

 

 

 

204.7

 

 

 

296.0

 

 

 

554.9

 

 

 

601.0

 

Other expense, net

 

 

(4.5

)

 

 

(1.1

)

 

 

(11.2

)

 

 

(8.7

)

 

 

(4.7

)

 

 

(2.9

)

 

 

(5.2

)

 

 

(6.5

)

Interest income

 

 

0.6

 

 

 

0.6

 

 

 

1.4

 

 

 

2.7

 

Interest expense

 

 

(82.3

)

 

 

(91.5

)

 

 

(247.5

)

 

 

(267.8

)

Interest expense, net

 

 

(59.7

)

 

 

(75.3

)

 

 

(117.7

)

 

 

(153.3

)

Earnings before income taxes

 

 

127.2

 

 

 

103.5

 

 

 

588.8

 

 

 

368.8

 

 

 

140.3

 

 

 

217.8

 

 

 

432.0

 

 

 

441.2

 

Provision (benefit) for income taxes

 

 

28.4

 

 

 

(54.4

)

 

 

6.6

 

 

 

133.9

 

Provision for income taxes

 

 

8.4

 

 

 

32.9

 

 

 

53.9

 

 

 

80.1

 

Net Earnings

 

 

98.8

 

 

 

157.9

 

 

 

582.2

 

 

 

234.9

 

 

 

131.9

 

 

 

184.9

 

 

 

378.1

 

 

 

361.1

 

Less: Net loss attributable to noncontrolling interest

 

 

-

 

 

 

(0.9

)

 

 

(0.2

)

 

 

(1.4

)

Less: Net (loss) earnings attributable to noncontrolling interest

 

 

(1.8

)

 

 

(0.1

)

 

 

(1.7

)

 

 

1.4

 

Net Earnings of Zimmer Biomet Holdings, Inc.

 

$

98.8

 

 

$

158.8

 

 

$

582.4

 

 

$

236.3

 

 

$

133.7

 

 

$

185.0

 

 

$

379.8

 

 

$

359.7

 

Earnings Per Common Share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.49

 

 

$

0.79

 

 

$

2.89

 

 

$

1.18

 

 

$

0.65

 

 

$

0.91

 

 

$

1.86

 

 

$

1.77

 

Diluted

 

$

0.48

 

 

$

0.78

 

 

$

2.86

 

 

$

1.17

 

 

$

0.65

 

 

$

0.90

 

 

$

1.84

 

 

$

1.76

 

Weighted Average Common Shares Outstanding

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

202.3

 

 

 

200.1

 

 

 

201.7

 

 

 

199.9

 

 

 

204.8

 

 

 

203.3

 

 

 

204.6

 

 

 

203.2

 

Diluted

 

 

204.0

 

 

 

202.9

 

 

 

203.6

 

 

 

202.3

 

 

 

206.2

 

 

 

204.6

 

 

 

206.0

 

 

 

204.6

 

Cash Dividends Declared Per Common Share

 

$

0.24

 

 

$

0.24

 

 

$

0.72

 

 

$

0.72

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3


ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(in millions, unaudited)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Net Earnings

 

$

98.8

 

 

$

157.9

 

 

$

582.2

 

 

$

234.9

 

Other Comprehensive Income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency cumulative translation adjustments, net of tax

 

 

129.7

 

 

 

58.3

 

 

 

367.9

 

 

 

113.9

 

Unrealized cash flow hedge losses, net of tax

 

 

(28.3

)

 

 

(9.7

)

 

 

(79.4

)

 

 

(53.0

)

Reclassification adjustments on hedges, net of tax

 

 

4.1

 

 

 

(13.9

)

 

 

(9.4

)

 

 

(58.0

)

Unrealized gains on securities, net of tax

 

 

-

 

 

 

-

 

 

 

-

 

 

 

0.4

 

Adjustments to prior service cost and unrecognized actuarial

   assumptions, net of tax

 

 

(1.0

)

 

 

1.2

 

 

 

(5.0

)

 

 

22.3

 

Total Other Comprehensive Income

 

 

104.5

 

 

 

35.9

 

 

 

274.1

 

 

 

25.6

 

Comprehensive Income

 

 

203.3

 

 

 

193.8

 

 

 

856.3

 

 

 

260.5

 

Comprehensive loss attributable to the noncontrolling interest

 

 

(0.2

)

 

 

(0.2

)

 

 

(0.6

)

 

 

(0.8

)

Comprehensive Income attributable to

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zimmer Biomet Holdings, Inc.

 

$

203.5

 

 

$

194.0

 

 

$

856.9

 

 

$

261.3

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net Earnings

 

$

131.9

 

 

$

184.9

 

 

$

378.1

 

 

$

361.1

 

Other Comprehensive Income (Loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency cumulative translation adjustments, net of tax

 

 

15.1

 

 

 

(177.8

)

 

 

10.7

 

 

 

(83.0

)

Unrealized cash flow hedge gains, net of tax

 

 

0.4

 

 

 

51.6

 

 

 

14.9

 

 

 

25.2

 

Reclassification adjustments on hedges, net of tax

 

 

(6.2

)

 

 

9.2

 

 

 

(14.4

)

 

 

18.9

 

Adjustments to prior service cost and unrecognized actuarial assumptions, net of tax

 

 

2.4

 

 

 

5.3

 

 

 

4.4

 

 

 

2.0

 

Total Other Comprehensive Income (Loss)

 

 

11.7

 

 

 

(111.7

)

 

 

15.6

 

 

 

(36.9

)

Comprehensive Income

 

 

143.6

 

 

 

73.2

 

 

 

393.7

 

 

 

324.2

 

Comprehensive (loss) income attributable to the noncontrolling interest

 

 

(1.8

)

 

 

-

 

 

 

(1.7

)

 

 

1.4

 

Comprehensive Income Attributable to

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zimmer Biomet Holdings, Inc.

 

$

145.4

 

 

$

73.2

 

 

$

395.4

 

 

$

322.8

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in millions, except share amounts, unaudited)

 

 

September 30,

 

 

December 31,

 

 

June 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

480.8

 

 

$

634.1

 

 

$

403.1

 

 

$

542.8

 

Accounts receivable, less allowance for doubtful accounts

 

 

1,318.5

 

 

 

1,604.4

 

 

 

1,247.1

 

 

 

1,275.8

 

Inventories

 

 

2,084.2

 

 

 

1,959.4

 

 

 

2,344.5

 

 

 

2,256.5

 

Prepaid taxes

 

 

229.6

 

 

 

214.7

 

Other prepaid expenses and current assets

 

 

320.2

 

 

 

251.0

 

Prepaid expenses and other current assets

 

 

396.5

 

 

 

352.3

 

Total Current Assets

 

 

4,433.3

 

 

 

4,663.6

 

 

 

4,391.2

 

 

 

4,427.4

 

Property, plant and equipment, net

 

 

2,048.6

 

 

 

2,037.9

 

 

 

2,035.8

 

 

 

2,015.4

 

Goodwill

 

 

10,904.9

 

 

 

10,643.9

 

 

 

9,593.7

 

 

 

9,594.4

 

Intangible assets, net

 

 

8,464.9

 

 

 

8,785.4

 

 

 

7,524.2

 

 

 

7,684.6

 

Other assets

 

 

565.8

 

 

 

553.6

 

 

 

660.8

 

 

 

405.0

 

Total Assets

 

$

26,417.5

 

 

$

26,684.4

 

 

$

24,205.7

 

 

$

24,126.8

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

327.1

 

 

$

364.5

 

 

$

347.5

 

 

$

362.6

 

Income taxes payable

 

 

289.6

 

 

 

183.5

 

 

 

144.7

 

 

 

142.4

 

Other current liabilities

 

 

1,185.6

 

 

 

1,391.3

 

Current portion of long-term debt

 

 

1,225.0

 

 

 

575.6

 

 

 

2,000.0

 

 

 

525.0

 

Other current liabilities

 

 

1,168.5

 

 

 

1,257.9

 

Total Current Liabilities

 

 

3,010.2

 

 

 

2,381.5

 

 

 

3,677.8

 

 

 

2,421.3

 

Deferred income taxes

 

 

2,879.8

 

 

 

3,030.9

 

Deferred income taxes, net

 

 

949.9

 

 

 

999.5

 

Long-term income tax payable

 

 

677.9

 

 

 

666.2

 

Other long-term liabilities

 

 

877.6

 

 

 

936.3

 

 

 

518.6

 

 

 

350.0

 

Long-term debt

 

 

9,199.7

 

 

 

10,665.8

 

 

 

6,719.3

 

 

 

8,413.7

 

Total Liabilities

 

 

15,967.3

 

 

 

17,014.5

 

 

 

12,543.5

 

 

 

12,850.7

 

Commitments and Contingencies (Note 15)

 

 

 

 

 

 

 

 

Commitments and Contingencies (Note 17)

 

 

 

 

 

 

 

 

Stockholders' Equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zimmer Biomet Holdings, Inc. Stockholders' Equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock, $0.01 par value, one billion shares authorized, 306.3 million

shares issued in 2017 (304.7 million in 2016)

 

 

3.0

 

 

 

3.1

 

Common stock, $0.01 par value, one billion shares authorized, 308.8 million shares in 2019 (307.9 million in 2018) issued

 

 

3.1

 

 

 

3.1

 

Paid-in capital

 

 

8,493.9

 

 

 

8,368.5

 

 

 

8,776.5

 

 

 

8,686.1

 

Retained earnings

 

 

8,837.2

 

 

 

8,467.1

 

 

 

9,772.7

 

 

 

9,491.2

 

Accumulated other comprehensive loss

 

 

(159.9

)

 

 

(434.0

)

 

 

(171.8

)

 

 

(187.4

)

Treasury stock, 103.9 million shares in 2017 (104.1 million shares in 2016)

 

 

(6,724.4

)

 

 

(6,735.8

)

Treasury stock, 103.9 million shares in 2019 (103.9 million shares in 2018)

 

 

(6,721.4

)

 

 

(6,721.7

)

Total Zimmer Biomet Holdings, Inc. stockholders' equity

 

 

10,449.8

 

 

 

9,668.9

 

 

 

11,659.1

 

 

 

11,271.3

 

Noncontrolling interest

 

 

0.4

 

 

 

1.0

 

 

 

3.1

 

 

 

4.8

 

Total Stockholders' Equity

 

 

10,450.2

 

 

 

9,669.9

 

 

 

11,662.2

 

 

 

11,276.1

 

Total Liabilities and Stockholders' Equity

 

$

26,417.5

 

 

$

26,684.4

 

 

$

24,205.7

 

 

$

24,126.8

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 


5


ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSSTOCKHOLDERS’ EQUITY

(in millions, except per share amounts, unaudited)

 

 

 

For the Nine Months Ended

 

 

 

September 30,

 

 

 

2017

 

 

2016

 

Cash flows provided by (used in) operating activities:

 

 

 

 

 

 

 

 

Net earnings

 

$

582.2

 

 

$

234.9

 

Adjustments to reconcile net earnings to cash provided

   by operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

798.2

 

 

 

787.3

 

Share-based compensation

 

 

40.1

 

 

 

45.9

 

Goodwill and intangible asset impairment

 

 

59.5

 

 

 

28.0

 

Inventory step-up

 

 

32.2

 

 

 

300.9

 

Changes in operating assets and liabilities, net of effect of acquisitions:

 

 

 

 

 

 

 

 

Income taxes

 

 

(245.4

)

 

 

(125.4

)

Receivables

 

 

349.7

 

 

 

(80.3

)

Inventories

 

 

(123.2

)

 

 

44.2

 

Accounts payable and accrued expenses

 

 

(173.6

)

 

 

(76.0

)

Other assets and liabilities

 

 

(140.3

)

 

 

(154.5

)

Net cash provided by operating activities

 

 

1,179.4

 

 

 

1,005.0

 

Cash flows provided by (used in) investing activities:

 

 

 

 

 

 

 

 

Additions to instruments

 

 

(255.7

)

 

 

(251.3

)

Additions to other property, plant and equipment

 

 

(109.8

)

 

 

(130.1

)

Purchases of investments

 

 

-

 

 

 

(1.4

)

Sales of investments

 

 

-

 

 

 

273.3

 

LDR acquisition, net of acquired cash

 

 

-

 

 

 

(1,021.1

)

Other business combination investments, net of acquired cash

 

 

(4.0

)

 

 

(421.9

)

Other investing activities

 

 

(13.1

)

 

 

7.8

 

Net cash used in investing activities

 

 

(382.6

)

 

 

(1,544.7

)

Cash flows provided by (used in) financing activities:

 

 

 

 

 

 

 

 

Proceeds from multicurrency revolving facility

 

 

400.0

 

 

 

-

 

Payments on multicurrency revolving facility

 

 

(400.0

)

 

 

-

 

Redemption of senior notes

 

 

(500.0

)

 

 

-

 

Proceeds from term loan

 

 

192.7

 

 

 

750.0

 

Payments on term loan

 

 

(640.0

)

 

 

(700.0

)

Net payments on other debt

 

 

(0.9

)

 

 

(33.1

)

Dividends paid to stockholders

 

 

(145.0

)

 

 

(140.3

)

Proceeds from employee stock compensation plans

 

 

132.6

 

 

 

113.5

 

Business combination contingent consideration payments

 

 

(9.1

)

 

 

-

 

Restricted stock withholdings

 

 

(7.6

)

 

 

(5.3

)

Debt issuance costs

 

 

(0.3

)

 

 

(3.4

)

Repurchase of common stock

 

 

-

 

 

 

(415.5

)

Net cash used in financing activities

 

 

(977.6

)

 

 

(434.1

)

Effect of exchange rates on cash and cash equivalents

 

 

27.5

 

 

 

(10.2

)

Decrease in cash and cash equivalents

 

 

(153.3

)

 

 

(984.0

)

Cash and cash equivalents, beginning of year

 

 

634.1

 

 

 

1,459.3

 

Cash and cash equivalents, end of period

 

$

480.8

 

 

$

475.3

 

 

 

Zimmer Biomet Holdings, Inc. Stockholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

Common Shares

 

 

Paid-in

 

 

Retained

 

 

Comprehensive

 

 

Treasury Shares

 

 

Noncontrolling

 

 

Stockholders'

 

 

 

Number

 

 

Amount

 

 

Capital

 

 

Earnings

 

 

(Loss) Income

 

 

Number

 

 

Amount

 

 

Interest

 

 

Equity

 

Balance April 1, 2019

 

 

308.7

 

 

$

3.1

 

 

$

8,748.1

 

 

$

9,688.1

 

 

$

(183.5

)

 

 

(103.9

)

 

$

(6,721.4

)

 

$

4.9

 

 

$

11,539.3

 

Net earnings

 

 

-

 

 

 

-

 

 

 

-

 

 

 

133.7

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1.8

)

 

 

131.9

 

Other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

11.7

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

11.7

 

Cash dividends declared

($0.24 per share)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(49.1

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(49.1

)

Stock compensation plans

 

 

0.1

 

 

 

-

 

 

 

28.4

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

28.4

 

Balance June 30, 2019

 

 

308.8

 

 

$

3.1

 

 

$

8,776.5

 

 

$

9,772.7

 

 

$

(171.8

)

 

 

(103.9

)

 

$

(6,721.4

)

 

$

3.1

 

 

$

11,662.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance April 1, 2018

 

 

307.1

 

 

$

3.1

 

 

$

8,576.6

 

 

$

10,191.7

 

 

$

(51.3

)

 

 

(103.8

)

 

$

(6,721.7

)

 

$

1.1

 

 

$

11,999.5

 

Net earnings

 

 

-

 

 

 

-

 

 

 

-

 

 

 

185.0

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(0.1

)

 

 

184.9

 

Other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(111.7

)

 

 

-

 

 

 

-

 

 

 

0.1

 

 

 

(111.6

)

Cash dividends declared

($0.24 per share)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(48.8

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(48.8

)

Stock compensation plans

 

 

0.1

 

 

 

-

 

 

 

20.2

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

20.2

 

Balance June 30, 2018

 

 

307.2

 

 

$

3.1

 

 

$

8,596.8

 

 

$

10,327.9

 

 

$

(163.0

)

 

 

(103.8

)

 

$

(6,721.7

)

 

$

1.1

 

 

$

12,044.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance January 1, 2019

 

 

307.9

 

 

$

3.1

 

 

$

8,686.1

 

 

$

9,491.2

 

 

$

(187.4

)

 

 

(103.9

)

 

$

(6,721.7

)

 

$

4.8

 

 

$

11,276.1

 

Net earnings

 

 

-

 

 

 

-

 

 

 

-

 

 

 

379.8

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1.7

)

 

 

378.1

 

Other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

15.6

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

15.6

 

Cash dividends declared

($0.48 per share)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(98.3

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(98.3

)

Stock compensation plans

 

 

0.9

 

 

 

-

 

 

 

90.4

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

0.3

 

 

 

-

 

 

 

90.7

 

Balance June 30, 2019

 

 

308.8

 

 

$

3.1

 

 

$

8,776.5

 

 

$

9,772.7

 

 

$

(171.8

)

 

 

(103.9

)

 

$

(6,721.4

)

 

$

3.1

 

 

$

11,662.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance January 1, 2018

 

 

306.5

 

 

$

3.1

 

 

$

8,514.9

 

 

$

10,022.8

 

 

$

(83.2

)

 

 

(103.9

)

 

$

(6,721.8

)

 

$

(0.3

)

 

$

11,735.5

 

Net earnings

 

 

-

 

 

 

-

 

 

 

-

 

 

 

359.7

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1.4

 

 

 

361.1

 

Other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(36.9

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(36.9

)

Cash dividends declared

($0.48 per share)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(97.5

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(97.5

)

Adoption of ASU 2018-02

 

 

-

 

 

 

-

 

 

 

-

 

 

 

42.9

 

 

 

(42.9

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock compensation plans

 

 

0.7

 

 

 

-

 

 

 

81.9

 

 

 

-

 

 

 

-

 

 

 

0.1

 

 

 

0.1

 

 

 

-

 

 

 

82.0

 

Balance June 30, 2018

 

 

307.2

 

 

$

3.1

 

 

$

8,596.8

 

 

$

10,327.9

 

 

$

(163.0

)

 

 

(103.8

)

 

$

(6,721.7

)

 

$

1.1

 

 

$

12,044.2

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

6


ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in millions, unaudited)

 

 

 

 

 

For the Six Months Ended June 30,

 

 

 

2019

 

 

2018

 

Cash flows provided by (used in) operating activities:

 

 

 

 

 

 

 

 

Net earnings

 

$

378.1

 

 

$

361.1

 

Adjustments to reconcile net earnings to cash provided

   by operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

500.7

 

 

 

525.1

 

Share-based compensation

 

 

40.0

 

 

 

26.0

 

Intangible asset impairment

 

 

70.1

 

 

 

-

 

Changes in operating assets and liabilities, net of acquired assets and liabilities

 

 

 

 

 

 

 

 

Income taxes

 

 

(44.2

)

 

 

(42.4

)

Receivables

 

 

29.3

 

 

 

177.7

 

Inventories

 

 

(83.0

)

 

 

(99.3

)

Accounts payable and accrued liabilities

 

 

(269.8

)

 

 

(27.1

)

Other assets and liabilities

 

 

(36.6

)

 

 

(37.3

)

Net cash provided by operating activities

 

 

584.6

 

 

 

883.8

 

Cash flows provided by (used in) investing activities:

 

 

 

 

 

 

 

 

Additions to instruments

 

 

(144.8

)

 

 

(126.1

)

Additions to other property, plant and equipment

 

 

(96.7

)

 

 

(53.7

)

Net investment hedge settlements

 

 

21.3

 

 

 

-

 

Acquisition of intellectual property rights

 

 

(197.6

)

 

 

-

 

Investments in other assets

 

 

(9.9

)

 

 

(15.5

)

Net cash used in investing activities

 

 

(427.7

)

 

 

(195.3

)

Cash flows provided by (used in) financing activities:

 

 

 

 

 

 

 

 

Proceeds from senior notes

 

 

-

 

 

 

749.5

 

Redemption of senior notes

 

 

-

 

 

 

(1,150.0

)

Proceeds from multicurrency revolving facility

 

 

-

 

 

 

400.0

 

Payments on multicurrency revolving facility

 

 

-

 

 

 

(375.0

)

Proceeds from term loans

 

 

200.0

 

 

 

-

 

Payments on term loans

 

 

(425.0

)

 

 

(225.0

)

Net payments on other debt

 

 

-

 

 

 

(0.2

)

Dividends paid to stockholders

 

 

(98.1

)

 

 

(97.4

)

Proceeds from employee stock compensation plans

 

 

54.8

 

 

 

56.4

 

Net cash flows from unremitted collections from factoring programs

 

 

(25.6

)

 

 

(62.9

)

Business combination contingent consideration payments

 

 

-

 

 

 

(16.7

)

Other financing activities

 

 

(4.9

)

 

 

(7.7

)

Net cash used in financing activities

 

 

(298.8

)

 

 

(729.0

)

Effect of exchange rates on cash and cash equivalents

 

 

2.2

 

 

 

(2.7

)

Decrease in cash and cash equivalents

 

 

(139.7

)

 

 

(43.2

)

Cash and cash equivalents, beginning of year

 

 

542.8

 

 

 

524.4

 

Cash and cash equivalents, end of period

 

$

403.1

 

 

$

481.2

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

7


ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1.  Basis of Presentation

The financial data presented herein is unaudited and should be read in conjunction with the consolidated financial statements and accompanying notes included in the 2016our Annual Report on Form 10-K filed by Zimmer Biomet Holdings, Inc.for the year ended December 31, 2018.

In our opinion, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of the financial position, results of operations and cash flows for the interim periods presented.  The December 31, 20162018 condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”).  Results for interim periods should not be considered indicative of results for the full year.

The words “we,” “us,” “our” and similar words and “Zimmer Biomet” refer to Zimmer Biomet Holdings, Inc. and its subsidiaries.  “Zimmer Biomet Holdings” refers to the parent company only.

2.  Significant Accounting Policies  

Special Items - We recognize expenses resulting directly from our business combinations, employee termination benefits, certain research and development (“R&D”) agreements, certain contract terminations, goodwill and intangible asset impairment, consulting and professional fees and asset impairment or loss on disposal charges connected with global restructuring, quality enhancement and remediation efforts, operational excellence initiatives, and other items as “Special items” in our condensed consolidated statement of earnings. “Special items” included (in millions):Accounting Pronouncements Recently Adopted

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Biomet merger-related

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consulting and professional fees

 

$

19.9

 

 

$

59.0

 

 

$

60.7

 

 

$

138.4

 

Employee termination benefits

 

 

5.4

 

 

 

7.1

 

 

 

12.0

 

 

 

14.3

 

Dedicated project personnel

 

 

10.2

 

 

 

21.9

 

 

 

33.1

 

 

 

64.8

 

Relocated facilities

 

 

1.8

 

 

 

9.5

 

 

 

6.1

 

 

 

17.5

 

Certain litigation matters

 

 

5.0

 

 

 

-

 

 

 

5.0

 

 

 

-

 

Contract terminations

 

 

-

 

 

 

3.5

 

 

 

-

 

 

 

28.8

 

Information technology integration

 

 

1.3

 

 

 

4.8

 

 

 

4.9

 

 

 

9.3

 

Goodwill and intangible asset impairment

 

 

32.7

 

 

 

-

 

 

 

59.5

 

 

 

28.0

 

Other

 

 

4.8

 

 

 

8.0

 

 

 

25.0

 

 

 

12.4

 

Total Biomet merger-related

 

 

81.1

 

 

 

113.8

 

 

 

206.3

 

 

 

313.5

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consulting and professional fees

 

 

56.3

 

 

 

14.6

 

 

 

158.4

 

 

 

30.3

 

Employee termination benefits

 

 

(0.6

)

 

 

3.2

 

 

 

2.0

 

 

 

3.2

 

Dedicated project personnel

 

 

14.0

 

 

 

8.2

 

 

 

35.5

 

 

 

11.5

 

Impairment/loss on disposal of assets

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1.1

 

LDR merger consideration compensation expense

 

 

-

 

 

 

24.1

 

 

 

-

 

 

 

24.1

 

Relocated facilities

 

 

0.6

 

 

 

-

 

 

 

3.1

 

 

 

0.2

 

Certain litigation matters

 

 

3.0

 

 

 

3.7

 

 

 

10.0

 

 

 

3.7

 

Contract terminations

 

 

-

 

 

 

0.1

 

 

 

-

 

 

 

1.1

 

Information technology integration

 

 

1.0

 

 

 

0.8

 

 

 

1.8

 

 

 

1.1

 

Certain R&D agreements

 

 

-

 

 

 

-

 

 

 

2.5

 

 

 

-

 

Contingent consideration adjustments

 

 

1.7

 

 

 

-

 

 

 

(1.5

)

 

 

-

 

Other

 

 

8.3

 

 

 

1.9

 

 

 

16.0

 

 

 

7.2

 

Total Other

 

 

84.3

 

 

 

56.6

 

 

 

227.8

 

 

 

83.5

 

Special items

 

$

165.4

 

 

$

170.4

 

 

$

434.1

 

 

$

397.0

 

7


Consulting and professional fees include expenditures related to third-party integration consulting performed in a variety of areas such as tax, compliance, logistics and human resources for our business combinations including our merger with Biomet, Inc. (“Biomet”); legal fees related to the consummation of mergers and acquisitions and certain litigation and compliance matters; other consulting and professional fees and contract labor related to our quality enhancement and remediation efforts and operational excellence initiatives; third-party fees related to severance and termination benefits matters; costs of complying with our deferred prosecution agreement; and consulting fees related to certain information system integrations.  

Dedicated project personnel expenses include the salary, benefits, travel expenses and other costs directly associated with employees who are 100 percent dedicated to our integration of acquired businesses, employees who have been notified of termination, but are continuing to work on transferring their responsibilities and employees working on our quality enhancement and remediation efforts and operational excellence initiatives.  

As part of the Biomet merger (defined below), we recognized $209.0 million of intangible assets for in-process research and development (“IPR&D”) projects.  We recorded impairment losses related to IPR&D intangible assets of $18.8 million and $28.0 million during the nine month periods ended September 30, 2017 and 2016, respectively.  The impairments were primarily due to the termination of certain IPR&D projects.  We also recognized $479.0 million of intangible assets for trademarks that we designated as having an indefinite life.  In the nine month period ended September 30, 2017, we reclassified one of these trademarks to a finite life asset which resulted in an impairment of $8.0 million.

During the three and nine month periods ended September 30, 2017, we recognized a $32.7 million goodwill impairment charge on our Office Based Technologies reporting unit.  See Note 9 for additional details.

A further detailed description of expenses included in “Special items” can be found in Note 2 to our Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2016.

On June 24, 2015, pursuant to an agreement and plan of merger dated April 24, 2014, we acquired LVB Acquisition, Inc. (“LVB”), the parent company of Biomet, and LVB and Biomet became our wholly-owned subsidiaries (sometimes hereinafter referred to as the “Biomet merger” or the “merger”).  After the closing date of the Biomet merger, we started to implement our integration plans to drive operational synergies.  Part of these integration plans included termination of employees and certain contracts with independent agents, distributors, suppliers and lessors.  Our integration plans are expected to last through mid-2018 and we expect to incur a total of $170 million for employee termination benefits and $140 million for contract termination expense in that time period.  As of September 30, 2017, we have incurred a cumulative total of $163.8 million for employee termination benefits and $134.9 million for contract termination expense.  The following table summarizes the liabilities related to these integration plans (in millions):

 

 

Employee

 

 

 

 

 

 

 

 

 

 

 

Termination

 

 

Contract

 

 

 

 

 

 

 

Benefits

 

 

Terminations

 

 

Total

 

Balance at December 31, 2016

 

$

38.1

 

 

$

35.1

 

 

$

73.2

 

Additions

 

 

12.0

 

 

 

-

 

 

 

12.0

 

Cash payments

 

 

(33.1

)

 

 

(9.4

)

 

 

(42.5

)

Foreign currency exchange rate changes

 

 

1.2

 

 

 

0.4

 

 

 

1.6

 

Balance at September 30, 2017

 

$

18.2

 

 

$

26.1

 

 

$

44.3

 

Recent Accounting Pronouncements – In January 2017,February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting StandardsStandard Update (“ASU”) 2017-04 – Simplifying the Test for Goodwill Impairment.  This ASU requires goodwill impairment to be measured as the amount by which a reporting unit's carrying value exceeds its fair value, not to exceed the carrying amount of goodwill.  Under previous guidance, if the carrying amount of a reporting unit’s net assets were greater than its fair value, impairment was measured as the excess of the carrying amount of the reporting unit’s goodwill over its implied fair value.  The determination of a reporting unit’s implied goodwill generally required significant estimates to fair value its net assets.  Therefore, this ASU simplifies goodwill impairment testing by eliminating the need to estimate the fair value of a reporting unit’s net assets.  The impact of this ASU is dependent on the specific facts and circumstances of future impairments and is applied prospectively on testing that occurs subsequent to adoption.  We elected to early adopt this ASU in the third quarter of 2017.  As a result, the new ASU was used to determine the goodwill impairment charge on our Office Based Technologies reporting unit that was recognized in the third quarter of 2017.  See Note 9 for additional details regarding this goodwill impairment charge.

8


In October 2016, the FASB issued ASU 2016-16 – Intra-Entity Asset Transfers of Assets Other than Inventory.  This ASU changes the accounting for the tax effects of intra-entity asset transfers/sales. Under current GAAP, the tax effects of intra-entity asset transfers/sales are deferred until the transferred asset is sold to a third party or otherwise recovered through use.  Under the new guidance, the tax expense from the sale of the asset in the seller’s tax jurisdiction is recognized when the transfer occurs, even though the pre-tax effects of that transaction are eliminated in consolidation.  Any deferred tax asset that arises in the buyer’s jurisdiction would also be recognized at the time of the transfer.  The new guidance does not apply to intra-entity transfers/sales of inventory.  We early adopted this standard effective January 1, 2017.  The modified retrospective approach is required for transition, which resulted in us recognizing a cumulative-effect adjustment in Retained earnings as of January 1, 2017 for intra-entity transfers/sales we had executed prior to that date.  The January 1, 2017 cumulative effect adjustment resulted in a $72.7 million decrease to Retained earnings, a $3.9 million decrease to Other prepaid expenses and current assets, a $22.4 million decrease in Other assets, a $2.0 million decrease to Income taxes payable, and a $48.4 million increase to Deferred income taxes.  The adoption of this ASU resulted in additional tax expense of $1.5 million and a tax benefit of $2.2 million to our provision for income taxes in the three and nine month periods ended September 30, 2017, respectively, compared to what it would have been under the previous accounting rules.

In May 2014, the FASB issued ASU 2014-09 – Revenue from Contracts with Customers.  This ASU provides a five-step model for revenue recognition that all industries will apply to recognize revenue when a customer obtains control of a good or service.  This ASU will be effective for us beginning January 1, 2018.  Entities are permitted to apply the standard and related amendments either retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying the ASU recognized at the date of initial application.

During the fourth quarter of 2016, we commenced an initial evaluation of the new standard and a related assessment and review of a representative sample of existing revenue contracts with our customers on some of our most significant revenue streams.  In 2017, we have expanded our scope to perform an analysis at locations with less significant revenue streams and have provided training on the new standard to finance personnel across all of our locations.  Our assessment of our revenue streams is substantially complete.  Based upon our assessment, we do not believe there will be a material change to the timing of our revenue recognition.  However, we will be required to reclassify certain immaterial costs from selling, general and administrative (“SG&A”) expense to net sales, which will result in a reduction of net sales, but have no impact on operating profit.  In the fourth quarter of 2017, we will focus on additional disclosures we may need to make and the effect of this ASU on our internal control over financial reporting or other changes in business practices and processes.  We plan to adopt this new standard using the retrospective method, which will result in us restating prior reporting periods presented.  As noted previously, we expect this will result in us reclassifying certain immaterial costs from SG&A expense to net sales in each of those prior reporting periods.  Our evaluation of ASU 2014-09 is ongoing and not complete.

In February 2016, the FASB issued ASU 2016-02 – Leases. Leases (Topic 842).  This ASU requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet. This ASU will bewas effective for us beginningas of January 1, 2019.  Early adoption is permitted. TheThis ASU must be adopted usingrequired a modified retrospective transition approachmethod that could either be applied at the beginning of the earliest comparative period in the consolidated financial statements.statements or the period of adoption.  We own mostelected to use the period of adoption (January 1, 2019) transition method and therefore did not recast prior periods.  This ASU allowed for certain practical expedients to make the adoption of the ASU less burdensome.  We elected the practical expedients upon transition which permitted us to not reassess lease identification, classification, and initial direct costs under the new standard for leases that commenced prior to the effective date.  We also elected not to recognize a right-of-use asset nor a lease liability for leases with an initial term of twelve months or less.  Finally, we elected not to separate non-lease components from the leased components in the valuation of our manufacturing facilities, butright-of-use asset and lease various office space throughout the world. We are formalizing our project team and in the fourth quarter of 2017 will begin evaluating our leases and the related impact this ASU will have on our consolidated financial statements.liability for all asset classes.

In March 2017, the FASB issued ASU 2017-07 – Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost.  This ASU requires us to report the service cost component of pensions in the same location as other compensation costs arising from services rendered by the pertinent employees during the period. We will be required to report the other components of net benefit costs in Other Income (Expense) in the statement of earnings.  This ASU will be effective for us beginning January 1, 2018.  The ASU must be applied retrospectively for the presentation of the service cost component and the other components of net periodic pension cost in the statement of earnings and prospectively, on and after the effective date, for the capitalization of the service cost component of net periodic pension cost in assets.  See Note 12 for further information on the components of our net benefit cost.

In August 2017, the FASB issued ASU 2017-12 – Targeted Improvements to Accounting for Hedging Activities.  This ASU amends the hedge accounting guidance to simplify the application of hedge accounting, makes more financial and nonfinancial hedging strategies eligible for hedge accounting treatment, changes how companies assess effectiveness and updates presentation and disclosure requirements.  We are currently evaluating the impact this ASU will have on our consolidated financial statements; however, based on our current hedging portfolio, we do not anticipate that this ASU will have a significant impact on our financial position, results of operations or cash flows.  This ASU will be effective for usOn January 1, 2019, with early adoption permitted.  After adoption, we may explore new hedging opportunities that are eligiblerecognized a right-of-use asset of $274.7 million in other assets and lease liabilities of $62.2 million and $221.2 million in other current liabilities and other long-term liabilities, respectively.  No cumulative adjustment to retained earnings was required upon adoption.  We do not have any significant finance leases.  See Note 7 for hedge accounting treatment under the new standard.  additional information.

There are no other recently issued accounting pronouncements that we have not yet adopted that are expected to have a material effect on our financial position, results of operations or cash flows.

9


3.  Business CombinationsRevenue Recognition

LDR Acquisition

On July 13, 2016, we completed our acquisition of LDR Holding Corporation (“LDR”).  We paid cash of $1,138.0 million.  The total amount of merger consideration utilized for the acquisition method of accounting,Net sales by geography are as reduced by the merger consideration paid to holders of unvested LDR stock options and LDR stock-based awards of $24.1 million, was $1,113.9 million.  The addition of LDR provided us with an immediate position in the growing cervical disc replacement (“CDR”) market.  The combination positioned us to accelerate the growth of our Spine business through the incremental revenues associated with entry into the CDR market and cross-portfolio selling opportunities to both Zimmer Biomet and LDR customer bases.  The goodwill was generated from the operational synergies and cross-selling opportunities we expected to achieve from our combined operations.  None of the goodwill is deductible for tax purposes.

The following table summarizes the final estimated fair value of the assets acquired and liabilities assumed in the LDR acquisitionfollows (in millions):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Final Values

 

Cash

$

92.8

 

Accounts receivable, net

 

30.5

 

Inventory

 

97.0

 

Other current assets

 

5.6

 

Property, plant and equipment

 

24.7

 

Intangible assets not subject to amortization:

 

 

 

In-process research and development (IPR&D)

 

2.0

 

Intangible assets subject to amortization:

 

 

 

Technology

 

447.0

 

Customer relationships

 

122.0

 

Trademarks and trade names

 

74.0

 

Other assets

 

73.8

 

Goodwill

 

507.2

 

Total assets acquired

 

1,476.6

 

Current liabilities

 

122.5

 

Long-term debt

 

0.5

 

Deferred taxes

 

236.7

 

Other long-term liabilities

 

3.0

 

Total liabilities assumed

 

362.7

 

Net assets acquired

$

1,113.9

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Americas

 

$

1,214.3

 

 

$

1,216.3

 

 

$

2,408.4

 

 

$

2,424.4

 

EMEA

 

 

438.0

 

 

 

457.7

 

 

 

901.9

 

 

 

954.2

 

Asia Pacific

 

 

336.3

 

 

 

333.6

 

 

 

653.8

 

 

 

646.6

 

Total

 

$

1,988.6

 

 

$

2,007.6

 

 

$

3,964.1

 

 

$

4,025.2

 

 

We have not included pro forma information and certain other information under GAAP for the LDR acquisition because it did not have a material impact on our financial position or results of operations.

Other acquisitions

During the year ended December 31, 2016, we completed individually immaterial acquisitions of companies including Cayenne Medical, Inc. (“Cayenne Medical”), a sports medicine company, Compression Therapy Concepts, Inc. (“CTC”), a provider of non-invasive products for the prevention of deep vein thrombosis, CD Diagnostics, Inc. (“CD Diagnostics”), a medical diagnostic testing company, and MedTech SA (“MedTech”), a designer and manufacturer of robotic equipment for brain and spine surgeries.  The total aggregate cash consideration was $441.7 million.  These acquisitions were completed primarily to expand ourNet sales by product offerings.  We have assigned a fair value of $58.0 million for settlement of preexisting relationships and additional payments related to these acquisitions thatcategory are contingent on the respective acquired companies’ product sales, commercial milestones and certain cost savings.  The fair value of the aggregate contingent payment liabilities was calculated based on the probability of achieving the specified sales growth, cost savings and commercial milestones and discounting to present value the payments.  The goodwill was generated from the operational synergies and cross-selling opportunities we expected to achieve from the technologies acquired.  None of the goodwill related to these acquisitions is deductible for tax purposes.

10


The following table summarizes the aggregate final estimated fair value of the assets acquired and liabilities assumed related to the Cayenne Medical, CTC, CD Diagnostics, MedTech, and other immaterial acquisitions that occurred during the year ended December 31, 2016 (in millions):

Current assets

 

$

66.4

 

Property, plant and equipment

 

 

4.5

 

Intangible assets

 

 

172.9

 

Goodwill

 

 

337.1

 

Other assets

 

 

38.2

 

Total assets acquired

 

 

619.1

 

Current liabilities

 

 

20.0

 

Long-term liabilities

 

 

99.4

 

Total liabilities assumed

 

 

119.4

 

Net assets acquired

 

$

499.7

 

We have not included pro forma information and certain other information under GAAP for the Cayenne Medical, CTC, CD Diagnostics, or MedTech acquisitions because, individually and in aggregate, they did not have a material impact on our financial position or results of operations.

Goodwill

The following table summarizes the changes in the carrying amount of our goodwillas follows (in millions):

 

8


 

 

Americas

 

 

EMEA

 

 

Asia Pacific

 

 

Product

Category

Operating

Segments

 

 

Total

 

Balance at December 31, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Goodwill

 

$

7,634.5

 

 

$

1,263.7

 

 

$

487.3

 

 

$

1,631.4

 

 

$

11,016.9

 

Accumulated impairment loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(373.0

)

 

 

(373.0

)

 

 

 

7,634.5

 

 

 

1,263.7

 

 

 

487.3

 

 

 

1,258.4

 

 

 

10,643.9

 

LDR purchase accounting

 

 

-

 

 

 

-

 

 

 

-

 

 

 

24.8

 

 

 

24.8

 

Other acquisitions

 

 

13.2

 

 

 

(24.1

)

 

 

-

 

 

 

27.6

 

 

 

16.7

 

Currency translation

 

 

82.5

 

 

 

110.0

 

 

 

10.0

 

 

 

49.7

 

 

 

252.2

 

Impairment

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(32.7

)

 

 

(32.7

)

Balance at September 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Goodwill

 

 

7,730.2

 

 

 

1,349.6

 

 

 

497.3

 

 

 

1,733.5

 

 

 

11,310.6

 

Accumulated impairment loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(405.7

)

 

 

(405.7

)

 

 

$

7,730.2

 

 

$

1,349.6

 

 

$

497.3

 

 

$

1,327.8

 

 

$

10,904.9

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Knees

 

$

703.5

 

 

$

703.0

 

 

$

1,397.6

 

 

$

1,416.3

 

Hips

 

 

479.4

 

 

 

486.9

 

 

 

963.6

 

 

 

978.9

 

S.E.T.

 

 

444.4

 

 

 

433.8

 

 

 

884.3

 

 

 

876.1

 

Spine & CMF

 

 

185.9

 

 

 

198.2

 

 

 

368.7

 

 

 

381.3

 

Dental

 

 

106.5

 

 

 

106.9

 

 

 

211.0

 

 

 

214.5

 

Other

 

 

68.9

 

 

 

78.8

 

 

 

138.9

 

 

 

158.1

 

Total

 

$

1,988.6

 

 

$

2,007.6

 

 

$

3,964.1

 

 

$

4,025.2

 

During the three“S.E.T.” refers to our Surgical, Sports Medicine, Extremities and nine month periods ended September 30, 2017, we recognized a $32.7 million goodwill impairment charge onTrauma product category.  “CMF” refers to our Office Based Technologies reporting unit.  See Note 9 for additional details.

craniomaxillofacial and thoracic products.

4.Inventories

 

 

September 30,

 

 

December 31,

 

 

June 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

(in millions)

 

 

(in millions)

 

Finished goods

 

$

1,674.2

 

 

$

1,556.9

 

 

$

1,837.1

 

 

$

1,797.7

 

Work in progress

 

 

189.6

 

 

 

141.7

 

 

 

252.9

 

 

 

230.4

 

Raw materials

 

 

220.4

 

 

 

260.8

 

 

 

254.5

 

 

 

228.4

 

Inventories

 

$

2,084.2

 

 

$

1,959.4

 

 

$

2,344.5

 

 

$

2,256.5

 

 

Finished goods inventory as of September 30, 2017 and December 31, 2016 included $0.7 million and $35.3 million, respectively, to step-up acquired inventory to fair value.

11


5.  Property, Plant and Equipment

 

 

September 30,

 

 

December 31,

 

 

June 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

(in millions)

 

 

(in millions)

 

Land

 

$

29.4

 

 

$

37.0

 

 

$

27.9

 

 

$

28.0

 

Buildings and equipment

 

 

1,833.5

 

 

 

1,789.9

 

 

 

1,954.3

 

 

 

1,885.6

 

Capitalized software costs

 

 

406.8

 

 

 

397.2

 

 

 

457.6

 

 

 

425.8

 

Instruments

 

 

2,634.4

 

 

 

2,347.6

 

 

 

3,137.0

 

 

 

2,950.5

 

Construction in progress

 

 

111.3

 

 

 

99.8

 

 

 

140.9

 

 

 

147.2

 

 

 

5,015.4

 

 

 

4,671.5

 

 

 

5,717.7

 

 

 

5,437.1

 

Accumulated depreciation

 

 

(2,966.8

)

 

 

(2,633.6

)

 

 

(3,681.9

)

 

 

(3,421.7

)

Property, plant and equipment, net

 

$

2,048.6

 

 

$

2,037.9

 

 

$

2,035.8

 

 

$

2,015.4

 

We had $38.1 million and $49.3 million of property, plant and equipment included in accounts payable as of June 30, 2019 and December 31, 2018, respectively.

6.  Intangible Assets

In the second quarter of 2019, we entered into an agreement and paid $192.5 million to buy out certain licensing arrangements from an unrelated third party.  This new agreement and the related payment replace the variable royalty payments that otherwise would have been due under the terms of previous licensing arrangements through 2029.  Under the new agreement, we maintain the rights to the counterparty’s intellectual property provided under the previous licensing arrangements.  The $192.5 million payment was recognized as an intangible asset and will be amortized through 2029, which represents the useful life of the intellectual property.

In the second quarter of 2019, we recognized $70.1 million of in-process research and development (“IPR&D”) intangible asset impairment due to the termination of certain IPR&D projects.  The termination of these projects is the result of the progress we are making to prioritize our internal research and development portfolio and focus our engineering resources on the opportunities that most closely link to our mission.  Since these projects were not a priority, their terminations are not expected to have a significant impact to our future cash flows.

9


7.  Leases

We own most of our manufacturing facilities, but lease various office space, vehicles and other less significant assets throughout the world.  Our contracts contain a lease if they convey a right to control the use of an identified asset, either explicitly or implicitly, in exchange for consideration.  Our lease contracts are a necessary part of our business, but we do not believe they are significant to our overall operations.  We do not have any significant finance leases.  Additionally, we do not have significant leases: where we are considered a lessor; where we sublease our assets; with an initial term of twelve months or less; with related parties; with residual value guarantees; that impose restrictions or covenants on us; or that have not yet commenced, but create significant rights and obligations against us.

Our real estate leases generally have terms of between 5 to 10 years and contain lease extension options that can vary from month-to-month extensions to up to 5 year extensions.  We include extension options in our lease term if we are reasonably certain to exercise that option.  In determining whether an extension is reasonably certain, we consider the uniqueness of the property for our needs, the availability of similar properties, whether the extension period payments remain the same or may change due to market rates or fixed price increases in the contract, and other economic factors.  Our vehicle leases generally have terms of between 3 to 5 years and contain lease extension options on a month-to-month basis. Our vehicle leases are generally not reasonably certain to be extended.

Under GAAP, we are required to discount our lease liabilities to present value using the rate implicit in the lease, or our incremental borrowing rate for a similar term as the lease term if the implicit rate is not readily available.  We generally do not have adequate information to know the implicit rate in a lease and therefore use our incremental borrowing rate.  Under GAAP, the incremental borrowing rate must be on a collateralized basis, but our debt arrangements are unsecured.  We have determined our incremental borrowing rate by using our credit rating to estimate our unsecured borrowing rate and applying reasonable assumptions to reduce the unsecured rate for a risk adjustment effect from collateral.

Information on our leases is as follows ($ in millions):

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30, 2019

 

 

June 30, 2019

 

Lease cost

 

$

18.4

 

 

$

37.0

 

Cash paid for leases recognized in operating cash flows

 

$

18.4

 

 

$

37.2

 

Right-of-use assets obtained in exchange for new lease liabilities

 

$

10.6

 

 

$

16.4

 

 

 

As of

 

 

 

June 30, 2019

 

Right-of-use assets recognized in Other assets

 

$

257.6

 

Lease liabilities recognized in Other current liabilities

 

$

62.5

 

Lease liabilities recognized in Other long-term liabilities

 

$

205.4

 

Weighted-average remaining lease term

 

6.2 years

 

Weighted-average discount rate

 

 

2.7

%

Our variable lease costs are not significant.

Our future minimum lease payments as of June 30, 2019 were (in millions):

For the Years Ending December 31,

 

 

 

 

2019 (July 1, 2019 to December 31, 2019)

 

$

35.4

 

2020

 

 

61.8

 

2021

 

 

48.3

 

2022

 

 

34.1

 

2023

 

 

28.7

 

Thereafter

 

 

84.8

 

Total

 

 

293.1

 

Less imputed interest

 

 

25.2

 

Total

 

$

267.9

 

10


Under GAAP, since we adopted the new standard using the period of adoption transition method (see Note 2 for additional information regarding the new standard), we are not required to present 2018 comparative disclosures.  However, we are required to present the required annual disclosures under the previous GAAP lease accounting standard.  Accordingly, the following were the future minimum rental commitments under non-cancelable operating leases as of December 31, 2018 (in millions):

For the Years Ending December 31,

 

 

 

 

2019

 

$

67.1

 

2020

 

 

56.9

 

2021

 

 

44.1

 

2022

 

 

32.2

 

2023

 

 

27.7

 

Thereafter

 

 

81.6

 

 

 

6.8.  Transfers of Financial Assets

In the fourth quarter of 2016, we executedWe have receivables purchase arrangements with unrelated third parties to liquidate portions of our trade accounts receivable balance with unrelated third parties.balance.  The receivables relate to products sold to customers and are short-term in nature.  The factorings wereare treated as sales of our accounts receivable.  Proceeds from the transfers reflect either the face value of the accounts receivable or the face value less factoring fees.  

In the U.S. and Japan, our programs are executed on a revolving basis with a maximum funding limit as of SeptemberJune 30, 20172019 of $315 million.$400.0 million combined.  We act as the collection agent on behalf of the third party, but have no significant retained interests or servicing liabilities related to the accounts receivable sold.  In order to mitigate credit risk, we purchased credit insurance for the factored accounts receivable.  TheAs a result, is our risk of loss beingis limited to the factored accounts receivable not covered by the insurance.  Additionally, we have provided guarantees for the factored accounts receivable.  The maximum exposures to loss associated with these arrangements were $24.4$33.5 million and $5.2$33.0 million as of SeptemberJune 30, 20172019 and December 31, 2016,2018, respectively.

In Europe, we sell to a third party and have no continuing involvement or significant risk with the factored accounts receivable.

Funds received from the transfers are recorded as an increase to cash and a reduction to accounts receivable outstanding in the condensed consolidated balance sheets.  We report the cash flows attributable to the sale of receivables to third parties in cash flows from operating activities in our condensed consolidated statements of cash flows.  Net expenses resulting from the sales of receivables are recognized in selling, general and administrative expense.  Net expenses include any resulting gains or losses from the sales of receivables, credit insurance and factoring fees.

In the ninesix month periodperiods ended SeptemberJune 30, 2017,2019 and 2018, we sold receivables having an aggregate face value of $1,050.5$1,595.9 million and $1,260.7 million to third parties in exchange for cash proceeds of $1,049.8 million.$1,594.9 million and $1,260.1 million, respectively.  Expenses recognized on these sales during the three and ninesix month periods ended SeptemberJune 30, 2017,2019 and 2018 were not significant.  In the ninesix month periodperiods ended SeptemberJune 30, 2017,2019 and 2018, under the U.S. and Japan programs, we collected $682.2$1,438.3 million and $1,007.8 million, respectively, from our customers and remitted that amount to the third party, and we effectively repurchased $58.9$73.9 million and $121.0 million, respectively, of previously sold accounts receivable from the third party, due to the programs’ revolving nature.  We estimateAs of June 30, 2019 and December 31, 2018, we had collected $41.2 million and $66.8 million, respectively, of funds that were unremitted to the incremental operatingthird party, which are reflected in our condensed consolidated balance sheets under other current liabilities.  The initial collection of cash inflows relatedfrom customers and its remittance to allthe third party is reflected in net cash provided by/(used in) financing activities in our condensed consolidated statements of our programs were approximately $273 million in the nine month period ended September 30, 2017.cash flows.  

At SeptemberJune 30, 2017,2019 and December 31, 2018, the outstanding principal amount of receivables that has been derecognized under the U.S. and Japan revolving arrangements amounted to $210.6$378.1 million and $65.5$365.9 million, respectively.

1211


7.9.  Debt

Our debt consisted of the following (in millions):

 

 

September 30,

 

 

December 31,

 

 

June 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

Current portion of long-term debt

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.450% Senior Notes due 2017

 

$

-

 

 

$

500.0

 

2.000% Senior Notes due 2018

 

 

1,150.0

 

 

 

-

 

4.625% Senior Notes due 2019

 

$

500.0

 

 

$

500.0

 

2.700% Senior Notes due 2020

 

 

1,500.0

 

 

 

-

 

U.S. Term Loan B

 

 

75.0

 

 

 

75.0

 

 

 

-

 

 

 

25.0

 

Other short-term debt

 

 

-

 

 

 

0.6

 

Total current portion of long-term debt

 

$

1,225.0

 

 

$

575.6

 

 

$

2,000.0

 

 

$

525.0

 

Long-term debt

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2.000% Senior Notes due 2018

 

$

-

 

 

$

1,150.0

 

4.625% Senior Notes due 2019

 

 

500.0

 

 

 

500.0

 

2.700% Senior Notes due 2020

 

 

1,500.0

 

 

 

1,500.0

 

 

$

-

 

 

$

1,500.0

 

Floating Rate Notes due 2021

 

 

450.0

 

 

 

450.0

 

3.375% Senior Notes due 2021

 

 

300.0

 

 

 

300.0

 

 

 

300.0

 

 

 

300.0

 

3.150% Senior Notes due 2022

 

 

750.0

 

 

 

750.0

 

 

 

750.0

 

 

 

750.0

 

3.700% Senior Notes due 2023

 

 

300.0

 

 

 

300.0

 

3.550% Senior Notes due 2025

 

 

2,000.0

 

 

 

2,000.0

 

 

 

2,000.0

 

 

 

2,000.0

 

4.250% Senior Notes due 2035

 

 

253.4

 

 

 

253.4

 

 

 

253.4

 

 

 

253.4

 

5.750% Senior Notes due 2039

 

 

317.8

 

 

 

317.8

 

 

 

317.8

 

 

 

317.8

 

4.450% Senior Notes due 2045

 

 

395.4

 

 

 

395.4

 

 

 

395.4

 

 

 

395.4

 

1.414% Euro Notes due 2022

 

 

591.1

 

 

 

527.4

 

 

 

569.4

 

 

 

571.6

 

2.425% Euro Notes due 2026

 

 

591.1

 

 

 

527.4

 

 

 

569.4

 

 

 

571.6

 

U.S. Term Loan A

 

 

1,135.0

 

 

 

1,700.0

 

U.S. Term Loan B

 

 

600.0

 

 

 

675.0

 

 

 

-

 

 

 

200.0

 

U.S. Term Loan C

 

 

535.0

 

 

 

535.0

 

Japan Term Loan A

 

 

103.9

 

 

 

99.6

 

 

 

108.7

 

 

 

105.3

 

Japan Term Loan B

 

 

189.1

 

 

 

-

 

 

 

197.9

 

 

 

191.7

 

Other long-term debt

 

 

4.1

 

 

 

4.2

 

Debt discount and issuance costs

 

 

(56.3

)

 

 

(65.8

)

 

 

(38.1

)

 

 

(42.7

)

Adjustment related to interest rate swaps

 

 

25.1

 

 

 

31.4

 

 

 

10.4

 

 

 

14.6

 

Total long-term debt

 

$

9,199.7

 

 

$

10,665.8

 

 

$

6,719.3

 

 

$

8,413.7

 

 

At SeptemberJune 30, 2017,2019, our total current and non-current debt balanceof $8.7 billion consisted of $8.3$7.9 billion aggregate principal amount of our senior notes, which included $1.2$1.1 billion of Euro-denominated senior notes (“Euro Notes”), $1.14 billion outstanding under a U.S. term loan (“U.S. Term Loan A”) that will mature on June 24, 2020, $675.0$535.0 million outstanding under a U.S. term loan (“U.S. Term Loan B”C”) that will mature on September 30, 2019,December 14, 2020, an11.7 billion Japanese Yen term loan agreement (“Japan Term Loan A”) and a 21.3 billion Japanese Yen term loan agreement (“Japan Term Loan B”) that will each will mature on September 27, 2022, and other debt and fair value adjustments totaling $29.2$10.4 million, partially offset by debt discount and issuance costs of $56.3$38.1 million.

On September 22, 2017,December 14, 2018, we entered into a credit agreement (the “2018 Credit Agreement”) that provides for U.S. Term Loan C, which is a two-year unsecured multi-draw term loan agreement forfacility in the Japanprincipal amount of $900.0 million, with a maturity date of December 14, 2020, and borrowed $675.0 million under that facility.  In January 2019, we borrowed an additional $200.0 million under U.S. Term Loan C and used those proceeds, along with cash on hand, to repay the remaining $225.0 million outstanding under a U.S. term loan issued under the 2016 Credit Agreement (as defined below) (“U.S. Term Loan B”).  Under the applicable accounting rules, since $200.0 million of U.S. Term Loan B and an amended and restated term loan agreement, which amended and restatedwas refinanced on a long-term basis before the Japanissuance of our consolidated financial statements for the year ended December 31, 2018, we classified the refinanced portion of U.S. Term Loan A loan agreement datedB as long-term as of May 24, 2012, as amended asDecember 31, 2018.

On March 19, 2018, we completed the offering of October 31, 2014. As described above,$450.0 million aggregate principal amount of our floating rate senior notes due March 19, 2021 and $300.0 million aggregate principal amount of our 3.700% senior notes due March 19, 2023.  Interest on the term loans under both of these agreements will maturefloating rate senior notes is equal to three-month LIBOR plus 0.750% and is payable quarterly, commencing on June 19, 2018, until maturity.  Interest is payable on the 3.700% senior notes semi-annually, commencing on September 27, 2022. Each19, 2018, until maturity.  We received net proceeds of these term loans bears interest at a fixed rate of 0.635% per annum.$749.5 million from this offering.

WeIn addition to the 2018 Credit Agreement, we have a revolving credit and term loan agreement (the “2016 Credit Agreement”) and a first amendment to our credit agreement executed in 2014 (the “2014 Credit Agreement”).  The 2016 Credit Agreement, which contains the U.S. Term Loan B and a five-year unsecured multicurrency revolving facility of $1.5 billion (the “Multicurrency Revolving Facility”)., and previously contained U.S. Term Loan B, which was paid in full during the six month period ended June 30, 2019.  The Multicurrency Revolving Facility replaced the previous multicurrency revolving facility under our credit agreement executed in 2014 (as amended,

12


the 2014“2014 Credit AgreementAgreement”) and will mature on September 30, 2021, with two available one-year extensions at our discretion.  The 2014 Credit Agreement also provided for the previously contained a term loan (“U.S. Term Loan A,A”), which remainswas paid in effect.full in December 2018.

Borrowings under the 20142018 and 2016 Credit Agreements generally bear interest at floating rates. We pay a facility fee on the aggregate amount of the Multicurrency Revolving Facility.  The 2018 and 2016 Credit Agreements contain customary affirmative and negative covenants and events of default for unsecured financing arrangements, including, among other things, limitations on consolidations, mergers and sales of assets.  If our credit rating falls below investment grade, additional restrictions would result, including restrictions on investments and payment of dividends.  We were in compliance with all financial covenants

13


under the 20142018 and 2016 Credit Agreements as of SeptemberJune 30, 2017.2019. As of SeptemberJune 30, 2017, there were2019, we had no borrowings outstanding under the Multicurrency Revolving Facility.  

During the six month period ended June 30, 2019, we repaid $200.0 million on U.S. Term Loan C with cash generated from operations.  Under the terms of U.S. Term Loan A, starting September 30, 2015, principal payments are due as follows: $75.0 million on a quarterly basis duringC, the first three years, $112.5 million on a quarterly basis during the fourth year, and $412.5 million on a quarterly basis during the fifth year.  We have paid $1.86 billion in principal under U.S. Term Loan A, resulting in $1.14 billion in outstanding borrowingsremaining balance as of SeptemberJune 30, 2017.    

Under the terms2019 of U.S. Term Loan B, future principal payments are due as follows:  $75.0$535.0 million on September 30, 2018, with the remaining balanceis due on the maturity date of September 30, 2019.  We have paid $75.0 million in principal under U.S. Term Loan B, resulting in $675.0 million outstanding on the U.S. Term Loan B as of September 30, 2017.December 14, 2020.      

The estimated fair value of our senior notes as of SeptemberJune 30, 2017,2019, based on quoted prices for the specific securities from transactions in over-the-counter markets (Level 2), was $8,520.9$8,126.5 million.  The estimated fair value of Japan Term Loan A and Japan Term Loan B, in the aggregate, as of SeptemberJune 30, 2017,2019, based upon publicly available market yield curves and the terms of the debt (Level 2), was $291.8$303.1 million.  The carrying valuesvalue of U.S. Term Loan A and U.S. Term Loan B approximate theirC approximates its fair valuesvalue as they bearit bears interest at short-term variable market rates.

8.10.  Accumulated Other Comprehensive Income

Accumulated other comprehensive income (loss) (“AOCI”) refers to certain gains and losses that under GAAP are included in comprehensive income but are excluded from net earnings as these amounts are initially recorded as an adjustment to stockholders’ equity.  Amounts in AOCI may be reclassified to net earnings upon the occurrence of certain events.  

Our AOCI is comprised of foreign currency translation adjustments, unrealized gains and losses on cash flow hedges unrealized gains and losses on available-for-sale securities, and amortization of prior service costs and unrecognized gains and losses in actuarial assumptions on our defined benefit plans.  Foreign currency translation adjustments are reclassified to net earnings upon sale or upon a complete or substantially complete liquidation of an investment in a foreign entity.  Unrealized gains and losses on cash flow hedges are reclassified to net earnings when the hedged item affects net earnings.  Unrealized gains and losses on available-for-sale securities are reclassified to net earnings if we sell the security before maturity or if the unrealized loss is considered to be other-than-temporary.  Amounts related to defined benefit plans that are in AOCI are reclassified over the service periods of employees in the plan.      The reclassification amounts are allocated to all employees in the plans and, therefore, the reclassified amounts may become part of inventory to the extent they are considered direct labor costs.  See Note 12 for more information on our defined benefit plans.    

The following table shows the changes in the components of AOCI, net of tax (in millions):

 

 

 

Foreign

 

 

Cash

 

 

Unrealized

 

 

Defined

 

 

 

Currency

 

 

Flow

 

 

(Losses) Gains on

 

 

Benefit

 

 

 

Translation

 

 

Hedges

 

 

Securities

 

 

Plan Items

 

Balance at December 31, 2016

 

$

(323.4

)

 

$

32.3

 

 

$

(0.1

)

 

$

(142.8

)

AOCI before reclassifications

 

 

367.9

 

 

 

(79.4

)

 

 

-

 

 

 

(10.1

)

Reclassifications

 

 

-

 

 

 

(9.4

)

 

 

-

 

 

 

5.1

 

Balance at September 30, 2017

 

$

44.5

 

 

$

(56.5

)

 

$

(0.1

)

 

$

(147.8

)

 

 

Foreign

 

 

Cash

 

 

Defined

 

 

 

 

 

 

 

Currency

 

 

Flow

 

 

Benefit

 

 

Total

 

 

 

Translation

 

 

Hedges

 

 

Plan Items

 

 

AOCI

 

Balance at December 31, 2018

 

$

(31.3

)

 

$

20.9

 

 

$

(177.0

)

 

$

(187.4

)

AOCI before reclassifications

 

 

10.7

 

 

 

14.9

 

 

 

-

 

 

 

25.6

 

Reclassifications to statement of earnings

 

 

-

 

 

 

(14.4

)

 

 

4.4

 

 

 

(10.0

)

Balance at June 30, 2019

 

$

(20.6

)

 

$

21.4

 

 

$

(172.6

)

 

$

(171.8

)

��

1413


The following table shows the reclassification adjustments from AOCI (in millions):

 

 

Amount of Gain (Loss)

 

 

 

 

Amount of Gain (Loss)

 

 

 

 

Reclassified from AOCI

 

 

 

 

Reclassified from AOCI

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

 

September 30,

 

 

September 30,

 

 

Location on

 

June 30,

 

 

June 30,

 

 

Location on

Component of AOCI

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

Statement of Earnings

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

Statements of Earnings

Cash flow hedges

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign exchange forward contracts

 

$

(5.1

)

 

$

18.1

 

 

$

12.0

 

 

$

76.5

 

 

Cost of products sold

 

$

7.4

 

 

$

(10.5

)

 

$

14.5

 

 

$

(21.6

)

 

Cost of products sold

Interest rate swaps

 

 

-

 

 

 

-

 

 

 

2.8

 

 

 

-

 

 

Interest expense, net

Forward starting interest rate swaps

 

 

(0.1

)

 

 

(0.4

)

 

 

(0.4

)

 

 

(1.3

)

 

Interest expense

 

 

(0.2

)

 

 

(0.2

)

 

 

(0.3

)

 

 

(0.3

)

 

Interest expense, net

 

 

(5.2

)

 

 

17.7

 

 

 

11.6

 

 

 

75.2

 

 

Total before tax

 

 

7.2

 

 

 

(10.7

)

 

 

17.0

 

 

 

(21.9

)

 

Total before tax

 

 

(1.1

)

 

 

3.8

 

 

 

2.2

 

 

 

17.2

 

 

Provision for income taxes

 

 

1.0

 

 

 

(1.5

)

 

 

2.6

 

 

 

(3.0

)

 

Provision for income taxes

 

$

(4.1

)

 

$

13.9

 

 

$

9.4

 

 

$

58.0

 

 

Net of tax

 

$

6.2

 

 

$

(9.2

)

 

$

14.4

 

 

$

(18.9

)

 

Net of tax

Defined benefit plans

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prior service cost

 

$

2.6

 

 

$

1.9

 

 

$

7.7

 

 

$

5.8

 

 

*

 

$

1.9

 

 

$

2.5

 

 

$

3.7

 

 

$

5.0

 

 

Other expense, net

Unrecognized actuarial (loss)

 

 

(5.4

)

 

 

(5.1

)

 

 

(16.2

)

 

 

(15.1

)

 

*

Unrecognized actuarial loss

 

 

(5.5

)

 

 

(6.7

)

 

 

(10.8

)

 

 

(12.8

)

 

Other expense, net

 

 

(2.8

)

 

 

(3.2

)

 

 

(8.5

)

 

 

(9.3

)

 

Total before tax

 

 

(3.6

)

 

 

(4.2

)

 

 

(7.1

)

 

 

(7.8

)

 

Total before tax

 

 

(1.1

)

 

 

(1.0

)

 

 

(3.4

)

 

 

(3.3

)

 

Benefit for income taxes

 

 

(1.2

)

 

 

(1.2

)

 

 

(2.7

)

 

 

(2.0

)

 

Provision for income taxes

 

$

(1.7

)

 

$

(2.2

)

 

$

(5.1

)

 

$

(6.0

)

 

Net of tax

 

$

(2.4

)

 

$

(3.0

)

 

$

(4.4

)

 

$

(5.8

)

 

Net of tax

Total reclassifications

 

$

(5.8

)

 

$

11.7

 

 

$

4.3

 

 

$

52.0

 

 

Net of tax

 

$

3.8

 

 

$

(12.2

)

 

$

10.0

 

 

$

(24.7

)

 

Net of tax

 

*

These AOCI components are included in the computation of net periodic pension expense (see Note 12).

The following table shows the tax effects on each component of AOCI recognized in our condensed consolidated statements of comprehensive income (in millions):

 

 

Three Months Ended September 30, 2017

 

 

Nine Months Ended September 30, 2017

 

 

Three Months Ended June 30, 2019

 

 

Six Months Ended June 30, 2019

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

Foreign currency cumulative translation adjustments

 

$

145.0

 

 

$

15.3

 

 

$

129.7

 

 

$

414.6

 

 

$

46.7

 

 

$

367.9

 

 

$

8.1

 

 

$

(7.0

)

 

$

15.1

 

 

$

16.0

 

 

$

5.3

 

 

$

10.7

 

Unrealized cash flow hedge (losses)

 

 

(35.9

)

 

 

(7.6

)

 

 

(28.3

)

 

 

(99.0

)

 

 

(19.6

)

 

 

(79.4

)

Unrealized cash flow hedge (losses) gains

 

 

(3.9

)

 

 

(4.3

)

 

 

0.4

 

 

 

12.8

 

 

 

(2.1

)

 

 

14.9

 

Reclassification adjustments on cash flow hedges

 

 

5.2

 

 

 

1.1

 

 

 

4.1

 

 

 

(11.6

)

 

 

(2.2

)

 

 

(9.4

)

 

 

(7.2

)

 

 

(1.0

)

 

 

(6.2

)

 

 

(17.0

)

 

 

(2.6

)

 

 

(14.4

)

Adjustments to prior service cost and unrecognized

actuarial assumptions

 

 

0.5

 

 

 

1.5

 

 

 

(1.0

)

 

 

(2.9

)

 

 

2.1

 

 

 

(5.0

)

 

 

3.6

 

 

 

1.2

 

 

 

2.4

 

 

 

7.1

 

 

 

2.7

 

 

 

4.4

 

Total Other Comprehensive Income

 

$

114.8

 

 

$

10.3

 

 

$

104.5

 

 

$

301.1

 

 

$

27.0

 

 

$

274.1

 

 

$

0.6

 

 

$

(11.1

)

 

$

11.7

 

 

$

18.9

 

 

$

3.3

 

 

$

15.6

 

 

 

Three Months Ended September 30, 2016

 

 

Nine Months Ended September 30, 2016

 

 

Three Months Ended June 30, 2018

 

 

Six Months Ended June 30, 2018

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

 

Before Tax

 

 

Tax

 

 

Net of Tax

 

Foreign currency cumulative translation adjustments

 

$

58.3

 

 

$

-

 

 

$

58.3

 

 

$

113.9

 

 

$

-

 

 

$

113.9

 

 

$

(192.0

)

 

$

(14.2

)

 

$

(177.8

)

 

$

(90.6

)

 

$

(7.6

)

 

$

(83.0

)

Unrealized cash flow hedge (losses) gains

 

 

(16.1

)

 

 

(6.4

)

 

 

(9.7

)

 

 

(80.9

)

 

 

(27.9

)

 

 

(53.0

)

Unrealized cash flow hedge gains

 

 

62.7

 

 

 

11.1

 

 

 

51.6

 

 

 

29.6

 

 

 

4.4

 

 

 

25.2

 

Reclassification adjustments on cash flow hedges

 

 

(17.7

)

 

 

(3.8

)

 

 

(13.9

)

 

 

(75.2

)

 

 

(17.2

)

 

 

(58.0

)

 

 

10.7

 

 

 

1.5

 

 

 

9.2

 

 

 

21.9

 

 

 

3.0

 

 

 

18.9

 

Unrealized gains on securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

0.4

 

 

 

-

 

 

 

0.4

 

Adjustments to prior service cost and unrecognized

actuarial assumptions

 

 

2.2

 

 

 

1.0

 

 

 

1.2

 

 

 

25.6

 

 

 

3.3

 

 

 

22.3

 

 

 

4.1

 

 

 

(1.2

)

 

 

5.3

 

 

 

-

 

 

 

(2.0

)

 

 

2.0

 

Total Other Comprehensive Loss

 

$

26.7

 

 

$

(9.2

)

 

$

35.9

 

 

$

(16.2

)

 

$

(41.8

)

 

$

25.6

 

 

$

(114.5

)

 

$

(2.8

)

 

$

(111.7

)

 

$

(39.1

)

 

$

(2.2

)

 

$

(36.9

)

 

1514


9.11.  Fair Value Measurement of Assets and Liabilities

The following financial assets and liabilities are recorded at fair value on a recurring basis (in millions):

 

 

As of September 30, 2017

 

 

As of June 30, 2019

 

 

 

 

 

 

Fair Value Measurements at Reporting Date Using:

 

 

 

 

 

 

Fair Value Measurements at Reporting Date Using:

 

Description

 

Recorded

Balance

 

 

Quoted Prices

in Active

Markets for

Identical

Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Recorded

Balance

 

 

Quoted Prices

in Active

Markets for

Identical

Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Derivatives, current and long-term

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency forward contracts

 

$

3.9

 

 

$

-

 

 

$

3.9

 

 

$

-

 

 

$

42.7

 

 

$

-

 

 

$

42.7

 

 

$

-

 

Interest rate swaps

 

 

3.8

 

 

 

-

 

 

 

3.8

 

 

 

-

 

 

 

31.8

 

 

 

-

 

 

 

31.8

 

 

 

-

 

Total Assets

 

$

7.7

 

 

$

-

 

 

$

7.7

 

 

$

-

 

 

$

74.5

 

 

$

-

 

 

$

74.5

 

 

$

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Derivatives, current and long-term

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency forward contracts

 

$

39.5

 

 

$

-

 

 

$

39.5

 

 

$

-

 

 

$

0.6

 

 

$

-

 

 

$

0.6

 

 

$

-

 

Contingent payments related to acquisitions

 

 

44.0

 

 

 

-

 

 

 

-

 

 

 

44.0

 

Total Liabilities

 

$

83.5

 

 

$

-

 

 

$

39.5

 

 

$

44.0

 

 

$

0.6

 

 

$

-

 

 

$

0.6

 

 

$

-

 

 

 

As of December 31, 2016

 

 

As of December 31, 2018

 

 

 

 

 

 

Fair Value Measurements at Reporting Date Using:

 

 

 

 

 

 

Fair Value Measurements at Reporting Date Using:

 

Description

 

Recorded

Balance

 

 

Quoted Prices

in Active

Markets for

Identical

Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Recorded

Balance

 

 

Quoted Prices

in Active

Markets for

Identical

Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Derivatives, current and long-term

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency forward contracts

 

$

65.3

 

 

$

-

 

 

$

65.3

 

 

$

-

 

 

$

45.7

 

 

$

-

 

 

$

45.7

 

 

$

-

 

Interest rate swaps

 

 

4.0

 

 

 

-

 

 

 

4.0

 

 

 

-

 

 

 

17.9

 

 

 

-

 

 

 

17.9

 

 

 

-

 

Total Assets

 

$

69.3

 

 

$

-

 

 

$

69.3

 

 

$

-

 

 

$

63.6

 

 

$

-

 

 

$

63.6

 

 

$

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Derivatives, current and long-term

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency forward contracts

 

$

0.3

 

 

$

-

 

 

$

0.3

 

 

$

-

 

 

$

0.5

 

 

$

-

 

 

$

0.5

 

 

$

-

 

Contingent payments related to acquisitions

 

 

62.8

 

 

 

-

 

 

 

-

 

 

 

62.8

 

Interest rate swaps

 

 

2.5

 

 

 

-

 

 

 

2.5

 

 

 

-

 

Total Liabilities

 

$

63.1

 

 

$

-

 

 

$

0.3

 

 

$

62.8

 

 

$

3.0

 

 

$

-

 

 

$

3.0

 

 

$

-

 

 

We value our foreign currency forward contracts and foreign currency options using a market approach based on foreign currency exchange rates obtained from active markets, and we perform ongoing assessments of counterparty credit risk.  

We value our interest rate swaps using a market approach based on publicly available market yield curves, foreign currency exchange rates and the terms of our swaps, and we perform ongoing assessments of counterparty credit risk.

Contingent payments related to acquisitions consist of commercial milestone, cost savings and sales-based payments, and are valued using discounted cash flow techniques.  The fair value of commercial milestone payments reflects management’s expectations of probability of payment, and increases as the probability of payment increases or expectation of timing of payments is accelerated.  The fair value of cost savings and sales-based payments is based upon probability-weighted future cost savings and revenue estimates, and increases as cost savings and revenue estimates increase, probability weighting of higher cost savings and revenue scenarios increase or expectation of timing of payment is accelerated.  In the three and nine month periods ended September 30, 2017, we recognized $1.7 million of loss and $1.5 million of income, respectively, related to contingent payments due to changes in estimates.  In the nine month period ended September 30, 2017, we also paid $13.7 million in contingent payments and made a fair value adjustment of $3.6 million to the preliminary estimate of contingent consideration that reduced the contingent payment liability.

16


In the third quarter of 2017, we performed a goodwill impairment test on our Office Based Technologies reporting unit due to continued revenue declines.  As a result, we recognized a $32.7 million impairment charge.  The $32.7 million impairment represented the entire goodwill balance of the reporting unit and therefore no goodwill remains.  This reporting unit was acquired as part of the Biomet merger in 2015 and therefore its assets and liabilities were recognized at their estimated fair values at the merger date.  Since the merger date valuation, operating performance has been lower than expected due to integration issues, management turnover and poor execution of its operating plans.

We estimated the fair value of the Office Based Technologies reporting unit using a market approach.  GAAP defines fair value as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.”  We used market indicators based upon the reporting unit’s operating performance to estimate what price would be paid for the assets in an orderly transaction.  

We have six other reporting units with goodwill assigned to them.  We did not perform goodwill impairment tests on our other reporting units as there were no indicators that their goodwill may be impaired.      

10.12.  Derivative Instruments and Hedging Activities

We are exposed to certain market risks relating to our ongoing business operations, including foreign currency exchange rate risk, commodity price risk, interest rate risk and credit risk.  We manage our exposure to these and other market risks through regular operating and financing activities.  Currently, the only risks that we manage through the use of derivative instruments are interest rate risk and foreign currency exchange rate risk.

15


Interest Rate Risk

Derivatives Designated as Fair Value Hedges

In prior years, we entered into various fixed-to-variable interest rate swap agreements that were accounted for as fair value hedges of a portion of our 4.625% Senior Notes due 2019 and all of our 3.375% Senior Notes due 2021.  In August 2016, we received cash for these interest rate swap assets by terminating the hedging instruments with the counterparties.  The remaining unamortized balance as of SeptemberJune 30, 20172019 related to these discontinued hedges was $25.1$10.4 million, which will be recognized using the effective interest rate method over the remaining maturity period of the hedged notes.  As of June 30, 2019 and December 31, 2018, the following amounts were recorded on our condensed consolidated balance sheets related to cumulative basis adjustments for fair value hedges (in millions):

 

 

Carrying Amount of the Hedged Liabilities

 

 

 

Cumulative Amount of Fair Value Hedging Adjustment Included in the Carrying Amount of the Hedged Liabilities

 

Balance Sheet Line Item

 

June 30, 2019

 

 

December 31, 2018

 

 

 

June 30, 2019

 

 

December 31, 2018

 

Long-term debt

 

$

560.3

 

 

$

564.4

 

 

 

$

10.4

 

 

$

14.6

 

 

Derivatives Designated as Cash Flow Hedges

In 2014, we entered into forward starting interest rate swaps that were designated as cash flow hedges of our thirty-year tranche of senior notes (the 4.450% Senior Notes due 2045) we expected to issue in 2015. The forward starting interest rate swaps mitigated the risk of changes in interest rates prior to the completion of the offering of senior notes in connection with our merger with LVB Acquisition, Inc., the parent company of Biomet, merger.Inc. (“Biomet”) (which merger is sometimes referred to herein as the “Biomet merger”).  The interest rate swaps were settled, and the remaining loss to be recognized at SeptemberJune 30, 20172019 was $27.8$26.8 million, which will be recognized using the effective interest rate method over the remaining maturity period of the hedged notes.

In September 2016, we entered into various variable-to-fixed interest rate swap agreements with a notional amount of $375$375.0 million that were accounted for as cash flow hedges of U.S. Term Loan B.  The interest rate swaps minimizeminimized the exposure to changes in the LIBOR interest rates while the variable-rate debt iswas outstanding.  The weighted average fixedIn the first quarter of 2019, we terminated these interest rate for allswaps concurrently with the repayment of the swaps executed is approximately 0.82 percent through September 30, 2019.    remaining balance of U.S. Term Loan B, and we recognized proceeds and interest income of $2.8 million related to the termination.

Foreign Currency Exchange Rate Risk

We operate on a global basis and are exposed to the risk that our financial condition, results of operations and cash flows could be adversely affected by changes in foreign currency exchange rates. To reduce the potential effects of foreign currency exchange rate movements on net earnings, we enter into derivative financial instruments in the form of foreign currency exchange forward contracts with major financial institutions. We also designated our Euro Notes as net investment hedges of investments in foreign subsidiaries. We are primarily exposed to foreign currency exchange rate risk with respect to transactions and net assets denominated in Euros, Swiss Francs, Japanese Yen, British Pounds, Canadian Dollars, Australian Dollars, Korean Won, Swedish Krona, Czech Koruna, Thai Baht, Taiwan Dollars, South African Rand, Russian Rubles, Indian Rupees, Turkish Lira, Polish Zloty, Danish Krone, and Norwegian Krone. We do not use derivative financial instruments for trading or speculative purposes.

17


Derivatives Designated as Net Investment Hedges

We are exposed to the impact of foreign exchange rate fluctuations in the investments in our wholly-owned foreign subsidiaries that are denominated in currencies other than the U.S. Dollar. In order to mitigate the volatility in foreign exchange rates, we issued Euro Notes in December 2016 and designated 100 percent of the Euro Notes to hedge our net investment in certain wholly-owned foreign subsidiaries that have a functional currency of the Euro. All changes in the fair value of thea hedging instrument designated as a net investment hedge are recorded as a component of accumulated other comprehensive lossAOCI in the condensed consolidated balance sheet.sheets.  

In the threeAt June 30, 2019, we had receive-fixed-rate, pay-fixed-rate cross-currency interest swaps with notional amounts outstanding of Euro 1,450 million, Japanese Yen 7 billion and nine month periods ended September 30, 2017, we recognized foreign exchange losses of $41.7 million and $127.5 million, respectively, in AOCI in foreign currency translation adjustments onSwiss Franc 50 million.  These transactions further hedge our net investment hedges.  We recognized no ineffectiveness from ourin certain wholly-owned foreign subsidiaries that have a functional currency of Euro, Japanese Yen and Swiss Franc.  All changes in the fair value of a derivative instrument designated as a net investment hedges forhedge are recorded as a component of AOCI in the three and nine month periods ended September 30, 2017.condensed consolidated balance sheets.  The portion of this change related to the excluded component will be amortized into earnings over the life of the derivative while the remainder will be recorded in AOCI until the hedged net investment is sold or substantially liquidated.  

16


We recognize the excluded component in interest expense, net on our condensed consolidated statements of earnings.  The net cash received related to the receive-fixed-rate, pay-fixed-rate component of the cross-currency interest rate swaps is reflected in investing cash flows in our condensed consolidated statements of cash flows.  

Derivatives Designated as Cash Flow Hedges

Our revenues are generated in various currencies throughout the world.  However, a significant amount of our inventory is produced in U.S. Dollars.  Therefore, movements in foreign currency exchange rates may have different proportional effects on our revenues compared to our cost of products sold.  To minimize the effects of foreign currency exchange rate movements on cash flows, we hedge intercompany sales of inventory expected to occur within the next 30 months with foreign currency exchange forward contracts.  We designate these derivative instruments as cash flow hedges.  

We perform quarterly assessments of hedge effectiveness by verifying and documenting the critical terms of the hedge instrument and confirming that forecasted transactions have not changed significantly.  We also assess on a quarterly basis whether there have been adverse developments regarding the risk of a counterparty default.  For derivatives which qualify as hedges of future cash flows, the effective portion of changes in fair value isgains and losses are temporarily recorded in other comprehensive incomeAOCI and then recognized in cost of products sold when the hedged item affects net earnings.  The ineffective portion of a derivative’s change in fair value, if any, is immediately reported in cost of products sold.  On our condensed consolidated statementstatements of cash flows, the settlements of these cash flow hedges are recognized in operating cash flows.

For foreign currency exchange forward contracts and options outstanding at SeptemberJune 30, 2017,2019, we had obligations to purchase U.S. Dollars and sell Euros, Japanese Yen, British Pounds, Canadian Dollars, Australian Dollars, Korean Won, Swedish Krona, Czech Koruna, Thai Baht, Taiwan Dollars, South African Rand, Russian Rubles, Indian Rupees, Turkish Lira, Polish Zloty, Danish Krone, and Norwegian Krone and obligations to purchase Swiss Francs and sell U.S. Dollars. These derivatives mature at dates ranging from October 2017July 2019 through March 2020.November 2021. As of SeptemberJune 30, 2017,2019, the notional amounts of outstanding forward contracts and options entered into with third parties to purchase U.S. Dollars were $1,683.9$1,535.1 million. As of SeptemberJune 30, 2017,2019, the notional amounts of outstanding forward contracts and options entered into with third parties to purchase Swiss Francs were $285.0$270.7 million.

Derivatives Not Designated as Hedging Instruments

We enter into foreign currency forward exchange contracts with terms of one month to manage currency exposures for monetary assets and liabilities denominated in a currency other than an entity’s functional currency.  As a result, any foreign currency re-measurement gains/losses recognized in earnings are generally offset with gains/losses on the foreign currency forward exchange contracts in the same reporting period.  The net amount of these offsetting gains/losses is recorded in Other expense.other expense, net.  These contracts are settled on the last day of each reporting period.  Therefore, there is no outstanding balance related to these contracts recorded on the balance sheet as of the end of the reporting period.  The notional amounts of these contracts are typically in a range of $1.5 billion to $2.0 billion per quarter.

Income Statement Presentation

Derivatives Designated as Fair Value Hedges

Derivative instruments designated as fair value hedges had the following effects on our condensed consolidated statements of earnings (in millions):

 

 

 

 

Gain (Loss) on

 

 

Gain (Loss) on

 

 

 

 

 

Instrument

 

 

Hedged Item

 

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

Location on

 

September 30,

 

 

September 30,

 

 

September 30,

 

 

September 30,

 

Derivative Instrument

 

Statement of Earnings

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Interest rate swaps

 

Interest expense

 

$

-

 

 

$

(3.8

)

 

$

-

 

 

$

10.1

 

 

$

-

 

 

$

3.8

 

 

$

-

 

 

$

(10.1

)

18


Derivatives Designated as Cash Flow Hedges

Derivative instruments designated as cash flow hedges had the following effects, before taxes, on AOCI and Netnet earnings on our condensed consolidated statements of earnings, condensed consolidated statements of comprehensive income and condensed consolidated balance sheets (in millions):

 

 

Amount of Gain (Loss)

 

 

 

 

Amount of Gain (Loss)

 

 

Amount of Gain (Loss)

 

 

 

 

Amount of Gain (Loss)

 

 

Recognized in AOCI

 

 

 

 

Reclassified from AOCI

 

 

Recognized in AOCI

 

 

 

 

Reclassified from AOCI

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

September 30,

 

 

September 30,

 

 

Location on

 

September 30,

 

 

September 30,

 

 

June 30,

 

 

June 30,

 

 

Location on

 

June 30,

 

 

June 30,

 

Derivative Instrument

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

Statement of Earnings

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

Statements of Earnings

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Foreign exchange

forward contracts

 

$

(35.6

)

 

$

(16.1

)

 

$

(98.7

)

 

$

(80.9

)

 

Cost of products sold

 

$

(5.1

)

 

$

18.1

 

 

$

12.0

 

 

$

76.5

 

 

$

(3.9

)

 

$

63.7

 

 

$

12.8

 

 

$

29.5

 

 

Cost of products sold

 

$

7.4

 

 

$

(10.5

)

 

$

14.5

 

 

$

(21.6

)

Interest rate swaps

 

 

(0.3

)

 

 

-

 

 

 

(0.3

)

 

 

-

 

 

Interest expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1.0

)

 

 

-

 

 

 

0.1

 

 

Interest expense, net

 

 

-

 

 

 

-

 

 

 

2.8

 

 

 

-

 

Forward starting

interest rate swaps

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

Interest expense

 

 

(0.1

)

 

 

(0.4

)

 

 

(0.4

)

 

 

(1.3

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

Interest expense, net

 

 

(0.2

)

 

 

(0.2

)

 

 

(0.3

)

 

 

(0.3

)

 

$

(35.9

)

 

$

(16.1

)

 

$

(99.0

)

 

$

(80.9

)

 

 

 

$

(5.2

)

 

$

17.7

 

 

$

11.6

 

 

$

75.2

 

 

$

(3.9

)

 

$

62.7

 

 

$

12.8

 

 

$

29.6

 

 

 

 

$

7.2

 

 

$

(10.7

)

 

$

17.0

 

 

$

(21.9

)

 

The net amounts recognized in earnings during the three and nine month periods ended September 30, 2017 and 2016 due to ineffectiveness and amounts excluded from the assessment of hedge effectiveness were not significant.  17


The fair value of outstanding derivative instruments designated as cash flow hedges and recorded on theour condensed consolidated balance sheet at SeptemberJune 30, 2017,2019, together with settled derivatives where the hedged item has not yet affected earnings, was a net unrealized lossgain of $74.3$19.2 million, or $56.6$21.4 million after taxes, which is deferred in AOCI.  A lossgain of $29.3$35.0 million, or $24.1$30.2 million after taxes, is expected to be reclassified to earnings in cost of products sold and a loss of $0.6 million, or $0.4$0.5 million after taxes, is expected to be reclassified to earnings in interest expense, net over the next twelve months.

The following table presents the effect of fair value and cash flow hedge accounting on our condensed consolidated statements of earnings (in millions):

 

 

Location and Amount of Gain/(Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships for the Period Ended:

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30, 2019

 

 

June 30, 2018

 

 

June 30, 2019

 

 

June 30, 2018

 

 

 

Cost of

 

 

Interest

 

 

Cost of

 

 

Interest

 

 

Cost of

 

 

 

 

 

 

Cost of

 

 

 

 

 

 

 

Goods

 

 

Expense,

 

 

Goods

 

 

Expense,

 

 

Goods

 

 

Interest

 

 

Goods

 

 

Interest

 

 

 

Sold

 

 

Net

 

 

Sold

 

 

Net

 

 

Sold

 

 

Expense

 

 

Sold

 

 

Expense

 

Total amounts of income and expense line items presented in the statements of earnings in which the effects of fair value or cash flow hedges are recorded

 

$

581.3

 

 

$

(59.7

)

 

$

583.7

 

 

$

(75.3

)

 

$

1,134.7

 

 

$

(117.7

)

 

$

1,159.5

 

 

$

(153.3

)

        The effects of fair value and cash flow hedging:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

             Gain on fair value hedging

                  relationships

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                       Discontinued interest rate swaps

 

 

-

 

 

 

2.1

 

 

 

-

 

 

 

2.1

 

 

 

-

 

 

 

4.2

 

 

 

-

 

 

 

4.2

 

             Gain (loss) on cash flow hedging

                  relationships

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                       Foreign exchange forward contracts

 

 

7.4

 

 

 

-

 

 

 

(10.5

)

 

 

-

 

 

 

14.5

 

 

 

-

 

 

 

(21.6

)

 

 

-

 

                       Interest rate swaps

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2.8

 

 

 

-

 

 

 

-

 

                       Forward starting interest rate swaps

 

 

-

 

 

 

(0.2

)

 

 

-

 

 

 

(0.2

)

 

 

-

 

 

 

(0.3

)

 

 

-

 

 

 

(0.3

)

             Gain on net investment hedging

                  relationships

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                       Cross-currency interest rate swaps

 

 

-

 

 

 

13.4

 

 

 

-

 

 

 

5.1

 

 

 

-

 

 

 

25.4

 

 

 

-

 

 

 

5.2

 

Derivatives Not Designated as Hedging Instruments

The following lossesgains and (losses) from these derivative instruments were recognized on our condensed consolidated statements of earnings (in millions):

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

Location on

 

September 30,

 

 

September 30,

 

 

Location on

 

June 30,

 

 

June 30,

 

Derivative Instrument

 

Statement of Earnings

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

Statements of Earnings

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Foreign exchange forward contracts

 

Other expense, net

 

$

(16.3

)

 

$

(5.1

)

 

$

(54.9

)

 

$

(42.3

)

 

Other expense, net

 

$

(6.3

)

 

$

27.6

 

 

$

(8.9

)

 

$

17.9

 

 

These gains/losses do not reflect offsetting gains of $11.1$1.3 million and $1.3$1.9 million in the three and six month periods ended SeptemberJune 30, 2017 and 2016,2019, respectively, and offsetting gainslosses of $43.0$32.9 million and $33.6$29.0 million in the ninethree and six month periods ended SeptemberJune 30, 2017 and 2016,2018, respectively, recognized in Otherother expense, net as a result of foreign currency re-measurement of monetary assets and liabilities denominated in a currency other than an entity’s functional currency.

1918


Balance Sheet Presentation

As of SeptemberJune 30, 20172019 and December 31, 2016,2018, all derivative instruments designated as fair value hedges, and cash flow hedges and net investment hedges were recorded at fair value on theour condensed consolidated balance sheet.sheets.  On our condensed consolidated balance sheets, we recognize individual forward contracts and options with the same counterparty on a net asset/liability basis if we have a master netting agreement with the counterparty.  Under these master netting agreements, we are able to settle derivative instrument assets and liabilities with the same counterparty in a single transaction, instead of settling each derivative instrument separately.  We have master netting agreements with all of our counterparties.  The fair value of derivative instruments on a gross basis is as follows (in millions):  

 

 

As of September 30, 2017

 

 

As of December 31, 2016

 

 

As of June 30, 2019

 

 

As of December 31, 2018

 

 

Balance

 

 

 

 

 

Balance

 

 

 

 

 

Balance

 

 

 

 

 

Balance

 

 

 

 

 

Sheet

 

Fair

 

 

Sheet

 

Fair

 

 

Sheet

 

Fair

 

 

Sheet

 

Fair

 

 

Location

 

Value

 

 

Location

 

Value

 

 

Location

 

Value

 

 

Location

 

Value

 

Asset Derivatives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign exchange forward contracts

 

Other current assets

 

$

15.9

 

 

Other current assets

 

$

57.9

 

 

Other current assets

 

$

42.0

 

 

Other current assets

 

$

37.9

 

Foreign exchange forward contracts

 

Other assets

 

 

7.4

 

 

Other assets

 

 

34.9

 

 

Other assets

 

 

12.5

 

 

Other assets

 

 

20.9

 

Interest rate swaps

 

Other assets

 

 

3.8

 

 

Other assets

 

 

4.0

 

 

Other assets

 

 

-

 

 

Other assets

 

 

2.8

 

Cross-currency interest rate swaps

 

Other assets

 

 

31.8

 

 

Other assets

 

 

15.1

 

Total asset derivatives

 

 

 

$

27.1

 

 

 

 

$

96.8

 

 

 

 

$

86.3

 

 

 

 

$

76.7

 

Liability Derivatives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign exchange forward contracts

 

Other current liabilities

 

$

37.2

 

 

Other current liabilities

 

$

20.9

 

 

Other current liabilities

 

$

8.5

 

 

Other current liabilities

 

$

9.9

 

Foreign exchange forward contracts

 

Other long-term liabilities

 

 

21.7

 

 

Other long-term liabilities

 

 

6.9

 

 

Other long-term liabilities

 

 

3.9

 

 

Other long-term liabilities

 

 

3.7

 

Cross-currency interest rate swaps

 

Other long-term liabilities

 

 

-

 

 

Other long-term liabilities

 

 

2.5

 

Total liability derivatives

 

 

 

$

58.9

 

 

 

 

$

27.8

 

 

 

 

$

12.4

 

 

 

 

$

16.1

 

 

The table below presents the effects of our master netting agreements on our condensed consolidated balance sheets (in millions):

 

 

 

 

As of September 30, 2017

 

 

As of December 31, 2016

 

 

 

 

As of June 30, 2019

 

 

As of December 31, 2018

 

Description

 

Location

 

Gross

Amount

 

 

Offset

 

 

Net Amount in

Balance Sheet

 

 

Gross

Amount

 

 

Offset

 

 

Net Amount in

Balance Sheet

 

 

Location

 

Gross

Amount

 

 

Offset

 

 

Net Amount in

Balance Sheet

 

 

Gross

Amount

 

 

Offset

 

 

Net Amount in

Balance Sheet

 

Asset Derivatives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flow hedges

 

Other current assets

 

$

15.9

 

 

$

13.6

 

 

$

2.3

 

 

$

57.9

 

 

$

20.6

 

 

$

37.3

 

 

Other current assets

 

$

42.0

 

 

$

8.3

 

 

$

33.7

 

 

$

37.9

 

 

$

9.6

 

 

$

28.3

 

Cash flow hedges

 

Other assets

 

 

7.4

 

 

 

5.8

 

 

 

1.6

 

 

 

34.9

 

 

 

6.8

 

 

 

28.1

 

 

Other assets

 

 

12.5

 

 

 

3.5

 

 

 

9.0

 

 

 

20.9

 

 

 

3.5

 

 

 

17.4

 

Liability Derivatives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flow hedges

 

Other current liabilities

 

 

37.2

 

 

 

13.6

 

 

 

23.6

 

 

 

20.9

 

 

 

20.6

 

 

 

0.3

 

 

Other current liabilities

 

 

8.5

 

 

 

8.3

 

 

 

0.2

 

 

 

9.9

 

 

 

9.6

 

 

 

0.3

 

Cash flow hedges

 

Other long-term liabilities

 

 

21.7

 

 

 

5.8

 

 

 

15.9

 

 

 

6.9

 

 

 

6.8

 

 

 

0.1

 

 

Other long-term liabilities

 

 

3.9

 

 

 

3.5

 

 

 

0.4

 

 

 

3.7

 

 

 

3.5

 

 

 

0.2

 

 

The following net investment hedge lossesgains (losses) were recognized on our condensed consolidated statements of comprehensive income (in millions):

 

 

Amount of Loss

 

 

Amount of Gain (Loss)

 

 

Recognized in OCI

 

 

Recognized in AOCI

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

September 30,

 

 

September 30,

 

 

June 30,

 

 

June 30,

 

Derivative Instrument

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Euro Notes

 

$

(41.7

)

 

$

-

 

 

$

(127.5

)

 

$

-

 

 

$

(16.0

)

 

$

62.3

 

 

$

4.4

 

 

$

33.3

 

Cross-currency interest rate swaps

 

 

(15.0

)

 

 

28.8

 

 

 

19.2

 

 

 

31.4

 

 

$

(31.0

)

 

$

91.1

 

 

$

23.6

 

 

$

64.7

 

 

11.

19


13.  Income Taxes

We operate on a global basis and are subject to numerous and complex tax laws and regulations.  Additionally, tax laws continue to undergo rapid changes in both application and interpretation by various countries, including state aid interpretations and initiatives led by the Organization for Economic Cooperation and Development led initiatives.Development.  Our income tax filings are subject to examinations by taxing authorities throughout the world. Income tax audits may require an extended period of time to reach resolution and may result in significant income tax adjustments when interpretation of tax laws or allocation of company profits is disputed.  Although ultimate timing is uncertain, the net amount of tax liability for unrecognized tax benefits may change within the next twelve months due to changes in audit status, expiration of statutes of limitations, settlements of tax assessments and other events.  Management’s best estimate of such change is within the range of a $115$175 million decrease to a $25 million increase.

Our U.S. Federal income tax returns have been audited through 2009 and are currently under audit for years 2010-2015.  The IRS has proposed adjustments for years 2005-2012, reallocating profits between certain of our U.S. and foreign subsidiaries.  We have

20


disputed these adjustments and intend to continue to vigorously defend our positions.  For years 2005-2007 and 2008-2009, we have filed a petitionpetitions with the U.S. Tax Court.  For years 2008-2009,2010-2012, we are pursuing resolution through the IRS Administrative Appeals Process.

OurIn the three and six month periods ended June 30, 2019, our effective tax rate (“ETR”) has been affected bywas 6.0 percent and 12.5 percent, respectively, compared to 15.1 percent and 18.2 percent in the significant expenses associated withthree and six month periods ended June 30, 2018, respectively.   The decline in ETR in the Biomet merger and other acquisitions which have generally been recognized in higher income tax jurisdictions.  Accordingly, this has reduced our ETR as our earnings have been lower in these higher income tax jurisdictions.  In the ninethree month period ended SeptemberJune 30, 2017, we recognized a tax benefit of $69.7 million resulting from a tax restructuring that lowered2019, compared to the tax rate on certain deferred tax liabilities recorded on intangible assets recognized insame prior year period was primarily due to the Biomet merger acquisition-related accounting.  In the three and nine month periods ended September 30, 2017, we recognized tax benefits of $39.8 million and $128.6 million, respectively, related tofavorable resolution of certain tax matters.  Inaudits.  The decline in ETR in the three and ninesix month periodsperiod ended SeptemberJune 30, 2017, we recognized net income tax expense of $7.7 million and $11.8 million, respectively, that related2019, compared to previous periods forthe same prior year period was primarily due to the favorable resolution of certain tax matters, certain tax restructurings and product liability matters.  We have evaluated the effect of these out-of-period corrections on the three and nine month periods ended September 30, 2017,audits as well as ona release of uncertain tax positions due to emerging foreign tax guidance in the previous interim and annual periods in which they should have been recognized, and concluded for both quantitative and qualitative reasons that these adjustments are not materialfirst quarter.  Absent discrete tax events, we expect our future ETR will continue to anybe lower than the U.S. corporate income tax rate of the periods affected.  Further, we do not believe these adjustments will be material21.0 percent due to our estimated netmix of earnings forbetween U.S. and foreign locations, which have lower corporate income tax rates.  Our ETR in future periods could also potentially be impacted by: changes in our mix of pre-tax earnings; changes in tax rates, tax laws or their interpretation, including the full year ended December 31, 2017.European Union rules on state aid; the outcome of various federal, state and foreign audits; and the expiration of certain statutes of limitations.  Currently, we cannot reasonably estimate the impact of these items on our financial results.

12.14.  Retirement Benefit Plans

We have defined benefit pension plans covering certain U.S. and Puerto Rico employees.  The employees who are not participating in the defined benefit plans receive additional benefits under our defined contribution plans.  Plan benefits are primarily based on years of credited service and the participant’s compensation.  In addition to the U.S. and Puerto Rico defined benefit pension plans, we sponsor various foreign pension arrangements, including retirement and termination benefit plans required by local law or coordinated with government sponsored plans.  

The components of net periodic pension expense for our U.S. and foreign defined benefit pension plans are as follows (in millions):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

September 30,

 

 

September 30,

 

 

June 30,

 

 

June 30,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Service cost

 

$

7.1

 

 

$

7.6

 

 

$

21.0

 

 

$

22.8

 

 

$

6.4

 

 

$

7.0

 

 

$

13.1

 

 

$

14.5

 

Interest cost

 

 

4.6

 

 

 

4.7

 

 

 

13.9

 

 

 

19.3

 

 

 

6.2

 

 

 

5.6

 

 

 

12.4

 

 

 

11.1

 

Expected return on plan assets

 

 

(10.1

)

 

 

(10.2

)

 

 

(30.3

)

 

 

(35.6

)

 

 

(11.4

)

 

 

(11.7

)

 

 

(22.9

)

 

 

(23.5

)

Curtailment gain (loss)

 

 

0.2

 

 

 

(0.4

)

 

 

0.4

 

 

 

(1.0

)

Amortization of prior service cost

 

 

(2.6

)

 

 

(1.9

)

 

 

(7.7

)

 

 

(5.8

)

 

 

(1.9

)

 

 

(2.5

)

 

 

(3.7

)

 

 

(5.0

)

Amortization of unrecognized actuarial loss

 

 

5.4

 

 

 

5.1

 

 

 

16.2

 

 

 

15.1

 

 

 

5.5

 

 

 

6.7

 

 

 

10.8

 

 

 

12.8

 

Net periodic pension expense

 

$

4.6

 

 

$

4.9

 

 

$

13.5

 

 

$

14.8

 

 

$

4.8

 

 

$

5.1

 

 

$

9.7

 

 

$

9.9

 

 

Service cost is recognized in the operating expense line item in which the related employee is classified.  All other components of net periodic pension expense are recognized in other expense, net.

20


We expect that we will have minimal legally required funding obligations in 20172019 for our U.S. and Puerto Rico defined benefit pension plans, and therefore we have not made, nor do we voluntarily expect to make, any material contributions to these plans during 2017.2019.  We contributed $13.2$11.3 million to our foreign-based defined benefit pension plans in the ninesix month period ended SeptemberJune 30, 2017,2019, and we expect to contribute $4.7$8.2 million to these foreign-based plans during the remainder of 2017.2019.

13.15.  Earnings Per Share

The following is a reconciliation of weighted average shares for the basic and diluted shares computations (in millions):

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Weighted average shares outstanding for basic

   net earnings per share

 

 

202.3

 

 

 

200.1

 

 

 

201.7

 

 

 

199.9

 

Effect of dilutive stock options and other equity awards

 

 

1.7

 

 

 

2.8

 

 

 

1.9

 

 

 

2.4

 

Weighted average shares outstanding for diluted

   net earnings per share

 

 

204.0

 

 

 

202.9

 

 

 

203.6

 

 

 

202.3

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Weighted average shares outstanding for basic net earnings per share

 

 

204.8

 

 

 

203.3

 

 

 

204.6

 

 

 

203.2

 

Effect of dilutive stock options and other equity awards

 

 

1.4

 

 

 

1.3

 

 

 

1.4

 

 

 

1.4

 

Weighted average shares outstanding for diluted net earnings per share

 

 

206.2

 

 

 

204.6

 

 

 

206.0

 

 

 

204.6

 

 

During the three and ninesix month periods ended SeptemberJune 30, 2017,2019, an average of 0.92.1 million options and 0.81.7 million options, respectively, to purchase shares of common stock were not included in the computation of diluted earnings per share because the

21


exercise prices of these options were greater than the average market price of our common stock.  In the three and ninesix month periods ended SeptemberJune 30, 2016,2018, an average of 0.13.4 million options and 0.52.3 million options, respectively, were not included for the same reason.  

14.16.  Segment Information

We design, manufacture and market orthopaedicorthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, craniomaxillofacial and thoracic products (“CMF”); office based technologies; dental implants; and related surgical products.  We allocateOur chief operating decision maker (“CODM”) allocates resources to achieve our operating profit goals through seven operating segments.  Our operating segments are comprised of both geographic and product category business units.  The geographic operating segments are the Americas, which is comprised principally of the U.S. and includes other North, Central and South American markets; EMEA, which is comprised principally of Europe and includes the Middle East and African markets; and Asia Pacific, which is comprised primarilyprincipally of Japan, China and Australia and includes other Asian and Pacific markets.  The product category operating segments are Spine, less Asia Pacific, Office Based Technologies, CMF and Dental.  The geographic operating segments include results from all of our product categories except those in the product category operating segments.  The Office Based Technologies, CMF and Dental product category operating segments reflect those respective product category results from all regions, whereas the Spine less Asia Pacific product category operating segment includes all spine product results excluding those from Asia Pacific.

As it relates to the geographic operating segments, managementour CODM evaluates performance based upon segment operating profit exclusive of operating expenses pertaining to inventory step-up and certain other inventory and manufacturing relatedmanufacturing-related charges, “Certain claims,” goodwill impairment, intangible asset amortization, “Special items,”intangible asset impairment, acquisition, integration and related, quality remediation, litigation, litigation settlement gain, certain European Union Medical Device Regulation expenses, other charges, and global operations and corporate functions.  Global operations and corporate functions include research, development engineering, medical education, brand management, corporate legal, finance and human resource functions, manufacturing operations and logistics and share-based payment expense.  As it relates to each product category operating segment, research, development engineering, medical education, brand management and other various costs that are specific to the product category operating segment’s operations are reflected in its operating profit results.  Due to these additional costs included in the product category operating segments, profitability metrics among the geographic operating segments and product category operating segments are not comparable.  Intercompany transactions have been eliminated from segment operating profit.

ManagementOur CODM does not review asset information by operating segment.  Instead, managementour CODM reviews cash flow and other financial ratios by operating segment.

These seven operating segments are the basis for our reportable segment information provided below.  The four product category operating segments are individually insignificant to our consolidated results and therefore do not constitute a reportablereporting segment either individually or combined.  For presentation purposes, these product category operating segments have been aggregated.  In 2017, due to a change in management responsibilities, the sales and operating profit results of our Spine business in EMEA were combined with the previous Americas Spine operating segment to form the product category operating segment, Spine less Asia Pacific.  Prior period reportable segment financial information has been restated to conform to the current presentation.

21


Net sales and operating profit by segment are as follows (in millions):

 

 

Net Sales

 

 

Operating Profit

 

 

Net Sales

 

 

Operating Profit

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Three Months Ended

 

 

September 30,

 

 

September 30,

 

 

June 30,

 

 

June 30,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Americas

 

$

921.2

 

 

$

946.6

 

 

$

502.3

 

 

$

515.6

 

 

$

989.1

 

 

$

979.3

 

 

$

538.8

 

 

$

530.1

 

EMEA

 

 

335.4

 

 

 

322.1

 

 

 

97.5

 

 

 

92.3

 

 

 

383.2

 

 

 

400.0

 

 

 

116.9

 

 

 

117.5

 

Asia Pacific

 

 

281.7

 

 

 

274.5

 

 

 

101.5

 

 

 

106.3

 

 

 

321.9

 

 

 

319.2

 

 

 

114.8

 

 

 

109.7

 

Product Category Operating Segments

 

 

279.8

 

 

 

289.6

 

 

 

51.1

 

 

 

47.5

 

 

 

294.4

 

 

 

309.1

 

 

 

49.7

 

 

 

39.4

 

Global Operations and Corporate Functions

 

 

-

 

 

 

-

 

 

 

(210.5

)

 

 

(208.7

)

 

 

-

 

 

 

-

 

 

 

(275.0

)

 

 

(235.2

)

Total

 

$

1,818.1

 

 

$

1,832.8

 

 

 

 

 

 

 

 

 

 

$

1,988.6

 

 

$

2,007.6

 

 

 

 

 

 

 

 

 

Inventory step-up and other inventory and manufacturing

related charges

 

 

 

 

 

 

 

 

 

 

(10.4

)

 

 

(22.8

)

Inventory and manufacturing-related charges

 

 

 

 

 

 

 

 

 

 

(34.1

)

 

 

(12.5

)

Intangible asset amortization

 

 

 

 

 

 

 

 

 

 

(152.7

)

 

 

(164.3

)

 

 

 

 

 

 

 

 

 

 

(146.9

)

 

 

(149.5

)

Special items

 

 

 

 

 

 

 

 

 

 

(165.4

)

 

 

(170.4

)

Intangible asset impairment

 

 

 

 

 

 

 

 

 

 

(70.1

)

 

 

-

 

Acquisition, integration and related

 

 

 

 

 

 

 

 

 

 

(10.5

)

 

 

(50.5

)

Quality remediation

 

 

 

 

 

 

 

 

 

 

(23.4

)

 

 

(45.4

)

Litigation

 

 

 

 

 

 

 

 

 

 

(7.0

)

 

 

4.2

 

European Union Medical Device Regulation

 

 

 

 

 

 

 

 

 

 

(5.1

)

 

 

(0.5

)

Other charges

 

 

 

 

 

 

 

 

 

 

(43.4

)

 

 

(11.3

)

Operating profit

 

 

 

 

 

 

 

 

 

$

213.4

 

 

$

195.5

 

 

 

 

 

 

 

 

 

 

$

204.7

 

 

$

296.0

 

 

 

Net Sales

 

 

Operating Profit

 

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Americas

 

$

1,964.5

 

 

$

1,970.4

 

 

$

1,045.9

 

 

$

1,062.3

 

EMEA

 

 

789.1

 

 

 

832.6

 

 

 

243.3

 

 

 

256.7

 

Asia Pacific

 

 

625.6

 

 

 

618.1

 

 

 

218.8

 

 

 

211.8

 

Product Category Operating Segments

 

 

584.9

 

 

 

604.1

 

 

 

90.6

 

 

 

92.6

 

Global Operations and Corporate Functions

 

 

-

 

 

 

-

 

 

 

(528.4

)

 

 

(490.1

)

Total

 

$

3,964.1

 

 

$

4,025.2

 

 

 

 

 

 

 

 

 

Inventory and manufacturing-related charges

 

 

 

 

 

 

 

 

 

 

(36.1

)

 

 

(19.7

)

Intangible asset amortization

 

 

 

 

 

 

 

 

 

 

(290.3

)

 

 

(300.3

)

Intangible asset impairment

 

 

 

 

 

 

 

 

 

 

(70.1

)

 

 

-

 

Acquisition, integration and related

 

 

 

 

 

 

 

 

 

 

(21.2

)

 

 

(96.5

)

Quality remediation

 

 

 

 

 

 

 

 

 

 

(43.1

)

 

 

(91.6

)

Litigation

 

 

 

 

 

 

 

 

 

 

(5.2

)

 

 

(1.5

)

Litigation settlement gain

 

 

 

 

 

 

 

 

 

 

23.5

 

 

 

-

 

European Union Medical Device Regulation

 

 

 

 

 

 

 

 

 

 

(6.7

)

 

 

(0.8

)

Other charges

 

 

 

 

 

 

 

 

 

 

(66.1

)

 

 

(21.9

)

Operating profit

 

 

 

 

 

 

 

 

 

$

554.9

 

 

$

601.0

 

22


 

 

Net Sales

 

 

Operating Profit

 

 

 

Nine Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Americas

 

$

2,900.0

 

 

$

2,909.6

 

 

$

1,568.8

 

 

$

1,574.1

 

EMEA

 

 

1,108.5

 

 

 

1,122.7

 

 

 

348.2

 

 

 

368.0

 

Asia Pacific

 

 

850.5

 

 

 

806.9

 

 

 

318.5

 

 

 

331.4

 

Product Category Operating Segments

 

 

890.8

 

 

 

831.6

 

 

 

197.2

 

 

 

177.1

 

Global Operations and Corporate Functions

 

 

-

 

 

 

-

 

 

 

(641.6

)

 

 

(628.6

)

Total

 

$

5,749.8

 

 

$

5,670.8

 

 

 

 

 

 

 

 

 

Inventory step-up and other inventory and manufacturing

   related charges

 

 

 

 

 

 

 

 

 

 

(58.5

)

 

 

(357.7

)

Intangible asset amortization

 

 

 

 

 

 

 

 

 

 

(452.4

)

 

 

(424.7

)

Special items

 

 

 

 

 

 

 

 

 

 

(434.1

)

 

 

(397.0

)

Operating profit

 

 

 

 

 

 

 

 

 

$

846.1

 

 

$

642.6

 

Net sales by product category are as follows (in millions):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Knees

 

$

623.7

 

 

$

631.5

 

 

$

2,005.9

 

 

$

2,031.7

 

Hips

 

 

434.5

 

 

 

440.6

 

 

 

1,380.0

 

 

 

1,385.7

 

S.E.T.

 

 

406.6

 

 

 

401.8

 

 

 

1,254.5

 

 

 

1,215.0

 

Dental

 

 

92.9

 

 

 

95.9

 

 

 

311.1

 

 

 

322.5

 

Spine & CMF

 

 

184.9

 

 

 

183.7

 

 

 

565.2

 

 

 

470.7

 

Other

 

 

75.5

 

 

 

79.3

 

 

 

233.1

 

 

 

245.2

 

Total

 

$

1,818.1

 

 

$

1,832.8

 

 

$

5,749.8

 

 

$

5,670.8

 

“S.E.T” refers to our Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma product category.

15.17.  Commitments and Contingencies

On a quarterly and annual basis, we review relevant information with respect to loss contingencies and update our accruals, disclosures and estimates of reasonably possible losses or ranges of loss based on such reviews.  We establish liabilities for loss contingencies when it is probable that a loss has been incurred and the amount of the loss can be reasonably estimated.  For matters where a loss is believed to be reasonably possible, but not probable, no accrual has been made.

Litigation

Durom® Cup-related claims:  On July 22, 2008, we temporarily suspended marketing and distribution of the Durom Cup in the U.S.  Subsequently, a number of product liability lawsuits were filed against us in various U.S. and foreign jurisdictions.  The plaintiffs seek damages for personal injury, and they generally allege that the Durom Cup contains defects that result in complications and premature revision of the device.  We have settled somethe majority of these claims and others are still pending.  The majority of the pending U.S. lawsuits are currently in a federal Multidistrict Litigation (“MDL”) in the District of New Jersey (In Re: Zimmer Durom Hip Cup Products Liability Litigation).  Multi-plaintiff state court cases are pending in St. Clair County, Illinois (Santas, et al. v. Zimmer, Inc., et al.) and Los Angeles County, California (McAllister, et al. v. Zimmer, Inc., et al.).  The initial trial in Santas took place in November 2014, the initial trial in the MDL took place in May 2015 and the initial trial in McAllister took place in July 2015.  As of September 30, 2017, litigationLitigation activity in the MDLSantas and McAllister is stayed to allow participation inpending finalization of the U.S. Durom Cup Settlement Program, an extrajudicial program created to resolve actions and claims of eligible U.S. plaintiffs and claimants.  Other lawsuits are pending in various domestic and foreign jurisdictions, and additional claims may be asserted in the future.  The majority of claims outside the U.S. are pending in Canada, Germany, Netherlands Italy and the U.K.  A Canadian class settlement was approved in late 2016.  Trials have commenced in Germany, and the majority of claims in the U.K. are consolidated in a Group Litigation Order.Italy.  

Since 2008, we have recognized net expense of $479.4$443.0 million for Durom Cup-related claims.  OurIn the three and six month periods ended June 30, 2019, we lowered our estimate of our total liability for these claims asthe number of September 30, 2017 remains consistent with our estimate as of December 31, 2016, and, accordingly, we did not

23


record any additional expense during the nine month period ended September 30, 2017.  With respect to the same prior year period, we also did not record any expense for Durom Cup-related claims.claims we expect to settle and, as a result, we recognized gains of $7.0 million and $9.5 million, respectively, in selling, general and administrative expense.  We recorded a $20.0 million gain in the three and six month periods ended June 30, 2018.

We maintain insurance for product liability claims, subject to self-insurance retention requirements.  AsWe have recovered insurance proceeds from certain of September 30, 2017, we have exhausted our self-insured retention under our insurance program andcarriers for Durom Cup-related claims.  While we may recover additional insurance proceeds in the future for Durom Cup-related claims, we do not have a claim for insurance proceeds for ultimate losses which exceed the self-insured retention amount, subject to a 20 percent co-payment requirement and a cap.  We believe our contracts with the insurance carriers are enforceable for these claims and, therefore, it is probable that we will recover some amount from our insurance carriers.  We have received a portion of the insurance proceeds we estimate we will recover.  We have a $95.3 million receivable in “Other assets” remainingrecorded on our condensed consolidated balance sheet as of SeptemberJune 30, 20172019 for estimatedany possible future insurance recoveries for Durom Cup-related claims.  As is customary in this process, our insurance carriers have reserved all rights under their respective policies and could still ultimately deny coverage for some or all of our insurancethese claims.

Our estimate as of SeptemberJune 30, 20172019 of the remaining liability for all Durom Cup-related claims is $218.3$73.5 million, of which $75.0$19.5 million is classified as short-term in “Otherother current liabilities”liabilities and $143.3$54.0 million is classified as long-term in “Otherother long-term liabilities”liabilities on our condensed consolidated balance sheet.  We expect to pay the majority of the Durom Cup-related claims within the next few years.

Our understanding of clinical outcomes with the Durom Cup and other large diameter hip cups continues to evolve.  We rely on significant estimates in determining the provisions for Durom Cup-related claims, including our estimate of the number of claims that we will receive and the average amount we will pay per claim.  The actual number of claims and the actual amount we pay per claim may differ from our estimates.  Among other factors, since our understanding of the clinical outcomes is still evolving, we cannot reasonably estimate the possible loss or range of loss that may result from Durom Cup-related claims in excess of the losses we have accrued.  Although we are vigorously defending these lawsuits, their ultimate resolution is uncertain.

Margo and Daniel Polett v. Zimmer, Inc. et al.:  On August 20, 2008, Margo and Daniel Polett filed an action against us and an unrelated third party, Public Communications, Inc. (“PCI”), in the Court of Common Pleas, Philadelphia, Pennsylvania seeking an unspecified amount of damages for injuries and loss of consortium allegedly suffered by Mrs. Polett and her spouse, respectively.  The complaint alleged that defendants were negligent in connection with Mrs. Polett’s participation in a promotional video featuring one of our knee products.  The case was tried in November 2010 and the jury returned a verdict in favor of plaintiffs.  The jury awarded $27.6 million in compensatory damages and apportioned fault 30 percent to plaintiffs, 34 percent to us and 36 percent to PCI.  Under applicable law, we may be liable for any portion of the damages apportioned to PCI that it does not pay.  On December 2, 2010, we and PCI filed a motion for post-trial relief seeking a judgment notwithstanding the verdict, a new trial or a remittitur.  On June 10, 2011, the trial court entered an order denying our motion for post-trial relief and affirming the jury verdict in full and entered judgment for $20.3 million against us and PCI.  On June 29, 2011, we filed a notice of appeal to the Superior Court of Pennsylvania and posted a bond for the verdict amount plus interest.  Oral argument before the appellate court in Philadelphia, Pennsylvania was held on March 13, 2012.  On March 1, 2013, the Superior Court of Pennsylvania vacated the $27.6 million judgment and remanded the case for a new trial.  On March 15, 2013, plaintiffs filed a motion for re-argument en banc, and on March 28, 2013, we filed our response in opposition.  On May 9, 2013, the Superior Court of Pennsylvania granted plaintiffs’ motion for re-argument en banc.  Oral argument (re-argument en banc) before the Superior Court of Pennsylvania was held on October 16, 2013.  On December 20, 2013, the Court issued its opinion again vacating the trial court judgment and remanding the case for a new trial.  On January 21, 2014, plaintiffs filed a petition for allowance of appeal in the Supreme Court of Pennsylvania, which was granted on May 21, 2014.  Oral argument before the Supreme Court of Pennsylvania took place on October 8, 2014.  On October 27, 2015, the Supreme Court of Pennsylvania reversed the order of the Superior Court of Pennsylvania and remanded the case to that court to consider the question of whether the trial court erred in refusing to remit the jury’s compensatory damages award.  On June 6, 2016, an en banc panel of the Superior Court of Pennsylvania vacated the $27.6 million verdict and remanded the case back to the trial court for remittitur.  On December 2, 2016, the trial court remitted the verdict to $21.5 million.  On December 5, 2016, we filed a notice of appeal to the Superior Court of Pennsylvania.  Oral argument before the Superior Court of Pennsylvania took place on September 20, 2017.  The Court has not yet issued its opinion.  Although we are defending this lawsuit vigorously, its ultimate resolution is uncertain.  In the future, we could be required to record a charge that could have a material adverse effect on our results of operations and cash flows.

NexGen® Knee System claims:  Following a wide-spread advertising campaign conducted by certain law firms beginning in 2010, a number of product liability lawsuits have been filed against us in various jurisdictions.  The plaintiffs seek damages for personal injury, alleging that certain products within the NexGen Knee System, specifically the NexGen Flex Femoral Components and MIS Stemmed Tibial Component, suffer from defects that cause them to loosen prematurely.  The majority of the cases are currently pending in a federalan MDL in the Northern District of Illinois (In Re: Zimmer NexGen Knee Implant Products Liability Litigation).  Other cases are pending in various state courts, and additional lawsuits may be filed.  Thus far, all cases decided by the MDL court or a jury on the merits have involved NexGen Flex Femoral Components, which represent the majority of cases in the MDL.  The initial bellwether trial took place in October 2015 and resulted in a defense verdict.  The next scheduled bellwether trial, which was set to commence in November 2016, was dismissed following the court’s grant of summary judgment in our favor in

24


October 2016.  That decision was appealed by the plaintiff and subsequently affirmed by the U.S. Court of Appeals for the Seventh Circuit in March 2018.  The second bellwether trial took place in January 2017 and resulted in a defense verdict.  The parties attended a court-ordered mediation in January 2018, at which a settlement in principle was reached that would resolve all MDL cases and all state court cases that involved MDL products.  On February 11, 2019, we informed the MDL court of our intention to consummate a confidential settlement that resolves nearly all of the remaining cases, which was completed in June 2019.  The settlement did not have a material adverse effect on our results of operations or cash flows.

Zimmer M/L Taper, M/L Taper with Kinectiv Technology, and Versys Femoral Head-related claims: We are a defendant in a number of product liability lawsuits relating to our M/L Taper and M/L Taper with Kinectiv Technology hip stems, and Versys Femoral Head implants.  The plaintiffs seek damages for personal injury, alleging that defects in the products lead to corrosion at the

23


head/stem junction resulting in, among other things, pain, inflammation and revision surgery.  The majority of the cases are consolidated in an MDL in the United States District Court for the Southern District of New York (In Re: Zimmer M/L Taper Hip Prosthesis or M/L Taper Hip Prosthesis with Kinectiv Technology and Versys Femoral Head Products Liability Litigation).  Other related cases are pending in various state courts, with the majority of state court cases pending in Oregon, New Mexico, Indiana and Florida.  Additional lawsuits are likely to be filed.  Although we are vigorously defending these lawsuits, their ultimate resolution is uncertain.  

Biomet metal-on-metal hip implant claims:  Biomet is a defendant in a number of product liability lawsuits relating to metal-on-metal hip implants.  The majorityimplants, most of these caseswhich involve the M2a-MagnumTM hip system.  The majority of the casesCases are currently consolidated in one federalan MDL proceeding in the U.S. District Court for the Northern District of Indiana (In Re: Biomet M2a Magnum Hip Implant Product Liability Litigation).  Other cases are pending andin various state and foreign courts.courts, with the majority of domestic state court cases pending in Indiana and Florida.

On February 3, 2014, Biomet announced the settlement of the MDL.  Lawsuits filed in the MDL by April 15, 2014 were eligible to participate in the settlement.  Those claims that did not settle via the MDL settlement program have re-commenced litigation in the MDL under a new case management plan.plan, or are in the process of being remanded to their originating jurisdictions.  The settlement does not affect certain other claims relating to Biomet’s metal-on-metal hip products that are pending in various state and foreign courts, or other claims that may be filed in the future.  Our estimate as of SeptemberJune 30, 20172019 of the remaining liability for all Biomet metal-on-metal hip implant claims is $39.7$64.3 million.

Biomet has exhausted the self-insured retention in its insurance program and has been reimbursed for claims related to its metal-on-metal products up to its policy limits in the program.  Zimmer Biomet is responsible for any amounts by which the ultimate losses exceed the amount of Biomet’s third-party insurance coverage.  As of SeptemberJune 30, 2017,2019, Biomet had received all of the insurance proceeds it expects to recover under the excess policies.  Although we are vigorously defending these lawsuits, their ultimate resolution is uncertain.

Heraeus trade secret misappropriation lawsuits:  In December 2008, Heraeus Kulzer GmbH (together with its affiliates, “Heraeus”) initiated legal proceedings in Germany against Biomet, Inc., Biomet Europe BV, certain other entities and certain employees alleging that the defendants misappropriated Heraeus trade secrets when developing Biomet Europe’s Refobacin and Biomet Bone Cement line of cements (“European Cements”).  The lawsuit sought to preclude the defendants from producing, marketing and offering for sale their currentthen-current line of European Cements and to compensate Heraeus for any damages incurred.

Germany: On June 5, 2014, the German appeals court in Frankfurt (i) enjoined Biomet, Inc., Biomet Europe BV and Biomet Deutschland GmbH from manufacturing, selling or offering the European Cements to the extent they contain certain raw materials in particular specifications; (ii) held the defendants jointly and severally liable to Heraeus for any damages from the sale of European Cements since 2005; and (iii) ruled that no further review may be sought (the “Frankfurt Decision”).  The Heraeus and Biomet parties both sought appeal against the Frankfurt Decision.  In a decision dated June 16, 2016, the German Supreme Court dismissed the parties’ appeals without reaching the merits, rendering that decision final.

In December 2016, Heraeus filed papers to restart proceedings against Biomet Orthopaedics Switzerland GmbH, seeking to require that entity to relinquish its CE certificates for the European Cements.  In January 2017, Heraeus notified Biomet it had filed a claim for damages in the amount of €121.9 million for sales in Germany.Germany, which it first increased to 125.9 million and with a filing in June 2019 further increased to €146.7 million plus statutory interest.  In September 2017, Heraeus filed an enforcement action in the FrankfurtDarmstadt court against Biomet Europe, requesting that a fine be imposed against Biomet Europe for failure to preventdisclose the amount of the European Cements which Biomet Orthopaedics Switzerland from having bone cementshad ordered to be manufactured in Germany (e.g., for the Chinese market manufactured in Germany.market).  In June 2018, the Darmstadt court dismissed Heraeus’ request.  Heraeus appealed the decision.  Also in September 2017, Heraeus filed suit against Zimmer Biomet Deutschland in the court of first instance in Freiberg concerning the sale of the European Cements with certain changed raw materials.  Heraeus seeks an injunction on the basis that the continued use of the product names for the European Cements is misleading for customers and thus an act of unfair competition.  AsOn June 29, 2018, the court in Freiberg, Germany dismissed Heraeus’ request for an injunction prohibiting the marketing of September 30, 2017, these claims were still pending.the European Cements under their current names on the grounds that the same request had already been decided upon by the Frankfurt Decision which became final and binding.  Heraeus has appealed this decision to the Court of Appeals in Karlsruhe, Germany.  The appeals hearing is scheduled for December 2019.

United States: On September 8, 2014, Heraeus filed a complaint against a Biomet supplier, Esschem, Inc. (“Esschem”), in the United StatesU.S. District Court for the Eastern District of Pennsylvania.  The lawsuit containscontained allegations that focusfocused on two copolymer compounds that Esschem sellssold to Biomet, which Biomet incorporatesincorporated into certain bone cement products that compete with Heraeus’ bone cement products.  The complaint allegesalleged that Biomet helped Esschem to develop these copolymers, using Heraeus trade secrets that Biomet allegedly misappropriated.  The complaint assertsasserted a claim under the Pennsylvania Uniform Trade Secrets Act, as well as other various common law tort claims, all based upon the same trade secret misappropriation theory.  Heraeus is seekingsought to enjoin

24


Esschem from supplying the copolymers to any third party and actual damages.  The complaint also seekssought punitive damages, costs and attorneys’ fees.  If Esschem is enjoined, Biomet may not be able to obtain the copolymers from another supplier and as a result may not be able to continue to manufacture the subject bone cement products.  Although Biomet iswas not a party to this lawsuit, Biomet has agreed, at Esschem’s request and subject to certain limitations, to indemnify Esschem for any liability, damages and legal costs related to this matter.  On November 3, 2014, the court entered an order denying Heraeus’ motion for a temporary restraining order.  On June 30, 2016, the court entered an order denying Heraeus’ request to give preclusive effect to the factual findings in the Frankfurt Decision.  On June 6, 2017, the court entered an order denying Heraeus’ motion to add Biomet as a party to the lawsuit.  TheOn January 26, 2018, the court has not setentered an order granting Esschem’s motion for summary judgment and dismissed all of Heraeus’ claims with prejudice.  On February 21, 2018, Heraeus filed a trial date.notice of appeal to the U.S. Court of Appeals for the Third Circuit, which heard oral argument on the appeal on October 23, 2018.  On June 21, 2019, the Third Circuit partially reversed the decision of the U.S. District Court for the Eastern District of Pennsylvania granting Esschem summary judgment and remanded the case back to the lower court.  On July 5, 2019, Esschem filed a petition in the Third Circuit for rehearing en banc and a motion in the alternative to certify a question of state law to the Supreme Court of Pennsylvania, which remained pending as of July 31, 2019.

On December 7, 2017, Heraeus filed a complaint against Zimmer Biomet Holdings, Inc. and Biomet, Inc. in the U.S. District Court for the Eastern District of Pennsylvania alleging a single claim of trade secret misappropriation under the Pennsylvania Uniform Trade Secrets Act based on the same factual allegations as the Esschem litigation.  On March 5, 2018, Heraeus filed an amended complaint adding a second claim of trade secret misappropriation under Pennsylvania common law.  Heraeus seeks to enjoin the Zimmer Biomet parties from future use of the allegedly misappropriated trade secrets and recovery of unspecified damages for alleged past use.  On April 18, 2018, the Zimmer Biomet parties filed a motion to dismiss both claims.  On March 8, 2019, the court stayed the case pending the Third Circuit’s decision in the Esschem case described above.

Other European Countries: Heraeus continues to pursue other related legal proceedings in Europe seeking various forms of relief, including injunctive relief and damages, against Biomet-related entities relating to the European Cements.  On October 2, 2018, the Belgian Court of Appeal of Mons issued a judgment in favor of Heraeus relating to its request for past damages caused by the alleged misappropriation of its trade secrets, and an injunction preventing future sales of certain European Cements in Belgium (the “Belgian Decision”).  We have appealed this judgment to the Belgian Supreme Court.  Heraeus subsequently filed a suit in Belgium concerning the continued sale of the European Cements with certain changed materials.  Like its suit in Germany, Heraeus seeks an injunction on the basis that the continued use of the product names for the European Cements is misleading for customers and thus an act of unfair competition.  On May 7, 2019, the Liège Commercial Court issued a judgment that Zimmer Biomet failed to inform its hospital and surgeon customers of the changes made to the composition of the cement with certain changed materials and ordered, as a sole remedy, that Zimmer Biomet send letters to those customers, which we have done.  We filed an appeal to the judgment.  

25On February 13, 2019, a Norwegian court of first instance issued a judgment in favor of Heraeus on its claim for misappropriation of trade secrets.  The court awarded damages of 19,500,000 NOK, or approximately $2.3 million, plus attorneys’ fees, and issued an injunction, which is not final and thus not currently being enforced, preventing Zimmer Biomet Norway from marketing in Norway bone cements identified with the current product names and bone cements making use of the trade secrets which were acknowledged in the Frankfurt Decision.  We have appealed the Norwegian judgment to the court of second instance.


Heraeus is pursuing damages and injunctive relief in France in an effort to prevent us from manufacturing, marketing and selling the European Cements (the “France Litigation”).  The European Cements are manufactured at our facility in Valence, France.  On December 11, 2018, a hearing was held in the France Litigation before the commercial court in Romans-sur-Isère.  On May 23, 2019, the commercial court ruled in our favor.  On July 12, 2019, Hereaus filed an appeal to the court of second instance in Grenoble, France.  Although we are vigorously defending the France Litigation, the ultimate outcome is uncertain.  An adverse ruling in the France Litigation could have a material adverse effect on our business, financial condition and results of operations.

We have accrued an estimated loss relating to the Frankfurt Decision, but have not recognized any losses for Heraeus-related lawsuits in other jurisdictions because we do not believe it is probable that we have incurred a liability, and we cannot reasonably estimate any loss that might eventually be incurred.collective European trade secret litigation, including estimated legal costs to defend.  Damages relating to the Frankfurt Decision are subject to separate proceedings, and the Belgian court appointed an expert to determine the amount of damages related to the Belgian Decision.  Thus, it is reasonably possible that our estimate of the loss we may incur may change in the future.  Although we are vigorously defending these lawsuits, their ultimate resolution is uncertain.

Stryker patent infringement lawsuit:  On December 10, 2010, Stryker Corporation and related entities (“Stryker”) filed suit against us in the U.S. District Court for the Western District of Michigan, alleging that certain of our Pulsavac® Plus Wound Debridement Products infringethreeU.S. patents assigned to Stryker.  The case was tried beginning on January 15, 2013, and on February 5, 2013, the jury found that we infringed certain claims of the subject patents.  The jury awarded $70.0 million in monetary damages for lost profits.  The jury also found that we willfully infringed the subject patents.  We filed multiple post-trial motions, including a motion seeking a new trial.  On August 7, 2013, the trial court issued a ruling denying all of our motions and awarded treble damages and attorneys’ fees to Stryker.  We filed a notice of appeal to the Court of Appeals for the Federal Circuit to seek reversal of both the jury’s verdict and the trial court’s rulings on our post-trial motions.  Oral argument before the Court of Appeals for the Federal Circuit took place on September 8, 2014.  On December 19, 2014, the Federal Circuit issued a decision affirming the $70.0 million lost profits award but reversed the willfulness finding, vacating the treble damages award and vacating and remanding the attorneys’ fees award.  We accrued an estimated loss of $70.0 million related to this matter in the three month period ended

25


December 31, 2014.  On January 20, 2015, Stryker filed a motion with the Federal Circuit for a rehearing en banc.  On March 23, 2015, the Federal Circuit denied Stryker’s petition.  Stryker subsequently filed a petition for certiorari to the U.S. Supreme Court.  In July 2015, we paid the final lost profits award of $90.3 million, which includes the original $70.0 million plus pre- and post-judgment interest and damages for sales that occurred post-trial but prior to our entry into a license agreement with Stryker.  On October 19, 2015, the U.S. Supreme Court granted Stryker’s petition for certiorari.  Oral argument took place on February 23, 2016.  On June 13, 2016, the U.S. Supreme Court issued its decision, vacating the judgment of the Federal Circuit and remanding the case for further proceedings related to the willfulness issue.  On September 12, 2016, the Federal Circuit issued an opinion affirming the jury’s willfulness finding and vacating and remanding the trial court’s award of treble damages, its finding that this was an exceptional case and its award of attorneys’ fees.  The case was remanded back to the trial court.  Oral argument on Stryker’s renewed consolidated motion for enhanced damages and attorneys’ fees took place on June 28, 2017.  On July 12, 2017, the trial court issued an order reaffirming its award of treble damages, its finding that this was an exceptional case and its award of attorney’sattorneys’ fees.  On July 24, 2017, we appealed the ruling to the Federal Circuit and obtained a supersedeas bond staying enforcement of the judgment pending appeal.  AlthoughOral argument before the Federal Circuit took place on December 3, 2018 and the Federal Circuit affirmed the trial court’s ruling in full on December 10, 2018.  We accrued an estimated loss of approximately $168.0 million related to the award of treble damages and attorneys’ fees in the three-month period ended December 31, 2018.  On January 23, 2019, we are defending this lawsuit vigorously,filed a petition with the ultimate resolutionFederal Circuit for a rehearing en banc.  On March 19, 2019, the petition for rehearing en banc was denied.  In late March 2019, we paid the outstanding judgment of this matter is uncertain.  Inapproximately $168.0 million.  On June 17, 2019, we filed a petition for certiorari seeking U.S. Supreme Court review of the future, we could be required to record a charge of up to $165.0 million that could have a material adverse effect on our results of operations and cash flows.Federal Circuit’s decision.

Putative Securities Class Action:  On December 2, 2016, a complaint was filed in the U.S. District Court for the Northern District of Indiana (Shah v. Zimmer Biomet Holdings, Inc. et al.), naming us, twoone of our officers and onetwo of our now former officers as defendants.  On June 28, 2017, the plaintiffs filed a corrected amended complaint, naming as defendants, in addition to those previously named, current and former members of our Board of Directors, one additional officer, and the underwriters in connection with secondary offerings of our common stock by certain selling stockholders in 2016.  On October 6, 2017, the plaintiffs voluntarily dismissed the underwriters without prejudice.  On October 8, 2017, the plaintiffs filed a second amended complaint, naming as defendants, in addition to those current and former officers and Board members previously named, certain former stockholders of ours who sold shares of our common stock in secondary public offerings in 2016.  We and our current and former officers and Board members named as defendants are sometimes hereinafter referred to as the “Zimmer Biomet Defendant group”.  The former stockholders of ours who sold shares of our common stock in secondary public offerings in 2016 are sometimes hereinafter referred to as the “Private Equity Fund Defendant group”.  The second amended complaint relates to a putative class action on behalf of persons who purchased our common stock between June 7, 2016 and November 7, 2016.  The second amended complaint generally alleges that the defendants violated federal securities laws by making materially false and/or misleading statements and/or omissions about our compliance with U.S. Food and Drug Administration (“FDA”)regulations and our ability to continue to accelerate our organic revenue growth rate in the second half of 2016.  The defendants filed their respective motions to dismiss on December 20, 2017, plaintiffs filed their omnibus response to the motions to dismiss on March 13, 2018 and the defendants filed their respective reply briefs on May 18, 2018.  On September 27, 2018, the court denied the Zimmer Biomet Defendant group’s motion to dismiss in its entirety.  The court granted the Private Equity Fund Defendant group’s motion to dismiss, without prejudice.  On October 9, 2018, the Zimmer Biomet Defendant group filed a motion (i) to amend the court’s order on the motion to certify two issues for interlocutory appeal, and (ii) to stay proceedings pending appeal.  On February 21, 2019, that motion was denied.  On April 11, 2019, the plaintiffs moved for class certification.  On June 20, 2019, the Zimmer Biomet Defendant group filed its response.  The plaintiffs seek unspecified damages and interest, attorneys’ fees, costs and other relief.  We believe this lawsuit is without merit, and we and the individual defendants are defending it vigorously.

Shareholder Derivative Actions:  On June 14 and July 29, 2019, two separate shareholder derivative actions, Green v. Begley et al. and Detectives Endowment Association Annuity Fund v. Begley et al., were filed in the court of Chancery in the State of Delaware.  The plaintiff in each action seeks to maintain the action purportedly on our behalf against certain of our current and former directors and officers (the “individual defendants”) and certain former stockholders of ours who sold shares of our common stock in various secondary public offerings in 2016 (the “private equity fund defendants”).  The plaintiff in each action alleges, among other things, breaches of fiduciary duties against the individual defendants and insider trading against two individual defendants and the private equity fund defendants, based on substantially the same factual allegations as the putative federal securities class action referenced above (Shah v. Zimmer Biomet Holdings, Inc. et al.).  The plaintiffs do not seek damages from us, but instead request damages from the defendants of an unspecified amount on our behalf.  The plaintiffs also seek attorneys’ fees, costs and other relief.  As of July 31, 2019, the parties were negotiating stipulations governing service of process and the timing for motions by the various defendants, including potential motions to stay, motions raising demand futility issues and substantive motions to dismiss some or all of the asserted claims.

26


Regulatory Matters, Government Investigations and Other Matters

U.S. International Trade Commission Investigation: On March 5, 2019, Heraeus filed a complaint with the U.S. International Trade Commission (“ITC”) against us and certain of our subsidiaries.  The complaint alleges that Biomet misappropriated Heraeus’ trade secrets in the formulation and manufacture of two bone cement products now sold by Zimmer Biomet, both of which are imported from our Valence, France facility.  Heraeus requested that the ITC institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.  On April 5, 2019, the ITC ordered an investigation be instituted into whether we have committed an “unfair act” in the importation, sale for importation, or sale after importation of certain bone cement products.  The investigation is ongoing, and an evidentiary hearing in front of an administrative law judge at the ITC is scheduled for January 2020.  We cannot currently predict the outcome of this investigation.

FDA warning letters:  In August 2018, we received a warning letter from the FDA related to observed non-conformities with current good manufacturing practice requirements of the FDA’s Quality System Regulation (21 CFR Part 820) (“QSR”) at our legacy Biomet manufacturing facility in Warsaw, Indiana (this facility is sometimes referred to in this report as the “Warsaw North Campus”).  In May 2016, we received a warning letter from the FDA related to observed non-conformities with current good manufacturing practice requirements of the QSR at our facility in Montreal, Quebec, Canada.  InSeptember 2012, Zimmerwe received a warning letter from the FDA citing concerns relating to certain processes pertaining to products manufactured at our Ponce, Puerto Rico manufacturing facility.  In May 2016, Zimmer received a warning letter from the FDA related to observed non-conformities with current good manufacturing practice requirements of the FDA’s Quality System Regulation (21 CFR Part 820) (“QSR”) at our facility in Montreal, Quebec, Canada.  We have provided detailed responses to the FDA as to our corrective actions and will continue to work expeditiously to address the issues identified by the FDA during inspections in PonceWarsaw, Montreal and Montreal.Ponce.  As of September 30, 2017,July 31, 2019, these warning letters remained pending.  Until the violations cited in the pending warning letters are corrected, we may be subject to additional regulatory action by the FDA, as described more fully below.  Additionally, requests for Certificates to Foreign Governments related to products manufactured at certain of our facilities may not be granted and premarket approval applications for Class III devices to which the QSR deviations at these facilities are reasonably related will not be approved until the violations have been corrected.  In addition to responding to the warning letters described above, we are in the process of addressing various FDA Form 483 inspectional observations at certain of our manufacturing facilities, including at both the legacy Zimmer and the legacy Biomet manufacturing facilities in Warsaw, Indiana.facilities.  The

26


ultimate outcome of these matters is presently uncertain.  Among other available regulatory actions, the FDA may impose operating restrictions, including a ceasing of operations, at one or more facilities, enjoining and restraining certain violations of applicable law pertaining to medical devices and assessing civil or criminal penalties against our officers, employees or us.  The FDA could also issue a corporate warning letter, a recidivist warning letter or a consent decree of permanent injunction.  The FDA may also recommend prosecution by the U.S. Department of Justice (“DOJ”).  Any adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition and results of operations.

Deferred Prosecution Agreement (“DPA”) relating to U.S. Foreign Corrupt Practices Act (“FCPA”) matters:  On January 12, 2017, we resolved previously-disclosed FCPA matters involving Biomet and certain of its subsidiaries.  As part of the settlement, (i) Biomet resolved matters with the U.S. Securities and Exchange Commission (“SEC”(the “SEC”) through an administrative cease-and-desist order (the “Order”); (ii) we entered into a DPA with the DOJ; and (iii) JERDS Luxembourg Holding S.à r.l. (“JERDS”), the direct parent company of Biomet 3i Mexico SA de CV and an indirect, wholly-owned subsidiary of Biomet, entered into a plea agreement (the “Plea Agreement”) with the DOJ.  The conduct underlying these resolutions occurred prior to our acquisition of Biomet.

Pursuant to the terms of the Order, Biomet resolved claims with the SEC related to violations of the books and records, internal controls and anti-bribery provisions of the FCPA by disgorging profits to the U.S. government in an aggregate amount of approximately $6.5 million, inclusive of pre-judgment interest, and paying a civil penalty in the amount of $6.5 million (collectively, the “Civil Settlement Payments”).  We also agreed to pay a criminal penalty of approximately $17.5 million (together(together with the Civil Settlement Payments, the “Settlement Payments”) to the U.S. government pursuant to the terms of the DPA.  We made the Settlement Payments in January 2017 and, as previously disclosed, had accrued, as of June 24, 2015, the closing date of the Biomet merger, an amount sufficient to cover this matter.

Under the DPA, which has a term of three years, the DOJ agreed to defer criminal prosecution of us in connection with the charged violation of the internal controls provision of the FCPA as long as we comply with the terms of the DPA.  In addition, we will beare subject to oversight by an independent compliance monitor, for at least 12 months.  The monitor, who was appointed effective as of July 2017, will focus on legacy Biomet operations as integrated into our operations.August 7, 2017.  The monitorship may remain in place until August 7, 2020.  If we remain in compliance with the DPA during its term, the charges against us will be dismissed with prejudice.  The term of the DPA and monitorship may be extended for up to one additional year at the DOJ’s discretion.  In addition, under its Plea Agreement with the DOJ, JERDS pleaded guilty on January 13, 2017 to aiding and abetting a violation of the books and records provision of the FCPA.  In light of the DPA we entered into, JERDS paid only a nominal assessment and no criminal penalty.

If we do not comply with the terms of the DPA, we could be subject to prosecution for violating the internal controls provisions of the FCPA and the conduct of Biomet and its subsidiaries described in the DPA, which conduct pre-dated our acquisition of Biomet, as well as any new or continuing violations.  We could also be subject to exclusion bythe Office of Inspector General of the Department of Health and Human Services (“OIG”) from participation in federal healthcare programs, including Medicaid and

27


Medicare.  Any of these events could have a material adverse effect on our business, financial condition, results of operations and cash flows.

OIG subpoena:  In June 2017, we received a subpoena from the OIG.  The subpoena requests that we produce a variety of records primarily related to our healthcare professional consulting arrangements (including in the areas of medical education, product development, and clinical research) for the period spanning January 1, 2010 to the present.  The subpoena does not indicate the nature of the OIG’s investigation beyond reference to possible false or otherwise improper claims submitted for payment.  We are in the process of responding to the subpoena.  We cannot currently predict the outcome of this investigation

27

28


Item 2.

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

The following discussion and analysis should be read in conjunction with the interim condensed consolidated financial statements and corresponding notes included elsewhere in this Form 10-Q.  Certain percentages presented in this discussion and analysis are calculated from the underlying whole-dollar amounts and, therefore, may not recalculate from the rounded numbers used for disclosure purposes.  In addition, certain amounts in the 2016 condensed consolidated financial statements have been reclassified to conform to the 2017 presentation.

Executive Level Overview

Results for the Three and NineSix Month Periods ended SeptemberJune 30, 20172019

Net sales declined by 0.80.9 percent and 1.5 percent in the three and six month periods ended June 30, 2019, compared to the same prior year periods.  The decline was driven by declines in pricing and the negative impacts from changes in foreign currency exchange rates, partially offset by strong volume/mix in our Knees, Hips and S.E.T (Surgical, Sports Medicine, Extremities and Trauma) product categories.    

Our net earnings declined in the three month period ended SeptemberJune 30, 2017 and2019, but increased by 1.4 percent in the ninesix month period ended SeptemberJune 30, 2017, in each case2019, when compared to the same prior year period.periods.  The sales decline in the three month period was driven primarily by a decrease in sales in the U.S. due to ongoing production challenges$70.1 million IPR&D intangible asset impairment on certain IPR&D projects that we terminated.  Additionally, we recognized a $20.8 million charge related to our legacy Biomet Warsaw facility, one less billing day, surgeries delayedthe termination of a raw material supply agreement.  These expenses were partially offset by the recent hurricaneslower quality remediation and a government mandated industry wide price reduction on all knee sales in India.  We continued to experience challenges across our Knees, Hipsacquisition, integration and S.E.T. product categories, as a result of production delays that impacted our ability to fully meet customer demand.  The production shortfall is directly impacting our ability to fully meet case demand.  During the third quarter, we continued to experience low inventory levels across some brands within our Knee, Hip and S.E.T. categories.  We achieved healthy supply of certain other brands.  However, some customers remain hesitant to fully return until we have restored supply of all products.  Given our overall progress to date, we now expect to achieve full recovery of safety stock across our entire portfolio in the first half of 2018.  

These product supply issues have existed throughout the nine month period ended September 30, 2017, but we experienced sales growth primarily due to the LDR acquisition.

Our net earningsrelated expenses in the three month period ended SeptemberJune 30, 2017 decreased2019, compared to the same prior year period.  Additionally, interest expense, net, declined $15.6 million in the three month period ended June 30, 2019, compared to the same prior year period, butdue to hedging strategies that have lowered our effective interest rate and lower average outstanding debt balances.  Our net earnings increased in the ninesix month period ended SeptemberJune 30, 20172019 when compared to the same prior year period.  The 37.8 percent declineIn the six month period ended June 30, 2019, lower quality remediation expenses, acquisition, integration and related expenses and interest expense, net, when compared to the same prior year period, along with a $23.5 million gain related to a litigation settlement in the three month period was driven primarily by a $32.7 million goodwillfirst quarter of 2019, more than offset the additional charges related to the IPR&D intangible asset impairment charge in the 2017 period and tax benefitsraw material supply agreement termination that were recognized in the 2016 period fromsecond quarter of 2019.      

2019 Outlook

2019 marks the finalizationsecond year of tax accounts from business combination purchase accounting.  The 146.5 percent increaseour two-year turnaround effort since the appointment of a new Chief Executive Officer in net earningsDecember 2017.  In late 2018 and early 2019, we had various product launches in our Knees product category, which we anticipate will drive improving commercial momentum, especially in the nine month period ended September 30, 2017 was driven primarily by a decrease in inventory step-up expense, a $69.7 million tax benefit recognized resulting from a tax restructuring that lowered the tax rate on certain deferred tax liabilities, favorable resolutionsecond half of various tax matters, net tax-related charges in the prior year related to business combination purchase accounting and operational leverage from increased sales.  

2017 Outlook

2019.  We estimate ourthe change in sales growth in 2017 over 20162019 compared to 2018 will be in a range of 1.0flat to 1.5positive 0.5 percent.  This range includes estimated negative effects of changes in foreign currency exchange rates of 1.25 percent to 1.75 percent.  We estimate assumesthe negative effects of foreign currency exchange rates will increase sales by approximately 0.1 percent, continued pricing pressure will decrease sales by approximately 2 percent and the inclusion of LDR sales for the full year will increase sales by approximately 1.2 percent.  We acquired LDR near the beginning of the third quarter of 2016.  Therefore,be much smaller in the second half of 2017, the inclusion of LDR sales will not have as significant of an impact on our year-over-year sales growth as it did inyear compared to the first half of 2017.the year.    

In 2019, we expect our net earnings to increase significantly compared to the net loss recognized in 2018.  In 2018, we incurred a net loss due to significant goodwill and intangible asset impairments and litigation charges.  At this point in time based upon information known or knowable by us, we do not expect to incur similar significant charges in 2019.  We expect to make additional progress in remediating supply constraints as we progress through the remainder of 2017.  

We estimate costour costs of products sold will be lowercontinue to reflect costs associated with our quality remediation efforts.  We anticipate continuing to make investments in 2017 comparedoperating expenses for R&D, salesforce specialization, and to the prior year due to lower inventory step-up expenses, lower excess and obsolete inventory charges fromsupport our decision to discontinue certain products in 2016 and lower U.S. medical device excise taxes.new product launches.  However, we believe we will experience unfavorable effects on costs of products sold as a percentage of sales from declining selling prices, lower hedge gains expectedexpect expenses related to be recognized in 2017 when compared to 2016, incremental manufacturing costs to maximize production flowour acquisition and regional and product sales mix.    

As it relates to other expenses, our intangible asset amortization expense is expected to increase as we recognize a full year of intangible asset amortization from the LDR and other 2016 acquisitions.  We expect research and development (“R&D”) expense for the year to be approximately 4.5 percent of sales.  Selling, general and administrative (“SG&A”) expense is expected to approximate 37.5 percent of sales, which is an improvement from 2016 as we expect to realize synergies from our acquisitions and leverage sales growth.  We estimate special items expense will be significant as we continue our integration activities and quality enhancement and remediation efforts.will decline as we complete these projects during 2019.  We expectbelieve that our interest expense, net, will decrease in 2017continue to decline throughout the year when compared to 2016the same prior year periods due to lower anticipated debt levels from planned debt repayments.levels.      

28


Results of Operations

We analyze sales by three geographies, the Americas, EMEA and Asia Pacific, and by the following product categories: Knees, Hips, S.E.T., Dental, Spine & CMF, Dental and Other.  This sales analysis differs from our reportable operating segments, which are based upon our senior management organizational structure and how we allocate resources towards achieving operating profit goals.  We analyze sales by geography because the underlying market trends in any particular geography tend to be similar across product categories and because we primarily sell the same products in all geographies.  Our business is seasonal in nature to some extent, as many of our products are used in elective procedures, which typically decline during the summer months and can increase at the end of the year once annual deductibles have been met on health insurance plans.

29


Net Sales by Geography

The following tables present our net sales by geography and the components of the percentage changes (dollars in millions):

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

 

2017

 

 

2016

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

Americas

 

$

1,142.0

 

 

$

1,175.9

 

 

 

(2.9

)

%

 

(0.8

)

%

 

(2.2

)

%

 

0.1

 

%

EMEA

 

 

381.1

 

 

 

368.8

 

 

 

3.3

 

 

 

1.0

 

 

 

(1.4

)

 

 

3.7

 

 

Asia Pacific

 

 

295.0

 

 

 

288.1

 

 

 

2.4

 

 

 

7.5

 

 

 

(2.3

)

 

 

(2.8

)

 

Total

 

$

1,818.1

 

 

$

1,832.8

 

 

 

(0.8

)

 

 

0.9

 

 

 

(2.1

)

 

 

0.4

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

June 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

2017

 

 

2016

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

 

2019

 

 

2018

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

Americas

 

$

3,585.6

 

 

$

3,534.1

 

 

 

1.5

 

%

 

3.8

 

%

 

(2.4

)

%

 

0.1

 

%

 

$

1,214.3

 

 

$

1,216.3

 

 

 

(0.2

)

%

 

3.0

 

%

 

(2.9

)

%

 

(0.3

)

%

EMEA

 

 

1,272.5

 

 

 

1,286.0

 

 

 

(1.0

)

 

 

1.9

 

 

 

(1.5

)

 

 

(1.4

)

 

 

 

438.0

 

 

 

457.7

 

 

 

(4.3

)

 

 

4.5

 

 

 

(2.6

)

 

 

(6.2

)

 

Asia Pacific

 

 

891.7

 

 

 

850.7

 

 

 

4.8

 

 

 

9.0

 

 

 

(3.0

)

 

 

(1.2

)

 

 

 

336.3

 

 

 

333.6

 

 

 

0.8

 

 

 

6.8

 

 

 

(2.1

)

 

 

(3.9

)

 

Total

 

$

5,749.8

 

 

$

5,670.8

 

 

 

1.4

 

 

 

4.1

 

 

 

(2.3

)

 

 

(0.4

)

 

 

$

1,988.6

 

 

$

2,007.6

 

 

 

(0.9

)

 

 

3.9

 

 

 

(2.7

)

 

 

(2.1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

2019

 

 

2018

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

Americas

 

$

2,408.4

 

 

$

2,424.4

 

 

 

(0.7

)

%

 

2.5

 

%

 

(2.9

)

%

 

(0.3

)

%

EMEA

 

 

901.9

 

 

 

954.2

 

 

 

(5.5

)

 

 

3.9

 

 

 

(2.2

)

 

 

(7.2

)

 

Asia Pacific

 

 

653.8

 

 

 

646.6

 

 

 

1.1

 

 

 

7.3

 

 

 

(2.2

)

 

 

(4.0

)

 

Total

 

$

3,964.1

 

 

$

4,025.2

 

 

 

(1.5

)

 

 

3.6

 

 

 

(2.6

)

 

 

(2.5

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

“Foreign Exchange,” as used in the tables in this report, represents the effect of changes in foreign currency exchange rates on sales.  

Net Sales by Product Category

The following tables present our net sales by product category and the components of the percentage changes (dollars in millions):

 

 

Three Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

June 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

2017

 

 

2016

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

 

2019

 

 

2018

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

Knees

 

$

623.7

 

 

$

631.5

 

 

 

(1.2

)

%

 

0.8

 

%

 

(2.5

)

%

 

0.5

 

%

 

$

703.5

 

 

$

703.0

 

 

 

0.1

 

%

 

5.7

 

%

 

(3.2

)

%

 

(2.4

)

%

Hips

 

 

434.5

 

 

 

440.6

 

 

 

(1.4

)

 

 

0.8

 

 

 

(2.5

)

 

 

0.3

 

 

 

 

479.4

 

 

 

486.9

 

 

 

(1.5

)

 

 

4.2

 

 

 

(3.3

)

 

 

(2.4

)

 

S.E.T.

 

 

406.6

 

 

 

401.8

 

 

 

1.2

 

 

 

3.0

 

 

 

(1.9

)

 

 

0.1

 

 

 

 

444.4

 

 

 

433.8

 

 

 

2.5

 

 

 

5.6

 

 

 

(1.3

)

 

 

(1.8

)

 

Spine & CMF

 

 

185.9

 

 

 

198.2

 

 

 

(6.2

)

 

 

(2.2

)

 

 

(2.7

)

 

 

(1.3

)

 

Dental

 

 

92.9

 

 

 

95.9

 

 

 

(3.2

)

 

 

(3.2

)

 

 

(1.2

)

 

 

1.2

 

 

 

 

106.5

 

 

 

106.9

 

 

 

(0.3

)

 

 

2.9

 

 

 

(1.2

)

 

 

(2.0

)

 

Spine & CMF

 

 

184.9

 

 

 

183.7

 

 

 

0.7

 

 

 

0.8

 

 

 

(0.5

)

 

 

0.4

 

 

Other

 

 

75.5

 

 

 

79.3

 

 

 

(4.8

)

 

 

(3.6

)

 

 

(1.7

)

 

 

0.5

 

 

 

 

68.9

 

 

 

78.8

 

 

 

(12.6

)

 

 

(6.0

)

 

 

(4.9

)

 

 

(1.7

)

 

Total

 

$

1,818.1

 

 

$

1,832.8

 

 

 

(0.8

)

 

 

0.9

 

 

 

(2.1

)

 

 

0.4

 

 

 

$

1,988.6

 

 

$

2,007.6

 

 

 

(0.9

)

 

 

3.9

 

 

 

(2.7

)

 

 

(2.1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

2019

 

 

2018

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

Knees

 

$

1,397.6

 

 

$

1,416.3

 

 

 

(1.3

)

%

 

4.6

 

%

 

(3.1

)

%

 

(2.8

)

%

Hips

 

 

963.6

 

 

 

978.9

 

 

 

(1.6

)

 

 

4.5

 

 

 

(3.2

)

 

 

(2.9

)

 

S.E.T.

 

 

884.3

 

 

 

876.1

 

 

 

0.9

 

 

 

4.3

 

 

 

(1.3

)

 

 

(2.1

)

 

Spine & CMF

 

 

368.7

 

 

 

381.3

 

 

 

(3.3

)

 

 

0.8

 

 

 

(2.6

)

 

 

(1.5

)

 

Dental

 

 

211.0

 

 

 

214.5

 

 

 

(1.6

)

 

 

2.1

 

 

 

(1.4

)

 

 

(2.3

)

 

Other

 

 

138.9

 

 

 

158.1

 

 

 

(12.2

)

 

 

(6.3

)

 

 

(3.8

)

 

 

(2.1

)

 

Total

 

$

3,964.1

 

 

$

4,025.2

 

 

 

(1.5

)

 

 

3.6

 

 

 

(2.6

)

 

 

(2.5

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2930


 

 

Nine Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

% Inc /

 

 

Volume /

 

 

 

 

 

 

Foreign

 

 

 

 

2017

 

 

2016

 

 

(Dec)

 

 

Mix

 

 

Price

 

 

Exchange

 

 

Knees

 

$

2,005.9

 

 

$

2,031.7

 

 

 

(1.3

)

%

 

1.8

 

%

 

(2.6

)

%

 

(0.5

)

%

Hips

 

 

1,380.0

 

 

 

1,385.7

 

 

 

(0.4

)

 

 

3.0

 

 

 

(2.8

)

 

 

(0.6

)

 

S.E.T.

 

 

1,254.5

 

 

 

1,215.0

 

 

 

3.3

 

 

 

5.7

 

 

 

(2.0

)

 

 

(0.4

)

 

Dental

 

 

311.1

 

 

 

322.5

 

 

 

(3.5

)

 

 

(1.3

)

 

 

(2.1

)

 

 

(0.1

)

 

Spine & CMF

 

 

565.2

 

 

 

470.7

 

 

 

20.1

 

 

 

21.2

 

 

 

(1.1

)

 

 

-

 

 

Other

 

 

233.1

 

 

 

245.2

 

 

 

(4.9

)

 

 

(2.8

)

 

 

(1.7

)

 

 

(0.4

)

 

Total

 

$

5,749.8

 

 

$

5,670.8

 

 

 

1.4

 

 

 

4.1

 

 

 

(2.3

)

 

 

(0.4

)

 

The following table presents our net sales by geography for our Knees and Hips product categories, which represent our most significant product categories (dollars in millions):  

 

 

Three Months Ended September 30,

 

 

% Inc /

 

 

 

Nine Months Ended September 30,

 

 

% Inc /

 

 

 

Three Months Ended June 30,

 

 

% Inc /

 

 

 

Six Months Ended June 30,

 

 

% Inc /

 

 

 

2017

 

 

2016

 

 

(Dec)

 

 

2017

 

 

2016

 

 

(Dec)

 

 

 

2019

 

 

2018

 

 

(Dec)

 

 

2019

 

 

2018

 

 

(Dec)

 

 

Knees

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Americas

 

$

382.4

 

 

$

397.5

 

 

 

(3.8

)

%

 

$

1,217.5

 

 

$

1,244.3

 

 

 

(2.2

)

%

 

$

414.5

 

 

$

408.1

 

 

 

1.6

 

%

 

$

823.7

 

 

$

825.3

 

 

 

(0.2

)

%

EMEA

 

 

135.1

 

 

 

130.2

 

 

 

3.7

 

 

 

462.7

 

 

 

472.8

 

 

 

(2.2

)

 

 

 

163.4

 

 

 

170.8

 

 

 

(4.3

)

 

 

339.1

 

 

 

359.7

 

 

 

(5.7

)

 

Asia Pacific

 

 

106.2

 

 

 

103.8

 

 

 

2.3

 

 

 

325.7

 

 

 

314.6

 

 

 

3.5

 

 

 

 

125.6

 

 

 

124.1

 

 

 

1.2

 

 

 

234.8

 

 

 

231.3

 

 

 

1.5

 

 

Total

 

$

623.7

 

 

$

631.5

 

 

 

(1.2

)

 

$

2,005.9

 

 

$

2,031.7

 

 

 

(1.3

)

 

 

$

703.5

 

 

$

703.0

 

 

 

0.1

 

 

$

1,397.6

 

 

$

1,416.3

 

 

 

(1.3

)

 

Hips

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Americas

 

$

228.2

 

 

$

239.0

 

 

 

(4.5

)

%

 

$

719.5

 

 

$

733.4

 

 

 

(1.9

)

%

 

$

253.3

 

 

$

250.0

 

 

 

1.3

 

%

 

$

500.4

 

 

$

497.8

 

 

 

0.5

 

%

EMEA

 

 

115.1

 

 

 

112.2

 

 

 

2.4

 

 

 

382.1

 

 

 

387.8

 

 

 

(1.5

)

 

 

 

125.9

 

 

 

133.8

 

 

 

(5.9

)

 

 

259.0

 

 

 

276.0

 

 

 

(6.1

)

 

Asia Pacific

 

 

91.2

 

 

 

89.4

 

 

 

2.1

 

 

 

278.4

 

 

 

264.5

 

 

 

5.3

 

 

 

 

100.2

 

 

 

103.1

 

 

 

(2.8

)

 

 

204.2

 

 

 

205.1

 

 

 

(0.5

)

 

Total

 

$

434.5

 

 

$

440.6

 

 

 

(1.4

)

 

$

1,380.0

 

 

$

1,385.7

 

 

 

(0.4

)

 

 

$

479.4

 

 

$

486.9

 

 

 

(1.5

)

 

$

963.6

 

 

$

978.9

 

 

 

(1.6

)

 

 

Demand (Volume and Mix) Trends  

Increased volume and changes in the mix of product sales had a positive effect of 0.93.9 percent and 4.13.6 percent on year-over-year sales during the three and ninesix month periods ended SeptemberJune 30, 2017,2019, respectively.  Volume/mix growth was driven by acquisitions in the prior year, recent product introductions, sales in key emerging markets and an aging population.  The year-over-year volume/mix growth in the three month period was lower than in the nine month period primarily because LDR was acquired in the third quarter of 2016.

We believe long-term indicators point toward sustained growth driven by an aging global population, growth in emerging markets, obesity, proven clinical benefits, new material technologies, advances in surgical techniques and more active lifestyles, among other factors.  In addition, demand for clinically proven premium products, and patient specific devices and robotic surgical assistance are expected to continue to positively affect sales growth in markets that recognize the value of these advanced technologies.    

Pricing Trends

Global selling prices had a negative effect of 2.12.7 percent and 2.32.6 percent on year-over-year sales during the three and ninesix month periods ended SeptemberJune 30, 2017,2019, respectively.  The majority of countries in which we operate continue to experience pricing pressure from governmental healthcare cost containment efforts and from local hospitals and health systems.  

Foreign Currency Exchange Rates

For the three and ninesix month periods ended SeptemberJune 30, 2017,2019, changes in foreign currency exchange rates had a positive effect of 0.4 percent and a negative effect of 0.42.1 percent and 2.5 percent, respectively, on year-over-year sales.  If foreign currency exchange rates remain at levels consistent with recent rates, we estimate foreign currency exchange rates2019 sales will have a positive effect of approximately 0.1be negatively affected by 1.25 percent on our year-over-year sales in 2017.to 1.75 percent.  

30


Sales by Product Category

Knees

Knee sales increased minimally in the three month period ended June 30, 2019, but declined in the three and ninesix month periodsperiod ended SeptemberJune 30, 20172019, when compared to the same prior year periods due primarily to the previously mentioned supply issues, the price reduction mandateperiods.  Price declines and changes in India and continued pricing pressure.foreign currency exchange rates negatively impacted sales, but were partially offset by volume/mix growth in all of our geographic operating segments.  Knee sales volume/mix growth was led by Persona® The Personalized Knee System, and the Oxford® Partial Knee.Knee and the ROSA® Knee System.  

Hips

Hip sales declined in the three and ninesix month periods ended SeptemberJune 30, 20172019 when compared to the same prior year periods.  Theperiods, primarily due to price declines were due primarily to the previously mentioned supply issues and continued pricing pressure.changes in foreign currency exchange rates, partially offset by volume/mix growth in all of our geographic operating segments.  Hip sales volume/mix growth was led by our Taperloc® Complete Hip System, Arcos® Modular Hip System and G7® Acetabular System.  

31


S.E.T.

Our S.E.T. product category sales increased in the three and ninesix month periods ended SeptemberJune 30, 2017 when compared to the same prior year periods, driven primarily by a growing emphasis on sales force specialization, strong performance by key brands and 2016 acquisitions, partially offset by the previously mentioned supply issues and continued pricing pressure.

Dental

Dental sales declined in the three and nine month periods ended September 30, 20172019 when compared to the same prior year periods, primarily due to restructuring of our dental organizationsupply stability, salesforce specialization and new product launches, partially offset by changes in certain European markets.foreign currency exchange rates and price declines.

Spine and CMF

Spine and CMF sales increaseddeclined in the three and ninesix month periods ended SeptemberJune 30, 20172019 when compared to the same prior year periods, primarily due to the LDR acquisitionprice declines, changes in foreign currency exchange rates, and ongoing sales channel consolidation, partially offset by continuing strong sales of our Thoracic products.

Dental

Dental sales declined in the three and six month periods ended June 30, 2019 when compared to the same prior year periods mostly due to changes in foreign exchange rates.  Volume/mix growth in our Dental product category has improved from recent years due to investing resources in priority areas and other operational improvements.  

Expenses as a Percentage of Net Sales

 

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

Six Months Ended

 

 

 

 

 

 

 

September 30,

 

 

 

% Inc /

 

 

 

September 30,

 

 

% Inc /

 

 

 

June 30,

 

 

 

% Inc /

 

 

 

June 30,

 

 

% Inc /

 

 

 

2017

 

 

2016

 

 

(Dec)

 

 

2017

 

 

2016

 

 

(Dec)

 

 

 

2019

 

 

2018

 

 

(Dec)

 

 

2019

 

 

2018

 

 

(Dec)

 

 

Cost of products sold, excluding intangible

asset amortization

 

 

27.5

 

%

 

 

26.2

 

%

 

 

1.3

 

%

 

 

26.8

 

%

 

 

31.0

 

%

 

 

(4.2

)

%

 

 

29.2

 

%

 

 

29.1

 

%

 

 

0.1

 

%

 

 

28.6

 

%

 

 

28.8

 

%

 

 

(0.2

)

%

Intangible asset amortization

 

 

8.4

 

 

 

9.0

 

 

 

(0.6

)

 

 

7.9

 

 

 

7.5

 

 

 

0.4

 

 

 

 

7.4

 

 

 

7.4

 

 

 

-

 

 

 

7.3

 

 

 

7.5

 

 

 

(0.2

)

 

Research and development

 

 

5.0

 

 

 

5.2

 

 

 

(0.2

)

 

 

4.7

 

 

 

4.8

 

 

 

(0.1

)

 

 

 

5.6

 

 

 

4.9

 

 

 

0.7

 

 

 

5.4

 

 

 

4.8

 

 

 

0.6

 

 

Selling, general and administrative

 

 

38.2

 

 

 

39.7

 

 

 

(1.5

)

 

 

38.3

 

 

 

38.4

 

 

 

(0.1

)

 

 

 

42.3

 

 

 

39.4

 

 

 

2.9

 

 

 

41.3

 

 

 

39.6

 

 

 

1.7

 

 

Special items

 

 

9.2

 

 

 

9.3

 

 

 

(0.1

)

 

 

7.5

 

 

 

7.0

 

 

 

0.5

 

 

Intangible asset impairment

 

 

3.5

 

 

 

-

 

 

 

3.5

 

 

 

1.8

 

 

 

-

 

 

 

1.8

 

 

Acquisition, integration and related

 

 

0.5

 

 

 

2.5

 

 

 

(2.0

)

 

 

0.5

 

 

 

2.4

 

 

 

(1.9

)

 

Quality remediation

 

 

1.1

 

 

 

1.9

 

 

 

(0.8

)

 

 

1.1

 

 

 

2.0

 

 

 

(0.9

)

 

Operating profit

 

 

11.7

 

 

 

10.7

 

 

 

1.0

 

 

 

14.7

 

 

 

11.3

 

 

 

3.4

 

 

 

 

10.3

 

 

 

14.7

 

 

 

(4.4

)

 

 

14.0

 

 

 

14.9

 

 

 

(0.9

)

 

 

The minimal increase in cost of products sold as a percentage of net sales for the three month period ended SeptemberJune 30, 20172019 compared to the same prior year period was primarily due to a $20.8 million charge incurred to terminate a long-term raw material supply agreement in the 2019 period as well as the effects of lower average selling prices and higher manufacturing costs.  These unfavorable items were mostly offset by the effects of our hedging program, lower excess and obsolete inventory charges and lower royalty expense.  We recognized hedge gains of $7.4 million in the three month period ended June 30, 2019 compared to hedge losses of $5.1$10.5 million recognized in the 2017 period compared to hedge gains of $18.1 million recognized in the 2016same prior year period.  For derivatives which qualify as hedges of future cash flows, the effective portion of changes in fair value is temporarily recorded in other comprehensive income and then recognized in cost of products sold when the hedged items affect earnings.  Additional unfavorable factorsThe reduction in royalty expense was the result of an agreement we entered into on April 1, 2019.  Under the agreement, we paid $192.5 million to buy out certain licensing arrangements from an unrelated third party.  This new agreement and the related payment replace the variable royalty payments that increased costotherwise would have been due under the terms of previous licensing arrangements through 2029.  The payment was recorded as an intangible asset and will be amortized through 2029.

Cost of products sold as a percentage of net sales decreased minimally in the threesix month 2017 period whenended June 30, 2019 compared to the same prior year period included lower average selling prices, increased manufacturing costs at our legacy Biomet Warsaw facilityperiod.  The drivers of the decrease were the same favorable and a mix of sales in regions and product categories that have lower gross margins.  These unfavorable items were partially offset by lower inventory step-up charges inas discussed for the 2017 period.  Inventory step-up charges representthree month period ended June 30, 2019.  However, the difference in cost of products sold between inventory expensed at fair value after business combination accounting is applied versus what cost of products sold would have been$20.8 million charge to terminate the long-term raw material supply agreement had inventory been recognized at historical cost.  The reduction in inventory step-up charges resulted from the LDR inventory that was stepped-up to fair value having been fully recognized by September 30, 2017.  

The decrease in costa lesser negative effect on costs of products sold as a percentage of net sales forin the ninesix month period ended SeptemberJune 30, 2017 compared to the same prior year period was primarily2019 simply due to a decrease in inventory step-up charges.  The reduction in inventory step-up charges resulted fromincluding the Biomet inventory that was stepped-up to fair value having been fully recognized by June 30, 2016 and LDR

31


inventory step-up that was fully recognized by September 30, 2017.  Additional favorability was driven by lower medical device excise tax expense due to the two year moratorium on the U.S. medical device excise tax and a favorable resolution on past excise taxes that were paid.  Under the applicable accounting rules that we apply to the U.S. medical device excise tax, we had a portion of the tax paid prior to the moratorium includedfull year-to-date amounts in the cost of inventory and recognized expense through the fourth quarter of 2016.  These favorable items were partially offset by lower hedge gains of $12.0 million in the 2017 period compared to $76.5 million in the 2016 period and the effect of lower average selling prices and sales mix.  ratio.

Intangible asset amortization expense and intangible asset amortization as a percentage of net sales decreaseddeclined in the three and six month periodperiods ended SeptemberJune 30, 20172019 when compared to the same prior year period due to certain intangible assets from past acquisitions being fully amortized, partially offset by additional amortization from the finalization of business combination accounting for 2016 acquisitions that resulted in lower intangible asset balances than estimated in the prior year period.  Intangible asset amortization expenseagreement to buy out certain licensing arrangements we entered into on April 1, 2019.

Research and intangible asset amortizationdevelopment (“R&D”) expenses and R&D expenses as a percentage of net sales increased in the ninethree and six month periodperiods ended SeptemberJune 30, 20172019 compared to the same prior year period, primarily due to amortization expenseincreased investment in our Knee

32


product pipeline, costs associated with the intangible assetsEuropean Union Medical Device Regulation and a patent license we acquired to be used in R&D activities that was expensed immediately.

Selling, general and administrative (“SG&A”) expenses and SG&A expenses as a resultpercentage of the LDR acquisition as well as the other acquisitions that occurred in 2016.

R&D expenses remained generally consistentnet sales increased in the three and ninesix month periods ended SeptemberJune 30, 20172019 when compared to the same prior year periods.  We expect RThe primary drivers of the increased expense were investments in preparation for new product launches, higher expenses related to legal entity, distribution and manufacturing restructuring, and higher litigation-related charges from commercial and product liability matters.  In the six month period, these increases were partially offset by a $23.5 million gain recognized in the first quarter of 2019 related to a litigation settlement.  

In the second quarter of 2019, we recognized a $70.1 million IPR&D spending in 2017 to be approximately 4.5 percent of sales.intangible asset impairment on certain IPR&D projects that we terminated.

SG&AAcquisition, integration and related expenses and SG&A as a percentage of net sales decreaseddeclined in the three and six month periodperiods ended SeptemberJune 30, 2017 when2019 compared to the same prior year period.  The primary driversperiods due to the natural regression of integration activities related to the decreased expense were lower sales as well as synergies realized from the LDR2015 Biomet merger and other 2016 acquisitions.  In the nine month period ended September 30, 2017, SG&Avarious acquisitions that were consummated in 2016.  Similarly, our quality remediation expenses increased while SG&Ahave declined as a percentage of net sales slightly decreased.  The increase in expenses was due to higher sales, the LDR acquisition and the other 2016 acquisitions for which we have incurred expenses for the entire nine month period in 2017, increased freight costs due to expedited product shipments and increased investments in our specialized sales force and medical training and education.  These increases were partially offset by continued savings in various SG&A expense categories stemming from our synergies initiatives.  

“Special items” expenses decreased slightly in dollars and as a percentage of net sales in the three month period ended September 30, 2017 compared to the same prior year period, but increased in the nine month period ended September 30, 2017 when compared to the same prior year period.  The decrease in the three month period ended September 30, 2017 was primarily due to expenses recognized in the 2016 periodprojects related to consummating the LDR acquisition and other significant, ongoing integration expenses associated with the Biomet merger.  The increases in the nine month period ended September 30, 2017 were primarily due to expenses related to our quality enhancement and remediation efforts.  See Note 2 to the interim condensed consolidated financial statements included in Part I, Item 1 of this report for more information regarding “Special items” charges.those efforts are completed.  

Other Expense, Net, Interest Income, Interest Expense, Net, and Income Taxes

In the three and ninesix month periods ended SeptemberJune 30, 20172019 and 2016,2018, other expense, net, was primarily related to certain components of pension expense, changes to the fair value of our equity investments and remeasuring monetary assets and liabilities denominated in a foreign currency other than an entity’s functional currency, partially offset by foreign currency forward exchange contracts we entered into to mitigate any gain or loss.  

Net interestInterest expense, net, decreased in the three and ninesix month periods ended SeptemberJune 30, 2017,2019, compared to the same prior year periods, primarily due to hedging strategies that have lowered our issuance of the Euro Notes in the fourth quarter of 2016effective interest rate and lower average outstanding debt balances due toduring the 2019 periods resulting from debt repayments.  We used the proceeds of the Euro Notes, which have a lower interest rate than most of our other debt, to repay certain senior notes with higher interest rates.repayments throughout 2018 and year-to-date 2019.    

Our ETR on earnings before income taxes has been significantly influenced by the Biomet merger and other acquisitions and special items charges.  We have incurred significant expenses associated with the Biomet merger and other acquisitions and special items charges which have generally been recognized in higher income tax jurisdictions.  Accordingly, this has reduced our ETR as our earnings have been lower in these higher income tax jurisdictions.  In the three and ninesix month periods ended SeptemberJune 30, 2017, we recognized2019, our effective tax benefits of $39.8 millionrate (“ETR”) was 6.0 percent and $128.6 million,12.5 percent, respectively, relatedcompared to 15.1 percent and 18.2 percent in the three and six month periods ended June 30, 2018, respectively.  The decline in ETR in the three month period ended June 30, 2019 compared to the same prior year period was primarily due to the favorable resolution of certain tax matters.  Additionally,audits.  The decline in ETR in the ninesix month period ended SeptemberJune 30, 2017, we recognized a tax benefit of $69.7 million resulting from a tax restructuring that lowered2019 compared to the tax rate on certain deferred tax liabilities recorded on intangible assets recognized insame prior year period was primarily due to the Biomet merger acquisition-related accounting.  In the three and nine month periods ended September 30, 2017, we recognized net income tax expense of $7.7 million and $11.8 million, respectively, that related to previous periods forfavorable resolution of certain tax matters, certainaudits as well as a release of uncertain tax restructurings and product liability matters.  Inpositions due to emerging foreign tax guidance in the three and nine month periods ended September 30, 2016,first quarter.  Absent discrete tax events, we recognizedexpect our future ETR will continue to be lower than the U.S. corporate income tax benefitsrate of $25.1 million21.0 percent due to our mix of earnings between U.S. and foreign locations, which have lower corporate income tax provisions of $27.6 million, respectively, related to the finalization of tax accounts for the Biomet merger.  We are subject to taxation in the U.S. and numerous foreign jurisdictions.rates.  Our ETR in future quartersperiods could also potentially be impacted byby: changes in our mix of pre-tax earnings; changes in tax rates, tax laws or their interpretation, including the European Union rules on state aid; the outcome of various federal, state and foreign audits; and the expiration of certain statutes of limitations.  Currently, we cannot reasonably estimate the impact of these items on our financial results.

3233


Segment Operating Profit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Profit as a

 

 

 

 

Net Sales

 

 

Operating Profit

 

 

Percentage of Net Sales

 

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Three Months Ended

 

 

 

 

June 30,

 

 

June 30,

 

 

June 30,

 

 

(dollars in millions)

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

Americas

 

$

989.1

 

 

$

979.3

 

 

$

538.8

 

 

$

530.1

 

 

 

54.5

 

%

 

54.1

 

%

EMEA

 

 

383.2

 

 

 

400.0

 

 

 

116.9

 

 

 

117.5

 

 

 

30.5

 

 

 

29.4

 

 

Asia Pacific

 

 

321.9

 

 

 

319.2

 

 

 

114.8

 

 

 

109.7

 

 

 

35.7

 

 

 

34.4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Profit as a

 

 

 

 

Net Sales

 

 

Operating Profit

 

 

Percentage of Net Sales

 

 

 

 

Six Months Ended

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

June 30,

 

 

June 30,

 

 

(dollars in millions)

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

Americas

 

$

1,964.5

 

 

$

1,970.4

 

 

$

1,045.9

 

 

$

1,062.3

 

 

 

53.2

 

%

 

53.9

 

%

EMEA

 

 

789.1

 

 

 

832.6

 

 

 

243.3

 

 

 

256.7

 

 

 

30.8

 

 

 

30.8

 

 

Asia Pacific

 

 

625.6

 

 

 

618.1

 

 

 

218.8

 

 

 

211.8

 

 

 

35.0

 

 

 

34.3

 

 

In the Americas, operating profit as a percentage of net sales has remained similar betweenincreased in the three and nine month periodsperiod ended SeptemberJune 30, 2017 when2019 compared to the same prior year periods.  The Americas has experienced lower operating marginsperiod, but decreased in the 2017 periods comparedsix month period ended June 30, 2019.   The increase in the three month period was primarily due to improved sales volume/mix and controlled spending.  In the same prior year periodssix month period, the decline was primarily due to price declines higher contribution of sales from products with lower gross profit margins and higher freight costs.  These unfavorable impacts were offset by lower U.S. medical device excise tax expenseexcess and continued savings from our SG&A synergies initiatives.  

obsolete inventory charges.  In EMEA, operating profit as a percentage of net sales decreasedincreased in the ninethree month period ended SeptemberJune 30, 20172019 compared to the same prior year period primarily due to price declines and a reduced impact of hedge gains.  Inwas flat in the six month period ended June 30, 2019.  The increase in the three month period ended September 30, 2017, operating profit as a percentage ofwas primarily due to higher sales increased slightly as SG&A synergies offset the negative effects from price declinesvolume/mix and lower hedge gains.

gains recognized related to our hedging program.  In Asia Pacific, operating profit as a percentage of net sales decreasedincreased in the three and ninesix month periods ended SeptemberJune 30, 2017 compared2019 due primarily to the same prior year periods duevolume/mix net sales growth and gains recognized related to a reduced impact of hedge gains and price declines.our hedging program.

Non-GAAP Operating Performance Measures

We use financial measures that differ from financial measures determined in accordance with GAAP to evaluate our operating performance.  These non-GAAP financial measures exclude the impact of inventory step-up; certain inventory and manufacturing-related charges connectedincluding charges to discontinuingterminate a long-term raw material supply agreement and discontinue certain product lines, quality enhancement and remediation efforts;lines; intangible asset amortization; “Special items;”intangible asset impairment; acquisition, integration and related expenses; quality remediation expenses; certain litigation gains and charges; expenses to comply with the new European Union Medical Device Regulation; other expenses related to acquisitions;charges; any related effects on our income tax provision associated with these items; and other certain tax adjustments.  Other certain tax adjustments include a tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in merger-related accounting, net favorable resolutions of various tax matters, and charges from internal restructuring transactions that provide us access to cash in a tax efficient manner.  We use these non-GAAP financial measures internally to evaluate the performance of the business andbusiness.  Additionally, we believe they are usefulthese non-GAAP measures that provide meaningful supplementalincremental information to investors to consider when evaluating our performance.  We believe these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported income but that do not impact the fundamentals of our operations.  The non-GAAP measures enable the evaluation of operating results to performand trend analysis by allowing a reader to better identify operating trends that may otherwise be masked or distorted by these types of items and to provide additional transparency of certain items.that are excluded from the non-GAAP measures.  In addition, certain of these non-GAAP financial measures areadjusted diluted earnings per share is used as a performance metricsmetric in our incentive compensation programs.

34


The following are reconciliations from our GAAP net earnings and diluted earnings per share to our non-GAAP adjusted net earnings and non-GAAP adjusted diluted earnings per share used for internal management purposes (in millions, except per share amounts):

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Net Earnings of Zimmer Biomet Holdings, Inc.

 

$

98.8

 

 

$

158.8

 

 

$

582.4

 

 

$

236.3

 

Inventory step-up and other inventory and

   manufacturing-related charges

 

 

10.4

 

 

 

22.8

 

 

 

58.5

 

 

 

357.7

 

Intangible asset amortization

 

 

152.7

 

 

 

164.3

 

 

 

452.4

 

 

 

424.7

 

Special items

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Biomet merger-related

 

 

81.1

 

 

 

113.8

 

 

 

206.3

 

 

 

313.5

 

Other special items

 

 

84.3

 

 

 

56.6

 

 

 

227.8

 

 

 

83.5

 

Merger-related and other (income) expense in other expense, net

 

 

(0.5

)

 

 

(2.6

)

 

 

0.5

 

 

 

(1.1

)

Taxes on above items (1)

 

 

(79.1

)

 

 

(111.6

)

 

 

(264.4

)

 

 

(297.0

)

Biomet merger-related measurement period tax adjustments (2)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

52.7

 

Other certain tax adjustments (3)

 

 

2.2

 

 

 

(39.7

)

 

 

(55.6

)

 

 

6.4

 

Adjusted Net Earnings

 

$

349.9

 

 

$

362.4

 

 

$

1,207.9

 

 

$

1,176.7

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net Earnings of Zimmer Biomet Holdings, Inc.

 

$

133.7

 

 

$

185.0

 

 

$

379.8

 

 

$

359.7

 

Inventory and manufacturing-related

   charges(1)

 

 

34.1

 

 

 

12.5

 

 

 

36.1

 

 

 

19.7

 

Intangible asset amortization(2)

 

 

146.9

 

 

 

149.5

 

 

 

290.3

 

 

 

300.3

 

Intangible asset impairment(3)

 

 

70.1

 

 

 

-

 

 

 

70.1

 

 

 

-

 

Acquisition, integration and related(4)

 

 

10.5

 

 

 

50.5

 

 

 

21.2

 

 

 

96.5

 

Quality remediation(5)

 

 

23.4

 

 

 

45.4

 

 

 

43.1

 

 

 

91.6

 

Litigation(6)

 

 

7.0

 

 

 

(4.2

)

 

 

5.2

 

 

 

1.5

 

Litigation settlement gain(7)

 

 

-

 

 

 

-

 

 

 

(23.5

)

 

 

-

 

European Union Medical Device

   Regulation(8)

 

 

5.1

 

 

 

0.5

 

 

 

6.7

 

 

 

0.8

 

Other charges(9)

 

 

42.8

 

 

 

11.3

 

 

 

64.9

 

 

 

21.9

 

Taxes on above items(10)

 

 

(69.8

)

 

 

(44.7

)

 

 

(100.6

)

 

 

(95.4

)

Other certain tax adjustments(11)

 

 

(6.1

)

 

 

(13.8

)

 

 

(11.4

)

 

 

(13.7

)

Adjusted Net Earnings

 

$

397.7

 

 

$

392.0

 

 

$

781.9

 

 

$

782.9

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Diluted Earnings Per Share

 

$

0.65

 

 

$

0.90

 

 

$

1.84

 

 

$

1.76

 

Inventory and manufacturing-related charges(1)

 

 

0.17

 

 

 

0.06

 

 

 

0.18

 

 

 

0.10

 

Intangible asset amortization(2)

 

 

0.71

 

 

 

0.73

 

 

 

1.41

 

 

 

1.47

 

Intangible asset impairment(3)

 

 

0.34

 

 

 

-

 

 

 

0.34

 

 

 

-

 

Acquisition, integration and related(4)

 

 

0.05

 

 

 

0.25

 

 

 

0.10

 

 

 

0.47

 

Quality remediation(5)

 

 

0.11

 

 

 

0.22

 

 

 

0.21

 

 

 

0.45

 

Litigation(6)

 

 

0.03

 

 

 

(0.02

)

 

 

0.03

 

 

 

0.01

 

Litigation settlement gain(7)

 

 

-

 

 

 

-

 

 

 

(0.11

)

 

 

-

 

European Union Medical Device Regulation(8)

 

 

0.02

 

 

 

-

 

 

 

0.03

 

 

 

-

 

Other charges(9)

 

 

0.21

 

 

 

0.06

 

 

 

0.32

 

 

 

0.11

 

Taxes on above items(10)

 

 

(0.34

)

 

 

(0.22

)

 

 

(0.50

)

 

 

(0.47

)

Other certain tax adjustments(11)

 

 

(0.02

)

 

 

(0.06

)

 

 

(0.05

)

 

 

(0.07

)

Adjusted Diluted Earnings Per Share

 

$

1.93

 

 

$

1.92

 

 

$

3.80

 

 

$

3.83

 

 

(1)

In the 2019 periods, inventory and manufacturing-related charges relate to a $20.8 million charge incurred to terminate a long-term raw material supply agreement, excess and obsolete inventory charges on certain product lines we intend to discontinue and other inventory and manufacturing-related charges.  The 2018 charges primarily relate to the excess and obsolete inventory charges on certain product lines we intend to discontinue and other inventory and manufacturing-related charges.   The excess and obsolete inventory charges on certain product lines are driven by acquisitions where there are competing product lines and we have plans to discontinue one of the competing product lines.  

(2)

We exclude intangible asset amortization from our non-GAAP financial measures because we internally assess our performance against our peers without this amortization.  Due to various levels of acquisitions among our peers, intangible asset amortization can vary significantly from company to company.

35


(3)

In the second quarter of 2019, we recognized $70.1 million of IPR&D intangible asset impairment due to the termination of certain IPR&D projects.

(4)

The acquisition, integration and related expenses we have excluded from our non-GAAP financial measures resulted from our merger with Biomet in 2015 and various acquisitions we consummated in 2016.  The acquisition, integration and related expenses include the following types of expenses:  

Consulting and professional fees related to third-party integration consulting performed in a variety of areas, such as tax, compliance, logistics and human resources, and legal fees related to the consummation of mergers and acquisitions.  

Employee termination benefits related to terminating employees with overlapping responsibilities in various areas of our business.  

Dedicated project personnel expenses which include the salary, benefits, travel expenses and other costs directly associated with employees who are 100 percent dedicated to our integration of acquired businesses and employees who have been notified of termination, but are continuing to work on transferring their responsibilities.  

Contract termination expenses related to terminated contracts, primarily with sales agents and distribution agreements.  

Other various expenses to relocate facilities, integrate information technology, losses incurred on assets resulting from the applicable acquisition, and other various expenses.

(5)

We are addressing inspectional observations on Form 483 and a warning letter issued by the FDA following its inspections of our Warsaw North Campus facility, among other matters.  This quality remediation has required us to devote significant financial resources and is for a discrete period of time.  The majority of the expenses are related to consultants who are helping us to update previous documents and redesign certain processes.

(6)

We are involved in routine patent litigation, product liability litigation, commercial litigation and other various litigation matters.  We review litigation matters from both a qualitative and quantitative perspective to determine if excluding the losses or gains will provide our investors with useful incremental information.  Litigation matters can vary in their characteristics, frequency and significance to our operating results.  The litigation charges and gains excluded from our non-GAAP financial measures in the periods presented relate to product liability matters where we have received numerous claims on specific products.  In regards to these product liability matters, due to the complexities involved and claims filed in multiple districts, the expenses associated with these matters are significant to our operating results.  Once the litigation matter has been excluded from our non-GAAP financial measures in a particular period, any additional expenses or gains from changes in estimates are also excluded, even if they are not significant, to ensure consistency in our non-GAAP financial measures from period-to-period.

(7)

In the first quarter of 2019, we settled a patent infringement lawsuit out of court, and the other party agreed to pay us an upfront, lump-sum amount for a non-exclusive license to the patent.

(8)

The European Union Medical Device Regulation imposes significant additional premarket and postmarket requirements.  The new regulations provide a transition period until May 2020 for currently-approved medical devices to meet the additional requirements.  For certain devices, this transition period can be extended until May 2024.  We are excluding from our non-GAAP financial measures the incremental costs incurred to establish initial compliance with the regulations related to our currently-approved medical devices.  The incremental costs primarily include third-party consulting necessary to supplement our internal resources.

(9)

We have incurred other various expenses from specific events or projects that we consider highly variable or that have a significant impact to our operating results that we have excluded from our non-GAAP measures.  These include costs related to legal entity, distribution and manufacturing restructuring as well as our costs of complying with our Deferred Prosecution Agreement (“DPA”) with the U.S. government related to certain Foreign Corrupt Practices Act matters involving Biomet and certain of its subsidiaries.  Under the DPA, which has a three-year term, we are subject to oversight by an independent compliance monitor, which monitorship commenced in August 2017.  The excluded costs include the fees paid to the independent compliance monitor and to external legal counsel assisting in the matter.  

(10)

Represents the tax effects on the previously specified items.  The tax effect for the U.S. jurisdiction is calculated based on an effective rate considering federal and state taxes, as well as permanent items.  For jurisdictions outside the U.S., the tax effect is calculated based upon the statutory rates where the items were incurred.

(2)(11)

The 2016 nine month period includes negative effects from finalizing the tax accounts for the Biomet merger.  Under the applicable U.S. GAAP rules, these measurement period adjustments are recognized on a prospective basis in the period of change.

33


(3)

In the 2017 periods, otherOther certain tax adjustments relate to avarious discrete tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in acquisition-related accounting, net favorable resolutions of various tax matters, and charges from internal restructuring transactions that provide us access to cash in a tax efficient manner.  The adjustments in the 2016 periods relate to internal restructuring transactions that provide us access to cash in a tax efficient manner.period adjustments.

36

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Diluted Earnings Per Share

 

$

0.48

 

 

$

0.78

 

 

$

2.86

 

 

$

1.17

 

Inventory step-up and other inventory and

   manufacturing-related charges

 

 

0.05

 

 

 

0.11

 

 

 

0.29

 

 

 

1.77

 

Intangible asset amortization

 

 

0.75

 

 

 

0.81

 

 

 

2.22

 

 

 

2.10

 

Special items

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Biomet merger-related

 

 

0.40

 

 

 

0.56

 

 

 

1.01

 

 

 

1.55

 

Other special items

 

 

0.41

 

 

 

0.28

 

 

 

1.12

 

 

 

0.41

 

Merger-related and other expense in other expense, net

 

 

-

 

 

 

(0.01

)

 

 

-

 

 

 

(0.01

)

Taxes on above items (1)

 

 

(0.38

)

 

 

(0.55

)

 

 

(1.30

)

 

 

(1.47

)

Biomet merger-related measurement period tax adjustments (2)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

0.26

 

Other certain tax adjustments (3)

 

 

0.01

 

 

 

(0.19

)

 

 

(0.27

)

 

 

0.04

 

Adjusted Diluted Earnings Per Share

 

$

1.72

 

 

$

1.79

 

 

$

5.93

 

 

$

5.82

 


(1)

The tax effect for the U.S. jurisdiction is calculated based on an effective rate considering federal and state taxes, as well as permanent items.  For jurisdictions outside the U.S., the tax effect is calculated based upon the statutory rates where the items were incurred.

(2)

The 2016 nine month period includes negative effects from finalizing the tax accounts for the Biomet merger.  Under the applicable U.S. GAAP rules, these measurement period adjustments are recognized on a prospective basis in the period of change.

(3)

In the 2017 periods, other certain tax adjustments relate to a tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in acquisition-related accounting, net favorable resolutions of various tax matters, and charges from internal restructuring transactions that provide us access to cash in a tax efficient manner.  The adjustments in the 2016 periods relate to internal restructuring transactions that provide us access to cash in a tax efficient manner.

Liquidity and Capital Resources

Cash flows provided by operating activities were $1,179.4$584.6 million in the ninesix month period ended SeptemberJune 30, 2017,2019, compared to $1,005.0$883.8 million in the same prior year period.  The increasedecrease was driven byprimarily due to an approximate $168 million payment on a patent infringement lawsuit as well as other product liability-related payments we made in the 2019 period.  Additionally, in the prior year period, we continued to expand our sale of accounts receivable in certain countries in the 2017 period which we estimated provided an incremental $273 million of additional cash partially offset by product liability payments relatedinflows, compared to the U.S. Durom Cup Settlement Program2019 period where our sales of accounts receivable have not expanded significantly and $30.5 million in penalties paidtherefore the incremental benefits to resolve previously-disclosed FCPA matters involving Biomet and certain of its subsidiaries as discussed in Note 15 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report.the period are less.

Cash flows used in investing activities were $382.6$427.7 million in the ninesix month period ended SeptemberJune 30, 2017,2019, compared to $1,544.7$195.3 million in the same prior year period.  Instrument and property, plant and equipment additions reflected ongoing investments in our product portfolio and optimization of our manufacturing and logistics network.  The 2016 period included cash outflows for LDR and other business acquisitions, comparedAdditionally, we paid $197.6 million to the same period in 2017.  Additionally, the 2017 period reflects no investing activity related to available-for-sale debt securities because as investments matured we used the cash to pay off debt.buy out certain licensing arrangements from unrelated third parties.

Cash flows used in financing activities were $977.6$298.8 million in the ninesix month period ended SeptemberJune 30, 2017,2019, compared to $434.1$729.0 million in the same prior year period.  Our primary use of available cash inIn the first nine months of 2017 was for debt repayment.  We2019 period, we borrowed amounts under a new Japan Term Loan B and used the borrowings to pay down a portion of$200.0 million on U.S. Term Loan A.  We also paid $500.0C and used those proceeds, along with cash on hand, to pay the remaining balance of $225.0 million on U.S. Term Loan B.  Additionally, we repaid $200.0 million on U.S. Term Loan C in connectionthe 2019 period with cash generated from operations.  In the redemption at maturity2018 period, we received net proceeds of our 1.450%$749.5 million from the issuance of additional senior notes and borrowed $400.0 million from our Multicurrency Revolving Facility to repay $1,150.0 million of senior notes that became due on April 1,2, 2018.  We repaid $375.0 million of the Multicurrency Revolving Facility borrowings and also repaid $225.0 million on a term loan in the 2018 period.  In the 2019 period, we had net cash outflows of $25.6 million related to our factoring programs caused by the timing differences of collections from customers and repayments to the financial institution to which we sold the collected receivables.  The 2019 outflow was lower than the prior year based upon the timing of when receivable sales occurred in December of 2018 compared to December of 2017.

In February and May and July 2017,2019, our Board of Directors declared a quarterly cash dividend of $0.24 per share.  We expect to continue paying cash dividends on a quarterly basis; however, future dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.  Additionally, our debt facilities restrict the payment of dividends in certain circumstances.

34


In February 2016, our Board of Directors authorized a new $1.0 billion share repurchase program effective March 1, 2016, with no expiration date.  The previous program expired on February 29, 2016.  As of SeptemberJune 30, 2017,2019, all $1.0 billion remained authorized.  

We will continue to exercise disciplined capital allocation designed to drive stockholder value creation.  We intend to use available cash for debt repayment, reinvestment in the business debt repayment, dividends and opportunistic share repurchases.dividends.  If the right opportunities arise, we may also use available cash to pursue business development opportunities.

In order to achieve operational synergies, we expect ongoing cash outlays related to our Biomet integration plans through mid-2018.  These cash outlays are necessary to achieve our integration goals, including net annual pre-tax operating profit synergies of $350.0 million.  Additionally, we will continue to incur cash outlays for our ongoing quality enhancement and remediation efforts at the legacy Biomet Warsaw facility throughout 2017 and 2018.

As discussed in Note 1113 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report, the IRS has issued proposed adjustments for years 2005 through 2012, reallocating profits between certain of our U.S. and foreign subsidiaries.  We have disputed these proposed adjustments and intend to continue to pursue resolution with the IRS.vigorously defend our positions.  Although the ultimate timing for resolution of the disputed tax issues is uncertain, future payments may be significant to our operating cash flows.

Also, as discussed in Note 1517 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report, as of SeptemberJune 30, 2017,2019, a short-term liability of $75.0$19.5 million and a long-term liability of $143.3$54.0 million related to Durom Cup product liability claims were recorded on our condensed consolidated balance sheet.  We expect to continue paying these claims over the next few years.  We expect to be reimbursed a portion of these paymentsmaintain insurance for product liability claims, subject to self-insurance retention requirements.  We have recovered insurance proceeds from certain of our insurance carriers.carriers for Durom Cup-related claims.  While we may recover additional insurance proceeds in the future for Durom Cup-related claims, we do not have a receivable recorded on our condensed consolidated balance sheet as of June 30, 2019 for any possible future insurance recoveries for these claims.  As of SeptemberJune 30, 2017, we have received a portion of the insurance proceeds we estimate we will recover.  We have a long-term receivable of $95.3 million remaining for future expected reimbursements from our insurance carriers.  As of September 30, 2017,2019, we also had a short-term liability of $39.7$64.3 million related to Biomet metal-on-metal hip implant claims.

37


At SeptemberJune 30, 2017, we had eleven tranches2019, our outstanding debt consisted of senior notes outstandingand term loans as follows (dollars(principal shown in U.S. Dollars in millions):

 

 

 

 

 

Interest

 

 

 

Principal

 

 

Rate

 

 

Maturity Date

$

1,150.0

 

 

 

2.000

%

 

April 1, 2018

 

500.0

 

 

 

4.625

 

 

November 30, 2019

 

1,500.0

 

 

 

2.700

 

 

April 1, 2020

 

300.0

 

 

 

3.375

 

 

November 30, 2021

 

750.0

 

 

 

3.150

 

 

April 1, 2022

 

591.1

 

*

 

1.414

 

 

December 13, 2022

 

2,000.0

 

 

 

3.550

 

 

April 1, 2025

 

591.1

 

*

 

2.425

 

 

December 13, 2026

 

253.4

 

 

 

4.250

 

 

August 15, 2035

 

317.8

 

 

 

5.750

 

 

November 30, 2039

 

395.4

 

 

 

4.450

 

 

August 15, 2045

 

 

 

 

 

 

 

 

Interest

 

 

 

Type

 

Principal

 

 

Currency

 

Rate

 

 

Maturity Date

Notes

 

$

500.0

 

 

U.S. Dollar

 

 

4.625

 

 

November 30, 2019

Notes

 

 

1,500.0

 

 

U.S. Dollar

 

 

2.700

 

 

April 1, 2020

Term

 

 

535.0

 

 

U.S. Dollar

 

Floating

 

 

December 14, 2020

Notes

 

 

450.0

 

 

U.S. Dollar

 

Floating

 

 

March 19, 2021

Notes

 

 

300.0

 

 

U.S. Dollar

 

 

3.375

 

 

November 30, 2021

Notes

 

 

750.0

 

 

U.S. Dollar

 

 

3.150

 

 

April 1, 2022

Term

 

 

108.7

 

 

Japanese Yen

 

 

0.635

 

 

September  27, 2022

Term

 

 

197.9

 

 

Japanese Yen

 

 

0.635

 

 

September  27, 2022

Notes

 

 

569.4

 

 

Euro

 

 

1.414

 

 

December 13, 2022

Notes

 

 

300.0

 

 

U.S. Dollar

 

 

3.700

 

 

March 19, 2023

Notes

 

 

2,000.0

 

 

U.S. Dollar

 

 

3.550

 

 

April 1, 2025

Notes

 

 

569.4

 

 

Euro

 

 

2.425

 

 

December 13, 2026

Notes

 

 

253.4

 

 

U.S. Dollar

 

 

4.250

 

 

August 15, 2035

Notes

 

 

317.8

 

 

U.S. Dollar

 

 

5.750

 

 

November 30, 2039

Notes

 

 

395.4

 

 

U.S. Dollar

 

 

4.450

 

 

August 15, 2045

*

Euro denominated debt securities

We also had four term loans with total principal of $2,103.0 million outstanding as of September 30, 2017. 

We have a $1.5 billion Multicurrency Revolving Facility that will mature on September 30, 2021.  There were no outstanding borrowings under this facility as of SeptemberJune 30, 2017.2019.  We also have other available uncommitted credit facilities totaling $57.8$51.7 million as of SeptemberJune 30, 2017.2019.

We plan to use cash generated from operations to continue servicing our debt obligations through at least the remainder of this year.  We have $500.0 million principal amount of notes due November 30, 2019 and $1.5 billion principal amount of notes due April 1, 2020.  We believe we can satisfy these debt obligations with cash generated from our operations, by issuing new debt, or by borrowing on our Multicurrency Revolving Facility.  We believe that our earnings, balance sheet and cash flows will allow us to obtain additional capital, if necessary, to satisfy these debt obligations.

For additional information on our debt, see Note 79 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report.

35


We place our cash and cash equivalents in highly-rated financial institutions and limit the amount of credit exposure to any one entity.  We invest only in high-quality financial instruments in accordance with our internal investment policy.

As of SeptemberJune 30, 2017, $375.22019, $346.8 million of our cash and cash equivalents were held in jurisdictions outside of the U.S.  Of this amount, $101.5$94.3 million is denominated in U.S. Dollars and, therefore, bears no foreign currency translation risk.  The balance of these assets is denominated in currencies of the various countries where we operate.

In light of our commitments under various credit facilities, as well as our expectation for continued business development, we have plans  We intend to repatriate a significant portionat least $5.1 billion of our offshoreunremitted earnings to the U.S.  We have unremitted foreign earnings of $3,648.1 million, which we plan to repatriate to the U.S. in future periods.  We have estimated a long-term deferred tax liability of $1,205.8 million for the estimated tax impact of this repatriation.years.

Our concentrations of credit risks with respect to trade accounts receivable is limited due to the large number of customers and their dispersion across a number of geographic areas and by frequent monitoring of the creditworthiness of the customers to whom credit is granted in the normal course of business.  Substantially all of our trade receivables are concentrated in the public and private hospital and healthcare industry in the U.S. and internationally or with distributors or dealers who operate in international markets and, accordingly, are exposed to their respective business, economic and country-specific variables.  

Our ability to collect accounts receivable in some countries depends in part upon the financial stability of the hospital and healthcare sectors and the respective countries’ national economic and healthcare systems.  Most notably, in Europe healthcare is typically sponsored by the government.  Since we sell products to public hospitals in those countries, we are indirectly exposed to government budget constraints.  The ongoing financial uncertainties in the Euro zone impact the indirect credit exposure we have to those governments through their public hospitals.  As of September 30, 2017, in Greece, Italy, Portugal and Spain, countries that have been widely recognized as presenting the highest risk, our gross short-term and long-term trade accounts receivable combined were $226.7 million.  With allowances for doubtful accounts of $19.5 million recorded in those countries, the net balance was $207.2 million, representing 17 percent of our total consolidated short-term and long-term trade accounts receivable balance, net.  Italy and Spain accounted for $187.2 million of that net amount.  We are actively monitoring the situations in these countries and we maintain contact with customers in these countries on a regular basis.  We believe our allowance for doubtful accounts is adequate in these countries, as ultimately we believe the governments in these countries will be able to pay.  To the extent the respective governments’ ability to fund their public hospital programs deteriorates, we may have to record significant bad debt expenses in the future.

Management believes that cash flows from operations and available borrowings under the Multicurrency Revolving Facility are sufficient to meet our working capital, capital expenditure and debt service needs, as well as return cash to stockholders in the form of dividends and share repurchases.  Should additional investment opportunities arise, we believe that our earnings, balance sheet and cash flows will allow us to obtain additional capital, if necessary.

Recent Accounting Pronouncements

Information pertaining to recent accounting pronouncements can be found in Note 2 to theour interim condensed consolidated financial statements included in Part I, Item 1 of this report.

38


Critical Accounting Estimates

Our financial results are affected by the selection and application of accounting policies and methods.  There were no changes in the three or ninesix month periods ended SeptemberJune 30, 20172019 to the application of critical accounting policies as described in our Annual Report on Form 10-K for the year ended December 31, 2016.2018.  

In the fourth quarter of 2018, we recognized a $567.0 million goodwill impairment charge related to our EMEA reporting unit.  The impairment charge represented the amount by which the reporting unit’s carrying value exceeded its estimated fair value.  We estimated the fair value of the reporting unit based on income and market approaches.  Since the carrying value of this reporting unit was written down to its estimated fair value, future impairment could occur if the estimates used in the income and market approaches change.  If our estimates of profitability in the reporting unit decline, the fair value estimate under the income approach will decline.  If there are negative outlooks of the broader economic environment, comparable company valuation indicators may decline, which would cause our fair value estimate under the market approach to decline.  The goodwill balance of our EMEA reporting unit was $754.7 million at June 30, 2019.

Additionally, in our annual impairment test in the fourth quarter of 2018, our Dental reporting unit’s fair value exceeded its carrying value by less than 5 percent.  If our future operating results are below the estimations used for our impairment assessment, or there are negative impacts from the broader economic environment, then we may have to recognize goodwill impairment charges on this reporting unit in the future.  The goodwill balance of our Dental reporting unit was $386.8 million at June 30, 2019.    

We have three other reporting units that have goodwill assigned to them.  As of the date of our last goodwill impairment test, each of the three reporting unit’s estimated fair value exceeded its carrying value by more than 25 percent.

Cautionary Note Regarding Forward-Looking Statements and Factors That May Affect Future Results

This quarterly report contains certain statements that are forward-looking statements within the meaning of federal securities laws.  Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts.  When used in this report, the words “may,” “will,” “can,” “should,” “would,” “could,” “anticipate,” “expect,” “plan,” “seek,” “believe,” “are confident that,” “predict,” “estimate,” “potential,” “project,” “target,” “forecast,” “intend,” “strategy,” “future,” “opportunity,” “assume,” “guide,” “position”“position,” “continue” and similar expressions are intended to identify forward-looking statements.  Forward-looking statements are based on current beliefs, expectations and assumptions that are subject to significant risks, uncertainties and changes in circumstances that could cause actual results to differ materially from such forward-looking statements.  These risks, uncertainties and changes in circumstances include, but are not limited to:

 

our chief executive officer transition, including disruptionscompliance with the Deferred Prosecution Agreement entered into in January 2017;

the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods;

the risks and uncertainties related thereto,to our ability to appoint a permanent successor withsuccessfully integrate the desired leveloperations, products, employees and distributors of experience and expertise in a timely manner,acquired companies;

the effect of the potential impactdisruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions;

the effect of mergers and acquisitions on our relationships with customers, vendors and lenders and on our operating results and business generally;

the success of our quality and operational excellence initiatives, including our ongoing quality remediation efforts at our Warsaw North Campus facility;

our ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA, while continuing to satisfy the demand for our products;

challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the FDA and foreign government regulators, such as more stringent requirements for regulatory clearance of our products;

the outcome of government investigations;

competition;

pricing pressures;

changes in customer demand for our products and services caused by demographic changes or other factors;

the impact of healthcare reform measures, including the impact of the U.S. excise tax on medical devices if such tax is not further suspended or repealed;

3639


 

businessreductions in reimbursement levels by third-party payors and future strategic direction resultingcost-containment efforts of healthcare purchasing organizations;

dependence on new product development, technological advances and innovation;

shifts in the product category or the regional sales mix of our products and services;

supply and prices of raw materials and products;

control of costs and expenses;

our ability to obtain and maintain adequate intellectual property protection;

our ability to form and implement alliances;

changes in tax obligations arising from our transition to a new chief executive officertax reform measures, including the European Union rules on state aid, or examinations by tax authorities;

product liability and intellectual property litigation losses;

our ability to retain other key members of senior management;the independent agents and distributors who market our products;

the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods;

our dependence on a limited number of suppliers for key raw materials and outsourced activities;

the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies;

changes in general industry and market conditions, including domestic and international growth rates;

the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions;

changes in general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and

the effect of mergers and acquisitions on our relationships with customers, vendors and lenders and on our operating results and business generally;

compliance with the Deferred Prosecution Agreement entered into in January 2017;

the success of our quality and operational excellence initiatives, including our ongoing quality enhancement and remediation efforts at the legacy Biomet Warsaw facility;

our ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA, while continuing to satisfy the demand for our products;

challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the FDA and foreign government regulators, such as more stringent requirements for regulatory clearance of our products;

the outcome of government investigations;

competition;

pricing pressures;

changes in customer demand for our products and services caused by demographic changes or other factors;

the impact of healthcare reform measures, including the possible reinstatement of the medical device excise tax beginning January 1, 2018;

reductions in reimbursement levels by third-party payors and cost-containment efforts of healthcare purchasing organizations;

dependence on new product development, technological advances and innovation;

shifts in the product category or the regional sales mix of our products and services;

supply and prices of raw materials and products;

control of costs and expenses;

our ability to obtain and maintain adequate intellectual property protection;

our ability to form and implement alliances;

changes in tax obligations arising from tax reform measures, including the European Union rules on state aid, or examinations by tax authorities;

product liability and intellectual property litigation losses;

our ability to retain the independent agents and distributors who market our products;

our dependence on a limited number of suppliers for key raw materials and outsourced activities;

changes in general industry and market conditions, including domestic and international growth rates;

changes in general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and

the impact of the ongoing financial and political uncertainty on countries in the Euro zone on our ability to collect accounts receivable in affected countries.

the impact of the ongoing financial and political uncertainty on countries in the Euro zone on our ability to collect accounts receivable in affected countries.

37


Our Annual Report on Form 10-K for the year ended December 31, 2016, our Quarterly Report on Form 10-Q for the quarter ended June 30, 20172018 and this Quarterly Report on Form 10-Qreport contain detailed discussions of these and other important factors under the heading “Risk Factors.” You should understand that it is not possible to predict or identify all factors that could cause actual results to differ materially from forward-looking statements.  Consequently, you should not consider any list or discussion of such factors to be a complete set of all potential risks or uncertainties.

Forward-looking statements speak only as of the date they are made and we expressly disclaim any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Readers of this report are cautioned not to rely on these forward-looking statements since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this report.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

There have been no material changes from the information provided in our Annual Report on Form 10-K for the year ended December 31, 2016.2018.

Item 4.

Controls and Procedures

Evaluation of Disclosure Controls and Procedures.  We maintain disclosure controls and procedures (as defined in RuleRules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (“Exchange Act”)) that are designed to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.  Because of inherent limitations, disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable, and not absolute, assurance that the objectives of disclosure controls and procedures are met.

Our management, with the participation of our Interim Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, and in light of the previously identified material weakness in internal control over financial reporting as of December 31, 2016, described in our 2016 Annual Report on Form 10-K, our Interim Chief Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were not effective as of September 30, 2017.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there isat a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.  The material weakness we identified in 2016 relates to management’s controls over accounting for income taxes.  Specifically, we did not maintain the appropriate complement of resources in our tax department commensurate with the increased volume and complexity of accounting for income taxes subsequent to the Biomet merger.  This material weakness did not result in a material misstatement to our financial statements or disclosures, but did result in out-of-period adjustments in our provision for income taxes and deferred tax liabilities that were individually and in aggregate immaterial.  Additionally, this control deficiency could result in misstatements of income tax related accounts and disclosures that would result in a material misstatement of the consolidated financial statements that would not be prevented or detected.assurance level.

Remediation Plan.  Our management believes that progress has been made as of the date of this report in remediating the underlying causes of the material weakness. We have taken, and will continue to take, steps to remediate the control deficiencies that led to the material weakness. These steps include adding resources to enhance our tax and intercompany accounting expertise and establishing additional controls within the income tax review processes. In the nine month period ended September 30, 2017, we added senior level employees responsible for income tax reporting and intercompany accounting, developed a formal plan for remediation, reevaluated financial reporting risks within the income tax accounting process, and completed an internal  review of our controls, with the assistance of a third party professional services firm. During the remainder of 2017, we intend to add additional resources and execute our remediation plan.

The material weakness will not be considered remediated until the applicable measures have been implemented for a sufficient period of time and management has concluded, through testing, the enhanced controls are operating effectively.  As we continue to evaluate and improve our internal control over financial reporting, we may decide to take additional measures to address this material weakness, which may require additional implementation time.  Further, we cannot provide any assurance that our remediation efforts will be successful or that our internal control over financial reporting will be effective as a result of these efforts.

3840


Notwithstanding the identified material weakness and the conclusion above that our disclosure controls and procedures were not effective as of September 30, 2017, our management believes that the unaudited condensed consolidated financial statements contained in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity with accounting principles generally accepted in the United States of America.

Changes in Internal Control Over Financial Reporting.ThereThere were no changes in our internal control over financial reporting that occurred during the quarter ended SeptemberJune 30, 20172019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. As previously reported, on January 1, 2019 we adopted ASU 2016-02 – Leases (Topic 842).  This ASU requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet.  As a result, we added additional internal controls to comply with the new standard in the first quarter of 2019.  

3941


Part II – OtherOther Information

Item 1.

Information pertaining to legal proceedings can be found in Note 1517 to theour interim condensed consolidated financial statements included in Part I, Item 1 of this report and is incorporated herein by reference.

Item 1A.

Risk Factors

Except as set forth below, there have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 20162018.  The risk factor set forth below replaces in its entirety the risk factor with the same title:

We incurred substantial additional indebtedness in connection with previous mergers and acquisitions and may not be able to meet all of our Quarterly Report on Form 10-Q for the quarter endeddebt obligations.

We incurred substantial additional indebtedness in connection with previous mergers and acquisitions.  At June 30, 2017.

2019, our total indebtedness was $8.7 billion, as compared to $1.4 billion at December 31, 2014.  As of June 30, 2019, our debt service obligations, comprised of principal and interest (excluding leases and equipment notes), during the next 12 months are expected to be $2.2 billion.  As a result of the increase in our debt, demands on our cash resources have increased.  The following risk factor is added:increased level of debt could, among other things:

If the medical device excise tax is not repealed or further suspended,

require us to dedicate a large portion of our cash flow from operations to the servicing and repayment of our debt, thereby reducing funds available for working capital, capital expenditures, research and development expenditures and other general corporate requirements;

limit our ability to obtain additional financing to fund future working capital, capital expenditures, research and development expenditures and other general corporate requirements;

limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;

restrict our ability to make strategic acquisitions or dispositions or to exploit business opportunities;

place us at a competitive disadvantage compared to our competitors that have less debt;

adversely affect our credit rating, with the result that the cost of servicing our indebtedness might increase and our ability to obtain surety bonds could be impaired;

adversely affect the market price of our common stock; and

limit our ability to apply proceeds from a future offering or asset sale to purposes other than the servicing and repayment of debt.

In addition, the annual interest rates applicable to certain of our debt obligations are based on a fluctuating rate of interest determined by reference to the London Interbank Offered Rate (“LIBOR”).  Any increase in interest rates applicable to our debt obligations would increase our cost of borrowing and could adversely affect our financial position, results of operations or cash flows.  Further, in July 2017, the U.K.’s Financial Conduct Authority, which regulates LIBOR, announced that it intends to stop persuading or compelling banks to submit rates for the calculation of LIBOR after 2021.  In response to concerns regarding the future of LIBOR, the Board of Governors of the Federal Reserve System and cash flowsthe Federal Reserve Bank of New York convened the Alternative Reference Rates Committee (“ARRC”) to identify alternatives to LIBOR.  The ARRC has recommended a benchmark replacement waterfall to assist issuers in continued capital market entry while safeguarding against LIBOR’s discontinuation.  The initial steps in the ARRC’s recommended provision reference variations of the Secured Overnight Financing Rate (“SOFR”).  At this time, it is not possible to predict whether SOFR will attain market traction as a LIBOR replacement.  Additionally, it is uncertain if LIBOR will cease to exist after calendar year 2021, or whether additional reforms to LIBOR may be adversely affected.

As partenacted, or whether alternative reference rates will gain market acceptance as a replacement for LIBOR.  At this time, all of our debt obligations that are based on LIBOR will mature before the end of 2021.  We will continue to monitor the situation and address the potential reference rate changes in future debt obligations that we may incur.  Accordingly, the potential effect of the Patient Protection and Affordable Care Actphase-out or replacement of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the Affordable Care Act or ACA), in January 2013 we began paying a 2.3 percent medical device excise taxLIBOR on the vast majority of our U.S sales.  A two-year moratorium was placed on the tax effective January 1, 2016.  Absent further legislative action, the tax will be automatically reinstated for U.S. medical device sales beginning January 1, 2018.

If the medical device excise tax is reinstated, we will again be forced to identify ways to reduce spending in other areas to offset the earnings impact due to the tax.  We do not expect to be able to pass along the cost of the tax to hospitals, which continue to face cuts to their Medicare reimbursement under the Affordable Care Act and other legislation.  Nor do we expect tocapital cannot yet be able to offset the cost of the tax through higher sales volumes resulting from any further expansion of health insurance coverage through ACA exchanges or Medicaid expansion because of the demographics of the current uninsured population.  Accordingly, reinstatement of the medical device excise tax could have a material adverse effect on our business, results of operations and cash flows.determined.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

None

Item 3.

Defaults Upon Senior Securities

None

42


Item 4.

Mine Safety Disclosures

Not applicable

Item 5.

Other Information

During the three month period ended SeptemberJune 30, 2017,2019, the Audit Committee of our Board of Directors was not asked to, and did not, approveapproved the engagement of PricewaterhouseCoopers LLP, our independent registered public accounting firm, to perform anycertain non-audit services.  This disclosure is made pursuant to Section 10A(i)(2) of the Exchange Act, as added by Section 202 of the Sarbanes-Oxley Act of 2002.

4043


Item 6.

ExhibitsExhibits

The following exhibits are filed or furnished as part of this report:

 

3.1

 

Restated Certificate of Incorporation of Zimmer Biomet Holdings, Inc., dated June 24, 2015 (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed June 26, 2015)

 

 

 

3.2

 

Restated By-Laws of Zimmer Biomet Holdings, Inc., effective June 24, 2015 (incorporated by reference to Exhibit 3.3 to the Registrant’s Current Report on Form 8-K filed June 26, 2015)

4.1

Specimen Common Stock Certificate

 

 

 

10.1

 

Term LoanFirst Amendment to Aircraft Time Sharing Agreement ¥21,300,000,000, dated as of September 22, 2017,by and between Zimmer, Biomet G.K.Inc. and Sumitomo Mitsui Banking Corporation (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed September 28, 2017)Bryan C. Hanson

 

 

 

10.2

 

Amended and Restated Term Loan Agreement ¥11,700,000,000, dated as of September 22, 2017,Offer letter between Zimmer Biomet G.K.Holdings, Inc. and Sumitomo Mitsui Banking CorporationSuketu Upadhyay dated June 13, 2019 (incorporated by reference to Exhibit 10.210.1 to the Registrant’s Current Report on Form 8-K filed September 28, 2017)June 19, 2019)

 

 

 

10.3

 

Amended and Restated LetterForm of Guarantee, dated as of September 22, 2017, made by Zimmer Biomet Holdings, Inc.Change in favor of Sumitomo Mitsui Banking CorporationControl Severance Agreement with Suketu Upadhyay (incorporated by reference to Exhibit 10.310.11 to the Registrant’s CurrentAnnual Report on Form 8-K10-K filed September 28, 2017)February 26, 2019)

 

 

 

10.4*10.4

 

Form of Restricted Stock Unit Award Agreement (two-year vesting) under the Zimmer Biomet Holdings, Inc. 2009 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed July 11, 2017)

10.5*

Form of Confidentiality, Non-Competition and Non-Solicitation Agreement with Daniel P. FlorinSuketu Upadhyay (incorporated by reference to Exhibit 10.12 to the Registrant’s Annual Report on Form 10-K filed February 26, 2019)

 

 

 

 21

 

List of Subsidiaries of Zimmer Biomet Holdings, Inc.

 

 

 

 3131.1

 

Certification pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 of the Interim Chief Executive Officer, andas adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 31.2

Certification pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 of the Chief Financial Officer, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 32

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

101.INS

 

XBRL Instance Document – The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

 

*  Management contract or compensatory plan or arrangement

 

4144


SIGNATURESSIGNATURES

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

 

 

 

ZIMMER BIOMET HOLDINGS, INC.

 

 

 

 

 

 

 

(Registrant)

 

 

 

 

 

Date:  November 6, 2017August 5, 2019

 

By:

 

/s/ Daniel P. FlorinSuketu Upadhyay

 

 

 

 

Daniel P. FlorinSuketu Upadhyay

 

 

 

 

InterimExecutive Vice President and Chief ExecutiveFinancial Officer

 

 

 

 

Senior Vice President(Principal Financial and Accounting Officer)

 

 

 

 

Chief Financial Officer

Date:  November 6, 2017

By:

/s/ Tony W. Collins

Tony W. Collins

Vice President, Corporate Controller

and Chief Accounting Officer

 

4245