Quarterly Report (10-q)

Date : 07/29/2019 @ 8:17PM
Source : Edgar (US Regulatory)
Stock : Mylan NV (MYL)
Quote : 17.24  -0.03 (-0.17%) @ 9:19PM

Quarterly Report (10-q)

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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 June 30, 2019
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from_____________to___________                 
Commission File Number 333-199861
MYLAN N.V.
(Exact name of registrant as specified in its charter)
Netherlands
 
98-1189497
(State or other jurisdiction
of incorporation or organization)
 
(I.R.S. Employer
Identification No.)
Building 4 , Trident Place , Mosquito Way , Hatfield , Hertfordshire , AL10 9UL , England
(Address of principal executive offices)
+ 44 (0) 1707 - 853-000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
 
 
 
 
 
Ordinary shares, nominal value €0.01
 
MYL
 
The NASDAQ Stock Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes        No  
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).     Yes        No  
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
 
 
Accelerated filer
 
 
 
 
 
 
 
 
Non-accelerated filer
 
 
 
Smaller reporting company
 
 
 
 
 
 
 
 
 
 
 
 
Emerging growth company
 
 
 
 
 
 
 
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes       No  
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
As of July 23, 2019 , there were 515,869,921 of the issuer’s €0.01 nominal value ordinary shares outstanding.
 



MYLAN N.V. AND SUBSIDIARIES
INDEX TO FORM 10-Q
For the Quarterly Period Ended
June 30, 2019

   
 
Page
 
PART I — FINANCIAL INFORMATION
 
ITEM 1.
Condensed Consolidated Financial Statements (unaudited)
 
 
 
 
 
 
 
 
 
 
 
 
 
ITEM 2.
 
 
 
ITEM 3.
 
 
 
ITEM 4.
 
 
 
 
PART II — OTHER INFORMATION
 
ITEM 1.
 
 
 
ITEM 1A.
 
 
 
ITEM 6.
 
 
 
 

2


PART I — FINANCIAL INFORMATION

MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited; in millions, except per share amounts)
 
Three Months Ended
 
Six Months Ended
 
June 30,
 
June 30,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Net sales
$
2,818.2

 
$
2,755.5

 
$
5,278.8

 
$
5,405.9

Other revenues
33.3

 
52.8

 
68.2


86.9

Total revenues
2,851.5

 
2,808.3

 
5,347.0

 
5,492.8

Cost of sales
1,918.9

 
1,845.8

 
3,609.2

 
3,546.0

Gross profit
932.6

 
962.5

 
1,737.8

 
1,946.8

Operating expenses:
 
 
 
 
 
 
 
Research and development
147.6

 
206.7

 
320.2

 
411.6

Selling, general and administrative
668.6

 
623.3

 
1,276.5

 
1,230.8

Litigation settlements and other contingencies, net
20.9

 
(46.4
)
 
21.6

 
(30.2
)
Total operating expenses
837.1

 
783.6

 
1,618.3

 
1,612.2

Earnings from operations
95.5

 
178.9

 
119.5

 
334.6

Interest expense
131.2

 
139.2

 
262.4

 
270.9

Other expense, net
16.4

 
21.0

 
23.7

 
34.5

(Loss) Earnings before income taxes
(52.1
)
 
18.7

 
(166.6
)
 
29.2

Income tax provision (benefit)
116.4

 
(18.8
)
 
26.9

 
(95.4
)
Net (loss) earnings
$
(168.5
)
 
$
37.5

 
$
(193.5
)
 
$
124.6

(Loss) Earnings per ordinary share:
 
 
 
 
 
 
 
Basic
$
(0.33
)
 
$
0.07

 
$
(0.38
)
 
$
0.24

Diluted
$
(0.33
)
 
$
0.07

 
$
(0.38
)
 
$
0.24

Weighted average ordinary shares outstanding:
 
 
 
 
 
 
 
Basic
515.5

 
514.4

 
515.3

 
514.4

Diluted
515.5

 
516.3

 
515.3

 
516.6




See Notes to Condensed Consolidated Financial Statements
3



MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Earnings
(Unaudited; in millions)
 
Three Months Ended
 
Six Months Ended
 
June 30,
 
June 30,
 
2019
 
2018
 
2019
 
2018
Net (loss) earnings
$
(168.5
)
 
$
37.5

 
$
(193.5
)
 
$
124.6

Other comprehensive earnings (loss), before tax:
 
 
 
 
 
 
 
Foreign currency translation adjustment
196.6

 
(1,088.7
)
 
(141.9
)
 
(826.8
)
Change in unrecognized gain (loss) and prior service cost related to defined benefit plans

 
2.8

 
0.2

 
(1.5
)
Net unrecognized gain (loss) on derivatives in cash flow hedging relationships
9.4

 
(62.2
)
 
35.4

 
(94.2
)
Net unrecognized (loss) gain on derivatives in net investment hedging relationships
(36.3
)
 
119.1

 
21.8

 
59.9

Net unrealized gain (loss) on marketable securities
0.2

 
0.3

 
0.6

 
(0.1
)
Other comprehensive earnings (loss), before tax
169.9

 
(1,028.7
)
 
(83.9
)
 
(862.7
)
Income tax provision (benefit)
1.1

 
(20.9
)
 
12.9

 
(32.1
)
Other comprehensive earnings (loss), net of tax
168.8

 
(1,007.8
)
 
(96.8
)
 
(830.6
)
Comprehensive earnings (loss)
$
0.3

 
$
(970.3
)
 
$
(290.3
)
 
$
(706.0
)




See Notes to Condensed Consolidated Financial Statements
4



MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited; in millions, except share and per share amounts)
 
June 30,
2019
 
December 31,
2018
ASSETS
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
211.5

 
$
388.1

Accounts receivable, net
2,703.8

 
2,881.0

Inventories
2,776.2

 
2,580.2

Prepaid expenses and other current assets
573.9

 
518.4

Total current assets
6,265.4

 
6,367.7

Property, plant and equipment, net
2,146.0

 
2,170.2

Intangible assets, net
12,730.7

 
13,664.6

Goodwill
9,692.9

 
9,747.8

Deferred income tax benefit
553.1

 
572.2

Other assets
428.8

 
212.4

Total assets
$
31,816.9

 
$
32,734.9

 
 
 
 
LIABILITIES AND EQUITY
Liabilities
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
1,538.2

 
$
1,617.0

Short-term borrowings
26.2

 
1.9

Income taxes payable
138.5

 
121.5

Current portion of long-term debt and other long-term obligations
724.4

 
699.8

Other current liabilities
2,133.0

 
2,147.6

Total current liabilities
4,560.3

 
4,587.8

Long-term debt
12,590.1

 
13,161.2

Deferred income tax liability
1,635.1

 
1,722.0

Other long-term obligations
1,128.6

 
1,096.8

Total liabilities
19,914.1

 
20,567.8

Equity
 
 
 
Mylan N.V. shareholders’ equity
 
 
 
Ordinary shares — nominal value €0.01 per ordinary share
 
 
 
Shares authorized: 1,200,000,000
 
 
 
Shares issued: 540,459,996 and 539,289,665 as of June 30, 2019 and December 31, 2018
6.1

 
6.0

Additional paid-in capital
8,617.3

 
8,591.4

Retained earnings
5,820.8

 
6,010.7

Accumulated other comprehensive loss
(1,541.7
)
 
(1,441.3
)
 
12,902.5

 
13,166.8

Less: Treasury stock — at cost
 
 
 
Ordinary shares: 24,598,074 and 23,490,867 as of June 30, 2019 and December 31, 2018
999.7

 
999.7

Total equity
11,902.8

 
12,167.1

Total liabilities and equity
$
31,816.9

 
$
32,734.9



See Notes to Condensed Consolidated Financial Statements
5



MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Equity
(Unaudited; in millions, except share amounts)
 
 
 
 
 
Additional Paid-In Capital
 
Retained
Earnings
 
 
 
 
 
Accumulated Other Comprehensive Loss
 
Total
Equity
 
Ordinary Shares
 
 
 
Treasury Stock
 
 
 
Shares
 
Cost
 
 
 
Shares
 
Cost
 
 
Balance at March 31, 2019
539,943,344

 
$
6.0

 
$
8,606.5

 
$
5,989.3

 
23,490,867

 
$
(999.7
)
 
$
(1,710.5
)
 
$
11,891.6

Net loss

 

 

 
(168.5
)
 

 

 

 
(168.5
)
Other comprehensive earnings, net of tax

 

 

 

 

 

 
168.8

 
168.8

Issuance of restricted stock and stock options exercised, net
516,652

 

 
1.6

 

 

 

 

 
1.6

Taxes related to the net share settlement of equity awards

 

 
(7.6
)
 

 

 

 

 
(7.6
)
Share-based compensation expense

 

 
16.8

 

 

 

 

 
16.8

Cancellation of restricted stock

 
0.1

 

 

 
1,107,207

 

 

 
0.1

Balance at June 30, 2019
540,459,996

 
$
6.1

 
$
8,617.3

 
$
5,820.8

 
24,598,074

 
$
(999.7
)
 
$
(1,541.7
)
 
$
11,902.8

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional Paid-In Capital
 
Retained
Earnings
 
 
 
 
 
Accumulated Other Comprehensive Loss
 
Total
Equity
 
Ordinary Shares
 
 
 
Treasury Stock
 
 
 
Shares
 
Cost
 
 
 
Shares
 
Cost
 
 
Balance at December 31, 2018
539,289,665

 
$
6.0

 
$
8,591.4

 
$
6,010.7

 
23,490,867

 
$
(999.7
)
 
$
(1,441.3
)
 
$
12,167.1

Net loss

 

 

 
(193.5
)
 

 

 

 
(193.5
)
Other comprehensive loss, net of tax

 

 

 

 

 

 
(96.8
)
 
(96.8
)
Issuance of restricted stock and stock options exercised, net
1,170,331

 

 
3.9

 

 

 

 

 
3.9

Taxes related to the net share settlement of equity awards

 

 
(12.8
)
 

 

 

 

 
(12.8
)
Share-based compensation expense

 

 
34.8

 

 

 

 

 
34.8

Cancellation of restricted stock

 
0.1

 

 

 
1,107,207

 

 

 
0.1

Cumulative effect of the adoption of new accounting standards

 

 

 
3.6

 

 

 
(3.6
)
 

Balance at June 30, 2019
540,459,996

 
$
6.1

 
$
8,617.3

 
$
5,820.8

 
24,598,074

 
$
(999.7
)
 
$
(1,541.7
)
 
$
11,902.8



See Notes to Condensed Consolidated Financial Statements
6



 
 
 
 
 
Additional Paid-In Capital
 
Retained
Earnings
 
 
 
 
 
Accumulated Other Comprehensive Loss
 
Total
Equity
 
Ordinary Shares
 
 
 
Treasury Stock
 
 
 
Shares
 
Cost
 
 
 
Shares
 
Cost
 
 
Balance at March 31, 2018
538,861,761

 
$
6.0

 
$
8,610.3

 
$
5,745.0

 
23,490,867

 
$
(999.7
)
 
$
(191.5
)
 
$
13,170.1

Net earnings

 

 

 
37.5

 

 

 

 
37.5

Other comprehensive loss, net of tax

 

 

 

 

 

 
(1,007.8
)
 
(1,007.8
)
Issuance of restricted stock and stock options exercised, net
149,149

 

 
3.1

 

 

 

 

 
3.1

Share-based compensation income

 

 
(0.8
)
 

 

 

 

 
(0.8
)
Balance at June 30, 2018
539,010,910

 
$
6.0

 
$
8,612.6

 
$
5,782.5

 
23,490,867

 
$
(999.7
)
 
$
(1,199.3
)
 
$
12,202.1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional Paid-In Capital
 
Retained
Earnings
 
 
 
 
 
Accumulated Other Comprehensive Loss
 
Total
Equity
 
Ordinary Shares
 
 
 
Treasury Stock
 
 
 
Shares
 
Cost
 
 
 
Shares
 
Cost
 
 
Balance at December 31, 2017
537,902,426

 
$
6.0

 
$
8,586.0

 
$
5,644.5

 
13,695,251

 
$
(567.7
)
 
$
(361.2
)
 
$
13,307.6

Net earnings

 

 

 
124.6

 

 

 

 
124.6

Other comprehensive loss, net of tax

 

 

 

 

 

 
(830.6
)
 
(830.6
)
Issuance of restricted stock and stock options exercised, net
1,108,484

 

 
13.7

 

 

 

 

 
13.7

Taxes related to the net share settlement of equity awards

 

 
(8.0
)
 

 

 

 

 
(8.0
)
Share-based compensation expense

 

 
20.6

 

 

 

 

 
20.6

Ordinary share repurchase

 

 

 

 
9,795,616

 
(432.0
)
 

 
(432.0
)
Cumulative effect of the adoption of new accounting standards

 

 

 
13.7

 

 

 
(7.5
)
 
6.2

Other

 

 
0.3

 
(0.3
)
 

 

 

 

Balance at June 30, 2018
539,010,910

 
$
6.0

 
$
8,612.6

 
$
5,782.5

 
23,490,867

 
$
(999.7
)
 
$
(1,199.3
)
 
$
12,202.1




See Notes to Condensed Consolidated Financial Statements
7



MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited; in millions)
 
Six Months Ended
 
June 30,
 
2019
 
2018
Cash flows from operating activities:
 
 
 
Net (loss) earnings
$
(193.5
)
 
$
124.6

Adjustments to reconcile net (loss) earnings to net cash provided by operating activities:
 
 
 
Depreciation and amortization
1,001.9

 
1,000.4

Share-based compensation expense
34.8

 
20.6

Deferred income tax benefit
(57.8
)
 
(65.4
)
Loss from equity method investments
33.2

 
46.0

Other non-cash items
63.5

 
261.6

Litigation settlements and other contingencies, net
24.4

 
(22.3
)
Changes in operating assets and liabilities:
 
 
 
Accounts receivable
198.9

 
479.0

Inventories
(326.8
)
 
(280.7
)
Accounts payable
(71.6
)
 
(130.6
)
Income taxes
(94.8
)
 
(122.9
)
Other operating assets and liabilities, net
17.0

 
(258.3
)
Net cash provided by operating activities
629.2

 
1,052.0

Cash flows from investing activities:
 
 
 
Cash paid for acquisitions, net
(7.1
)
 
(63.3
)
Capital expenditures
(97.2
)
 
(75.9
)
Purchase of available for sale securities and other investments
(12.7
)
 
(44.4
)
Proceeds from the sale of marketable securities
12.5

 
65.3

Payments for product rights and other, net
(129.5
)
 
(614.4
)
Net cash used in investing activities
(234.0
)
 
(732.7
)
Cash flows from financing activities:
 
 
 
Proceeds from issuance of long-term debt
5.5

 
2,577.2

Payments of long-term debt
(555.5
)
 
(2,598.6
)
Purchase of ordinary shares

 
(432.0
)
Change in short-term borrowings, net
24.3

 
179.0

Taxes paid related to net share settlement of equity awards
(8.3
)
 
(10.1
)
Contingent consideration payments
(38.8
)
 
(0.2
)
Payments of financing fees
(2.1
)
 
(18.4
)
Proceeds from exercise of stock options
4.0

 
13.7

Other items, net
(1.0
)
 
(0.5
)
Net cash used in financing activities
(571.9
)
 
(289.9
)
Effect on cash of changes in exchange rates
0.1

 
(15.1
)
Net (decrease) increase in cash, cash equivalents and restricted cash
(176.6
)
 
14.3

Cash, cash equivalents and restricted cash — beginning of period
389.3

 
369.9

Cash, cash equivalents and restricted cash — end of period
$
212.7

 
$
384.2



See Notes to Condensed Consolidated Financial Statements
8


MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited)


1. General
The accompanying unaudited condensed consolidated financial statements (“ interim financial statements ”) of Mylan N.V. and subsidiaries (“Mylan” or the “Company”) were prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q; therefore, as permitted under these rules, certain footnotes and other financial information included in audited financial statements were condensed or omitted. The interim financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the interim results of operations, comprehensive earnings, financial position, equity and cash flows for the periods presented.
These interim financial statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto in Mylan N.V. ’s Annual Report on Form 10-K for the year ended December 31, 2018 , as amended (the “ 2018 Form 10-K”). The December 31, 2018 condensed consolidated balance sheet was derived from audited financial statements.
The interim results of operations and comprehensive earnings for the three and six months ended June 30, 2019 , and cash flows for the six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the full fiscal year or any other future period. Certain prior year amounts have been reclassified to conform to the current year presentation.
2.
Revenue Recognition and Accounts Receivable
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes net revenue for product sales when control of the promised goods or services is transferred to our customers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Revenues are recorded net of provisions for variable consideration, including discounts, rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the condensed consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash).
Wholesaler and distributor inventory levels of our products can fluctuate throughout the year due to the seasonality of certain products, the timing of product demand and other factors. Such fluctuations may impact the comparability of our net sales between periods.
Consideration received from licenses of intellectual property is recorded as revenue. Royalty or profit share amounts, which are based on sales of licensed products or technology, are recorded when the customer’s subsequent sales or usages occur. Such consideration is included in other revenue in the condensed consolidated statements of operations.

9

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Revenue Disaggregation
The following table presents the Company’s net sales by therapeutic franchise for each of our reportable segments for the three and six months ended June 30, 2019 and 2018 , respectively:
(In millions)
North America
 
Europe
 
Rest of World
 
Total
Three Months Ended June 30, 2019
 
 
 
 
 
 
 
Central Nervous System & Anesthesia
$
135.2

 
$
214.7

 
$
92.9

 
$
442.8

Infectious Disease
30.5

 
61.9

 
297.1

 
389.5

Respiratory & Allergy
258.2

 
121.9

 
56.2

 
436.3

Cardiovascular
48.9

 
131.7

 
40.6

 
221.2

Gastroenterology
30.7

 
159.2

 
102.9

 
292.8

Diabetes & Metabolism
83.8

 
81.9

 
37.0

 
202.7

Dermatology
25.5

 
80.3

 
21.0

 
126.8

Women’s Healthcare
90.2

 
60.2

 
24.2

 
174.6

Oncology
246.9

 
20.3

 
35.2

 
302.4

Immunology
9.0

 
13.8

 
10.9

 
33.7

Other (1)
64.5

 
43.7

 
87.2

 
195.4

Total
$
1,023.4

 
$
989.6

 
$
805.2

 
$
2,818.2

 
 
 
 
 
 
 
 
Six Months Ended June 30, 2019
 
 
 
 
 
 
 
Central Nervous System & Anesthesia
$
270.9

 
$
405.0

 
$
156.9

 
$
832.8

Infectious Disease
48.6

 
120.7

 
512.7

 
682.0

Respiratory & Allergy
496.8

 
229.7

 
99.9

 
826.4

Cardiovascular
95.8

 
232.4

 
74.8

 
403.0

Gastroenterology
64.9

 
287.0

 
180.4

 
532.3

Diabetes & Metabolism
234.8

 
139.1

 
76.2

 
450.1

Dermatology
39.4

 
141.9

 
41.4

 
222.7

Women’s Healthcare
169.1

 
104.8

 
39.3

 
313.2

Oncology
371.7

 
37.9

 
64.2

 
473.8

Immunology
19.1

 
21.0

 
17.3

 
57.4

Other (1)
135.2

 
165.4

 
184.5

 
485.1

Total
$
1,946.3

 
$
1,884.9

 
$
1,447.6

 
$
5,278.8


10

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

(In millions)
North America
 
Europe
 
Rest of World
 
Total
Three Months Ended June 30, 2018
 
 
 
 
 
 
 
Central Nervous System & Anesthesia
$
199.9

 
$
220.7

 
$
76.4

 
$
497.0

Infectious Disease
62.6

 
58.2

 
251.6

 
372.4

Respiratory & Allergy
181.6

 
129.4

 
53.7

 
364.7

Cardiovascular
76.1

 
149.1

 
46.2

 
271.4

Gastroenterology
33.9

 
145.1

 
92.1

 
271.1

Diabetes & Metabolism
114.1

 
80.2

 
33.5

 
227.8

Dermatology
84.5

 
74.3

 
27.2

 
186.0

Women’s Healthcare
85.2

 
66.8

 
22.2

 
174.2

Oncology
102.2

 
18.4

 
32.8

 
153.4

Immunology
14.1

 
2.5

 
10.7

 
27.3

Other (1)
46.6

 
45.9

 
117.7

 
210.2

Total
$
1,000.8

 
$
990.6

 
$
764.1

 
$
2,755.5

 
 
 
 
 
 
 
 
Six Months Ended June 30, 2018
 
 
 
 
 
 
 
Central Nervous System & Anesthesia
$
399.5

 
$
446.1

 
$
159.3

 
$
1,004.9

Infectious Disease
109.0

 
122.7

 
420.6

 
652.3

Respiratory & Allergy
295.5

 
257.0

 
100.3

 
652.8

Cardiovascular
166.5

 
295.9

 
85.7

 
548.1

Gastroenterology
78.0

 
298.3

 
158.2

 
534.5

Diabetes & Metabolism
223.7

 
154.0

 
58.3

 
436.0

Dermatology
179.0

 
154.6

 
52.1

 
385.7

Women’s Healthcare
178.3

 
136.8

 
41.4

 
356.5

Oncology
211.5

 
37.2

 
63.7

 
312.4

Immunology
28.1

 
5.0

 
19.1

 
52.2

Other (1)
117.0

 
121.4

 
232.1

 
470.5

Total
$
1,986.1

 
$
2,029.0

 
$
1,390.8

 
$
5,405.9

____________
(1)  
Other consists of numerous therapeutic franchises, none of which individually exceeds 5% of consolidated net sales.
Variable Consideration and Accounts Receivable
The following table presents a reconciliation of gross sales to net sales by each significant category of variable consideration during the three and six months ended June 30, 2019 and 2018 , respectively:
 
Three Months Ended
 
Six Months Ended
 
June 30,
 
June 30,
(In millions)
2019
 
2018
 
2019
 
2018
Gross sales
$
4,631.0

 
$
4,825.3

 
$
8,789.5

 
$
9,557.6

Gross to net adjustments:
 
 
 
 
 
 
 
Chargebacks
(751.6
)
 
(816.4
)
 
(1,455.3
)
 
(1,688.5
)
Rebates, promotional programs and other sales allowances
(874.5
)
 
(1,088.0
)
 
(1,730.7
)
 
(2,118.6
)
Returns
(75.2
)
 
(23.8
)
 
(121.0
)
 
(101.1
)
Governmental rebate programs
(111.5
)
 
(141.6
)
 
(203.7
)
 
(243.5
)
Total gross to net adjustments
$
(1,812.8
)
 
$
(2,069.8
)
 
$
(3,510.7
)
 
$
(4,151.7
)
Net sales
$
2,818.2

 
$
2,755.5

 
$
5,278.8

 
$
5,405.9



11

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

No significant revisions were made to the methodology used in determining these provisions or the nature of the provisions during the three and six months ended June 30, 2019 . Such allowances were comprised of the following at June 30, 2019 and December 31, 2018 , respectively:
(In millions)
June 30,
2019
 
December 31,
2018
Accounts receivable, net
$
1,499.8

 
$
1,715.6

Other current liabilities
645.1

 
626.7

Total
$
2,144.9

 
$
2,342.3

Accounts receivable, net was comprised of the following at June 30, 2019 and December 31, 2018 , respectively:
(In millions)
June 30,
2019
 
December 31,
2018
Trade receivables, net
$
2,276.6

 
$
2,416.5

Other receivables
427.2

 
464.5

Accounts receivable, net
$
2,703.8

 
$
2,881.0


Through its wholly owned subsidiary Mylan Pharmaceuticals Inc. (“MPI”), the Company has access to a $400 million accounts receivable securitization facility (the “Receivables Facility”). The receivables underlying any borrowings are included in accounts receivable, net, in the condensed consolidated balance sheets . There were $231.1 million and $322.0 million of securitized accounts receivable at June 30, 2019 and December 31, 2018 , respectively.

12

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

3.
Recent Accounting Pronouncements
Adoption of New Accounting Standards
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02,  Leases (Topic 842),  which supersedes FASB Topic 840,  Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use (“ROU”) asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. In July 2018, the FASB issued ASU 2018-10,  Codification Improvements to Topic 842 (Leases) , and ASU 2018-11,  Leases (Topic 842), Targeted Improvements , which provide (i) narrow amendments to clarify how to apply certain aspects of the new lease standard, (ii) entities with an additional transition method to adopt the new standard, and (iii) lessors with a practical expedient for separating components of a contract. In December 2018, the FASB issued ASU 2018-20, Leases (Topic 842): Narrow-Scope Improvements for Lessors, which provides certain narrow-scope improvements to Topic 842 as it relates to lessors. The Company adopted the provisions of Topic 842 as of January 1, 2019 on a modified retrospective basis applying the guidance to leases existing as of this effective date. We elected to apply the available package of transitional practical expedients which permitted us not to reassess under the new standard our prior conclusions regarding lease identification, lease classification and initial direct costs. We have also elected to apply the short-term lease recognition exemption which means we will not recognize ROU assets or lease liabilities for leases that qualify both at transition and on a go-forward basis. In addition, we have elected to apply the practical expedient to not separate lease and non-lease components for our leases except for those related to certain limited supply arrangements. The Company has determined that there was no cumulative-effect adjustment to beginning retained earnings on the condensed consolidated balance sheet. We will continue to report periods prior to January 1, 2019 in our financial statements under prior guidance as outlined in Topic 840. Refer to Note 8 Leases for additional information.
In February 2018, the FASB issued ASU 2018-02,  Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (“ASU 2018-02”) which allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the newly enacted federal corporate income tax rate under the comprehensive tax legislation enacted by the U.S. government on December 22, 2017 commonly referred to as the Tax Cuts and Jobs Act. The amount of the reclassification would be the difference between the historical corporate income tax rate and the newly enacted 21% corporate income tax rate. The Company applied the provisions of ASU 2018-02 as of January 1, 2019. Upon adoption, the Company recorded a cumulative effect adjustment of $3.6 million to retained earnings and accumulated other comprehensive loss.
In June 2018, the FASB issued ASU 2018-07,  Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting , which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The changes took effect for the Company as of January 1, 2019. The impact of the adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements and disclosures.
Accounting Standards Issued Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective for fiscal years beginning after December 15, 2019 and for interim periods therein. The Company is currently assessing the impact of the adoption of this guidance on its consolidated financial statements and disclosures.

13

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

In addition, the following recently issued accounting standards have not been adopted. Refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 , as amended, for additional information and their potential impacts.
Accounting Standard Update
Effective Date
ASU 2018-18:  Collaborative Arrangements (Topic 808) - Clarifying the Interaction between Topic 808 and Topic 606
January 1, 2020
ASU 2018-14: Compensation-Retirement Benefits-Defined Benefit Plans-General (Subtopic 715-20) Disclosure Framework-Changes to the Disclosure Requirements for Defined Benefit Plans
January 1, 2021
ASU 2018-13: Fair Value Measurement (Topic 820) Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement
January 1, 2020

4.
Acquisitions and Other Transactions
On February 28, 2018, the Company and Revance Therapeutics, Inc. (“Revance”) entered into a collaboration agreement (the “Revance Collaboration Agreement”) pursuant to which the Company and Revance will collaborate exclusively, on a world-wide basis (excluding Japan), to develop, manufacture and commercialize a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX®.
Under the Revance Collaboration Agreement, the Company will be primarily responsible for (a) clinical development activities outside of North America (excluding Japan) (the “ex-U.S. Mylan territories”), (b) regulatory activities, and (c) commercialization for any approved product. Revance will be primarily responsible for (a) non-clinical development activities, (b) clinical development activities in North America, and (c) manufacturing and supply of clinical drug substance and drug product; Revance will be solely responsible for an initial portion of non-clinical development costs. The remaining portion of any non-clinical development costs and clinical development costs for obtaining approval in the U.S. and Europe will be shared equally between the parties, and the Company will be responsible for all other clinical development costs and commercialization expenses. Upon closing, Revance received a non-refundable upfront payment of $25.0 million . In addition, under the Revance Collaboration Agreement, Revance can receive potential development milestone payments of up to $100.0 million , in the aggregate, upon the achievement of specified clinical and regulatory milestones and potential tiered sales milestones of up to $225.0 million . In addition, Mylan will pay Revance royalties on sales of the biosimilar in the ex-U.S. Mylan territories. The Company accounted for this transaction as an asset acquisition of in-process research and development (“IPR&D”) and the total upfront payment was expensed as a component of research and development (“R&D”) expense during the year ended December 31, 2018.
On August 31, 2018, the Company completed an agreement (the “purchase agreement”) with certain subsidiaries of Novartis AG (“Novartis”) to purchase the worldwide rights to their global cystic fibrosis products consisting of the TOBI Podhaler® and TOBI® solution. Under the terms of the purchase agreement, Novartis will receive fixed consideration of $463.0 million , which consists of $240.0 million which was paid at closing and deferred payments of $130.0 million due in August 2019 and $93.0 million due in August 2020, respectively. The Company also entered into a supply agreement with Novartis to purchase the products for up to three years from the date of closing and initially recorded a liability of approximately $91.8 million related to supply obligations. Additionally, Novartis was also eligible to receive a contingent payment of up to $20.0 million if the Company did not acquire the Facility (as defined below), which the Company accrued for at closing. The Company accounted for this transaction as an asset acquisition and recognized an intangible asset for the product rights of $574.8 million .
In conjunction with the purchase agreement, Mylan and Novartis entered into an option agreement pursuant to which Novartis granted Mylan an exclusive option to acquire certain equipment and employees relating to the Novartis TOBI Podhaler® production facility in San Carlos, California (the “Facility”). The option also includes the transfer of certain agreements to Mylan. On May 28, 2019, Mylan notified Novartis of its election to exercise the purchase option. As a result of the option exercise Novartis is no longer eligible to receive the contingent payment and during the second quarter of 2019 the Company reversed the accrual for the $20.0 million contingent payment with the offset being a reduction in the value of the intangible asset.
In addition, the Company will pay Novartis $10.0 million for the Facility and will receive reimbursement from Novartis for certain restructuring and other costs at the Facility. This transaction is expected to close in the third quarter of 2019.

14

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

During the year ended December 31, 2018, the Company completed four agreements to acquire certain intellectual property rights and marketing authorizations for products that were in the development stage, including agreements with Fujifilm Kyowa Kirin Biologics Co., Ltd. (“FKB”), Mapi Pharma Ltd., and Lupin Limited. The Company also completed the acquisition of intellectual property rights and marketing authorizations related to a commercialized product in certain rest of world markets for  $220.0 million , of which $160.0 million was paid at closing, $20.0 million was paid in the fourth quarter of 2018 and the remaining amount was paid in the second quarter of 2019. The Company is accounting for these transactions as asset acquisitions and a useful life of five years is being used to amortize the asset related to the commercialized product. The Company recorded expense of approximately $53.7 million as a component of R&D expense related to non-refundable upfront payments for agreements for products in development during the year ended December 31, 2018. Certain of the agreements include additional development and commercial milestones.
On February 22, 2018, the Company in-licensed European rights to Hulio™, a biosimilar to AbbVie Inc.'s (“AbbVie”) Humira® (adalimumab), including a sub-license to certain of AbbVie’s European patents, from FKB. On February 27, 2019, the Company updated its arrangements with FKB for the commercialization of Hulio™. Under the updated arrangements, Mylan has in-licensed exclusive global commercialization rights for Hulio™. The Company accounted for this transaction as an asset acquisition of IPR&D and a net non-contingent amount due to FKB of approximately $23.3 million was expensed as a component of R&D expense during the three months ended March 31, 2019.    
On December 1, 2018, the Company and certain subsidiaries of Aspen Pharmacare Holdings Limited entered into an agreement for Mylan to distribute a portfolio of prescription and over-the-counter (“OTC”) products in Australia and New Zealand. The agreement includes an option for Mylan to purchase the rights to the portfolio. In March 2019, the Company exercised the option, and acquired the product rights in the second quarter of 2019 for approximately $130.9 million . The purchase consideration of approximately $130.9 million includes a payment made at closing of approximately $64.3 million and amounts payable in 2020 totaling approximately $66.6 million .
The Company accounted for this transaction as an asset acquisition and recognized an intangible asset for the product rights of approximately $130.9 million . The intangible asset is being amortized over a useful life of five years .
On January 30, 2015, the Company entered into a development and commercialization collaboration with Theravance Biopharma, Inc. (“Theravance Biopharma”) for the development and, subject to U.S. Food and Drug Administration (“FDA”) approval, commercialization of Revefenacin. During the second quarter of 2019, the Company and Theravance Biopharma announced the expansion of this agreement to include China and certain adjacent territories (the “Territory”). Revefenacin, marketed as YUPELRI® in the U.S., is a long-acting muscarinic antagonist, which is the first and only once-daily, nebulized bronchodilator approved for the treatment of chronic obstructive pulmonary disease in the U.S. and is currently under development in the Territory. The Company accounted for this transaction as an asset acquisition of IPR&D and the total upfront payment of $18.5 million was expensed as a component of R&D expense.
5.
Share-Based Incentive Plan
The Company’s shareholders have approved the 2003 Long-Term Incentive Plan (as amended, the “ 2003 Plan ”). Under the 2003 Plan , 55,300,000 ordinary shares are reserved for issuance to key employees, consultants, independent contractors and non-employee directors of the Company through a variety of incentive awards, including: stock options, stock appreciation rights (“SAR”), restricted ordinary shares and units, performance awards (“PSU”), other stock-based awards and short-term cash awards. Stock option awards are granted with an exercise price equal to the fair market value of the ordinary shares underlying the stock options at the date of the grant, generally become exercisable over periods ranging from three to four years , and generally expire in ten years .

15

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

The following table summarizes stock option and SAR (together, “stock awards”) activity:
 
Number of Shares Under Stock Awards
 
Weighted Average Exercise Price per Share
Outstanding at December 31, 2018
6,815,278

 
$
36.61

Granted
712,850

 
27.32

Exercised
(287,578
)
 
13.94

Forfeited
(505,070
)
 
40.96

Outstanding at June 30, 2019
6,735,480

 
$
36.27

Vested and expected to vest at June 30, 2019
6,530,358

 
$
36.26

Exercisable at June 30, 2019
5,130,316

 
$
36.62


As of June 30, 2019 , stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable had average remaining contractual terms of 5.4 years , 5.3 years and 4.3 years , respectively. Also, at June 30, 2019 , stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable had aggregate intrinsic values of $1.4 million , $1.4 million and $1.3 million , respectively.
A summary of the status of the Company’s nonvested restricted ordinary shares and restricted stock unit awards, including PSUs (collectively, “restricted stock awards”), as of June 30, 2019 and the changes during the six months ended June 30, 2019 are presented below:
 
Number of Restricted Stock Awards
 
Weighted Average Grant-Date Fair Value per Share
Nonvested at December 31, 2018
6,393,081

 
$
40.75

Granted
2,288,255

 
27.41

Released
(1,432,837
)
 
43.60

Forfeited
(3,056,283
)
 
38.13

Nonvested at June 30, 2019
4,192,216

 
$
34.41


As of June 30, 2019 , the Company had $109.0 million of total unrecognized compensation expense, net of estimated forfeitures, related to all of its stock-based awards, which we expect to recognize over the remaining weighted average vesting period of 1.7 years . The total intrinsic value of stock awards exercised and restricted stock units released during the six months ended June 30, 2019 and 2018 was $36.7 million and $41.2 million , respectively.
In February 2014, Mylan’s Compensation Committee and the independent members of the Board of Directors adopted the One-Time Special Performance-Based Five-Year Realizable Value Incentive Program (the “2014 Program”) under the 2003 Plan. Under the 2014 Program, certain key employees received a one-time, performance-based incentive award (the “Awards”) either in the form of a grant of SARs or PSUs. The initial Awards were granted in February 2014 and contained a five-year cliff-vesting feature based on the achievement of various performance targets, external market conditions and the employee’s continued services. Additional Awards were granted in 2016 and 2017, subject to the same performance condition. The performance condition was not achieved by December 31, 2018 and approximately 2.6 million Awards outstanding under the 2014 Program were canceled in the first quarter of 2019, and approximately 1.1 million ordinary shares of restricted stock were canceled and returned to treasury stock in the second quarter of 2019. There was no impact to share based compensation expense during the three and six months ended June 30, 2019 as all of the cumulative expense related to the Awards was reversed during the year ended December 31, 2018.

16

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

6.
Pensions and Other Postretirement Benefits
Defined Benefit Plans
The Company sponsors various defined benefit pension plans in several countries. Benefits provided generally depend on length of service, pay grade and remuneration levels. The Company maintains two fully frozen defined benefit pension plans in the U.S., and employees in the U.S. and Puerto Rico are generally provided retirement benefits through defined contribution plans.
The Company also sponsors other postretirement benefit plans including plans that provide for postretirement supplemental medical coverage. Benefits from these plans are provided to employees and their spouses and dependents who meet various minimum age and service requirements. In addition, the Company sponsors other plans that provide for life insurance benefits and postretirement medical coverage for certain officers and management employees.
Net Periodic Benefit Cost
Components of net periodic benefit cost for the three and six months ended June 30, 2019 and 2018 were as follows:
 
Pension and Other Postretirement Benefits
 
Three Months Ended
 
Six Months Ended
 
June 30,
 
June 30,
(In millions)
2019
 
2018
 
2019
 
2018
Service cost
$
5.3

 
$
5.1

 
$
10.6

 
$
10.1

Interest cost
3.9

 
3.7

 
7.7

 
7.3

Expected return on plan assets
(3.1
)
 
(3.7
)
 
(6.1
)
 
(7.3
)
Amortization of prior service costs
0.2

 
0.1

 
0.5

 
0.2

Recognized net actuarial (gains) losses
(0.2
)
 

 
(0.4
)
 
0.1

Net periodic benefit cost
$
6.1

 
$
5.2

 
$
12.3

 
$
10.4


The Company is making the minimum mandatory contributions to its U.S. defined benefit pension plans in the 2019 plan year. The Company expects to make total benefit payments of approximately $33.7 million from pension and other postretirement benefit plans in 2019 . The Company anticipates making contributions to pension and other postretirement benefit plans of approximately $29.3 million in 2019 .
7.
Balance Sheet Components
Selected balance sheet components consist of the following:
Cash and restricted cash
(In millions)
June 30,
2019
 
December 31,
2018
 
June 30,
2018
Cash and cash equivalents
$
211.5

 
$
388.1

 
$
330.2

Restricted cash, included in prepaid expenses and other current assets
1.2

 
1.2

 
54.0

Cash, cash equivalents and restricted cash
$
212.7

 
$
389.3

 
$
384.2


Inventories
(In millions)
June 30,
2019
 
December 31,
2018
Raw materials
$
1,001.2

 
$
955.7

Work in process
472.0

 
369.9

Finished goods
1,303.0

 
1,254.6

Inventories
$
2,776.2

 
$
2,580.2



17

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Prepaid and other current assets
(In millions)
June 30,
2019
 
December 31, 2018
Prepaid expenses
$
154.0

 
$
130.6

Restricted cash
1.2

 
1.2

Available-for-sale fixed income securities
26.4

 
25.0

Fair value of financial instruments
54.3

 
33.8

Equity securities
36.7

 
32.5

Other current assets
301.3

 
295.3

Prepaid expenses and other current assets
$
573.9

 
$
518.4


Prepaid expenses consist primarily of prepaid rent, insurance and other individually insignificant items.
Property, plant and equipment, net
(In millions)
June 30,
2019
 
December 31, 2018
Machinery and equipment
$
2,473.4

 
$
2,421.2

Buildings and improvements
1,200.7

 
1,182.3

Construction in progress
248.5

 
239.7

Land and improvements
132.1

 
131.3

Gross property, plant and equipment
4,054.7

 
3,974.5

Accumulated depreciation
1,908.7

 
1,804.3

Property, plant and equipment, net
$
2,146.0

 
$
2,170.2


Other assets
(In millions)
June 30,
2019
 
December 31, 2018
Equity method investments, clean energy investments
$
118.4

 
$
138.7

Operating lease right-of-use assets
250.8

 

Other long-term assets
59.6

 
73.7

Other assets
$
428.8

 
$
212.4


Accounts payable
(In millions)
June 30,
2019
 
December 31,
2018
Trade accounts payable
$
1,017.0

 
$
1,123.2

Other payables
521.2

 
493.8

Accounts payable
$
1,538.2

 
$
1,617.0



18

MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Other current liabilities
(In millions)
June 30,
2019
 
December 31, 2018
Accrued sales allowances
$
645.1

 
$
626.7

Legal and professional accruals, including litigation accruals
186.1

 
128.1

Payroll and employee benefit liabilities
354.9

 
399.7

Contingent consideration
101.1

 
158.3

Accrued interest
86.5