x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
FOR THE TRANSITION PERIOD FROM TO
|
Ireland
|
68-0683755
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification Number)
|
|
|
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland
|
Not applicable
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Title of each class
|
Name of each exchange on which registered
|
Ordinary shares, nominal value $0.0001 per share
|
The NASDAQ Global Market, The Toronto Stock Exchange
|
Large accelerated filer
|
x
|
Accelerated filer
|
o
|
|
|
|
|
Non-accelerated filer
|
o
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
o
|
Ordinary shares, $0.0001 par value
|
Number of ordinary shares outstanding as of
|
April 29, 2016
|
:
|
222,661,344
|
|
|
|
Page
|
Forward-Looking Statements
|
||
|
|
|
PART I. FINANCIAL INFORMATION
|
|
|
Item 1.
|
Financial Statements
|
|
|
Condensed Consolidated Balance Sheets as of March 31, 2016 (Unaudited) and December 31, 2015
|
|
|
Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended March 31, 2016 and 2015
|
|
|
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) Three Months Ended March 31, 2016 and 2015
|
|
|
Condensed Consolidated Statements of Cash Flows (Unaudited) Three Months Ended March 31, 2016 and 2015
|
|
|
Notes to Condensed Consolidated Financial Statements (Unaudited)
|
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
|
Item 4.
|
Controls and Procedures
|
|
|
|
|
PART II. OTHER INFORMATION
|
|
|
Item 1.
|
Legal Proceedings
|
|
Item 1A.
|
Risk Factors
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
|
Item 3.
|
Defaults Upon Senior Securities
|
|
Item 4.
|
Mine Safety Disclosures
|
|
Item 5.
|
Other Information
|
|
Item 6.
|
Exhibits
|
|
|
|
|
Signatures
|
||
Exhibit Index
|
|
March 31,
2016 |
|
December 31,
2015 |
||||
ASSETS
|
|
|
|
||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
221,968
|
|
|
$
|
272,348
|
|
Restricted cash and cash equivalents
|
521,968
|
|
|
585,379
|
|
||
Marketable securities
|
39
|
|
|
34
|
|
||
Accounts receivable
|
867,829
|
|
|
1,014,808
|
|
||
Inventories, net
|
670,454
|
|
|
752,493
|
|
||
Prepaid expenses and other current assets
|
47,728
|
|
|
55,052
|
|
||
Income taxes receivable
|
749,917
|
|
|
735,901
|
|
||
Assets held for sale (NOTE 3)
|
—
|
|
|
36,522
|
|
||
Total current assets
|
$
|
3,079,903
|
|
|
$
|
3,452,537
|
|
MARKETABLE SECURITIES
|
2,441
|
|
|
3,855
|
|
||
PROPERTY, PLANT AND EQUIPMENT, NET
|
674,097
|
|
|
675,624
|
|
||
GOODWILL
|
7,424,782
|
|
|
7,299,354
|
|
||
OTHER INTANGIBLES, NET
|
7,354,386
|
|
|
7,828,942
|
|
||
DEFERRED INCOME TAXES
|
8,937
|
|
|
10,423
|
|
||
OTHER ASSETS
|
92,254
|
|
|
79,601
|
|
||
TOTAL ASSETS
|
$
|
18,636,800
|
|
|
$
|
19,350,336
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
CURRENT LIABILITIES:
|
|
|
|
||||
Accounts payable
|
$
|
303,290
|
|
|
$
|
347,503
|
|
Accrued expenses
|
987,976
|
|
|
1,162,612
|
|
||
Current portion of legal settlement accrual
|
1,571,448
|
|
|
1,606,726
|
|
||
Current portion of long-term debt
|
335,579
|
|
|
328,705
|
|
||
Income taxes payable
|
8,674
|
|
|
8,551
|
|
||
Liabilities held for sale (NOTE 3)
|
—
|
|
|
20,215
|
|
||
Total current liabilities
|
$
|
3,206,967
|
|
|
$
|
3,474,312
|
|
DEFERRED INCOME TAXES
|
659,323
|
|
|
871,040
|
|
||
LONG-TERM DEBT, LESS CURRENT PORTION, NET
|
8,229,191
|
|
|
8,251,657
|
|
||
LONG-TERM LEGAL SETTLEMENT ACCRUAL, LESS CURRENT PORTION, NET
|
377,880
|
|
|
549,098
|
|
||
OTHER LIABILITIES
|
239,293
|
|
|
236,253
|
|
||
COMMITMENTS AND CONTINGENCIES (NOTE 12)
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY:
|
|
|
|
||||
Euro deferred shares, $0.01 par value; 4,000,000 shares authorized and issued
|
46
|
|
|
43
|
|
||
Ordinary shares, $0.0001 par value; 1,000,000,000 shares authorized; 222,657,468 and 222,124,282 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively
|
22
|
|
|
22
|
|
||
Additional paid-in capital
|
8,703,520
|
|
|
8,693,385
|
|
||
Accumulated deficit
|
(2,475,084
|
)
|
|
(2,341,215
|
)
|
||
Accumulated other comprehensive loss
|
(304,358
|
)
|
|
(384,205
|
)
|
||
Total Endo International plc shareholders’ equity
|
$
|
5,924,146
|
|
|
$
|
5,968,030
|
|
Noncontrolling interests
|
—
|
|
|
(54
|
)
|
||
Total shareholders’ equity
|
$
|
5,924,146
|
|
|
$
|
5,967,976
|
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
$
|
18,636,800
|
|
|
$
|
19,350,336
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
TOTAL REVENUES
|
$
|
963,539
|
|
|
$
|
714,128
|
|
COSTS AND EXPENSES:
|
|
|
|
||||
Cost of revenues
|
688,705
|
|
|
384,266
|
|
||
Selling, general and administrative
|
178,355
|
|
|
211,578
|
|
||
Research and development
|
41,692
|
|
|
17,897
|
|
||
Litigation-related and other contingencies, net
|
5,200
|
|
|
13,000
|
|
||
Asset impairment charges
|
129,625
|
|
|
7,000
|
|
||
Acquisition-related and integration items
|
12,554
|
|
|
34,640
|
|
||
OPERATING (LOSS) INCOME FROM CONTINUING OPERATIONS
|
$
|
(92,592
|
)
|
|
$
|
45,747
|
|
INTEREST EXPENSE, NET
|
116,793
|
|
|
73,139
|
|
||
LOSS ON EXTINGUISHMENT OF DEBT
|
—
|
|
|
980
|
|
||
OTHER INCOME, NET
|
(1,907
|
)
|
|
(11,995
|
)
|
||
LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAX
|
$
|
(207,478
|
)
|
|
$
|
(16,377
|
)
|
INCOME TAX BENEFIT
|
(118,715
|
)
|
|
(166,869
|
)
|
||
(LOSS) INCOME FROM CONTINUING OPERATIONS
|
$
|
(88,763
|
)
|
|
$
|
150,492
|
|
DISCONTINUED OPERATIONS, NET OF TAX (NOTE 3)
|
(45,108
|
)
|
|
(226,210
|
)
|
||
CONSOLIDATED NET LOSS
|
$
|
(133,871
|
)
|
|
$
|
(75,718
|
)
|
Less: Net loss attributable to noncontrolling interests
|
(2
|
)
|
|
—
|
|
||
NET LOSS ATTRIBUTABLE TO ENDO INTERNATIONAL PLC
|
$
|
(133,869
|
)
|
|
$
|
(75,718
|
)
|
NET LOSS PER SHARE ATTRIBUTABLE TO ENDO INTERNATIONAL PLC ORDINARY SHAREHOLDERS—BASIC:
|
|
|
|
||||
Continuing operations
|
$
|
(0.40
|
)
|
|
$
|
0.89
|
|
Discontinued operations
|
(0.20
|
)
|
|
(1.34
|
)
|
||
Basic
|
$
|
(0.60
|
)
|
|
$
|
(0.45
|
)
|
NET LOSS PER SHARE ATTRIBUTABLE TO ENDO INTERNATIONAL PLC ORDINARY SHAREHOLDERS—DILUTED:
|
|
|
|
||||
Continuing operations
|
$
|
(0.40
|
)
|
|
$
|
0.85
|
|
Discontinued operations
|
(0.20
|
)
|
|
(1.28
|
)
|
||
Diluted
|
$
|
(0.60
|
)
|
|
$
|
(0.43
|
)
|
WEIGHTED AVERAGE SHARES:
|
|
|
|
||||
Basic
|
222,302
|
|
|
169,653
|
|
||
Diluted
|
222,302
|
|
|
176,825
|
|
|
Three Months Ended March 31,
|
||||||||||||||
|
2016
|
|
2015
|
||||||||||||
CONSOLIDATED NET LOSS
|
|
|
$
|
(133,871
|
)
|
|
|
|
$
|
(75,718
|
)
|
||||
OTHER COMPREHENSIVE INCOME (LOSS), NET OF TAX:
|
|
|
|
|
|
|
|
||||||||
Net unrealized (loss) gain on securities:
|
|
|
|
|
|
|
|
||||||||
Unrealized (loss) gain arising during the period
|
$
|
(860
|
)
|
|
|
|
$
|
1,513
|
|
|
|
||||
Less: reclassification adjustments for loss (gain) realized in net loss
|
—
|
|
|
(860
|
)
|
|
—
|
|
|
1,513
|
|
||||
Foreign currency translation gain (loss)
|
|
|
|
80,763
|
|
|
|
|
|
(131,348
|
)
|
||||
OTHER COMPREHENSIVE INCOME (LOSS)
|
|
|
$
|
79,903
|
|
|
|
|
$
|
(129,835
|
)
|
||||
CONSOLIDATED COMPREHENSIVE LOSS
|
|
|
$
|
(53,968
|
)
|
|
|
|
$
|
(205,553
|
)
|
||||
Less: Net loss attributable to noncontrolling interests
|
|
|
(2
|
)
|
|
|
|
—
|
|
||||||
Less: Other comprehensive income (loss) attributable to noncontrolling interests
|
|
|
56
|
|
|
|
|
(606
|
)
|
||||||
COMPREHENSIVE LOSS ATTRIBUTABLE TO ENDO INTERNATIONAL PLC
|
|
|
$
|
(54,022
|
)
|
|
|
|
$
|
(204,947
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
OPERATING ACTIVITIES:
|
|
|
|
||||
Consolidated net loss
|
$
|
(133,871
|
)
|
|
$
|
(75,718
|
)
|
Adjustments to reconcile consolidated net loss to Net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
236,089
|
|
|
119,590
|
|
||
Inventory step-up
|
61,370
|
|
|
37,554
|
|
||
Share-based compensation
|
14,967
|
|
|
13,837
|
|
||
Amortization of debt issuance costs and discount
|
6,373
|
|
|
5,947
|
|
||
Provision for bad debts
|
7,311
|
|
|
232
|
|
||
Deferred income taxes
|
(161,301
|
)
|
|
(164,535
|
)
|
||
Net loss on disposal of property, plant and equipment
|
527
|
|
|
52
|
|
||
Change in fair value of contingent consideration
|
(10,688
|
)
|
|
(808
|
)
|
||
Loss on extinguishment of debt
|
—
|
|
|
980
|
|
||
Asset impairment charges
|
150,804
|
|
|
229,753
|
|
||
Gain on sale of business and other assets
|
(525
|
)
|
|
—
|
|
||
Changes in assets and liabilities which (used) provided cash:
|
|
|
|
||||
Accounts receivable
|
142,153
|
|
|
(39,941
|
)
|
||
Inventories
|
18,483
|
|
|
(10,166
|
)
|
||
Prepaid and other assets
|
17,648
|
|
|
7,388
|
|
||
Accounts payable
|
(44,254
|
)
|
|
6,267
|
|
||
Accrued expenses
|
(192,075
|
)
|
|
80,034
|
|
||
Other liabilities
|
(146,938
|
)
|
|
(223,415
|
)
|
||
Income taxes payable/receivable
|
(15,898
|
)
|
|
(76,859
|
)
|
||
Net cash used in operating activities
|
$
|
(49,825
|
)
|
|
$
|
(89,808
|
)
|
INVESTING ACTIVITIES:
|
|
|
|
||||
Purchases of property, plant and equipment
|
(25,998
|
)
|
|
(17,189
|
)
|
||
Proceeds from sale of intellectual property and property, plant and equipment
|
2,313
|
|
|
—
|
|
||
Acquisitions, net of cash acquired
|
—
|
|
|
(911,892
|
)
|
||
Proceeds from notes receivable
|
—
|
|
|
17
|
|
||
Patent acquisition costs and license fees
|
(13,000
|
)
|
|
—
|
|
||
Proceeds from sale of business, net
|
4,108
|
|
|
4,712
|
|
||
Increase in restricted cash and cash equivalents
|
(121,031
|
)
|
|
(172,900
|
)
|
||
Decrease in restricted cash and cash equivalents
|
184,678
|
|
|
166,768
|
|
||
Net cash provided by (used in) investing activities
|
$
|
31,070
|
|
|
$
|
(930,484
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
FINANCING ACTIVITIES:
|
|
|
|
||||
Proceeds from issuance of notes
|
—
|
|
|
1,200,000
|
|
||
Principal payments on term loans
|
(20,750
|
)
|
|
(11,375
|
)
|
||
Principal payments on other indebtedness, net
|
(1,109
|
)
|
|
(270
|
)
|
||
Repurchase of convertible senior subordinated notes
|
—
|
|
|
(149,068
|
)
|
||
Deferred financing fees
|
(500
|
)
|
|
(20,482
|
)
|
||
Payment for contingent consideration
|
(9,405
|
)
|
|
(4,723
|
)
|
||
Tax benefits of share awards
|
4,058
|
|
|
16,797
|
|
||
Payments of tax withholding for restricted shares
|
(10,272
|
)
|
|
(11,930
|
)
|
||
Exercise of options
|
1,952
|
|
|
18,470
|
|
||
Issuance of ordinary shares related to the employee stock purchase plan
|
1,434
|
|
|
1,118
|
|
||
Payments related to the issuance of ordinary shares
|
—
|
|
|
(2,068
|
)
|
||
Cash buy-out of noncontrolling interests
|
—
|
|
|
(39,608
|
)
|
||
Net cash (used in) provided by financing activities
|
$
|
(34,592
|
)
|
|
$
|
996,861
|
|
Effect of foreign exchange rate
|
$
|
2,967
|
|
|
$
|
(7,861
|
)
|
NET DECREASE IN CASH AND CASH EQUIVALENTS
|
$
|
(50,380
|
)
|
|
$
|
(31,292
|
)
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
272,348
|
|
|
408,753
|
|
||
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
221,968
|
|
|
$
|
377,461
|
|
SUPPLEMENTAL INFORMATION:
|
|
|
|
||||
Cash paid into Qualified Settlement Funds for mesh legal settlements
|
$
|
120,919
|
|
|
$
|
170,739
|
|
Cash paid out of Qualified Settlement Funds for mesh legal settlements
|
$
|
184,678
|
|
|
$
|
127,160
|
|
Other cash distributions for mesh legal settlements
|
$
|
1,561
|
|
|
$
|
3,815
|
|
SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
|
|
|
||||
Purchases of property, plant and equipment financed by capital leases
|
$
|
—
|
|
|
$
|
54
|
|
Accrual for purchases of property, plant and equipment
|
$
|
1,897
|
|
|
$
|
3,179
|
|
Acquisition financed by ordinary shares
|
$
|
—
|
|
|
$
|
1,519,318
|
|
Repurchase of convertible senior subordinated notes financed by ordinary shares
|
$
|
—
|
|
|
$
|
408,585
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Revenue
|
$
|
28,851
|
|
|
$
|
118,665
|
|
Litigation related and other contingencies, net
|
$
|
2,450
|
|
|
$
|
5,200
|
|
Asset impairment charges
|
$
|
21,179
|
|
|
$
|
222,753
|
|
Loss from discontinued operations before income taxes
|
$
|
(68,832
|
)
|
|
$
|
(229,858
|
)
|
Income tax benefit
|
$
|
(23,724
|
)
|
|
$
|
(3,648
|
)
|
Discontinued operations, net of tax
|
$
|
(45,108
|
)
|
|
$
|
(226,210
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Cash flows from discontinued operating activities:
|
|
|
|
||||
Net loss
|
$
|
(45,108
|
)
|
|
$
|
(226,210
|
)
|
Depreciation and amortization
|
$
|
—
|
|
|
$
|
11,555
|
|
Net cash used in discontinued investing activities:
|
|
|
|
||||
Purchases of property, plant and equipment
|
$
|
(138
|
)
|
|
$
|
(934
|
)
|
|
Three Months Ended March 31, 2016
|
||
Employee separation, retention and other benefit-related costs
|
$
|
16,149
|
|
Asset impairment charges
|
21,179
|
|
|
Contract termination charges
|
10,224
|
|
|
Other wind down costs
|
13,121
|
|
|
Total
|
$
|
60,673
|
|
|
Employee Separation, Retention and Other Benefit-Related Costs
|
|
Contract Termination Charges
|
|
Other Restructuring Costs
|
|
Total
|
||||||||
Liability balance as of January 1, 2016
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Expenses
|
16,149
|
|
|
10,224
|
|
|
13,121
|
|
|
39,494
|
|
||||
Cash distributions
|
—
|
|
|
—
|
|
|
(445
|
)
|
|
(445
|
)
|
||||
Liability balance as of March 31, 2016
|
$
|
16,149
|
|
|
$
|
10,224
|
|
|
$
|
12,676
|
|
|
$
|
39,049
|
|
|
Total
|
||
Liability balance as of January 1, 2016
|
$
|
17,914
|
|
Expenses
|
3,464
|
|
|
Cash distributions
|
(4,056
|
)
|
|
Liability balance as of March 31, 2016
|
$
|
17,322
|
|
|
Employee Separation, Retention and Other Benefit-Related Costs
|
|
Other Restructuring Costs
|
|
Total
|
||||||
Liability balance as of January 1, 2016
|
$
|
5,353
|
|
|
$
|
6,910
|
|
|
$
|
12,263
|
|
Cash distributions
|
(3,222
|
)
|
|
(377
|
)
|
|
(3,599
|
)
|
|||
Liability balance as of March 31, 2016
|
$
|
2,131
|
|
|
$
|
6,533
|
|
|
$
|
8,664
|
|
Revenue
|
$
|
66,796
|
|
Net loss attributable to Endo International plc
|
$
|
(50,907
|
)
|
Basic net loss per share
|
$
|
(0.30
|
)
|
Diluted net loss per share
|
$
|
(0.29
|
)
|
|
September 25, 2015
|
|
Measurement period adjustments
|
|
September 25, 2015
(As adjusted) |
||||||
Cash and cash equivalents
|
$
|
215,612
|
|
|
$
|
—
|
|
|
$
|
215,612
|
|
Accounts and other receivables
|
530,664
|
|
|
(13,500
|
)
|
|
517,164
|
|
|||
Inventories
|
330,406
|
|
|
(1,849
|
)
|
|
328,557
|
|
|||
Prepaid expenses and other current assets
|
31,124
|
|
|
—
|
|
|
31,124
|
|
|||
Deferred income tax assets, current
|
14,652
|
|
|
660
|
|
|
15,312
|
|
|||
Property, plant and equipment
|
256,293
|
|
|
4,744
|
|
|
261,037
|
|
|||
Intangible assets
|
3,627,000
|
|
|
(154,500
|
)
|
|
3,472,500
|
|
|||
Other assets
|
8,477
|
|
|
—
|
|
|
8,477
|
|
|||
Total identifiable assets
|
$
|
5,014,228
|
|
|
$
|
(164,445
|
)
|
|
$
|
4,849,783
|
|
Accounts payable and accrued expenses
|
$
|
551,614
|
|
|
$
|
(13,500
|
)
|
|
$
|
538,114
|
|
Deferred income tax liabilities
|
1,093,779
|
|
|
(53,515
|
)
|
|
1,040,264
|
|
|||
Other liabilities
|
16,057
|
|
|
—
|
|
|
16,057
|
|
|||
Total liabilities assumed
|
$
|
1,661,450
|
|
|
$
|
(67,015
|
)
|
|
$
|
1,594,435
|
|
Net identifiable assets acquired
|
$
|
3,352,778
|
|
|
$
|
(97,430
|
)
|
|
$
|
3,255,348
|
|
Goodwill
|
4,782,876
|
|
|
97,430
|
|
|
4,880,306
|
|
|||
Net assets acquired
|
$
|
8,135,654
|
|
|
$
|
—
|
|
|
$
|
8,135,654
|
|
|
Valuation (in millions)
|
|
Amortization period (in years)
|
||
Developed Technology:
|
|
|
|
||
Vasostrict
TM
|
$
|
556.0
|
|
|
8
|
Aplisol
®
|
312.4
|
|
|
11
|
|
Developed - Other - Non-Partnered (Generic Non-Injectable)
|
230.4
|
|
|
7
|
|
Developed - Other - Partnered (Combined)
|
164.4
|
|
|
7
|
|
Nascobal
®
|
118.3
|
|
|
9
|
|
Developed - Other - Non-Partnered (Generic Injectable)
|
116.4
|
|
|
10
|
|
Other
|
517.9
|
|
|
9
|
|
Total
|
$
|
2,015.8
|
|
|
|
In Process Research & Development (IPR&D):
|
|
|
|
||
IPR&D 2019 Launch
|
$
|
401.0
|
|
|
n/a
|
IPR&D 2018 Launch
|
283.8
|
|
|
n/a
|
|
Ezetimibe
|
147.6
|
|
|
n/a
|
|
IPR&D 2016 Launch
|
133.3
|
|
|
n/a
|
|
Ephedrine Sulphate
|
128.6
|
|
|
n/a
|
|
Neostigmine vial
|
118.6
|
|
|
n/a
|
|
Other
|
243.8
|
|
|
n/a
|
|
Total
|
$
|
1,456.7
|
|
|
n/a
|
Total other intangible assets
|
$
|
3,472.5
|
|
|
n/a
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Net revenues to external customers:
|
|
|
|
||||
U.S. Branded Pharmaceuticals
|
$
|
308,813
|
|
|
$
|
284,507
|
|
U.S. Generic Pharmaceuticals
|
583,390
|
|
|
356,962
|
|
||
International Pharmaceuticals (1)
|
71,336
|
|
|
72,659
|
|
||
Total net revenues to external customers
|
$
|
963,539
|
|
|
$
|
714,128
|
|
|
|
|
|
||||
Adjusted income from continuing operations before income tax:
|
|
|
|
||||
U.S. Branded Pharmaceuticals
|
$
|
168,781
|
|
|
$
|
158,794
|
|
U.S. Generic Pharmaceuticals
|
$
|
211,768
|
|
|
$
|
183,457
|
|
International Pharmaceuticals
|
$
|
21,754
|
|
|
$
|
16,567
|
|
(1)
|
Revenues generated by our
International Pharmaceuticals
segment are primarily attributable to Canada, Mexico and South Africa.
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Total segment adjusted income from continuing operations before income tax:
|
$
|
402,303
|
|
|
$
|
358,818
|
|
Corporate unallocated costs (1)
|
(153,073
|
)
|
|
(111,068
|
)
|
||
Upfront and milestone payments to partners
|
(1,417
|
)
|
|
(2,667
|
)
|
||
Asset impairment charges (2)
|
(129,625
|
)
|
|
(7,000
|
)
|
||
Acquisition-related and integration items (3)
|
(12,554
|
)
|
|
(34,640
|
)
|
||
Separation benefits and other cost reduction initiatives (4)
|
(38,456
|
)
|
|
(41,807
|
)
|
||
Amortization of intangible assets
|
(211,669
|
)
|
|
(95,269
|
)
|
||
Inventory step-up and certain manufacturing costs that will be eliminated pursuant to integration plans
|
(68,476
|
)
|
|
(39,916
|
)
|
||
Non-cash interest expense related to the 1.75% Convertible Senior Subordinated Notes
|
—
|
|
|
(1,379
|
)
|
||
Loss on extinguishment of debt
|
—
|
|
|
(980
|
)
|
||
Impact of Voltaren
®
Gel generic competition
|
7,750
|
|
|
—
|
|
||
Certain litigation-related charges, net (5)
|
(5,200
|
)
|
|
(13,000
|
)
|
||
Costs associated with unused financing commitments
|
—
|
|
|
(11,810
|
)
|
||
Acceleration of Auxilium employee equity awards at closing
|
—
|
|
|
(37,603
|
)
|
||
Foreign currency impact related to the remeasurement of intercompany debt instruments
|
(1,255
|
)
|
|
21,090
|
|
||
Other, net
|
4,194
|
|
|
854
|
|
||
Total consolidated loss from continuing operations before income tax
|
$
|
(207,478
|
)
|
|
$
|
(16,377
|
)
|
(1)
|
Corporate unallocated costs include certain corporate overhead costs, interest expense, net, and certain other income and expenses.
|
(2)
|
Asset impairment charges primarily related to charges to write down intangible assets as further described in
Note 9. Goodwill and Other Intangibles
.
|
(3)
|
Acquisition-related and integration-items include costs directly associated with previous acquisitions of
$23.2 million
for the
three months
ended
March 31, 2016
and
$35.4 million
for the comparable
2015
period. During
2016
and
2015
, these costs are net of a benefit due to changes in the fair value of contingent consideration of
$10.7 million
and
$0.8 million
, respectively.
|
(4)
|
Separation benefits and other cost reduction initiatives include charges to increase excess inventory reserves of
$26.9 million
related to the 2016
U.S. Generic Pharmaceuticals
restructuring initiative, employee separation costs of
$6.8 million
and other restructuring costs of
$4.4 million
for the
three
months ended
March 31, 2016
. Amounts in the comparable
2015
period include employee separation costs of
$32.4 million
and a
$7.9 million
charge recorded upon the cease use date of our Auxilium subsidiary’s former corporate headquarters, representing the liability for our remaining obligations under the respective lease agreement, net of estimated sublease income. These amounts were primarily recorded as
Selling, general and administrative
expense in our
Condensed Consolidated Statements of Operations
. See
Note 4. Restructuring
for discussion of our material restructuring initiatives.
|
(5)
|
These amounts include charges for Litigation-related and other contingencies, net as further described in
Note 12. Commitments and Contingencies
.
|
•
|
Level 1—Quoted prices in active markets for identical assets or liabilities.
|
•
|
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
•
|
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
|
Fair Value Measurements at Reporting Date using:
|
||||||||||||||
March 31, 2016
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
56,135
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
56,135
|
|
Equity securities
|
2,480
|
|
|
—
|
|
|
—
|
|
|
2,480
|
|
||||
Total
|
$
|
58,615
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
58,615
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
48,045
|
|
|
$
|
48,045
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
76,466
|
|
|
76,466
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
124,511
|
|
|
$
|
124,511
|
|
|
Fair Value Measurements at Reporting Date using:
|
||||||||||||||
December 31, 2015
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
51,145
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,145
|
|
Equity securities
|
3,889
|
|
|
—
|
|
|
—
|
|
|
3,889
|
|
||||
Total
|
$
|
55,034
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
55,034
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
65,265
|
|
|
$
|
65,265
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
78,237
|
|
|
78,237
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
143,502
|
|
|
$
|
143,502
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Beginning of period
|
$
|
143,502
|
|
|
$
|
46,005
|
|
Amounts acquired
|
—
|
|
|
148,100
|
|
||
Amounts settled
|
(9,474
|
)
|
|
(4,723
|
)
|
||
Transfers (in) and/or out of Level 3
|
—
|
|
|
—
|
|
||
Measurement period adjustments
|
—
|
|
|
(4,313
|
)
|
||
Changes in fair value recorded in earnings
|
(10,688
|
)
|
|
(808
|
)
|
||
Effect of currency translation
|
1,171
|
|
|
—
|
|
||
End of period
|
$
|
124,511
|
|
|
$
|
184,261
|
|
|
Balance as of December 31, 2015
|
|
Acquisitions
|
|
Fair Value Adjustments and Accretion
|
|
Payments and Other
|
|
Balance as of March 31, 2016
|
||||||||||
Qualitest acquisition
|
$
|
1,137
|
|
|
$
|
—
|
|
|
$
|
(1,137
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
Sumavel acquisition
|
631
|
|
|
—
|
|
|
55
|
|
|
—
|
|
|
686
|
|
|||||
Auxilium acquisition
|
26,435
|
|
|
—
|
|
|
3,157
|
|
|
(3,081
|
)
|
|
26,511
|
|
|||||
Lehigh Valley Technologies, Inc. acquisitions
|
97,003
|
|
|
—
|
|
|
(12,710
|
)
|
|
(6,393
|
)
|
|
77,900
|
|
|||||
Other
|
18,296
|
|
|
—
|
|
|
1,118
|
|
|
—
|
|
|
19,414
|
|
|||||
Total
|
$
|
143,502
|
|
|
$
|
—
|
|
|
$
|
(9,517
|
)
|
|
$
|
(9,474
|
)
|
|
$
|
124,511
|
|
|
Available-for-sale
|
||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized (Losses) |
|
Fair Value
|
||||||||
March 31, 2016
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
56,135
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
56,135
|
|
Total included in cash and cash equivalents
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total included in restricted cash and cash equivalents
|
$
|
56,135
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
56,135
|
|
Equity securities
|
$
|
26
|
|
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
39
|
|
Total other short-term available-for-sale securities
|
$
|
26
|
|
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
39
|
|
Equity securities
|
$
|
1,766
|
|
|
$
|
675
|
|
|
$
|
—
|
|
|
$
|
2,441
|
|
Long-term available-for-sale securities
|
$
|
1,766
|
|
|
$
|
675
|
|
|
$
|
—
|
|
|
$
|
2,441
|
|
|
Available-for-sale
|
||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized (Losses) |
|
Fair Value
|
||||||||
December 31, 2015
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
51,145
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,145
|
|
Total included in cash and cash equivalents
|
$
|
3
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3
|
|
Total included in restricted cash and cash equivalents
|
$
|
51,142
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,142
|
|
Equity securities
|
$
|
24
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
34
|
|
Total other short-term available-for-sale securities
|
$
|
24
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
34
|
|
Equity securities
|
$
|
1,766
|
|
|
$
|
2,089
|
|
|
$
|
—
|
|
|
$
|
3,855
|
|
Long-term available-for-sale securities
|
$
|
1,766
|
|
|
$
|
2,089
|
|
|
$
|
—
|
|
|
$
|
3,855
|
|
|
Fair Value Measurements at Reporting Date using:
|
|
Total Expense for the Three Months Ended March 31, 2016
|
||||||||||||
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
|||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Certain Astora property, plant and equipment (Note 3)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(4,892
|
)
|
Certain U.S. Generic Pharmaceuticals intangible assets (Note 9)
|
—
|
|
|
—
|
|
|
45,522
|
|
|
(129,625
|
)
|
||||
Certain Astora intangible assets (Note 3)
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,287
|
)
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,522
|
|
|
$
|
(150,804
|
)
|
|
March 31, 2016
|
|
December 31, 2015
|
||||
Raw materials (1)
|
$
|
206,404
|
|
|
$
|
210,038
|
|
Work-in-process (1)
|
134,017
|
|
|
177,821
|
|
||
Finished goods (1)
|
330,033
|
|
|
364,634
|
|
||
Total
|
$
|
670,454
|
|
|
$
|
752,493
|
|
|
Carrying Amount
|
||||||||||||||
|
U.S. Branded Pharmaceuticals
|
|
U.S. Generic Pharmaceuticals
|
|
International Pharmaceuticals
|
|
Total
|
||||||||
Balance as of December 31, 2015:
|
|
|
|
|
|
|
|
||||||||
Goodwill
|
$
|
1,676,276
|
|
|
$
|
5,789,934
|
|
|
$
|
592,424
|
|
|
$
|
8,058,634
|
|
Accumulated impairment losses
|
(673,500
|
)
|
|
—
|
|
|
(85,780
|
)
|
|
(759,280
|
)
|
||||
Balance as of December 31, 2015
|
$
|
1,002,776
|
|
|
$
|
5,789,934
|
|
|
$
|
506,644
|
|
|
$
|
7,299,354
|
|
Measurement period adjustments
|
—
|
|
|
97,430
|
|
|
435
|
|
|
97,865
|
|
||||
Effect of currency translation on gross balance
|
—
|
|
|
—
|
|
|
29,485
|
|
|
29,485
|
|
||||
Effect of currency translation on accumulated impairment
|
—
|
|
|
—
|
|
|
(1,922
|
)
|
|
(1,922
|
)
|
||||
Balance as of March 31, 2016:
|
|
|
|
|
|
|
|
||||||||
Goodwill
|
$
|
1,676,276
|
|
|
$
|
5,887,364
|
|
|
$
|
622,344
|
|
|
$
|
8,185,984
|
|
Accumulated impairment losses
|
(673,500
|
)
|
|
—
|
|
|
(87,702
|
)
|
|
(761,202
|
)
|
||||
|
$
|
1,002,776
|
|
|
$
|
5,887,364
|
|
|
$
|
534,642
|
|
|
$
|
7,424,782
|
|
Cost basis:
|
Balance as of December 31, 2015
|
|
Acquisitions
(1) |
|
Impairments
(2) |
|
Other
(3) |
|
Effect of Currency Translation
|
|
Balance as of March 31, 2016
|
||||||||||||
Indefinite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
In-process research and development
|
$
|
1,742,880
|
|
|
$
|
(114,200
|
)
|
|
$
|
(55,100
|
)
|
|
$
|
(3,821
|
)
|
|
$
|
3,027
|
|
|
$
|
1,572,786
|
|
Total indefinite-lived intangibles
|
$
|
1,742,880
|
|
|
$
|
(114,200
|
)
|
|
$
|
(55,100
|
)
|
|
$
|
(3,821
|
)
|
|
$
|
3,027
|
|
|
$
|
1,572,786
|
|
Definite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Licenses (weighted average life of 10 years)
|
$
|
676,867
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
676,867
|
|
Customer relationships (weighted average life of 15 years)
|
11,318
|
|
|
—
|
|
|
(11,318
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Tradenames (weighted average life of 12 years)
|
7,537
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5
|
)
|
|
7,532
|
|
||||||
Developed technology (weighted average life of 12 years)
|
6,731,573
|
|
|
(32,300
|
)
|
|
(89,525
|
)
|
|
1,862
|
|
|
31,986
|
|
|
6,643,596
|
|
||||||
Total definite-lived intangibles (weighted average life of 11 years)
|
$
|
7,427,295
|
|
|
$
|
(32,300
|
)
|
|
$
|
(100,843
|
)
|
|
$
|
1,862
|
|
|
$
|
31,981
|
|
|
$
|
7,327,995
|
|
Total other intangibles
|
$
|
9,170,175
|
|
|
$
|
(146,500
|
)
|
|
$
|
(155,943
|
)
|
|
$
|
(1,959
|
)
|
|
$
|
35,008
|
|
|
$
|
8,900,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Accumulated amortization:
|
Balance as of December 31, 2015
|
|
Amortization
|
|
Impairments
|
|
Other
|
|
Effect of Currency Translation
|
|
Balance as of March 31, 2016
|
||||||||||||
Indefinite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
In-process research and development
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total indefinite-lived intangibles
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Definite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Licenses
|
$
|
(508,225
|
)
|
|
$
|
(14,881
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(523,106
|
)
|
Customer relationships
|
(7,858
|
)
|
|
—
|
|
|
7,858
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Tradenames
|
(6,544
|
)
|
|
(22
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,566
|
)
|
||||||
Developed technology
|
(818,606
|
)
|
|
(196,766
|
)
|
|
2,173
|
|
|
322
|
|
|
(3,846
|
)
|
|
(1,016,723
|
)
|
||||||
Total definite-lived intangibles
|
$
|
(1,341,233
|
)
|
|
$
|
(211,669
|
)
|
|
$
|
10,031
|
|
|
$
|
322
|
|
|
$
|
(3,846
|
)
|
|
$
|
(1,546,395
|
)
|
Total other intangibles
|
$
|
(1,341,233
|
)
|
|
$
|
(211,669
|
)
|
|
$
|
10,031
|
|
|
$
|
322
|
|
|
$
|
(3,846
|
)
|
|
$
|
(1,546,395
|
)
|
Net other intangibles
|
$
|
7,828,942
|
|
|
|
|
|
|
|
|
|
|
$
|
7,354,386
|
|
(1)
|
Includes measurement period adjustments relating to the Par acquisition, partially offset by the capitalization of payments relating to XIAFLEX
®
.
|
(2)
|
Includes the impairment of certain intangible assets of our
U.S. Generic Pharmaceuticals
segment of approximately
$129.6 million
, and the impairment of certain intangible assets in connection with the wind down of our Astora business, with a net impairment of approximately
$16.3 million
, which is reported as
Discontinued operations, net of tax
in the
Condensed Consolidated Statements of Operations
for the
three months
ended
March 31, 2016
. See
Note 3. Discontinued Operations and Held for Sale
for further information relating to the Astora wind down.
|
(3)
|
Includes the sale of certain intangible assets in our
International Pharmaceuticals
segment, partially offset by certain IPR&D assets totaling
$3.8 million
being placed into service.
|
2016
|
$
|
807,613
|
|
2017
|
$
|
690,977
|
|
2018
|
$
|
609,018
|
|
2019
|
$
|
549,786
|
|
2020
|
$
|
522,080
|
|
|
Gross
Carrying Amount |
||
December 31, 2015
|
$
|
9,170,175
|
|
Impairment of certain Astora intangible assets
|
(26,318
|
)
|
|
Capitalization of payments relating to XIAFLEX®
|
8,000
|
|
|
Sale of certain International Pharmaceuticals intangible assets
|
(1,959
|
)
|
|
Impairment of certain U.S. Generic Pharmaceuticals intangible assets
|
(129,625
|
)
|
|
Measurement period adjustments relating to acquisitions closed during 2015
|
(154,500
|
)
|
|
Effect of currency translation
|
35,008
|
|
|
March 31, 2016
|
$
|
8,900,781
|
|
|
March 31, 2016
|
|
December 31, 2015
|
||||||||||||
|
Principal Amount
|
|
Unamortized Discount and Deferred Loan Costs
|
|
Principal Amount
|
|
Unamortized Discount and Deferred Loan Costs
|
||||||||
7.25% Senior Notes due 2022
|
$
|
400,000
|
|
|
$
|
(12,127
|
)
|
|
$
|
400,000
|
|
|
$
|
(12,535
|
)
|
5.75% Senior Notes due 2022
|
700,000
|
|
|
(9,739
|
)
|
|
700,000
|
|
|
(10,088
|
)
|
||||
5.375% Senior Notes due 2023
|
750,000
|
|
|
(10,206
|
)
|
|
750,000
|
|
|
(10,511
|
)
|
||||
6.00% Senior Notes due 2023
|
1,635,000
|
|
|
(26,968
|
)
|
|
1,635,000
|
|
|
(27,694
|
)
|
||||
6.00% Senior Notes due 2025
|
1,200,000
|
|
|
(22,245
|
)
|
|
1,200,000
|
|
|
(22,713
|
)
|
||||
Term Loan A Facility Due 2019
|
1,003,750
|
|
|
(12,616
|
)
|
|
1,017,500
|
|
|
(13,831
|
)
|
||||
Term Loan B Facility Due 2021
|
2,793,000
|
|
|
(48,213
|
)
|
|
2,800,000
|
|
|
(49,900
|
)
|
||||
Revolving Credit Facility
|
225,000
|
|
|
—
|
|
|
225,000
|
|
|
—
|
|
||||
Other debt
|
134
|
|
|
—
|
|
|
134
|
|
|
—
|
|
||||
Total long-term debt, net
|
$
|
8,706,884
|
|
|
$
|
(142,114
|
)
|
|
$
|
8,727,634
|
|
|
$
|
(147,272
|
)
|
Less current portion, net
|
335,579
|
|
|
—
|
|
|
328,705
|
|
|
—
|
|
||||
Total long-term debt, less current portion, net
|
$
|
8,371,305
|
|
|
$
|
(142,114
|
)
|
|
$
|
8,398,929
|
|
|
$
|
(147,272
|
)
|
|
Qualified Settlement Funds
|
|
Product Liability
|
||||
Balance as of December 31, 2015
|
$
|
578,970
|
|
|
$
|
2,086,176
|
|
Additional charges
|
—
|
|
|
2,450
|
|
||
Cash distributions to Qualified Settlement Funds
|
120,919
|
|
|
—
|
|
||
Cash distributions to settle disputes from Qualified Settlement Funds
|
(184,678
|
)
|
|
(184,678
|
)
|
||
Cash distributions to settle disputes
|
—
|
|
|
(1,561
|
)
|
||
Balance as of March 31, 2016
|
$
|
515,211
|
|
|
$
|
1,902,387
|
|
|
Three Months Ended March 31,
|
||||||||||||||||||||||
|
2016
|
|
2015
|
||||||||||||||||||||
|
Before-
Tax Amount |
|
Tax Benefit (Expense)
|
|
Net-of-Tax
Amount |
|
Before-Tax
Amount |
|
Tax (Expense) Benefit
|
|
Net-of-
Tax Amount |
||||||||||||
Net unrealized (loss) gain on securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized (loss) gain arising during the period
|
$
|
(1,386
|
)
|
|
$
|
526
|
|
|
$
|
(860
|
)
|
|
$
|
2,198
|
|
|
$
|
(685
|
)
|
|
$
|
1,513
|
|
Net unrealized gain (loss) on foreign currency:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign currency translation gain (loss) arising during the period
|
54,572
|
|
|
26,191
|
|
|
80,763
|
|
|
(131,380
|
)
|
|
32
|
|
|
(131,348
|
)
|
||||||
Other comprehensive income (loss)
|
$
|
53,186
|
|
|
$
|
26,717
|
|
|
$
|
79,903
|
|
|
$
|
(129,182
|
)
|
|
$
|
(653
|
)
|
|
$
|
(129,835
|
)
|
|
March 31,
2016 |
|
December 31,
2015 |
||||
Net unrealized gains
|
$
|
955
|
|
|
$
|
1,815
|
|
Foreign currency translation loss
|
(305,313
|
)
|
|
(386,020
|
)
|
||
Accumulated other comprehensive loss
|
$
|
(304,358
|
)
|
|
$
|
(384,205
|
)
|
|
Attributable to:
|
||||||||||
|
Endo
International plc |
|
Noncontrolling
interests |
|
Total
Shareholders’ Equity |
||||||
Shareholders’ equity at January 1, 2016
|
$
|
5,968,030
|
|
|
$
|
(54
|
)
|
|
$
|
5,967,976
|
|
Net loss
|
(133,869
|
)
|
|
(2
|
)
|
|
(133,871
|
)
|
|||
Other comprehensive income
|
79,847
|
|
|
56
|
|
|
79,903
|
|
|||
Compensation related to share-based awards
|
14,967
|
|
|
—
|
|
|
14,967
|
|
|||
Tax withholding for restricted shares
|
(10,272
|
)
|
|
—
|
|
|
(10,272
|
)
|
|||
Exercise of options
|
1,952
|
|
|
—
|
|
|
1,952
|
|
|||
Issuance of ordinary shares related to the employee stock purchase plan
|
1,434
|
|
|
—
|
|
|
1,434
|
|
|||
Other
|
2,057
|
|
|
—
|
|
|
2,057
|
|
|||
Shareholders’ equity at March 31, 2016
|
$
|
5,924,146
|
|
|
$
|
—
|
|
|
$
|
5,924,146
|
|
|
Attributable to:
|
||||||||||
|
Endo
International plc |
|
Noncontrolling
interests |
|
Total
Shareholders’ Equity |
||||||
Shareholders’ equity at January 1, 2015
|
$
|
2,374,757
|
|
|
$
|
33,456
|
|
|
$
|
2,408,213
|
|
Net loss
|
(75,718
|
)
|
|
—
|
|
|
(75,718
|
)
|
|||
Other comprehensive loss
|
(129,229
|
)
|
|
(606
|
)
|
|
(129,835
|
)
|
|||
Compensation related to share-based awards
|
13,837
|
|
|
—
|
|
|
13,837
|
|
|||
Tax withholding for restricted shares
|
(11,930
|
)
|
|
—
|
|
|
(11,930
|
)
|
|||
Exercise of options
|
18,470
|
|
|
—
|
|
|
18,470
|
|
|||
Buy-out of noncontrolling interests, net of contributions
|
(6,876
|
)
|
|
(32,732
|
)
|
|
(39,608
|
)
|
|||
Ordinary shares issued in connection with the Auxilium acquisition
|
1,519,320
|
|
|
—
|
|
|
1,519,320
|
|
|||
Fair value of equity component of acquired Auxilium Notes
|
278,014
|
|
|
—
|
|
|
278,014
|
|
|||
Conversion of Auxilium Notes
|
145,101
|
|
|
—
|
|
|
145,101
|
|
|||
Other
|
13,852
|
|
|
—
|
|
|
13,852
|
|
|||
Shareholders’ equity at March 31, 2015
|
$
|
4,139,598
|
|
|
$
|
118
|
|
|
$
|
4,139,716
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Foreign currency loss (gain), net
|
$
|
996
|
|
|
$
|
(23,134
|
)
|
Equity (earnings) loss from unconsolidated subsidiaries, net
|
(2,344
|
)
|
|
851
|
|
||
Costs associated with unused financing commitments
|
—
|
|
|
11,810
|
|
||
Other miscellaneous
|
(559
|
)
|
|
(1,522
|
)
|
||
Other income, net
|
$
|
(1,907
|
)
|
|
$
|
(11,995
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Numerator:
|
|
|
|
||||
(Loss) income from continuing operations
|
$
|
(88,763
|
)
|
|
$
|
150,492
|
|
Less: Net loss from continuing operations attributable to noncontrolling interests
|
(2
|
)
|
|
—
|
|
||
(Loss) income from continuing operations attributable to Endo International plc ordinary shareholders
|
(88,761
|
)
|
|
150,492
|
|
||
Loss from discontinued operations attributable to Endo International plc ordinary shareholders, net of tax
|
(45,108
|
)
|
|
(226,210
|
)
|
||
Net loss attributable to Endo International plc ordinary shareholders
|
$
|
(133,869
|
)
|
|
$
|
(75,718
|
)
|
Denominator:
|
|
|
|
||||
For basic per share data—weighted average shares
|
222,302
|
|
|
169,653
|
|
||
Dilutive effect of ordinary share equivalents
|
—
|
|
|
2,375
|
|
||
Dilutive effect of various convertible notes and warrants
|
—
|
|
|
4,797
|
|
||
For diluted per share data—weighted average shares
|
222,302
|
|
|
176,825
|
|
|
Three Months Ended March 31,
|
||||||||||
|
2016
|
|
2015
|
||||||||
|
$
|
|
% of Revenue
|
|
$
|
|
% of Revenue
|
||||
Cost of revenues
|
$
|
688,705
|
|
|
71
|
|
$
|
384,266
|
|
|
54
|
Selling, general and administrative
|
178,355
|
|
|
19
|
|
211,578
|
|
|
30
|
||
Research and development
|
41,692
|
|
|
4
|
|
17,897
|
|
|
3
|
||
Litigation-related and other contingencies, net
|
5,200
|
|
|
1
|
|
13,000
|
|
|
2
|
||
Asset impairment charges
|
129,625
|
|
|
13
|
|
7,000
|
|
|
1
|
||
Acquisition-related and integration items
|
12,554
|
|
|
1
|
|
34,640
|
|
|
5
|
||
Total costs and expenses*
|
$
|
1,056,131
|
|
|
110
|
|
$
|
668,381
|
|
|
94
|
*
|
Percentages may not add due to rounding.
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Interest expense
|
$
|
117,470
|
|
|
$
|
73,849
|
|
Interest income
|
(677
|
)
|
|
(710
|
)
|
||
Interest expense, net
|
$
|
116,793
|
|
|
$
|
73,139
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Foreign currency loss (gain), net
|
$
|
996
|
|
|
$
|
(23,134
|
)
|
Equity (earnings) loss from unconsolidated subsidiaries, net
|
(2,344
|
)
|
|
851
|
|
||
Costs associated with unused financing commitments
|
—
|
|
|
11,810
|
|
||
Other miscellaneous
|
(559
|
)
|
|
(1,522
|
)
|
||
Other income, net
|
$
|
(1,907
|
)
|
|
$
|
(11,995
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Net revenues to external customers:
|
|
|
|
||||
U.S. Branded Pharmaceuticals
|
$
|
308,813
|
|
|
$
|
284,507
|
|
U.S. Generic Pharmaceuticals
|
583,390
|
|
|
356,962
|
|
||
International Pharmaceuticals (1)
|
71,336
|
|
|
72,659
|
|
||
Total net revenues to external customers
|
$
|
963,539
|
|
|
$
|
714,128
|
|
(1)
|
Revenues generated by our
International Pharmaceuticals
segment are primarily attributable to Canada, Mexico and South Africa.
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Pain Management:
|
|
|
|
||||
Lidoderm®
|
$
|
19,712
|
|
|
$
|
25,160
|
|
OPANA® ER
|
44,670
|
|
|
46,859
|
|
||
Percocet®
|
33,593
|
|
|
36,299
|
|
||
Voltaren® Gel
|
35,747
|
|
|
45,471
|
|
||
|
$
|
133,722
|
|
|
$
|
153,789
|
|
Specialty Pharmaceuticals:
|
|
|
|
||||
Supprelin® LA
|
$
|
17,252
|
|
|
$
|
16,282
|
|
XIAFLEX®
|
44,045
|
|
|
27,966
|
|
||
|
$
|
61,297
|
|
|
$
|
44,248
|
|
Branded Other Revenues
|
113,794
|
|
|
86,470
|
|
||
Total U.S. Branded Pharmaceuticals
|
$
|
308,813
|
|
|
$
|
284,507
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
U.S. Generic Pharmaceuticals
|
|
|
|
||||
U.S. Generics Base (1)
|
$
|
347,429
|
|
|
$
|
241,696
|
|
Sterile Injectables
|
123,689
|
|
|
—
|
|
||
New Launches and Alternative Dosages (2)
|
112,272
|
|
|
115,266
|
|
||
Total U.S. Generic Pharmaceuticals
|
$
|
583,390
|
|
|
$
|
356,962
|
|
(1)
|
U.S. Generics Base
includes solid oral-extended release, solid oral-immediate release and pain/controlled substances products.
|
(2)
|
New Launches and Alternative Dosages
includes liquids, semi-solids, patches, powders, ophthalmics, sprays and new product launches. Products are included in New Launches during the calendar year of launch and the subsequent calendar year such that the period of time any product will be considered a New Launch will range from thirteen to twenty-four months. New Launches contributed
$29.3 million
and
$7.3 million
of revenues to the three months ended March 31, 2016 and 2015. The table below presents the top 5 New Launch products by revenue for each period presented.
|
Year of
|
|
Three Months Ended March 31,
|
||||||||||
Launch
|
|
2016
|
|
2015
|
||||||||
2014
|
|
|
|
|
|
|
|
Telemisartan
|
|
Valsartan/HCTZ
|
|
Lorazepam
|
|
|
|
|
|
|
|
Methylphenidate
|
|
Disulfiram
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
Ethacrynate Sodium
|
|
Megace ES AG
|
|
Dutas/Tams Caps
|
|
Isosorbide ER
|
|
Gildess FE 24
|
|
Zafirlukast
|
|
Propranolol
|
|
Testosterone Gel Sachets
|
|
|
|
Hydrocortisone Cream
|
|
Pramipexole DHCI
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2016
|
|
Dantrolene Caps
|
|
Frova AG
|
|
Darifenacin HBr ER Tabs
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Adjusted income (loss) from continuing operations before income tax:
|
|
|
|
||||
U.S. Branded Pharmaceuticals
|
$
|
168,781
|
|
|
$
|
158,794
|
|
U.S. Generic Pharmaceuticals
|
$
|
211,768
|
|
|
$
|
183,457
|
|
International Pharmaceuticals
|
$
|
21,754
|
|
|
$
|
16,567
|
|
Corporate unallocated
|
$
|
(153,073
|
)
|
|
$
|
(111,068
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Total segment adjusted income from continuing operations before income tax:
|
$
|
402,303
|
|
|
$
|
358,818
|
|
Corporate unallocated costs (1)
|
(153,073
|
)
|
|
(111,068
|
)
|
||
Upfront and milestone payments to partners
|
(1,417
|
)
|
|
(2,667
|
)
|
||
Asset impairment charges (2)
|
(129,625
|
)
|
|
(7,000
|
)
|
||
Acquisition-related and integration items (3)
|
(12,554
|
)
|
|
(34,640
|
)
|
||
Separation benefits and other cost reduction initiatives (4)
|
(38,456
|
)
|
|
(41,807
|
)
|
||
Amortization of intangible assets
|
(211,669
|
)
|
|
(95,269
|
)
|
||
Inventory step-up and certain manufacturing costs that will be eliminated pursuant to integration plans
|
(68,476
|
)
|
|
(39,916
|
)
|
||
Non-cash interest expense related to the 1.75% Convertible Senior Subordinated Notes
|
—
|
|
|
(1,379
|
)
|
||
Loss on extinguishment of debt
|
—
|
|
|
(980
|
)
|
||
Impact of Voltaren
®
Gel generic competition
|
7,750
|
|
|
—
|
|
||
Certain litigation-related charges, net (5)
|
(5,200
|
)
|
|
(13,000
|
)
|
||
Costs associated with unused financing commitments
|
—
|
|
|
(11,810
|
)
|
||
Acceleration of Auxilium employee equity awards at closing
|
—
|
|
|
(37,603
|
)
|
||
Foreign currency impact related to the remeasurement of intercompany debt instruments
|
(1,255
|
)
|
|
21,090
|
|
||
Other, net
|
4,194
|
|
|
854
|
|
||
Total consolidated loss from continuing operations before income tax
|
$
|
(207,478
|
)
|
|
$
|
(16,377
|
)
|
(1)
|
Corporate unallocated costs include certain corporate overhead costs, interest expense, net, and certain other income and expenses.
|
(2)
|
Asset impairment charges primarily related to charges to write down intangible assets as further described in
Note 9. Goodwill and Other Intangibles
.
|
(3)
|
Acquisition-related and integration-items include costs directly associated with previous acquisitions of
$23.2 million
for the
three months
ended
March 31, 2016
and
$35.4 million
for the comparable
2015
period. During
2016
and
2015
, these costs are net of a benefit due to changes in the fair value of contingent consideration of
$10.7 million
and
$0.8 million
, respectively.
|
(4)
|
Separation benefits and other cost reduction initiatives include charges to increase excess inventory reserves of
$26.9 million
related to the 2016
U.S. Generic Pharmaceuticals
restructuring initiative, employee separation costs of
$6.8 million
and other restructuring costs of
$4.4 million
for the
three
months ended
March 31, 2016
. Amounts in the comparable
2015
period include employee separation costs of
$32.4 million
and a
$7.9 million
charge recorded upon the cease use date of our Auxilium subsidiary’s former corporate headquarters, representing the liability for our remaining obligations under the respective lease agreement, net of estimated sublease income. These amounts were primarily recorded as
Selling, general and administrative
expense in our
Condensed Consolidated Statements of Operations
. See
Note 4. Restructuring
for discussion of our material restructuring initiatives.
|
(5)
|
These amounts include charges for Litigation-related and other contingencies, net as further described in
Note 12. Commitments and Contingencies
.
|
|
March 31, 2016
|
|
December 31, 2015
|
||||
Total current assets
|
$
|
3,079,903
|
|
|
$
|
3,452,537
|
|
Less: total current liabilities
|
(3,206,967
|
)
|
|
(3,474,312
|
)
|
||
Working capital
|
$
|
(127,064
|
)
|
|
$
|
(21,775
|
)
|
Current ratio
|
-1.0:1
|
|
|
-1.0:1
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Net cash flow (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(49,825
|
)
|
|
$
|
(89,808
|
)
|
Investing activities
|
31,070
|
|
|
(930,484
|
)
|
||
Financing activities
|
(34,592
|
)
|
|
996,861
|
|
||
Effect of foreign exchange rate
|
2,967
|
|
|
(7,861
|
)
|
||
Net decrease in cash and cash equivalents
|
$
|
(50,380
|
)
|
|
$
|
(31,292
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Payments for mesh-related product liability and other litigation matters
|
$
|
213,886
|
|
|
$
|
130,975
|
|
Unused commitment fees
|
—
|
|
|
11,810
|
|
||
Separation and restructuring payments
|
19,351
|
|
|
11,719
|
|
||
Transaction costs and certain integration charges paid in connection with acquisitions
|
30,462
|
|
|
44,206
|
|
||
Total
|
$
|
263,699
|
|
|
$
|
198,710
|
|
•
|
FDA approval or disapproval of any of the drug applications we have submitted;
|
•
|
the success or failure of our clinical trials;
|
•
|
new data or new analyses of older data that raises potential safety or effectiveness issues concerning our approved products;
|
•
|
product recalls;
|
•
|
competitors announcing technological innovations or new commercial products;
|
•
|
introduction of generic substitutes for our products, including the filing of ANDAs with respect to generic versions of our branded products;
|
•
|
developments concerning our or others’ proprietary rights, including patents;
|
•
|
competitors’ publicity regarding actual or potential products under development or other activities affecting our competitors or the industry in general;
|
•
|
regulatory developments in the U.S. and foreign countries, or announcements relating to these matters;
|
•
|
period-to-period fluctuations in our financial results;
|
•
|
new legislation in the U.S. relating to the development, sale or pricing of pharmaceutical products or changes in interpretation of existing legislation relating thereto;
|
•
|
a determination by a regulatory agency that we are engaging or have engaged in inappropriate sales or marketing activities, including promoting the “off-label” use of our products;
|
•
|
social and political pressure to lower the cost of drugs;
|
•
|
social and political scrutiny over increases in prices of shares of pharmaceutical companies that are perceived to be caused by a strategy of growth through acquisitions;
|
•
|
litigation; and
|
•
|
economic and other external factors, including market speculation or disasters and other crises.
|
|
ENDO INTERNATIONAL PLC
|
|
(Registrant)
|
|
|
|
/s/ RAJIV DE SILVA
|
Name:
|
Rajiv De Silva
|
Title:
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
|
/s/ SUKETU P. UPADHYAY
|
Name:
|
Suketu P. Upadhyay
|
Title:
|
Executive Vice President and Chief Financial Officer
|
|
(Principal Financial Officer)
|
Exhibit
No.
|
Title
|
|
|
2.1
|
Amended and Restated Agreement and Plan of Merger, dated as of November 17, 2014, by and among Auxilium Pharmaceuticals, Inc., Endo International plc, Endo U.S. Inc., and Avalon Merger Sub Inc. (incorporated by reference to Annex A of the prospectus on Form 424B3 filed with the Commission on December 24, 2014)
|
|
|
2.2
|
Agreement and Plan of Merger by and among Generics International (US), Inc., DAVA Pharmaceuticals, Inc. and certain other parties listed therein, dated June 24, 2014 (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on June 26, 2014)
|
|
|
2.3
|
Purchase Agreement, dated March 2, 2015, by and among American Medical Systems Holdings, Inc., Endo Health Solutions Inc., and Boston Scientific Corporation (incorporated by reference to Exhibit 10.239 of the Endo International plc Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, filed with the Commission May 11, 2015)
|
|
|
2.4
|
Agreement and Plan of Merger, dated as of May 18, 2015, by and among Par Pharmaceutical Holdings, Inc., a Delaware corporation, Endo International plc, a public limited company incorporated under the laws of Ireland, Endo Limited, a private limited company incorporated under the laws of Ireland, Endo Health Solutions Inc., a Delaware corporation, Banyuls Limited, a private limited company incorporated under the laws of Ireland, Hawk Acquisition ULC, a Bermudian unlimited liability company and Shareholder Representative Services LLC, a Colorado limited liability company, solely as the Stakeholder Representative (as defined therein) (incorporated by reference to Exhibit 2.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 21, 2015)
|
|
|
3.1
|
Certificate of Incorporation on re-registration as a public limited company of Endo International plc (incorporated by reference to Exhibit 3.1 of the Endo International plc Current Report on Form 8-K12B, filed with the Commission on February 28, 2014)
|
|
|
3.2
|
Memorandum and Articles of Association of Endo International plc (incorporated by reference to Exhibit 3.2 of the Endo International plc Current Report on Form 8-K12B, filed with the Commission on February 28, 2014)
|
|
|
4.1
|
Specimen Share Certificate of Endo International plc (incorporated by reference to Exhibit 4.3 of the Endo International plc Form S-8, filed with the Commission on February 28, 2014)
|
|
|
4.2
|
Indenture among the Company, the guarantors named therein and Wells Fargo Bank, National Association, as trustee, dated June 8, 2011 (including Form of 7 1/4% Senior Notes due 2022 and Form of Supplemental Indenture relating to the 7 1/4% Senior Notes due 2022) (incorporated by reference to Exhibit 4.3 of the Endo Health Solutions Inc. Current Report on Form 8-K, filed with the Commission on June 9, 2011)
|
|
|
4.3
|
Fourth Supplemental Indenture, among Generics Bidco II, LLC, Generics International (US Holdco), Inc., Generics International (US Midco), Inc., Generics International (US Parent), Inc., Moores Mill Properties L.L.C., Quartz Specialty Pharmaceuticals, LLC and Wood Park Properties LLC, as guaranteeing subsidiaries, Endo, the guarantors named therein and Wells Fargo Bank, National Association, as trustee, dated September 26, 2011, to the Indenture among Endo, the guarantors named therein and Wells Fargo Bank, National Association, as trustee, dated June 8, 2011 (incorporated by reference to Exhibit 10.157 of the Endo Health Solutions Inc. Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Commission on March 3, 2014)
|
|
|
4.4
|
Fifth Supplemental Indenture, among Endo Health Solutions Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, dated as of April 17, 2014, to the Indenture among Endo Health Solutions Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, dated as of June 8, 2011, governing Endo Health Solutions Inc.’s 7 1⁄4% Senior Notes due 2022 (incorporated by reference to Exhibit 10.3 of the Endo International plc Current Report on Form 8-K, filed with the Commission on April 17, 2014)
|
|
|
4.5
|
Indenture, dated December 19, 2013, between Endo Finance Co. and Wells Fargo Bank, National Association, as trustee (including Form of 5.75% Senior Notes due 2022 and Form of Supplemental Indenture relating to the 5.75% Senior Notes due 2022) (incorporated by reference to Exhibit 4.1 of the Endo Health Solutions Inc. Current Report on Form 8-K, filed with the Commission on December 19, 2013)
|
|
|
4.6
|
Supplemental Indenture, dated February 28, 2014, among Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, to the Indenture, dated December 19, 2013 (incorporated by reference to Exhibit 4.1 of Endo International plc’s Current Report on Form 8-K, filed with the Commission on February 28, 2014)
|
|
|
4.7
|
Supplemental Indenture, dated March 27, 2015, among Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, to the Indenture, dated December 19, 2013 (incorporated by reference to Exhibit 4.7 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
|
|
|
4.8
|
Indenture, dated May 6, 2014, among Endo Finance LLC, Endo Finco Inc. the guarantors named therein and Wells Fargo Bank, National Association, as trustee, relating to the 7.25% Senior Notes due 2022 (including Form of 7.25% Senior Notes due 2022 and Form of Supplemental Indenture relating to the 7.25% Senior Notes due 2022) (incorporated by reference to Exhibit 10.5 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 7, 2014)
|
|
|
4.9
|
Supplemental Indenture, dated March 27, 2015, among Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, to the Indenture, dated May 6, 2014 (incorporated by reference to Exhibit 4.9 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
|
|
|
4.10
|
Registration Rights Agreement, dated May 6, 2014, by and among Endo Finance LLC, Endo Finco Inc. the guarantors named therein and RBC Capital Markets, LLC and Deutsche Bank Securities Inc., relating to the 7.25% Senior Notes due 2022 (including Form of Counterpart to the Registration Rights Agreement relating to the 7.25% Senior Notes due 2022) (incorporated by reference to Exhibit 10.9 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 7, 2014)
|
|
|
4.11
|
Indenture, dated June 30, 2014, among Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, relating to the 5.375% Senior Notes due 2023 (including Form of 5.375% Senior Notes due 2023 and Form of Supplemental Indenture relating to the 5.375% Senior Notes due 2023) (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on July 1, 2014)
|
|
|
4.12
|
Supplemental Indenture, dated March 27, 2015, among Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, to the Indenture, dated June 30, 2014 (incorporated by reference to Exhibit 4.12 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
|
|
|
4.13
|
Registration Rights Agreement, dated June 30, 2014, by and among Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Citigroup Global Markets Inc. and RBC Capital Markets, LLC, relating to the 5.375% Senior Notes due 2023 (including Form of Counterpart to the Registration Rights Agreement relating to the 5.375% Senior Notes due 2023) (incorporated by reference to Exhibit 10.3 of the Endo International plc Current Report on Form 8-K, filed with the Commission on July 1, 2014)
|
|
|
4.14
|
Indenture, dated January 27, 2015, among Endo Limited, Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, relating to the 6.00% Senior Notes due 2025 (including Form of 6.00% Senior Notes due 2025 and Form of Supplemental Indenture relating to the 6.00% Senior Notes due 2025) (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on January 27, 2015)
|
|
|
4.15
|
Supplemental Indenture, dated March 27, 2015, among Endo Limited, Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, to the Indenture, dated January 27, 2015 (incorporated by reference to Exhibit 4.15 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
|
|
|
4.16
|
Registration Rights Agreement, dated January 27, 2015, by and among Endo Limited, Endo Finance LLC, Endo Finco Inc., the guarantors named therein and RBC Capital Markets, LLC and Citigroup Global Markets Inc., relating to the 6.00% Senior Notes due 2025 (including Form of Counterpart to the Registration Rights Agreement relating to the 6.00% Senior Notes due 2025) (incorporated by reference to Exhibit 10.3 of the Endo International plc Current Report on Form 8-K, filed with the Commission on January 27, 2015)
|
|
|
4.17
|
Indenture, dated July 9, 2015, among Endo Limited, Endo Finance LLC, Endo Finco Inc., the guarantors named therein and Wells Fargo Bank, National Association, as trustee, relating to the 6.000% Senior Notes due 2023 (including Form of 6.000% Notes due 2023 and Form of Supplemental Indenture relating to the 6.000% Notes due 2023) (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on July 9, 2015)
|
|
|
4.18
|
Shareholders Agreement, dated as of May 18, 2015, by and among Endo International plc and the signatories thereto (incorporated by reference to Exhibit 10.2 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 21, 2015)
|
|
|
4.18.1
|
Amendment to Shareholders and Registration Rights Agreements, dated as of May 5, 2016, by and among Endo International plc and the signatories thereto (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 5, 2016)
|
|
|
4.19
|
Registration Rights Agreement dated April 26, 2013, by and between Auxilium Pharmaceuticals, Inc., a Delaware corporation and GTCR Fund IX/A, L.P., a Delaware limited partnership, solely in its capacity as representative for the GTCR Fund IX/B, L.P., and the Actient Holdings LLC's Unitholders and Optionholders (incorporated by reference to Exhibit 10.2 to the Auxilium Current Report on Form 8-K, filed with the Commission on April 29, 2013)
|
|
|
4.20
|
Registration Rights Agreement, dated as of May 18, 2015, by and among Endo International plc and the persons listed on Schedule A thereto (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 21, 2015)
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|
|
10.1
|
Amended and Restated Executive Deferred Compensation Plan (incorporated by reference to Exhibit 10.11 of the Endo Health Solutions Inc. Annual Report on Form 10-K for the year ended December 31, 2012, filed with the Commission on March 1, 2013)
|
|
|
10.2
|
Amended and Restated 401(k) Restoration Plan (incorporated by reference to Exhibit 10.12 of the Endo Health Solutions Inc. Annual Report on Form 10-K for the year ended December 31, 2012, filed with the Commission on March 1, 2013)
|
|
|
10.3
|
Directors Deferred Compensation Plan (incorporated by reference to Exhibit 10.13 of the Endo Health Solutions Inc. Annual Report on Form 10-K for the year ended December 31, 2012, filed with the Commission on March 1, 2013)
|
|
|
10.4*
|
Supply and Manufacturing Agreement, dated as of November 23, 1998, by and between Endo Pharmaceuticals and Teikoku Seiyaku Co., Ltd. (incorporated by reference to Exhibit 10.14 of the Endo Health Solutions Inc. Registration Statement filed with the Commission on June 9, 2000)
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|
|
10.4.1*
|
First Amendment, dated April 24, 2007, to the Supply and Manufacturing Agreement, dated as of November 23, 1998, by and between Endo Pharmaceuticals and Teikoku Seiyaku Co., Ltd. / Teikoku Pharma USA, Inc. (incorporated by reference to Exhibit 10.14.1 of the Endo Health Solutions Inc. Current Report on Form 8-K, filed with the Commission on April 30, 2007)
|
|
|
10.4.2*
|
Second Amendment, effective December 16, 2009, to the Supply and Manufacturing Agreement, dated as of November 23, 1998 and as amended as of April 24, 2007, by and between Endo Pharmaceuticals and Teikoku Seiyaku Co., Ltd. / Teikoku Pharma USA, Inc. (incorporated by reference to Exhibit 10.14.2 of the Endo Health Solutions Inc. Current Report on Form 8-K, filed with the Commission on January 11, 2010)
|
|
|
10.4.3*
|
Third Amendment, effective November 1, 2010, to the Supply and Manufacturing Agreement, dated as of November 23, 1998 and as amended as of December 16, 2009, by and between Endo Pharmaceuticals and Teikoku Seiyaku Co., Ltd. / Teikoku Pharma USA, Inc. (incorporated by reference to Exhibit 10.14.3 of the Endo Health Solutions Inc. Form 10-Q for the Quarter ended September 30, 2010 filed with the Commission on November 2, 2010)
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|
|
10.4.4*
|
Fourth Amendment, effective February 25, 2015, to the Supply and Manufacturing Agreement, dated as of November 23, 1998 and as amended as of November 1, 2010, by and between Endo Pharmaceuticals and Teikoku Seiyaku Co., Ltd. / Teikoku Pharma USA, Inc. (incorporated by reference to Exhibit 10.14.4 of the Endo International plc Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Commission on March 2, 2015)
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|
|
10.5*
|
Supply Agreement, dated as of April 27, 2012, between Endo Pharmaceuticals and Noramco, Inc. (incorporated by reference to Exhibit 10.17 of the Endo Health Solutions Inc. Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2012, filed with the Commission on May 1, 2012)
|
|
|
10.5.1*
|
Third Amendment, dated as of January 1, 2015, to the Supply Agreement, dated as of April 27, 2012, as amended, between Endo Pharmaceuticals and Noramco, Inc. (filed herewith)
|
|
|
10.5.2*
|
Fourth Amendment, dated as of October 22, 2015, to the Supply Agreement, dated as of April 27, 2012, as amended, between Endo Pharmaceuticals and Noramco, Inc. (filed herewith)
|
|
|
10.5.3*
|
Fifth Amendment, dated as of April 25, 2016, to the Supply Agreement, dated as of April 27, 2012, as amended, between Endo Pharmaceuticals and Noramco, Inc. (filed herewith)
|
|
|
10.6
|
Executive Employment Agreement between Endo and Ivan P. Gergel, dated as of October 27, 2011 (incorporated by reference to Exhibit 10.122 of the Endo Health Solutions Inc. Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2011, filed with the Commission on October 31, 2011)
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|
|
10.7
|
Executive Employment Agreement between Endo and Rajiv De Silva, dated as of February 24, 2013 and effective as of March 18, 2013 (incorporated by reference to Exhibit 10.1 of the Endo Health Solutions Inc. Current Report on Form 8-K, filed with the Commission on February 25, 2013)
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|
|
10.8
|
Endo International plc Amended and Restated Employee Stock Purchase Plan (incorporated by reference to Exhibit 4.9 of the Endo International plc Form S-8, filed with the Commission on February 28, 2014)
|
|
|
10.9*
|
Development, License and Supply Agreement, dated as of December 18, 2007, between Endo Pharmaceuticals and Grünenthal GmbH (incorporated by reference to Exhibit 10.139 of the Endo Health Solutions Inc. Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2012 filed with the Commission on May 1, 2012)
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|
|
10.9.1*
|
First Amendment to Development, License and Supply Agreement, dated as of December 19, 2012, between Endo Pharmaceuticals and Grünenthal GmbH (incorporated by reference to Exhibit 10.139.1 of the Endo Health Solutions Inc. Form 10-K for the year ended December 31, 2012 filed with the Commission on March 1, 2013)
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|
|
10.9.2*
|
Second Amendment to Development, License and Supply Agreement, dated as of February 18, 2014, between Endo Pharmaceuticals and Grünenthal GmbH (incorporated by reference to Exhibit 10.139.2 of the Endo Health Solutions Inc. Form 10-K for the year ended December 31, 2013 filed with the Commission on March 3, 2014)
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|
|
10.10
|
Executive Employment Agreement between Endo Health Solutions Inc. and Suketu P. Upadhyay, dated as of September 4, 2013 and effective as of September 23, 2013 (incorporated by reference to Exhibit 10.1 of the Endo Health Solutions Inc. Current Report on Form 8-K, filed with the Commission on September 10, 2013)
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|
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10.11
|
Executive Employment Agreement between Endo Health Solutions Inc. and Donald W. DeGolyer, dated as of May 24, 2013 and effective as of August 1, 2013 (incorporated by reference to Exhibit 10.147 of the Endo Health Solutions Inc. Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Commission on March 3, 2014)
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|
|
10.12
|
Credit Agreement, dated as of February 28, 2014, among Endo Limited, Endo Management Limited, Endo Luxembourg Holding Company S.a.r.l., Endo Luxembourg Finance Company I S.a.r.l., Endo LLC (formerly known as NIMA Acquisition, LLC), the lenders from time to time party thereto, and Deutsche Bank AG New York Branch, as administrative agent, collateral agent, issuing bank and swingline lender (incorporated by reference to Exhibit 4.3 of the Endo International plc Current Report on Form 8-K, filed with the Commission on February 28, 2014)
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|
|
10.13
|
Amendment No. 1 to Credit Agreement, dated as of June 12, 2015, by and among Endo Luxembourg Finance Company I S.à.r.l and Endo LLC, as borrowers, the subsidiary guarantors party thereto, the lenders and other financial institutions party thereto and Deutsche Bank AG New York Branch, as administrative agent (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on June 15, 2015)
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|
|
10.14
|
Incremental Amendment, dated as of September 25, 2015, by and among Endo Designated Activity Company, Endo Management Limited, Endo Luxembourg Holding Company S.à r.l., Endo Luxembourg Finance Company I S.à.r.l., as borrower, Endo LLC, as borrower, the subsidiary guarantors party thereto, the lenders party thereto and Deutsche Bank AG New York Branch, as administrative agent (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, with the Commission on September 28, 2015)
|
|
|
10.15
|
Executive Employment Agreement between Endo Health Solutions Inc., a wholly-owned subsidiary of Endo International plc, and Susan Hall, dated as of March 6, 2014 and effective March 10, 2014 (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on March 13, 2014)
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|
|
10.15.1
|
First Amendment to Executive Employment Agreement between Endo Health Solutions Inc., a wholly-owned subsidiary of Endo International plc, and Susan Hall, dated as of April 21, 2014 and effective April 22, 2014 (incorporated by reference to Exhibit 10.162.1 of the Endo International plc Quarterly Report on Form 10-Q for the Quarter ended March 31, 2014, filed with the Commission on May 9, 2014)
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|
|
10.16
|
Retention Agreement, dated as of January 8, 2015, between Endo Health Solutions Inc. and Caroline B. Manogue (incorporated by reference to Exhibit 10.207 of the Endo International plc Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Commission on March 2, 2015)
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|
|
10.17
|
Executive Employment Agreement by and between American Medical Systems, Inc. and Camille Farhat, effective as of July 17, 2012 (incorporated by reference to Exhibit 10.208 of the Endo International plc Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Commission on March 2, 2015)
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|
|
10.18*
|
Second Amended and Restated Development and License Agreement, dated August 31, 2011, by and between BioSpecifics Technologies Corp. and Auxilium (incorporated by reference to Exhibit 10.1 to the Auxilium Current Report on Form 8-K, filed with the Commission on September 1, 2011)
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|
|
10.18.1*
|
First Amendment to Second Amended and Restated Development and License Agreement, dated February 1, 2016, by and between BioSpecifics Technologies Corp. and Endo Global Ventures (incorporated by reference to Exhibit 10.18.1 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
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|
|
10.19*
|
Supply Agreement, dated June 26, 2008, between Auxilium and Hollister-Stier Laboratories LLC (incorporated by reference to Exhibit 10.1 to the Auxilium Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, filed with the Commission on August 8, 2008)
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|
|
10.20
|
Executive Employment Agreement between Endo Health Solutions Inc. and Matthew J. Maletta, effective as of April 28, 2015 (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on April 30, 2015)
|
|
|
10.21
|
Endo International plc 2015 Stock Incentive Plan (incorporated by reference to Exhibit 4.2 of the Endo International plc Registration Statement on Form S-8, filed with the Commission on June 15, 2015)
|
|
|
10.22
|
Form of Stock Option Agreement to Optionee under the Endo International plc 2015 Stock Incentive Plan (filed herewith)
|
|
|
10.23
|
Form of Stock Award Agreement to Participant under the Endo International plc 2015 Stock Incentive Plan (filed herewith)
|
|
|
10.24
|
Form of Performance Award Agreement to Participant under the Endo International plc 2015 Stock Incentive Plan (filed herewith)
|
|
|
10.25
|
Form of Matched Performance Award Agreement to Participant under the Endo International plc 2015 Stock Incentive Plan (incorporated by reference to Exhibit 10.276 of the Endo International plc Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, filed with the Commission August 10, 2015)
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|
|
10.26
|
Executive Employment Agreement between Endo Health Solutions, Inc. and Paul V. Campanelli, effective as of September 25, 2015 (incorporated by reference to Exhibit 10.310 of the Endo International plc Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, filed with the Commission November 9, 2015)
|
|
|
10.27
|
License and Supply Agreement by and by and among Novartis, AG, Novartis Consumer Health, Inc. and Endo Pharmaceuticals dated as of March 4, 2008 (incorporated by reference to Exhibit 10.31 of the Endo International plc Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, filed with the Commission November 9, 2015)
|
|
|
10.27.1
|
Amendment No. 1 to the License and Supply Agreement by and by and among Novartis, AG, Novartis Consumer Health, Inc. and Endo Pharmaceuticals dated as of March 28, 2008 (incorporated by reference to Exhibit 10.31.1 of the Endo International plc Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, filed with the Commission November 9, 2015)
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|
|
10.27.2
|
Amendment No. 2 to License and Supply Agreement, by and among Novartis AG, Novartis Consumer Health, Inc. and Endo Pharmaceuticals dated as of December 31, 2012 (incorporated by reference to Exhibit 10.31.2 of the Endo International plc Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, filed with the Commission November 9, 2015)
|
|
|
10.28*
|
Amended and Restated License and Supply Agreement by and among Novartis, AG, Sandoz Inc. and Endo Ventures Limited dated as of December 11, 2015 (incorporated by reference to Exhibit 10.28 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
|
|
|
10.28.1*
|
Letter Agreement by and among Novartis AG, Sandoz, Inc. and Endo Ventures Limited dated as of March 25, 2016 (filed herewith)
|
|
|
10.29*
|
License and Commercialization Agreement, dated October 10, 2013, by and between VIVUS, Inc. and Auxilium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.14 to the Auxilium Annual Report on Form 10-K, filed with the Commission on February 28, 2014)
|
|
|
10.30*
|
Commercial Supply Agreement, dated October 10, 2013, by and between VIVUS, Inc. and Auxilium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.15 to the Auxilium Annual Report on Form 10-K, filed with the Commission on February 28, 2014)
|
|
|
10.31
|
Notice of Termination, effective as of June 30, 2016, of (i) the License and Commercialization Agreement by and between Auxilium and VIVUS and (ii) the Commercial Supply Agreement, by and between Endo Ventures (by assignment from Auxilium) and VIVUS (incorporated by reference to Exhibit 10.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on December 30, 2015)
|
|
|
10.32
|
Form of Indemnification Agreement with Endo Health Solutions Inc. (incorporated by reference to Exhibit 10.32 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
|
|
|
10.33
|
Executive Employment Agreement between Endo Health Solutions, Inc. and Rajiv De Silva, effective as of March 18, 2016 (incorporated by reference to Exhibit 10.33 of Endo International plc Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Commission on February 29, 2016)
|
|
|
10.34
|
Director Confidentiality Agreement, dated as of May 5, 2016, by and among Endo International plc, Todd B. Sisitsky and TPG Global, LLC (incorporated by reference to Exhibit 10.2 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 5, 2016)
|
|
|
10.35
|
Form of Indemnification Agreement with Endo International plc (filed herewith)
|
|
|
14.1
|
Code of Conduct of the Board of Directors, as amended and restated on May 3, 2016 (incorporated by reference to Exhibit 14.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on May 5, 2016)
|
|
|
16.1
|
Letter Regarding Change in Certifying Accountant, dated June 13, 2014 (incorporated by reference to Exhibit 16.1 of the Endo International plc Current Report on Form 8-K, filed with the Commission on June 13, 2014)
|
|
|
31.1
|
Certification of the President and Chief Executive Officer of Endo pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
31.2
|
Certification of the Chief Financial Officer of Endo pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
By:
|
/s/Rajiv De Silva
|
Name:
|
Rajiv De Silva
|
Title:
|
President and Chief Executive Officer
|
Date:
|
8/17/2015
|
By:
|
/s/John Giannone
|
Name:
|
John Giannone
|
Title:
|
Director of US Sales
|
Date:
|
7/27/2015
|
By:
|
/s/Michael Moes
|
Name:
|
Michael Moes
|
Title:
|
VP
|
By:
|
/s/John Giannone
|
Name:
|
John Giannone
|
Title:
|
Director of US Sales
|
(A)
|
The Parties hereto entered into a Supply Agreement dated April 27, 2012 (the “Supply Agreement”), and as amended on December 12, 2013 (the “First Amendment”), on April 29, 2015 (the “Second Amendment”), on January 1, 2015 (the “Third Amendment”), on April 16, 2015 (the “Assignment of Contract”) and on October 22, 2015 (the “Fourth Amendment”)(collectively, the “Agreement”), and now the Parties desire to amend the Agreement as set forth herein;
|
(B)
|
The Agreement contains a provision for automatic one (1) year renewals of the Agreement provided a termination notice has not been sent by *** of the then current renewal year pursuant to Section 10.1; and
|
(C)
|
The Parties desire to temporarily change the termination notice date for the *** notification period pursuant to Section 10.1 from *** to ***.
|
1.
|
Capitalized terms used in this Fifth Amendment and not otherwise defined herein shall have the meanings given to such terms in the Agreement.
|
2.
|
As of the Fifth Amendment Effective Date, Section 10.1 of the Agreement shall be deleted in its entirety and replaced with the following:
|
3.
|
Save as otherwise expressly referred to in this Fifth Amendment, the terms and conditions of the Agreement shall apply in all other respects and remain in full force and effect.
|
Expiration Date:
|
The 10th anniversary of the Date of Grant
|
Vesting Dates:
|
Option vests ratably over the first, second, third [and fourth] anniversaries of the Date of Grant
|
(a)
|
Termination of Service for Cause
. Upon the Participant’s termination of service with the Company and its Subsidiaries by the Company or its Subsidiary for Cause, the portion of outstanding Options that are exercisable as of the date of such termination of service shall remain exercisable for thirty (30) days from and including the date of termination of service (and shall thereafter terminate). Any portion of outstanding Options that are not exercisable as of the date of such termination of service shall terminate upon the date of termination of service.
|
(b)
|
Termination of Service on Account of Death
. Upon the Participant’s termination of service with the Company and its Subsidiaries on account of death, all of the Participant’s unvested Options shall immediately vest and become exercisable. The Options shall remain exercisable for one (1) year from and including the date of the Participant’s death (and shall thereafter terminate).
|
(c)
|
Termination of Service on Account of Disability or Voluntary Retirement with Consent of Company
. If the Participant voluntarily Retires with the consent of the Company or if the Participant’s service with the Company and its Subsidiaries terminates due to Disability, the Participant’s unvested Options as of the date of such termination shall continue to vest in accordance with the original vesting schedule set forth above. The Options shall remain exercisable for a period of one (1) year from and including the later to occur of (i) the date such entire Option becomes exercisable in accordance with the vesting schedule or (ii) the date of termination of service (and shall thereafter terminate).
|
(d)
|
Termination of Service by the Company without Cause or by the Participant for Good Reason
. Upon termination of the Participant’s service with the Company and its Subsidiaries by the Company or its Subsidiaries without Cause or by the Participant for “good reason” (or any like term as defined under any employment agreement with the Company or a Subsidiary to which the Participant is a party, as modified below), the portion of outstanding Options that are exercisable as of the date of such termination of service shall remain exercisable for one (1) year from and including the date of termination of service (and shall thereafter terminate). Any portion of outstanding Options that are not exercisable as of the date of such termination of service shall terminate upon the date of termination of service. For any Participant who is a party to an employment agreement with the Company or a Subsidiary, “good reason” shall also include the Participant's termination of his or her employment within ninety (90) days following the expiration of the employment term of the Participant's employment agreement under circumstances that would have constituted good reason had such termination occurred during the employment term.
|
(e)
|
Termination of Service for any Other Reason
. Upon the Participant’s termination of service with the Company and its Subsidiaries for any reason other than the
|
(a)
|
if the Option is assumed or substituted (within the meaning of the Plan) in connection with such Change in Control, and the Participant incurs a termination of service with the Company and its Subsidiaries by the Company or its Subsidiary without Cause or by the Participant for good reason (or any like term as defined under any employment agreement with the Company or a Subsidiary to which the Participant is a party, as modified by Section 4(d)) during the 24-month period following such Change in Control, then the Option shall vest and become fully exercisable on the date of such termination of services and shall remain exercisable for one (1) year from and including the date of such termination of services (and shall thereafter terminate).
|
(b)
|
if the Option is not assumed or substituted in connection with such Change in Control, then the Option shall immediately vest and become fully exercisable on the occurrence of the Change in Control.
|
(a)
|
Any “Person” (as defined below) is or becomes the “beneficial owner” (“Beneficial Owner”) within the meaning set forth in Rule 13d-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), directly or indirectly, of securities of the Company (not including in the securities beneficially owned by such Person any securities acquired directly from the Company or its “Affiliates” (as defined in Rule 12b-2 promulgated under Section 12 of the Exchange Act)) representing 30% or more of the combined voting power of the Company’s then outstanding securities, excluding any Person who becomes such a Beneficial Owner in connection with a transaction described in clause (A) of Subparagraph (c) below; or
|
(b)
|
The following individuals cease for any reason to constitute a majority of the number of directors then serving: individuals who, on the date hereof, constitute the Board of Directors and any new director (other than a director whose initial assumption of office is in connection with an actual or threatened election contest, including but not limited to a consent solicitation, relating to the election of directors of the Company) whose appointment or election by the Board of Directors or nomination for election by the Company’s shareholders was approved or recommended by a vote of at least two-thirds (2/3) of the directors then still in office who either were directors on the date hereof or whose appointment, election or nomination for election was previously so approved or recommended; or
|
(c)
|
There is consummated a merger or consolidation of the Company or any direct or indirect subsidiary of the Company with any other corporation or other entity, other than (A) a merger or consolidation which results in (i) the voting securities of the Company outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof), in combination with the ownership of any trustee or other fiduciary holding securities under an employee benefit plan of the Company or any subsidiary of the Company, at least 60% of the combined voting power of the securities of the Company or such surviving entity or any parent thereof outstanding immediately after such merger or consolidation and (ii) the individuals who comprise the Board of Directors immediately prior thereto constituting immediately thereafter at least a majority of the board of directors of the Company, the entity surviving such merger or consolidation or, if the Company or the entity surviving such merger is then a subsidiary, the ultimate parent thereof, or (B) a merger or consolidation effected to implement a recapitalization of the Company (or similar transaction) in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company (not including in the securities Beneficially Owned by such Person any securities acquired directly from the Company or its Affiliates) representing 30% or more of the combined voting power of the Company’s then outstanding securities; or
|
(d)
|
The shareholders of the Company approve a plan of complete liquidation or dissolution of the Company or there is consummated an agreement for the sale or disposition by the Company of all or substantially all of the Company’s assets (it being conclusively presumed that any sale or disposition is a sale or disposition by the Company of all or substantially all of its assets if the consummation of the sale or disposition is contingent upon approval by the Company’s shareholders unless the Board of Directors expressly determines in writing that such approval is required solely by reason of any relationship between the Company and any other Person or an Affiliate of the Company and any other Person), other than a sale or disposition by the Company of all or substantially all of the Company’s assets to an entity (A) at least 60% of the combined voting power of the voting
|
If to Company:
|
Endo International plc
|
If to the Participant:
|
At the address on file with the Company.
|
If to Company:
|
Endo International plc
|
If to the Participant:
|
At the address on file with the Company.
|
Performance Period:
|
The period beginning on the Date of Grant and ending on the third anniversary of the Date of Grant.
|
(a)
|
if the Performance Award is assumed or substituted (within the meaning of the Plan) in connection with such Change in Control, and the Participant incurs a termination of service from the Company and its Subsidiaries by the Company or its Subsidiary without Cause or by the Participant for good reason (or any like term as defined under any employment agreement with the Company or a Subsidiary to which the Participant is a party, as modified by Section 4(e)) during the 24-month period following such Change in Control, then the restrictions, deferral limitations, payment conditions, and forfeiture conditions applicable to any Performance Awards shall lapse and the Performance Awards shall be settled in shares of Company Stock on the date of such termination based on the greater of (i) actual achievement of Performance Criteria or (ii) target achievement of Performance Criteria, in either case measured as of the date of such termination; provided, however, if such termination of service occurs prior to the first anniversary of the Date of Grant, CAGR will be determined based on an assumed measurement period of one year.
|
(b)
|
if the Performance Award is not assumed or substituted in connection with such Change in Control, then the restrictions, deferral limitations, payment conditions, and forfeiture conditions applicable to any Performance Awards shall lapse and the Performance Awards shall be settled in shares of Company Stock immediately prior to the Change in Control based on the greater of (i) actual achievement of Performance Criteria or (ii) target achievement of Performance Criteria, in either case measured as of the date of the Change in Control; provided, however, if the Change in Control occurs prior to the first anniversary of the Date of Grant, CAGR will be determined based on an assumed measurement period of one year.
|
(c)
|
Any portion of the Performance Award that could have been earned in accordance with Section 5(a) or Section 5(b) that is not earned shall be immediately forfeited
|
(a)
|
Any “Person” (as defined below) is or becomes the “beneficial owner” (“Beneficial Owner”) within the meaning set forth in Rule 13d-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), directly or indirectly, of securities of the Company (not including in the securities beneficially owned by such Person any securities acquired directly from the Company or its “Affiliates” (as defined in Rule 12b-2 promulgated under Section 12 of the Exchange Act)) representing 30% or more of the combined voting power of the Company’s then outstanding securities, excluding any Person who becomes such a Beneficial Owner in connection with a transaction described in clause (A) of Subparagraph (c) below; or
|
(b)
|
The following individuals cease for any reason to constitute a majority of the number of directors then serving: individuals who, on the date hereof, constitute the Board of Directors and any new director (other than a director whose initial assumption of office is in connection with an actual or threatened election contest, including but not limited to a consent solicitation, relating to the election of directors of the Company) whose appointment or election by the Board of Directors or nomination for election by the Company’s shareholders was approved or recommended by a vote of at least two-thirds (2/3) of the directors then still in office who either were directors on the date hereof or whose appointment, election or nomination for election was previously so approved or recommended; or
|
(c)
|
There is consummated a merger or consolidation of the Company or any direct or indirect subsidiary of the Company with any other corporation or other entity, other than (A) a merger or consolidation which results in (i) the voting securities of the Company outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof), in combination with the ownership of any trustee or other fiduciary holding securities under an employee benefit plan of the Company or any subsidiary of the Company, at least 60% of the combined voting power of the securities of the Company or such surviving entity or any parent thereof outstanding immediately after such merger or consolidation and (ii) the individuals who comprise the Board of Directors immediately prior thereto constituting immediately thereafter at least a majority of the board of directors of the Company, the entity surviving such merger or consolidation or, if the Company or the entity surviving such merger is then a subsidiary, the ultimate parent thereof, or (B) a merger or consolidation effected to
|
(d)
|
The shareholders of the Company approve a plan of complete liquidation or dissolution of the Company or there is consummated an agreement for the sale or disposition by the Company of all or substantially all of the Company’s assets (it being conclusively presumed that any sale or disposition is a sale or disposition by the Company of all or substantially all of its assets if the consummation of the sale or disposition is contingent upon approval by the Company’s shareholders unless the Board of Directors expressly determines in writing that such approval is required solely by reason of any relationship between the Company and any other Person or an Affiliate of the Company and any other Person), other than a sale or disposition by the Company of all or substantially all of the Company’s assets to an entity (A) at least 60% of the combined voting power of the voting securities of which are owned by shareholders of the Company in substantially the same proportions as their ownership of the Company immediately prior to such sale or disposition and (B) the majority of whose board of directors immediately following such sale or disposition consists of individuals who comprise the Board of Directors immediately prior thereto.
|
If to Company:
|
Endo International plc
|
(I)
|
Performance Criteria
.
|
Relative TSR
|
Multiple Applicable to Target
Performance Award
|
Equal to or above 90
th
percentile*
|
3
|
Equal to or above 80
th
percentile but below 90
th
percentile
|
1.75 - 2
|
Equal to or above 70
th
percentile but below 80
th
percentile
|
1.5 – 1.74
|
Equal to or above 60
th
percentile but below 70
th
percentile
|
1.25 – 1.49
|
Equal to or above 50
th
percentile but below 60
th
percentile
|
1 – 1.24
|
Equal to or above 40
th
percentile but below 50
th
percentile
|
.5
|
Below 40
th
percentile
|
0
|
(II)
|
Definitions
.
|
1.
|
AbbVie Inc. (ABBV)
|
2.
|
Abbott Laboratories (ABT)
|
3.
|
Akorn, Inc. (AKRX)
|
4.
|
Alexion Pharmaceuticals Inc. (ALXN)
|
5.
|
Alkermes plc (ALKS)
|
6.
|
Allergan plc (AGN)
|
7.
|
Amgen Inc. (AMGN)
|
8.
|
AstraZeneca PLC (AZN)
|
9.
|
Biogen Inc. (BIIB)
|
10.
|
BioMarin Pharmaceutical Inc. (BMRN)
|
11.
|
Bristol-Myers Squibb Company (BMY)
|
12.
|
Celgene Corporation (CELG)
|
13.
|
Dr. Reddy's Laboratories Ltd. (RDY)
|
14.
|
Eli Lilly and Company (LLY)
|
15.
|
Gilead Sciences Inc. (GILD)
|
16.
|
GlaxoSmithKline plc (GSK)
|
17.
|
Impax Labs Inc. (IPXL)
|
18.
|
Incyte Corporation (INCY)
|
19.
|
Jazz Pharmaceuticals Public Limited Company (JAZZ)
|
20.
|
Johnson & Johnson (JNJ)
|
21.
|
Mallinckrodt Public Limited Company (MNK)
|
22.
|
Medivation, Inc. (MDVN)
|
23.
|
Merck & Co. Inc. (MRK)
|
24.
|
Mylan N.V. (MYL)
|
25.
|
Novartis AG (NVS)
|
26.
|
Novo Nordisk A/S (NVO)
|
27.
|
Perrigo Company Public Limited Company (PRGO)
|
28.
|
Pfizer Inc. (PFE)
|
29.
|
Qiagen NV (QGEN)
|
30.
|
Regeneron Pharmaceuticals Inc. (REGN)
|
31.
|
Roche Holding AG (RHHBY)
|
32.
|
Sanofi (SNY)
|
33.
|
Shire plc (SHPG)
|
34.
|
Taro Pharmaceutical Industries Ltd. (TARO)
|
35.
|
Teva Pharmaceutical Industries Limited (TEVA)
|
36.
|
The Medicines Company (MDCO)
|
37.
|
United Therapeutics Corporation (UTHR)
|
38.
|
Valeant Pharmaceuticals International, Inc. (VRX)
|
39.
|
Vertex Pharmaceuticals Inc. (VRTX)
|
40.
|
Zoetis Inc. (ZTS)
|
1.
|
Manufacturing
. Notwithstanding anything to the contrary in the License Agreement, Sandoz shall: (a) manufacture (or have manufactured on Sandoz’s behalf) Endo’s orders for Generic Licensed Product pursuant to the Manufacturing Plan attached hereto as
Exhibit A
(the “
Manufacturing Plan
”); and (b) shall use commercially reasonable efforts to deliver Endo’s orders for Generic Licensed Product pursuant to the Manufacturing Plan, or related Purchase Order(s) issued thereunder, (and further shall use commercially reasonable efforts to expedite delivery in advance of the dates specified therein). Sandoz and Endo shall cooperate and confer regularly regarding the progress of such manufacturing efforts, and shall notify each other promptly of any delays (actual or reasonably forseeable) that result or may result in a manufacturing or delivery delay of Generic Licensed Product.
|
2.
|
Purchase Orders
. Notwithstanding anything to the contrary in the License Agreement, the parties agree that the terms and conditions of the License Agreement shall apply to all purchase orders submitted pursuant to Section 1.
|
3.
|
Contingent Royalty
. Section 6.1(c) of the License Agreement is hereby amended to modify the Contingent Royalty payable on July 1, 2016 as follows:
|
(i)
|
if, as of July 1, 2016, there has been no Generic Entry, the Contingent Royalty payable on July 1 equals ***;
|
(ii)
|
if, as of July 1, 2016, there has been at least ***, but not more than *** Generic Entries, the Contingent Royalty payable on July 1 equals ***; or
|
(iii)
|
if, as of July 1, 2016, there have been more than *** Generic Entries, the Contingent Royalty payable on July 1 ***.
|
4.
|
The terms and conditions of this Letter Agreement and any disclosures made thereunder shall remain confidential as among the Parties, pursuant to the confidentiality obligations set forth in the License Agreement; provided, that for the purposes of this Letter Agreement, such obligations shall become effective as of the Effective Date.
|
5.
|
This Letter Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.
|
6.
|
Except as specifically amended hereby, all terms and conditions of the License Agreement remain in full force and effect.
|
BY:
|
/s/ Peter Goldschmidt
|
NAME:
|
Peter Goldschmidt
|
TITLE:
|
President, Sandoz US, Head of N. America
|
BY:
|
/s/Felix R Ehrat
|
NAME:
|
Felix R. Ehrate
|
TITLE:
|
Group General Counsel
|
BY:
|
/s/ Harry Kirsch
|
NAME:
|
Harry Kirch
|
TITLE:
|
CFO
|
|
|
/S/ RAJIV DE SILVA
|
|
Rajiv De Silva
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Date:
|
May 6, 2016
|
|
|
/S/ SUKETU P. UPADHYAY
|
|
Suketu P. Upadhyay
|
|
Executive Vice President, Chief Financial Officer
(Principal Financial Officer)
|
|
|
|
Date:
|
May 6, 2016
|
|
|
|
|
|
|
/S/ RAJIV DE SILVA
|
|
Name:
|
|
Rajiv De Silva
|
|
Title:
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
/S/ SUKETU P. UPADHYAY
|
|
Name:
|
|
Suketu P. Upadhyay
|
|
Title:
|
|
Executive Vice President, Chief Financial Officer
(Principal Financial Officer) |