|
|
ý
|
Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
¨
|
Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
Ireland
|
98-1032470
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
Large accelerated filer
|
ý
|
|
Accelerated filer
|
¨
|
|
|
|
|
|
Non-accelerated filer
|
¨
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
¨
|
Item 1.
|
Financial Statements
|
|
September 30,
2014 |
|
December 31,
2013 |
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
575,040
|
|
|
$
|
636,504
|
|
Accounts receivable, net of allowances
|
187,604
|
|
|
124,805
|
|
||
Inventories
|
37,612
|
|
|
28,669
|
|
||
Prepaid expenses
|
24,206
|
|
|
7,183
|
|
||
Deferred tax assets, net
|
35,696
|
|
|
33,613
|
|
||
Other current assets
|
18,362
|
|
|
33,843
|
|
||
Total current assets
|
878,520
|
|
|
864,617
|
|
||
Property and equipment, net
|
44,205
|
|
|
14,246
|
|
||
Intangible assets, net
|
1,550,624
|
|
|
812,396
|
|
||
Goodwill
|
724,388
|
|
|
450,456
|
|
||
Deferred tax assets, net, non-current
|
101,249
|
|
|
74,597
|
|
||
Deferred financing costs
|
35,068
|
|
|
14,605
|
|
||
Other non-current assets
|
13,482
|
|
|
7,304
|
|
||
Total assets
|
$
|
3,347,536
|
|
|
$
|
2,238,221
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
29,671
|
|
|
$
|
21,005
|
|
Accrued liabilities
|
161,476
|
|
|
119,718
|
|
||
Current portion of long-term debt
|
9,444
|
|
|
5,572
|
|
||
Income taxes payable
|
15,755
|
|
|
336
|
|
||
Contingent consideration
|
—
|
|
|
50,000
|
|
||
Deferred tax liability, net
|
6,259
|
|
|
6,259
|
|
||
Deferred revenue
|
1,138
|
|
|
1,138
|
|
||
Total current liabilities
|
223,743
|
|
|
204,028
|
|
||
Deferred revenue, non-current
|
4,784
|
|
|
5,718
|
|
||
Long-term debt, less current portion
|
1,331,340
|
|
|
544,404
|
|
||
Deferred tax liability, net, non-current
|
413,460
|
|
|
168,497
|
|
||
Other non-current liabilities
|
33,596
|
|
|
20,040
|
|
||
Commitments and contingencies (Note 8)
|
|
|
|
|
|||
Shareholders’ equity:
|
|
|
|
||||
Jazz Pharmaceuticals plc shareholders' equity
|
|
|
|
||||
Ordinary shares
|
6
|
|
|
6
|
|
||
Non-voting euro deferred shares
|
55
|
|
|
55
|
|
||
Capital redemption reserve
|
471
|
|
|
471
|
|
||
Additional paid-in capital
|
1,431,790
|
|
|
1,220,317
|
|
||
Accumulated other comprehensive income (loss)
|
(57,133
|
)
|
|
56,153
|
|
||
Retained earnings (accumulated deficit)
|
(34,666
|
)
|
|
18,532
|
|
||
Total Jazz Pharmaceuticals plc shareholders’ equity
|
1,340,523
|
|
|
1,295,534
|
|
||
Noncontrolling interests
|
90
|
|
|
—
|
|
||
Total shareholders’ equity
|
1,340,613
|
|
|
1,295,534
|
|
||
Total liabilities and shareholders’ equity
|
$
|
3,347,536
|
|
|
$
|
2,238,221
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Product sales, net
|
$
|
304,407
|
|
|
$
|
230,386
|
|
|
$
|
838,493
|
|
|
$
|
631,602
|
|
Royalties and contract revenues
|
2,177
|
|
|
1,774
|
|
|
6,240
|
|
|
5,047
|
|
||||
Total revenues
|
306,584
|
|
|
232,160
|
|
|
844,733
|
|
|
636,649
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of product sales (excluding amortization of acquired developed technologies and intangible asset impairment)
|
26,994
|
|
|
24,252
|
|
|
88,610
|
|
|
76,503
|
|
||||
Selling, general and administrative
|
93,501
|
|
|
74,970
|
|
|
300,420
|
|
|
223,004
|
|
||||
Research and development
|
22,423
|
|
|
11,826
|
|
|
60,622
|
|
|
27,823
|
|
||||
Acquired in-process research and development
|
75,000
|
|
|
988
|
|
|
202,000
|
|
|
4,988
|
|
||||
Intangible asset amortization
|
30,630
|
|
|
19,564
|
|
|
94,607
|
|
|
58,518
|
|
||||
Intangible asset impairment
|
—
|
|
|
—
|
|
|
32,806
|
|
|
—
|
|
||||
Total operating expenses
|
248,548
|
|
|
131,600
|
|
|
779,065
|
|
|
390,836
|
|
||||
Income from operations
|
58,036
|
|
|
100,560
|
|
|
65,668
|
|
|
245,813
|
|
||||
Interest expense, net
|
(14,530
|
)
|
|
(6,202
|
)
|
|
(36,035
|
)
|
|
(20,743
|
)
|
||||
Foreign currency gain (loss)
|
6,483
|
|
|
(614
|
)
|
|
6,680
|
|
|
(728
|
)
|
||||
Loss on extinguishment and modification of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,749
|
)
|
||||
Income before income tax provision
|
49,989
|
|
|
93,744
|
|
|
36,313
|
|
|
220,593
|
|
||||
Income tax provision
|
24,221
|
|
|
18,335
|
|
|
60,598
|
|
|
59,574
|
|
||||
Net income (loss)
|
25,768
|
|
|
75,409
|
|
|
(24,285
|
)
|
|
161,019
|
|
||||
Net income (loss) attributable to noncontrolling interests, net of tax
|
2
|
|
|
—
|
|
|
(1,060
|
)
|
|
—
|
|
||||
Net income (loss) attributable to Jazz Pharmaceuticals plc
|
$
|
25,766
|
|
|
$
|
75,409
|
|
|
$
|
(23,225
|
)
|
|
$
|
161,019
|
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
0.43
|
|
|
$
|
1.30
|
|
|
$
|
(0.39
|
)
|
|
$
|
2.76
|
|
Diluted
|
$
|
0.41
|
|
|
$
|
1.23
|
|
|
$
|
(0.39
|
)
|
|
$
|
2.62
|
|
Weighted-average ordinary shares used in calculating net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc:
|
|
|
|
|
|
|
|
||||||||
Basic
|
60,305
|
|
|
58,217
|
|
|
59,457
|
|
|
58,437
|
|
||||
Diluted
|
62,680
|
|
|
61,519
|
|
|
59,457
|
|
|
61,532
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Net income (loss)
|
$
|
25,768
|
|
|
$
|
75,409
|
|
|
$
|
(24,285
|
)
|
|
$
|
161,019
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Foreign currency translation adjustments
|
(117,089
|
)
|
|
25,402
|
|
|
(113,293
|
)
|
|
13,576
|
|
||||
Other comprehensive income (loss)
|
(117,089
|
)
|
|
25,402
|
|
|
(113,293
|
)
|
|
13,576
|
|
||||
Total comprehensive income (loss)
|
(91,321
|
)
|
|
100,811
|
|
|
(137,578
|
)
|
|
174,595
|
|
||||
Comprehensive loss attributable to noncontrolling interests, net of tax
|
(8
|
)
|
|
—
|
|
|
(1,067
|
)
|
|
—
|
|
||||
Comprehensive income (loss) attributable to Jazz Pharmaceuticals plc
|
$
|
(91,313
|
)
|
|
$
|
100,811
|
|
|
$
|
(136,511
|
)
|
|
$
|
174,595
|
|
|
Nine Months Ended
September 30, |
||||||
|
2014
|
|
2013
|
||||
Operating activities
|
|
|
|
||||
Net income (loss)
|
$
|
(24,285
|
)
|
|
$
|
161,019
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
||||
Amortization of intangible assets
|
94,607
|
|
|
58,518
|
|
||
Share-based compensation
|
50,618
|
|
|
32,139
|
|
||
Intangible asset impairment
|
32,806
|
|
|
—
|
|
||
Depreciation
|
5,037
|
|
|
2,065
|
|
||
Acquired in-process research and development
|
202,000
|
|
|
4,988
|
|
||
Loss on disposal of property and equipment
|
—
|
|
|
47
|
|
||
Excess tax benefit from share-based compensation
|
(4,075
|
)
|
|
(82
|
)
|
||
Acquisition accounting inventory fair value step-up adjustments
|
10,477
|
|
|
3,143
|
|
||
Change in fair value of contingent consideration
|
—
|
|
|
12,900
|
|
||
Deferred income taxes
|
(36,246
|
)
|
|
(17,962
|
)
|
||
Provision for losses on accounts receivable and inventory
|
2,873
|
|
|
1,758
|
|
||
Loss on extinguishment and modification of debt
|
—
|
|
|
3,749
|
|
||
Other non-cash transactions
|
221
|
|
|
4,435
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(50,690
|
)
|
|
(37,649
|
)
|
||
Inventories
|
(10,184
|
)
|
|
(3,445
|
)
|
||
Prepaid expenses and other current assets
|
4,262
|
|
|
(11,300
|
)
|
||
Other long-term assets
|
(5,775
|
)
|
|
(3,421
|
)
|
||
Accounts payable
|
(33,865
|
)
|
|
6,670
|
|
||
Accrued liabilities
|
19,468
|
|
|
1,562
|
|
||
Income taxes payable
|
19,003
|
|
|
(19,086
|
)
|
||
Deferred revenue
|
(918
|
)
|
|
(776
|
)
|
||
Contingent consideration
|
(14,900
|
)
|
|
—
|
|
||
Other non-current liabilities
|
12,910
|
|
|
10,125
|
|
||
Net cash provided by operating activities
|
273,344
|
|
|
209,397
|
|
||
Investing activities
|
|
|
|
||||
Acquisitions, net of cash acquired
|
(828,676
|
)
|
|
—
|
|
||
Acquisition of in-process research and development
|
(202,000
|
)
|
|
(4,988
|
)
|
||
Purchases of property and equipment
|
(22,799
|
)
|
|
(6,874
|
)
|
||
Acquisition of intangible assets
|
—
|
|
|
(1,300
|
)
|
||
Net cash used in investing activities
|
(1,053,475
|
)
|
|
(13,162
|
)
|
||
Financing activities
|
|
|
|
||||
Net proceeds from issuance of debt
|
1,195,366
|
|
|
553,425
|
|
||
Proceeds from employee equity incentive and purchase plans and exercise of warrants
|
48,452
|
|
|
23,577
|
|
||
Share repurchases
|
(29,973
|
)
|
|
(102,397
|
)
|
||
Acquisition of noncontrolling interests
|
(136,950
|
)
|
|
—
|
|
||
Payment of contingent consideration
|
(35,100
|
)
|
|
—
|
|
||
Payment of employee withholding taxes related to share-based awards
|
(17,306
|
)
|
|
(5,303
|
)
|
||
Excess tax benefit from share-based compensation
|
4,075
|
|
|
82
|
|
||
Repayments of long-term debt
|
(7,090
|
)
|
|
(464,517
|
)
|
||
Repayments under revolving credit facility
|
(300,000
|
)
|
|
—
|
|
||
Net cash provided by financing activities
|
721,474
|
|
|
4,867
|
|
||
Effect of exchange rates on cash and cash equivalents
|
(2,807
|
)
|
|
164
|
|
||
Net increase (decrease) in cash and cash equivalents
|
(61,464
|
)
|
|
201,266
|
|
||
Cash and cash equivalents, at beginning of period
|
636,504
|
|
|
387,196
|
|
||
Cash and cash equivalents, at end of period
|
$
|
575,040
|
|
|
$
|
588,462
|
|
•
|
Growing sales of the existing products in our portfolio, including by identifying new growth opportunities;
|
•
|
Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
|
•
|
Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net income (loss) attributable to Jazz Pharmaceuticals plc
|
$
|
25,766
|
|
|
$
|
75,409
|
|
|
$
|
(23,225
|
)
|
|
$
|
161,019
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted-average ordinary shares used in calculating net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - basic
|
60,305
|
|
|
58,217
|
|
|
59,457
|
|
|
58,437
|
|
||||
Dilutive effect of employee equity incentive and purchase plans
|
2,288
|
|
|
1,852
|
|
|
—
|
|
|
1,587
|
|
||||
Dilutive effect of warrants
|
87
|
|
|
1,450
|
|
|
—
|
|
|
1,508
|
|
||||
Weighted-average ordinary shares used in calculating net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - diluted
|
62,680
|
|
|
61,519
|
|
|
59,457
|
|
|
61,532
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
0.43
|
|
|
$
|
1.30
|
|
|
$
|
(0.39
|
)
|
|
$
|
2.76
|
|
Diluted
|
$
|
0.41
|
|
|
$
|
1.23
|
|
|
$
|
(0.39
|
)
|
|
$
|
2.62
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||
Options to purchase ordinary shares and RSUs
|
883
|
|
|
1,028
|
|
|
5,475
|
|
|
2,074
|
|
1.875% exchangeable senior notes due 2021
|
1,502
|
|
|
—
|
|
|
506
|
|
|
—
|
|
Warrants to purchase ordinary shares
|
—
|
|
|
—
|
|
|
618
|
|
|
—
|
|
Ordinary shares under ESPP
|
—
|
|
|
—
|
|
|
130
|
|
|
—
|
|
Cash consideration for shares acquired in initial tender offer period
|
$
|
697,917
|
|
Liability for shares committed under guaranteed delivery procedures
|
76,666
|
|
|
Liability for options committed for exercise
|
82,503
|
|
|
Total acquisition consideration
|
$
|
857,086
|
|
Cash and cash equivalents
|
$
|
28,410
|
|
Short-term deposit
|
5,418
|
|
|
Accounts receivable (1)
|
13,855
|
|
|
Inventories
|
13,525
|
|
|
Prepaid and other current assets
|
1,383
|
|
|
Intangible assets
|
960,350
|
|
|
Goodwill
|
308,642
|
|
|
Deferred tax assets
|
22,999
|
|
|
Property, plant and equipment
|
10,201
|
|
|
Other long-term assets
|
431
|
|
|
Accounts payable
|
(11,778
|
)
|
|
Accrued expenses
|
(51,477
|
)
|
|
Income taxes payable
|
(502
|
)
|
|
Other long-term liabilities
|
(654
|
)
|
|
Debt (current and long-term)
|
(2,351
|
)
|
|
Deferred tax liabilities
|
(304,788
|
)
|
|
Noncontrolling interests
|
(136,578
|
)
|
|
Total acquisition consideration
|
$
|
857,086
|
|
(1)
|
The estimated fair value of trade receivables acquired was
$13.9 million
and the gross contractual amount was
$14.9 million
, of which we expect that
$1.0 million
will be uncollectible.
|
Finite-lived intangible assets:
|
|
||
Currently marketed product:
|
|
||
Defibrotide VOD (Non Americas)
|
$
|
719,500
|
|
Manufacturing contracts
|
14,500
|
|
|
Tradename
|
350
|
|
|
Total finite-lived intangible assets
|
734,350
|
|
|
IPR&D:
|
|
||
Defibrotide VOD Prophylaxis
|
168,000
|
|
|
Defibrotide VOD (Americas)
|
58,000
|
|
|
Total IPR&D
|
226,000
|
|
|
Total intangible assets
|
$
|
960,350
|
|
•
|
An increase in amortization expense related to the fair value of acquired identifiable intangible assets of
$2.8 million
for the
nine months ended September 30, 2014
, and
$12.2 million
and
$36.7 million
for the
three and nine months ended September 30, 2013, respectively
.
|
•
|
The exclusion of acquisition-related expenses of
$40.7 million
for the
nine months ended September 30, 2014
.
|
•
|
An increase in interest expense of
$1.4 million
for the
nine months ended September 30, 2014
, and
$5.7 million
and
$16.9 million
for the
three and nine months ended September 30, 2013, respectively
, incurred on additional borrowings made to fund the Gentium Acquisition as if the borrowings had occurred on January 1, 2013.
|
•
|
The exclusion of other non-recurring expenses of
$0.4 million
and
$39.9 million
for the
three and nine months ended September 30, 2014, respectively
, and the inclusion of
$0.5 million
and
$17.8 million
for the
three and nine months ended September 30, 2013, respectively
, primarily related to Gentium transaction bonus costs, the fair value step-up to acquired inventory, costs of change in control obligations and share-based compensation incurred from the acceleration of stock option vesting upon the closing date of the Gentium Acquisition.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Revenues
|
$
|
306,584
|
|
|
$
|
247,478
|
|
|
$
|
848,036
|
|
|
$
|
674,491
|
|
Net income (loss) attributable to Jazz Pharmaceuticals plc
|
$
|
26,317
|
|
|
$
|
61,330
|
|
|
$
|
(1,887
|
)
|
|
$
|
98,418
|
|
Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - basic
|
$
|
0.44
|
|
|
$
|
1.05
|
|
|
$
|
(0.03
|
)
|
|
$
|
1.68
|
|
Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - diluted
|
$
|
0.42
|
|
|
$
|
1.00
|
|
|
$
|
(0.03
|
)
|
|
$
|
1.60
|
|
|
September 30,
2014 |
|
December 31,
2013 |
||||
Raw materials
|
$
|
3,177
|
|
|
$
|
3,506
|
|
Work in process
|
13,980
|
|
|
10,301
|
|
||
Finished goods
|
20,455
|
|
|
14,862
|
|
||
Total inventories
|
$
|
37,612
|
|
|
$
|
28,669
|
|
|
September 30, 2014
|
||||||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|
Cash and Cash Equivalents
|
||||||||||
Cash
|
$
|
163,040
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
163,040
|
|
|
$
|
163,040
|
|
Time deposits
|
412,000
|
|
|
—
|
|
|
—
|
|
|
412,000
|
|
|
412,000
|
|
|||||
Totals
|
$
|
575,040
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
575,040
|
|
|
$
|
575,040
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
|
December 31, 2013
|
||||||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|
Cash and
Cash
Equivalents
|
||||||||||
Cash
|
$
|
495,990
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
495,990
|
|
|
$
|
495,990
|
|
Time deposits
|
140,514
|
|
|
—
|
|
|
—
|
|
|
140,514
|
|
|
140,514
|
|
|||||
Totals
|
$
|
636,504
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
636,504
|
|
|
$
|
636,504
|
|
|
September 30, 2014
|
|
December 31, 2013
|
||||||||||||
|
Significant Other
Observable
Inputs
(Level 2)
|
|
Total
Estimated Fair Value |
|
Significant
Other Observable Inputs (Level 2) |
|
Total
Estimated Fair Value |
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Available-for-sale securities
|
|
|
|
|
|
|
|
||||||||
Time deposits
|
$
|
412,000
|
|
|
$
|
412,000
|
|
|
$
|
140,514
|
|
|
$
|
140,514
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
50,000
|
|
|
$
|
50,000
|
|
|
|
|
|
|
|
|
|
|
September 30,
2014 |
|
December 31,
2013 |
||||
Construction-in-progress
|
$
|
24,247
|
|
|
$
|
4,388
|
|
Computer software
|
8,941
|
|
|
7,960
|
|
||
Leasehold improvements
|
7,192
|
|
|
4,587
|
|
||
Machinery and equipment
|
7,111
|
|
|
417
|
|
||
Computer equipment
|
6,609
|
|
|
5,610
|
|
||
Furniture and fixtures
|
2,254
|
|
|
1,897
|
|
||
Land and buildings
|
1,614
|
|
|
—
|
|
||
Subtotal
|
57,968
|
|
|
24,859
|
|
||
Less accumulated depreciation and amortization
|
(13,763
|
)
|
|
(10,613
|
)
|
||
Property and equipment, net
|
$
|
44,205
|
|
|
$
|
14,246
|
|
|
September 30,
2014 |
|
December 31,
2013 |
||||
Rebates and other sales deductions
|
$
|
52,861
|
|
|
$
|
38,772
|
|
Employee compensation and benefits
|
48,437
|
|
|
31,829
|
|
||
Sales returns reserve
|
15,137
|
|
|
21,110
|
|
||
Royalties
|
9,738
|
|
|
6,082
|
|
||
Accrued interest
|
7,940
|
|
|
4,150
|
|
||
Professional fees
|
4,396
|
|
|
5,225
|
|
||
Accrued construction-in-progress
|
3,117
|
|
|
450
|
|
||
Other
|
19,850
|
|
|
12,100
|
|
||
Total accrued liabilities
|
$
|
161,476
|
|
|
$
|
119,718
|
|
Balance at December 31, 2013
|
$
|
450,456
|
|
Goodwill arising from the Gentium Acquisition
|
308,642
|
|
|
Foreign exchange
|
(34,710
|
)
|
|
Balance at September 30, 2014
|
$
|
724,388
|
|
|
September 30, 2014
|
|
December 31, 2013
|
||||||||||||||||||||||
|
Remaining
Weighted- Average Useful Life (In years) |
|
Gross
Carrying Amount |
|
Accumulated
Amortization |
|
Net Book
Value |
|
Gross
Carrying Amount |
|
Accumulated
Amortization |
|
Net Book
Value |
||||||||||||
Acquired developed technologies
|
13.0
|
|
$
|
1,541,698
|
|
|
$
|
(248,191
|
)
|
|
$
|
1,293,507
|
|
|
$
|
957,089
|
|
|
$
|
(179,225
|
)
|
|
$
|
777,864
|
|
Manufacturing contracts
|
3.3
|
|
13,581
|
|
|
(2,346
|
)
|
|
11,235
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Trademarks
|
0.3
|
|
2,928
|
|
|
(2,758
|
)
|
|
170
|
|
|
2,600
|
|
|
(2,327
|
)
|
|
273
|
|
||||||
Total finite-lived intangible assets
|
|
|
1,558,207
|
|
|
(253,295
|
)
|
|
1,304,912
|
|
|
959,689
|
|
|
(181,552
|
)
|
|
778,137
|
|
||||||
Acquired IPR&D assets
|
|
|
245,712
|
|
|
—
|
|
|
245,712
|
|
|
34,259
|
|
|
—
|
|
|
34,259
|
|
||||||
Total intangible assets
|
|
|
$
|
1,803,919
|
|
|
$
|
(253,295
|
)
|
|
$
|
1,550,624
|
|
|
$
|
993,948
|
|
|
$
|
(181,552
|
)
|
|
$
|
812,396
|
|
Year Ending December 31,
|
Estimated
Amortization
Expense
|
||
2014 (remainder)
|
$
|
29,440
|
|
2015
|
113,009
|
|
|
2016
|
108,659
|
|
|
2017
|
108,568
|
|
|
2018
|
105,310
|
|
|
Thereafter
|
839,926
|
|
|
Total
|
$
|
1,304,912
|
|
|
September 30, 2014
|
|
December 31, 2013
|
||||
1.875% exchangeable senior notes due 2021
|
$
|
575,000
|
|
|
$
|
—
|
|
Unamortized discount on 1.875% exchangeable senior notes due 2021
|
(128,552
|
)
|
|
—
|
|
||
1.875% exchangeable senior notes due 2021, net
|
$
|
446,448
|
|
|
$
|
—
|
|
Term loans
|
892,402
|
|
|
549,976
|
|
||
Other borrowings
|
1,934
|
|
|
—
|
|
||
Total debt
|
1,340,784
|
|
|
549,976
|
|
||
Less current portion
|
9,444
|
|
|
5,572
|
|
||
Total long-term debt
|
$
|
1,331,340
|
|
|
$
|
544,404
|
|
Year Ending December 31,
|
Scheduled Long-Term Debt Maturities
|
||
2014 (remainder)
|
$
|
2,437
|
|
2015
|
9,445
|
|
|
2016
|
9,450
|
|
|
2017
|
9,455
|
|
|
2018
|
868,490
|
|
|
Thereafter
|
575,275
|
|
|
Total
|
$
|
1,474,552
|
|
Year Ending December 31,
|
Lease
Payments
|
||
2014 (remainder)
|
$
|
2,577
|
|
2015
|
9,989
|
|
|
2016
|
7,467
|
|
|
2017
|
4,533
|
|
|
2018
|
1,334
|
|
|
Thereafter
|
772
|
|
|
Total
|
$
|
26,672
|
|
|
Attributable to:
|
||||||||||
|
Jazz Pharmaceuticals plc
|
|
Noncontrolling interests
|
|
Total Shareholders' Equity
|
||||||
Shareholders' equity at January 1, 2014
|
$
|
1,295,534
|
|
|
$
|
—
|
|
|
$
|
1,295,534
|
|
Noncontrolling interests from the Gentium Acquisition
|
—
|
|
|
136,578
|
|
|
136,578
|
|
|||
Acquisition of noncontrolling interests
|
(1,529
|
)
|
|
(135,421
|
)
|
|
(136,950
|
)
|
|||
Issuance of 1.875% exchangeable senior notes due 2021
|
126,862
|
|
|
—
|
|
|
126,862
|
|
|||
Issuance of ordinary shares in conjunction with employee equity incentive and purchase plans and warrant exercises
|
48,452
|
|
|
—
|
|
|
48,452
|
|
|||
Employee withholding taxes related to share-based awards
|
(17,306
|
)
|
|
—
|
|
|
(17,306
|
)
|
|||
Share-based compensation
|
50,919
|
|
|
—
|
|
|
50,919
|
|
|||
Tax benefit from employee share options
|
4,075
|
|
|
—
|
|
|
4,075
|
|
|||
Shares repurchased
|
(29,973
|
)
|
|
—
|
|
|
(29,973
|
)
|
|||
Other comprehensive loss
|
(113,286
|
)
|
|
(7
|
)
|
|
(113,293
|
)
|
|||
Net loss
|
(23,225
|
)
|
|
(1,060
|
)
|
|
(24,285
|
)
|
|||
Shareholders' equity at September 30, 2014
|
$
|
1,340,523
|
|
|
$
|
90
|
|
|
$
|
1,340,613
|
|
|
Jazz Pharmaceuticals plc
|
||
Shareholders' equity at January 1, 2013
|
$
|
1,121,292
|
|
Issuance of ordinary shares in conjunction with employee equity incentive and purchase plans and warrant exercises
|
23,577
|
|
|
Employee withholding taxes related to share-based awards
|
(5,303
|
)
|
|
Share-based compensation
|
31,855
|
|
|
Tax benefit from employee share options
|
82
|
|
|
Shares repurchased
|
(102,397
|
)
|
|
Other comprehensive income
|
13,576
|
|
|
Net income
|
161,019
|
|
|
Shareholders' equity at September 30, 2013
|
$
|
1,243,701
|
|
|
Foreign
Currency Translation Adjustments |
|
Total
Accumulated Other Comprehensive Income (Loss) |
||||
Balance at December 31, 2013
|
$
|
56,153
|
|
|
$
|
56,153
|
|
Other comprehensive loss
|
(113,286
|
)
|
|
(113,286
|
)
|
||
Balance at September 30, 2014
|
$
|
(57,133
|
)
|
|
$
|
(57,133
|
)
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Selling, general and administrative
|
$
|
14,834
|
|
|
$
|
9,354
|
|
|
$
|
40,051
|
|
|
$
|
25,898
|
|
Research and development
|
3,177
|
|
|
1,931
|
|
|
8,862
|
|
|
4,453
|
|
||||
Cost of product sales
|
240
|
|
|
591
|
|
|
1,705
|
|
|
1,788
|
|
||||
Total share-based compensation expense, pre-tax
|
18,251
|
|
|
11,876
|
|
|
50,618
|
|
|
32,139
|
|
||||
Tax benefit from share-based compensation expense
|
(5,469
|
)
|
|
(3,502
|
)
|
|
(15,171
|
)
|
|
(9,850
|
)
|
||||
Total share-based compensation expense, net of tax
|
$
|
12,782
|
|
|
$
|
8,374
|
|
|
$
|
35,447
|
|
|
$
|
22,289
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Shares underlying options granted (in thousands)
|
135
|
|
|
105
|
|
|
942
|
|
|
1,277
|
|
||||
Grant date fair value
|
$
|
51.73
|
|
|
$
|
37.17
|
|
|
$
|
60.40
|
|
|
$
|
28.49
|
|
Black-Scholes option pricing model assumption information:
|
|
|
|
|
|
|
|
||||||||
Volatility
|
42
|
%
|
|
57
|
%
|
|
45
|
%
|
|
59
|
%
|
||||
Expected term (years)
|
4.3
|
|
|
4.4
|
|
|
4.3
|
|
|
4.4
|
|
||||
Range of risk-free rates
|
1.3-1.4%
|
|
|
1.0-1.4%
|
|
|
1.1-1.4%
|
|
|
0.5-1.4%
|
|
||||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
RSUs granted (in thousands)
|
68
|
|
|
46
|
|
|
459
|
|
|
568
|
|
||||
Grant date fair value
|
$
|
145.58
|
|
|
$
|
80.35
|
|
|
$
|
160.00
|
|
|
$
|
60.73
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Xyrem
®
(sodium oxybate) oral solution
|
$
|
204,337
|
|
|
$
|
153,664
|
|
|
$
|
556,081
|
|
|
$
|
404,932
|
|
Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)/Erwinase
®
|
52,121
|
|
|
44,078
|
|
|
146,910
|
|
|
130,754
|
|
||||
Defitelio
®
(defibrotide)/defibrotide
|
18,892
|
|
|
—
|
|
|
51,345
|
|
|
—
|
|
||||
Prialt
®
(ziconotide) intrathecal infusion
|
6,282
|
|
|
11,046
|
|
|
16,422
|
|
|
20,726
|
|
||||
Psychiatry
|
10,833
|
|
|
10,679
|
|
|
32,431
|
|
|
40,093
|
|
||||
Other
|
11,942
|
|
|
10,919
|
|
|
35,304
|
|
|
35,097
|
|
||||
Product sales, net
|
304,407
|
|
|
230,386
|
|
|
838,493
|
|
|
631,602
|
|
||||
Royalties and contract revenues
|
2,177
|
|
|
1,774
|
|
|
6,240
|
|
|
5,047
|
|
||||
Total revenues
|
$
|
306,584
|
|
|
$
|
232,160
|
|
|
$
|
844,733
|
|
|
$
|
636,649
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
United States
|
$
|
264,719
|
|
|
$
|
209,299
|
|
|
$
|
727,200
|
|
|
$
|
577,484
|
|
Europe
|
32,578
|
|
|
19,332
|
|
|
87,608
|
|
|
46,769
|
|
||||
All other
|
9,287
|
|
|
3,529
|
|
|
29,925
|
|
|
12,396
|
|
||||
Total revenues
|
$
|
306,584
|
|
|
$
|
232,160
|
|
|
$
|
844,733
|
|
|
$
|
636,649
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||
Express Scripts
|
67
|
%
|
|
66
|
%
|
|
66
|
%
|
|
63
|
%
|
Accredo
|
14
|
%
|
|
16
|
%
|
|
14
|
%
|
|
17
|
%
|
|
September 30,
2014 |
|
December 31,
2013 |
||||
Ireland
|
$
|
24,572
|
|
|
$
|
5,799
|
|
Italy
|
9,146
|
|
|
—
|
|
||
United States
|
9,143
|
|
|
7,734
|
|
||
Other
|
1,344
|
|
|
713
|
|
||
Total long-lived assets
|
$
|
44,205
|
|
|
$
|
14,246
|
|
•
|
Growing sales of the existing products in our portfolio, including by identifying new growth opportunities;
|
•
|
Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
|
•
|
Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
|
•
|
JZP-110
. JZP-110 is a late-stage investigational compound being developed for potential treatment of EDS in patients with narcolepsy. We also intend to pursue development of JZP-110 for EDS in patients with obstructive sleep apnea. Based on feedback from the FDA on our development plans for JZP-110, we are currently conducting one additional preclinical study. We expect to commence our planned Phase 3 clinical program in the first half of 2015, subject to the availability of clinical trial materials. In January 2014, we acquired from Aerial BioPharma LLC, or Aerial, the worldwide development, manufacturing and commercial rights to JZP-110, other than in certain jurisdictions in Asia where SK Biopharmaceuticals Co., Ltd, or SK, retains rights, with an upfront payment totaling $125.0 million.
|
•
|
JZP-386
. JZP-386 is a deuterium-modified analog of sodium oxybate, the active pharmaceutical ingredient in Xyrem, which we licensed from Concert Pharmaceuticals, Inc. We have conducted preclinical research and development work on JZP-386 for potential use in patients with narcolepsy. We submitted an investigational medicinal product dossier, or IMPD, for JZP-386 in Europe at the end of 2013 and received approval of the IMPD in January 2014. In July 2014, we initiated our first study of JZP-386 in humans to evaluate the safety, pharmacokinetics and pharmacodynamics of the compound. Enrollment in this study has completed.
|
•
|
Xyrem.
While in many patients narcolepsy can begin during childhood and adolescence, there is limited information on the treatment of pediatric narcolepsy patients with Xyrem. We have worked with the FDA and several leading specialists to design a clinical study to generate additional data on the treatment of pediatric narcolepsy patients with Xyrem. We initiated clinical sites for this study in the third quarter of 2014.
|
•
|
Erwinaze
. In the second quarter of 2014, we initiated a clinical trial to further evaluate the use of Erwinaze in young adults age 18 to 39 with ALL who are hypersensitive to
E. coli
-derived asparaginase. In 2013, we also completed a pharmacokinetic clinical trial of the intravenous administration of Erwinaze in North America. We submitted the data collected in the study, which met the primary endpoint, as a supplemental biologic license application, or sBLA, to allow intravenous administration of Erwinaze. The sBLA was accepted for filing by the FDA in April 2014. The Prescription Drug User Fee Act, or PDUFA, date for an FDA decision on the sBLA is December 28, 2014.
|
•
|
JZP-416 (formerly known as Asparec)
. We are conducting a Phase 1 clinical trial in Europe of JZP-416 (pegcrisantaspase), the PEGylated recombinant
Erwinia chrysanthemi
L-asparaginase, being developed for the treatment of patients with ALL who are hypersensitive to
E. coli-
derived
asparaginase. In June 2013, the FDA granted Fast Track designation to the investigation of JZP-416 for the treatment of ALL. After reviewing our development plans with the FDA, in the third quarter of 2014, we initiated our first study of JZP-416 in children in a pivotal Phase 2 trial in North America.
|
•
|
Leukotac
TM
(inolimomab)
. We are conducting a Phase 3 clinical trial in Europe of Leukotac, an anti-CD25 monoclonal antibody for the treatment of steroid-refractory acute GvHD. We completed enrollment for this study in March 2014 and expect to receive preliminary data before mid-2015.
|
•
|
the challenges of protecting and enhancing our intellectual property rights;
|
•
|
delays or problems in the supply or manufacture of our products, particularly with respect to certain products as to which we maintain limited inventories, including products for which our supply demands are growing, and our dependence on single source suppliers to continue to meet our ongoing commercial demand or our requirements for clinical trial supplies;
|
•
|
the need to obtain appropriate pricing and reimbursement for our products in an increasingly challenging environment due to, among other things, the attention being paid to healthcare cost containment and other austerity measures in the United States and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the United States in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by third party payors;
|
•
|
the ongoing regulation and oversight by the FDA, the U.S. Drug Enforcement Administration, or DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals;
|
•
|
the challenges of achieving and maintaining commercial success of our products, such as obtaining sustained acceptance of our products by patients, physicians and payors;
|
•
|
the risks associated with business combination or product or product candidate acquisition transactions, such as the challenges inherent in the integration of acquired businesses, including the acquired Gentium business, with our historic business, the increase in geographic dispersion among our centers of operation, taking on the operation of a manufacturing plant as a result of the Gentium Acquisition and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such acquisition transactions;
|
•
|
the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates;
|
•
|
the inherent uncertainty associated with the regulatory approval process, especially as we continue to undertake increased activities and make growing investment in our product pipeline development projects;
|
•
|
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business; and
|
•
|
possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations, which have increased significantly in 2014.
|
|
Three Months Ended
September 30, |
|
|
|
Nine Months Ended
September 30, |
|
|
||||||||||||||
|
2014 (1)
|
|
2013
|
|
Increase
|
|
2014 (1)
|
|
2013
|
|
Increase
|
||||||||||
Product sales, net
|
$
|
304,407
|
|
|
$
|
230,386
|
|
|
32
|
%
|
|
$
|
838,493
|
|
|
$
|
631,602
|
|
|
33
|
%
|
Royalties and contract revenues
|
2,177
|
|
|
1,774
|
|
|
23
|
%
|
|
6,240
|
|
|
5,047
|
|
|
24
|
%
|
||||
Cost of product sales (excluding amortization of acquired developed technologies and intangible asset impairment)
|
26,994
|
|
|
24,252
|
|
|
11
|
%
|
|
88,610
|
|
|
76,503
|
|
|
16
|
%
|
||||
Selling, general and administrative
|
93,501
|
|
|
74,970
|
|
|
25
|
%
|
|
300,420
|
|
|
223,004
|
|
|
35
|
%
|
||||
Research and development
|
22,423
|
|
|
11,826
|
|
|
90
|
%
|
|
60,622
|
|
|
27,823
|
|
|
118
|
%
|
||||
Acquired in-process research and development
|
75,000
|
|
|
988
|
|
|
N/A(2)
|
|
|
202,000
|
|
|
4,988
|
|
|
N/A(2)
|
|
||||
Intangible asset amortization
|
30,630
|
|
|
19,564
|
|
|
57
|
%
|
|
94,607
|
|
|
58,518
|
|
|
62
|
%
|
||||
Intangible asset impairment
|
—
|
|
|
—
|
|
|
—
|
%
|
|
32,806
|
|
|
—
|
|
|
N/A(2)
|
|
||||
Interest expense, net
|
14,530
|
|
|
6,202
|
|
|
134
|
%
|
|
36,035
|
|
|
20,743
|
|
|
74
|
%
|
||||
Foreign currency (gain) loss
|
(6,483
|
)
|
|
614
|
|
|
N/A(2)
|
|
|
(6,680
|
)
|
|
728
|
|
|
N/A(2)
|
|
||||
Loss on extinguishment and modification of debt
|
—
|
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|
3,749
|
|
|
N/A(2)
|
|
||||
Income tax provision
|
24,221
|
|
|
18,335
|
|
|
32
|
%
|
|
60,598
|
|
|
59,574
|
|
|
2
|
%
|
||||
Net income (loss) attributable to noncontrolling interests, net of tax
|
2
|
|
|
—
|
|
|
N/A(2)
|
|
|
(1,060
|
)
|
|
—
|
|
|
N/A(2)
|
|
(1)
|
Our financial results include the financial results of the historic Gentium business since the closing of the Gentium Acquisition on January 23, 2014.
|
(2)
|
Comparison to prior period not meaningful.
|
|
Three Months Ended
September 30, |
|
Increase/
|
|
Nine Months Ended
September 30, |
|
Increase/
|
||||||||||||||
|
2014
|
|
2013
|
|
(Decrease)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||||||
Xyrem
|
$
|
204,337
|
|
|
$
|
153,664
|
|
|
33
|
%
|
|
$
|
556,081
|
|
|
$
|
404,932
|
|
|
37
|
%
|
Erwinaze/Erwinase
|
52,121
|
|
|
44,078
|
|
|
18
|
%
|
|
146,910
|
|
|
130,754
|
|
|
12
|
%
|
||||
Defitelio/defibrotide
|
18,892
|
|
|
—
|
|
|
N/A(1)
|
|
|
51,345
|
|
|
—
|
|
|
N/A(1)
|
|
||||
Prialt
|
6,282
|
|
|
11,046
|
|
|
(43
|
%)
|
|
16,422
|
|
|
20,726
|
|
|
(21
|
%)
|
||||
Psychiatry
|
10,833
|
|
|
10,679
|
|
|
1
|
%
|
|
32,431
|
|
|
40,093
|
|
|
(19
|
)%
|
||||
Other
|
11,942
|
|
|
10,919
|
|
|
9
|
%
|
|
35,304
|
|
|
35,097
|
|
|
1
|
%
|
||||
Product sales, net
|
304,407
|
|
|
230,386
|
|
|
32
|
%
|
|
838,493
|
|
|
631,602
|
|
|
33
|
%
|
||||
Royalties and contract revenues
|
2,177
|
|
|
1,774
|
|
|
23
|
%
|
|
6,240
|
|
|
5,047
|
|
|
24
|
%
|
||||
Total revenues
|
$
|
306,584
|
|
|
$
|
232,160
|
|
|
32
|
%
|
|
$
|
844,733
|
|
|
$
|
636,649
|
|
|
33
|
%
|
(1)
|
Comparison to prior period not meaningful since our financial results include the financial results of the historic Gentium business since the closing of the Gentium Acquisition on January 23, 2014.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Clinical studies and outside services
|
$
|
10,535
|
|
|
$
|
4,920
|
|
|
$
|
29,287
|
|
|
$
|
10,154
|
|
Personnel expenses
|
9,201
|
|
|
5,989
|
|
|
25,166
|
|
|
15,328
|
|
||||
Other
|
2,687
|
|
|
917
|
|
|
6,169
|
|
|
2,341
|
|
||||
Total
|
$
|
22,423
|
|
|
$
|
11,826
|
|
|
$
|
60,622
|
|
|
$
|
27,823
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
GAAP reported net income (loss) attributable to Jazz Pharmaceuticals plc
|
$
|
25,766
|
|
|
$
|
75,409
|
|
|
$
|
(23,225
|
)
|
|
$
|
161,019
|
|
Intangible asset amortization
|
30,630
|
|
|
19,564
|
|
|
94,607
|
|
|
58,518
|
|
||||
Share-based compensation expense
|
18,251
|
|
|
11,876
|
|
|
50,618
|
|
|
32,139
|
|
||||
Intangible asset impairment
|
—
|
|
|
—
|
|
|
32,806
|
|
|
—
|
|
||||
Upfront and milestone payments
|
75,000
|
|
|
988
|
|
|
202,000
|
|
|
4,988
|
|
||||
Transaction and integration costs
|
878
|
|
|
113
|
|
|
23,518
|
|
|
1,846
|
|
||||
Acquisition accounting inventory fair value step-up adjustments
|
—
|
|
|
512
|
|
|
10,477
|
|
|
3,143
|
|
||||
Restructuring charges
|
—
|
|
|
—
|
|
|
—
|
|
|
1,457
|
|
||||
Change in fair value of contingent consideration
|
—
|
|
|
5,000
|
|
|
—
|
|
|
12,900
|
|
||||
Depreciation
|
1,868
|
|
|
895
|
|
|
5,037
|
|
|
2,065
|
|
||||
Loss on extinguishment and modification of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
3,749
|
|
||||
Non-cash interest expense
|
4,065
|
|
|
1,083
|
|
|
7,603
|
|
|
3,505
|
|
||||
Income tax adjustments (1)
|
(10,649
|
)
|
|
(6,043
|
)
|
|
(27,493
|
)
|
|
(3,198
|
)
|
||||
Adjustments for amount attributable to noncontrolling interests (2)
|
(2
|
)
|
|
—
|
|
|
(1,504
|
)
|
|
—
|
|
||||
Non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc
|
$
|
145,807
|
|
|
$
|
109,397
|
|
|
$
|
374,444
|
|
|
$
|
282,131
|
|
|
|
|
|
|
|
|
|
||||||||
GAAP reported net income (loss) attributable to Jazz Pharmaceuticals plc per diluted share
|
$
|
0.41
|
|
|
$
|
1.23
|
|
|
$
|
(0.39
|
)
|
|
$
|
2.62
|
|
Non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc per diluted share
|
$
|
2.33
|
|
|
$
|
1.78
|
|
|
$
|
5.99
|
|
|
$
|
4.59
|
|
Shares used in computing GAAP reported net income (loss) attributable to Jazz Pharmaceuticals plc per diluted share amounts
|
62,680
|
|
|
61,519
|
|
|
59,457
|
|
|
61,532
|
|
||||
Shares used in computing non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc per diluted share amounts
|
62,680
|
|
|
61,519
|
|
|
62,532
|
|
|
61,532
|
|
(1)
|
Tax adjustments to convert the income tax provision to the estimated amount of taxes payable in cash.
|
(2)
|
The noncontrolling interests’ share of the above adjustments, as applicable.
|
|
Nine Months Ended
September 30, |
||||||
|
2014
|
|
2013
|
||||
Net cash provided by operating activities
|
$
|
273,344
|
|
|
$
|
209,397
|
|
Net cash used in investing activities
|
(1,053,475
|
)
|
|
(13,162
|
)
|
||
Net cash provided by financing activities
|
721,474
|
|
|
4,867
|
|
||
Effect of foreign currency exchange rates on cash and cash equivalents
|
(2,807
|
)
|
|
164
|
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
(61,464
|
)
|
|
$
|
201,266
|
|
|
Payments Due By Period
|
||||||||||||||||||
Contractual Obligations (1)
|
Total
|
|
Less than
1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than
5 years
|
||||||||||
Term and other loans - principal
|
$
|
899,552
|
|
|
$
|
9,444
|
|
|
$
|
18,902
|
|
|
$
|
871,019
|
|
|
$
|
187
|
|
Term and other loans - interest (2)
|
107,787
|
|
|
29,534
|
|
|
58,213
|
|
|
20,031
|
|
|
9
|
|
|||||
2021 Notes - principal
|
575,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
575,000
|
|
|||||
2021 Notes - interest (3)
|
75,529
|
|
|
10,841
|
|
|
21,562
|
|
|
21,563
|
|
|
21,563
|
|
|||||
Revolving credit facility - commitment fee (4)
|
5,820
|
|
|
2,154
|
|
|
3,666
|
|
|
—
|
|
|
—
|
|
|||||
Purchase obligations (5)
|
27,478
|
|
|
25,718
|
|
|
400
|
|
|
410
|
|
|
950
|
|
|||||
Operating lease obligations (6)
|
26,672
|
|
|
10,082
|
|
|
14,074
|
|
|
2,513
|
|
|
3
|
|
|||||
Total
|
$
|
1,717,838
|
|
|
$
|
87,773
|
|
|
$
|
116,817
|
|
|
$
|
915,536
|
|
|
$
|
597,712
|
|
(1)
|
This table does not include potential future milestone payment or royalty obligations to third parties under asset purchase, product development, license and other agreements as the timing and likelihood of such milestone payments are not known, and, in the case of royalty obligations, as the amount of such obligations are not estimable. On January 13, 2014, we signed a definitive agreement with Aerial under which we acquired rights to JZP-110. Under the agreement, we acquired worldwide development, manufacturing and commercial rights to JZP-110 (other than in certain jurisdictions in Asia where SK retains rights). Under the agreement, Aerial received an upfront payment of
$125.0 million
and SK received a milestone payment of
$2.0 million
. Aerial and SK are eligible to receive additional milestone payments up to an aggregate of
$270.0 million
based on development, regulatory and sales milestones and tiered royalties from high single digits to mid-teens based on potential future sales of JZP-110. On July 1, 2014, we entered into a definitive agreement to acquire rights to defibrotide in the United States and all other countries in the Americas from Sigma-Tau. Pursuant to the agreement, upon the closing of the transaction on August 4, 2014, we paid Sigma-Tau an upfront payment of
$75.0 million
. Sigma-Tau is also eligible to receive milestone payments of
$25.0 million
upon the acceptance for filing by the FDA of the first NDA for defibrotide for VOD and up to an additional
$150.0 million
based on the timing of potential FDA approval of defibrotide for VOD.
Potential future milestone payments to other third parties under other agreements could be up to an aggregate of $286.0 million, of which up to $120.0 million will become due and payable to Perrigo Company plc (formerly Elan Pharmaceuticals, Inc.) in tiered contingent payments, with the first such payment becoming due if net sales of Prialt of at least $75.0 million are achieved in a calendar year. The remainder would become due and payable to other third parties upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones, the timing and likelihood of which are not known. We are also obligated under these agreements to pay royalties on net sales of certain products at specified rates, which royalties are dependent on future product sales and are not provided for in the table above as they are not estimable.
|
(2)
|
The interest rate was
3.25%
at
September 30, 2014
, which we used to estimate interest owed on the term loans outstanding on
September 30, 2014
until the final maturity date in June 2018.
|
(4)
|
Our revolving credit facility has a commitment fee payable on the undrawn amount ranging from 0.25% to 0.50% per annum based upon our secured leverage ratio. In the table above, we used a rate of 0.50% and assumed undrawn amounts of $425.0 million to estimate commitment fees owed.
|
(5)
|
Consists primarily of non-cancelable commitments to third party manufacturers.
|
(6)
|
Includes the minimum lease payments for our office buildings, manufacturing plant and automobile lease payments for our sales force.
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors
|
•
|
the potential introduction of a generic version of Xyrem or an alternative sodium oxybate product for treating cataplexy and/or excessive daytime sleepiness in narcolepsy;
|
•
|
changed or increased regulatory restrictions, including changes to our risk management program and the terms of the final risk evaluation and mitigation strategy, or REMS, documents for Xyrem, and the pressure to develop a single shared system REMS with potential generic competitors, or regulatory actions by the FDA, as discussed in more detail in the risk factors below;
|
•
|
our manufacturing partners’ ability to obtain sufficient quota from the U.S. Drug Enforcement Administration, or the DEA, to satisfy our needs for Xyrem;
|
•
|
any supply, manufacturing or distribution problems arising with any of our manufacturing and distribution partners, all of whom are sole source providers for us;
|
•
|
any increase in restrictive conditions for reimbursement required by, and the availability of reimbursement from, third party payors, as discussed in more detail in the risk factor in this Item 1A entitled
“Price approvals and reimbursement may not be available for our products, which could diminish our sales or affect our ability to sell our products profitably
;”
|
•
|
changes in healthcare laws and policy, including changes in requirements for rebates, reimbursement and coverage by federal healthcare programs;
|
•
|
continued acceptance of Xyrem as safe and effective by physicians and patients, even in the face of negative publicity that surfaces from time to time; and
|
•
|
changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem.
|
•
|
the potential disruption of our historical core business;
|
•
|
the risk that our relative lack of experience in the hematology/oncology market will not allow us to achieve anticipated sales of Defitelio;
|
•
|
the strain on, and need to continue to expand, our existing operational, technical, financial and administrative infrastructure;
|
•
|
the difficulties in assimilating employees and corporate cultures, including our lack of experience in maintaining positive interactions with unionized employees;
|
•
|
the failure to retain key managers and other personnel, including the employees from the acquired Gentium business;
|
•
|
the challenges in controlling additional costs and expenses in connection with and as a result of the acquisition;
|
•
|
the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures;
|
•
|
any unanticipated liabilities for activities of or related to Gentium or its operations, products or product candidates; and
|
•
|
the challenges and risks associated with Gentium not being our wholly owned subsidiary, including needing to consider the rights of, and duties owed to, the minority shareholders of Gentium under Italian law when making future decisions that might impact Gentium, its business or operations.
|
•
|
the increased complexity and costs inherent in managing international operations;
|
•
|
diverse regulatory, financial and legal requirements, and any future changes to such requirements, in one or more countries where we are located or do business;
|
•
|
country-specific tax, labor and employment laws and regulations;
|
•
|
applicable trade laws, tariffs, export quotas, custom duties or other trade restrictions and any changes to them;
|
•
|
challenges inherent in efficiently managing employees in diverse geographies, including the need to adapt systems, policies, benefits and compliance programs to differing labor and other regulations, as well as maintaining positive interactions with unionized employees in one of our international locations;
|
•
|
liabilities for activities of, or related to, our international operations, products or product candidates;
|
•
|
changes in currency rates; and
|
•
|
regulations relating to data security and the unauthorized use of, or access to, commercial and personal information.
|
•
|
the clinical indications for which a product is approved, including any restrictions placed upon the product in connection with its approval, such as a REMS, patient registry or labeling restrictions;
|
•
|
the prevalence of the disease or condition for which the product is approved and the severity of side effects;
|
•
|
acceptance by physicians and patients of each product as a safe and effective treatment;
|
•
|
perceived advantages over alternative treatments;
|
•
|
relative convenience and ease of administration;
|
•
|
the cost of treatment in relation to alternative treatments, including generic products;
|
•
|
the extent to which the product is approved for inclusion on formularies of hospitals and managed care organizations; and
|
•
|
the conditions for reimbursement required by, and the availability of reimbursement from, third party payors.
|
•
|
delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;
|
•
|
delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;
|
•
|
delays or failures in reaching agreement on acceptable terms with prospective study sites;
|
•
|
delays or failures in obtaining approval of our clinical trial protocol from an institutional review board, also known as Ethics Committees in Europe, to conduct a clinical trial at a prospective study site;
|
•
|
delays in recruiting patients to participate in a clinical trial;
|
•
|
failure of our clinical trials and clinical investigators to be in compliance with the FDA and other regulatory agencies’ good clinical practice guidelines;
|
•
|
unforeseen safety issues, including negative results from ongoing preclinical studies and clinical trials and adverse events associated with product candidates;
|
•
|
inability to monitor patients adequately during or after treatment;
|
•
|
difficulty monitoring multiple study sites;
|
•
|
failure of our third party clinical trial managers to satisfactorily perform their contractual duties, comply with regulations or meet expected deadlines; or
|
•
|
insufficient funds to complete the trials.
|
•
|
others may be able to make products that are similar to our product candidates but that are not covered by the claims of our patents, or for which we are not licensed under our license agreements;
|
•
|
we or our licensors or partners might not have been the first to invent or file, as appropriate, subject matters covered by our issued patents or pending patent applications or the pending patent applications or issued patents of our licensors or partners;
|
•
|
others may independently develop similar or alternative products without infringing our intellectual property rights;
|
•
|
our pending patent applications may not result in issued patents;
|
•
|
our issued patents and the issued patents of our licensors or partners may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
|
•
|
our issued patents may not cover our competitors’ products;
|
•
|
our issued patents and the issued patents of our licensors or partners may be vulnerable to legal challenges as a result of changes in applicable law;
|
•
|
we may not develop additional proprietary products that are patentable; or
|
•
|
the patents of others may have an adverse effect on our business.
|
•
|
limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions or other general business purposes;
|
•
|
limit our ability to use our cash flow or obtain additional financing for future working capital, capital expenditures, acquisitions or other general business purposes;
|
•
|
require us to use a substantial portion of our cash flow from operations to make debt service payments;
|
•
|
limit our flexibility to plan for, or react to, changes in our business and industry;
|
•
|
result in dilution to our existing shareholders in the event exchanges of our 2021 Notes are settled in our ordinary shares;
|
•
|
place us at a competitive disadvantage compared to our less leveraged competitors; and
|
•
|
increase our vulnerability to the impact of adverse economic and industry conditions.
|
•
|
incur or assume liens or additional debt or provide guarantees in respect of obligations of other persons;
|
•
|
issue redeemable preferred stock;
|
•
|
pay dividends or distributions or redeem or repurchase capital stock;
|
•
|
prepay, redeem or repurchase certain debt;
|
•
|
make loans, investments, acquisitions (including acquisitions of exclusive licenses) and capital expenditures;
|
•
|
enter into agreements that restrict distributions from our subsidiaries;
|
•
|
sell assets and capital stock of our subsidiaries;
|
•
|
enter into certain transactions with affiliates; and
|
•
|
consolidate or merge with or into, or sell substantially all of our assets to, another person.
|
•
|
the revenues from our commercial products, which may be affected by many factors, including the extent of generic competition for our products;
|
•
|
the costs of our commercial operations;
|
•
|
the costs of integration activities related to any future strategic transactions we may engage in;
|
•
|
the cost of acquiring and/or licensing any new products and product candidates;
|
•
|
the scope, rate of progress, results and costs of our development and clinical activities;
|
•
|
the cost and timing of obtaining regulatory approvals and of compliance with laws and regulations;
|
•
|
the cost of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
|
•
|
the cost of investigations, litigation and/or settlements related to regulatory oversight and third party claims; and
|
•
|
changes in laws and regulations, including, for example, healthcare reform legislation.
|
•
|
impose advance notice requirements for shareholder proposals and nominations of directors to be considered at shareholder meetings;
|
•
|
stagger the terms of our board of directors into three classes;
|
•
|
require the approval of a supermajority of the voting power of the shares of our share capital entitled to vote generally at a meeting of shareholders to amend or repeal our articles of association; and
|
•
|
permit our board of directors to issue one or more series of preferred shares with rights and preferences, as our shareholders may determine by ordinary resolution.
|
|
Total Number of Shares Purchased (1)
|
|
Average Price Paid per Share (2)
|
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (3)
|
|
Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs (4)
|
||||||
July 1 - July 31, 2014
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
40,069,724
|
|
August 1 - August 31, 2014
|
32,031
|
|
|
$
|
144.35
|
|
|
32,031
|
|
|
$
|
35,446,577
|
|
September 1 - September 30, 2014
|
11,683
|
|
|
$
|
159.41
|
|
|
11,683
|
|
|
$
|
33,584,431
|
|
Total
|
43,714
|
|
|
$
|
148.38
|
|
|
43,714
|
|
|
|
(1)
|
This table does not include ordinary shares that we withheld in order to satisfy minimum tax withholding requirements in connection with the vesting or exercise of restricted stock units.
|
(2)
|
Average price paid per ordinary share includes brokerage commissions.
|
(3)
|
The ordinary shares reported in the table above were purchased pursuant to our publicly announced share repurchase program. On May 7, 2013, we announced that our board of directors authorized the use of up to $200 million to repurchase our ordinary shares. This authorization has no expiration date.
|
(4)
|
The dollar amount shown represents, as of the end of each period, the approximate dollar value of ordinary shares that may yet be purchased under our publicly announced share repurchase program, exclusive of any brokerage commissions. The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under our credit agreement, corporate and regulatory requirements and market conditions, and may be discontinued at any time without prior notice.
|
Exhibit
Number
|
Description of Document
|
2.1
|
Agreement and Plan of Merger and Reorganization, dated as of September 19, 2011, by and among Azur Pharma Limited (now Jazz Pharmaceuticals plc), Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on September 19, 2011).
|
2.2
|
Letter Agreement, dated as of January 17, 2012, by and among Jazz Pharmaceuticals plc, Jaguar Merger Sub Inc. Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated by reference to Exhibit 2.2 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
2.3
|
Agreement and Plan of Merger, dated as of April 26, 2012, by and among Jazz Pharmaceuticals plc, Jewel Merger Sub Inc., EUSA Pharma Inc., and Essex Woodlands Health Ventures, Inc., Mayflower L.P., and Bryan Morton, in their capacity as the representatives of the equity holders of EUSA Pharma Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on April 27, 2012).
|
2.4
|
Assignment, dated as of June 11, 2012, by and among Jazz Pharmaceuticals plc and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1B in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on June 12, 2012).
|
2.5
|
Tender Offer Agreement, dated December 19, 2013, by and among Jazz Pharmaceuticals Public Limited Company, Jazz Pharmaceuticals Italy S.r.l. and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K/A (File No. 001-33500), as filed with the SEC on December 20, 2013).
|
2.6†
|
Asset Purchase Agreement, dated January 13, 2014, by and among Jazz Pharmaceuticals International III Limited, Aerial BioPharma, LLC and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 13, 2014).
|
2.7†
|
Assignment Agreement, dated July 1, 2014, by and among Jazz Pharmaceuticals International II Limited, Sigma-Tau Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on August 5, 2014).
|
3.1
|
Memorandum and Articles of Association of Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
4.1
|
Reference is made to Exhibit 3.1.
|
4.2
|
Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Registered Direct Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 4.5 in the annual report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
4.3A
|
Investor Rights Agreement, dated July 7, 2009 by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 10.88 in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 7, 2009).
|
4.3B
|
Assignment, Assumption and Amendment Agreement, dated as of January 18, 2012, by and among Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and the other parties named therein (incorporated herein by reference to Exhibit 4.7B in the annual report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
4.4A
|
Indenture, dated as of August 13, 2014, by and among Jazz Pharmaceuticals plc, Jazz Investments I Limited and U.S. Bank National Association (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
4.4B
|
Form of 1.875% Exchangeable Senior Note due 2021 (included in Exhibit 4.4A).
|
10.1+
|
Employment Agreement by and between EUSA Pharma Inc. and Iain McGill.
|
10.2+
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Michael Miller.
|
10.3+
|
Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy.
|
31.1
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
Exhibit
Number
|
Description of Document
|
31.2
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
32.1*
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101.INS
|
XBRL Instance Document
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
XBRL Taxonomy Extension Labels Linkbase Document
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Indicates management contract or compensatory plan.
|
†
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the SEC.
|
*
|
The certifications attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
Jazz Pharmaceuticals Public Limited Company
(Registrant)
|
|
/s/ Bruce C. Cozadd
|
Bruce C. Cozadd
|
Chairman and Chief Executive Officer and Director
(Principal Executive Officer)
|
|
/s/ Matthew P. Young
|
Matthew P. Young
|
Senior Vice President and Chief Financial Officer
(Principal Financial Officer)
|
|
/s/ Karen J. Wilson
|
Karen J. Wilson
|
Senior Vice President, Finance
(Principal Accounting Officer)
|
Exhibit
Number
|
Description of Document
|
2.1
|
Agreement and Plan of Merger and Reorganization, dated as of September 19, 2011, by and among Azur Pharma Limited (now Jazz Pharmaceuticals plc), Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on September 19, 2011).
|
2.2
|
Letter Agreement, dated as of January 17, 2012, by and among Jazz Pharmaceuticals plc, Jaguar Merger Sub Inc. Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated by reference to Exhibit 2.2 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
2.3
|
Agreement and Plan of Merger, dated as of April 26, 2012, by and among Jazz Pharmaceuticals plc, Jewel Merger Sub Inc., EUSA Pharma Inc., and Essex Woodlands Health Ventures, Inc., Mayflower L.P., and Bryan Morton, in their capacity as the representatives of the equity holders of EUSA Pharma Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on April 27, 2012).
|
2.4
|
Assignment, dated as of June 11, 2012, by and among Jazz Pharmaceuticals plc and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1B in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on June 12, 2012).
|
2.5
|
Tender Offer Agreement, dated December 19, 2013, by and among Jazz Pharmaceuticals Public Limited Company, Jazz Pharmaceuticals Italy S.r.l. and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K/A (File No. 001-33500), as filed with the SEC on December 20, 2013).
|
2.6†
|
Asset Purchase Agreement, dated January 13, 2014, by and among Jazz Pharmaceuticals International III Limited, Aerial BioPharma, LLC and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 13, 2014).
|
2.7†
|
Assignment Agreement, dated July 1, 2014, by and among Jazz Pharmaceuticals International II Limited, Sigma-Tau Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on August 5, 2014).
|
3.1
|
Memorandum and Articles of Association of Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
4.1
|
Reference is made to Exhibit 3.1.
|
4.2
|
Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Registered Direct Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 4.5 in the annual report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
4.3A
|
Investor Rights Agreement, dated July 7, 2009 by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 10.88 in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 7, 2009).
|
4.3B
|
Assignment, Assumption and Amendment Agreement, dated as of January 18, 2012, by and among Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and the other parties named therein (incorporated herein by reference to Exhibit 4.7B in the annual report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
4.4A
|
Indenture, dated as of August 13, 2014, by and among Jazz Pharmaceuticals plc, Jazz Investments I Limited and U.S. Bank National Association (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
4.4B
|
Form of 1.875% Exchangeable Senior Note due 2021 (included in Exhibit 4.4A).
|
10.1+
|
Employment Agreement by and between EUSA Pharma Inc. and Iain McGill.
|
10.2+
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Michael Miller.
|
10.3+
|
Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy.
|
31.1
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
Exhibit
Number
|
Description of Document
|
31.2
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
32.1*
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101.INS
|
XBRL Instance Document
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
XBRL Taxonomy Extension Labels Linkbase Document
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Indicates management contract or compensatory plan.
|
†
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the SEC.
|
*
|
The certifications attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
1.
|
POSITION
|
2.
|
COMMENCEMENT DATE
|
3.
|
PROBATION
|
3.1.
|
Initially, your employment will be on a probationary basis for six (6) months
although the Company reserves the right to extend your probation at its discretion. During the probationary period, your performance and suitability for continued employment will be monitored.
|
3.2.
|
During the probationary period, employment may be terminated by the Company by giving two (2) weeks’ notice in writing. Payment may be made in lieu of notice.
|
3.3.
|
During the probation period you must give two (2) weeks’ notice in writing of termination of employment.
|
4.
|
PLACE OF WORK
|
4.1.
|
You will be based at the Company's offices at 4th Floor, Connaught House, 1 Burlington Road, Dublin 4.
|
4.2.
|
You may be required to travel to other locations from time to time, including the United States. Where you are required to work at another location for a period of at least one month, prior to departure, you will be provided with written terms and conditions which will apply for the period specified.
|
5.
|
HOURS OF WORK
|
6.
|
REPORTING STRUCTURE
|
7.
|
SALARY
|
7.1.
|
Your initial salary will be €240,000 per annum and shall accrue from day to day. This will be paid to you monthly in arrears on the last day of each month by credit transfer directly to your bank account. Your salary will be subject to annual review each year with the next review date being April 2015. There is no obligation to award an increase. There will be no review of the salary after notice has been given by either party to terminate your employment.
|
7.2.
|
All payments to you will be subject to deductions of tax, PRSI, Universal Social Charge and any other deductions required by law or provided for in this contract. You will be notified each month by the Company of the amount of your gross and net remuneration and of the nature and amount of all deductions.
|
7.3.
|
For the purposes of the National Minimum Wage Act, 2000, the pay reference period shall be a month. In accordance with section 23 of the Act, you may request from the Company a written statement of your average hourly rate of pay for any pay reference period (other than a current pay reference period) falling within the twelve month period immediately preceding the request.
|
7.4.
|
The Company may deduct from your salary, or other sums owed to you, any money owed to the Company by you. Where the Company suffers loss as a result of your actions or omissions, deductions will be made only after you have received written notification providing at least one full week's notice that the deduction will be made. The deduction must take place within 6 months of the loss/cost originally being incurred.
|
8.
|
HEALTH INSURANCE AND OTHER BENEFITS
|
9.
|
BONUS
|
9.1.
|
You may be entitled to be considered for a bonus based on your performance. Any bonus payment will be made entirely at the sole discretion of the Board, at such intervals and subject to such conditions as the Board may in its absolute discretion determine from time to time. The Company reserves the right to amend the terms of the bonus scheme from time to time or to withdraw the bonus scheme at any time in its absolute discretion.
|
9.2.
|
Any bonus payment to you shall be purely discretionary and shall not form part of your contractual remuneration under this Agreement. If the Company makes a payment to you, it shall not be obliged to make subsequent bonus payments.
|
9.3.
|
You will not be entitled to a bonus if your employment has been terminated, or notice of such termination has been given by either you or the Company, prior to the date the bonus is paid.
|
10.
|
EQUITY AWARDS
|
10.1.
|
You may be entitled to be considered for an equity award based on your performance. Any equity award will be made by Jazz Pharmaceuticals plc (the “
Parent
”) entirely at the sole discretion of the Board of Directors of Jazz Pharmaceuticals plc. (the “
Parent Board
”). Any equity award will be at such intervals and subject to such conditions as the Parent Board may in its absolute discretion determine from time to time. The Parent reserves the right to amend the terms of the equity scheme from time to time or to withdraw the equity scheme at any time in its absolute discretion.
|
10.2.
|
Any equity award to you shall be purely discretionary on the part of the Parent Board and shall not form part of your contractual remuneration under this Agreement. If the Parent makes an award to you, it shall not be obliged to make subsequent equity awards.
|
10.3.
|
You will not be entitled to an equity award if your employment has been terminated, or notice of such termination has been given by either you or the Company, prior to the date the equity is awarded.
|
11.
|
EXPENSES
|
12.
|
HOLIDAYS
|
12.1.
|
You will be entitled to 21 days' holidays (exclusive of all Irish bank and other public holidays in accordance with the Organisation of Working Time Act 1997) in each year. Your holidays are to be taken by arrangement with the Company, at such time or times that the Company considers to be most convenient having regard to the requirements of your position.
|
12.2.
|
The Company's holiday year runs from 1 January to 31 December. Holidays from the previous year may not be carried over to the following year except with
the Company's consent. Upon notice of termination of employment being served by either party, the Company may, subject to the provisions of the Organisation of Working Time Act 1997, require you to take any unused holidays accrued at that time during any notice period. Alternatively, the Company may, at its discretion, on termination of the employment, make a payment in lieu of accrued contractual holiday entitlement.
|
12.3.
|
If you are ill during a period of annual leave and have a valid medical certificate for the days that you were ill, these sick days will not be counted as annual leave days.
|
12.4.
|
If on termination of employment, you have taken in excess of your accrued holiday entitlement, the Company shall be entitled to recover from you by way of deduction from any payments due to you or otherwise, one day's pay for each excess day (calculated at 1/260th of your salary for each excess day).
|
12.5.
|
You are also entitled to paid public holidays subject to compliance with the Organisation of Working Time Act 1997.
|
13.
|
PENSION
|
14.
|
DUTIES
|
15.
|
PERIOD OF EMPLOYMENT
|
16.
|
PAYMENT IN LIEU OF NOTICE/GARDEN LEAVE
|
16.1.
|
pay you in lieu of notice the amount of your entitlement to salary in respect of such notice period; or
|
16.2.
|
require you to cease performing or exercising during some or all of the remainder of any notice period some or all of the powers, authorities and discretions delegated to you in your employment and/or to cease attending your place of work during such period.
|
17.
|
TERMINATION WITHOUT NOTICE
|
17.1.
|
are guilty of any material breach or non-observance of the provisions contained in this Agreement;
|
17.2.
|
are guilty of any serious or gross misconduct and/or negligence in the discharge of the duties of your employment or in connection with or affecting the business of the Company;
|
17.3.
|
commit any serious act of dishonesty or repeated acts of dishonesty;
|
17.4.
|
cease to be eligible to work in the Republic of Ireland; or
|
17.5.
|
are convicted of a criminal offence which the Company considers affects or could affect your position within the Company (other than minor traffic offences).
|
18.
|
NORMAL RETIREMENT AGE
|
19.
|
Illness
|
19.1.
|
Absences from work for whatever reason must be notified to your Manager as soon as possible before your usual start time on the first day of absence. You should telephone your Manager and confirm the
|
19.2.
|
Payment of salary for any absences attributable to illness will at all times be entirely at the sole discretion of the Company.
|
19.3.
|
If you are at any time prevented by illness, injury, accident or any other circumstances from discharging all your duties for a period of three consecutive days, then a satisfactory certificate will be required from your doctor in respect of such absence.
|
19.4.
|
The Company reserves the right, at any time, to require you to undergo a medical examination by a Doctor or Consultant nominated by the Company, in which event you agree to consent to this request and the Company will bear the cost of such examination.
|
19.5.
|
If your absence is or appears to be occasioned by actionable negligence, nuisance or breach of any statutory duty on the part of a third party in respect of which damages are or may be recoverable, you shall immediately notify your Manager of that fact and of any claim, compromise, settlement or judgment made or awarded in connection with it and all relevant particulars that the Company may reasonably require. You shall, if you have been in receipt of salary for a period of absence and if required by the Company, refund to the Company that part of any damages or compensation recovered by you relating to the loss of earnings for the period of sickness as the Company may reasonably determine less any costs borne by you in connection with the recovery of such damages or compensation, provided that the amount to be refunded shall not exceed the total amount paid to you by the Company in respect of the period of sickness.
|
20.
|
POLICIES AND PROCEDURES
|
21.
|
DISCIPLINARY RULES AND PROCEDURE
|
21.1.
|
You will conduct yourself with propriety at all times and with due regard for the Company and each of its associated companies and the clients and employees of each such company.
|
21.2.
|
In the event that your conduct or performance falls short of the standards required by the Company or the Board in any respect (other than cases of misconduct), you will receive at first instance, a verbal warning, followed, if necessary in the event of a repetition, by a written warning which, in appropriate circumstances, may be deemed to be a final written warning. In the event of further breach of conduct or poor performance, and following due investigation during which you will be afforded an opportunity to make whatever representations you consider appropriate, your employment may be terminated by the Company, with or without notice as is deemed appropriate. Where appropriate, because of the gravity of your conduct or performance, the Company reserves the right to commence this procedure at any stage. The disciplinary procedures do not apply to employees who have not completed probation.
|
21.3.
|
In order to investigate a complaint against you, the Company may suspend you on full pay for as long as may be necessary to carry out an investigation and hold a disciplinary hearing.
|
22.
|
MONITORING
|
22.1.
|
You consent to the Company monitoring and recording any use that you make of the Company's electronic communications systems for the purpose of ensuring that the Company's rules are being complied with and for legitimate business purposes. You shall comply with any electronic communication systems policies that the Company may issue from time to time.
|
23.
|
CONFIDENTIALITY
|
23.1.
|
You will not, except as authorised or required by your duties, reveal to any person, persons or company any information of a confidential or proprietary nature, including any trade secrets, secret or confidential operations, processes or dealings or any information concerning the organisation, business, finances, transactions or affairs of the Company, its subsidiary or associated companies or their existing or potential customers including but not limited to: client lists, prices, financial information, information on the marketing and development of products, which may come to your knowledge during the period of your employment with the Company ("
Confidential Information
"). You will keep all Confidential Information entrusted to you completely secret and will not use or attempt to use any Confidential Information in any manner which may injure or cause loss either directly or indirectly to the Company or any of its subsidiary or associated companies or their existing or potential customers or its or their business or businesses. This restriction will continue to apply after the termination of your employment without limit in point of time but will cease to apply to information or knowledge which may reasonably be said to have come into the public domain other than by reason of breach of the provisions of this Agreement.
|
23.2.
|
You will not during the term of your employment with the Company make, otherwise than for the benefit of the Company, any notes or memoranda relating to any matter within the scope of the business of the Company, its subsidiary or associated companies or their existing or potential customers or concerning any of the dealings or affairs of any such company nor will you either during the term of your employment with the Company or afterwards use or permit to be used any such notes or memoranda otherwise than for the benefit of the Company, it being the intention of the parties that all such notes or memoranda made by you will be the property of the Company and left at its offices upon the termination of your employment with the Company.
|
24.
|
Proprietary Rights
|
24.1.
|
In this Clause 24, "
IP
" means all intellectual property rights of whatever nature, including copyright (present and future), moral rights, patents, trademarks, trade names, domain names, rights in get-up, goodwill and the right to sue for passing off or unfair competition, rights in computer software, design rights, rights to inventions and database rights (whether or not any of these is registered and including any applications for registration of any such rights), rights to preserve the confidentiality of information(including trade secrets and know-how) and any other intellectual property rights, in each case whether registered or unregistered and including all applications (or rights to apply) for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which may now or in the future subsist in any part of the world.
|
24.2.
|
You will immediately disclose to the Company in writing full details of any discovery, invention, process or improvement in procedure made or discovered by you (whether or not in conjunction with any other person or persons) together with all works embodying IP rights while in the employment of the Company in connection with or in any way affecting or relating to the business of the Company, its subsidiary or associated companies or capable of being used or adapted for use therein or in connection therewith ("
Inventions
"). You acknowledge that all IP rights subsisting (or which may in the future subsist) in all such Inventions and works shall automatically, on creation, vest in the Company absolutely. To the extent that they do not vest automatically, you hold them on trust for the Company. You agree promptly
|
24.3.
|
If and whenever required so to do (whether during or after the termination of your employment), you will without charge and at the expense of the Company or its nominee apply or join in applying for letters, patents or other forms of protection for any IP referred to in this Clause 24 and execute all instruments and do all things considered necessary in the absolute discretion of the Company in relation to the said IP including vesting all rights and titles to such IP, when obtained, in the Company (or its nominee) as sole beneficial owner, or in such other person as the Company may require.
|
24.4.
|
You irrevocably appoint the Company to be your attorney in your name and on your behalf to execute and do any such instruments or things and generally to use your name for the purpose of giving to the Company (or its nominee) the full benefit of the provisions of this Clause 24. A certificate in writing signed by any executive or the Secretary of the Company that any instrument or act falls within the authority conferred in this Clause 24.4 will be conclusive evidence that such is the case in favour of a third party.
|
25.
|
RESTRICTIVE COVENANTS
|
25.1.
|
You may not during the period of your employment with the Company, without prior written consent of the Company, engage, whether directly or indirectly, in any business or employment which is similar to or competitive with the business of the Company or its subsidiary or associated companies or which may in the Company's opinion impair your ability to act at all times in the best interest of the Company.
|
25.2.
|
In order to protect the Confidential Information and business connections of the Company to which you have access as a result of your employment, you covenant with the Company that you shall not:
|
25.2.1.
|
for twelve (12) months after the date of the termination of your employment, in the Republic of Ireland be employed, engaged, concerned or interested, in any business directly competing with the products sold by the Company or its subsidiary or associated companies at that time.
|
25.2.2.
|
for a period of twelve (12) months after the termination of your employment, offer to employ or otherwise entice away from the Company or its subsidiary or associated companies, any person who was at any time in the twelve months prior to the termination of your employment with the Company employed or engaged by the Company or its subsidiary or associated companies.
|
25.2.3.
|
for a period of twelve (12) months after the termination of your employment, solicit or endeavour to entice away from the Company or its subsidiary or associated companies the business or custom of any firm, company or person who, during the 12 months before your termination of employment was a customer or prospective customer of the Company or its subsidiary or associated companies and with whom you had contact in the course of that period, with a view to providing goods or services to that firm, company or person in competition with the services provided by the Company.
|
25.2.4.
|
for a period of twelve (12) months after the termination of your employment, be involved with the provision of goods or services to (or otherwise have any business dealings with) any firm, company or person who, during the 12 months before the termination of your employment, was in the habit of dealing with the Company or its subsidiary or associated companies, in the course of any business concern which is in competition with the business of the Company.
|
25.2.5.
|
at any time after the termination of your employment, represent yourself as connected with the Company as agent, consultant, director, employee, owner, partner, shareholder or in any other capacity.
|
25.3.
|
Where during employment by the Company or at any time after termination of employment while this restriction is in force, you apply for employment, is offered employment, has discussions in relation to potential employment or otherwise participates in any recruitment process with another employer, you shall bring this clause expressly to the attention of such other employer or potential employer.
|
25.4.
|
You acknowledge and agree that all of the restrictions contained in this Agreement are reasonable and necessary to protect the interests of the Company and its subsidiary and associated companies and you agree that the Company may seek equitable remedies to enforce them in addition to any other legal remedies it has.
|
25.5.
|
The restrictions above apply to you acting directly or indirectly and on your own behalf or on behalf of, or in conjunction with, any firm, company or person.
|
25.6.
|
The time periods for which the restrictions apply shall be reduced by any period that you spend on garden leave.
|
25.7.
|
If any provision in this Clause 25 is deemed to be, or becomes invalid, illegal, void or unenforceable under applicable laws, such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable (including, by way of example, by restricting the area, duration and/or scope of the covenants in to such area, duration and/or scope as would be held reasonable), or if it cannot be so amended without materially altering the intention of the parties, it will be deleted, but the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
|
26.
|
DATA PROTECTION ACTS 1988 AND 2003
|
26.1.
|
You hereby acknowledge that during the course of your employment with the Company, the Company will keep personal data and sensitive personal data (e.g. doctor's certificates or medical reports) relating to you on computer and in manual files/paper files. You hereby acknowledge, agree and consent that the Company is permitted to hold and process personal information about you as part of its personnel and other business records and may use such information in the course of the Company's business. You further agree and consent that the Company may disclose such information to third parties in the event that such disclosure is in the Company's view required by the proper conduct of the Company's business. This clause applies to information held, used or disclosed in any medium.
|
27.
|
HEALTH AND SAFETY
|
27.1.
|
The Company takes seriously its obligations regarding the safety, health and welfare of its employees and in that regard your attention is drawn to the Company safety statement (which is available for viewing on the intranet). By signing this Agreement, you agree to take reasonable care of your own safety and health and that of any other persons who may be affected by your acts or admissions while at work. You also agree to cooperate with the Company and any other person to enable compliance with any provision of the Safety, Health and Welfare at Work Acts 1989 and 2005 and any Regulation made thereunder.
|
28.
|
COLLECTIVE AGREEMENT
|
28.1.
|
There is no collective agreement which directly affects your employment.
|
29.
|
EMPLOYEE'S WARRANTIES
|
29.1.
|
You hereby warrant that by virtue of entering into this Agreement you will not be in breach of any express or implied terms of any Court order, contract or any other obligation legally binding upon you.
|
29.2.
|
You warrant that you will not without the written consent of the Company work for anyone else while in the employment of the Company.
|
30.
|
MISCELLANEOUS PROVISIONS
|
30.1.
|
Notices
. Any notice under this Agreement will be given in writing and will be deemed to have been duly given if delivered personally to the addressee or the duly authorised agent of the addressee or sent by prepaid registered post to the last known address of the party to whom such notice is given. Any such notice will be deemed to have been duly given at the time of delivery if delivered personally, or two working days after posting if sent by prepaid registered post.
|
30.2.
|
Entire Agreement
. This Agreement is in substitution for all previous agreements and undertakings (if any) either written or verbal between the Company and you, and all such agreements and undertakings will be deemed to have been terminated by mutual consent as from the date of your execution of this Agreement.
|
30.3.
|
Variation
In addition to any specific reservations referred to in this Agreement, the Company reserves the right to make reasonable changes to the terms and conditions of your employment from time to time. Wherever practicable, you will be given advance notice of any such change.
|
30.4.
|
Governing Law and Jurisdiction
. This Agreement shall be governed by and construed in accordance with the laws of Ireland, and shall be subject to the exclusive jurisdiction of the Irish courts.
|
30.5.
|
The information contained in this Agreement constitutes a written statement of particulars of your employment with the Company in accordance with the requirements of section 3 of the Terms of Employment Act 1994 and 2001.
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Jazz Pharmaceuticals Public Limited Company;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: November 4, 2014
|
By:
|
/s/ Bruce C. Cozadd
|
|
|
Bruce C. Cozadd
Chairman and Chief Executive Officer and Director
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Jazz Pharmaceuticals Public Limited Company;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: November 4, 2014
|
By:
|
/s/ Matthew P. Young
|
|
|
Matthew P. Young
Senior Vice President and Chief Financial Officer
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2014
, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Bruce C. Cozadd
|
Bruce C. Cozadd
|
Chairman and Chief Executive Officer and Director
|
|
/s/ Matthew P. Young
|
Matthew P. Young
|
Senior Vice President and Chief Financial Officer
|
(1)
|
This certification accompanies the Quarterly Report on Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Jazz Pharmaceuticals Public Limited Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Jazz Pharmaceuticals Public Limited Company and will be retained by Jazz Pharmaceuticals Public Limited Company and furnished to the Securities and Exchange Commission or its staff upon request.
|