|
|
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
|
¨
|
|
|
Page
|
|
||
|
|
|
Item 1.
|
||
|
||
|
||
|
||
|
||
|
||
|
|
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Item 2.
|
||
|
|
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Item 3.
|
||
|
|
|
Item 4.
|
||
|
|
|
|
||
|
|
|
Item 1.
|
||
|
|
|
Item 1A.
|
||
|
|
|
Item 2.
|
||
|
|
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Item 6.
|
Item 1.
|
Financial Statements
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
366,567
|
|
|
$
|
988,785
|
|
Investments
|
59,418
|
|
|
—
|
|
||
Accounts receivable, net of allowances
|
238,072
|
|
|
209,685
|
|
||
Inventories
|
32,351
|
|
|
19,451
|
|
||
Prepaid expenses
|
23,304
|
|
|
20,699
|
|
||
Other current assets
|
24,517
|
|
|
19,047
|
|
||
Total current assets
|
744,229
|
|
|
1,257,667
|
|
||
Property and equipment, net
|
99,898
|
|
|
85,572
|
|
||
Intangible assets, net
|
3,110,439
|
|
|
1,185,606
|
|
||
Goodwill
|
927,993
|
|
|
657,139
|
|
||
Deferred tax assets, net, non-current
|
—
|
|
|
122,863
|
|
||
Deferred financing costs
|
10,258
|
|
|
7,209
|
|
||
Other non-current assets
|
37,764
|
|
|
27,548
|
|
||
Total assets
|
$
|
4,930,581
|
|
|
$
|
3,343,604
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
17,626
|
|
|
$
|
21,807
|
|
Accrued liabilities
|
172,418
|
|
|
164,070
|
|
||
Current portion of long-term debt
|
36,094
|
|
|
37,587
|
|
||
Income taxes payable
|
5,222
|
|
|
1,808
|
|
||
Deferred revenue
|
1,499
|
|
|
1,370
|
|
||
Total current liabilities
|
232,859
|
|
|
226,642
|
|
||
Deferred revenue, non-current
|
2,881
|
|
|
3,721
|
|
||
Long-term debt, less current portion
|
2,147,379
|
|
|
1,150,857
|
|
||
Deferred tax liability, net, non-current
|
725,358
|
|
|
294,485
|
|
||
Other non-current liabilities
|
106,101
|
|
|
69,253
|
|
||
Commitments and contingencies (Note 8)
|
|
|
|
|
|||
Shareholders’ equity:
|
|
|
|
||||
Ordinary shares
|
6
|
|
|
6
|
|
||
Non-voting euro deferred shares
|
55
|
|
|
55
|
|
||
Capital redemption reserve
|
472
|
|
|
471
|
|
||
Additional paid-in capital
|
1,635,431
|
|
|
1,562,900
|
|
||
Accumulated other comprehensive loss
|
(235,376
|
)
|
|
(267,472
|
)
|
||
Retained earnings
|
315,415
|
|
|
302,686
|
|
||
Total shareholders’ equity
|
1,716,003
|
|
|
1,598,646
|
|
||
Total liabilities and shareholders’ equity
|
$
|
4,930,581
|
|
|
$
|
3,343,604
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Product sales, net
|
$
|
371,621
|
|
|
$
|
338,754
|
|
|
$
|
1,084,647
|
|
|
$
|
977,895
|
|
Royalties and contract revenues
|
2,560
|
|
|
2,118
|
|
|
6,705
|
|
|
6,027
|
|
||||
Total revenues
|
374,181
|
|
|
340,872
|
|
|
1,091,352
|
|
|
983,922
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of product sales (excluding amortization of intangible assets)
|
24,311
|
|
|
28,385
|
|
|
71,730
|
|
|
78,496
|
|
||||
Selling, general and administrative
|
124,368
|
|
|
104,044
|
|
|
375,751
|
|
|
323,564
|
|
||||
Research and development
|
47,796
|
|
|
50,784
|
|
|
118,139
|
|
|
105,798
|
|
||||
Acquired in-process research and development
|
15,000
|
|
|
—
|
|
|
23,750
|
|
|
—
|
|
||||
Intangible asset amortization
|
26,453
|
|
|
26,127
|
|
|
75,832
|
|
|
74,472
|
|
||||
Total operating expenses
|
237,928
|
|
|
209,340
|
|
|
665,202
|
|
|
582,330
|
|
||||
Income from operations
|
136,253
|
|
|
131,532
|
|
|
426,150
|
|
|
401,592
|
|
||||
Interest expense, net
|
(18,498
|
)
|
|
(12,650
|
)
|
|
(42,811
|
)
|
|
(44,707
|
)
|
||||
Foreign currency loss
|
(749
|
)
|
|
(977
|
)
|
|
(1,568
|
)
|
|
(646
|
)
|
||||
Loss on extinguishment and modification of debt
|
(638
|
)
|
|
—
|
|
|
(638
|
)
|
|
(16,815
|
)
|
||||
Income before income tax provision and equity in loss of investee, net of tax
|
116,368
|
|
|
117,905
|
|
|
381,133
|
|
|
339,424
|
|
||||
Income tax provision
|
29,120
|
|
|
29,945
|
|
|
108,482
|
|
|
92,651
|
|
||||
Equity in loss of investee, net of tax
|
103
|
|
|
—
|
|
|
103
|
|
|
—
|
|
||||
Net income
|
87,145
|
|
|
87,960
|
|
|
272,548
|
|
|
246,773
|
|
||||
Net loss attributable to noncontrolling interests, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
||||
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
87,145
|
|
|
$
|
87,960
|
|
|
$
|
272,548
|
|
|
$
|
246,774
|
|
|
|
|
|
|
|
|
|
||||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
1.44
|
|
|
$
|
1.43
|
|
|
$
|
4.49
|
|
|
$
|
4.04
|
|
Diluted
|
$
|
1.41
|
|
|
$
|
1.39
|
|
|
$
|
4.40
|
|
|
$
|
3.91
|
|
Weighted-average ordinary shares used in per share calculations - basic
|
60,437
|
|
|
61,435
|
|
|
60,692
|
|
|
61,145
|
|
||||
Weighted-average ordinary shares used in per share calculations - diluted
|
61,644
|
|
|
63,154
|
|
|
61,983
|
|
|
63,072
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Net income
|
$
|
87,145
|
|
|
$
|
87,960
|
|
|
$
|
272,548
|
|
|
$
|
246,773
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Foreign currency translation adjustments
|
14,612
|
|
|
16,779
|
|
|
32,096
|
|
|
(109,174
|
)
|
||||
Other comprehensive income (loss)
|
14,612
|
|
|
16,779
|
|
|
32,096
|
|
|
(109,174
|
)
|
||||
Total comprehensive income
|
101,757
|
|
|
104,739
|
|
|
304,644
|
|
|
137,599
|
|
||||
Comprehensive income attributable to noncontrolling interests, net of tax
|
—
|
|
|
14
|
|
|
—
|
|
|
5
|
|
||||
Comprehensive income attributable to Jazz Pharmaceuticals plc
|
$
|
101,757
|
|
|
$
|
104,725
|
|
|
$
|
304,644
|
|
|
$
|
137,594
|
|
|
Nine Months Ended
September 30, |
||||||
|
2016
|
|
2015
|
||||
Operating activities
|
|
|
|
||||
Net income
|
$
|
272,548
|
|
|
$
|
246,773
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
Intangible asset amortization
|
75,832
|
|
|
74,472
|
|
||
Share-based compensation
|
74,490
|
|
|
67,233
|
|
||
Depreciation
|
8,165
|
|
|
7,143
|
|
||
Acquired in-process research and development
|
23,750
|
|
|
—
|
|
||
Loss on disposal of property and equipment
|
3
|
|
|
117
|
|
||
Excess tax benefit from share-based compensation
|
—
|
|
|
320
|
|
||
Deferred income taxes
|
(16,462
|
)
|
|
(25,368
|
)
|
||
Provision for losses on accounts receivable and inventory
|
1,764
|
|
|
4,021
|
|
||
Loss on extinguishment and modification of debt
|
638
|
|
|
16,815
|
|
||
Amortization of debt discount and deferred financing costs
|
16,418
|
|
|
17,348
|
|
||
Other non-cash transactions
|
1,460
|
|
|
(3,834
|
)
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(28,274
|
)
|
|
(10,661
|
)
|
||
Inventories
|
(14,117
|
)
|
|
(3,595
|
)
|
||
Prepaid expenses and other current assets
|
(8,512
|
)
|
|
(5,298
|
)
|
||
Other long-term assets
|
(4,920
|
)
|
|
(9,555
|
)
|
||
Accounts payable
|
(4,288
|
)
|
|
4,826
|
|
||
Accrued liabilities
|
(9,647
|
)
|
|
4,642
|
|
||
Income taxes payable
|
3,323
|
|
|
8,993
|
|
||
Deferred revenue
|
(682
|
)
|
|
(659
|
)
|
||
Other non-current liabilities
|
18,352
|
|
|
18,469
|
|
||
Net cash provided by operating activities
|
409,841
|
|
|
412,202
|
|
||
Investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(6,555
|
)
|
|
(32,591
|
)
|
||
Acquisitions, net of cash acquired
|
(1,502,443
|
)
|
|
—
|
|
||
Acquisition of in-process research and development
|
(23,750
|
)
|
|
—
|
|
||
Acquisition of investments
|
(64,693
|
)
|
|
—
|
|
||
Acquisition of intangible assets
|
(150,000
|
)
|
|
—
|
|
||
Net proceeds from sale of business
|
—
|
|
|
33,703
|
|
||
Net cash provided by (used in) investing activities
|
(1,747,441
|
)
|
|
1,112
|
|
||
Financing activities
|
|
|
|
||||
Net proceeds from issuance of debt
|
994,777
|
|
|
898,960
|
|
||
Proceeds from employee equity incentive and purchase plans
|
17,951
|
|
|
34,025
|
|
||
Repayments of long-term debt
|
(19,282
|
)
|
|
(896,363
|
)
|
||
Payment of employee withholding taxes related to share-based awards
|
(20,595
|
)
|
|
(25,402
|
)
|
||
Share repurchases
|
(259,819
|
)
|
|
(21,302
|
)
|
||
Excess tax benefit from share-based compensation
|
—
|
|
|
(320
|
)
|
||
Acquisition of noncontrolling interests
|
—
|
|
|
(60
|
)
|
||
Repayments under revolving credit facility
|
—
|
|
|
(80,000
|
)
|
||
Net cash provided by (used in) financing activities
|
713,032
|
|
|
(90,462
|
)
|
||
Effect of exchange rates on cash and cash equivalents
|
2,350
|
|
|
(8,035
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
(622,218
|
)
|
|
314,817
|
|
||
Cash and cash equivalents, at beginning of period
|
988,785
|
|
|
684,042
|
|
||
Cash and cash equivalents, at end of period
|
$
|
366,567
|
|
|
$
|
998,859
|
|
•
|
Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
|
•
|
Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
|
•
|
Defitelio
®
(defibrotide sodium)
, a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, or SOS, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio
®
(defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy.
|
•
|
Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications;
|
•
|
Acquiring clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
|
•
|
Pursuing targeted development of post-discovery differentiated product candidates.
|
•
|
the acceptance of Defitelio in the U.S. by hospital pharmacy and therapeutics committees and the availability of adequate coverage and reimbursement by government programs and third party payors;
|
•
|
U.S. market acceptance of Defitelio at its commercial price now that it is no longer available to new patients under an expanded access treatment protocol;
|
•
|
the lack of experience of U.S. physicians in diagnosing and treating VOD, particularly in adults, and the possibility that physicians may delay initiation of treatment or terminate treatment before the end of the recommended dosing schedule;
|
•
|
our ability to successfully maintain or grow sales of Defitelio in Europe;
|
•
|
delays or problems in the supply or manufacture of the product;
|
•
|
the limited size of the population of VOD patients who are indicated for treatment with Defitelio (particularly if changes in HSCT treatment protocols reduce the incidence of VOD);
|
•
|
our ability to meet the post-marketing commitments and requirements imposed by the FDA in connection with its approval of our NDA for Defitelio; and
|
•
|
our ability to obtain marketing approval in other countries and to develop the product for additional indications.
|
•
|
our ability to successfully obtain marketing approval for Vyxeos in the U.S. and Europe;
|
•
|
risks associated with developing products based on the CombiPlex technology platform that we acquired in the Celator Acquisition, such as Vyxeos, the first injectable fixed ratio, drug delivery combination oncology product that the FDA would potentially be considering for approval;
|
•
|
our ability to differentiate Vyxeos from other liposomal chemotherapies and generically available chemotherapy combinations with which physicians and treatment centers are more familiar;
|
•
|
the need to establish pricing and reimbursement support for Vyxeos in the event we are able to obtain marketing approval for Vyxeos in the U.S. or in other countries;
|
•
|
the acceptance of Vyxeos in the U.S. and other countries by hospital pharmacy and therapeutics committees and the availability of adequate coverage and reimbursement by government programs and third party payors;
|
•
|
delays or problems in the supply or manufacture of the product, including with respect to the requirement of the third parties upon which we rely to manufacture Vyxeos and its active pharmaceutical ingredients, or APIs, to obtain the approval of the FDA and/or other regulatory authorities to manufacture Vyxeos; and
|
•
|
the limited size of the population of AML patients who may potentially be indicated for treatment with Vyxeos.
|
•
|
the challenges of protecting and enhancing our intellectual property rights;
|
•
|
the challenges of achieving and maintaining commercial success of our products;
|
•
|
delays or problems in the supply or manufacture of our products and product candidates, particularly with respect to certain products as to which we maintain limited inventories, and our dependence on single source suppliers for most of our products, product candidates and APIs;
|
•
|
the need to obtain and maintain 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 U.S. and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the U.S. in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by government programs and third party payors;
|
•
|
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business;
|
•
|
the challenges of compliance with the requirements of the FDA, the 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, patient assistance programs, adverse event reporting and product recalls or withdrawals;
|
•
|
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;
|
•
|
the risks associated with business combination or product or product candidate acquisition transactions, including risks associated with the Celator Acquisition, such as the challenges inherent in the integration of acquired businesses with our historical business, the increase in geographic dispersion among our centers of operation 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 transactions; 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 as a result of, among other things, the Celator Acquisition.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
87,145
|
|
|
$
|
87,960
|
|
|
$
|
272,548
|
|
|
$
|
246,774
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted-average ordinary shares used in per share calculation - basic
|
60,437
|
|
|
61,435
|
|
|
60,692
|
|
|
61,145
|
|
||||
Dilutive effect of employee equity incentive and purchase plans
|
1,207
|
|
|
1,719
|
|
|
1,291
|
|
|
1,927
|
|
||||
Weighted-average ordinary shares used in per share calculation - diluted
|
61,644
|
|
|
63,154
|
|
|
61,983
|
|
|
63,072
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
1.44
|
|
|
$
|
1.43
|
|
|
$
|
4.49
|
|
|
$
|
4.04
|
|
Diluted
|
$
|
1.41
|
|
|
$
|
1.39
|
|
|
$
|
4.40
|
|
|
$
|
3.91
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
1.875% exchangeable senior notes due 2021
|
2,878
|
|
|
2,878
|
|
|
2,878
|
|
|
2,878
|
|
Options to purchase ordinary shares and RSUs
|
2,851
|
|
|
1,644
|
|
|
2,688
|
|
|
1,517
|
|
Ordinary shares under ESPP
|
45
|
|
|
—
|
|
|
72
|
|
|
—
|
|
Cash and cash equivalents
|
$
|
26,137
|
|
Other receivables
|
386
|
|
|
Prepaid expenses and deposits
|
151
|
|
|
Property and equipment
|
767
|
|
|
Intangible assets
|
1,825,000
|
|
|
Goodwill
|
261,783
|
|
|
Other non-current assets
|
43
|
|
|
Accrued liabilities
|
(19,076
|
)
|
|
Deferred tax liability, net, non-current
|
(565,609
|
)
|
|
Other non-current liabilities
|
(1,002
|
)
|
|
Total acquisition consideration - cash paid
|
$
|
1,528,580
|
|
•
|
The exclusion of acquisition-related and integration expenses of
$10.8 million
and
$13.0 million
for the
three and nine months ended September 30, 2016, respectively
, and the inclusion of acquisition-related and integration expenses of
$13.0 million
for the nine months ended September 30, 2015.
|
•
|
An increase in interest expense of
$0.1 million
and
$13.7 million
for the
three and nine months ended September 30, 2016, respectively
, and
$6.5 million
and
$19.4 million
for the
three and nine months ended September 30, 2015, respectively
, incurred on additional borrowings made to partially fund the Celator Acquisition as if the borrowings had occurred on January 1, 2015.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Revenues
|
$
|
374,181
|
|
|
$
|
341,008
|
|
|
$
|
1,091,497
|
|
|
$
|
985,229
|
|
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
94,137
|
|
|
$
|
78,903
|
|
|
$
|
261,452
|
|
|
$
|
209,517
|
|
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - basic
|
$
|
1.56
|
|
|
$
|
1.28
|
|
|
$
|
4.31
|
|
|
$
|
3.43
|
|
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - diluted
|
$
|
1.53
|
|
|
$
|
1.25
|
|
|
$
|
4.22
|
|
|
$
|
3.32
|
|
|
September 30, 2016
|
||||||||||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Investments
|
||||||||||||
Cash
|
$
|
211,567
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
211,567
|
|
|
$
|
211,567
|
|
|
$
|
—
|
|
Time deposits
|
214,418
|
|
|
—
|
|
|
—
|
|
|
214,418
|
|
|
155,000
|
|
|
59,418
|
|
||||||
Totals
|
$
|
425,985
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
425,985
|
|
|
$
|
366,567
|
|
|
$
|
59,418
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
December 31, 2015
|
||||||||||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Investments
|
||||||||||||
Cash
|
$
|
274,945
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
274,945
|
|
|
$
|
274,945
|
|
|
$
|
—
|
|
Time deposits
|
713,840
|
|
|
—
|
|
|
—
|
|
|
713,840
|
|
|
713,840
|
|
|
—
|
|
||||||
Totals
|
$
|
988,785
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
988,785
|
|
|
$
|
988,785
|
|
|
$
|
—
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||||||||||
|
Significant Other
Observable
Inputs
(Level 2)
|
|
Total
Estimated Fair Value |
|
Significant
Other Observable Inputs (Level 2) |
|
Total
Estimated Fair Value |
||||||||
Time deposits
|
$
|
214,418
|
|
|
$
|
214,418
|
|
|
$
|
713,840
|
|
|
$
|
713,840
|
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
Raw materials
|
$
|
2,357
|
|
|
$
|
2,608
|
|
Work in process
|
20,666
|
|
|
11,836
|
|
||
Finished goods
|
9,328
|
|
|
5,007
|
|
||
Total inventories
|
$
|
32,351
|
|
|
$
|
19,451
|
|
Balance at December 31, 2015
|
$
|
657,139
|
|
Goodwill arising from the Celator Acquisition
|
261,783
|
|
|
Foreign exchange
|
9,071
|
|
|
Balance at September 30, 2016
|
$
|
927,993
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||||||||||||||||||||
|
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
|
11.6
|
|
$
|
1,542,813
|
|
|
$
|
(400,343
|
)
|
|
$
|
1,142,470
|
|
|
$
|
1,321,324
|
|
|
$
|
(324,044
|
)
|
|
$
|
997,280
|
|
Manufacturing contracts
|
1.3
|
|
12,001
|
|
|
(8,073
|
)
|
|
3,928
|
|
|
11,697
|
|
|
(5,676
|
)
|
|
6,021
|
|
||||||
Trademarks
|
—
|
|
2,890
|
|
|
(2,890
|
)
|
|
—
|
|
|
2,882
|
|
|
(2,882
|
)
|
|
—
|
|
||||||
Total finite-lived intangible assets
|
|
|
1,557,704
|
|
|
(411,306
|
)
|
|
1,146,398
|
|
|
1,335,903
|
|
|
(332,602
|
)
|
|
1,003,301
|
|
||||||
Acquired IPR&D assets
|
|
|
1,964,041
|
|
|
—
|
|
|
1,964,041
|
|
|
182,305
|
|
|
—
|
|
|
182,305
|
|
||||||
Total intangible assets
|
|
|
$
|
3,521,745
|
|
|
$
|
(411,306
|
)
|
|
$
|
3,110,439
|
|
|
$
|
1,518,208
|
|
|
$
|
(332,602
|
)
|
|
$
|
1,185,606
|
|
Year Ending December 31,
|
Estimated
Amortization
Expense
|
||
2016 (remaining)
|
$
|
26,671
|
|
2017
|
106,683
|
|
|
2018
|
103,805
|
|
|
2019
|
103,582
|
|
|
2020
|
102,381
|
|
|
Thereafter
|
703,276
|
|
|
Total
|
$
|
1,146,398
|
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
Land and buildings
|
$
|
45,946
|
|
|
$
|
1,775
|
|
Construction-in-progress
|
25,571
|
|
|
63,008
|
|
||
Manufacturing equipment and machinery
|
18,234
|
|
|
5,828
|
|
||
Computer software
|
17,198
|
|
|
15,797
|
|
||
Computer equipment
|
10,597
|
|
|
10,963
|
|
||
Leasehold improvements
|
9,245
|
|
|
9,301
|
|
||
Furniture and fixtures
|
2,770
|
|
|
2,580
|
|
||
Subtotal
|
129,561
|
|
|
109,252
|
|
||
Less accumulated depreciation and amortization
|
(29,663
|
)
|
|
(23,680
|
)
|
||
Property and equipment, net
|
$
|
99,898
|
|
|
$
|
85,572
|
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
Rebates and other sales deductions
|
$
|
71,472
|
|
|
$
|
67,454
|
|
Employee compensation and benefits
|
39,768
|
|
|
35,595
|
|
||
Royalties
|
6,791
|
|
|
4,211
|
|
||
Clinical trial accruals
|
6,310
|
|
|
1,601
|
|
||
Sales returns reserve
|
5,010
|
|
|
6,110
|
|
||
Inventory-related accruals
|
4,746
|
|
|
1,017
|
|
||
Professional fees
|
4,615
|
|
|
3,038
|
|
||
Accrued interest
|
2,607
|
|
|
4,043
|
|
||
Accrued construction-in-progress
|
929
|
|
|
1,637
|
|
||
Contract claim settlement
|
—
|
|
|
18,000
|
|
||
Other
|
30,170
|
|
|
21,364
|
|
||
Total accrued liabilities
|
$
|
172,418
|
|
|
$
|
164,070
|
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
1.875% exchangeable senior notes due 2021
|
$
|
575,000
|
|
|
$
|
575,000
|
|
Unamortized discount on 1.875% exchangeable senior notes due 2021
|
(105,829
|
)
|
|
(119,467
|
)
|
||
1.875% exchangeable senior notes due 2021, net
|
469,171
|
|
|
455,533
|
|
||
Borrowings under revolving credit facility
|
1,000,000
|
|
|
—
|
|
||
Term loan
|
714,302
|
|
|
732,398
|
|
||
Other borrowings
|
—
|
|
|
513
|
|
||
Total debt
|
2,183,473
|
|
|
1,188,444
|
|
||
Less current portion
|
36,094
|
|
|
37,587
|
|
||
Total long-term debt
|
$
|
2,147,379
|
|
|
$
|
1,150,857
|
|
Year Ending December 31,
|
Lease
Payments
|
||
2016 (remainder)
|
$
|
3,457
|
|
2017
|
15,465
|
|
|
2018
|
11,901
|
|
|
2019
|
10,375
|
|
|
2020
|
9,606
|
|
|
Thereafter
|
78,037
|
|
|
Total
|
$
|
128,841
|
|
|
Total Shareholders' Equity
|
||
Shareholders' equity at January 1, 2016
|
$
|
1,598,646
|
|
Issuance of ordinary shares in conjunction with employee equity incentive and purchase plans
|
17,951
|
|
|
Employee withholding taxes related to share-based awards
|
(20,595
|
)
|
|
Share-based compensation
|
75,176
|
|
|
Shares repurchased
|
(259,819
|
)
|
|
Other comprehensive income
|
32,096
|
|
|
Net income
|
272,548
|
|
|
Shareholders' equity at September 30, 2016
|
$
|
1,716,003
|
|
|
Attributable to:
|
||||||||||
|
Jazz Pharmaceuticals plc
|
|
Noncontrolling interests
|
|
Total Shareholders' Equity
|
||||||
Shareholders' equity at January 1, 2015
|
$
|
1,371,144
|
|
|
$
|
64
|
|
|
$
|
1,371,208
|
|
Acquisition of noncontrolling interests
|
(5
|
)
|
|
(55
|
)
|
|
(60
|
)
|
|||
Issuance of ordinary shares in conjunction with employee equity incentive and purchase plans
|
34,025
|
|
|
—
|
|
|
34,025
|
|
|||
Employee withholding taxes related to share-based awards
|
(25,402
|
)
|
|
—
|
|
|
(25,402
|
)
|
|||
Share-based compensation
|
67,729
|
|
|
—
|
|
|
67,729
|
|
|||
Tax benefit from employee share options
|
(320
|
)
|
|
—
|
|
|
(320
|
)
|
|||
Shares repurchased
|
(21,302
|
)
|
|
—
|
|
|
(21,302
|
)
|
|||
Other comprehensive income (loss)
|
(109,180
|
)
|
|
6
|
|
|
(109,174
|
)
|
|||
Net income (loss)
|
246,774
|
|
|
(1
|
)
|
|
246,773
|
|
|||
Shareholders' equity at September 30, 2015
|
$
|
1,563,463
|
|
|
$
|
14
|
|
|
$
|
1,563,477
|
|
|
Foreign
Currency Translation Adjustments |
|
Total
Accumulated Other Comprehensive Loss |
||||
Balance at December 31, 2015
|
$
|
(267,472
|
)
|
|
$
|
(267,472
|
)
|
Other comprehensive income
|
32,096
|
|
|
32,096
|
|
||
Balance at September 30, 2016
|
$
|
(235,376
|
)
|
|
$
|
(235,376
|
)
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Xyrem
|
$
|
285,907
|
|
|
$
|
242,899
|
|
|
$
|
816,412
|
|
|
$
|
703,435
|
|
Erwinaze/Erwinase
|
42,986
|
|
|
56,317
|
|
|
143,907
|
|
|
152,821
|
|
||||
Defitelio/defibrotide
|
28,137
|
|
|
19,639
|
|
|
79,280
|
|
|
52,259
|
|
||||
Prialt
®
(ziconotide) intrathecal infusion
|
8,783
|
|
|
6,042
|
|
|
23,065
|
|
|
19,944
|
|
||||
Psychiatry
|
3,875
|
|
|
9,910
|
|
|
14,744
|
|
|
28,375
|
|
||||
Other
|
1,933
|
|
|
3,947
|
|
|
7,239
|
|
|
21,061
|
|
||||
Product sales, net
|
371,621
|
|
|
338,754
|
|
|
1,084,647
|
|
|
977,895
|
|
||||
Royalties and contract revenues
|
2,560
|
|
|
2,118
|
|
|
6,705
|
|
|
6,027
|
|
||||
Total revenues
|
$
|
374,181
|
|
|
$
|
340,872
|
|
|
$
|
1,091,352
|
|
|
$
|
983,922
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
United States
|
$
|
339,825
|
|
|
$
|
305,585
|
|
|
$
|
991,557
|
|
|
$
|
877,397
|
|
Europe
|
25,788
|
|
|
26,076
|
|
|
79,557
|
|
|
82,837
|
|
||||
All other
|
8,568
|
|
|
9,211
|
|
|
20,238
|
|
|
23,688
|
|
||||
Total revenues
|
$
|
374,181
|
|
|
$
|
340,872
|
|
|
$
|
1,091,352
|
|
|
$
|
983,922
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
Express Scripts
|
76
|
%
|
|
71
|
%
|
|
75
|
%
|
|
71
|
%
|
McKesson Corporation and affiliates
|
13
|
%
|
|
14
|
%
|
|
14
|
%
|
|
5
|
%
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
Ireland
|
$
|
63,388
|
|
|
$
|
62,795
|
|
United States
|
27,587
|
|
|
12,794
|
|
||
Italy
|
7,181
|
|
|
7,928
|
|
||
Other
|
1,742
|
|
|
2,055
|
|
||
Total long-lived assets
|
$
|
99,898
|
|
|
$
|
85,572
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Selling, general and administrative
|
$
|
19,511
|
|
|
$
|
19,542
|
|
|
$
|
60,664
|
|
|
$
|
54,843
|
|
Research and development
|
4,056
|
|
|
2,786
|
|
|
10,867
|
|
|
10,137
|
|
||||
Cost of product sales
|
1,307
|
|
|
786
|
|
|
2,959
|
|
|
2,253
|
|
||||
Total share-based compensation expense, pre-tax
|
24,874
|
|
|
23,114
|
|
|
74,490
|
|
|
67,233
|
|
||||
Tax benefit from share-based compensation expense
|
(7,255
|
)
|
|
(6,658
|
)
|
|
(21,413
|
)
|
|
(19,722
|
)
|
||||
Total share-based compensation expense, net of tax
|
$
|
17,619
|
|
|
$
|
16,456
|
|
|
$
|
53,077
|
|
|
$
|
47,511
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Shares underlying options granted (in thousands)
|
147
|
|
|
106
|
|
|
1,247
|
|
|
1,056
|
|
||||
Grant date fair value
|
$
|
42.89
|
|
|
$
|
60.34
|
|
|
$
|
40.85
|
|
|
$
|
57.85
|
|
Black-Scholes option pricing model assumption information:
|
|
|
|
|
|
|
|
||||||||
Volatility
|
37
|
%
|
|
40
|
%
|
|
39
|
%
|
|
39
|
%
|
||||
Expected term (years)
|
4.2
|
|
|
4.2
|
|
|
4.2
|
|
|
4.2
|
|
||||
Range of risk-free rates
|
0.8-1.0%
|
|
|
1.3-1.4%
|
|
|
0.8-1.5%
|
|
|
1.1-1.4%
|
|
||||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
RSUs granted (in thousands)
|
59
|
|
|
40
|
|
|
495
|
|
|
406
|
|
||||
Grant date fair value
|
$
|
138.55
|
|
|
$
|
179.10
|
|
|
$
|
126.80
|
|
|
$
|
175.22
|
|
|
Termination Benefits
|
||
Balance at December 31, 2015
|
$
|
1,105
|
|
Expense
|
1,520
|
|
|
Payments
|
(2,305
|
)
|
|
Balance at September 30, 2016
|
$
|
320
|
|
•
|
Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
|
•
|
Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
|
•
|
Defitelio
®
(defibrotide sodium)
, a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, or SOS, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio
®
(defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy.
|
•
|
Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications;
|
•
|
Acquiring clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
|
•
|
Pursuing targeted development of post-discovery differentiated product candidates.
|
Project
|
Disease Area
|
Status
|
Sleep
|
|
|
JZP-110
|
Excessive sleepiness, or ES, in obstructive sleep apnea, or OSA
|
Patient enrollment in two Phase 3 trials completed in third quarter of 2016; expect preliminary data in first quarter of 2017; subject to results, expect to submit an NDA to the FDA in late 2017
|
JZP-110
|
ES in narcolepsy
|
Expect to complete patient enrollment in Phase 3 trial in fourth quarter of 2016; expect preliminary data in second quarter of 2017; subject to results, expect to submit an NDA to the FDA in late 2017
|
Xyrem
|
EDS and cataplexy in pediatric narcolepsy patients with cataplexy
|
Enrollment for Phase 3 trial completed in fourth quarter of 2016; subject to results of trial, expect to submit a supplemental NDA, or sNDA, and pediatric written request report to the FDA in late 2017
|
JZP-507
|
EDS and cataplexy in narcolepsy
|
Expect to complete pivotal bioequivalence, or BE, study in 2017; subject to results of study, expect to submit an NDA to the FDA in early 2018
|
JZP-258
|
EDS and cataplexy in narcolepsy
|
Expect to initiate Phase 3 trial in the EU and U.S. by early 2017
|
Oxybate once-nightly dosing
|
Narcolepsy
|
Program progressing; evaluation of deuterated oxybate continues as part of once-nightly development process
|
Hematology/Oncology
|
|
|
Vyxeos
|
High-risk (secondary) AML
|
Initiated a rolling submission of an NDA to the FDA in third quarter of 2016; expect to complete the NDA submission in first quarter of 2017
|
Defibrotide
|
Prevention of VOD in high-risk patients following HSCT
|
Activated clinical sites in Phase 3 trial in third quarter of 2016
|
•
|
JZP-110.
|
•
|
Xyrem.
|
•
|
JZP-507.
|
•
|
JZP-258.
|
•
|
Erwinaze.
We are pursuing activities related to the potential development of an effective and well-tolerated long-acting recombinant crisantaspase that could offer meaningful clinical benefits compared to Erwinaze. We are also assessing the potential to pursue regulatory approval of Erwinaze in additional countries.
|
•
|
Vyxeos.
Celator completed a Phase 3 clinical trial in high-risk (secondary) AML. Vyxeos is currently not approved as a marketed product in any jurisdiction. We initiated a rolling submission of an NDA for Vyxeos to the FDA in the third quarter of 2016. We expect to complete the NDA submission in the first quarter of 2017 and to make a regulatory submission for Vyxeos in Europe in the second half of 2017. FDA Breakthrough Therapy designation has been granted for Vyxeos for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes. Breakthrough Therapy designation is a process designed to expedite the development and review of a drug that is intended to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. We are also assessing the potential for approval of Vyxeos in other countries and for development of Vyxeos in indications in addition to the treatment of high risk (secondary) AML.
|
•
|
Defibrotide.
|
•
|
the acceptance of Defitelio in the U.S. by hospital pharmacy and therapeutics committees and the availability of adequate coverage and reimbursement by government programs and third party payors;
|
•
|
U.S. market acceptance of Defitelio at its commercial price now that it is no longer available to new patients under an expanded access treatment protocol;
|
•
|
the lack of experience of U.S. physicians in diagnosing and treating VOD, particularly in adults, and the possibility that physicians may delay initiation of treatment or terminate treatment before the end of the recommended dosing schedule;
|
•
|
our ability to successfully maintain or grow sales of Defitelio in Europe;
|
•
|
delays or problems in the supply or manufacture of the product;
|
•
|
the limited size of the population of VOD patients who are indicated for treatment with Defitelio (particularly if changes in HSCT treatment protocols reduce the incidence of VOD);
|
•
|
our ability to meet the post-marketing commitments and requirements imposed by the FDA in connection with its approval of our NDA for Defitelio; and
|
•
|
our ability to obtain marketing approval in other countries and to develop the product for additional indications.
|
•
|
our ability to successfully obtain marketing approval for Vyxeos in the U.S. and Europe;
|
•
|
risks associated with developing products based on the CombiPlex technology platform that we acquired in the Celator Acquisition, such as Vyxeos, the first injectable fixed ratio, drug delivery combination oncology product that the FDA would potentially be considering for approval;
|
•
|
our ability to differentiate Vyxeos from other liposomal chemotherapies and generically available chemotherapy combinations with which physicians and treatment centers are more familiar;
|
•
|
the need to establish pricing and reimbursement support for Vyxeos in the event we are able to obtain marketing approval for Vyxeos in the U.S. or in other countries;
|
•
|
the acceptance of Vyxeos in the U.S. and other countries by hospital pharmacy and therapeutics committees and the availability of adequate coverage and reimbursement by government programs and third party payors;
|
•
|
delays or problems in the supply or manufacture of the product, including with respect to the requirement of the third parties upon which we rely to manufacture Vyxeos and its active pharmaceutical ingredients, or APIs, to obtain the approval of the FDA and/or other regulatory authorities to manufacture Vyxeos; and
|
•
|
the limited size of the population of AML patients who may potentially be indicated for treatment with Vyxeos.
|
•
|
the challenges of protecting and enhancing our intellectual property rights;
|
•
|
the challenges of achieving and maintaining commercial success of our products;
|
•
|
delays or problems in the supply or manufacture of our products and product candidates, particularly with respect to certain products as to which we maintain limited inventories, and our dependence on single source suppliers for most of our products, product candidates and APIs;
|
•
|
the need to obtain and maintain 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 U.S. and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the U.S. in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by government programs and third party payors;
|
•
|
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business;
|
•
|
the challenges of compliance with the requirements of 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, patient assistance programs, adverse event reporting and product recalls or withdrawals;
|
•
|
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;
|
•
|
the risks associated with business combination or product or product candidate acquisition transactions, including risks associated with the Celator Acquisition, such as the challenges inherent in the integration of acquired businesses with our historical business, the increase in geographic dispersion among our centers of operation 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 transactions; and
|
•
|
possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations, as a result of, among other things, the Celator Acquisition.
|
|
Three Months Ended
September 30, |
|
Increase/
|
|
Nine Months Ended
September 30, |
|
Increase/
|
||||||||||||||
|
2016 (1)
|
|
2015
|
|
(Decrease)
|
|
2016 (1)
|
|
2015
|
|
(Decrease)
|
||||||||||
Product sales, net
|
$
|
371,621
|
|
|
$
|
338,754
|
|
|
10
|
%
|
|
$
|
1,084,647
|
|
|
$
|
977,895
|
|
|
11
|
%
|
Royalties and contract revenues
|
2,560
|
|
|
2,118
|
|
|
21
|
%
|
|
6,705
|
|
|
6,027
|
|
|
11
|
%
|
||||
Cost of product sales (excluding amortization of intangible assets)
|
24,311
|
|
|
28,385
|
|
|
(14
|
%)
|
|
71,730
|
|
|
78,496
|
|
|
(9
|
)%
|
||||
Selling, general and administrative
|
124,368
|
|
|
104,044
|
|
|
20
|
%
|
|
375,751
|
|
|
323,564
|
|
|
16
|
%
|
||||
Research and development
|
47,796
|
|
|
50,784
|
|
|
(6
|
%)
|
|
118,139
|
|
|
105,798
|
|
|
12
|
%
|
||||
Acquired in-process research and development
|
15,000
|
|
|
—
|
|
|
N/A(2)
|
|
|
23,750
|
|
|
—
|
|
|
N/A(2)
|
|
||||
Intangible asset amortization
|
26,453
|
|
|
26,127
|
|
|
1
|
%
|
|
75,832
|
|
|
74,472
|
|
|
2
|
%
|
||||
Interest expense, net
|
18,498
|
|
|
12,650
|
|
|
46
|
%
|
|
42,811
|
|
|
44,707
|
|
|
(4
|
)%
|
||||
Foreign currency loss
|
749
|
|
|
977
|
|
|
(23
|
)%
|
|
1,568
|
|
|
646
|
|
|
143
|
%
|
||||
Loss on extinguishment and modification of debt
|
638
|
|
|
—
|
|
|
N/A(2)
|
|
|
638
|
|
|
16,815
|
|
|
(96
|
%)
|
||||
Income tax provision
|
29,120
|
|
|
29,945
|
|
|
(3
|
%)
|
|
108,482
|
|
|
92,651
|
|
|
17
|
%
|
||||
Equity in loss of investee, net of tax
|
103
|
|
|
—
|
|
|
N/A(2)
|
|
|
103
|
|
|
—
|
|
|
N/A(2)
|
|
||||
Net loss attributable to noncontrolling interests, net of tax
|
—
|
|
|
—
|
|
|
N/A(2)
|
|
|
—
|
|
|
1
|
|
|
N/A(2)
|
|
(1)
|
Our financial results include the financial results of the historical Celator business since the closing of the Celator Acquisition on July 12, 2016.
|
(2)
|
Comparison to prior period not meaningful.
|
|
Three Months Ended
September 30, |
|
Increase/
|
|
Nine Months Ended
September 30, |
|
Increase/
|
||||||||||||||
|
2016
|
|
2015
|
|
(Decrease)
|
|
2016
|
|
2015
|
|
(Decrease)
|
||||||||||
Xyrem
|
$
|
285,907
|
|
|
$
|
242,899
|
|
|
18
|
%
|
|
$
|
816,412
|
|
|
$
|
703,435
|
|
|
16
|
%
|
Erwinaze/Erwinase
|
42,986
|
|
|
56,317
|
|
|
(24
|
%)
|
|
143,907
|
|
|
152,821
|
|
|
(6
|
%)
|
||||
Defitelio/defibrotide
|
28,137
|
|
|
19,639
|
|
|
43
|
%
|
|
79,280
|
|
|
52,259
|
|
|
52
|
%
|
||||
Prialt
®
(ziconotide) intrathecal infusion
|
8,783
|
|
|
6,042
|
|
|
45
|
%
|
|
23,065
|
|
|
19,944
|
|
|
16
|
%
|
||||
Psychiatry
|
3,875
|
|
|
9,910
|
|
|
(61
|
)%
|
|
14,744
|
|
|
28,375
|
|
|
(48
|
)%
|
||||
Other
|
1,933
|
|
|
3,947
|
|
|
(51
|
)%
|
|
7,239
|
|
|
21,061
|
|
|
(66
|
)%
|
||||
Product sales, net
|
371,621
|
|
|
338,754
|
|
|
10
|
%
|
|
1,084,647
|
|
|
977,895
|
|
|
11
|
%
|
||||
Royalties and contract revenues
|
2,560
|
|
|
2,118
|
|
|
21
|
%
|
|
6,705
|
|
|
6,027
|
|
|
11
|
%
|
||||
Total revenues
|
$
|
374,181
|
|
|
$
|
340,872
|
|
|
10
|
%
|
|
$
|
1,091,352
|
|
|
$
|
983,922
|
|
|
11
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Clinical studies and outside services
|
$
|
31,040
|
|
|
$
|
15,732
|
|
|
$
|
74,898
|
|
|
$
|
47,045
|
|
Personnel expenses
|
12,957
|
|
|
8,437
|
|
|
34,184
|
|
|
28,291
|
|
||||
Milestone
|
—
|
|
|
25,000
|
|
|
—
|
|
|
25,000
|
|
||||
Other
|
3,799
|
|
|
1,615
|
|
|
9,057
|
|
|
5,462
|
|
||||
Total
|
$
|
47,796
|
|
|
$
|
50,784
|
|
|
$
|
118,139
|
|
|
$
|
105,798
|
|
|
Nine Months Ended
September 30, |
||||||
|
2016
|
|
2015
|
||||
Net cash provided by operating activities
|
$
|
409,841
|
|
|
$
|
412,202
|
|
Net cash provided by (used in) investing activities
|
(1,747,441
|
)
|
|
1,112
|
|
||
Net cash provided by (used in) financing activities
|
713,032
|
|
|
(90,462
|
)
|
||
Effect of exchange rates on cash and cash equivalents
|
2,350
|
|
|
(8,035
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
(622,218
|
)
|
|
$
|
314,817
|
|
|
Payments Due By Period
|
||||||||||||||||||
Contractual Obligations (1)
|
Total
|
|
Less than
1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than
5 years
|
||||||||||
Term loan - principal
|
$
|
721,875
|
|
|
$
|
36,094
|
|
|
$
|
90,234
|
|
|
$
|
595,547
|
|
|
$
|
—
|
|
Term loan - interest (2)
|
75,990
|
|
|
18,129
|
|
|
33,314
|
|
|
24,547
|
|
|
—
|
|
|||||
2021 Notes - principal
|
575,000
|
|
|
—
|
|
|
—
|
|
|
575,000
|
|
|
—
|
|
|||||
2021 Notes - interest (3)
|
53,907
|
|
|
10,781
|
|
|
21,563
|
|
|
21,563
|
|
|
—
|
|
|||||
Revolving credit facility - principal
|
1,000,000
|
|
|
—
|
|
|
—
|
|
|
1,000,000
|
|
|
—
|
|
|||||
Revolving credit facility - interest (2)
|
123,323
|
|
|
26,791
|
|
|
51,064
|
|
|
45,468
|
|
|
—
|
|
|||||
Revolving credit facility - commitment fee (4)
|
4,233
|
|
|
885
|
|
|
1,771
|
|
|
1,577
|
|
|
—
|
|
|||||
Commitment to investee (5)
|
20,000
|
|
|
5,000
|
|
|
10,000
|
|
|
5,000
|
|
|
—
|
|
|||||
Purchase obligations (6)
|
24,481
|
|
|
23,121
|
|
|
410
|
|
|
452
|
|
|
498
|
|
|||||
Operating and facility lease obligations (7)
|
128,841
|
|
|
14,317
|
|
|
24,423
|
|
|
19,240
|
|
|
70,861
|
|
|||||
Total
|
$
|
2,727,650
|
|
|
$
|
135,118
|
|
|
$
|
232,779
|
|
|
$
|
2,288,394
|
|
|
$
|
71,359
|
|
(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. In 2014, we signed a definitive agreement with Aerial under which we acquired worldwide development, manufacturing and commercial rights to JZP-110 (other than in certain jurisdictions in Asia where SK retains rights). Aerial and SK are currently eligible to receive milestone payments up to an aggregate of $270 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. In July 2016, we entered into an agreement with Pfenex under which Pfenex granted us worldwide rights to develop and commercialize multiple early stage hematology product candidates. The agreement also includes an option for us to negotiate a license for a recombinant pegaspargase product candidate with Pfenex. Under the agreement, Pfenex received upfront and option payments totaling $15 million and may be eligible to receive additional payments of up to $166 million based on the achievement of development, regulatory, and sales milestones. Potential future milestone payments to other third parties under other agreements could be up to an aggregate of $257 million, of which up to $120 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 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)
|
Estimated interest was calculated based on the interest rates in effect as of
September 30, 2016
. The interest rate for our term loan and revolving credit facility borrowings was
2.52%
at
September 30, 2016
.
|
(3)
|
We used the fixed interest rate of
1.875%
to estimate interest owed on the 2021 Notes as of
September 30, 2016
until the final maturity date in August 2021.
|
(4)
|
Our revolving credit facility has a commitment fee payable on the undrawn amount ranging from 0.25% to 0.35% per annum based upon our secured leverage ratio. In the table above, we used a rate of 0.35% and assumed undrawn amounts of
$249.5 million
as of
September 30, 2016
to estimate commitment fees owed. Undrawn borrowing capacity as of
September 30, 2016
does not include an amount of
$0.5 million
committed under an outstanding letter of credit.
|
(5)
|
We committed to invest $25.0 million in Arrivo Bioventures, LLC which can be called on an annual basis over a five year period. The first capital call of $5.0 million was made during the second quarter of 2016. Our equity method investment is included within other non-current assets on the condensed consolidated balance sheet as of
September 30, 2016
.
|
(6)
|
Consists primarily of non-cancelable commitments to third party manufacturers.
|
(7)
|
Consists primarily of the minimum lease payments for our office buildings and automobile lease payments for our sales force, including a lease agreement we entered into in January 2015 to lease office space located in Palo Alto, California. We expect to occupy this office space by the end of 2017. We are obligated to make lease payments totaling approximately
$88 million
over the initial term of the lease. Not included in the table above are our estimated costs of approximately $20 million associated with the design, development and construction of tenant improvements under this lease agreement, which estimate does not include a tenant improvement allowance to be provided by the landlord. Operating expenses associated with our leased office buildings are also not included in table above.
|
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 product for treating cataplexy and/or excessive daytime sleepiness, or EDS, in narcolepsy;
|
•
|
changed or increased regulatory restrictions, including changes to our Xyrem risk evaluation and mitigation strategy, or REMS, the development of a single shared REMS for sodium oxybate with or by potential generic competitors or other regulatory actions by the FDA;
|
•
|
our suppliers’ ability to obtain sufficient quotas from the U.S. Drug Enforcement Administration, or DEA, to satisfy our needs for Xyrem;
|
•
|
any supply, manufacturing or distribution problems arising with any of our suppliers or distributors, most of whom are sole source providers for us;
|
•
|
any increase in pricing pressure from or restrictions on reimbursement imposed by third party payors;
|
•
|
changes in healthcare laws and policy, including changes in requirements for patient assistance programs, rebates, reimbursement and coverage by federal healthcare programs;
|
•
|
continued acceptance of Xyrem by physicians and patients, even in the face of negative publicity that surfaces from time to time;
|
•
|
changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem; and
|
•
|
operational disruptions at the central pharmacy or any failure to comply with our REMS obligations to the satisfaction of the FDA.
|
•
|
the acceptance of Defitelio in the U.S. by hospital pharmacy and therapeutics committees and the availability of adequate coverage and reimbursement by government programs and third party payors;
|
•
|
U.S. market acceptance of Defitelio at its commercial price now that it is no longer available to new patients under an expanded access treatment protocol;
|
•
|
the lack of experience of U.S. physicians in diagnosing and treating VOD, particularly in adults, and the possibility that physicians may delay initiation of treatment or terminate treatment before the end of the recommended dosing schedule;
|
•
|
our ability to successfully maintain or grow sales of Defitelio in Europe;
|
•
|
delays or problems in the supply or manufacture of the product;
|
•
|
the limited size of the population of VOD patients who are indicated for treatment with Defitelio (particularly if changes in HSCT treatment protocols reduce the incidence of VOD);
|
•
|
our ability to meet the post-marketing commitments and requirements imposed by the FDA in connection with its approval of our NDA for Defitelio; and
|
•
|
our ability to obtain marketing approval in other countries and to develop the product for additional indications.
|
•
|
our ability to successfully obtain marketing approval for Vyxeos in the U.S. and Europe;
|
•
|
risks associated with developing products based on the CombiPlex technology platform that we acquired in the Celator Acquisition, such as Vyxeos, the first injectable fixed ratio, drug delivery combination oncology product that the FDA would potentially be considering for approval;
|
•
|
our ability to differentiate Vyxeos from other liposomal chemotherapies and generically available chemotherapy combinations with which physicians and treatment centers are more familiar;
|
•
|
the need to establish pricing and reimbursement support for Vyxeos in the event we are able to obtain marketing approval for Vyxeos in the U.S. or in other countries;
|
•
|
the acceptance of Vyxeos in the U.S. and other countries by hospital pharmacy and therapeutics committees and the availability of adequate coverage and reimbursement by government programs and third party payors;
|
•
|
delays or problems in the supply or manufacture of the product, including with respect to the requirement of the third parties upon which we rely to manufacture Vyxeos and its APIs, to obtain the approval of the FDA and/or other regulatory authorities to manufacture Vyxeos; and
|
•
|
the limited size of the population of AML patients who may potentially be indicated for treatment with Vyxeos.
|
•
|
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 its diagnosis, and the severity of side effects;
|
•
|
acceptance by physicians and patients of each product as a safe and effective treatment;
|
•
|
availability of sufficient product inventory to meet demand, particularly with respect to Erwinaze;
|
•
|
physicians’ decisions relating to treatment practices based on availability of product inventory;
|
•
|
perceived advantages over alternative treatments;
|
•
|
relative convenience and ease of administration;
|
•
|
physician and patient assessment of the burdens associated with obtaining or maintaining the certifications required under the Xyrem REMS;
|
•
|
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 appropriate pricing and availability of reimbursement from, third party payors.
|
•
|
we are unable to obtain and maintain adequate funding to complete the development of, obtain regulatory approval for and commercialize an acquired product candidate;
|
•
|
a product candidate proves not to be safe or effective in later clinical trials;
|
•
|
a product fails to reach its forecasted commercial potential as a result of pricing pressures;
|
•
|
we experience negative publicity regarding actual or potential future price increases for that product or otherwise; or
|
•
|
the integration of a product or product candidate gives rise to unforeseen difficulties and expenditures.
|
•
|
high acquisition costs;
|
•
|
the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions;
|
•
|
the potential disruption of our historical core business;
|
•
|
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;
|
•
|
the failure to retain key managers and other personnel;
|
•
|
the challenges in controlling additional costs and expenses in connection with and as a result of any acquisition;
|
•
|
the need to write down assets or recognize impairment charges;
|
•
|
the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures; and
|
•
|
any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates.
|
•
|
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 or failures 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 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 in-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, 2016
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
96,550,303
|
|
August 1 - August 31, 2016
|
142,500
|
|
|
$
|
129.40
|
|
|
142,500
|
|
|
$
|
78,114,732
|
|
September 1 - September 30, 2016
|
637,296
|
|
|
$
|
122.60
|
|
|
637,296
|
|
|
$
|
—
|
|
Total
|
779,796
|
|
|
$
|
123.84
|
|
|
779,796
|
|
|
|
(1)
|
This table does not include ordinary shares that we withheld in order to satisfy minimum tax withholding requirements in connection with the vesting and release 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. In November 2015, we announced that our board of directors authorized the use of up to $300 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 depends 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. The share repurchase program may be modified, suspended, otherwise discontinued or resumed at any time without prior notice. We temporarily suspended our share repurchase program in June 2016 in connection with the Celator Acquisition and resumed the program in August 2016. As of
September 30, 2016
, we completed repurchases under this share repurchase program, and no authorized amounts remained under this program.
|
Item 6.
|
Exhibits
|
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 between 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).
|
2.8
|
Amended and Restated Agreement for the Acquisition of the Topaz Portfolio Business of Jazz Pharmaceuticals plc, dated March 20, 2015, between Jazz Pharmaceuticals plc and Essex Bidco Limited (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 March 23, 2015).
|
2.9
|
Agreement and Plan of Merger, dated as of May 27, 2016, by and among Jazz Pharmaceuticals plc, Plex Merger Sub, Inc. and Celator Pharmaceuticals, 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 May 31, 2016).
|
3.1
|
Amended and Restated Memorandum and Articles of Association of Jazz Pharmaceuticals plc, as amended on August 4, 2016 (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceutical plc’s quarterly report on Form 10‑Q (File No. 001-33500), as filed with the SEC on August 9, 2016).
|
4.1
|
Reference is made to Exhibit 3.1.
|
4.2A
|
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).
|
4.2B
|
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).
|
4.2C
|
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).
|
Exhibit
Number
|
Description of Document
|
4.2D
|
Form of 1.875% Exchangeable Senior Note due 2021 (incorporated herein by reference to Exhibit 4.2 in Jazz Pharmaceuticals plc’s current report on Form 8‑K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
10.1
|
Amendment No. 1, dated as of July 12, 2016, to Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceutical plc’s quarterly report on Form 10‑Q (File No. 001-33500), as filed with the SEC on August 9, 2016).
|
10.2+
|
Amended and Restated 2011 Equity Incentive Plan.
|
10.3+
|
Amended and Restated 2007 Non-Employee Directors Stock Award Plan.
|
10.4+
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan.
|
10.5+
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated Non-Employee Directors 2007 Stock Award Plan.
|
10.6+
|
Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan.
|
10.7+
|
Form of U.S. Option Grant Notice and Form of U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan.
|
10.8+
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan.
|
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.
|
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
|
Executive 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 between 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).
|
2.8
|
Amended and Restated Agreement for the Acquisition of the Topaz Portfolio Business of Jazz Pharmaceuticals plc, dated March 20, 2015, between Jazz Pharmaceuticals plc and Essex Bidco Limited (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 March 23, 2015).
|
2.9
|
Agreement and Plan of Merger, dated as of May 27, 2016, by and among Jazz Pharmaceuticals plc, Plex Merger Sub, Inc. and Celator Pharmaceuticals, 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 May 31, 2016).
|
3.1
|
Amended and Restated Memorandum and Articles of Association of Jazz Pharmaceuticals plc, as amended on August 4, 2016 (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceutical plc’s quarterly report on Form 10‑Q (File No. 001-33500), as filed with the SEC on August 9, 2016).
|
4.1
|
Reference is made to Exhibit 3.1.
|
4.2A
|
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).
|
4.2B
|
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).
|
4.2C
|
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).
|
4.2D
|
Form of 1.875% Exchangeable Senior Note due 2021 (incorporated herein by reference to Exhibit 4.2 in Jazz Pharmaceuticals plc’s current report on Form 8‑K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
10.1
|
Amendment No. 1, dated as of July 12, 2016, to Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceutical plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on August 9, 2016).
|
10.2+
|
Amended and Restated 2011 Equity Incentive Plan.
|
10.3+
|
Amended and Restated 2007 Non-Employee Directors Stock Award Plan.
|
10.4+
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan.
|
10.5+
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated Non-Employee Directors 2007 Stock Award Plan.
|
10.6+
|
Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan.
|
10.7+
|
Form of U.S. Option Grant Notice and Form of U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan.
|
10.8+
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan.
|
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.
|
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.
|
General.
|
2.
|
Administration.
|
Participant:
|
|
RSU #:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of RSUs Subject to Award:
|
|
Consideration:
|
Participant's Services
(payment of par value of newly issued shares)
|
Vesting Schedule:
|
Subject to Section 3 of the Agreement and any country-specific Appendix to the Agreement, the Award will vest as follows:
[
______________________________________
]
|
Issuance Schedule:
|
One Ordinary Share will be issuable for each RSU which vests at the time set forth in Section 4 of the Agreement.
|
Optionholder:
|
|
Option #:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of Ordinary Shares Subject to Option:
|
|
Exercise Price (Per Ordinary Share):
|
|
Total Exercise Price:
|
|
Expiration Date:
|
|
Type of Grant:
|
Nonstatutory Stock Option
|
Vesting Schedule:
|
Subject to Section 1 of the Agreement and any country-specific Appendix to the Agreement, this option will vest as follows:
[
___________________
]
|
Payment:
|
By one or a combination of the following items (described in the Agreement):
|
x
|
By cash or check
|
x
|
Pursuant to a Regulation T Program if the Ordinary Shares are publicly traded
|
¨
|
By delivery of already-owned Ordinary Shares if the Ordinary Shares are publicly traded
|
(i)
|
The revocation must be made within one (1) week after acceptance of the option.
|
(ii)
|
The revocation must be in written form to be valid. It is sufficient if you return the Agreement to the Company or the Company’s representative with language which can be
|
A.
|
The individual who has received this Election (the “
Employee
”), who is employed by one of the employing companies listed in the attached schedule (the “
Employer
”) and who is eligible to receive stock options (the “
Awards
”) pursuant to the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan (the “
Plan
”), and
|
B.
|
Jazz Pharmaceuticals plc, Fourth Floor, Connaught House, 1 Burlington Road, Dublin 4, Ireland (the “
Company
”), which may grant Awards under the Plan and is entering into this Election on behalf of the Employer.
|
1.
|
Introduction
|
1.1
|
This Election relates to all Awards granted to the Employee under the Plan on or after January 18, 2012 up to the termination date of the Plan.
|
1.2
|
In this Election the following words and phrases have the following meanings:
|
(a)
|
“
Chargeable Event
” means, in relation to the Awards:
|
(i)
|
the acquisition of securities pursuant to the Awards (within section 477(3)(a) of ITEPA);
|
(ii)
|
the assignment (if applicable) or release of the Awards in return for consideration (within section 477(3)(b) of ITEPA);
|
(iii)
|
the receipt of a benefit in connection with the Awards, other than a benefit within (i) or (ii) above (within section 477(3)(c) of ITEPA);
|
(iv)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 427 of ITEPA); and/or
|
(v)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 439 of ITEPA).
|
(b)
|
“
ITEPA
” means the Income Tax (Earnings and Pensions) Act 2003.
|
(c)
|
“
SSCBA
” means the Social Security Contributions and Benefits Act 1992.
|
1.3
|
This Election relates to the Employer’s secondary Class 1 National Insurance Contributions (the “
Employer’s Liability
”) which may arise on the occurrence of a Chargeable Event in
|
1.4
|
This Election does not apply in relation to any liability, or any part of any liability, arising as a result of regulations being given retrospective effect by virtue of section 4B(2) of either the SSCBA, or the Social Security Contributions and Benefits (Northern Ireland) Act 1992.
|
1.5
|
This Election does not apply to the extent that it relates to relevant employment income which is employment income of the earner by virtue of Chapter 3A of Part VII of ITEPA (employment income: securities with artificially depressed market value).
|
2.
|
The Election
|
3.
|
Payment of the Employer’s Liability
|
3.1
|
The Employee hereby authorises the Company and/or the Employer to collect the Employer’s Liability from the Employee at any time after the Chargeable Event:
|
(i)
|
by deduction from salary or any other payment payable to the Employee at any time on or after the date of the Chargeable Event; and/or
|
(ii)
|
directly from the Employee by payment in cash or cleared funds; and/or
|
(iii)
|
by arranging, on behalf of the Employee, for the sale of some of the securities which the Employee is entitled to receive in respect of the Awards, the proceeds from which must be delivered to the Employer in sufficient time for payment to be made to Her Majesty’s Revenue & Customs (“
HMRC
”) by the due date; and/or
|
(iv)
|
where the proceeds of the gain are to be made through a third party, the Employee will authorize that party to withhold an amount from the payment or to sell some of the securities which the Employee is entitled to receive in respect of the Award, such amount to be paid in sufficient time to enable the Company and/or the Employer to make payment to HMRC by the due date; and/or
|
(v)
|
by any other means specified in the applicable Award agreement entered into between the Employee and the Company.
|
3.2
|
The Company hereby reserves for itself and the Employer the right to withhold the transfer of any securities to the Employee in respect of the Awards until full payment of the Employer’s Liability is received.
|
3.3
|
The Company or the Employer agrees to remit the Employer’s Liability to HMRC on behalf of the Employee within 14 days after the end of the UK tax month during which the Chargeable Event occurs (or within 17 days if payments are made electronically).
|
4.
|
Duration of Election
|
4.1
|
The Employee and the Company agree to be bound by the terms of this Election regardless of whether the Employee is transferred abroad or is not employed by the Employer on the date on which the Employer’s Liability becomes due.
|
4.2
|
This Election will continue in effect until the earliest of the following:
|
(i)
|
the date on which the Employee and the Company agree in writing that it should cease to have effect;
|
(ii)
|
the date on which the Company serves written notice on the Employee terminating its effect;
|
(iii)
|
the date on which HMRC withdraws approval of this Election; or
|
(iv)
|
the date on which, after due payment of the Employer’s Liability in respect of the entirety of the Awards to which this Election relates or could relate, the Election ceases to have effect in accordance with its own terms.
|
Registered Office:
|
EUSA Pharma
The Magdalen Centre
Oxford Science Park
Oxford, OX4 4GA
|
Company Registration Number:
|
4555273
|
Corporation Tax Reference:
|
452/76424 00934
|
Corporation Tax Address:
|
HM Revenue & Customs
CT Operations (Large & Complex Specialist)
16 North
Government Buildings
Ty Glas, Llanishen
Cardiff, CF14 5 FP
|
PAYE Reference:
|
120/WZ72892
|
Participant:
|
|
RSU #:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of RSUs Subject to Award:
|
|
Consideration:
|
Participant's Services
(payment of par value of newly issued shares)
|
Issuance Schedule:
|
One Ordinary Share will be issuable for each RSU which vests at the time set forth in Section 6 of the Agreement.
|
Withholding Right:
o
|
You may direct the Company (i) to withhold, from Ordinary Shares otherwise issuable in respect of the Award, a portion of those Ordinary Shares with an aggregate fair market value (measured as of the delivery date) equal to the amount of the applicable withholding taxes, and (ii) to make a cash payment equal to such fair market value directly to the appropriate taxing authorities, as provided in Section 10 of the Agreement.
|
x
|
None
|
Optionholder:
|
|
Option #:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of Ordinary Shares Subject to Option:
|
|
Exercise Price (Per Ordinary Share):
|
|
Total Exercise Price:
|
|
Expiration Date:
|
|
Type of Grant:
|
¨
Incentive Stock Option
1
¨
Nonstatutory Stock Option
|
Payment:
|
By one or a combination of the following items (described in the Agreement):
|
x
|
By cash, check, bank draft or money order payable to the Company
|
x
|
Pursuant to a Regulation T Program if the Ordinary Shares are publicly traded
|
¨
|
By delivery of already-owned Ordinary Shares if the Ordinary Shares are publicly traded
|
x
|
If and only to the extent this option is a Nonstatutory Stock Option, and subject to the Company's consent at the time of exercise, by a "net exercise" arrangement
|
Participant:
|
|
RSU #:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of RSUs Subject to Award:
|
|
Consideration:
|
Participant's Services
(payment of par value of newly issued shares)
|
Issuance Schedule:
|
One Ordinary Share will be issuable for each RSU which vests at the time set forth in Section 6 of the Agreement.
|
A.
|
The individual who has received this Election (the “
Employee
”), who is employed by one of the employing companies listed in the attached schedule (the “
Employer
”) and who is eligible to receive stock options and/or restricted stock units (together, the “
Awards
”) pursuant to the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (the “
Plan
”), and
|
B.
|
Jazz Pharmaceuticals plc, Fourth Floor, Connaught House, 1 Burlington Road, Dublin 4, Ireland (the “
Company
”), which may grant Awards under the Plan and is entering into this Election on behalf of the Employer.
|
1.
|
Introduction
|
1.1
|
This Election relates to all Awards granted to the Employee under the Plan on or after January 18, 2012 up to the termination date of the Plan.
|
1.2
|
In this Election the following words and phrases have the following meanings:
|
(a)
|
“
Chargeable Event
” means, in relation to the Awards:
|
(i)
|
the acquisition of securities pursuant to the Awards (within section 477(3)(a) of ITEPA);
|
(ii)
|
the assignment (if applicable) or release of the Awards in return for consideration (within section 477(3)(b) of ITEPA);
|
(iii)
|
the receipt of a benefit in connection with the Awards, other than a benefit within (i) or (ii) above (within section 477(3)(c) of ITEPA);
|
(iv)
|
post-acquisition charges relating to the Awards and/or ordinary shares of the Company acquired pursuant to the Awards (within section 427 of ITEPA); and/or
|
(v)
|
post-acquisition charges relating to the Awards and/or ordinary shares of the Company acquired pursuant to the Awards (within section 439 of ITEPA).
|
(b)
|
“
ITEPA
” means the Income Tax (Earnings and Pensions) Act 2003.
|
(c)
|
“
SSCBA
” means the Social Security Contributions and Benefits Act 1992.
|
1.3
|
This Election relates to the Employer’s secondary Class 1 National Insurance Contributions (the “
Employer’s Liability
”) which may arise on the occurrence of a Chargeable Event in respect of the Awards pursuant to section 4(4)(a) and/or paragraph 3B(1A) of Schedule 1 of the SSCBA.
|
1.4
|
This Election does not apply in relation to any liability, or any part of any liability, arising as a result of regulations being given retrospective effect by virtue of section 4B(2) of either the SSCBA, or the Social Security Contributions and Benefits (Northern Ireland) Act 1992.
|
1.5
|
This Election does not apply to the extent that it relates to relevant employment income which is employment income of the earner by virtue of Chapter 3A of Part VII of ITEPA (employment income: securities with artificially depressed market value).
|
2.
|
The Election
|
3.
|
Payment of the Employer’s Liability
|
3.1
|
The Employee hereby authorises the Company and/or the Employer to collect the Employer’s Liability from the Employee at any time after the Chargeable Event:
|
(i)
|
by deduction from salary or any other payment payable to the Employee at any time on or after the date of the Chargeable Event; and/or
|
(ii)
|
directly from the Employee by payment in cash or cleared funds; and/or
|
(iii)
|
by arranging, on behalf of the Employee, for the sale of some of the securities which the Employee is entitled to receive in respect of the Awards, the proceeds from which must be delivered to the Employer in sufficient time for payment to be made to Her Majesty’s Revenue & Customs (“
HMRC
”) by the due date; and/or
|
(iv)
|
where the proceeds of the gain are to be made through a third party, the Employee will authorize that party to withhold an amount from the payment or to sell some of the securities which the Employee is entitled to receive in respect of the Award, such amount to be paid in sufficient
|
(v)
|
by any other means specified in the applicable Award agreement entered into between the Employee and the Company.
|
3.2
|
The Company hereby reserves for itself and the Employer the right to withhold the transfer of any securities to the Employee in respect of the Awards until full payment of the Employer’s Liability is received.
|
3.3
|
The Company agrees to procure the remittance by the Employer of the Employer’s Liability to HMRC on behalf of the Employee within 14 days after the end of the UK tax month during which the Chargeable Event occurs (or within 17 days after the end of the UK tax month during which the Chargeable Event occurs if payments are made electronically).
|
4.
|
Duration of Election
|
4.1
|
The Employee and the Company agree to be bound by the terms of this Election regardless of whether the Employee is transferred abroad or is not employed by the Employer on the date on which the Employer’s Liability becomes due.
|
4.2
|
Any reference to the Company and/or the Employer shall include that entity’s successors in title and assigns as permitted in accordance with the terms of the Plan and relevant award agreement. This Election will continue in effect in respect of any awards which replace the Awards in circumstances where section 483 of ITEPA applies.
|
4.3
|
This Election will continue in effect until the earliest of the following:
|
(i)
|
the date on which the Employee and the Company agree in writing that it should cease to have effect;
|
(ii)
|
the date on which the Company serves written notice on the Employee terminating its effect;
|
(iii)
|
the date on which HMRC withdraws approval of this Election; or
|
(iv)
|
the date on which, after due payment of the Employer’s Liability in respect of the entirety of the Awards to which this Election relates or could relate, the Election ceases to have effect in accordance with its own terms.
|
Registered Office:
|
EUSA Pharma (Europe) Limited
Wing B, Building 5700 Spires House
John Smith Drive - Oxford Business Park South, Oxford OX4 2RW, United Kingdom
|
Company Registration Number:
|
4555273
|
Corporation Tax Reference:
|
452/76424 00934
|
Corporation Tax Address:
|
HM Revenue & Customs
CT Operations (Large & Complex Specialist)
16 North
Government Buildings
Ty Glas, Llanishen
Cardiff, CF14 5 FP
|
PAYE Reference:
|
120/WZ72892
|
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 8, 2016
|
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;
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b)
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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;
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c)
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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
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d)
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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
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5.
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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):
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a)
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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
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b)
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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.
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Date: November 8, 2016
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By:
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/s/ Matthew P. Young
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Matthew P. Young
Executive Vice President and Chief Financial Officer
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1.
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The Company’s Quarterly Report on Form 10-Q for the period ended
September 30, 2016
, 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
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2.
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The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Bruce C. Cozadd
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Bruce C. Cozadd
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Chairman and Chief Executive Officer and Director
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/s/ Matthew P. Young
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Matthew P. Young
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Executive Vice President and Chief Financial Officer
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(1)
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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.
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