JAZZ 2014 Q3 DOC
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 
FORM 10-Q
 
(Mark One)
ý
Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended September 30, 2014
or
¨
Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from              to             
Commission File Number: 001-33500
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter) 
Ireland
98-1032470
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
Fourth Floor, Connaught House,
One Burlington Road, Dublin 4, Ireland
011-353-1-634-7800
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ý    No  ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ý    No  ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
ý
 
Accelerated filer
¨
 
 
 
 
 
Non-accelerated filer
¨
(Do not check if a smaller reporting company)
Smaller reporting company
¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No ý
As of October 28, 2014, 60,491,676 ordinary shares of the registrant, nominal value $0.0001 per share, were outstanding.


Table of Contents


JAZZ PHARMACEUTICALS PLC
QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2014

INDEX
 
 
 
Page
 
 
 
 
Item 1.
 
Condensed Consolidated Balance Sheets – September 30, 2014 and December 31, 2013
 
Condensed Consolidated Statements of Operations - Three and Nine Months Ended September 30, 2014 and 2013
 
Condensed Consolidated Statements of Comprehensive Income (Loss) - Three and Nine Months Ended September 30, 2014 and 2013
 
Condensed Consolidated Statements of Cash Flows – Nine Months Ended September 30, 2014 and 2013
 
 
 
 
Item 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations
 
 
 
Item 3.
 
 
 
Item 4.
 
 
 
 
 
 
Item 1.
 
 
 
Item 1A.
 
 
 
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
 
 
 
Item 6.

We own or have rights to various copyrights, trademarks, and trade names used in our business in the United States and/or other countries, including the following: Jazz Pharmaceuticals®, Xyrem® (sodium oxybate) oral solution, Xyrem Success Program®, Erwinaze® (asparaginase Erwinia chrysanthemi), Erwinase®, Defitelio® (defibrotide), Prialt® (ziconotide) intrathecal infusion, FazaClo® (clozapine, USP), Versacloz® (clozapine) oral suspension, LeukotacTM (inolimomab) and ProstaScint® (capromab pendetide). This report also includes trademarks, service marks, and trade names of other companies.



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PART I – FINANCIAL INFORMATION
 
Item 1.
Financial Statements
JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
 
September 30,
2014
 
December 31,
2013
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
575,040

 
$
636,504

Accounts receivable, net of allowances
187,604

 
124,805

Inventories
37,612

 
28,669

Prepaid expenses
24,206

 
7,183

Deferred tax assets, net
35,696

 
33,613

Other current assets
18,362

 
33,843

Total current assets
878,520

 
864,617

Property and equipment, net
44,205

 
14,246

Intangible assets, net
1,550,624

 
812,396

Goodwill
724,388

 
450,456

Deferred tax assets, net, non-current
101,249

 
74,597

Deferred financing costs
35,068

 
14,605

Other non-current assets
13,482

 
7,304

Total assets
$
3,347,536

 
$
2,238,221

LIABILITIES AND SHAREHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
29,671

 
$
21,005

Accrued liabilities
161,476

 
119,718

Current portion of long-term debt
9,444

 
5,572

Income taxes payable
15,755

 
336

Contingent consideration

 
50,000

Deferred tax liability, net
6,259

 
6,259

Deferred revenue
1,138

 
1,138

Total current liabilities
223,743

 
204,028

Deferred revenue, non-current
4,784

 
5,718

Long-term debt, less current portion
1,331,340

 
544,404

Deferred tax liability, net, non-current
413,460

 
168,497

Other non-current liabilities
33,596

 
20,040

Commitments and contingencies (Note 8)

 


Shareholders’ equity:
 
 
 
Jazz Pharmaceuticals plc shareholders' equity
 
 
 
Ordinary shares
6

 
6

Non-voting euro deferred shares
55

 
55

Capital redemption reserve
471

 
471

Additional paid-in capital
1,431,790

 
1,220,317

Accumulated other comprehensive income (loss)
(57,133
)
 
56,153

Retained earnings (accumulated deficit)
(34,666
)
 
18,532

Total Jazz Pharmaceuticals plc shareholders’ equity
1,340,523

 
1,295,534

Noncontrolling interests
90

 

Total shareholders’ equity
1,340,613

 
1,295,534

Total liabilities and shareholders’ equity
$
3,347,536

 
$
2,238,221

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

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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
 
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Revenues:
 
 
 
 
 
 
 
Product sales, net
$
304,407

 
$
230,386

 
$
838,493

 
$
631,602

Royalties and contract revenues
2,177

 
1,774

 
6,240

 
5,047

Total revenues
306,584

 
232,160

 
844,733

 
636,649

Operating expenses:
 
 
 
 

 
 
Cost of product sales (excluding amortization of acquired developed technologies and intangible asset impairment)
26,994

 
24,252

 
88,610

 
76,503

Selling, general and administrative
93,501

 
74,970

 
300,420

 
223,004

Research and development
22,423

 
11,826

 
60,622

 
27,823

Acquired in-process research and development
75,000

 
988

 
202,000

 
4,988

Intangible asset amortization
30,630

 
19,564

 
94,607

 
58,518

Intangible asset impairment

 

 
32,806

 

Total operating expenses
248,548

 
131,600

 
779,065

 
390,836

Income from operations
58,036

 
100,560

 
65,668

 
245,813

Interest expense, net
(14,530
)
 
(6,202
)
 
(36,035
)
 
(20,743
)
Foreign currency gain (loss)
6,483

 
(614
)
 
6,680

 
(728
)
Loss on extinguishment and modification of debt

 

 

 
(3,749
)
Income before income tax provision
49,989

 
93,744

 
36,313

 
220,593

Income tax provision
24,221

 
18,335

 
60,598

 
59,574

Net income (loss)
25,768

 
75,409

 
(24,285
)
 
161,019

Net income (loss) attributable to noncontrolling interests, net of tax
2

 

 
(1,060
)
 

Net income (loss) attributable to Jazz Pharmaceuticals plc
$
25,766

 
$
75,409

 
$
(23,225
)
 
$
161,019

 
 
 
 
 
 
 
 
Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc:
 
 
 
 
 
 
 
Basic
$
0.43

 
$
1.30

 
$
(0.39
)
 
$
2.76

Diluted
$
0.41

 
$
1.23

 
$
(0.39
)
 
$
2.62

Weighted-average ordinary shares used in calculating net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc:
 
 
 
 
 
 
 
Basic
60,305

 
58,217

 
59,457

 
58,437

Diluted
62,680

 
61,519

 
59,457

 
61,532

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

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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
 
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Net income (loss)
$
25,768

 
$
75,409

 
$
(24,285
)
 
$
161,019

Other comprehensive income (loss):
 
 
 
 
 
 
 
Foreign currency translation adjustments
(117,089
)
 
25,402

 
(113,293
)
 
13,576

Other comprehensive income (loss)
(117,089
)
 
25,402

 
(113,293
)
 
13,576

Total comprehensive income (loss)
(91,321
)
 
100,811

 
(137,578
)
 
174,595

Comprehensive loss attributable to noncontrolling interests, net of tax
(8
)
 

 
(1,067
)
 

Comprehensive income (loss) attributable to Jazz Pharmaceuticals plc
$
(91,313
)
 
$
100,811

 
$
(136,511
)
 
$
174,595

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

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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited) 
 
Nine Months Ended
September 30,
 
2014
 
2013
Operating activities
 
 
 
Net income (loss)
$
(24,285
)
 
$
161,019

Adjustments to reconcile net income (loss) to net cash provided by operating activities:
 
 
 
Amortization of intangible assets
94,607

 
58,518

Share-based compensation
50,618

 
32,139

Intangible asset impairment
32,806

 

Depreciation
5,037

 
2,065

Acquired in-process research and development
202,000

 
4,988

Loss on disposal of property and equipment

 
47

Excess tax benefit from share-based compensation
(4,075
)
 
(82
)
Acquisition accounting inventory fair value step-up adjustments
10,477

 
3,143

Change in fair value of contingent consideration

 
12,900

Deferred income taxes
(36,246
)
 
(17,962
)
Provision for losses on accounts receivable and inventory
2,873

 
1,758

Loss on extinguishment and modification of debt

 
3,749

Other non-cash transactions
221

 
4,435

Changes in assets and liabilities:
 
 
 
Accounts receivable
(50,690
)
 
(37,649
)
Inventories
(10,184
)
 
(3,445
)
Prepaid expenses and other current assets
4,262

 
(11,300
)
Other long-term assets
(5,775
)
 
(3,421
)
Accounts payable
(33,865
)
 
6,670

Accrued liabilities
19,468

 
1,562

Income taxes payable
19,003

 
(19,086
)
Deferred revenue
(918
)
 
(776
)
Contingent consideration
(14,900
)
 

Other non-current liabilities
12,910

 
10,125

Net cash provided by operating activities
273,344

 
209,397

Investing activities
 
 
 
Acquisitions, net of cash acquired
(828,676
)
 

Acquisition of in-process research and development
(202,000
)
 
(4,988
)
Purchases of property and equipment
(22,799
)
 
(6,874
)
  Acquisition of intangible assets

 
(1,300
)
Net cash used in investing activities
(1,053,475
)
 
(13,162
)
Financing activities
 
 
 
Net proceeds from issuance of debt
1,195,366

 
553,425

Proceeds from employee equity incentive and purchase plans and exercise of warrants
48,452

 
23,577

Share repurchases
(29,973
)
 
(102,397
)
Acquisition of noncontrolling interests
(136,950
)
 

Payment of contingent consideration
(35,100
)
 

Payment of employee withholding taxes related to share-based awards
(17,306
)
 
(5,303
)
Excess tax benefit from share-based compensation
4,075

 
82

Repayments of long-term debt
(7,090
)
 
(464,517
)
Repayments under revolving credit facility
(300,000
)
 

Net cash provided by financing activities
721,474

 
4,867

Effect of exchange rates on cash and cash equivalents
(2,807
)
 
164

Net increase (decrease) in cash and cash equivalents
(61,464
)
 
201,266

Cash and cash equivalents, at beginning of period
636,504

 
387,196

Cash and cash equivalents, at end of period
$
575,040

 
$
588,462


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

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JAZZ PHARMACEUTICALS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)

1. The Company and Summary of Significant Accounting Policies
Jazz Pharmaceuticals plc, a public limited company formed under the laws of Ireland, is a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing differentiated products that address unmet medical needs. Our strategy is to continue to create shareholder value by:
Growing sales of the existing products in our portfolio, including by identifying new growth opportunities;
Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
On January 23, 2014, pursuant to a tender offer, we became the indirect majority shareholder of Gentium S.p.A., or Gentium, thereby acquiring control of Gentium on that date. In February 2014, we completed a subsequent offering period of the tender offer, resulting in total purchases pursuant to the tender offer of approximately 98% of the fully diluted voting securities of Gentium. As of September 30, 2014, we had acquired a further 1.8% interest in Gentium for cash consideration of $17.8 million, resulting in an aggregate acquisition cost to us of $994.0 million, comprising cash payments of $1,011.1 million offset by proceeds from the exercise of Gentium share options of $17.1 million. Please see Note 2 for additional information regarding our acquisition of Gentium, which is referred to in this report as the Gentium Acquisition.
Throughout this report, unless otherwise indicated or the context otherwise requires, all references to “Jazz Pharmaceuticals,” “the registrant,” “we,” “us,” and “our” refer to Jazz Pharmaceuticals plc and its consolidated subsidiaries. Throughout this report, all references to “ordinary shares” refer to Jazz Pharmaceuticals plc’s ordinary shares.
Basis of Presentation
These unaudited condensed consolidated financial statements have been prepared following the requirements of the Securities and Exchange Commission, or SEC, for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. generally accepted accounting principles, or GAAP, can be condensed or omitted. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our annual consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2013. The results of operations of the acquired Gentium business, along with the estimated fair values of the assets acquired and liabilities assumed in the transaction, have been included in our condensed consolidated financial statements since we acquired control of Gentium on January 23, 2014, which date we refer to in this report as the closing date of the Gentium Acquisition.
In the opinion of management, these condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair presentation of our financial position and operating results. The results for the three and nine months ended September 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014, for any other interim period or for any future period.
These condensed consolidated financial statements include the accounts of Jazz Pharmaceuticals plc and our subsidiaries and intercompany transactions and balances have been eliminated. We record noncontrolling interests in our condensed consolidated financial statements which represent the ownership interest of minority shareholders in the equity of Gentium. Our condensed consolidated financial statements include the results of operations of businesses we have acquired from the date of each acquisition for the applicable reporting periods.
Reclassifications
Certain prior period amounts presented in these condensed consolidated financial statements and the accompanying footnotes have been reclassified to conform to the current period presentation. Upfront license fees previously classified as research and development expense in the three and nine months ended September 30, 2013, have been reclassified to acquired in-process research and development, or IPR&D, in the condensed consolidated statements of operations and reclassified from operating activities to investing activities in the condensed consolidated statements of cash flows to conform to current period presentation. Inventories of $1.4 million previously classified as raw materials as of December 31, 2013 have been reclassified to work-in-process to conform to the current period presentation.

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Significant Risks and Uncertainties
Our financial results are significantly influenced by sales of Xyrem® (sodium oxybate) oral solution. In the three and nine months ended September 30, 2014, net product sales of Xyrem were $204.3 million and $556.1 million, respectively, which represented 67.1% and 66.3% of total net product sales, respectively. Our ability to maintain or increase sales of Xyrem in its approved indications is subject to a number of risks and uncertainties, including the potential introduction of generic competition, changed or increased regulatory restrictions and continued acceptance of Xyrem as safe and effective by physicians and patients. Five abbreviated new drug applications, or ANDAs, have been filed with the U.S. Food and Drug Administration, or FDA, by third parties seeking to market generic versions of Xyrem, including the most recent in the fourth quarter of 2014. We have initiated lawsuits against four of the third parties, and the litigation proceedings are ongoing; we intend to initiate a lawsuit against the fifth third party. We cannot predict the timing or outcome of these proceedings. Although no trial date has been scheduled in the lawsuit against the first ANDA filer, Roxane Laboratories, Inc., or Roxane, we anticipate that trial on some of the patents in that case could occur as early as the second quarter of 2015. In addition, since late June 2014, petitions for covered business method, or CBM, post-grant patent review by the Patent Trial and Appeal Board, or PTAB, of the U.S. Patent and Trademark Office, or USPTO, have been filed by certain of the ANDA filers with respect to the validity of our patents covering the distribution system for Xyrem. To date, these petitions have not been accepted by the PTAB, and in October 2014, we filed preliminary responses to the petitions in which, among other things, we asserted that the challenged patents should not be subject to CBM review. We cannot predict the outcome of the PTAB’s decision on whether to institute any of the petitioned CBM review proceedings, whether additional post-grant patent review challenges will be filed, the outcome of any CBM review or other proceeding if the PTAB decides to institute one or more CBM review or other proceedings, or the impact any CBM review or other proceeding might have on ongoing ANDA litigation proceedings. We expect that the approval of an ANDA that results in the launch of a generic version of Xyrem, or the approval and launch of other sodium oxybate products that compete with Xyrem, would have a material adverse effect on our business, financial condition, results of operations and growth prospects.
In addition, we are continuing our efforts on various regulatory matters, including updating documents that we have submitted to the FDA on our risk management and controlled distribution system for Xyrem, which we refer to as the Xyrem Risk Management Program. We have not reached agreement with the FDA on certain significant terms of our risk evaluation and mitigation strategies, or REMS, documents for Xyrem. In late 2013, the FDA notified us that it would exercise its claimed authority to modify our REMS and that it would finalize the REMS as modified by the FDA unless we initiated dispute resolution procedures with respect to the modification of the Xyrem deemed REMS.  Among other things, we disagree with the FDA’s position in the late 2013 notice that, as part of the current REMS process, the Xyrem deemed REMS should be modified to enable the distribution of Xyrem through more than one pharmacy, or potentially through retail pharmacies and wholesalers, as well as with certain modifications proposed by the FDA that would, in the FDA’s view, be sufficient to ensure that the REMS includes only those elements necessary to ensure that the benefits of Xyrem outweigh its risks, and that would, in the FDA’s view, reduce the burden on the healthcare system. Given these circumstances, we initiated dispute resolution procedures with the FDA at the end of February 2014. We received the FDA’s denial of our initial dispute resolution submission in the second quarter of 2014, and our dispute is currently subject to further supervisory review at the next administrative level of the FDA. We have received an interim response from the FDA in which the FDA has requested additional information. We expect to provide the requested information and receive the FDA’s response to this further appeal in the fourth quarter of 2014. We cannot predict whether, or on what terms, we will reach agreement with the FDA on final REMS documents for Xyrem, the outcome or timing of the current dispute resolution procedure, whether we will initiate additional dispute resolution proceedings with the FDA or other legal proceedings prior to finalizing the REMS documents, or the outcome or timing of any such proceedings. We expect that final REMS documents for Xyrem will include modifications to, and/or requirements that are not currently implemented in, the Xyrem Risk Management Program. Any such modifications or additional requirements could potentially make it more difficult or expensive for us to distribute Xyrem, make it easier for future generic competitors, and/or negatively affect sales of Xyrem.
We also expect to face pressure to license or share our Xyrem Risk Management Program, which is the subject of multiple issued patents, or elements of our Xyrem Risk Management Program, with generic competitors. In January 2014, the FDA held an initial meeting with us and the then-current Xyrem ANDA applicants to facilitate the development of a single shared system REMS for Xyrem (sodium oxybate). The parties have had numerous interactions with respect to a single shared system REMS since the initial meeting, and we expect the interactions to continue. We cannot predict the outcome or impact on our business of any future action that we may take with respect to the development of a single shared system REMS for Xyrem (sodium oxybate), licensing or sharing our REMS, or the FDA’s response to a certification that a third party had been unable to obtain a license.
Sales of our second largest product, Erwinaze® (asparaginase Erwinia chrysanthemi), called Erwinase® in markets outside of the United States, continue to grow. In the three and nine months ended September 30, 2014, net product sales of Erwinaze/Erwinase were $52.1 million and $146.9 million, respectively, which represented 17.1% and 17.5% of total net

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product sales, respectively. We seek to maintain and increase sales of Erwinaze, as well as to make Erwinaze more widely available, through ongoing research and development activities. However, our ability to successfully and sustainably maintain and grow sales of Erwinaze is subject to a number of risks and uncertainties, including the limited population of patients with acute lymphoblastic leukemia, or ALL, and the incidence of hypersensitivity reactions to E. coli-derived asparaginase within that population, our ability to obtain data on the use of Erwinaze in young adults age 18 to 39 with ALL who are hypersensitive to E. coli-derived asparaginase, as well as our need to apply for and receive marketing authorizations, through the European Union’s, or EU’s, mutual recognition procedure or otherwise, in certain additional countries so we can launch promotional efforts in those countries. Another significant challenge to our ability to maintain current sales levels and to increase sales is our need to avoid supply interruptions of Erwinaze due to capacity constraints, production delays, quality challenges or other manufacturing difficulties. We maintain limited inventory of Erwinaze, which puts us at significant risk of not being able to meet product demand. The current manufacturing capacity for Erwinaze is nearly completely absorbed by demand for the product. As a consequence of constrained manufacturing capacity, we have had an extremely limited ability to build an excess level of product inventory that could be used to absorb disruptions to supply resulting from any quality or other issues. For example, in 2013, we experienced a temporary disruption of supply of Erwinase in the European market due to the failure of a batch to meet certain specifications. If we continue to be subject to capacity constraints or experience quality or other manufacturing challenges in the future, we may be unable to build a desired excess level of product inventory, and our ability to supply the market may be compromised. Although we are taking steps to improve the Erwinaze manufacturing process, if our ongoing efforts are not successful, we could experience additional Erwinaze supply interruptions in the future, which could have a material adverse effect on our sales of and revenues from Erwinaze and limit our potential future maintenance and growth of the market for this product. In addition, while we continue to work with the manufacturer of Erwinaze to evaluate potential steps to expand production capacity to increase the supply of Erwinaze over the longer term to address worldwide demand, our ability to maintain or increase sales of Erwinaze may be limited by our ability to obtain a sufficient supply of the product.
In furtherance of our growth strategy, we made a significant investment in Defitelio® (defibrotide). We added the product to our portfolio as a result of the Gentium Acquisition and secured worldwide rights to the product by acquiring rights to defibrotide in the Americas in August 2014. Our ability to realize the anticipated benefits from this investment is subject to a number of risks and uncertainties, including our ability to successfully commercialize Defitelio in Europe and to obtain marketing approval in other countries, including the United States, so that we can launch promotional efforts in those countries. We commenced the launch of Defitelio in certain countries in Europe in March 2014, and as of October 2014, we had launched Defitelio in Germany, Austria, Italy (with reimbursement under Law 648/96), the United Kingdom and several Nordic countries.  We expect to launch in additional European countries on a rolling basis during the remainder of 2014 and in 2015 and are engaged in pricing and reimbursement submissions in preparation for these planned launches. A key challenge to our success in commercializing Defitelio in Europe is our ability to obtain appropriate pricing and reimbursement approvals in those European countries where we have not yet launched Defitelio, including in countries where pricing and reimbursement approvals are required for launch. If we experience delays and unforeseen difficulties in obtaining favorable pricing and reimbursement approvals, planned launches in the affected countries would be delayed, or, if we are unable to ultimately obtain favorable pricing and reimbursement approvals in countries that represent significant markets, our growth prospects in Europe could be negatively affected.
We are also engaged in activities related to our anticipated submission of a new drug application, or NDA, for potential approval of defibrotide in the United States. We held pre-NDA meetings with the FDA in August 2014 relating to our plans for the submission of an NDA for defibrotide for the treatment of severe hepatic veno-occlusive disease, or VOD, in patients undergoing hematopoietic stem cell transplantation, or HSCT, therapy. Based on these meetings and in light of the current status of our acquisition and remediation of key information to be included in the data package for the NDA, we plan to initiate a rolling submission of an NDA to the FDA by the end of 2014 and to complete the submission in the first half of 2015, and we do not expect to be required to complete any additional clinical trials prior to the completion of the NDA submission. However, we may be unable to acquire and remediate key information in the data package in a timely manner, which would delay our planned NDA submission, and we may be unable to otherwise obtain regulatory approval of defibrotide in the United States in a timely manner, if at all. We also face other challenges that could impact the anticipated value of Defitelio/defibrotide, including the limited size of the population of patients who undergo HSCT therapy and develop severe VOD, the need to establish U.S. pricing and reimbursement support for the product in the event we are able to obtain U.S. marketing approval for defibrotide, the possibility that we may be required to conduct time-consuming and costly clinical trials as a condition of any U.S. marketing approval for the product, the lack of experience of U.S. physicians in diagnosing and treating VOD, and challenges to our ability to develop the product for indications in addition to the treatment of severe VOD in adults and children undergoing HSCT therapy. If sales of Defitelio/defibrotide do not reach the levels we expect, our anticipated revenue from the product would be negatively affected, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

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In addition to risks related specifically to Xyrem, Erwinaze and Defitelio/defibrotide, we are subject to other challenges and risks specific to our business, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including: the challenges of protecting and enhancing our intellectual property rights; delays or problems in the supply or manufacture of our products, particularly with respect to certain products as to which we maintain limited inventories, and our dependence on single source suppliers to continue to meet our ongoing commercial demand or our requirements for clinical trial supplies; the need to obtain 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 United States and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the United States in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by third party payors; and the ongoing regulation and oversight by the FDA, the U.S. Drug Enforcement Administration, or DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals.  For example, in April 2014, we received a Form FDA 483 at the conclusion of a pharmacovigilance inspection conducted by the FDA. The Form FDA 483 included observations relating to certain aspects of our adverse drug experience reporting system for all of our products, including Xyrem. We responded to the Form FDA 483 with a description of the corrective actions and improvements we had implemented before or shortly following the inspection and additional improvements that we planned to implement, and have now implemented, to address the observations in the Form FDA 483. In August 2014, the FDA issued an Establishment Inspection Report to us, which indicates that the inspection is closed.
Other risks and uncertainties related to our ability to execute on our strategy include: the challenges of achieving and maintaining commercial success of our products, such as obtaining sustained acceptance of our products by patients, physicians and payors; the risks associated with business combination or product or product candidate acquisition transactions, such as the challenges inherent in the integration of acquired businesses, including the acquired Gentium business, with our historic business, the increase in geographic dispersion among our centers of operation, taking on the operation of a manufacturing plant as a result of the Gentium Acquisition, and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such acquisition transactions; the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates; the inherent uncertainty associated with the regulatory approval process, especially as we continue to undertake increased activities and make growing investment in our product pipeline development projects; our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business; and possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations, which have increased significantly in 2014.
Business Acquisitions
Our consolidated financial statements include the results of operations of an acquired business from the date of acquisition. We account for acquired businesses using the acquisition method of accounting. The acquisition method of accounting for acquired businesses requires, among other things, that assets acquired, liabilities assumed and any noncontrolling interests in the acquired business be recognized at their estimated fair values as of the acquisition date, with limited exceptions, and that the fair value of acquired IPR&D be recorded on the balance sheet. Also, transaction costs are expensed as incurred. Any excess of the acquisition consideration over the assigned values of the net assets acquired is recorded as goodwill. Contingent consideration is included within the acquisition cost and is recognized at its fair value on the acquisition date. A liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved and changes in fair value are recognized in earnings.
Acquired In-Process Research and Development
The initial costs of rights to IPR&D projects acquired in an asset acquisition are expensed as IPR&D unless the project has an alternative future use. The fair value of IPR&D projects acquired in a business combination are capitalized and accounted for as indefinite-lived intangible assets until the underlying project receives regulatory approval, at which point the intangible asset will be accounted for as a finite-lived intangible asset, or discontinued, at which point the intangible asset will be written off. Development costs incurred after an acquisition are expensed as incurred.
Intangible Assets
Intangible assets with finite useful lives consist primarily of purchased developed technology and are amortized on a straight-line basis over their estimated useful lives, which range from two to 16 years. The estimated useful lives associated with finite-lived intangible assets are consistent with the estimated lives of the associated products and may be modified when

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circumstances warrant. Such assets are reviewed for impairment when events or circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset and its eventual disposition are less than its carrying amount. The amount of any impairment is measured as the difference between the carrying amount and the fair value of the impaired asset.
Concentrations of Risk
Financial instruments that potentially subject us to concentrations of credit risk consist of cash, cash equivalents and marketable securities. Our investment policy permits investments in U.S. federal government and federal agency securities, corporate bonds or commercial paper issued by U.S. corporations, money market instruments, certain qualifying money market mutual funds, certain repurchase agreements, and tax-exempt obligations of U.S. states, agencies and municipalities and places restrictions on credit ratings, maturities, and concentration by type and issuer. We are exposed to credit risk in the event of a default by the financial institutions holding our cash, cash equivalents and marketable securities and issuers of investments to the extent recorded on the balance sheet.
We are also subject to credit risk from our accounts receivable related to our product sales. We monitor our exposure within accounts receivable and record a reserve against uncollectible accounts receivable as necessary. We extend credit to pharmaceutical wholesale distributors and specialty pharmaceutical distribution companies, primarily in the United States, and to other international distributors and hospitals. Customer creditworthiness is monitored and collateral is not required. We monitor deteriorating economic conditions in certain European countries which may result in variability of the timing of cash receipts and an increase in the average length of time that it takes to collect accounts receivable outstanding. Historically, we have not experienced significant credit losses on our accounts receivable and we do not expect to have write-offs or adjustments to accounts receivable which would have a material adverse effect on our financial position, liquidity or results of operations. As of September 30, 2014, five customers accounted for 86% of gross accounts receivable, including Express Scripts Specialty Distribution Services, Inc. and its affiliate CuraScript, Inc., or Express Scripts, which accounted for 62% of gross accounts receivable, Accredo Health Group, Inc., or Accredo, which accounted for 11% of gross accounts receivable, and Idis Limited, which accounted for 10% of gross accounts receivable.  As of December 31, 2013, five customers accounted for 85% of gross accounts receivable, including Express Scripts, which accounted for 69% of gross accounts receivable, and Accredo, which accounted for 9% of gross accounts receivable. 
We depend on single source suppliers and manufacturers for each of our products, product candidates and their active pharmaceutical ingredients.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
Net Income (Loss) per Ordinary Share Attributable to Jazz Pharmaceuticals plc
Basic net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc is based on the weighted-average number of ordinary shares outstanding. Diluted net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc is based on the weighted-average number of ordinary shares outstanding and potentially dilutive ordinary shares outstanding.
Basic and diluted net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc were computed as follows (in thousands, except per share amounts): 

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Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Numerator:
 
 
 
 
 
 
 
Net income (loss) attributable to Jazz Pharmaceuticals plc
$
25,766

 
$
75,409

 
$
(23,225
)
 
$
161,019

Denominator:
 
 
 
 
 
 
 
Weighted-average ordinary shares used in calculating net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - basic
60,305

 
58,217

 
59,457

 
58,437

Dilutive effect of employee equity incentive and purchase plans
2,288

 
1,852

 

 
1,587

Dilutive effect of warrants
87

 
1,450

 

 
1,508

Weighted-average ordinary shares used in calculating net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - diluted
62,680

 
61,519

 
59,457

 
61,532

 
 
 
 
 
 
 
 
Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc:
 
 
 
 
 
 
 
Basic
$
0.43

 
$
1.30

 
$
(0.39
)
 
$
2.76

Diluted
$
0.41

 
$
1.23

 
$
(0.39
)
 
$
2.62

Potentially dilutive ordinary shares from employee equity incentive and purchase plans and warrants were not included in the diluted net loss per ordinary share attributable to Jazz Pharmaceuticals plc for the nine months ended September 30, 2014 because the inclusion of such shares would have an anti-dilutive effect.
Potentially dilutive ordinary shares from our employee equity incentive and purchase plans, warrants and exchangeable senior notes are determined by applying the treasury stock method to the assumed exercise of share options and warrants, the assumed vesting of outstanding restricted stock units, or RSUs, the assumed issuance of ordinary shares under our employee stock purchase plan, or ESPP, and the assumed issuance of ordinary shares upon exchange of our exchangeable senior notes. The effect of approximately 2.9 million ordinary shares issuable upon exchange of our exchangeable senior notes had no effect on diluted net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc because the average price of our ordinary shares for the three and nine months ended September 30, 2014 did not exceed the effective exchange price of $199.77 per ordinary share. For additional information relating to our exchangeable senior notes, see Note 7.
The following table represents the weighted-average ordinary shares that were excluded from the computation of diluted net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc for the periods presented because including them would have an anti-dilutive effect (in thousands): 
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Options to purchase ordinary shares and RSUs
883

 
1,028

 
5,475

 
2,074

1.875% exchangeable senior notes due 2021
1,502

 

 
506

 

Warrants to purchase ordinary shares

 

 
618

 

Ordinary shares under ESPP

 

 
130

 

Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board, or the FASB, issued Accounting Standards Update, or ASU, No. 2014-09, “Revenue from Contracts with Customers”, or ASU No. 2014-09, which states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this, an entity will need to identify the contract with a customer; identify the separate performance obligations in the contract; determine the transaction price; allocate the transaction price to the separate performance obligations in the contract; and recognize revenue when (or as) the entity satisfies each performance obligation. ASU No. 2014-09 will be effective for us beginning January 1, 2017 and can be adopted on a full retrospective basis or on a modified retrospective basis. We are currently assessing our approach to the adoption of this standard and the impact on our results of operations and financial position.

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In April 2014, the FASB issued ASU No. 2014-08, “Presentation of Financial Statements (Topic 205) and Property, Plant, and Equipment (Topic 360): Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity”, or ASU 2014-08. Under ASU 2014-08, only disposals representing a strategic shift in operations should be presented as discontinued operations. Those strategic shifts should have a major effect on the organization’s operations and financial results. Additionally, ASU 2014-08 requires expanded disclosures about discontinued operations that will provide financial statement users with more information about the assets, liabilities, income, and expenses of discontinued operations. ASU 2014-08 is effective for fiscal and interim periods beginning on or after December 15, 2014, with early adoption permitted. The impact of the adoption of this ASU on our results of operations, financial position, cash flows and disclosures will be based on our future disposal activity.

2. Business Combination and Asset Acquisitions
Gentium Acquisition
On December 19, 2013, we entered into a definitive agreement with Gentium, or the Gentium tender offer agreement, pursuant to which we made a cash tender offer of $57.00 per share for all outstanding Gentium ordinary shares and American Depositary Shares, or ADSs. As of the expiration of the initial offering period on January 22, 2014, 12,244,156 Gentium ordinary shares and ADSs were properly tendered and not withdrawn in the tender offer. These ordinary shares and ADSs represented approximately 79% of Gentium’s issued and outstanding ordinary shares and ADSs and 69% of the fully diluted number of ordinary shares and ADSs (in each case without duplication for ordinary shares underlying ADSs). All properly tendered ordinary shares and ADSs as of such date were accepted for payment, which was made in accordance with the terms of the tender offer.
Upon payment for the properly tendered ordinary shares and ADSs on January 23, 2014, we became the indirect majority shareholder of Gentium and acquired control of Gentium. Following the expiration of the initial offering period, and in accordance with the terms of the Gentium tender offer agreement, we commenced a subsequent offering period to acquire all remaining untendered ordinary shares and ADSs. The subsequent offering period expired on February 20, 2014. In total, pursuant to the tender offer agreement, we purchased approximately 98% of Gentium’s fully diluted ordinary shares and ADSs. In June and August 2014, we acquired additional Gentium ordinary shares, representing a further 1.8% interest in Gentium, for cash consideration of $17.8 million. As of September 30, 2014, the aggregate acquisition cost of the Gentium ordinary shares and ADSs was $994.0 million, comprising cash payments of $1,011.1 million offset by proceeds from the exercise of Gentium share options of $17.1 million. $857.1 million of the acquisition consideration is attributable to the 12,244,156 Gentium ordinary shares and ADSs purchased on the closing date of the Gentium Acquisition, as well as 1,345,023 ADSs committed to tender in accordance with the guaranteed delivery procedures contemplated by the tender offer and options to acquire 1,666,608 ordinary shares of Gentium subject to support agreements requiring that such options be exercised and the underlying ordinary shares be tendered in a subsequent offering period. These ADSs and ordinary shares represented in the aggregate approximately 86% of the fully diluted number of ordinary shares and ADSs of Gentium.  The remaining $137.0 million of the acquisition cost is attributable to the acquisition of an additional 12% of the fully diluted Gentium ordinary shares and ADSs during the subsequent offering period of the tender offer and the acquisition of an additional 1.8% interest in Gentium in June and August 2014, which is accounted for as an acquisition of noncontrolling interests.
We believe the Gentium Acquisition provides us with an opportunity to diversify our development and commercial portfolio and complement our clinical experience in hematology/oncology and our expertise in reaching targeted physicians who treat serious medical conditions.
The Gentium Acquisition was accounted for using the acquisition method of accounting under which assets and liabilities of Gentium were recorded at their respective estimated fair values as of the closing date of the Gentium Acquisition and added to the assets and liabilities of Jazz Pharmaceuticals plc, including an amount for goodwill representing the difference between the acquisition consideration and the estimated fair value of the identifiable net assets. The results of operations of Gentium and the estimated fair values of the assets acquired and liabilities assumed have been included in our consolidated financial statements since the closing date of the Gentium Acquisition.
During the nine months ended September 30, 2014, we incurred $10.0 million in acquisition-related costs related to the Gentium Acquisition, which primarily consisted of banking, legal, accounting and valuation-related expenses. In addition, during the three and nine months ended September 30, 2014, we incurred $0.3 million and $4.7 million, respectively, related to change in control obligations associated with the Gentium Acquisition. These expenses were recorded in selling, general and administrative expense in the accompanying condensed consolidated statements of operations. The change in control obligations are included within accrued liabilities in the accompanying condensed consolidated balance sheets. During the three and nine months ended September 30, 2014, our condensed consolidated statements of operations included revenues of $21.1 million and $57.1 million, respectively, from the acquired Gentium business, as measured from the closing date of the Gentium

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Acquisition. The portion of total expenses and net income associated with the acquired Gentium business was not separately identifiable due to the integration of Gentium operations with our historic operations.
The acquisition consideration (not including the acquisition cost of $119.2 million to acquire the 12% noncontrolling interests in the subsequent offering period of the tender offer and the acquisition cost of $17.8 million to acquire the 1.8% noncontrolling interests in June and August 2014) was comprised of (in thousands): 
Cash consideration for shares acquired in initial tender offer period
$
697,917

Liability for shares committed under guaranteed delivery procedures
76,666

Liability for options committed for exercise
82,503

Total acquisition consideration
$
857,086

The fair values of assets acquired and liabilities assumed at the closing date of the Gentium Acquisition, as well as the fair value at the acquisition date of the noncontrolling interests in Gentium, are summarized below (in thousands):
Cash and cash equivalents
$
28,410

Short-term deposit
5,418

Accounts receivable (1)
13,855

Inventories
13,525

Prepaid and other current assets
1,383

Intangible assets
960,350

Goodwill
308,642

Deferred tax assets
22,999

Property, plant and equipment
10,201

Other long-term assets
431

Accounts payable
(11,778
)
Accrued expenses
(51,477
)
Income taxes payable
(502
)
Other long-term liabilities
(654
)
Debt (current and long-term)
(2,351
)
Deferred tax liabilities
(304,788
)
Noncontrolling interests
(136,578
)
Total acquisition consideration
$
857,086

 ___________________
(1)
The estimated fair value of trade receivables acquired was $13.9 million and the gross contractual amount was $14.9 million, of which we expect that $1.0 million will be uncollectible.
The intangible assets as of the closing date of the Gentium Acquisition included (in thousands): 
Finite-lived intangible assets:
 
Currently marketed product:
 
Defibrotide VOD (Non Americas)
$
719,500

Manufacturing contracts
14,500

Tradename
350

Total finite-lived intangible assets
734,350

IPR&D:
 
Defibrotide VOD Prophylaxis
168,000

Defibrotide VOD (Americas)
58,000

Total IPR&D
226,000

Total intangible assets
$
960,350

The fair value of the currently marketed product was determined using the income approach. The income approach explicitly recognizes that the fair value of an asset is premised upon the expected receipt of future economic benefits such as earnings and cash inflows based on current sales projections and estimated costs for each product line. Indications of value

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were developed by discounting these benefits to their present worth at a discount rate that reflects the current return requirements of the market. The fair value of the currently marketed product was capitalized as of the closing date of the Gentium Acquisition and subsequently will be amortized over the estimated remaining life of the product of approximately 16 years.
Gentium produces active pharmaceutical ingredients, or APIs, including the defibrotide compound, urokinase, sodium heparin and sulglicotide. Other than defibrotide, these APIs are subsequently used to make the finished forms of various drugs and are distributed via supply contracts. The fair value of these supply contracts was determined using the income approach based on the expected cash flows from the projected net earnings of each API. The fair value of the API supply contracts was capitalized as of the closing date of the Gentium Acquisition and subsequently will be amortized over 4 years which approximates the remaining contractual term and reasonably expected renewal periods.
The fair value of IPR&D was determined using the income approach, including the application of probability factors related to the likelihood of success of the respective products reaching final development and commercialization. This approach also took into consideration information and certain program-related documents and forecasts prepared by management. The fair value of IPR&D was capitalized as of the closing date of the Gentium Acquisition and is subsequently accounted for as an indefinite-lived intangible asset until completion or abandonment of the associated research and development efforts. Accordingly, during the development period after the closing of the Gentium Acquisition, these assets will not be amortized into earnings; instead, these assets will be subject to periodic impairment testing. Upon successful completion of the development process for an acquired IPR&D project, determination as to the useful life of the asset will be made. The asset would then be considered a finite-lived intangible asset and amortization of the asset into earnings would begin over the remaining estimated useful life of the asset.
The excess of the total acquisition consideration over the fair value amounts assigned to the assets acquired and the liabilities assumed represents the goodwill amount resulting from the Gentium Acquisition. We believe that the factors that contributed to goodwill included the Gentium workforce, which will complement our clinical experience in hematology/oncology and our expertise in reaching targeted physicians who treat serious medical conditions, and the deferred tax consequences of intangible assets recorded for financial statement purposes. We do not expect any portion of this goodwill to be deductible for tax purposes.
The noncontrolling interests at the closing date of the Gentium Acquisition comprised 2,007,452 of Gentium’s issued and outstanding ordinary shares and ADSs and options to acquire 484,097 ordinary shares of Gentium that were not subject to support agreements. The fair value of the noncontrolling interests was estimated using Gentium’s closing market price quoted on the NASDAQ Global Market on January 22, 2014.
Pro Forma Financial Information (Unaudited)
The following unaudited supplemental pro forma information presents our combined historical results of operations with adjustments to reflect one-time charges and amortization of fair value adjustments in the appropriate pro forma periods as if the Gentium Acquisition had been completed on January 1, 2013. These adjustments include:
An increase in amortization expense related to the fair value of acquired identifiable intangible assets of $2.8 million for the nine months ended September 30, 2014, and $12.2 million and $36.7 million for the three and nine months ended September 30, 2013, respectively.
The exclusion of acquisition-related expenses of $40.7 million for the nine months ended September 30, 2014.
An increase in interest expense of $1.4 million for the nine months ended September 30, 2014, and $5.7 million and $16.9 million for the three and nine months ended September 30, 2013, respectively, incurred on additional borrowings made to fund the Gentium Acquisition as if the borrowings had occurred on January 1, 2013.
The exclusion of other non-recurring expenses of $0.4 million and $39.9 million for the three and nine months ended September 30, 2014, respectively, and the inclusion of $0.5 million and $17.8 million for the three and nine months ended September 30, 2013, respectively, primarily related to Gentium transaction bonus costs, the fair value step-up to acquired inventory, costs of change in control obligations and share-based compensation incurred from the acceleration of stock option vesting upon the closing date of the Gentium Acquisition.
The unaudited pro forma results do not assume any operating efficiencies as a result of the consolidation of operations and are as follows (in thousands, except per share data):

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Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Revenues
$
306,584

 
$
247,478

 
$
848,036

 
$
674,491

Net income (loss) attributable to Jazz Pharmaceuticals plc
$
26,317

 
$
61,330

 
$
(1,887
)
 
$
98,418

Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - basic
$
0.44

 
$
1.05

 
$
(0.03
)
 
$
1.68

Net income (loss) per ordinary share attributable to Jazz Pharmaceuticals plc - diluted
$
0.42

 
$
1.00

 
$
(0.03
)
 
$
1.60

Acquisition of Rights to Defibrotide in the Americas
As a result of the Gentium Acquisition, we acquired defibrotide, which is marketed under the name Defitelio in Europe. In October 2013, the European Commission granted marketing authorization under exceptional circumstances for Defitelio for the treatment of severe VOD in adults and children undergoing HSCT therapy. In March 2014, we commenced the launch of Defitelio on a rolling, country-by-country, basis in Europe. At the time of the Gentium Acquisition, Gentium had licensed to Sigma-Tau Pharmaceuticals, Inc., or Sigma-Tau, the rights to commercialize defibrotide for the treatment and prevention of VOD in North America, Central America and South America, subject to receipt of marketing authorization, if any, in the applicable territory. On July 1, 2014, we entered into a definitive agreement to acquire the rights to defibrotide in the Americas from Sigma-Tau. Pursuant to the agreement, upon the closing of the transaction on August 4, 2014, we paid Sigma-Tau an upfront payment of $75.0 million. This transaction was accounted for as a purchase of IPR&D assets with no alternative future use. Accordingly, the $75.0 million upfront payment was charged to acquired IPR&D expense upon closing of the transaction. Sigma-Tau is also eligible to receive milestone payments of $25.0 million upon the acceptance for filing by the FDA of the first NDA for defibrotide for VOD and up to an additional $150.0 million based on the timing of potential FDA approval of defibrotide for VOD. We funded the upfront payment with cash on hand.
Acquisition of Rights to JZP-110 (formerly known as ADX-N05)
On January 13, 2014, we entered into a definitive agreement with Aerial BioPharma, LLC, or Aerial, under which we acquired certain assets related to JZP-110, a novel compound in clinical development for the treatment of excessive daytime sleepiness in patients with narcolepsy. Under the agreement, and in exchange for an upfront initial payment from us totaling $125.0 million, we acquired worldwide development, manufacturing and commercial rights to JZP-110, other than in certain jurisdictions in Asia where SK Biopharmaceuticals Co., Ltd, or SK, retains rights. Aerial and SK are eligible to receive milestone payments, in an aggregate amount of up $270.0 million, based on development, regulatory and sales milestones and tiered royalties from high single digits to mid-teens based on potential future sales. This acquisition was accounted for as a purchase of IPR&D assets with no alternative future use. Accordingly, the $125.0 million upfront payment was charged to acquired IPR&D expense in the nine months ended September 30, 2014. The assignment of the JZP-110 rights from Aerial to us triggered a milestone payment of $2.0 million to SK, which was also charged to acquired IPR&D expense in the nine months ended September 30, 2014.

3. Inventories
Inventories consisted of the following (in thousands): 
 
September 30,
2014
 
December 31,
2013
Raw materials
$
3,177

 
$
3,506

Work in process
13,980

 
10,301

Finished goods
20,455

 
14,862

Total inventories
$
37,612

 
$
28,669

As of September 30, 2014, the step-up in the value of inventories acquired had been fully expensed. As of December 31, 2013, the fair value of inventories acquired included a step-up in the value of inventories of $0.2 million.


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4. Fair Value Measurement
Cash and cash equivalents consisted of the following (in thousands): 
 
September 30, 2014
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Estimated
Fair Value
 
Cash and Cash Equivalents
Cash
$
163,040

 
$

 
$

 
$
163,040

 
$
163,040

Time deposits
412,000

 

 

 
412,000

 
412,000

Totals
$
575,040

 
$

 
$

 
$
575,040

 
$
575,040

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
December 31, 2013
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Estimated
Fair Value
 
Cash and
Cash
Equivalents
Cash
$
495,990

 
$

 
$

 
$
495,990

 
$
495,990

Time deposits
140,514

 

 

 
140,514

 
140,514

Totals
$
636,504

 
$

 
$

 
$
636,504

 
$
636,504

Cash equivalents are considered available-for-sale. We use the specific-identification method for calculating realized gains and losses on securities sold and include them in interest expense, net in the condensed consolidated statements of operations.
The following table summarizes, by major security type, our available-for-sale securities and liabilities as of September 30, 2014 and December 31, 2013 that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands): 
 
September 30, 2014
 
December 31, 2013
 
Significant Other
Observable
Inputs
(Level 2)
 
Total
Estimated
Fair Value    
 
Significant
Other
Observable
Inputs
(Level 2)
 
Total
Estimated
Fair Value    
Assets:
 
 
 
 
 
 
 
Available-for-sale securities
 
 
 
 
 
 
 
Time deposits
$
412,000

 
$
412,000

 
$
140,514

 
$
140,514

Liabilities:
 
 
 
 
 
 
 
Contingent consideration
$

 
$

 
$
50,000

 
$
50,000

 
 
 
 
 
 
 
 
As of September 30, 2014 and December 31, 2013, our available-for-sale securities included time deposits which were measured at fair value using Level 2 inputs and their carrying values were approximately equal to their fair values. There were no transfers between the different levels of the fair value hierarchy in 2014 or in 2013.
As of September 30, 2014, the estimated fair value of the $897.6 million principal amount of our term loans was $889.8 million and the carrying amount was $892.4 million. The fair value was determined using quotes from the administrative agent of our credit facility that are based on the bid/ask prices of our term loans (Level 2). For additional information related to our term loans, see Note 7. As of September 30, 2014, the estimated fair value of our exchangeable senior notes was $639.7 million. The fair value of the exchangeable senior notes was estimated using quoted market prices obtained from brokers (Level 2). The fair value of other borrowings approximates book value based on the borrowing rates currently available for variable rate loans (Level 2).


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5. Certain Balance Sheet Items
Property and equipment consisted of the following (in thousands):
 
 
September 30,
2014
 
December 31,
2013
Construction-in-progress
$
24,247

 
$
4,388

Computer software
8,941

 
7,960

Leasehold improvements
7,192

 
4,587

Machinery and equipment
7,111

 
417

Computer equipment
6,609

 
5,610

Furniture and fixtures
2,254

 
1,897

Land and buildings
1,614

 

Subtotal
57,968

 
24,859

Less accumulated depreciation and amortization
(13,763
)
 
(10,613
)
Property and equipment, net
$
44,205

 
$
14,246

Accrued liabilities consisted of the following (in thousands): 
 
September 30,
2014
 
December 31,
2013
Rebates and other sales deductions
$
52,861

 
$
38,772

Employee compensation and benefits
48,437

 
31,829

Sales returns reserve
15,137

 
21,110

Royalties
9,738

 
6,082

Accrued interest
7,940

 
4,150

Professional fees
4,396

 
5,225

Accrued construction-in-progress
3,117

 
450

Other
19,850

 
12,100

Total accrued liabilities
$
161,476

 
$
119,718


6. Goodwill and Intangible Assets
The gross carrying amount of goodwill was as follows (in thousands):
Balance at December 31, 2013
$
450,456

Goodwill arising from the Gentium Acquisition
308,642

Foreign exchange
(34,710
)
Balance at September 30, 2014
$
724,388


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The gross carrying amounts and net book values of our intangible assets were as follows (in thousands): 
 
September 30, 2014
 
December 31, 2013
 
Remaining
Weighted-
Average Useful
Life
(In years)
 
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net Book
Value
 
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net Book
Value
Acquired developed technologies
13.0
 
$
1,541,698

 
$
(248,191
)
 
$
1,293,507

 
$
957,089

 
$
(179,225
)
 
$
777,864

Manufacturing contracts
3.3
 
13,581

 
(2,346
)
 
11,235

 

 

 

Trademarks
0.3
 
2,928

 
(2,758
)
 
170

 
2,600

 
(2,327
)
 
273

Total finite-lived intangible assets
 
 
1,558,207

 
(253,295
)
 
1,304,912

 
959,689

 
(181,552
)
 
778,137

Acquired IPR&D assets
 
 
245,712

 

 
245,712

 
34,259

 

 
34,259

Total intangible assets
 
 
$
1,803,919

 
$
(253,295
)
 
$
1,550,624

 
$
993,948

 
$
(181,552
)
 
$
812,396

The increase in the gross carrying amount of intangible assets as of September 30, 2014 compared to December 31, 2013 reflects the acquisition of the Gentium intangible assets, as described in Note 2, offset by the negative impact of foreign currency exchange which is primarily due to the strengthening of the U.S. dollar against the Euro and the impairment charge discussed below.
The assumptions and estimates used to determine future cash flows and remaining useful lives of our intangible and other long-lived assets are complex and subjective. They can be affected by various factors, including external factors, such as industry and economic trends, and internal factors such as changes in our business strategy and our forecasts for specific product lines.
In the nine months ended September 30, 2014, we recorded an impairment charge of $32.8 million on acquired developed technologies related to certain products acquired as part of our acquisition of EUSA Pharma Inc. in June 2012. We report sales of these products under "Other” products. The impairment charge resulted from the reorganization of our operations in Europe to focus on our hematology/oncology franchise following the Gentium Acquisition.  We determined the fair value of the acquired developed technologies using a discounted cash flow approach, which contains significant unobservable inputs and therefore is considered a Level 3 fair value measurement. The unobservable inputs in the analysis included future cash flow projections and a discount rate.
Based on finite-lived intangible assets recorded as of September 30, 2014, and assuming the underlying assets will not be further impaired and that we will not change the expected lives of the assets, future amortization expenses were estimated as follows (in thousands): 
Year Ending December 31,
Estimated
Amortization  
Expense
2014 (remainder)
$
29,440

2015
113,009

2016
108,659

2017
108,568

2018
105,310

Thereafter
839,926

Total
$
1,304,912



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7. Debt
The following table summarizes the carrying amount of our indebtedness (in thousands):
 
September 30, 2014
 
December 31, 2013
1.875% exchangeable senior notes due 2021
$
575,000

 
$

Unamortized discount on 1.875% exchangeable senior notes due 2021
(128,552
)
 

1.875% exchangeable senior notes due 2021, net
$
446,448

 
$

Term loans
892,402

 
549,976

Other borrowings
1,934

 

Total debt
1,340,784

 
549,976

Less current portion
9,444

 
5,572

Total long-term debt
$
1,331,340

 
$
544,404

Exchangeable Senior Notes
In August 2014, we completed a private placement of $575.0 million principal amount of 1.875% exchangeable senior notes due 2021, or the 2021 Notes, resulting in net proceeds to us, after debt issuance costs, of $558.9 million. Interest on the 2021 Notes is payable semi-annually in cash in arrears on February 15 and August 15 of each year, beginning on February 15, 2015, at a rate of 1.875% per year. In certain circumstances, we may be required to pay additional amounts as a result of any applicable tax withholding or deductions required in respect of payments on the 2021 Notes. The 2021 Notes mature on August 15, 2021, unless earlier exchanged, repurchased or redeemed.
The holders of the 2021 Notes have the ability to require us to repurchase all or a portion of their 2021 Notes for cash in the event Jazz Pharmaceuticals plc undergoes certain fundamental changes. Prior to August 15, 2021, we may redeem the 2021 Notes, in whole but not in part, subject to compliance with certain conditions, if we have, or on the next interest payment date would, become obligated to pay to the holder of any 2021 Note additional amounts as a result of certain tax-related events. We also may redeem the 2021 Notes on or after August 20, 2018, in whole or in part, if the last reported sale price per ordinary share has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide the notice of redemption.
The 2021 Notes are exchangeable at an initial exchange rate of 5.0057 ordinary shares per $1,000 principal amount of 2021 Notes, which is equivalent to an initial exchange price of approximately $199.77 per ordinary share. Upon exchange, the 2021 Notes may be settled in cash, ordinary shares or a combination of cash and ordinary shares, at our election. Our intent and policy is to settle the principal amount of the 2021 Notes in cash upon exchange. The exchange rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain make-whole fundamental changes occurring prior to the maturity date of the 2021 Notes or upon our issuance of a notice of redemption, we will in certain circumstances increase the exchange rate for holders of the 2021 Notes who elect to exchange their 2021 Notes in connection with that make-whole fundamental change or during the related redemption period. Prior to February 15, 2021, the 2021 Notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.
The 2021 Notes were issued by Jazz Investments I Limited, or the Issuer, a 100%-owned finance subsidiary of Jazz Pharmaceuticals plc. The Issuer's obligations under the 2021 Notes are fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals plc. No subsidiary of Jazz Pharmaceuticals plc guaranteed the 2021 Notes. Subject to certain local law restrictions on payment of dividends, among other things, and potential negative tax consequences, we are not aware of any significant restrictions on the ability of Jazz Pharmaceuticals plc to obtain funds from the Issuer or Jazz Pharmaceuticals plc’s other subsidiaries by dividend or loan, or any legal or economic restrictions on the ability of the Issuer or Jazz Pharmaceuticals plc’s other subsidiaries to transfer funds to Jazz Pharmaceuticals plc in the form of cash dividends, loans or advances. There is no assurance that in the future such restrictions will not be adopted.
In accounting for the issuance of the 2021 Notes, we separated the 2021 Notes into liability and equity components. The carrying amount of the liability component was calculated by measuring the estimated fair value of a similar liability that does not have an associated exchange feature. The carrying amount of the equity component representing the exchange option was determined by deducting the fair value of the liability component from the face value of the 2021 Notes as a whole. The excess of the principal amount of the liability component over its carrying amount will be amortized to interest expense over the expected life of the 2021 Notes using the effective interest method with an effective interest rate of 6.4% per annum. We have determined the expected life of the 2021 Notes to be equal to the original seven-year term. The equity component is not remeasured as long as it continues to meet the conditions for equity classification.

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We allocated the total issuance costs incurred of $16.1 million to the liability and equity components based on their relative values. Issuance costs attributable to the liability component will be amortized to expense over the term of the 2021 Notes, and issuance costs attributable to the equity component were included with the equity component in our shareholders’ equity.
As of September 30, 2014, the carrying value of the equity component related to the 2021 Notes, net of equity issuance costs, was $126.9 million.
Amendment of Credit Facility and Term Loan Refinancing
In June 2012, Jazz Pharmaceuticals plc, as guarantor, and certain of its wholly owned subsidiaries, as borrowers, entered into a credit agreement providing for $475.0 million principal amount of term loans and a $100.0 million revolving credit facility. On June 13, 2013, we amended the credit agreement to provide for $557.2 million principal amount of new term loans and a $200.0 million revolving credit facility that replaced the $100.0 million revolving credit facility. We used a portion of the proceeds from these new term loans to refinance in full the $457.2 million aggregate principal amount of outstanding term loans under the credit agreement prior to the amendment. As a result of the June 2013 amendment, interest rate margins on the term loans and the revolving loans were reduced by 150 basis points.
On January 23, 2014, we entered into a second amendment to the credit agreement to provide for (i) a tranche of incremental term loans in the aggregate principal amount of $350.0 million, (ii) a tranche of term loans to refinance the $554.4 million aggregate principal amount of term loans previously outstanding under the amended credit agreement, or the prior term loans, in their entirety, and (iii) a $425.0 million revolving credit facility that replaced the $200.0 million revolving credit facility. We used the proceeds from the incremental term loans and $300.0 million of loans under the revolving credit facility, together with cash on hand, to purchase the Gentium ordinary shares and ADSs properly tendered and accepted for payment on the January 22, 2014 expiration of the initial tender offer period relating to the Gentium Acquisition. The January 2014 amendment also reduced the interest rate margins on the terms loans by 25 basis points. In August 2014, we used a portion of the net proceeds from the issuance of the 2021 Notes to repay all outstanding borrowings under the revolving credit facility.
The term loans under the current credit agreement mature on June 12, 2018 and the current revolving credit facility terminates, and any loans outstanding thereunder become due and payable, on June 12, 2017.
The term loans under the current credit agreement, as amended in January 2014, bear interest, at our option, at a rate equal to either the LIBOR, plus an applicable margin of 2.50% per annum (subject to a 0.75% LIBOR floor), or the prime lending rate, plus an applicable margin equal to 1.50% per annum (subject to a 1.75% prime rate floor). Borrowings under the current revolving credit facility bear interest, at our option, at a rate equal to either the LIBOR, plus an applicable margin of 2.50% per annum, or the prime lending rate, plus an applicable margin equal to 1.50% per annum, subject to reduction by 0.25% or 0.50% based upon our secured leverage ratio. The revolving credit facility has a commitment fee payable on the undrawn amount ranging from 0.25% to 0.50% per annum based upon our secured leverage ratio.
The borrowers’ obligations under the current credit agreement and any hedging or cash management obligations entered into with a lender or an affiliate of a lender are guaranteed on a senior secured basis by Jazz Pharmaceuticals plc and certain of its subsidiaries (including the Issuer) and are secured by substantially all of Jazz Pharmaceuticals plc’s, the borrowers’ and the subsidiary guarantors’ assets.
We may make voluntary prepayments of principal at any time without payment of a premium. We are required to make mandatory prepayments of the term loans (without payment of a premium) with (1) net cash proceeds from certain non-ordinary course asset sales (subject to reinvestment rights and other exceptions), (2) net cash proceeds from issuances of debt (other than certain permitted debt), (3) 50% of our excess cash flow as defined in the current credit agreement (subject to decrease to 25% if our secured leverage ratio is equal to or less than 2.25 to 1.00 and greater than 1.25 to 1.00 or 0% if our secured leverage ratio is equal to or less than 1.25 to 1.00), and (4) casualty proceeds and condemnation awards (subject to reinvestment rights and other exceptions).
Principal repayments of the term loans, which are due quarterly, began in March 2014 and are equal to 1.0% per annum of the original principal amount of $904.4 million, with any remaining balance payable on the final maturity date.
The credit agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to Jazz Pharmaceuticals plc and its restricted subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions. The credit agreement also contains a financial covenant that requires Jazz Pharmaceuticals plc and its restricted subsidiaries to maintain a maximum secured leverage ratio. We were, as of September 30, 2014, and are currently in compliance with this financial covenant.
The refinancing of the term loans involved multiple lenders who were considered members of a loan syndicate. In determining whether the refinancing was to be accounted for as a debt extinguishment or modification, we considered whether the creditors remained the same or changed and whether the change in debt terms was substantial. The debt terms were

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considered substantially different if the present value of the cash flows of the new term loans was at least 10% different from the present value of the remaining cash flows of the original term loans, or the 10% Test. We performed a separate 10% Test for each individual creditor participating in the loan syndication. When there was a change in principal balance for individual creditors, in applying the 10% Test, we used the cash flows related to the lowest common principal balance, or the Net Method. Under the Net Method, any principal in excess of a creditor’s reinvested principal balance was treated as a new, separate debt issuance. The refinancing was accounted for as a modification as the change in debt terms was determined to not be substantial using the 10% Test.
Deferred financing costs of $21.7 million and an original issue discount of $6.1 million were associated with modified and new debt and will be amortized to interest expense using the interest method over the life of the term loans. As of September 30, 2014, the interest rate on the term loans was 3.25% and the effective interest rate was 4.1%.
As the borrowing capacity relating to each creditor under the current revolving credit facility was greater than that under the original revolving credit facility, deferred financing costs totaling $5.4 million were associated with the new arrangement and are being amortized to interest expense on a straight-line basis over the life of the facility. As of September 30, 2014, there were no borrowings outstanding under the revolving credit facility.
Maturities
Scheduled maturities with respect to our long-term debt are as follows (in thousands):
Year Ending December 31,
Scheduled Long-Term Debt Maturities
2014 (remainder)
$
2,437

2015
9,445

2016
9,450

2017
9,455

2018
868,490

Thereafter
575,275

Total
$
1,474,552


8. Commitments and Contingencies
Indemnification
In the normal course of business, we enter into agreements that contain a variety of representations and warranties and provide for general indemnification, including indemnification associated with product liability or infringement of intellectual property rights. Our exposure under these agreements is unknown because it involves future claims that may be made but have not yet been made against us. To date, we have not paid any claims or been required to defend any action related to these indemnification obligations.
We have agreed to indemnify our executive officers, directors and certain other employees for losses and costs incurred in connection with certain events or occurrences, including advancing money to cover certain costs, subject to certain limitations. The maximum potential amount of future payments we could be required to make under the indemnification obligations is unlimited; however, we maintain insurance policies that may limit our exposure and may enable us to recover a portion of any future amounts paid. Assuming the applicability of coverage and the willingness of the insurer to assume coverage, and subject to certain retention, loss limits and other policy provisions, we believe the fair value of these indemnification obligations is not significant. Accordingly, we did not recognize any liabilities relating to these obligations as of September 30, 2014 and December 31, 2013. No assurances can be given that the covering insurers will not attempt to dispute the validity, applicability, or amount of coverage without expensive litigation against these insurers, in which case we may incur substantial liabilities as a result of these indemnification obligations.

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Lease and Other Commitments
We have noncancelable operating leases for our office buildings and we are obligated to make payments under noncancelable operating leases for automobiles used by our sales force. Future minimum lease payments under our noncancelable operating leases at September 30, 2014 were as follows (in thousands): 
Year Ending December 31,
Lease
  Payments  
2014 (remainder)
$
2,577

2015
9,989

2016
7,467

2017
4,533

2018
1,334

Thereafter
772

Total
$
26,672

As of September 30, 2014, we had $25.7 million of noncancelable purchase commitments due within one year, primarily related to agreements with third party manufacturers.
Legal Proceedings
We are involved in several legal proceedings, including the following matters:
Xyrem ANDA Matters: On October 18, 2010, we received a Paragraph IV Patent Certification notice, or Paragraph IV Certification, from Roxane that it had submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem® (sodium oxybate) oral solution. Roxane’s initial Paragraph IV Certification alleged that all five patents then listed for Xyrem in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” or Orange Book, on the date of the Paragraph IV Certification are invalid, unenforceable or not infringed by Roxane’s proposed generic product. On November 22, 2010, we filed a lawsuit against Roxane in response to Roxane’s Paragraph IV Certification in the U.S. District Court for the District of New Jersey, or the District Court. We are seeking a permanent injunction to prevent Roxane from introducing a generic version of Xyrem that would infringe our patents. In accordance with the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Act, as a result of our having filed a timely lawsuit against Roxane, FDA approval of Roxane’s ANDA had been stayed until April 18, 2013, which was 30 months after our October 18, 2010 receipt of Roxane’s initial Paragraph IV Certification, but that stay has expired. Additional patents covering Xyrem have issued since the original suit against Roxane was filed, and cases involving some of these patents have been consolidated with the original action.
In December 2013, the District Court permitted Roxane to amend its answer in the consolidated case to allege additional equitable defenses, and the parties were given additional time for discovery on those new defenses. In addition, in March 2014, the District Court granted our motion to bifurcate and stay the portion of the lawsuit regarding certain patents covering the distribution system for Xyrem. Although no trial date for the case has been scheduled, based on the District Court’s current scheduling order, we anticipate that trial on the patents that are not subject to the court’s stay could occur as early as the second quarter of 2015. We do not have any estimate of a possible trial date for trial on the stayed patents. The actual timing of events in this litigation may be significantly earlier or later than contemplated by the scheduling order or than we currently anticipate, and we cannot predict the specific timing or outcome of events in this litigation.
On April 1, 2014, we received an additional Paragraph IV Certification from Roxane alleging that a tenth patent listed in the Orange Book for Xyrem in December 2013 is invalid or not infringed. We have not yet responded to this Paragraph IV Certification and cannot predict the timing or outcome of this matter or its impact on the other ongoing proceedings with Roxane.
On December 10, 2012, we received a Paragraph IV Certification from Amneal Pharmaceuticals, LLC, or Amneal, that it had submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. Amneal’s initial Paragraph IV Certification alleged that seven patents listed for Xyrem in the Orange Book are not infringed by Amneal’s proposed generic product and that an eighth patent listed in the Orange Book for Xyrem is invalid. On December 13, 2012, we received a supplemental Paragraph IV Certification alleging that a ninth patent listed in the Orange Book for Xyrem is invalid. On January 18, 2013, we filed a lawsuit against Amneal in response to Amneal’s Paragraph IV Certifications in the District Court seeking a permanent injunction to prevent Amneal from introducing a generic version of Xyrem that would infringe our patents.
On April 7, 2014, we received an additional Paragraph IV Certification from Amneal alleging that a tenth patent listed in the Orange Book for Xyrem in December 2013 is invalid. We filed suit against Amneal on this patent in the District Court on

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May 20, 2014 and cannot predict the timing or outcome of this matter or its impact on the other ongoing proceedings with Amneal.
On November 21, 2013, we received a Paragraph IV Certification from Par Pharmaceutical, Inc., or Par, that it had submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. Par’s Paragraph IV Certification alleged that ten patents listed in the Orange Book for Xyrem are invalid, unenforceable, and/or will not be infringed by Par’s proposed generic product. On December 27, 2013, we filed a lawsuit against Par in the District Court in response to Par’s Paragraph IV Certification seeking a permanent injunction to prevent Par from introducing a generic version of Xyrem that would infringe our patents, including an eleventh patent listed in the Orange Book for Xyrem for which Par later sent us a Paragraph IV Certification.
On April 23, 2014, Amneal asked the District Court to consolidate its case with the Par case, stating that both cases would proceed on the schedule for the Par case. The District Court granted this request on May 5, 2014. The order consolidating the cases provides that Amneal’s 30-month stay period will be extended to coincide with the date of Par’s 30-month stay period, calculated to be May 20, 2016. As a result, FDA’s approval of both ANDAs is stayed until the earlier of (i) May 20, 2016, or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. We cannot predict the timing or outcome of events in the consolidated case.
On July 3, 2014, we received an additional Paragraph IV Certification from Par alleging that a twelfth patent listed in the Orange Book for Xyrem in June 2014 is invalid, unenforceable, and/or will not be infringed by Par’s proposed generic product. On August 15, 2014, we filed a lawsuit against Par in the District Court in response to Par’s Paragraph IV Certification seeking a permanent injunction to prevent Par from introducing a generic version of Xyrem that would infringe this patent. We cannot predict the timing or outcome of events in this litigation.
On August 6, 2014, we received an additional Paragraph IV Certification from Par alleging that a thirteenth patent listed in the Orange Book for Xyrem in July 2014 is invalid, unenforceable, and/or will not be infringed by Par’s proposed generic product. On October 2, 2014, we filed a lawsuit against Par in the District Court in response to Par’s Paragraph IV Certification seeking a permanent injunction to prevent Par from introducing a generic version of Xyrem that would infringe this patent. We cannot predict the timing or outcome of events in this litigation.
On June 4, 2014, we received a Paragraph IV Certification from Ranbaxy Laboratories Limited, or Ranbaxy, that it had submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. Ranbaxy’s Paragraph IV Certification alleged that eleven patents listed in the Orange Book for Xyrem are invalid, unenforceable, and/or will not be infringed by Ranbaxy’s proposed generic product. On June 6, 2014, we received an amended Paragraph IV Certification from Ranbaxy adding a twelfth patent listed in the Orange Book for Xyrem. On July 15, 2014, we filed a lawsuit against Ranbaxy in the District Court in response to Ranbaxy’s Paragraph IV Certification seeking a permanent injunction to prevent Ranbaxy from introducing a generic version of Xyrem that would infringe our patents. On August 20, 2014, we received an additional Paragraph IV Certification from Ranbaxy alleging that a thirteenth patent listed in the Orange Book for Xyrem in July 2014 is invalid, unenforceable, and/or will not be infringed by Ranbaxy’s proposed generic product. On October 2, 2014, we filed a lawsuit against Ranbaxy in the District Court in response to Ranbaxy’s Paragraph IV Certification seeking a permanent injunction to prevent Ranbaxy from introducing a generic version of Xyrem that would infringe this patent. We cannot predict the timing or outcome of events in this litigation.
On October 30, 2014, we received a Paragraph IV Certification from Watson Laboratories, Inc., or Watson, that it has submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. Watson’s Paragraph IV Certification alleged that thirteen patents listed in the Orange Book for Xyrem are invalid, unenforceable, and/or will not be infringed by Watson’s proposed generic product.
Since late June 2014, petitions for CBM post-grant patent review by the PTAB of the USPTO have been filed by certain of the ANDA filers with respect to the validity of our patents covering the distribution system for Xyrem. To date, these petitions have not been accepted by the PTAB, and in October 2014, we filed preliminary responses to the petitions in which, among other things, we asserted that the challenged patents should not be subject to CBM review. We cannot predict the outcome of the PTAB’s decision on whether to institute any of the petitioned CBM review proceedings, whether additional post-grant patent review challenges will be filed, the outcome of any CBM review or other proceeding if the PTAB decides to institute one or more CBM review or other proceedings, or the impact any CBM review or other proceeding might have on ongoing ANDA litigation proceedings.
FazaClo ANDA Matters: Azur Pharma Public Limited Company, or Azur Pharma, received Paragraph IV Certifications from three generics manufacturers, Barr Laboratories, Inc., or Barr, Novel Laboratories, Inc., or Novel, and Mylan Pharmaceuticals, Inc., or Mylan, indicating that ANDAs had been filed with the FDA requesting approval to market generic versions of FazaClo® (clozapine, USP) LD orally disintegrating clozapine tablets. Azur Pharma and CIMA Labs Inc., or CIMA, a subsidiary of Teva Pharmaceutical Industries Limited, or Teva, our licensor and the entity whose drug-delivery technology is incorporated into FazaClo LD, filed a lawsuit in response to each certification claiming infringement based on

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such certification against Barr on August 21, 2008, against Novel on November 25, 2008 and against Mylan on July 23, 2010. Each case was filed in the U.S. District Court for the District of Delaware, or the Delaware Court. On July 6, 2011, CIMA, Azur Pharma and Teva, which had acquired Barr, entered into an agreement settling the patent litigation and Azur Pharma granted a sublicense to an affiliate of Teva of Azur Pharma’s rights to have manufactured, market and sell a generic version of both FazaClo LD and FazaClo HD, as well as an option for supply of authorized generic product. The sublicense for FazaClo LD commenced in July 2012, and the sublicense for FazaClo HD will commence in May 2015, or earlier upon the occurrence of certain events. Teva exercised its option for supply of an authorized generic product for FazaClo LD and launched the authorized generic product at the end of August 2012. The Novel and Mylan matters had been stayed pending reexamination of the patents in the lawsuits. In September 2013 and January 2014, reexamination certificates were issued for the two patents-in-suit, and the patentability of the claims of the patents confirmed. The Delaware Court lifted the stay of litigation in the two cases in March 2014. Trial is currently set for the third quarter of 2015, but we cannot predict the specific timing or outcome of this litigation.
Cutler Matter: On October 19, 2011, Dr. Neal Cutler, one of the original owners of FazaClo, filed a complaint against Azur Pharma and one of its subsidiaries, as well as Avanir Pharmaceuticals, Inc., or Avanir, in the California Superior Court in the County of Los Angeles, or the Superior Court. The complaint alleges that Azur Pharma and its subsidiary breached certain contractual obligations. Azur Pharma acquired rights to FazaClo from Avanir in 2007. The complaint alleges that as part of the acquisition of FazaClo, Azur Pharma’s subsidiary agreed to assume certain contingent payment obligations to Dr. Cutler. The complaint further alleges that certain contingent payments are due because revenue thresholds have been achieved, entitling Dr. Cutler to a $10.5 million and an additional $25.0 million contingent payment, plus unspecified punitive damages and attorneys’ fees. In March 2012, the Superior Court granted our petition to compel arbitration of the dispute in New York and stayed the Superior Court litigation. In July 2012, the arbitrator dismissed the arbitration on the grounds that the parties’ dispute falls outside of the scope of the arbitration clause in the applicable contract. That ruling was affirmed by the California Court of Appeal in January 2014, and the case was remanded to Superior Court for discovery and trial. Trial has been scheduled for October 2015. We cannot predict the specific timing or outcome of this litigation.
Shareholder Litigation Matter: In January 2014, we became aware of a purported class action lawsuit filed in the U.S. District Court for the Southern District of New York in connection with the Gentium Acquisition.  The lawsuit, captioned Xavion Jyles, Individually and on Behalf of All Others Similarly Situated v. Gentium S.P.A. et al., names Gentium, each of the Gentium’s directors, us and our Italian subsidiary as defendants. The lawsuit alleges, among other things, that Gentium’s directors breached their fiduciary duties to Gentium’s shareholders in connection with the Gentium tender offer agreement that Gentium entered into with us and our Italian subsidiary valuing Gentium ordinary shares and ADSs at $57.00 per share, and that we and our Italian subsidiary violated Sections 14(e) and 20(a) of the Securities Exchange Act of 1934, as amended, by allegedly overseeing Gentium’s preparation of an allegedly false and misleading Section 14D-9 Solicitation/Recommendation Statement. The lawsuit seeks, among other relief, class action status, rescission, and unspecified costs, attorneys’ fees and other expenses. Since the initial filing, a lead plaintiff was named for the class, and the case has been recaptioned Adjit Sodhi, Individually and on Behalf of All Others Similarly Situated v. Gentium S.P.A. et al. Only one individual defendant has been served, and the defendant has moved to dismiss the suit. We cannot predict the specific timing or outcome of this litigation.
From time to time we are involved in legal proceedings arising in the ordinary course of business. We believe there is no other litigation pending that could have, individually or in the aggregate, a material adverse effect on our results of operations or financial condition.
Other Contingencies
We have not previously submitted pricing data for two radiopharmaceutical products, ProstaScint® (capromab pendetide) and Quadramet® (samarium sm 153 lexidronam injection), for Medicaid and 340B programs.  We have been engaged in interactions with the Centers for Medicare and Medicaid Services, or CMS, and a trade group, the Council on Radionuclides and Radiopharmaceuticals, or CORAR, regarding the reporting of Medicaid pricing data and paying Medicaid rebates for radiopharmaceutical products.  For ProstaScint, we plan to begin making any required reports when CMS issues guidance on any requirements and reporting methodologies.  We sold Quadramet to a third party in December 2013, but have retained any liabilities related to sales of the product during prior periods.  In addition to the discussions with CMS as part of CORAR, we have had separate discussions with CMS directly regarding Quadramet.  We are currently unable to predict whether price reporting and rebates will be required for ProstaScint and Quadramet and, if so, for what period they will be required.  The initiation of any reporting of Medicaid pricing data for ProstaScint and Quadramet could result in retroactive 340B ceiling price liability for these two products as well as prospective 340B ceiling price obligations for ProstaScint. We are currently unable to reasonably estimate an amount or range of a contingent loss. Any material liability resulting from radiopharmaceutical price reporting would negatively impact our financial results.


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9. Shareholders’ Equity
The following tables present a reconciliation of our beginning and ending balances in shareholders’ equity for the nine months ended September 30, 2014 and 2013, respectively (in thousands): 
 
Attributable to:
 
Jazz Pharmaceuticals plc
 
Noncontrolling interests
 
Total Shareholders' Equity
Shareholders' equity at January 1, 2014
$
1,295,534

 
$

 
$
1,295,534

Noncontrolling interests from the Gentium Acquisition

 
136,578

 
136,578

Acquisition of noncontrolling interests
(1,529
)
 
(135,421
)
 
(136,950
)
Issuance of 1.875% exchangeable senior notes due 2021
126,862

 

 
126,862

Issuance of ordinary shares in conjunction with employee equity incentive and purchase plans and warrant exercises
48,452

 

 
48,452

Employee withholding taxes related to share-based awards
(17,306
)
 

 
(17,306
)
Share-based compensation
50,919

 

 
50,919

Tax benefit from employee share options
4,075

 

 
4,075

Shares repurchased
(29,973
)
 

 
(29,973
)
Other comprehensive loss
(113,286
)
 
(7
)
 
(113,293
)
Net loss
(23,225
)
 
(1,060
)
 
(24,285
)
Shareholders' equity at September 30, 2014
$
1,340,523

 
$
90

 
$
1,340,613


 
Jazz Pharmaceuticals plc
Shareholders' equity at January 1, 2013
$
1,121,292

Issuance of ordinary shares in conjunction with employee equity incentive and purchase plans and warrant exercises
23,577

Employee withholding taxes related to share-based awards
(5,303
)
Share-based compensation
31,855

Tax benefit from employee share options
82

Shares repurchased
(102,397
)
Other comprehensive income
13,576

Net income
161,019

Shareholders' equity at September 30, 2013
$
1,243,701

 Share Repurchase Program
In May 2013, our board of directors authorized a share repurchase program pursuant to which we may repurchase a number of ordinary shares having an aggregate repurchase price of up to $200 million, exclusive of any brokerage commissions. The authorization became effective immediately and has no set expiration date. Under this authorization, we may repurchase our ordinary shares through open market purchases, privately negotiated purchases or a combination of these transactions. The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under the current credit agreement, corporate and regulatory requirements and market conditions. Share repurchases may be suspended or discontinued at any time without prior notice. In the nine months ended September 30, 2014, we spent a total of $30.0 million to purchase 0.2 million of our ordinary shares under the share repurchase program at an average total purchase price, including commissions, of $131.88 per share. All ordinary shares repurchased by us were canceled. As of September 30, 2014, the remaining amount authorized under the share repurchase program was $33.6 million excluding commissions.

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Accumulated Other Comprehensive Income (Loss)
The components of accumulated other comprehensive income (loss) as of September 30, 2014 and December 31, 2013 were as follows (in thousands): 
 
Foreign
Currency
Translation
Adjustments
 
Total
Accumulated
Other
Comprehensive
Income (Loss)
Balance at December 31, 2013
$
56,153

 
$
56,153

Other comprehensive loss
(113,286
)
 
(113,286
)
Balance at September 30, 2014
$
(57,133
)
 
$
(57,133
)

During the nine months ended September 30, 2014, other comprehensive loss reflects foreign currency translation adjustments which are primarily due to the strengthening of the U.S. dollar against the Euro.

10. Share-Based Compensation
Share-based compensation expense related to share options, RSUs and grants under our ESPP was as follows (in thousands): 
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Selling, general and administrative
$
14,834

 
$
9,354

 
$
40,051

 
$
25,898

Research and development
3,177

 
1,931

 
8,862

 
4,453

Cost of product sales
240

 
591

 
1,705

 
1,788

Total share-based compensation expense, pre-tax
18,251

 
11,876

 
50,618

 
32,139

Tax benefit from share-based compensation expense
(5,469
)
 
(3,502
)
 
(15,171
)
 
(9,850
)
Total share-based compensation expense, net of tax
$
12,782

 
$
8,374

 
$
35,447

 
$
22,289

Share Options
The table below shows the number of shares underlying options granted to purchase our ordinary shares, the weighted-average assumptions used in the Black-Scholes option pricing model and the resulting weighted-average grant date fair value of share options granted: 
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Shares underlying options granted (in thousands)
135

 
105

 
942

 
1,277

Grant date fair value
$
51.73

 
$
37.17

 
$
60.40

 
$
28.49

Black-Scholes option pricing model assumption information:
 
 
 
 
 
 
 
Volatility
42
%
 
57
%
 
45
%
 
59
%
Expected term (years)
4.3

 
4.4

 
4.3

 
4.4

Range of risk-free rates
1.3-1.4%

 
1.0-1.4%

 
1.1-1.4%

 
0.5-1.4%

Expected dividend yield
%
 
%
 
%
 
%
Restricted Stock Units
The table below shows the number of RSUs granted covering an equal number of our ordinary shares and the weighted-average grant date fair value of RSUs granted:

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Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
RSUs granted (in thousands)
68

 
46

 
459

 
568

Grant date fair value
$
145.58

 
$
80.35

 
$
160.00

 
$
60.73

The fair value of RSUs is determined on the date of grant based on the market price of our ordinary shares on that date. The fair value of RSUs is recognized as expense ratably over the vesting period of four years.
As of September 30, 2014, compensation cost not yet recognized related to unvested share options and RSUs was $74.7 million and $78.5 million, respectively, which is expected to be recognized over a weighted-average period of 2.5 years and 2.6 years, respectively.

11. Related Party Transactions
In February 2014, certain holders of warrants to purchase 947,867 of our ordinary shares exercised the warrants in full for an aggregate cash purchase price payable to us of $3.8 million. The warrant holders are entities affiliated with one of our directors. In accordance with the terms of an existing investor rights agreement with the warrant holders, we registered the resale of the ordinary shares underlying the warrants and, pursuant to such agreement, we paid expenses of approximately $0.1 million in connection with the resale registration. 

12. Segment and Other Information
Our operating segment is reported in a manner consistent with the internal reporting provided to the chief operating decision maker, or CODM. Our CODM has been identified as our chief executive officer. We have determined that we operate in one business segment which is the development and commercialization of specialty pharmaceutical products. The following table presents a summary of total revenues (in thousands): 
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Xyrem® (sodium oxybate) oral solution
$
204,337

 
$
153,664

 
$
556,081

 
$
404,932

Erwinaze® (asparaginase Erwinia chrysanthemi)/Erwinase®
52,121

 
44,078

 
146,910

 
130,754

Defitelio® (defibrotide)/defibrotide
18,892

 

 
51,345

 

Prialt® (ziconotide) intrathecal infusion
6,282

 
11,046

 
16,422

 
20,726

Psychiatry
10,833

 
10,679

 
32,431

 
40,093

Other
11,942

 
10,919

 
35,304

 
35,097

Product sales, net
304,407

 
230,386

 
838,493

 
631,602

Royalties and contract revenues
2,177

 
1,774

 
6,240

 
5,047

Total revenues
$
306,584

 
$
232,160

 
$
844,733

 
$
636,649

The following table presents a summary of total revenues attributed to geographic sources (in thousands): 
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
United States
$
264,719

 
$
209,299

 
$
727,200

 
$
577,484

Europe
32,578

 
19,332

 
87,608

 
46,769

All other
9,287

 
3,529

 
29,925

 
12,396

Total revenues
$
306,584

 
$
232,160

 
$
844,733

 
$
636,649

The following table presents a summary of the percentage of total revenues from customers that represented more than 10% of our total revenues: 

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Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2014
 
2013
 
2014
 
2013
Express Scripts
67
%
 
66
%
 
66
%
 
63
%
Accredo
14
%
 
16
%
 
14
%
 
17
%

The following table presents total long-lived assets, consisting of property and equipment, by location (in thousands): 
 
September 30,
2014
 
December 31,
2013
Ireland
$
24,572

 
$
5,799

Italy
9,146

 

United States
9,143

 
7,734

Other
1,344

 
713

Total long-lived assets
$
44,205

 
$
14,246



13. Income Taxes
Our income tax provision for the three and nine months ended September 30, 2014 was $24.2 million and $60.6 million, respectively, compared to $18.3 million and $59.6 million for the same periods in 2013. Our effective tax rates for the three and nine months ended September 30, 2014 were 48.5% and 166.9%, respectively. After adjusting the income before income tax provision for the three months ended September 30, 2014 by excluding an upfront payment of $75.0 million for rights to defibrotide in the Americas, the effective tax rate on the resulting income before income tax provision for the three months ended September 30, 2014 was 19.4%, compared to 19.6% for the same period in 2013. After adjusting the income before income tax provision for the nine months ended September 30, 2014 by excluding a total of $202.0 million in upfront and milestone payments for rights to JZP-110 and to defibrotide in the Americas, the effective tax rate on the resulting income before income tax provision for the nine months ended September 30, 2014 was 25.4%, compared to 27.0% for the same period in 2013. The decreases in the effective tax rates, after excluding the upfront and milestone payments, for the three and nine months ended September 30, 2014 compared to the same periods in 2013 were primarily due to changes in income mix among the various jurisdictions in which we operate, changes in U.S. state valuation allowances and reductions in tax rates in certain jurisdictions.  The effective tax rates for the three and nine months ended September 30, 2014 were higher than the Irish statutory rate of 12.5% primarily due to income taxable at a rate higher than the Irish statutory rate, uncertain tax positions, current year losses in some jurisdictions for which no tax benefit is available and various expenses not deductible for tax purposes, partially offset by changes in U.S. state valuation allowances and reductions in tax rates in certain jurisdictions. No provision for income tax in Ireland has been recognized on undistributed earnings of our foreign subsidiaries because we consider such earnings to be indefinitely reinvested.
Our deferred tax assets are comprised primarily of U.S. federal and state net operating loss carryforwards and tax credit carryforwards, foreign net operating loss carryforwards and other temporary differences. We maintain a valuation allowance against certain U.S. state and foreign deferred tax assets. Each reporting period, we evaluate the need for a valuation allowance on our deferred tax assets by jurisdiction and adjust our estimates as more information becomes available.
We are required to recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. As a result, we have established a liability for certain tax benefits which we judge may not be sustained upon examination. We file income tax returns in Ireland, in the United States (both at the federal level and in various state jurisdictions) and in certain other foreign jurisdictions, all of which typically have three to four tax years open at any point in time. Because of our net operating loss carryforwards and tax credit carryforwards, substantially all of our tax years remain open to federal, state, and foreign tax examination. Certain of our subsidiaries are currently under examination by the French tax authorities for fiscal years 2012 and 2013 and by the U.S. Internal Revenue Service for fiscal year 2010. We do not anticipate that the amount of our existing liability for unrecognized tax benefits will significantly change within the next 12 months.


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Item 2.        Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the notes to condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties. When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that could impact our business. In particular, we encourage you to review the risks and uncertainties described in Part II, Item 1A “Risk Factors” included elsewhere in this report. These risks and uncertainties could cause actual results to differ materially from those projected in forward-looking statements contained in this report or implied by past results and trends. Forward-looking statements are statements that attempt to forecast or anticipate future developments in our business, financial condition or results of operations. See the “Cautionary Note Regarding Forward-Looking Statements” that appears at the end of this discussion. These statements, like all statements in this report, speak only as of their date (unless another date is indicated), and we undertake no obligation to update or revise these statements in light of future developments.
Overview
We are a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing differentiated products that address unmet medical needs. Our strategy is to continue to create shareholder value by:
Growing sales of the existing products in our portfolio, including by identifying new growth opportunities;
Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
We continue to focus on the execution of our strategy and have made significant progress in the first nine months of 2014. In the three and nine months ended September 30, 2014, our total net product sales increased by 32% and 33%, respectively, compared to the same periods in 2013, primarily from sales of our lead marketed products, Xyrem® (sodium oxybate) oral solution and Erwinaze® (asparaginase Erwinia chrysanthemi), called Erwinase® in markets outside of the United States and from the addition of defibrotide, marketed under the name Defitelio® (defibrotide) in Europe, to our product portfolio. Sales of Xyrem increased 33% and 37% in the three and nine months ended September 30, 2014, respectively, compared to the same periods in 2013. Sales of Erwinaze/Erwinase increased 18% and 12% in the three and nine months ended September 30, 2014, respectively, compared to the same periods in 2013. Total product sales will increase in 2014 over 2013 primarily due to growth in sales of Xyrem and Erwinaze and the addition of sales of defibrotide.
We acquired Defitelio/defibrotide as a result of our acquisition of a controlling interest in Gentium S.p.A., or Gentium, which acquisition we refer to as the Gentium Acquisition. Our aggregate acquisition cost for the Gentium Acquisition to date is $994.0 million, comprising cash payments of $1,011.1 million offset by proceeds from the exercise of Gentium share options of $17.1 million.
In October 2013, the European Commission granted marketing authorization for Defitelio under exceptional circumstances for the treatment of severe hepatic veno-occlusive disease, or VOD, in adults and children undergoing hematopoietic stem cell transplantation, or HSCT, therapy. We commenced the launch of Defitelio in certain countries in Europe in March 2014, and as of October 2014, Defitelio has been launched in Germany, Austria, Italy (with reimbursement under Law 648/96), the United Kingdom and several Nordic countries.  We expect to launch Defitelio in additional European countries on a rolling basis during the remainder of 2014 and in 2015 and are engaged in pricing and reimbursement submissions in preparation for these planned launches. We intend to eventually promote Defitelio in all European markets where it has marketing authorization. In addition, we expect to continue to provide patients access to defibrotide in countries where it is not commercially available through continuation of an expanded access treatment protocol that is open under an investigational new drug application in the United States and on a named patient basis elsewhere.
At the time of the Gentium Acquisition, Gentium had licensed to Sigma-Tau Pharmaceuticals, Inc., or Sigma-Tau, the rights to commercialize defibrotide for the treatment and prevention of VOD in North America, Central America and South America, subject to receipt of marketing authorization, if any, in the applicable territory. We acquired these rights from Sigma-Tau in August 2014, paying Sigma-Tau an upfront payment of $75.0 million. Sigma-Tau is also eligible to receive milestone payments of $25.0 million upon the acceptance for filing by the U.S. Food and Drug Administration, or FDA, of the first new drug application, or NDA, for defibrotide for VOD and up to an additional $150.0 million based on the timing of potential FDA approval of defibrotide for VOD. We funded the upfront payment with cash on hand.
We have a portfolio of approved products that address medical needs in the following therapeutic areas:
Narcolepsy: Xyrem, the only product approved by the FDA for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;

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Hematology/Oncology: Erwinaze, a treatment for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to E. coli-derived asparaginase, and Defitelio, a product approved in Europe for the treatment of severe VOD in adults and children undergoing HSCT therapy;
Pain: Prialt® (ziconotide) intrathecal infusion, the only non-opioid intrathecal analgesic indicated for the management of severe chronic pain for patients who are intolerant of or refractory to other treatments; and
Psychiatry: A portfolio of products, including FazaClo® (clozapine, USP) HD and FazaClo LD orally disintegrating clozapine tablets and Versacloz® (clozapine) oral suspension, each indicated for treatment-resistant schizophrenia and for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorders.
We also commercialize a portfolio of other products, mostly in markets outside of the United States. These products are primarily in the oncology, critical care and oncology supportive care therapeutic areas.
We continue to make progress and investment in our expanded product development pipeline, which currently includes clinical development of new product candidates, line extensions for existing products and the generation of additional clinical data for existing products. These projects are concentrated in our sleep and hematology/oncology therapeutic areas, where we believe we will be able to leverage our existing specialty commercial expertise and infrastructure, as well as our strong clinical, medical and commercial teams.
In the sleep area, we have ongoing and planned clinical studies for our product and product candidates.
JZP-110. JZP-110 is a late-stage investigational compound being developed for potential treatment of EDS in patients with narcolepsy. We also intend to pursue development of JZP-110 for EDS in patients with obstructive sleep apnea. Based on feedback from the FDA on our development plans for JZP-110, we are currently conducting one additional preclinical study. We expect to commence our planned Phase 3 clinical program in the first half of 2015, subject to the availability of clinical trial materials. In January 2014, we acquired from Aerial BioPharma LLC, or Aerial, the worldwide development, manufacturing and commercial rights to JZP-110, other than in certain jurisdictions in Asia where SK Biopharmaceuticals Co., Ltd, or SK, retains rights, with an upfront payment totaling $125.0 million.
JZP-386. JZP-386 is a deuterium-modified analog of sodium oxybate, the active pharmaceutical ingredient in Xyrem, which we licensed from Concert Pharmaceuticals, Inc. We have conducted preclinical research and development work on JZP-386 for potential use in patients with narcolepsy. We submitted an investigational medicinal product dossier, or IMPD, for JZP-386 in Europe at the end of 2013 and received approval of the IMPD in January 2014. In July 2014, we initiated our first study of JZP-386 in humans to evaluate the safety, pharmacokinetics and pharmacodynamics of the compound. Enrollment in this study has completed.
Xyrem. While in many patients narcolepsy can begin during childhood and adolescence, there is limited information on the treatment of pediatric narcolepsy patients with Xyrem. We have worked with the FDA and several leading specialists to design a clinical study to generate additional data on the treatment of pediatric narcolepsy patients with Xyrem. We initiated clinical sites for this study in the third quarter of 2014.
In the hematology/oncology area, we also have a number of ongoing and planned clinical studies.
Erwinaze. In the second quarter of 2014, we initiated a clinical trial to further evaluate the use of Erwinaze in young adults age 18 to 39 with ALL who are hypersensitive to E. coli-derived asparaginase. In 2013, we also completed a pharmacokinetic clinical trial of the intravenous administration of Erwinaze in North America. We submitted the data collected in the study, which met the primary endpoint, as a supplemental biologic license application, or sBLA, to allow intravenous administration of Erwinaze. The sBLA was accepted for filing by the FDA in April 2014. The Prescription Drug User Fee Act, or PDUFA, date for an FDA decision on the sBLA is December 28, 2014.
JZP-416 (formerly known as Asparec). We are conducting a Phase 1 clinical trial in Europe of JZP-416 (pegcrisantaspase), the PEGylated recombinant Erwinia chrysanthemi L-asparaginase, being developed for the treatment of patients with ALL who are hypersensitive to E. coli-derived asparaginase. In June 2013, the FDA granted Fast Track designation to the investigation of JZP-416 for the treatment of ALL. After reviewing our development plans with the FDA, in the third quarter of 2014, we initiated our first study of JZP-416 in children in a pivotal Phase 2 trial in North America.
LeukotacTM (inolimomab). We are conducting a Phase 3 clinical trial in Europe of Leukotac, an anti-CD25 monoclonal antibody for the treatment of steroid-refractory acute GvHD. We completed enrollment for this study in March 2014 and expect to receive preliminary data before mid-2015.
We are also engaged in activities related to the potential approval of defibrotide in the United States. A prior NDA submission by Gentium seeking approval in the United States for defibrotide for the treatment of VOD was voluntarily withdrawn from consideration in 2011 in order to address issues raised by the FDA. We held pre-NDA meetings with the FDA

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in August 2014 relating to our plans for the submission of an NDA for defibrotide for the treatment of severe VOD in patients undergoing HSCT therapy. Based on these meetings and in light of the current status of our acquisition and remediation of key information to be included in the data package for the NDA, we plan to initiate a rolling submission of an NDA to the FDA by the end of 2014 and to complete the submission in the first half of 2015, and we do not expect to be required to complete any additional clinical trials prior to the completion of the NDA submission. We are also assessing the potential for approval of defibrotide in other countries and for development of defibrotide in indications in addition to the treatment of severe VOD.
For 2014 and beyond, we expect that our research and development expenses will increase substantially from historical levels, particularly as we initiate our various planned clinical trials.
In addition, through the Gentium Acquisition, we acquired a manufacturing facility that produces active pharmaceutical ingredients, including defibrotide, the drug substance in Defitelio, and in February 2014 we announced we commenced construction of a manufacturing and development facility in Ireland.
In June 2012, we entered into a credit agreement that provided for $475.0 million principal amount of term loans and a $100.0 million revolving credit facility. The proceeds from the term loans were used to partially finance our acquisition of EUSA Pharma Inc., or the EUSA Acquisition, in June 2012. In June 2013, we amended the credit agreement to provide for $557.2 million principal amount of term loans and a new revolving credit facility of $200.0 million that replaced the $100.0 million revolving credit facility. We used a portion of the proceeds from the new term loans to refinance in full the $457.2 million principal amount of term loans outstanding under the credit agreement prior to the amendment. In January 2014, in connection with the Gentium Acquisition, we further amended the credit agreement to provide for a tranche of incremental term loans in the aggregate principal amount of $350.0 million, a tranche of term loans that refinanced the approximately $554.4 million principal amount of term loans outstanding prior to this amendment, and a $425.0 million revolving credit facility that replaced the $200.0 million revolving credit facility. We used the proceeds from the incremental term loans and $300.0 million of loans under the revolving credit facility, together with cash on hand, to purchase Gentium ordinary shares and ADSs.
In August 2014, we completed a private placement of $575.0 million aggregate principal amount of 1.875% exchangeable senior notes due 2021, or the 2021 Notes, to several investment banks acting as initial purchasers who subsequently resold the 2021 Notes to qualified institutional buyers. The net proceeds from this offering were approximately $558.9 million, after deducting initial purchasers’ discounts and related offering expenses. We used a portion of the net proceeds from this offering to repay outstanding borrowings under the revolving credit facility provided for under our current credit agreement and intend to use the remainder of the net proceeds for general corporate purposes, including potential business development activities. For a more detailed discussion regarding our 2021 Notes, see “Liquidity and Capital Resources” below.
In 2013, we initiated purchases under a share repurchase program for up to $200 million of our ordinary shares. As of September 30, 2014, we had spent a total of $166.5 million, including commissions, to repurchase our ordinary shares under this program.
Over the past two years, we have made targeted investments to strengthen our capabilities and enhance and diversify our commercial and development portfolio. We intend to continue to leverage our commercial, medical and scientific experience to seek to maximize the potential of our existing and potential products. Our investments have allowed us to build a scalable infrastructure to support future growth and to continue to create shareholder value.
We anticipate that we will continue to face a number of challenges and risks to our business and our ability to execute our strategy in 2014. For example, while we now have a more diversified product portfolio than in the past, our financial results remain significantly influenced by sales of Xyrem, which accounted for 67.1% and 66.3% of our net product sales in the three and nine months ended September 30, 2014, respectively, and 65.8% of our net product sales for the year ended December 31, 2013. As a result, we continue to place a high priority on seeking to maintain and increase sales of Xyrem in its approved indications, while remaining focused on ensuring the safe and effective use of the product. We are also focusing on the lifecycle management of Xyrem, including seeking to enhance and enforce our intellectual property rights and to develop product, service and safety improvements for patients. For example, in April 2014, we updated our Xyrem label in consultation with the FDA to include additional information for using Xyrem safely and effectively, specifically a recommendation to reduce the dose of Xyrem when used concomitantly with divalproex sodium, which is based on data from a drug interaction study we conducted. In July 2014, the U.S. Patent and Trademark Office, or USPTO, issued us a method of use patent relating to the safety information that was added to our Xyrem label. We have listed this new patent in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” or Orange Book.
Our ability to maintain or increase Xyrem product sales is subject to a number of risks and uncertainties, including those discussed in Part II, Item 1A of this Quarterly Report on Form 10-Q. In particular, five abbreviated new drug applications, or ANDAs, have been filed with the FDA by third parties seeking to market generic versions of Xyrem, including the most recent in the fourth quarter of 2014. We have initiated lawsuits against four of the third parties, and the litigation proceedings are

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ongoing; we intend to initiate a lawsuit against the fifth third party. We cannot predict the timing or outcome of these proceedings. Although no trial date has been scheduled in the lawsuit against the first ANDA filer, Roxane Laboratories, Inc., or Roxane, we anticipate that trial on some of the patents in that case could occur as early as the second quarter of 2015. In addition, since late June 2014, petitions for covered business method, or CBM, post-grant patent review by the Patent Trial and Appeal Board, or PTAB, of the USPTO have been filed by certain of the ANDA filers with respect to the validity of our patents covering the distribution system for Xyrem. To date, these petitions have not been accepted by the PTAB, and in October 2014, we filed preliminary responses to the petitions in which, among other things, we asserted that the challenged patents should not be subject to CBM review. We cannot predict the outcome of the PTAB’s decision on whether to institute any of the petitioned CBM review proceedings, whether additional post-grant patent review challenges will be filed, the outcome of any CBM review or other proceeding if the PTAB decides to institute one or more CBM review or other proceedings, or the impact any CBM review or other proceeding might have on ongoing ANDA litigation proceedings. We expect that the approval of an ANDA that results in the launch of a generic version of Xyrem, or the approval and launch of other sodium oxybate products that compete with Xyrem, would have a material adverse effect on our business, financial condition, results of operations and growth prospects.
We are continuing our efforts on various regulatory matters, including updating documents that we have submitted to the FDA on our risk management and controlled distribution system for Xyrem, which we refer to as the Xyrem Risk Management Program. We have not reached agreement with the FDA on certain significant terms of our risk evaluation and mitigation strategies, or REMS, documents for Xyrem. In late 2013, the FDA notified us that it would exercise its claimed authority to modify our REMS and that it would finalize the REMS as modified by the FDA unless we initiated dispute resolution procedures with respect to the modification of the Xyrem deemed REMS.  Among other things, we disagree with the FDA’s position in the late 2013 notice that, as part of the current REMS process, the Xyrem deemed REMS should be modified to enable the distribution of Xyrem through more than one pharmacy, or potentially through retail pharmacies and wholesalers, as well as with certain modifications proposed by the FDA that would, in the FDA’s view, be sufficient to ensure that the REMS includes only those elements necessary to ensure that the benefits of Xyrem outweigh its risks, and that would, in the FDA’s view, reduce the burden on the healthcare system. Given these circumstances, we initiated dispute resolution procedures with the FDA at the end of February 2014. We received the FDA’s denial of our initial dispute resolution submission in the second quarter of 2014, and our dispute is currently subject to further supervisory review at the next administrative level of the FDA. We have received an interim response from the FDA in which the FDA has requested additional information. We expect to provide the requested information and receive the FDA’s response to this further appeal in the fourth quarter of 2014. We cannot predict whether, or on what terms, we will reach agreement with the FDA on final REMS documents for Xyrem, the outcome or timing of the current dispute resolution procedure, whether we will initiate additional dispute resolution proceedings with the FDA or other legal proceedings prior to finalizing the REMS documents, or the outcome or timing of any such proceedings. We expect that final REMS documents for Xyrem will include modifications to, and/or requirements that are not currently implemented in, the Xyrem Risk Management Program. Any such modifications or additional requirements could potentially make it more difficult or expensive for us to distribute Xyrem, make it easier for future generic competitors, and/or negatively affect sales of Xyrem.
We also expect to face pressure to license or share our Xyrem Risk Management Program, which is the subject of multiple issued patents, or elements of our Xyrem Risk Management Program, with generic competitors. In January 2014, the FDA held an initial meeting with us and the then-current Xyrem ANDA applicants to facilitate the development of a single shared system REMS for Xyrem (sodium oxybate). The parties have had numerous interactions with respect to a single shared system REMS since the initial meeting, and we expect the interactions to continue. We cannot predict the outcome or impact on our business of any future action that we may take with respect to the development of a single shared system REMS for Xyrem (sodium oxybate), licensing or sharing our REMS, or the FDA’s response to a certification that a third party had been unable to obtain a license.
Sales of our second largest product, Erwinaze/Erwinase continue to grow. Sales of Erwinaze/Erwinase accounted for 17.1% and 17.5% of our total net product sales in the three and nine months ended September 30, 2014, respectively, and 20.1% of our total net product sales for the year ended December 31, 2013. We seek to maintain and increase sales of Erwinaze, as well as to make Erwinaze more widely available, through ongoing research and development activities. However, our ability to successfully and sustainably maintain and grow sales of Erwinaze is subject to a number of risks and uncertainties, including those discussed in Part II, Item 1A of this Quarterly Report on Form 10-Q. In particular, a significant challenge to our ability to maintain current sales levels and to increase sales is our need to avoid supply interruptions of Erwinaze due to capacity constraints, production delays, quality challenges or other manufacturing difficulties. We maintain limited inventory of Erwinaze, which puts us at significant risk of not being able to meet product demand. The current manufacturing capacity for Erwinaze is nearly completely absorbed by demand for the product. As a consequence of constrained manufacturing capacity, we have had extremely limited ability to build an excess level of product inventory that could be used to absorb disruptions to supply resulting from any quality or other issues. For example, in 2013, we experienced a temporary disruption of supply of Erwinase in the European market due to the failure of a batch to meet certain

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specifications. If we continue to be subject to capacity constraints or experience quality or other manufacturing challenges in the future, we may be unable to build a desired excess level of product inventory, and our ability to supply the market may be compromised. Although we are taking steps to improve the Erwinaze manufacturing process, if our ongoing efforts are not successful, we could experience additional Erwinaze supply interruptions in the future, which could have a material adverse effect on our sales of and revenues from Erwinaze and limit our potential future maintenance and growth of the market for this product. In addition, while we continue to work with the manufacturer of Erwinaze to evaluate potential steps to expand production capacity to increase the supply of Erwinaze over the longer term to address worldwide demand, our ability to maintain or increase sales of Erwinaze may be limited by our ability to obtain a sufficient supply of the product.
In furtherance of our growth strategy, we have made a significant investment in Defitelio. We added the product to our portfolio as a result of the Gentium Acquisition and secured worldwide rights to the product by acquiring rights to defibrotide in the Americas in August 2014. Our ability to realize the anticipated benefits from this investment is subject to a number of risks and uncertainties, including those discussed in Part II, Item 1A of this Quarterly Report on Form 10-Q. In particular, we may not be able to successfully commercialize Defitelio in Europe, or obtain marketing approval in other countries, including the United States, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects. A key challenge to our success in commercializing Defitelio in Europe is our ability to obtain appropriate pricing and reimbursement approvals in those European countries where we have not yet launched Defitelio, including in countries where pricing and reimbursement approvals are required for launch. If we experience delays and unforeseen difficulties in obtaining favorable pricing and reimbursement approvals, planned launches in the affected countries would be delayed, or if we are unable to ultimately obtain favorable pricing and reimbursement approvals in countries that represent significant markets, our growth prospects in Europe could be negatively affected.
With respect to our planned submission of an NDA for defibrotide in the United States, we may be unable to acquire and remediate key information in the data package in a timely manner, which would delay our planned NDA submission, and we may be unable to otherwise obtain regulatory approval of defibrotide in the United States in a timely manner, if at all. We also face other challenges that could impact the anticipated value of Defitelio/defibrotide, including the limited size of the population of patients who undergo HSCT therapy and develop severe VOD, the need to establish U.S. pricing and reimbursement support for the product in the event we are able to obtain U.S. marketing approval for defibrotide, the possibility that we may be required to conduct time-consuming and costly clinical trials as a condition of any U.S. marketing approval for the product, the lack of experience of U.S. physicians in diagnosing and treating VOD, and challenges to our ability to develop the product for indications in addition to the treatment of severe VOD in adults and children undergoing HSCT therapy. If sales of Defitelio/defibrotide do not reach the levels we expect, our anticipated revenue from the product would be negatively affected, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
In April 2014, we received a Form FDA 483 at the conclusion of a pharmacovigilance inspection conducted by the FDA. The Form FDA 483 included observations relating to certain aspects of our adverse drug experience, or ADE, reporting system for all of our products, including Xyrem. Since May 2012, all of the approximately 3,500 ADEs reported to us for all products that were categorized as “serious and unexpected” had been reported to the FDA. However, reports related to 92 of these ADEs had been submitted beyond the 15-day regulatory deadline. The Form FDA 483 included an observation related to these late filings. In addition, the Form FDA 483 included observations regarding our lack of written procedures for certain aspects of our evaluation of ADEs and certain deficiencies in our investigation of ADEs. We responded to the Form FDA 483 with a description of the corrective actions and improvements we had implemented before or shortly following the inspection and additional improvements that we planned to implement, and have now implemented, to address the observations in the Form FDA 483. In August 2014, the FDA issued an Establishment Inspection Report to us, which indicates that the inspection is closed. Although we have implemented improvements to our ADE reporting system, there can be no assurance that the FDA or other regulatory agencies will not identify additional matters in future pharmacovigilance inspections or that we will be able to adequately address any matters that may be identified by the FDA or other regulatory agencies in the future, and the failure to do so could have a material adverse effect on our business, financial condition and results of operations.
The implementation of our strategy is also subject to other challenges and risks specific to our business, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations. In addition to risks related to Xyrem, Erwinaze and Defitelio/defibrotide, other key challenges and risks that we face include risks and uncertainties related to:
the challenges of protecting and enhancing our intellectual property rights;
delays or problems in the supply or manufacture of our products, particularly with respect to certain products as to which we maintain limited inventories, including products for which our supply demands are growing, and our dependence on single source suppliers to continue to meet our ongoing commercial demand or our requirements for clinical trial supplies;

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the need to obtain appropriate pricing and reimbursement for our products in an increasingly challenging environment due to, among other things, the attention being paid to healthcare cost containment and other austerity measures in the United States and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the United States in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by third party payors;
the ongoing regulation and oversight by the FDA, the U.S. Drug Enforcement Administration, or DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals;
the challenges of achieving and maintaining commercial success of our products, such as obtaining sustained acceptance of our products by patients, physicians and payors;
the risks associated with business combination or product or product candidate acquisition transactions, such as the challenges inherent in the integration of acquired businesses, including the acquired Gentium business, with our historic business, the increase in geographic dispersion among our centers of operation, taking on the operation of a manufacturing plant as a result of the Gentium Acquisition and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such acquisition transactions;
the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates;
the inherent uncertainty associated with the regulatory approval process, especially as we continue to undertake increased activities and make growing investment in our product pipeline development projects;
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business; and
possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations, which have increased significantly in 2014.
All of these risks are discussed in greater detail, along with other risks, in Part II, Item 1A of this Quarterly Report on Form 10-Q.


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Results of Operations
The following table presents revenues and expenses for the three and nine months ended September 30, 2014 and 2013, respectively (amounts in thousands): 
 
Three Months Ended
September 30,
 

 
Nine Months Ended
September 30,
 

 
2014 (1)
 
2013
 
Increase
 
2014 (1)
 
2013
 
Increase
Product sales, net
$
304,407

 
$
230,386

 
32
%
 
$
838,493

 
$
631,602

 
33
%
Royalties and contract revenues
2,177

 
1,774

 
23
%
 
6,240

 
5,047

 
24
%
Cost of product sales (excluding amortization of acquired developed technologies and intangible asset impairment)
26,994

 
24,252

 
11
%
 
88,610

 
76,503

 
16
%
Selling, general and administrative
93,501

 
74,970

 
25
%
 
300,420

 
223,004

 
35
%
Research and development
22,423

 
11,826

 
90
%
 
60,622

 
27,823

 
118
%
Acquired in-process research and development
75,000

 
988

 
N/A(2)

 
202,000

 
4,988

 
N/A(2)

Intangible asset amortization
30,630

 
19,564

 
57
%
 
94,607

 
58,518

 
62
%
Intangible asset impairment

 

 
%
 
32,806

 

 
N/A(2)

Interest expense, net
14,530

 
6,202

 
134
%
 
36,035

 
20,743

 
74
%
Foreign currency (gain) loss
(6,483
)
 
614

 
N/A(2)

 
(6,680
)
 
728

 
N/A(2)

Loss on extinguishment and modification of debt

 

 
%
 

 
3,749

 
N/A(2)

Income tax provision
24,221

 
18,335

 
32
%
 
60,598

 
59,574

 
2
%
Net income (loss) attributable to noncontrolling interests, net of tax
2

 

 
N/A(2)

 
(1,060
)
 

 
N/A(2)

_____________________________
(1)
Our financial results include the financial results of the historic Gentium business since the closing of the Gentium Acquisition on January 23, 2014.
(2)
Comparison to prior period not meaningful.
Revenues
The following table presents product sales, royalties and contract revenues, and total revenues for the three and nine months ended September 30, 2014 and 2013, respectively (amounts in thousands):
 
Three Months Ended
September 30,
 
Increase/
 
Nine Months Ended
September 30,
 
Increase/
 
2014
 
2013
 
(Decrease)
 
2014
 
2013
 
(Decrease)
Xyrem
$
204,337

 
$
153,664

 
33
%
 
$
556,081

 
$
404,932

 
37
%
Erwinaze/Erwinase
52,121

 
44,078

 
18
%
 
146,910

 
130,754

 
12
%
Defitelio/defibrotide
18,892

 

 
N/A(1)

 
51,345

 

 
N/A(1)

Prialt
6,282

 
11,046

 
(43
%)
 
16,422

 
20,726

 
(21
%)
Psychiatry
10,833

 
10,679

 
1
 %
 
32,431

 
40,093

 
(19
)%
Other
11,942

 
10,919

 
9
 %
 
35,304

 
35,097

 
1
%
Product sales, net
304,407

 
230,386

 
32
%
 
838,493

 
631,602

 
33
%
Royalties and contract revenues
2,177

 
1,774

 
23
%
 
6,240

 
5,047

 
24
%
Total revenues
$
306,584

 
$
232,160

 
32
%
 
$
844,733

 
$
636,649

 
33
%
_____________________________
(1)
Comparison to prior period not meaningful since our financial results include the financial results of the historic Gentium business since the closing of the Gentium Acquisition on January 23, 2014.

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Product Sales, Net
Xyrem product sales increased in the three and nine months ended September 30, 2014 compared to the same periods in 2013, primarily due to a higher average net selling price and, to a lesser extent, an increase in sales volume.  Price increases were instituted in February 2014 and August 2014 based on market analyses. Xyrem product sales volume increased by 9% in both the three and nine months ended September 30, 2014, respectively, compared to the same periods in 2013. The sales volume increases in both periods were driven by an increase in the average number of patients on Xyrem which includes both new patients and active patients who remained on Xyrem therapy. Erwinaze/Erwinase product sales increased in the three and nine months ended September 30, 2014 compared to the same periods in 2013, primarily due to increases in sales volume and to a lesser extent, price increases instituted in January 2014 and July 2014. The sales volume increases in both periods were driven primarily by a growth in new treatment sites prescribing Erwinaze as well as existing treatment sites identifying additional ALL patients with hypersensitivity to E. coli-derived asparaginase. Defitelio/defibrotide product sales in the three and nine months ended September 30, 2014, beginning from the closing of the Gentium Acquisition on January 23, 2014, were $18.9 million and $51.3 million, respectively. On a pro forma basis, Defitelio/defibrotide product sales in the three and nine months ended September 30, 2014 were $18.9 million and $54.2 million, respectively, compared with $13.1 million and $31.8 million, respectively, in the same periods in 2013. On a pro forma basis, Defitelio/defibrotide product sales increased in the three months ended September 30, 2014 compared to the same period in 2013 as we continue to transition to commercial pricing in countries where the product has been launched.  On a pro forma basis, Defitelio/defibrotide product sales increased in the nine months ended September 30, 2014 compared to the same period in 2013 primarily due to territory-specific price increases instituted in April 2013 and commercial pricing in launch territories. Until commencement of the commercial launch of Defitelio in Europe in March 2014, we provided, and continue to provide, access to defibrotide to patients in countries where it is not commercially available. We expect to see growth in sales of Defitelio/defibrotide in 2014 over 2013 as the commercial launch continues in Europe. Prialt product sales decreased in the three and nine months ended September 30, 2014 compared to the same periods in 2013 primarily due to the timing of shipments to our European distributor for Prialt, which in 2013 occurred in the three months ended September 30, 2013. Excluding the impact of the timing of these shipments, Prialt product sales were consistent year-over-year. Psychiatry product sales in the three months ended September 30, 2014 were in line with the same period in 2013. Psychiatry product sales decreased in the nine months ended September 30, 2014 compared to the same period in 2013, primarily due to the launch of a generic version of Luvox CR in March 2013 and, to a lesser extent, the continued impact of the sale of the authorized generic product for FazaClo LD. Total product sales will increase in 2014 over 2013, primarily due to growth in sales of Xyrem and Erwinaze/Erwinase and the inclusion of Defitelio/defibrotide product sales, partially offset by decreases in sales of certain other products.
Royalties and Contract Revenues
Royalties and contract revenues increased in the three and nine months ended September 30, 2014 compared to the same periods in 2013, primarily due to increased royalties in relation to our out-licensed products. We expect royalties and contract revenues to increase slightly in 2014 compared to 2013.

Cost of Product Sales
Cost of product sales increased by $2.7 million in the three months ended September 30, 2014 compared to the same period in 2013, primarily due to an increase in net sales. Cost of product sales increased by $12.1 million in the nine months ended September 30, 2014 compared to the same period in 2013, primarily due to an increase in acquisit