Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 17, 2016 | Jun. 30, 2015 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Jazz Pharmaceuticals plc | ||
Entity Central Index Key | 1,232,524 | ||
Trading Symbol | jazz | ||
Entity Filer Category | Large Accelerated Filer | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 61,184,623 | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Public Float | $ 7,451,638,590 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 988,785 | $ 684,042 |
Accounts receivable, net of allowances of $3,693 and $3,483 at December 31, 2015 and 2014, respectively | 209,685 | 186,371 |
Inventories | 19,451 | 30,037 |
Prepaid expenses | 20,699 | 12,800 |
Deferred tax assets, net | 0 | 48,440 |
Other current assets | 19,047 | 21,322 |
Assets held for sale | 0 | 32,833 |
Total current assets | 1,257,667 | 1,015,845 |
Property and equipment, net | 85,572 | 58,363 |
Intangible assets, net | 1,185,606 | 1,437,435 |
Goodwill | 657,139 | 702,713 |
Deferred tax assets, net, non-current | 122,863 | 75,494 |
Deferred financing costs | 23,268 | 33,174 |
Other non-current assets | 27,548 | 15,931 |
Total assets | 3,359,663 | 3,338,955 |
Current liabilities: | ||
Accounts payable | 21,807 | 25,126 |
Accrued liabilities | 164,070 | 164,091 |
Current portion of long-term debt | 37,587 | 9,428 |
Income taxes payable | 1,808 | 7,588 |
Deferred tax liability, net | 0 | 9,430 |
Deferred revenue | 1,370 | 1,138 |
Total current liabilities | 226,642 | 216,801 |
Deferred revenue, non-current | 3,721 | 4,499 |
Long-term debt, less current portion | 1,166,916 | 1,333,000 |
Deferred tax liability, net, non-current | 294,485 | 375,054 |
Other non-current liabilities | $ 69,253 | $ 38,393 |
Commitments and contingencies (Note 11) | ||
Shareholders’ equity: | ||
Ordinary shares, nominal value $0.0001 per share; 300,000 shares authorized; 61,305 and 60,643 shares issued and outstanding at December 31, 2015 and 2014, respectively | $ 6 | $ 6 |
Non-voting euro deferred shares, €0.01 par value per share; 4,000 shares authorized, issued and outstanding at both December 31, 2015 and 2014 | 55 | 55 |
Capital redemption reserve | 471 | 471 |
Additional paid-in capital | 1,562,900 | 1,458,005 |
Accumulated other comprehensive loss | (267,472) | (122,097) |
Retained earnings | 302,686 | 34,704 |
Total Jazz Pharmaceuticals plc shareholders’ equity | 1,598,646 | 1,371,144 |
Noncontrolling interests | 0 | 64 |
Total shareholders’ equity | 1,598,646 | 1,371,208 |
Total liabilities and shareholders’ equity | $ 3,359,663 | $ 3,338,955 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) $ in Thousands | Dec. 31, 2015€ / shares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014€ / shares | Dec. 31, 2014USD ($)$ / sharesshares |
Statement of Financial Position [Abstract] | ||||
Accounts receivable, allowances | $ | $ 3,693 | $ 3,483 | ||
Ordinary shares, nominal value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||
Ordinary shares, number of shares authorized | 300,000,000 | 300,000,000 | ||
Ordinary shares, number of shares issued | 61,305,000 | 60,643,000 | ||
Ordinary shares, number of shares outstanding | 61,305,000 | 60,643,000 | ||
Nonvoting Euro Deferred shares, par value (in euros per share) | € / shares | € 0.01 | € 0.01 | ||
Nonvoting Euro Deferred shares, number of shares authorized | 4,000,000 | 4,000,000 | ||
Nonvoting Euro Deferred shares, number of shares issued | 4,000,000 | 4,000,000 | ||
Nonvoting Euro Deferred shares, number of shares outstanding | 4,000,000 | 4,000,000 |
Consolidated Statements of Inco
Consolidated Statements of Income - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues: | |||
Product sales, net | $ 1,316,819 | $ 1,162,716 | $ 865,398 |
Royalties and contract revenues | 7,984 | 10,159 | 7,025 |
Total revenues | 1,324,803 | 1,172,875 | 872,423 |
Operating expenses: | |||
Cost of product sales (excluding amortization and impairment of intangible assets) | 102,526 | 117,418 | 102,146 |
Selling, general and administrative | 449,119 | 406,114 | 304,303 |
Research and development | 135,253 | 85,181 | 41,632 |
Acquired in-process research and development | 0 | 202,626 | 4,988 |
Intangible asset amortization | 98,162 | 126,584 | 79,042 |
Impairment charges | 31,523 | 39,365 | 0 |
Total operating expenses | 816,583 | 977,288 | 532,111 |
Income from operations | 508,220 | 195,587 | 340,312 |
Interest expense, net | (56,917) | (52,713) | (26,916) |
Foreign currency gain (loss) | 1,445 | 8,683 | (1,697) |
Loss on extinguishment and modification of debt | (16,815) | 0 | (3,749) |
Income before income tax provision | 435,933 | 151,557 | 307,950 |
Income tax provision | 106,399 | 94,231 | 91,638 |
Net income | 329,534 | 57,326 | 216,312 |
Net loss attributable to noncontrolling interests, net of tax | (1) | (1,061) | 0 |
Net income attributable to Jazz Pharmaceuticals plc | $ 329,535 | $ 58,387 | $ 216,312 |
Basic, net income (in dollars per share) | $ 5.38 | $ 0.98 | $ 3.71 |
Diluted, net income (in dollars per share) | $ 5.23 | $ 0.93 | $ 3.51 |
Weighted-average ordinary shares used in calculating net income (loss) attributable to Jazz Pharmaceuticals plc per ordinary share: | |||
Basic (in shares) | 61,232 | 59,746 | 58,298 |
Diluted (in shares) | 63,036 | 62,614 | 61,569 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Statement of Comprehensive Income [Abstract] | |||
Net income | $ 329,534 | $ 57,326 | $ 216,312 |
Other comprehensive income (loss): | |||
Foreign currency translation adjustments | (145,375) | (178,264) | 25,107 |
Other comprehensive income (loss) | (145,375) | (178,264) | 25,107 |
Total comprehensive income (loss) | 184,159 | (120,938) | 241,419 |
Comprehensive loss attributable to noncontrolling interests, net of tax | (1) | (1,075) | 0 |
Comprehensive income (loss) attributable to Jazz Pharmaceuticals plc | $ 184,160 | $ (119,863) | $ 241,419 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Ordinary Shares [Member] | Non-voting Euro Deferred [Member] | Capital Redemption Reserve [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Retained Earnings (Accumulated Deficit) [Member] | Total Jazz Pharmaceuticals plc Shareholders' Equity [Member] | Noncontrolling Interest [Member] |
Balance, beginning of period at Dec. 31, 2012 | $ 1,121,292 | $ 6 | $ 55 | $ 471 | $ 1,151,010 | $ 31,046 | $ (61,296) | $ 1,121,292 | $ 0 |
Balance, shares, beginning of period at Dec. 31, 2012 | 58,014 | 4,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuance of ordinary shares in conjunction with exercise of share options | 20,895 | 20,895 | 20,895 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options, shares | 904 | ||||||||
Issuance of ordinary shares under employee stock purchase plan | 5,410 | 5,410 | 5,410 | ||||||
Issuance of ordinary shares under employee stock purchase plan, shares | 147 | ||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units, shares | 146 | ||||||||
Shares withheld for payment of employee's withholding tax liability | (5,590) | (5,590) | (5,590) | ||||||
Issuance of ordinary shares in conjunction with exercise of warrants | 4,398 | 4,398 | 4,398 | ||||||
Issuance of ordinary shares in conjunction with exercise of warrants, shares | 471 | ||||||||
Share-based compensation | 44,367 | 44,367 | 44,367 | ||||||
Excess tax benefits from employee share options | (173) | (173) | (173) | ||||||
Shares repurchased | (136,484) | (136,484) | (136,484) | ||||||
Stock repurchased, shares | (1,828) | ||||||||
Other comprehensive income (loss) | 25,107 | 25,107 | 25,107 | ||||||
Net income | 216,312 | 216,312 | 216,312 | ||||||
Balance, end of period at Dec. 31, 2013 | 1,295,534 | $ 6 | $ 55 | 471 | 1,220,317 | 56,153 | 18,532 | 1,295,534 | 0 |
Balance, shares, end of period at Dec. 31, 2013 | 57,854 | 4,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Noncontrolling interest on Gentium Acquisition | 136,578 | 136,578 | |||||||
Acquisition of noncontrolling interest | (136,969) | (1,530) | (1,530) | (135,439) | |||||
Issuance of exchangeable senior notes | 126,863 | 126,863 | 126,863 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options | 43,043 | 43,043 | 43,043 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options, shares | 1,185 | ||||||||
Issuance of ordinary shares under employee stock purchase plan | 7,197 | 7,197 | 7,197 | ||||||
Issuance of ordinary shares under employee stock purchase plan, shares | 117 | ||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units, shares | 222 | ||||||||
Shares withheld for payment of employee's withholding tax liability | (18,030) | (18,030) | (18,030) | ||||||
Issuance of ordinary shares in conjunction with exercise of warrants | 8,247 | 8,247 | 8,247 | ||||||
Issuance of ordinary shares in conjunction with exercise of warrants, shares | 1,552 | ||||||||
Shares issued under directors deferred compensation plan, shares | 17 | ||||||||
Share-based compensation | 70,057 | 70,057 | 70,057 | ||||||
Excess tax benefits from employee share options | 1,841 | 1,841 | 1,841 | ||||||
Shares repurchased | (42,215) | (42,215) | (42,215) | ||||||
Stock repurchased, shares | (304) | ||||||||
Other comprehensive income (loss) | (178,264) | (178,250) | (178,250) | (14) | |||||
Net income | 57,326 | 58,387 | 58,387 | (1,061) | |||||
Balance, end of period at Dec. 31, 2014 | 1,371,208 | $ 6 | $ 55 | 471 | 1,458,005 | (122,097) | 34,704 | 1,371,144 | 64 |
Balance, shares, end of period at Dec. 31, 2014 | 60,643 | 4,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Acquisition of noncontrolling interest | (73) | (10) | (10) | (63) | |||||
Issuance of ordinary shares in conjunction with exercise of share options | 32,982 | 32,982 | 32,982 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options, shares | 732 | ||||||||
Issuance of ordinary shares under employee stock purchase plan | 7,541 | 7,541 | 7,541 | ||||||
Issuance of ordinary shares under employee stock purchase plan, shares | 75 | ||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units, shares | 265 | ||||||||
Shares withheld for payment of employee's withholding tax liability | (26,102) | (26,102) | (26,102) | ||||||
Share-based compensation | 91,795 | 91,795 | 91,795 | ||||||
Excess tax benefits from employee share options | (1,311) | (1,311) | (1,311) | ||||||
Shares repurchased | (61,553) | (61,553) | (61,553) | ||||||
Stock repurchased, shares | (410) | ||||||||
Other comprehensive income (loss) | (145,375) | (145,375) | (145,375) | 0 | |||||
Net income | 329,534 | 329,535 | 329,535 | (1) | |||||
Balance, end of period at Dec. 31, 2015 | $ 1,598,646 | $ 6 | $ 55 | $ 471 | $ 1,562,900 | $ (267,472) | $ 302,686 | $ 1,598,646 | $ 0 |
Balance, shares, end of period at Dec. 31, 2015 | 61,305 | 4,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating activities | |||
Net income | $ 329,534 | $ 57,326 | $ 216,312 |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Intangible asset amortization | 98,162 | 126,584 | 79,042 |
Share-based compensation | 91,550 | 69,638 | 44,551 |
Impairment charges | 31,523 | 39,365 | 0 |
Depreciation | 9,894 | 7,097 | 3,048 |
Acquired in-process research and development | 0 | 202,626 | 4,988 |
Loss on disposal of property and equipment | 172 | 24 | 46 |
Excess tax benefit from share-based compensation | 0 | (1,841) | 0 |
Acquisition accounting inventory fair value step-up adjustments | 0 | 10,477 | 3,826 |
Change in fair value of contingent consideration | 0 | 0 | 15,200 |
Deferred income taxes | (61,209) | (43,423) | (10,097) |
Provision for losses on accounts receivable and inventory | 4,062 | 2,493 | 2,446 |
Loss on extinguishment and modification of debt | 16,815 | 0 | 3,749 |
Amortization of debt discount and deferred financing costs | 22,738 | 13,725 | 4,591 |
Other non-cash transactions | (5,187) | (11,986) | 1,687 |
Changes in assets and liabilities: | |||
Accounts receivable | (24,841) | (55,041) | (48,846) |
Inventories | 6,271 | (7,630) | (8,516) |
Prepaid expenses and other current assets | 3,720 | 11,936 | (13,871) |
Other long-term assets | (11,722) | (8,891) | (4,306) |
Accounts payable | (2,280) | (37,966) | 5,089 |
Accrued liabilities | 2,986 | 20,997 | 14,717 |
Income taxes payable | (6,271) | 8,634 | (38,984) |
Deferred revenue | (536) | (1,203) | (1,061) |
Contingent consideration | 0 | (14,900) | 0 |
Other non-current liabilities | 26,562 | 17,724 | 14,820 |
Net cash provided by operating activities | 531,943 | 405,765 | 288,431 |
Investing activities | |||
Acquisitions, net of cash acquired | 0 | (828,676) | 0 |
Acquisition of in-process research and development | 0 | (202,626) | (4,988) |
Purchases of property and equipment | (35,958) | (36,347) | (9,976) |
Net proceeds from sale of business | 33,703 | 0 | 0 |
Acquisition of intangible assets | 0 | 0 | (1,300) |
Net cash used in investing activities | (2,255) | (1,067,649) | (16,264) |
Financing activities | |||
Net proceeds from issuance of debt | 898,642 | 1,194,385 | 553,425 |
Proceeds from employee equity incentive and purchase plans and exercise of warrants | 40,523 | 58,487 | 30,703 |
Share repurchases | (61,553) | (42,215) | (136,484) |
Acquisition of noncontrolling interests | (73) | (136,969) | 0 |
Payment of contingent consideration | 0 | (35,100) | 0 |
Payment of employee withholding taxes related to share-based awards | (26,102) | (18,030) | (5,590) |
Excess tax benefit from share-based compensation | 0 | 1,841 | 0 |
Repayments of long-term debt | (905,760) | (9,524) | (465,910) |
Repayments under revolving credit facility | (160,000) | (300,000) | 0 |
Net cash provided by (used in) financing activities | (214,323) | 712,875 | (23,856) |
Effect of exchange rates on cash and cash equivalents | (10,622) | (3,453) | 997 |
Net increase in cash and cash equivalents | 304,743 | 47,538 | 249,308 |
Cash and cash equivalents, at beginning of period | 684,042 | 636,504 | 387,196 |
Cash and cash equivalents, at end of period | 988,785 | 684,042 | 636,504 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 40,099 | 31,978 | 18,278 |
Cash paid for income taxes | 145,597 | 108,189 | 137,616 |
Non-cash investing activities: | |||
Construction-in-progress related to facility lease obligation | $ 4,351 | $ 0 | $ 0 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Jazz Pharmaceuticals plc is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We have a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. Our lead marketed products are: • Xyrem ® (sodium oxybate) oral solution , the only product approved by the U.S. Food and Drug Administration, or FDA, for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy; • Erwinaze ® (asparaginase Erwinia chrysanthemi ) , a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase ® ) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to E. coli -derived asparaginase; and • Defitelio ® (defibrotide) , a product approved in Europe for the treatment of severe hepatic veno-occlusive disease, or VOD, in adults and children undergoing hematopoietic stem cell transplantation, or HSCT, therapy. Our strategy is to create shareholder value by: • Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications; • Acquiring clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and • Pursuing targeted development of post-discovery differentiated product candidates. We apply a disciplined approach to allocating our resources between investments in our current commercial and development portfolio and acquisitions or in-licensing of new assets. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, and include the accounts of Jazz Pharmaceuticals plc and our subsidiaries and intercompany transactions and balances have been eliminated. Our consolidated financial statements include the results of operations of businesses we have acquired from the date of each acquisition for the applicable reporting periods. Significant Risks and Uncertainties Our financial results remain significantly influenced by sales of Xyrem. In 2015, net product sales of Xyrem were $955.2 million , which represented 73% of total net product sales. 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 or an alternative sodium oxybate product that competes with Xyrem; changed or increased regulatory restrictions or regulatory actions by the FDA; our suppliers’ ability to obtain sufficient quotas from the U.S. Drug Enforcement Administration, or DEA; any supply, manufacturing or distribution problems arising with any of our suppliers or distributors, all of whom are sole source providers for us; any increase in pricing pressure from or restrictive conditions for reimbursement required by, and the availability of reimbursement from, third party payors; changes in healthcare laws and policy; continued acceptance of Xyrem by physicians and patients; changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem; and operational disruptions at the central pharmacy or any failure to comply with our REMS obligations to the satisfaction of the FDA. Seven companies have sent us notices that they have filed abbreviated new drug applications, or ANDAs, with the FDA seeking approval to market a generic version of Xyrem. We have filed lawsuits against each of these companies seeking to prevent the introduction of a generic version of Xyrem that would infringe our patents, and the litigation proceedings are ongoing. We cannot predict the timing or outcome of these proceedings. Although no trial date has been set in any of the ANDA suits, we anticipate that trial on some of the patents in the case against the first ANDA filer, Roxane Laboratories, Inc., or Roxane, could occur as early as the second quarter of 2016. Some of the ANDA filers have also filed petitions for inter partes review, or IPR, by the Patent Trial and Appeal Board, or the PTAB, of the U.S. Patent and Trademark Office, or USPTO, with respect to the validity of certain distribution, method of use and formulation patents covering Xyrem. In July 2015, the PTAB issued decisions instituting IPR trials with respect to petitions related to certain patents covering the Xyrem distribution system, and we expect the PTAB to issue final decisions on the validity of these patents in July 2016. We cannot predict whether additional post-grant patent review challenges will be filed by any of the ANDA filers or any other entity, the outcome of any IPR or other proceeding, whether the PTAB will institute any petitioned IPR proceeding that has not yet been instituted, or the impact any IPR or other proceeding might have on ongoing ANDA litigation proceedings or other aspects of our Xyrem business. 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. I n late August 2015, we implemented the final REMS that was approved by the FDA in February 2015. The process under which enrolled patients receive Xyrem is complex and includes multiple mandatory steps taken by the central pharmacy. The transition to the final approved REMS necessitated significant operational changes at the central pharmacy and revised documentation requirements for patients and prescribers. In the third quarter of 2015, Xyrem product sales were adversely impacted by operational disruption and resulting delays in prescription fills and refills. As physicians and patients familiarized themselves with the new REMS process and documentation requirements, the central pharmacy experienced a significantly increased volume of calls from patients and physicians’ offices that the pharmacy was not able to timely address, resulting in a backlog of prescription fills and refills that were delayed. We identified and addressed with the central pharmacy to the extent feasible the processes that led to the operational delays. In the fourth quarter of 2015, we observed an improvement in key operational metrics compared to the third quarter of 2015, and we believe that central pharmacy operations have stabilized. However, we cannot guarantee that we will not experience further disruptions and resulting adverse impacts on Xyrem product sales. Any failure to comply with the REMS obligations could result in enforcement action by the FDA; lead to changes in our Xyrem REMS obligations; continue to negatively affect sales of Xyrem; result in additional costs and expenses for us; and/or take a significant amount of time, any of which could materially and adversely affect our business, financial condition, results of operations and growth prospects. Further, we cannot predict whether the FDA will seek to require or ultimately require modifications to the Xyrem REMS, including with respect to the distribution system, or seek to otherwise impose or ultimately impose additional requirements to the Xyrem REMS, or the potential timing, terms or propriety thereof. 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 may face pressure to develop a single shared REMS with potential generic competitors for Xyrem that is different from the approved Xyrem REMS or to license or share intellectual property pertinent to the Xyrem REMS, or elements of the Xyrem REMS, including proprietary data required for safe distribution of sodium oxybate, with generic competitors. The Xyrem REMS is the subject of multiple issued patents. In January 2014, the FDA held an initial meeting with us and the three then-current sodium oxybate ANDA applicants to facilitate the development of a single shared REMS for sodium oxybate. In October 2015, the FDA held a telephonic meeting with us and the seven current sodium oxybate ANDA applicants to discuss the status of the development of a single shared REMS for sodium oxybate. The parties had regular interactions with respect to developing a single shared REMS prior to this meeting, and we are seeking to continue the interactions with the goal of developing a single shared REMS. However, we are aware that, separate from the discussions with us, the FDA and ANDA applicants have exchanged communications regarding the potential development of a single shared REMS for sodium oxybate. We cannot predict whether, or to what extent, interactions among the parties will continue or whether we will develop a single shared REMS. If we do not develop a single shared REMS or license or share intellectual property pertinent to our Xyrem REMS with generic competitors within a time frame or on terms that the FDA considers acceptable, the FDA may assert that its waiver authority permits it to approve the ANDA of one or more generic competitors with a separate REMS that differs from our approved Xyrem REMS. 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 REMS for sodium oxybate, licensing or sharing intellectual property pertinent to our Xyrem REMS, or the FDA’s response to a request by one or more ANDA applicants for a waiver of the requirement for a single shared REMS, including in connection with a certification that the applicant had been unable to obtain a license. In addition, the Federal Trade Commission, other governmental authorities or others could claim or determine that we are using the Xyrem REMS in an anticompetitive manner (including in light of the FDA’s statement in the Xyrem REMS approval notice that the Xyrem REMS could be used in an anticompetitive manner inconsistent with applicable provisions of the Federal Food, Drug and Cosmetic Act) or have engaged in other anticompetitive practices. Obtaining and maintaining appropriate reimbursement for Xyrem in the U.S. is increasingly challenging due to, among other things, the attention being paid to healthcare cost containment and prescription drug pricing, pricing pressure from third party payors and increasingly restrictive reimbursement conditions being imposed by third party payors. In this regard, we have experienced and expect to continue to experience increasing pressure from third party payors to agree to discounts, rebates or other pricing terms for Xyrem. Any such restrictive pricing terms or additional reimbursement conditions could have a material adverse effect on our Xyrem revenues. In addition, drug pricing by pharmaceutical companies has recently come under close scrutiny, particularly with respect to companies that have increased the price of products after acquiring those products from other companies. We expect that healthcare policies and reforms intended to curb healthcare costs will continue to be proposed, which could limit the prices that we charge for our products, including Xyrem, limit our commercial opportunity and/or negatively impact revenues from sales of our products. Also, price increases on Xyrem and our other products, and negative publicity regarding pricing and price increases generally, whether with respect to our products or products distributed by other pharmaceutical companies, could negatively affect market acceptance of Xyrem and our other products. In 2015, sales of our second largest product, Erwinaze/Erwinase (which we refer to in this report as Erwinaze unless otherwise indicated or the context otherwise requires) were $203.3 million , which represented 15% of total net product sales. We seek to maintain and increase sales of Erwinaze, as well as to make Erwinaze more widely available, through ongoing sales and marketing and research and development activities. However, our ability to successfully and sustainably maintain or grow sales of Erwinaze is subject to a number of risks and uncertainties, including the limited population of patients with ALL and the incidence of hypersensitivity reactions to E. coli -derived asparaginase within that population, our need to apply for and receive marketing authorizations, through the European Union’s mutual recognition procedure or otherwise, in certain additional countries so we can launch promotional efforts in those countries, as well as those other risks and uncertainties discussed in “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K. 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 or regulatory challenges or other manufacturing difficulties. Erwinaze is licensed from and manufactured by a single source, Porton Biopharma Limited, or PBL. The current manufacturing capacity for Erwinaze is nearly completely absorbed by demand for the product. We are working with PBL to evaluate potential expansion of its production capacity to increase the supply of Erwinaze over the longer term. As a consequence of constrained manufacturing capacity, we have had an extremely limited or no ability to build an excess level of product inventory that can be used to absorb disruptions to supply resulting from quality, regulatory or other issues, and we have experienced, and expect to continue to experience, manufacturing and inventory challenges that have resulted in disruptions in our ability to supply certain markets. If capacity constraints continue, whether as a result of continued quality or other manufacturing issues or otherwise, we may be unable to build a desired excess level of product inventory, and our ability to supply the market may continue to be compromised. Additional Erwinaze supply interruptions and/or our inability to expand production capacity could materially adversely affect our sales of and revenues from Erwinaze and our potential future maintenance and growth of the market for this product. Sales of Defitelio/defibrotide were 5% of our net product sales in 2015. We acquired this product in January 2014 in connection with our acquisition of Gentium S.r.l., or Gentium, which we refer to as the Gentium Acquisition, and secured worldwide rights to the product by acquiring rights to defibrotide in the Americas in August 2014. We launched Defitelio in certain European countries in 2014 and continued to launch in additional European countries on a rolling basis through 2015. We are in the process of making pricing and reimbursement submissions with respect to Defitelio in those European countries where Defitelio is not yet launched, including in countries where pricing and reimbursement approvals are required for launch. Our ability to realize the anticipated benefits from our investment in Defitelio/defibrotide is subject to risks and uncertainties, including those discussed in “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K. In particular, we may not be able to successfully maintain or grow sales of Defitelio in Europe, or obtain marketing approval in other countries, 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 maintaining or growing sales of Defitelio in Europe is our ability to obtain appropriate pricing and reimbursement approvals in those European countries where Defitelio is not yet launched. If we experience delays or 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, especially where a country’s reimbursed price influences other countries, our growth prospects in Europe could be negatively affected. In September 2015, the FDA accepted for filing with priority review our NDA for defibrotide for the treatment of VOD with evidence of multi-organ dysfunction following HSCT. Based on timelines established by the Prescription Drug User Fee Act, or PDUFA, we expect FDA review of the NDA to be completed by March 31, 2016. However, the FDA does not always meet the timelines established by PDUFA, and it is possible that the FDA’s review of our NDA will not be completed by the PDUFA date, in which case our plans for commercialization of defibrotide in the U.S. may be delayed. In any event, we cannot predict whether our NDA will be approved in a timely manner, if at all. Approval of our NDA is dependent on our and our supplier’s ability to obtain FDA certification of current Good Manufacturing Practices in connection with the manufacturing of the defibrotide drug compound and the processing of defibrotide into finished product for the U.S. market and on the outcome of FDA inspections of clinical sites and potentially other entities involved in the development of defibrotide. In 2015, the FDA issued a Form FDA 483 to Patheon Italia S.p.A., or Patheon Italia, that included observations related to the Ferentino, Italy facility that manufactures the defibrotide finished product. Failure by Patheon Italia to timely remediate the observations to the FDA’s satisfaction or the discovery of issues that impact the defibrotide finished product could have an adverse impact on the potential approval of our NDA for defibrotide, including the timing thereof. In the event we are able to obtain U.S. marketing approval, we will also face other challenges that could impact the anticipated value of Defitelio/defibrotide, including the limited size of the population of VOD patients who are indicated for treatment with Defitelio/defibrotide (particularly if the FDA requires more narrow or restricted labeling than we have proposed or if changes in HSCT treatment protocols reduce the incidence of VOD); U.S. market acceptance of defibrotide at its commercial price, particularly in light of past access to defibrotide free of charge through an expanded access treatment protocol; the need to establish U.S. pricing and reimbursement support for defibrotide, including through acceptance by hospital pharmacy and therapeutics committees; 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 additional indications. 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 addition to risks specifically related to Xyrem, Erwinaze and Defitelio/defibrotide, we are subject to other challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations. These risks and uncertainties include: • the challenges of protecting and enhancing our intellectual property rights; • the challenges of achieving and maintaining commercial success of our products; • delays or problems in the supply or manufacture of our products, 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; • our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business; • the challenges of compliance with the requirements of the FDA, the DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals; • the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates; • the inherent uncertainty associated with the regulatory approval process, especially as we continue to undertake increased activities and make growing investment in our product pipeline development projects; • the risks associated with business combination or product or product candidate acquisition transactions, such as the challenges inherent in the integration of acquired businesses with our historic business, the increase in geographic dispersion among our centers of operation and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such transactions; and • possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations. 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 in-process research and development, or 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. 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 December 31, 2015 , five customers accounted for 90% of gross accounts receivable including Express Scripts Specialty Distribution Services, Inc. and its affiliate CuraScript, Inc., or Express Scripts, which accounted for 69% of gross accounts receivable, and IDIS Limited, which accounted for 11% of gross accounts receivable. As of December 31, 2014 , five customers accounted for 86% of gross accounts receivable including Express Scripts, which accounted for 66% of gross accounts receivable, and IDIS Limited, which accounted for 11% of gross accounts receivable. We depend on single source suppliers for each of our products, product candidates and their active pharmaceutical ingredients. Cash Equivalents and Marketable Securities We consider all highly liquid investments, readily convertible to cash, that mature within three months or less from date of purchase to be cash equivalents. Marketable securities are investments in debt securities with maturities of less than one year from the balance sheet date, or securities with maturities of greater than one year that are specifically identified to fund current operations. Collectively, cash equivalents and marketable securities are considered available-for-sale and are recorded at fair value. Unrealized gains and losses, net of tax, are recorded in accumulated other comprehensive loss in shareholders’ equity. We use the specific-identification method for calculating realized gains and losses on securities sold. Realized gains and losses and declines in value judged to be other than temporary on marketable securities are included in interest expense, net in the consolidated statements of income. Inventories Inventories are valued at the lower of cost or market. Cost is determined using the first-in, first-out method for all inventories. Our policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on our estimates of future demand for a particular product. If our estimate of future demand changes, we consider the impact on the reserve for excess inventory and adjust the reserve as required. Increases in the reserve are recorded as charges in cost of product sales. For product candidates that have not been approved by the FDA, inventory used in clinical trials is expensed at the time of production and recorded as research and development expense. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the clinical trial. Prior to receiving FDA approval, costs related to purchases of the active pharmaceutical ingredient and the manufacturing of the product candidate are recorded as research and development expense. All direct manufacturing costs incurred after approval are capitalized into inventory. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which range from three to 10 years. Leasehold improvements are amortized over the shorter of the noncancelable term of our operating leases or their economic useful lives. Maintenance and repairs are expensed as incurred. Goodwill Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. We have determined that we operate in a single segment and have a single reporting unit associated with the development and commercialization of pharmaceutical products. The annual test for goodwill impairment is a two-step process. The first step is a comparison of the fair value of the reporting unit with its carrying amount, including goodwill. If this step indicates impairment, then, in the second step, the loss is measured as the excess of recorded goodwill over its implied fair value. Implied fair value is the excess of the fair value of the reporting unit over the fair value of all identified assets and liabilities. We test goodwill for impairment annually in October and when events or changes in circumstances indicate that the carrying value may not be recoverable. 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 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. Revenue Recognition Revenues are recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured. Product Sales, Net Product sales revenue is recognized when title has transferred to the customer and the customer has assumed the risks and rewards of ownership, which is typically on delivery to the customer or, in the case of products that are subject to consignment agreements, when the customer removes product from our consigned inventory location for shipment directly to a patient. Revenue from sales transactions where the buyer has the right to return the product is recognized at the time of sale only if (i) the seller’s price to the buyer is substantially fixed or determinable at the date of sale, (ii) the buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product, (iii) the buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product, (iv) the buyer acquiring the product for resale has economic substance apart from that provided by the seller, (v) the seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer, and (vi) the amount of future returns can be reasonably estimated. Revenues from sales of products are recorded net of estimated allowances for returns, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans. Provisions for returns, specialty distributor fees, wholesaler fees, government rebates, coupon programs and rebates under managed care plans are included within current liabilities in our consolidated balance sheets. Provisions for government chargebacks and prompt payment discounts are generally shown as a reduction in accounts receivable. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates for these programs and channel inventory data. Adjustments to estimates for these allowances have not been material. Royalties and Contract Revenues We receive royalties from third parties based on sales of our products under licensing and distribution arrangements. For those arrangements where royalties are reasonably estimable, we recognize revenues based on estimates of royalties earned during the applicable period, and adjust for differences between the estimated and actual royalties in the following quarter. Historically, these adjustments have not been significant. Our contract revenues consist of fees and milestone payments. Non-refundable fees where we have no continuing performance obligations are recognized as revenues when there is persuasive evidence of an arrangement and collection is reasonably assured. In situations where we have continuing performance obligations, non-refundable fees are deferred and are recognized ratably over our projected perform |
Disposition
Disposition | 12 Months Ended |
Dec. 31, 2015 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Disposition | Disposition In March 2015, we sold certain products and the related business that we originally acquired as part of our June 2012 acquisition of EUSA Pharma Inc., or the EUSA Acquisition. The purchase price for the products and related business was $34.0 million , subject to pre- and post-closing purchase price adjustments. We recognized a loss on disposal of $0.2 million within selling, general and administrative expenses in our consolidated statements of income. The related assets met the assets held for sale criteria and were reclassified to assets held for sale as of December 31, 2014. Goodwill was allocated to these assets using the relative fair value method. We have determined that the disposition of these assets did not qualify for reporting as a discontinued operation, because the sale did not represent a strategic shift that had or will have a major effect on our operations and financial results. |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Fair Value Measurement Cash and cash equivalents consisted of the following (in thousands): December 31, 2015 Amortized Gross Gross Estimated Cash and Cash Equivalents Cash $ 274,945 $ — $ — $ 274,945 $ 274,945 Time deposits 713,840 — — 713,840 713,840 Totals $ 988,785 $ — $ — $ 988,785 $ 988,785 December 31, 2014 Amortized Gross Gross Estimated Cash and Cash $ 338,262 $ — $ — $ 338,262 $ 338,262 Time deposits 345,780 — — 345,780 345,780 Totals $ 684,042 $ — $ — $ 684,042 $ 684,042 Cash equivalents are considered available-for-sale securities. We use the specific-identification method for calculating realized gains and losses on securities sold and include them in interest expense, net in the consolidated statements of income. The following table summarizes, by major security type, our available-for-sale securities that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands): December 31, 2015 December 31, 2014 Significant Total Significant Total Time deposits $ 713,840 $ 713,840 $ 345,780 $ 345,780 As of December 31, 2015 , 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. Level 2 inputs, obtained from various third party data providers, represent quoted prices for similar assets in active markets, or these inputs were derived from observable market data, or if not directly observable, were derived from or corroborated by other observable market data. There were no transfers between the different levels of the fair value hierarchy in 2015 or in 2014 . As of December 31, 2015 , the estimated fair value of our 2021 Notes, which had a carrying value of $466.0 million , was approximately $601 million . The fair value of the 2021 Notes was estimated using quoted market prices obtained from brokers (Level 2). The estimated fair value of our borrowings under our term loan and other borrowings were approximately equal to their respective book values based on the borrowing rates currently available for variable rate loans (Level 2). |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consisted of the following (in thousands): December 31, 2015 2014 Raw materials $ 2,608 $ 3,570 Work in process 11,836 9,870 Finished goods 5,007 16,597 Total inventories $ 19,451 $ 30,037 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2015 2014 Construction-in-progress $ 63,008 $ 37,145 Computer software 15,797 10,634 Leasehold improvements 9,301 7,931 Computer equipment 10,963 7,670 Machinery and equipment 5,828 6,408 Furniture and fixtures 2,580 2,220 Land and buildings 1,775 1,547 Subtotal 109,252 73,555 Less accumulated depreciation and amortization (23,680 ) (15,192 ) Property and equipment, net $ 85,572 $ 58,363 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The gross carrying amount of goodwill was as follows (in thousands): Balance at December 31, 2014 $ 702,713 Foreign exchange (45,574 ) Balance at December 31, 2015 $ 657,139 The gross carrying amounts and net book values of our intangible assets were as follows (in thousands): December 31, 2015 December 31, 2014 Remaining Gross Accumulated Net Book Gross Accumulated Net Book Acquired developed technologies 12.0 $ 1,321,324 $ (324,044 ) $ 997,280 $ 1,450,606 $ (259,889 ) $ 1,190,717 Manufacturing contracts 2.1 11,697 (5,676 ) 6,021 13,012 (3,060 ) 9,952 Trademarks — 2,882 (2,882 ) — 2,914 (2,896 ) 18 Total finite-lived intangible assets 1,335,903 (332,602 ) 1,003,301 1,466,532 (265,845 ) 1,200,687 Acquired IPR&D assets 182,305 — 182,305 236,748 — 236,748 Total intangible assets $ 1,518,208 $ (332,602 ) $ 1,185,606 $ 1,703,280 $ (265,845 ) $ 1,437,435 The decrease in the gross carrying amount of intangible assets as of December 31, 2015 compared to December 31, 2014 is primarily due to the negative impact of foreign currency translation adjustments due to the strengthening of the U.S. dollar against the euro. 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. As a result of our decision to terminate a pivotal Phase 2 clinical trial of JZP-416, we recognized an impairment charge of $31.5 million to our acquired IPR&D asset in the fourth quarter of 2015. Based on finite-lived intangible assets recorded as of December 31, 2015 , and assuming the underlying assets will not be 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 2016 $ 90,442 2017 90,442 2018 87,636 2019 87,419 2020 86,249 Thereafter 561,113 Total $ 1,003,301 |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2015 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2015 2014 Rebates and other sales deductions $ 67,454 $ 51,899 Employee compensation and benefits 35,595 46,143 Contract claim settlement 18,000 — Sales returns reserve 6,110 14,039 Royalties 4,211 7,964 Accrued interest 4,043 10,327 Professional fees 3,038 3,295 Accrued construction-in-progress 1,637 4,931 Other 23,982 25,493 Total accrued liabilities $ 164,070 $ 164,091 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following table summarizes the carrying amount of our indebtedness (in thousands): December 31, 2015 2014 1.875% exchangeable senior notes due 2021 $ 575,000 $ 575,000 Unamortized discount on 1.875% exchangeable senior notes due 2021 (109,048 ) (124,735 ) 1.875% exchangeable senior notes due 2021, net 465,952 450,265 Term loans 738,038 890,479 Other borrowings 513 1,684 Total debt 1,204,503 1,342,428 Less current portion 37,587 9,428 Total long-term debt $ 1,166,916 $ 1,333,000 Credit Agreement On June 18, 2015, Jazz Pharmaceuticals plc, as guarantor, and certain of its wholly owned subsidiaries, as borrowers, entered into a credit agreement, which we refer to as the June 2015 credit agreement, that provides for a $750.0 million principal amount term loan, which was drawn in full at closing, and a $750.0 million revolving credit facility, of which $160.0 million was drawn at closing and subsequently repaid. We used the proceeds from initial borrowings under the June 2015 credit agreement to repay in full the $893.1 million principal amount of term loans outstanding under the credit agreement that we entered into in June 2012, as subsequently amended, which we refer to as the previous credit agreement, and to pay related fees and expenses. The previous credit agreement was terminated upon repayment of the term loans outstanding thereunder. Under the June 2015 credit agreement, the term loan matures on June 18, 2020 and the revolving credit facility terminates, and any loans outstanding thereunder become due and payable, on June 18, 2020 . Borrowings under the June 2015 credit agreement bear interest, at our option, at a rate equal to either (a) the LIBOR rate, plus an applicable margin ranging from 1.50% to 2.25% per annum, based upon our secured leverage ratio, or (b) the prime lending rate, plus an applicable margin ranging from 0.50% to 1.25% per annum, based upon our secured leverage ratio. The revolving credit facility has a commitment fee payable on the undrawn amount ranging from 0.25% to 0.35% per annum based upon our secured leverage ratio. As of December 31, 2015 , the interest rate on the term loan was 2.36% and the effective interest rate was 2.38% . As of December 31, 2015 , we had undrawn revolving credit facilities totaling $750.0 million of which $1.1 million was committed for an outstanding letter of credit. Jazz Pharmaceuticals plc and certain of our wholly owned subsidiaries are borrowers under the June 2015 credit agreement. The borrowers’ obligations under the June 2015 credit agreement, and any hedging or cash management obligations entered into with a lender, are guaranteed on a senior secured basis by Jazz Pharmaceuticals plc and certain of its subsidiaries (including the issuer of the 2021 Notes as described below) and are secured by substantially all of Jazz Pharmaceuticals plc’s, the borrowers’ and the guarantor subsidiaries’ 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 loan (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), and (3) casualty proceeds and condemnation awards (subject to reinvestment rights and other exceptions). Principal repayments of the term loan, which are due quarterly, began in December 2015 and are equal to 5.0% per annum of the original principal amount of $750.0 million during the first two years, 7.5% per annum during the third year, 10.0% per annum during the fourth year and 12.5% per annum during the fifth year, with any remaining balance payable on the maturity date. The June 2015 credit agreement contains financial covenants that require Jazz Pharmaceuticals plc and its restricted subsidiaries to not (a) exceed a maximum secured net leverage ratio or (b) fall below a cash interest coverage ratio. We were, as of December 31, 2015 , and are currently, in compliance with these financial covenants. In connection with our entry into the June 2015 credit agreement and termination of the previous credit agreement, we recorded a loss on extinguishment and modification of debt of $16.8 million , which was comprised of $16.0 million related to the expensing of unamortized deferred financing costs and unamortized original issue discount associated with extinguished debt and $0.8 million related to new third party fees associated with modified debt. Exchangeable Senior Notes In August 2014, we completed a private placement of the 2021 Notes. 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. As of December 31, 2015 , the “if-converted value” did not exceed the principal amount of the 2021 Notes. 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. For the years ended December 31, 2015 and 2014, we recognized $26.5 million and $9.9 million , respectively, in interest expense, net related to the contractual coupon rate and amortization of the debt discount on the 2021 Notes. As of December 31, 2015 , the carrying value of the equity component of the 2021 Notes, net of equity issuance costs, was $126.9 million . Scheduled maturities with respect to our long-term debt are as follows (in thousands): Year Ending December 31, Scheduled Long-Term Debt Maturities 2016 $ 37,587 2017 42,280 2018 61,034 2019 79,789 2020 520,420 Thereafter 575,028 Total $ 1,316,138 |
Deferred Revenue
Deferred Revenue | 12 Months Ended |
Dec. 31, 2015 | |
Other Liabilities [Abstract] | |
Deferred Revenue | Deferred Revenue The deferred revenue balance primarily relates to an agreement we have with UCB Pharma Limited, or UCB, under which UCB has the right to market Xyrem for certain indications in various countries outside of the U.S. We recognized contract revenues of $1.1 million during each of 2015 , 2014 and 2013 relating to two upfront payments received from UCB in 2006 totaling $15.0 million . The deferred revenue balance related to this agreement is being recognized ratably through 2019. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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 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, 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 have not recognized any liabilities relating to these obligations as of December 31, 2015 and December 31, 2014 . 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. 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. Lease expense under our operating leases was as follows (in thousands): Year Ended December 31, 2015 2014 2013 Lease expense $ 10,479 $ 10,678 $ 9,114 Future minimum lease payments under our noncancelable operating and facility leases at December 31, 2015 , were as follows (in thousands): Year ending December 31, Lease Payments 2016 $ 11,757 2017 12,709 2018 8,310 2019 7,165 2020 6,735 Thereafter 66,562 Total $ 113,238 In January 2015, we entered into an agreement to lease office space located in Palo Alto, California in a building to be constructed by the landlord. We expect to occupy this office space by the end of 2017. The lease has a term of 12 years from the commencement date as defined in the lease agreement and we have an option to extend the term of the lease twice for a period of five years each. We are obligated to make lease payments totaling approximately $88 million over the initial term of the lease. In connection with this lease, the landlord is providing a tenant improvement allowance for the costs associated with the design, development and construction of tenant improvements for the leased facility. We are obligated to fund all costs incurred in excess of the tenant improvement allowance. The scope of the planned tenant improvements do not qualify as “normal tenant improvements” under the lease accounting guidance. Accordingly, for accounting purposes, we have concluded we are the deemed owner of the building during the construction period. As of December 31, 2015 , we recorded project construction costs of $4.4 million incurred by the landlord as construction-in-progress in property and equipment, net and a corresponding financing obligation in other non-current liabilities in our consolidated balance sheets. We will increase the asset and financing obligation as additional building costs are incurred by the landlord during the construction period. In the year ended December 31, 2015 , we recorded rent expense associated with the ground lease of $ 1.8 million in our consolidated statements of income. As of December 31, 2015 , we had $97.5 million of noncancelable purchase commitments due within one year, primarily related to agreements with third party manufacturers. Legal Proceedings We are involved in legal proceedings, including the following matters: Xyrem ANDA Matters. On October 18, 2010, we received a notice of Paragraph IV Certification from Roxane that it had submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. Roxane’s initial notice 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 notice 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 initial notice in the U.S. District Court for the District of New Jersey, or the District Court, seeking a permanent injunction to prevent Roxane from introducing a generic version of Xyrem that would infringe our patents. In accordance with the Hatch-Waxman Act, as a result of our having filed a timely lawsuit against Roxane, FDA approval of Roxane’s ANDA was stayed for 30 months , or until April 2013. That stay has expired. Additional patents covering Xyrem have been issued since December 2010, and after receiving Paragraph IV Certification notices from Roxane with respect to those patents, we have filed additional lawsuits against Roxane to include these additional patents in the litigation. All of the lawsuits filed against Roxane between 2010 and 2012 have been consolidated by the District Court into a single case, or the first Roxane consolidated case, alleging that 10 of our patents covering Xyrem are or will be infringed by Roxane’s ANDA and seeking a permanent injunction to prevent Roxane from launching a generic version of Xyrem that would infringe these patents. After receiving additional Paragraph IV Certification notices from Roxane, on February 20, 2015 and June 1, 2015, we filed two actions against Roxane in the District Court that have since been consolidated, or the second Roxane consolidated case, alleging that four of our patents covering Xyrem are or will be infringed by Roxane’s ANDA and seeking a permanent injunction to prevent Roxane from introducing a generic version of Xyrem that would infringe those patents. After receiving an additional Paragraph IV Certification notice from Roxane on December 14, 2015, we filed an action against Roxane on January 27, 2016 alleging that one of our patents covering Xyrem is or will be infringed by Roxane’s ANDA and seeking a permanent injunction to prevent Roxane from introducing a generic version of Xyrem that would infringe that patent. In December 2013, the District Court permitted Roxane to amend its answer in the first Roxane consolidated case to allege certain 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 first Roxane consolidated case regarding patents related to the distribution system for Xyrem. Although no trial date has been scheduled, based on the District Court’s current schedule, we anticipate that trial on the patents in the first Roxane consolidated case that are not subject to the stay could occur as early as the second quarter of 2016. We do not have any estimate of a possible trial date for trial on the patents in the first Roxane consolidated case that are currently subject to the stay or for any other Roxane cases. On April 20, 2015, Roxane moved in the second Roxane consolidated case to dismiss claims involving our patent covering a part of the Xyrem label that instructs prescribers on adjusting the dose of Xyrem when it is being co-administered with divalproex sodium (also known as valproate or valproic acid) on the grounds that this patent does not cover patentable subject matter. On October 29, 2015, the District Court administratively terminated this motion to dismiss (without prejudice) pending the outcome of IPR proceedings before the PTAB, relating to the patent that was the subject of Roxane’s motion. The actual timing of events in our litigation with Roxane may be significantly earlier or later than we currently anticipate. We cannot predict the specific timing or outcome of events in these matters or the impact of these matters on any of the Roxane cases or other ongoing proceedings with any ANDA filer. On December 10, 2012, we received notice of 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. On January 18, 2013, we filed a lawsuit against Amneal in the District Court alleging that our patents covering Xyrem are infringed or will be infringed by Amneal’s ANDA and seeking a permanent injunction to prevent Amneal from introducing a generic version of Xyrem that would infringe these patents. On November 21, 2013, we received notice of 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. On December 27, 2013, we filed a lawsuit against Par in the District Court, alleging that our patents covering Xyrem are infringed or will be infringed by Par’s ANDA and seeking a permanent injunction to prevent Par from introducing a generic version of Xyrem that would infringe these patents. In April 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 in May 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. As a result, FDA’s approval of both Amneal’s and Par’s 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. Additional patents covering Xyrem have issued since April 2014 and have been listed in the Orange Book for Xyrem. Amneal and Par have given us additional notices of Paragraph IV Certifications regarding such patents, and we have filed additional lawsuits against Amneal and Par in the District Court alleging that our patents covering Xyrem are infringed or will be infringed by Amneal’s and Par’s ANDAs and seeking a permanent injunction to prevent Amneal and Par from introducing a generic version of Xyrem that would infringe these patents. On June 4, 2014, we received a notice of 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. On July 15, 2014, we filed a lawsuit against Ranbaxy in the District Court alleging that our patents covering Xyrem are infringed or will be infringed by Ranbaxy’s ANDA and seeking a permanent injunction to prevent Ranbaxy from introducing a generic version of Xyrem that will infringe these patents. Since June 2014, we have received additional notices of Paragraph IV Certification from Ranbaxy regarding newly issued patents for Xyrem listed in the Orange Book, and we have filed additional lawsuits against Ranbaxy in the District Court alleging that our patents covering Xyrem are infringed or will be infringed by Ranbaxy’s ANDA and seeking a permanent injunction to prevent Ranbaxy from introducing a generic version of Xyrem that would infringe these patents. On October 30, 2014, we received a notice of Paragraph IV Certification from Watson Laboratories, Inc., or Watson, that it had submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. On December 11, 2014, we filed a lawsuit against Watson in the District Court alleging that our patents covering Xyrem are or will be infringed by Watson’s ANDA and seeking a permanent injunction to prevent Watson from introducing a generic version of Xyrem that would infringe these patents. On March 23, 2015, Watson moved to dismiss the portion of the case based on our Orange Book-listed patents covering the distribution system for Xyrem on the grounds that these patents do not cover patentable subject matter. On November 4, 2015, the District Court administratively terminated this motion to dismiss (without prejudice) pending the outcome of IPR proceedings before the PTAB relating to the patents that were the subject of Watson’s motion. Since March 2015, we have received an additional notice of Paragraph IV Certification from Watson regarding newly issued patents for Xyrem listed in the Orange Book, and we have filed an additional lawsuit against Watson in the District Court alleging that our patents covering Xyrem are infringed or will be infringed by Watson’s ANDA and seeking a permanent injunction to prevent Watson from introducing a generic version of Xyrem that would infringe these patents. In April 2015, the District Court issued an order that consolidated all then-pending lawsuits against Amneal, Par, Ranbaxy and Watson into one case. On June 8, 2015, we received a Paragraph IV Certification from Wockhardt Bio AG, or Wockhardt, that it has submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. On July 17, 2015, we filed a lawsuit in the District Court alleging that our patents covering Xyrem are or will be infringed by Wockhardt’s ANDA and seeking a permanent injunction to prevent Wockhardt from introducing a generic version of Xyrem that would infringe our patents. Since July 2015, we have received an additional notice of Paragraph IV Certification from Wockhardt regarding newly issued patents listed in the Orange Book, and we have filed an additional lawsuit against Wockhardt in the District Court alleging that our patents covering Xyrem are infringed or will be infringed by Watson’s ANDA and seeking a permanent injunction to prevent Watson from introducing a generic version of Xyrem that would infringe these patents. On July 23, 2015, we received a Paragraph IV Certification from Lupin Inc., or Lupin, that it has submitted an ANDA to the FDA requesting approval to market a generic version of Xyrem. On September 2, 2015, we filed a lawsuit in the District Court alleging that our patents covering Xyrem are or will be infringed by Lupin’s ANDA and seeking a permanent injunction to prevent Lupin from introducing a generic version of Xyrem that would infringe our patents. On January 14, 2016, the District Court issued an order consolidating all of the cases then pending against Amneal, Par, Ranbaxy, Watson, Wockhardt and Lupin into a single case for all purposes. We cannot predict the timing or outcome of events in this matter or the impact of developments involving any specific parties or patents on other ongoing proceedings with any ANDA filer. Xyrem Post-Grant Patent Review Matters. In January 2015, certain of the ANDA filers filed petitions for IPR with respect to the validity of six patents covering the distribution system for Xyrem. In July 2015, the PTAB issued decisions instituting IPR trials with respect to these petitions, and we expect the PTAB to issue final decisions on the validity of the patents in July 2016. In September 2015, certain of the ANDA filers filed a petition for IPR with respect to the validity of an additional patent covering the distribution system for Xyrem. In October 2015, certain of the ANDA filers filed petitions for IPR with respect to the validity of one of our patents covering a method for prescribing Xyrem when it is being co-administered with divalproex sodium (also known as valproate or valproic acid). In December 2015, Wockhardt filed a petition for IPR with respect to the validity of one of our patents covering the formulation of Xyrem. In February 2016, Amneal filed a petition for IPR with respect to the validity of one of our patents covering a method for prescribing Xyrem when it is being co-administered with divalproex sodium. We cannot predict whether additional post-grant patent review challenges will be filed by any of the ANDA filers or any other entity, the outcome of any IPR or other proceeding, whether the PTAB will institute any petitioned IPR proceeding that has not yet been instituted, or the impact any IPR or other proceeding might have on ongoing ANDA litigation proceedings or other aspects of our Xyrem business. Cutler Matter. On October 19, 2011, Dr. Neal Cutler, one of the original owners of FazaClo, filed a complaint against Azur Pharma Public Limited Company, or 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 alleged that Azur Pharma and its subsidiary breached certain contractual obligations that would have required Azur Pharma to pay Cutler approximately $35 million under a contract it assumed when it acquired FazaClo from Avanir in 2007, and further alleged that Cutler was entitled to unspecified punitive damages and attorneys’ fees. On December 21, 2015, Cutler filed a First Amended Complaint, and the Superior Court set a trial date for July 2016. Effective February 10, 2016, we entered into a settlement agreement with Cutler resolving all claims in the lawsuit. The settlement amount was included within accrued liabilities in our consolidated balance sheet as of December 31, 2015. 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, Quadramet ® (samarium sm 153 lexidronam injection) and ProstaScint ® (capromab pendetide), for Medicaid and the Public Health Service’s 340B drug pricing discount program. We 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. In addition to the discussions with CMS as part of CORAR, we have had separate discussions with CMS directly regarding Quadramet. We sold Quadramet to a third party in December 2013, but we retained any liabilities related to sales of the product during prior periods. Similarly, we sold ProstaScint to a third party in May 2015, but we retained any liabilities related to sales of the product during prior periods. We are currently unable to predict whether price reporting and rebates will be required for Quadramet and ProstaScint and, if so, for what period they will be required. The initiation of any reporting of Medicaid pricing data for Quadramet or ProstaScint could result in retroactive 340B ceiling price liability for these two products. We are currently unable to reasonably estimate an amount or range of a potential contingent loss. Any material liability resulting from radiopharmaceutical price reporting would negatively impact our financial results. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders’ Equity Share Repurchase Program In May 2013, our board of directors authorized a share repurchase program pursuant to which we were authorized to repurchase a number of ordinary shares having an aggregate repurchase price of up to $200.0 million , exclusive of any brokerage commissions. In August 2015, we completed repurchases under the May 2013 share repurchase program. On November 5, 2015, our board of directors authorized a new share repurchase program pursuant to which we are authorized to repurchase a number of ordinary shares having an aggregate purchase price of up to $300.0 million , exclusive of any brokerage commissions. Under this share repurchase program, which has no expiration date, we may repurchase ordinary shares from time to time on the open market. The timing and amount of repurchases will be at management’s discretion and will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under the June 2015 credit agreement, corporate and regulatory requirements and market conditions. The share repurchase program may be modified, suspended or discontinued at any time without prior notice. In 2015, under both repurchase programs, we spent a total of $61.6 million to repurchase 0.4 million of our ordinary shares at an average total purchase price, including brokerage commissions, of $150.24 per share. All ordinary shares repurchased were canceled. As of December 31, 2015 , the remaining amount authorized under the November 2015 share repurchase program was $259.8 million . Authorized But Unissued Ordinary Shares We had reserved the following shares of authorized but unissued ordinary shares (in thousands): December 31, 2015 2011 Equity Incentive Plan 11,900 2007 Equity Incentive Plan 937 2007 Employee Stock Purchase Plan 512 Amended and Restated 2007 Non-Employee Directors Stock Option Plan 451 Amended and Restated Directors Deferred Compensation Plan 178 Total 13,978 |
Comprehensive Income (Loss)
Comprehensive Income (Loss) | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Comprehensive Loss | Comprehensive Income (Loss) Comprehensive income (loss) includes net income and all changes in shareholders’ equity during a period, except for those changes resulting from investments by shareholders or distributions to shareholders. Accumulated Other Comprehensive Loss The components of accumulated other comprehensive loss attributable to Jazz Pharmaceuticals plc at December 31, 2015 and December 31, 2014 were as follows (in thousands): Foreign Total Balance at December 31, 2014 $ (122,097 ) $ (122,097 ) Other comprehensive loss (145,375 ) (145,375 ) Balance at December 31, 2015 $ (267,472 ) $ (267,472 ) In 2015, other comprehensive loss reflects foreign currency translation adjustments, primarily due to the strengthening of the U.S. dollar against the euro, resulting in a reduction in the dollar value of certain non-current euro denominated assets. |
Segment and Other Information
Segment and Other Information | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
Segment and Other Information | 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 meaningful products that address unmet medical needs. The following table presents a summary of total revenues (in thousands): Year Ended December 31, 2015 2014 2013 Xyrem $ 955,187 $ 778,584 $ 569,113 Erwinaze/Erwinase 203,261 199,665 174,251 Defitelio/defibrotide 70,731 70,537 — Prialt ® (ziconotide) intrathecal infusion 26,440 26,421 27,103 Psychiatry 37,135 40,879 49,226 Other 24,065 46,630 45,705 Product sales, net 1,316,819 1,162,716 865,398 Royalties and contract revenues 7,984 10,159 7,025 Total revenues $ 1,324,803 $ 1,172,875 $ 872,423 The following table presents a summary of total revenues attributed to geographic sources (in thousands): Year Ended December 31, 2015 2014 2013 United States $ 1,192,879 $ 1,007,396 $ 792,518 Europe 103,614 126,715 61,843 All other 28,310 38,764 18,062 Total revenues $ 1,324,803 $ 1,172,875 $ 872,423 The following table presents a summary of the percentage of total revenues from customers that represented more than 10% of our total revenues: Year Ended December 31, 2015 2014 2013 Express Scripts 72 % 66 % 65 % Accredo Health Group, Inc. 6 % 14 % 16 % The following table presents total long-lived assets by location (in thousands): December 31, 2015 2014 Ireland $ 62,795 $ 37,775 United States 12,794 9,795 Italy 7,928 8,462 Other 2,055 2,331 Total long-lived assets (1) $ 85,572 $ 58,363 _________________________ (1) Long-lived assets consist of property and equipment. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | Share-Based Compensation 2011 Equity Incentive Plan On January 18, 2012, the businesses of Jazz Pharmaceuticals, Inc. and Azur Pharma were combined in a merger transaction, or the Azur Merger. In connection with the Azur Merger, Jazz Pharmaceuticals, Inc.’s board of directors adopted the 2011 Equity Incentive Plan, or the 2011 Plan, in October 2011 and its stockholders approved the 2011 Plan at the special meeting of the stockholders held in December 2011 in connection with the Azur Merger. The 2011 Plan became effective immediately before the consummation of the Azur Merger and was assumed and adopted by us upon the consummation of the Azur Merger. The terms of the 2011 Plan provide for the grant of stock options, stock appreciation rights, restricted stock awards, RSUs, other stock awards, and performance awards that may be settled in cash, shares, or other property. All outstanding grants under the 2011 Plan were granted to employees and vest ratably over service periods of four years and expire no more than 10 years after the date of grant. As of December 31, 2015 , a total of 16,278,263 of our ordinary shares had been authorized for issuance under the 2011 Plan. In addition, the share reserve under the 2011 Plan will automatically increase on January 1 of each year through January 1, 2022, by the least of (a) 4.5% of the total number of ordinary shares outstanding on December 31 of the preceding calendar year, (b) 5,000,000 shares, or (c) such lesser number of ordinary shares as determined by our board of directors. On January 1, 2016, the share reserve under the 2011 Plan automatically increased by 2,758,722 ordinary shares pursuant to this provision. 2007 Equity Incentive Plan The 2007 Equity Incentive Plan, or the 2007 Plan, which was initially adopted by the Jazz Pharmaceuticals, Inc. board of directors and approved by the Jazz Pharmaceuticals, Inc. stockholders in connection with its initial public offering, was continued and assumed by us upon consummation of the Azur Merger. The 2007 Plan provided for the grant of stock options, restricted stock awards, RSUs, stock appreciation rights, performance stock awards and other forms of equity compensation to employees, including officers, non-employee directors and consultants. Prior to the consummation of the Azur Merger, all of the grants under the 2007 Plan were granted to employees and vest ratably over service periods of three to five years and expire no more than 10 years after the date of grant. Effective as of the closing of the Azur Merger on January 18, 2012, the number of shares reserved for issuance under the 2007 Plan was set to 1,000,000 ordinary shares. The share reserve under the 2007 Plan will not automatically increase. Since the Azur Merger, all of the new grants under the 2007 Plan were granted to non-employee directors, vest ratably over service periods of one to three years and expire no more than 10 years after the date of grant. 2007 Employee Stock Purchase Plan In 2007, Jazz Pharmaceuticals, Inc.’s employees became eligible to participate in the Employee Stock Purchase Plan, or ESPP. The ESPP was amended and restated by Jazz Pharmaceuticals, Inc.’s board of directors in October 2011 and approved by its stockholders in December 2011. The amended and restated ESPP became effective immediately prior to the effective time of the Azur Merger and was assumed by us upon the consummation of the Azur Merger. The amended and restated ESPP allows our eligible employee participants (including employees of any of a parent or subsidiary company if our board of directors designates such company as eligible to participate) to purchase our ordinary shares at a discount of 15% through payroll deductions. The ESPP consists of a fixed offering period of 24 months with four purchase periods within each offering period. The number of shares available for issuance under our ESPP during any six-month purchase period is 175,000 shares. As of December 31, 2015 , a total of 2,660,000 of our ordinary shares had been authorized for issuance under the ESPP. The share reserve under the ESPP will automatically increase on January 1 of each year through January 1, 2022, by the least of (a) 1.5% of the total number of ordinary shares outstanding on December 31 of the preceding calendar year, (b) 1,000,000 shares, or (c) such lesser number of ordinary shares as determined by our board of directors or a duly-authorized committee thereof. Our compensation committee determined not to automatically increase the share reserve under the ESPP on January 1, 2016. Amended and Restated 2007 Non-Employee Directors Stock Option Plan The Amended and Restated 2007 Non-Employee Directors Stock Option Plan, or the 2007 Directors Option Plan, which was initially adopted by the Jazz Pharmaceuticals, Inc. board of directors and approved by the Jazz Pharmaceuticals, Inc. stockholders in connection with its initial public offering, was continued and assumed by us upon the consummation of the Azur Merger. Until October 2011, the 2007 Directors Option Plan provided for the automatic grant of stock options to purchase shares of Jazz Pharmaceuticals, Inc.’s common stock to its non-employee directors initially at the time any individual first became a non-employee director, which vest over three years, and then annually over their period of service on its board of directors, which vest over one year. On October 24, 2011, Jazz Pharmaceuticals, Inc.’s board of directors amended the 2007 Directors Option Plan to eliminate all future initial and annual automatic grants so that future automatic grants would not be made that would be subject to the excise tax imposed by Section 4985 of the Internal Revenue Code of 1986, as amended, or the Internal Revenue Code, in connection with the Azur Merger. Accordingly, all future stock option grants under the 2007 Directors Option Plan will be at the discretion of our board of directors. Since the Azur Merger, all of the new grants under the 2007 Directors Option Plan were granted to non-employee directors and vest ratably over service periods of one to three years and expire no more than 10 years after the date of grant. In addition, the 2007 Directors Option Plan provides the source of shares to fund distributions made prior to August 15, 2010 under the Directors Deferred Compensation Plan described below. As of December 31, 2015 , a total of 869,768 of our ordinary shares had been authorized for issuance under the 2007 Directors Option Plan. The number of shares reserved for issuance under the 2007 Directors Plan automatically increases on each January 1, from January 1, 2008 through (and including) January 1, 2017, by the excess of (a) the number of shares subject to options granted, over (b) the number of shares added back to the share reserve, in each case, during the preceding calendar year under the 2007 Directors Plan; provided, that, for any year, the automatic increase may not exceed 200,000 shares and the board of directors may approve a lesser, or no, automatic increase. On January 1, 2016, the share reserve under the 2007 Directors Option Plan automatically increased by 34,150 ordinary shares pursuant to this provision. Amended and Restated Directors Deferred Compensation Plan In May 2007, the Jazz Pharmaceuticals, Inc. board of directors adopted the Directors Deferred Compensation Plan, or the Directors Deferred Plan, which was amended in December 2008 and was then amended and restated in August 2010, and which was continued and assumed by us upon consummation of the Azur Merger. The Directors Deferred Plan allows each non-employee director to elect to defer receipt of all or a portion of his or her annual retainer fees to a future date or dates. Amounts deferred under the Directors Deferred Plan are credited as shares of Jazz Pharmaceuticals, Inc.’s common stock (or our ordinary shares following the Azur Merger) to a phantom stock account, the number of which are based on the amount of the retainer fees deferred divided by the market value of Jazz Pharmaceuticals, Inc.’s common stock (or our ordinary shares following the Azur Merger) on the first trading day of the first open window period following the date the retainer fees are deemed earned. On the 10th business day following the day of separation from the board of directors or the occurrence of a change in control, or as soon thereafter as practical once the non-employee director has provided the necessary information for electronic deposit of the deferred shares, each non-employee director will receive (or commence receiving, depending upon whether the director has elected to receive distributions from his or her phantom stock account in a lump sum or in installments over time) a distribution of his or her phantom stock account, in our ordinary shares (i) reserved under the 2007 Directors Option Plan prior to August 15, 2010 and (ii) from a new reserve of 200,000 shares set up under the Directors Deferred Plan on August 15, 2010. Although we continue to maintain the Directors Deferred Plan, since the consummation of the Azur Merger we have not permitted and will not permit non-employee directors to defer any annual retainer fees under the Directors Deferred Plan. We recorded no expense in 2015, 2014 and 2013 related to retainer fees earned and deferred. As of December 31, 2015 , 14,499 of our ordinary shares that were unissued related to retainer fees that were deferred under the Directors Deferred Plan. Share-Based Compensation The table below shows, for all share option grants, 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 in each of the past three years: Year Ended December 31, 2015 2014 2013 Grant date fair value $ 57.19 $ 60.29 $ 29.09 Volatility 39 % 45 % 58 % Expected term (years) 4.2 4.3 4.4 Range of risk-free rates 1.1-1.5% 1.1-1.4% 0.5-1.4% Expected dividend yield — % — % — % We rely on a blend of the historical and implied volatilities of our own ordinary shares to determine expected volatility for share option grants. In addition, we use a single volatility estimate for each share option grant. The weighted-average volatility is determined by calculating the weighted average of volatilities for all share options granted in a given year. The expected term of share option grants represents the weighted-average period the awards are expected to remain outstanding and our estimates were based on historical exercise data. The risk-free interest rate assumption was based on zero coupon U.S. Treasury instruments whose term was consistent with the expected term of our share option grants. The expected dividend yield assumption was based on our history and expectation of dividend payouts. Share-based compensation expense related to share options, RSUs and grants under our ESPP was as follows (in thousands): Year Ended December 31, 2015 2014 2013 Selling, general and administrative $ 74,653 $ 55,083 $ 35,674 Research and development 13,356 12,179 6,673 Cost of product sales 3,541 2,376 2,204 Total share-based compensation expense, pre-tax 91,550 69,638 44,551 Tax benefit from share-based compensation expense (26,608 ) (20,795 ) (13,822 ) Total share-based compensation expense, net of tax $ 64,942 $ 48,843 $ 30,729 We realized tax benefits related to share option exercises of $15.4 million , $11.8 million and $6.7 million in 2015 , 2014 and 2013 , respectively. Share Options The following table summarizes information as of December 31, 2015 and activity during 2015 related to our share option plans: Shares Subject to Outstanding Options (In thousands) Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In thousands) Outstanding at January 1, 2015 3,870 $ 72.77 Options granted 1,118 173.30 Options exercised (732 ) 45.04 Options forfeited (319 ) 118.05 Options expired — — Outstanding at December 31, 2015 3,937 102.81 7.4 $ 198,666 Vested and expected to vest at December 31, 2015 3,731 99.87 7.3 196,654 Exercisable at December 31, 2015 1,992 64.48 6.3 159,156 Aggregate intrinsic value shown in the table above is equal to the difference between the exercise price of the underlying share options and the fair value of our ordinary shares for share options that were in the money. The aggregate intrinsic value changes based on the fair market value of our ordinary shares. The aggregate intrinsic value of share options exercised was $93.3 million , $138.2 million and $46.0 million during 2015 , 2014 and 2013 , respectively. We issued new ordinary shares upon exercise of share options. As of December 31, 2015 , total compensation cost not yet recognized related to unvested share options was $75.2 million , which is expected to be recognized over a weighted-average period of 2.4 years. As of December 31, 2015 , total compensation cost not yet recognized related to grants under the ESPP was $4.0 million , which is expected to be recognized over a weighted-average period of less than one year . Restricted Stock Units In 2015 , we granted RSUs covering an equal number of our ordinary shares to employees with a weighted-average grant date fair value of $173.25 . The fair value of RSUs is determined on the date of grant based on the market price of our ordinary shares as of that date. The fair value of the RSUs is recognized as expense ratably over the vesting period of four years . In 2015 , 414,000 RSUs were released with 265,000 ordinary shares issued and 149,000 ordinary shares withheld for tax purposes. The total fair value of shares vested was $72.2 million , $50.9 million and $16.1 million during 2015 , 2014 and 2013 , respectively. As of December 31, 2015 , total compensation cost not yet recognized related to unvested RSUs was $84.9 million , which is expected to be recognized over a weighted-average period of 2.1 years. The following table summarizes information as of December 31, 2015 and activity during 2015 related to our RSUs: Number of RSUs (in thousands) Weighted- Weighted- Aggregate Outstanding at January 1, 2015 1,188 $ 96.41 RSUs granted 430 173.25 RSUs released (414 ) 86.03 RSUs forfeited (150 ) 113.44 RSUs expired — — Outstanding at December 31, 2015 1,054 129.40 1.2 $ 148,172 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2015 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plans | Employee Benefit Plans We operate a number of defined contribution retirement plans. The costs of these plans are charged to the consolidated statements of income in the period they are incurred. We recorded expense related to our defined contribution plans of $2.2 million , $2.0 million and $1.1 million in 2015, 2014 and 2013 , respectively. In Ireland, we operate a defined contribution plan in which we contribute up to 8% of an employee’s eligible earnings. We recorded expense of $0.6 million , $0.5 million and $0.3 million in 2015, 2014 and 2013 , respectively, in connection with the contributions we made under the Irish defined contribution plan. In the United States, we provide a qualified 401(k) savings plan for our U.S.-based employees. All U.S.-based employees are eligible to participate, provided they meet the requirements of the plan. In 2013, we elected to match certain employee contributions under the 401(k) savings plan and recorded expense of $1.1 million , $1.0 million and $0.4 million in 2015, 2014 and 2013 , respectively. In the United Kingdom, we operate a defined contribution plan in which we contribute up to 12% of an employee’s eligible earnings. We recorded expense of $0.4 million , $0.5 million and $0.4 million in 2015, 2014 and 2013 , respectively, in connection with contributions we made under the U.K. defined contribution plan. In France, we accrue for a potential liability which is payable if an employee retires. The accrued liability for France was $0.2 million , $0.4 million and $0.3 million as of December 31, 2015 , 2014 and 2013 , respectively. In Italy, we accrue for a potential liability which is payable if an employee leaves employment. The accrued liability for Italy was $0.3 million and $0.4 million as of December 31, 2015 and 2014, respectively. |
Restructuring
Restructuring | 12 Months Ended |
Dec. 31, 2015 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | Restructuring In the fourth quarter of 2015, we recorded severance costs of $1.1 million for terminated employees in connection with the reorganization of our operations in France. These one-time termination benefits were recorded over the remaining service period where employees were required to stay through their termination date to receive the benefits and included within cost of product sales and selling, general and administrative expenses in our consolidated statements of income. We expect to incur additional one-time termination benefit costs of $0.6 million in 2016. In 2014, we recorded severance costs for terminated employees in connection with our decision to discontinue sales representative-led promotion of our psychiatry products starting in 2015. In addition, we initiated a restructuring plan related to the consolidation of our U.K. office locations and recorded severance costs for terminated employees and facility closure costs in connection with this plan. The one-time termination benefits were recorded over the remaining service period where employees were required to stay through their termination date to receive the benefits. We recorded costs related to these one-time termination benefits of $0.4 million and $1.8 million in 2015 and 2014, respectively, within selling, general and administrative expenses in our consolidated statements of income. Facility closure costs of $0.2 million and $0.1 million were incurred in 2015 and 2014, respectively, and recorded within selling, general and administrative expenses in our consolidated statements of income. In June 2012, we initiated a restructuring plan to re-align certain support functions across the company following the Azur Merger and the EUSA Acquisition. In connection with this restructuring plan, we incurred restructuring costs of $1.5 million in the year ended December 31, 2013, which were recorded within selling, general and administrative expenses in our consolidated statements of income. The following table summarizes the amounts related to restructuring through December 31, 2015 (in thousands): Termination Benefits Facility Closure Costs Total Balance at December 31, 2012 $ 1,227 $ — $ 1,227 Expense 1,045 412 1,457 Payments (2,272 ) (160 ) (2,432 ) Balance at December 31, 2013 — 252 252 Expense 1,823 118 1,941 Payments — (252 ) (252 ) Balance at December 31, 2014 1,823 118 1,941 Expense 1,469 172 1,641 Payments (2,187 ) (290 ) (2,477 ) Balance at December 31, 2015 $ 1,105 $ — $ 1,105 The balances as of December 31, 2015, 2014 and 2013 were included within accrued liabilities in our consolidated balance sheets. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of income before the income tax provision were as follows (in thousands): Year Ended December 31, 2015 2014 2013 Ireland $ 233,785 $ 238,351 $ 186,903 United States 285,420 222,328 132,855 Other (83,272 ) (309,122 ) (11,808 ) Total $ 435,933 $ 151,557 $ 307,950 The following table sets forth the details of the income tax provision (in thousands): Year Ended December 31, 2015 2014 2013 Current Ireland $ 22,599 $ 23,506 $ 17,089 United States 116,301 97,679 71,964 Other 28,708 16,469 12,682 Total current income tax 167,608 137,654 101,735 Deferred, exclusive of other components below Ireland 494 2,323 8,353 United States 332 (15,003 ) (3,513 ) Other (40,532 ) (30,743 ) (14,937 ) Total deferred, exclusive of other components (39,706 ) (43,423 ) (10,097 ) Deferred, change in tax rates United States 294 — — Other (21,797 ) — — Total deferred, change in tax rates (21,503 ) — — Total deferred income tax benefit (61,209 ) (43,423 ) (10,097 ) Total income tax provision $ 106,399 $ 94,231 $ 91,638 Our income tax provision was $106.4 million , $94.2 million and $91.6 million in 2015 , 2014 and 2013 , respectively, related to tax arising on income in Ireland, the United States and certain other foreign jurisdictions, certain unrecognized tax benefits and various expenses not deductible for tax purposes. The effective tax rates for 2015, 2014 and 2013 were 24.4% , 62.2% and 29.8% , respectively. After adjusting the income before income tax provision for the year ended December 31, 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, which were acquired by our subsidiaries in a non-taxable jurisdiction, the effective tax rate on the resulting income before income tax provision for 2014 was 26.7% . The effective tax rate for 2015 was higher than the Irish statutory rate of 12.5% , primarily due to income taxable at a rate higher than the Irish statutory rate, unrecognized tax benefits, and various expenses not deductible for tax purposes, partially offset by originating tax credits, deductions available in relation to subsidiary equity and reductions in tax rates in certain jurisdictions. The effective tax rates for 2014 and 2013 were higher than the Irish statutory rate of 12.5% , primarily due to income taxable at a rate higher than the Irish statutory rate, unrecognized tax benefits, 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 in 2014 and benefits from certain originating income tax credits. The decrease in the effective tax rate in 2015 compared to 2014 was primarily due to changes in income mix among the various jurisdictions in which we operate, increased originating tax credits, increased deductions available in relation to subsidiary equity and reductions in tax rates in certain jurisdictions, partially offset by the impact of impairments of intangible assets and changes in U.S. state valuation allowances during 2014. The decrease in the effective tax rate, after excluding the upfront and milestone payments, for 2014 compared to 2013 was primarily due to changes in income mix among the various jurisdictions in which we operate, changes in U.S. state valuation allowances and benefits from certain originating income tax credits. We are currently paying taxes in Ireland, the United States and certain other foreign jurisdictions where we have operations and either all net operating losses, or NOLs, have been utilized, or are restricted as a result of the Azur Merger. The reconciliation between the statutory income tax rate applied to income before income tax provision and our effective income tax rate was as follows: Year Ended December 31, 2015 2014 2013 Statutory income tax rate 12.5 % 12.5 % 12.5 % Foreign income tax rate differential 19.1 % 50.0 % 10.3 % Change in tax rate (4.5 )% — % — % Research and other tax credits (3.8 )% (9.4 )% (1.9 )% Change in unrecognized tax benefits 3.6 % 6.2 % 2.8 % Deduction on subsidiary equity (2.7 )% (7.5 )% — % Change in estimates (1.0 )% (3.0 )% 1.1 % Non-deductible compensation 1.9 % 4.6 % 1.3 % Change in valuation allowance (0.6 )% 5.7 % 1.1 % Financing costs (0.4 )% 0.7 % — % Acquisition-related costs — % 3.1 % 1.7 % Other 0.3 % (0.7 )% 0.9 % Effective income tax rate 24.4 % 62.2 % 29.8 % Deferred income taxes reflect the tax effects of NOLs and tax credit carryforwards and the net temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes using currently enacted tax rates and regulations that are expected to be in effect when the differences are expected to be recovered or settled. Significant components of our net deferred tax assets/(liabilities) were as follows (in thousands): December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ 57,091 $ 74,057 Tax credit carryforwards 36,797 23,946 Intangible assets 25,384 19,507 Share-based compensation 20,050 14,033 Accruals 32,355 36,157 Other 31,144 36,222 Total deferred tax assets 202,821 203,922 Valuation allowance (33,949 ) (29,697 ) Net deferred tax assets 168,872 174,225 Deferred tax liabilities: Acquired intangible assets (307,356 ) (395,651 ) Other (33,138 ) (39,124 ) Total deferred tax liabilities (340,494 ) (434,775 ) Net deferred tax liabilities $ (171,622 ) $ (260,550 ) The net change in valuation allowance was $4.3 million , $9.0 million and $3.2 million in 2015 , 2014 and 2013 , respectively. The following table presents the breakdown between current and non-current deferred tax assets/(liabilities) (in thousands): Year Ended December 31, 2015 2014 Current deferred tax assets $ — $ 48,440 Current deferred tax liabilities — (9,430 ) Non-current deferred tax assets 122,863 75,494 Non-current deferred tax liabilities (294,485 ) (375,054 ) Net deferred tax liabilities $ (171,622 ) $ (260,550 ) During November 2015, the FASB issued ASU 2015-17 which simplifies the presentation of deferred income taxes. This ASU requires that deferred tax assets and liabilities be classified as non-current in a statement of financial position. We early adopted ASU 2015-17 effective December 31, 2015 on a prospective basis. Adoption of this ASU resulted in a reclassification of our net current deferred tax assets and liabilities to net non-current deferred tax assets and liabilities in our consolidated balance sheet as of December 31, 2015. No prior periods were retrospectively adjusted. As of December 31, 2015 , we had NOL carryforwards and tax credit carryforwards for U.S. federal income tax purposes of approximately $227.7 million and $60.5 million , respectively, available to reduce future income subject to income taxes. The NOL carryforwards are inclusive of $97.1 million from the EUSA Acquisition in 2012. The federal NOL carryforwards will expire, if not utilized, in the tax years 2016 to 2034 , and the federal tax credits will expire, if not utilized, in the tax years 2016 to 2035 , with the exception of alternative minimum tax credits, which have no expiration date. In addition, we had approximately $234.7 million of NOL carryforwards and $7.0 million of tax credit carryforwards as of December 31, 2015 available to reduce future taxable income for state income tax purposes. The state NOL carryforwards will expire, if not utilized, in the tax years 2016 to 2034 . The state tax credits have no expiration date. In addition, as of December 31, 2015 , there were NOL carryforwards for income tax purposes of approximately $64.8 million and $65.3 million available to reduce future income subject to income taxes in the United Kingdom and Italy, respectively. The NOLs generated in the United Kingdom and Italy have no expiration period. We also had excess foreign tax credits, as of December 31, 2015 , of $4.2 million , which may only be utilized against certain sources of income. The excess foreign tax credits have no expiration period. Utilization of certain of our NOL and tax credit carryforwards in the United States is subject to annual limitation due to the ownership change limitations provided by Sections 382 and 383 of the Internal Revenue Code and similar state provisions. Such an annual limitation may result in the expiration of certain NOLs and tax credits before future utilization. We currently estimate that we have an annual limitation on the utilization of certain acquired federal NOLs and credits of $23.5 million , before tax effect, for 2016 and a combined total of $27.5 million , before tax effect, for 2017 to 2026. In addition, as a result of the Azur Merger, until 2022 we are subject to certain limitations under the Internal Revenue Code in relation to the utilization of U.S. NOLs to offset U.S. taxable income resulting from certain transactions. Approximately $170.4 million of both the U.S. federal and state NOL carryforwards as of December 31, 2015 included above resulted from exercises of employee share options and certain sales by employees of shares issued under other employee equity compensation plans. We have not recorded the tax benefit of the deduction related to these exercises and sales as deferred tax assets on our balance sheet. When we realize the tax benefit as a reduction to taxable income in our tax returns, we will account for the tax benefit as a credit to shareholders’ equity rather than as a reduction of our income tax provision in our financial statements. Valuation allowances require an assessment of both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. Such assessment is required on a jurisdiction-by-jurisdiction basis. Our valuation allowance was $33.9 million and $29.7 million as of December 31, 2015 and 2014 , respectively, for certain U.S. state and foreign deferred tax assets which we maintain until sufficient positive evidence exists to support reversal. During 2015, as part of the overall change in valuation allowance, we recognized a net income tax expense of $2.4 million relating to the creation of a valuation allowance against certain deferred tax assets primarily associated with NOLs arising during the year, partially offset by a release of a valuation allowance due to the impact of the reduction of tax rates in certain jurisdictions on certain deferred tax assets primarily associated with NOLs. During 2014, as part of the overall change in valuation allowance, we recognized a net income tax benefit of $7.7 million relating to the net reversal of a valuation allowance against certain deferred tax assets associated with NOLs and tax credit carryforwards. During 2013, as part of the overall change in valuation allowance, we recognized an income tax expense of $2.3 million relating to the creation of a valuation allowance against certain U.S. state deferred tax assets associated with tax credit carryforwards. We periodically evaluate the likelihood of the realization of deferred tax assets and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of tax audits and the regulatory approval of products currently under development. Realization of substantially all the deferred tax assets is dependent on future book income. Temporary differences related to investments in foreign subsidiaries totaled approximately $983.8 million and $736.9 million as of December 31, 2015 and 2014 , respectively. In the event of the distribution of those earnings in the form of dividends, a sale of the subsidiaries, or certain other transactions, we may be liable for income taxes, subject to an adjustment, if any, for foreign tax credits and foreign withholding taxes payable to certain foreign tax authorities. As of December 31, 2015 , it was not practicable to determine the amount of the income tax liability related to these investments. 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. A reconciliation of our gross unrecognized tax benefits follows (in thousands): December 31, 2015 2014 2013 Balance at the beginning of the year $ 40,802 $ 21,637 $ 7,288 Increases related to current year tax positions 23,664 19,837 14,308 Increases related to prior year tax positions 2,833 — 183 Decreases related to prior year tax positions (646 ) (672 ) (142 ) Lapse of the applicable statute of limitations (268 ) — — Balance at the end of the year $ 66,385 $ 40,802 $ 21,637 The unrecognized tax benefits were included in other non-current liabilities and deferred tax assets, net, non-current in our consolidated balance sheets. Interest related to our unrecognized tax benefits is recorded in income tax provision in our consolidated statements of income. As of December 31, 2015 and 2014 , our accrued interest and penalties related to unrecognized tax benefits were not significant. Included in the balance of unrecognized tax benefits were potential benefits of $48.1 million and $29.7 million at December 31, 2015 and 2014 , respectively, that, if recognized, would affect the effective tax rate on income. Our most significant tax jurisdictions are Ireland, the United States (both at the federal level and in various state jurisdictions), Italy and France. Because of our NOL 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 Italian tax authorities for fiscal year 2012. These examinations may lead to ordinary course adjustments or proposed adjustments to our taxes. In December 2015, we received proposed tax assessment notices from the French tax authorities for 2012 and 2013 relating to certain transfer pricing adjustments. The notices propose additional French tax of approximately $41.8 million , including interest and penalties, based on the foreign exchange rate at December 31, 2015 through the date of the assessment. We disagree with the proposed assessment and intend to contest it vigorously. |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (Unaudited) | Quarterly Financial Data (Unaudited) The following interim financial information presents our 2015 and 2014 results of operations on a quarterly basis (in thousands, except per share amounts): 2015 March 31 June 30 September 30 December 31 Revenues $ 309,303 $ 333,747 $ 340,872 $ 340,881 Gross margin (1) 278,737 310,293 310,369 314,894 Net income attributable to Jazz Pharmaceuticals plc 70,700 88,114 87,960 82,761 Net income attributable to Jazz Pharmaceuticals plc per ordinary share, basic 1.16 1.44 1.43 1.35 Net income attributable to Jazz Pharmaceuticals plc per ordinary share, diluted 1.12 1.40 1.39 1.32 2014 March 31 June 30 September 30 December 31 Revenues $ 246,919 $ 291,230 $ 306,584 $ 328,142 Gross margin (1) 214,062 258,408 277,413 295,415 Net income (loss) attributable to Jazz Pharmaceuticals plc (92,650 ) 43,659 25,766 81,612 Net income (loss) attributable to Jazz Pharmaceuticals plc per ordinary share, basic (1.58 ) 0.73 0.43 1.35 Net income (loss) attributable to Jazz Pharmaceuticals plc per ordinary share, diluted (1.58 ) 0.70 0.41 1.30 __________________________ (1) Gross margin is computed by subtracting cost of product sales (excluding amortization and impairment of intangible assets) from product sales, net. The tables above include the following items: • Impairment charges of $31.5 million in the fourth quarter of 2015 and $32.8 million and $6.6 million in the second and fourth quarters of 2014, respectively. The 2015 charge resulted from our decision to terminate a pivotal Phase 2 clinical trial of JZP-416. The 2014 charges related to certain products acquired as part of the EUSA Acquisition that we sold in March 2015; • Upfront and milestone payments of $25.0 million in the third quarter of 2015 and $127.0 million , $75.0 million and $0.6 million in the first, third and fourth quarters of 2014, respectively; • A one-time charge of $18.0 million in the fourth quarter of 2015 for settlement of a contract claim that was originally asserted against Azur Pharma prior to the Azur Merger; • A loss on extinguishment and modification of debt of $16.8 million in the second quarter of 2015; • Acquisition accounting inventory value step-up adjustments $8.0 million and $2.5 million in the first and second quarters of 2014, respectively; and • Transaction costs of $17.1 million , $4.4 million , $0.7 million and $5.2 million in the first, second, third and fourth quarters of 2014, respectively. |
Schedule II Valuation and Quali
Schedule II Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2015 | |
Valuation and Qualifying Accounts [Abstract] | |
Schedule II Valuation and Qualifying Accounts | Schedule II Valuation and Qualifying Accounts (In thousands) Balance at beginning of period Additions charged to costs and expenses Other Additions Deductions Balance at end of period For the year ended December 31, 2015 Allowance for doubtful accounts (1 ) $ 530 $ — $ — $ (41 ) $ 489 Allowance for sales discounts (1 ) 238 2,900 — (2,957 ) 181 Allowance for chargebacks (1 ) 2,715 39,079 — (38,771 ) 3,023 Deferred tax asset valuation allowance (2)(3)(4) 29,697 5,044 1,888 (2,680 ) 33,949 For the year ended December 31, 2014 Allowance for doubtful accounts (1 ) $ 594 $ — $ — $ (64 ) $ 530 Allowance for sales discounts (1 ) 378 3,794 — (3,934 ) 238 Allowance for chargebacks (1 ) 2,708 28,614 — (28,607 ) 2,715 Deferred tax asset valuation allowance (2)(3) 20,691 18,971 — (9,965 ) 29,697 For the year ended December 31, 2013 Allowance for doubtful accounts (1 ) $ 715 $ (4 ) $ — $ (117 ) $ 594 Allowance for sales discounts (1 ) 528 5,267 — (5,417 ) 378 Allowance for chargebacks (1 ) 2,536 21,047 — (20,875 ) 2,708 Deferred tax asset valuation allowance (2 ) 17,471 3,220 — — 20,691 __________________________ (1) Shown as a reduction of accounts receivable. Charges related to sales discounts and chargebacks are reflected as a reduction of revenue. (2) Additions to the deferred tax asset valuation allowance relate to movements on certain U.S. state and other foreign deferred tax assets where we continue to maintain a valuation allowance until sufficient positive evidence exists to support reversal. (3) Deductions to the deferred tax asset valuation allowance include movements relating to utilization of NOLs and tax credit carryforwards, release in valuation allowance and other movements including adjustments following finalization of tax returns. (4) Other additions to the deferred tax asset valuation allowance relate to currency translation adjustments recorded directly in equity. |
Summary of Significant Accoun28
Summary of Significant Accounting Policies (Policy) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Basis Of Presentation | Basis of Presentation The consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, and include the accounts of Jazz Pharmaceuticals plc and our subsidiaries and intercompany transactions and balances have been eliminated. Our consolidated financial statements include the results of operations of businesses we have acquired from the date of each acquisition for the applicable reporting periods. |
Significant Risks And Uncertainties | Significant Risks and Uncertainties Our financial results remain significantly influenced by sales of Xyrem. In 2015, net product sales of Xyrem were $955.2 million , which represented 73% of total net product sales. 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 or an alternative sodium oxybate product that competes with Xyrem; changed or increased regulatory restrictions or regulatory actions by the FDA; our suppliers’ ability to obtain sufficient quotas from the U.S. Drug Enforcement Administration, or DEA; any supply, manufacturing or distribution problems arising with any of our suppliers or distributors, all of whom are sole source providers for us; any increase in pricing pressure from or restrictive conditions for reimbursement required by, and the availability of reimbursement from, third party payors; changes in healthcare laws and policy; continued acceptance of Xyrem by physicians and patients; changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem; and operational disruptions at the central pharmacy or any failure to comply with our REMS obligations to the satisfaction of the FDA. Seven companies have sent us notices that they have filed abbreviated new drug applications, or ANDAs, with the FDA seeking approval to market a generic version of Xyrem. We have filed lawsuits against each of these companies seeking to prevent the introduction of a generic version of Xyrem that would infringe our patents, and the litigation proceedings are ongoing. We cannot predict the timing or outcome of these proceedings. Although no trial date has been set in any of the ANDA suits, we anticipate that trial on some of the patents in the case against the first ANDA filer, Roxane Laboratories, Inc., or Roxane, could occur as early as the second quarter of 2016. Some of the ANDA filers have also filed petitions for inter partes review, or IPR, by the Patent Trial and Appeal Board, or the PTAB, of the U.S. Patent and Trademark Office, or USPTO, with respect to the validity of certain distribution, method of use and formulation patents covering Xyrem. In July 2015, the PTAB issued decisions instituting IPR trials with respect to petitions related to certain patents covering the Xyrem distribution system, and we expect the PTAB to issue final decisions on the validity of these patents in July 2016. We cannot predict whether additional post-grant patent review challenges will be filed by any of the ANDA filers or any other entity, the outcome of any IPR or other proceeding, whether the PTAB will institute any petitioned IPR proceeding that has not yet been instituted, or the impact any IPR or other proceeding might have on ongoing ANDA litigation proceedings or other aspects of our Xyrem business. 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. I n late August 2015, we implemented the final REMS that was approved by the FDA in February 2015. The process under which enrolled patients receive Xyrem is complex and includes multiple mandatory steps taken by the central pharmacy. The transition to the final approved REMS necessitated significant operational changes at the central pharmacy and revised documentation requirements for patients and prescribers. In the third quarter of 2015, Xyrem product sales were adversely impacted by operational disruption and resulting delays in prescription fills and refills. As physicians and patients familiarized themselves with the new REMS process and documentation requirements, the central pharmacy experienced a significantly increased volume of calls from patients and physicians’ offices that the pharmacy was not able to timely address, resulting in a backlog of prescription fills and refills that were delayed. We identified and addressed with the central pharmacy to the extent feasible the processes that led to the operational delays. In the fourth quarter of 2015, we observed an improvement in key operational metrics compared to the third quarter of 2015, and we believe that central pharmacy operations have stabilized. However, we cannot guarantee that we will not experience further disruptions and resulting adverse impacts on Xyrem product sales. Any failure to comply with the REMS obligations could result in enforcement action by the FDA; lead to changes in our Xyrem REMS obligations; continue to negatively affect sales of Xyrem; result in additional costs and expenses for us; and/or take a significant amount of time, any of which could materially and adversely affect our business, financial condition, results of operations and growth prospects. Further, we cannot predict whether the FDA will seek to require or ultimately require modifications to the Xyrem REMS, including with respect to the distribution system, or seek to otherwise impose or ultimately impose additional requirements to the Xyrem REMS, or the potential timing, terms or propriety thereof. 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 may face pressure to develop a single shared REMS with potential generic competitors for Xyrem that is different from the approved Xyrem REMS or to license or share intellectual property pertinent to the Xyrem REMS, or elements of the Xyrem REMS, including proprietary data required for safe distribution of sodium oxybate, with generic competitors. The Xyrem REMS is the subject of multiple issued patents. In January 2014, the FDA held an initial meeting with us and the three then-current sodium oxybate ANDA applicants to facilitate the development of a single shared REMS for sodium oxybate. In October 2015, the FDA held a telephonic meeting with us and the seven current sodium oxybate ANDA applicants to discuss the status of the development of a single shared REMS for sodium oxybate. The parties had regular interactions with respect to developing a single shared REMS prior to this meeting, and we are seeking to continue the interactions with the goal of developing a single shared REMS. However, we are aware that, separate from the discussions with us, the FDA and ANDA applicants have exchanged communications regarding the potential development of a single shared REMS for sodium oxybate. We cannot predict whether, or to what extent, interactions among the parties will continue or whether we will develop a single shared REMS. If we do not develop a single shared REMS or license or share intellectual property pertinent to our Xyrem REMS with generic competitors within a time frame or on terms that the FDA considers acceptable, the FDA may assert that its waiver authority permits it to approve the ANDA of one or more generic competitors with a separate REMS that differs from our approved Xyrem REMS. 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 REMS for sodium oxybate, licensing or sharing intellectual property pertinent to our Xyrem REMS, or the FDA’s response to a request by one or more ANDA applicants for a waiver of the requirement for a single shared REMS, including in connection with a certification that the applicant had been unable to obtain a license. In addition, the Federal Trade Commission, other governmental authorities or others could claim or determine that we are using the Xyrem REMS in an anticompetitive manner (including in light of the FDA’s statement in the Xyrem REMS approval notice that the Xyrem REMS could be used in an anticompetitive manner inconsistent with applicable provisions of the Federal Food, Drug and Cosmetic Act) or have engaged in other anticompetitive practices. Obtaining and maintaining appropriate reimbursement for Xyrem in the U.S. is increasingly challenging due to, among other things, the attention being paid to healthcare cost containment and prescription drug pricing, pricing pressure from third party payors and increasingly restrictive reimbursement conditions being imposed by third party payors. In this regard, we have experienced and expect to continue to experience increasing pressure from third party payors to agree to discounts, rebates or other pricing terms for Xyrem. Any such restrictive pricing terms or additional reimbursement conditions could have a material adverse effect on our Xyrem revenues. In addition, drug pricing by pharmaceutical companies has recently come under close scrutiny, particularly with respect to companies that have increased the price of products after acquiring those products from other companies. We expect that healthcare policies and reforms intended to curb healthcare costs will continue to be proposed, which could limit the prices that we charge for our products, including Xyrem, limit our commercial opportunity and/or negatively impact revenues from sales of our products. Also, price increases on Xyrem and our other products, and negative publicity regarding pricing and price increases generally, whether with respect to our products or products distributed by other pharmaceutical companies, could negatively affect market acceptance of Xyrem and our other products. In 2015, sales of our second largest product, Erwinaze/Erwinase (which we refer to in this report as Erwinaze unless otherwise indicated or the context otherwise requires) were $203.3 million , which represented 15% of total net product sales. We seek to maintain and increase sales of Erwinaze, as well as to make Erwinaze more widely available, through ongoing sales and marketing and research and development activities. However, our ability to successfully and sustainably maintain or grow sales of Erwinaze is subject to a number of risks and uncertainties, including the limited population of patients with ALL and the incidence of hypersensitivity reactions to E. coli -derived asparaginase within that population, our need to apply for and receive marketing authorizations, through the European Union’s mutual recognition procedure or otherwise, in certain additional countries so we can launch promotional efforts in those countries, as well as those other risks and uncertainties discussed in “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K. 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 or regulatory challenges or other manufacturing difficulties. Erwinaze is licensed from and manufactured by a single source, Porton Biopharma Limited, or PBL. The current manufacturing capacity for Erwinaze is nearly completely absorbed by demand for the product. We are working with PBL to evaluate potential expansion of its production capacity to increase the supply of Erwinaze over the longer term. As a consequence of constrained manufacturing capacity, we have had an extremely limited or no ability to build an excess level of product inventory that can be used to absorb disruptions to supply resulting from quality, regulatory or other issues, and we have experienced, and expect to continue to experience, manufacturing and inventory challenges that have resulted in disruptions in our ability to supply certain markets. If capacity constraints continue, whether as a result of continued quality or other manufacturing issues or otherwise, we may be unable to build a desired excess level of product inventory, and our ability to supply the market may continue to be compromised. Additional Erwinaze supply interruptions and/or our inability to expand production capacity could materially adversely affect our sales of and revenues from Erwinaze and our potential future maintenance and growth of the market for this product. Sales of Defitelio/defibrotide were 5% of our net product sales in 2015. We acquired this product in January 2014 in connection with our acquisition of Gentium S.r.l., or Gentium, which we refer to as the Gentium Acquisition, and secured worldwide rights to the product by acquiring rights to defibrotide in the Americas in August 2014. We launched Defitelio in certain European countries in 2014 and continued to launch in additional European countries on a rolling basis through 2015. We are in the process of making pricing and reimbursement submissions with respect to Defitelio in those European countries where Defitelio is not yet launched, including in countries where pricing and reimbursement approvals are required for launch. Our ability to realize the anticipated benefits from our investment in Defitelio/defibrotide is subject to risks and uncertainties, including those discussed in “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K. In particular, we may not be able to successfully maintain or grow sales of Defitelio in Europe, or obtain marketing approval in other countries, 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 maintaining or growing sales of Defitelio in Europe is our ability to obtain appropriate pricing and reimbursement approvals in those European countries where Defitelio is not yet launched. If we experience delays or 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, especially where a country’s reimbursed price influences other countries, our growth prospects in Europe could be negatively affected. In September 2015, the FDA accepted for filing with priority review our NDA for defibrotide for the treatment of VOD with evidence of multi-organ dysfunction following HSCT. Based on timelines established by the Prescription Drug User Fee Act, or PDUFA, we expect FDA review of the NDA to be completed by March 31, 2016. However, the FDA does not always meet the timelines established by PDUFA, and it is possible that the FDA’s review of our NDA will not be completed by the PDUFA date, in which case our plans for commercialization of defibrotide in the U.S. may be delayed. In any event, we cannot predict whether our NDA will be approved in a timely manner, if at all. Approval of our NDA is dependent on our and our supplier’s ability to obtain FDA certification of current Good Manufacturing Practices in connection with the manufacturing of the defibrotide drug compound and the processing of defibrotide into finished product for the U.S. market and on the outcome of FDA inspections of clinical sites and potentially other entities involved in the development of defibrotide. In 2015, the FDA issued a Form FDA 483 to Patheon Italia S.p.A., or Patheon Italia, that included observations related to the Ferentino, Italy facility that manufactures the defibrotide finished product. Failure by Patheon Italia to timely remediate the observations to the FDA’s satisfaction or the discovery of issues that impact the defibrotide finished product could have an adverse impact on the potential approval of our NDA for defibrotide, including the timing thereof. In the event we are able to obtain U.S. marketing approval, we will also face other challenges that could impact the anticipated value of Defitelio/defibrotide, including the limited size of the population of VOD patients who are indicated for treatment with Defitelio/defibrotide (particularly if the FDA requires more narrow or restricted labeling than we have proposed or if changes in HSCT treatment protocols reduce the incidence of VOD); U.S. market acceptance of defibrotide at its commercial price, particularly in light of past access to defibrotide free of charge through an expanded access treatment protocol; the need to establish U.S. pricing and reimbursement support for defibrotide, including through acceptance by hospital pharmacy and therapeutics committees; 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 additional indications. 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 addition to risks specifically related to Xyrem, Erwinaze and Defitelio/defibrotide, we are subject to other challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations. These risks and uncertainties include: • the challenges of protecting and enhancing our intellectual property rights; • the challenges of achieving and maintaining commercial success of our products; • delays or problems in the supply or manufacture of our products, 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; • our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business; • the challenges of compliance with the requirements of the FDA, the DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals; • the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates; • the inherent uncertainty associated with the regulatory approval process, especially as we continue to undertake increased activities and make growing investment in our product pipeline development projects; • the risks associated with business combination or product or product candidate acquisition transactions, such as the challenges inherent in the integration of acquired businesses with our historic business, the increase in geographic dispersion among our centers of operation and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such transactions; and • possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations. |
Business Acquisitions | 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 in-process research and development, or 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. |
Concentrations Of Risk | 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 December 31, 2015 , five customers accounted for 90% of gross accounts receivable including Express Scripts Specialty Distribution Services, Inc. and its affiliate CuraScript, Inc., or Express Scripts, which accounted for 69% of gross accounts receivable, and IDIS Limited, which accounted for 11% of gross accounts receivable. As of December 31, 2014 , five customers accounted for 86% of gross accounts receivable including Express Scripts, which accounted for 66% of gross accounts receivable, and IDIS Limited, which accounted for 11% of gross accounts receivable. We depend on single source suppliers for each of our products, product candidates and their active pharmaceutical ingredients. |
Cash Equivalents And Marketable Securities | Cash Equivalents and Marketable Securities We consider all highly liquid investments, readily convertible to cash, that mature within three months or less from date of purchase to be cash equivalents. Marketable securities are investments in debt securities with maturities of less than one year from the balance sheet date, or securities with maturities of greater than one year that are specifically identified to fund current operations. Collectively, cash equivalents and marketable securities are considered available-for-sale and are recorded at fair value. Unrealized gains and losses, net of tax, are recorded in accumulated other comprehensive loss in shareholders’ equity. We use the specific-identification method for calculating realized gains and losses on securities sold. Realized gains and losses and declines in value judged to be other than temporary on marketable securities are included in interest expense, net in the consolidated statements of income. |
Inventories | Inventories Inventories are valued at the lower of cost or market. Cost is determined using the first-in, first-out method for all inventories. Our policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on our estimates of future demand for a particular product. If our estimate of future demand changes, we consider the impact on the reserve for excess inventory and adjust the reserve as required. Increases in the reserve are recorded as charges in cost of product sales. For product candidates that have not been approved by the FDA, inventory used in clinical trials is expensed at the time of production and recorded as research and development expense. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the clinical trial. Prior to receiving FDA approval, costs related to purchases of the active pharmaceutical ingredient and the manufacturing of the product candidate are recorded as research and development expense. All direct manufacturing costs incurred after approval are capitalized into inventory. |
Property And Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which range from three to 10 years. Leasehold improvements are amortized over the shorter of the noncancelable term of our operating leases or their economic useful lives. Maintenance and repairs are expensed as incurred. |
Goodwill, Acquired In-Process Research and Development, And Intangible Assets | Goodwill Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. We have determined that we operate in a single segment and have a single reporting unit associated with the development and commercialization of pharmaceutical products. The annual test for goodwill impairment is a two-step process. The first step is a comparison of the fair value of the reporting unit with its carrying amount, including goodwill. If this step indicates impairment, then, in the second step, the loss is measured as the excess of recorded goodwill over its implied fair value. Implied fair value is the excess of the fair value of the reporting unit over the fair value of all identified assets and liabilities. We test goodwill for impairment annually in October and when events or changes in circumstances indicate that the carrying value may not be recoverable. 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 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. |
Revenue Recognition | Revenue Recognition Revenues are recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured. Product Sales, Net Product sales revenue is recognized when title has transferred to the customer and the customer has assumed the risks and rewards of ownership, which is typically on delivery to the customer or, in the case of products that are subject to consignment agreements, when the customer removes product from our consigned inventory location for shipment directly to a patient. Revenue from sales transactions where the buyer has the right to return the product is recognized at the time of sale only if (i) the seller’s price to the buyer is substantially fixed or determinable at the date of sale, (ii) the buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product, (iii) the buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product, (iv) the buyer acquiring the product for resale has economic substance apart from that provided by the seller, (v) the seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer, and (vi) the amount of future returns can be reasonably estimated. Revenues from sales of products are recorded net of estimated allowances for returns, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans. Provisions for returns, specialty distributor fees, wholesaler fees, government rebates, coupon programs and rebates under managed care plans are included within current liabilities in our consolidated balance sheets. Provisions for government chargebacks and prompt payment discounts are generally shown as a reduction in accounts receivable. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates for these programs and channel inventory data. Adjustments to estimates for these allowances have not been material. Royalties and Contract Revenues We receive royalties from third parties based on sales of our products under licensing and distribution arrangements. For those arrangements where royalties are reasonably estimable, we recognize revenues based on estimates of royalties earned during the applicable period, and adjust for differences between the estimated and actual royalties in the following quarter. Historically, these adjustments have not been significant. Our contract revenues consist of fees and milestone payments. Non-refundable fees where we have no continuing performance obligations are recognized as revenues when there is persuasive evidence of an arrangement and collection is reasonably assured. In situations where we have continuing performance obligations, non-refundable fees are deferred and are recognized ratably over our projected performance period. We recognize at-risk milestone payments, which are typically related to regulatory, commercial or other achievements by us or our licensees and distributors, as revenues when the milestone is accomplished and collection is reasonably assured. Sales-based milestone payments are typically payments made to us that are triggered when aggregate net sales of a product by a collaborator for a specified period (for example, an annual period) reach an agreed upon threshold amount. We recognize sales-based milestone payments from a collaborator when the event which triggers the obligation of payment has occurred, there is no further obligation on our part in connection with the payment, and collection is reasonably assured. Refundable fees are deferred and recognized as revenues upon the later of when they become nonrefundable or when our performance obligations are completed. |
Cost Of Product Sales | Cost of Product Sales Cost of product sales includes manufacturing and distribution costs, the cost of drug substance, royalties due to third parties on product sales, product liability and cargo insurance, FDA user fees, freight, shipping, handling and storage costs and salaries and related costs of employees involved with production. |
Research And Development | Research and Development Research and development expenses consist primarily of costs related to clinical studies and outside services, personnel expenses and other research and development costs, including milestone payments incurred prior to regulatory approval of products. Clinical study and outside services costs relate primarily to services performed by clinical research organizations, clinical studies performed at clinical sites, materials and supplies, and other third party fees. Personnel expenses relate primarily to salaries, benefits and share-based compensation. Other research and development expenses primarily include overhead allocations consisting of various support and facilities-related costs. Research and development costs are expensed as incurred. For product candidates that have not been approved by the FDA, inventory used in clinical trials is expensed at the time of production and recorded as research and development expense. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the trial. |
Advertising Expenses | Advertising Expenses We expense the costs of advertising, including promotional expenses, as incurred. |
Income Taxes | Income Taxes We use the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amount and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more-likely-than-not that some portion or all of a deferred tax asset will not be realized. We account for unrecognized tax benefits using a “more-likely-than-not” threshold for recognizing and resolving unrecognized tax benefits. A recognized tax benefit is then measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon settlement. Interest and penalties related to unrecognized tax benefits are included in the income tax provision and classified with the related liability on the consolidated balance sheets. |
Foreign Currency | Foreign Currency Our functional and reporting currency is the U.S. dollar. The assets and liabilities of our subsidiaries that have a functional currency other than the U.S. dollar are translated into U.S. dollars at the exchange rate prevailing at the balance sheet date with the results of operations of subsidiaries translated at the average exchange rate for the reporting period. The cumulative foreign currency translation adjustment is recorded as a component of accumulated other comprehensive income (loss) in shareholders’ equity. Transactions in foreign currencies are translated into the functional currency of the relevant subsidiary at the rate of exchange prevailing at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the relevant functional currency at exchange rates prevailing at the balance sheet date or on settlement. Resulting gains and losses are recorded in foreign currency gain (loss) in our consolidated statements of income. |
Financing Costs | Financing Costs Deferred financing costs are reported at cost, less accumulated amortization and the related amortization expense is included in interest expense, net in our consolidated statements of income. The carrying amount of debt includes any related unamortized original issue discount. |
Contingencies | Contingencies From time to time, we may become involved in claims and other legal matters arising in the ordinary course of business. We record accruals for loss contingencies to the extent that we conclude that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. Legal fees and other expenses related to litigation are expensed as incurred and included in selling, general and administrative expenses. |
Use Of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles, or 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 per Ordinary Share | Net Income per Ordinary Share Basic net income per ordinary share attributable to Jazz Pharmaceuticals plc is based on the weighted-average number of ordinary shares outstanding. Diluted net income 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. |
Share-Based Compensation | Share-Based Compensation We account for compensation cost for all share-based awards at fair value on the date of grant. The fair value is recognized as expense over the service period, net of estimated forfeitures, using the straight-line method. The estimation of share-based awards that will ultimately vest requires judgment, and, to the extent actual results or updated estimates differ from current estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised. We primarily consider historical experience when estimating expected forfeitures. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2015, the Financial Accounting Standards Board, or the FASB, issued Accounting Standards Update, or ASU, No. 2015-17, “Balance Sheet Classification of Deferred Taxes”, or ASU No. 2015-17, which simplifies the presentation of deferred income taxes. ASU No. 2015-17 requires that deferred tax assets and liabilities be classified as non-current in a statement of financial position. We early adopted ASU 2015-17 effective December 31, 2015 on a prospective basis. Adoption of this ASU resulted in a reclassification of our net current deferred tax assets and liabilities to net non-current deferred tax assets and liabilities in our consolidated balance sheet as of December 31, 2015 . No prior periods were retrospectively adjusted. In April 2015, the FASB issued ASU No. 2015-03, “Interest - Imputation of Interest”, or ASU No. 2015-03. ASU No. 2015-03 requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the debt liability instead of as an asset. ASU No. 2015-03 does not affect the recognition and measurement guidance for debt issuance costs. In August 2015, the FASB issued ASU No. 2015-15, “Interest-Imputation of Interest (Subtopic 835-30): Presentation and Subsequent Measurement of Debt Issuance Costs Associated with Line-of-Credit Arrangements - Amendments to SEC Paragraphs Pursuant to Staff Announcements at the June 2015 EITF Meeting”, or ASU No. 2015-15 . ASU No. 2015-15 indicates that the guidance in ASU No. 2015-03 did not address presentation or subsequent measurement of debt issuance costs related to line of credit arrangements. Given the absence of authoritative guidance within ASU No. 2015-03, the SEC staff has indicated that they would not object to an entity deferring and presenting debt issuance costs as an asset and subsequently amortizing the costs ratably over the term of the line of credit arrangement, regardless of whether there are any outstanding borrowings on the line of credit arrangement. This guidance is effective for us beginning January 1, 2016 and requires retrospective application. This guidance is not expected to have a material impact on our consolidated balance sheets or related disclosures. In April 2015, the FASB issued ASU No. 2015-05, “Intangibles-Goodwill and Other-Internal-Use Software”, or ASU No. 2015-05. ASU No. 2015-05 provides guidance on whether a cloud computing arrangement contains a software license to be accounted for as internal-use software to assist in the evaluation of the accounting for fees paid by a customer in the arrangement. ASU No. 2015-05 will be effective for us beginning January 1, 2016 and may be applied either prospectively to new cloud computing arrangements or retrospectively. This guidance is not expected to have a material impact on our financial position or results of operations. In May 2014, the FASB issued 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. In August 2015, the FASB issued ASU No. 2015-14, “Revenue from Contracts with Customers: Deferral of the Effective Date”, which deferred by one year the effective date of ASU No. 2014-09 which will now be effective for us beginning January 1, 2018 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 potential impact on our results of operations and financial position. |
Summary of Significant Accoun29
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Schedule Of Net Income per Ordinary Share | Basic and diluted net income per ordinary share attributable to Jazz Pharmaceuticals plc were computed as follows (in thousands, except per share amounts): Year Ended December 31, 2015 2014 2013 Numerator: Net income attributable to Jazz Pharmaceuticals plc $ 329,535 $ 58,387 $ 216,312 Denominator: Weighted-average ordinary shares used in per share calculation - basic 61,232 59,746 58,298 Dilutive effect of employee equity incentive and purchase plans 1,804 2,402 1,772 Dilutive effect of warrants — 466 1,499 Weighted-average ordinary shares used in per share calculation - diluted 63,036 62,614 61,569 Net income attributable to Jazz Pharmaceuticals plc per ordinary share : Basic $ 5.38 $ 0.98 $ 3.71 Diluted $ 5.23 $ 0.93 $ 3.51 |
Schedule Of Computation Of Diluted Net Income (Loss) Per Share Having Anti-Dilutive Effect | The following table represents the weighted-average ordinary shares that were excluded from the computation of diluted net income attributable to Jazz Pharmaceuticals plc per ordinary share for the periods presented because including them would have an anti-dilutive effect (in thousands): Year Ended December 31, 2015 2014 2013 Options to purchase ordinary shares and RSUs 1,609 819 1,584 1.875% exchangeable senior notes due 2021 2,878 1,112 — |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Schedule Of Available-For-Sale Securities | Cash and cash equivalents consisted of the following (in thousands): December 31, 2015 Amortized Gross Gross Estimated Cash and Cash Equivalents Cash $ 274,945 $ — $ — $ 274,945 $ 274,945 Time deposits 713,840 — — 713,840 713,840 Totals $ 988,785 $ — $ — $ 988,785 $ 988,785 December 31, 2014 Amortized Gross Gross Estimated Cash and Cash $ 338,262 $ — $ — $ 338,262 $ 338,262 Time deposits 345,780 — — 345,780 345,780 Totals $ 684,042 $ — $ — $ 684,042 $ 684,042 |
Schedule Of Available-For-Sale Investments Measured At Fair Value On Recurring Basis | The following table summarizes, by major security type, our available-for-sale securities that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands): December 31, 2015 December 31, 2014 Significant Total Significant Total Time deposits $ 713,840 $ 713,840 $ 345,780 $ 345,780 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |
Components of Inventories | Inventories consisted of the following (in thousands): December 31, 2015 2014 Raw materials $ 2,608 $ 3,570 Work in process 11,836 9,870 Finished goods 5,007 16,597 Total inventories $ 19,451 $ 30,037 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Schedule Of Property And Equipment | Property and equipment consisted of the following (in thousands): December 31, 2015 2014 Construction-in-progress $ 63,008 $ 37,145 Computer software 15,797 10,634 Leasehold improvements 9,301 7,931 Computer equipment 10,963 7,670 Machinery and equipment 5,828 6,408 Furniture and fixtures 2,580 2,220 Land and buildings 1,775 1,547 Subtotal 109,252 73,555 Less accumulated depreciation and amortization (23,680 ) (15,192 ) Property and equipment, net $ 85,572 $ 58,363 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule Of Gross Carrying Amount Of Goodwill | The gross carrying amount of goodwill was as follows (in thousands): Balance at December 31, 2014 $ 702,713 Foreign exchange (45,574 ) Balance at December 31, 2015 $ 657,139 |
Schedule Of Gross Carrying Amounts And Net Book Values Of Intangible Assets | The gross carrying amounts and net book values of our intangible assets were as follows (in thousands): December 31, 2015 December 31, 2014 Remaining Gross Accumulated Net Book Gross Accumulated Net Book Acquired developed technologies 12.0 $ 1,321,324 $ (324,044 ) $ 997,280 $ 1,450,606 $ (259,889 ) $ 1,190,717 Manufacturing contracts 2.1 11,697 (5,676 ) 6,021 13,012 (3,060 ) 9,952 Trademarks — 2,882 (2,882 ) — 2,914 (2,896 ) 18 Total finite-lived intangible assets 1,335,903 (332,602 ) 1,003,301 1,466,532 (265,845 ) 1,200,687 Acquired IPR&D assets 182,305 — 182,305 236,748 — 236,748 Total intangible assets $ 1,518,208 $ (332,602 ) $ 1,185,606 $ 1,703,280 $ (265,845 ) $ 1,437,435 |
Schedule Of Estimated Future Amortization Costs | Based on finite-lived intangible assets recorded as of December 31, 2015 , and assuming the underlying assets will not be 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 2016 $ 90,442 2017 90,442 2018 87,636 2019 87,419 2020 86,249 Thereafter 561,113 Total $ 1,003,301 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2015 2014 Rebates and other sales deductions $ 67,454 $ 51,899 Employee compensation and benefits 35,595 46,143 Contract claim settlement 18,000 — Sales returns reserve 6,110 14,039 Royalties 4,211 7,964 Accrued interest 4,043 10,327 Professional fees 3,038 3,295 Accrued construction-in-progress 1,637 4,931 Other 23,982 25,493 Total accrued liabilities $ 164,070 $ 164,091 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Schedule of long-term debt | The following table summarizes the carrying amount of our indebtedness (in thousands): December 31, 2015 2014 1.875% exchangeable senior notes due 2021 $ 575,000 $ 575,000 Unamortized discount on 1.875% exchangeable senior notes due 2021 (109,048 ) (124,735 ) 1.875% exchangeable senior notes due 2021, net 465,952 450,265 Term loans 738,038 890,479 Other borrowings 513 1,684 Total debt 1,204,503 1,342,428 Less current portion 37,587 9,428 Total long-term debt $ 1,166,916 $ 1,333,000 |
Schedule of maturities of long-term debt | Scheduled maturities with respect to our long-term debt are as follows (in thousands): Year Ending December 31, Scheduled Long-Term Debt Maturities 2016 $ 37,587 2017 42,280 2018 61,034 2019 79,789 2020 520,420 Thereafter 575,028 Total $ 1,316,138 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule Of Lease Expense Under Operating Leases | Lease expense under our operating leases was as follows (in thousands): Year Ended December 31, 2015 2014 2013 Lease expense $ 10,479 $ 10,678 $ 9,114 |
Schedule Of Future Minimum Lease Payments Under Noncancelable Operating Leases | Future minimum lease payments under our noncancelable operating and facility leases at December 31, 2015 , were as follows (in thousands): Year ending December 31, Lease Payments 2016 $ 11,757 2017 12,709 2018 8,310 2019 7,165 2020 6,735 Thereafter 66,562 Total $ 113,238 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Schedule of Authorized But Unissued Ordinary Shares | We had reserved the following shares of authorized but unissued ordinary shares (in thousands): December 31, 2015 2011 Equity Incentive Plan 11,900 2007 Equity Incentive Plan 937 2007 Employee Stock Purchase Plan 512 Amended and Restated 2007 Non-Employee Directors Stock Option Plan 451 Amended and Restated Directors Deferred Compensation Plan 178 Total 13,978 |
Comprehensive Income (Loss) (Ta
Comprehensive Income (Loss) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Components of Accumulated Other Comprehensive Income/(Loss) | The components of accumulated other comprehensive loss attributable to Jazz Pharmaceuticals plc at December 31, 2015 and December 31, 2014 were as follows (in thousands): Foreign Total Balance at December 31, 2014 $ (122,097 ) $ (122,097 ) Other comprehensive loss (145,375 ) (145,375 ) Balance at December 31, 2015 $ (267,472 ) $ (267,472 ) |
Segment and Other Information (
Segment and Other Information (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
Summary Of Total Revenues | The following table presents a summary of total revenues (in thousands): Year Ended December 31, 2015 2014 2013 Xyrem $ 955,187 $ 778,584 $ 569,113 Erwinaze/Erwinase 203,261 199,665 174,251 Defitelio/defibrotide 70,731 70,537 — Prialt ® (ziconotide) intrathecal infusion 26,440 26,421 27,103 Psychiatry 37,135 40,879 49,226 Other 24,065 46,630 45,705 Product sales, net 1,316,819 1,162,716 865,398 Royalties and contract revenues 7,984 10,159 7,025 Total revenues $ 1,324,803 $ 1,172,875 $ 872,423 |
Summary Of Total Revenues Attributed To Geographic Sources | The following table presents a summary of total revenues attributed to geographic sources (in thousands): Year Ended December 31, 2015 2014 2013 United States $ 1,192,879 $ 1,007,396 $ 792,518 Europe 103,614 126,715 61,843 All other 28,310 38,764 18,062 Total revenues $ 1,324,803 $ 1,172,875 $ 872,423 |
Summary Of Revenues From Customers Representing More Then 10% Of Total Revenues | The following table presents a summary of the percentage of total revenues from customers that represented more than 10% of our total revenues: Year Ended December 31, 2015 2014 2013 Express Scripts 72 % 66 % 65 % Accredo Health Group, Inc. 6 % 14 % 16 % |
Total Long-Lived Assets by Location | The following table presents total long-lived assets by location (in thousands): December 31, 2015 2014 Ireland $ 62,795 $ 37,775 United States 12,794 9,795 Italy 7,928 8,462 Other 2,055 2,331 Total long-lived assets (1) $ 85,572 $ 58,363 _________________________ (1) Long-lived assets consist of property and equipment. |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Weighted-Average Assumptions Used in Black-Scholes Option Pricing Model and Resulting Weighted-Average Grant Date Fair Value of Share Options Granted | The table below shows, for all share option grants, 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 in each of the past three years: Year Ended December 31, 2015 2014 2013 Grant date fair value $ 57.19 $ 60.29 $ 29.09 Volatility 39 % 45 % 58 % Expected term (years) 4.2 4.3 4.4 Range of risk-free rates 1.1-1.5% 1.1-1.4% 0.5-1.4% Expected dividend yield — % — % — % |
Schedule of Share-Based Compensation Expense Related to Share Options, RSUs, and Grants under ESPP | Share-based compensation expense related to share options, RSUs and grants under our ESPP was as follows (in thousands): Year Ended December 31, 2015 2014 2013 Selling, general and administrative $ 74,653 $ 55,083 $ 35,674 Research and development 13,356 12,179 6,673 Cost of product sales 3,541 2,376 2,204 Total share-based compensation expense, pre-tax 91,550 69,638 44,551 Tax benefit from share-based compensation expense (26,608 ) (20,795 ) (13,822 ) Total share-based compensation expense, net of tax $ 64,942 $ 48,843 $ 30,729 |
Schedule of Information and Activity Related to Share Option Plans Activity | The following table summarizes information as of December 31, 2015 and activity during 2015 related to our share option plans: Shares Subject to Outstanding Options (In thousands) Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In thousands) Outstanding at January 1, 2015 3,870 $ 72.77 Options granted 1,118 173.30 Options exercised (732 ) 45.04 Options forfeited (319 ) 118.05 Options expired — — Outstanding at December 31, 2015 3,937 102.81 7.4 $ 198,666 Vested and expected to vest at December 31, 2015 3,731 99.87 7.3 196,654 Exercisable at December 31, 2015 1,992 64.48 6.3 159,156 |
Schedule of Information and Activity Related to RSUs Activity | The following table summarizes information as of December 31, 2015 and activity during 2015 related to our RSUs: Number of RSUs (in thousands) Weighted- Weighted- Aggregate Outstanding at January 1, 2015 1,188 $ 96.41 RSUs granted 430 173.25 RSUs released (414 ) 86.03 RSUs forfeited (150 ) 113.44 RSUs expired — — Outstanding at December 31, 2015 1,054 129.40 1.2 $ 148,172 |
Restructuring (Tables)
Restructuring (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Restructuring and Related Activities [Abstract] | |
Schedule of restructuring amounts | The following table summarizes the amounts related to restructuring through December 31, 2015 (in thousands): Termination Benefits Facility Closure Costs Total Balance at December 31, 2012 $ 1,227 $ — $ 1,227 Expense 1,045 412 1,457 Payments (2,272 ) (160 ) (2,432 ) Balance at December 31, 2013 — 252 252 Expense 1,823 118 1,941 Payments — (252 ) (252 ) Balance at December 31, 2014 1,823 118 1,941 Expense 1,469 172 1,641 Payments (2,187 ) (290 ) (2,477 ) Balance at December 31, 2015 $ 1,105 $ — $ 1,105 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Components of Income from Continuing Operations before Income Tax Provision (Benefit) | The components of income before the income tax provision were as follows (in thousands): Year Ended December 31, 2015 2014 2013 Ireland $ 233,785 $ 238,351 $ 186,903 United States 285,420 222,328 132,855 Other (83,272 ) (309,122 ) (11,808 ) Total $ 435,933 $ 151,557 $ 307,950 |
Details of Income Tax Provision (Benefit) | The following table sets forth the details of the income tax provision (in thousands): Year Ended December 31, 2015 2014 2013 Current Ireland $ 22,599 $ 23,506 $ 17,089 United States 116,301 97,679 71,964 Other 28,708 16,469 12,682 Total current income tax 167,608 137,654 101,735 Deferred, exclusive of other components below Ireland 494 2,323 8,353 United States 332 (15,003 ) (3,513 ) Other (40,532 ) (30,743 ) (14,937 ) Total deferred, exclusive of other components (39,706 ) (43,423 ) (10,097 ) Deferred, change in tax rates United States 294 — — Other (21,797 ) — — Total deferred, change in tax rates (21,503 ) — — Total deferred income tax benefit (61,209 ) (43,423 ) (10,097 ) Total income tax provision $ 106,399 $ 94,231 $ 91,638 |
Reconciliation of Income Taxes at the Statutory Income Tax Rate to Effective Income Tax Rate | The reconciliation between the statutory income tax rate applied to income before income tax provision and our effective income tax rate was as follows: Year Ended December 31, 2015 2014 2013 Statutory income tax rate 12.5 % 12.5 % 12.5 % Foreign income tax rate differential 19.1 % 50.0 % 10.3 % Change in tax rate (4.5 )% — % — % Research and other tax credits (3.8 )% (9.4 )% (1.9 )% Change in unrecognized tax benefits 3.6 % 6.2 % 2.8 % Deduction on subsidiary equity (2.7 )% (7.5 )% — % Change in estimates (1.0 )% (3.0 )% 1.1 % Non-deductible compensation 1.9 % 4.6 % 1.3 % Change in valuation allowance (0.6 )% 5.7 % 1.1 % Financing costs (0.4 )% 0.7 % — % Acquisition-related costs — % 3.1 % 1.7 % Other 0.3 % (0.7 )% 0.9 % Effective income tax rate 24.4 % 62.2 % 29.8 % |
Schedule of Net Deferred Tax Assets/(Liabilities) | Significant components of our net deferred tax assets/(liabilities) were as follows (in thousands): December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ 57,091 $ 74,057 Tax credit carryforwards 36,797 23,946 Intangible assets 25,384 19,507 Share-based compensation 20,050 14,033 Accruals 32,355 36,157 Other 31,144 36,222 Total deferred tax assets 202,821 203,922 Valuation allowance (33,949 ) (29,697 ) Net deferred tax assets 168,872 174,225 Deferred tax liabilities: Acquired intangible assets (307,356 ) (395,651 ) Other (33,138 ) (39,124 ) Total deferred tax liabilities (340,494 ) (434,775 ) Net deferred tax liabilities $ (171,622 ) $ (260,550 ) The net change in valuation allowance was $4.3 million , $9.0 million and $3.2 million in 2015 , 2014 and 2013 , respectively. The following table presents the breakdown between current and non-current deferred tax assets/(liabilities) (in thousands): Year Ended December 31, 2015 2014 Current deferred tax assets $ — $ 48,440 Current deferred tax liabilities — (9,430 ) Non-current deferred tax assets 122,863 75,494 Non-current deferred tax liabilities (294,485 ) (375,054 ) Net deferred tax liabilities $ (171,622 ) $ (260,550 ) |
Reconciliation of Unrecognized Tax Benefits | A reconciliation of our gross unrecognized tax benefits follows (in thousands): December 31, 2015 2014 2013 Balance at the beginning of the year $ 40,802 $ 21,637 $ 7,288 Increases related to current year tax positions 23,664 19,837 14,308 Increases related to prior year tax positions 2,833 — 183 Decreases related to prior year tax positions (646 ) (672 ) (142 ) Lapse of the applicable statute of limitations (268 ) — — Balance at the end of the year $ 66,385 $ 40,802 $ 21,637 |
Quarterly Financial Data (Una43
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule Of Interim Financial Information Of Results Of Operations On Quarterly Basis | The following interim financial information presents our 2015 and 2014 results of operations on a quarterly basis (in thousands, except per share amounts): 2015 March 31 June 30 September 30 December 31 Revenues $ 309,303 $ 333,747 $ 340,872 $ 340,881 Gross margin (1) 278,737 310,293 310,369 314,894 Net income attributable to Jazz Pharmaceuticals plc 70,700 88,114 87,960 82,761 Net income attributable to Jazz Pharmaceuticals plc per ordinary share, basic 1.16 1.44 1.43 1.35 Net income attributable to Jazz Pharmaceuticals plc per ordinary share, diluted 1.12 1.40 1.39 1.32 2014 March 31 June 30 September 30 December 31 Revenues $ 246,919 $ 291,230 $ 306,584 $ 328,142 Gross margin (1) 214,062 258,408 277,413 295,415 Net income (loss) attributable to Jazz Pharmaceuticals plc (92,650 ) 43,659 25,766 81,612 Net income (loss) attributable to Jazz Pharmaceuticals plc per ordinary share, basic (1.58 ) 0.73 0.43 1.35 Net income (loss) attributable to Jazz Pharmaceuticals plc per ordinary share, diluted (1.58 ) 0.70 0.41 1.30 __________________________ (1) Gross margin is computed by subtracting cost of product sales (excluding amortization and impairment of intangible assets) from product sales, net. |
Summary of Significant Accoun44
Summary of Significant Accounting Policies (Narrative) (Details) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2014applicant | Dec. 31, 2015USD ($)sharesCustomerapplication$ / shares | Dec. 31, 2014USD ($)Customer | Dec. 31, 2013USD ($) | Aug. 31, 2014 | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Product sales, net | $ 1,316,819 | $ 1,162,716 | $ 865,398 | ||
Number of customer with significant accounts receivable | Customer | 5 | 5 | |||
Percentage of gross accounts receivable | 90.00% | 86.00% | |||
Acquisition accounting inventory fair value step-up adjustments | $ 0 | $ 10,477 | 3,826 | ||
Intangible asset amortization | 98,162 | 126,584 | 79,042 | ||
Advertising expenses | $ 4,200 | $ 1,000 | 1,000 | ||
Convertible Debt [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Interest rate | 1.875% | 1.875% | 1.875% | ||
Number of shares issuable from exchangeable senior notes | shares | 2.9 | ||||
Debt conversion price (in dollars per share) | $ / shares | $ 199.77 | ||||
Acquired Developed Technologies [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Intangible assets, useful life | 12 years | ||||
Intangible asset amortization | $ 93,000 | $ 122,600 | 78,800 | ||
Minimum [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Estimated useful life of property and equipment | 3 years | ||||
Intangible assets, useful life | 2 years | ||||
Maximum [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Estimated useful life of property and equipment | 10 years | ||||
Intangible assets, useful life | 16 years | ||||
Express Scripts [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Percentage of gross accounts receivable | 69.00% | 66.00% | |||
Idis Limited [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Percentage of gross accounts receivable | 11.00% | 11.00% | |||
Xyrem [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Product sales, net | $ 955,187 | $ 778,584 | 569,113 | ||
Number of ANDAs filed by third parties | application | 7 | ||||
Number of additional ANDA applicants | applicant | 3 | ||||
Xyrem [Member] | Product Concentration Risk [Member] | Sales Revenue, Product Line [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Percentage of total revenues | 73.00% | ||||
Erwinaze And Erwinase [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Product sales, net | $ 203,261 | $ 199,665 | $ 174,251 | ||
Erwinaze And Erwinase [Member] | Product Concentration Risk [Member] | Sales Revenue, Product Line [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Percentage of total revenues | 15.00% | ||||
Defitelio/defibrotide [Member] | Product Concentration Risk [Member] | Sales Revenue, Product Line [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Percentage of total revenues | 5.00% |
Summary of Significant Accoun45
Summary of Significant Accounting Policies (Schedule of Net Income (Loss) Per Ordinary Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Numerator: | |||||||||||
Net income attributable to Jazz Pharmaceuticals plc | $ 82,761 | $ 87,960 | $ 88,114 | $ 70,700 | $ 81,612 | $ 25,766 | $ 43,659 | $ (92,650) | $ 329,535 | $ 58,387 | $ 216,312 |
Denominator: | |||||||||||
Weighted-average ordinary shares used in calculating net income per ordinary share attributable to Jazz Pharmaceuticals plc - basic (in shares) | 61,232 | 59,746 | 58,298 | ||||||||
Dilutive effect of employee equity incentive and purchase plans (in shares) | 1,804 | 2,402 | 1,772 | ||||||||
Dilutive effect of warrants (in shares) | 0 | 466 | 1,499 | ||||||||
Weighted-average ordinary shares used in calculating net income per ordinary share attributable to Jazz Pharmaceuticals plc - diluted (in shares) | 63,036 | 62,614 | 61,569 | ||||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share : | |||||||||||
Basic, net income (in dollars per share) | $ 1.35 | $ 1.43 | $ 1.44 | $ 1.16 | $ 1.35 | $ 0.43 | $ 0.73 | $ (1.58) | $ 5.38 | $ 0.98 | $ 3.71 |
Diluted, net income (in dollars per share) | $ 1.32 | $ 1.39 | $ 1.40 | $ 1.12 | $ 1.30 | $ 0.41 | $ 0.70 | $ (1.58) | $ 5.23 | $ 0.93 | $ 3.51 |
Summary of Significant Accoun46
Summary of Significant Accounting Policies (Schedule Of Computation Of Diluted Net Income (Loss) Per Share Having Anti-Dilutive Effect) (Details) - shares shares in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Aug. 31, 2014 | |
Ordinary Shares and RSUs [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities (in shares) | 1,609 | 819 | 1,584 | |
Convertible Debt Securities [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities (in shares) | 2,878 | 1,112 | 0 | |
Convertible Debt [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Interest rate | 1.875% | 1.875% | 1.875% |
Disposition (Narrative) (Detail
Disposition (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2015 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Net proceeds from sale of business | $ 33,703 | $ 0 | $ 0 | |
Certain EUSA Products [Member] | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Consideration | $ 34,000 | |||
Selling, General and Administrative [Member] | Certain EUSA Products [Member] | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Loss on disposal | $ 200 |
Fair Value Measurement (Narrati
Fair Value Measurement (Narrative) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying amount of long-term debt | $ 1,204,503 | $ 1,342,428 |
Convertible Debt [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying amount of long-term debt | 465,952 | $ 450,265 |
Convertible debt fair value | $ 601,000 |
Fair Value Measurement (Schedul
Fair Value Measurement (Schedule of Available-For-Sale Securities) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | $ 988,785 | $ 684,042 | ||
Gross Unrealized Gains | 0 | 0 | ||
Gross Unrealized Losses | 0 | 0 | ||
Estimated Fair Value | 988,785 | 684,042 | ||
Cash and Cash Equivalents | 988,785 | 684,042 | $ 636,504 | $ 387,196 |
Cash [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 274,945 | 338,262 | ||
Gross Unrealized Gains | 0 | 0 | ||
Gross Unrealized Losses | 0 | 0 | ||
Estimated Fair Value | 274,945 | 338,262 | ||
Cash and Cash Equivalents | 274,945 | 338,262 | ||
Time Deposits [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Amortized Cost | 713,840 | 345,780 | ||
Gross Unrealized Gains | 0 | 0 | ||
Gross Unrealized Losses | 0 | 0 | ||
Estimated Fair Value | 713,840 | 345,780 | ||
Cash and Cash Equivalents | $ 713,840 | $ 345,780 |
Fair Value Measurement (Sched50
Fair Value Measurement (Schedule of Available-For-Sale Investments Measured at Fair Value on Recurring Basis) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 988,785 | $ 684,042 |
Time Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 713,840 | 345,780 |
Fair Value, Measurements, Recurring [Member] | Time Deposits [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 713,840 | 345,780 |
Fair Value, Measurements, Recurring [Member] | Time Deposits [Member] | Estimate of Fair Value, Fair Value Disclosure [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 713,840 | $ 345,780 |
Inventories (Schedule of Invent
Inventories (Schedule of Inventories) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Components of Inventories | ||
Raw materials | $ 2,608 | $ 3,570 |
Work in process | 11,836 | 9,870 |
Finished goods | 5,007 | 16,597 |
Total inventories | $ 19,451 | $ 30,037 |
Property and Equipment (Schedul
Property and Equipment (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Abstract] | ||
Construction-in-progress | $ 63,008 | $ 37,145 |
Computer software | 15,797 | 10,634 |
Leasehold improvements | 9,301 | 7,931 |
Computer equipment | 10,963 | 7,670 |
Machinery and equipment | 5,828 | 6,408 |
Furniture and fixtures | 2,580 | 2,220 |
Land and buildings | 1,775 | 1,547 |
Subtotal | 109,252 | 73,555 |
Less accumulated depreciation and amortization | (23,680) | (15,192) |
Property and equipment, net | $ 85,572 | $ 58,363 |
Goodwill and Intangible Asset53
Goodwill and Intangible Assets (Schedule Of Gross Carrying Amount Of Goodwill) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Goodwill [Roll Forward] | |
Balance at December 31, 2014 | $ 702,713 |
Foreign exchange | (45,574) |
Balance at December 31, 2015 | $ 657,139 |
Goodwill and Intangible Asset54
Goodwill and Intangible Assets (Schedule Of Gross Carrying Amounts And Net Book Values Of Intangible Assets) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Finite-Lived and Indefinite Lived Intangible Assets [Line Items] | |||
Gross Carrying Amount | $ 1,335,903 | $ 1,335,903 | $ 1,466,532 |
Accumulated Amortization | (332,602) | (332,602) | (265,845) |
Total | 1,003,301 | 1,003,301 | 1,200,687 |
Intangible assets, gross | 1,518,208 | 1,518,208 | 1,703,280 |
Intangible assets, net | 1,185,606 | 1,185,606 | 1,437,435 |
In Process Research and Development [Member] | |||
Finite-Lived and Indefinite Lived Intangible Assets [Line Items] | |||
Acquired IPR&D assets | $ 182,305 | 236,748 | |
Impairment charge | 31,500 | ||
Acquired Developed Technologies [Member] | |||
Finite-Lived and Indefinite Lived Intangible Assets [Line Items] | |||
Remaining Weighted- Average Useful Life (In years) | 12 years | ||
Gross Carrying Amount | 1,321,324 | $ 1,321,324 | 1,450,606 |
Accumulated Amortization | (324,044) | (324,044) | (259,889) |
Total | 997,280 | $ 997,280 | 1,190,717 |
Manufacturing Contracts [Member] | |||
Finite-Lived and Indefinite Lived Intangible Assets [Line Items] | |||
Remaining Weighted- Average Useful Life (In years) | 2 years 1 month | ||
Gross Carrying Amount | 11,697 | $ 11,697 | 13,012 |
Accumulated Amortization | (5,676) | (5,676) | (3,060) |
Total | 6,021 | $ 6,021 | 9,952 |
Trademarks [Member] | |||
Finite-Lived and Indefinite Lived Intangible Assets [Line Items] | |||
Remaining Weighted- Average Useful Life (In years) | 0 years | ||
Gross Carrying Amount | 2,882 | $ 2,882 | 2,914 |
Accumulated Amortization | (2,882) | (2,882) | (2,896) |
Total | $ 0 | $ 0 | $ 18 |
Goodwill and Intangible Asset55
Goodwill and Intangible Assets (Schedule Of Estimated Future Amortization Costs) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2,016 | $ 90,442 | |
2,017 | 90,442 | |
2,018 | 87,636 | |
2,019 | 87,419 | |
2,020 | 86,249 | |
Thereafter | 561,113 | |
Total | $ 1,003,301 | $ 1,200,687 |
Accrued Liabilities (Schedule o
Accrued Liabilities (Schedule of Accrued Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Payables and Accruals [Abstract] | ||
Rebates and other sales deductions | $ 67,454 | $ 51,899 |
Employee compensation and benefits | 35,595 | 46,143 |
Contract claim settlement | 18,000 | 0 |
Sales returns reserve | 6,110 | 14,039 |
Royalties | 4,211 | 7,964 |
Accrued interest | 4,043 | 10,327 |
Professional fees | 3,038 | 3,295 |
Accrued construction-in-progress | 1,637 | 4,931 |
Other | 23,982 | 25,493 |
Total accrued liabilities | $ 164,070 | $ 164,091 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Jun. 18, 2015USD ($) | Aug. 31, 2014USD ($)d | Jun. 30, 2015USD ($) | Dec. 31, 2015USD ($)$ / shares | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
Debt Instrument [Line Items] | ||||||
Loss on extinguishment and modification of debt | $ 16,800,000 | $ 16,815,000 | $ 0 | $ 3,749,000 | ||
Interest expense, net | (56,917,000) | $ (52,713,000) | $ (26,916,000) | |||
Revolving Credit Facility [Member] | Credit Agreement June 2015 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Maximum amount available under revolving credit facility | $ 750,000,000 | |||||
Amount outstanding under revolving credit facility | $ 160,000,000 | |||||
Maturity date | Jun. 18, 2020 | |||||
Outstanding letters of credit | $ 1,100,000 | |||||
Revolving Credit Facility [Member] | Credit Agreement June 2015 [Member] | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Commitment fee percentage | 0.25% | |||||
Revolving Credit Facility [Member] | Credit Agreement June 2015 [Member] | Maximum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Commitment fee percentage | 0.35% | |||||
Term Loan [Member] | Credit Agreement June 2015 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Principle amount of long term debt | $ 750,000,000 | |||||
Maturity date | Jun. 18, 2020 | |||||
Interest rate during the period | 2.36% | |||||
Effective interest rate | 2.38% | |||||
Principal repayment in year one and two (percent) | 5.00% | |||||
Principal repayment in year three (percent) | 7.50% | |||||
Principal repayment in year four (percent) | 10.00% | |||||
Principal repayment in year five (percent) | 12.50% | |||||
Term Loan [Member] | Credit Agreement June 2015 [Member] | London Interbank Offered Rate (LIBOR) [Member] | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 1.50% | |||||
Term Loan [Member] | Credit Agreement June 2015 [Member] | London Interbank Offered Rate (LIBOR) [Member] | Maximum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 2.25% | |||||
Term Loan [Member] | Credit Agreement June 2015 [Member] | Prime Rate [Member] | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 0.50% | |||||
Term Loan [Member] | Credit Agreement June 2015 [Member] | Prime Rate [Member] | Maximum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 1.25% | |||||
Term Loan [Member] | Credit Agreement 2012 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Extinguishment of debt | $ 893,100,000 | |||||
Loss on extinguishment and modification of debt | $ 16,800,000 | |||||
Unamortized deferred financing costs and unamortized discount | 16,000,000 | |||||
Debt issuance cost | $ 800,000 | |||||
Convertible Debt [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Effective interest rate | 6.40% | |||||
Debt issuance cost | $ 16,100,000 | |||||
Frequency of periodic payment | payable semi-annually in cash in arrears on February 15 and August 15 of each year | |||||
Interest rate | 1.875% | 1.875% | 1.875% | |||
Percentage of conversion price | 130.00% | |||||
Number of trading days | d | 20 | |||||
Number of consecutive days in trading period | 30 days | |||||
Conversion rate of shares | 5.0057 | |||||
Conversion denominator | $ 1,000 | |||||
Debt conversion price (in dollars per share) | $ / shares | $ 199.77 | |||||
Debt term | 7 years | |||||
Interest expense, net | $ 26,500,000 | $ 9,900,000 | ||||
Carrying value of the equity component | $ 126,900,000 |
Debt (Schedule of Debt) (Detail
Debt (Schedule of Debt) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Aug. 31, 2014 |
Debt Instrument [Line Items] | |||
Principal amount | $ 1,316,138 | ||
Total debt | 1,204,503 | $ 1,342,428 | |
Less current portion | 37,587 | 9,428 | |
Total long-term debt | $ 1,166,916 | $ 1,333,000 | |
Convertible Debt 2021 Notes [Member] | |||
Debt Instrument [Line Items] | |||
Interest rate | 1.875% | 1.875% | 1.875% |
Principal amount | $ 575,000 | $ 575,000 | |
Unamortized discount | (109,048) | (124,735) | |
Total debt | 465,952 | 450,265 | |
Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Total debt | 738,038 | 890,479 | |
Other borrowings [Member] | |||
Debt Instrument [Line Items] | |||
Total debt | $ 513 | $ 1,684 |
Debt (Schedule of Debt Maturiti
Debt (Schedule of Debt Maturities) (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2,016 | $ 37,587 |
2,017 | 42,280 |
2,018 | 61,034 |
2,019 | 79,789 |
2,020 | 520,420 |
Thereafter | 575,028 |
Total debt | $ 1,316,138 |
Deferred Revenue (Narrative) (D
Deferred Revenue (Narrative) (Details) - UCB Pharma Limited [Member] $ in Millions | 12 Months Ended | |||
Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2006USD ($)payment | |
Other Long Term Liabilities [Line Items] | ||||
Contract revenues | $ 1.1 | $ 1.1 | $ 1.1 | |
Payments received upfront from UCB | payment | 2 | |||
Deferred contract revenues upfront payment received | $ 15 |
Commitments and Contingencies61
Commitments and Contingencies (Leases and Other Commitments) (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2015USD ($)renewal_term | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Other Commitments [Line Items] | ||||
Lease expense | $ 10,479 | $ 10,678 | $ 9,114 | |
Total future lease payments | 113,238 | |||
Construction-in-progress | 63,008 | $ 37,145 | ||
Noncancelable purchase commitments due within one year | 97,500 | |||
Office Building [Member] | Palo Alto [Member] | ||||
Other Commitments [Line Items] | ||||
Lease expense | 1,800 | |||
Operating lease, term (in years) | 12 years | |||
Total future lease payments | $ 88,000 | |||
Office Building [Member] | Palo Alto [Member] | Property, Plant and Equipment [Member] | ||||
Other Commitments [Line Items] | ||||
Construction-in-progress | $ 4,400 | |||
Office Building [Member] | Palo Alto [Member] | Lease Agreements [Member] | ||||
Other Commitments [Line Items] | ||||
Number of renewal option terms | renewal_term | 2 | |||
Operating lease, extended term option (in years) | 5 years |
Commitments and Contingencies62
Commitments and Contingencies (Schedule Of Future Minimum Lease Payments Under Noncancelable Operating Leases) (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2,016 | $ 11,757 |
2,017 | 12,709 |
2,018 | 8,310 |
2,019 | 7,165 |
2,020 | 6,735 |
Thereafter | 66,562 |
Total | $ 113,238 |
Commitments and Contingencies63
Commitments and Contingencies (Legal Proceedings and Other Contingencies Narrative) (Details) $ in Millions | Oct. 19, 2011USD ($) | Oct. 18, 2010patent | Jan. 31, 2015patent | Apr. 30, 2014 | Feb. 06, 2015patent | Dec. 31, 2015product | Dec. 05, 2012patent | Jun. 01, 2015lawsuit |
Loss Contingencies [Line Items] | ||||||||
Number of radiopharmaceutical products | product | 2 | |||||||
Pending Litigation [Member] | Xyrem [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Number of patents named in IPR Petitions | 6 | |||||||
Pending Litigation [Member] | Xyrem ANDA Matters [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Number of patents allegedly infringed upon | 5 | 4 | 10 | |||||
Term of court ordered stay | 30 months | 30 months | ||||||
Number of claims filed | lawsuit | 2 | |||||||
Settled Litigation [Member] | FazaClo, Cutler Matter [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Amount sought in alleged breach of contractual obligation | $ | $ 35 |
Shareholders' Equity (Narrative
Shareholders' Equity (Narrative) (Details) - Ordinary Shares [Member] - USD ($) $ / shares in Units, shares in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Nov. 05, 2015 | May. 31, 2013 | |
Stockholders' Equity Note [Line Items] | |||
Share repurchases | $ 61,600,000 | ||
Stock repurchased, shares | 0.4 | ||
Treasury stock acquired, average cost per share (in dollars per share) | $ 150.24 | ||
May 2013 Share Repurchase Program [Member] | |||
Stockholders' Equity Note [Line Items] | |||
Total amount authorized for repurchase of shares under share repurchase program | $ 200,000,000 | ||
November 2015 Share Repurchase Program [Member] | |||
Stockholders' Equity Note [Line Items] | |||
Total amount authorized for repurchase of shares under share repurchase program | $ 300,000,000 | ||
Remaining amount authorized for repurchase of shares | $ 259,800,000 |
Shareholders' Equity (Schedule
Shareholders' Equity (Schedule of Authorized But Unissued Ordinary Shares) (Details) shares in Thousands | Dec. 31, 2015shares |
Class of Stock [Line Items] | |
Authorized but unissued ordinary shares reserved (in shares) | 13,978 |
2011 Equity Incentive Plan [Member] | |
Class of Stock [Line Items] | |
Authorized but unissued ordinary shares reserved (in shares) | 11,900 |
2007 Equity Incentive Plan [Member] | |
Class of Stock [Line Items] | |
Authorized but unissued ordinary shares reserved (in shares) | 937 |
2007 Employee Stock Purchase Plan [Member] | |
Class of Stock [Line Items] | |
Authorized but unissued ordinary shares reserved (in shares) | 512 |
Amended and Restated 2007 Non-Employee Directors Stock Option Plan [Member] | |
Class of Stock [Line Items] | |
Authorized but unissued ordinary shares reserved (in shares) | 451 |
Amended and Restated Directors Deferred Compensation Plan [Member] | |
Class of Stock [Line Items] | |
Authorized but unissued ordinary shares reserved (in shares) | 178 |
Comprehensive Income (Loss) (Co
Comprehensive Income (Loss) (Components of Accumulated Other Comprehensive Loss) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Increase (Decrease) in Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at December 31, 2014 | $ (122,097) | ||
Other comprehensive loss | (145,375) | $ (178,264) | $ 25,107 |
Balance at December 31, 2015 | (267,472) | (122,097) | |
Foreign Currency Translation Adjustments [Member] | |||
Increase (Decrease) in Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at December 31, 2014 | (122,097) | ||
Other comprehensive loss | (145,375) | ||
Balance at December 31, 2015 | (267,472) | (122,097) | |
Parent [Member] | |||
Increase (Decrease) in Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at December 31, 2014 | (122,097) | ||
Other comprehensive loss | (145,375) | (178,250) | $ 25,107 |
Balance at December 31, 2015 | $ (267,472) | $ (122,097) |
Segment and Other Information67
Segment and Other Information (Narrative) (Details) | 12 Months Ended |
Dec. 31, 2015Segment | |
Segment Reporting [Abstract] | |
Number of operating business segment | 1 |
Segment and Other Information68
Segment and Other Information (Summary of Total Revenues) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Segment Reporting Information [Line Items] | |||||||||||
Product sales, net | $ 1,316,819 | $ 1,162,716 | $ 865,398 | ||||||||
Royalties and contract revenues | 7,984 | 10,159 | 7,025 | ||||||||
Total revenues | $ 340,881 | $ 340,872 | $ 333,747 | $ 309,303 | $ 328,142 | $ 306,584 | $ 291,230 | $ 246,919 | 1,324,803 | 1,172,875 | 872,423 |
Xyrem [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product sales, net | 955,187 | 778,584 | 569,113 | ||||||||
Erwinaze And Erwinase [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product sales, net | 203,261 | 199,665 | 174,251 | ||||||||
Defitelio/defibrotide [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product sales, net | 70,731 | 70,537 | 0 | ||||||||
Prialt® (ziconotide) intrathecal infusion [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product sales, net | 26,440 | 26,421 | 27,103 | ||||||||
Psychiatry [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product sales, net | 37,135 | 40,879 | 49,226 | ||||||||
Other [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Product sales, net | $ 24,065 | $ 46,630 | $ 45,705 |
Segment and Other Information69
Segment and Other Information (Summary of Total Revenues Attributed to Geographic Sources) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Segment Reporting Information [Line Items] | |||||||||||
Total revenues | $ 340,881 | $ 340,872 | $ 333,747 | $ 309,303 | $ 328,142 | $ 306,584 | $ 291,230 | $ 246,919 | $ 1,324,803 | $ 1,172,875 | $ 872,423 |
United States [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenues | 1,192,879 | 1,007,396 | 792,518 | ||||||||
Europe [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenues | 103,614 | 126,715 | 61,843 | ||||||||
All other [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenues | $ 28,310 | $ 38,764 | $ 18,062 |
Segment and Other Information70
Segment and Other Information (Summary of Revenues from Customers Representing at Least 10% of Total Revenues) (Details) - Customer Concentration Risk [Member] - Sales Revenue, Goods, Net [Member] | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Express Scripts [Member] | |||
Concentration Risk [Line Items] | |||
Percentage of total revenues | 72.00% | 66.00% | 65.00% |
Accredo Health Group, Inc. [Member] | |||
Concentration Risk [Line Items] | |||
Percentage of total revenues | 6.00% | 14.00% | 16.00% |
Segment and Other Information71
Segment and Other Information (Total Long-Lived Assets by Location) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | $ 85,572 | $ 58,363 |
Ireland [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | 62,795 | 37,775 |
United States [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | 12,794 | 9,795 |
Italy [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | 7,928 | 8,462 |
Other [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | $ 2,055 | $ 2,331 |
Share-Based Compensation (Narra
Share-Based Compensation (Narrative) (Details) | Jan. 01, 2016shares | Jan. 18, 2012shares | Oct. 24, 2011 | Dec. 31, 2011periodshares | Aug. 31, 2010shares | Sep. 30, 2011 | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Jan. 17, 2012 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Recognized tax benefits related to share options exercised | $ | $ 15,400,000 | $ 11,800,000 | $ 6,700,000 | |||||||
Aggregate intrinsic value of share options exercised | $ | 93,300,000 | 138,200,000 | 46,000,000 | |||||||
Share Options [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Unrecognized compensation cost related to unvested share options and RSUs | $ | $ 75,200,000 | |||||||||
Unrecognized compensation cost, weighted-average period of recognition (in years) | 2 years 5 months | |||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period (in years) | 4 years | |||||||||
Unrecognized compensation cost related to unvested share options and RSUs | $ | $ 84,900,000 | |||||||||
Unrecognized compensation cost, weighted-average period of recognition (in years) | 2 years 1 month | |||||||||
RSUs weighted-average grant date fair value (in dollars per share) | $ / shares | $ 173.25 | |||||||||
Number of RSUs released (in shares) | 414,000 | |||||||||
Shares issued (in shares) | 265,000 | |||||||||
Shares withheld for tax purposes (in shares) | 149,000 | |||||||||
Total fair value of shares vested | $ | $ 72,200,000 | 50,900,000 | 16,100,000 | |||||||
2011 Equity Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Requisite service periods (in years) | 4 years | |||||||||
Shares authorized for issuance (in shares) | 16,278,263 | |||||||||
2011 Equity Incentive Plan [Member] | Subsequent Event [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Increase in shares reserved under plan (in shares) | 2,758,722 | |||||||||
2011 Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Grants expiration period (in years) | 10 years | |||||||||
2011 Equity Incentive Plan, Option One [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares authorized for issuance, annual automatic increase, maximum percentage of outstanding shares | 4.50% | |||||||||
2011 Equity Incentive Plan, Option Two [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Increase in shares reserved under plan (in shares) | 5,000,000 | |||||||||
2007 Equity Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares authorized for issuance (in shares) | 1,000,000 | |||||||||
2007 Equity Incentive Plan [Member] | Minimum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Requisite service periods (in years) | 1 year | 3 years | ||||||||
2007 Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Requisite service periods (in years) | 3 years | 5 years | ||||||||
Grants expiration period (in years) | 10 years | 10 years | ||||||||
2007 Employee Stock Purchase Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares authorized for issuance (in shares) | 2,660,000 | |||||||||
ESPP discount rate | 15.00% | |||||||||
ESPP offering period (in months) | 24 months | |||||||||
Number of purchase periods within each ESPP offering period | period | 4 | |||||||||
Number of shares available for issuance (in shares) | 175,000 | |||||||||
Unrecognized compensation cost related to unvested share options and RSUs | $ | $ 4,000,000 | |||||||||
2007 Employee Stock Purchase Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Unrecognized compensation cost, weighted-average period of recognition (in years) | 1 year | |||||||||
2007 Employee Stock Purchase Plan Option One [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares authorized for issuance, annual automatic increase, maximum percentage of outstanding shares | 1.50% | |||||||||
2007 Employee Stock Purchase Plan Option Two [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Increase in shares reserved under plan (in shares) | 1,000,000 | |||||||||
2007 Directors Option Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Shares authorized for issuance under deferred compensation plan (in shares) | 869,768 | |||||||||
2007 Directors Option Plan [Member] | Subsequent Event [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Increase in shares reserved under plan (in shares) | 34,150 | |||||||||
2007 Directors Option Plan [Member] | Initial Grant [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period (in years) | 3 years | |||||||||
2007 Directors Option Plan [Member] | Annual Automatic Grant [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period (in years) | 1 year | |||||||||
2007 Directors Option Plan [Member] | Minimum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Requisite service periods (in years) | 1 year | |||||||||
2007 Directors Option Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Requisite service periods (in years) | 3 years | |||||||||
Grants expiration period (in years) | 10 years | |||||||||
Shares authorized for issuance under deferred compensation plan (in shares) | 200,000 | |||||||||
Directors Deferred Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Increase in shares reserved under plan (in shares) | 200,000 | |||||||||
Recorded expense related to retainer fees earned and deferred | $ | $ 0 | $ 0 | $ 0 | |||||||
Deferred Compensation Arrangement With Individual Shares Unissued | 14,499 |
Share-Based Compensation (Sched
Share-Based Compensation (Schedule of Weighted-Average Assumptions Used in Black-Scholes Option Pricing Model and Resulting Weighted-Average Grant Date Fair Value of Share Options Granted) (Details) - Share Options [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Grant date fair value (in dollars per share) | $ 57.19 | $ 60.29 | $ 29.09 |
Volatility | 39.00% | 45.00% | 58.00% |
Expected term (in years) | 4 years 2 months 24 days | 4 years 3 months 24 days | 4 years 4 months 24 days |
Range of risk-free rates, minimum | 1.10% | 1.10% | 0.50% |
Range of risk-free rates, maximum | 1.50% | 1.40% | 1.40% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Share-Based Compensation (Sch74
Share-Based Compensation (Schedule of Stock-Based Compensation Expense Related to Stock Options, RSUs, Ordinary Shares Credited to Directors' Phantom Share Accounts and Grants under ESPP) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total share-based compensation expense, pre-tax | $ 91,550 | $ 69,638 | $ 44,551 |
Tax benefit from share-based compensation expense | (26,608) | (20,795) | (13,822) |
Total share-based compensation expense, net of tax | 64,942 | 48,843 | 30,729 |
Selling, General and Administrative [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total share-based compensation expense, pre-tax | 74,653 | 55,083 | 35,674 |
Research and Development [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total share-based compensation expense, pre-tax | 13,356 | 12,179 | 6,673 |
Cost of Product Sales [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total share-based compensation expense, pre-tax | $ 3,541 | $ 2,376 | $ 2,204 |
Share-Based Compensation (Sch75
Share-Based Compensation (Schedule of Share Option Plans Activity) (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
Shares Subject to Outstanding Options [Roll Forward] | |
Outstanding, beginning balance | shares | 3,870 |
Options granted | shares | 1,118 |
Options exercised | shares | (732) |
Options forfeited | shares | (319) |
Options expired | shares | 0 |
Outstanding, ending balance | shares | 3,937 |
Vested and expected to vest | shares | 3,731 |
Exercisable, balance | shares | 1,992 |
Weighted Average Exercise Price (in dollars per share) [Roll Forward] | |
Outstanding, beginning balance (in dollars per share) | $ / shares | $ 72.77 |
Options granted (in dollars per share) | $ / shares | 173.30 |
Options exercised (in dollars per share) | $ / shares | 45.04 |
Options forfeited (in dollars per share) | $ / shares | 118.05 |
Options expired (in dollars per share) | $ / shares | 0 |
Outstanding, ending balance (in dollars per share) | $ / shares | 102.81 |
Vested and expected to vest (in dollars per share) | $ / shares | 99.87 |
Exercisable (in dollars per share) | $ / shares | $ 64.48 |
Weighted Average Remaining Contractual Term and Aggregate Intrinsic Value | |
Weighted-average remaining contractual term, outstanding | 7 years 4 months 14 days |
Weighted-average remaining contractual term, vested and expected to vest, exercisable | 7 years 3 months |
Weighted-average remaining contractual term, exercisable | 6 years 3 months |
Aggregate intrinsic value, outstanding | $ | $ 198,666 |
Aggregate intrinsic value, vested and expected to vest | $ | 196,654 |
Aggregate intrinsic value, exercisable | $ | $ 159,156 |
Share-Based Compensation (Sch76
Share-Based Compensation (Schedule of RSUs Activity) (Details) - Restricted Stock Units (RSUs) [Member] $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
Number of RSUs [Roll Forward] | |
Number of RSUs, outstanding, beginning balance (in shares) | shares | 1,188 |
Number of RSUs granted (in shares) | shares | 430 |
Number of RSUs released (in shares) | shares | (414) |
Number of RSUs forfeited (in shares) | shares | (150) |
Number of RSUs expired (in shares) | shares | 0 |
Number of RSUs, outstanding, ending balance (in shares) | shares | 1,054 |
Weighted-Average Grant-Date Fair Value [Roll Forward] | |
Weighted-average grant-date fair value, outstanding, beginning balance (in dollars per share) | $ / shares | $ 96.41 |
Weighted-average grant-date fair value, RSUs granted (in dollars per share) | $ / shares | 173.25 |
Weighted-average grant-date fair value, RSUs released (in dollars per share) | $ / shares | 86.03 |
Weighted-average grant-date fair value, RSUs forfeited (in dollars per share) | $ / shares | 113.44 |
Weighted-average grant-date fair value, RSUs expired (in dollars per share) | $ / shares | 0 |
Weighted-average grant-date fair value, outstanding, ending balance (in dollars per share) | $ / shares | $ 129.40 |
Weighted-average remaining contractual term, outstanding | 1 year 2 months |
Aggregate intrinsic value, outstanding | $ | $ 148,172 |
Employee Benefit Plans (Narrati
Employee Benefit Plans (Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Expenses related to defined contribution plans | $ 2.2 | $ 2 | $ 1.1 |
Ireland [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Expenses related to defined contribution plans | $ 0.6 | 0.5 | 0.3 |
Defined contribution plans, employer matching percentage of employee's eligible contributions | 8.00% | ||
United States [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Expenses related to defined contribution plans | $ 1.1 | 1 | 0.4 |
United Kingdom [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Expenses related to defined contribution plans | $ 0.4 | 0.5 | 0.4 |
Defined contribution plans, employer matching percentage of employee's eligible contributions | 12.00% | ||
France [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Accrued retirement liability | $ 0.2 | 0.4 | $ 0.3 |
Italy [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Accrued retirement liability | $ 0.3 | $ 0.4 |
Restructuring (Schedule of Rest
Restructuring (Schedule of Restructuring) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Restructuring Reserve [Roll Forward] | |||||
Restructuring Reserve, Beginning Balance | $ 1,941 | ||||
Expense | 1,641 | $ 1,941 | $ 1,457 | ||
Payments | (2,477) | (252) | (2,432) | ||
Restructuring Reserve, Ending Balance | 1,941 | ||||
Accrued Liabilities [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Restructuring Reserve, Beginning Balance | $ 1,105 | 252 | 1,227 | ||
Restructuring Reserve, Ending Balance | $ 1,105 | 1,105 | 252 | ||
Selling, General and Administrative [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Expense | 1,500 | ||||
One-time Termination Benefits | |||||
Restructuring Reserve [Roll Forward] | |||||
Restructuring Reserve, Beginning Balance | 1,823 | ||||
Expense | 1,469 | 1,823 | 1,045 | ||
Payments | (2,187) | 0 | (2,272) | ||
Restructuring Reserve, Ending Balance | 1,823 | ||||
One-time Termination Benefits | Accrued Liabilities [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Restructuring Reserve, Beginning Balance | 1,105 | 0 | 1,227 | ||
Restructuring Reserve, Ending Balance | 1,105 | 1,105 | 0 | ||
One-time Termination Benefits | Cost of Product Sales [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Expense | 1,100 | ||||
One-time Termination Benefits | Selling, General and Administrative [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Expense | 400 | 1,800 | |||
One-time Termination Benefits | Selling, General and Administrative [Member] | Scenario, Forecast [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Expense | 600 | ||||
Facility Closing [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Restructuring Reserve, Beginning Balance | 118 | ||||
Expense | 172 | 118 | 412 | ||
Payments | (290) | (252) | (160) | ||
Restructuring Reserve, Ending Balance | 118 | ||||
Facility Closing [Member] | Accrued Liabilities [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Restructuring Reserve, Beginning Balance | $ 0 | 252 | 0 | ||
Restructuring Reserve, Ending Balance | $ 0 | 0 | $ 252 | ||
Facility Closing [Member] | Selling, General and Administrative [Member] | |||||
Restructuring Reserve [Roll Forward] | |||||
Expense | $ 200 | $ 100 |
Income Taxes (Components of Inc
Income Taxes (Components of Income before Income Tax Provision (Benefit)) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Components of Income from Continuing Operations before Income Tax Provision (Benefit) | |||
Ireland | $ 233,785 | $ 238,351 | $ 186,903 |
United States | 285,420 | 222,328 | 132,855 |
Other | (83,272) | (309,122) | (11,808) |
Total | $ 435,933 | $ 151,557 | $ 307,950 |
Income Taxes (Details of Income
Income Taxes (Details of Income Tax Provision) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current | |||
Ireland | $ 22,599 | $ 23,506 | $ 17,089 |
United States | 116,301 | 97,679 | 71,964 |
Other | 28,708 | 16,469 | 12,682 |
Total current income tax | 167,608 | 137,654 | 101,735 |
Deferred | |||
Ireland | 494 | 2,323 | 8,353 |
United States | 332 | (15,003) | (3,513) |
Other | (40,532) | (30,743) | (14,937) |
Total deferred, exclusive of other components | (39,706) | (43,423) | (10,097) |
Deferred, change in tax rates | |||
United States | 294 | 0 | 0 |
Other | (21,797) | 0 | 0 |
Total deferred, change in tax rates | (21,503) | 0 | 0 |
Total deferred income tax benefit | (61,209) | (43,423) | (10,097) |
Total income tax provision | $ 106,399 | $ 94,231 | $ 91,638 |
Income Taxes (Effective Income
Income Taxes (Effective Income Tax Rate Reconciliation) (Details) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Effective Income Tax Rate Reconciliation [Abstract] | |||
Statutory income tax rate | 12.50% | 12.50% | 12.50% |
Foreign income tax rate differential | 19.10% | 50.00% | 10.30% |
Change in tax rate | (4.50%) | 0.00% | 0.00% |
Research and other tax credits | (3.80%) | (9.40%) | (1.90%) |
Change in unrecognized tax benefits | 3.60% | 6.20% | 2.80% |
Deduction on subsidiary equity | (2.70%) | (7.50%) | (0.00%) |
Change in estimates | (1.00%) | (3.00%) | 1.10% |
Non-deductible compensation | 1.90% | 4.60% | 1.30% |
Change in valuation allowance | (0.60%) | 5.70% | 1.10% |
Financing costs | (0.40%) | 0.70% | 0.00% |
Acquisition-related costs | 0.00% | 3.10% | 1.70% |
Other | 0.30% | (0.70%) | 0.90% |
Effective income tax rate | 24.40% | 62.20% | 29.80% |
Income Taxes (Schedule of Net D
Income Taxes (Schedule of Net Deferred Tax Assets/(Liabilities)) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 57,091 | $ 74,057 |
Tax credit carryforwards | 36,797 | 23,946 |
Intangible assets | 25,384 | 19,507 |
Share-based compensation | 20,050 | 14,033 |
Accruals | 32,355 | 36,157 |
Other | 31,144 | 36,222 |
Total deferred tax assets | 202,821 | 203,922 |
Valuation allowance | (33,949) | (29,697) |
Net deferred tax assets | 168,872 | 174,225 |
Deferred tax liabilities: | ||
Acquired intangible assets | (307,356) | (395,651) |
Other | (33,138) | (39,124) |
Total deferred tax liabilities | (340,494) | (434,775) |
Net deferred tax liabilities | $ (171,622) | $ (260,550) |
Income Taxes (Current and Non-c
Income Taxes (Current and Non-current Deferred Assets/(Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current and Non-current Deferred Tax Assets (Liabilities) [Abstract] | ||
Current deferred tax assets | $ 0 | $ 48,440 |
Current deferred tax liabilities | 0 | (9,430) |
Non-current deferred tax assets | 122,863 | 75,494 |
Non-current deferred tax liabilities | (294,485) | (375,054) |
Net deferred tax liabilities | $ (171,622) | $ (260,550) |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Reconciliation of Beginning and Ending Amounts of Unrecognized Tax Benefits | |||
Balance at the beginning of the year | $ 40,802 | $ 21,637 | $ 7,288 |
Increases related to current year tax positions | 23,664 | 19,837 | 14,308 |
Increases related to prior year tax positions | 2,833 | 0 | 183 |
Decreases related to prior year tax positions | (646) | (672) | (142) |
Lapse of the applicable statute of limitations | (268) | 0 | 0 |
Balance at the end of the year | $ 66,385 | $ 40,802 | $ 21,637 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Operating Loss Carryforwards [Line Items] | ||||||||
Income tax provision | $ 106,399 | $ 94,231 | $ 91,638 | |||||
Effective income tax rate | 24.40% | 62.20% | 29.80% | |||||
Acquired in-process research and development | $ 600 | $ 75,000 | $ 127,000 | $ 0 | $ 202,626 | $ 4,988 | ||
Statutory income tax rate | 12.50% | 12.50% | 12.50% | |||||
Net change in valuation allowance | $ 4,300 | $ 9,000 | $ 3,200 | |||||
Non-recurring income tax benefit | (2,400) | 7,700 | $ (2,300) | |||||
Deferred tax assets, valuation allowance | $ 33,949 | 29,697 | 33,949 | 29,697 | ||||
Cumulated unremitted earnings of overseas subsidiaries | 983,800 | 736,900 | 983,800 | 736,900 | ||||
Unrecognized tax benefits that would impact the effective tax rate | 48,100 | $ 29,700 | 48,100 | $ 29,700 | ||||
Employee Share Options [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
NOL carryforwards | 170,400 | $ 170,400 | ||||||
Non-Taxable Jurisdiction [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
Tax rate excluding certain milestone payments | 26.70% | |||||||
Non-Taxable Jurisdiction [Member] | Aerial and Defibrotide in Americas [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
Acquired in-process research and development | $ 202,000 | |||||||
Ireland [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
Statutory income tax rate | 12.50% | 12.50% | 12.50% | |||||
U.S. Federal [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
NOL carryforwards | 227,700 | $ 227,700 | ||||||
Tax credit carryforwards | 60,500 | 60,500 | ||||||
U.S. Federal [Member] | Year 2016 [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
Annual limitation on utilization of certain acquired federal NOLs | 23,500 | 23,500 | ||||||
U.S. Federal [Member] | Year 2017 to 2026 [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
Annual limitation on utilization of certain acquired federal NOLs | 27,500 | 27,500 | ||||||
U.S. Federal [Member] | EUSA Pharma Acquisition [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
NOL carryforwards | $ 97,100 | |||||||
U.S. State [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
NOL carryforwards | 234,700 | 234,700 | ||||||
Tax credit carryforwards | 7,000 | 7,000 | ||||||
Foreign Tax Authorities [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
Tax credit carryforwards | 4,200 | 4,200 | ||||||
Foreign Tax Authorities [Member] | United Kingdom [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
NOL carryforwards | 64,800 | 64,800 | ||||||
Foreign Tax Authorities [Member] | Italy [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
NOL carryforwards | 65,300 | $ 65,300 | ||||||
French Tax Authorities [Member] | ||||||||
Operating Loss Carryforwards [Line Items] | ||||||||
Income Tax Examination, Estimate of Possible Loss | $ 41,800 |
Quarterly Financial Data (Una86
Quarterly Financial Data (Unaudited) (Schedule Of Interim Financial Information Presents Results Of Operations On Quarterly Basis) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Data [Line Items] | |||||||||||
Revenues | $ 340,881 | $ 340,872 | $ 333,747 | $ 309,303 | $ 328,142 | $ 306,584 | $ 291,230 | $ 246,919 | $ 1,324,803 | $ 1,172,875 | $ 872,423 |
Gross margin | 314,894 | 310,369 | 310,293 | 278,737 | 295,415 | 277,413 | 258,408 | 214,062 | |||
Net income attributable to Jazz Pharmaceuticals plc | $ 82,761 | $ 87,960 | $ 88,114 | $ 70,700 | $ 81,612 | $ 25,766 | $ 43,659 | $ (92,650) | $ 329,535 | $ 58,387 | $ 216,312 |
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, basic (in dollars per share) | $ 1.35 | $ 1.43 | $ 1.44 | $ 1.16 | $ 1.35 | $ 0.43 | $ 0.73 | $ (1.58) | $ 5.38 | $ 0.98 | $ 3.71 |
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, diluted (in dollars per share) | $ 1.32 | $ 1.39 | $ 1.40 | $ 1.12 | $ 1.30 | $ 0.41 | $ 0.70 | $ (1.58) | $ 5.23 | $ 0.93 | $ 3.51 |
Impairment charges | $ 31,500 | $ 6,600 | $ 32,800 | $ 31,523 | $ 39,365 | $ 0 | |||||
Research and development | 135,253 | 85,181 | 41,632 | ||||||||
Acquired in-process research and development | 600 | $ 75,000 | $ 127,000 | 0 | 202,626 | 4,988 | |||||
Loss on extinguishment and modification of debt | $ 16,800 | $ 16,815 | $ 0 | $ 3,749 | |||||||
Fair value step-up adjustments, purchase accounting inventory | 2,500 | 8,000 | |||||||||
Transaction costs | $ 5,200 | $ 700 | $ 4,400 | $ 17,100 | |||||||
Milestone Payment [Member] | |||||||||||
Quarterly Financial Data [Line Items] | |||||||||||
Research and development | $ 25,000 | ||||||||||
Azur Pharma [Member] | |||||||||||
Quarterly Financial Data [Line Items] | |||||||||||
Contract claim settlement | $ 18,000 |
Schedule II Valuation and Qua87
Schedule II Valuation and Qualifying Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Allowance for Doubtful Accounts [Member] | |||
Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of period | $ 530 | $ 594 | $ 715 |
Additions charged to costs and expenses | 0 | 0 | (4) |
Other Additions | 0 | 0 | 0 |
Deductions | (41) | (64) | (117) |
Balance at end of period | 489 | 530 | 594 |
Allowance for Sales Discounts [Member] | |||
Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of period | 238 | 378 | 528 |
Additions charged to costs and expenses | 2,900 | 3,794 | 5,267 |
Other Additions | 0 | 0 | 0 |
Deductions | (2,957) | (3,934) | (5,417) |
Balance at end of period | 181 | 238 | 378 |
Allowance for Chargebacks [Member] | |||
Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of period | 2,715 | 2,708 | 2,536 |
Additions charged to costs and expenses | 39,079 | 28,614 | 21,047 |
Other Additions | 0 | 0 | 0 |
Deductions | (38,771) | (28,607) | (20,875) |
Balance at end of period | 3,023 | 2,715 | 2,708 |
Deferred Tax Asset Valuation Allowance [Member] | |||
Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of period | 29,697 | 20,691 | 17,471 |
Additions charged to costs and expenses | 5,044 | 18,971 | 3,220 |
Other Additions | 1,888 | 0 | 0 |
Deductions | (2,680) | (9,965) | 0 |
Balance at end of period | $ 33,949 | $ 29,697 | $ 20,691 |