Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Cover page. | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2019 | |
Document Transition Report | false | |
Entity File Number | 001-33500 | |
Entity Incorporation, State or Country Code | L2 | |
Entity Tax Identification Number | 98-1032470 | |
Entity Address, Address Line One | Fifth Floor, Waterloo Exchange, | |
Entity Address, Address Line Two | Waterloo Road | |
Entity Address, City or Town | Dublin 4 | |
Entity Address, Country | IE | |
Entity Address, Postal Zip Code | D04 E5W7 | |
Country Region | 353 | |
City Area Code | 1 | |
Local Phone Number | 634-7800 | |
Title of 12(b) Security | Ordinary shares, nominal value $0.0001 per share | |
Trading Symbol | JAZZ | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Smaller Reporting Company | false | |
Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 56,621,139 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal period Focus | Q2 | |
Entity Central Index Key | 0001232524 | |
Current Fiscal Year End Date | --12-31 | |
Entity Shell Company | false | |
Entity Registrant Name | Jazz Pharmaceuticals plc |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 637,739 | $ 309,622 |
Investments | 245,000 | 515,000 |
Accounts receivable, net of allowances | 311,249 | 263,838 |
Inventories | 68,999 | 52,956 |
Prepaid expenses | 31,712 | 25,017 |
Other current assets | 75,367 | 67,572 |
Total current assets | 1,370,066 | 1,234,005 |
Property, plant and equipment, net | 127,183 | 200,358 |
Operating lease assets | 144,746 | 0 |
Intangible assets, net | 2,687,941 | 2,731,334 |
Goodwill | 924,990 | 927,630 |
Deferred tax assets, net | 184,383 | 57,879 |
Deferred financing costs | 8,517 | 9,589 |
Other non-current assets | 40,835 | 42,696 |
Total assets | 5,488,661 | 5,203,491 |
Current liabilities: | ||
Accounts payable | 82,222 | 40,602 |
Accrued liabilities | 218,751 | 264,887 |
Current portion of long-term debt | 33,387 | 33,387 |
Income taxes payable | 30,413 | 1,197 |
Deferred revenue | 4,720 | 5,414 |
Total current liabilities | 369,493 | 345,487 |
Deferred revenue, non-current | 7,221 | 9,581 |
Long-term debt, less current portion | 1,567,842 | 1,563,025 |
Operating lease liabilities, less current portion | 156,289 | 0 |
Deferred tax liabilities, net | 283,669 | 309,097 |
Other non-current liabilities | 120,713 | 218,879 |
Commitments and contingencies (Note 11) | ||
Shareholders’ equity: | ||
Ordinary shares | 6 | 6 |
Non-voting euro deferred shares | 55 | 55 |
Capital redemption reserve | 472 | 472 |
Additional paid-in capital | 2,171,458 | 2,113,630 |
Accumulated other comprehensive loss | (210,436) | (197,791) |
Retained earnings | 1,021,879 | 841,050 |
Total shareholders’ equity | 2,983,434 | 2,757,422 |
Total liabilities and shareholders’ equity | $ 5,488,661 | $ 5,203,491 |
Condensed Consolidated Statemen
Condensed Consolidated Statements Of Income - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenues: | ||||
Total revenues | $ 534,133 | $ 500,479 | $ 1,042,319 | $ 945,092 |
Operating expenses: | ||||
Cost of product sales (excluding amortization of intangible assets) | 27,676 | 34,714 | 61,182 | 68,633 |
Selling, general and administrative | 176,014 | 158,579 | 343,961 | 365,792 |
Research and development | 62,384 | 56,132 | 122,489 | 118,799 |
Intangible asset amortization | 61,576 | 54,959 | 118,461 | 107,966 |
Impairment charges | 0 | 42,896 | 0 | 42,896 |
Acquired in-process research and development | 2,200 | 0 | 58,200 | 0 |
Total operating expenses | 329,850 | 347,280 | 704,293 | 704,086 |
Income from operations | 204,283 | 153,199 | 338,026 | 241,006 |
Interest expense, net | (18,234) | (19,646) | (36,156) | (40,251) |
Foreign exchange loss | (1,933) | (2,697) | (2,544) | (4,425) |
Loss on extinguishment and modification of debt | 0 | (1,425) | 0 | (1,425) |
Income before income tax provision (benefit) and equity in loss of investees | 184,116 | 129,431 | 299,326 | 194,905 |
Income tax provision (benefit) | (78,650) | 36,524 | (49,534) | 55,670 |
Equity in loss of investees | 868 | 586 | 1,761 | 923 |
Net income | $ 261,898 | $ 92,321 | $ 347,099 | $ 138,312 |
Net income per ordinary share: | ||||
Basic (in dollars per share) | $ 4.62 | $ 1.53 | $ 6.09 | $ 2.30 |
Diluted (in dollars per share) | $ 4.56 | $ 1.50 | $ 6.01 | $ 2.26 |
Weighted-average ordinary shares used in per share calculations - basic (in shares) | 56,707 | 60,177 | 56,955 | 60,053 |
Weighted-average ordinary shares used in per share calculations - diluted (in shares) | 57,427 | 61,438 | 57,753 | 61,309 |
Product sales, net | ||||
Revenues: | ||||
Total revenues | $ 523,423 | $ 496,095 | $ 1,026,754 | $ 936,942 |
Royalties and contract revenues | ||||
Revenues: | ||||
Total revenues | $ 10,710 | $ 4,384 | $ 15,565 | $ 8,150 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Comprehensive Income - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income | $ 261,898 | $ 92,321 | $ 347,099 | $ 138,312 |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | 13,319 | (70,814) | (7,823) | (31,961) |
Unrealized gain (loss) on hedging activities, net of income tax (benefit) provision of ($440), $193, ($689) and $651, respectively | (3,081) | 1,354 | (4,822) | 4,558 |
Other comprehensive income (loss) | 10,238 | (69,460) | (12,645) | (27,403) |
Total comprehensive income | $ 272,136 | $ 22,861 | $ 334,454 | $ 110,909 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements Of Comprehensive Income (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Tax (benefit) effect on hedging activities | $ (440) | $ 193 | $ (689) | $ 651 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements Of Shareholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Ordinary Shares | Non-voting Euro Deferred | Capital Redemption Reserve | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Retained Earnings |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Cumulative effect adjustment from adoption of new accounting standards | $ (298) | $ 53 | $ (351) | ||||
Beginning balance (in shares) at Dec. 31, 2017 | 59,898 | 4,000 | |||||
Beginning balance at Dec. 31, 2017 | 2,713,097 | $ 6 | $ 55 | $ 472 | $ 1,935,486 | (140,878) | 917,956 |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Issuance of ordinary shares in conjunction with exercise of share options (in shares) | 133 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options | 10,588 | 10,588 | |||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units (in shares) | 195 | ||||||
Shares withheld for payment of employee's withholding tax liability | (14,594) | (14,594) | |||||
Share-based compensation | 24,276 | 24,276 | |||||
Shares repurchased (in shares) | (237) | ||||||
Shares repurchased | (34,546) | (34,546) | |||||
Other comprehensive (loss) income | 42,057 | 42,057 | |||||
Net income | 45,991 | 45,991 | |||||
Ending balance (in shares) at Mar. 31, 2018 | 59,989 | 4,000 | |||||
Ending balance at Mar. 31, 2018 | 2,786,571 | $ 6 | $ 55 | 472 | 1,955,756 | (98,768) | 929,050 |
Beginning balance (in shares) at Dec. 31, 2017 | 59,898 | 4,000 | |||||
Beginning balance at Dec. 31, 2017 | 2,713,097 | $ 6 | $ 55 | 472 | 1,935,486 | (140,878) | 917,956 |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Net income | 138,312 | ||||||
Ending balance (in shares) at Jun. 30, 2018 | 60,386 | 4,000 | |||||
Ending balance at Jun. 30, 2018 | 2,869,752 | $ 6 | $ 55 | 472 | 2,037,091 | (168,228) | 1,000,356 |
Beginning balance (in shares) at Mar. 31, 2018 | 59,989 | 4,000 | |||||
Beginning balance at Mar. 31, 2018 | 2,786,571 | $ 6 | $ 55 | 472 | 1,955,756 | (98,768) | 929,050 |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Issuance of ordinary shares in conjunction with exercise of share options (in shares) | 457 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options | 51,023 | 51,023 | |||||
Issuance of ordinary shares under employee stock purchase plan (in shares) | 59 | ||||||
Issuance of ordinary shares under employee stock purchase plan | 5,447 | 5,447 | |||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units (in shares) | 16 | ||||||
Shares withheld for payment of employee's withholding tax liability | (1,429) | (1,429) | |||||
Share-based compensation | 26,294 | 26,294 | |||||
Shares repurchased (in shares) | (135) | ||||||
Shares repurchased | (21,015) | (21,015) | |||||
Other comprehensive (loss) income | (69,460) | (69,460) | |||||
Net income | 92,321 | 92,321 | |||||
Ending balance (in shares) at Jun. 30, 2018 | 60,386 | 4,000 | |||||
Ending balance at Jun. 30, 2018 | 2,869,752 | $ 6 | $ 55 | 472 | 2,037,091 | (168,228) | 1,000,356 |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Cumulative effect adjustment from adoption of new accounting standards | 4,848 | 0 | 4,848 | ||||
Beginning balance (in shares) at Dec. 31, 2018 | 57,504 | 4,000 | |||||
Beginning balance at Dec. 31, 2018 | 2,757,422 | $ 6 | $ 55 | 472 | 2,113,630 | (197,791) | 841,050 |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Issuance of ordinary shares in conjunction with exercise of share options (in shares) | 54 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options | 3,057 | 3,057 | |||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units (in shares) | 203 | ||||||
Shares withheld for payment of employee's withholding tax liability | (13,810) | (13,810) | |||||
Share-based compensation | 27,861 | 27,861 | |||||
Shares repurchased (in shares) | (858) | ||||||
Shares repurchased | (111,249) | (111,249) | |||||
Other comprehensive (loss) income | (22,883) | (22,883) | |||||
Net income | 85,201 | 85,201 | |||||
Ending balance (in shares) at Mar. 31, 2019 | 56,903 | 4,000 | |||||
Ending balance at Mar. 31, 2019 | 2,730,447 | $ 6 | $ 55 | 472 | 2,130,738 | (220,674) | 819,850 |
Beginning balance (in shares) at Dec. 31, 2018 | 57,504 | 4,000 | |||||
Beginning balance at Dec. 31, 2018 | 2,757,422 | $ 6 | $ 55 | 472 | 2,113,630 | (197,791) | 841,050 |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Net income | 347,099 | ||||||
Ending balance (in shares) at Jun. 30, 2019 | 56,626 | 4,000 | |||||
Ending balance at Jun. 30, 2019 | 2,983,434 | $ 6 | $ 55 | 472 | 2,171,458 | (210,436) | 1,021,879 |
Beginning balance (in shares) at Mar. 31, 2019 | 56,903 | 4,000 | |||||
Beginning balance at Mar. 31, 2019 | 2,730,447 | $ 6 | $ 55 | 472 | 2,130,738 | (220,674) | 819,850 |
Increase (Decrease) in Shareholders' Equity [Roll Forward] | |||||||
Issuance of ordinary shares in conjunction with exercise of share options (in shares) | 98 | ||||||
Issuance of ordinary shares in conjunction with exercise of share options | 7,033 | 7,033 | |||||
Issuance of ordinary shares under employee stock purchase plan (in shares) | 57 | ||||||
Issuance of ordinary shares under employee stock purchase plan | 6,032 | 6,032 | |||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units (in shares) | 15 | ||||||
Shares withheld for payment of employee's withholding tax liability | (1,003) | (1,003) | |||||
Share-based compensation | 28,658 | 28,658 | |||||
Shares repurchased (in shares) | (447) | ||||||
Shares repurchased | (59,869) | (59,869) | |||||
Other comprehensive (loss) income | 10,238 | 10,238 | |||||
Net income | 261,898 | 261,898 | |||||
Ending balance (in shares) at Jun. 30, 2019 | 56,626 | 4,000 | |||||
Ending balance at Jun. 30, 2019 | $ 2,983,434 | $ 6 | $ 55 | $ 472 | $ 2,171,458 | $ (210,436) | $ 1,021,879 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements Of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities | ||
Net income | $ 347,099 | $ 138,312 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Intangible asset amortization | 118,461 | 107,966 |
Share-based compensation | 55,841 | 50,615 |
Impairment charges | 0 | 42,896 |
Depreciation | 6,894 | 7,457 |
Acquired in-process research and development | 58,200 | 0 |
Loss on disposal of assets | 7 | 115 |
Deferred tax benefit | (151,347) | (32,228) |
Provision for losses on accounts receivable and inventory | 2,403 | 2,670 |
Loss on extinguishment and modification of debt | 0 | 1,425 |
Amortization of debt discount and deferred financing costs | 22,584 | 21,504 |
Other non-cash transactions | (2,547) | 10,996 |
Changes in assets and liabilities: | ||
Accounts receivable | (47,574) | (54,356) |
Inventories | (18,562) | (8,938) |
Prepaid expenses and other current assets | (15,929) | (5,268) |
Other non-current assets | 694 | 1,767 |
Operating lease assets | 7,399 | |
Accounts payable | (14,096) | 7,371 |
Accrued liabilities | (59,031) | 60,108 |
Income taxes payable | 29,050 | (3,285) |
Deferred revenue | (3,054) | (3,749) |
Other non-current liabilities | 14,177 | 13,955 |
Operating lease liabilities, less current portion | 431 | |
Net cash provided by operating activities | 351,100 | 359,333 |
Investing activities | ||
Proceeds from maturity of investments | 630,000 | 385,000 |
Acquired in-process research and development | (58,200) | 0 |
Purchases of property, plant and equipment | (21,911) | (11,281) |
Acquisition of intangible assets | (25,500) | (111,102) |
Acquisition of investments | (360,975) | (505,350) |
Net cash provided by (used in) investing activities | 163,414 | (242,733) |
Financing activities | ||
Proceeds from employee equity incentive and purchase plans | 16,122 | 67,058 |
Payment of employee withholding taxes related to share-based awards | (14,813) | (16,023) |
Repayments of long-term debt | (16,693) | (9,023) |
Share repurchases | (171,118) | (55,561) |
Proceeds from tenant improvement allowance on build-to-suit lease | 0 | 1,253 |
Payment of debt modification costs | 0 | (6,406) |
Net cash used in financing activities | (186,502) | (18,702) |
Effect of exchange rates on cash and cash equivalents | 105 | 1,148 |
Net increase in cash and cash equivalents | 328,117 | 99,046 |
Cash and cash equivalents, at beginning of period | 309,622 | 386,035 |
Cash and cash equivalents, at end of period | $ 637,739 | $ 485,081 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
The Company and Summary of Significant Accounting Policies | The Company and Summary of Significant Accounting Policies Jazz Pharmaceuticals plc is a global biopharmaceutical company dedicated to developing life-changing medicines for people with limited or no options. As a leader in sleep medicine and with a growing hematology/oncology portfolio, we have a diverse portfolio of products and product candidates in development. Our lead marketed products are: • Sunosi™ (solriamfetol) , our newest lead marketed product launched in July 2019 and approved in the U.S. to improve wakefulness in adult patients with excessive daytime sleepiness, or EDS, associated with narcolepsy or obstructive sleep apnea. We are also seeking approval for solriamfetol in Europe and submitted a marketing authorization application to the European Medicines Agency in the fourth quarter of 2018; • Xyrem ® (sodium oxybate) oral solution , the only product approved by the U.S. Food and Drug Administration, or FDA, and marketed in the U.S. for the treatment of both cataplexy and EDS in both adult and pediatric patients with narcolepsy; • Defitelio ® (defibrotide sodium) , a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio ® (defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy; • 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 who have developed hypersensitivity to E. coli -derived asparaginase; and • Vyxeos ® (daunorubicin and cytarabine) liposome for injection , a product approved in the U.S. and in Europe (where it is marketed as Vyxeos ® 44 mg/100 mg powder for concentrate for solution for infusion) for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia, or acute myeloid leukemia with myelodysplasia-related changes. In March 2019, we announced positive top-line results from our Phase 3 study evaluating the efficacy and safety of JZP-258, an oxybate product candidate that contains 92% less sodium than Xyrem, for the treatment of cataplexy and EDS in adult patients with narcolepsy, and we expect to submit a new drug application, or NDA, for this product by as early as the end of 2019. Our strategy to create shareholder value is focused on: • Strong financial execution through growth in sales of our current lead marketed products; • Building a diversified product portfolio and development pipeline through a combination of our internal research and development efforts and obtaining rights to clinically meaningful and differentiated on- or near-market products and early- to late-stage product candidates through acquisitions, collaborations, licensing arrangements, partnerships and venture investments; and • Maximizing the value of our products and product candidates by continuing to implement our comprehensive global development plans, including through generating additional clinical data and seeking regulatory approval for new indications. Throughout this report, unless otherwise indicated or the context otherwise requires, all references to “Jazz Pharmaceuticals,” “the registrant,” “we,” “us,” and “our” refer to Jazz Pharmaceuticals plc and its consolidated subsidiaries. Throughout this report, all references to “ordinary shares” refer to Jazz Pharmaceuticals plc’s ordinary shares. Basis of Presentation These unaudited condensed consolidated financial statements have been prepared following the requirements of the U.S. Securities and Exchange Commission for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. generally accepted accounting principles, or U.S. GAAP, can be condensed or omitted. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our annual consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2018 . In the opinion of management, these condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair presentation of our financial position and operating results. The results for the three and six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 , for any other interim period or for any future period. Our significant accounting policies have not changed substantially from those previously described in our Annual Report on Form 10-K for the year ended December 31, 2018 with the exception of the accounting policy relating to operating leases and financing obligations which was updated as a result of adopting Accounting Standards Update No. 2016-02, “Leases”, or ASU No. 2016-02. These condensed consolidated financial statements include the accounts of Jazz Pharmaceuticals plc and our subsidiaries, and intercompany transactions and balances have been eliminated. 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 identification, development and commercialization of meaningful pharmaceutical products that address unmet medical needs. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Leases We determine if an arrangement is a lease at inception. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on our condensed consolidated balance sheets. Operating lease assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. In determining the net present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date. The operating lease asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. We have lease agreements with lease and non-lease components, which are generally accounted for separately. For vehicle leases we account for the lease and non-lease components as a single lease component. We have elected the short-term lease exemption and, therefore, do not recognize a right-of-use asset or corresponding liability for lease arrangements with an original term of 12 months or less. Adoption of New Accounting Standards In February 2016, the Financial Accounting Standards Board, or FASB, issued ASU No. 2016-02. Under the new guidance, lessees are required to recognize a right-of-use asset, which represents the lessee’s right to use, or control the use of, a specified asset for the lease term, and a corresponding lease liability, which represents the lessee’s obligation to make lease payments under a lease, measured on a discounted basis. We adopted ASU No. 2016-02 on a modified retrospective basis applied to leases existing as of, or entered into after, January 1, 2019. We elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification of those leases in place as of January 1, 2019. The adoption of ASU No. 2016-02 resulted in the recognition of right-of-use assets and lease liabilities of $149.4 million and $162.9 million , respectively, on the consolidated balance sheet as of January 1, 2019, and the de-recognition of the build-to-suit assets and related financing obligations on the consolidated balance sheet as of December 31, 2018 of $95.4 million and $109.8 million , respectively, with the balance impacting retained earnings, deferred rent and deferred tax liabilities. The right-of-use assets and lease liabilities primarily relate to real estate leases. Refer to Note 10 for lease-related disclosures. The cumulative effect of the changes made to our consolidated balance sheet as of January 1, 2019 for the adoption of the ASU No. 2016-02 was as follows (in thousands): Balance at December 31, Transition Adjustments Balance at January 1, Assets: Property, plant and equipment, net $ 200,358 $ (95,397 ) $ 104,961 Operating lease assets — 149,442 149,442 Liabilities: Accrued liabilities 264,887 8,165 273,052 Operating lease liabilities, less current portion — 153,158 153,158 Deferred tax liabilities, net 309,097 1,489 310,586 Other non-current liabilities 218,879 (113,615 ) 105,264 Shareholders' Equity: Retained earnings 841,050 4,848 845,898 Significant Risks and Uncertainties Our financial results are significantly influenced by sales of Xyrem. Our ability to maintain or increase Xyrem product sales is subject to a number of risks and uncertainties, including, without limitation, the introduction of new products in the U.S. market that compete with, or otherwise disrupt the market for, Xyrem in the treatment of cataplexy and/or EDS in narcolepsy, including our recently-approved product, Sunosi; the introduction of a generic version of Xyrem in the U.S. market before the entry dates specified in our settlements with the abbreviated new drug application, or ANDA, filers or on terms that are different from those contemplated by the settlement agreements; increased pricing pressure from, changes in policies by, or restrictions on reimbursement imposed by, third party payors, including pressure to agree to discounts, rebates or other restrictive pricing terms for Xyrem; changes in healthcare laws and policy, including changes in requirements for patient assistance programs, rebates, reimbursement and coverage by federal healthcare programs, and changes resulting from increased scrutiny on pharmaceutical pricing and risk evaluation and mitigation strategy, or REMS, programs by government entities; changes to or uncertainties around our Xyrem REMS, or any failure to comply with our REMS obligations to the satisfaction of the FDA; challenges to our intellectual property around Xyrem, including the possibility of new ANDA or NDA filers or new post-grant patent review proceedings; operational disruptions at the Xyrem central pharmacy; any supply or manufacturing problems, including any problems with our sole source Xyrem active pharmaceutical ingredient, or API, provider; continued acceptance of Xyrem by physicians and patients, including as a result of negative publicity that surfaces from time to time; and changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem. In addition to risks related specifically to Xyrem, 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, including, without limitation, risks and uncertainties associated with: effectively commercializing our other products, including effectively launching and commercializing new products such as our recently-approved product Sunosi; competition; obtaining and maintaining adequate coverage and reimbursement for our products; increasing scrutiny of pharmaceutical product pricing and resulting changes in healthcare laws and policy; market acceptance; delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations; regulatory approval and successful launch of our late-stage product candidates; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the regulatory approval process; the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements; and possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations. Concentrations of Risk Financial instruments that potentially subject us to concentrations of credit risk consist of cash, cash equivalents, investments and derivative contracts. 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 investments to the extent recorded on the balance sheet. We manage our foreign currency transaction risk and interest rate risk within specified guidelines through the use of derivatives. All of our derivative instruments are utilized for risk management purposes, and we do not use derivatives for speculative trading purposes. As of June 30, 2019 , we had foreign exchange forward contracts with notional amounts totaling $288.9 million . As of June 30, 2019 , the outstanding foreign exchange forward contracts had a net asset fair value of $1.6 million . As of June 30, 2019 , we had interest rate swap contracts with notional amounts totaling $300.0 million . These outstanding interest rate swap contracts had a net liability fair value of $1.4 million as of June 30, 2019 . The counterparties to these contracts are large multinational commercial banks, and we believe the risk of nonperformance is not significant. 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 U.S., 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 as of June 30, 2019 and December 31, 2018 , allowances on receivables were not material. As of June 30, 2019 , two customers accounted for 88% of gross accounts receivable, Express Scripts Specialty Distribution Services, Inc. and its affiliates, or Express Scripts, the central pharmacy for Xyrem, which accounted for 78% of gross accounts receivable, and McKesson Corporation and affiliates, or McKesson, which accounted for 10% of gross accounts receivable. As of December 31, 2018 , two customers accounted for 89% of gross accounts receivable, Express Scripts, which accounted for 74% of gross accounts receivable, and McKesson, which accounted for 15% of gross accounts receivable. We depend on single source suppliers for most of our products, product candidates and their APIs. With respect to Xyrem, the API is manufactured for us by a single source supplier and the finished product is manufactured both by us in our facility in Athlone, Ireland and by our U.S.-based Xyrem supplier. Recent Accounting Pronouncements In August 2018, the FASB issued ASU No. 2018-15, “Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract”, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The standard is effective for us beginning January 1, 2020 and early adoption is permitted. The new guidance is not expected to have a material impact on our results of operations and financial position. |
Collaboration and License Agree
Collaboration and License Agreement | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration and License Agreement | Collaboration and License Agreement On January 2, 2019, we entered into a strategic collaboration agreement with Codiak BioSciences, Inc., or Codiak, focused on the research, development and commercialization of exosome therapeutics to treat cancer. Codiak granted us an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize therapeutic candidates directed at five targets to be developed using Codiak's engEx™ precision engineering platform for exosome therapeutics. Under the terms of the agreement, Codiak is responsible for the execution of preclinical and early clinical development of therapeutic candidates directed at all five targets through Phase 1/2 proof of concept studies. Following the conclusion of the applicable Phase 1/2 study, we will be responsible for future development, potential regulatory submissions and commercialization for each product. Codiak has the option to participate in co-commercialization and cost/profit-sharing in the U.S. and Canada on up to two products. As part of the agreement, we paid Codiak an upfront payment of $56.0 million in January 2019, which was recorded as acquired IPR&D expense in our condensed consolidated statements of income for the six months ended June 30, 2019 . Codiak is eligible to receive up to $20 million in preclinical development milestone payments across all five programs. Codiak is also eligible to receive milestone payments totaling up to $200 million per target based on investigational new drug application acceptance, clinical and regulatory milestones, including approvals in the U.S., the European Union and Japan, and certain sales milestones. Codiak is also eligible to receive tiered royalties on net sales of each approved product. |
Cash and Available-for-Sale Sec
Cash and Available-for-Sale Securities | 6 Months Ended |
Jun. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash and Available-for-Sale Securities | Cash and Available-for-Sale Securities Cash, cash equivalents and investments consisted of the following (in thousands): June 30, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Investments Cash $ 261,194 $ — $ — $ 261,194 $ 261,194 $ — Time deposits 370,000 — — 370,000 125,000 245,000 Money market funds 251,545 — — 251,545 251,545 — Totals $ 882,739 $ — $ — $ 882,739 $ 637,739 $ 245,000 December 31, 2018 Amortized Gross Gross Estimated Cash and Investments Cash $ 215,606 $ — $ — $ 215,606 $ 215,606 $ — Time deposits 515,000 — — 515,000 — 515,000 Money market funds 94,016 — — 94,016 94,016 — Totals $ 824,622 $ — $ — $ 824,622 $ 309,622 $ 515,000 Cash equivalents and investments 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 condensed consolidated statements of income. Our investment balances represent time deposits with original maturities of greater than three months and less than one year. |
Fair Value Measurement
Fair Value Measurement | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Fair Value Measurement The following table summarizes, by major security type, our available-for-sale securities and derivative contracts as of June 30, 2019 and December 31, 2018 that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands): June 30, 2019 December 31, 2018 Quoted Significant Total Quoted Significant Total Assets: Available-for-sale securities: Time deposits $ — $ 370,000 $ 370,000 $ — $ 515,000 $ 515,000 Money market funds 251,545 — 251,545 94,016 — 94,016 Interest rate contracts — 13 13 — 4,070 4,070 Foreign exchange forward contracts — 1,732 1,732 — 1,194 1,194 Totals $ 251,545 $ 371,745 $ 623,290 $ 94,016 $ 520,264 $ 614,280 Liabilities: Interest rate contracts $ — $ 1,445 $ 1,445 $ — $ — $ — Foreign exchange forward contracts — 142 142 — 1,460 1,460 Totals $ — $ 1,587 $ 1,587 $ — $ 1,460 $ 1,460 As of June 30, 2019 , our available-for-sale securities included time deposits and money market funds, and their carrying values were approximately equal to their fair values. Time deposits were measured at fair value using Level 2 inputs and money market funds were measured using quoted prices in active markets, which represent Level 1 inputs. 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. Our derivative assets and liabilities include interest rate and foreign exchange derivatives that are measured at fair value using observable market inputs such as forward rates, interest rates and our own credit risk, as well as an evaluation of our counterparties’ credit risks. Based on these inputs, the derivative assets and liabilities are classified within Level 2 of the fair value hierarchy. There were no transfers between the different levels of the fair value hierarchy in 2019 or 2018 . As of June 30, 2019 , the carrying amount of investments measured using the measurement alternative for equity investments without a readily determinable fair value was $4.5 million . The carrying amount, which is recorded within other non-current assets, represents the purchase price paid in December 2018. As of June 30, 2019 , the estimated fair values of our 1.875% exchangeable senior notes due 2021, or the 2021 Notes, and our 1.50% exchangeable senior notes due 2024, or the 2024 Notes, were approximately $587 million and $567 million |
Derivative Instruments and Hedg
Derivative Instruments and Hedging Activities | 6 Months Ended |
Jun. 30, 2019 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Instruments and Hedging Activities | Derivative Instruments and Hedging Activities We are exposed to certain risks arising from operating internationally, including fluctuations in interest rates on our outstanding term loan borrowings and fluctuations in foreign exchange rates primarily related to the translation of euro-denominated net monetary liabilities, including intercompany balances, held by subsidiaries with a U.S. dollar functional currency. We manage these exposures within specified guidelines through the use of derivatives. All of our derivative instruments are utilized for risk management purposes, and we do not use derivatives for speculative trading purposes. To achieve a desired mix of floating and fixed interest rates on our variable rate debt, we entered into interest rate swap agreements in March 2017 which are effective until July 2021. These agreements hedge contractual term loan interest rates. As of June 30, 2019 and December 31, 2018 , the interest rate swap agreements had a notional amount of $300.0 million . As a result of these agreements, the interest rate on a portion of our term loan borrowings was fixed at 1.895% , plus the borrowing spread, until July 12, 2021 . The effective portion of changes in the fair value of derivatives designated as and that qualify as cash flow hedges is recorded in accumulated other comprehensive loss and is subsequently reclassified into earnings in the period that the hedged forecasted transaction affects earnings. The impact on accumulated other comprehensive loss and earnings from derivative instruments that qualified as cash flow hedges for the three and six months ended June 30, 2019 and 2018 was as follows (in thousands): Three Months Ended Six Months Ended Interest Rate Contracts: 2019 2018 2019 2018 Gain (loss) recognized in accumulated other comprehensive loss, net of tax $ (2,698 ) $ 1,372 $ (4,039 ) $ 4,409 Loss (gain) reclassified from accumulated other comprehensive loss to interest expense, net of tax (383 ) (18 ) (783 ) 149 A ssuming no change in LIBOR-based interest rates from market rates as of June 30, 2019 , $0.1 million of losses, net of tax, recognized in accumulated other comprehensive loss will be reclassified to earnings over the next 12 months. We enter into foreign exchange forward contracts, with durations of up to 12 months , designed to limit the exposure to fluctuations in foreign exchange rates related to the translation of certain non-U.S. dollar denominated liabilities, including intercompany balances. Hedge accounting is not applied to these derivative instruments as gains and losses on these hedge transactions are designed to offset gains and losses on underlying balance sheet exposures. As of June 30, 2019 and December 31, 2018 , the notional amount of foreign exchange contracts where hedge accounting is not applied was $288.9 million and $271.5 million , respectively. The foreign exchange loss in our condensed consolidated statements of income included the following gains and losses associated with foreign exchange contracts not designated as hedging instruments (in thousands): Three Months Ended Six Months Ended Foreign Exchange Forward Contracts: 2019 2018 2019 2018 Gain (loss) recognized in foreign exchange loss $ 121 $ (12,238 ) $ (3,288 ) $ (8,487 ) The cash flow effects of our derivative contracts for the six months ended June 30, 2019 and 2018 are included within net cash provided by operating activities in the condensed consolidated statements of cash flows. The following tables summarize the fair value of outstanding derivatives (in thousands): June 30, 2019 Asset Derivatives Liability Derivatives Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Interest rate contracts Other current assets $ 13 Accrued liabilities $ 128 Other non-current liabilities 1,317 Derivatives not designated as hedging instruments: Foreign exchange forward contracts Other current assets 1,732 Accrued liabilities 142 Total fair value of derivative instruments $ 1,745 $ 1,587 December 31, 2018 Asset Derivatives Liability Derivatives Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Interest rate contracts Other current assets $ 1,929 Accrued liabilities $ — Other non-current assets 2,141 Derivatives not designated as hedging instruments: Foreign exchange forward contracts Other current assets 1,194 Accrued liabilities 1,460 Total fair value of derivative instruments $ 5,264 $ 1,460 Although we do not offset derivative assets and liabilities within our condensed consolidated balance sheets, our International Swap and Derivatives Association agreements provide for net settlement of transactions that are due to or from the same counterparty upon early termination of the agreement due to an event of default or other termination event. The following tables summarize the potential effect on our condensed consolidated balance sheets of offsetting our interest rate contracts and foreign exchange forward contracts subject to such provisions (in thousands): June 30, 2019 Gross Amounts of Recognized Assets/ Liabilities Gross Amounts Offset in the Consolidated Balance Sheet Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet Gross Amounts Not Offset in the Consolidated Balance Sheet Description Derivative Financial Instruments Cash Collateral Received (Pledged) Net Amount Derivative assets $ 1,745 $ — $ 1,745 $ (512 ) $ — $ 1,233 Derivative liabilities (1,587 ) — (1,587 ) 512 — (1,075 ) December 31, 2018 Gross Amounts of Recognized Assets/ Liabilities Gross Amounts Offset in the Consolidated Balance Sheet Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet Gross Amounts Not Offset in the Consolidated Balance Sheet Description Derivative Financial Instruments Cash Collateral Received (Pledged) Net Amount Derivative assets $ 5,264 $ — $ 5,264 $ (935 ) $ — $ 4,329 Derivative liabilities (1,460 ) — (1,460 ) 935 — (525 ) |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consisted of the following (in thousands): June 30, December 31, Raw materials $ 14,893 $ 10,895 Work in process 29,185 20,743 Finished goods 24,921 21,318 Total inventories $ 68,999 $ 52,956 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 6 Months Ended |
Jun. 30, 2019 | |
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, 2018 $ 927,630 Foreign exchange (2,640 ) Balance at June 30, 2019 $ 924,990 The gross carrying amounts and net book values of our intangible assets were as follows (in thousands): June 30, 2019 December 31, 2018 Remaining Gross Accumulated Net Book Gross Accumulated Net Book Acquired developed technologies 13.6 $ 3,184,381 $ (748,678 ) $ 2,435,703 $ 3,110,641 $ (632,413 ) $ 2,478,228 Priority review voucher 111,101 — 111,101 111,101 — 111,101 Manufacturing contracts — 12,181 (12,181 ) — 12,256 (12,256 ) — Trademarks — 2,894 (2,894 ) — 2,896 (2,896 ) — Total finite-lived intangible assets 3,310,557 (763,753 ) 2,546,804 3,236,894 (647,565 ) 2,589,329 Acquired IPR&D assets 141,137 — 141,137 142,005 — 142,005 Total intangible assets $ 3,451,694 $ (763,753 ) $ 2,687,941 $ 3,378,899 $ (647,565 ) $ 2,731,334 The increase in the gross carrying amount of intangible assets as of June 30, 2019 compared to December 31, 2018 reflects the capitalization of milestone payments triggered by FDA approval of Sunosi in March 2019 and subsequent U.S. Drug Enforcement Agency scheduling in June 2019, partially offset by the negative impact of foreign currency translation adjustments due to the weakening of the euro against the U.S. dollar. 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. We reduced the estimated remaining useful life of the Erwinaze intangible asset due to the receipt of a contract termination notice from Porton Biopharma Limited in February 2019. The reduction in the estimated remaining useful life increased intangible asset amortization expense by $15.0 million and $25.2 million , reduced net income by $10.2 million and $17.1 million , and reduced basic and diluted net income per ordinary share by $0.18 and $0.30 during the three and six months ended June 30, 2019 , respectively. Based on acquired developed technology intangible assets recorded as of June 30, 2019 , 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 2019 (remainder) $ 126,961 2020 252,774 2021 205,135 2022 159,563 2023 159,563 Thereafter 1,531,707 Total $ 2,435,703 |
Certain Balance Sheet Items
Certain Balance Sheet Items | 6 Months Ended |
Jun. 30, 2019 | |
Certain Balance Sheet Items [Abstract] | |
Certain Balance Sheet Items | Certain Balance Sheet Items Property, plant and equipment consisted of the following (in thousands): June 30, December 31, Land and buildings $ 46,636 $ 46,650 Construction-in-progress 33,483 51,243 Leasehold improvements 32,572 33,273 Manufacturing equipment and machinery 26,859 25,837 Computer software 18,193 19,062 Computer equipment 14,341 13,679 Furniture and fixtures 7,759 8,155 Build-to-suit facility — 52,067 Subtotal 179,843 249,966 Less accumulated depreciation and amortization (52,660 ) (49,608 ) Property, plant and equipment, net $ 127,183 $ 200,358 The decrease in the carrying amount of construction-in-progress and build-to-suit facility assets as of June 30, 2019 compared to December 31, 2018 reflects the de-recognition of assets related to build-to-suit facility leases on adoption of ASU No. 2016-02. Accrued liabilities consisted of the following (in thousands): June 30, December 31, Rebates and other sales deductions $ 79,134 $ 86,495 Employee compensation and benefits 49,050 58,543 Clinical trial accruals 9,780 5,904 Current portion of operating lease liabilities 8,722 — Accrued interest 7,531 7,407 Accrued construction-in-progress 7,669 1,065 Inventory-related accruals 7,130 8,753 Selling and marketing accruals 6,275 6,780 Royalties 5,101 2,679 Professional fees 4,083 2,333 Sales returns reserve 2,395 2,510 Derivative instrument liabilities 270 1,460 Accrued loss contingency — 58,154 Other 31,611 22,804 Total accrued liabilities $ 218,751 $ 264,887 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following table summarizes the carrying amount of our indebtedness (in thousands): June 30, December 31, 2021 Notes $ 575,000 $ 575,000 Unamortized discount and debt issuance costs on 2021 Notes (50,194 ) (60,910 ) 2021 Notes, net 524,806 514,090 2024 Notes 575,000 575,000 Unamortized discount and debt issuance costs on 2024 Notes (128,683 ) (138,914 ) 2024 Notes, net 446,317 436,086 Term loan 630,106 646,236 Total debt 1,601,229 1,596,412 Less current portion 33,387 33,387 Total long-term debt $ 1,567,842 $ 1,563,025 Exchangeable Senior Notes The Exchangeable Senior Notes were issued by Jazz Investments I Limited, or the Issuer, a 100% -owned finance subsidiary of Jazz Pharmaceuticals plc. The Exchangeable Senior Notes are senior unsecured obligations of the Issuer and are fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals plc. No subsidiary of Jazz Pharmaceuticals plc guaranteed the Exchangeable Senior 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. As of June 30, 2019 , the carrying values of the equity component of the 2021 Notes and the 2024 Notes, net of equity issuance costs, were $126.9 million and $149.8 million , respectively. Maturities Scheduled maturities with respect to our long-term debt principal balances outstanding as of June 30, 2019 were as follows (in thousands): Year Ending December 31, Scheduled Long-Term Debt Maturities 2019 (remainder) $ 16,693 2020 33,387 2021 608,387 2022 33,387 2023 517,493 Thereafter 575,000 Total $ 1,784,347 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Leases | Leases The components of the lease expense for the three and six months ended June 30, 2019 were as follows (in thousands): Lease Cost Three Months Ended Six Months Ended Operating lease cost $ 6,056 $ 11,926 Short-term lease cost 619 1,220 Variable lease cost 1 4 Sublease income (158 ) (320 ) Net lease cost $ 6,518 $ 12,830 Supplemental balance sheet information related to operating leases was as follows (in thousands): Leases Classification June 30, Assets Operating lease assets Operating lease assets $ 144,746 Liabilities Current Operating lease liabilities Accrued liabilities 8,722 Non-current Operating lease liabilities Operating lease liabilities, less current portion 156,289 Total operating lease liabilities $ 165,011 Lease Term and Discount Rate June 30, Weighted-average remaining lease term - operating leases (years) 10.1 Weighted-average discount rate - operating leases 5.3 % Supplemental cash flow information related to operating leases was as follows (in thousands): Six Months Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows from operating leases $ 8,240 Non-cash operating activities: Right-of-use assets obtained in exchange for new operating lease liabilities (1) 152,142 _____________________________ (1) Includes the balances recognized on January 1, 2019 on adoption of ASU No. 2016-02. Maturities of operating lease liabilities were as follows (in thousands): Year Ending December 31, Operating leases 2019 (remainder) $ 6,716 2020 21,050 2021 20,923 2022 20,889 2023 21,066 Thereafter 128,223 Total lease payments $ 218,867 Less imputed interest (53,856 ) Present value of lease liabilities $ 165,011 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
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 executive officers, directors and certain other employees for losses and costs incurred in connection with certain events or occurrences, including advancing money to cover certain costs, subject to certain limitations. The maximum potential amount of future payments we could be required to make under the indemnification obligations is unlimited; however, we maintain insurance policies that may limit our exposure and may enable us to recover a portion of any future amounts paid. Assuming the applicability of coverage, the willingness of the insurer to assume coverage, and subject to certain retention, loss limits and other policy provisions, we believe the fair value of these indemnification obligations is not significant. Accordingly, we did not recognize any liabilities relating to these obligations as of June 30, 2019 and December 31, 2018 . 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 Operating Leases. 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. Refer to Note 10 for details of the maturity of our operating lease liabilities. Other Commitments. As of June 30, 2019 , we had $69.6 million of noncancelable purchase commitments due within one year, primarily related to agreements with third party manufacturers. Legal Proceedings From time to time we are involved in legal proceedings arising in the ordinary course of business. We believe there is no litigation pending that could have, individually or in the aggregate, a material adverse effect on our results of operations or financial condition. Other Contingencies In May and October 2016 and in February 2017, we received subpoenas from the U.S. Attorney’s Office for the District of Massachusetts requesting documents related to our support of charitable organizations that provide financial assistance to Medicare patients. In April 2018, we reached an agreement in principle with the U.S. Department of Justice, or DOJ, on terms for a civil settlement of potential claims by the DOJ in the amount of $57.0 million plus interest to accrue at the statutory rate of 2.75% , subject to negotiation of a definitive settlement agreement and other contingencies. On April 4, 2019, we finalized the settlement agreement with the DOJ and the Office of Inspector General of the U.S. Department of Health and Human Services, and we entered into a corporate integrity agreement requiring us to maintain our ongoing corporate compliance program and obligating us to implement or continue, as applicable, a set of defined corporate integrity activities for a period of five years from the effective date of the corporate integrity agreement. During 2018, we recorded $58.2 million related to this matter, including related interest, within selling, general and administrative expenses on our consolidated statement of income. During the six months ended June 30, 2019 , we recorded an additional $0.4 million of interest related to this matter. The settlement amount was paid in April 2019. Under the settlement agreement, we are released from any civil or administrative monetary claim arising from allegations relating to our conduct between 2011 and May 2014 in supporting a charitable foundation that provided financial assistance to Medicare patients. The settlement agreement is not an admission of any wrongdoing or liability by us but a settlement of claims. In the event of a breach of the corporate integrity agreement, we could become liable for payment of certain stipulated penalties or could be excluded from participation in federal health programs. |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' Equity | Shareholders’ Equity Share Repurchase Program In November 2016, our board of directors authorized a 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. In November and December 2018, our board of directors increased the existing share repurchase program authorization by $320.0 million and $400.0 million , respectively, thereby increasing the total amount authorized to $1.02 billion . Under this 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 depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under the amended 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 the six months ended June 30, 2019 , we spent a total of $171.1 million to purchase 1.3 million of our ordinary shares under the share repurchase program at an average total purchase price, including commissions, of $131.17 per share. All ordinary shares repurchased were canceled. As of June 30, 2019 , the remaining amount authorized under the share repurchase program was $208.0 million . Accumulated Other Comprehensive Loss The components of accumulated other comprehensive loss as of June 30, 2019 and December 31, 2018 were as follows (in thousands): Net Unrealized Foreign Total Balance at December 31, 2018 $ 3,557 $ (201,348 ) $ (197,791 ) Other comprehensive loss before reclassifications (4,039 ) (7,823 ) (11,862 ) Amounts reclassified from accumulated other comprehensive loss (783 ) — (783 ) Other comprehensive loss, net (4,822 ) (7,823 ) (12,645 ) Balance at June 30, 2019 $ (1,265 ) $ (209,171 ) $ (210,436 ) During the six months ended June 30, 2019 , other comprehensive loss reflects foreign currency translation adjustments, primarily due to the weakening of the euro against the U.S. dollar, and the net unrealized loss on derivatives that qualify as cash flow hedges. |
Net Income per Ordinary Share
Net Income per Ordinary Share | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Income per Ordinary Share | Net Income per Ordinary Share Basic net income per ordinary share is based on the weighted-average number of ordinary shares outstanding. Diluted net income per ordinary share is based on the weighted-average number of ordinary shares outstanding and potentially dilutive ordinary shares outstanding. Basic and diluted net income per ordinary share were computed as follows (in thousands, except per share amounts): Three Months Ended Six Months Ended 2019 2018 2019 2018 Numerator: Net income $ 261,898 $ 92,321 $ 347,099 $ 138,312 Denominator: Weighted-average ordinary shares used in per share calculations - basic 56,707 60,177 56,955 60,053 Dilutive effect of employee equity incentive and purchase plans 720 1,261 798 1,256 Weighted-average ordinary shares used in per share calculations - diluted 57,427 61,438 57,753 61,309 Net income per ordinary share: Basic $ 4.62 $ 1.53 $ 6.09 $ 2.30 Diluted $ 4.56 $ 1.50 $ 6.01 $ 2.26 Potentially dilutive ordinary shares from our employee equity incentive and purchase plans and the Exchangeable Senior Notes are determined by applying the treasury stock method to the assumed exercise of share options, the assumed vesting of outstanding restricted stock units, or RSUs, the assumed issuance of ordinary shares under our employee stock purchase plan, or ESPP, and the assumed issuance of ordinary shares upon exchange of the Exchangeable Senior Notes. The potential issue of ordinary shares issuable upon exchange of the Exchangeable Senior Notes had no effect on diluted net income per ordinary share because the average price of our ordinary shares for the three and six months ended June 30, 2019 and 2018 did not exceed the effective exchange prices per ordinary share of the Exchangeable Senior Notes. The following table represents the weighted-average ordinary shares that were excluded from the calculation of diluted net income per ordinary share for the periods presented because including them would have an anti-dilutive effect (in thousands): Three Months Ended Six Months Ended 2019 2018 2019 2018 Exchangeable Senior Notes 5,504 5,504 5,504 5,504 Options, RSUs and ESPP 5,202 3,374 5,095 3,340 |
Revenues
Revenues | 6 Months Ended |
Jun. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | Revenues The following table presents a summary of total revenues (in thousands): Three Months Ended Six Months Ended 2019 2018 2019 2018 Xyrem $ 413,212 $ 356,008 $ 781,529 $ 672,785 Erwinaze/Erwinase 27,622 58,713 88,521 109,340 Defitelio/defibrotide 46,055 40,498 87,555 75,559 Vyxeos 31,362 27,951 60,305 54,179 Other 5,172 12,925 8,844 25,079 Product sales, net 523,423 496,095 1,026,754 936,942 Royalties and contract revenues 10,710 4,384 15,565 8,150 Total revenues $ 534,133 $ 500,479 $ 1,042,319 $ 945,092 The following table presents a summary of total revenues attributed to geographic sources (in thousands): Three Months Ended Six Months Ended 2019 2018 2019 2018 United States $ 480,932 $ 455,359 $ 943,794 $ 861,046 Europe 36,518 35,018 71,919 63,349 All other 16,683 10,102 26,606 20,697 Total revenues $ 534,133 $ 500,479 $ 1,042,319 $ 945,092 The following table presents a summary of the percentage of total revenues from customers that represented more than 10% of our total revenues: Three Months Ended Six Months Ended 2019 2018 2019 2018 Express Scripts 77 % 71 % 75 % 71 % McKesson 12 % 20 % 15 % 20 % Financing and payment Our payment terms vary by the type and location of our customer but payment is generally required in a term ranging from 30 to 45 days. Contract Liabilities - Deferred Revenue The deferred revenue balance as of June 30, 2019 primarily related to deferred upfront fees received from Nippon Shinyaku Co., Ltd., or Nippon Shinyaku, in connection with two license, development and commercialization agreements granting Nippon Shinyaku exclusive rights to develop and commercialize each of Defitelio and Vyxeos in Japan. We recognized contract revenues of $1.2 million and $3.1 million during the three and six months ended June 30, 2019, respectively , relating to these upfront payments. The deferred revenue balances are being recognized over an average of four years representing the period over which we expect to perform our research and developments obligations under each agreement. The following table presents a reconciliation of our beginning and ending balances in contract liabilities from contracts with customers for the six months ended June 30, 2019 (in thousands): Contract Liabilities Balance as of December 31, 2018 $ 14,995 Amount recognized within royalties and contract revenues (3,054 ) Balance as of June 30, 2019 $ 11,941 |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation Share-based compensation expense related to share options, RSUs and grants under our ESPP was as follows (in thousands): Three Months Ended Six Months Ended 2019 2018 2019 2018 Selling, general and administrative $ 20,685 $ 19,800 $ 41,055 $ 38,034 Research and development 5,896 4,709 11,419 9,084 Cost of product sales 1,708 1,803 3,367 3,497 Total share-based compensation expense, pre-tax 28,289 26,312 55,841 50,615 Income tax benefit from share-based compensation expense (4,473 ) (4,846 ) (8,140 ) (8,514 ) Total share-based compensation expense, net of tax $ 23,816 $ 21,466 $ 47,701 $ 42,101 Share Options The table below shows the number of shares underlying options granted to purchase our ordinary shares, the weighted-average assumptions used in the Black-Scholes option pricing model and the resulting weighted-average grant date fair value of share options granted: Three Months Ended Six Months Ended 2019 2018 2019 2018 Shares underlying options granted (in thousands) 102 80 1,399 1,232 Grant date fair value $ 38.95 $ 49.28 $ 42.56 $ 46.28 Black-Scholes option pricing model assumption information: Volatility 31 % 34 % 32 % 35 % Expected term (years) 4.5 4.5 4.5 4.5 Range of risk-free rates 1.8-2.3% 2.5-2.7% 1.8-2.5% 2.2-2.7% Expected dividend yield — % — % — % — % Restricted Stock Units The table below shows the number of RSUs granted covering an equal number of our ordinary shares and the weighted-average grant date fair value of RSUs granted: Three Months Ended Six Months Ended 2019 2018 2019 2018 RSUs granted (in thousands) 42 32 561 493 Grant date fair value $ 132.73 $ 152.36 $ 138.87 $ 141.36 The fair value of RSUs is determined on the date of grant based on the market price of our ordinary shares on that date. The fair value of RSUs is expensed ratably over the vesting period, generally over four years . As of June 30, 2019 , compensation cost not yet recognized related to unvested share options and RSUs was $98.7 million and $124.0 million , respectively, which is expected to be recognized over a weighted-average period of 2.8 years. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Our income tax benefit was $78.7 million and $49.5 million in the three and six months ended June 30, 2019 , respectively, compared to an income tax provision of $36.5 million and $55.7 million for the same periods in 2018 . The effective tax rate was (42.7)% and (16.5)% in the three and six months ended June 30, 2019 , respectively, compared to 28.2% and 28.6% for the same periods in 2018 . The income tax benefit for the three and six months ended June 30, 2019 includes a discrete tax benefit of $112.3 million resulting from an intra-entity intellectual property asset transfer. The tax benefit, which represents a deferred future benefit, was recorded as a deferred tax asset. The decrease in the effective tax rates for the three and six months ended June 30, 2019 compared to the same periods in 2018 was primarily due to the impact of the intra-entity intellectual property asset transfer. Excluding this effect, the decrease in the effective tax rate for the three months ended June 30, 2019 compared to the same period in 2018 was primarily due to the impairment charge recognized on the Prialt assets held for sale in 2018, and the decrease in the effective tax rate for the six months ended June 30, 2019 compared to the same period in 2018 was primarily due to the impairment charge recognized on the Prialt assets held for sale and the impact of the loss contingency expense in 2018. The effective tax rates for the three and six months ended June 30, 2019 were lower than the Irish statutory rate of 12.5% primarily due to the impact of the intra-entity intellectual property asset transfer. We do not provide for Irish income taxes on undistributed earnings of our foreign operations that are intended to be indefinitely reinvested in our foreign subsidiaries. Our net deferred tax liability primarily arose due to the acquisition of Celator Pharmaceuticals, Inc. The balance is net of deferred tax assets which are comprised primarily of U.S. federal and state tax credits, U.S. federal and state and foreign net operating loss carryforwards and other temporary differences. We maintain a valuation allowance against certain foreign and U.S. federal and state deferred tax assets. Each reporting period, we evaluate the need for a valuation allowance on our deferred tax assets by jurisdiction and adjust our estimates as more information becomes available. We are required to recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. As a result, we have recorded an unrecognized tax benefit for certain tax benefits which we judge may not be sustained upon examination. Our most significant tax jurisdictions are Ireland and the U.S. (both at the federal level and in various state jurisdictions). In Ireland, we are no longer subject to income tax audits by taxing authorities for the years prior to 2013. The U.S. jurisdictions generally have statutes of limitations three to four years from the later of the return due date or the date when the return was filed. However, in the U.S. (at the federal level and in most states), carryforward tax attributes that were generated in 2014 and earlier may still be adjusted upon examination by the tax authorities. Certain of our subsidiaries are currently under examination by the French tax authorities for the years ended December 31, 2012, 2013, 2015, 2016 and 2017. These examinations may lead to ordinary course adjustments or proposed adjustments to our taxes. In December 2015, we received proposed tax assessment notices, and, in October 2018, we received revised tax assessment notices from the French tax authorities for 2012 and 2013, and in December 2018, we received a proposed tax assessment notice for 2015, relating to certain transfer pricing adjustments. The notices provide for additional French tax of approximately $43 million for 2012 and 2013 and approximately $4 million for 2015, including interest and penalties through the respective dates of the proposed assessments, translated at the foreign exchange rate at June 30, 2019 . We disagree with the assessments and are contesting them vigorously. |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies - (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These unaudited condensed consolidated financial statements have been prepared following the requirements of the U.S. Securities and Exchange Commission for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. generally accepted accounting principles, or U.S. GAAP, can be condensed or omitted. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our annual consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2018 . In the opinion of management, these condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair presentation of our financial position and operating results. The results for the three and six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 , for any other interim period or for any future period. Our significant accounting policies have not changed substantially from those previously described in our Annual Report on Form 10-K for the year ended December 31, 2018 with the exception of the accounting policy relating to operating leases and financing obligations which was updated as a result of adopting Accounting Standards Update No. 2016-02, “Leases”, or ASU No. 2016-02. These condensed consolidated financial statements include the accounts of Jazz Pharmaceuticals plc and our subsidiaries, and intercompany transactions and balances have been eliminated. 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 identification, development and commercialization of meaningful pharmaceutical products that address unmet medical needs. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. |
Leases | Leases We determine if an arrangement is a lease at inception. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on our condensed consolidated balance sheets. Operating lease assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. In determining the net present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date. The operating lease asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. We have lease agreements with lease and non-lease components, which are generally accounted for separately. For vehicle leases we account for the lease and non-lease components as a single lease component. We have elected the short-term lease exemption and, therefore, do not recognize a right-of-use asset or corresponding liability for lease arrangements with an original term of 12 months or less. |
Adoption of New Accounting Standards and Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2018, the FASB issued ASU No. 2018-15, “Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract”, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The standard is effective for us beginning January 1, 2020 and early adoption is permitted. The new guidance is not expected to have a material impact on our results of operations and financial position. In January 2017, the FASB issued ASU No. 2017-04, “Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment” which simplifies the accounting for goodwill impairment by eliminating Step 2 of the current goodwill impairment test. Goodwill impairment will now be the amount by which the reporting unit’s carrying value exceeds its fair value, limited to the carrying value of the goodwill. The standard is effective for us beginning January 1, 2020. Early adoption is permitted for any impairment tests performed after January 1, 2017. The new guidance is not expected to have a material impact on our results of operations and financial position. Adoption of New Accounting Standards In February 2016, the Financial Accounting Standards Board, or FASB, issued ASU No. 2016-02. Under the new guidance, lessees are required to recognize a right-of-use asset, which represents the lessee’s right to use, or control the use of, a specified asset for the lease term, and a corresponding lease liability, which represents the lessee’s obligation to make lease payments under a lease, measured on a discounted basis. We adopted ASU No. 2016-02 on a modified retrospective basis applied to leases existing as of, or entered into after, January 1, 2019. We elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification of those leases in place as of January 1, 2019. The adoption of ASU No. 2016-02 resulted in the recognition of right-of-use assets and lease liabilities of $149.4 million and $162.9 million , respectively, on the consolidated balance sheet as of January 1, 2019, and the de-recognition of the build-to-suit assets and related financing obligations on the consolidated balance sheet as of December 31, 2018 of $95.4 million and $109.8 million , respectively, with the balance impacting retained earnings, deferred rent and deferred tax liabilities. The right-of-use assets and lease liabilities primarily relate to real estate leases. Refer to Note 10 for lease-related disclosures. |
Significant Risks and Uncertainties | Significant Risks and Uncertainties Our financial results are significantly influenced by sales of Xyrem. Our ability to maintain or increase Xyrem product sales is subject to a number of risks and uncertainties, including, without limitation, the introduction of new products in the U.S. market that compete with, or otherwise disrupt the market for, Xyrem in the treatment of cataplexy and/or EDS in narcolepsy, including our recently-approved product, Sunosi; the introduction of a generic version of Xyrem in the U.S. market before the entry dates specified in our settlements with the abbreviated new drug application, or ANDA, filers or on terms that are different from those contemplated by the settlement agreements; increased pricing pressure from, changes in policies by, or restrictions on reimbursement imposed by, third party payors, including pressure to agree to discounts, rebates or other restrictive pricing terms for Xyrem; changes in healthcare laws and policy, including changes in requirements for patient assistance programs, rebates, reimbursement and coverage by federal healthcare programs, and changes resulting from increased scrutiny on pharmaceutical pricing and risk evaluation and mitigation strategy, or REMS, programs by government entities; changes to or uncertainties around our Xyrem REMS, or any failure to comply with our REMS obligations to the satisfaction of the FDA; challenges to our intellectual property around Xyrem, including the possibility of new ANDA or NDA filers or new post-grant patent review proceedings; operational disruptions at the Xyrem central pharmacy; any supply or manufacturing problems, including any problems with our sole source Xyrem active pharmaceutical ingredient, or API, provider; continued acceptance of Xyrem by physicians and patients, including as a result of negative publicity that surfaces from time to time; and changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem. In addition to risks related specifically to Xyrem, 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, including, without limitation, risks and uncertainties associated with: effectively commercializing our other products, including effectively launching and commercializing new products such as our recently-approved product Sunosi; competition; obtaining and maintaining adequate coverage and reimbursement for our products; increasing scrutiny of pharmaceutical product pricing and resulting changes in healthcare laws and policy; market acceptance; delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations; regulatory approval and successful launch of our late-stage product candidates; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the regulatory approval process; the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements; and possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations. |
Concentrations of Risk | Concentrations of Risk Financial instruments that potentially subject us to concentrations of credit risk consist of cash, cash equivalents, investments and derivative contracts. 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 investments to the extent recorded on the balance sheet. We manage our foreign currency transaction risk and interest rate risk within specified guidelines through the use of derivatives. All of our derivative instruments are utilized for risk management purposes, and we do not use derivatives for speculative trading purposes. As of June 30, 2019 , we had foreign exchange forward contracts with notional amounts totaling $288.9 million . As of June 30, 2019 , the outstanding foreign exchange forward contracts had a net asset fair value of $1.6 million . As of June 30, 2019 , we had interest rate swap contracts with notional amounts totaling $300.0 million . These outstanding interest rate swap contracts had a net liability fair value of $1.4 million as of June 30, 2019 . The counterparties to these contracts are large multinational commercial banks, and we believe the risk of nonperformance is not significant. 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 U.S., 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 as of June 30, 2019 and December 31, 2018 , allowances on receivables were not material. As of June 30, 2019 , two customers accounted for 88% of gross accounts receivable, Express Scripts Specialty Distribution Services, Inc. and its affiliates, or Express Scripts, the central pharmacy for Xyrem, which accounted for 78% of gross accounts receivable, and McKesson Corporation and affiliates, or McKesson, which accounted for 10% of gross accounts receivable. As of December 31, 2018 , two customers accounted for 89% of gross accounts receivable, Express Scripts, which accounted for 74% of gross accounts receivable, and McKesson, which accounted for 15% of gross accounts receivable. We depend on single source suppliers for most of our products, product candidates and their APIs. With respect to Xyrem, the API is manufactured for us by a single source supplier and the finished product is manufactured both by us in our facility in Athlone, Ireland and by our U.S.-based Xyrem supplier. |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | The cumulative effect of the changes made to our consolidated balance sheet as of January 1, 2019 for the adoption of the ASU No. 2016-02 was as follows (in thousands): Balance at December 31, Transition Adjustments Balance at January 1, Assets: Property, plant and equipment, net $ 200,358 $ (95,397 ) $ 104,961 Operating lease assets — 149,442 149,442 Liabilities: Accrued liabilities 264,887 8,165 273,052 Operating lease liabilities, less current portion — 153,158 153,158 Deferred tax liabilities, net 309,097 1,489 310,586 Other non-current liabilities 218,879 (113,615 ) 105,264 Shareholders' Equity: Retained earnings 841,050 4,848 845,898 |
Cash and Available-for-Sale S_2
Cash and Available-for-Sale Securities - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash and Cash Equivalents and Investments | Cash, cash equivalents and investments consisted of the following (in thousands): June 30, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Investments Cash $ 261,194 $ — $ — $ 261,194 $ 261,194 $ — Time deposits 370,000 — — 370,000 125,000 245,000 Money market funds 251,545 — — 251,545 251,545 — Totals $ 882,739 $ — $ — $ 882,739 $ 637,739 $ 245,000 December 31, 2018 Amortized Gross Gross Estimated Cash and Investments Cash $ 215,606 $ — $ — $ 215,606 $ 215,606 $ — Time deposits 515,000 — — 515,000 — 515,000 Money market funds 94,016 — — 94,016 94,016 — Totals $ 824,622 $ — $ — $ 824,622 $ 309,622 $ 515,000 |
Fair Value Measurement - (Table
Fair Value Measurement - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table summarizes, by major security type, our available-for-sale securities and derivative contracts as of June 30, 2019 and December 31, 2018 that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands): June 30, 2019 December 31, 2018 Quoted Significant Total Quoted Significant Total Assets: Available-for-sale securities: Time deposits $ — $ 370,000 $ 370,000 $ — $ 515,000 $ 515,000 Money market funds 251,545 — 251,545 94,016 — 94,016 Interest rate contracts — 13 13 — 4,070 4,070 Foreign exchange forward contracts — 1,732 1,732 — 1,194 1,194 Totals $ 251,545 $ 371,745 $ 623,290 $ 94,016 $ 520,264 $ 614,280 Liabilities: Interest rate contracts $ — $ 1,445 $ 1,445 $ — $ — $ — Foreign exchange forward contracts — 142 142 — 1,460 1,460 Totals $ — $ 1,587 $ 1,587 $ — $ 1,460 $ 1,460 |
Derivative Instruments and He_2
Derivative Instruments and Hedging Activities - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of gains (losses) on derivative instruments | The impact on accumulated other comprehensive loss and earnings from derivative instruments that qualified as cash flow hedges for the three and six months ended June 30, 2019 and 2018 was as follows (in thousands): Three Months Ended Six Months Ended Interest Rate Contracts: 2019 2018 2019 2018 Gain (loss) recognized in accumulated other comprehensive loss, net of tax $ (2,698 ) $ 1,372 $ (4,039 ) $ 4,409 Loss (gain) reclassified from accumulated other comprehensive loss to interest expense, net of tax (383 ) (18 ) (783 ) 149 |
Schedule of foreign exchange gain (loss) of outstanding derivatives | The foreign exchange loss in our condensed consolidated statements of income included the following gains and losses associated with foreign exchange contracts not designated as hedging instruments (in thousands): Three Months Ended Six Months Ended Foreign Exchange Forward Contracts: 2019 2018 2019 2018 Gain (loss) recognized in foreign exchange loss $ 121 $ (12,238 ) $ (3,288 ) $ (8,487 ) |
Schedule of the fair value of outstanding derivatives | The following tables summarize the fair value of outstanding derivatives (in thousands): June 30, 2019 Asset Derivatives Liability Derivatives Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Interest rate contracts Other current assets $ 13 Accrued liabilities $ 128 Other non-current liabilities 1,317 Derivatives not designated as hedging instruments: Foreign exchange forward contracts Other current assets 1,732 Accrued liabilities 142 Total fair value of derivative instruments $ 1,745 $ 1,587 December 31, 2018 Asset Derivatives Liability Derivatives Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Interest rate contracts Other current assets $ 1,929 Accrued liabilities $ — Other non-current assets 2,141 Derivatives not designated as hedging instruments: Foreign exchange forward contracts Other current assets 1,194 Accrued liabilities 1,460 Total fair value of derivative instruments $ 5,264 $ 1,460 |
Schedule of offsetting assets | The following tables summarize the potential effect on our condensed consolidated balance sheets of offsetting our interest rate contracts and foreign exchange forward contracts subject to such provisions (in thousands): June 30, 2019 Gross Amounts of Recognized Assets/ Liabilities Gross Amounts Offset in the Consolidated Balance Sheet Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet Gross Amounts Not Offset in the Consolidated Balance Sheet Description Derivative Financial Instruments Cash Collateral Received (Pledged) Net Amount Derivative assets $ 1,745 $ — $ 1,745 $ (512 ) $ — $ 1,233 Derivative liabilities (1,587 ) — (1,587 ) 512 — (1,075 ) December 31, 2018 Gross Amounts of Recognized Assets/ Liabilities Gross Amounts Offset in the Consolidated Balance Sheet Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet Gross Amounts Not Offset in the Consolidated Balance Sheet Description Derivative Financial Instruments Cash Collateral Received (Pledged) Net Amount Derivative assets $ 5,264 $ — $ 5,264 $ (935 ) $ — $ 4,329 Derivative liabilities (1,460 ) — (1,460 ) 935 — (525 ) |
Schedule of offsetting liabilities | The following tables summarize the potential effect on our condensed consolidated balance sheets of offsetting our interest rate contracts and foreign exchange forward contracts subject to such provisions (in thousands): June 30, 2019 Gross Amounts of Recognized Assets/ Liabilities Gross Amounts Offset in the Consolidated Balance Sheet Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet Gross Amounts Not Offset in the Consolidated Balance Sheet Description Derivative Financial Instruments Cash Collateral Received (Pledged) Net Amount Derivative assets $ 1,745 $ — $ 1,745 $ (512 ) $ — $ 1,233 Derivative liabilities (1,587 ) — (1,587 ) 512 — (1,075 ) December 31, 2018 Gross Amounts of Recognized Assets/ Liabilities Gross Amounts Offset in the Consolidated Balance Sheet Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet Gross Amounts Not Offset in the Consolidated Balance Sheet Description Derivative Financial Instruments Cash Collateral Received (Pledged) Net Amount Derivative assets $ 5,264 $ — $ 5,264 $ (935 ) $ — $ 4,329 Derivative liabilities (1,460 ) — (1,460 ) 935 — (525 ) |
Inventories - (Tables)
Inventories - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Components of Inventories | Inventories consisted of the following (in thousands): June 30, December 31, Raw materials $ 14,893 $ 10,895 Work in process 29,185 20,743 Finished goods 24,921 21,318 Total inventories $ 68,999 $ 52,956 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Gross Carrying Amount of Goodwill | The gross carrying amount of goodwill was as follows (in thousands): Balance at December 31, 2018 $ 927,630 Foreign exchange (2,640 ) Balance at June 30, 2019 $ 924,990 |
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): June 30, 2019 December 31, 2018 Remaining Gross Accumulated Net Book Gross Accumulated Net Book Acquired developed technologies 13.6 $ 3,184,381 $ (748,678 ) $ 2,435,703 $ 3,110,641 $ (632,413 ) $ 2,478,228 Priority review voucher 111,101 — 111,101 111,101 — 111,101 Manufacturing contracts — 12,181 (12,181 ) — 12,256 (12,256 ) — Trademarks — 2,894 (2,894 ) — 2,896 (2,896 ) — Total finite-lived intangible assets 3,310,557 (763,753 ) 2,546,804 3,236,894 (647,565 ) 2,589,329 Acquired IPR&D assets 141,137 — 141,137 142,005 — 142,005 Total intangible assets $ 3,451,694 $ (763,753 ) $ 2,687,941 $ 3,378,899 $ (647,565 ) $ 2,731,334 |
Estimated Future Amortization Costs | Based on acquired developed technology intangible assets recorded as of June 30, 2019 , 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 2019 (remainder) $ 126,961 2020 252,774 2021 205,135 2022 159,563 2023 159,563 Thereafter 1,531,707 Total $ 2,435,703 |
Certain Balance Sheet Items - (
Certain Balance Sheet Items - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Certain Balance Sheet Items [Abstract] | |
Property and Equipment | Property, plant and equipment consisted of the following (in thousands): June 30, December 31, Land and buildings $ 46,636 $ 46,650 Construction-in-progress 33,483 51,243 Leasehold improvements 32,572 33,273 Manufacturing equipment and machinery 26,859 25,837 Computer software 18,193 19,062 Computer equipment 14,341 13,679 Furniture and fixtures 7,759 8,155 Build-to-suit facility — 52,067 Subtotal 179,843 249,966 Less accumulated depreciation and amortization (52,660 ) (49,608 ) Property, plant and equipment, net $ 127,183 $ 200,358 |
Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): June 30, December 31, Rebates and other sales deductions $ 79,134 $ 86,495 Employee compensation and benefits 49,050 58,543 Clinical trial accruals 9,780 5,904 Current portion of operating lease liabilities 8,722 — Accrued interest 7,531 7,407 Accrued construction-in-progress 7,669 1,065 Inventory-related accruals 7,130 8,753 Selling and marketing accruals 6,275 6,780 Royalties 5,101 2,679 Professional fees 4,083 2,333 Sales returns reserve 2,395 2,510 Derivative instrument liabilities 270 1,460 Accrued loss contingency — 58,154 Other 31,611 22,804 Total accrued liabilities $ 218,751 $ 264,887 |
Debt - (Tables)
Debt - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | The following table summarizes the carrying amount of our indebtedness (in thousands): June 30, December 31, 2021 Notes $ 575,000 $ 575,000 Unamortized discount and debt issuance costs on 2021 Notes (50,194 ) (60,910 ) 2021 Notes, net 524,806 514,090 2024 Notes 575,000 575,000 Unamortized discount and debt issuance costs on 2024 Notes (128,683 ) (138,914 ) 2024 Notes, net 446,317 436,086 Term loan 630,106 646,236 Total debt 1,601,229 1,596,412 Less current portion 33,387 33,387 Total long-term debt $ 1,567,842 $ 1,563,025 |
Schedule of Maturities of Long-term Debt | Scheduled maturities with respect to our long-term debt principal balances outstanding as of June 30, 2019 were as follows (in thousands): Year Ending December 31, Scheduled Long-Term Debt Maturities 2019 (remainder) $ 16,693 2020 33,387 2021 608,387 2022 33,387 2023 517,493 Thereafter 575,000 Total $ 1,784,347 |
Leases - (Tables)
Leases - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Schedule of Lease Cost and Supplemental Cash Flow Information | The components of the lease expense for the three and six months ended June 30, 2019 were as follows (in thousands): Lease Cost Three Months Ended Six Months Ended Operating lease cost $ 6,056 $ 11,926 Short-term lease cost 619 1,220 Variable lease cost 1 4 Sublease income (158 ) (320 ) Net lease cost $ 6,518 $ 12,830 Lease Term and Discount Rate June 30, Weighted-average remaining lease term - operating leases (years) 10.1 Weighted-average discount rate - operating leases 5.3 % Supplemental cash flow information related to operating leases was as follows (in thousands): Six Months Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows from operating leases $ 8,240 Non-cash operating activities: Right-of-use assets obtained in exchange for new operating lease liabilities (1) 152,142 _____________________________ (1) Includes the balances recognized on January 1, 2019 on adoption of ASU No. 2016-02. |
Schedule of Lease Supplemental Balance Sheet Information | Supplemental balance sheet information related to operating leases was as follows (in thousands): Leases Classification June 30, Assets Operating lease assets Operating lease assets $ 144,746 Liabilities Current Operating lease liabilities Accrued liabilities 8,722 Non-current Operating lease liabilities Operating lease liabilities, less current portion 156,289 Total operating lease liabilities $ 165,011 |
Schedule of Operating Lease Liability Maturities | Maturities of operating lease liabilities were as follows (in thousands): Year Ending December 31, Operating leases 2019 (remainder) $ 6,716 2020 21,050 2021 20,923 2022 20,889 2023 21,066 Thereafter 128,223 Total lease payments $ 218,867 Less imputed interest (53,856 ) Present value of lease liabilities $ 165,011 |
Shareholders' Equity - (Tables)
Shareholders' Equity - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Components of Accumulated Other Comprehensive Loss | The components of accumulated other comprehensive loss as of June 30, 2019 and December 31, 2018 were as follows (in thousands): Net Unrealized Foreign Total Balance at December 31, 2018 $ 3,557 $ (201,348 ) $ (197,791 ) Other comprehensive loss before reclassifications (4,039 ) (7,823 ) (11,862 ) Amounts reclassified from accumulated other comprehensive loss (783 ) — (783 ) Other comprehensive loss, net (4,822 ) (7,823 ) (12,645 ) Balance at June 30, 2019 $ (1,265 ) $ (209,171 ) $ (210,436 ) |
Net Income per Ordinary Share -
Net Income per Ordinary Share - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Income per Ordinary Share Computation | Basic and diluted net income per ordinary share were computed as follows (in thousands, except per share amounts): Three Months Ended Six Months Ended 2019 2018 2019 2018 Numerator: Net income $ 261,898 $ 92,321 $ 347,099 $ 138,312 Denominator: Weighted-average ordinary shares used in per share calculations - basic 56,707 60,177 56,955 60,053 Dilutive effect of employee equity incentive and purchase plans 720 1,261 798 1,256 Weighted-average ordinary shares used in per share calculations - diluted 57,427 61,438 57,753 61,309 Net income per ordinary share: Basic $ 4.62 $ 1.53 $ 6.09 $ 2.30 Diluted $ 4.56 $ 1.50 $ 6.01 $ 2.26 |
Weighted-Average Ordinary Shares Excluded from Computation of Diluted Net Income per Share | The following table represents the weighted-average ordinary shares that were excluded from the calculation of diluted net income per ordinary share for the periods presented because including them would have an anti-dilutive effect (in thousands): Three Months Ended Six Months Ended 2019 2018 2019 2018 Exchangeable Senior Notes 5,504 5,504 5,504 5,504 Options, RSUs and ESPP 5,202 3,374 5,095 3,340 |
Revenues - (Tables)
Revenues - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Summary of disaggregation of revenue | The following table presents a summary of total revenues (in thousands): Three Months Ended Six Months Ended 2019 2018 2019 2018 Xyrem $ 413,212 $ 356,008 $ 781,529 $ 672,785 Erwinaze/Erwinase 27,622 58,713 88,521 109,340 Defitelio/defibrotide 46,055 40,498 87,555 75,559 Vyxeos 31,362 27,951 60,305 54,179 Other 5,172 12,925 8,844 25,079 Product sales, net 523,423 496,095 1,026,754 936,942 Royalties and contract revenues 10,710 4,384 15,565 8,150 Total revenues $ 534,133 $ 500,479 $ 1,042,319 $ 945,092 The following table presents a summary of total revenues attributed to geographic sources (in thousands): Three Months Ended Six Months Ended 2019 2018 2019 2018 United States $ 480,932 $ 455,359 $ 943,794 $ 861,046 Europe 36,518 35,018 71,919 63,349 All other 16,683 10,102 26,606 20,697 Total revenues $ 534,133 $ 500,479 $ 1,042,319 $ 945,092 |
Summary of Revenues from Customers Representing More Than 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: Three Months Ended Six Months Ended 2019 2018 2019 2018 Express Scripts 77 % 71 % 75 % 71 % McKesson 12 % 20 % 15 % 20 % |
Summary of a reconciliation in contract liabilities from contracts with customer | The following table presents a reconciliation of our beginning and ending balances in contract liabilities from contracts with customers for the six months ended June 30, 2019 (in thousands): Contract Liabilities Balance as of December 31, 2018 $ 14,995 Amount recognized within royalties and contract revenues (3,054 ) Balance as of June 30, 2019 $ 11,941 |
Share-Based Compensation - (Tab
Share-Based Compensation - (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
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): Three Months Ended Six Months Ended 2019 2018 2019 2018 Selling, general and administrative $ 20,685 $ 19,800 $ 41,055 $ 38,034 Research and development 5,896 4,709 11,419 9,084 Cost of product sales 1,708 1,803 3,367 3,497 Total share-based compensation expense, pre-tax 28,289 26,312 55,841 50,615 Income tax benefit from share-based compensation expense (4,473 ) (4,846 ) (8,140 ) (8,514 ) Total share-based compensation expense, net of tax $ 23,816 $ 21,466 $ 47,701 $ 42,101 |
Weighted-Average Assumptions Used in Black-Scholes Option Pricing Model which was Used to Estimate Grant Date Fair Value per Share | The table below shows the number of shares underlying options granted to purchase our ordinary shares, the weighted-average assumptions used in the Black-Scholes option pricing model and the resulting weighted-average grant date fair value of share options granted: Three Months Ended Six Months Ended 2019 2018 2019 2018 Shares underlying options granted (in thousands) 102 80 1,399 1,232 Grant date fair value $ 38.95 $ 49.28 $ 42.56 $ 46.28 Black-Scholes option pricing model assumption information: Volatility 31 % 34 % 32 % 35 % Expected term (years) 4.5 4.5 4.5 4.5 Range of risk-free rates 1.8-2.3% 2.5-2.7% 1.8-2.5% 2.2-2.7% Expected dividend yield — % — % — % — % |
Schedule of Restricted Stock Unit activity | The table below shows the number of RSUs granted covering an equal number of our ordinary shares and the weighted-average grant date fair value of RSUs granted: Three Months Ended Six Months Ended 2019 2018 2019 2018 RSUs granted (in thousands) 42 32 561 493 Grant date fair value $ 132.73 $ 152.36 $ 138.87 $ 141.36 |
The Company and Summary of Si_4
The Company and Summary of Significant Accounting Policies - Basis of Presentation Narrative (Details) | 6 Months Ended |
Jun. 30, 2019Segment | |
Accounting Policies [Abstract] | |
Number of operating business segment | 1 |
The Company and Summary of Si_5
The Company and Summary of Significant Accounting Policies - Adoption of New Accounting Standards Narrative (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease assets | $ 144,746 | $ 149,442 | $ 0 |
Operating lease, liability | 165,011 | ||
Adjustment to property and equipment due to adoption of new accounting guidance | (127,183) | (104,961) | (200,358) |
Other non-current liabilities | $ (120,713) | (105,264) | (218,879) |
ASU 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease assets | 149,442 | ||
Operating lease, liability | 162,900 | ||
Adjustment to property and equipment due to adoption of new accounting guidance | 95,397 | ||
Other non-current liabilities | $ 113,615 | 109,800 | |
Build-to-suit facility | ASU 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Adjustment to property and equipment due to adoption of new accounting guidance | $ 95,400 |
The Company and Summary of Si_6
The Company and Summary of Significant Accounting Policies - Cumulative Effect on the Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Assets: | |||
Property, plant and equipment, net | $ 127,183 | $ 104,961 | $ 200,358 |
Operating lease assets | 144,746 | 149,442 | 0 |
Liabilities: | |||
Accrued liabilities | 218,751 | 273,052 | 264,887 |
Operating lease liabilities, less current portion | 156,289 | 153,158 | 0 |
Deferred tax liabilities, net | 283,669 | 310,586 | 309,097 |
Other non-current liabilities | 120,713 | 105,264 | 218,879 |
Shareholders' Equity: | |||
Retained earnings | $ 1,021,879 | 845,898 | 841,050 |
ASU 2016-02 | |||
Assets: | |||
Property, plant and equipment, net | (95,397) | ||
Operating lease assets | 149,442 | ||
Liabilities: | |||
Accrued liabilities | 8,165 | ||
Operating lease liabilities, less current portion | 153,158 | ||
Deferred tax liabilities, net | 1,489 | ||
Other non-current liabilities | (113,615) | $ (109,800) | |
Shareholders' Equity: | |||
Retained earnings | $ 4,848 |
The Company and Summary of Si_7
The Company and Summary of Significant Accounting Policies - Concentrations of Risk Narrative (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Customer concentration risk | Gross accounts receivable | ||
Concentration Risk [Line Items] | ||
Percentage of gross accounts receivable (as a percent) | 88.00% | 89.00% |
Customer concentration risk | Gross accounts receivable | Express Scripts | ||
Concentration Risk [Line Items] | ||
Percentage of gross accounts receivable (as a percent) | 78.00% | 74.00% |
Customer concentration risk | Gross accounts receivable | McKesson | ||
Concentration Risk [Line Items] | ||
Percentage of gross accounts receivable (as a percent) | 10.00% | 15.00% |
Foreign exchange forward contracts | Derivatives not designated as hedging instruments | ||
Concentration Risk [Line Items] | ||
Notional amount | $ 288,900,000 | $ 271,500,000 |
Net fair value | 1,600,000 | |
Interest rate contracts | Derivatives designated as hedging instruments | ||
Concentration Risk [Line Items] | ||
Notional amount | 300,000,000 | $ 300,000,000 |
Net fair value | $ (1,400,000) |
Collaboration and License Agr_2
Collaboration and License Agreement - Narrative (Details) $ in Thousands | Jan. 02, 2019USD ($)targetproduct | Jan. 31, 2019USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront payment paid | $ 2,200 | $ 0 | $ 58,200 | $ 0 | ||
Codiak Biosciences Inc | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Number of targets/programs | target | 5 | |||||
Number of projects subject to right to co-commercialize | product | 2 | |||||
Upfront Payment | Codiak Biosciences Inc | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront payment paid | $ 56,000 | |||||
Preclinical Development Milestone Payment | Codiak Biosciences Inc | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone payments per target not yet due or paid | $ 20,000 | |||||
Milestone Payment | Codiak Biosciences Inc | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone payments per target not yet due or paid | $ 200,000 |
Cash and Available-for-Sale S_3
Cash and Available-for-Sale Securities - Summary of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 882,739 | $ 824,622 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 882,739 | 824,622 |
Cash and Cash Equivalents | 637,739 | 309,622 |
Investments | 245,000 | 515,000 |
Cash | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 261,194 | 215,606 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 261,194 | 215,606 |
Cash and Cash Equivalents | 261,194 | 215,606 |
Investments | 0 | 0 |
Time deposits | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 370,000 | 515,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 370,000 | 515,000 |
Cash and Cash Equivalents | 125,000 | 0 |
Investments | 245,000 | 515,000 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 251,545 | 94,016 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 251,545 | 94,016 |
Cash and Cash Equivalents | 251,545 | 94,016 |
Investments | $ 0 | $ 0 |
Fair Value Measurement - Assets
Fair Value Measurement - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Available-for-sale securities: | ||
Available-for-sale securities | $ 882,739 | $ 824,622 |
Time deposits | ||
Available-for-sale securities: | ||
Available-for-sale securities | 370,000 | 515,000 |
Money market funds | ||
Available-for-sale securities: | ||
Available-for-sale securities | 251,545 | 94,016 |
Recurring | ||
Available-for-sale securities: | ||
Totals | 623,290 | 614,280 |
Liabilities: | ||
Totals | 1,587 | 1,460 |
Recurring | Time deposits | ||
Available-for-sale securities: | ||
Available-for-sale securities | 370,000 | 515,000 |
Recurring | Money market funds | ||
Available-for-sale securities: | ||
Available-for-sale securities | 251,545 | 94,016 |
Recurring | Interest rate contracts | ||
Available-for-sale securities: | ||
Derivative asset | 13 | 4,070 |
Liabilities: | ||
Derivative liabilities | 1,445 | 0 |
Recurring | Foreign exchange forward contracts | ||
Available-for-sale securities: | ||
Derivative asset | 1,732 | 1,194 |
Liabilities: | ||
Derivative liabilities | 142 | 1,460 |
Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale securities: | ||
Totals | 251,545 | 94,016 |
Liabilities: | ||
Totals | 0 | 0 |
Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Time deposits | ||
Available-for-sale securities: | ||
Available-for-sale securities | 0 | 0 |
Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Available-for-sale securities: | ||
Available-for-sale securities | 251,545 | 94,016 |
Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Interest rate contracts | ||
Available-for-sale securities: | ||
Derivative asset | 0 | 0 |
Liabilities: | ||
Derivative liabilities | 0 | 0 |
Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Foreign exchange forward contracts | ||
Available-for-sale securities: | ||
Derivative asset | 0 | 0 |
Liabilities: | ||
Derivative liabilities | 0 | 0 |
Recurring | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale securities: | ||
Totals | 371,745 | 520,264 |
Liabilities: | ||
Totals | 1,587 | 1,460 |
Recurring | Significant Other Observable Inputs (Level 2) | Time deposits | ||
Available-for-sale securities: | ||
Available-for-sale securities | 370,000 | 515,000 |
Recurring | Significant Other Observable Inputs (Level 2) | Money market funds | ||
Available-for-sale securities: | ||
Available-for-sale securities | 0 | 0 |
Recurring | Significant Other Observable Inputs (Level 2) | Interest rate contracts | ||
Available-for-sale securities: | ||
Derivative asset | 13 | 4,070 |
Liabilities: | ||
Derivative liabilities | 1,445 | 0 |
Recurring | Significant Other Observable Inputs (Level 2) | Foreign exchange forward contracts | ||
Available-for-sale securities: | ||
Derivative asset | 1,732 | 1,194 |
Liabilities: | ||
Derivative liabilities | $ 142 | $ 1,460 |
Fair Value Measurement - Narrat
Fair Value Measurement - Narrative (Details) $ in Millions | Jun. 30, 2019USD ($) |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Equity securities without readily determinable fair value | $ 4.5 |
2021 Notes | Convertible Debt | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Interest rate (as a percent) | 1.875% |
2024 Notes | Convertible Debt | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Interest rate (as a percent) | 1.50% |
Significant Other Observable Inputs (Level 2) | 2021 Notes | Convertible Debt | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Fair value of exchangeable senior notes | $ 587 |
Significant Other Observable Inputs (Level 2) | 2024 Notes | Convertible Debt | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Fair value of exchangeable senior notes | $ 567 |
Derivative Instruments and He_3
Derivative Instruments and Hedging Activities - Narrative (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Interest rate contracts | ||
Derivative [Line Items] | ||
Losses recognized in AOCI to be reclassified over the next 12 months | $ 100,000 | |
Interest rate contracts | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Notional amount | $ 300,000,000 | $ 300,000,000 |
Interest rate contracts | Derivatives not designated as hedging instruments | ||
Derivative [Line Items] | ||
Fixed interest rate | 1.895% | |
Foreign exchange forward contracts | Derivatives not designated as hedging instruments | ||
Derivative [Line Items] | ||
Notional amount | $ 288,900,000 | $ 271,500,000 |
Foreign exchange forward contracts | Derivatives not designated as hedging instruments | Maximum | ||
Derivative [Line Items] | ||
Contract term | 12 months |
Derivative Instruments and He_4
Derivative Instruments and Hedging Activities - Gains on Derivative Instruments (Details) - Interest rate contracts - Cash Flow Hedges - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Gain (loss) recognized in accumulated other comprehensive loss, net of tax | $ (2,698) | $ 1,372 | $ (4,039) | $ 4,409 |
Loss (gain) reclassified from accumulated other comprehensive loss to interest expense, net of tax | $ (383) | $ (18) | $ (783) | $ 149 |
Derivative Instruments and He_5
Derivative Instruments and Hedging Activities - Foreign Exchange Gain (Loss) Derivative Instruments (Details) - Derivatives not designated as hedging instruments - Foreign exchange forward contracts - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Derivative [Line Items] | ||||
Gain recognized in other income and expense | $ 121 | |||
Loss recognized in other income and expense | $ (12,238) | $ (3,288) | $ (8,487) |
Derivative Instruments and He_6
Derivative Instruments and Hedging Activities - Fair Value of Outstanding Derivatives (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Derivatives, Fair Value [Line Items] | ||
Asset Derivatives | $ 1,745 | $ 5,264 |
Liability Derivatives | 1,587 | 1,460 |
Derivatives designated as hedging instruments | Interest rate contracts | Other current assets | ||
Derivatives, Fair Value [Line Items] | ||
Asset Derivatives | 13 | 1,929 |
Derivatives designated as hedging instruments | Interest rate contracts | Other non-current assets | ||
Derivatives, Fair Value [Line Items] | ||
Asset Derivatives | 2,141 | |
Derivatives designated as hedging instruments | Interest rate contracts | Other non-current liabilities | ||
Derivatives, Fair Value [Line Items] | ||
Liability Derivatives | 1,317 | |
Derivatives designated as hedging instruments | Interest rate contracts | Accrued liabilities | ||
Derivatives, Fair Value [Line Items] | ||
Liability Derivatives | 128 | 0 |
Derivatives not designated as hedging instruments | Foreign exchange forward contracts | Other current assets | ||
Derivatives, Fair Value [Line Items] | ||
Asset Derivatives | 1,732 | 1,194 |
Derivatives not designated as hedging instruments | Foreign exchange forward contracts | Accrued liabilities | ||
Derivatives, Fair Value [Line Items] | ||
Liability Derivatives | $ 142 | $ 1,460 |
Derivative Instruments and He_7
Derivative Instruments and Hedging Activities - Offsetting Assets and Liabilities (Details) - Pro Forma - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Derivative assets | ||
Gross Amounts of Recognized Assets/ Liabilities | $ 1,745 | $ 5,264 |
Gross Amounts Offset in the Consolidated Balance Sheet | 0 | 0 |
Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet | 1,745 | 5,264 |
Gross Amounts Not Offset in the Consolidated Balance Sheet | ||
Derivative Financial Instruments | (512) | (935) |
Cash Collateral Received (Pledged) | 0 | 0 |
Net Amount | 1,233 | 4,329 |
Derivative liabilities | ||
Gross Amounts of Recognized Assets/ Liabilities | (1,587) | (1,460) |
Gross Amounts Offset in the Consolidated Balance Sheet | 0 | 0 |
Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet | (1,587) | (1,460) |
Gross Amounts Not Offset in the Consolidated Balance Sheet | ||
Derivative Financial Instruments | 512 | 935 |
Cash Collateral Received (Pledged) | 0 | 0 |
Net Amount | $ (1,075) | $ (525) |
Inventories - Components of Inv
Inventories - Components of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 14,893 | $ 10,895 |
Work in process | 29,185 | 20,743 |
Finished goods | 24,921 | 21,318 |
Total inventories | $ 68,999 | $ 52,956 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Goodwill Activity (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Goodwill [Roll Forward] | |
Goodwill, beginning of period | $ 927,630 |
Foreign exchange | (2,640) |
Goodwill, end of period | $ 924,990 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Gross Carrying Amounts and Net Book Values of Intangible Assets (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 3,310,557 | $ 3,236,894 |
Accumulated Amortization | (763,753) | (647,565) |
Total | 2,546,804 | 2,589,329 |
Indefinite-lived Intangible Assets [Line Items] | ||
Gross Carrying Amount - Total Intangible Assets | 3,451,694 | 3,378,899 |
Net Book Value - Total Intangible Assets | 2,687,941 | 2,731,334 |
Acquired IPR&D assets | ||
Indefinite-lived Intangible Assets [Line Items] | ||
In-process research and development | $ 141,137 | 142,005 |
Acquired developed technologies | ||
Finite-Lived Intangible Assets [Line Items] | ||
Remaining Weighted- Average Useful Life (In years) | 13 years 7 months 6 days | |
Gross Carrying Amount | $ 3,184,381 | 3,110,641 |
Accumulated Amortization | (748,678) | (632,413) |
Total | 2,435,703 | 2,478,228 |
Priority review voucher | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 111,101 | 111,101 |
Accumulated Amortization | 0 | 0 |
Total | $ 111,101 | 111,101 |
Manufacturing contracts | ||
Finite-Lived Intangible Assets [Line Items] | ||
Remaining Weighted- Average Useful Life (In years) | 0 years | |
Gross Carrying Amount | $ 12,181 | 12,256 |
Accumulated Amortization | (12,181) | (12,256) |
Total | $ 0 | 0 |
Trademarks | ||
Finite-Lived Intangible Assets [Line Items] | ||
Remaining Weighted- Average Useful Life (In years) | 0 years | |
Gross Carrying Amount | $ 2,894 | 2,896 |
Accumulated Amortization | (2,894) | (2,896) |
Total | $ 0 | $ 0 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Increase of amortization of intangible assets | $ 61,576 | $ 54,959 | $ 118,461 | $ 107,966 | ||
Reduction of net income (loss) attributable to parent | $ (261,898) | $ (85,201) | $ (92,321) | $ (45,991) | $ (347,099) | $ (138,312) |
Reduction of earnings per share, basic (in dollars per share) | $ (4.62) | $ (1.53) | $ (6.09) | $ (2.30) | ||
Reduction of earnings per share, diluted (in dollars per share) | $ (4.56) | $ (1.50) | $ (6.01) | $ (2.26) | ||
Intangible Assets, Amortization Period | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Increase of amortization of intangible assets | $ 15,000 | $ 25,200 | ||||
Reduction of net income (loss) attributable to parent | $ 10,200 | $ 17,100 | ||||
Reduction of earnings per share, basic (in dollars per share) | $ 0.18 | $ 0.30 | ||||
Reduction of earnings per share, diluted (in dollars per share) | $ 0.18 | $ 0.30 |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets - Estimated Future Amortization Costs (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Estimated Amortization Expense | ||
Total | $ 2,546,804 | $ 2,589,329 |
Acquired developed technologies | ||
Estimated Amortization Expense | ||
2019 (remainder) | 126,961 | |
2020 | 252,774 | |
2021 | 205,135 | |
2022 | 159,563 | |
2023 | 159,563 | |
Thereafter | 1,531,707 | |
Total | $ 2,435,703 | $ 2,478,228 |
Certain Balance Sheet Items - P
Certain Balance Sheet Items - Property and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 179,843 | $ 249,966 | |
Less accumulated depreciation and amortization | (52,660) | (49,608) | |
Property, plant and equipment, net | 127,183 | $ 104,961 | 200,358 |
Land and buildings | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 46,636 | 46,650 | |
Construction-in-progress | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 33,483 | 51,243 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 32,572 | 33,273 | |
Manufacturing equipment and machinery | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 26,859 | 25,837 | |
Computer software | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 18,193 | 19,062 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 14,341 | 13,679 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 7,759 | 8,155 | |
Build-to-suit facility | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 0 | $ 52,067 |
Certain Balance Sheet Items - A
Certain Balance Sheet Items - Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Certain Balance Sheet Items [Abstract] | |||
Rebates and other sales deductions | $ 79,134 | $ 86,495 | |
Employee compensation and benefits | 49,050 | 58,543 | |
Clinical trial accruals | 9,780 | 5,904 | |
Current portion of operating lease liabilities | 8,722 | 0 | |
Accrued interest | 7,531 | 7,407 | |
Accrued construction-in-progress | 7,669 | 1,065 | |
Inventory-related accruals | 7,130 | 8,753 | |
Selling and marketing accruals | 6,275 | 6,780 | |
Royalties | 5,101 | 2,679 | |
Professional fees | 4,083 | 2,333 | |
Sales returns reserve | 2,395 | 2,510 | |
Derivative instrument liabilities | 270 | 1,460 | |
Accrued loss contingency | 0 | 58,154 | |
Other | 31,611 | 22,804 | |
Total accrued liabilities | $ 218,751 | $ 273,052 | $ 264,887 |
Debt - Schedule of Long-term De
Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Long term debt outstanding | $ 1,784,347 | |
Total debt | 1,601,229 | $ 1,596,412 |
Less current portion | 33,387 | 33,387 |
Total long-term debt | 1,567,842 | 1,563,025 |
Convertible Debt | 2021 Notes | ||
Debt Instrument [Line Items] | ||
Long term debt outstanding | 575,000 | 575,000 |
Unamortized discount and debt issuance costs | (50,194) | (60,910) |
Total debt | 524,806 | 514,090 |
Convertible Debt | 2024 Notes | ||
Debt Instrument [Line Items] | ||
Long term debt outstanding | 575,000 | 575,000 |
Unamortized discount and debt issuance costs | (128,683) | (138,914) |
Total debt | 446,317 | 436,086 |
Term Loan | ||
Debt Instrument [Line Items] | ||
Total debt | $ 630,106 | $ 646,236 |
Debt - Narrative (Details)
Debt - Narrative (Details) - Convertible Debt $ in Millions | Jun. 30, 2019USD ($) |
2021 Notes | |
Debt Instrument [Line Items] | |
Carrying value of the equity component | $ 126.9 |
2024 Notes | |
Debt Instrument [Line Items] | |
Carrying value of the equity component | $ 149.8 |
Jazz Investments I Limited | |
Debt Instrument [Line Items] | |
Percentage of ownership (as a percent) | 100.00% |
Debt - Schedule of Maturities o
Debt - Schedule of Maturities of Long-term Debt (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Debt Disclosure [Abstract] | |
2019 (remainder) | $ 16,693 |
2020 | 33,387 |
2021 | 608,387 |
2022 | 33,387 |
2023 | 517,493 |
Thereafter | 575,000 |
Total | $ 1,784,347 |
Leases - Lease Cost (Details)
Leases - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Leases [Abstract] | ||
Operating lease cost | $ 6,056 | $ 11,926 |
Short-term lease cost | 619 | 1,220 |
Variable lease cost | 1 | 4 |
Sublease income | (158) | (320) |
Net lease cost | $ 6,518 | $ 12,830 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Assets: | |||
Operating lease assets | $ 144,746 | $ 149,442 | $ 0 |
Liabilities | |||
Current portion of operating lease liabilities | 8,722 | 0 | |
Operating lease liabilities, less current portion | 156,289 | $ 153,158 | $ 0 |
Total operating lease liabilities | $ 165,011 |
Leases - Weighted Average Terms
Leases - Weighted Average Terms and Discount Rates (Details) | Jun. 30, 2019 |
Leases [Abstract] | |
Weighted-average remaining lease term - operating leases (years) | 10 years 1 month 6 days |
Weighted-average discount rate - operating leases | 5.30% |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash outflows from operating leases | $ 8,240 |
Non-cash operating activities: | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 152,142 |
Leases - Maturities of Operatin
Leases - Maturities of Operating Lease Liabilities (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Leases [Abstract] | |
2019 (remainder) | $ 6,716 |
2020 | 21,050 |
2021 | 20,923 |
2022 | 20,889 |
2023 | 21,066 |
Thereafter | 128,223 |
Total lease payments | 218,867 |
Less imputed interest | (53,856) |
Present value of lease liabilities | $ 165,011 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Millions | Apr. 04, 2019 | Apr. 30, 2018 | Jun. 30, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Line Items] | ||||
Noncancelable purchase commitments due within one year | $ 69.6 | |||
DOJ Investigation | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Proposed settlement amount | $ 57 | |||
Statutory interest rate, DOJ Settlement | 2.75% | |||
Settlement agreement compliance period | 5 years | |||
Loss contingency | $ 0.4 | $ 58.2 |
Shareholders' Equity - Share Re
Shareholders' Equity - Share Repurchase Programs (Details) - Ordinary Options - November 2016 Share Repurchase Program - USD ($) $ / shares in Units, shares in Millions | 6 Months Ended | |||
Jun. 30, 2019 | Dec. 31, 2018 | Nov. 30, 2018 | Nov. 30, 2016 | |
Stock Activity [Line Items] | ||||
Total amount authorized for repurchase of shares under share repurchase program | $ 1,020,000,000 | $ 300,000,000 | ||
Total amount additionally authorized for repurchase of shares under share repurchase program | $ 400,000,000 | $ 320,000,000 | ||
Shares repurchased | $ 171,100,000 | |||
Shares repurchased (in shares) | 1.3 | |||
Average price of shares repurchased (in dollars per share) | $ 131.17 | |||
Remaining amount authorized for repurchase of shares | $ 208,000,000 |
Shareholders' Equity - Componen
Shareholders' Equity - Component of Accumulated Other Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Increase (Decrease) in Accumulated Other Comprehensive Income (Loss) [Roll Forward] | ||||
Beginning balance | $ 2,730,447 | $ 2,786,571 | $ 2,757,422 | $ 2,713,097 |
Other comprehensive loss before reclassifications | (11,862) | |||
Amounts reclassified from accumulated other comprehensive loss | (783) | |||
Other comprehensive income (loss) | 10,238 | (69,460) | (12,645) | (27,403) |
Ending balance | 2,983,434 | 2,869,752 | 2,983,434 | 2,869,752 |
Net Unrealized Gain (Loss) From Hedging Activities | ||||
Increase (Decrease) in Accumulated Other Comprehensive Income (Loss) [Roll Forward] | ||||
Beginning balance | 3,557 | |||
Other comprehensive loss before reclassifications | (4,039) | |||
Amounts reclassified from accumulated other comprehensive loss | (783) | |||
Other comprehensive income (loss) | (4,822) | |||
Ending balance | (1,265) | (1,265) | ||
Foreign Currency Translation Adjustments | ||||
Increase (Decrease) in Accumulated Other Comprehensive Income (Loss) [Roll Forward] | ||||
Beginning balance | (201,348) | |||
Other comprehensive loss before reclassifications | (7,823) | |||
Amounts reclassified from accumulated other comprehensive loss | 0 | |||
Other comprehensive income (loss) | (7,823) | |||
Ending balance | (209,171) | (209,171) | ||
Total Accumulated Other Comprehensive Loss | ||||
Increase (Decrease) in Accumulated Other Comprehensive Income (Loss) [Roll Forward] | ||||
Beginning balance | (220,674) | (98,768) | (197,791) | (140,878) |
Ending balance | $ (210,436) | $ (168,228) | $ (210,436) | $ (168,228) |
Net Income per Ordinary Share_2
Net Income per Ordinary Share - Basic and Diluted Net Income (Loss) per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Numerator: | ||||||
Net income | $ 261,898 | $ 85,201 | $ 92,321 | $ 45,991 | $ 347,099 | $ 138,312 |
Denominator: | ||||||
Weighted-average ordinary shares used in per share calculation - basic (in shares) | 56,707 | 60,177 | 56,955 | 60,053 | ||
Dilutive effect of employee equity incentive and purchase plans (in shares) | 720 | 1,261 | 798 | 1,256 | ||
Weighted-average ordinary shares used in per share calculation - diluted (in shares) | 57,427 | 61,438 | 57,753 | 61,309 | ||
Net income per ordinary share: | ||||||
Basic (in dollars per share) | $ 4.62 | $ 1.53 | $ 6.09 | $ 2.30 | ||
Diluted (in dollars per share) | $ 4.56 | $ 1.50 | $ 6.01 | $ 2.26 |
Net Income per Ordinary Share_3
Net Income per Ordinary Share - Weighted-Average Ordinary Shares Excluded from Computation of Diluted Net Income per Share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Exchangeable Senior Notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Ordinary shares (in shares) | 5,504 | 5,504 | 5,504 | 5,504 |
Options, RSUs and ESPP | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Ordinary shares (in shares) | 5,202 | 3,374 | 5,095 | 3,340 |
Revenues - Summary of Disaggreg
Revenues - Summary of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 534,133 | $ 500,479 | $ 1,042,319 | $ 945,092 |
United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 480,932 | 455,359 | 943,794 | 861,046 |
Europe | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 36,518 | 35,018 | 71,919 | 63,349 |
All other | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 16,683 | 10,102 | 26,606 | 20,697 |
Product sales, net | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 523,423 | 496,095 | 1,026,754 | 936,942 |
Xyrem | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 413,212 | 356,008 | 781,529 | 672,785 |
Erwinaze/Erwinase | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 27,622 | 58,713 | 88,521 | 109,340 |
Defitelio/defibrotide | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 46,055 | 40,498 | 87,555 | 75,559 |
Vyxeos | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 31,362 | 27,951 | 60,305 | 54,179 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 5,172 | 12,925 | 8,844 | 25,079 |
Royalties and contract revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 10,710 | $ 4,384 | $ 15,565 | $ 8,150 |
Revenues - Summary of the Perce
Revenues - Summary of the Percentage of Total Revenues from Customers (Details) - Total Revenues - Customer concentration risk | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Express Scripts | ||||
Concentration Risk [Line Items] | ||||
Percentage of total revenues (as a percent) | 77.00% | 71.00% | 75.00% | 71.00% |
McKesson | ||||
Concentration Risk [Line Items] | ||||
Percentage of total revenues (as a percent) | 12.00% | 20.00% | 15.00% | 20.00% |
Revenues - Narrative (Details)
Revenues - Narrative (Details) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019USD ($)agreement | Jun. 30, 2019USD ($)agreement | |
Summary Of Deferred Revenue [Line Items] | ||
Contract revenue recognized | $ 3,054 | |
Minimum | ||
Summary Of Deferred Revenue [Line Items] | ||
Payment terms, range | 30 days | |
Maximum | ||
Summary Of Deferred Revenue [Line Items] | ||
Payment terms, range | 45 days | |
Nippon Shinyaku | ||
Summary Of Deferred Revenue [Line Items] | ||
Number of license, development and commercialization agreements | agreement | 2 | 2 |
Contract revenue recognized | $ 1,200 | $ 3,100 |
Revenue, performance obligation, description of timing | The deferred revenue balances are being recognized over an average of four years representing the period over which we expect to perform our research and developments obligations under each agreement. |
Revenues - Summary of Contract
Revenues - Summary of Contract Liabilities (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Change In Contract With Customer, Liability [Roll Forward] | |
Beginning balance | $ 14,995 |
Amount recognized within royalties and contract revenues | (3,054) |
Ending balance | $ 11,941 |
Share-Based Compensation - Expe
Share-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense, pre-tax | $ 28,289 | $ 26,312 | $ 55,841 | $ 50,615 |
Income tax benefit from share-based compensation expense | (4,473) | (4,846) | (8,140) | (8,514) |
Total share-based compensation expense, net of tax | 23,816 | 21,466 | 47,701 | 42,101 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense, pre-tax | 20,685 | 19,800 | 41,055 | 38,034 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense, pre-tax | 5,896 | 4,709 | 11,419 | 9,084 |
Cost of product sales | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense, pre-tax | $ 1,708 | $ 1,803 | $ 3,367 | $ 3,497 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted-Average Assumptions and Resulting Grant Date Fair Value (Details) - Employee Stock Option - $ / shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Schedule of Weighted Average Assumptions for Fair Values of Stock Options[Line Items] | ||||
Shares underlying options granted (in shares) | 102 | 80 | 1,399 | 1,232 |
Weighted-average grant date fair value (in dollars per share) | $ 38.95 | $ 49.28 | $ 42.56 | $ 46.28 |
Weighted-average volatility (as a percent) | 31.00% | 34.00% | 32.00% | 35.00% |
Weighted-average expected term | 4 years 6 months | 4 years 6 months | 4 years 6 months | 4 years 6 months |
Range of risk-free rates, minimum (as a percent) | 1.80% | 2.50% | 1.80% | 2.20% |
Range of risk-free rates, maximum (as a percent) | 2.30% | 2.70% | 2.50% | 2.70% |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Units (Details) - Restricted Stock Units (RSUs) - $ / shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
RSUs granted (in shares) | 42 | 32 | 561 | 493 |
Grant date fair value (in dollars per share) | $ 132.73 | $ 152.36 | $ 138.87 | $ 141.36 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Restricted Stock Units (RSUs) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 4 years |
Unrecognized compensation cost related to unvested stock option and RSUs | $ 124 |
Weighted-average period expected to be recognized | 2 years 9 months 18 days |
Employee Stock Option | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost related to unvested stock option and RSUs | $ 98.7 |
Weighted-average period expected to be recognized | 2 years 9 months 18 days |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income Taxes [Line Items] | ||||
Income tax provision (benefit) | $ (78,650) | $ 36,524 | $ (49,534) | $ 55,670 |
Effective income tax rate (as a percent) | (42.70%) | 28.20% | (16.50%) | 28.60% |
Discrete income tax (benefit) | $ (112,300) | $ (112,000) | ||
Ireland | ||||
Income Taxes [Line Items] | ||||
Ireland statutory income tax rate (as a percent) | 12.50% | 12.50% | ||
Tax Year 2012 And 2013 | France | ||||
Income Taxes [Line Items] | ||||
Proposed additional tax including interest and penalties | $ 43,000 | |||
Tax Year 2015 | France | ||||
Income Taxes [Line Items] | ||||
Proposed additional tax including interest and penalties | $ 4,000 |