JAZZ - Jazz Pharmaceuticals plc
Form 10-Q Period: MAR.31.18 Date Filed: MAY.08.18
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  Form 10-Q (Entire Filing)

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Page 1: UNITED STATES

Page 2: JAZZ PHARMACEUTICALS PLC

Page 3: PART I FINANCIAL INFORMATION

Page 4: JAZZ PHARMACEUTICALS PLC

Page 5: JAZZ PHARMACEUTICALS PLC

Page 6: JAZZ PHARMACEUTICALS PLC

Page 7: JAZZ PHARMACEUTICALS PLC

Page 8: Use of Estimates

Page 9: Revenue Recognition

Page 10: Significant Risks and Uncertainties

Page 11: Recent Accounting Pronouncements

Page 12: 3. Fair Value Measurement

Page 13: 4. Derivative Instruments and Hedging Activities

Page 14: 5. Inventories

Page 15: 7. Certain Balance Sheet Items

Page 16: 8. Debt

Page 17: 9. Commitments and Contingencies

Page 18: Xyrem ANDA Litigation Settlements.

Page 19: Xyrem Post-Grant Patent Review Matters

Page 20: 10. Shareholders Equity

Page 21: Accumulated Other Comprehensive Loss

Page 22: 12. Revenues

Page 23: 13. Share-Based Compensation

Page 24: 14. Income Taxes

Page 25: Item 2. Management s Discussion and Analysis of Financial Condition and Results of Operations

Page 26: Continued Emphasis on Research and Development

Page 27: Challenges, Risks and Trends Related to Our Lead Marketed Products and Product Candidates Submitted

Page 28: N/A

Page 29: N/A

Page 30: We face substantial competition from other companies, including companies with greater resources, in

Page 31: Defitelio/defibrotide.

Page 32: Changes in healthcare law and implementing regulations, including those based on recently enacted le

Page 33: Results of Operations

Page 34: Royalties and Contract Revenues

Page 35: Intangible Asset Amortization

Page 36: Equity in Loss of Investees

Page 37: Debt

Page 38: Cautionary Note Regarding Forward-Looking Statements

Page 39: PART II OTHER INFORMATION

Page 40: The launch of a generic version of Xyrem or other sodium oxybate products that compete with Xyrem wo

Page 41: N/A

Page 42: We face substantial competition from other companies, including companies with greater resources, in

Page 43: The launch of a generic version of Xyrem or other sodium oxybate products that compete with Xyrem wo

Page 44: We are subject to significant ongoing regulatory obligations and oversight, which may result in sign

Page 45: or problems in the supply of our products for commercial sale or our product candidates for use in o

Page 46: Vyxeos

Page 47: Solriamfetol

Page 48: N/A

Page 49: While Xyrem remains our largest product, our success also depends on our ability to

Page 50: effectively commercialize our other products and, in the case of our product candidates, our ability

Page 51: The commercial success of our products depends upon their market acceptance by physicians, patients,

Page 52: We face substantial competition from other companies, including companies with greater resources, in

Page 53: E. coli

Page 54: Conducting clinical trials is costly and time-consuming, and the outcomes are uncertain. A failure t

Page 55: We have substantially expanded our international footprint and operations, and we may expand further

Page 56: The results of the UK s referendum on withdrawal from the EU may have a negative effect on global ec

Page 57: If we fail to attract, retain and motivate key personnel or to retain the members of our executive m

Page 58: The results of the UK s referendum on withdrawal from the EU may have a negative effect on global ec

Page 59: We have incurred and expect to continue to incur substantial costs as a result of litigation or othe

Page 60: N/A

Page 61: We have incurred and expect to continue to incur substantial costs as a result of litigation or othe

Page 62: N/A

Page 63: Risks Related to Our Industry

Page 64: The distribution and sale of Xyrem are subject to significant regulatory oversight and restrictions

Page 65: The results of the UK s referendum on withdrawal from the EU may have a negative effect on global ec

Page 66: bona fide

Page 67: We are subject to significant ongoing regulatory obligations and oversight, which may result in sign

Page 68: Other U.S. Regulatory Authorities

Page 69: N/A

Page 70: N/A

Page 71: Changes in healthcare law and implementing regulations, including those based on recently enacted le

Page 72: N/A

Page 73: N/A

Page 74: If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate progr

Page 75: Access and adequate reimbursement coverage may not be available for our products, which could dimini

Page 76: N/A

Page 77: N/A

Page 78: Changes in healthcare law and implementing regulations, including those based on recently enacted le

Page 79: Product liability and product recalls could harm our business.

Page 80: Risks Related to Our Financial Condition and Results

Page 81: We may not be able to generate sufficient cash to service our debt obligations.

Page 82: We may not be able to access the capital and credit markets on terms that are favorable to us, or at

Page 83: Future changes to the tax laws under which we expect to be treated as a foreign corporation for U.S.

Page 84: Future changes to the tax laws under which we expect to be treated as a foreign corporation for U.S.

Page 85: Future sales of our ordinary shares in the public market could cause our share price to fall.

Page 86: Our articles of association, Irish law and the indentures governing the Exchangeable Senior Notes co

Page 87: Dividends paid by us may be subject to Irish dividend withholding tax.

Page 88: Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Page 89: N/A

Page 90: N/A

Page 91: SIGNATURES

Exhibits

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