1 unchanged sentence
Evaluation of Disclosure Controls and Procedures .
−Removed: We have carried out an evaluation under the supervision and with the participation of management, including our principal executive officer and interim principal financial officer, of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this Annual Report on Form 10‑K.
−Removed: Based on their evaluation, our principal executive officer and interim principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2023.
+Added: We have carried out an evaluation under the supervision and with the participation of management, including our principal executive officer and principal financial officer, of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this Annual Report on Form 10‑K.
+Added: Based on their evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2024.
Limitations on the Effectiveness of Controls.
1 unchanged sentence
Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected.
−Removed: Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and interim principal financial officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.
+Added: Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.
Changes in Internal Control over Financial Reporting.
3 unchanged sentences
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
−Removed: Our management used the Committee of Sponsoring Organizations of the Treadway Commission Internal Control - Integrated Framework (2013), or the COSO framework, to evaluate the effectiveness of internal control over financial reporting.
+Added: Our management used the COSO framework to evaluate the effectiveness of internal control over financial reporting.
Management believes that the COSO framework is a suitable framework for its evaluation of financial reporting because it is free from bias, permits reasonably consistent qualitative and quantitative measurements of our internal control over financial reporting, is sufficiently complete so that those relevant factors that would alter a conclusion about the effectiveness of our internal control over financial reporting are not omitted and is relevant to an evaluation of internal control over financial reporting.
30 unchanged sentences
Insider Trading Arrangements
−Removed: During the quarter ended December 31, 2023, no director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements.
+Added: The following is a summary of the material terms of the contracts, instructions or written plans for the purchase or sale of the Company’s securities adopted or terminated by our officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) and directors during the quarter ended December 31, 2024:
+Added: Type of Trading Arrangement
+Added: Name and Position
+Added: Expiration Date
+Added: Total Ordinary Shares to be Sold
+Added: Robert Iannone
+Added: December 6, 2024
+Added: Termination (1)
+Added: March 7, 2025
+Added: Robert Iannone
+Added: December 6, 2024
+Added: December 6, 2025
+Added: Executive Vice President, Global Head of Research and Development, Chief Medical Officer
+Added: (1) Represents the modification, as described in Rule 10b5-1(c)(1)(iv) under the Exchange Act, of a written plan initially adopted on March 7, 2024 that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
+Added: * Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
−Removed: Certain information required by Part III is omitted from this Annual Report on Form 10‑K and incorporated by reference to our definitive proxy statement for our 2024 annual general meeting of shareholders, or our 2024 Proxy Statement, to be filed pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, or Exchange Act.
+Added: Certain information required by Part III is omitted from this Annual Report on Form 10‑K and incorporated by reference to our 2025 Proxy Statement, to be filed pursuant to Regulation 14A of the Exchange Act.
If our 2025 Proxy Statement is not filed within 120 days after the end of the fiscal year covered by this Annual Report on Form 10‑K, the omitted information will be included in an amendment to this Annual Report on Form 10‑K filed not later than the end of such 120-day period.
3 unchanged sentences
• The information relating to our executive officers is to be included in the section entitled “Executive Officers;”
−Removed: • The information relating to our audit committee, audit committee financial expert and procedures by which shareholders may recommend nominees to our board of directors is to be included in the section entitled “Corporate Governance and Board Matters;” and
+Added: • The information relating to our Audit Committee, audit committee financial expert, procedures by which shareholders may recommend nominees to our board of directors and our insider trading policies and procedures is to be included in the section entitled “Corporate Governance and Board Matters;” and
• If required, the information regarding compliance with Section 16(a) of the Exchange Act is to be included in the section entitled “Delinquent Section 16(a) Reports.”
Such information is incorporated herein by reference to our 2025 Proxy Statement, provided that if the 2025 Proxy Statement is not filed within 120 days after the end of the fiscal year covered by this Annual Report on Form 10‑K, the omitted information will be included in an amendment to this Annual Report on Form 10‑K filed not later than the end of such 120-day period.
−Removed: Our Code of Conduct applies to all of our employees, directors and officers, including our principal executive officer, interim principal financial officer, principal accounting officer or controller, or persons performing similar functions, and those of our subsidiaries.
+Added: Our Code of Conduct applies to all of our employees, directors and officers, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, and those of our
+Added: subsidiaries.
The Code of Conduct is available on our website at www.jazzpharmaceuticals.com under the section entitled “Our Purpose” under “Ethical Standards.” We intend to satisfy the disclosure requirements under Item 5.05 of the SEC Form 8-K regarding an amendment to, or waiver from, a provision of our Code of Conduct by posting such information on our website at the website address and location specified above.
49 unchanged sentences
Bank National Association, as trustee and acknowledged by U.S.
−Removed: Bank National Association, as collateral trustee.
−Removed: (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
+Added: Bank National Association, as collateral trustee (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
001-033500), as filed with the SEC on April 29, 2021).
4 unchanged sentences
001-33500) for the period ended June 30, 2021, as filed with the SEC on August 3, 2021).
+Added: 4.5D Indenture, dated as of September 6, 2024 among Jazz Pharmaceuticals Public Limited Company, Jazz Investments I Limited and U.S.
+Added: Bank Trust Company, National Association (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
+Added: 001-033500), as filed with the SEC on September 6, 2024 ).
+Added: 4.5E Form of 3.12 5 % Exchangeable S enior Note due 20 30 (incorporated herein by reference to Exhibit 4.
+Added: 2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
+Added: 001-033500), as filed with the SEC on September 6, 2024).
4.6 Description of Share Capital.
11 unchanged sentences
001-033500), as filed with the SEC on January 25, 2024).
−Removed: 10.2A# Settlement Agreement, dated as of April 5, 2017, by and between Jazz Pharmaceuticals, Inc.
+Added: 10.1D Amendment No.
+Added: 2 , dated as of January 19, 2024, by and among Jazz Pharmaceuticals Public Limited Company, the other borrowers party thereto, the guarantors party ther e to , the l enders party thereto, Bank of America, N.A., as administrative agent, and U.S.
+Added: Bank Trust Company, National Association, (as succ essor in interest to U.S.
+Added: Bank National Association), as collateral trustee (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
+Added: 001-033500), as filed with the SEC on July 22 , 2024).
+Added: 10.2 Amendment No.
+Added: 3, dated as of November 26, 2024, by and among Jazz Pharmaceuticals Public Limited Company, the other borrowers party thereto, the guarantors party thereto, the lenders and issuing banks party thereto, Bank of America, N.A., as administrative agent, and U.S.
+Added: Bank Trust Company, National Association (as successor in interest to U.S.
+Added: Bank National Association), as collateral trustee (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
+Added: 001-033500), as filed with the SEC on November 26 , 2024).
+Added: 10.3# Settlement Agreement, dated as of April 5, 2017, by and between Jazz Pharmaceuticals, Inc.
and Jazz Pharmaceuticals Ireland Limited, and Roxane Laboratories, Inc., West-Ward Pharmaceuticals Corp., Eurohealth (USA), Inc., and Hikma Pharmaceuticals PLC (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
001-33500) for the period ended September 30, 2022, as filed with the SEC on November 9, 2022).
−Removed: 10.2B Settlement Agreement, dated as of April 4, 2019, by and among United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General of the Department of Health and Human Services, Jazz Pharmaceuticals plc, Jazz Pharmaceuticals, Inc., and Jazz Pharmaceuticals Ireland Ltd.
−Removed: (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended March 31, 2019, as filed with the SEC on May 7, 2019).
−Removed: 10.3 Corporate Integrity Agreement, dated as of April 3, 2019, by and between Jazz Pharmaceuticals plc and the Office of Inspector General of the United States Department of Health and Human Services (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended March 31, 2019, as filed with the SEC on May 7, 2019).
10.4† Supply Agreement, dated as of April 1, 2010, by and between Jazz Pharmaceuticals, Inc.
9 unchanged sentences
and Express Scripts Specialty Distribution Services, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.8# in Jazz Pharmaceuticals plc ’ s Annual R eport on Form 10-K ( File No.
+Added: (incorporated herein by reference to Exhibit 10.8# in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
001-33500) for the period ended December 31, 2022, as filed with the SEC on March 1, 2023).
8 unchanged sentences
001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
−Removed: 10.10A Commercial Lease, dated as of January 7, 2015, by and between The Board of Trustees of the Leland Stanford Junior University and Jazz Pharmaceuticals, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
−Removed: 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
−Removed: 10.10B First Amendment, dated as of January 29, 2018, to Commercial Lease, dated as of January 7, 2015, by and between The Board of Trustees of the Leland Stanford Junior University and Jazz Pharmaceuticals, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended June 30, 2018, as filed with the SEC on August 7, 2018).
−Removed: 10.10C Second Amendment, dated as of July 26, 2018, to Commercial Lease, dated as of January 7, 2015, by and between The Board of Trustees of the Leland Stanford Junior University and Jazz Pharmaceuticals, Inc., as previously amended by the First Amendment to Lease, dated as of January 29, 2018 (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended September 30, 2018, as filed with the SEC on November 6, 2018).
10.10+ Form of Indemnification Agreement between Jazz Pharmaceuticals plc and its officers and directors (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
15 unchanged sentences
001-33500) for the period ended December 31, 2019, as filed with the SEC on February 25, 2020).
−Removed: 10.15B+ Amendment to Employment Contract, dated as of April 21, 2020, by and between Jazz Pharmaceuticals UK Limited and Samantha Pearce (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended March 31, 2020, as filed with the SEC on May 5, 2020).
−Removed: 10.15C+ Equity Award Letter, dated as of December 9, 2019, by and between Jazz Pharmaceuticals UK Limited and Samantha Pearce (incorporated herein by reference to Exhibit 10.28B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
+Added: 10.14B+ Equity Award Letter, dated as of December 9, 2019, by and between Jazz Pharmaceuticals UK Limited and Samantha Pearce (incorporated herein by reference to Exhibit 10.28B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
001-33500) for the period ended December 31, 2019, as filed with the SEC on February 25, 2020).
+Added: 10.14C+ Amendment to Employment Contract, dated as of April 21, 2020, by and between Jazz Pharmaceuticals UK Limited and Samantha Pearce (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 001-33500) for the period ended March 31, 2020, as filed with the SEC on May 5, 2020).
+Added: 10.14D+ Offer Letter from Jazz Pharmaceuticals, Inc.
+Added: to Samantha Pearce (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 001-33500) for the period ended June 30, 2024 , as filed with the SEC on A ugust 1 , 202 4 ).
10.15+ Offer Letter, dated as of February 23, 2020, by and between Jazz Pharmaceuticals, Inc.
1 unchanged sentence
001-33500) for the period ended March 31, 2020, as filed with the SEC on May 5, 2020).
−Removed: 10.17A+ Offer Letter , dated as of April 4, 2023 , by and between Jazz Pharmaceuticals Ireland and Liz Henderson .
−Removed: 10.17B+ New Hire E quity Letter , dated as of April 4, 2023 , from Jazz Pharmace uticals to Liz Henderson.
+Added: 10.16A+ Offer Letter, dated as of April 4, 2023, by and between Jazz Pharmaceuticals Ireland and Liz Henderson (incorporated herein by reference to Exhibit 10.
+Added: 17A in the Annual Report on Form 10-K (File No.
+Added: 001-33500) for the period ended December 31, 20 23 , as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc.
+Added: with the SEC on February 28, 20 24 ) .
+Added: 10.16B+ New Hire Equity Letter, dated as of April 4, 2023, from Jazz Pharmaceuticals to Liz Henderson (incorporated herein by reference to Exhibit 10.
+Added: 17 B in the Annual Report on Form 10-K (File No.
+Added: 001-33500) for the period ended December 31, 20 23 , as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc.
+Added: with the SEC on February 28, 20 24 ) .
+Added: 10.17A+ Offer Letter, dated as of January 30, 2024, by and between Jazz Pharmaceuticals, Inc.
+Added: and Philip Johnson (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 001-33500) for the period ended March 31, 2024, as filed with the SEC on May 2, 2024).
+Added: 10.17B+ Sign-On Bonus Repayment Agreement, dated as of February 25, 2024, by and between Jazz Pharmaceuticals, Inc.
+Added: and Philip Johnson.
10.18A+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.1 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No.
21 unchanged sentences
001-33500) for the period ended December 31, 2022, as filed with the SEC on March 1, 2023).
−Removed: 10.18I+ Amended and Restated 2011 Equity Incentive Plan (approved November 1, 2023).
+Added: 10.18I+ Amended and Restated 2011 Equity Incentive Plan (approved November 1, 2023) (incorporated herein by reference to Exhibit 10.18I in the Annual Report on Form 10-K (File No.
+Added: 001-33500) for the period ended December 31, 2023, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc.
+Added: with the SEC on February 28, 2024) .
10.18J+ Form of U.S.
54 unchanged sentences
001-33500) for the period ended June 30, 2020, as filed with the SEC on August 4, 2020).
−Removed: 10.19G+ Form of Non-U.S.
+Added: 10.19G+ Amended and Restated 2007 Non-Employee Directors Stock Award Plan (approved July 30, 2020) (incorporated herein by reference to Exhibit 10.
+Added: 2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 001-33500) for the period ended March 31 , 202 4 , as filed with the SEC on May 2 , 202 4 ).
+Added: 10.19H+ Form of Non-U.S.
Option Grant Notice and Form of Non-U.S.
1 unchanged sentence
001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
−Removed: 10.19H+ Form of Non-U.S.
+Added: 10.19I+ Form of Non-U.S.
Option Grant Notice and Non-U.S.
1 unchanged sentence
001-33500) for the period ended September 30, 2018, as filed with the SEC on November 6, 2018).
−Removed: 10.19I+ Form of Non-U.S.
+Added: 10.19J+ Form of Non-U.S.
Option Grant Notice and Non-U.S.
1 unchanged sentence
001-33500) for the period ended March 31, 2019, as filed with the SEC on May 7, 2019).
−Removed: 10.19J+ Form of Non-U.S.
+Added: 10.19K+ Form of Non-U.S.
Option Grant Notice and Non-U.S.
1 unchanged sentence
001-33500) for the period ended September 30, 2020, as filed with the SEC on November 2, 2020).
−Removed: 10.19K+ Form of Non-U.S.
+Added: 10.19L+ Form of Non-U.S.
Restricted Stock Unit Award Grant Notice and Non-U.S.
1 unchanged sentence
001-33500) for the period ended September 30, 2020, as filed with the SEC on November 2, 2020).
−Removed: 10.20A+ Amended and Restated GW Pharmaceuticals plc 2020 Long-Term Incentive Plan .
+Added: 10.20A+ Amended and Restated GW Pharmaceuticals plc 2020 Long-Term Incentive Plan ((incorporated herein by reference to Exhibit 10.
+Added: 20A in the Annual Report on Form 10-K (File No.
+Added: 001-33500) for the period ended December 31, 2023, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc.
+Added: with the SEC on February 28, 2024).
10.20B+ Form of Restricted Stock Unit Award Agreement under the GW Pharmaceuticals plc 2020 Long-Term Incentive Plan (incorporated herein by reference to Exhibit 10.10B in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
7 unchanged sentences
10.21B+ Amended and Restated 2007 Employee Stock Purchase Plan (approved November 2, 2022).
−Removed: (incorporated herein by reference to Exhibit 10.
−Removed: 30B + in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
+Added: (incorporated herein by reference to Exhibit 10.30B+ in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
001-33500) for the period ended December 31, 2022, as filed with the SEC on March 1, 2023).
−Removed: 10.21C+ Amended and Restated 2007 Employee Stock Purchase Plan (approved November 1, 2023).
+Added: 10.21C+ Amended and Restated 2007 Employee Stock Purchase Plan (approved November 1, 2023) (incorporated herein by reference to Exhibit 10.21C in the Annual Report on Form 10-K (File No.
+Added: 001-33500) for the period ended December 31, 2023, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc.
+Added: with the SEC on February 28, 2024).
10.21D+ Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan Sub-Plan Governing Purchase Rights to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.14C in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
16 unchanged sentences
001-33500) for the period ended June 30, 2023, as filed with the SEC on August 9, 2023).
+Added: 19.1 Jazz Pharmaceuticals plc Insider Trading Policy
21.1 Subsidiaries of Jazz Pharmaceuticals plc.
2 unchanged sentences
31.1 Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
−Removed: 31.2 Certification of Interim Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
−Removed: 32.1* Certification of Principal Executive Officer and Interim Principal Financial Officer pursuant to 18 U.S.C.
+Added: 31.2 Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
+Added: 32.1* Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
−Removed: 97.1 Jazz Pharmaceuticals plc Policy for Recoupment of Incentive Compensation
+Added: 97.1 Jazz Pharmaceuticals plc Policy for Recoupment of Incentive Compensation (incorporated herein by reference to Exhibit 97.1 in the Annual Report on Form 10-K (File No.
+Added: 001-33500) for the period ended December 31, 2023, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc.
+Added: with the SEC on February 28, 2024).
101.INS XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
17 unchanged sentences
/s/ B RUCE C.
−Removed: Chairman and Chief Executive Officer and Director
+Added: Chairman, Chief Executive Officer and Director
(Principal Executive Officer)
+Added: /s/ P HILIP L.
+Added: Executive Vice President and Chief Financial Officer
+Added: (Principal Financial Officer)
/s/ P ATRICIA C ARR
1 unchanged sentence
Senior Vice President, Chief Accounting Officer
−Removed: (Principal Accounting Officer and Interim Principal Financial Officer)
+Added: (Principal Accounting Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Bruce C.
−Removed: Cozadd, Renée Galá, Neena M.
+Added: Cozadd, Philip L.
+Added: Johnson, Neena M.
Patil and Patricia Carr, and each of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution for him or her, and in his or her name in any and all capacities, to sign any and all amendments to this Annual Report on Form 10‑K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and any of them, his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
5 unchanged sentences
February 26, 2025
+Added: /s/ P HILIP L.
+Added: Executive Vice President and Chief Financial Officer
+Added: (Principal Financial Officer)
+Added: February 26, 2025
/s/ P ATRICIA C ARR
Senior Vice President, Chief Accounting Officer
−Removed: (Principal Accounting Officer and Interim Principal Financial Officer)
+Added: (Principal Accounting Officer)
February 26, 2025
4 unchanged sentences
Director February 26, 2025
−Removed: /s/ P ETER G RAY
+Added: /s/ L AURA H AMILL
Director February 26, 2025
+Added: /s/ P ATRICK K ENNEDY
+Added: Director February 26, 2025
+Added: Patrick Kennedy
/s/ H EATHER A NN M CSHARRY
14 unchanged sentences
Director February 26, 2025
−Removed: /s/ C ATHERINE A.
−Removed: S OHN, P HARM .D.
−Removed: Director February 28, 2024
−Removed: Sohn, Pharm.D.
/s/ R ICK E W INNINGHAM
5 unchanged sentences
Opinion on the Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of Jazz Pharmaceuticals plc..
−Removed: and subsidiaries (the Company) as of December 31, 2023 and 2022, the related consolidated statements of income (loss), comprehensive income (loss), shareholders’ equity, and cash flows for each of the years in the three‑year period ended December 31, 2023, and the related notes and financial statement schedule at item 15(a)2 (collectively, ‘the consolidated financial statements’).
+Added: We have audited the accompanying consolidated balance sheets of Jazz Pharmaceuticals Plc and subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements of income (loss), comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the three‑year period ended December 31, 2024 and the related notes and financial statement schedules at item 15(a)2 (collectively, the consolidated financial statements).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years in the three‑year period ended December 31, 2024, in conformity with U.S.
12 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: The critical audit matter communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
−Removed: Assessment of the carrying value of the Vyxeos intangible asset
−Removed: As discussed in Note 10 to the consolidated financial statements, the finite-lived intangible assets balance as of December 31 ,2023 was $5,418,039 thousand, a portion of which related to finite-lived intangible asset in respect of Vyxeos.
−Removed: As discussed in Note 2, the Company reviews finite-lived intangible assets for impairment when events or circumstances indicate that the carrying value of such assets may not be recoverable.
−Removed: We identified the assessment of the carrying value of the Vyxeos intangible asset as a critical audit matter.
−Removed: There was a high degree of subjectivity in assessing the carrying value of Vyxeos, specifically revenue forecast assumptions for Vyxeos, which are key inputs to the determination of estimated undiscounted future cash flows.
+Added: Critical Audit Matters
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Assessment of Epidiolex Medicaid Rebate Accrual
+Added: As discussed in Note 2 to the consolidated financial statements, sales made under governmental and managed-care pricing programs and commercial payor contracts in the U.S.
+Added: are subject to rebates and requires significant judgment in determining the sales utilization percentage used in calculating the Epidiolex Medicaid rebate accrual.
+Added: As discussed in Note 10 to the consolidated financial statements, the Company reported rebates and other sales deductions of $342,717 thousands, which included rebates related to the Epidiolex Medicate rebate program in the U.S..
+Added: We identified the assessment of the Epidiolex Medicaid rebate accrual as a critical audit matter.
+Added: Significant and complex auditor judgment was required to assess the Epidiolex Medicaid rebate accrual, specifically due to the significant judgment required in determining the sales utilization percentage used in the calculation of the Epidiolex Medicaid rebate accrual amount.
The following are the primary procedures we performed to address this critical audit matter.
−Removed: – We evaluated the design and tested the operating effectiveness of certain internal controls related to the Vyxeos intangible asset impairment review process, including the Company’s control related to the development of the revenue forecast assumptions for Vyxeos
−Removed: – We evaluated the reasonableness of the Company’s revenue forecast assumptions for Vyxeos by comparing certain underlying assumptions against (1) company-specific operational information and management’s communication to the Board of Directors and (2) available industry or other third-party reports
−Removed: – We challenged management’s ability to accurately forecast revenue by comparing historical projections to actual results
+Added: - We evaluated the design and tested the operating effectiveness of certain internal controls related to the assessment of Epidiolex Medicaid rebate accrual.
+Added: - We compared the Company’s historical Epidiolex Medicaid rebate accrual amount to the actual claims received to assess the Company’s ability to accurately forecast.
+Added: - We assessed the assumption for reasonableness by comparing it against a sales utilization percentage range that was independently developed based on historical utilization rates.
We have served as the Company’s auditor since 2012.
27 unchanged sentences
Income taxes payable 18,757 35,074
−Removed: Deferred revenue — 463
Total current liabilities 1,038,573 1,536,692
36 unchanged sentences
Foreign exchange gain (loss) ( 8,182 ) 8,787 ( 19,014 )
−Removed: Income (loss) before income tax expense (benefit) and equity in loss of investees 297,929 ( 372,784 ) ( 112,838 )
−Removed: Income tax expense (benefit) ( 119,912 ) ( 158,645 ) 216,116
+Added: Income (loss) before income tax benefit and equity in loss of investees 470,351 297,929 ( 372,784 )
+Added: Income tax benefit ( 91,429 ) ( 119,912 ) ( 158,645 )
Equity in loss of investees 1,660 3,009 9,921
14 unchanged sentences
Foreign currency translation adjustments ( 106,025 ) 283,127 ( 725,277 )
−Removed: Loss on fair value hedging activities reclassified from accumulated other comprehensive income (loss) to foreign exchange gain (loss), net of income tax benefit of $ — , $ 43 , and $ — , respectively
−Removed: Unrealized gain (loss) on cash flow hedging activities, net of income tax expense (benefit) of $ 1,215 , $ — and ($ 2 ), respectively
+Added: Loss on fair value hedging activities reclassified from accumulated other comprehensive loss to foreign exchange gain (loss), net of income tax benefit of $ — , $ — , and $ 43 , respectively
+Added: Unrealized gain on cash flow hedging activities, net of income tax expense of $ 1,760 , $ 1,215 and $ — , respectively
5,298 3,658 —
−Removed: (Gain) loss on cash flow hedging activities reclassified from accumulated other comprehensive income (loss) to interest expense, net of income tax expense (benefit) of $ 1,137 , $ — and ($ 355 )
+Added: Gain on cash flow hedging activities reclassified from accumulated other comprehensive loss to interest expense, net of income tax expense of $ 1,593 , $ 1,137 and $ — , respectively
( 4,793 ) ( 3,423 ) —
−Removed: Unrealized loss on fair value hedging activities, net of income tax benefit of $ — , $ — and $ 43 , respectively
Other comprehensive income (loss) ( 105,520 ) 283,362 ( 725,149 )
2 unchanged sentences
JAZZ PHARMACEUTICALS PLC
−Removed: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
+Added: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY—(Continued)
(In thousands)
5 unchanged sentences
Balance at December 31, 2023 62,255 $ 6 4,000 $ 55 $ 473 $ 3,699,954 $ ( 842,147 ) $ 878,656 $ 3,736,997
−Removed: Issuance of ordinary shares in connection with the acquisition of GW Pharmaceuticals plc 3,798 — — — — 608,456 — — 608,456
−Removed: Share-based payment -precombination service in connection with the acquisition of GW Pharmaceuticals plc — — — — — 3,555 — — 3,555
Issuance of ordinary shares in conjunction with exercise of share options 22 — — — — 1,629 — — 1,629
1 unchanged sentence
Issuance of ordinary shares in conjunction with vesting of restricted stock units 892 — — — — — — — —
+Added: Issuance of ordinary shares in conjunction with vesting of performance-based restricted stock units 80 — — — — — — — —
Shares withheld for payment of employee's withholding tax liability — — — — — ( 57,753 ) — — ( 57,753 )
Share-based compensation — — — — — 250,694 — — 250,694
+Added: Shares repurchased ( 2,830 ) — — — — — — ( 311,429 ) ( 311,429 )
Other comprehensive loss — — — — — — ( 105,520 ) — ( 105,520 )
−Removed: Net loss — — — — — — — ( 329,668 ) ( 329,668 )
+Added: Net income — — — — — — — 560,120 560,120
Balance at December 31, 2024 60,631 $ 6 4,000 $ 55 $ 473 $ 3,913,542 $ ( 947,667 ) $ 1,127,347 $ 4,093,756
+Added: The accompanying notes are an integral part of these consolidated financial statements.
+Added: JAZZ PHARMACEUTICALS PLC
+Added: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
+Added: (In thousands)
+Added: Ordinary Shares Non-voting Euro Deferred Capital Redemption Reserve Additional
+Added: Capital Accumulated
+Added: Comprehensive
+Added: Loss Retained Earnings Total
+Added: Shares Amount Shares Amount
+Added: Balance at December 31, 2021 61,633 $ 6 4,000 $ 55 $ 472 $ 3,534,792 $ ( 400,360 ) $ 830,226 $ 3,965,191
Cumulative effect adjustment from adoption of ASU 2020-06 — — — — — ( 333,524 ) — 127,474 ( 206,050 )
8 unchanged sentences
Balance at December 31, 2022 63,214 6 4,000 55 472 3,477,124 ( 1,125,509 ) 733,586 3,085,734
−Removed: JAZZ PHARMACEUTICALS PLC
−Removed: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY—(Continued)
−Removed: (In thousands)
−Removed: Ordinary Shares Non-voting Euro Deferred Capital Redemption Reserve Additional
−Removed: Capital Accumulated
−Removed: Comprehensive
−Removed: Loss Retained Earnings Total
−Removed: Shares Amount Shares Amount
−Removed: Balance at December 31, 2022 63,214 $ 6 4,000 $ 55 $ 472 $ 3,477,124 $ ( 1,125,509 ) $ 733,586 $ 3,085,734
Issuance of ordinary shares in conjunction with exercise of share options 280 — — — — 30,189 — — 30,189
7 unchanged sentences
Balance at December 31, 2023 62,255 $ 6 4,000 $ 55 $ 473 $ 3,699,954 $ ( 842,147 ) $ 878,656 $ 3,736,997
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
JAZZ PHARMACEUTICALS PLC
9 unchanged sentences
Acquisition accounting inventory fair value step-up adjustment 135,014 151,446 273,392
−Removed: Impairment of property, plant and equipment 61,014 — —
Depreciation 32,754 30,412 30,302
+Added: Provision for losses on accounts receivable and inventory 27,758 11,113 14,537
Non-cash interest expense 21,973 22,378 37,973
Acquired in-process research and development 10,000 19,000 444,148
−Removed: Provision for losses on accounts receivable and inventory 11,113 14,537 19,668
−Removed: Deferred tax expense (benefit) ( 260,217 ) ( 292,251 ) 69,198
+Added: Deferred tax benefit ( 208,327 ) ( 260,217 ) ( 292,251 )
+Added: Impairment of property, plant and equipment — 61,014 —
Intangible asset impairment charge — — 133,648
15 unchanged sentences
Investing activities
−Removed: Proceeds from maturity of investments 270,000 60,000 1,095,000
−Removed: Acquired in-process research and development ( 19,000 ) ( 444,148 ) —
−Removed: Purchases of property, plant and equipment ( 23,962 ) ( 29,046 ) ( 27,641 )
Acquisition of investments ( 1,305,125 ) ( 390,100 ) ( 61,036 )
−Removed: Proceeds from sale of a business — 53,000 —
+Added: Purchases of property, plant and equipment ( 38,070 ) ( 23,962 ) ( 29,046 )
+Added: Acquired in-process research and development ( 10,000 ) ( 19,000 ) ( 444,148 )
+Added: Proceeds from maturity of investments 845,000 270,000 60,000
Acquisition of intangible assets — — ( 25,000 )
−Removed: Acquisition of a business, net of cash acquired — — ( 6,234,792 )
+Added: Proceeds from sale of a business — — 53,000
Net cash used in investing activities ( 508,195 ) ( 163,062 ) ( 446,230 )
Financing activities
+Added: Net proceeds from issuance of 2030 Notes 980,767 — —
Proceeds from employee equity incentive and purchase plans 20,647 46,459 98,020
+Added: Payment of debt modification costs ( 5,716 ) — —
Repayments of long-term debt ( 31,000 ) ( 31,000 ) ( 582,014 )
1 unchanged sentence
Share repurchases ( 311,429 ) ( 269,761 ) ( 54 )
−Removed: Net proceeds from issuance of borrowings under credit agreement — — 3,719,930
−Removed: Net proceeds from issuance of Senior Secured Notes, due 2029 — — 1,471,533
−Removed: Payments for repurchase of Exchangeable Senior Notes, due 2021 — — ( 218,812 )
−Removed: Net cash (used in) provided by financing activities ( 305,254 ) ( 529,491 ) 3,970,522
+Added: Repayment of 2024 Notes ( 575,000 ) — —
+Added: Net cash provided by (used in) financing activities 20,516 ( 305,254 ) ( 529,491 )
Effect of exchange rates on cash and cash equivalents ( 1,675 ) 1,137 ( 6,222 )
−Removed: Net increase (decrease) in cash and cash equivalents 624,828 290,034 ( 466,321 )
+Added: Net increase in cash and cash equivalents 906,554 624,828 290,034
Cash and cash equivalents, at beginning of period 1,506,310 881,482 591,448
14 unchanged sentences
We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.
−Removed: We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.
−Removed: Within these therapeutic areas, we strive to identify new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science.
+Added: We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
+Added: Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
Our lead marketed products, listed below, are approved in countries around the world to improve patient care.
−Removed: • Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution , a product approved by the U.S.
−Removed: Food and Drug Administration, or FDA, in July 2020 and launched in the U.S.
−Removed: in November 2020 for the treatment of cataplexy or excessive daytime sleepiness, or EDS, in patients seven years of age and older with narcolepsy, and also approved by FDA in August 2021 for the treatment of idiopathic hypersomnia, or IH, in adults and launched in the U.S.
+Added: • Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution , a product approved by FDA in July 2020, and launched in the U.S.
+Added: in November 2020 for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy, and also approved by FDA in August 2021 for the treatment of IH in adults and launched in the U.S.
in November 2021.
Xywav contains 92% less sodium than Xyrem®.
−Removed: • Xyrem (sodium oxybate) oral solution , a product approved by FDA and distributed in the U.S.
−Removed: for the treatment of cataplexy or EDS in patients seven years of age or older with narcolepsy;
−Removed: Jazz also markets Xyrem in Canada for the treatment of cataplexy in patients with narcolepsy.
−Removed: Xyrem is also approved and distributed in the European Union, or EU (EU market authorizations include Northern Ireland), Great Britain and other markets through a licensing agreement;
+Added: Xywav is also approved in Canada for the treatment of cataplexy in patients with narcolepsy.
• Epidiolex® (cannabidiol) oral solution , a product approved by FDA and launched in the U.S.
−Removed: in 2018 by GW Pharmaceuticals plc, or GW, and currently indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, or LGS, Dravet syndrome, or DS, or tuberous sclerosis complex, or TSC, in patients one year of age or older;
+Added: in 2018 by GW and currently indicated for the treatment of seizures associated with LGS, DS, or TSC in patients one year of age or older;
in the EU and Great Britain (where it is marketed as Epidyolex®) and other markets, it is approved for adjunctive treatment of seizures associated with LGS or DS, in conjunction with clobazam (EU and Great Britain only), in patients 2 years of age and older and for adjunctive treatment of seizures associated with TSC in patients 2 years of age and older.
• Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) , a product approved by FDA in June 2021 and launched in the U.S.
−Removed: in July 2021 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia or lymphoblastic lymphoma in adults and pediatric patients aged one month or older who have developed hypersensitivity to E.
+Added: in July 2021 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL or LBL in adults and pediatric patients aged one month or older who have developed hypersensitivity to E.
coli -derived asparaginase.
−Removed: In September 2023, the European Commission granted marketing authorization for this therapy under the trade name Enrylaze;
+Added: In September 2023, the European Commission granted marketing authorization under the trade name Enrylaze.
+Added: This therapy is also approved in markets including Great Britain, Canada and Switzerland.
• Zepzelca® (lurbinectedin) , a product approved by FDA in June 2020 under FDA's accelerated approval pathway and launched in the U.S.
−Removed: in July 2020 for the treatment of adult patients with metastatic small cell lung cancer, or SCLC, with disease progression on or after platinum-based chemotherapy;
+Added: in July 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy;
in Canada, Zepzelca received conditional approval in September 2021 for the treatment of adults with Stage III or metastatic SCLC, who have progressed on or after platinum-containing therapy.
+Added: • Ziihera® (zanidatamab-hrii) , a product approved by FDA in November 2024 under FDA’s accelerated approval pathway and launched in the U.S.
+Added: in December 2024 for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as detected by an FDA-approved test.
Throughout this report, unless otherwise indicated or the context otherwise requires, all references to “Jazz Pharmaceuticals,” “the registrant,” "the Company", “we,” “us,” and “our” refer to Jazz Pharmaceuticals plc and its consolidated subsidiaries.
3 unchanged sentences
The consolidated financial statements have been prepared in accordance with U.S.
−Removed: generally accepted accounting principles, or U.S.
GAAP, and include the accounts of Jazz Pharmaceuticals plc and our subsidiaries.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: transactions and balances have been eliminated.
+Added: Intercompany transactions and balances have been eliminated.
Our consolidated financial statements include the results of operations of businesses we have acquired from the date of each acquisition for the applicable reporting periods.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Use of Estimates
4 unchanged sentences
Adoption of New Accounting Standards
−Removed: In October 2021, the Financial Accounting Standards Board issued ASU 2021-08, “Business Combinations (Topic 805):
−Removed: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”, or ASU 2021-08, which requires entities to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC 2014-09, “Revenue from Contracts with Customers (Topic 606)”.
−Removed: The update will generally result in an entity recognizing contract assets and contract liabilities at amounts consistent with those recorded by the acquiree immediately before the acquisition date rather than at fair value.
−Removed: ASU 2021-08 was effective for the Company from January 1, 2023 and adoption did not have a material impact on our consolidated financial statements.
−Removed: We will apply to future business combinations, if any.
+Added: In November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures”, which requires enhanced disclosures about significant segment expenses.
+Added: The amendments are effective retrospectively to all prior periods presented in the financial statements, for fiscal years beginning after December 15, 2023.
+Added: The new guidance has not had a material impact on our financial statement disclosures.
Significant Risks and Uncertainties
−Removed: Historically, our business was substantially dependent on Xyrem and while we expect that our business will continue to meaningfully depend on oxybate revenues from both Xywav and Xyrem, there is no guarantee that oxybate revenues will remain at current levels, or that oxybate revenues will otherwise grow in future periods.
−Removed: In this regard, our ability to maintain or increase oxybate revenues and realize the anticipated benefits from our investment in Xywav are subject to a number of risks and uncertainties including, without limitation, those related to the launch of Xywav for the treatment of IH in adults and adoption in that indication;
−Removed: competition from the recent introduction of two authorized generic, or AG, versions of high-sodium oxybate and new products, such as Avadel’s Lumryz, for treatment of cataplexy and/or EDS in narcolepsy in the U.S.
+Added: We expect that our business will continue to meaningfully depend on oxybate revenues;
+Added: however, there is no guarantee that oxybate revenues will remain at current levels.
+Added: In this regard, our ability to maintain oxybate revenues and realize the anticipated benefits from our investment in Xywav are subject to a number of risks and uncertainties including, without limitation, those related to the commercialization of Xywav for the treatment of IH in adults and adoption in that indication;
+Added: competition from the introduction of two AG versions of high-sodium oxybate and a branded fixed-dose, high-sodium oxybate, Avadel’s Lumryz, for treatment of cataplexy and/or EDS in narcolepsy in the U.S.
market, as well as potential future competition from additional AG versions of high-sodium oxybate and from generic versions of high-sodium oxybate and from other competitors;
−Removed: increased pricing pressure from, changes in policies by, or restrictions on reimbursement imposed by, third party payors, including our ability to maintain adequate coverage and reimbursement for Xywav and Xyrem;
+Added: increased pricing pressure from, changes in policies by, or restrictions on reimbursement imposed by, third party payors, including our ability to maintain adequate coverage and reimbursement for Xywav;
increased rebates required to maintain access to our products;
1 unchanged sentence
and continued acceptance of Xywav and Xyrem by physicians and patients.
−Removed: A significant decline in oxybate revenues could cause us to reduce our operating expenses or seek to raise additional funds, which would have a material adverse effect on our business, financial condition, results of operations and growth prospects, including on our ability to acquire, in-license or develop new products to grow our business.
+Added: A significant decline in oxybate revenues could cause us to reduce our operating expenses or seek to raise additional funds and would have a material adverse effect on our business, financial condition, results of operations and growth prospects, including on our ability to acquire, in-license or develop new products to grow our business.
In addition to risks related specifically to Xywav and Xyrem, we are subject to other challenges and risks related to successfully commercializing a portfolio of oncology products and other neuroscience products, and other 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:
−Removed: ongoing clinical research activity and related outcomes, obtaining regulatory approval of our late-stage product candidates;
−Removed: effectively commercializing our approved or acquired products such as Epidiolex, Rylaze and Zepzelca;
+Added: ongoing clinical research activity and related outcomes;
+Added: obtaining regulatory approval of our late-stage product candidates;
+Added: effectively commercializing our approved products such as Epidiolex, Rylaze, Zepzelca and Ziihera;
obtaining and maintaining adequate coverage and reimbursement for our products;
3 unchanged sentences
regulatory concerns with controlled substances generally and the potential for abuse;
−Removed: future legislation, action by the U.S.
+Added: future legislation;
+Added: action by the U.S.
Federal Government authorizing the sale, distribution, use, and insurance reimbursement of non-FDA approved cannabinoid products;
−Removed: delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations;
+Added: delays or problems in the supply of our products;
+Added: loss of single source suppliers or failure to comply with manufacturing regulations;
delays or problems with third parties that are part of our manufacturing and supply chain;
identifying, acquiring or in-licensing additional products or product candidates;
−Removed: our ability to realize the anticipated benefits of acquired or in-licensed products or product candidates, such as Epidiolex and Zanidatamab, at the expected levels, with the expected costs and within the expected timeframe;
+Added: our ability to realize the anticipated benefits of acquired or in-licensed products or product candidates, such as Epidiolex and Ziihera, at the expected levels, with the expected costs and within the expected timeframe;
pharmaceutical product development and the inherent uncertainty of clinical success;
2 unchanged sentences
and possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Concentrations of Risk
5 unchanged sentences
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.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
We manage our foreign currency transaction risk and interest rate risk within specified guidelines through the use of derivatives.
1 unchanged sentence
As of December 31, 2024 and 2023, we had foreign exchange forward contracts with notional amounts totaling $ 461.2 million and $ 511.7 million, respectively.
−Removed: As of December 31, 2023 and 2022, the outstanding foreign exchange forward contracts had a net asset fair value of $ 17.4 million.
−Removed: As of December 31, 2023, we had interest rate swap contracts with notional amounts totaling $ 500.0 million.
−Removed: These outstanding interest rate swap contracts had a net asset fair value of $ 0.4 million as of December 31, 2023.
+Added: As of December 31, 2024 and 2023, the outstanding foreign exchange forward contracts had a net liability fair value of $ 7.9 million and a net asset fair value of $ 17.4 million, respectively.
+Added: As of December 31, 2024 and 2023, we had interest rate swap contracts with notional amounts totaling $ 500.0 million.
+Added: As of December 31, 2024 and 2023, these outstanding interest rate swap contracts had a net asset fair value of $ 1.0 million and $ 0.4 million, respectively.
The counterparties to these contracts are large multinational commercial banks, and we believe the risk of nonperformance is not significant.
5 unchanged sentences
Historically, we have not experienced significant credit losses on our accounts receivable and as of December 31, 2024, allowances on receivables were not material.
−Removed: As of December 31, 2023, five customers accounted for 79 % of gross accounts receivable, including Express Scripts Specialty Distribution Services, Inc.
−Removed: and its affiliates, or ESSDS, which accounted for 41 % of gross accounts receivable, ASD Specialty Healthcare LLC, which accounted for 13 % of gross accounts receivable and McKesson Corporation and affiliates, or McKesson, which accounted for 11 % of gross accounts receivable.
−Removed: As of December 31, 2022, five customers accounted for 87 % of gross accounts receivable, including ESSDS, which accounted for 55 % of gross accounts receivable, Cardinal Health Inc, which accounted for 10 % of gross accounts receivable and McKesson, which accounted for 9 % of gross accounts receivable.
−Removed: We depend on single source suppliers for most of our products, product candidates and their active pharmaceutical ingredients, or APIs.
+Added: As of December 31, 2024, five customers accounted for 80 % of gross accounts receivable, including ESSDS, which accounted for 39 % of gross accounts receivable, ASD, which accounted for 15 % of gross accounts receivable and McKesson, which accounted for 13 % of gross accounts receivable.
+Added: As of December 31, 2023, five customers accounted for 79 % of gross accounts receivable, including ESSDS, which accounted for 41 % of gross accounts receivable, ASD, which accounted for 13 % of gross accounts receivable and McKesson, which accounted for 11 % of gross accounts receivable.
+Added: We depend on single source suppliers for most of our products, product candidates and their APIs.
With respect to our oxybate products, the API is manufactured for us by a single source supplier and the finished products are manufactured both by us in our facility in Athlone, Ireland and by our U.S.-based supplier.
2 unchanged sentences
We account for acquired businesses using the acquisition method of accounting.
−Removed: The acquisition method of accounting for acquired businesses requires, among other things, that assets acquired, liabilities assumed and any noncontrolling interests in the acquired business be recognized at their estimated fair values as of the acquisition date, with limited exceptions, and that the fair value of acquired in-process research and development, or IPR&D, be recorded on the balance sheet.
+Added: The acquisition method of accounting for acquired businesses requires, among other things, that assets acquired, liabilities assumed and any noncontrolling interests in the acquired business be recognized at their estimated fair values as of the acquisition date, with limited exceptions, and that the fair value of acquired IPR&D, be recorded on the balance sheet.
Also, transaction costs are expensed as incurred.
9 unchanged sentences
Realized gains and losses and declines in value judged to be other than temporary on investments are included in interest expense, net in the consolidated statements of income (loss).
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Derivative Instruments and Hedging Activities
3 unchanged sentences
For derivatives formally designated as hedges, we assess both at inception and quarterly thereafter, whether the hedging derivatives are highly effective in offsetting changes in either the fair value or cash flows of the hedged item.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Gains or losses on cash flow hedges are reclassified from other comprehensive income (loss) to earnings when the hedged transaction occurs.
31 unchanged sentences
Operating leases are included in operating lease assets, accrued liabilities, and operating lease liabilities on our consolidated balance sheets.
−Removed: Finance lease assets are included in property, plant and equipment, net, and
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: finance lease liabilities are included in accrued liabilities and other non-current liabilities in our consolidated balance sheets.
+Added: Finance lease assets are included in property, plant and equipment, net, and finance lease liabilities are included in accrued liabilities and other non-current liabilities in our consolidated balance sheets.
Lease assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date.
4 unchanged sentences
Finance lease expense is recognized as depreciation expense of property, plant and equipment and interest expense on finance lease liabilities.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
We have lease agreements with lease and non-lease components, which are generally accounted for separately.
18 unchanged sentences
Revenue Recognition
−Removed: Our revenue comprises product sales, net and royalty and contract revenues.
+Added: Our revenue is comprised of product sales, net and royalties and contract revenues.
Revenues are recognized when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.
4 unchanged sentences
Reserves for Variable Consideration
−Removed: Revenues from sales of products are recorded at the net sales price, which includes estimates of variable consideration for which reserves are established and which relate to returns, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans and
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: commercial payor contracts.
+Added: Revenues from sales of products are recorded at the net sales price, which includes estimates of variable consideration for which reserves are established and which relate to returns, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans and commercial payor contracts.
Calculating certain of these reserves involves estimates and judgments and we determine their expected value based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates for these programs and channel inventory data.
These reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract.
−Removed: The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
+Added: A large portion of the reserve relates to rebates where there is significant judgment, in particular in the determination of the sales utilization percentage used to calculate the Epidiolex Medicaid rebate accrual.
+Added: The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: the cumulative revenue recognized will not occur in a future period.
We reassess our reserves for variable consideration at each reporting date.
19 unchanged sentences
Research and Development
−Removed: Research and development expenses consist primarily of costs related to clinical studies and outside services, personnel expenses, milestone expenses and other research and development costs, including milestone payments incurred prior to regulatory approval of products.
+Added: Research and development expenses consist primarily of costs related to clinical studies and outside services, personnel expenses, and other research and development costs, including milestone payments incurred prior to regulatory approval of products.
Clinical study and outside services costs relate primarily to services performed by clinical research organizations, clinical studies performed at clinical sites, materials and supplies, and other third party fees.
4 unchanged sentences
For products that have been approved by FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the trial.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Advertising Expenses
2 unchanged sentences
We use the asset and liability method of accounting for income taxes.
−Removed: Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amount and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse.
+Added: Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amount and the tax basis of assets and
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse.
A valuation allowance is provided to reduce deferred tax assets to the amount that is more-likely-than-not to be realized.
1 unchanged sentence
A recognized tax benefit is then measured as the largest amount of tax benefit that is greater than fifty percent likely of being realized upon settlement.
−Removed: Interest and penalties related to income taxes are included in the income tax expense and classified with the related liability on the consolidated balance sheets.
+Added: Interest and penalties related to income taxes are included in income tax expense and classified with the related liability on the consolidated balance sheets.
Foreign Currency
20 unchanged sentences
Performance-Based Restricted Stock Unit Awards
−Removed: Performance-based restricted stock units, or PRSUs, awarded to employees vest upon the achievement of certain performance criteria at the end of a specified performance period, subject to a relative total shareholder return, or TSR, modifier.
+Added: PRSUs awarded to employees vest upon the achievement of certain performance criteria at the end of a specified performance period.
+Added: For PRSUs granted prior to 2024, the amount of shares awarded will be subject to adjustment based on the application of a TSR modifier.
+Added: For PRSUs granted in 2024, the relative TSR modifier represents one of the performance metrics.
The estimated fair value of these PRSUs is based on a Monte Carlo simulation model.
2 unchanged sentences
Variable Interest Entity
−Removed: In the year ended December 31, 2021, we invested in a cell of a protected cell company, or the protected cell, as part of our directors’ and officers’ liability risk financing strategy.
+Added: In 2021, we invested in a protected cell as part of our directors’ and officers’ liability risk financing strategy.
Based on our control and the structure of the protected cell, we concluded that Jazz is the primary beneficiary of the protected cell and is required to consolidate the protected cell.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: insurance premium payable to the protected cell for the years ended December 31, 2022 and 2021 and the protected cell’s assets and liabilities as of December 31, 2023 and 2022 were immaterial.
−Removed: No premium was payable for the year ended December 31, 2023.
+Added: There was no insurance premium payable to the protected cell for the years ended December 31, 2024 and 2023 and it was immaterial for the year ended December 31, 2022.
+Added: The protected cell’s assets and liabilities as of December 31, 2024 and 2023 were immaterial .
Recent Accounting Pronouncements
−Removed: In November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures”, which requires enhanced disclosures about significant segment expenses.
−Removed: The amendments are effective retrospectively to all prior periods presented in the financial statements, for fiscal years beginning after December 15, 2023.
+Added: In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures”, which requires enhanced income tax disclosures providing greater disaggregation of information in the
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: Company's effective tax rate reconciliation and disaggregates income taxes paid by jurisdiction.
+Added: The amendments are effective on a prospective basis, with the option to apply it retrospectively, for fiscal years beginning after December 15, 2024.
We are currently evaluating the impact of adopting this new accounting guidance.
−Removed: In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures”, which requires additional enhanced tax disclosures.
+Added: In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-04) - Disaggregation of Income Statement Expenses”, which requires additional disclosure in the notes to the financial statements of the nature of certain expenses included in the income statement.
The amendments are effective on a prospective basis, with the option to apply it retrospectively, for fiscal years beginning after December 15, 2026.
We are currently evaluating the impact of adopting this new accounting guidance.
−Removed: Collaborations, Disposition and Business Combination
+Added: Collaborations and Disposition
License Agreements
−Removed: In November 2023, we entered into an exclusive licensing and collaboration agreement with Autifony Therapeutics Limited, or Autifony, to discover and develop drug candidates targeting two different ion channel targets associated with neurological disorders.
+Added: In February 2024, we entered into a definitive asset purchase agreement with Redx to acquire global rights to a KRAS inhibitor program.
+Added: Under the terms of the agreement, we made an upfront payment of $ 10.0 million to Redx which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the year ended December 31, 2024.
+Added: Redx is eligible to receive development and commercial milestone payments of up to $ 870.0 million and, if a product is approved, a tiered, mid-single-digit percentage royalty on net sales of that product.
+Added: In November 2023, we entered into an exclusive licensing and collaboration agreement with Autifony to discover and develop drug candidates targeting two different ion channel targets associated with neurological disorders.
Under the terms of the agreement, we made an upfront payment of $ 18.0 million to Autifony, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the year ended December 31, 2023.
Autifony is eligible to receive development and commercial milestone payments of up to $ 752.5 million and, if a product is approved, a tiered, mid-single-digit percentage royalty on net sales of that product.
−Removed: In October 2022, we entered into an exclusive licensing and collaboration agreement with Zymeworks Inc., or Zymeworks, providing us the right to acquire development and commercialization rights to Zymeworks' zanidatamab across all indications in the United States, Europe, Japan and all other territories except for those Asia/Pacific territories previously licensed by Zymeworks.
+Added: In October 2022, we entered into an exclusive licensing and collaboration agreement with Zymeworks providing us the right to acquire development and commercialization rights to Zymeworks' zanidatamab across all indications in the United States, Europe, Japan and all other territories except for those Asia/Pacific territories previously licensed by Zymeworks.
In December 2022, we exercised the option to continue with the exclusive development and commercialization rights to zanidatamab.
2 unchanged sentences
We recorded the $ 375.0 million as acquired IPR&D expense in our consolidated statements of income (loss) for the year ended December 31, 2022.
−Removed: Zymeworks is also eligible to receive regulatory and commercial milestone payments of up to $ 1.4 billion, for total potential payments of $ 1.76 billion.
−Removed: Pending approval, Zymeworks is eligible to receive tiered royalties between 10 % and 20 % on our net sales.
−Removed: In May 2022, we entered into a licensing agreement with Sumitomo Pharma Co., Ltd, or Sumitomo, to acquire exclusive development and commercialization rights in the U.S., Europe and other territories for DSP-0187, now referred to as JZP441.
+Added: In November 2024, we announced FDA accelerated approval of Ziihera for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, triggering a regulatory milestone payment of $ 25.0 million, which was capitalized as an intangible asset on our consolidated balance sheet.
+Added: Zymeworks is also eligible to receive regulatory and commercial milestone payments of up to $ 1.4 billion, for total potential payments of $ 1.8 billion, as well as incremental tiered royalties on future net sales of Ziihera ranging from 10 % to 20 %.
+Added: In May 2022, we entered into a licensing agreement with Sumitomo to acquire exclusive development and commercialization rights in the U.S., Europe and other territories for DSP-0187, now referred to as JZP441.
JZP441 is a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, IH and other sleep disorders.
1 unchanged sentence
Sumitomo is eligible to receive development, regulatory and commercial milestone payments of up to $ 1.09 billion and, if JZP441 is approved, a tiered, low double-digit royalty on Jazz's net sales of JZP441.
−Removed: In April 2022, we entered into a licen sing and collaboration agreement with Werewolf Therapeutics, Inc., or Werewolf, to acquire exclusive global development and commercialization rights t o Werewolf's investigational WTX-613, now referred to as JZP898.
+Added: In April 2022, we entered into a licensing and collaboration agreement with Werewolf to acquire exclusive global development and commercialization rights to Werewolf's investigational WTX-613, now referred to as JZP898.
JZP898 is a differentiated, conditionally-activated interferon alpha (IFNα) INDUKINE™ molecule.
1 unchanged sentence
Werewolf is eligible to receive further development, regulatory and commercial milestone payments of up to $ 1.26 billion and, if JZP898 is approved, a tiered, mid-single-digit percentage royalty on net sales of JZP898.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Sunosi Disposition
−Removed: In March 2022, we entered into a definitive agreement to divest Sunosi to Axsome Therapeutics, Inc., or Axsome.
+Added: In March 2022, we entered into a definitive agreement to divest Sunosi to Axsome.
In May 2022, we completed the U.S.
2 unchanged sentences
Under the terms of the sale agreement, Axsome received the rights to Sunosi in all of the existing territories available to us.
−Removed: We received an
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: upfront payment of $ 53.0 million, and have the right to receive a high single-digit royalty on Axsome’s U.S.
+Added: We received an upfront payment of $ 53.0 million, and have the right to receive a high single-digit royalty on Axsome’s U.S.
net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome’s U.S.
3 unchanged sentences
We determined that the disposal of Sunosi did not qualify for reporting as a discontinued operation since it did not represent a strategic shift that has or will have a major effect on our operations and financial results.
−Removed: GW Acquisition
−Removed: On May 5, 2021, or the Closing Date, we acquired the entire issued share capital of GW.
−Removed: As a result, GW became an indirect wholly owned subsidiary of the Company.
−Removed: We acquired GW with the objective of broadening our neuroscience portfolio, further diversifying our revenue and driving sustainable, long-term value creation opportunities.
−Removed: GW was a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid research to address a broad range of diseases.
−Removed: The aggregate consideration for the GW Acquisition was $ 7.2 billion as follows (all amounts in thousands except American Depositary Shares, or ADS, and per GW ADS amounts):
−Removed: GW ADS outstanding May 5, 2021 31,556,200
−Removed: Cash consideration per GW ADS $ 200
−Removed: Total cash consideration to GW ADS holders $ 6,311,240
−Removed: Cash consideration to GW share option holders (inclusive of payroll taxes) 267,450
−Removed: Total cash consideration 6,578,690
−Removed: Equity consideration to GW ADS holders (1) 608,456
−Removed: Consideration related to replacement share option pre-combination service 3,555
−Removed: Total equity consideration 612,011
−Removed: Total purchase consideration $ 7,190,701
−Removed: ________________________
−Removed: (1) 3.8 million ordinary shares were issued to GW ADS holders.
−Removed: The closing price of the ordinary shares on May 4, 2021 ($ 160.20 ) was used to determine the fair value of this equity consideration because the closing of the transaction on May 5, 2021 occurred prior to the opening of regular trading.
−Removed: In April 2021, we closed an offering of $ 1.5 billion in aggregate principal amount of 4.375 % senior secured notes, due 2029, or the Secured Notes.
−Removed: In May 2021, we entered into a credit agreement, or the Credit Agreement, that provides for (i) a seven-year $ 3.1 billion term loan B facility, or the Dollar Term Loan, (ii) a seven-year € 625.0 million term loan B facility, or the Euro Term Loan and, together with the Dollar Term Loan, collectively known as the Term Loan and (iii) a five-year $ 500.0 million revolving credit facility, or the Revolving Credit Facility.
−Removed: We financed the cash portion of the GW Acquisition consideration through a combination of cash on hand and borrowings under the Term Loan and the Secured Notes.
−Removed: For further information on the Term Loan and the Secured Notes, please see Note 12.
−Removed: The GW Acquisition was accounted for as a business combination using the acquisition method under which assets and liabilities of GW were recorded at their respective estimated fair values as of the Closing Date and added to the assets and liabilities of the Company, including an amount for goodwill representing the difference between the acquisition consideration and the estimated fair value of the identifiable net assets.
−Removed: The results of operations of GW have been included in our consolidated financial statements since the Closing Date.
−Removed: In 2021, we incurred $ 81.9 million in acquisition-related costs related to the GW Acquisition, which primarily consisted of banking, legal, accounting and valuation-related expenses.
−Removed: These expenses were recorded in selling, general and administrative expense in the accompanying consolidated statements of income (loss).
−Removed: In 2021, our consolidated statements of income (loss) included revenues of $ 476.4 million and a net loss of $ 704.6 million from the acquired GW business, as measured from the Closing Date.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: The following table summarizes the fair values of assets acquired and liabilities assumed at the Closing Date (in thousands):
−Removed: Fair Values of Assets Acquired and Liabilities Assumed
−Removed: Cash and cash equivalents $ 343,898
−Removed: Accounts receivable 76,355
−Removed: Inventory 1,206,290
−Removed: Prepaid expenses and other current assets 72,758
−Removed: Property, plant and equipment 154,407
−Removed: Acquired developed technologies 5,480,000
−Removed: In-process research and development
−Removed: Total acquired identifiable intangible assets 5,640,000
−Removed: Goodwill 933,234
−Removed: Deferred tax liabilities, net ( 1,069,076 )
−Removed: Accrued liabilities ( 131,971 )
−Removed: Other assets/liabilities ( 35,194 )
−Removed: Total purchase consideration $ 7,190,701
−Removed: Inventories acquired included raw materials, work in progress and finished goods.
−Removed: Inventories were recorded at their estimated fair values.
−Removed: The inventory was valued at estimated selling price less the estimated costs to be incurred to complete (in the case of work in progress) and sell the inventory, the associated margins on these activities and holding costs.
−Removed: A step-up in value of inventory of $ 1,062.6 million was recorded in connection with the GW Acquisition.
−Removed: The step-up expense will be recorded in cost of product sales on our consolidated statements of income (loss) as the inventory is sold to customers from the Closing Date.
−Removed: Intangible assets
−Removed: The fair value of acquired intangible assets was $ 5,640.0 million.
−Removed: The intangible assets included acquired developed technologies, primarily related to Epidiolex, and IPR&D.
−Removed: The fair value of the Epidiolex acquired developed technology asset was determined by applying the income approach, which recognizes that the fair value of an asset is premised upon the expected receipt of future economic benefits such as earnings and cash inflows based on current sales projections and estimated direct costs, using a discount rate of 9.4 % that reflects the return requirements of the market.
−Removed: This intangible asset is being amortized over an estimated useful life of 12 years.
−Removed: We acquired a nabiximols IPR&D asset in the acquisition.
−Removed: In 2022, we recorded an impairment charge of $ 133.6 million to write off the value of this asset as a result of our decision to discontinue the program.
−Removed: Some of the more significant assumptions inherent in the development of intangible asset fair values include:
−Removed: the amount and timing of projected future cash flows (including revenue, cost of sales, research and development cost and sales and marketing expenses);
−Removed: probability of success;
−Removed: the discount rate selected to measure inherent risk of future cash flows;
−Removed: and the assessment of the asset’s life cycle and the competitive trends impacting the asset, among other factors.
−Removed: Deferred tax liabilities, net
−Removed: The net deferred tax liability relates to the difference between the financial statement carrying amount and the tax basis of acquired intangible assets and inventory, partially offset by acquired net operating loss carryforwards and other temporary differences.
−Removed: Other tangible assets and liabilities
−Removed: Other tangible assets and liabilities were valued at their respective carrying amounts as management believes that these amounts approximated their acquisition-date fair values.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: Goodwill represents the excess of the total purchase consideration over the estimated fair value of net assets acquired and was recorded in the consolidated balance sheet as of the Closing Date.
−Removed: The goodwill was primarily attributable to the establishment of the deferred tax liability for the acquired intangible assets and inventory.
−Removed: We do not expect any portion of this goodwill to be deductible for income tax purposes.
Cash and Available-for-Sale Securities
30 unchanged sentences
Available-for-sale securities:
−Removed: Time deposits $ — $ 420,000 $ 420,000 $ — $ 30,000 $ 30,000
Money market funds $ 1,253,970 $ — $ 1,253,970 $ 768,586 $ — $ 768,586
−Removed: Interest rate contracts — 3,784 3,784 — — —
+Added: Time deposits — 790,000 790,000 — 420,000 420,000
Foreign exchange forward contracts — 2,250 2,250 — 18,035 18,035
−Removed: Totals $ 768,586 $ 441,819 $ 1,210,405 $ 517,464 $ 47,356 $ 564,820
Interest rate contracts — 991 991 — 3,784 3,784
+Added: Totals $ 1,253,970 $ 793,241 $ 2,047,211 $ 768,586 $ 441,819 $ 1,210,405
Foreign exchange forward contracts $ — $ 10,198 $ 10,198 $ — $ 681 $ 681
+Added: Interest rate contracts — — — — 3,410 3,410
Totals $ — $ 10,198 $ 10,198 $ — $ 4,091 $ 4,091
7 unchanged sentences
The carrying amount, which is recorded within other non-current assets, is based on the latest observable transaction price.
−Removed: As of December 31, 2023, the estimated fair values of the 1.50 % exchangeable senior notes due 2024, or 2024 Notes and the 2.00 % exchangeable senior notes due 2026, or 2026 Notes, which we refer to collectively as the Exchangeable Senior Notes, were approximately $ 559.0 million and $ 1.0 billion, respectively.
−Removed: As of December 31, 2023, the estimated fair value of the Secured Notes and the Dollar Term Loan were approximately $ 1.4 billion and $ 2.7 billion , respectively.
+Added: As of December 31, 2024, the estimated fair values of the 2026 Notes, the 2030 Notes, the Secured Notes and the Tranche B-2 Dollar Term Loans were $ 1.0 billion, $ 1.1 billion, $ 1.4 billion and $ 2.7 billion, respectively.
The fair values of each of these debt facilities was estimated using quoted market prices obtained from brokers (Level 2).
6 unchanged sentences
dollar denominated liabilities, including intercompany balances.
−Removed: Hedge accounting is not applied to these derivative instruments as gains and losses on these hedge
+Added: 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.
+Added: As of December 31, 2024 and 2023 ,
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: transactions are designed to offset gains and losses on underlying balance sheet exposures.
−Removed: As of December 31, 2023 and 2022 , the notional amount of foreign exchange contracts where hedge accounting was not applied was $ 511.7 million and $ 505.0 million, respectively.
−Removed: The foreign exchange gain (loss) in our consolidated statements of income (loss) included the following gains and losses associated with foreign exchange contracts not designated as hedging instruments (in thousands):
+Added: the notional amount of foreign exchange contracts where hedge accounting was not applied was $ 461.2 million and $ 511.7 million, respectively.
+Added: The foreign exchange gain (loss) in our consolidated statements of income (loss) included the following gains (losses) associated with foreign exchange contracts not designated as hedging instruments (in thousands):
Year Ended December 31,
6 unchanged sentences
As a result of these agreements, the interest rate on a portion of our term loan borrowings is fixed at 3.9086 %, plus the borrowing spread, until April 30, 2026.
−Removed: Our previous interest rate swap was entered into in March 2017.
−Removed: In May 2021, we repaid the term loan to which these interest rate swap agreements related, at which point the interest rate swap contracts were de-designated as cash flow hedges.
−Removed: These interest rate swap agreements matured in July 2021.
−Removed: The impact on accumulated other comprehensive income (loss) and earnings from derivative instruments that qualified as cash flow hedges was as follows (in thousands):
+Added: The impact on accumulated other comprehensive loss and earnings from derivative instruments that qualified as cash flow hedges was as follows (in thousands):
Year Ended December 31,
Interest Rate Contracts:
−Removed: 2023 2022 2021
−Removed: Gain (loss) recognized in accumulated other comprehensive income (loss), net of tax $ 3,658 $ — $ ( 14 )
−Removed: (Gain) loss reclassified from accumulated other comprehensive income (loss) to interest expense, net of tax ( 3,423 ) — 2,482
−Removed: Assuming no change in the U.S dollar Secured Overnight Financing Rate, or Term SOFR based interest rates from market rates as of December 31, 2023, $ 2.8 million of gains, net of tax, recognized in accumulated other comprehensive income (loss) will be reclassified to earnings over the next 12 months.
+Added: Gain recognized in accumulated other comprehensive loss, net of tax $ 5,298 $ 3,658
+Added: Gain reclassified from accumulated other comprehensive loss to interest expense, net of tax ( 4,793 ) ( 3,423 )
+Added: Assuming no change in the Term SOFR based interest rates from market rates as of December 31, 2024, $ 0.7 million of gains, net of tax, recognized in accumulated other comprehensive loss will be reclassified to earnings over the next 12 months.
In order to hedge our exposure to foreign currency exchange risk associated with our Euro Term Loan, we entered into a cross-currency interest rate swap contract in May 2021, which matured in March 2022, and was de-designated as a fair value hedge.
2 unchanged sentences
dollar foreign exchange rates recognized within foreign exchange gain (loss) in the consolidated statements of income (loss).
−Removed: The impact on accumulated other comprehensive income (loss) and earnings from the cross-currency interest rate swap contract was as follows (in thousands):
+Added: The impact on accumulated other comprehensive loss and earnings from the cross-currency interest rate swap contract was as follows (in thousands):
Year Ended December 31,
Cross-Currency Interest Rate Contract:
−Removed: Loss recognized in accumulated other comprehensive income (loss), net of tax $ — $ ( 375 )
−Removed: Loss reclassified from accumulated other comprehensive income (loss) to foreign exchange loss, net of tax 128 246
+Added: Loss reclassified from accumulated other comprehensive loss to foreign exchange loss, net of tax $ 128
Loss recognized in foreign exchange loss 2,646
14 unchanged sentences
Balance Sheet Location Fair Value Balance Sheet Location Fair Value
+Added: Derivatives designated as hedging instruments:
+Added: Interest rate contracts Other current assets $ 3,784 Accrued liabilities $ —
+Added: Other non-current assets — Other non-current liabilities 3,410
Derivatives not designated as hedging instruments:
2 unchanged sentences
Although we do not offset derivative assets and liabilities within our 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.
−Removed: These provisions were not applicable as of December 31, 2022 since all derivatives were in an asset position.
−Removed: The following table summarizes the potential effect on our consolidated balance sheets of offsetting our interest rate contracts and foreign exchange forward contracts subject to such provisions as of December 31, 2023 (in thousands):
+Added: The following table summarizes the potential effect on our consolidated balance sheets of offsetting our interest rate and foreign exchange forward contracts subject to such provisions (in thousands):
December 31, 2024
3 unchanged sentences
Derivative liabilities ( 10,198 ) — ( 10,198 ) 2,910 — ( 7,288 )
+Added: December 31, 2023
+Added: 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
+Added: Description Derivative Financial Instruments Cash Collateral Received (Pledged) Net Amount
+Added: Derivative assets $ 21,819 $ — $ 21,819 $ ( 4,091 ) $ — $ 17,728
+Added: Derivative liabilities ( 4,091 ) — ( 4,091 ) 4,091 — —
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Inventories consisted of the following (in thousands):
3 unchanged sentences
Total inventories $ 480,445 $ 597,039
−Removed: As of December 31, 2023 and 2022, inventories included $ 328.0 million and $ 457.6 million, respectively, related to the purchase accounting inventory fair value step-up on inventory acquired in the GW Acquisition.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: Other Current Assets
−Removed: Other current assets consisted of the following (in thousands):
−Removed: Deferred charge for income taxes on intercompany profit $ 171,507 $ 176,057
−Removed: Other 149,302 91,135
−Removed: Total other current assets $ 320,809 $ 267,192
+Added: As of December 31, 2024 and 2023, inventories included $ 191.2 million and $ 328.0 million, respectively, related to the purchase accounting inventory fair value step-up on inventory acquired as part of our GW Acquisition.
Property, Plant and Equipment
16 unchanged sentences
Balance at December 31, 2024 $ 1,716,323
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The gross carrying amounts and net book values of our intangible assets were as follows (in thousands):
10 unchanged sentences
Total finite-lived intangible assets $ 7,713,412 $ ( 2,957,717 ) $ 4,755,695 $ 7,800,209 $ ( 2,382,170 ) $ 5,418,039
−Removed: The increase in the gross carrying amount of intangible assets as of December 31, 2023 compared to December 31, 2022 primarily relates to the positive impact of foreign currency translation adjustments due to the strengthening of sterling against the U.S.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: The decrease in the gross carrying amount of intangible assets as of December 31, 2024 compared to December 31, 2023 primarily relates to the negative impact of foreign currency translation adjustments due to the weakening of sterling and euro against the U.S.
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.
5 unchanged sentences
Total $ 4,755,695
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Accrued Liabilities
2 unchanged sentences
Employee compensation and benefits 153,133 121,209
−Removed: Accrued facilities expenses 55,455 25,864
Clinical trial accruals 49,962 44,757
1 unchanged sentence
Accrued royalties 36,802 30,706
+Added: Accrued milestones 27,500 —
+Added: Selling and marketing accruals 26,981 14,743
Sales return reserve 26,428 20,435
Consulting and professional services 26,221 19,538
−Removed: Current portion of lease liabilities 19,447 15,938
−Removed: Selling and marketing accruals 14,743 18,553
Inventory-related accruals 25,509 13,977
+Added: Accrued development expenses 23,099 15,431
Accrued collaboration expenses 18,005 10,158
−Removed: Accrued construction-in-progress 5,141 3,298
+Added: Current portion of lease liabilities 14,779 19,447
Derivative instrument liabilities 10,198 681
+Added: Accrued construction-in-progress 10,061 5,141
+Added: Accrued facilities expenses 6,107 55,455
Other 71,819 60,082
Total accrued liabilities $ 910,947 $ 793,914
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The following table summarizes the carrying amount of our indebtedness (in thousands):
5 unchanged sentences
2026 Notes, net 996,253 993,600
+Added: 2030 Notes 1,000,000 —
+Added: Unamortized - debt issuance costs ( 19,135 ) —
+Added: 2030 Notes, net 980,865 —
Secured Notes 1,483,841 1,480,214
4 unchanged sentences
Total long-term debt $ 6,077,640 $ 5,107,988
−Removed: ______________________________
−Removed: (1) Balance as of December 31, 2023 includes the 2024 Notes since they mature in August 2024.
+Added: (1) Balance as of December 31, 2023 includes the 2024 Notes as they matured in August 2024.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Credit Agreement
−Removed: On May 5, 2021, the Company, Jazz Financing Lux S.à.r.l., or Jazz Lux, and certain of our other subsidiaries, as borrowers, or collectively with the Company and Jazz Lux, the “Borrowers”, entered into the Credit Agreement by and among the Borrowers, the lenders and issuing banks from time to time party thereto, Bank of America, N.A., as administrative agent and U.S.
−Removed: Bank Trust Company, National Association, as collateral trustee, or the Credit Agreement, that provided for (i) the Dollar Term Loan which was drawn by Jazz Lux on the Closing Date in U.S.
−Removed: dollars (ii) the Euro Term Loan which was drawn by Jazz Lux on the Closing Date in Euros and (iii) the Revolving Credit Facility.
−Removed: We used the proceeds from the Term Loan (i) to repay in full $ 575.9 million under that certain credit agreement, dated as of June 18, 2015 (as amended) among the Company, and certain of our other subsidiaries as borrowers, the lenders party thereto and Bank of America, N.A., as administrative agent and collateral agent, or the Existing Credit Agreement, (ii) to fund, in part, the cash consideration payable in connection with the GW Acquisition and (iii) to pay related fees and expenses.
−Removed: Upon the repayment in full of loans under the Existing Credit Agreement, it was terminated and all guarantees and liens thereunder were released.
+Added: On May 5, 2021, Jazz Pharmaceuticals plc, Jazz Lux, and certain of our other subsidiaries, as borrowers, or, collectively with Jazz Pharmaceuticals plc and Jazz Lux, the “Borrowers”, entered into the Credit Agreement.
+Added: The Credit Agreement initially provided for (i) the Dollar Term Loan, which was drawn by Jazz Lux on the closing date thereof in U.S.
+Added: dollars (ii) the Euro Term Loan, which was drawn by Jazz Lux on the closing date thereof in Euros and (iii) the Initial Revolving Credit Facility.
+Added: We used the proceeds from the Dollar Term Loan (i) to repay in full $ 575.9 million under the 2015 Credit Agreement, (ii) to fund, in part, the cash consideration payable in connection with the GW Acquisition and (iii) to pay related fees and expenses.
+Added: Upon the repayment in full of loans under the 2015 Credit Agreement, it was terminated and all guarantees and liens thereunder were released.
In 2021, we made voluntary prepayments on the Euro Term Loan totaling € 416.7 million, or $ 502.0 million, and in March 2022 we repaid the remaining outstanding principal of € 208.3 million, or $ 251.0 million.
−Removed: The Euro Term Loan bore interest at the Euro Inter-Bank Offered Rate, or EURIBOR, plus an applicable margin.
−Removed: The applicable margin for the Euro Term Loan was 3.50 %.
+Added: The Euro Term Loan bore interest at the EURIBOR plus an applicable margin.
During the term of the Euro Term Loan, the interest rate and effective interest rate were 4.43 % and 4.93 %, respectively.
−Removed: In January 2024, Jazz Lux entered into an amendment, or Repricing Amendment, to the Credit Agreement.
−Removed: Upon entry into the Repricing Amendment, certain existing lenders converted outstanding Dollar Term Loans into a new tranche of U.S.
−Removed: dollar term loans, or the Tranche B-1 Dollar Term Loans, and Jazz Lux borrowed $ 201.9 million aggregate principal amount of additional Tranche B-1 Dollar Term Loans, the proceeds of which were used to repay the outstanding Dollar Term Loans that were not converted.
−Removed: The Tranche B-1 Dollar Term Loans are a separate class of term loans under the Credit Agreement with the same material terms (including with respect to maturity, prepayment, security, covenants and events of default) as the previously outstanding Dollar Term Loans, with the interest rate amended as described below.
−Removed: The principal amount of Dollar Term Loans outstanding immediately prior to the Repricing Amendment and the outstanding principal amount of Tranche B-1 Dollar Term Loans immediately following the Repricing Amendment, each totaled $ 2.723 billion.
+Added: In January 2024, Jazz Lux entered into the Repricing Amendment No.1 to the Credit Agreement.
+Added: Upon entry into the Repricing Amendment No.1, certain existing lenders converted a portion of the outstanding Dollar Term Loan into the Tranche B-1 Dollar Term Loans, and Jazz Lux borrowed $ 201.9 million aggregate principal amount of additional Tranche B-1 Dollar Term Loans, the proceeds of which were used to repay the portion of the outstanding Dollar Term Loan that was not converted.
+Added: In July 2024, Jazz Lux entered into the Repricing Amendment No.
+Added: 2 to the Credit Agreement, as amended by the Repricing Amendment No.
+Added: Upon entry into Repricing Amendment No.
+Added: 2, certain existing lenders converted a portion of the outstanding Tranche B-1 Dollar Term Loans into the Tranche B-2 Dollar Term Loans, and Jazz Lux borrowed $ 289.6 million aggregate principal amount of additional Tranche B-2 Dollar Term Loans, the proceeds of which were used to repay the portion of the outstanding Tranche B-1 Dollar Term Loans that were not converted.
+Added: The Tranche B-2 Dollar Term Loans are a separate class of term loans under the Credit Agreement, as amended by Repricing Amendment No.
+Added: 1 and Repricing Amendment No.
+Added: 2, with the same material terms (including with respect to maturity, prepayment, security, covenants and events of default) as the previously outstanding Tranche B-1 Dollar Term Loans and the initial Dollar Term Loan incurred on May 5, 2021, with the interest rate amended as described below and the credit spread adjustment removed.
+Added: The principal amount of Tranche B-1 Dollar Term Loans outstanding immediately prior to the Repricing Amendment No.
+Added: 2 and the outstanding principal amount of Tranche B-2 Dollar Term Loans immediately following the Repricing Amendment No.2, each totaled $ 2.7 billion.
The Tranche B-2 Dollar Term Loans bear interest at a rate equal to either (a) Term SOFR or (b) the prime lending rate, in each case, plus an applicable margin.
−Removed: The applicable margin for the Tranche B-1 Dollar Term Loans is 3.00 % (in the case of Term SOFR borrowings) and
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: 2.00 % (in the case of borrowings at the prime lending rate), a decrease of 50 basis points from the applicable margin on the Initial Dollar Term Loans.
+Added: The applicable margin for the Tranche B-2 Dollar Term Loans is 2.25 % (in the case of Term SOFR borrowings) and 1.25 % (in the case of borrowings at the prime lending rate), a decrease, in each case, of 75 basis points from the applicable margin on the Tranche B-1 Dollar Term Loans.
The Tranche B-2 Dollar Term Loans are subject to a Term SOFR floor of 0.50 %.
−Removed: The applicable margin for the Revolving Credit Facility ranges from 3.25 % to 2.75 % (in the case of Term SOFR borrowings) and 2.25 % to 1.75 % (in the case of borrowings at the prime lending rate), depending on our first lien secured net leverage ratio level.
−Removed: The Tranche B-1 Dollar Term Loan is subject to a Term SOFR floor of 0.50 % and loans under the Revolving Credit Facility are not subject to a floor.
−Removed: The Revolving Credit Facility has a commitment fee payable on the undrawn amount ranging from 0.50 % to 0.40 % per annum based upon our first lien secured net leverage ratio.
−Removed: As of December 31, 2023, the interest rate and effective interest rate on the Dollar Term Loan were 8.97 % and 4.56 %, respectively.
−Removed: Pursuant to the Repricing Amendment, the interest rate and effective interest rate on the Tranche B-1 Dollar Term Loans are 8.90 % and 9.50 %, respectively.
−Removed: As of December 31 ,2023, we had an undrawn Revolving Credit Facility totaling $ 500.0 million.
−Removed: We may make voluntary prepayments at any time without payment of a premium or penalty, subject to certain exceptions, and are required to make certain mandatory prepayments of outstanding indebtedness under the Credit Agreement in certain circumstances.
+Added: As of December 31, 2024, the interest rate and effective interest rate on the Tranche B-2 Dollar Term Loans were 6.61 % and 8.27 %, respectively.
+Added: In November 2024, we entered into Amendment No.
+Added: 3 to the Credit Agreement, as amended by the Repricing Amendment No.
+Added: 1 and Repricing Amendment No.
+Added: 2, to increase the Initial Revolving Credit Facility from $ 500.0 million to $ 885.0 million and extend the maturity date, or Amended Revolving Credit Facility, from May 5, 2026 to November 26, 2029 (such date, the “Amended Revolving Facility Maturity Date”), provided that:
+Added: • if, as of any date from March 16, 2026 to the maturity date of the 2026 Notes (any such date, the “2026 Notes Springing Maturity Date”), (x) any 2026 Notes (or any permitted refinancing indebtedness in respect thereof with a maturity date that is not later than the date that is 91 days after the Amended Revolving Facility Maturity Date) (any such indebtedness, the “2026 Maturity Indebtedness”) remain outstanding and (y) the aggregate amount of unrestricted cash of Jazz Pharmaceuticals plc and its subsidiaries is less than an amount equal to 125 % of the aggregate principal amount of 2026 Maturity Indebtedness outstanding, then the maturity date for the Amended Revolving Credit Facility will be shortened to the 2026 Notes Springing Maturity Date;
+Added: • if, as of February 4, 2028, (x) more than $ 500,000,000 of the Tranche B-2 Dollar Term Loans under the Amended Credit Agreement (and any extended term loans, refinancing term loans, refinancing notes and permitted refinancing indebtedness, in each case, in respect thereof) (any such indebtedness, the “Term Loan Indebtedness”) remains outstanding and (y) the maturity date of such Term Loan Indebtedness is not later than the date that is 91 days after
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: the Amended Revolving Facility Maturity Date, then the maturity date for the Amended Revolving Credit Facility will be shortened to February 4, 2028;
+Added: • if, as of October 16, 2028 (such date, the “Senior Notes Springing Maturity Date”), (x) more than $ 500,000,000 of the Secured Notes (and permitted refinancing indebtedness in respect thereof) (any such indebtedness, the “Senior Note Indebtedness”) remains outstanding and (y) the maturity date with respect to such Senior Note Indebtedness is not later than the date that is 91 days after the Amended Revolving Facility Maturity Date, then the maturity date for the Amended Revolving Credit Facility will be shortened to October 16, 2028.
+Added: Initially, the applicable margin for the loans under the Amended Revolving Credit Facility will be 2.00 % (in the case of Term SOFR borrowings) and 1.00 % (in the case of borrowings at the prime lending rate).
+Added: Thereafter, the applicable margin for the Amended Revolving Credit Facility ranges from 1.75 % to 2.75 % (in the case of Term SOFR borrowings) and 0.75 % to 1.75 % (in the case of borrowings at the prime lending rate), depending on our first lien secured net leverage ratio level, and any loans under the Amended Revolving Credit Facility are subject to a Term SOFR floor of 0.00 %.
+Added: The Amended Revolving Credit Facility has a commitment fee payable on the undrawn amount ranging from 0.25 % to 0.45 % per annum based upon our first lien secured net leverage ratio.
+Added: As of December 31, 2024, we had an undrawn Amended Revolving Credit Facility totaling $ 885.0 million.
+Added: We may make voluntary prepayments at any time without payment of a premium or penalty, subject to certain exceptions, and are required to make certain mandatory prepayments of outstanding indebtedness under the Amended Credit Agreement in certain circumstances.
Principal repayments of the Dollar Term Loan, which were due quarterly, began in September 2021 and were equal to 1.0 % per annum of the original principal amount of $ 3.1 billion with any remaining balance payable on the maturity date.
In September 2022, we made a voluntary repayment on the Dollar Term Loan totaling $ 300.0 million.
−Removed: The Tranche B-1 Dollar Term Loans will amortize in quarterly installments equal to 0.284664830 % of the initial principal amount thereof, with the remaining balance payable on May 5, 2028.
−Removed: The Borrowers’ obligations under the Credit Agreement and any hedging or cash management obligations entered into with any lender thereunder are guaranteed by the Company, the other borrowers, and each of the Company’s other existing or subsequently acquired or organized direct and indirect subsidiaries (subject to certain exceptions), or the Guarantors.
+Added: In January 2025, we made a voluntary repayment on the Tranche B-2 Dollar Term Loans totaling $ 750.0 million.
+Added: The Tranche B-2 Dollar Term Loans will amortize in quarterly installments equal to 0.286294791 % of the initial aggregate principal amount thereof, with the remaining balance payable on May 5, 2028.
+Added: Our obligations under the Amended Credit Agreement and any hedging or cash management obligations entered into with any lender thereunder are guaranteed by Jazz Pharmaceuticals plc, the other borrowers, and each of the Jazz Pharmaceuticals plc’s other existing or subsequently acquired or organized direct and indirect subsidiaries (subject to certain exceptions), or the Guarantors.
We refer to the Borrowers and the Guarantors collectively as the “Loan Parties.”
−Removed: The Loan Parties’ obligations under the Credit Agreement are secured, subject to customary permitted liens and other exceptions, by a security interest in (a) all tangible and intangible assets of the Loan Parties, except for certain excluded assets, and (b) all of the equity interests of the subsidiaries of the Loan Parties held by the Loan Parties.
−Removed: The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to the Company and its restricted subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of junior indebtedness and dividends and other distributions.
−Removed: The Credit Agreement contains financial covenants that require the Company and its restricted subsidiaries to (a) not exceed a maximum first lien secured net leverage ratio and (b) not fall below a minimum interest coverage ratio, provided that such covenants apply only to the Revolving Credit Facility and are applicable only if amounts are drawn (or non-cash collateralized letters of credit in excess of $ 50 million are outstanding) under the Revolving Credit Facility.
−Removed: The Credit Agreement also contains customary events of default relating to, among other things, failure to make payments, breach of covenants and breach of representations.
+Added: The Loan Parties’ obligations under the Amended Credit Agreement are secured, subject to customary permitted liens and other exceptions, by a security interest in (a) all tangible and intangible assets of the Loan Parties, except for certain excluded assets, and (b) all of the equity interests of the subsidiaries of the Loan Parties held by the Loan Parties.
+Added: The Amended Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to Jazz Pharmaceuticals plc and its restricted subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of junior indebtedness and dividends and other distributions.
+Added: The Amended Credit Agreement contains financial covenants that require Jazz Pharmaceuticals plc and its restricted subsidiaries to (a) not exceed a maximum first lien secured net leverage ratio and (b) not fall below a minimum interest coverage ratio, provided that such covenants apply only to the Amended Revolving Credit Facility and are applicable only if amounts are drawn (or non-cash collateralized letters of credit in excess of $ 50.0 million are outstanding) under the Amended Revolving Credit Facility.
+Added: The Amended Credit Agreement also contains customary events of default relating to, among other things, failure to make payments, breach of covenants and breach of representations.
2029 Senior Secured Notes
−Removed: On April 29, 2021, Jazz Securities Designated Activity Company, or Jazz Securities, a direct wholly owned subsidiary of the Company, closed the offering of the Secured Notes in a private placement.
+Added: On April 29, 2021, Jazz Securities, a wholly owned subsidiary of Jazz Pharmaceuticals plc, closed the offering of the Secured Notes in a private placement.
We used the proceeds from the Secured Notes to fund, in part, the cash consideration payable in connection with the GW Acquisition.
1 unchanged sentence
The Secured Notes mature on January 15, 2029.
−Removed: The Secured Notes are jointly and severally guaranteed by the Company and each of its restricted subsidiaries, other than Jazz Securities, that is a borrower, or a guarantor, under the Credit Agreement.
−Removed: The Secured Notes and related guarantees are secured by a first priority lien (subject to permitted liens and certain other exceptions), equally and ratably with the Credit Agreement, on the collateral securing the Credit Agreement.
−Removed: Except as described below, the Secured Notes may not be optionally redeemed before July 15, 2024.
−Removed: Thereafter, some or all of the Secured Notes, may be redeemed at any time and from time to time at a specified redemption prices, plus accrued and unpaid interest, if any, to, but excluding, to the redemption date.
−Removed: Jazz Securities may redeem all but not part of the Secured Notes at its option at any time in connection with certain tax-related events and may redeem some or all of the Secured Notes at any time and from time to time prior to July 15, 2024 at a price equal to 100 % of the principal amount of the Secured Notes to be redeemed plus a “make whole” premium, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.
−Removed: In addition, Jazz Securities may redeem up to 40 % of the aggregate principal amount of the Secured Notes at any time and from time to time prior to July 15, 2024, with the net proceeds of certain equity offerings at a price of 104.375 % of the principal amount of such Secured Notes, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.
−Removed: In addition, during each of the three consecutive twelve-month periods commencing on the issue date of the Secured Notes, Jazz Securities
+Added: The Secured Notes are jointly and severally guaranteed by Jazz Pharmaceuticals plc and each of its restricted subsidiaries, other than Jazz Securities, that is a borrower, or a guarantor, under the Amended Credit Agreement.
+Added: The Secured Notes and related guarantees are secured by a first priority lien (subject to permitted liens and certain other exceptions), equally and ratably with the Amended Credit Agreement, on the collateral securing the Amended Credit Agreement.
+Added: Some or all of the Secured Notes, may be redeemed at any time and from time to time at a specified redemption prices, plus accrued and unpaid interest, if any, to, but excluding, to the redemption date.
+Added: In addition, Jazz Securities may redeem all
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: may redeem up to 10 % of the original aggregate initial principal amount of the Secured Notes at a redemption price of 103 % of the principal amount of such Secured Notes, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.
+Added: but not part of the Secured Notes at its option at any time in connection with certain tax-related events at a price equal to 100 % of the principal amount of the Secured Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.
If Jazz undergoes a change of control, Jazz Securities will be required to make an offer to purchase all of the Secured Notes at a purchase price in cash equal to 101 % of the principal amount thereof, plus accrued and unpaid interest, if any, to, but excluding, the date of repurchase, subject to certain exceptions.
−Removed: The indenture governing the Secured Notes contains customary affirmative covenants and negative covenants applicable to the Company and its restricted subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of junior indebtedness and dividends and other distributions.
−Removed: If Jazz Securities or the Company’s restricted subsidiaries engage in certain asset sales, Jazz Securities will be required under certain circumstances to make an offer to purchase the Secured Notes at 100 % of the principal amount, plus accrued and unpaid interest, if any, to, but excluding, the repurchase date.
+Added: The indenture governing the Secured Notes contains customary affirmative covenants and negative covenants applicable to Jazz Pharmaceuticals plc and its restricted subsidiaries, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of junior indebtedness and dividends and other distributions.
+Added: If Jazz Securities or Jazz Pharmaceuticals plc’s restricted subsidiaries engage in certain asset sales, Jazz Securities will be required under certain circumstances to make an offer to purchase the Secured Notes at 100 % of the principal amount, plus accrued and unpaid interest, if any, to, but excluding, the repurchase date.
As of December 31, 2024, the interest rate and effective interest rate on the Secured Notes were 4.375 % and 4.64 %, respectively.
−Removed: Exchangeable Senior Notes Due 2026
+Added: In September 2024, Jazz Investments, a wholly owned subsidiary of Jazz Pharmaceuticals plc , completed a private placement of $ 1.0 billion principal amount of the 2030 Notes.
+Added: Interest on the 2030 Notes is payable semi-annually in cash in arrears on March 15 and September 15 of each year, beginning on March 15, 2025, at a rate of 3.125 % per year.
+Added: In certain circumstances, we may be required to pay additional amounts as a result of any applicable tax withholding or deductions required in respect of payments on the 2030 Notes.
+Added: The 2030 Notes mature on September 15, 2030, unless earlier exchanged, redeemed or repurchased.
+Added: The holders of the 2030 Notes have the ability to require us to repurchase all or a portion of their 2030 Notes for cash at a fundamental change repurchase price equal to 100 % of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date in the event we undergo a fundamental change (as defined in the indenture related to the 2030 Notes), such as specified change of control transactions, our liquidation or dissolution or the delisting of our ordinary shares from any of The New York Stock Exchange, The Nasdaq Global Market, The Nasdaq Global Select Market or The Nasdaq Capital Market (or any of their respective successors).
+Added: Additionally, the terms and covenants in the indenture related to the 2030 Notes include certain events of default after which the 2030 Notes may be due and payable immediately.
+Added: Prior to September 15, 2030, we may redeem the 2030 Notes, in whole but not in part, in connection with certain tax-related events.
+Added: We also may redeem the 2030 Notes on or after September 20, 2027 and prior to June 15, 2030, in whole or in part (subject to the partial redemption limitation described in the indenture related to the 2030 Notes), if the last reported sale price per ordinary share has been at least 130 % of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100 % of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.
+Added: The 2030 Notes are exchangeable at an initial exchange rate of 6.5339 ordinary shares per $1,000 principal amount of 2030 Notes, which is equivalent to an initial exchange price of approximately $ 153.05 per ordinary share.
+Added: Upon exchange of the 2030 Notes, we will pay cash up to the aggregate principal amount of the 2030 Notes to be exchanged and pay or deliver, as the case may be, cash, ordinary shares or a combination of cash and ordinary shares, at our election, in respect of the remainder, if any, of our exchange obligation in excess of the aggregate principal amount of the 2030 Notes being exchanged.
+Added: The exchange rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.
+Added: In addition, following certain make-whole fundamental changes (as defined in the indenture related to the 2030 Notes) that occur prior to the maturity date or upon our issuance of a notice of redemption, we will, in certain circumstances, increase the exchange rate for a holder who elects to exchange its 2030 Notes in connection with that make-whole fundamental change or exchange its 2030 Notes called (or deemed called) for redemption during the related redemption period.
+Added: Prior to June 15, 2030, the 2030 Notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.
+Added: As of December 31, 2024, the “if converted value” did not exceed the principal amount of the 2030 Notes.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: The total liability is reflected net of issuance costs of $ 19.2 million which will be amortized over the term of the 2030 Notes.
+Added: We have determined the expected life of the 2030 Notes to be equal to the original six-year term.
+Added: The effective interest rate of the 2030 Notes is 3.47 %.
In 2020 we completed a private placement of $ 1.0 billion principal amount of the 2026 Notes.
−Removed: We used a portion of the net proceeds from this offering to repurchase for cash $ 332.9 million aggregate principal amount of the 1.875 % exchangeable senior notes due 2021, or 2021 Notes, through privately-negotiated transactions concurrently with the offering of the 2026 Notes.
+Added: We used a portion of the net proceeds from this offering to repurchase for cash $ 332.9 million aggregate principal amount of the 1.875 % exchangeable senior notes due 2021, through privately-negotiated transactions concurrently with the offering of the 2026 Notes.
Interest on the 2026 Notes is payable semi-annually in cash in arrears on June 15 and December 15 of each year, beginning on December 15, 2020, at a rate of 2.00 % per year.
4 unchanged sentences
Prior to June 15, 2026, we may redeem the 2026 Notes, in whole but not in part, subject to compliance with certain conditions, if we have, or on the next interest payment date would, become obligated to pay to the holder of any 2026 Notes additional amounts as a result of certain tax-related events.
−Removed: We also may redeem the 2026 Notes on or after June 20, 2023 and prior to March 15, 2026, in whole or in part, if the last reported sale price per ordinary share has been at least 130 % of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide the notice of redemption.
+Added: We also may redeem the 2026 Notes prior to March 15, 2026, in whole or in part, if the last reported sale price per ordinary share has been at least 130 % of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide the notice of redemption.
The 2026 Notes are exchangeable at an initial exchange rate of 6.4182 ordinary shares per $1,000 principal amount of 2026 Notes, which is equivalent to an initial exchange price of approximately $ 155.81 per ordinary share.
−Removed: Upon exchange, the 2026 Notes may be settled in cash, ordinary shares or a combination of cash and ordinary shares, at our election.
−Removed: Our intent and policy is to settle the principal amount of the 2026 Notes in cash upon exchange.
+Added: On July 22, 2024, we irrevocably elected to fix the settlement method for exchanges of the 2026 Notes to a combination of cash and ordinary shares of Jazz Pharmaceuticals plc with a specified cash amount per $1,000 principal amount of 2026 Notes exchanged equal to or in excess of $ 1,000 .
+Added: As a result, for any 2026 Notes exchanged subsequent to such notice, an exchanging holder will receive (i) up to $ 1,000 in cash per $1,000 principal amount of 2026 Notes exchanged and (ii) cash, ordinary shares, or any combination thereof, at our election, in respect of the remainder, if any, of its exchange obligation in excess of $ 1,000 per $1,000 principal amount of 2026 Notes exchanged.
The exchange rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.
1 unchanged sentence
Prior to March 15, 2026, the 2026 Notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.
−Removed: As of December 31, 2023, the “if converted value” did not exceed the principal amount of the 2026 Notes.
−Removed: As of December 31, 2022, the “if converted value” of the 2026 Notes exceeded the principal amount by $ 22.5 million.
+Added: As of December 31, 2024 and 2023, the “if converted value” did not exceed the principal amount of the 2026 Notes.
The total liability is reflected net of issuance costs of $ 15.3 million which will be amortized over the term of the 2026 Notes.
1 unchanged sentence
The effective interest rate of the 2026 Notes is 2.26 %.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: Exchangeable Senior Notes Due 2024
In 2017, we completed a private placement of $ 575.0 million principal amount of 2024 Notes.
−Removed: We used the net proceeds from this offering to repay $ 500.0 million in outstanding loans under the revolving credit facility and to pay related fees and expenses.
+Added: We used the net proceeds from this offering to repay $ 500.0 million in outstanding loans under the Initial Revolving Credit Facility and to pay related fees and expenses.
We used the remainder of the net proceeds for general corporate purposes.
−Removed: Interest on the 2024 Notes is payable semi-annually in cash in arrears on February 15 and August 15 of each year, beginning on February 15, 2018, at a rate of 1.50 % per year.
−Removed: In certain circumstances, we may be required to pay additional amounts as a result of any applicable tax withholding or deductions required in respect of payments on the 2024 Notes.
−Removed: The 2024 Notes mature on August 15, 2024, unless earlier exchanged, repurchased or redeemed.
−Removed: The holders of the 2024 Notes have the ability to require us to repurchase all or a portion of their 2024 Notes for cash in the event we undergo certain fundamental changes, such as specified change of control transactions, our liquidation or dissolution or the delisting of our ordinary shares from The Nasdaq Global Select Market.
−Removed: Prior to August 15, 2024, we may redeem the 2024 Notes, in whole but not in part, subject to compliance with certain conditions, if we have, or on the next interest payment date would, become obligated to pay to the holder of any 2024 Notes additional amounts as a result of certain tax-related events.
−Removed: We also may redeem the 2024 Notes on or after August 20, 2021, in whole or in part, if the last reported sale price per ordinary share has been at least 130 % of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide the notice of redemption.
−Removed: The 2024 Notes are exchangeable at an initial exchange rate of 4.5659 ordinary shares per $1,000 principal amount of 2024 Notes, which is equivalent to an initial exchange price of approximately $ 219.02 per ordinary share.
−Removed: In August 2023, we made an irrevocable election to fix the settlement method for exchanges of the 2024 Notes to a combination of cash and ordinary shares of the Company with a specified cash amount per $1,000 principal amount of the 2024 Notes of $1,000.
−Removed: The exchange rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.
−Removed: In addition, following certain make-whole fundamental changes occurring prior to the maturity date of the 2024 Notes or upon our issuance of a notice of redemption, we will in certain circumstances increase the exchange rate for holders of the 2024 Notes who elect to exchange their 2024 Notes in connection with that make-whole fundamental change or during the related redemption period.
−Removed: Prior to May 15, 2024, the 2024 Notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.
−Removed: As of December 31, 2023 and 2022, the “if-converted value” did not exceed the principal amount of the 2024 Notes.
−Removed: The total liability is reflected net of issuance costs of $ 11.4 million which will be amortized over the term of the 2024 Notes.
−Removed: We have determined the expected life of the 2024 Notes to be equal to the original seven-year term.
−Removed: The effective interest rate of the 2024 Notes is 1.79 %.
+Added: Interest on the 2024 Notes was payable semi-annually in cash in arrears on February 15 and August 15 of each year, beginning on February 15, 2018, at a rate of 1.50 % per year.
+Added: The 2024 Notes were exchangeable at an initial exchange rate of 4.5659 ordinary shares per $1,000 principal amount of 2024 Notes, which was equivalent to an initial exchange price of approximately $ 219.02 per ordinary share.
+Added: On August 15, 2024, the maturity date for the 2024 Notes, we repaid the $ 575.0 million aggregate principal amount, plus accrued and unpaid interest thereon.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The Exchangeable Senior Notes were issued by Jazz Investments I Limited, or the Issuer, a 100 %-owned finance subsidiary of Jazz Pharmaceuticals plc.
3 unchanged sentences
There is no assurance that in the future such restrictions will not be adopted.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: For the years ended December 31, 2023 and 2022, we recognized $ 32.8 million, in interest expense, net, of which, $ 28.6 million related to the contractual coupon rate and $ 4.2 million related the amortization of the debt issuance costs on the Exchangeable Senior Notes.
−Removed: For the year ended December 31, 2021, we recognized $ 89.9 million in interest expense, net, of which, $ 31.2 million related to the contractual coupon rate, $ 4.4 million related to the debt issuance costs and $ 54.3 million related to the amortization of the debt discount costs.
+Added: For the year ended December 31, 2024, we recognized $ 40.0 million, in interest expense, net, of which $ 35.3 million related to the contractual coupon rate and $ 4.7 million related the amortization of the debt issuance costs on the 2024 Notes and the Exchangeable Senior Notes.
+Added: For the years ended December 31, 2023 and 2022, we recognized $ 32.8 million in interest expense, net, of which $ 28.6 million related to the contractual coupon rate and $ 4.2 million related to the amortization of the debt issuance costs.
Scheduled maturities with respect to our long-term debt are as follows (in thousands):
3 unchanged sentences
2028 2,598,500
+Added: 2029 1,500,000
Thereafter 1,000,000
9 unchanged sentences
Finance Lease Cost
−Removed: Amortization of leased asset 481 472 324
Interest on lease liabilities 442 377 429
+Added: Amortization of leased asset 413 481 472
Net lease cost $ 30,822 $ 26,601 $ 25,664
26 unchanged sentences
Operating lease assets obtained in exchange for new operating lease liabilities $ 25,819 $ 9,953 $ 4,312
−Removed: Finance lease assets obtained in exchange for new finance lease liabilities — — 650
De-recognition of operating lease asset on lease assignment / termination 19,877 4,169 —
12 unchanged sentences
Present value of lease liabilities $ 53,269 $ 5,009
+Added: On October 11, 2024, we entered into a new lease agreement for premises located at 3000 El Camino Real, Palo Alto, California, with occupancy expected by July 1, 2025.
+Added: The lease will be recognized on the lease commencement date with the lease ending in 2035.
Commitments and Contingencies
14 unchanged sentences
Xyrem Antitrust Litigation
−Removed: From June 2020 to May 2022, a number of lawsuits were filed on behalf of purported direct and indirect Xyrem purchasers, alleging that the patent litigation settlement agreements we entered with generic drug manufacturers who had filed Abbreviated New Drug Applications, or ANDA, violate state and federal antitrust and consumer protection laws, as follows:
−Removed: On June 17, 2020, a class action lawsuit was filed in the United States District Court for the Northern District of Illinois by Blue Cross and Blue Shield Association, or BCBS, against Jazz Pharmaceuticals plc, Jazz Pharmaceuticals, Inc., and Jazz Pharmaceuticals Ireland Limited, or, collectively, the Company Defendants (hereinafter referred to as the BCBS Lawsuit).
−Removed: The BCBS Lawsuit also names Roxane Laboratories, Inc., Hikma Pharmaceuticals USA Inc., Eurohealth (USA), Inc., Hikma Pharmaceuticals plc, Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., and Lupin Inc., or, collectively, the BCBS Defendants.
+Added: From June 2020 to May 2022, a number of lawsuits were filed on behalf of purported direct and indirect Xyrem purchasers, alleging that the patent litigation settlement agreements we entered with generic drug manufacturers who had filed ANDAs violate state and federal antitrust and consumer protection laws, as follows:
+Added: On June 17, 2020, a class action lawsuit was filed in the United States District Court for the Northern District of Illinois by BCBS against the Company Defendants.
+Added: The BCBS Lawsuit also the BCBS Defendants.
On June 18 and June 23, 2020, respectively, two additional class action lawsuits were filed against the Company Defendants and the BCBS Defendants:
one by the New York State Teamsters Council Health and Hospital Fund in the United States District Court for the Northern District of California, and another by the Government Employees Health Association Inc.
−Removed: in the United States District Court for the Northern District of Illinois (hereinafter referred to as the GEHA Lawsuit).
+Added: in the United States District Court for the Northern District of Illinois.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: On June 18, 2020, a class action lawsuit was filed in the United States District Court for the Northern District of California by the City of Providence, Rhode Island, on behalf of itself and all others similarly situated, against Jazz Pharmaceuticals plc, and Roxane Laboratories, Inc., West-Ward Pharmaceuticals Corp., Hikma Labs Inc., Hikma Pharmaceuticals USA Inc., and Hikma Pharmaceuticals plc, or, collectively, the City of Providence Defendants.
−Removed: On June 30, 2020, a class action lawsuit was filed in the United States District Court for the Northern District of Illinois by UFCW Local 1500 Welfare Fund on behalf of itself and all others similarly situated, against Jazz Pharmaceuticals Ireland Ltd., Jazz Pharmaceuticals, Inc., Roxane Laboratories, Inc., Hikma Pharmaceuticals plc, Eurohealth (USA), Inc.
−Removed: and West-Ward Pharmaceuticals Corp., or collectively the UFCW Defendants (hereinafter referred to as the UFCW Lawsuit).
+Added: On June 18, 2020, a class action lawsuit was filed in the United States District Court for the Northern District of California by the City of Providence, Rhode Island, on behalf of itself and all others similarly situated, against the City of Providence Defendants.
+Added: On June 30, 2020, a class action lawsuit was filed in the United States District Court for the Northern District of Illinois by UFCW Local 1500 Welfare Fund on behalf of itself and all others similarly situated, against UFCW Defendants.
On July 13, 2020, the plaintiffs in the BCBS Lawsuit and the GEHA Lawsuit dismissed their complaints in the United States District Court for the Northern District of Illinois and refiled their respective lawsuits in the United States District Court for the Northern District of California.
1 unchanged sentence
On July 31, 2020, a class action lawsuit was filed in the United States District Court for the Southern District of New York by the A.F.
−Removed: Building Trades Welfare Plan on behalf of itself and all others similarly situated, against Jazz Pharmaceuticals plc (hereinafter referred to as the AFL Plan Lawsuit).
+Added: Building Trades Welfare Plan on behalf of itself and all others similarly situated, against Jazz Pharmaceuticals plc.
The AFL Plan Lawsuit also names Roxane Laboratories Inc., West-Ward Pharmaceuticals Corp., Hikma Labs Inc., Hikma Pharmaceuticals plc, Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc.
−Removed: On August 14, 2020, an additional class action lawsuit was filed in the United States District Court for the Southern District of New York by the Self-Insured Schools of California on behalf of itself and all others similarly situated, against the Company Defendants, as well as Hikma Pharmaceuticals plc, Eurohealth (USA) Inc., Hikma Pharmaceuticals USA, Inc., West-Ward Pharmaceuticals Corp., Roxane Laboratories, Inc., Amneal Pharmaceuticals LLC, Endo International, plc, Endo Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., Lupin Inc., Sun Pharmaceutical Industries Ltd., Sun Pharmaceutical Holdings USA, Inc., Sun Pharmaceutical Industries, Inc., Ranbaxy Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Watson Laboratories, Inc., Wockhardt Ltd., Morton Grove Pharmaceuticals, Inc., Wockhardt USA LLC, Mallinckrodt plc, and Mallinckrodt LLC (hereinafter referred to as the Self-Insured Schools Lawsuit).
+Added: On August 14, 2020, an additional class action lawsuit was filed in the United States District Court for the Southern District of New York by the Self-Insured Schools of California on behalf of itself and all others similarly situated, against the Company Defendants, as well as Hikma Pharmaceuticals plc, Eurohealth (USA) Inc., Hikma Pharmaceuticals USA, Inc., West-Ward Pharmaceuticals Corp., Roxane Laboratories, Inc., Amneal Pharmaceuticals LLC, Endo International, plc, Endo Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., Lupin Inc., Sun Pharmaceutical Industries Ltd., Sun Pharmaceutical Holdings USA, Inc., Sun Pharmaceutical Industries, Inc., Ranbaxy Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Watson Laboratories, Inc., Wockhardt Ltd., Morton Grove Pharmaceuticals, Inc., Wockhardt USA LLC, Mallinckrodt plc, and Mallinckrodt LLC.
On September 16, 2020, an additional class action lawsuit was filed in the United States District Court for the Northern District of California, by Ruth Hollman on behalf of herself and all others similarly situated, against the same defendants named in the Self-Insured Schools Lawsuit.
1 unchanged sentence
On March 18, 2021, United Healthcare Services, Inc.
−Removed: filed a lawsuit in the United States District Court for the District of Minnesota against the Company Defendants, Hikma Pharmaceuticals plc, Roxane Laboratories, Inc., Hikma Pharmaceuticals USA Inc., Eurohealth (USA) Inc., Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc., raising similar allegations, or the UHS Lawsuit.
+Added: filed a lawsuit in the United States District Court for the District of Minnesota against the Company Defendants, Hikma Pharmaceuticals plc, Roxane Laboratories, Inc., Hikma Pharmaceuticals USA Inc., Eurohealth (USA) Inc., Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc., raising similar allegations.
On March 24, 2021, the U.S.
6 unchanged sentences
On February 17, 2022, Health Care Service Corporation filed a lawsuit in the United States District Court for the Northern District of California against the Company Defendants, Hikma Pharmaceuticals plc, Hikma Pharmaceuticals USA Inc., Hikma Labs, Inc., Eurohealth (USA), Inc., Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc, raising similar allegations.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
On April 19, 2023, the Court held a hearing on class certification in the consolidated multi-district litigation referenced above.
1 unchanged sentence
The Court excluded Xywav purchasers from the classes.
−Removed: Trial in this matter is scheduled for October 28, 2024.
+Added: On April 26, 2024, we,
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: Hikma, and the plaintiffs filed motions for summary judgment.
+Added: The Court held oral argument on these motions on July 19, 2024.
+Added: On August 26, 2024, the Court issued a decision granting in part and denying in part the parties’ motions for summary judgment.
+Added: Certain administrative service organization plaintiffs filed a motion for reconsideration of a portion of the Court’s summary judgment ruling.
+Added: On December 16, 2024, the Court denied the motion for reconsideration.
+Added: On January 15, 2025, Aetna, Inc., which is not a party to the consolidated multi-district litigation, filed a notice of appeal of the order denying reconsideration.
+Added: On June 13, 2024, we filed a motion to decertify the class.
+Added: On June 28, 2024, the plaintiffs filed a motion to amend the definition of the certified class.
+Added: The Court held oral argument on these motions on August 22, 2024.
+Added: On October 18, 2024, the Court issued a decision denying our motion to decertify the class and granting the plaintiffs’ motion to amend the class definition.
+Added: On November 1, 2024, we filed a petition with the United States Court of Appeals for the Ninth Circuit seeking leave to appeal the Court’s decision amending the class definition.
+Added: On January 29, 2025, the Ninth Circuit denied our petition for permission to appeal.
+Added: Trial in this matter has been rescheduled for May 19, 2025.
On January 13, 2023, Amneal Pharmaceuticals LLC, Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc, notified the Court that they had reached a settlement-in-principle with the class action plaintiffs.
3 unchanged sentences
The Court deferred ruling and scheduled a further hearing for final approval of the proposed settlement on April 17, 2024.
+Added: During February and March 2024, the parties notified the Court of settlements between certain non-class action plaintiffs and each of Amneal and Lupin, and the Court dismissed those plaintiffs’ claims against the applicable parties.
+Added: On April 17, 2024, the Court issued an order granting the motion for final approval of the settlement between the class action plaintiffs, Amneal, and Lupin.
On December 11, 2023, Blue Cross and Blue Shield of Florida, Inc.
2 unchanged sentences
On January 23 , 2024, the Blue Cross Florida case was transferred to the United States District Court for the Northern District of California and consolidated with the above referenced multidistrict litigation for pretrial purposes.
−Removed: On May 9, 2022, Aetna Inc., or Aetna, filed a lawsuit in the Superior Court of California for the County of Alameda against the Company Defendants, Hikma Pharmaceuticals plc, Hikma Pharmaceuticals USA Inc., Hikma Labs, Inc., Eurohealth (USA), Inc., Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc, raising similar allegations.
+Added: On May 9, 2022, Aetna, filed a lawsuit in the Superior Court of California for the County of Alameda against the Company Defendants, Hikma Pharmaceuticals plc, Hikma Pharmaceuticals USA Inc., Hikma Labs, Inc., Eurohealth (USA), Inc., Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc, raising similar allegations.
On December 27, 2022, the Court granted in part and denied in part our motion to dismiss Aetna’s complaint.
5 unchanged sentences
On February 2 , 2024, we filed our answer to the second amended complaint and Hikma filed a motion to quash service.
−Removed: That motion remains pending.
+Added: The Court scheduled a hearing on Hikma’s motion for December 4, 2024.
+Added: The Court has not set a further schedule in this case.
The plaintiffs in certain of these lawsuits are seeking to represent a class of direct purchasers of Xyrem, and the plaintiffs in the remaining lawsuits are seeking to represent a class of indirect purchasers of Xyrem.
4 unchanged sentences
If the plaintiffs were to be successful in their claims, they may be entitled to injunctive relief or we may be required to pay significant monetary damages, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
−Removed: GW Acquisition Litigation
−Removed: On March 15, 2021, GW filed a definitive proxy statement, or Proxy Statement, with the Securities and Exchange Commission in connection with the GW Acquisition.
−Removed: Since the filing of the Proxy Statement, Jazz Pharmaceuticals plc has been named in two lawsuits filed in state and federal courts in New York on March 17, 2021 by purported GW shareholders in connection with the GW Acquisition.
−Removed: The first was filed in the United States District Court for the Southern District of New York by James Farrell (hereinafter referred to as the Farrell Lawsuit) and an additional suit was filed in New York state court by Brian Levy (hereinafter referred to as the Levy Lawsuit).
−Removed: In addition to Jazz Pharmaceuticals plc, Jazz Pharmaceuticals U.K.
−Removed: Holdings Ltd., GW Pharmaceuticals plc, and the GW board of directors are named as defendants in the Farrell Lawsuit.
−Removed: In the Levy Lawsuit, GW Pharmaceuticals plc, the GW board of directors, Centerview Partners LLC, and Goldman Sachs & Co.
−Removed: LLC are named as defendants.
−Removed: In addition to the Farrell Lawsuit and the Levy Lawsuit, ten additional suits have been filed in New York, California, and Pennsylvania federal courts by purported GW shareholders against GW Pharmaceuticals plc and its board of directors, but which do not name any Jazz Pharmaceuticals parties (hereinafter referred to as the GW Litigation, and collectively with the Farrell Lawsuit and the Levy Lawsuit, as the Transaction Litigation).
−Removed: In the Transaction Litigation, the plaintiffs allege that the Proxy Statement omitted material information and contained misrepresentations, and that the individual members of the GW board of directors breached their fiduciary duties, in violation of state and federal laws, including the Securities Exchange Act of 1934.
−Removed: The plaintiffs in the Transaction Litigation sought various remedies, including injunctive relief to prevent the consummation of the GW Acquisition unless certain allegedly material information was disclosed, or in the alternative, rescission or damages.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: On April 14, 2021, GW filed a Form 8-K containing supplemental disclosures related to the GW Acquisition.
−Removed: Pursuant to a memorandum of understanding between the parties, the Levy Lawsuit was dismissed on April 14, 2021.
−Removed: On May 27, 2021, a class action lawsuit was filed in the United States District Court for the Southern District of California by plaintiff Kurt Ziegler against GW and its former Directors asserting claims under Sections 14(a) and 20(a) of the Securities Exchange Act of 1934, referred to as the Ziegler Lawsuit.
−Removed: The allegations in the Ziegler Lawsuit are similar to those in the previously dismissed Transaction Litigation.
−Removed: On June 3, 2022, we filed a motion to dismiss the Ziegler Lawsuit.
−Removed: While the motion to dismiss was pending, in December 2022, the parties participated in a mediation and reached a tentative settlement, which remains subject to court approval.
−Removed: On March 20, 2023, the plaintiffs in the Ziegler Lawsuit filed a motion for preliminary approval of the settlement.
−Removed: On July 28, 2023, the Court granted the motion for preliminary approval, which conditionally certified a class for settlement purposes.
−Removed: On December 11, 2023, the Court held a hearing regarding final approval of the proposed settlement and took the matter under advisement.
−Removed: The Court has yet to issue a final written order approving the settlement.
Patent Infringement Litigation
−Removed: Avadel Patent Litigation
−Removed: On May 13, 2021, we filed a patent infringement suit against Avadel Pharmaceuticals plc, or Avadel, and several of its corporate affiliates in the United States District Court for the District of Delaware.
+Added: Avadel Litigation
+Added: On May 13, 2021, we filed a patent infringement suit against Avadel, and several of its corporate affiliates in the United States District Court for the District of Delaware.
The suit alleges that Avadel’s Lumryz will infringe five of our patents related to controlled release formulations of oxybate and the safe and effective distribution of oxybate.
The suit seeks an injunction to prevent Avadel from launching a product that would infringe these patents, and an award of monetary damages if Avadel does launch an infringing product.
−Removed: Avadel filed an answer to the complaint and counterclaims asserting that the patents are invalid or not enforceable, and that its product will not infringe our patents.
+Added: Avadel filed an answer to the complaint and counterclaims asserting that the patents are invalid
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: or not enforceable, and that its product will not infringe our patents.
Avadel filed a motion for partial judgment on the pleadings on its counterclaim that one of our patents should be delisted from the Orange Book.
14 unchanged sentences
On April 14, 2022, Avadel sued us in the United States District Court for the District of Delaware.
−Removed: Avadel’s new suit alleges that we misappropriated trade secrets related to Avadel’s once-nightly sodium oxybate development program and breached certain contracts between the parties.
+Added: Avadel’s suit alleges that we misappropriated trade secrets related to Avadel’s once-nightly sodium oxybate development program and breached certain contracts between the parties.
Avadel seeks monetary damages, an injunction preventing us from using Avadel’s confidential information, and an order directing the United States Patent and Trademark Office to modify the inventorship of one of our oxybate patents.
5 unchanged sentences
On July 15, 2022, we filed an additional lawsuit against Avadel asserting infringement of that patent.
−Removed: The suit alleges that the filing of Avadel’s application for approval of FT218 is an act of infringement, and that Avadel’s product
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: would infringe the patent if launched.
+Added: The suit alleges that the filing of Avadel’s application for approval of FT218 is an act of infringement, and that Avadel’s product would infringe the patent if launched.
The suit seeks an injunction to prevent Avadel from launching a product that would infringe the patent, and an award of damages if Avadel does launch an infringing product.
2 unchanged sentences
On June 29, 2023, we filed a motion seeking leave to supplement our motion to dismiss, as well as a motion to stay discovery pending resolution of the motion to dismiss.
−Removed: The Court has not yet ruled on these motions.
As noted above, on March 3, 2023, we and Avadel stipulated to the dismissal without prejudice of the claims and counterclaims related to infringement and validity of the delisted patent.
3 unchanged sentences
On February 14, 2024, the Court issued a written opinion and order denying both parties’ motions for summary judgment.
−Removed: Trial regarding our patent infringement claims against Avadel began on February 26, 2024, and the jury has not yet reached a verdict.
+Added: Trial regarding our patent infringement claims against Avadel began on February 26, 2024, and concluded on March 4, 2024, with the jury finding both of our asserted patents valid, and awarding us damages for infringement for Avadel’s past sales of Lumryz.
+Added: On April 12, 2024, we filed a motion for a permanent injunction and ongoing royalties.
+Added: On August 27, 2024, the Court granted our motion for an injunction in part, and requested additional briefing about ongoing royalties.
+Added: The issued injunction prevents Avadel from seeking FDA approval or marketing Lumryz for the treatment of idiopathic hypersomnia or other indications not already a part of Lumryz’s product labeling as of March 4, 2024, and enjoins Avadel from infringing in any way Claim 24 of our ’782 patent by making, using or selling Lumryz through and including the February 2036 expiration date of the ’782 patent, subject to certain exclusions including, among other things (i) for the treatment of narcolepsy, (ii) for the treatment of patients who have been prescribed Lumryz as of the effective date of the
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: injunction conditioned on the payment of an amount to be determined and (iii) in clinical trials and studies ongoing as of the effective date of the injunction.
+Added: The Court also granted our motion for an ongoing royalty for any future sale of Lumryz to patients with narcolepsy at a rate to be determined based upon further briefing by the parties on the appropriate ongoing rate above 3.5 %.
+Added: Avadel is appealing this injunction to the United States Court of Appeals for the Federal Circuit.
+Added: The Federal Circuit held oral argument on this appeal on February 7, 2025, but has not yet issued a decision.
+Added: Avadel filed a motion with the district court for a stay of the injunction pending appeal, which the district court denied.
+Added: Avadel also filed a motion to stay the injunction pending appeal with the Federal Circuit, which the Federal Circuit granted to the limited extent that the injunction enjoins initiating new clinical trials or studies and denied in all other respects.
The Court scheduled a trial regarding Avadel’s counterclaims for unlawful monopolization for November 3, 2025 and a trial regarding Avadel’s trade secret misappropriation claims for December 15, 2025.
+Added: On March 13, 2024 and March 19, 2024, we filed motions to stay Avadel’s unlawful monopolization counterclaim and trade secret claims, respectively, pending resolution of post-trial motions and potential appeals in the patent infringement suit.
+Added: On May 24, 2024, the Court denied the motion to stay the unlawful monopolization counterclaim and the previously-filed motion to dismiss the same.
+Added: On June 7, 2024, we filed a motion for reargument or, in the alternative, to certify the decision for interlocutory appeal.
+Added: That motion remains pending and no hearing date has been set.
+Added: The Court stayed Avadel’s trade secret misappropriation claims pending appeal of the injunction in the related patent matter.
+Added: We filed a further motion to stay the unlawful monopolization counterclaims, which remains pending.
On July 21, 2022, Avadel filed a lawsuit against FDA in the United States District Court for the District of Columbia, challenging FDA’s determination that Avadel was required to file a paragraph IV certification regarding one of our Orange Book listed patents.
3 unchanged sentences
On November 3, 2022, the Court granted our and FDA’s motions for summary judgment and denied Avadel’s motion.
+Added: From December 2024 through February 2025, Avadel filed a series of patent infringement suits against us in the United States District Court for the District of Delaware.
+Added: The suits allege that Jazz’s sales of Xywav infringe on certain newly-issued Avadel patents, and Avadel seeks an award of monetary damages.
+Added: We have not yet responded to these lawsuits.
Xywav Patent Litigation
−Removed: In June 2021, we received notice from Lupin Inc., or Lupin, that it has filed with FDA an ANDA, for a generic version of Xywav.
+Added: In June 2021, we received notice from Lupin, that it has filed with FDA an ANDA, for a generic version of Xywav.
The notice from Lupin included a paragraph IV certification with respect to ten of our patents listed in FDA’s Orange Book for Xywav on the date of our receipt of the notice.
12 unchanged sentences
On January 19, 2023, we filed an additional lawsuit against Lupin in the United States District Court for the District of New Jersey alleging that by filing its ANDA, Lupin infringed the newly-issued patent referenced in its November 2022 paragraph IV certification, as well as another patent that issued in January 2023.
−Removed: The suit seeks a permanent injunction to prevent Lupin from introducing a generic version of Xywav that would infringe the two patents in suit.
+Added: The suit seeks a permanent injunction to prevent Lupin from introducing a generic version of Xywav that would infringe the two patents
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
On February 15, 2023, the Court consolidated the new lawsuit with the two suits we previously filed against Lupin.
No trial date has been set in the consolidated case against Lupin.
−Removed: In February 2023, we received notice from Teva Pharmaceuticals, Inc., or Teva, that it had filed with FDA an ANDA for a generic version of Xywav.
+Added: In February 2023, we received notice from Teva that it had filed with FDA an ANDA for a generic version of Xywav.
The notice from Teva included a paragraph IV certification with respect to thirteen of our patents listed in FDA’s Orange Book for Xywav on the date of the receipt of the notice.
−Removed: The asserted patents relate generally to the
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: composition and method of use of Xywav, and methods of treatment when Xywav is administered concomitantly with certain other medications.
+Added: The asserted patents relate generally to the composition and method of use of Xywav, and methods of treatment when Xywav is administered concomitantly with certain other medications.
In March 2023, we filed a patent infringement suit against Teva in the United States District Court for the District of New Jersey.
5 unchanged sentences
No trial date has been set in the consolidated case.
−Removed: Alkem Patent Litigation
−Removed: In April 2023, we received notice from Alkem Laboratories Ltd., or Alkem, that it has filed with FDA an ANDA, for a generic version of Xyrem.
−Removed: The notice from Alkem included a paragraph IV certification with respect to six of our patents listed in FDA’s Orange Book for Xyrem on the date of our receipt of the notice.
−Removed: The asserted patents relate generally to methods of treatment when Xyrem is administered concomitantly with certain other medications.
−Removed: In June 2023, we filed a patent infringement suit against Alkem in the United States District Court for the District of New Jersey.
−Removed: The complaint alleges that by filing its ANDA, Alkem has infringed six of our Orange Book listed patents.
−Removed: We are seeking a permanent injunction to prevent Alkem from introducing a generic version of Xyrem that would infringe our patents.
−Removed: As a result of this lawsuit, we expect that a stay of approval of up to 30 months will be imposed by FDA on Alkem’s ANDA.
−Removed: On October 4, 2023, we entered into a settlement agreement with Alkem that resolves our patent litigation.
−Removed: Under the settlement agreement, we granted Alkem a license to manufacture, market, and sell its generic version of Xyrem on or after December 31, 2025, or earlier under certain circumstances, including circumstances where Hikma launches its own generic sodium oxybate product.
+Added: In July 2024, we received notices from Lupin and Teva that they had each filed a paragraph IV certification regarding a newly-issued patent listed in the Orange Book for Xywav.
+Added: On August 27, 2024, we filed an additional lawsuit in the United States District Court for the District of New Jersey against each of Lupin and Teva, alleging that, by filing its ANDA, each party infringed the newly-issued patent related to a method of treatment using Xywav.
+Added: The suits seek orders that the effective date of FDA approval of each defendant’s application shall be a date no earlier than the expiration of the newly-issued patent.
Epidiolex Patent Litigation
−Removed: In November and December 2022, we received notices from Teva Pharmaceuticals, Inc.;
−Removed: Padagis US LLC;
−Removed: API Pharma Tech LLC and InvaGen Pharmaceuticals, Inc.;
−Removed: Lupin Limited;
−Removed: Taro Pharmaceutical Industries Ltd.;
−Removed: Zenara Pharma Private Limited and Biophore Pharma, Inc.;
−Removed: MSN Laboratories Pvt.
−Removed: and MSN Pharmaceuticals, Inc.;
−Removed: Alkem Laboratories Ltd.;
−Removed: and Ascent Pharmaceuticals, Inc.
−Removed: (hereinafter referred to as the “Epidiolex ANDA Filers”), that they have each filed with FDA an ANDA for a generic version of Epidiolex (cannabidiol) oral solution.
+Added: In November and December 2022, we received notices from the Epidiolex ANDA Filers, that they have each filed with FDA an ANDA for a generic version of Epidiolex (cannabidiol) oral solution.
As of the date of this filing, we are not aware of other ANDA filers.
9 unchanged sentences
On January 11, 2024, the Court issued an order granting in part and denying in part our motion to dismiss.
+Added: On September 20, 2024, the Court held a claim construction hearing relating to disputed terms in the asserted patents.
+Added: The Court has not yet issued a decision on the claim construction disputes .
The Court in the Epidiolex Patent Litigation scheduled trial for September 2025.
2 unchanged sentences
The suit seeks an order that the effective date of FDA approval of each Epidiolex ANDA Filer’s application shall be a date no earlier than the expiration of the newly-issued patent.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: On October 24, 2023, we entered into a settlement agreement with Padagis US LLC, or Padagis, that resolved our patent litigation with Padagis related to Epidiolex.
−Removed: Under the settlement agreement, we granted Padagis a license to manufacture, market, and sell its generic version of Epidiolex on a date that depends on the occurrence of certain other events.
−Removed: The specific terms of the Padagis settlement agreement are confidential.
−Removed: On November 20, 2023, we entered into a settlement agreement with Teva Pharmaceuticals, Inc., or Teva, that resolved our patent litigation with Teva related to Epidiolex.
−Removed: Under the settlement agreement, we granted Teva a license to manufacture, market and sell its generic version of Epidiolex on a date which remains confidential.
−Removed: The specific terms of the Teva settlement agreement are confidential.
−Removed: On December 4, 2023, we entered into a settlement agreement with Alkem Laboratories Ltd., or Alkem, that resolved our patent litigation with Alkem related to Epidiolex.
−Removed: Under the settlement agreement, we granted Alkem a license to manufacture, market, and sell its generic version of Epidiolex on a date which remains confidential.
−Removed: The specific terms of the Alkem settlement are confidential.
−Removed: The settlements with Padagis, Teva and Alkem do not resolve the litigation against the other seven Epidiolex ANDA Filers, which is ongoing.
−Removed: We cannot predict the specific timing or outcome of events in these matters with respect to the remaining defendants or the impact of developments involving any specific parties or patents on other ongoing proceedings with any specific Epidiolex ANDA Filer.
In September and October 2023, we received notice from certain of the Epidiolex ANDA Filers that they had each filed a paragraph IV certification regarding one or more newly-issued patents listed in the Orange Book for Epidiolex.
On December 15, 2023, we filed an additional lawsuit against seven of the original Epidiolex ANDA Filers with whom we have not previously settled.
+Added: We filed this lawsuit in the United States District Court for the District of New Jersey alleging that, by filing its ANDA, each Epidiolex ANDA Filer infringed the newly-issued patents related to methods of treatment using
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: The suit seeks an order that the effective date of FDA approval of each Epidiolex ANDA Filer’s application shall be a date no earlier than the expiration of the newly-issued patents.
+Added: In March and April 2024, we received notice from certain of the Epidiolex ANDA Filers that they had each filed a paragraph IV certification regarding one or more newly-issued patents listed in the Orange Book for Epidiolex.
+Added: On July 3, 2024, we filed an additional lawsuit against six of the original Epidiolex ANDA Filers with whom we had not previously settled.
We filed this lawsuit in the United States District Court for the District of New Jersey alleging that, by filing its ANDA, each Epidiolex ANDA Filer infringed the newly-issued patents related to methods of treatment using Epidiolex.
The suit seeks an order that the effective date of FDA approval of each Epidiolex ANDA Filer’s application shall be a date no earlier than the expiration of the newly-issued patents.
−Removed: Epidiolex also has ODE for the treatment of seizures associated with LGS or DS in patients 2 years of age and older through September 28, 2025, and for the treatment of seizures associated with LGS or DS in patients between 1 and 2 years of age and for the treatment of seizures associated with TSC through July 31, 2027.
−Removed: The Company vigorously enforces its intellectual property rights but cannot predict the outcome of these matters.
+Added: From October 2023 through January 2025, we entered into settlement agreements with each of the Epidiolex ANDA Filers that resolved our patent litigation with them related to Epidiolex.
+Added: Under the settlement agreements, we granted each of the Epidiolex ANDA Filers a license to manufacture, market, and sell its own generic version of Epidiolex beginning in the very late 2030s, or earlier under certain circumstances, including but not limited to the launch of another generic Epidiolex product or a final decision that all unexpired claims of the Epidiolex patents are not infringed, or are invalid and/or unenforceable.
+Added: Zepzelca Patent Litigation
+Added: In July and August 2024, we received notices from the Zepzelca ANDA Filers that they have each filed with FDA an ANDA for a generic version of Zepzelca (lurbinectedin).
+Added: As of the date of this filing, we are not aware of other ANDA filers.
+Added: The notices from the Zepzelca ANDA Filers each included a paragraph IV certification with respect to a patent listed in the Orange Book for Zepzelca on the date of the receipt of the notice.
+Added: The listed patent relates to the drug substance, drug product and approved use of Zepzelca.
+Added: Jazz is the exclusive licensee to this Zepzelca patent pursuant to an agreement with PharmaMar.
+Added: A paragraph IV certification is a certification by a generic applicant that alleges that the patent covering the branded product is invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product.
+Added: On September 11, 2024, we and PharmaMar filed a patent infringement suit against the Zepzelca ANDA Filers in the United States District Court for the District of New Jersey.
+Added: The complaint alleges that by filing their ANDAs, the Zepzelca ANDA Filers have infringed the Orange Book listed patent for Zepzelca, and seeks an order that the effective date of FDA approval of the ANDAs shall be a date no earlier than the expiration of the asserted patent.
+Added: In December 2024, we received the Zepzelca ANDA Filers’ answers to the complaint.
+Added: The answers include defenses and counterclaims asserting that the Zepzelca ANDA Filers’ products, if launched, would not infringe our patents and that our patents are invalid.
+Added: No trial date has been set in this matter.
+Added: On September 12, 2024, we and PharmaMar filed a patent infringement suit against RK Pharma, in the United States District Court for the District of Delaware.
+Added: The complaint alleges that by filing its ANDA, RK Pharma has infringed the Orange Book listed patent for Zepzelca, and seeks an order that the effective date of FDA approval of RK Pharma’s ANDA shall be no earlier than the expiration of the asserted patent.
+Added: On November 13, 2024, we voluntarily dismissed this action against RK Pharma in the United States District Court for the District of Delaware.
+Added: RK Pharma remains a defendant in the litigation referenced above in the United States District Court for the District of New Jersey.
MSP Litigation
−Removed: On April 3, 2023, MSP Recovery Claims, Series LLC, or MSP, filed a class action lawsuit on behalf itself and others similarly situated against Jazz Pharmaceuticals plc, Jazz Pharmaceuticals, Inc., and Jazz Pharmaceuticals Ireland Limited, (collectively, the Company Defendants), Express Scripts, Inc., Express Scripts Holding Company, Express Scripts Specialty Distribution Services, Inc., Curascript, Inc.
−Removed: d/b/a Curascript, S.D., Priority Healthcare Distribution, Inc.
−Removed: d/b/a Curascript SD and Curascript Specialty Distribution SD, Caring Voice Coalition, and Adira Foundation (collectively with the Company Defendants, referred to as the Defendants) in the United States District Court for the Northern District of California.
+Added: On April 3, 2023, MSP filed a class action lawsuit on behalf itself and others similarly situated against the Defendants in the United States District Court for the Northern District of California.
The MSP complaint alleges that the Defendants conspired to increase the price and quantity dispensed of Xyrem and Prialt, in violation of the Racketeer Influenced and Corrupt Organizations Act and several state laws.
4 unchanged sentences
On February 20, 2024, we filed a motion to dismiss MSP’s amended complaint.
−Removed: No trial date has been set for this matter.
+Added: The Court scheduled a hearing on the motion for June 13, 2024.
+Added: On June 21, 2024, the Court cancelled the hearing.
+Added: On July 22, 2024, the Court granted the motion.
+Added: The Court set a deadline of August 12, 2024, to file a second amended complaint.
+Added: On August 12, 2024, MSP voluntarily dismissed its complaint.
FDA Litigation
−Removed: On June 22, 2023, we filed a complaint in the United States District Court for the District of Columbia seeking a declaration that FDA’s approval on May 1, 2023 of the New Drug Application, or NDA, for Avadel's Lumryz was unlawful.
−Removed: In the complaint, we allege that FDA acted outside its authority under the Orphan Drug Act, when, despite the orphan drug exclusivity, or ODE, protecting Jazz’s low-sodium oxybate product Xywav, FDA approved the Lumryz NDA and granted Lumryz ODE based on FDA’s finding that Lumryz makes a major contribution to patient care and is therefore clinically superior to Xywav and Xyrem.
−Removed: Jazz further alleges that in doing so, FDA failed to follow its own regulations, failed to follow established agency policy without providing a reasoned explanation for the departure, reversed prior decisions by its own staff and experts without a reasoned explanation, and disregarded the relevant scientific literature and data.
−Removed: The complaint, filed
+Added: On June 22, 2023, we filed a complaint in the United States District Court for the District of Columbia seeking a declaration that FDA’s approval on May 1, 2023, of the NDA for Avadel's Lumryz was unlawful.
+Added: In the complaint, we alleged that FDA acted outside its authority under the Orphan Drug Act, when, despite ODE protecting Jazz’s low-sodium oxybate
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: pursuant to the Administrative Procedure Act, seeks to have the Court vacate and set aside FDA’s approval of the Lumryz NDA and seeks a declaration that FDA’s approval of the Lumryz NDA was arbitrary, capricious, an abuse of discretion and otherwise not in accordance with law;
−Removed: and that approval of the Lumryz NDA was in excess of FDA’s statutory authority and was made without observance of procedure required by law.
+Added: product Xywav, FDA approved the Lumryz NDA and granted Lumryz ODE based on FDA’s finding that Lumryz makes a major contribution to patient care and is therefore clinically superior to Xywav and Xyrem.
+Added: Jazz further alleged that, in doing so, FDA failed to follow its own regulations, failed to follow established agency policy without providing a reasoned explanation for the departure, reversed prior decisions by its own staff and experts without a reasoned explanation, and disregarded the relevant scientific literature and data.
+Added: The complaint, filed pursuant to the Administrative Procedure Act, asked the Court to vacate and set aside FDA’s approval of the Lumryz NDA and sought a declaration that FDA’s approval of the Lumryz NDA was arbitrary, capricious, an abuse of discretion and otherwise not in accordance with law and that approval of the Lumryz NDA was in excess of FDA’s statutory authority and was made without observance of procedure required by law.
On September 15, 2023, we filed a motion for summary judgment.
On October 20, 2023, Avadel and FDA filed cross motions for summary judgment.
−Removed: Oral argument on these motions is currently scheduled for April 9, 2024.
+Added: Oral argument on these motions was held on May 10, 2024 and on October 30, 2024, the District Court issued an order denying Jazz’s motion for summary judgment and granting Avadel’s and FDA’s cross-motions for summary judgment.
+Added: Jazz respectfully disagrees with the Court’s decision and is appealing the matter to the United States Court of Appeals for the District of Columbia Circuit.
+Added: We filed our opening appeal brief on January 31, 2025.
+Added: No argument date has been set.
+Added: Qui tam matter
+Added: In July 2022, we received a subpoena from the USAO for the District of Massachusetts requesting documents related to Xyrem and U.S.
+Added: 8,772,306 (“Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters”), product labeling changes for Xyrem, communications with FDA and the USPTO, pricing of Xyrem, and other related documents.
+Added: On July 18, 2024, the United States District Court for the District of Massachusetts unsealed a qui tam whistleblower lawsuit underlying the USAO’s subpoena, captioned 1:21-cv-10891-PBS and originally filed under seal on May 27, 2021.
+Added: The public docket in this matter indicates that on May 24 and June 7, 2024, respectively, the United States and a number of states named in the whistleblower complaint declined to intervene in this matter.
+Added: As such, private whistleblower litigation will proceed in the United States District Court for the District of Massachusetts.
+Added: The Court set a deadline of September 1, 2024, for the plaintiff to file an amended complaint, and December 2, 2024, for us to file a motion to dismiss the amended complaint.
+Added: The p laintiff filed the amended complaint on September 1, 2024.
+Added: We filed our motion to dismiss on December 2, 2024.
+Added: The Court scheduled a hearing on the motion to dismiss for April 2, 2025.
From time to time, we are involved in legal proceedings arising in the ordinary course of business.
2 unchanged sentences
Share Repurchase Program
−Removed: In November 2016, our board of directors authorized a share repurchase program and as of December 31, 2023, had authorized the repurchase of up to $ 1.5 billion, exclusive of any brokerage commissions.
−Removed: Under this program, which has no expiration date, we may repurchase ordinary shares from time to time on the open market.
−Removed: 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 May 2021 credit agreement, corporate and regulatory requirements and market conditions.
−Removed: The share repurchase program may be modified, suspended or discontinued at any time without prior notice.
−Removed: In 2023, we spent a total of $ 269.8 million to purchase 2.1 million of our ordinary shares under the share repurchase program at an average total purchase price, including commissions, of $ 126.65 per share.
−Removed: In 2022, we spent a total of $ 0.1 million to repurchase 338 of our ordinary shares at a total purchase price, including brokerage commissions, of $ 160.70 per share.
−Removed: As of December 31, 2023, the remaining amount authorized under the share repurchase program was $ 161.4 million, exclusive of any brokerage commissions.
+Added: In July 2024, our board of directors authorized the New Repurchase Program, to repurchase ordinary shares having an aggregate purchase price of $ 500.0 million, exclusive of any brokerage commissions.
+Added: Under the New Repurchase Program, which has no expiration date, we may repurchase ordinary shares from time to time by any methods and/or structures permitted by applicable law.
+Added: 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 and the indenture for our Secured Notes, corporate and regulatory requirements and market conditions.
+Added: The New Repurchase Program may be modified, suspended or discontinued at any time without our prior notice.
+Added: The New Repurchase Program replaces and supersedes the Old Repurchase Program, a share repurchase program to repurchase ordinary shares having an aggregate purchase price of $ 1.5 billion, exclusive of any brokerage commissions.
+Added: In 2024, we spent a total of $ 150.0 million to repurchase 1.4 million of our ordinary shares, all under the New Repurchase Program, at a purchase price, including commissions, of $ 109.32 per share and $ 161.4 million to repurchase 1.5 million of our ordinary shares, all under the Old Repurchase Program, at a purchase price, including commissions, of $ 110.75 per share.
+Added: The repurchases made under the New Share Repurchase Program in 2024 were effected in privately negotiated transactions with or through one of the initial purchasers of the 2030 Notes concurrently with the pricing of the offering of the 2030 Notes.
+Added: In 2023, we spent a total of $ 269.8 million to purchase 2.1 million of our ordinary shares under the Old Repurchase Program at an average total purchase price, including commissions, of $ 126.65 per share.
+Added: All ordinary shares repurchased were cancelled.
+Added: As of December 31, 2024, the remaining amount authorized for repurchases under the New Repurchase Program was $ 350.0 million, exclusive of any brokerage commissions.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Authorized But Unissued Ordinary Shares
6 unchanged sentences
In 2024 and 2023, we did not declare or pay cash dividends on our common equity.
−Removed: Under Irish law, dividends may only be paid, and share repurchases and redemptions must generally be funded only out of, “distributable reserves.” In addition, the terms of our credit agreement restrict our ability to make certain restricted payments, including dividends and other distributions by us in respect of our ordinary shares, subject to, among other exceptions, (1) a general exception for dividends and restricted payments up to $ 30 million in the aggregate and (2) an exception that allows for restricted payments, subject to a cap equal to the sum of (i) $ 100 million plus (ii) so long as our secured leverage ratio (as defined in our credit agreement) does not exceed 3 :1 after giving pro forma effect to the restricted payment, a formula-based amount tied to our consolidated net income;
−Removed: provided that such cap applies only if our total leverage ratio (as defined in our credit agreement) exceeds 2 :1 after giving pro forma effect to the restricted payment.
−Removed: Any future determination as to the payment of dividends will, subject to Irish legal requirements, be at the sole discretion of our board of directors and will depend on our consolidated financial condition, results of operations, capital requirements, compliance with the terms of our credit agreement or other future borrowing arrangements, and other factors our board of directors deems relevant.
+Added: Under Irish law, dividends may only be paid, and share repurchases and redemptions must generally be funded only out of, “distributable reserves.” In addition, the terms of the Amended Credit Agreement restrict our ability to make certain restricted payments, including dividends and other distributions by us in respect of our ordinary shares, subject to, among other exceptions, (1) a general exception for dividends and other restricted payments not to exceed in the aggregate the greater of $ 350 million and 3.5 % of consolidated total assets (as defined in the Amended Credit Agreement) when made, and (2) an exception that allows for dividends and other restricted payments equal to an amount tied to our financial performance, so long as no default or event of default shall have occurred and is continuing under the Amended Credit Agreement and the total net leverage ratio (as defined in in the Amended Credit Agreement) on a pro forma basis does not exceed 5 :1, and (3) an exception that allows for additional dividends and other restricted payments, so long as no default or event of default shall have occurred and is continuing under the Amended Credit Agreement and the total net total leverage ratio (as defined in the Amended Credit Agreement) on a pro forma basis is not greater than 4 :1.
+Added: Any future determination as to the payment of dividends will, subject to Irish legal requirements, be at the sole discretion of our board of directors and will depend on our consolidated financial condition, results of operations, capital requirements, compliance with the terms of the Amended Credit Agreement or other future borrowing arrangements, and other factors our board of directors deems relevant.
Comprehensive Income (Loss)
Comprehensive income (loss) includes net income (loss) and all changes in shareholders’ equity during a period, except for those changes resulting from investments by shareholders or distributions to shareholders.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Accumulated Other Comprehensive Loss
5 unchanged sentences
Balance at December 31, 2023 $ 235 $ ( 842,382 ) $ ( 842,147 )
−Removed: Other comprehensive income before reclassifications 3,658 283,127 286,785
−Removed: Amounts reclassified from accumulated other comprehensive income (loss) ( 3,423 ) — ( 3,423 )
−Removed: Other comprehensive income, net 235 283,127 283,362
+Added: Other comprehensive income (loss) before reclassifications 5,298 ( 106,025 ) ( 100,727 )
+Added: Amounts reclassified from accumulated other comprehensive loss ( 4,793 ) — ( 4,793 )
+Added: Other comprehensive income (loss), net 505 ( 106,025 ) ( 105,520 )
Balance at December 31, 2024 $ 740 $ ( 948,407 ) $ ( 947,667 )
−Removed: In 2023, other comprehensive income primarily reflects foreign currency translation adjustments due to the strengthening of the sterling and the euro against the U.S.
+Added: In 2024, other comprehensive income (loss) primarily reflects foreign currency translation adjustments due to the weakening of sterling and the euro against the U.S.
Net Income (Loss) per Ordinary Share
1 unchanged sentence
Diluted net income (loss) per ordinary share is based on the weighted-average number of ordinary shares outstanding and potentially dilutive ordinary shares outstanding.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Basic and diluted net income (loss) per ordinary share were computed as follows (in thousands, except per share amounts):
2 unchanged sentences
Net income (loss) $ 560,120 $ 414,832 $ ( 224,060 )
−Removed: Effect of interest on assumed conversions of Exchangeable Senior Notes, net of tax 24,876 — —
+Added: Effect of interest on assumed conversions of the 2026 Notes and the 2024 Notes, net of tax 10,762 24,876 —
Net income (loss) for dilutive net income (loss) per ordinary share $ 570,882 $ 439,708 $ ( 224,060 )
Weighted-average ordinary shares used in per share calculations - basic 61,838 63,291 62,539
−Removed: Dilutive effect of Exchangeable Senior Notes 8,016 — —
+Added: Dilutive effect of the 2026 Notes and the 2024 Notes 3,540 8,016 —
Dilutive effect of employee equity incentive and purchase plans 629 759 —
3 unchanged sentences
Diluted $ 8.65 $ 6.10 $ ( 3.58 )
−Removed: Potentially dilutive ordinary shares from our employee equity incentive and purchase plans are determined by applying the treasury stock method to the assumed vesting of outstanding restricted stock units, or RSUs, and PRSUs, the assumed exercise of share options and the assumed issuance of ordinary shares under our employee stock purchase plan, or ESPP.
+Added: Potentially dilutive ordinary shares from our employee equity incentive and purchase plans are determined by applying the treasury stock method to the assumed vesting of outstanding RSUs and PRSUs, the assumed exercise of share options and the assumed issuance of ordinary shares under our ESPP.
On January 1, 2022, we adopted ASU No.
1 unchanged sentence
Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” on a modified retrospective basis, which requires the use of the if-converted method to calculate potentially dilutive ordinary shares for convertible instruments.
−Removed: In August 2023, we made an irrevocable election to
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: fix the settlement method for exchanges of the 2024 Notes to a combination of cash and ordinary shares of the Company with a specified cash amount per $1,000 principal amount of the 2024 Notes of $1,000.
+Added: In August 2023, we made an irrevocable election to fix the settlement method for exchanges of the 2024 Notes to a combination of cash and ordinary shares of the Company with a specified cash amount per $1,000 principal amount of the 2024 Notes of $ 1,000 .
+Added: As a result of the election, an exchanging holder will receive (i) up to $ 1,000 in cash per $1,000 principal amount of 2024 Notes exchanged and (ii) cash, ordinary shares, or any combination thereof, at our election, in respect of the remainder, if any, of its exchange obligation in excess of $ 1,000 per $1,000 principal amount of 2024 Notes exchanged.
As a result, the assumed issuance of ordinary shares upon exchange of the 2024 Notes has only been included in the calculation of diluted net income per ordinary share in 2023 up to the date the irrevocable election was made.
−Removed: The potential issue of ordinary shares upon exchange of the Exchangeable Senior Notes was anti-dilutive and had no impact on diluted net loss per ordinary share for 2022.
−Removed: In 2021, potentially dilutive ordinary shares from the Exchangeable Senior Notes were determined by applying the treasury stock method to the assumed issuance of ordinary shares upon exchange of the Exchangeable Senior Notes.
−Removed: The average price of our ordinary shares in 2021 exceeded the effective exchange price per ordinary share of the 2026 Notes.
−Removed: However, the potential ordinary shares issuable upon exchange were excluded from the calculation of diluted net loss per ordinary shares because their effect would have been anti-dilutive.
−Removed: The average price of our ordinary shares in 2021 did not exceed the effective exchange price per ordinary share of the 2021 Notes and 2024 Notes.
+Added: In July 2024, we irrevocably elected to fix the settlement method for exchanges of the 2026 Notes to a combination of cash and ordinary shares of Jazz Pharmaceuticals plc with a specified cash amount per $1,000 principal amount of 2026 Notes exchanged equal to or in excess of $ 1,000 .
+Added: As a result of the election, an exchanging holder will receive (i) up to $ 1,000 in cash per $1,000 principal amount of 2026 Notes exchanged and (ii) cash, ordinary shares, or any combination thereof, at our election, in respect of the remainder, if any, of its exchange obligation in excess of $ 1,000 per $1,000 principal amount of 2026 Notes exchanged.
+Added: As a result, the assumed issuance of ordinary shares upon exchange of the 2026 Notes has only been included in the calculation of diluted net income per ordinary share in 2024, up to the date the irrevocable election was made.
+Added: The potential issue of ordinary shares upon exchange of the 2026 Notes and the 2024 Notes was anti-dilutive and had no impact on diluted net loss per ordinary share for 2022.
+Added: For the 2030 Notes, we are required to settle the principal amount in cash and have the option to settle the conversion feature for the amount above the conversion price, or the conversion spread, in cash, ordinary shares or a combination of cash and ordinary shares.
+Added: The conversion spread will have a dilutive impact on diluted net income per ordinary share when the average market price of our ordinary shares for a given period exceeds the conversion price of the 2030 Notes.
+Added: For the year ended December 31, 2024, the 2030 Notes have been excluded from the computation of diluted net income per ordinary share, as the effect would be anti-dilutive since the conversion price of the 2030 Notes exceeded the average market price of our ordinary shares for the year ended December 31, 2024.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The following table represents the weighted-average ordinary shares that were excluded from the computation of diluted net income (loss) per ordinary share for the years presented because including them would have an anti-dilutive effect (in thousands):
2 unchanged sentences
Employee equity incentive and purchase plans 4,074 2,973 2,751
−Removed: Exchangeable Senior Notes — 9,044 9,725
+Added: 2026 Notes and 2024 Notes
Segment and Other Information
−Removed: Our operating segment is reported in a manner consistent with the internal reporting provided to the chief operating decision maker, or CODM.
+Added: Our operating segment is reported in a manner consistent with the internal reporting provided to the 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.
+Added: The CODM assesses performance and decides how to allocate resources for the segment based on net income (loss) and measure of segment assets which is reported on the Consolidated Statements of Income (Loss) and Consolidated Balance Sheet.
The following table presents total long-lived assets by location (in thousands):
15 unchanged sentences
Sativex 18,877 19,668 16,825
−Removed: — 28,844 57,914
Total Neuroscience 2,698,318 2,707,843 2,760,945
−Removed: Rylaze 394,226 281,659 85,629
+Added: Rylaze/Enrylaze 410,846 394,226 281,659
Zepzelca 320,318 289,533 269,912
1 unchanged sentence
Vyxeos 162,595 147,495 127,980
−Removed: Erwinaze/Erwinase — — 69,382
+Added: Ziihera 1,051 — —
Total Oncology 1,111,375 1,015,254 873,841
23 unchanged sentences
GW Incentive Plans
−Removed: On May 5, 2021, Jazz Pharmaceuticals plc acquired the entire issued share capital of GW Pharmaceuticals plc.
−Removed: In connection with the GW Acquisition, we assumed the GW Pharmaceuticals plc 2008 Long-Term Incentive Plan, GW Pharmaceuticals plc 2017 Long-Term Incentive Plan and GW Pharmaceuticals plc 2020 Long-Term Incentive Plan, each as
+Added: On May 5, 2021, Jazz Pharmaceuticals plc acquired the entire issued share capital of GW.
+Added: In connection with the GW Acquisition, we assumed the GW Incentive Plans.
+Added: The terms of the GW Incentive Plans provide for the grant of stock options, stock appreciation rights, RSUs, other stock awards, and performance awards that may be settled in cash, shares, or other
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: amended from time to time, together referred to as the GW Incentive Plans.
−Removed: The terms of the GW Incentive Plans provide for the grant of stock options, stock appreciation rights, RSUs, other stock awards, and performance awards that may be settled in cash, shares, or other property.
Ordinary shares granted to employees in exchange for GW ADS, in connection with the GW Acquisition, vest ratably over service periods of two years , while all post-acquisition grants vest ratably over service periods of four years and expire no more than 10 years after the date of grant.
1 unchanged sentence
2011 Equity Incentive Plan
−Removed: On January 18, 2012, the businesses of Jazz Pharmaceuticals, Inc.
−Removed: and Azur Pharma were combined in a merger transaction, or the Azur Merger.
−Removed: In connection with the Azur Merger, Jazz Pharmaceuticals, Inc.’s board of directors adopted the 2011 Equity Incentive Plan, or the 2011 Plan, in October 2011 and its stockholders approved the 2011 Plan at the special meeting of the stockholders held in December 2011 in connection with the Azur Merger.
+Added: In connection with the Azur Merger, Jazz Pharmaceuticals, Inc.’s board of directors adopted the 2011 Plan in October 2011, and its stockholders approved the 2011 Plan at the special meeting of the stockholders held in December 2011.
The 2011 Plan became effective immediately before the consummation of the Azur Merger and was assumed and adopted by us upon the consummation of the Azur Merger.
11 unchanged sentences
Amended and Restated 2007 Non-Employee Directors Stock Award Plan
−Removed: The Amended and Restated 2007 Non-Employee Directors Stock Award Plan, or the 2007 Directors Award Plan, which was initially adopted by the Jazz Pharmaceuticals, Inc.
+Added: The Amended and Restated 2007 Directors Award Plan, which was initially adopted by the Jazz Pharmaceuticals, Inc.
board of directors and approved by the Jazz Pharmaceuticals, Inc.
1 unchanged sentence
Until October 2011, the 2007 Directors Award Plan provided for the automatic grant of stock options to purchase shares of Jazz Pharmaceuticals, Inc.’s common stock to its non-employee directors initially at the time any individual first became a non-employee director, which vest over three years , and then annually over their period of service on its board of directors, which vest over one year .
−Removed: On October 24, 2011, Jazz Pharmaceuticals, Inc.’s board of directors amended the 2007 Directors Award Plan to eliminate all future initial and annual automatic grants so that future automatic grants would not be made that would be subject to the excise tax imposed by Section 4985 of the Internal Revenue Code of 1986, as amended, or the Internal Revenue Code, in connection with the Azur Merger.
+Added: On October 24, 2011, Jazz Pharmaceuticals, Inc.’s board of directors amended the 2007 Directors Award Plan to eliminate all future initial and annual automatic grants so that future automatic grants would not be made that would be subject to the excise tax imposed by the Internal Revenue Code in connection with the Azur Merger.
Accordingly, all future stock option grants under the 2007 Directors Award Plan will be at the discretion of our board of directors.
5 unchanged sentences
Share-Based Compensation
−Removed: Share-based compensation expense related to share options, RSUs, PRSUs and grants under our ESPP was as follows (in thousands):
+Added: Share-based compensation expense related to RSUs, PRSUs, grants under our ESPP and share options was as follows (in thousands):
Year Ended December 31,
10 unchanged sentences
The fair value of RSUs is determined on the date of grant based on the market price of our ordinary shares as of that date.
−Removed: The fair value of the RSUs is recognized as an expense ratably over the vesting period of four years .
+Added: The fair value of RSUs is recognized as an expense ratably over the vesting period of four years .
In 2024, 2023 and 2022, 1,341,000 , 1,094,000 and 910,000 RSUs were released, respectively, with 892,000 , 735,000 and 610,000 ordinary shares issued, respectively, and 449,000 , 359,000 and 300,000 ordinary shares withheld for tax purposes, respectively.
13 unchanged sentences
The Compensation & Management Development Committee of our board of directors and, in the case of our Chief Executive Officer, the independent members of our board of directors, approved awards of PRSUs to certain employees of the Company, subject to vesting on the achievement of certain commercial and pipeline performance criteria to be assessed over a performance period from the date of the grant to December 31, 2024, December 31, 2025 and December 31, 2026, respectively.
−Removed: Following the determination of the Company’s achievement with respect to the performance criteria, the amount of shares awarded will be subject to adjustment based on the application of a relative TSR modifier.
−Removed: The number of shares that may be earned ranges between 0 % and 200 % of the target number of PRSUs granted based on the degree of achievement of the applicable performance metric and the application of the relative TSR modifier.
+Added: The number of shares that vest is determined based on the Company’s achievement with respect to the performance criteria.
+Added: For PRSUs granted prior to 2024, the amount of shares that vest will be subject to adjustment based on the application of a relative TSR modifier.
+Added: For PRSUs granted in 2024, the relative TSR represents one of the performance metrics.
+Added: In both cases, the number of shares that may be earned ranges between 0 % and 200 % of the target number of PRSUs granted.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
6 unchanged sentences
PRSUs granted 377 131.04
+Added: PRSUs released ( 124 ) 190.81
PRSUs forfeited ( 136 ) 169.40
4 unchanged sentences
The Company evaluated the performance targets in the context of its current long-range financial plan and its product candidate development pipeline and recognized compensation expense based on the probable number of awards that will ultimately vest.
+Added: In 2024, 124,000 PRSUs were released, with 80,000 ordinary shares issued and 44,000 ordinary shares withheld for tax purposes.
+Added: The total fair value of shares vested was $ 14.8 million during 2024.
Share Options
There were no share options granted in 2024, 2023 and 2022.
−Removed: The table below shows, for market strike price option grants, the weighted-average assumptions used in the Black-Scholes option pricing model and the resulting weighted-average grant date fair value of market strike price options granted in 2021:
−Removed: December 31, 2021
−Removed: Grant date fair value $ 51.39
−Removed: Volatility 37 %
−Removed: Expected term (years) 4.5
−Removed: Range of risk-free rates 0.4 - 0.8 %
−Removed: Expected dividend yield — %
−Removed: We relied on a blend of the historical and implied volatilities of our own ordinary shares to determine expected volatility for share option grants.
−Removed: In addition, we used a single volatility estimate for each share option grant.
−Removed: The weighted-average volatility was determined by calculating the weighted average of volatilities for all share options granted in a given year.
−Removed: The expected term of share option grants represented the weighted-average period the awards were expected to remain outstanding and our estimates were based on historical exercise data.
−Removed: The risk-free interest rate assumption was based on zero coupon U.S.
−Removed: Treasury instruments whose term was consistent with the expected term of our share option grants.
−Removed: The expected dividend yield assumption was based on our history and expectation of dividend payouts.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The following table summarizes information as of December 31, 2024 and activity during 2024 related to our share option plans:
16 unchanged sentences
As of December 31, 2024, total compensation cost not yet recognized related to grants under the ESPP was $ 7.6 million, which is expected to be recognized over a weighted-average period of 1.1 years.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Nominal Strike Price Options
20 unchanged sentences
Expenses related to contributions to such plans for the years ended December 31, 2024, 2023 and 2022 were $ 15.2 million, $ 14.0 million and $ 14.6 million, respectively.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: The components of income (loss) before income tax expense (benefit) and equity in loss of investees were as follows (in thousands):
+Added: The components of income (loss) before income tax benefit and equity in loss of investees were as follows (in thousands):
Year Ended December 31,
5 unchanged sentences
Total $ 470,351 $ 297,929 $ ( 372,784 )
−Removed: The following table sets forth the details of income tax expense (benefit) (in thousands):
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: The following table sets forth the details of income tax benefit (in thousands):
Year Ended December 31,
16 unchanged sentences
Total deferred, change in tax rates 938 ( 556 ) ( 16,791 )
−Removed: Total deferred tax expense (benefit) ( 260,217 ) ( 292,251 ) 69,198
−Removed: Total income tax expense (benefit) $ ( 119,912 ) $ ( 158,645 ) $ 216,116
−Removed: Our income tax benefit was $ 119.9 million and $ 158.6 million in 2023 and 2022, respectively, and our income tax expense was $ 216.1 million in 2021, relating to tax arising on income or losses in Ireland, the U.K., the U.S.
−Removed: and certain other foreign jurisdictions, offset by deductions on subsidiary equity, foreign derived intangible income benefits and originating tax credits.
+Added: Total deferred tax benefit ( 208,327 ) ( 260,217 ) ( 292,251 )
+Added: Total income tax benefit $ ( 91,429 ) $ ( 119,912 ) $ ( 158,645 )
+Added: Our income tax benefit was $ 91.4 million, $ 119.9 million and $ 158.6 million in 2024, 2023 and 2022, respectively, relating to tax arising on income or losses in Ireland, the U.K., the U.S.
+Added: and certain other foreign jurisdictions, offset by deductions on subsidiary equity, patent box benefits, foreign derived intangible income benefits and originating tax credits.
+Added: Our income tax benefit in 2024 decreased compared to 2023 primarily due to the change in income mix across jurisdictions, partially offset by patent box benefits.
Our income tax benefit in 2023 decreased compared to 2022 primarily due to pretax losses from payments for acquired IPR&D made in 2022 and the 2022 impairment of our acquired IPR&D asset as a result of the decision to discontinue our nabiximols program, partially offset by the change in income mix across jurisdictions.
−Removed: Our income tax expense in 2021 included an expense of $ 259.9 million arising on the remeasurement of our U.K.
−Removed: net deferred tax liability, which arose primarily in relation to the GW Acquisition, due to a change in the statutory tax rate in the U.K.
−Removed: following enactment of the U.K.
−Removed: Finance Act 2021.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: The reconciliation between income tax expense (benefit) at the Irish statutory trading income tax rate of 12.5 percent, the jurisdiction of tax domicile of Jazz Pharmaceuticals, applied to income before the income tax expense (benefit) and equity in loss of investees and our reported income tax expense (benefit) was as follows (in thousands):
+Added: The reconciliation between income tax expense (benefit) at the Irish statutory trading income tax rate of 12.5 percent, the jurisdiction of tax domicile of Jazz Pharmaceuticals, applied to income before the income tax expense (benefit) and equity in loss of investees and our reported income tax benefit was as follows (in thousands):
Year Ended December 31,
1 unchanged sentence
Income tax expense (benefit) at the statutory income tax rate $ 58,794 $ 37,241 $ ( 46,598 )
−Removed: Deduction on subsidiary equity ( 153,655 ) ( 158,488 ) ( 116,438 )
Change in valuation allowance 201,996 75,081 95,051
+Added: Deduction on subsidiary equity ( 180,460 ) ( 153,655 ) ( 158,488 )
+Added: Change in estimates ( 106,007 ) ( 5,472 ) ( 14,065 )
+Added: Patent box incentive benefit ( 65,413 ) ( 13,862 ) ( 6,203 )
Research and other tax credits ( 65,255 ) ( 49,900 ) ( 27,976 )
Foreign derived intangible income benefit ( 39,470 ) ( 42,400 ) ( 29,541 )
−Removed: Non-deductible facility expense 16,618 8,093 —
+Added: Foreign income tax rate differential 38,346 ( 7,763 ) 5,863
Non-deductible financing costs 22,437 15,705 4,504
+Added: Tax deficiencies/(excess tax benefits) from share-based compensation 18,074 3,959 ( 1,690 )
Non-deductible compensation 10,889 14,092 13,505
−Removed: Patent box incentive benefit ( 13,862 ) ( 6,203 ) —
Change in unrecognized tax benefits 9,767 ( 12,612 ) 5,029
−Removed: Foreign income tax rate differential ( 7,763 ) 5,863 ( 4,343 )
−Removed: Change in estimates ( 5,472 ) ( 14,065 ) ( 2,653 )
−Removed: Tax deficiencies/(excess tax benefits) from share-based compensation 3,959 ( 1,690 ) ( 5,555 )
Change in tax rate 938 ( 605 ) ( 16,790 )
+Added: Non-deductible facility expense 22 16,618 8,093
Non-deductible royalty expense — — 6,274
−Removed: Non-deductible acquisition-related costs — — 20,929
Other 3,913 3,661 4,387
−Removed: Reported income tax expense (benefit) $ ( 119,912 ) $ ( 158,645 ) $ 216,116
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: Reported income tax benefit $ ( 91,429 ) $ ( 119,912 ) $ ( 158,645 )
+Added: The 2024 patent box incentive benefit above includes a non-recurring benefit of $ 40.9 million related to a claim for benefits in Italy in respect of tax years 2020 to 2023.
+Added: The 2024 change in estimates above includes a benefit of $ 103.3 million that is fully offset by a related change in valuation allowance, resulting in a net nil impact to our income tax benefit.
Significant components of our net deferred tax assets (liabilities) were as follows (in thousands):
Deferred tax assets:
−Removed: Operating loss carryforwards $ 296,490 $ 263,235
−Removed: Intangible assets 238,062 236,462
Deduction on subsidiary equity carryforwards $ 393,960 $ 212,015
+Added: Operating loss carryforwards 307,413 296,490
Capitalized research and development 295,779 201,186
+Added: Intangible assets 243,391 238,062
Tax credit carryforwards 127,483 142,854
2 unchanged sentences
Indirect effects of unrecognized tax benefits 35,000 40,811
−Removed: Lease liabilities 13,415 14,081
Other 15,714 19,340
5 unchanged sentences
Inventories ( 47,802 ) ( 81,995 )
−Removed: Operating lease assets ( 10,628 ) ( 10,978 )
Other ( 10,530 ) ( 13,221 )
1 unchanged sentence
Net deferred tax liabilities $ ( 116,491 ) $ ( 369,872 )
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The net change in valuation allowance was an increase of $ 196.9 million, $ 77.6 million, and $ 80.5 million in 2024, 2023 and 2022, respectively.
3 unchanged sentences
Net deferred tax liabilities $ ( 116,491 ) $ ( 369,872 )
−Removed: As of December 31, 2023, we had net operating losses, or NOL, carryforwards and tax credit carryforwards for U.S.
−Removed: federal income tax purposes of approximately $ 15.2 million and $ 47.2 million, respectively, available to reduce future income subject to income taxes.
+Added: As of December 31, 2024, we had NOL and tax credit carryforwards for U.S.
+Added: federal income tax purposes of $ 11.0 million and $ 20.5 million, respectively, available to reduce future income subject to income taxes.
federal NOL carryforwards will expire, if not utilized, in the tax years 2025 to 2033 and the U.S.
federal tax credits will expire, if not utilized, in the tax years 2027 to 2044.
−Removed: In addition, we had approximately $ 13.5 million of NOL carryforwards and $ 6.4 million of tax credit carryforwards as of December 31, 2023 available to reduce future taxable income for U.S.
+Added: In addition, we had $ 4.9 million of NOL carryforwards and $ 5.8 million of tax credit carryforwards as of December 31, 2024 available to reduce future taxable income for U.S.
state income tax purposes.
state NOL carryforwards will expire, if not utilized, in the tax years 2025 to 2034.
−Removed: As of December 31, 2023, there were NOL and other carryforwards for income tax purposes of approximately $ 1,017.5 million, $ 605.8 million and $ 295.5 million available to reduce future income subject to income taxes in the United Kingdom, Malta and Ireland respectively.
−Removed: The NOLs and other carryforwards generated in the United Kingdom, Malta and Ireland have no expiration date.
+Added: As of December 31, 2024, there were NOL and other carryforwards for income tax purposes of $ 1,125.6 million, $ 790.3 million and $ 374.8 million available to reduce future income subject to income taxes in Malta, the United Kingdom and Ireland respectively.
+Added: The NOLs and other carryforwards generated in Malta, the United Kingdom and Ireland have no expiration date.
We also had foreign tax credit carryforwards in Ireland, as of December 31, 2024, of $ 100.9 million, which may only be utilized against certain sources of income.
3 unchanged sentences
Such an annual limitation may result in the expiration of certain NOLs and tax credits before future utilization.
−Removed: In addition, as a
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: result of the Azur Merger, until 2022 we were subject to certain limitations under the Internal Revenue Code in relation to the utilization of U.S.
+Added: In addition, as a result of the Azur Merger, until 2022 we were subject to certain limitations under the Internal Revenue Code in relation to the utilization of U.S.
NOLs to offset U.S.
4 unchanged sentences
(federal and state) and foreign deferred tax assets which we maintain until sufficient positive evidence exists to support reversal.
−Removed: As part of the overall change in valuation allowance, we recognized a net income tax expense of $ 76.2 million, $ 95.1 million and $ 81.3 million in 2023, 2022 and 2021, respectively, relating primarily to the creation of a valuation allowance against certain deferred tax assets primarily associated with temporary differences related to carryforwards in foreign subsidiaries and foreign tax credit carryforwards.
+Added: As part of the overall change in valuation allowance, we recognized a net income tax expense of $ 202.0 million, $ 76.2 million and $ 95.1 million in 2024, 2023 and 2022, respectively, relating primarily to the creation of a valuation allowance against certain deferred tax assets primarily associated with carryforwards in foreign subsidiaries and foreign tax credit carryforwards in Ireland.
We periodically evaluate the likelihood of the realization of deferred tax assets and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant taxing authorities, the progress of tax examinations and the regulatory approval of products currently under development.
2 unchanged sentences
No provision has been made for income tax on undistributed earnings of the Company’s foreign subsidiaries where such earnings are considered indefinitely reinvested in the foreign operations.
−Removed: Temporary differences related to such earnings totaled approximately $ 1.6 billion as of December 31, 2023.
+Added: Temporary differences related to such earnings totaled $ 1.6 billion as of December 31, 2024.
In the event of the distribution of those earnings in the form of dividends, a sale of the subsidiaries, or certain other transactions, we may be liable for income taxes, subject to an adjustment, if any, for foreign tax credits.
−Removed: The Company estimates that it would incur additional income taxes of up to approximately $ 79.8 million on repatriation of these unremitted earnings to Ireland.
+Added: The Company estimates that it would incur additional income taxes of up to $ 81.0 million on repatriation of these unremitted earnings to Ireland.
We only 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 positions which we judge may not be sustained upon examination.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
A reconciliation of our unrecognized tax benefits follows (in thousands):
4 unchanged sentences
Decreases related to prior year tax positions ( 150 ) ( 12,702 ) ( 164 )
−Removed: Increases recognized through purchase accounting — — 5,916
Decreases related to settlements with taxing authorities ( 2,605 ) — ( 223 )
2 unchanged sentences
The unrecognized tax benefits were included in income taxes payable, other non-current liabilities and deferred tax assets, net, in our consolidated balance sheets.
−Removed: Interest related to income taxes is recorded in the income tax expense (benefit) in our consolidated statements of income (loss).
+Added: Interest related to income taxes is recorded in income tax benefit in our consolidated statements of income (loss).
As of December 31, 2024 and 2023, our accrued interest related to income taxes was $ 8.6 million and $ 8.4 million, respectively.
1 unchanged sentence
Included in the balance of unrecognized tax benefits were potential benefits of $ 86.8 million and $ 77.1 million at December 31, 2024 and 2023, respectively, that, if recognized, would affect the effective tax rate on income.
−Removed: The Company believes that it is reasonably possible that approximately $ 26.5 million of its currently remaining unrecognized tax benefits may be recognized by the end of 2024 as a result of a lapse of the statute of limitations.
+Added: The Company believes that it is reasonably possible that $ 26.7 million of its currently remaining unrecognized tax benefits may be recognized by the end of 2025 as a result of a lapse of the statute of limitations.
We file income tax returns in multiple tax jurisdictions, the most significant of which are Ireland, the U.K.
7 unchanged sentences
In October 2022 and January 2023, we received tax assessment notices from the Luxembourg taxing authorities for all open tax years relating to certain transfer pricing and other adjustments.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: propose additional Luxembourg income tax of approximately $ 24.7 million, translated at the foreign exchange rate as at December 31, 2023.
+Added: The notices propose additional Luxembourg income tax of approximately $ 23.3 million, translated at the foreign exchange rate as at December 31, 2024.
We disagree with the proposed assessments and are contesting them vigorously.
+Added: The Government of Ireland, the jurisdiction in which Jazz Pharmaceuticals Plc is incorporated, transposed the Global Minimum Tax Pillar Two rules into domestic legislation as part of the Finance (No.
+Added: 2) Act 2023 (the "Finance Act").
+Added: The Finance Act closely follows the EU Minimum Tax Directive and certain OECD Guidance released to date.
+Added: The Company is within the scope of these rules, which took effect from January 1, 2024.
+Added: Under the new legislation, we are liable to pay a top-up tax for the difference between the Pillar Two effective tax rate per jurisdiction and the 15% minimum rate.
+Added: The rules on how to calculate the Pillar Two effective tax rate are detailed and highly complex and specific adjustments envisaged in the Pillar Two legislation can give rise to different effective tax rates compared to those calculated for accounting purposes.
+Added: We account for Pillar Two top-up taxes as a current tax when they are incurred.
+Added: We do not believe we were subject to the top-up tax in 2024.
+Added: The proportion of our profit before tax which is subject to the top-up tax and our exposure to Pillar Two top-up taxes in future years will depend on factors such as future revenues, costs and foreign currency exchange rates.
+Added: We will continue to monitor changes in law and guidance in relation to Pillar Two.
Valuation and Qualifying Accounts
21 unchanged sentences
(federal and state) and other foreign deferred tax assets where we continue to maintain a valuation allowance until sufficient positive evidence exists to support reversal.
−Removed: (3) Other additions to the deferred tax asset valuation allowance in 2021 relate to currency translation adjustments recorded directly in other comprehensive income.
(3) Deductions from the deferred tax asset valuation allowance include movements relating to utilization of NOLs and tax credit carryforwards, release in valuation allowance and other movements including adjustments following finalization of tax returns and currency translation adjustments.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.