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 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 principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2022.
+Added: 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.
+Added: 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.
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 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 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.
Changes in Internal Control over Financial Reporting.
9 unchanged sentences
Report of Independent Registered Public Accounting Firm
−Removed: To the Stockholders and Board of Directors
+Added: To the Shareholders and Board of Directors
Jazz Pharmaceuticals plc:
2 unchanged sentences
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2022 and 2021, 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, 2022, and the related notes and financial statement schedule at Item 15(a)2 (collectively, ‘the consolidated financial statements’), and our report dated March 1, 2023 expressed an unqualified opinion on those consolidated financial statements.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of 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 schedules at item 15(a)2 (collectively, ‘the consolidated financial statements’), and our report dated February 28, 2024 expressed an unqualified opinion on those consolidated financial statements.
Basis for Opinion
16 unchanged sentences
Dublin, Ireland
−Removed: March 1, 2023
+Added: February 28, 2024
Other Information
−Removed: Not applicable.
+Added: Insider Trading Arrangements
+Added: 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.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
9 unchanged sentences
Such information is incorporated herein by reference to our 2024 Proxy Statement, provided that if the 2024 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, principal financial officer, principal accounting officer or controller, or persons performing similar functions, and those of our subsidiaries.
−Removed: The Code of Conduct is available on our website at www.jazzpharmaceuticals.com under the section entitled “About” under “Corporate Ethics.” 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.
+Added: 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: 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.
Executive Compensation
−Removed: The information required by this item is to be included in our 2023 Proxy Statement under the sections entitled “Executive Compensation,” “Director Compensation,” “Corporate Governance and Board Matters—Compensation Committee Interlocks and Insider Participation” and “Corporate Governance and Board Matters—Compensation Committee Report” and is incorporated herein by reference.
+Added: The information required by this item is to be included in our 2024 Proxy Statement under the sections entitled “Executive Compensation,” “Director Compensation,” “Corporate Governance and Board Matters—Compensation Committee Interlocks and Insider Participation” and “Corporate Governance and Board Matters—Compensation Committee Report” and is incorporated herein by reference, provided that if the 2024 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.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: The information required by this item with respect to equity compensation plans is to be included in our 2023 Proxy Statement under the section entitled “Equity Compensation Plan Information” and the information required by this item with respect to security ownership of certain beneficial owners and management is to be included in our 2023 Proxy Statement under the section entitled “Security Ownership of Certain Beneficial Owners and Management” and in each case is incorporated herein by reference.
+Added: The information required by this item with respect to equity compensation plans is to be included in our 2024 Proxy Statement under the section entitled “Equity Compensation Plan Information” and the information required by this item with respect to security ownership of certain beneficial owners and management is to be included in our 2024 Proxy Statement under the section entitled “Security Ownership of Certain Beneficial Owners and Management” and in each case is incorporated herein by reference, provided that if the 2024 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.
Certain Relationships and Related Transactions, and Director Independence
−Removed: The information required by this item is to be included in our 2023 Proxy Statement under the sections entitled “Certain Relationships and Related Party Transactions” and “Corporate Governance and Board Matters—Independence of the Board of Directors” and is incorporated herein by reference.
+Added: The information required by this item is to be included in our 2024 Proxy Statement under the sections entitled “Certain Relationships and Related Party Transactions” and “Corporate Governance and Board Matters—Independence of the Board of Directors” and is incorporated herein by reference, provided that if the 2024 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.
Principal Accountant Fees and Services
−Removed: The information required by this item is to be included in our 2023 Proxy Statement under the section entitled “Proposal 2—On a Non-Binding Advisory Basis, Ratify Appointment of Independent Registered Accounting Firm and, On a Binding Basis, Authorize the Board of Directors, Acting Through the Audit Committee, to Determine the Independent Auditors’ Remuneration” and is incorporated herein by reference.
+Added: The information required by this item is to be included in our 2024 Proxy Statement under the section entitled “Proposal 2—On a Non-Binding Advisory Basis, Ratify Appointment of Independent Registered Accounting Firm and, On a Binding Basis, Authorize the Board of Directors, Acting Through the Audit Committee, to Determine the Independent Auditors’ Remuneration” and is incorporated herein by reference, provided that if the 2024 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.
Exhibits and Financial Statement Schedules
11 unchanged sentences
001-33500) filed with the SEC on September 19, 2011).
−Removed: 2.2 Letter Agreement, dated as of January 17, 2012, by and among Jazz Pharmaceuticals plc, Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc.
−Removed: and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated herein by reference to Exhibit 2.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
−Removed: 001-33500), as filed with the SEC on January 18, 2012).
−Removed: 2.3 Agreement and Plan of Merger, dated as of April 26, 2012, by and among Jazz Pharmaceuticals plc, Jewel Merger Sub Inc., EUSA Pharma Inc., and Essex Woodlands Health Ventures, Inc., Mayflower L.P., and Bryan Morton, in their capacity as the representatives of the equity holders of EUSA Pharma Inc.
−Removed: (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
−Removed: 001-33500), as filed with the SEC on April 27, 2012).
−Removed: 2.4 Assignment, dated as of June 11, 2012, by and among Jazz Pharmaceuticals plc and Jazz Pharmaceuticals, Inc.
−Removed: (incorporated herein by reference to Exhibit 2.1B in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
−Removed: 001-33500), as filed with the SEC on June 12, 2012).
−Removed: 2.5 Tender Offer Agreement, dated December 19, 2013, by and among Jazz Pharmaceuticals Public Limited Company, Jazz Pharmaceuticals Italy S.r.l.
−Removed: and Gentium S.p.A.
−Removed: (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K/A (File No.
−Removed: 001-33500), as filed with the SEC on December 20, 2013).
−Removed: 2.6† Assignment Agreement, dated July 1, 2014, by and among Jazz Pharmaceuticals International II Limited, Sigma-Tau Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and Gentium S.p.A.
−Removed: (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
−Removed: 001-33500), as filed with the SEC on August 5, 2014).
−Removed: 2.7 Amended and Restated Agreement for the Acquisition of the Topaz Portfolio Business of Jazz Pharmaceuticals plc, dated March 20, 2015, between Jazz Pharmaceuticals plc and Essex Bidco Limited (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
−Removed: 001-33500), as filed with the SEC on March 23, 2015).
2.2 Agreement and Plan of Merger, dated as of May 27, 2016, by and among Jazz Pharmaceuticals plc, Plex Merger Sub, Inc., and Celator Pharmaceuticals, Inc.
3 unchanged sentences
001-33500), as filed with the SEC on February 4, 2021).
+Added: 2.4# License and Collaboration Agreement, dated October 18, 2022, between Jazz Pharmaceuticals Ireland Limited and Zymeworks BC Inc.
+Added: (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
+Added: 001-033500), as filed with the SEC on December 5, 2022).
3.1 Amended and Restated Memorandum and Articles of Association of Jazz Pharmaceuticals plc, as amended on August 4, 2016 (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
28 unchanged sentences
4.6 Description of Share Capital.
−Removed: 10.1# Settlement Agreement, dated as of April 5, 2017, by and between Jazz Pharmaceuticals, Inc.
−Removed: 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.
−Removed: 1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended September 30, 20 22 , as filed with the SEC on No vember 9 , 20 22 ).
−Removed: 10.2 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.
+Added: 10.1A Credit Agreement, dated as of May 5, 2021, by and among Jazz Pharmaceuticals Public Limited Company, the other borrowers from time to time party thereto, the lenders and issuing banks from time to time party thereto, Bank of America, N.A., as administrative agent, and 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 May 5, 2021).
+Added: 10.1B Conforming Changes Amendment, dated as of June 7, 2023, entered into by Bank of America, N.A.
+Added: as administrative agent to Credit Agreement, dated as of May 5, 2021, by and among Jazz Pharmaceuticals Public Limited Company, the other borrowers from time to time party thereto, the lenders and issuing banks from time to time party thereto, Bank of America, N.A., as administrative agent, and U.S.
+Added: Bank National Association, as collateral trustee (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 June 30, 202 3 , as filed with the SEC on August 9 , 202 3 ).
+Added: 10.1C Amendment No.
+Added: 1, dated as of January 19, 2024, by and among Jazz Pharmaceuticals Public Limited Company, the other borrowers from time to time party thereto, the lenders and issuing banks from time to time party thereto, Bank of America, N.A., as administrative agent, and U.S.
+Added: Bank Trust Company, National Association, as collateral trustee.
+Added: (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 January 25, 2024).
+Added: 10.2A# Settlement Agreement, dated as of April 5, 2017, by and between Jazz Pharmaceuticals, Inc.
+Added: 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.
+Added: 001-33500) for the period ended September 30, 2022, as filed with the SEC on November 9, 2022).
+Added: 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.
(incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
9 unchanged sentences
001-33500) for the period ended December 31, 2020, as filed with the SEC on February 23, 2021).
−Removed: Clinical and Commercial Manufacturing and Supply Agreement, dated as of December 22, 2010, between Celator Pharmaceuticals, Inc.
−Removed: and Baxter Oncology GmbH (incorporated herein by reference to Exhibit 10.
−Removed: 2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended September 30, 2022, as filed with the SEC on November 9, 2022).
−Removed: Amendment No.
−Removed: 1 Clinical and Commercial Manufacturing and Supply Agreement, dated as of January 18, 2018, by and between Jazz Pharmaceuticals Ireland Limited and Baxter Oncology GmbH (incorporated herein by reference to Exhibit 10.
−Removed: 3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended September 30, 2022, as filed with the SEC on November 9, 2022).
Contract Manufacturing Agreement, dated as of January 20, 2020, by and between Jazz Pharmaceuticals Ireland Limited and Siegfried AG (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
2 unchanged sentences
and Express Scripts Specialty Distribution Services, Inc.
−Removed: 10.9‡ Amended and Restated License Agreement, dated as of October 14, 2020, between Pharma Mar, S.A.
+Added: (incorporated herein by reference to Exhibit 10.8# in Jazz Pharmaceuticals plc ’ s Annual R eport on Form 10-K ( File No.
+Added: 001-33500) for the period ended December 31, 20 22 , as filed with the SEC on March 1, 2023 ).
+Added: 10.8A‡ Amended and Restated License Agreement, dated as of October 14, 2020, between Pharma Mar, S.A.
and Jazz Pharmaceuticals Ireland Limited (incorporated herein by reference to Exhibit 10.12 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
001-33500) for the period ended December 31, 2020, as filed with the SEC on February 23, 2021).
−Removed: 10.10‡ Amendment No.
+Added: 10.8B‡ Amendment No.
1, dated as of May 6, 2021, to Amended and Restated License Agreement, dated as of October 14, 2020, between Pharma Mar, S.A.
1 unchanged sentence
001-33500) for the period ended June 30, 2021, as filed with the SEC on August 3, 2021).
−Removed: 10.11# License and Collaboration Agreement, dated October 18, 2022, between Jazz Pharmaceuticals Ireland Limited and Zymeworks BC Inc.
−Removed: (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No.
−Removed: 001-033500), as filed with the SEC on December 5, 2022).
−Removed: 10.12 Credit Agreement, dated as of May 5, 2021, by and among Jazz Pharmaceuticals Public Limited Company, the other borrowers from time to time party thereto, the lenders and issuing banks from time to time party thereto, Bank of America, N.A., as administrative agent, and U.S.
−Removed: 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.
−Removed: 001-033500), as filed with the SEC on May 5, 2021).
−Removed: 10.13A Commercial Lease, dated as of June 2, 2004, by and between Jazz Pharmaceuticals, Inc.
−Removed: and The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.52 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No.
−Removed: 333-141164), as filed with the SEC on March 27, 2007).
−Removed: 10.13B First Amendment of Lease, dated June 1, 2009, by and between Jazz Pharmaceuticals, Inc.
−Removed: and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.86 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No.
−Removed: 001-33500), as filed with the SEC on June 4, 2009).
−Removed: 10.13C Second Amendment of Lease, dated February 28, 2012, by and between Jazz Pharmaceuticals, Inc.
−Removed: and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.31 in the Annual Report on Form 10-K (File No.
−Removed: 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc.
−Removed: with the SEC on February 28, 2012).
10.9 Lease, dated May 8, 2012, by and between John Ronan and Castle Cove Property Developments Limited and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
11 unchanged sentences
10.12+ Offer Letter from Jazz Pharmaceuticals, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.21 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
−Removed: 001-33500) for the year ended December 31, 2017, as filed with the SEC on February 27, 2018).
−Removed: 10.18+ Offer Letter from Jazz Pharmaceuticals, Inc.
to Robert Iannone dated as of April 11, 2019 (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
10 unchanged sentences
001-33500) for the period ended September 30, 2019, as filed with the SEC on November 5, 2019).
−Removed: 10.21A+ Employment Contract, dated as of February 22, 2013, by and between Jazz Pharmaceuticals Ireland Limited and Finbar Larkin (incorporated herein by reference to Exhibit 10.27 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
−Removed: 001-33500) for the period ended December 31, 2019, as filed with the SEC on February 25, 2020).
−Removed: 10.21B+ Amendment to Employment Contract, dated as of February 26, 2020, by and between Jazz Pharmaceuticals Ireland Limited and Finbar Larkin ((incorporated herein by reference to Exhibit 10.2 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).
10.15A+ Employment Contract, dated as of December 14, 2019, by and between Jazz Pharmaceuticals UK Limited and Samantha Pearce (incorporated herein by reference to Exhibit 10.28A in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
7 unchanged sentences
001-33500) for the period ended March 31, 2020, as filed with the SEC on May 5, 2020).
−Removed: 10.24+ Offer Letter, dated as of May 2, 2020, by and between Jazz Pharmaceuticals, Inc.
−Removed: and Kim Sablich (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 June 30, 2020, as filed with the SEC on August 4, 2020).
−Removed: 10.25A+ Service Agreement, dated as of May 5, 2021, by and between Chris Tovey and Jazz Pharmaceuticals UK Limited (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 June 30, 2021, as filed with the SEC on August 3, 2021).
−Removed: 10.25B+ Participation Agreement, dated as of May 5, 2021, by and between Chris Tovey and Jazz Pharmaceuticals UK Limited (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, 2021, as filed with the SEC on August 3, 2021).
+Added: 10.17A+ Offer Letter , dated as of April 4, 2023 , by and between Jazz Pharmaceuticals Ireland and Liz Henderson .
+Added: 10.17B+ New Hire E quity Letter , dated as of April 4, 2023 , from Jazz Pharmace uticals to Liz Henderson.
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.
3 unchanged sentences
with the SEC on February 28, 2012).
−Removed: 10.26C+ Form of Stock Option Grant Notice and Form of Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (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 June 30, 2012, as filed with the SEC on August 7, 2012).
−Removed: 10.26D+ Form of Stock Option Grant Notice and Form of Option Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
−Removed: 10.26E+ Form of Non-U.S.
−Removed: Option Grant Notice and Form of Non-U.S.
−Removed: Option Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
−Removed: 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
−Removed: 10.26F+ Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.9 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
−Removed: 10.26G+ Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
−Removed: 10.26H+ Form of Non-U.S.
−Removed: Restricted Stock Unit Grant Notice and Form of Non-U.S.
−Removed: Restricted Stock Unit Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28H in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
−Removed: 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
−Removed: 10.26I+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S.
+Added: 10.18C+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S.
Option Grant Notice and Form of U.S.
1 unchanged sentence
001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
−Removed: 10.26J+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Form of U.S.
−Removed: Restricted Stock Unit Award Agreement (approved July 31, 2013) (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 September 30, 2013, as filed with the SEC on November 5, 2013).
−Removed: 10.26K+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S.
+Added: 10.18D+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - 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, 2013, as filed with the SEC on November 5, 2013).
−Removed: 10.26L+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Form of Non-U.S.
−Removed: Restricted Stock Unit Award Agreement (approved July 31, 2013) (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 September 30, 2013, as filed with the SEC on November 5, 2013).
−Removed: 10.26M+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S.
+Added: 10.18E+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S.
Option Grant Notice and Form of Non-U.S.
1 unchanged sentence
001-33500) for the period ended March 31, 2016, as filed with the SEC on May 10, 2016).
−Removed: 10.26N+ Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S.
−Removed: Restricted Stock Unit Grant Notice and Form of Non-U.S.
−Removed: Restricted Stock Unit Award Agreement (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended March 31, 2016, as filed with the SEC on May 10, 2016).
−Removed: 10.26O+ Amended and Restated 2011 Equity Incentive Plan (approved August 4, 2016) (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 10.18F+ Amended and Restated 2011 Equity Incentive Plan (approved August 4, 2016) (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
−Removed: 10.26P+ Amended and Restated 2011 Equity Incentive Plan (approved November 3, 2016) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
−Removed: 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
−Removed: 10.26Q+ Amended and Restated 2011 Equity Incentive Plan (approved November 2, 2022) .
−Removed: 10.26R+ Form of U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Form of U.S.
−Removed: Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 10.18G+ Amended and Restated 2011 Equity Incentive Plan (approved November 3, 2016) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
−Removed: 10.26S+ Form of U.S.
+Added: 10.18H+ Amended and Restated 2011 Equity Incentive Plan (approved November 2, 2022) (incorporated herein by reference to Exhibit 10.2 6 Q+ in Jazz Pharmaceuticals plc’s Annual Report on Form 10- K (File No.
+Added: 001-33500) for the period ended December 31 , 20 22 , as filed with the SEC on March 1, 20 23 ).
+Added: 10.18I+ Amended and Restated 2011 Equity Incentive Plan (approved November 1, 2023).
+Added: 10.18J+ Form of U.S.
Option Grant Notice and Form of U.S.
1 unchanged sentence
001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
−Removed: 10.26T+ Form of Non-U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Form of Non-U.S.
+Added: 10.18K+ Form of U.S.
+Added: Restricted Stock Unit Award Grant Notice and Form of U.S.
Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
−Removed: 10.26U+ Form of Non-U.S.
+Added: 10.18L+ Form of Non-U.S.
Option Grant Notice and Non-U.S.
1 unchanged sentence
001-33500) for the period ended June 30, 2018, as filed with the SEC on August 7, 2018).
−Removed: 10.26V+ Form of Non-U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Non-U.S.
−Removed: Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.3 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: 10.26W+ Form of Non-U.S.
+Added: 10.18M+ 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: 10.26X+ Form of Non-U.S.
+Added: 10.18N+ Form of Non-U.S.
Restricted Stock Unit Award 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: 10.26Y+ Form of U.S.
+Added: 10.18O+ Form of U.S.
Restricted Stock Unit Award Grant Notice and Form of U.S.
1 unchanged sentence
001-33500) for the period ended June 30, 2021, as filed with the SEC on August 3, 2021).
−Removed: 10.26Z+ Form of Non-U.S.
+Added: 10.18P+ Form of Non-U.S.
Restricted Stock Unit Award Grant Notice and Form of Non-U.S.
1 unchanged sentence
001-33500) for the period ended June 30, 2021, as filed with the SEC on August 3, 2021).
−Removed: 10.26AA+ Form of Non-U.S.
+Added: 10.18Q+ Form of Non-U.S.
Restricted Stock Unit Award Grant Notice and Form of Non-U.S.
1 unchanged sentence
001-33500) for the period ended September 30, 2021, as filed with the SEC on November 9, 2021).
−Removed: 10.26BB+ Form of U.S.
+Added: 10.18R+ Form of U.S.
Performance Restricted Stock Unit Award Grant Notice and Form of U.S.
1 unchanged sentence
001-33500) for the period ended June 30, 2021, as filed with the SEC on August 3, 2021).
−Removed: 10.26CC+ Form of Non-U.S.
+Added: 10.18S+ Form of Non-U.S.
Performance Restricted Stock Unit Award Grant Notice and Form of Non-U.S.
1 unchanged sentence
001-33500) for the period ended June 30, 2021, as filed with the SEC on August 3, 2021).
−Removed: 10.27+ Jazz Pharmaceuticals plc Amended and Restated Directors Deferred Compensation Plan (incorporated herein by reference to Exhibit 99.6 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No.
−Removed: 333-179075), as filed with the SEC on January 18, 2012).
10.19A+ Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 99.4 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No.
15 unchanged sentences
10.19G+ Form of Non-U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Form of Non-U.S.
−Removed: Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan (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 September 30, 2016, as filed with the SEC on November 8, 2016).
−Removed: 10.28H+ 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: 10.28I+ Form of Non-U.S.
+Added: 10.19H+ 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: 10.28J+ Form of Non-U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Non-U.S.
−Removed: Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan (incorporated herein by reference to Exhibit 10.3 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).
−Removed: 10.28K+ 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 March 31, 2019, as filed with the SEC on May 7, 2019).
−Removed: 10.28L+ Form of Non-U.S.
−Removed: Restricted Stock Unit Award Grant Notice and Non-U.S.
−Removed: Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan (incorporated herein by reference to Exhibit 10.3 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: 10.28M+ 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 September 30, 2020, as filed with the SEC on November 2, 2020).
−Removed: 10.28N+ Form of Non-U.S.
+Added: 10.19K+ 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: 10.29A+ GW Pharmaceuticals plc 2020 Long-Term Incentive Plan (incorporated herein by reference to Exhibit 4.1 in GW’s Registration Statement on Form S-8 (file no.
−Removed: 333-238737), filed with the SEC on May 27, 2020).
+Added: 10.20A+ Amended and Restated GW Pharmaceuticals plc 2020 Long-Term Incentive Plan .
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: 10.30C+ 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.
+Added: (incorporated herein by reference to Exhibit 10.
+Added: 30B + in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
+Added: 001-33500) for the period ended December 31, 2022, as filed with the SEC on March 1, 2023).
+Added: 10.21C+ Amended and Restated 2007 Employee Stock Purchase Plan (approved November 1, 2023).
+Added: 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.
001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012 ).
9 unchanged sentences
001-33500) for the period ended December 31, 2020, as filed with the SEC on February 23, 2021).
−Removed: 10.31E+ Jazz Pharmaceuticals plc Global Cash Bonus Plan (approved November, 2021) (incorporated herein by referen ce to Exhibit 10.34E + in Jazz Pharmaceuticals plc ’ s Annual R eport on F o rm 10-K (File No.
+Added: 10.22E+ Jazz Pharmaceuticals plc Global Cash Bonus Plan (approved November, 2021) (incorporated herein by reference to Exhibit 10.34E+ in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No.
001-33500) for the period ended December 31, 2021, as filed with the SEC on March 1, 2022).
−Removed: 10.32+ Amended and Restated Executive Change in Control and Severance Benefit Plan, dated as of July 31, 2019 (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 September 30, 2019, as filed with the SEC on November 5, 2019).
−Removed: 10.33A+ Amended and Restated Non-Employee Director Compensation Policy (approved May 3, 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 June 30, 2018, as filed with the SEC on August 7, 2018).
−Removed: 10.33B+ Amended and Restated Non-Employee Director Compensation Policy (approved July 21, 2020) (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, 2020, as filed with the SEC on November 2, 2020).
−Removed: 10.33C+ Amended and Restated Non-Employee Director Compensation Policy (approved July 29, 2021) (incorporated herein by reference to Exhibit 10.11 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 10.23+ Amended and Restated Executive Change in Control and Severance Benefit Plan, dated as of May 3, 2023 (incorporated herein by reference to Exhibit 10.2+ in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
001-33500) for the period ended June 30, 2023, as filed with the SEC on August 9, 2023).
−Removed: 10.33D+ Amended and Restated Non-Employee Director Compensation Policy (approved April 28 , 202 2 ) (incorporated herein by reference to Exhibit 10.
−Removed: 2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
+Added: 10.24+ Amended and Restated Non-Employee Director Compensation Policy (approved May 4, 2023) (incorporated herein by reference to Exhibit 10.3+ in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No.
001-33500) for the period ended June 30, 2023, as filed with the SEC on August 9, 2023).
3 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 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 Principal Financial Officer pursuant to 18 U.S.C.
+Added: 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.
+Added: 32.1* Certification of Principal Executive Officer and Interim Principal Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
+Added: 97.1 Jazz Pharmaceuticals plc Policy for Recoupment of Incentive Compensation
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
15 unchanged sentences
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
−Removed: March 1, 2023 Jazz Pharmaceuticals public limited company
+Added: February 28, 2024 Jazz Pharmaceuticals public limited company
/s/ B RUCE C.
1 unchanged sentence
(Principal Executive Officer)
−Removed: /s/ R ENÉE G ALÁ
−Removed: Executive Vice President and Chief Financial Officer
−Removed: (Principal Financial Officer)
/s/ P ATRICIA C ARR
1 unchanged sentence
Senior Vice President, Chief Accounting Officer
−Removed: (Principal Accounting Officer)
+Added: (Principal Accounting Officer and Interim Principal Financial Officer)
POWER OF ATTORNEY
7 unchanged sentences
(Principal Executive Officer)
−Removed: March 1, 2023
−Removed: /s/ R ENÉE G ALÁ
−Removed: Executive Vice President and Chief Financial Officer
−Removed: (Principal Financial Officer)
−Removed: March 1, 2023
+Added: February 28, 2024
/s/ P ATRICIA C ARR
Senior Vice President, Chief Accounting Officer
−Removed: (Principal Accounting Officer)
−Removed: March 1, 2023
+Added: (Principal Accounting Officer and Interim Principal Financial Officer)
+Added: February 28, 2024
Patricia Carr
/s/ J ENNIFER E .
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
/s/ P ATRICK G .
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
/s/ P ETER G RAY
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
/s/ H EATHER A NN M CSHARRY
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
Heather Ann McSharry
/s/ S EAMUS C.
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
/s/ K ENNETH W.
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
/s/ A NNE O’ RIORDAN
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
Anne O’Riordan
1 unchanged sentence
R IEDEL, P H.
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
Riedel, Ph.D.
/s/ M ARK D .
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
/s/ C ATHERINE A.
S OHN, P HARM .D.
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
Sohn, Pharm.D.
/s/ R ICK E W INNINGHAM
−Removed: Director March 1, 2023
+Added: Director February 28, 2024
Rick E Winningham
Report of Independent Registered Public Accounting Firm
−Removed: To the Stockholders and Board of Directors
+Added: To the Shareholders and Board of Directors
Jazz Pharmaceuticals plc:
1 unchanged sentence
We have audited the accompanying consolidated balance sheets of Jazz Pharmaceuticals plc..
−Removed: and subsidiaries (the Company) as of December 31, 2022 and 2021, 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, 2022, and the related notes and financial statement schedules at Item 15(a)2 (collectively, ‘the consolidated financial statements’).
+Added: 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’).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the three‑year period ended December 31, 2023, in conformity with U.S.
generally accepted accounting principles.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated March 1, 2023 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated February 28, 2024 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
Basis for Opinion
13 unchanged sentences
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: Valuation 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, 2022 was $5,794,437 thousand, a portion of which related to the finite-lived intangible asset in respect of Vyxeos.
+Added: Assessment of the carrying value of the Vyxeos intangible asset
+Added: 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.
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.
2 unchanged sentences
The following are the primary procedures we performed to address this critical audit matter.
−Removed: – 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: – 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: – performed a sensitivity analysis over Vyxeos revenue forecast assumptions to assess the impact of changes to those assumptions on the Company’s determination of the carrying value of Vyxeos;
−Removed: – 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 Vyxeos intangible asset impairment review process, including the Company’s control related to the development of the revenue forecast assumptions for Vyxeos
+Added: – 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
+Added: – We challenged management’s ability to accurately forecast revenue by comparing historical projections to actual results
We have served as the Company’s auditor since 2012.
Dublin, Ireland
−Removed: March 1, 2023
+Added: February 28, 2024
JAZZ PHARMACEUTICALS PLC
3 unchanged sentences
Cash and cash equivalents $ 1,506,310 $ 881,482
+Added: Investments 120,000 —
Accounts receivable, net of allowances of $ 21,136 and $ 17,843 at December 31, 2023 and 2022, respectively
20 unchanged sentences
Total current liabilities 1,536,692 933,193
−Removed: Deferred revenue, non-current — 463
Long-term debt, less current portion 5,107,988 5,693,341
29 unchanged sentences
Intangible asset amortization 608,284 599,169 525,769
−Removed: Impairment charge 133,648 — 136,139
Acquired in-process research and development 19,000 444,148 —
+Added: Intangible asset impairment charge — 133,648 —
Total operating expenses 3,255,624 3,724,902 2,923,960
1 unchanged sentence
Interest expense, net ( 289,438 ) ( 288,242 ) ( 278,766 )
−Removed: Foreign exchange loss ( 19,014 ) ( 4,350 ) ( 3,271 )
+Added: Foreign exchange gain (loss) 8,787 ( 19,014 ) ( 4,350 )
Income (loss) before income tax expense (benefit) and equity in loss of investees 297,929 ( 372,784 ) ( 112,838 )
16 unchanged sentences
Foreign currency translation adjustments 283,127 ( 725,277 ) ( 268,347 )
−Removed: Loss on fair value hedging activities reclassified from accumulated other comprehensive income (loss) to foreign exchange loss, net of income tax benefit of $ 43 , $ — , and $ — , respectively
−Removed: Unrealized loss on cash flow hedging activities, net of income tax benefit of $ — , $ 2 and $ 649 , respectively
+Added: 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
+Added: Unrealized gain (loss) on cash flow hedging activities, net of income tax expense (benefit) of $ 1,215 , $ — and ($ 2 ), respectively
3,658 — ( 14 )
−Removed: Loss on cash flow hedging activities reclassified from accumulated other comprehensive income (loss) to interest expense, net of income tax expense of $ — , $ 355 and $ 486
+Added: (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 )
( 3,423 ) — 2,482
12 unchanged sentences
Balance at December 31, 2020 56,171 $ 6 4,000 $ 55 $ 472 $ 2,633,670 $ ( 134,352 ) $ 1,159,894 $ 3,659,745
−Removed: Stock issued under directors deferred compensation plan 37 — — — — — — — —
−Removed: Issuance of Exchangeable Senior Notes, due 2026 — — — — — 176,260 — — 176,260
−Removed: Partial repurchase of Exchangeable Senior Notes, due 2021 — — — — — ( 12,513 ) — — ( 12,513 )
+Added: Issuance of ordinary shares in connection with the acquisition of GW Pharmaceuticals plc 3,798 — — — — 608,456 — — 608,456
+Added: 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 1,042 — — — — 119,058 — — 119,058
3 unchanged sentences
Share-based compensation — — — — — 189,452 — — 189,452
−Removed: Shares repurchased ( 1,201 ) — — — — — — ( 146,537 ) ( 146,537 )
−Removed: Other comprehensive income — — — — — — 89,041 — 89,041
−Removed: Net income — — — — — — — 238,616 238,616
+Added: Other comprehensive loss — — — — — — ( 266,008 ) — ( 266,008 )
+Added: Net loss — — — — — — — ( 329,668 ) ( 329,668 )
Balance at December 31, 2021 61,633 6 4,000 55 472 3,534,792 ( 400,360 ) 830,226 3,965,191
−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
+Added: Cumulative effect adjustment from adoption of ASU 2020-06 — — — — — ( 333,524 ) — 127,474 ( 206,050 )
Issuance of ordinary shares in conjunction with exercise of share options 832 — — — — 82,897 — — 82,897
3 unchanged sentences
Share-based compensation — — — — — 223,279 — — 223,279
+Added: Shares repurchased — — — — — — — ( 54 ) ( 54 )
Other comprehensive loss — — — — — — ( 725,149 ) — ( 725,149 )
10 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: Cumulative effect adjustment from adoption of ASU 2020-06 — — — — — ( 333,524 ) — 127,474 ( 206,050 )
Issuance of ordinary shares in conjunction with exercise of share options 280 — — — — 30,189 — — 30,189
4 unchanged sentences
Shares repurchased ( 2,130 ) — — — 1 — — ( 269,762 ) ( 269,761 )
−Removed: Other comprehensive loss — — — — — — ( 725,149 ) — ( 725,149 )
−Removed: Net loss — — — — — — — ( 224,060 ) ( 224,060 )
+Added: Other comprehensive income — — — — — — 283,362 — 283,362
+Added: Net income — — — — — — — 414,832 414,832
Balance at December 31, 2023 62,255 $ 6 4,000 $ 55 $ 473 $ 3,699,954 $ ( 842,147 ) $ 878,656 $ 3,736,997
9 unchanged sentences
Intangible asset amortization 608,284 599,169 525,769
−Removed: Acquired in-process research and development 444,148 — 251,250
−Removed: Acquisition accounting inventory fair value step-up adjustment 273,392 223,085 —
Share-based compensation 226,841 221,996 189,006
−Removed: Impairment charge 133,648 — 136,139
−Removed: Non-cash interest expense 37,973 92,655 61,748
−Removed: Loss on disposal of a business 37,704 — —
+Added: Acquisition accounting inventory fair value step-up adjustment 151,446 273,392 223,085
+Added: Impairment of property, plant and equipment 61,014 — —
Depreciation 30,412 30,302 26,714
+Added: Non-cash interest expense 22,378 37,973 92,655
+Added: Acquired in-process research and development 19,000 444,148 —
Provision for losses on accounts receivable and inventory 11,113 14,537 19,668
−Removed: Other non-cash transactions ( 14,486 ) 10,032 14,580
Deferred tax expense (benefit) ( 260,217 ) ( 292,251 ) 69,198
−Removed: Distributions from equity method investees — — 5,438
+Added: Intangible asset impairment charge — 133,648 —
+Added: Loss on disposal of a business — 37,704 —
+Added: Other non-cash transactions 11,343 ( 14,486 ) 10,032
Changes in assets and liabilities:
13 unchanged sentences
Proceeds from maturity of investments 270,000 60,000 1,095,000
−Removed: Proceeds from sale of a business 53,000 — 14,259
−Removed: Acquisition of intangible assets ( 25,000 ) ( 17,891 ) ( 113,000 )
+Added: Acquired in-process research and development ( 19,000 ) ( 444,148 ) —
Purchases of property, plant and equipment ( 23,962 ) ( 29,046 ) ( 27,641 )
Acquisition of investments ( 390,100 ) ( 61,036 ) ( 26,819 )
−Removed: Acquired in-process research and development ( 444,148 ) — ( 251,250 )
+Added: Proceeds from sale of a business — 53,000 —
+Added: Acquisition of intangible assets — ( 25,000 ) ( 17,891 )
Acquisition of a business, net of cash acquired — — ( 6,234,792 )
2 unchanged sentences
Proceeds from employee equity incentive and purchase plans 46,459 98,020 135,261
−Removed: Share repurchases ( 54 ) — ( 146,537 )
−Removed: Payment of employee withholding taxes related to share-based awards ( 45,443 ) ( 35,602 ) ( 16,877 )
Repayments of long-term debt ( 31,000 ) ( 582,014 ) ( 1,101,788 )
+Added: Payment of employee withholding taxes related to share-based awards ( 50,952 ) ( 45,443 ) ( 35,602 )
+Added: Share repurchases ( 269,761 ) ( 54 ) —
Net proceeds from issuance of borrowings under credit agreement — — 3,719,930
1 unchanged sentence
Payments for repurchase of Exchangeable Senior Notes, due 2021 — — ( 218,812 )
−Removed: Net proceeds from issuance of Exchangeable Senior Notes, due 2026 — — 981,381
−Removed: Net proceeds from revolving credit facility — — 500,000
−Removed: Repayments under revolving credit facility — — ( 500,000 )
Net cash (used in) provided by financing activities ( 305,254 ) ( 529,491 ) 3,970,522
19 unchanged sentences
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.
−Removed: Our lead marketed products are:
+Added: Our lead marketed products, listed below, are approved in countries around the world to improve patient care.
• Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution , a product approved by the U.S.
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 with narcolepsy seven years of age and older, 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: 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.
in November 2021.
1 unchanged sentence
• 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 with narcolepsy seven years of age and older;
+Added: for the treatment of cataplexy or EDS in patients seven years of age or older with narcolepsy;
Jazz also markets Xyrem in Canada for the treatment of cataplexy in patients with narcolepsy.
3 unchanged sentences
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.
+Added: • Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) , a product approved by FDA in June 2021 and launched in the U.S.
+Added: 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: coli -derived asparaginase.
+Added: In September 2023, the European Commission granted marketing authorization for this therapy under the trade name Enrylaze;
• Zepzelca® (lurbinectedin) , a product approved by FDA in June 2020 under FDA's accelerated approval pathway and launched in the U.S.
1 unchanged sentence
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.
−Removed: • 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 ALL, or lymphoblastic lymphoma, or LBL, in adults and pediatric patients aged one month or older who have developed hypersensitivity to E.
−Removed: coli -derived asparaginase;
−Removed: • Vyxeos® (daunorubicin and cytarabine) liposome for injection , a product approved in the U.S., Canada, EU, Great Britain and other markets (marketed as Vyxeos® liposomal in the EU, Great Britain and other markets) for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia, or t-AML, or AML with myelodysplasia-related changes, or AML-MRC.
−Removed: An expanded indication was granted in the U.S.
−Removed: for the treatment of newly diagnosed t-AML or AML-MRC in pediatric patients aged 1 year and older;
−Removed: • Defitelio® (defibrotide sodium) , a product approved in the U.S.
−Removed: and Brazil for the treatment of hepatic veno-occlusive disease, or VOD, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Japan for the treatment of hepatic sinusoidal obstruction syndrome (hepatic VOD).
−Removed: It is currently approved in the EU, Great Britain and other markets for the treatment of severe hepatic VOD, also known as sinusoidal obstructive syndrome, or SOS, in HSCT therapy.
−Removed: It is indicated in adults and pediatric patients over 1 month of age.
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.
5 unchanged sentences
GAAP, and include the accounts of Jazz Pharmaceuticals plc and our subsidiaries.
−Removed: Intercompany transactions and balances have been eliminated.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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.
5 unchanged sentences
Adoption of New Accounting Standards
−Removed: In August 2020, the Financial Accounting Standards Board, or FASB, issued ASU No.
−Removed: 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40):
−Removed: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, or ASU 2020-06.
−Removed: ASU 2020-06 simplifies the accounting for convertible instruments by eliminating the requirement to separate embedded conversion features from the host contract when the conversion features are not required to be accounted for as derivatives under Topic 815, Derivatives and Hedging, or that do not result in substantial premiums accounted for as paid-in capital.
−Removed: The Company adopted ASU 2020-06 on January 1, 2022, on a modified retrospective basis.
−Removed: This impacted the accounting for our 1.50 % exchangeable senior notes due 2024, or the 2024 Notes, and our 2.00 % exchangeable senior notes due 2026, or the 2026 Notes, collectively known as the Exchangeable Senior Notes.
−Removed: As a result of the adoption of ASU 2020-06, the Exchangeable Senior Notes are now accounted for entirely as liabilities measured at amortized cost.
−Removed: ASU 2020-06 also removes certain settlement conditions that are required for contracts to qualify for equity classification and eliminates the treasury stock method to calculate diluted earnings per share for convertible instruments and requires the use of the if-converted method.
−Removed: The adoption of ASU 2020-06 resulted in the following adjustments to the consolidated balance sheet (in thousands):
−Removed: Balance Sheet Item:
−Removed: December 31, 2021 Adoption of ASU 2020-06 January 1, 2022
−Removed: Deferred tax assets, net $ 311,103 $ 109 $ 311,212
−Removed: Long-term debt, less current portion 6,018,943 206,159 6,225,102
−Removed: Retained earnings 830,226 127,474 957,700
−Removed: Additional paid-in capital 3,534,792 ( 333,524 ) 3,201,268
−Removed: Interest expense on the Exchangeable Senior Notes will be lower as a result of adoption of this guidance.
−Removed: During the year ended December 31, 2022 the effect of adoption reduced interest expense, net and increased net income by approximately $ 49 million and increased basic and diluted EPS by approximately $ 0.78 per share.
−Removed: The Exchangeable Senior Notes were determined to be anti-dilutive for the year ended December 31, 2022.
−Removed: The adoption of ASU 2020-06 did not impact our cash flows or compliance with debt covenants.
+Added: In October 2021, the Financial Accounting Standards Board issued ASU 2021-08, “Business Combinations (Topic 805):
+Added: 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)”.
+Added: 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.
+Added: 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.
+Added: We will apply to future business combinations, if any.
Significant Risks and Uncertainties
−Removed: Historically, our business has been substantially dependent on Xyrem and while we expect that our business will continue to be substantially dependent on oxybate product sales from both Xywav and Xyrem, there is no guarantee that we can maintain oxybate sales at or near historical levels, or that oxybate sales will continue to grow.
−Removed: In this regard, o ur ability to maintain or increase oxybate product sales 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 an authorized generic version of Xyrem and in the future from additional authorized generic versions of sodium oxybate and generic versions of sodium oxybate and new products for treatment of cataplexy and/or EDS in narcolepsy in the U.S.
−Removed: market and from other competitors;
−Removed: increased pricing pressure
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: 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: 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.
+Added: 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;
+Added: 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: 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;
+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 and Xyrem;
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 product sales 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, 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.
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:
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, Zepzelca and Rylaze;
+Added: effectively commercializing our approved or acquired products such as Epidiolex, Rylaze and Zepzelca;
obtaining and maintaining adequate coverage and reimbursement for our products;
4 unchanged sentences
future legislation, action by the U.S.
−Removed: Drug Enforcement Agency, or DEA, or FDA action authorizing the sale, distribution, use, and insurance reimbursement of non-FDA approved cannabinoid products;
+Added: Federal Government authorizing the sale, distribution, use, and insurance reimbursement of non-FDA approved cannabinoid products;
delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations;
1 unchanged sentence
identifying, acquiring or in-licensing additional products or product candidates;
+Added: 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;
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: In addition, the success of the GW Acquisition will depend, in part, on our ability to realize the anticipated benefits from our and GW's historical businesses.
−Removed: The anticipated benefits to us of the GW Acquisition may not be realized at the expected levels, within the expected timeframe or at all or may take longer to realize or cost more than expected, which could materially and adversely affect our business, financial condition, results of operations and growth prospects.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Concentrations of Risk
8 unchanged sentences
As of December 31, 2023 and 2022, we had foreign exchange forward contracts with notional amounts totaling $ 511.7 million and $ 505.0 million, respectively.
−Removed: As of December 31, 2022 and 2021, the outstanding foreign exchange forward contracts had a net asset fair value of $ 17.4 million and a net liability fair value of $ 2.6 million, respectively.
−Removed: We had no interest rate swap contracts outstanding as of December 31, 2022 and 2021.
−Removed: As of December 31, 2021, we had a cross-currency interest rate swap outstanding with a notional amount of $ 251.0 million and a net liability fair value of $ 15.2 million.
+Added: As of December 31, 2023 and 2022, the outstanding foreign exchange forward contracts had a net asset fair value of $ 17.4 million.
+Added: As of December 31, 2023, we had interest rate swap contracts with notional amounts totaling $ 500.0 million.
+Added: These outstanding interest rate swap contracts had a net asset fair value of $ 0.4 million as of December 31, 2023.
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, 2023, allowances on receivables were not material.
−Removed: As of December 31, 2022, three customers accounted for 74 % of gross accounts receivable, Express Scripts Specialty Distribution Services, Inc.
−Removed: and its affiliates, or ESSDS, which accounted for 55 % of gross accounts receivable, Cardinal Health Inc., or Cardinal, which accounted for 10 % of gross accounts receivable and McKesson Corporation and affiliates, or
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: McKesson, which accounted for 9 % of gross accounts receivable.
−Removed: As of December 31, 2021, three customers accounted for 74 % of gross accounts receivable, ESSDS, which accounted for 52 % of gross accounts receivable, McKesson, which accounted for 12 % of gross accounts receivable and Cardinal which accounted for 10 % of gross accounts receivable.
+Added: As of December 31, 2023, five customers accounted for 79 % of gross accounts receivable, including Express Scripts Specialty Distribution Services, Inc.
+Added: 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.
+Added: 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.
We depend on single source suppliers for most of our products, product candidates and their active pharmaceutical ingredients, or APIs.
−Removed: With respect to our oxybate products, the API is manufactured for us by a single source supplier and the finished product are manufactured both by us in our facility in Athlone, Ireland and by our U.S.-based supplier.
+Added: 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.
Business Acquisitions
6 unchanged sentences
A liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved and changes in fair value are recognized in earnings.
−Removed: Cash Equivalents
+Added: Cash Equivalents and Investments
We consider all highly liquid investments, readily convertible to cash, that mature within three months or less from date of purchase to be cash equivalents.
+Added: Investments consist of time deposits with initial maturities of greater than three months.
+Added: Collectively, cash equivalents and investments are considered available-for-sale and are recorded at fair value.
+Added: Unrealized gains and losses, net of tax, are recorded in accumulated other comprehensive loss in shareholders’ equity.
+Added: We use the specific-identification method for calculating realized gains and losses on securities sold.
+Added: 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).
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Derivative Instruments and Hedging Activities
18 unchanged sentences
otherwise, such costs are expensed as research and development.
−Removed: The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns,
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: potential labeling restrictions, and any other impediments to obtaining regulatory approval.
+Added: The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval.
We had no pre-approval inventory on our consolidated balance sheet as of December 31, 2023 or 2022.
14 unchanged sentences
Leases are classified at lease commencement as either operating leases or finance leases.
−Removed: Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on our consolidated balance sheets.
−Removed: Finance lease assets are included in property, plant and equipment, net, and finance lease liabilities are included in other current liabilities and other non-current liabilities in our consolidated balance sheets.
+Added: Operating leases are included in operating lease assets, accrued liabilities, and operating lease liabilities on our consolidated balance sheets.
+Added: Finance lease assets are included in property, plant and equipment, net, and
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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.
3 unchanged sentences
Operating lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
−Removed: Finance lease expense is recognized as depreciation expense of fixed assets and interest expense on finance lease liabilities.
+Added: Finance lease expense is recognized as depreciation expense of property, plant and equipment and interest expense on finance lease liabilities.
We have lease agreements with lease and non-lease components, which are generally accounted for separately.
12 unchanged sentences
Intangible Assets
−Removed: Intangible assets with finite useful lives consist primarily of purchased developed technology and are amortized on a straight-line basis over their estimated useful lives, which range from five to eighteen years .
−Removed: The estimated useful lives
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: associated with finite-lived intangible assets are consistent with the estimated lives of the associated products and may be modified when circumstances warrant.
+Added: Intangible assets with finite useful lives consist primarily of purchased developed technology and are amortized on a straight-line basis over their estimated useful lives, which range from seven to sixteen years .
+Added: The estimated useful lives associated with finite-lived intangible assets are consistent with the estimated lives of the associated products and may be modified when circumstances warrant.
Such assets are reviewed for impairment when events or circumstances indicate that the carrying value of an asset may not be recoverable.
9 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 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
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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.
17 unchanged sentences
At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
For arrangements that include sales-based royalties and milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties and sales-based milestones relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty or sales-based milestone has been allocated has been satisfied (or partially satisfied).
3 unchanged sentences
Research and Development
−Removed: 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.
+Added: 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.
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.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Advertising Expenses
3 unchanged sentences
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.
−Removed: A valuation allowance is provided when it is more-likely-than-not that some portion or all of a deferred tax asset will not be realized.
+Added: A valuation allowance is provided to reduce deferred tax assets to the amount that is more-likely-than-not to be realized.
We recognize the benefits of a tax position if it is more-likely-than-not of being sustained.
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 an underpayment of 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 the income tax expense and classified with the related liability on the consolidated balance sheets.
Foreign Currency
10 unchanged sentences
The related amortization expense is included in interest expense, net in our consolidated statements of income (loss).
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Contingencies
15 unchanged sentences
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: The 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, 2022 and 2021 were immaterial.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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.
+Added: No premium was payable for the year ended December 31, 2023.
Recent Accounting Pronouncements
−Removed: In October 2021, the FASB issued ASU 2021-08, “Business Combinations (Topic 805):
−Removed: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”, 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: The new standard is effective on a prospective basis for fiscal years beginning after December 15, 2022, with early adoption permitted.
−Removed: The new guidance is not expected to have a material impact on our results of operations, financial position, or cash flows.
−Removed: Business Combination, Disposition, Asset Acquisitions and Collaborations
+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: We are currently evaluating the impact of adopting this new accounting guidance.
+Added: 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: The amendments are effective on a prospective basis, with the option to apply it retrospectively, for fiscal years beginning after December 15, 2024.
+Added: We are currently evaluating the impact of adopting this new accounting guidance.
+Added: Collaborations, Disposition and Business Combination
+Added: License Agreements
+Added: 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: 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.
+Added: 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.
+Added: 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 December 2022, we exercised the option to continue with the exclusive development and commercialization rights to zanidatamab.
+Added: Zanidatamab is a bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding.
+Added: Under the terms of the agreement, Zymeworks received an upfront payment of $ 50.0 million, and, following our decision to continue the collaboration after the readout of the top-line clinical data from HERIZON-BTC-01, a second, one-time payment of $ 325.0 million.
+Added: 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.
+Added: 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.
+Added: Pending approval, Zymeworks is eligible to receive tiered royalties between 10 % and 20 % on our net sales.
+Added: 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: JZP441 is a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, IH and other sleep disorders.
+Added: Under the terms of the agreement, we made an upfront payment of $ 50.0 million to Sumitomo, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the year ended December 31, 2022.
+Added: 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.
+Added: 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: JZP898 is a differentiated, conditionally-activated interferon alpha (IFNα) INDUKINE™ molecule.
+Added: We made an upfront payment of $ 15.0 million to Werewolf in 2022, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the year ended December 31, 2022, and a milestone payment of $ 5.0 million in September 2023 which was recorded within research and development expense in our consolidated statements of income (loss) for the year ended December 31, 2023.
+Added: 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: Sunosi Disposition
+Added: In March 2022, we entered into a definitive agreement to divest Sunosi to Axsome Therapeutics, Inc., or Axsome.
+Added: In May 2022, we completed the U.S.
+Added: divestiture and in November 2022, the ex-U.S.
+Added: divestiture was completed.
+Added: Under the terms of the sale agreement, Axsome received the rights to Sunosi in all of the existing territories available to us.
+Added: We received an
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: upfront payment of $ 53.0 million, and have the right to receive a high single-digit royalty on Axsome’s U.S.
+Added: net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome’s U.S.
+Added: net sales of Sunosi in future indications.
+Added: Upon closing, we recognized a loss on disposal of $ 40.8 million within selling, general and administrative expenses in our consolidated statements of income (loss) in the year ended December 31, 2022.
+Added: We are accounting for the contingent consideration in the form of the future royalty as it is earned.
+Added: 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.
GW Acquisition
2 unchanged sentences
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 platform to address a broad range of diseases.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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.
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):
47 unchanged sentences
We acquired a nabiximols IPR&D asset in the acquisition.
−Removed: In the third quarter of 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.
+Added: 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.
Some of the more significant assumptions inherent in the development of intangible asset fair values include:
11 unchanged sentences
We do not expect any portion of this goodwill to be deductible for income tax purposes.
−Removed: Sunosi Disposition
−Removed: In March 2022, we entered into a definitive agreement to divest Sunosi to Axsome Therapeutics, Inc., or Axsome.
−Removed: In May 2022, we completed the U.S.
−Removed: divestiture and in November 2022, the ex-U.S.
−Removed: divestiture was completed.
−Removed: 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 upfront payment of $ 53.0 million, and have the right to receive a high single-digit royalty on Axsome’s U.S.
−Removed: net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome’s U.S.
−Removed: net sales of Sunosi in future indications.
−Removed: Upon closing, we recognized a loss on disposal of $ 40.8 million within selling, general and administrative expenses in our consolidated statements of income (loss) in the year ended December 31, 2022.
−Removed: We are accounting for the contingent consideration in the form of the future royalty as it is earned.
−Removed: We determined that the disposal of Sunosi does not qualify for reporting as a discontinued operation since it does not represent a strategic shift that has or will have a major effect on our operations and financial results.
−Removed: License Agreements
−Removed: In October 2022, we entered into a 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.
−Removed: In December 2022, we exercised the option to continue with the exclusive development and commercialization rights to zanidatamab.
−Removed: Zanidatamab is a bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding.
−Removed: Under the terms of the agreement, Zymeworks received an upfront payment of $ 50.0 million, and, following our decision to continue the collaboration after the readout of the top-line clinical data from HERIZON-BTC-01, a second, one-time payment of $ 325.0 million.
−Removed: 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.
−Removed: JZP441 is a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, IH and other sleep disorders.
−Removed: Under the terms of the agreement, we made an upfront payment of $ 50.0 million to Sumitomo, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the year ended December 31, 2022.
−Removed: 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.
−Removed: JZP898 is a differentiated, conditionally-activated interferon alpha (IFNα) INDUKINE™ molecule.
−Removed: Under the terms of the agreement, we made an upfront payment of $ 15.0 million to Werewolf, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the year ended December 31, 2022.
−Removed: Werewolf is eligible to receive 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.
−Removed: In December 2019, we entered into an exclusive license agreement, or original license agreement, with Pharma Mar, S.A., or PharmaMar, for development and U.S.
−Removed: commercialization of Zepzelca.
−Removed: Under the terms of the original license agreement we paid PharmaMar an upfront payment of $ 200.0 million, which was recorded as acquired IPR&D expense in our consolidated statement of income for the year ended December 31, 2020.
−Removed: In June 2020, we made a milestone payment of $ 100.0 million to PharmaMar following FDA accelerated approval of Zepzelca, which was capitalized as an intangible asset on our consolidated balance sheet.
−Removed: In October 2021, we reached our first sales milestone triggering a payment of $ 25.0 million, which was capitalized as an intangible asset on our consolidated balance sheet.
−Removed: PharmaMar is eligible to receive potential future regulatory milestone payments of up to $ 150.0 million upon the achievement of continued U.S.
−Removed: regulatory approval of Zepzelca following the successful completion of confirmatory trials
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: within certain timelines.
−Removed: PharmaMar is also eligible to receive up to $ 525.0 million in potential U.S.
−Removed: commercial milestone payments, as well as incremental tiered royalties on future net sales of Zepzelca ranging from the high teens up to 30 percent.
−Removed: PharmaMar may receive additional payments on approval of other indications, with any such payments creditable against commercial milestone payment obligations.
−Removed: PharmaMar retains production rights for Zepzelca and will supply the product to us.
−Removed: In October 2020, we entered into an amendment and restatement of the original license agreement with PharmaMar, or the amended license agreement, which expanded our exclusive license to include rights to develop and commercialize Zepzelca in Canada.
−Removed: To date, we have paid PharmaMar an upfront payment of $ 1.0 million, which was recorded as acquired IPR&D expense in our consolidated statement of income for the year ended December 31, 2020, and a milestone payment of $ 1.0 million in September 2021 following the first New Drug Application Approval by Health Canada, which was capitalized as an intangible asset on our consolidated balance sheet.
−Removed: PharmaMar is also eligible to receive up to $ 6.0 million in potential Canadian regulatory and commercial milestone payments, as well as incremental tiered royalties on future Canadian net sales of Zepzelca ranging from the high teens up to 30 percent.
−Removed: Asset Acquisition and Exclusive License Agreement
−Removed: In October 2020, we entered into an asset purchase and exclusive license agreement with SpringWorks Therapeutics, Inc., or SpringWorks, under which we acquired SpringWorks’ fatty acid amide hydrolase, or FAAH, inhibitor program.
−Removed: Under the terms of the agreement, SpringWorks has assigned or exclusively licensed all assets relating to its FAAH inhibitor program to us, including assignment of SpringWorks’ proprietary FAAH inhibitor PF-04457845, or PF-’845, now named JZP150 and its license agreement with Pfizer, Inc., or Pfizer, under which Pfizer exclusively licensed PF-’845 to SpringWorks in 2017.
−Removed: In addition to assuming all milestone and royalty obligations owed by SpringWorks to Pfizer, we made an upfront payment of $ 35.0 million to SpringWorks, which was recorded as acquired IPR&D expense in our consolidated statement of income (loss) for the year ended December 31, 2021, and may make potential milestone payments to SpringWorks of up to $ 375.0 million upon the achievement of certain clinical, regulatory and commercial milestones, and pay incremental tiered royalties to SpringWorks on future net sales of JZP150 in the mid- to high-single digit percentages.
Cash and Available-for-Sale Securities
−Removed: Cash and cash equivalents consisted of the following (in thousands):
+Added: Cash, cash equivalents and investments consisted of the following (in thousands):
December 31, 2023
1 unchanged sentence
Fair Value Cash and
+Added: Equivalents Investments
Cash $ 437,724 $ — $ — $ 437,724 $ 437,724 $ —
5 unchanged sentences
Fair Value Cash and
+Added: Equivalents Investments
Cash $ 334,018 $ — $ — $ 334,018 $ 334,018 $ —
+Added: Time deposits 30,000 — — 30,000 30,000 —
Money market funds 517,464 — — 517,464 517,464 —
Totals $ 881,482 $ — $ — $ 881,482 $ 881,482 $ —
−Removed: Cash equivalents are considered available-for-sale securities.
+Added: Cash equivalents and investments are considered available-for-sale securities.
We use the specific-identification method for calculating realized gains and losses on securities sold and include them in interest expense, net in the consolidated statements of income (loss).
+Added: Our investment balances represent time deposits with original maturities of greater than three months and less than one year.
Interest income from available-for-sale securities was $ 65.1 million, $ 11.5 million and $ 1.8 million in 2023, 2022 and 2021, respectively.
11 unchanged sentences
Money market funds 768,586 — 768,586 517,464 — 517,464
+Added: Interest rate contracts — 3,784 3,784 — — —
Foreign exchange forward contracts — 18,035 18,035 — 17,356 17,356
Totals $ 768,586 $ 441,819 $ 1,210,405 $ 517,464 $ 47,356 $ 564,820
−Removed: Cross-currency interest rate contracts $ — $ — $ — $ — $ 15,232 $ 15,232
+Added: Interest rate contracts $ — $ 3,410 $ 3,410 $ — $ — $ —
Foreign exchange forward contracts — 681 681 — — —
Totals $ — $ 4,091 $ 4,091 $ — $ — $ —
−Removed: As of December 31, 2022 our available-for-sale securities included money market funds and time deposits and their carrying values were approximately equal to their fair values.
+Added: As of December 31, 2023 and 2022, our available-for-sale securities included money market funds and time deposits and their carrying values were approximately equal to their fair values.
Money market funds were measured using quoted prices in active markets, which represent Level 1 inputs and time deposits were measured at fair value using Level 2 inputs.
Level 2 inputs are obtained from various third party data providers and represent quoted prices for similar assets in active markets, or these inputs were derived from observable market data, or if not directly observable, were derived from or corroborated by other observable market data.
−Removed: As of December 31, 2021, our available-for-sale securities were comprised of money market funds.
−Removed: Our derivative assets and liabilities include cross-currency interest rate and foreign exchange derivatives that are measured at fair value using observable market inputs such as forward rates, interest rates, our own credit risk as well as an evaluation of our counterparties’ credit risks.
+Added: Our derivative assets and liabilities include interest rate and foreign exchange derivatives that are measured at fair value using observable market inputs such as forward rates, interest rates, our own credit risk as well as an evaluation of our counterparties’ credit risks.
Based on these inputs, the derivative assets and liabilities are classified within Level 2 of the fair value hierarchy.
−Removed: The cross-currency interest rate swap contract matured on March 31, 2022.
There were no transfers between the different levels of the fair value hierarchy in 2023 or in 2022.
1 unchanged sentence
The carrying amount, which is recorded within other non-current assets, is based on the latest observable transaction price.
−Removed: As of December 31, 2022, the estimated fair values of our 2024 Notes and our 2026 Notes, were approximately $ 568.0 million and $ 1.2 billion, respectively.
+Added: 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.
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.
2 unchanged sentences
We are exposed to certain risks arising from operating internationally, including fluctuations in foreign exchange rates primarily related to the translation of sterling and euro-denominated net monetary liabilities, including intercompany balances, held by subsidiaries with a U.S.
−Removed: dollar functional currency.
+Added: dollar functional currency and fluctuations in interest rates on our outstanding term loan borrowings.
We manage these exposures within specified guidelines through the use of derivatives.
All of our derivative instruments are utilized for risk management purposes, and we do not use derivatives for speculative trading purposes.
−Removed: 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 on March 31, 2022, and was de-designated as a fair value hedge.
−Removed: The terms of this contract converted the principal repayments and interest payments on the Euro Term Loan into U.S.
−Removed: The carrying amount of the Euro Term Loan and the fair value of the cross-currency interest rate swap contract
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: were remeasured on a monthly basis, with changes in the euro to U.S.
−Removed: dollar foreign exchange rates recognized within foreign exchange 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):
−Removed: Year Ended December 31,
−Removed: 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
−Removed: Loss recognized in foreign exchange loss 2,646 35,885
We enter into foreign exchange forward contracts, with durations of up to 12 months, designed to limit the exposure to fluctuations in foreign exchange rates related to the translation of certain non-U.S.
dollar denominated liabilities, including intercompany balances.
−Removed: 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: Hedge accounting is not applied to these derivative instruments as gains and losses on these hedge
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: transactions are designed to offset gains and losses on underlying balance sheet exposures.
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 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 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):
Year Ended December 31,
1 unchanged sentence
2023 2022 2021
−Removed: Gain (loss) recognized in foreign exchange loss $ ( 58,755 ) $ ( 19,585 ) $ 19,843
−Removed: The cash flow effects of our derivative contracts are included within net cash provided by operating activities in the consolidated statements of cash flows, except for the settlement of notional amounts of the cross-currency swap, which were included in net cash (used in) provided by financing activities.
−Removed: To achieve a desired mix of floating and fixed interest rates on our variable rate debt, we entered into interest rate swap agreements in March 2017.
+Added: Gain (loss) recognized in foreign exchange gain (loss) $ 13,543 $ ( 58,755 ) $ ( 19,585 )
+Added: To achieve a desired mix of floating and fixed interest rates on our variable rate debt, we entered into interest rate swap agreements in April 2023 which are effective until April 2026.
+Added: These agreements hedge contractual term loan interest rates.
+Added: As of December 31, 2023, the interest rate swap agreements had a notional amount of $ 500.0 million.
+Added: 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.
+Added: Our previous interest rate swap was entered into in March 2017.
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: The interest rate swap agreements matured in July 2021.
−Removed: The impact on accumulated other comprehensive income (loss) and earnings from interest rate swap contracts was as follows (in thousands):
+Added: These interest rate swap agreements matured in July 2021.
+Added: The impact on accumulated other comprehensive income (loss) and earnings from derivative instruments that qualified as cash flow hedges was as follows (in thousands):
Year Ended December 31,
1 unchanged sentence
2023 2022 2021
+Added: Gain (loss) recognized in accumulated other comprehensive income (loss), net of tax $ 3,658 $ — $ ( 14 )
+Added: (Gain) loss reclassified from accumulated other comprehensive income (loss) to interest expense, net of tax ( 3,423 ) — 2,482
+Added: 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: 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.
+Added: The terms of this contract converted the principal repayments and interest payments on the Euro Term Loan into U.S.
+Added: The carrying amount of the Euro Term Loan and the fair value of the cross-currency interest rate swap contract were remeasured on a monthly basis, with changes in the euro to U.S.
+Added: dollar foreign exchange rates recognized within foreign exchange gain (loss) in the consolidated statements of income (loss).
+Added: The impact on accumulated other comprehensive income (loss) and earnings from the cross-currency interest rate swap contract was as follows (in thousands):
+Added: Year Ended December 31,
+Added: Cross-Currency Interest Rate Contract:
Loss recognized in accumulated other comprehensive income (loss), net of tax $ — $ ( 375 )
−Removed: Gain reclassified from accumulated other comprehensive income (loss) to interest expense, net of tax — 2,482 3,401
+Added: Loss reclassified from accumulated other comprehensive income (loss) to foreign exchange loss, net of tax 128 246
+Added: Loss recognized in foreign exchange loss 2,646 35,885
+Added: The cash flow effects of our derivative contracts are included within net cash provided by operating activities in the consolidated statements of cash flows, except for the settlement of notional amounts of the cross-currency swap, which were included in net cash used in financing activities.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The following tables summarize the fair value of outstanding derivatives (in thousands):
2 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:
1 unchanged sentence
Total fair value of derivative instruments $ 21,819 $ 4,091
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
December 31, 2022
1 unchanged sentence
Balance Sheet Location Fair Value Balance Sheet Location Fair Value
−Removed: Derivatives designated as hedging instruments:
−Removed: Cross-currency interest rate contracts Other current assets $ — Accrued liabilities $ 15,232
Derivatives not designated as hedging instruments:
3 unchanged sentences
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 (in thousands) for 2021:
+Added: 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):
December 31, 2023
9 unchanged sentences
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.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Other Current Assets
3 unchanged sentences
Total other current assets $ 320,809 $ 267,192
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Property, Plant and Equipment
2 unchanged sentences
Land and buildings 70,912 68,935
−Removed: Construction-in-progress 67,385 86,511
Leasehold improvements 67,722 64,776
Computer software 38,134 34,116
+Added: Construction-in-progress 18,661 67,385
Computer equipment 15,398 16,424
7 unchanged sentences
Balance at December 31, 2022 $ 1,692,662
−Removed: Goodwill allocated to divestiture of Sunosi (1)
Foreign exchange 60,468
Balance at December 31, 2023 $ 1,753,130
−Removed: ________________________
−Removed: (1) See Note 3 for further information relating to this divestiture.
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 $ 7,800,209 $ ( 2,382,170 ) $ 5,418,039 $ 7,506,287 $ ( 1,711,850 ) $ 5,794,437
−Removed: Acquired IPR&D assets — — — 154,986 — 154,986
−Removed: Total intangible assets $ 7,506,287 $ ( 1,711,850 ) $ 5,794,437 $ 8,365,678 $ ( 1,213,350 ) $ 7,152,328
−Removed: The decrease in the gross carrying amount of intangible assets as of December 31, 2022 compared to December 31, 2021 primarily reflects the negative impact of foreign currency translation adjustments due to the weakening of sterling and euro against the U.S.
−Removed: dollar, the impairment of our acquired IPR&D asset of $ 133.6 million as a result of the decision to discontinue our nabiximols program and the sale of the Sunosi acquired developed technology asset to Axsome.
−Removed: The assumptions and estimates used to determine future cash flows including revenues and operating profits resulting from completed products and in-process projects, and remaining useful lives of our intangible and other long-lived assets are
+Added: 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.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: complex and subjective.
+Added: The assumptions and estimates used to determine future cash flows and remaining useful lives of our intangible and other long-lived assets are complex and subjective.
They can be affected by various factors, including external factors, such as industry and economic trends, and internal factors such as changes in our business strategy and our forecasts for specific product lines.
8 unchanged sentences
Employee compensation and benefits 121,209 143,243
−Removed: Accrued royalties 57,347 20,345
−Removed: Accrued interest 35,614 48,640
−Removed: Accrued collaboration expenses 33,205 1,386
+Added: Accrued facilities expenses 55,455 25,864
Clinical trial accruals 44,757 31,338
+Added: Accrued interest 36,443 35,614
+Added: Accrued royalties 30,706 57,347
Sales return reserve 20,435 26,164
−Removed: Accrued facilities expenses 25,864 698
Consulting and professional services 19,538 22,278
−Removed: Selling and marketing accruals 18,553 21,566
Current portion of lease liabilities 19,447 15,938
+Added: Selling and marketing accruals 14,743 18,553
Inventory-related accruals 13,977 8,565
+Added: Accrued collaboration expenses 10,158 33,205
Accrued construction-in-progress 5,141 3,298
−Removed: Accrued milestones — 25,000
Derivative instrument liabilities 681 —
5 unchanged sentences
Unamortized - debt issuance costs ( 1,046 ) ( 2,738 )
−Removed: Unamortized discount - equity component — ( 66,836 )
2024 Notes, net 573,954 572,262
1 unchanged sentence
Unamortized - debt issuance costs ( 6,400 ) ( 8,932 )
−Removed: Unamortized discount - equity component — ( 139,323 )
2026 Notes, net 993,600 991,068
3 unchanged sentences
Less current portion (1)
+Added: 604,954 31,000
Total long-term debt $ 5,107,988 $ 5,693,341
+Added: ______________________________
+Added: (1) Balance as of December 31, 2023 includes the 2024 Notes since they mature in August 2024.
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, (collectively with the Company and Jazz Lux, the “Borrowers”), entered into the Credit Agreement, that provides 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, which is available to be drawn by any Borrower in U.S.
+Added: 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.
+Added: 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.
+Added: dollars (ii) the Euro Term Loan which was drawn by Jazz Lux on the Closing Date in Euros and (iii) the Revolving Credit Facility.
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.
4 unchanged sentences
During the term of the Euro Term Loan, the interest rate and effective interest rate were 4.43 % and 4.93 %, respectively.
−Removed: Loans under the Dollar Term Loan and Revolving Credit Facility bear interest at a rate equal to, at the applicable Borrower’s option, either (a) London Inter-Bank Offered Rate, or LIBOR or (b) the prime lending rate.
−Removed: The applicable margin for the Dollar Term Loan is 3.50 % (in the case of LIBOR) and 2.50 % (in the case of borrowings at the prime lending rate).
−Removed: The applicable margin for the Revolving Credit Facility ranges from 3.25 % to 2.75 % (in the case of LIBOR 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 Dollar Term Loan is subject to a LIBOR floor of 0.50 % and loans under the Revolving Credit Facility are not subject to a EURIBOR or LIBOR (as applicable) floor.
+Added: In January 2024, Jazz Lux entered into an amendment, or Repricing Amendment, to the Credit Agreement.
+Added: Upon entry into the Repricing Amendment, certain existing lenders converted outstanding Dollar Term Loans into a new tranche of U.S.
+Added: 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.
+Added: 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.
+Added: 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: The Tranche B-1 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.
+Added: The applicable margin for the Tranche B-1 Dollar Term Loans is 3.00 % (in the case of Term SOFR borrowings) and
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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 Tranche B-1 Dollar Term Loans are subject to a Term SOFR floor of 0.50 %.
+Added: 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.
+Added: 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.
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.
As of December 31, 2023, the interest rate and effective interest rate on the Dollar Term Loan were 8.97 % and 4.56 %, respectively.
+Added: 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.
As of December 31 ,2023, we had an undrawn Revolving Credit Facility totaling $ 500.0 million.
−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
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: subsequently acquired or organized direct and indirect subsidiaries (subject to certain exceptions), or the Guarantors.
−Removed: 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.
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.
−Removed: Principal repayments of the Dollar Term Loan, which are due quarterly, began in September 2021 and are equal to 1.0 % per annum of the original principal amount of $ 3.1 billion with any remaining balance payable on the maturity date.
+Added: 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.
+Added: 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.
+Added: 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: We refer to the Borrowers and the Guarantors collectively as the “Loan Parties.”
+Added: 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.
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.
12 unchanged sentences
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 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: In addition, during each of the three consecutive twelve-month periods commencing on the issue date of the Secured Notes, Jazz Securities
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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.
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.
1 unchanged sentence
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.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
As of December 31, 2023, the interest rate and effective interest rate on the Secured Notes were 4.375 % and 4.64 %, respectively.
15 unchanged sentences
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.
+Added: As of December 31, 2023, the “if converted value” did not exceed the principal amount of the 2026 Notes.
As of December 31, 2022, the “if converted value” of the 2026 Notes exceeded the principal amount by $ 22.5 million.
−Removed: As of December 31, 2021, the “if converted value” of the 2026 Notes did not exceed the principal amount of the 2026 Notes.
−Removed: Following the adoption of ASU 2020-06, the 2026 Notes are accounted for as a single liability measured at its amortized cost.
The total liability is reflected net of issuance costs of $ 15.3 million which will be amortized over the term of the 2026 Notes.
−Removed: We have determined the expected life of the 2026 Notes to be equal to the original 6 -year term.
+Added: We have determined the expected life of the 2026 Notes to be equal to the original six-year term.
The effective interest rate of the 2026 Notes is 2.26 %.
−Removed: Please see Note 2 for further information on the adoption of ASU 2020-06.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Exchangeable Senior Notes Due 2024
6 unchanged sentences
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
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: tax-related events.
+Added: 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.
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.
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: Upon exchange, the 2024 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 2024 Notes in cash upon exchange.
+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.
The exchange rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.
2 unchanged sentences
As of December 31, 2023 and 2022, the “if-converted value” did not exceed the principal amount of the 2024 Notes.
−Removed: Following adoption of ASU 2020-06, the 2024 Notes are accounted for as a single liability measured at its amortized cost.
The total liability is reflected net of issuance costs of $ 11.4 million which will be amortized over the term of the 2024 Notes.
1 unchanged sentence
The effective interest rate of the 2024 Notes is 1.79 %.
−Removed: Please see Note 2 for further information on the adoption of ASU 2020-06.
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: For the years ended December 31, 2022, 2021 and 2020, we recognized $ 32.8 million, $ 89.9 million and $ 87.6 million, respectively, in interest expense, net related to the contractual coupon rate and the amortization of the debt issuance costs on the Exchangeable Senior Notes, and the years ended December 31, 2021 and 2020, also included the amortization of the debt discount costs.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+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 the amortization of the debt issuance costs on the Exchangeable Senior Notes.
+Added: 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.
Scheduled maturities with respect to our long-term debt are as follows (in thousands):
2 unchanged sentences
2026 1,031,000
+Added: 2028 2,598,500
Thereafter 1,500,000
Total $ 5,797,500
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
We have noncancelable leases for our buildings and growing facilities and we are obligated to make payments under noncancelable operating leases for automobiles used by our sales force.
10 unchanged sentences
Net lease cost $ 26,601 $ 25,664 $ 30,038
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Supplemental balance sheet information related to operating and finance leases was as follows (in thousands):
15 unchanged sentences
Finance leases 7.5 % 7.4 %
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Supplemental cash flow information related to operating and finance leases was as follows (in thousands):
8 unchanged sentences
Finance lease assets obtained in exchange for new finance lease liabilities — — 650
−Removed: De-recognition of operating lease asset on lease assignment — 56,968 —
−Removed: De-recognition of operating lease liability on lease assignment — 68,064 —
+Added: De-recognition of operating lease asset on lease assignment / termination 4,169 — 56,968
+Added: De-recognition of operating lease liability on lease assignment / termination 4,457 — 68,064
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Maturities of operating and finance lease liabilities were as follows (in thousands):
22 unchanged sentences
As of December 31, 2023, we had $ 56.6 million of noncancelable purchase commitments due within one year, primarily related to agreements with third party manufacturers.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Legal Proceedings
We are involved in legal proceedings, including the following matters:
−Removed: Xyrem Class Action
+Added: Xyrem Antitrust Litigation
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:
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 Pharmaceuticals, Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., and Lupin Inc., or, collectively, the BCBS Defendants.
+Added: 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.
On June 18 and June 23, 2020, respectively, two additional class action lawsuits were filed against the Company Defendants and the BCBS Defendants:
1 unchanged sentence
in the United States District Court for the Northern District of Illinois (hereinafter referred to as the GEHA Lawsuit).
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
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.
5 unchanged sentences
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).
−Removed: The AFL Plan Lawsuit also names Roxane Laboratories Inc., West-Ward Pharmaceuticals Corp., Hikma Labs Inc., Hikma Pharmaceuticals plc, Amneal Pharmaceuticals LLC, Par Pharmaceuticals Inc., Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc.
+Added: 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.
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).
2 unchanged sentences
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
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: 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, or the UHS Lawsuit.
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: 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 (hereinafter referred to as the Aetna Case).
−Removed: On November 7, 2022, the court in the Aetna Case issued a tentative ruling granting in part and denying in part our motion to dismiss.
−Removed: On December 27, 2022, the Court issued a final order confirming that tentative ruling.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: On April 19, 2023, the Court held a hearing on class certification in the consolidated multi-district litigation referenced above.
+Added: On May 12, 2023, the Court granted the plaintiffs’ motion and preliminarily certified classes of Xyrem purchasers seeking monetary and injunctive relief.
+Added: The Court excluded Xywav purchasers from the classes.
+Added: Trial in this matter is scheduled for October 28, 2024.
+Added: 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.
+Added: On April 19, 2023, the Court held a hearing on a motion for preliminary approval of this proposed settlement.
+Added: On May 12, 2023, the Court granted the motion for preliminary approval of the proposed settlement.
+Added: On January 11, 2024, the Court held a hearing on the motion for final approval of the proposed settlement.
+Added: The Court deferred ruling and scheduled a further hearing for final approval of the proposed settlement on April 17, 2024.
+Added: On December 11, 2023, Blue Cross and Blue Shield of Florida, Inc.
+Added: and Health Options, Inc.
+Added: filed a lawsuit in the United States District Court for the Middle District of Florida against the Company Defendants, Hikma Pharmaceuticals plc, Hikma Pharmaceuticals USA Inc., Hikma Labs, Inc., and Eurohealth (USA), Inc., raising similar allegations.
+Added: 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.
+Added: 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 December 27, 2022, the Court granted in part and denied in part our motion to dismiss Aetna’s complaint.
As a result of that ruling, the generic defendants have been dismissed from the case, and certain of Aetna’s claims against Jazz have been dismissed.
On January 27, 2023, Aetna filed an amended complaint against Jazz.
−Removed: 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.
−Removed: A hearing on class certification in the consolidated multi-district litigation referenced above is scheduled for April 2023.
−Removed: A trial date will be set following a ruling on class certification.
+Added: On March 22, 2023, we filed motions to dismiss and to strike portions of the amended complaint.
+Added: On June 26, 2023, the Court granted our motions, and granted Aetna leave to further amend its complaint.
+Added: On November 17, 2023, Aetna filed its second amended complaint.
+Added: On February 2 , 2024, we filed our answer to the second amended complaint and Hikma filed a motion to quash service.
+Added: That motion remains pending.
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.
12 unchanged sentences
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
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: Levy Lawsuit, as the Transaction Litigation).
+Added: 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).
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.
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.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
On April 14, 2021, GW filed a Form 8-K containing supplemental disclosures related to the GW Acquisition.
2 unchanged sentences
The allegations in the Ziegler Lawsuit are similar to those in the previously dismissed Transaction Litigation.
−Removed: In December 2022, the parties reached a settlement in principle.
+Added: On June 3, 2022, we filed a motion to dismiss the Ziegler Lawsuit.
+Added: 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.
+Added: On March 20, 2023, the plaintiffs in the Ziegler Lawsuit filed a motion for preliminary approval of the settlement.
+Added: On July 28, 2023, the Court granted the motion for preliminary approval, which conditionally certified a class for settlement purposes.
+Added: On December 11, 2023, the Court held a hearing regarding final approval of the proposed settlement and took the matter under advisement.
+Added: The Court has yet to issue a final written order approving the settlement.
Patent Infringement Litigation
1 unchanged sentence
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.
−Removed: The suit alleges that Avadel’s product candidate FT218 will infringe five of our patents related to controlled release formulations of oxybate and the safe and effective distribution of oxybate.
+Added: 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, if approved, will not infringe our patents.
+Added: 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.
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.
2 unchanged sentences
The Federal Circuit temporarily stayed the District Court’s delisting order.
−Removed: Oral argument in the appeal took place on February 14, 2023.
On February 24, 2023, the Federal Circuit affirmed the District Court’s delisting order, lifted the temporary stay, and gave Jazz 14 days to request that FDA delist the patent from the Orange Book.
Jazz complied with the Federal Circuit’s order and requested delisting on February 28, 2023.
+Added: 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 in both this suit and a later-filed suit described below related to the same patent.
On August 4, 2021, we filed an additional patent infringement suit against Avadel in the United States District Court for the District of Delaware.
−Removed: The second suit alleges that Avadel’s product candidate FT218 will infringe a newly-issued patent related to sustained-release formulations of oxybate.
+Added: The second suit alleges that Avadel’s Lumryz will infringe a newly-issued patent related to sustained-release formulations of oxybate.
The suit seeks an injunction to prevent Avadel from launching a product that would infringe this patent, 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, if approved, will not infringe our patents.
+Added: 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.
On November 10, 2021, we filed an additional patent infringement suit against Avadel in the United States District Court for the District of Delaware.
−Removed: The third suit alleges that Avadel’s product candidate FT218 will infringe a newly-issued patent related to sustained-release formulations of oxybate.
+Added: The third suit alleges that Avadel’s Lumryz will infringe a newly-issued patent related to sustained-release formulations of oxybate.
The suit seeks an injunction to prevent Avadel from launching a product that would infringe this patent, 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, if approved, will not infringe our patents.
+Added: 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.
On April 14, 2022, Avadel sued us in the United States District Court for the District of Delaware.
1 unchanged sentence
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.
+Added: On July 8, 2022, we filed a motion for judgment on the pleadings, which the Court denied on July 18, 2023.
+Added: The denial is not a ruling that Jazz misappropriated Avadel‘s trade secrets or breached any contract.
+Added: The case will go forward in discovery and the Court instructed the parties to submit a proposed scheduling order.
On June 7, 2022, we received notice from Avadel that it had filed a "paragraph IV certification" regarding one patent listed in the Orange Book for Xyrem.
1 unchanged sentence
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 would infringe the patent if launched.
−Removed: 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.
−Removed: Avadel filed an answer to the complaint and counterclaims asserting that the patent is invalid, that its product, if approved, would not infringe, and that by listing the patent in the Orange Book, we engaged in unlawful monopolization in violation of the Sherman Act.
+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
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: would infringe the patent if launched.
+Added: 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.
+Added: Avadel filed an answer to the complaint and counterclaims asserting that the patent is invalid, that its product would not infringe, and that by listing the patent in the Orange Book, we engaged in unlawful monopolization in violation of the Sherman Act.
+Added: On December 9, 2022, we filed a motion to dismiss Avadel’s counterclaims.
+Added: 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.
+Added: The Court has not yet ruled on these motions.
+Added: 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.
+Added: On November 1, 2023, the Court held a claim construction hearing relating to disputed terms in the asserted patents.
+Added: On December 15, 2023, the Court issued a written opinion and order resolving the parties’ remaining claim construction disputes.
+Added: On November 20, 2023, we and Avadel each filed motions for summary judgment.
+Added: On February 14, 2024, the Court issued a written opinion and order denying both parties’ motions for summary judgment.
+Added: Trial regarding our patent infringement claims against Avadel began on February 26, 2024, and the jury has not yet reached a verdict.
+Added: 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.
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.
−Removed: Canopy Patent Litigation
−Removed: In December 2020, Canopy Growth Corporation filed a complaint against our subsidiary, GW, in the United States District Court for the Western District of Texas, alleging infringement of its patent, U.S.
−Removed: Canopy claims that our extraction process used to produce material used to produce Epidiolex infringes its patent.
−Removed: Canopy seeks a judgment that we have infringed their patent and an award of monetary damages.
−Removed: In July 2021, we filed an answer to the amended complaint, and counterclaims seeking judgment that the ‘632 patent is invalid and that we have not infringed the patent.
−Removed: In October 2021, the United States District Court for the Western District of Texas held a claim construction hearing regarding the disputed term of the ‘632 patent.
−Removed: In November 2021, the Court issued a claim construction order.
−Removed: On February 23, 2022, the parties filed a Joint Motion and Stipulation to Enter Final Judgment in favor of GW.
−Removed: On February 25, 2022, the Court granted the parties’ motion and entered final judgment in favor of GW.
−Removed: Pursuant to the stipulation, Canopy filed a notice of appeal of the Court’s ruling on the disputed term in March 2022.
−Removed: Lupin Patent Litigation
+Added: Xywav Patent Litigation
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.
15 unchanged sentences
On February 15, 2023, the Court consolidated the new lawsuit with the two suits we previously filed against Lupin.
−Removed: No trial date has been set in the consolidated case.
−Removed: Otsuka Patent Litigation
−Removed: In October 2021, Otsuka Pharmaceutical Co., Ltd., or Otsuka, filed claims against GW Pharma Limited and GW Pharmaceuticals Limited, or collectively, the GW Parties, in the English High Court, Patents Court.
−Removed: Otsuka alleges that under a now-expired Research Collaboration and License Agreement between Otsuka and the GW Parties, Otsuka and the GW Parties jointly own certain patents and other intellectual property, that Epidiolex is covered by that intellectual property, and that Otsuka is therefore due a royalty on net sales of Epidiolex.
+Added: No trial date has been set in the consolidated case against Lupin.
+Added: 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: 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.
+Added: The asserted patents relate generally to the
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: In December 2021, GW filed an application contesting the jurisdiction of the Patents Court.
−Removed: On May 3, 2022, the Patents Court denied GW’s application.
−Removed: GW has filed papers with the Court of Appeal seeking leave to challenge the Patents Court’s decision.
−Removed: The Court of Appeal held a hearing on GW’s appeal on October 12, 2022.
−Removed: On November 8, 2022, the Court of Appeal ruled against GW on the jurisdictional challenge, so the case will continue in the Patents Court.
−Removed: In January 2022, we filed a lawsuit against Otsuka in the Supreme Court of the State of New York, County of New York, seeking a declaration that Otsuka is not entitled to any royalties on sales of Epidiolex under the Research Collaboration and License Agreement.
−Removed: In February 2023, we reached an agreement with Otsuka to settle all outstanding litigation and disputes between the parties related to Epidiolex royalties.
−Removed: Pursuant to that agreement, Otsuka will assign to GW its rights in certain jointly-owned intellectual property, and GW will pay Otsuka royalties on net sales of Epidiolex from product launch through 2032 and, potentially, on certain future cannabidiol products.
+Added: composition and method of use of Xywav, and methods of treatment when Xywav is administered concomitantly with certain other medications.
+Added: In March 2023, we filed a patent infringement suit against Teva in the United States District Court for the District of New Jersey.
+Added: The complaint alleges that by filing its ANDA, Teva has infringed thirteen of our Orange Book listed patents.
+Added: We are seeking a permanent injunction to prevent Teva from introducing a generic version of Xywav that would infringe our patents.
+Added: As a result of this lawsuit, we expect that a stay of approval of up to 30 months will be imposed by FDA on Teva’s ANDA.
+Added: On May 23, 2023, Teva filed an answer to the complaint and counterclaims asserting that the patents are invalid or not enforceable, and that its product, if approved, will not infringe our patents.
+Added: On December 15, 2023, based on a stipulation between all parties, the Court consolidated the Lupin lawsuits and the Teva lawsuit for all purposes.
+Added: No trial date has been set in the consolidated case.
+Added: Alkem Patent Litigation
+Added: 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.
+Added: 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.
+Added: The asserted patents relate generally to methods of treatment when Xyrem is administered concomitantly with certain other medications.
+Added: In June 2023, we filed a patent infringement suit against Alkem in the United States District Court for the District of New Jersey.
+Added: The complaint alleges that by filing its ANDA, Alkem has infringed six of our Orange Book listed patents.
+Added: We are seeking a permanent injunction to prevent Alkem from introducing a generic version of Xyrem that would infringe our patents.
+Added: 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.
+Added: On October 4, 2023, we entered into a settlement agreement with Alkem that resolves our patent litigation.
+Added: 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.
Epidiolex Patent Litigation
9 unchanged sentences
and Ascent Pharmaceuticals, Inc.
−Removed: (hereinafter referred to as the “Epidiolex ANDA Filers”), that they have each filed with FDA an Abbreviated New Drug Application, or ANDA, for a generic version of Epidiolex (cannabidiol) oral solution.
+Added: (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.
As of the date of this filing, we are not aware of other ANDA filers.
5 unchanged sentences
As a result of this lawsuit, we expect that a stay of approval of up to 30 months will be imposed by FDA on the Epidiolex ANDA Filers’ ANDAs.
−Removed: Epidiolex also has Orphan Drug Exclusivity for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older through September 28, 2025, and for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients between 1 and 2 years of age and for the treatment of seizures associated with tuberous sclerosis complex through July 31, 2027.
+Added: From March 2023 through May 2023, we received the Epidiolex ANDA Filers’ answers to the complaint.
+Added: The answers include defenses and counterclaims asserting that the Epidiolex ANDA Filers’ products, if launched would not infringe our patents, that our patents are invalid, and in one instance, counterclaims related to allegations of inequitable conduct and improper listing of patents in the Orange Book.
+Added: On May 25, 2023, we filed a motion to dismiss certain of the counterclaims.
+Added: On January 11, 2024, the Court issued an order granting in part and denying in part our motion to dismiss.
+Added: The Court in the Epidiolex Patent Litigation scheduled trial for September 2025.
+Added: In June and July 2023, we received notice from certain of the Epidiolex ANDA Filers that they had each filed a paragraph IV certification regarding a newly-issued patent listed in the Orange Book for Epidiolex.
+Added: On July 21, 2023, we filed an additional lawsuit against all of the Epidiolex ANDA Filers 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 patent related to a method of treatment using Epidiolex.
+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 patent.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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.
+Added: 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.
+Added: The specific terms of the Padagis settlement agreement are confidential.
+Added: 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.
+Added: 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.
+Added: The specific terms of the Teva settlement agreement are confidential.
+Added: 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.
+Added: 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.
+Added: The specific terms of the Alkem settlement are confidential.
+Added: The settlements with Padagis, Teva and Alkem do not resolve the litigation against the other seven Epidiolex ANDA Filers, which is ongoing.
+Added: 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.
+Added: 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.
+Added: 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 Epidiolex.
+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: 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.
The Company vigorously enforces its intellectual property rights but cannot predict the outcome of these matters.
+Added: MSP Litigation
+Added: 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.
+Added: d/b/a Curascript, S.D., Priority Healthcare Distribution, Inc.
+Added: 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: 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.
+Added: The allegations relate generally to the conduct at issue in the investigation conducted by the United States Department of Justice from 2016-2019, involving the Company’s contributions to certain charitable foundations.
+Added: MSP seeks monetary damages, restitution, disgorgement, and a declaration that the conduct alleged is unlawful.
+Added: On July 25, 2023, we and certain other defendants filed motions to dismiss MSP's complaint, which the Court granted on December 12, 2023.
+Added: On January 5, 2024, the MSP filed an amended complaint.
+Added: On February 20, 2024, we filed a motion to dismiss MSP’s amended complaint.
+Added: No trial date has been set for this matter.
+Added: FDA Litigation
+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 New Drug Application, or NDA, for Avadel's Lumryz was unlawful.
+Added: 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.
+Added: 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.
+Added: The complaint, filed
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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;
+Added: 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: On September 15, 2023, we filed a motion for summary judgment.
+Added: On October 20, 2023, Avadel and FDA filed cross motions for summary judgment.
+Added: Oral argument on these motions is currently scheduled for April 9, 2024.
From time to time we are involved in legal proceedings arising in the ordinary course of business.
4 unchanged sentences
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 amended credit agreement, corporate and regulatory requirements and market conditions.
+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 May 2021 credit agreement, corporate and regulatory requirements and market conditions.
The share repurchase program may be modified, suspended or discontinued at any time without prior notice.
+Added: 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.
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: In 2021, we did not repurchase any of our ordinary shares under the share repurchase program.
−Removed: As of December 31, 2022, the remaining amount authorized under the share repurchase program was $ 431.2 million.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: As of December 31, 2023, the remaining amount authorized under the share repurchase program was $ 161.4 million, exclusive of any brokerage commissions.
Authorized But Unissued Ordinary Shares
11 unchanged sentences
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.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Accumulated Other Comprehensive Loss
5 unchanged sentences
Balance at December 31, 2022 $ — $ ( 1,125,509 ) $ ( 1,125,509 )
−Removed: Other comprehensive loss before reclassifications — ( 725,277 ) ( 725,277 )
+Added: Other comprehensive income before reclassifications 3,658 283,127 286,785
Amounts reclassified from accumulated other comprehensive income (loss) ( 3,423 ) — ( 3,423 )
−Removed: Other comprehensive income (loss), net 128 ( 725,277 ) ( 725,149 )
+Added: Other comprehensive income, net 235 283,127 283,362
Balance at December 31, 2023 $ 235 $ ( 842,382 ) $ ( 842,147 )
−Removed: In 2022, other comprehensive loss reflects foreign currency translation adjustments, primarily due to the weakening of sterling and the euro against the U.S.
+Added: 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.
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.
−Removed: 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) $ 414,832 $ ( 224,060 ) $ ( 329,668 )
+Added: Effect of interest on assumed conversions of Exchangeable Senior Notes, net of tax 24,876 — —
+Added: Net income (loss) for dilutive net income (loss) per ordinary share $ 439,708 $ ( 224,060 ) $ ( 329,668 )
Weighted-average ordinary shares used in per share calculations - basic 63,291 62,539 59,694
+Added: Dilutive effect of Exchangeable Senior Notes 8,016 — —
Dilutive effect of employee equity incentive and purchase plans 759 — —
3 unchanged sentences
Diluted $ 6.10 $ ( 3.58 ) $ ( 5.52 )
−Removed: Potentially dilutive ordinary shares from our employee equity incentive and purchase plans are determined by applying the treasury stock method to the assumed exercise of share options, the assumed vesting of outstanding restricted stock units, or RSUs and PRSUs, and the assumed issuance of ordinary shares under our employee stock purchase plan, or ESPP.
−Removed: We adopted ASU 2020-06 on January 1, 2022, on a modified retrospective basis, which eliminates the treasury stock method to calculate diluted earnings per share for convertible instruments and requires the use of the if-converted method.
+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 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: On January 1, 2022, we adopted ASU No.
+Added: 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40):
+Added: 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.
+Added: In August 2023, we made an irrevocable election to
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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, 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.
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 and 2020, 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.
+Added: 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.
The average price of our ordinary shares in 2021 exceeded the effective exchange price per ordinary share of the 2026 Notes.
1 unchanged sentence
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.
−Removed: The potential issue of ordinary shares issuable upon exchange of the Exchangeable Senior Notes had no effect on diluted net income per ordinary share for 2020 as the average price of our ordinary shares during 2020 did not exceed the effective exchange prices per ordinary share of the Exchangeable Senior Notes.
The following table represents the weighted-average ordinary shares that were excluded from the computation of diluted net income (loss) per ordinary share for the years presented because including them would have an anti-dilutive effect (in thousands):
1 unchanged sentence
2023 2022 2021
−Removed: Exchangeable Senior Notes 9,044 9,725 8,077
Employee equity incentive and purchase plans 2,973 2,751 3,927
+Added: Exchangeable Senior Notes — 9,044 9,725
Segment and Other Information
2 unchanged sentences
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.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The following table presents total long-lived assets by location (in thousands):
7 unchanged sentences
(1) Long-lived assets consist of property, plant and equipment and operating lease assets.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The following table presents a summary of total revenues (in thousands):
1 unchanged sentence
2023 2022 2021
−Removed: Xyrem $ 1,020,453 $ 1,265,830 $ 1,741,758
Xywav $ 1,272,977 $ 958,425 $ 535,297
−Removed: Total Oxybate 1,978,878 1,801,127 1,757,022
+Added: Xyrem 569,730 1,020,453 1,265,830
Epidiolex/Epidyolex 845,468 736,398 463,645
Sativex 19,668 16,825 12,707
−Removed: Sunosi 28,844 57,914 28,333
+Added: — 28,844 57,914
Total Neuroscience 2,707,843 2,760,945 2,335,393
−Removed: Zepzelca 269,912 246,808 90,380
Rylaze 394,226 281,659 85,629
−Removed: Vyxeos 127,980 134,060 121,105
+Added: Zepzelca 289,533 269,912 246,808
Defitelio/defibrotide 184,000 194,290 197,931
+Added: Vyxeos 147,495 127,980 134,060
Erwinaze/Erwinase — — 69,382
2 unchanged sentences
Product sales, net 3,736,943 3,641,429 3,079,001
−Removed: Royalties and contract revenues 17,945 15,237 16,907
+Added: High-sodium oxybate AG royalty revenue 75,918 — —
+Added: Other royalty and contract revenues 21,343 17,945 15,237
Total revenues $ 3,834,204 $ 3,659,374 $ 3,094,238
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: ____________________________
+Added: (1) Divestiture of Sunosi U.S.
+Added: was completed in May 2022.
The following table presents a summary of total revenues attributed to geographic sources (in thousands):
12 unchanged sentences
Our payment terms vary by the type and location of our customer, but payment is generally required in a term ranging from 30 to 65 days.
−Removed: Contract Liabilities - Deferred Revenue
−Removed: The deferred revenue balance as of December 31, 2022 primarily related to deferred upfront fees received from Nippon Shinyaku Co., Ltd., or Nippon Shinyaku, in connection with two license, development and commercialization agreements granting Nippon Shinyaku exclusive rights to develop and commercialize each of Defitelio and Vyxeos in Japan.
−Removed: We recognized contract revenues of $ 2.1 million in 2022 relating to these upfront payments.
−Removed: The deferred revenue balances are being recognized over an average of four years representing the period we expect to perform our research and developments obligations under each agreement.
−Removed: The following table presents a reconciliation of our beginning and ending balances in contract liabilities from contracts with customers for the year ended December 31, 2022 (in thousands):
−Removed: Contract Liabilities
−Removed: Balance as of December 31, 2021 $ 2,556
−Removed: Amount recognized within royalties and contract revenues ( 2,093 )
−Removed: Balance as of December 31, 2022 $ 463
Share-Based Compensation
1 unchanged sentence
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 amended from time to time, together referred to as the GW Incentive Plans.
+Added: 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: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: amended from time to time, together referred to as the GW Incentive Plans.
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.
5 unchanged sentences
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.
−Removed: The 2011 Plan became effective
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: immediately before the consummation of the Azur Merger and was assumed and adopted by us upon the consummation of the Azur Merger.
+Added: The 2011 Plan became effective immediately before the consummation of the Azur Merger and was assumed and adopted by us upon the consummation of the Azur Merger.
The terms of the 2011 Plan provide for the grant of stock options, stock appreciation rights, RSUs, other stock awards, and performance awards that may be settled in cash, shares, or other property.
5 unchanged sentences
The amended and restated ESPP became effective immediately prior to the effective time of the Azur Merger and was assumed by us upon the consummation of the Azur Merger.
−Removed: The amended and restated ESPP allows our eligible employee participants (including employees of any of a parent or subsidiary company if our board of directors designates such company as eligible to participate) to purchase our ordinary shares at a discount of 15 % through payroll deductions.
+Added: The amended and restated ESPP allows our eligible employee participants (including employees of any parent or subsidiary company if our board of directors designates such company as eligible to participate) to purchase our ordinary shares at a discount of 15 % through payroll deductions.
The ESPP consists of a fixed offering period of 24 months with four purchase periods within each offering period.
9 unchanged sentences
Since the Azur Merger, all of the new grants under the 2007 Directors Award Plan were granted to non-employee directors and vest ratably over service periods of one to three years and expire no more than 10 years after the date of grant.
−Removed: In addition, the 2007 Directors Award Plan provides the source of shares to fund distributions made prior to August 15, 2010 under the Directors Deferred Compensation Plan described below.
In August 2016, our shareholders approved our proposal to expand the types of stock awards that may be granted to our non-employee directors under the 2007 Directors Award Plan and eliminate the final automatic share reserve increase under the 2007 Directors Award Plan that was scheduled to occur on January 1, 2017.
1 unchanged sentence
As of December 31, 2023, a total of 1,403,938 of our ordinary shares had been authorized for issuance under the 2007 Directors Award Plan.
−Removed: Amended and Restated Directors Deferred Compensation Plan
−Removed: In May 2007, the Jazz Pharmaceuticals, Inc.
−Removed: board of directors adopted the Directors Deferred Compensation Plan, or the Directors Deferred Plan, which was amended in December 2008 and was then amended and restated in August 2010, and which was continued and assumed by us upon consummation of the Azur Merger.
−Removed: The Directors Deferred Plan allows each non-employee director to elect to defer receipt of all or a portion of his or her annual retainer fees to a future date or dates.
−Removed: Amounts deferred under the Directors Deferred Plan are credited as shares of Jazz Pharmaceuticals, Inc.’s common stock (or our ordinary shares following the Azur Merger) to a phantom stock account, the number of which are based on the amount of the retainer fees deferred divided by the market value of Jazz Pharmaceuticals, Inc.’s common stock (or our ordinary shares following the Azur Merger) on the first trading day of the first open window period following the date the retainer fees are deemed earned.
−Removed: On the 10th business day following the day of separation from the board of directors or the occurrence of a change in control, or as soon thereafter as practical once the non-employee director has provided the necessary information for electronic deposit of the deferred shares, each non-employee director will receive (or commence receiving, depending upon whether the director has elected to receive distributions from his or her phantom stock account in a lump sum or in installments over time) a distribution of his or her phantom stock account, in our ordinary shares (i) reserved under the 2007 Directors Option Plan prior to August 15, 2010 and (ii) from a new reserve of 200,000 shares set up under the Directors Deferred Plan on August 15, 2010.
−Removed: Since the consummation of the Azur Merger, we have not permitted non-employee directors to defer any annual retainer fees under the Directors Deferred Plan.
−Removed: On October 31, 2019, our board of directors approved the termination of the Directors
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: Deferred Plan, and all outstanding phantom stock was distributed to each applicable non-employee director on November 2, 2020.
−Removed: We recorded no expense in 2022, 2021 and 2020 related to retainer fees earned and deferred.
Share-Based Compensation
−Removed: There were no share options granted in 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 option grants granted in 2021 and 2020:
−Removed: Year Ended December 31,
−Removed: Grant date fair value $ 51.39 $ 34.68
−Removed: Volatility 37 % 33 %
−Removed: Expected term (years) 4.5 4.6
−Removed: Range of risk-free rates 0.4 - 0.8 %
−Removed: Expected dividend yield — % — %
−Removed: We rely 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 use a single volatility estimate for each share option grant.
−Removed: The weighted-average volatility is 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 represents the weighted-average period the awards are 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.
Share-based compensation expense related to share options, RSUs, PRSUs and grants under our ESPP was as follows (in thousands):
8 unchanged sentences
We recognized income tax benefits related to share option exercises of $ 1.9 million, $ 8.0 million and $ 9.3 million in 2023, 2022 and 2021, respectively.
+Added: Restricted Stock Units
+Added: In 2023, 2022 and 2021, we granted RSUs covering an equal number of our ordinary shares to employees with a weighted-average grant date fair value of $ 144.65 , $ 152.08 and $ 168.10 , respectively.
+Added: 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.
+Added: The fair value of the RSUs is recognized as an expense ratably over the vesting period of four years .
+Added: In 2023, 2022 and 2021, 1,094,000 , 910,000 and 692,000 RSUs were released, respectively, with 735,000 , 610,000 and 465,000 ordinary shares issued, respectively, and 359,000 , 300,000 and 227,000 ordinary shares withheld for tax purposes, respectively.
+Added: The total fair value of shares vested was $ 155.5 million, $ 138.1 million and $ 109.2 million during 2023, 2022 and 2021, respectively.
+Added: As of December 31, 2023, total compensation cost not yet recognized related to unvested RSUs was $ 307.7 million, which is expected to be recognized over a weighted-average period of 2.4 years.
+Added: The following table summarizes information as of December 31, 2023 and activity during 2023 related to our RSUs:
+Added: Number of RSUs (In thousands) Weighted-
+Added: Fair Value Weighted-
+Added: Term (Years) Aggregate
+Added: (In thousands)
+Added: Outstanding at January 1, 2023 3,209 $ 151.11
+Added: RSUs granted 1,768 144.65
+Added: RSUs released ( 1,094 ) 148.68
+Added: RSUs forfeited ( 320 ) 149.54
+Added: Outstanding at December 31, 2023 3,563 $ 148.79 1.3 $ 438,224
+Added: Performance-Based Restricted Stock Units
+Added: 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, 2023, December 31, 2024 and December 31, 2025, respectively.
+Added: 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.
+Added: 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.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: The following table summarizes information as of December 31, 2023 and activity during 2023 related to our PRSUs:
+Added: Number of PRSUs (In thousands) Weighted-
+Added: Fair Value Weighted-
+Added: Term (Years) Aggregate
+Added: (In thousands)
+Added: Outstanding at January 1, 2023 440 $ 183.68
+Added: PRSUs granted 271 156.91
+Added: PRSUs forfeited ( 47 ) 176.06
+Added: Outstanding at December 31, 2023 664 $ 173.30 1.5 $ 81,729
+Added: As of December 31, 2023, total compensation cost not yet recognized related to unvested PRSUs was $ 24.6 million, which is expected to be recognized over a weighted-average period of 1.5 years.
+Added: As the PRSUs granted in each year are subject to a market condition, the grant date fair value for such PRSUs was based on a Monte Carlo simulation model.
+Added: In 2023, 2022 and 2021, we granted PRSUs to employees with a weighted-average grant date fair value of $ 156.91 , $ 178.78 and $ 190.81 , respectively.
+Added: 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.
Share Options
+Added: There were no share options granted in 2023 and 2022.
+Added: 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:
+Added: December 31, 2021
+Added: Grant date fair value $ 51.39
+Added: Volatility 37 %
+Added: Expected term (years) 4.5
+Added: Range of risk-free rates 0.4 - 0.8 %
+Added: Expected dividend yield — %
+Added: We relied on a blend of the historical and implied volatilities of our own ordinary shares to determine expected volatility for share option grants.
+Added: In addition, we used a single volatility estimate for each share option grant.
+Added: The weighted-average volatility was determined by calculating the weighted average of volatilities for all share options granted in a given year.
+Added: 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.
+Added: The risk-free interest rate assumption was based on zero coupon U.S.
+Added: Treasury instruments whose term was consistent with the expected term of our share option grants.
+Added: The expected dividend yield assumption was based on our history and expectation of dividend payouts.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The following table summarizes information as of December 31, 2023 and activity during 2023 related to our share option plans:
15 unchanged sentences
As of December 31, 2023, total compensation cost not yet recognized related to unvested share options was $ 1.5 million, which is expected to be recognized over a weighted-average period of 0.5 years.
−Removed: As of December 31, 2022, total compensation cost not yet recognized related to grants under the ESPP was $ 6.3 million, which is expected to be recognized over a weighted-average period of 1.0 year.
+Added: As of December 31, 2023, total compensation cost not yet recognized related to grants under the ESPP was $ 11.3 million, which is expected to be recognized over a weighted-average period of 1.2 years.
Nominal Strike Price Options
8 unchanged sentences
Options exercised ( 29 ) 0.02
−Removed: Options forfeited ( 5 ) 0.02
Outstanding at December 31, 2023 27 $ 0.02 6.4 $ 3,357
1 unchanged sentence
Exercisable at December 31, 2023 27 $ 0.02 6.4 $ 3,357
−Removed: The aggregate intrinsic value of nominal strike price options exercised was $ 8.4 million and $ 0.2 million during 2022 and 2021, respectively.
+Added: The aggregate intrinsic value of nominal strike price options exercised was $ 3.9 million, $ 8.4 million and $ 0.2 million during 2023, 2022 and 2021, respectively.
We issued new ordinary shares upon exercise of nominal strike price options.
−Removed: As of December 31, 2022, total compensation cost not yet recognized related to unvested nominal strike price options was $ 0.8 million, which is expected to be recognized over a weighted-average period of 0.2 years.
−Removed: Restricted Stock Units
−Removed: In 2022, 2021 and 2020, we granted RSUs covering an equal number of our ordinary shares to employees with a weighted-average grant date fair value of $ 152.08 , $ 168.10 and $ 117.23 , respectively.
−Removed: 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 .
−Removed: In 2022, 2021 and 2020, 910,000 , 692,000 and 423,000 RSUs were
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: released, respectively, with 610,000 , 465,000 and 290,000 ordinary shares issued, respectively, and 300,000 , 227,000 and 133,000 ordinary shares withheld for tax purposes, respectively.
−Removed: The total fair value of shares vested was $ 138.1 million, $ 109.2 million and $ 53.5 million during 2022, 2021 and 2020, respectively.
−Removed: As of December 31, 2022, total compensation cost not yet recognized related to unvested RSUs was $ 288.8 million, which is expected to be recognized over a weighted-average period of 2.5 years.
−Removed: The following table summarizes information as of December 31, 2022 and activity during 2022 related to our RSUs:
−Removed: Number of RSUs (In thousands) Weighted-
−Removed: Fair Value Weighted-
−Removed: Term (Years) Aggregate
−Removed: (In thousands)
−Removed: Outstanding at January 1, 2022 2,631 $ 149.05
−Removed: RSUs granted 2,138 152.08
−Removed: RSUs released ( 910 ) 146.63
−Removed: RSUs forfeited ( 650 ) 152.24
−Removed: Outstanding at December 31, 2022 3,209 $ 151.11 1.4 $ 511,185
−Removed: Performance-Based Restricted Stock Units
−Removed: The Compensation & Management Development Committee 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, 2023 and December 31, 2024, 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.
−Removed: The following table summarizes information as of December 31, 2022 and activity during 2022 related to our PRSUs:
−Removed: Number of PRSUs (In thousands) Weighted-
−Removed: Fair Value Weighted-
−Removed: Term (Years) Aggregate
−Removed: (In thousands)
−Removed: Outstanding at January 1, 2022 214 $ 190.81
−Removed: PRSUs granted 293 178.78
−Removed: PRSUs forfeited ( 67 ) 184.99
−Removed: Outstanding at December 31, 2022 440 $ 183.68 1.6 $ 70,066
−Removed: As of December 31, 2022, total compensation cost not yet recognized related to unvested PRSUs was $ 46.0 million, which is expected to be recognized over a weighted-average period of 1.6 years.
−Removed: As the PRSUs granted in 2021 and 2022 are subject to a market condition, the grant date fair value for such PRSUs was based on a Monte Carlo simulation model.
−Removed: In 2022 and 2021, we granted PRSUs to employees with a weighted-average grant date fair value of $ 178.78 and $ 190.81 , respectively.
−Removed: 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.
Employee Benefit Plans
35 unchanged sentences
Total income tax expense (benefit) $ ( 119,912 ) $ ( 158,645 ) $ 216,116
−Removed: Our income tax benefit was $ 158.6 million in 2022 and our income tax expense was $ 216.1 million and $ 33.5 million in 2021 and 2020, respectively, 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, originating tax credits and FDII benefits.
−Removed: Our income tax benefit in 2022 increased primarily due to payments for acquired IPR&D made in the year and the impact of the impairment of our acquired IPR&D asset as a result of the decision to discontinue our nabiximols program.
+Added: 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.
+Added: and certain other foreign jurisdictions, offset by deductions on subsidiary equity, foreign derived intangible income benefits and originating tax credits.
+Added: 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.
Our income tax expense in 2021 included an expense of $ 259.9 million arising on the remeasurement of our U.K.
2 unchanged sentences
Finance Act 2021.
−Removed: Our income tax expense in 2020 included the impact of the disallowance of certain interest deductions and a provision for a proposed settlement reached with the French taxing authorities.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: The reconciliation between income tax expense (benefit) at the Irish statutory 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 expense (benefit) was as follows (in thousands):
Year Ended December 31,
3 unchanged sentences
Change in valuation allowance 75,081 95,051 81,280
−Removed: Foreign derived intangible income benefit ( 29,541 ) ( 3,416 ) —
Research and other tax credits ( 49,900 ) ( 27,976 ) ( 31,069 )
−Removed: Change in tax rate ( 16,790 ) 261,663 ( 1,836 )
−Removed: Change in estimates ( 14,065 ) ( 2,653 ) ( 3,604 )
−Removed: Non-deductible compensation 13,505 19,914 8,604
+Added: Foreign derived intangible income benefit ( 42,400 ) ( 29,541 ) ( 3,416 )
Non-deductible facility expense 16,618 8,093 —
−Removed: Non-deductible royalty expense 6,274 — —
+Added: Non-deductible financing costs 15,705 4,504 14,418
+Added: Non-deductible compensation 14,092 13,505 19,914
Patent box incentive benefit ( 13,862 ) ( 6,203 ) —
−Removed: Foreign income tax rate differential 5,863 ( 4,343 ) 16,126
Change in unrecognized tax benefits ( 12,612 ) 5,029 ( 6,436 )
−Removed: Non-deductible financing costs 4,504 14,418 7,132
+Added: Foreign income tax rate differential ( 7,763 ) 5,863 ( 4,343 )
+Added: Change in estimates ( 5,472 ) ( 14,065 ) ( 2,653 )
Tax deficiencies/(excess tax benefits) from share-based compensation 3,959 ( 1,690 ) ( 5,555 )
+Added: Change in tax rate ( 605 ) ( 16,790 ) 261,663
+Added: Non-deductible royalty expense — 6,274 —
Non-deductible acquisition-related costs — — 20,929
1 unchanged sentence
Reported income tax expense (benefit) $ ( 119,912 ) $ ( 158,645 ) $ 216,116
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Significant components of our net deferred tax assets (liabilities) were as follows (in thousands):
2 unchanged sentences
Intangible assets 238,062 236,462
−Removed: Tax credit carryforwards 189,792 284,155
Deduction on subsidiary equity carryforwards 212,015 157,367
−Removed: Accrued liabilities 109,257 84,110
Capitalized research and development 201,186 88,009
−Removed: Indirect effects of unrecognized tax benefits 47,224 46,876
+Added: Tax credit carryforwards 142,854 189,792
+Added: Accrued liabilities 128,948 109,257
Share-based compensation 48,403 42,795
+Added: Indirect effects of unrecognized tax benefits 40,811 47,224
Lease liabilities 13,415 14,081
9 unchanged sentences
Total deferred tax liabilities ( 1,385,641 ) ( 1,493,175 )
−Removed: Net of deferred tax assets and (liabilities) $ ( 568,090 ) $ ( 989,438 )
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: Net deferred tax liabilities $ ( 369,872 ) $ ( 568,090 )
The net change in valuation allowance was an increase of $ 77.6 million, $ 80.5 million and $ 76.9 million in 2023, 2022 and 2021, respectively.
2 unchanged sentences
Deferred tax liabilities ( 847,706 ) ( 944,337 )
−Removed: Net of deferred tax assets and (liabilities) $ ( 568,090 ) $ ( 989,438 )
+Added: Net deferred tax liabilities $ ( 369,872 ) $ ( 568,090 )
As of December 31, 2023, we had net operating losses, or NOL, carryforwards and tax credit carryforwards for U.S.
12 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 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
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: 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 $ 95.1 million and $ 81.3 million in 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 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 $ 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.
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.
6 unchanged sentences
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.
−Removed: As a result, we have recorded an unrecognized tax benefit for certain tax benefits which we judge may not be sustained upon examination.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
−Removed: A reconciliation of our gross unrecognized tax benefits follows (in thousands):
+Added: As a result, we have recorded an unrecognized tax benefit for certain tax positions which we judge may not be sustained upon examination.
+Added: A reconciliation of our unrecognized tax benefits follows (in thousands):
2023 2022 2021
8 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 our unrecognized tax benefits is recorded in the income tax benefit in our consolidated statements of income (loss).
+Added: Interest related to income taxes is recorded in the income tax expense (benefit) in our consolidated statements of income (loss).
As of December 31, 2023 and 2022, our accrued interest related to income taxes was $ 8.4 million and $ 5.8 million, respectively.
−Removed: Interest related to income taxes benefits recognized in the consolidated statements of income (loss) were not significant.
+Added: Interest related to income taxes recognized in the consolidated statements of income (loss) were not significant.
Included in the balance of unrecognized tax benefits were potential benefits of $ 77.1 million and $ 91.7 million at December 31, 2023 and 2022, respectively, that, if recognized, would affect the effective tax rate on income.
+Added: 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.
We file income tax returns in multiple tax jurisdictions, the most significant of which are Ireland, the U.K.
6 unchanged sentences
Certain of our Luxembourg subsidiaries are currently under examination by the Luxembourg taxing authorities for the years ended December 31, 2017, 2018 and 2019.
−Removed: In October 2022, we received tax assessment notices from the Luxembourg taxing authorities for 2017 and 2018 relating to certain transfer pricing and other adjustments.
−Removed: The notices propose additional Luxembourg income tax of approximately $ 18.8 million, translated at the foreign exchange rate as December 31, 2022.
+Added: 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.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
+Added: propose additional Luxembourg income tax of approximately $ 24.7 million, translated at the foreign exchange rate as at December 31, 2023.
We disagree with the proposed assessments and are contesting them vigorously.
22 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 2020 and 2021 relate to currency translation adjustments recorded directly in other comprehensive income.
+Added: (3) Other additions to the deferred tax asset valuation allowance in 2021 relate to currency translation adjustments recorded directly in other comprehensive income.
(4) 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.