What changed in this filing

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Item 1. Financial Statements

2024-11-07 compared with 2024-08-01 · 247 added, 187 removed, 786 unchanged (36% of the section changed)

3 unchanged sentences

(In thousands)

September 30,

2024 December 31,

41 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

11 unchanged sentences

Interest expense, net ( 58,702 ) ( 71,497 ) ( 186,841 ) ( 219,114 )

Foreign exchange gain (loss) 507 ( 2,382 ) ( 1,186 ) 811

Income before income tax benefit and equity in loss of investees 137,927 81,784 136,325 136,885

Foreign exchange loss ( 701 ) ( 1,377 ) ( 1,887 ) ( 566 )

Income before income tax benefit and equity in loss (gain) of investees 200,807 99,518 337,132 236,403

Income tax benefit ( 14,533 ) ( 47,176 ) ( 33,517 ) ( 86,823 )

Equity in loss of investees 12 1,669 1,359 2,674

Equity in loss (gain) of investees 285 ( 126 ) 1,644 2,548

Net income $ 215,055 $ 146,820 $ 369,005 $ 320,678

6 unchanged sentences

JAZZ PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands)

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

2 unchanged sentences

Foreign currency translation adjustments 291,367 ( 170,826 ) 241,218 82,952

Unrealized gain on cash flow hedging activities, net of income tax expense of $ 529 , $ 1,887 , $ 2,249 and $ 1,887 respectively

Unrealized gain (loss) on cash flow hedging activities, net of income tax (benefit) expense of $( 1,727 ), $ 1,176 , $ 522 and $ 3,063 respectively

( 5,197 ) 3,539 1,572 9,218

Gain on cash flow hedging activities reclassified from accumulated other comprehensive income (loss) to interest expense, net of income tax expense of $ 446 , $ 256 , $ 897 and $ 256 respectively

Gain on cash flow hedging activities reclassified from accumulated other comprehensive loss to interest expense, net of income tax expense of $ 445 , $ 428 , $ 1,342 and $ 684 respectively

( 1,340 ) ( 1,289 ) ( 4,040 ) ( 2,060 )

Other comprehensive income (loss) 284,830 ( 168,576 ) 238,750 90,110

Total comprehensive income $ 162,735 $ 217,845 $ 107,870 $ 432,544

Total comprehensive income (loss) $ 499,885 $ ( 21,756 ) $ 607,755 $ 410,788

The accompanying notes are an integral part of these condensed consolidated financial statements.

27 unchanged sentences

Balance at June 30, 2024 61,745 $ 6 4,000 $ 55 $ 473 $ 3,779,114 $ ( 888,227 ) $ 871,178 $ 3,762,599

Issuance of ordinary shares in conjunction with exercise of share options 1 — — — — 17 — — 17

Issuance of ordinary shares in conjunction with vesting of restricted stock units 69 — — — — — — — —

Shares withheld for payment of employee's withholding tax liability — — — — — ( 1,605 ) — — ( 1,605 )

Share-based compensation — — — — — 60,172 — — 60,172

Shares repurchased ( 1,372 ) — — — — — — ( 150,001 ) ( 150,001 )

Other comprehensive income — — — — — — 284,830 — 284,830

Net income — — — — — — — 215,055 215,055

Balance at September 30, 2024 60,443 $ 6 4,000 $ 55 $ 473 $ 3,837,698 $ ( 603,397 ) $ 936,232 $ 4,171,067

JAZZ PHARMACEUTICALS PLC

25 unchanged sentences

Balance at June 30, 2023 63,398 $ 6 4,000 $ 55 $ 473 $ 3,580,115 $ ( 866,823 ) $ 811,849 $ 3,525,675

Issuance of ordinary shares in conjunction with exercise of share options 50 — — — — 5,512 — — 5,512

Issuance of ordinary shares in conjunction with vesting of restricted stock units 59 — — — — — — — —

Shares withheld for payment of employee's withholding tax liability — — — — — ( 1,884 ) — — ( 1,884 )

Share-based compensation — — — — — 56,197 — — 56,197

Shares repurchased ( 562 ) — — — — — — ( 74,371 ) ( 74,371 )

Other comprehensive loss — — — — — — ( 168,576 ) — ( 168,576 )

Net income — — — — — — — 146,820 146,820

Balance at September 30, 2023 62,945 $ 6 4,000 $ 55 $ 473 $ 3,639,940 $ ( 1,035,399 ) $ 884,298 $ 3,489,373

The accompanying notes are an integral part of these condensed consolidated financial statements.

2 unchanged sentences

(In thousands)

Six Months Ended

Nine Months Ended

September 30,

Operating activities

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Depreciation 23,240 22,764

Provision for losses on accounts receivable and inventory 13,186 5,550

Non-cash interest expense 18,877 16,255

Provision for losses on accounts receivable and inventory 15,866 7,732

Acquired in-process research and development 10,000 1,000

21 unchanged sentences

Financing activities

Share repurchases ( 161,428 ) ( 95,595 )

Payment of employee withholding taxes related to share-based awards ( 52,143 ) ( 47,454 )

Repayments of long-term debt ( 15,500 ) ( 15,500 )

Net proceeds from issuance of exchangeable senior notes, due 2030 980,767 —

Proceeds from employee equity incentive and purchase plans 11,451 37,606

Net cash used in financing activities ( 217,637 ) ( 126,455 )

Repayments of long-term debt ( 23,250 ) ( 23,250 )

Payment of employee withholding taxes related to share-based awards ( 53,748 ) ( 49,338 )

Share repurchases ( 311,429 ) ( 169,966 )

Repayment of exchangeable senior notes, due 2024 ( 575,000 ) —

Net cash provided by (used in) financing activities 28,791 ( 204,948 )

Effect of exchange rates on cash and cash equivalents 614 ( 652 )

Net increase (decrease) in cash and cash equivalents ( 150,508 ) 400,822

Net increase in cash and cash equivalents 711,825 454,208

Cash and cash equivalents, at beginning of period 1,506,310 881,482

15 unchanged sentences

Xywav is also approved in Canada for the treatment of cataplexy in patients with narcolepsy.

• Xyrem (sodium oxybate) oral solution , a product approved by FDA and distributed in the U.S.

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.

Xyrem is also approved and distributed in the European Union, or EU (EU market authorizations include Northern Ireland), Great Britain and other markets through a licensing agreement.

• Epidiolex® (cannabidiol) oral solution , a product approved by FDA and launched in the U.S.

17 unchanged sentences

GAAP, can be condensed or omitted.

The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with our

annual audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10‑K for the year ended December 31, 2023.

The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with our annual audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10‑K for the year ended December 31, 2023.

In the opinion of management, these condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair presentation of our financial position and operating results.

The results for the three and six months ended June 30, 2024, are not necessarily indicative of the results to be expected for the year ending December 31, 2024, for any other interim period or for any future period.

The results for the

three and nine months ended September 30, 2024, are not necessarily indicative of the results to be expected for the year ending December 31, 2024, for any other interim period or for any future period.

Our significant accounting policies have not changed substantially from those previously described in our Annual Report on Form 10‑K for the year ended December 31, 2023.

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Significant Risks and Uncertainties

Historically, our business was substantially dependent on Xyrem.

While we expect that our business will continue to meaningfully depend on oxybate revenues, there is no guarantee that oxybate revenues will remain at current levels.

We expect that our business will continue to meaningfully depend on oxybate revenues;

however, there is no guarantee that oxybate revenues will remain at current levels.

In this regard, our ability to maintain oxybate revenues and realize the anticipated benefits from our investment in Xywav are subject to a number of risks and uncertainties including, without limitation, those related to the commercialization of Xywav for the treatment of IH in adults and adoption in that indication;

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ongoing clinical research activity and related outcomes;

obtaining regulatory approval of our late-stage product candidates;

effectively commercializing our approved or acquired products such as Epidiolex, Rylaze and Zepzelca;

obtaining regulatory approval of our late-stage product candidates, such as zanidatamab;

effectively commercializing our approved products such as Epidiolex, Rylaze and Zepzelca;

obtaining and maintaining adequate coverage and reimbursement for our products;

contracting and rebates to pharmacy benefit managers and similar organizations that reduce our net revenue;

increasing scrutiny of pharmaceutical product pricing and resulting

changes in healthcare laws and policy;

increasing scrutiny of pharmaceutical product pricing and resulting changes in healthcare laws and policy;

market acceptance;

8 unchanged sentences

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;

pharmaceutical product

development and the inherent uncertainty of clinical success;

the challenges of protecting and enhancing our intellectual property rights;

10 unchanged sentences

All of our derivative instruments are utilized for risk management purposes, and we do not use derivatives for speculative trading purposes.

As of June 30, 2024, we had foreign exchange forward contracts with notional amounts totaling $ 489.1 million.

As of June 30, 2024, the outstanding foreign exchange forward contracts had a net liability fair value of $ 0.7 million.

As of June 30, 2024, we had interest rate swap contracts with notional amounts totaling $ 500.0 million.

These outstanding interest rate swap contracts had an asset fair value of $ 5.8 million as of June 30, 2024.

As of September 30, 2024, we had foreign exchange forward contracts with notional amounts totaling $ 292.7 million.

As of September 30, 2024, the outstanding foreign exchange forward contracts had a net asset fair value of $ 8.4 million.

As of September 30, 2024, we had interest rate swap contracts with notional amounts totaling $ 500.0 million with a liability fair value of $ 3.0 million.

The counterparties to these contracts are large multinational commercial banks, and we believe the risk of nonperformance is not significant.

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We monitor economic conditions in certain European countries which may result in variability of the timing of cash receipts and an increase in the average length of time that it takes to collect accounts receivable outstanding.

Historically, we have not experienced significant credit losses on our accounts receivable and, as of June 30, 2024 and December 31, 2023, allowances on receivables were not material.

As of June 30, 2024, five customers accounted for 80 % of gross accounts receivable, including Express Scripts Specialty Distribution Services, Inc.

Historically, we have not experienced significant credit losses on our accounts receivable and, as of September 30, 2024 and December 31, 2023, allowances on receivables were not material.

As of September 30, 2024, five customers accounted for 81 % of gross accounts receivable, including Express Scripts Specialty Distribution Services, Inc.

and its affiliates, or ESSDS, which accounted for 41 % of gross accounts receivable, ASD Specialty Healthcare LLC, or ASD, which accounted for 14 % of gross accounts receivable and McKesson Corporation and affiliates, or McKesson, which accounted for 14 % of gross accounts receivable.

3 unchanged sentences

Recent Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures”, which requires additional enhanced tax disclosures providing greater disaggregation of information in the Company's effective tax rate reconciliation and disaggregates income taxes paid by jurisdiction.

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures”, which requires enhanced tax disclosures providing greater disaggregation of information in the Company's effective tax rate reconciliation and disaggregates income taxes paid by jurisdiction.

The amendments are effective on a prospective basis, with the option to apply it retrospectively, for fiscal years beginning after December 15, 2024.

2 unchanged sentences

Cash, cash equivalents and investments consisted of the following (in thousands):

June 30, 2024

September 30, 2024

Losses Estimated

16 unchanged sentences

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 $ 25.4 million and $ 48.6 million in the three and six months ended June 30, 2024, respectively, and $ 14.7 million and $ 25.3 million in the three and six months ended June 30, 2023, respectively .

Interest income from available-for-sale securities was $ 26.0 million and $ 74.6 million in the three and nine months ended September 30, 2024, respectively, and $ 19.2 million and $ 44.4 million in the three and nine months ended September 30, 2023, respectively .

Fair Value Measurement

The following table summarizes, by major security type, our available-for-sale securities and derivative contracts as of June 30, 2024 and December 31, 2023, that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands):

June 30, 2024 December 31, 2023

The following table summarizes, by major security type, our available-for-sale securities and derivative contracts as of September 30, 2024 and December 31, 2023, that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands):

September 30, 2024 December 31, 2023

(Level 1) Significant

6 unchanged sentences

Time deposits — 650,000 650,000 — 420,000 420,000

Interest rate contracts — 5,794 5,794 — 3,784 3,784

Foreign exchange forward contracts — 8,364 8,364 — 18,035 18,035

Interest rate contracts — 13 13 — 3,784 3,784

Totals $ 1,170,552 $ 658,377 $ 1,828,929 $ 768,586 $ 441,819 $ 1,210,405

Foreign exchange forward contracts $ — $ 1,579 $ 1,579 $ — $ 681 $ 681

Interest rate contracts $ — $ 2,976 $ 2,976 $ — $ 3,410 $ 3,410

Foreign exchange forward contracts — — — — 681 681

Totals $ — $ 2,976 $ 2,976 $ — $ 4,091 $ 4,091

As of June 30, 2024, our available-for-sale securities included money market funds and time deposits and their carrying values were approximately equal to their fair values.

As of September 30, 2024, 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.

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.

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.

1 unchanged sentence

There were no transfers between the different levels of the fair value hierarchy in 2024 or 2023.

As of June 30, 2024 and December 31, 2023, the carrying amount of investments measured using the measurement alternative for equity investments without a readily determinable fair value was $ 4.3 million.

As of September 30, 2024 and December 31, 2023, the carrying amount of investments measured using the measurement alternative for equity investments without a readily determinable fair value was $ 4.3 million and $ 4.7 million, respectively.

The carrying amount, which is recorded within other non-current assets, is based on the latest observable transaction price.

As of June 30, 2024, the estimated fair values of the 1.50 % exchangeable senior notes due 2024, or 2024 Notes, the 2.00 % exchangeable senior notes due 2026, or 2026 Notes, which we refer to collectively as the Exchangeable Senior Notes, the 4.375 % senior secured notes, due 2029, or the Secured Notes, and the seven-year $ 3.1 billion term loan B facility, or the Dollar Term Loan were approximately $ 572 million, $ 1.0 billion, $ 1.4 billion and $ 2.7 billion, respectively.

As of September 30, 2024, the estimated fair values of the 2.000 % exchangeable senior notes due 2026, or 2026 Notes, and the 3.125 % exchangeable senior notes due 2030, or 2030 Notes, were approximately $ 1.0 billion and $ 1.0 billion, respectively.

The 2030 Notes together with the 2026 Notes and the 1.50 % exchangeable senior notes due 2024, or 2024 Notes, that were repaid upon maturity on August 15, 2024, are collectively known as the Exchangeable Senior Notes.

As of September 30, 2024, the estimated fair values of the 4.375 % senior secured notes, due 2029, or the Secured Notes, and the seven-year U.S.

dollar term loan B facility were approximately $ 1.4 billion and $ 2.7 billion, respectively.

The fair values of each of these debt facilities was estimated using quoted market prices obtained from brokers (Level 2).

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Hedge accounting is not applied to these derivative instruments as gains and losses on these hedge transactions are designed to offset gains and losses on underlying balance sheet exposures.

As of June 30, 2024 and December 31, 2023, the notional amount of foreign exchange contracts where hedge accounting is not applied was $ 489.1 million and $ 511.7 million, respectively.

The foreign exchange gain (loss) in our condensed consolidated statements of income included the following gains (losses) associated with foreign exchange contracts not designated as hedging instruments (in thousands):

As of September 30, 2024 and December 31, 2023, the notional amount of foreign exchange contracts where hedge accounting is not applied was $ 292.7 million and $ 511.7 million, respectively.

The foreign exchange loss in our condensed consolidated statements of income included the following gains (losses) associated with foreign exchange contracts not designated as hedging instruments (in thousands):

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

Foreign Exchange Forward Contracts:

2024 2023 2024 2023

Gain (loss) recognized in foreign exchange gain (loss) $ ( 825 ) $ 353 $ ( 4,911 ) $ 4,628

Gain (loss) recognized in foreign exchange loss $ 14,396 $ ( 13,549 ) $ 9,485 $ ( 8,921 )

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.

These agreements hedge contractual term loan interest rates.

As of June 30, 2024 , the interest rate swap agreements had a notional amount of $ 500.0 million.

As of September 30, 2024 , the interest rate swap agreements had a notional amount of $ 500.0 million.

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.

The impact on accumulated other comprehensive loss and earnings from derivative instruments that qualified as cash flow hedges for the three and six months ended June 30, 2024 was as follows (in thousands):

The impact on accumulated other comprehensive loss and earnings from derivative instruments that qualified as cash flow hedges for the three and nine months ended September 30, 2024 was as follows (in thousands):

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

Interest Rate Contracts:

2024 2023 2024 2023

Gain recognized in accumulated other comprehensive loss, net of tax $ 1,592 $ 5,679 $ 6,769 $ 5,679

Gain (loss) recognized in accumulated other comprehensive loss, net of tax $ ( 5,197 ) $ 3,539 $ 1,572 $ 9,218

Gain reclassified from accumulated other comprehensive loss to interest expense, net of tax ( 1,340 ) ( 1,289 ) ( 4,040 ) ( 2,060 )

Assuming no change in the U.S dollar Secured Overnight Financing Rate, or Term SOFR, based interest rates from market rates as of June 30, 2024 , $ 3.7 million of gains, net of tax, recognized in accumulated other comprehensive loss will be reclassified to earnings over the next 12 months.

The cash flow effects of our derivative contracts for the six months ended June 30, 2024 and 2023 are included within net cash provided by operating activities in the condensed consolidated statements of cash flows.

Assuming no change in the U.S dollar Secured Overnight Financing Rate, or Term SOFR, based interest rates from market rates as of September 30, 2024 , $ 0.5 million of loss, net of tax, recognized in accumulated other comprehensive loss will be reclassified to earnings over the next 12 months.

The cash flow effects of our derivative contracts for the nine months ended September 30, 2024 and 2023 are included within net cash provided by operating activities in the condensed consolidated statements of cash flows.

The following tables summarize the fair value of outstanding derivatives (in thousands):

Classification June 30,

Classification September 30,

2024 December 31,

1 unchanged sentence

Interest rate contracts Other current assets $ 13 $ 3,784

Other non-current assets 772 —

Derivatives not designated as hedging instruments:

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Derivatives designated as hedging instruments:

Interest rate contracts Accrued liabilities $ 572 $ —

Interest rate contracts Other non-current liabilities 2,404 3,410

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The following table summarizes the potential effect on our condensed consolidated balance sheets of offsetting our interest rate and foreign exchange forward contracts subject to such provisions (in thousands):

June 30, 2024

September 30, 2024

Gross Amounts of Recognized Assets/ Liabilities Gross Amounts Offset in the Consolidated Balance Sheet Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet Gross Amounts Not Offset in the Consolidated Balance Sheet

8 unchanged sentences

Inventories consisted of the following (in thousands):

September 30,

2024 December 31,

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Total inventories $ 539,302 $ 597,039

As of June 30, 2024 and December 31, 2023, inventories included $ 264.1 million and $ 328.0 million, respectively, related to the purchase accounting inventory fair value step-up on inventory acquired as part of our acquisition of GW, which we refer to as the GW Acquisition.

As of September 30, 2024 and December 31, 2023, inventories included $ 243.4 million and $ 328.0 million, respectively, related to the purchase accounting inventory fair value step-up on inventory acquired as part of our acquisition of GW.

Goodwill and Intangible Assets

2 unchanged sentences

Foreign exchange 51,516

Balance at June 30, 2024 $ 1,735,931

Balance at September 30, 2024 $ 1,804,646

The gross carrying amounts and net book values of our intangible assets were as follows (in thousands):

June 30, 2024 December 31, 2023

September 30, 2024 December 31, 2023

Average Useful

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Total finite-lived intangible assets $ 8,079,066 $ ( 2,934,849 ) $ 5,144,217 $ 7,800,209 $ ( 2,382,170 ) $ 5,418,039

The decrease in the gross carrying amount of intangible assets as of June 30, 2024, compared to December 31, 2023, relates to the negative impact of foreign currency translation adjustments due to the weakening of the sterling and the euro against the U.S.

The increase in the gross carrying amount of intangible assets as of September 30, 2024, compared to December 31, 2023, relates to the positive impact of foreign currency translation adjustments due to the strengthening of sterling against the U.S.

The assumptions and estimates used to determine future cash flows and remaining useful lives of our intangible and other long-lived assets are complex and subjective.

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.

Based on finite-lived intangible assets recorded as of June 30, 2024, and assuming the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses were estimated as follows (in thousands):

Based on finite-lived intangible assets recorded as of September 30, 2024, and assuming the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses were estimated as follows (in thousands):

Year Ending December 31, Estimated Amortization Expense

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Property, plant and equipment consisted of the following (in thousands):

September 30,

2024 December 31,

Manufacturing equipment and machinery $ 91,560 $ 82,897

Land and buildings 69,729 70,912

Leasehold improvements 71,950 67,722

Land and buildings 70,762 70,912

Computer software 41,847 38,134

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Property, plant and equipment, net $ 176,422 $ 169,646

Other current assets consisted of the following (in thousands):

2024 December 31,

Deferred charge for income taxes on intercompany profit $ 185,740 $ 171,507

Other 140,111 149,302

Total other current assets $ 325,851 $ 320,809

Accrued liabilities consisted of the following (in thousands):

September 30,

2024 December 31,

1 unchanged sentence

Employee compensation and benefits 125,497 121,209

Clinical trial accruals 39,043 44,757

Accrued royalties 40,923 30,706

Accrued interest 36,316 36,443

Clinical trial accruals 37,620 44,757

Consulting and professional services 32,844 19,538

1 unchanged sentence

Selling and marketing accruals 24,539 14,743

Accrued interest 22,445 36,443

Current portion of lease liabilities 19,103 19,447

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The following table summarizes the carrying amount of our indebtedness (in thousands):

September 30,

2024 December 31,

5 unchanged sentences

2026 Notes, net 995,544 993,600

2030 Notes 1,000,000 —

Unamortized - debt issuance costs ( 19,081 ) —

2030 Notes, net 980,919 —

Secured Notes 1,482,824 1,480,214

5 unchanged sentences

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.

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.

dollars (ii) the Euro Term Loan which was drawn by Jazz Lux on the Closing Date in Euros and (iii) the Revolving Credit Facility.

In January 2024, Jazz Lux entered into an amendment, or Repricing Amendment No.1, to the Credit Agreement.

Upon entry into the Repricing Amendment No.1, certain existing lenders converted outstanding Dollar Term Loan into a new tranche of U.S.

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 Loan that were not converted.

In July 2024, Jazz Lux entered into an amendment, or Repricing Amendment No.

Bank Trust Company, National Association, as collateral trustee, or the Credit Agreement.

The Credit Agreement initially provided for (i) a seven-year $ 3.1 billion term loan B facility, or the Dollar Term Loan, which was drawn by Jazz Lux on the closing date thereof in U.S.

dollars (ii) a seven-year € 625.0 million term loan B facility, or the Euro Term Loan, which was drawn by Jazz Lux on the closing date thereof in Euros and (iii) a five-year $ 500.0 million revolving credit facility, or the Revolving Credit Facility.

In January 2024, Jazz Lux entered into an amendment, or the Repricing Amendment No.1, to the Credit Agreement.

Upon entry into the Repricing Amendment No.1, certain existing lenders converted a portion of the outstanding Dollar Term Loan into a new tranche of U.S.

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 portion of the outstanding Dollar Term Loan that was not converted.

In July 2024, Jazz Lux entered into an amendment, or the Repricing Amendment No.

2, to the Credit Agreement, or the Amended Credit Agreement.

Upon entry into the Amended Credit Agreement, certain existing lenders converted the outstanding Tranche B-1 Dollar Term Loans into a new tranche of U.S.

dollar term loans, or the Tranche B-2 Dollar Term Loans, and Jazz Lux borrowed $ 289.6 million aggregate principal amount of additional Tranche B-2 Dollar Term Loans, the proceeds of which were used to repay the outstanding Tranche B-1 Dollar Term Loans that were not converted.

The Tranche B-2 Dollar Term Loans are a separate class of term loans under the Amended Credit Agreement with the same material terms (including with respect to maturity, prepayment, security, covenants and events of default) as the previously outstanding Tranche B-1 Dollar Term Loans and the initial Dollar Term Loans incurred on May 5, 2021, with the interest rate amended as described below and the removal of the credit spread adjustment.

Upon entry into the Amended Credit Agreement, certain existing lenders converted a portion of the outstanding Tranche B-1 Dollar Term Loans into a new tranche of U.S.

dollar term loans, or the Tranche B-2 Dollar Term Loans, and Jazz Lux borrowed $ 289.6 million aggregate principal amount of additional Tranche B-2 Dollar Term Loans, the proceeds of which were used to repay the portion of the outstanding Tranche B-1 Dollar Term Loans that were not converted.

The Tranche B-2 Dollar Term Loans are a separate class of term loans under the Amended Credit Agreement with the same material terms (including with respect to maturity, prepayment, security, covenants and events of default) as the previously outstanding Tranche B-1 Dollar Term Loans and the initial Dollar Term Loan incurred on May 5, 2021, with the interest rate amended as described below and the credit spread adjustment removed.

The principal amount of Tranche B-1 Dollar Term Loans outstanding immediately prior to the Repricing Amendment No.

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The Tranche B-2 Dollar Term Loans bear interest at a rate equal to either (a) Term SOFR, or (b) the prime lending rate, in each case, plus an applicable margin.

The applicable margin for the Tranche B-2 Dollar Term Loans is 2.25 % (in the case of Term SOFR borrowings) and 1.25 % (in the case of borrowings at the prime lending rate), a decrease of 75 basis points from the applicable margin on the Tranche B-1 Dollar Term Loans.

The Tranche B-2 Dollar Term Loan is subject to a Term SOFR floor of 0.50 %.

As of June 30, 2024, the interest rate and effective interest rate on the Tranche B-1 Dollar Term Loans were 8.46 % and 9.04 %, respectively.

At the closing of Repricing Amendment no.

2, the interest rate and effective interest rate on the Tranche B-2 Dollar Term Loans were 7.59 % and 8.27 %, respectively.

The applicable margin for the Tranche B-2 Dollar Term Loans is 2.25 % (in the case of

Term SOFR borrowings) and 1.25 % (in the case of borrowings at the prime lending rate), a decrease of 75 basis points from the applicable margin on the Tranche B-1 Dollar Term Loans.

The Tranche B-2 Dollar Term Loans are subject to a Term SOFR floor of 0.50 %.

As of September 30, 2024, the interest rate and effective interest rate on the Tranche B-2 Dollar Term Loans were 7.10 % and 8.27 %, respectively.

The Tranche B-2 Dollar Term Loans will amortize in quarterly installments equal to 0.286294791 % of the initial aggregate principal amount thereof, with the remaining balance payable on May 5, 2028.

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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 June 30, 2024, we had an undrawn Revolving Credit Facility totaling $ 500.0 million.

As of September 30, 2024, we had an undrawn Revolving Credit Facility totaling $ 500.0 million.

In September 2024, Jazz Investments I Limited, or Jazz Investments, our wholly owned subsidiary, completed a private placement of $ 1.0 billion principal amount of the 2030 Notes.

Interest on the 2030 Notes is payable semi-annually in cash in arrears on March 15 and September 15 of each year, beginning on March 15, 2025, at a rate of 3.125 % per year.

In certain circumstances, we may be required to pay additional amounts as a result of any applicable tax withholding or deductions required in respect of payments on the 2030 Notes.

The 2030 Notes mature on September 15, 2030, unless earlier exchanged, redeemed or repurchased.

The holders of the 2030 Notes have the ability to require us to repurchase all or a portion of their 2030 Notes for cash at a fundamental change repurchase price equal to 100 % of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date in the event we undergo a fundamental change (as defined in the indenture related to the 2030 Notes), such as specified change of control transactions, our liquidation or dissolution or the delisting of our ordinary shares from any of The New York Stock Exchange, The Nasdaq Global Market, The Nasdaq Global Select Market or The Nasdaq Capital Market (or any of their respective successors).

Additionally, the terms and covenants in the indenture related to the 2030 Notes include certain events of default after which the 2030 Notes may be due and payable immediately.

Prior to September 15, 2030, we may redeem the 2030 Notes, in whole but not in part, in connection with certain tax-related events.

We also may redeem the 2030 Notes on or after September 20, 2027 and prior to June 15, 2030, in whole or in part (subject to the partial redemption limitation described in the indenture related to the 2030 Notes), if the last reported sale price per ordinary share has been at least 130 % of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100 % of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

The 2030 Notes are exchangeable at an initial exchange rate of 6.5339 ordinary shares per $1,000 principal amount of 2030 Notes, which is equivalent to an initial exchange price of approximately $ 153.05 per ordinary share.

Upon exchange of the 2030 Notes, we will pay cash up to the aggregate principal amount of the 2030 Notes to be exchanged and pay or deliver, as the case may be, cash, ordinary shares or a combination of cash and ordinary shares, at our election, in respect of the remainder, if any, of our exchange obligation in excess of the aggregate principal amount of the 2030 Notes being exchanged.

The exchange rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.

In addition, following certain make-whole fundamental changes (as defined in the indenture related to the 2030 Notes) that occur prior to the maturity date or upon our issuance of a notice of redemption, we will, in certain circumstances, increase the exchange rate for a holder who elects to exchange its 2030 Notes in connection with that make-whole fundamental change or exchange its 2030 Notes called (or deemed called) for redemption during the related redemption period.

Prior to June 15, 2030, the 2030 Notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.

Exchangeable Senior Notes

The Exchangeable Senior Notes were issued by Jazz Investments I Limited, or the Issuer, a 100 %-owned finance subsidiary of Jazz Pharmaceuticals plc.

The Exchangeable Senior Notes were issued by Jazz Investments, or the Issuer, a 100 %-owned finance subsidiary of Jazz Pharmaceuticals plc.

The Exchangeable Senior Notes are senior unsecured obligations of the Issuer and are fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals plc.

No subsidiary of Jazz Pharmaceuticals plc guaranteed the Exchangeable Senior Notes.

Subject to certain local law restrictions on payment of dividends, among other things, and potential negative tax consequences, we are not aware of any significant restrictions on the ability of Jazz Pharmaceuticals plc to obtain funds from the Issuer or Jazz Pharmaceuticals plc’s other subsidiaries by dividend or loan, or any legal or economic restrictions on the ability of the Issuer or Jazz Pharmaceuticals plc’s other subsidiaries to transfer funds to Jazz Pharmaceuticals plc in the form of cash dividends, loans or advances.

legal or economic restrictions on the ability of the Issuer or Jazz Pharmaceuticals plc’s other subsidiaries to transfer funds to Jazz Pharmaceuticals plc in the form of cash dividends, loans or advances.

There is no assurance that in the future such restrictions will not be adopted.

The total liability of the 2026 Notes is reflected net of issuance costs of $ 15.3 million which will be amortized over the term of the 2026 Notes.

The 2030 Notes are accounted for as a single liability measured at its amortized cost.

The total liability is reflected net of issuance costs of $ 19.2 million which will be amortized over the term of the 2030 Notes.

The effective interest rate of the 2030 Notes is 3.46 %.

During the three months ended June 30, 2024 and 2023, we recognized interest expense of $ 5.6 million, of which $ 5.0 million related to the contractual coupon rate and $ 0.6 million related to the amortization of debt issuance costs, respectively.

During the six months ended June 30, 2024 and 2023, we recognized interest expense of $ 11.1 million, of which $ 10.0 million related to the contractual coupon rate and $ 1.1 million related to the amortization of debt issuance costs, respectively.

During the three months ended September 30, 2024 we recognized interest expense of $ 2.3 million, of which $ 2.2 million related to the contractual coupon rate and $ 0.1 million related to the amortization of debt issuance costs.

The total liability of the 2026 Notes is reflected net of issuance costs of $ 15.3 million which will be amortized over the term of the 2026 Notes.

The effective interest rate of the 2026 Notes is 2.26 %.

During the three months ended June 30, 2024 and 2023, we recognized interest expense of $ 2.5 million, of which $ 2.1 million related to the contractual coupon rate and $ 0.4 million related to the amortization of debt issuance costs, respectively.

During the six months ended June 30, 2024 and 2023, we recognized interest expense of $ 5.0 million, of which $ 4.2 million related to the contractual coupon rate and $ 0.8 million related to the amortization of debt issuance costs, respectively.

Scheduled maturities with respect to our long-term debt principal balances outstanding as of June 30, 2024 were as follows (in thousands):

During the three months ended September 30, 2024 and 2023, we recognized interest expense of $ 5.7 million, of which $ 5.0 million related to the contractual coupon rate and $ 0.7 million related to the amortization of debt issuance costs, respectively.

During the nine months ended September 30, 2024 and 2023, we recognized interest expense of $ 16.8 million, of which $ 15.0 million related to the contractual coupon rate and $ 1.8 million related to the amortization of debt issuance costs, respectively.

On August 15, 2024, the maturity date for the 2024 Notes, we repaid the $ 575.0 million aggregate principal amount, plus accrued and unpaid interest thereon.

During the three months ended September 30, 2024, we recognized interest expense of $ 1.3 million, of which $ 1.0 million related to the contractual coupon rate and $ 0.3 million related to the amortization of debt issuance costs.

During the three months ended September 30, 2023, we recognized interest expense of $ 2.5 million, of which $ 2.1 million related to the contractual coupon rate and $ 0.4 million related to the amortization of debt issuance costs.

During the nine months ended September 30, 2024, we recognized interest expense of $ 6.4 million, of which $ 5.3 million related to the contractual coupon rate and $ 1.1 million related to the amortization of debt issuance costs.

During the nine months ended September 30, 2023, we recognized interest expense of $ 7.6 million, of which $ 6.4 million related to the contractual coupon rate and $ 1.2 million related to the amortization of debt issuance costs, respectively.

Scheduled maturities with respect to our long-term debt principal balances outstanding as of September 30, 2024 were as follows (in thousands):

Year Ending December 31, Scheduled Long-Term Debt Maturities

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Assuming the applicability of coverage, the willingness of the insurer to assume coverage, and subject to certain retention, loss limits and other policy provisions, we believe the fair value of these indemnification obligations is not significant.

Accordingly, we did not recognize any liabilities relating to these obligations as of June 30, 2024 and December 31, 2023.

No assurances can be given that the covering insurers will not attempt to dispute the validity, applicability, or amount of coverage without expensive litigation against these insurers, in which case we may incur substantial liabilities as a result of these indemnification obligations.

Accordingly, we did not recognize any liabilities relating to these obligations as of September 30, 2024 and December 31, 2023 .

No assurances can be given that the covering insurers will not attempt to dispute

the validity, applicability, or amount of coverage without expensive litigation against these insurers, in which case we may incur substantial liabilities as a result of these indemnification obligations.

Legal Proceedings

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in the United States District Court for the Northern District of Illinois (hereinafter referred to as the GEHA Lawsuit).

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.

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.

On June 30, 2020, a class action lawsuit was filed in the United States District Court for the Northern District of Illinois by UFCW Local 1500 Welfare Fund on behalf of itself and all others similarly situated, against Jazz Pharmaceuticals Ireland Ltd., Jazz Pharmaceuticals, Inc., Roxane Laboratories, Inc., Hikma Pharmaceuticals plc, Eurohealth (USA), Inc.

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On March 18, 2021, United Healthcare Services, Inc.

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.

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.

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On April 26, 2024, we, Hikma, and the plaintiffs filed motions for summary judgment.

The Court held oral argument on these motions on

July 19, 2024, and has not yet issued a decision.

The Court held oral argument on these motions on July 19, 2024.

On August 26, 2024, the Court issued a decision granting in part and denying in part the parties’ motions for summary judgment.

On June 13, 2024, we filed a motion to decertify the class.

On June 28, 2024, the plaintiffs filed a motion to amend the definition of the certified class.

The Court scheduled a hearing on these motions for August 22, 2024.

Trial in this matter is scheduled for October 28, 2024.

The Court held oral argument on these motions on August 22, 2024.

On October 18, 2024, the Court issued a decision denying our motion to decertify the class and granting the plaintiffs’ motion to amend the class definition.

On November 1, 2024, we filed a petition with the United States Court of Appeals for the Ninth Circuit seeking leave to appeal the Court’s decision amending the class definition.

The Ninth Circuit has not yet ruled on the petition.

Trial in this matter has been rescheduled for May 19, 2025.

On January 13, 2023, Amneal Pharmaceuticals LLC, Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc, notified the Court that they had reached a settlement-in-principle with the class action plaintiffs.

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On February 2 , 2024, we filed our answer to the second amended complaint and Hikma filed a motion to quash service.

That motion remains pending.

The Court scheduled a hearing on Hikma’s motion for December 4, 2024.

The Court has not set a further schedule in this case.

The plaintiffs in certain of these lawsuits are seeking to represent a class of direct purchasers of Xyrem, and the plaintiffs in the remaining lawsuits are seeking to represent a class of indirect purchasers of Xyrem.

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If the plaintiffs were to be successful in their claims, they may be entitled to injunctive relief or we may be required to pay significant monetary damages, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

GW Acquisition Litigation

On March 15, 2021, GW filed a definitive proxy statement, or Proxy Statement, with the Securities and Exchange Commission in connection with the GW Acquisition.

Since the filing of the Proxy Statement, Jazz Pharmaceuticals plc has been named in two lawsuits filed in state and federal courts in New York on March 17, 2021, by purported GW shareholders in connection with the GW Acquisition.

The first was filed in the United States District Court for the Southern District of New York by James Farrell (hereinafter referred to as the Farrell Lawsuit) and an additional suit was filed in New York state court by Brian Levy (hereinafter referred to as the Levy Lawsuit).

In addition to Jazz Pharmaceuticals plc, Jazz Pharmaceuticals U.K.

Holdings Ltd., GW Pharmaceuticals plc, and the GW board of directors are named as defendants in the Farrell Lawsuit.

In the Levy Lawsuit, GW Pharmaceuticals plc, the GW board of directors, Centerview Partners LLC, and Goldman Sachs & Co.

LLC are named as defendants.

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.

On April 14, 2021, GW filed a Form 8-K containing supplemental disclosures related to the GW Acquisition.

Pursuant to a memorandum of understanding between the parties, the Levy Lawsuit was dismissed on April 14, 2021.

On May 27, 2021, a class action lawsuit was filed in the United States District Court for the Southern District of California by plaintiff Kurt Ziegler against GW and its former Directors asserting claims under Sections 14(a) and 20(a) of the Securities Exchange Act of 1934, referred to as the Ziegler Lawsuit.

The allegations in the Ziegler Lawsuit are similar to those in the previously dismissed Transaction Litigation.

On June 3, 2022, we filed a motion to dismiss the Ziegler Lawsuit.

While the motion to dismiss was pending, in December 2022, the parties participated in a mediation and reached a tentative settlement, subject to court approval.

On March 20, 2023, the plaintiffs in the Ziegler Lawsuit filed a motion for preliminary approval of the settlement.

On July 28, 2023, the Court granted the motion for preliminary approval, which conditionally certified a class for settlement purposes.

On December 11, 2023, the Court held a hearing regarding final approval of the proposed settlement and took the matter under advisement.

On March 25, 2024, the Court issued an order finally approving the settlement and a judgment dismissing the case.

On April 4, 2024, the Court issued amended versions of the order and judgment.

Patent Infringement Litigation

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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.

Avadel filed a motion for partial judgment on the pleadings on its counterclaim that one of our patents should be delisted from FDA's Orange Book, or the Orange Book.

On November 18, 2022, the Court issued an order that we delist the patent from the Orange Book.

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The suit alleges that the filing of Avadel’s application for approval of FT218 is an act of infringement, and that Avadel’s product would infringe the patent if launched.

The suit seeks an injunction to prevent Avadel from launching a product that would

infringe the patent, and an award of damages if Avadel does launch an infringing product.

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.

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.

On December 9, 2022, we filed a motion to dismiss Avadel’s counterclaims.

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.

The Court has not yet ruled on these motions.

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.

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.

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On April 12, 2024, we filed a motion for a permanent injunction and ongoing royalties.

The Court held a hearing on that motion on June 4, 2024, but has not yet issued a decision.

On August 27, 2024, the Court granted our motion for an injunction in part, and requested additional briefing about ongoing royalties.

The issued injunction prevents Avadel from seeking FDA approval or marketing Lumryz for the treatment of idiopathic hypersomnia or other indications not already a part of Lumryz’s product labeling as of March 4, 2024, and enjoins Avadel from infringing in any way Claim 24 of our ’782 patent by making, using or selling Lumryz through and including the February 2036 expiration date of the ’782 patent, subject to certain exclusions including, among other things (i) for the treatment of narcolepsy, (ii) for the treatment of patients who have been prescribed Lumryz as of the effective date of the injunction conditioned on the payment of an amount to be determined and (iii) in clinical trials and studies ongoing as of the effective date of the injunction.

The Court also granted our motion for an ongoing royalty for any future sale of Lumryz to patients with narcolepsy at a rate to be determined based upon further briefing by the parties on the appropriate ongoing rate above 3.5 %.

Avadel is appealing this injunction to the United States Court of Appeals for the Federal Circuit.

The Federal Circuit has said the appeal will be placed on its February 2025 oral argument calendar.

Avadel filed a motion with the district court for a stay of the injunction pending appeal, which the district court denied.

Avadel also filed a motion to stay the injunction pending appeal with the Federal Circuit, which the Federal Circuit granted to the limited extent that the injunction enjoins initiating new clinical trials or studies and denied in all other respects.

The Court scheduled a trial regarding Avadel’s counterclaims for unlawful monopolization for November 3, 2025 and a trial regarding Avadel’s trade secret misappropriation claims for December 15, 2025.

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That motion remains pending and no hearing date has been set.

The Court stayed Avadel’s trade secret misappropriation claims pending appeal of the injunction in the related patent matter.

We filed a further motion to stay the unlawful monopolization counterclaims, which remains pending.

On July 21, 2022, Avadel filed a lawsuit against FDA in the United States District Court for the District of Columbia, challenging FDA’s determination that Avadel was required to file a paragraph IV certification regarding one of our Orange Book listed patents.

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On January 19, 2023, we filed an additional lawsuit against Lupin in the United States District Court for the District of New Jersey alleging that by filing its ANDA, Lupin infringed the newly-issued patent referenced in its November 2022 paragraph IV certification, as well as another patent that issued in January 2023.

The suit seeks a permanent injunction to prevent Lupin from introducing a generic version of Xywav that would infringe the two patents

The suit seeks a permanent injunction to prevent Lupin from introducing a generic version of Xywav that would infringe the two patents in suit.

On February 15, 2023, the Court consolidated the new lawsuit with the two suits we previously filed against Lupin.

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No trial date has been set in the consolidated case.

Alkem Patent Litigation

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.

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.

The asserted patents relate generally to methods of treatment when Xyrem is administered concomitantly with certain other medications.

In June 2023, we filed a patent infringement suit against Alkem in the United States District Court for the District of New Jersey.

The complaint alleges that by filing its ANDA, Alkem has infringed six of our Orange Book listed patents.

We are seeking a permanent injunction to prevent Alkem from introducing a generic version of Xyrem that would infringe our patents.

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.

On October 4, 2023, we entered into a settlement agreement with Alkem that resolves our patent litigation.

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.

In July 2024, we received notices from Lupin and Teva that they had each filed a paragraph IV certification regarding a newly-issued patent listed in the Orange Book for Xywav.

On August 27, 2024, we filed an additional lawsuit in the United States District Court for the District of New Jersey against each of Lupin and Teva, alleging that, by filing its ANDA, each party infringed the newly-issued patent related to a method of treatment using Xywav.

The suits seek orders that the effective date of FDA approval of each defendant’s application shall be a date no earlier than the expiration of the newly-issued patent.

Epidiolex Patent Litigation

In November and December 2022, we received notices from Teva Pharmaceuticals, Inc.;

In November and December 2022, we received notices from:

Teva Pharmaceuticals, Inc.;

Padagis US LLC;

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On January 11, 2024, the Court issued an order granting in part and denying in part our motion to dismiss.

The Court scheduled a claim construction hearing for September 20, 2024 relating to disputed terms in the asserted patents.

On September 20, 2024, the Court held a claim construction hearing relating to disputed terms in the asserted patents.

The Court has not yet issued a decision on the claim construction disputes .

The Court in the Epidiolex Patent Litigation scheduled trial for September 2025.

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The specific terms of the MSN settlement are confidential.

The settlements with Padagis, Teva, Alkem and MSN do not resolve the litigation against the other six Epidiolex ANDA Filers, which is ongoing.

On September 4, 2024, we entered into a settlement agreement with Lupin, Ltd., that resolved our patent litigation with Lupin related to Epidiolex.

Under the settlement agreement, we granted Lupin a license to manufacture, market, and sell its generic version of Epidiolex on a date which remains confidential.

The specific terms of the Lupin settlement are confidential.

On November 1, 2024, we entered into a settlement agreement with InvaGen Pharmaceuticals, Inc., Cipla Ltd., Cipla USA, Inc., and API Pharma Tech LLC (collectively “InvaGen”) that resolved our patent litigation with InvaGen related to Epidiolex.

Under the settlement agreement, we granted InvaGen a license to manufacture, market, and sell its generic version of Epidiolex on a date which remains confidential.

The specific terms of the InvaGen settlement are confidential.

The settlements with Padagis, Teva, Alkem, MSN, Lupin and InvaGen do not resolve the litigation against the other four Epidiolex ANDA Filers, which is ongoing.

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.

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In March and April 2024, we received notice from certain of the Epidiolex ANDA Filers that they had each filed a paragraph IV certification regarding one or more newly-issued patents listed in the Orange Book for Epidiolex.

On July 3, 2024, we filed an additional lawsuit against six of the original Epidiolex ANDA Filers with whom we have not previously settled.

On July 3, 2024, we filed an additional lawsuit against six of the original Epidiolex ANDA Filers with whom we had not previously settled.

We filed this lawsuit in the United States District Court for the District of New Jersey alleging that, by filing its ANDA, each Epidiolex ANDA Filer infringed the newly-issued patents related to methods of treatment using Epidiolex.

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The Company vigorously enforces its intellectual property rights but cannot predict the outcome of these matters.

Zepzelca Patent Litigation

In July and August 2024, we received notices from Sandoz Inc., InvaGen Pharmaceuticals, Inc., CIPLA USA, Inc.

CIPLA (EU) Limited, CIPLA Limited, Zydus Lifesciences Global FZE, Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Limited, RK Pharma, Inc., Apicore US LLC, Archis Pharma LLC, Vgyaan Pharmaceuticals LLC, MSN Pharmaceuticals Inc., and MSN Laboratories PVT.

(hereinafter referred to as the “Zepzelca ANDA Filers”), that they have each filed with FDA an ANDA for a generic version of Zepzelca (lurbinectedin).

As of the date of this filing, we are not aware of other ANDA filers.

The notices from the Zepzelca ANDA Filers each included a paragraph IV certification with respect to a patent listed in the Orange Book for Zepzelca on the date of the receipt of the notice.

The listed patent relates to the drug substance, drug product and approved use of Zepzelca.

Jazz is the exclusive licensee to this Zepzelca patent pursuant to an agreement with Pharma Mar, S.A , or PharmaMar.

A paragraph IV certification is a certification by a generic applicant that alleges that the patent covering the branded product is invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product.

On September 11, 2024, we and PharmaMar filed a patent infringement suit against the Zepzelca ANDA Filers in the United States District Court for the District of New Jersey.

The complaint alleges that by filing their ANDAs, the Zepzelca ANDA Filers have infringed the Orange Book listed patent for Zepzelca, and seeks an order that the effective date of FDA approval of the ANDAs shall be a date no earlier than the expiration of the asserted patent.

On September 12, 2024, we and PharmaMar filed a patent infringement suit against RK Pharma, Inc., Apicore US LLC, Archis Pharma LLC, Vgyaan Pharmaceuticals LLC (collectively “RK Pharma”), in the United States District Court for the District of Delaware.

The complaint alleges that by filing its ANDA, RK Pharma has infringed the Orange Book listed patent for Zepzelca, and seeks an order that the effective date of FDA approval of RK Pharma’s ANDA shall be no earlier than the expiration of the asserted patent.

MSP Litigation

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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.

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.

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.

MSP seeks monetary damages, restitution, disgorgement, and a declaration that the conduct alleged is unlawful.

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The Court set a deadline of August 12, 2024, to file a second amended complaint.

No trial date has been set for this matter.

On August 12, 2024, MSP voluntarily dismissed its complaint.

FDA Litigation

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.

In the complaint, we allege that FDA acted outside its authority under the Orphan Drug Act, when, despite 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.

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.

The complaint, filed 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 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.

In the complaint, we alleged that FDA acted outside its authority under the Orphan Drug Act, when, despite ODE protecting Jazz’s low-sodium oxybate 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.

Jazz further alleged that, in doing so, FDA failed to follow its own regulations, failed to follow established agency policy without providing a reasoned explanation for the departure, reversed prior decisions by its own staff and experts without a reasoned explanation, and disregarded the relevant scientific literature and data.

The complaint, filed pursuant to the Administrative Procedure Act, asked the Court to vacate and set aside FDA’s approval of the Lumryz NDA and sought a declaration that FDA’s approval of the Lumryz NDA was arbitrary, capricious, an abuse of discretion and otherwise not in accordance with law and that approval of the Lumryz NDA was in excess of FDA’s statutory authority and was made without observance of procedure required by law.

On September 15, 2023, we filed a motion for summary judgment.

On October 20, 2023, Avadel and FDA filed cross motions for summary judgment.

Oral argument on these motions was held on May 10, 2024.

The Court has not yet issued a decision.

Oral argument on these motions was held on May 10, 2024 and on October 30, 2024, the

District Court issued an order denying Jazz’s motion for summary judgment and granting Avadel’s and the FDA’s cross-motions for summary judgment.

Jazz respectfully disagrees with the Court’s decision and is evaluating potential options for appeal.

Qui tam matter

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As such, private whistleblower litigation will proceed in the United States District Court for the District of Massachusetts.

The Court set a deadline of September 1, 2024, for the plaintiff to file an amended complaint, and December 1, 2024, for Jazz to file a motion to dismiss the amended complaint.

The p laintiff filed the amended complaint on September 1, 2024.

From time to time, we are involved in legal proceedings arising in the ordinary course of business.

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Share Repurchase Program

In November 2016, our board of directors authorized a share repurchase program and, as of June 30, 2024, had authorized the repurchase of ordinary shares having an aggregate purchase price of up to $ 1.5 billion, exclusive of any brokerage commissions.

Under this program, which has no expiration date, we may repurchase ordinary shares from time to time on the open market.

The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under the 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.

During the three and six months ended June 30, 2024, we spent a total of $ 161.4 million to purchase 1.5 million of our ordinary shares under the share repurchase program at an average total purchase price, including commissions, of $ 110.75 per share.

During the three and six months ended June 30, 2023 , we spent a total of $ 95.6 million to purchase 0.8 million of our ordinary shares under the share repurchase program at an average total purchase price, including commissions, of $ 126.37 per share.

In July 2024, our board of directors authorized a share repurchase program to repurchase ordinary shares having an aggregate purchase price of $ 500.0 million, exclusive of any brokerage commissions, or the New Repurchase Program.

Under the New Repurchase Program, which has no expiration date, we may repurchase ordinary shares from time to time by any methods and/or structures permitted by applicable law.

The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under the Amended Credit Agreement and the indenture for our Secured Notes, corporate and regulatory requirements and market conditions.

The New Repurchase Program may be modified, suspended or discontinued at any time without our prior notice.

The New Repurchase Program replaces and supersedes the share repurchase program authorized by our board of directors in November 2016, which, as of the date of it being superseded by the New Repurchase Program, had authorized the repurchase of ordinary shares having an aggregate purchase price of up to $ 1.5 billion, exclusive of any brokerage commissions, or the Old Repurchase Program, and, together with the New Repurchase Program, the “repurchase programs”.

During the three months ended September 30, 2024, we spent a total of $ 150.0 million to repurchase 1.4 million of our ordinary shares, all under the New Repurchase Program, at a purchase price, including commissions, of $ 109.32 per share.

The repurchases during the three months ended September 30, 2024, were effected in privately negotiated transactions with or through one of the initial purchasers of the 2030 Notes concurrently with the pricing of the offering of the 2030 Notes.

During the nine months ended September 30, 2024, we spent a total of $ 311.4 million to purchase 2.8 million of our ordinary shares under the repurchase programs at an average total purchase price, including commissions, of $ 110.06 per share.

During the nine months ended September 30, 2023, we spent a total of $ 170.0 million to purchase 1.3 million of our ordinary shares under the Old Repurchase Program at an average total purchase price, including commissions, of $ 128.89 per share.

All ordinary shares repurchased were cancelled.

As of June 30, 2024, the remaining amount authorized under the share repurchase program was $ 47,475 , exclusive of any brokerage commissions.

In July 2024, our board of directors authorized a new share repurchase program to repurchase ordinary shares having an aggregate purchase price of $ 500 million, exclusive of any brokerage commissions.

As of September 30, 2024, the remaining amount authorized for repurchases under the New Repurchase Program was $ 350.0 million, exclusive of any brokerage commissions.

Accumulated Other Comprehensive Loss

The components of accumulated other comprehensive loss as of June 30, 2024 and December 31, 2023 were as follows (in thousands):

The components of accumulated other comprehensive loss as of September 30, 2024 and December 31, 2023 were as follows (in thousands):

Net Unrealized

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Balance at December 31, 2023 $ 235 $ ( 842,382 ) $ ( 842,147 )

Other comprehensive income (loss) before reclassifications 6,769 ( 50,149 ) ( 43,380 )

Other comprehensive income before reclassifications 1,572 241,218 242,790

Amounts reclassified from accumulated other comprehensive loss ( 4,040 ) — ( 4,040 )

Other comprehensive income (loss), net ( 2,468 ) 241,218 238,750

Balance at June 30, 2024 $ 4,304 $ ( 892,531 ) $ ( 888,227 )

During the six months ended June 30, 2024, other comprehensive income (loss) primarily reflects foreign currency translation adjustments, primarily due to the weakening of the sterling and the euro against the U.S.

Balance at September 30, 2024 $ ( 2,233 ) $ ( 601,164 ) $ ( 603,397 )

During the nine months ended September 30, 2024, other comprehensive income (loss) primarily reflects foreign currency translation adjustments, primarily due to the strengthening of the sterling against the U.S.

Net Income per Ordinary Share

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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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 performance-based restricted stock units, or PRSUs, the assumed exercise of share options and the assumed issuance of ordinary shares under our employee stock purchase plan, or ESPP.

Potentially dilutive ordinary shares from the Exchangeable Senior Notes are determined by applying the if-converted method to the assumed issuance of ordinary shares upon exchange of the

Exchangeable Senior Notes.

Potentially dilutive ordinary shares from the Exchangeable Senior Notes are determined by applying the if-converted method to the assumed issuance of ordinary shares upon exchange of the Exchangeable Senior Notes.

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 .

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 the three and six months ended June 30, 2023.

In July 2024, we made an irrevocable election to fix the settlement method for exchanges of the 2026 Notes and, as a result, an exchanging noteholder will receive (i) up to $ 1,000 in cash per $1,000 principal amount of the 2026 Notes and (ii) any combination of cash and/or ordinary shares of the Company, for any exchange consideration in excess of $ 1,000 per $1,000 principal amount of the 2026 Notes.

In July 2024, we made an irrevocable election to fix the settlement method for exchanges of the 2026 Notes to a combination of cash and ordinary shares of the Company with a specified cash amount per $1,000 principal amount of the 2026 Notes of $ 1,000 .

As a result, the assumed issuance of ordinary shares upon exchange of the 2026 Notes has only been included in the calculation of diluted net income per ordinary share in the three and nine months ended September 30, 2024, up to the date the irrevocable election was made.

For the 2030 Notes, we are required to settle the principal amount in cash and have the option to settle the conversion feature for the amount above the conversion price, or the conversion spread, in cash, ordinary shares or a combination of cash and ordinary shares.

The conversion spread will have a dilutive impact on diluted net income per ordinary share when the average market price of our ordinary shares for a given period exceeds the conversion price of the 2030 Notes.

For the three and nine months ended September 30, 2024, the 2030 Notes have been excluded from the computation of diluted net income per ordinary share, as the effect would be anti-dilutive since the conversion price of the 2030 Notes exceeded the average market price of our ordinary shares for the three and nine months ended September 30, 2024.

The following table represents the weighted-average ordinary shares that were excluded from the calculation of diluted net income per ordinary share for the periods presented because including them would have an anti-dilutive effect (in thousands):

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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ASD 10 % 9 % 9 % 7 %

Cardinal Health, Inc.

8 % 10 % 8 % 10 %

Financing and payment

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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The Company evaluated the performance targets in the context of its current long-range financial plan and its product candidate development pipeline and recognized expense based on the probable number of awards that will ultimately vest.

As of June 30, 2024, compensation cost not yet recognized related to unvested RSUs, PRSUs, ESPP and share options was $ 389.4 million, $ 41.1 million, $ 12.3 million and $ 0.2 million, respectively, which is expected to be recognized over a weighted-average period of 2.8 years, 1.6 years, 1.3 years and 0.5 years, respectively.

Our income tax benefit was $ 30.7 million and $ 19.0 million for the three and six months ended June 30, 2024, respectively, compared to $ 24.3 million and $ 39.6 million for the same periods in 2023, relating to tax arising on income or losses in Ireland, the U.K., the U.S.

As of September 30, 2024, compensation cost not yet recognized related to unvested RSUs, PRSUs, ESPP and share options was $ 347.2 million, $ 37.3 million, $ 9.2 million and $ 0.1 million, respectively, which is expected to be recognized over a weighted-average period of 2.6 years, 1.4 years, 1.1 years and 0.3 years, respectively.

Our income tax benefit was $ 14.5 million and $ 33.5 million for the three and nine months ended September 30, 2024, respectively, compared to $ 47.2 million and $ 86.8 million for the same periods in 2023, relating to tax arising on income or losses in Ireland, the U.K., the U.S.

and certain other foreign jurisdictions and tax deficiencies from share based compensation, offset by deductions on subsidiary equity, foreign derived intangible income benefits and tax credits.

The decrease in the income tax benefit for the three and nine months ended September 30, 2024 compared to the same periods in 2023 resulted primarily from changes in the mix of pre-tax income and losses across tax jurisdictions.

Our net deferred tax liability is primarily related to acquired intangible assets, and is net of deferred tax assets related to U.S.

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In October 2022 and in January 2023, we received tax assessment notices from the Luxembourg taxing authorities for all years under examination relating to certain transfer pricing and other adjustments.

The notices propose additional Luxembourg income tax of approximately $ 24.0 million, translated at the foreign exchange rate as June 30, 2024.

The notices propose additional Luxembourg income tax of approximately $ 25.0 million, translated at the foreign exchange rate as September 30, 2024.

We disagree with the proposed assessments and are contesting them vigorously.

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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.

What changed 10-Q

Item 1. Financial Statements