Jazz Pharmaceuticals plc
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 5, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Condensed Consolidated Financial Statements
- The Company and Summary of Significant Accounting Policies
Jazz Pharmaceuticals plc is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
Our lead marketed products, listed below, are approved in countries around the world to improve patient care.
Neuroscience
Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, a product approved by FDA in July 2020, and launched in the U.S. in November 2020 for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy, and also approved by FDA in August 2021 for the treatment of IH in adults and launched in the U.S. in November 2021. Xywav contains 92% less sodium than Xyrem®. Xywav is also approved in Canada for the treatment of cataplexy in patients with narcolepsy.
Epidiolex® (cannabidiol) oral solution, a product approved by FDA and launched in the U.S. in 2018 by GW and currently indicated for the treatment of seizures associated with LGS, DS, or TSC in patients one year of age or older; in the EU and Great Britain (where it is marketed as Epidyolex®) and other markets, it is approved for adjunctive treatment of seizures associated with LGS or DS, in conjunction with clobazam (EU and Great Britain only), in patients 2 years of age and older and for adjunctive treatment of seizures associated with TSC in patients 2 years of age and older.
Oncology
Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn), a product approved by FDA in June 2021 and launched in the U.S. in July 2021 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL or LBL in adults and pediatric patients aged one month or older who have developed hypersensitivity to E. coli-derived asparaginase. In September 2023, the EC granted marketing authorization under the trade name Enrylaze®. This therapy is also approved in markets including Great Britain, Canada, Switzerland and Australia.
Zepzelca® (lurbinectedin), a product approved by FDA in June 2020 under FDA's accelerated approval pathway and launched in the U.S. in July 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy; approved by FDA in October 2025 in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs as a maintenance treatment for adults with extensive-stage SCLC whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide; 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.
Ziihera® (zanidatamab-hrii), a product approved by FDA in November 2024 under FDA’s accelerated approval pathway and launched in the U.S. in December 2024 for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as detected by an FDA-approved test. In June 2025, the EC granted conditional marketing authorization for Ziihera® for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) BTC previously treated with at least one prior line of systemic therapy.
Modeyso™ (dordaviprone), a product approved by FDA in August 2025 under FDA's accelerated approval pathway for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
In April 2025, we acquired Chimerix for a total cash consideration of $944.2 million. For further information regarding the Chimerix Acquisition, please see Note 2.
Throughout this Quarterly Report on Form 10-Q, 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. Throughout this Quarterly Report on Form 10-Q, all references to “ordinary shares” refer to Jazz Pharmaceuticals plc’s ordinary shares.
Basis of Presentation
These unaudited condensed consolidated financial statements have been prepared following the requirements of the U.S. Securities and Exchange Commission for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. 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, 2024.
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 nine months ended September 30, 2025, are not necessarily indicative of the results to be expected for the year ending December 31, 2025, 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, 2024.
These condensed consolidated financial statements include the accounts of Jazz Pharmaceuticals plc and our subsidiaries, and intercompany transactions and balances have been eliminated.
Our operating segment is reported in a manner consistent with the internal reporting provided to the CODM. Our CODM has been identified as our president and chief executive officer. We have determined that we operate inone business segment, which is the identification, development and commercialization of meaningful pharmaceutical products that address unmet medical needs. The CODM assesses performance and decides how to allocate resources for the segment based on net income (loss) and measure of segment assets which is reported on the condensed consolidated statements of income (loss) and condensed consolidated balance sheet.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
Adoption of New Accounting Standards
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. The adoption of ASU 2023-09 will expand our income tax disclosures in our Annual Report on Form 10-K, but will have no impact on reported income tax (benefit) expense or related tax assets or liabilities.
Significant Risks and Uncertainties
Our financial condition, results of operations and growth prospects are also dependent on our ability to maintain or increase sales of our commercialized products, which is subject to many risks and there is no guarantee that we will be able to continue to successfully commercialize those products for their approved indications. In that regard, 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; competition from the introduction of two AG versions of high-sodium oxybate and a branded fixed-dose, high-sodium oxybate, Avadel’s Lumryz, for treatment of cataplexy and/or EDS in narcolepsy in the U.S. market, as well as potential future competition from additional AG versions of high-sodium oxybate and from generic versions of high-sodium oxybate, including a generic version of high-sodium oxybate from Amneal approved in September 2025, and from other competitors; increased pricing pressure from, changes in policies by, or restrictions on reimbursement imposed by, third party payors, including our ability to maintain adequate coverage and reimbursement for Xywav; increased rebates required to maintain access to our products; challenges to our intellectual property around Xywav and/or Xyrem, including from pending antitrust and intellectual property litigation; and continued acceptance of Xywav by physicians and patients. A significant decline in oxybate revenues could cause us to reduce our operating expenses or seek to raise additional funds and would have a material adverse effect on our business, financial condition, results of operations and growth prospects, including on our ability to acquire, in-license or develop new products to grow our business.
Our financial condition, results of operations and growth prospects are also dependent on our ability to maintain or increase sales of Epidiolex/Epidyolex in the U.S. and Europe, which is subject to many risks and there is no guarantee that we will be able to continue to successfully commercialize Epidiolex/Epidyolex for its approved indications. The commercial success of Epidiolex/Epidyolex depends on the extent to which patients and physicians accept and adopt Epidiolex/Epidyolex as a treatment for seizures associated with LGS, DS and TSC, and we do not know whether our or others’ estimates in this regard will be accurate. Physicians may not prescribe Epidiolex and patients may be unwilling to use Epidiolex/Epidyolex if coverage is not provided or reimbursement is inadequate to cover a significant portion of the cost. Additionally, any negative development for Epidiolex/Epidyolex in the market, in clinical development for additional indications, or in regulatory processes in other jurisdictions, may adversely impact the commercial results and potential of Epidiolex/Epidyolex.
In addition to risks related specifically to Xywav and Epidiolex/Epidyolex, 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: pharmaceutical product development, ongoing clinical research activity and related outcomes; obtaining regulatory approval of our late-stage product candidates; effectively commercializing our approved products such as Rylaze, Zepzelca, Ziihera and Modeyso; 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; market acceptance; regulatory concerns with controlled substances generally and the potential for abuse; future legislation; action by the U.S. 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; delays or problems with third parties that are part of our manufacturing and supply chain; identifying, acquiring or in-licensing additional products or product candidates; our ability to realize the anticipated benefits of acquired or in-licensed products or product candidates, such as Ziihera and Modeyso, at the expected levels, with the expected costs and within the expected timeframe; the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements; the impact of new or increased tariffs and escalating trade tensions; and possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations.
Concentrations of Risk
Financial instruments that potentially subject us to concentrations of credit risk consist of cash, cash equivalents, investments and derivative contracts. Our investment policy permits investments in U.S. federal government and federal agency securities, corporate bonds or commercial paper issued by U.S. corporations, money market instruments, certain qualifying money market mutual funds, certain repurchase agreements, and tax-exempt obligations of U.S. states, agencies and municipalities and places restrictions on credit ratings, maturities, and concentration by type and issuer. We are exposed to credit risk in the event of a default by the financial institutions holding our cash, cash equivalents and investments to the extent recorded on the balance sheet.
We manage our foreign currency transaction risk and interest rate risk within specified guidelines through the use of derivatives. All of our derivative instruments are utilized for risk management purposes, and we do not use derivatives for speculative trading purposes. As of September 30, 2025 and December 31, 2024, we had foreign exchange forward contracts with notional amounts totaling $398.0 million and $461.2 million, respectively. As of September 30, 2025 and December 31, 2024, the outstanding foreign exchange forward contracts had a net liability fair value of $2.9 million and $7.9 million, respectively. As of September 30, 2025 and December 31, 2024, we had interest rate swap contracts with notional amounts totaling $500.0 million. As of September 30, 2025 and December 31, 2024, these outstanding interest rate swap contracts had a net liability fair value of $0.4 million and a net asset fair value of $1.0 million, respectively. The counterparties to these contracts are large multinational commercial banks, and we believe the risk of nonperformance is not significant.
We are also subject to credit risk from our accounts receivable related to our product sales. We monitor our exposure within accounts receivable and record a reserve against uncollectible accounts receivable as necessary. We extend credit to pharmaceutical wholesale distributors and specialty pharmaceutical distribution companies, primarily in the U.S., and to other international distributors and hospitals. Customer creditworthiness is monitored and collateral is not required. We monitor 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 September 30, 2025 and December 31, 2024, allowances on receivables were not material. As of September 30, 2025, five customers accounted for 83% of gross accounts receivable, including ESSDS, which accounted for 41% of gross accounts receivable, ASD, which accounted for 16% of gross accounts receivable and McKesson, which accounted for 12% of gross accounts receivable. As of December 31, 2024, five customers accounted for 80% of gross accounts receivable, including ESSDS, which accounted for 39% of gross accounts receivable, ASD, which accounted for 15% of gross accounts receivable and McKesson, which accounted for 13% of gross accounts receivable.
We depend on single source suppliers for most of our products, product candidates and their APIs. With respect to our oxybate products, the API is manufactured for us by a single source supplier and the finished products are manufactured both by us in our facility in Athlone, Ireland and by our U.S.-based supplier, which is certified to produce Xyrem and Xywav.
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-04) - Disaggregation of Income Statement Expenses”, which requires additional disclosure in the notes to the financial statements of the nature of certain expenses included in the income statement. The amendments are effective on a prospective basis, with the option to apply them retrospectively, for fiscal years beginning after December 15, 2026. We are currently evaluating the impact of adopting this new accounting guidance.
In November 2024, the FASB issued ASU 2024-04, “Induced Conversions of Convertible Debt Instruments”, which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion or extinguishment of convertible debt. The amendments are effective on a prospective basis, with the option to apply them retrospectively, for fiscal years beginning after December 15, 2025. We are currently evaluating the impact of adopting this new accounting guidance.
In September 2025, the FASB issued ASU 2025-06, “Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software”, which modernizes the recognition and disclosure framework for internal-use software costs, removing the previous “development stage” model and introducing a more judgment-based approach. ASU 2025-06 is effective for the Company for annual reporting periods beginning with the fiscal year ending December 15, 2027 and for interim reporting periods beginning in that fiscal year. We are currently evaluating the impact that this update may have on our consolidated financial statements.
- License Agreement and Asset Acquisition
License Agreement
In August 2025, we entered into a global license agreement with Saniona to obtain exclusive worldwide rights to develop SAN2355, a highly differentiated, subtype-selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy and other potential indications, designed to overcome the limitations of non-selective Kv7-targeting compounds. Under the terms of the agreement, we made an upfront payment of $42.5 million to Saniona, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the three and nine months ended September 30, 2025. Saniona is eligible to receive development, regulatory and commercial milestone payments of up to $992.5 million and, if SAN2355 is approved, a tiered, mid-single digit to low-double digit royalty on our net sales of SAN2355.
Asset Acquisition
In April 2025, we acquired the entire issued share capital of Chimerix at a price of $8.55 per share, payable in cash at closing, representing a total cash consideration of $944.2 million, funded with our cash and cash equivalents. As a result of this, Chimerix became an indirect wholly owned subsidiary of the Company. The acquisition of Chimerix was accounted for as an asset acquisition because it did not meet the definition of a business.
The total consideration paid and the allocation to assets acquired and liabilities assumed was (in thousands):
| Consideration | |
|---|---|
| Cash consideration to acquire Chimerix’s outstanding common stock | $802,023 |
| Cash consideration for Chimerix’s outstanding equity awards | 142,131 |
| Total cash consideration paid to Chimerix | 944,154 |
| Transaction costs | 13,237 |
| Total consideration | $957,391 |
| Assets Acquired and Liabilities Assumed | |
| Cash | $99,338 |
| In-process research and development | 905,362 |
| Accrued liabilities | (53,066) |
| Other assets and liabilities | 5,757 |
| Total net assets acquired | $957,391 |
The value attributed to in-process research and development related to Modeyso and was expensed as it was determined to have no alternative future use at the time of the acquisition.
- Cash and Available-for-Sale Securities
Cash, cash equivalents and investments consisted of the following (in thousands):
| September 30, 2025 | ||||||
|---|---|---|---|---|---|---|
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | EstimatedFair Value | Cash andCashEquivalents | Investments | |
| Cash | $712,772 | $— | $— | $712,772 | $712,772 | $— |
| Time deposits | 810,000 | — | — | 810,000 | 90,000 | 720,000 |
| Money market funds | 523,298 | — | — | 523,298 | 523,298 | — |
| Totals | $2,046,070 | $— | $— | $2,046,070 | $1,326,070 | $720,000 |
| December 31, 2024 | ||||||
|---|---|---|---|---|---|---|
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | EstimatedFair Value | Cash and CashEquivalents | Investments | |
| Cash | $948,894 | $— | $— | $948,894 | $948,894 | $— |
| Time deposits | 790,000 | — | — | 790,000 | 210,000 | 580,000 |
| Money market funds | 1,253,970 | — | — | 1,253,970 | 1,253,970 | — |
| Totals | $2,992,864 | $— | $— | $2,992,864 | $2,412,864 | $580,000 |
Cash equivalents and investments are considered available-for-sale securities. We use the specific-identification method for calculating realized gains and losses on securities sold and include them in interest expense, net in the condensed consolidated statements of income (loss). 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 $18.6 million and$65.3 million inthe three and nine months ended September 30, 2025, respectively, and $26.0 million and $74.6 million in the three and nine months ended September 30, 2024, respectively.
- Fair Value Measurement
The following table summarizes, by major security type, our available-for-sale securities and derivative contracts as of September 30, 2025 and December 31, 2024, that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands):
| September 30, 2025 | December 31, 2024 | |||||
|---|---|---|---|---|---|---|
| QuotedPrices inActiveMarkets forIdenticalAssets(Level 1) | SignificantOtherObservableInputs(Level 2) | TotalEstimatedFair Value | QuotedPrices inActiveMarkets forIdenticalAssets(Level 1) | SignificantOtherObservableInputs(Level 2) | TotalEstimatedFair Value | |
| Assets: | ||||||
| Available-for-sale securities: | ||||||
| Money market funds | $523,298 | $— | $523,298 | $1,253,970 | $— | $1,253,970 |
| Time deposits | — | 810,000 | 810,000 | — | 790,000 | 790,000 |
| Foreign exchange forward contracts | — | 1,715 | 1,715 | — | 2,250 | 2,250 |
| Interest rate contracts | — | 4 | 4 | — | 991 | 991 |
| Totals | $523,298 | $811,719 | $1,335,017 | $1,253,970 | $793,241 | $2,047,211 |
| Liabilities: | ||||||
| Foreign exchange forward contracts | $— | $4,663 | $4,663 | $— | $10,198 | $10,198 |
| Interest rate contracts | — | 439 | 439 | — | — | — |
| Totals | $— | $5,102 | $5,102 | $— | $10,198 | $10,198 |
As of September 30, 2025 and December 31, 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.
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.
There were no transfers between the different levels of the fair value hierarchy in 2025 or 2024.
As of September 30, 2025 and December 31, 2024, the carrying amount of investments measured using the measurement alternative for equity investments without a readily determinable fair value was $4.3 million. The carrying amount, which is recorded within other non-current assets, is based on the latest observable transaction price.
As of September 30, 2025 the estimated fair values of the 2026 Notes, the 2030 Notes, the Secured Notes and the Tranche B-2 Dollar Term Loans were $1.1 billion, $1.2 billion, $1.5 billion and $1.9 billion, respectively. As of December 31, 2024, the estimated fair values of the 2026 Notes, the 2030 Notes, the Secured Notes and the Tranche B-2 Dollar Term Loans were $1.0 billion, $1.1 billion, $1.4 billion and $2.7 billion, respectively. The fair values of each of these debt facilities was estimated using quoted market prices obtained from brokers (Level 2).
- Derivative Instruments and Hedging Activities
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. 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.
We enter into foreign exchange forward contracts, with durations of up to 12 months, designed to limit the exposure to fluctuations in foreign exchange rates related to the translation of certain non-U.S. dollar denominated liabilities, including intercompany balances. Hedge accounting is not applied to these derivative instruments as gains and losses on these hedge transactions are designed to offset gains and losses on underlying balance sheet exposures. As of September 30, 2025 and
December 31, 2024, the notional amount of foreign exchange contracts where hedge accounting is not applied was $398.0 million and $461.2 million, respectively.
The foreign exchange gain (loss) in our condensed consolidated statements of income (loss) included the following gains (losses) associated with foreign exchange contracts not designated as hedging instruments (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| Foreign Exchange Forward Contracts: | 2025 | 2024 | 2025 | 2024 |
| Gain (loss) recognized in foreign exchange gain (loss) | $(6,822) | $14,396 | $14,178 | $9,485 |
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 September 30, 2025, 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 was as follows (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| Interest Rate Contracts: | 2025 | 2024 | 2025 | 2024 |
| Gain (loss) recognized in accumulated other comprehensive loss, net of tax | $113 | $(5,197) | $128 | $1,572 |
| Gain reclassified from accumulated other comprehensive loss to interest expense, net of tax | (411) | (1,340) | (1,213) | (4,040) |
Assuming no change in the Term SOFR based interest rates from market rates as of September 30, 2025, $0.3 million of losses, 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, 2025 and 2024 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 | September 30,2025 | December 31,2024 | |
|---|---|---|---|
| Assets | |||
| Derivatives designated as hedging instruments: | |||
| Interest rate contracts | Other current assets | $4 | $959 |
| Other non-current assets | — | 32 | |
| Derivatives not designated as hedging instruments: | |||
| Foreign exchange forward contracts | Other current assets | 1,715 | 2,250 |
| Total fair value of derivative asset instruments | $1,719 | $3,241 | |
| Liabilities | |||
| Derivatives designated as hedging instruments: | |||
| Interest rate contracts | Accrued liabilities | $439 | $— |
| Derivatives not designated as hedging instruments: | |||
| Foreign exchange forward contracts | Accrued liabilities | 4,663 | 10,198 |
| Total fair value of derivative liability instruments | $5,102 | $10,198 | |
Although we do not offset derivative assets and liabilities within our condensed consolidated balance sheets, our International Swap and Derivatives Association agreements provide for net settlement of transactions that are due to or from the same counterparty upon early termination of the agreement due to an event of default or other termination event. The following 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):
| September 30, 2025 | ||||||
|---|---|---|---|---|---|---|
| Gross Amounts of Recognized Assets/ Liabilities · Gross Amounts Offset in the Consolidated Balance Sheet · Net Amounts of Assets/ Liabilities Presented in the Consolidated Balance Sheet · Gross Amounts Not Offset in the Consolidated Balance Sheet | ||||||
| Description · Derivative Financial Instruments · Cash Collateral Received (Pledged) · Net Amount | ||||||
| Derivative assets | $1,719 | $— | $1,719 | $(1,719) | $— | $— |
| Derivative liabilities | (5,102) | — | (5,102) | 1,719 | — | (3,383) |
| December 31, 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 | ||||||
| Description · Derivative Financial Instruments · Cash Collateral Received (Pledged) · Net Amount | ||||||
| Derivative assets | $3,241 | $— | $3,241 | $(2,910) | $— | $331 |
| Derivative liabilities | (10,198) | — | (10,198) | 2,910 | — | (7,288) |
- Inventories
Inventories consisted of the following (in thousands):
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Raw materials | $22,066 | $20,161 |
| Work in process | 298,033 | 311,752 |
| Finished goods | 163,012 | 148,532 |
| Total inventories | $483,111 | $480,445 |
As of September 30, 2025 and December 31, 2024, inventories included $95.2 million and $191.2 million, respectively, related to the purchase accounting inventory fair value step-up on inventory acquired as part of our GW Acquisition.
- Goodwill and Intangible Assets
The gross carrying amount of goodwill was as follows (in thousands):
| Balance at December 31, 2024 | $1,716,323 |
|---|---|
| Foreign exchange | 111,160 |
| Balance at September 30, 2025 | $1,827,483 |
The gross carrying amounts and net book values of our intangible assets were as follows (in thousands):
| September 30, 2025 · December 31, 2024 | |||||||
|---|---|---|---|---|---|---|---|
| RemainingWeighted-Average UsefulLife(In years) | GrossCarryingAmount | AccumulatedAmortization | Net BookValue | GrossCarryingAmount | AccumulatedAmortization | Net BookValue | |
| Acquired developed technologies | 7.1 | $8,170,408 | $(3,604,671) | $4,565,737 | $7,699,423 | $(2,943,728) | $4,755,695 |
| Manufacturing contracts | — | 12,568 | (12,568) | — | 11,121 | (11,121) | — |
| Trademarks | — | 2,903 | (2,903) | — | 2,868 | (2,868) | — |
| Total finite-lived intangible assets | $8,185,879 | $(3,620,142) | $4,565,737 | $7,713,412 | $(2,957,717) | $4,755,695 | |
The increase in the gross carrying amount of intangible assets as of September 30, 2025, compared to December 31, 2024, primarily relates to the positive impact of foreign currency translation adjustments primarily due to the strengthening of sterling against the U.S. dollar.
The assumptions and estimates used to determine future cash flows and remaining useful lives of our intangible and other long-lived assets are complex and subjective. They can be affected by various factors, including external factors, such as industry and economic trends, and internal factors such as changes in our business strategy and our forecasts for specific product lines.
Based on finite-lived intangible assets recorded as of September 30, 2025, 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 |
|---|---|
| 2025 (remainder) | $168,558 |
| 2026 | 671,723 |
| 2027 | 663,324 |
| 2028 | 640,152 |
| 2029 | 638,418 |
| Thereafter | 1,783,562 |
| Total | $4,565,737 |
- Certain Balance Sheet Items
Property, plant and equipment consisted of the following (in thousands):
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Manufacturing equipment and machinery | $95,877 | $87,451 |
| Land and buildings | 73,488 | 71,902 |
| Computer software | 60,816 | 42,635 |
| Leasehold improvements | 60,740 | 70,201 |
| Construction-in-progress | 38,872 | 34,493 |
| Computer equipment | 21,180 | 20,137 |
| Furniture and fixtures | 9,153 | 8,551 |
| Subtotal | 360,126 | 335,370 |
| Less accumulated depreciation and amortization | (171,213) | (161,957) |
| Property, plant and equipment, net | $188,913 | $173,413 |
Accrued liabilities consisted of the following (in thousands):
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Rebates and other sales deductions | $428,843 | $342,717 |
| Employee compensation and benefits | 148,802 | 153,133 |
| Accrued litigation settlement | 90,000 | — |
| Clinical trial accruals | 49,469 | 49,962 |
| Accrued royalties | 36,774 | 36,802 |
| Sales return reserve | 31,323 | 26,428 |
| Inventory-related accruals | 27,947 | 25,509 |
| Consulting and professional services | 27,349 | 26,221 |
| Accrued interest | 21,474 | 41,626 |
| Selling and marketing accruals | 21,375 | 26,981 |
| Accrued development expenses | 16,616 | 23,099 |
| Current portion of lease liabilities | 13,938 | 14,779 |
| Accrued construction-in-progress | 7,431 | 10,061 |
| Derivative instrument liabilities | 5,102 | 10,198 |
| Accrued collaboration expenses | 1,400 | 18,005 |
| Accrued milestones | — | 27,500 |
| Other | 73,713 | 77,926 |
| Total accrued liabilities | $1,001,556 | $910,947 |
- Debt
The following table summarizes the carrying amount of our indebtedness (in thousands):
| September 30,2025 | December 31,2024 | |
|---|---|---|
| 2026 Notes | $1,000,000 | $1,000,000 |
| Unamortized - debt issuance costs | (1,821) | (3,747) |
| 2026 Notes, net | 998,179 | 996,253 |
| 2030 Notes | 1,000,000 | 1,000,000 |
| Unamortized - debt issuance costs | (16,865) | (19,135) |
| 2030 Notes, net | 983,135 | 980,865 |
| Secured Notes | 1,486,385 | 1,483,841 |
| Term Loan (1) | 1,893,462 | 2,647,681 |
| Total debt | 5,361,161 | 6,108,640 |
| Less current portion (2) | 1,029,179 | 31,000 |
| Total long-term debt | $4,331,982 | $6,077,640 |
(1) In January 2025, we made a voluntary repayment on the Tranche B-2 Dollar Term Loan totaling $750.0 million.
(2) Balance as of September 30, 2025 includes the 2026 Notes since they mature in June 2026.
Exchangeable Senior Notes
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. There is no assurance that in the future such restrictions will not be adopted.
In September 2024, Jazz Investments completed a private placement of $1.0 billion aggregate principal amount of the 2030 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 3.47%. During the three months ended September 30, 2025, we recognized interest expense of $8.7 million, of which $7.8 million related to the contractual coupon rate and $0.9 million related to the amortization of debt issuance costs. During the nine months ended September 30, 2025, we recognized interest expense of $25.7 million, of which $23.4 million related to the contractual coupon rate and $2.3 million related to the amortization of debt issuance costs. During the three and nine 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 September 30, 2025 and 2024, 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. During the nine months ended September 30, 2025 and 2024, 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.
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. The effective interest rate of the 2024 Notes was 1.79%. 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 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.
Maturities
Scheduled maturities with respect to our long-term debt principal balances outstanding as of September 30, 2025 were as follows (in thousands):
| Year Ending December 31, | Scheduled Long-Term Debt Maturities |
|---|---|
| 2025 (remainder) | $7,750 |
| 2026 | 1,031,000 |
| 2027 | 31,000 |
| 2028 | 1,848,500 |
| 2029 | 1,500,000 |
| Thereafter | 1,000,000 |
| Total | $5,418,250 |
- Commitments and Contingencies
Indemnification
In the normal course of business, we enter into agreements that contain a variety of representations and warranties and provide for general indemnification, including indemnification associated with product liability or infringement of intellectual property rights. Our exposure under these agreements is unknown because it involves future claims that may be made but have not yet been made against us. To date, we have not paid any claims or been required to defend any action related to these indemnification obligations.
We have agreed to indemnify our executive officers, directors and certain other employees for losses and costs incurred in connection with certain events or occurrences, including advancing money to cover certain costs, subject to certain limitations. The maximum potential amount of future payments we could be required to make under the indemnification obligations is unlimited; however, we maintain insurance policies that may limit our exposure and may enable us to recover a portion of any future amounts paid. Assuming the applicability of coverage, the willingness of the insurer to assume coverage, and subject to certain retention, loss limits and other policy provisions, we believe the fair value of these indemnification obligations is not significant. Accordingly, we did not recognize any liabilities relating to these obligations as of September 30, 2025 and December 31, 2024. 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
We are involved in legal proceedings, including the following matters:
Xyrem Antitrust Litigation
From June 2020 to May 2022, the Xyrem Antitrust Litigation was filed on behalf of purported direct and indirect Xyrem purchasers, alleging that the patent litigation settlement agreements we entered with generic drug manufacturers who had filed ANDAs violate state and federal antitrust and consumer protection laws. The Xyrem Antitrust Litigation wasconsolidated for multi-district litigation in the United States District Court for the Northern District of California (the “Court”), as previously disclosed in the notes to our consolidated financial statements for the year ended December 31, 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2024, and the notes to our unaudited condensed consolidated financial statements for the quarters ended March 31, 2025 and June 30, 2025 included in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, respectively. As of the date of this filing, pursuant to the settlement agreements described below, we have resolved the entirety of the Xyrem Antitrust Litigation.
On April 7, 2025, Jazz Pharmaceuticals Ireland Limited, our wholly-owned subsidiary, entered into a class settlement agreement with the class of indirect Xyrem purchasers to settle all claims of participating class members against the Company with respect to our actions leading up to, and entering into, patent litigation settlement agreements with the ANDA filers.
Pursuant to the class settlement agreement, which was entered into with counsel representing the class representatives, we agreed to pay a total of $145.0 million in a lump sum. The class settlement agreement, in which we deny all alleged wrongdoing, also includes specified releases by class members of Jazz and its past, present and future affiliates, directors, officers, employees and other related parties, for all conduct concerning any of the matters alleged, or that could have been alleged, in the lawsuit. Plaintiffs who affirmatively opt out of the class will not be bound by the release and will not receive any settlement proceeds. Additionally, the class settlement agreement grants us the right to rescind the settlement agreement in the event an agreed upon percentage based on Xyrem purchases or payments made by potential class members that opt out. This settlement, if finalized on the agreed-upon terms, will resolve the majority of claims at issue in themultidistrict litigation. If we terminate the class settlement agreement, we intend to defend against these claims vigorously. We also remain confident in our defenses to the other claims brought by plaintiffs described above, including that the patent settlement agreements at issue were and are pro-competitive, and intend to continue to vigorously defend against these claims.
The Court held a preliminary approval hearing regarding the class settlement agreement on May 15, 2025, and granted the motion for preliminary approval on May 16, 2025. The Court held a final approval hearing regarding the class settlement on October 23, 2025 and approved the class settlement agreement on October 27, 2025.
On May 20, 2025, Jazz Pharmaceuticals Ireland Limited entered into a settlement agreement with United Healthcare to settle all of United Healthcare’s claims against us with respect to our actions leading up to, and entering into, patent litigation settlement agreements with the ANDA filers. Pursuant to that settlement agreement, on June 23, 2025, United Healthcare filed a motion for voluntary dismissal with prejudice of its claims against us. The Court granted United Healthcare’s motion on July 16, 2025. The terms of the settlement between Jazz Pharmaceuticals Ireland Limited and United Healthcare are confidential.
On August 29, 2025, Jazz Pharmaceuticals Ireland entered into a settlement agreement with the Federal Opt-Out Plaintiffs and Aetna Inc. to settle all of the Federal Opt-Out Plaintiffs’ and Aetna's claims against us with respect to our actions leading up to, and entering into, patent litigation settlement agreements with the ANDA filers. Pursuant to the settlement agreement, on September 29, 2025, Aetna filed a Request for Dismissal with prejudice of its claims against us. On September 30, 2025, the Court dismissed Aetna’s claims. On September 30, 2025, the Federal Opt-Out Plaintiffs filed a motion for voluntary dismissal with prejudice of their claims against us. The Court granted the Federal Opt-Out Plaintiffs’ motion on September 30, 2025. On October 7, 2025, we, Hikma, and Aetna filed a stipulation for voluntary dismissal of Aetna’s pending appeal to the Ninth Circuit. On October 10, 2025, the Ninth Circuit dismissed Aetna’s appeal. The terms of the settlement agreement between Jazz Pharmaceuticals Ireland Limited and the Federal Opt-Out Plaintiffs and Aetna are confidential.
Duringthe three and nine months ended September 30, 2025, we recognized expenses of $61.5 million and $233.5 million, respectively, within selling, general and administrative expenses in our condensed consolidated statements of income (loss) for charges related to the resolution of the Xyrem Antitrust Litigation, including the class settlement.
Patent Infringement Litigation
Avadel Litigation
As previously disclosed in the notes to our consolidated financial statements for the year ended December 31, 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2024, and the notes to our unaudited condensed consolidated financial statements for the quarters ended March 31, 2025 and June 30, 2025 included in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, respectively, we are a party to certain legal proceedings against Avadel. From May 2021 to July 2022, we filed a number of patent infringement suits against Avadel, and several of its corporate affiliates in the United States District Court for the District of Delaware, alleging that Avadel’s Lumryz infringes a number of our patents. In response, Avadel filed a series of counterclaims, including counterclaims asserting that we engaged in unlawful monopolization in violation of the Sherman Act, and in April 2022, Avadel sued us in the District Court alleging that we misappropriated trade secrets and breached certain contracts between the parties. Additionally, from December 2024 through April 2025, Avadel filed a series of patent infringement suits against us in the United States District Court for the District of Delaware, alleging that Jazz’s sales of Xywav infringe on certain newly-issued Avadel patents.
On October 21, 2025, we entered into a global settlement agreement (the “Settlement Agreement”) with Avadel CNS Pharmaceuticals LLC and Flamel Ireland Limited, subsidiaries of Avadel Pharmaceuticals plc (collectively, “Avadel”) to settle all claims relating to all disputes between the parties, including the Company’s previously disclosed ongoing patent infringement litigation against Avadel in the U.S. District Court for the District of Delaware (the “Court”) and Avadel’s counterclaims alleging anticompetitive conduct by us and other alleged conduct related to Avadel trade secrets and contracts between the parties, as well as Avadel’s ongoing patent infringement litigation in the Court against us. Pursuant to the Settlement Agreement, we agreed to (a) grant a license to Avadel, effective immediately to any past, present, or future patents that could be asserted by us against Avadel’s Lumryz product for use in indications currently approved by the U.S. Food and Drug Administration (the “FDA” and such indications, the “Narcolepsy Indications”), and (b) grant a license to Avadel effective March 1, 2028 to any past, present, or future patents that could be asserted by us against Avadel’s Lumryz products for any other indications or uses not currently approved by the FDA (the “Non-Narcolepsy Indications”), including all present and future indications, strengths, conditions of use, dosages, doses, dosage forms, and presentations. Pursuant to the Settlement Agreement, Avadel has agreed to pay royalties to us of 3.85% (subject to a potential reduction to 3.75%) on net sales of its Lumryz product for Narcolepsy Indications commencing October 1, 2025, and beginning March 1, 2028, to pay royalties to us of 10% (subject to a potential reduction to 9.5%) on net sales of its Lumryz product for Non-Narcolepsy Indications. Avadel has also agreed not to market, offer for sale, take orders for, distribute, promote, or provide patient support services with respect to Avadel Licensed Products for Non-Narcolepsy Indications before March 1, 2028, and to pay royalties to us of 80% of such unpermitted net sales of its Lumryz product for Non-Narcolepsy Indications from October 1, 2025 through February 29, 2028. Pursuant to the Settlement Agreement, Avadel grants us a covenant not to sue for infringement of any past, present or future patents that could be asserted against the Xywav or Xyrem products, including all present and future indications, strengths, conditions of use, dosages, doses, dosage forms, and presentations. We have not agreed to waive or otherwise consent to the “breaking” of the Orphan Drug Exclusivity for Xywav in idiopathic hypersomnia as part of this settlement. Pursuant to the Settlement Agreement, we agreed to (a) pay a total of $90.0 million in a lump sum in settlement of Avadel’s pending claims against us and (b) waive our right to receive certain royalties the Court previously ordered Avadel to pay us on sales of Avadel’s Lumryz product through September 30, 2025.
The Settlement Agreement obligated the parties to promptly file stipulations of dismissal with the Court or otherwise abandon the pending legal proceedings, and as of October 27, 2025, the Court dismissed all relevant matters with prejudice. The Settlement Agreement, in which we deny all alleged wrongdoing, also includes releases by us, on the one hand, and Avadel, on the other hand, and each of their past, present and future affiliates, directors, officers, employees and other related parties, for all conduct concerning any of the matters alleged, or that could have been alleged, in the lawsuit.
As of September 30, 2025, we recorded an accrual of $90.0 million within accrued liabilities in our condensed consolidated balance sheets, for charges related to the resolution of the Avadel litigation. The related expense is included within selling, general and administrative expenses in our condensed consolidated statements of income (loss) for the three and nine months ended September 30, 2025.
Xywav Patent Litigation
In June 2021, we received notice from Lupin, that it has filed with FDA an ANDA, for a generic version of Xywav. The notice from Lupin included a paragraph IV certification with respect toten of our patents listed in FDA’s Orange Book for Xywav on the date of our receipt of the notice. The asserted patents relate generally to the composition and method of use of Xywav, and methods of treatment when Xywav is administered concomitantly with certain other medications.
In July 2021, we filed a patent infringement suit against Lupin in the United States District Court for the District of New Jersey. The complaint alleges that by filing its ANDA, Lupin has infringedten of our Orange Book listed patents. We are seeking a permanent injunction to prevent Lupin from introducing a generic version of Xywav 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 Lupin's ANDA. In June 2021, FDA recognized seven years of Orphan Drug Exclusivity for Xywav through July 21, 2027. On October 4, 2021, Lupin 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.
In April 2022, we received notice from Lupin that it had filed a paragraph IV certification regarding a newly-issued patent listed in the Orange Book for Xywav. On May 11, 2022, 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 related to a method of treatment when Xywav is administered concomitantly with certain other medications. The suit seeks a permanent injunction to prevent Lupin from introducing a generic version of Xywav that would infringe our patent. On June 22, 2022, the Court consolidated thetwo lawsuits we filed against Lupin.
In November 2022, we received notice from Lupin that it had filed a paragraph IV certification regarding a newly-issued patent listed in the Orange Book for Xywav. 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 thetwo patents in suit. On February 15, 2023, the Court consolidated the new lawsuit with thetwo suits we previously filed against Lupin. No trial date has been set in the consolidated case against Lupin.
In February 2023, we received notice from Teva that it had filed with FDA an ANDA for a generic version of Xywav. The notice from Teva included a paragraph IV certification with respect tothirteen of our patents listed in FDA’s Orange Book for Xywav on the date of the receipt of the notice. The asserted patents relate generally to the composition and method of use of Xywav, and methods of treatment when Xywav is administered concomitantly with certain other medications.
In March 2023, we filed a patent infringement suit against Teva in the United States District Court for the District of New Jersey. The complaint alleges that by filing its ANDA, Teva has infringed thirteen of our Orange Book listed patents. We are seeking a permanent injunction to prevent Teva from introducing a generic version of Xywav 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 Teva’s ANDA. 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.
On December 15, 2023, based on a stipulation between all parties, the Court consolidated the Lupin lawsuits and the Teva lawsuit for all purposes. No trial date has been set in the consolidated case.
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.
In July 2025, we received notice from Granules India Limited that it has filed with FDA an ANDA for a generic version of Xywav. The notice from Granules included a paragraph IV certification with respect tofourteen of our patents listed in FDA’s Orange Book for Xywav on the date of the receipt of the notice. The asserted patents relate generally to the composition and method of use of Xywav, and methods of treatment when Xywav is administered concomitantly with certain other medications.
In August 2025, we filed a patent infringement suit against Granules in the United States District Court for the District of New Jersey. The complaint alleges that by filing its ANDA, Granules has infringed fourteen of our Orange Book-listed patents. We are seeking a permanent injunction to prevent Granules from introducing a generic version of Xywav 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 Granules’ ANDA.
Zepzelca Patent Litigation
In July and August 2024, we received notices from the Zepzelca ANDA Filers that they have each filed with FDA an ANDA for a generic version of Zepzelca (lurbinectedin). 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 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.
In December 2024, we received the Zepzelca ANDA Filers’ answers to the complaint. The answers include defenses and counterclaims asserting that the Zepzelca ANDA Filers’ products, if launched, would not infringe our patents and that our patents are invalid. No trial date has been set in this matter.
On March 26, 2025, we and Sandoz stipulated to the dismissal of our lawsuit against Sandoz without prejudice.
On September 12, 2024, we and PharmaMar filed a patent infringement suit against RK Pharma, in the United States District Court for the District of Delaware. 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. On November 13, 2024, we voluntarily dismissed this action against RK Pharma in the United States District Court for the District of Delaware. RK Pharma remains a defendant in the litigation referenced above in the United States District Court for the District of New Jersey.
In July 2025, we received notice from InvaGen Pharmaceuticals, Inc. that it had filed a paragraph IV certification regarding a newly-issued patent listed in the Orange Book for Zepzelca. On September 4, 2025, we filed an additional lawsuit in the United States District Court for the District of New Jersey against each of the Zepzelca ANDA Filers, alleging that, by filing its ANDA, each party infringed the newly-issued patent related to a method of treatment using Zepzelca. The suit seeks orders that the effective date of FDA approval for each defendant’s application shall be no earlier than the expiration of the newly-issued patent.
Defitelio Patent Litigation
In March 2025, we received a notice from Almaject that it had filed with FDA an ANDA for a generic version of Defitelio (defibrotide sodium). The notice from Almaject included a paragraph IV certification respect to certain of our patents listed in FDA’s Orange Book for Defitelio on the date of the notice. The listed patents relate generally to the Defitelio drug product and its approved use. On April 16, 2025, we filed a patent infringement lawsuit against Almaject in the United States District Court for the District of New Jersey. The complaint alleges that by filing its ANDA, Almaject has infringed certain of our Orange Book listed patents, and seeks an order that the effective date of FDA approval for the Almaject ANDA shall be on a date no earlier than the expiration of the last to expire of the asserted 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 Almaject’s ANDA.
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 NDA for Avadel's Lumryz was unlawful. 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 and on October 30, 2024, the District Court issued an order denying Jazz’s motion for summary judgment and granting Avadel’s and FDA’s cross-motions for summary judgment. Jazz appealed the matter to the United States Court of Appeals for the District of Columbia Circuit. We filed our opening appeal brief on January 31, 2025 and the D.C. Circuit held oral argument on the appeal on May 5, 2025. On June 27, 2025, the D.C. Circuit affirmed District Court’s ruling.
Qui tam matter
In July 2022, we received a subpoena from the USAO for the District of Massachusetts requesting documents related to Xyrem and U.S. Patent No. 8,772,306 (“Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters”), product labeling changes for Xyrem, communications with FDA and the USPTO, pricing of Xyrem, and other related documents. On July 18, 2024, the United States District Court for the District of Massachusetts unsealed a qui tam whistleblower lawsuit underlying the USAO’s subpoena, captioned 1:21-cv-10891-PBS and originally filed under seal on May 27, 2021. The public docket in this matter indicates that on May 24 and June 7, 2024, respectively, the United States and a number of states named in the whistleblower complaint declined to intervene in this matter. 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 2, 2024, for us to file a motion to dismiss the amended complaint. The plaintiff filed the amended complaint on September 1, 2024. We filed our motion to dismiss on December 2, 2024. The Court held oral argument on the motion to dismiss on April 2, 2025. On September 23, 2025, the Court granted our motion and dismissed the plaintiff’s federal claims with prejudice and state-law claims without prejudice.
Chimerix Acquisition Litigation
On March 21, 2025, Chimerix filed a Recommendation Statement with the SEC in relation to the proposed acquisition of Chimerix by Jazz. Also on March 21, 2025, Jazz disseminated a Tender Offer Statement to Chimerix shareholders in relation to the proposed transaction.
Following filing of the filing and dissemination of the Tender Offer Documents, Jazz Pharmaceuticals plc, its wholly-owned subsidiary Pinetree Acquisition Sub, Inc., Chimerix Inc., the Chimerix Board of Directors, Centerview Partners LLC, were named as defendants in the Rosenthal Lawsuit in the Supreme Court of the State of New York, County of Chemung. In addition to the Rosenthal Lawsuit, the Chimerix Shareholder Litigation was filed in the Supreme Court of the State of New York, County of New York. Collectively, in the Chimerix Transaction Litigation, the plaintiffs alleged that the Tender Offer Documents omitted material information and contained misrepresentations, in violation of various New York and North Carolina laws. The plaintiffs in the Chimerix Transaction Litigation sought various remedies, including injunctive relief to prevent the consummation of the Chimerix Acquisition unless certain allegedly material information was disclosed, or in the alternative, rescission or damages.
On April 7, 2025, Chimerix filed an amended Recommendation Statement and Jazz filed an amended Tender Offer Document, each containing supplemental disclosures related to the Chimerix Acquisition. Pursuant to a memorandum of understanding between the parties, the Rosenthal Lawsuit was dismissed on April 7, 2025. The remaining lawsuits in the Chimerix Transaction Litigation were dismissed on June 26, 2025.
From time to time, we are involved in legal proceedings arising in the ordinary course of business. We believe there is no other litigation pending that could have, individually or in the aggregate, a material adverse effect on our results of operations or financial condition.
- Shareholders’ Equity
Share Repurchase Program
In July 2024, our board of directors authorized the New Repurchase Program to repurchase ordinary shares having an aggregate purchase price of $500.0 million, exclusive of any brokerage commissions. 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 Old Repurchase Program, a share repurchase program to repurchase ordinary shares having an aggregate purchase price of $1.5 billion, exclusive of any brokerage commissions. During the three months ended September 30, 2025, no shares were repurchased. During the nine months ended September 30, 2025, we spent a total of $125.0 million to repurchase 1.1 million of our ordinary shares, all under the New Repurchase Program, at a purchase price, including commissions, of $109.52 per share.
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 $150.0 million to repurchase 1.4 million of our ordinary shares, all under the New Repurchase Program, at a purchase price, including commissions, of $109.32 per share and $161.4 million to repurchase 1.5 million of our ordinary shares, all under the Old Repurchase Program, at a purchase price, including commissions, of $110.75 per share.
As of September 30, 2025, the remaining amount authorized for repurchases under the New Repurchase Program was $225.0 million, exclusive of any brokerage commissions.
Accumulated Other Comprehensive Loss
The components of accumulated other comprehensive loss as of September 30, 2025 and December 31, 2024 were as follows (in thousands):
| Net UnrealizedGain (Loss) From Hedging Activities | ForeignCurrencyTranslationAdjustments | TotalAccumulatedOtherComprehensiveLoss | |
|---|---|---|---|
| Balance at December 31, 2024 | $740 | $(948,407) | $(947,667) |
| Other comprehensive income before reclassifications | 128 | 378,854 | 378,982 |
| Amounts reclassified from accumulated other comprehensive loss | (1,213) | — | (1,213) |
| Other comprehensive income (loss), net | (1,085) | 378,854 | 377,769 |
| Balance at September 30, 2025 | $(345) | $(569,553) | $(569,898) |
During the nine months ended September 30, 2025, other comprehensive income (loss) primarily reflects foreign currency translation adjustments, primarily due to the strengthening of sterling against the U.S. dollar.
- Net Income (Loss) per Ordinary Share
Basic net income (loss) per ordinary share is based on the weighted-average number of ordinary shares outstanding. Diluted net income (loss) per ordinary share is based on the weighted-average number of ordinary shares outstanding and potentially dilutive ordinary shares outstanding.
Basic and diluted net income (loss) per ordinary share were computed as follows (in thousands, except per share amounts):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Numerator: | ||||
| Net income (loss) | $251,412 | $215,055 | $(559,599) | $369,005 |
| Effect of interest on assumed conversions of the 2026 Notes, net of tax | — | 1,028 | — | 10,761 |
| Net income (loss) for dilutive net income (loss) per ordinary share | $251,412 | $216,083 | $(559,599) | $379,766 |
| Denominator: | ||||
| Weighted-average ordinary shares used in per share calculations - basic | 60,696 | 61,414 | 60,955 | 62,275 |
| Dilutive effect of employee equity incentive and purchase plans | 910 | 435 | — | 515 |
| Dilutive effect of the 2026 Notes | — | 1,325 | — | 4,721 |
| Weighted-average ordinary shares used in per share calculations - diluted | 61,606 | 63,174 | 60,955 | 67,511 |
| Net income (loss) per ordinary share: | ||||
| Basic | $4.14 | $3.50 | $(9.18) | $5.93 |
| Diluted | $4.08 | $3.42 | $(9.18) | $5.63 |
Potentially dilutive ordinary shares from our employee equity incentive and purchase plans are determined by applying the treasury stock method to the assumed vesting of outstanding RSUs and PRSUs, the assumed exercise of share options and the assumed issuance of ordinary shares under our ESPP.
In July 2024, we irrevocably elected to fix the settlement method for exchanges of the 2026 Notes to a combination of cash and ordinary shares of Jazz Pharmaceuticals plc with a specified cash amount per $1,000 principal amount of 2026 Notes exchanged equal to or in excess of $1,000. As a result of the election, an exchanging holder will receive (i) up to $1,000 in cash per $1,000 principal amount of 2026 Notes exchanged and (ii) cash, ordinary shares, or any combination thereof, at our election, in respect of the remainder, if any, of its exchange obligation in excess of $1,000 per $1,000 principal amount of 2026 Notes exchanged. The potential issue of ordinary shares upon exchange of the 2026 Notes was anti-dilutive and had no impact on diluted net income (loss) per ordinary share for the three and nine months ended September 30, 2025.
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 approximately $153.05 per ordinary share, of the 2030 Notes. The average market price of our ordinary shares for the three and nine months ended September 30, 2025 did not exceed the conversion price of the 2030 Notes.
The following table represents the weighted-average ordinary shares that were excluded from the calculation of diluted net income (loss) per ordinary share for the periods presented because including them would have an anti-dilutive effect (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Employee equity incentive and purchase plans | 3,376 | 4,465 | 4,992 | 4,701 |
- Revenues
The following table presents a summary of total revenues (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Xywav | $431,410 | $388,466 | $1,191,535 | $1,072,238 |
| Xyrem | 35,663 | 58,114 | 108,253 | 184,526 |
| Epidiolex/Epidyolex | 302,608 | 251,558 | 772,075 | 697,376 |
| Sativex | 4,752 | 4,586 | 14,774 | 13,704 |
| Total Neuroscience | 774,433 | 702,724 | 2,086,637 | 1,967,844 |
| Rylaze/Enrylaze | 99,868 | 98,780 | 294,760 | 309,359 |
| Zepzelca | 79,295 | 85,843 | 216,869 | 241,990 |
| Defitelio/defibrotide | 51,752 | 65,818 | 140,520 | 158,915 |
| Vyxeos | 37,583 | 34,313 | 111,978 | 109,348 |
| Ziihera | 8,306 | — | 16,272 | — |
| Modeyso | 11,032 | — | 11,502 | — |
| Total Oncology | 287,836 | 284,754 | 791,901 | 819,612 |
| Other | 2,143 | 2,229 | 10,863 | 8,497 |
| Product sales, net | 1,064,412 | 989,707 | 2,889,401 | 2,795,953 |
| High-sodium oxybate AG royalty revenue | 52,945 | 58,157 | 156,029 | 162,268 |
| Other royalty and contract revenues | 8,750 | 7,105 | 24,230 | 22,556 |
| Total revenues | $1,126,107 | $1,054,969 | $3,069,660 | $2,980,777 |
The following table presents a summary of total revenues attributed to geographic sources (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| United States | $1,020,476 | $953,669 | $2,755,273 | $2,686,486 |
| Europe | 86,405 | 77,318 | 252,206 | 230,821 |
| All other | 19,226 | 23,982 | 62,181 | 63,470 |
| Total revenues | $1,126,107 | $1,054,969 | $3,069,660 | $2,980,777 |
The following table presents a summary of the percentage of total revenues from customers that represented more than 10% of our total revenues:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| ESSDS | 41% | 42% | 42% | 42% |
| ASD | 11% | 10% | 11% | 9% |
| McKesson | 11% | 13% | 11% | 12% |
Financing and payment
Our payment terms vary by the type and location of our customer but payment is generally required in a term ranging from 30 to 65 days.
- Share-Based Compensation
Share-based compensation expense related to RSUs, PRSUs, share options and grants under our ESPP was as follows (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Selling, general and administrative | $61,295 | $37,101 | $143,968 | $112,451 |
| Research and development | 21,767 | 18,927 | 63,348 | 55,030 |
| Cost of product sales | 5,063 | 3,732 | 12,963 | 10,374 |
| Total share-based compensation expense, pre-tax | 88,125 | 59,760 | 220,279 | 177,855 |
| Income tax benefit from share-based compensation expense | (16,619) | (12,190) | (38,412) | (25,218) |
| Total share-based compensation expense, net of tax | $71,506 | $47,570 | $181,867 | $152,637 |
- Income Taxes
Our income tax benefit was $242.4 million and $277.4 million for the three and nine months ended September 30, 2025, respectively, and arose primarily due to the reversal of a valuation allowance against certain U.S. federal and state deferred tax assets acquired through the Chimerix Acquisition. This compared to an income tax benefit of $14.5 million and $33.5 million for the same periods in 2024. Apart from the reversal of the valuation allowance, the income tax benefits related to tax arising on income or losses in Ireland, the U.K., the U.S. and certain other foreign jurisdictions and Pillar Two top-up taxes, offset by deductions on subsidiary equity, patent box and foreign derived intangible income benefits and tax credits.
Our net deferred tax asset comprises U.S. federal and state tax credits, U.S. federal and state and foreign net operating loss carryforwards and other temporary differences and is net of deferred tax liabilities primarily related to acquired intangible assets. We maintain a valuation allowance against certain deferred tax assets. Each reporting period, we evaluate the need for a valuation allowance on our deferred tax assets by jurisdiction and adjust our estimates as more information becomes available. The FDA approval of Modeyso and its commercial launch, in August 2025, has provided sufficient positive evidence to support a change in judgment regarding the realizability of the deferred tax assets acquired through the Chimerix Acquisition. The Company concluded it is more-likely-than-not that the assets will be realized through related future income. Accordingly, the valuation allowance recorded at the acquisition date was released during the third quarter, and the Company recognized a deferred tax asset of $205.9 million on the balance sheet, with a corresponding credit to income tax benefit in the income statement for the three and nine months ended September 30, 2025.
We are required to recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. As a result, we have recorded an unrecognized tax benefit for certain tax benefits which we judge may not be sustained upon examination. We file income tax returns in multiple tax jurisdictions, the most significant of which are Ireland, the U.K. and the U.S. (both at the federal level and in various state jurisdictions). For Ireland, we are no longer subject to income tax examinations by taxing authorities for the years prior to 2020. For the U.K., we are no longer subject to income tax examinations by taxing authorities for the years prior to 2016. The U.S. jurisdictions generally have statute of limitations three to four years from the later of the return due date or the date when the return was filed. However, in the U.S. (at the federal level and in most states), carryforwards that were generated in 2020 and earlier may still be adjusted upon examination by the taxing authorities. Certain of our subsidiaries are under examination by the Italian tax authorities for the years ended December 31, 2019, 2023, 2024 and 2025.
The Government of Ireland, the jurisdiction in which Jazz Pharmaceuticals Plc is incorporated, transposed the Global Minimum Tax Pillar Two rules into domestic legislation as part of the Finance Act. The Finance Act closely follows the EU Minimum Tax Directive and certain OECD Guidance released to date. The Company is within the scope of these rules, which took effect from January 1, 2024. Under the legislation, we are liable to pay a top-up tax for the difference between the Pillar Two effective tax rate per jurisdiction and the 15% minimum rate. The rules on how to calculate the Pillar Two effective tax rate are detailed and highly complex and specific adjustments envisaged in the Pillar Two legislation can give rise to different effective tax rates compared to those calculated for accounting purposes. We account for Pillar Two top-up taxes as a current tax when they are incurred. The income tax benefit for the nine months ended September 30, 2025 includes an amount for forecasted Pillar Two top-up taxes, as required under the applicable rules. The proportion of our profit before tax which is subject to the top-up tax and our exposure to Pillar Two top-up taxes in future years will depend on factors such as future revenues, costs and foreign currency exchange rates. We will continue to monitor changes in law and guidance in relation to Pillar Two.
- Subsequent Events
Sativex Disposition
On October 31, 2025, we completed the sale of Sativex to CNX Therapeutics, in a simultaneous sign-and-close transaction, for total cash consideration of $39.6 million, including payment for acquired inventory. Under the terms of the agreement, CNX Therapeutics will acquire the rights to Sativex in all of the existing territories available to us. The assets subject to sale were classified as held and used as of September 30, 2025, as the criteria for classification as held for sale was not met at the balance sheet date. This divestiture is not expected to have a material impact on our consolidated financial statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.