Jazz Pharmaceuticals plc
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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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
JAZZ$243.55+3.7%Stored close · as of Nov 9, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
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Defined Terms and Products
Defined terms
We use several terms in this Form 10-Q, including but not limited to those that are finance, regulation and disease-state related as well as names of other companies, which are given below.
| Term | Description |
|---|---|
| 2024 Notes | 1.50% exchangeable senior notes due 2024 |
| 2026 Notes | 2.00% exchangeable senior notes due 2026 |
| 2030 Notes | 3.125% exchangeable senior notes due 2030 |
| Aetna | Aetna Inc. |
| AG | authorized generic |
| ALL | acute lymphoblastic leukemia |
| Almaject | Almaject Inc., Alvogen, Inc., and Alvogen PB Research and Development LLC |
| Amended Credit Agreement | Credit Agreement amended to include the Repricing Amendment No. 1, the Repricing Amendment No. 2 and Amendment No. 3 |
| Amended Revolving Credit Facility | Revolving credit facility amended to increase the Initial Revolving Credit Facility to $885.0 million and extend the maturity date |
| Amendment No. 3 | amendment to the Credit Agreement entered into by Jazz Lux in November 2024 |
| AML | acute myeloid leukemia |
| Amneal | Amneal Pharmaceuticals LLC |
| ANDA | abbreviated new drug application |
| API | active pharmaceutical ingredient |
| ASD | ASD Specialty Healthcare LLC |
| ASU | Accounting Standards Update |
| Avadel | Avadel Pharmaceuticals plc |
| Avadel Litigation | All claims relating to all disputes between the parties subject to the global settlement agreement dated October 21, 2025, with Avadel CNS Pharmaceuticals LLC and Flamel Ireland Limited, subsidiaries of Avadel Pharmaceuticals plc |
| BLA | Biologics License Application |
| BTC | biliary tract cancers |
| Chimerix | Chimerix, Inc. |
| Chimerix Acquisition | our acquisition of Chimerix on April 21, 2025 |
| Chimerix Common Stock | the common stock, par value $0.001 per share, of Chimerix |
| Chimerix Shareholder Litigation | two suits filed in the Supreme Court of the State of New York, County of New York, by purported Chimerix shareholders against Chimerix and its Board of Directors, but which do not name any Jazz Pharmaceuticals parties |
| Chimerix Transaction Litigation | the Rosenthal Lawsuit as well as the Chimerix Shareholder Litigation |
| CHMP | Committee for Medicinal Products for Human Use |
| CMS | U.S. Centers for Medicare & Medicaid Services |
| CNX Therapeutics | CNX Therapeutics Limited |
| CODM | chief operating decision maker |
| COG | Children’s Oncology Group |
| Credit Agreement | Credit Agreement entered into on May 5, 2021, by and among us, Jazz Lux, and certain of our other subsidiaries, as 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 |
| DDI | drug-drug interaction |
| Dollar Term Loan | our former seven-year $3.1 billion term loan B facility under the Credit Agreement |
| DS | Dravet syndrome |
| EC | European Commission |
| EDS | excessive daytime sleepiness |
| Term | Description |
|---|---|
| EEA | European Economic Area |
| Epidiolex ANDA Filers | Teva Pharmaceuticals, Inc.; Padagis US LLC; Apotex Inc.; API Pharma Tech LLC and InvaGen Pharmaceuticals, Inc.; Lupin Limited; Taro Pharmaceutical Industries Ltd.; Zenara Pharma Private Limited and Biophore Pharma, Inc.; MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals, Inc.; Alkem Laboratories Ltd.; and Ascent Pharmaceuticals, Inc. |
| ESPP | employee stock purchase plan |
| ESSDS | Express Scripts Specialty Distribution Services, Inc. |
| EU | European Union |
| Euro Term Loan | our now repaid seven-year €625.0 million term loan B facility under the Credit Agreement |
| Exchange Act | Securities Exchange Act of 1934, as amended |
| Exchangeable Senior Notes | our 2026 Notes and 2030 Notes |
| Fair value step-upexpense | the acquisition accounting inventory fair value step-up expense |
| FASB | Financial Accounting Standards Board |
| FDA | U.S. Food and Drug Administration |
| Federal Opt-Out Plaintiffs | Humana Inc, Health Care Services Corporation, Molina Healthcare Inc., Blue Cross and Blue Shield of Florida and Health Options, Inc., collectively |
| Finance Act | the Finance (No. 2) Act 2023 |
| FTC | Federal Trade Commission |
| GEA | gastroesophageal adenocarcinoma |
| Granules | Granules India Limited |
| GW | GW Pharmaceuticals plc |
| GW Acquisition | our acquisition of GW Pharmaceuticals plc in May 2021 |
| HHS | U.S. Department of Health and Human Services |
| Hikma | Hikma Pharmaceuticals PLC |
| HSCT | post-hematopoietic stem-cell transplantation |
| IFNα | interferon alpha |
| IH | idiopathic hypersomnia |
| IM | intramuscular |
| Initial Revolving Credit Facility | our five-year $500.0 million revolving credit facility under the Credit Agreement entered into in May 2021 |
| IPR&D | in-process research and development |
| IRA | Inflation Reduction Act of 2022 |
| IRS | U.S. Internal Revenue Service |
| Jazz Investments | Jazz Investments I Limited |
| Jazz Lux | Jazz Financing Lux S.à.r.l. |
| JNDA | Japanese new drug application |
| KRAS | Kirsten rat sarcoma virus |
| LBL | lymphoblastic lymphoma |
| LGS | Lennox-Gastaut syndrome |
| Lupin | Lupin Inc. |
| McKesson | McKesson Corporation |
| MDS | Myelodysplastic Syndrome |
| MWT | Maintenance of Wakefulness Test |
| NDA | new drug application |
| New Repurchase Program | our share repurchase program announced on July 31, 2024 |
| NHS | U.K. National Health Service |
| ODE | Orphan Drug Exclusivity in the U.S. |
| OECD | Organisation for Economic Co-operation and Development |
| Term | Description |
|---|---|
| Old Repurchase Program | our share repurchase program authorized by our board of directors in November 2016 |
| Orange Book | FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” |
| Par | Par Pharmaceutical, Inc. |
| PBMs | pharmacy benefit managers |
| PharmaMar | Pharma Mar, S.A. |
| Pillar Two | the OECD framework proposal to implement a global minimum tax rate of 15% for large multinational corporations on a jurisdiction-by-jurisdiction basis |
| PRSUs | Performance-based restricted stock units |
| R&D | research and development |
| R/R | relapsed/refractory |
| Recommendation Statement | Chimerix's Schedule 14D-9 Solicitation/Recommendation Statement |
| Redx | Redx Pharma plc |
| REMS | risk evaluation and mitigation strategy |
| Repricing Amendment No.1 | amendment to the Credit Agreement entered into by Jazz Lux in January 2024 |
| Repricing Amendment No.2 | amendment to the Credit Agreement entered into by Jazz Lux in July 2024 |
| RK Pharma | RK Pharma, Inc., Apicore US LLC, Archis Pharma LLC, Vgyaan Pharmaceuticals LLC |
| Roche | F. Hoffmann-La Roche Ltd |
| Rosenthal Lawsuit | a lawsuit filed in the Supreme Court of the State of New York, County of Chemung, by David Rosenthal, purportedly on behalf of Chimerix Shareholders |
| RSUs | restricted stock units |
| Saniona | Saniona A/S |
| sBLA | supplemental Biologics License Application |
| SCLC | small cell lung cancer |
| SEC | U.S. Securities and Exchange Commission |
| Secured Notes | our issued $1.5 billion in aggregate principal amount of 4.375% senior secured notes, due 2029 |
| sNDA | supplemental New Drug Application |
| Sumitomo | Sumitomo Pharma Co., Ltd |
| sVOD | severe VOD |
| T-DXd | trastuzumab deruxtecan |
| Tender Offer Documents | our Tender Offer Statement together with the Recommendation Statement |
| Term SOFR | U.S. dollar Secured Overnight Financing Rate |
| Teva | Teva Pharmaceuticals, Inc. |
| Tranche B-1 Dollar Term Loans | upon entry into the Repricing Amendment No.1, the then outstanding Dollar Term Loan was refinanced into a new tranche of U.S. dollar term loans |
| Tranche B-2 Dollar Term Loans | upon entry into the Repricing Amendment No.2, the then outstanding Tranche B-1 Dollar Term Loans were refinanced into a new tranche of U.S. dollar term loans |
| TSC | tuberous sclerosis complex |
| U.K. | United Kingdom |
| U.S. | United States of America |
| U.S. GAAP | U.S. generally accepted accounting principles |
| United Healthcare | United Healthcare Services, Inc. |
| USPTO | U.S. Patent and Trademark Office |
| VOD | veno-occlusive disease |
| WCLC | World Conference on Lung Cancer |
| Werewolf | Werewolf Therapeutics, Inc. |
| Xyrem Antitrust Litigation | collectively, a number of lawsuits filed from June 2020 to May 2022 on behalf of purported direct and indirect Xyrem purchasers |
| Term | Description |
|---|---|
| Zepzelca ANDA Filers | 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. LTD. |
| Zymeworks | Zymeworks Inc. |
Products
The brand names of our products, our delivery devices and certain of our product candidates and their associated generic names are given below.
| Term | Description |
|---|---|
| CombiPlex | CombiPlex® (delivery technology platform) |
| Defitelio | Defitelio® (defibrotide sodium), Defitelio® (defibrotide) |
| Epidiolex | Epidiolex® (cannabidiol) oral solution, Epidyolex® (the trade name in Europe and other countries outside the U.S. for Epidiolex) |
| Modeyso | ModeysoTM (dordaviprone) |
| Rylaze | Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn), Enrylaze® (the trade name in Europe and other countries outside the U.S. and Canada for Rylaze) |
| Sativex | Sativex® (nabiximols) oral solution |
| Suvecaltamide | Suvecaltamide (JZP385) |
| Vyxeos | Vyxeos® (daunorubicin and cytarabine) liposome for injection, Vyxeos® liposomal 44 mg/100 mg powder for concentrate for solution for infusion |
| Xyrem | Xyrem® (sodium oxybate) oral solution |
| Xywav | Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution |
| Zepzelca | Zepzelca® (lurbinectedin) |
| Ziihera | Ziihera® (zanidatamab-hrii) |
We own or have rights to various copyrights, trademarks, and trade names used in our business in the U.S. and/or other countries, including the following: Jazz Pharmaceuticals®, Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, Xyrem® (sodium oxybate) oral solution, Epidiolex® (cannabidiol) oral solution, Epidyolex® (the trade name in Europe and other countries outside the U.S. for Epidiolex), Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn), Enrylaze® (the trade name in Europe and other countries outside the U.S. and Canada for Rylaze), Zepzelca® (lurbinectedin), Defitelio® (defibrotide sodium), Defitelio® (defibrotide), Vyxeos®(daunorubicin and cytarabine) liposome for injection, Vyxeos® liposomal 44 mg/100 mg powder for concentrate for solution for infusion, Modeyso TM(dordaviprone), CombiPlex®, Sativex® (nabiximols) oral solution and Ziihera® (zanidatamab-hrii).
This Quarterly Report on Form 10-Q also includes trademarks, service marks and trade names of other companies. Trademarks, service marks and trade names appearing in this Quarterly Report on Form 10‑Q are the property of their respective owners.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.