Jazz Pharmaceuticals plc
For the period ended Sep 30, 2026. Filed Nov 2, 2026.
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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, 2026 · Filed Nov 2, 2026
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 |
|---|---|
| 2026 Notes | 2.00% exchangeable senior notes due 2026 |
| 2030 Notes | 3.125% exchangeable senior notes due 2030 |
| 2032 Notes | 1.875% exchangeable senior notes due 2032 |
| AbCellera | AbCellera Biologics Inc. |
| Actio | Actio Biosciences, Inc. |
| Actio Acquisition | our acquisition of Actio on September 15, 2026 |
| AG | authorized generic |
| Alkermes | Alkermes plc |
| ALL | acute lymphoblastic leukemia |
| Almaject | Almaject Inc., Alvogen, Inc., and Alvogen PB Research and Development LLC |
| Amended Credit Agreement | Credit Agreement amended to include Amendment No. 1, Amendment No. 2, Amendment No. 3 and Amendment No. 4 |
| 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. 1 | amendment to the Credit Agreement entered into by Jazz Lux in January 2024 |
| Amendment No. 2 | amendment to the Credit Agreement entered into by Jazz Lux in July 2024 |
| Amendment No. 3 | amendment to the Credit Agreement entered into by Jazz Lux in November 2024 |
| Amendment No. 4 | amendment to the Credit Agreement entered into by Jazz Lux in September 2026 |
| Amneal | Amneal Pharmaceuticals LLC |
| ANDA | abbreviated NDA |
| Ascent | Ascent Pharmaceuticals, Inc. |
| ASD | ASD Specialty Healthcare LLC |
| ASU | Accounting Standards Update |
| Avadel | Avadel Pharmaceuticals plc |
| Axsome | Axsome Therapeutics, Inc. |
| BLA | Biologics License Application |
| Borrowers | Jazz Pharmaceuticals plc, Jazz Lux, and certain of our other subsidiaries, as borrowers under the Credit Agreement |
| BTC | biliary tract cancers |
| BTD | Breakthrough Therapy designation |
| CBD | cannabidiol |
| Chimerix | Chimerix, Inc. |
| Chimerix Acquisition | our acquisition of Chimerix on April 21, 2025 |
| ClpP | mitochondrial caseinolytic protease P |
| CMS | U.S. Centers for Medicare & Medicaid Services |
| CNX Therapeutics | CNX Therapeutics Limited |
| CODM | chief operating decision maker |
| CRC | colorectal cancer |
| 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 |
| DEA | U.S. Drug Enforcement Administration |
| DOJ | U.S. Department of Justice |
| Dollar Term Loan | our former seven-year $3.1 billion term loan B facility under the Credit Agreement |
| DRD2 | dopamine D2 receptor |
| Term | Description |
|---|---|
| DS | Dravet syndrome |
| EC | European Commission |
| EDS | excessive daytime sleepiness |
| Epidiolex ANDA Filers | Teva; Padagis US LLC; Apotex Inc.; API Pharma Tech LLC and InvaGen; 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 |
| ES-SCLC | extensive-stage small cell lung cancer |
| ESPP | Amended and Restated 2007 Employee Stock Purchase Plan |
| ESSDS | Express Scripts Specialty Distribution Services, Inc. |
| ET | essential tremor |
| 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 2030 Notes and 2032 Notes |
| Fair value step-up expense | the acquisition accounting inventory fair value step-up expense |
| FASB | Financial Accounting Standards Board |
| FDA | U.S. Food and Drug Administration |
| Finance Act | the Finance (No. 2) Act of 2023 |
| FTC | Federal Trade Commission |
| g | gram |
| GEA | gastroesophageal adenocarcinoma |
| Granules | Granules India Limited |
| GW | GW Pharmaceuticals plc |
| GW Acquisition | our acquisition of GW in May 2021 |
| HER2 | human epidermal growth factor receptor 2 |
| HHS | U.S. Department of Health and Human Services |
| Hikma | Hikma Pharmaceuticals PLC |
| IFNα | interferon alpha |
| IH | idiopathic hypersomnia |
| IHC3+ | immunohistochemistry 3+ |
| IM | intramuscular |
| IND | investigational NDA |
| Initial Revolving Credit Facility | our five-year $500.0 million revolving credit facility under the Credit Agreement entered into in May 2021 |
| InvaGen | InvaGen Pharmaceuticals, Inc. |
| IPR | inter partes review |
| IPR&D | in-process research and development |
| IRA | Inflation Reduction Act of 2022 |
| Jazz Investments | Jazz Investments I Limited |
| Jazz Lux | Jazz Financing Lux S.à.r.l. |
| KCNT1 | Potassium channel subfamily T, member 1 |
| LBL | lymphoblastic lymphoma |
| LGS | Lennox-Gastaut syndrome |
| Lupin | Lupin Inc. |
| MAPK | mitogen-activated protein kinase |
| McKesson | McKesson Corporation |
| MDS | Myelodysplastic Syndrome |
| MFN | Most-Favored-Nation |
| Term | Description |
|---|---|
| mg | milligram |
| mGEA | metastatic gastroesophageal adenocarcinoma |
| MHRA | Medicines and Healthcare products Regulatory Agency |
| NDA | New Drug Application |
| Nippon Zoki | Nippon Zoki Pharmaceutical Co., Ltd. |
| ODE | Orphan Drug Exclusivity in the U.S. |
| OECD | Organization for Economic Co-operation and Development |
| Orange Book | FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” |
| OS | overall survival |
| Par | Par Pharmaceutical, Inc. |
| Patheon | Patheon Pharmaceuticals Inc., together with its affiliates |
| PBMs | pharmacy benefit managers |
| PD-L1 | programmed death-ligand 1 |
| PDUFA | Prescription Drug User Fee Act |
| PharmaMar | Pharma Mar, S.A. |
| Pillar Two | the OECD framework proposal to implement a two-pillar plan on global tax reform, including a global minimum tax rate of 15% for large multinational corporations on a jurisdiction-by-jurisdiction basis |
| Praxis | Praxis Precision Medicines, Inc. |
| PRC | People's Republic of China |
| PRSUs | Performance-based restricted stock units |
| PRV | priority review voucher received in connection with the approval of Modeyso in August 2025 |
| PTAB | Patent Trial and Appeal Board of the USPTO |
| Qilu | Qilu Pharmaceutical (Hainan) Co., Ltd. |
| Quarterly Report on Form 10-Q | this Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 |
| R&D | research and development |
| Redx | Redx Pharma plc |
| REMS | risk evaluation and mitigation strategy |
| Repurchase Program | our share repurchase program announced on July 31, 2024 |
| RK Pharma | RK Pharma, Inc., Apicore US LLC, Archis Pharma LLC, Vgyaan Pharmaceuticals LLC, Dr. Reddy's Laboratories, Inc. |
| RSUs | restricted stock units |
| Saniona | Saniona A/S |
| sBLA | supplemental BLA |
| 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 |
| Securities Act | Securities Act of 1933, as amended |
| Share price condition | During any calendar quarter commencing after the calendar quarter ending on December 31, 2024 (and only during such calendar quarter), if the last reported sale price of our ordinary shares for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the exchange price on each applicable trading day. |
| T-DXd | trastuzumab deruxtecan |
| Takeda | Takeda Pharmaceutical Company Limited |
| Term Loans | Dollar Term Loans, Tranche B-1 Dollar Term Loans, Tranche B-2 Dollar Term Loans, and Tranche B-3 Dollar Term Loans |
| Teva | Teva Pharmaceuticals, Inc. |
| Tranche B-1 Dollar Term Loans | upon entry into Amendment No. 1, the then outstanding Dollar Term Loan was refinanced into a new tranche of U.S. dollar term loans |
| Term | Description |
|---|---|
| Tranche B-2 Dollar Term Loans | upon entry into Amendment No. 2, the then outstanding Tranche B-1 Dollar Term Loans were refinanced into a new tranche of U.S. dollar term loans |
| Tranche B-3 Dollar Term Loans | upon entry into Amendment No. 4, the then outstanding Tranche B-2 Dollar Term Loans were refinanced into a new tranche of U.S. dollar term loans |
| Tris Pharma | Tris Pharma, Inc. |
| TSC | tuberous sclerosis complex |
| U.K. | United Kingdom |
| U.S. | United States of America |
| U.S. GAAP | U.S. generally accepted accounting principles |
| USAO | U.S. Attorney's Office |
| USPTO | U.S. Patent and Trademark Office |
| Werewolf | Werewolf Therapeutics, Inc. |
| Zepzelca ANDA Filers | Sandoz Inc., InvaGen, CIPLA USA, Inc., CIPLA (EU) Limited, CIPLA Limited, Zydus Lifesciences Global FZE, Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Limited, RK Pharma, MSN Pharmaceuticals Inc., MSN Laboratories PVT. LTD., Qilu Pharmaceutical (Hainan) Co. Ltd., and Qilu Pharma, Inc. |
| 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 |
| 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) |
*On October 31, 2025, we completed the sale of Sativex to CNX Therapeutics.
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), Ziihera® (zanidatamab-hrii), Modeyso TM(dordaviprone), Zepzelca® (lurbinectedin), Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn), Enrylaze® (the trade name in Europe and other countries outside the U.S. and Canada for Rylaze), 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), and CombiPlex®.
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.