Jazz Pharmaceuticals plc
For the period ended Mar 31, 2026. Filed May 5, 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.
Mar 31, 2026 · Filed May 5, 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 |
| 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 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 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 |
| 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 |
| CNX Therapeutics | CNX Therapeutics Limited |
| CODM | chief operating decision maker |
| 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 |
| Dollar Term Loan | our former seven-year $3.1 billion term loan B facility under the Credit Agreement |
| DRD2 | dopamine D2 receptor |
| 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 |
| ESPP | Amended and Restated 2007 Employee Stock Purchase Plan |
| ESSDS | Express Scripts Specialty Distribution Services, Inc. |
| ET | essential tremor |
| EU | European Union |
| Term | Description |
|---|---|
| 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-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 |
| g | gram |
| GEA | gastroesophageal adenocarcinoma |
| Granules | Granules India Limited |
| GW | GW Pharmaceuticals plc |
| GW Acquisition | our acquisition of GW in May 2021 |
| HHS | U.S. Department of Health and Human Services |
| Hikma | Hikma Pharmaceuticals PLC |
| IFNα | interferon alpha |
| IH | idiopathic hypersomnia |
| 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. |
| IRA | Inflation Reduction Act of 2022 |
| Jazz Investments | Jazz Investments I Limited |
| Jazz Lux | Jazz Financing Lux S.à.r.l. |
| KRAS | Kirsten rat sarcoma virus |
| 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 |
| mg | milligram |
| MHRA | Medicines and Healthcare products Regulatory Agency |
| MWT | Maintenance of Wakefulness Test |
| 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” |
| Par | Par Pharmaceutical, Inc. |
| PBMs | pharmacy benefit managers |
| 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 |
| PRC | People's Republic of China |
| Term | Description |
|---|---|
| PRSUs | Performance-based restricted stock units |
| PRV | priority review voucher |
| Quarterly Report on Form 10-Q | this Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 |
| R&D | research and development |
| R/R | relapsed/refractory |
| 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 |
| 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 |
| RSUs | restricted stock units |
| RTOR | Real-Time Oncology Review |
| 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 |
| sNDA | supplemental NDA |
| Sumitomo | Sumitomo Pharma Co., Ltd. |
| T-DXd | trastuzumab deruxtecan |
| Takeda | Takeda Pharmaceutical Company Limited |
| 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 |
| 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., 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 |
| 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.