# Jazz Pharmaceuticals plc (JAZZ)

Informational only - not investment advice.

CIK: 0001232524
SIC: 2834 Pharmaceutical Preparations
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2834 Pharmaceutical Preparations](/industry/2834/)
Latest 10-K filed: 2026-02-24
SEC page: https://www.sec.gov/edgar/browse/?CIK=1232524
Filing source: https://www.sec.gov/Archives/edgar/data/1232524/000123252426000013/jazz-20251231.htm

## At a glance

FY2025 · period end 2025-12-31 · filed 2026-02-24 · accession 0001232524-26-000013 · source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001232524.json

| Metric | Value | FY | Provenance |
| --- | ---: | ---: | --- |
| Revenue | 4,267,586,000 USD | 2025 | verified |
| Net income | -356,148,000 USD | 2025 | verified |
| Assets | 11,659,340,000 USD | 2025 | verified |
| Free cash flow | 1,297,021,000 USD | 2025 | computed |
| Net margin | -8.35% | 2025 | computed |
| Operating margin | -10.08% | 2025 | computed |
| Revenue YoY | +4.88% | 2025 | computed |
| ROE | -8.25% | 2025 | computed |

Computed values are grepcent-computed from the verified facts above and may differ from ratios the company itself reports. Free cash flow = operating cash flow − capital expenditures. Net margin = net income ÷ revenue. Operating margin = operating income ÷ revenue. Revenue YoY = FY2025 revenue ÷ FY2024 revenue − 1 (consecutive fiscal years only). ROE = net income ÷ period-end stockholders' equity.

No market price, no rating, no forecast on this site. Not investment advice.

### Peer percentile fingerprint

| Ratio | JAZZ | Peer median | Percentile | N |
| --- | ---: | ---: | ---: | ---: |
| Net margin | -8.3% | 1.0% | 37 | 107 |
| Operating margin | -10.1% | -1.3% | 42 | 100 |
| Revenue growth | 4.9% | 14.7% | 33 | 127 |
| FCF margin | 30.4% | -14.0% | 88 | 127 |
| ROE | -8.2% | -30.7% | 69 | 171 |
| ROA | -3.1% | -21.8% | 68 | 187 |
| Liabilities / equity | 1.70 | 0.38 | 78 | 173 |
| Current ratio | 1.86 | 4.89 | 11 | 188 |

Percentile = share of the N covered peers reporting that ratio whose value is lower (ties counted half); computed among grepcent-covered companies in SIC industry 2834 Pharmaceutical Preparations, not the whole market. A higher percentile means a higher value of the ratio, not a better company. Ratios with fewer than 8 reporting peers are omitted. Latest reported values per company; fiscal periods may differ. Descriptive arithmetic - not a score, rating, or ranking.

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Revenue | 4267586000 | USD | 2025 | 2026-02-24 |
| Net income | -356148000 | USD | 2025 | 2026-02-24 |
| Assets | 11659340000 | USD | 2025 | 2026-02-24 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-24. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001232524.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenue | 1,487,973,000 | 1,618,693,000 | 1,890,922,000 | 2,161,761,000 | 2,363,567,000 | 3,094,238,000 | 3,659,374,000 | 3,834,204,000 | 4,068,950,000 | 4,267,586,000 |
| Net income | 396,831,000 | 487,848,000 | 447,098,000 | 523,367,000 | 238,616,000 | -329,668,000 | -224,060,000 | 414,832,000 | 560,120,000 | -356,148,000 |
| Operating income | 591,654,000 | 528,842,000 | 614,838,000 | 532,374,000 | 378,073,000 | 170,278,000 | -65,528,000 | 578,580,000 | 716,630,000 | -430,240,000 |
| Diluted EPS | 6.41 | 7.96 | 7.30 | 9.09 | 4.22 | -5.52 | -3.58 | 6.10 | 8.65 | -5.84 |
| Operating cash flow | 592,391,000 | 693,087,000 | 798,904,000 | 776,401,000 | 899,648,000 | 778,507,000 | 1,271,977,000 | 1,092,007,000 | 1,395,908,000 | 1,355,773,000 |
| Capital expenditures |  |  | 20,370,000 | 40,135,000 | 15,004,000 | 27,641,000 | 29,046,000 | 23,962,000 | 38,070,000 | 58,752,000 |
| Share buybacks | 278,296,000 | 98,799,000 | 523,672,000 | 301,450,000 | 146,537,000 | 0.00 | 54,000 | 269,761,000 | 311,429,000 | 125,023,000 |
| Assets | 4,800,227,000 | 5,123,672,000 | 5,203,491,000 | 5,538,897,000 | 6,535,901,000 | 12,298,639,000 | 10,835,255,000 | 11,393,359,000 | 12,012,257,000 | 11,659,340,000 |
| Stockholders' equity | 1,877,339,000 | 2,713,097,000 | 2,757,422,000 | 3,110,981,000 | 3,659,745,000 | 3,965,191,000 | 3,085,734,000 | 3,736,997,000 | 4,093,756,000 | 4,318,584,000 |
| Cash and cash equivalents | 365,963,000 | 386,035,000 | 309,622,000 | 637,344,000 | 1,057,769,000 | 591,448,000 | 881,482,000 | 1,506,310,000 | 2,412,864,000 | 1,391,899,000 |
| Free cash flow |  |  | 778,534,000 | 736,266,000 | 884,644,000 | 750,866,000 | 1,242,931,000 | 1,068,045,000 | 1,357,838,000 | 1,297,021,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net margin | 26.67% | 30.14% | 23.64% | 24.21% | 10.10% | -10.65% | -6.12% | 10.82% | 13.77% | -8.35% |
| Operating margin | 39.76% | 32.67% | 32.52% | 24.63% | 16.00% | 5.50% | -1.79% | 15.09% | 17.61% | -10.08% |
| Return on equity | 21.14% | 17.98% | 16.21% | 16.82% | 6.52% | -8.31% | -7.26% | 11.10% | 13.68% | -8.25% |
| Return on assets | 8.27% | 9.52% | 8.59% | 9.45% | 3.65% | -2.68% | -2.07% | 3.64% | 4.66% | -3.05% |
| Liabilities / equity | 1.56 | 0.89 | 0.89 | 0.78 | 0.79 | 2.10 | 2.51 | 2.05 | 1.93 | 1.70 |
| Current ratio | 2.91 | 3.29 | 3.57 | 4.47 | 4.34 | 3.23 | 2.79 | 2.24 | 4.46 | 1.86 |

## As-reported value updates

No tracked differences above grepcent's stated thresholds and capped precision rule were found between the earliest XBRL-filed value and the value currently on file for the standardized annual metrics grepcent tracks.


## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-08-03. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001232524.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2022-Q3 | 2022-09-30 |  |  | -0.31 | reported discrete quarter |
| 2023-Q1 | 2023-03-31 |  |  | 1.04 | reported discrete quarter |
| 2023-Q2 | 2023-06-30 |  |  | 1.52 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | 104,438,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 | 972,140,000 |  | 2.14 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 | 1,011,935,000 | 94,154,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 | 901,983,000 | -14,618,000 | -0.23 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | -14,618,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 | 1,023,825,000 |  | 2.49 | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | 168,568,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-09-30 | 1,054,969,000 |  | 3.42 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 | 1,088,173,000 | 191,115,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 | 897,841,000 | -92,541,000 | -1.52 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | -92,541,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 | 1,045,712,000 |  | -11.74 | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | -718,470,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-09-30 | 1,126,107,000 |  | 4.08 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 | 1,197,926,000 | 203,451,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 | 1,068,900,000 | 293,100,000 | 4.43 | reported discrete quarter |
| 2026-Q2 | 2026-03-31 |  | 293,100,000 |  | reported discrete quarter |
| 2026-Q2 | 2026-06-30 | 1,208,300,000 |  | 2.78 | reported discrete quarter |

## Filed narrative (10-K & 10-Q)

## Business

Verbatim Item 1 Business section from JAZZ's latest 10-K: [/company/JAZZ/business/](/company/JAZZ/business/).

## Risk Factors

Verbatim Item 1A Risk Factors from JAZZ's latest 10-K: [/company/JAZZ/risk-factors/](/company/JAZZ/risk-factors/).

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1232524/000123252426000045/jazz-20260630.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary.
Confidence: high
Filing date: 2026-08-03
Report date: 2026-06-30

Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10‑Q. This discussion contains forward-looking statements that involve risks and uncertainties. You should review the risks and uncertainties described in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025 for a discussion of important factors that could cause actual results to differ materially from those projected in forward-looking statements contained in this report or implied by past results and trends. Forward-looking statements are statements that attempt to forecast or anticipate future developments in our business, financial condition or results of operations. See the “Cautionary Note Regarding Forward-Looking Statements” that appears at the end of this discussion. These statements, like all statements in this report, speak only as of the date of this Quarterly Report on Form 10‑Q (unless another date is indicated), and we undertake no obligation to update or revise these statements in light of future developments.

Overview

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 rare disease – often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering R&D advancements across our robust pipeline of innovative therapeutics.

Our strategy for growth is rooted in executing commercial launches and ongoing commercialization initiatives, advancing robust R&D programs and delivering impactful clinical results, effectively deploying capital to strengthen the prospects of achieving our short- and long-term goals through strategic corporate development, and delivering strong financial performance. We focus on rare diseases, which often have high unmet needs and small patient populations, resulting in efficient, concentrated call points. We seek to identify and develop highly differentiated therapies for these patients that we expect will be long-lived assets and that we can support with an efficient commercialization model. In addition, we leverage our efficient, scalable operating model and integrated capabilities across our global infrastructure to effectively reach patients around the world.

We continue to invest in pipeline programs that further our rare disease strategy.

Our lead marketed products, listed below, are approved in countries around the world to improve patient care.

[[GREPCENT_TABLE]]
[["Product","Indications","Initial Approval Date","Markets"],["Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates)","Treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy.","July 2020","U.S."],["Treatment of IH in adults.","August 2021","U.S."],["Treatment of cataplexy in patients with narcolepsy.","May 2023","Canada"],["Epidiolex\u00ae (cannabidiol)","Treatment of seizures associated with LGS, DS, or TSC in patients 1 year of age and older.","June 2018 and July 2020","U.S."],["Adjunctive therapy of seizures associated with LGS, DS, or TSC in patients 1 year of age and older.","April and October 2021","Israel"],["For adjunctive therapy of seizures associated with LGS, DS or TSC for patients 2 years of age and older.","November 2023","Canada"],["Epidyolex\u00ae (cannabidiol)","For adjunctive therapy of seizures associated with LGS or DS, in conjunction with clobazam, for patients 2 years of age and older.1","September 2019","EU, U.K., Switzerland, Australia, and other markets"],["For adjunctive therapy of seizures associated with TSC for patients 2 years of age and older.","April 2021","EU, U.K., Switzerland, and other markets"]]
[[/GREPCENT_TABLE]]

28

Table of Content

[[GREPCENT_TABLE]]
[["Ziihera\u00ae (zanidatamab-hrii)","Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC3+) BTC, as detected by an FDA-approved test.","November 2024","U.S. (licensed from Zymeworks)2"],["Treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) BTC previously treated with at least one prior line of systemic therapy.","June 2025","EU (licensed from Zymeworks)3"],["Treatment of adults with previously treated, unresectable locally advanced or metastatic HER2-positive (IHC3+) BTC, as monotherapy.","January 2026","Canada (licensed from Zymeworks)4"],["For treatment as a monotherapy of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) BTC previously treated with at least one prior line of systemic therapy","February 2026","U.K. (licensed from Zymeworks)5"],["Modeyso\u2122 (dordaviprone)","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.","August 2025","U.S.2"],["Zepzelca\u00ae (lurbinectedin)","Treatment of adult patients with metastatic SCLC, with disease progression on or after platinum-based chemotherapy.","June 2020","U.S. (licensed from PharmaMar)2"],["Treatment of adults with Stage III or metastatic SCLC who have progressed on or after platinum-containing therapy.","September 2021","Canada (licensed from PharmaMar)4"],["In combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for the maintenance treatment of adult patients with extensive-stage SCLC whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.","October 2025","U.S. (licensed from PharmaMar)"],["Rylaze\u00ae (asparaginase erwinia chrysanthemi (recombinant)- rywn)","A component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.","June 2021","U.S."],["Rylaze\u00ae (crisantaspase recombinant)","A component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adults and pediatric patients 1 year or older who have developed hypersensitivity to E. coli-derived asparaginase.","September 2022","Canada"],["Enrylaze\u00ae (recombinant crisantaspase)","A component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and pediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.","September 2023","EU, U.K., Switzerland, other markets"]]
[[/GREPCENT_TABLE]]

1 The clobazam restriction limited to EU and U.K.

2 Accelerated approval received from FDA

3 Conditional marketing authorization granted by EC

4 Conditional approval received from Health Canada

5 Conditional marketing authorization granted by MHRA

29

Table of Content

Rare Sleep Disorders

We are the leader in the development and commercialization of oxybate therapy for patients with rare sleep disorders. In 2020, we received FDA approval for Xywav for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy. In August 2021, Xywav became the first and only therapy approved by FDA for the treatment of IH in adults. Xywav has become a standard of care for patients with narcolepsy and IH.

Since there is no cure for narcolepsy and long-term disease management is needed, we believe that Xywav represents an important therapeutic option for patients with this sleep disorder. Our first medicine in sleep was Xyrem, which was approved by FDA in 2002, and contains 1640 mg of sodium per 9 g dose per night. Xyrem is indicated for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy. Xywav contains 92% less sodium than Xyrem and is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake.

Our commercial efforts are focused on educating patients and physicians on the strength of clinical evidence that supports the use of Xywav for treating narcolepsy and IH. Xywav has demonstrated efficacy for the treatment of cataplexy and EDS in narcolepsy and multiple daytime symptoms such as sleep inertia in IH. Analysis from the Phase 4 DUET trial showed improvements across multiple polysomnography measures in both narcolepsy and IH, suggesting Xywav improves measures of sleep fragmentation in these conditions. In addition, we are also focused on educating patients and physicians on the long-term health impacts of high sodium intake, and how the use of Xywav helps address a modifiable risk factor for cardiovascular morbidity. We view the continued adoption of Xywav in narcolepsy as a positive indication that physicians and patients appreciate the benefits of a low-sodium oxybate option.

In June 2021, FDA recognized seven years of ODE for Xywav in EDS and cataplexy in narcolepsy through July 2027. Subsequently, FDA granted pediatric exclusivity, which extends the period of orphan exclusivity to January 2028. FDA continues to recognize seven years of ODE for Xywav in narcolepsy. In connection with granting ODE, FDA stated that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem.” FDA's summary also stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated." FDA has also recognized that the difference in sodium content between Xywav and Lumryz, which is a high-sodium oxybate launched in the U.S. market in June 2023, is likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than Lumryz in all such patients. Lumryz has the same sodium content as Xyrem.

On August 12, 2021, FDA approved Xywav for the treatment of IH in adults. Xywav remains the first and only FDA-approved therapy to treat IH. We initiated the U.S. commercial launch of Xywav for the treatment of IH in adults in November 2021. In January 2022, we announced that FDA recognized seven years of ODE for Xywav in IH through August 2028. IH is a debilitating neurologic sleep disorder characterized by chronic EDS (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness), severe sleep inertia, and prolonged and non-restorative nighttime sleep. An estimated 37,000 people in the U.S. have been diagnosed with IH and are actively seeking healthcare.

We have agreements in place for Xywav with all three major PBMs in the U.S. To date, we have entered into agreements with various entities and have achieved benefit coverage for Xywav in both narcolepsy and IH indications for approximately 90% of commercial lives.

Since Xywav's launch in November 2020, HCPs and patients continue to drive demand for safer, low-sodium Xywav, and we have seen strong new patient growth in IH since its launch in November 2021. Exiting the second quarter of 2026, there were approximately 17,125 active patients taking Xywav, including approximately 11,275 patients with narcolepsy and approximately 5,850 patients with IH.

Rare Epilepsies

We acquired Epidiolex (Epidyolex in certain markets outside the U.S.) in May 2021 as part of the GW Acquisition, which added a durable and long-lived asset in epilepsies to our portfolio. Epidiolex was approved in the U.S. in June 2018 for the treat

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A (excerpt)

Latest 10-K Item 7 source: https://www.sec.gov/Archives/edgar/data/1232524/000123252426000013/jazz-20251231.htm
Complete FY 2025 MD&A: /company/JAZZ/mda/fy2025/

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary. Published MD&A gate trimmed front/tail over-capture.
Confidence: high
Filing date: 2026-02-24
Report date: 2025-12-31

Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations

The purpose of the Management Discussion and Analysis is to present information that management believes is relevant to promote an understanding of our results of operations and cash flows for the fiscal year ended December 31, 2025 and our financial condition as of December 31, 2025 and should be read in conjunction with the consolidated financial statements and notes to consolidated financial statements included elsewhere in this Annual Report on Form 10‑K. This discussion contains forward-looking statements that involve risks and uncertainties. You should review the risks and uncertainties described in “Risk Factors” in Part I, Item 1A in this Annual Report on Form 10‑K for a discussion of important factors that could cause actual results to differ materially from those projected in forward-looking statements contained in this report or implied by past results and trends. Forward-looking statements are statements that attempt to forecast or anticipate future developments in our business, financial condition or results of operations. See the “Cautionary Note Regarding Forward-Looking Statements” that appears at the beginning of this Annual Report on Form 10-K. These statements, like all statements in this report, speak only as of the date of this Annual Report on Form 10-K (unless another date is indicated), and we undertake no obligation to update or revise these statements in light of future developments.

Overview

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 rare disease – often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering R&D advancements across our robust pipeline of innovative therapeutics.

Our strategy for growth is rooted in executing commercial launches and ongoing commercialization initiatives, advancing robust R&D programs and delivering impactful clinical results, effectively deploying capital to strengthen the prospects of achieving our short- and long-term goals through strategic corporate development, and delivering strong financial performance. We focus on rare disease, which often have high unmet needs and small patient populations, resulting in efficient, concentrated call points. We seek to identify and develop highly differentiated therapies for these patients that we expect will be long-lived assets and that we can support with an efficient commercialization model. In addition, we leverage our efficient, scalable operating model and integrated capabilities across our global infrastructure to effectively reach patients around the world.

We continue to invest in pipeline programs that further our rare disease strategy. For a summary of our ongoing R&D activities, see “Business—Research and Development Progress” in Part I, Item 1 of this Annual Report on Form 10-K.

81

Table of Contents

Our lead marketed products, listed below, are approved in countries around the world to improve patient care.

[[GREPCENT_TABLE]]
[["Product","Indications","Initial Approval Date","Markets"],["Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates)","Treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy.","July 2020","U.S."],["Treatment of IH in adults.","August 2021","U.S."],["Treatment of cataplexy in patients with narcolepsy.","May 2023","Canada"],["Epidiolex\u00ae (cannabidiol)","Treatment of seizures associated with LGS, DS, or TSC in patients 1 year of age and older.","June 2018 and July 2020","U.S."],["Adjunctive therapy of seizures associated with LGS, DS, or TSC in patients 1 year of age and older.","April and October 2021","Israel"],["For adjunctive therapy of seizures associated with LGS, DS or TSC for patients 2 years of age and older.","November 2023","Canada"],["Epidyolex\u00ae (cannabidiol)","For adjunctive therapy of seizures associated with LGS or DS, in conjunction with clobazam, for patients 2 years of age and older.1","September 2019","EU, Great Britain, EEA, Switzerland, Australia, other markets"],["For adjunctive therapy of seizures associated with TSC for patients 2 years of age and older.","April 2021","EU, Great Britain, EEA and Switzerland"],["Ziihera\u00ae (zanidatamab-hrii)","Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC3+) BTC, as detected by an FDA-approved test.","November 2024","U.S. (licensed from Zymeworks)2"],["Treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) BTC previously treated with at least one prior line of systemic therapy.","June 2025","EU (licensed from Zymeworks)3"],["Treatment of adults with previously treated, unresectable locally advanced or metastatic HER2-positive (IHC3+) BTC, as monotherapy.","January 2026","Canada (licensed from Zymeworks)4"],["Modeyso\u2122 (dordaviprone)","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.","August 2025","U.S.2"],["Zepzelca\u00ae (lurbinectedin)","Treatment of adult patients with metastatic SCLC, with disease progression on or after platinum-based chemotherapy.","June 2020","U.S. (licensed from PharmaMar)2"],["Treatment of adults with Stage III or metastatic SCLC who have progressed on or after platinum-containing therapy.","September 2021","Canada (licensed from PharmaMar)4"],["In combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for the first-line maintenance treatment of adult patients with extensive-stage SCLC whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.","October 2025","U.S. (licensed from PharmaMar)"]]
[[/GREPCENT_TABLE]]

82

Table of Contents

[[GREPCENT_TABLE]]
[["Product","Indications","Initial Approval Date","Markets"],["Rylaze\u00ae (asparaginase erwinia chrysanthemi (recombinant)- rywn)","A component of a multi-agent chemotherapeutic regimen for the treatment of ALL, and LBL, in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.","June 2021","U.S."],["Rylaze\u00ae (crisantaspase recombinant)","A component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL, in adults and pediatric patients 1 year or older who have developed hypersensitivity to E. coli-derived asparaginase.","September 2022","Canada"],["Enrylaze\u00ae (recombinant crisantaspase)","A component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and pediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.","September 2023","EU, Great Britain, Switzerland, other markets"]]
[[/GREPCENT_TABLE]]

1 The clobazam restriction limited to EU and Great Britain

2 Accelerated approval received from FDA

3 Conditional marketing authorization granted by EC

4 Conditional approval received from Health Canada

Rare Sleep Disorders

We are the leader in the development and commercialization of oxybate therapy for patients with rare sleep disorders. In 2020, we received FDA approval for Xywav for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy. In August 2021, Xywav became the first and only therapy approved by FDA for the treatment of IH in adults. Xywav has become a standard of care for patients with narcolepsy and IH.

Since there is no cure for narcolepsy and long-term disease management is needed, we believe that Xywav represents an important therapeutic option for patients with this sleep disorder. Our commercial efforts are focused on educating patients and physicians on the strength of clinical evidence that supports the use of Xywav for treating narcolepsy and IH. Xywav has demonstrated efficacy for the treatment of cataplexy and EDS in narcolepsy and multiple daytime symptoms such as sleep inertia in IH. Analysis from the Phase 4 DUET trial showed improvements across multiple polysomnography measures in both narcolepsy and IH, suggesting Xywav improves measures of sleep fragmentation in these conditions. In addition, we are also focused on educating patients and physicians on the long-term health impacts of high sodium intake, and how the use of Xywav helps address a modifiable risk factor for cardiovascular morbidity. We view the continued adoption of Xywav in narcolepsy as a positive indication that physicians and patients appreciate the benefits of a low-sodium oxybate option.

In June 2021, FDA recognized seven years of ODE for Xywav in EDS and cataplexy in narcolepsy through July 2027 (which was subsequently extended to January 2028). Nevertheless, Lumryz, a fixed-dose, high-sodium oxybate, was approved by FDA on May 1, 2023, for the treatment of cataplexy or EDS in adults with narcolepsy and was launched in the U.S. market by Avadel in June 2023. FDA continues to recognize seven years of ODE for Xywav in narcolepsy. In connection with granting ODE, FDA stated that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem.” FDA's summary also stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated." FDA has also recognized that the difference in sodium content between Xywav and Lumryz is likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than Lumryz in all such patients. Lumryz has the same sodium content as Xyrem. Our first medicine in rare sleep disorders was Xyrem, which was approved by FDA in 2002, and contains 1640mg of sodium per 9gram dose per night. Xyrem is indicated for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy. Xywav contains 92% less sodium than Xyrem and is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake.

On August 12, 2021, FDA approved Xywav for the treatment of IH in adults. Xywav remains the first and only FDA-approved therapy to treat IH. We initiated the U.S. commercial launch of Xywav for the treatment of IH in adults in November 2021. In January 2022, we announced that FDA recognized seven years of ODE for Xywav in IH through August 2028. IH is a debilitating neurologic sleep disorder characterized by chronic EDS (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness), severe sleep inertia, and

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prolonged and non-restorative nighttime sleep. An estimated 37,000 people in the U.S. have been diagnosed with IH and are actively seeking healthcare.

We have agreements in place for Xywav with all three major PBMs in the U.S. To date, we have entered into agreements with various entities and have achieved benefit coverage for Xywav in both narcolepsy and IH indications for approximately 90% of commercial lives.

We have seen strong adoption of Xywav in narcolepsy since its launch in November 2020, and increasing adoption in IH since its launch in November 2021. At the end of 2025, there were approximately 16,175 patients taking Xywav, including approximately 10,950 patients with narcolepsy and approximately 5,225 patients with IH.

Rare Epilepsies

We acquired Epidiolex (Epidyolex in certain markets outside the U.S.) in May

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]

Read the full FY 2025 MD&A: /company/JAZZ/mda/fy2025/
All MD&A years: /company/JAZZ/mda/


## MD&A history

Prior-year 10-K MD&A spans are extracted from SEC filings with the same bounded parser used for the latest filing. Each year's full verbatim text is on its own sub-page.

- [FY 2024 MD&A](/company/JAZZ/mda/fy2024/): filed 2025-02-26; accession 0001232524-25-000011 (https://www.sec.gov/Archives/edgar/data/1232524/000123252425000011/jazz-20241231.htm)
- [FY 2023 MD&A](/company/JAZZ/mda/fy2023/): filed 2024-02-28; accession 0001232524-24-000015 (https://www.sec.gov/Archives/edgar/data/1232524/000123252424000015/jazz-20231231.htm)
- [FY 2022 MD&A](/company/JAZZ/mda/fy2022/): filed 2023-03-01; accession 0001232524-23-000015 (https://www.sec.gov/Archives/edgar/data/1232524/000123252423000015/jazz-20221231.htm)
- [FY 2021 MD&A](/company/JAZZ/mda/fy2021/): filed 2022-03-01; accession 0001232524-22-000012 (https://www.sec.gov/Archives/edgar/data/1232524/000123252422000012/jazz-20211231.htm)


## FDA-approved drug applications

Applications listed under this company's exact-matched sponsor name. Approved applications only.

| FDA-listed trade name | Active ingredient | Application | Original approval |
| --- | --- | --- | --- |
| ZIIHERA | ZANIDATAMAB-HRII | [BLA761416](/drug/bla-761416/) | 2024-11-20 |
| RYLAZE | ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN | [BLA761179](/drug/bla-761179/) | 2021-06-30 |
| DEFITELIO | DEFIBROTIDE SODIUM | [NDA208114](/drug/nda-208114/) | 2016-03-30 |
| LUVOX CR | FLUVOXAMINE MALEATE | [NDA022033](/drug/nda-022033/) | 2008-02-28 |
| XYREM | SODIUM OXYBATE | [NDA021196](/drug/nda-021196/) | 2002-07-17 |

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

This list covers FDA applications whose listed sponsor name maps to this company by an exact-unique match; applications listed under sponsor names not mapped to this company (subsidiaries, name variants, joint ventures) are absent.


## Macro cross-references

Indicators mapped to this company's SIC classification (industry 2834 Pharmaceutical Preparations) by grepcent's deterministic macro-sector crosswalk. A navigational mapping, not a statistical or causal claim.

- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm

Macro-to-micro threads including this sector: [Inflation (CPI / PCE / PPI)](/thread/inflation-cpi-pce-ppi/), [US labor market](/thread/us-labor-market/), [Growth & output](/thread/growth-output/), [Money & trade](/thread/money-trade/), [Government finances](/thread/government-finances/), [Sector employment](/thread/sector-employment/), [Industrial orders & inventories](/thread/industrial-orders/), [Trade & external](/thread/trade-external/).

All macro indicators: /indicators/


## For LLMs & downloads

Markdown twin: /company/JAZZ.md · JSON record: /company/JAZZ.json · verified financials: /company/JAZZ/financials.json / /company/JAZZ/financials.csv · machine TOC for the whole site: /llms.txt