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Jazz Pharmaceuticals (JAZZ) swings to H1 2026 profit and trims $1B in debt

(Moderate)
(Neutral)
Form Type
10-Q

Rhea-AI Filing Summary

Jazz Pharmaceuticals reported second-quarter 2026 revenues of $1,208.3 million, up from $1,045.7 million a year earlier, and net income of $192.8 million versus a net loss of $718.5 million. For the first six months, revenues were $2,277.2 million and net income was $485.9 million, compared with a loss of $811.0 million in the prior-year period. Results reflect $77.0 million of acquired in-process R&D versus $905.4 million last year and a $122.8 million gain on sale of a priority review voucher.

Product sales reached $1,156.1 million, led by Xywav at $471.2 million, Epidiolex/Epidyolex at $292.1 million, and oncology medicines at $362.3 million, including Zepzelca, Rylaze/Enrylaze, Defitelio, Modeyso and Ziihera. U.S. revenues were $1,077.9 million. Exiting the quarter, there were approximately 17,125 active Xywav patients, including about 11,275 with narcolepsy and 5,850 with idiopathic hypersomnia.

Jazz generated $823.9 million of operating cash flow in the first half, ending June 30, 2026 with $1,619.8 million in cash and cash equivalents and $580.0 million in investments. Total debt declined to $4,351.4 million from $5,358.3 million after repaying the $1.0 billion 2026 exchangeable notes, issuing 1.89 million shares for the conversion premium, while the $1.0 billion 2030 notes became exchangeable and were classified as current. During the quarter, Jazz paid $56.0 million upfront to AbCellera for a multispecific antibody collaboration and $21.0 million to acquire remaining rights to JZP898 from Werewolf, both expensed as acquired in-process R&D.

Positive

  • Net income of $192.8 million in Q2 2026 and $485.9 million year-to-date, after a prior-year loss, alongside $823.9 million operating cash flow and a $1.0 billion reduction in debt from repaying the 2026 Notes.

Negative

  • None.

Filing Explained

As of June 30, 2030 Notes were exchangeable but none had been exchanged; $225 million of repurchase authorization remained unused.

This Form 10-Q is an unaudited interim report covering the quarter ended June 30, 2026, including updates on financial statements, risks and liquidity. The filing states that the 2030 Notes became exchangeable for the quarter ended September 30, 2026, but no notes had been exchanged as of the filing date.

The exchange feature requires Jazz to pay the $1.0 billion principal in cash; the conversion spread may be settled in cash, ordinary shares or a combination. An exchange could therefore affect the company’s future cash or share-settlement obligations, but the filing does not report that an exchange has occurred.

Jazz had no share repurchases during the three or six months ended June 30, 2026. The board’s repurchase program still had $225.0 million authorized at that date, which is capacity rather than money already spent.

For follow-up, the next status point for the 2030 Notes is the quarter ended September 30, 2026. Separately, the June 26, 2026 lawsuit involving Qilu placed its Zepzelca application under a statutory stay of up to 30 months, while a July 2026 court ruling denied Tris Pharma’s motions to dismiss and the case proceeded with answers and counterclaims.

Q2 2026 Total Revenues $1,208.3 million Three months ended June 30, 2026
Q2 2026 Net Income $192.8 million Three months ended June 30, 2026
H1 2026 Operating Cash Flow $823.9 million Net cash provided by operating activities, six months ended June 30, 2026
Cash and Cash Equivalents $1,619.8 million Balance at June 30, 2026
Investments $580.0 million Time deposits classified as investments at June 30, 2026
Total Debt $4,351.4 million Carrying amount of indebtedness at June 30, 2026
Xywav Q2 2026 Sales $471.2 million Product sales for the three months ended June 30, 2026
Epidiolex/Epidyolex Q2 2026 Sales $292.1 million Product sales for the three months ended June 30, 2026
Orphan Drug Exclusivity regulatory
"FDA recognized seven years of Orphan Drug Exclusivity for Xywav in EDS"
A regulatory right that gives a drugmaker sole approval to market a medicine for a specific rare disease for a set number of years, during which the regulator will not approve the same medicine from competitors for that same use. For investors, this is like a temporary exclusive sales permit that can protect revenue and justify higher valuation because it reduces near‑term competition and helps the company recover development costs and capture market share.
priority review voucher regulatory
"we completed the sale of our rare pediatric disease PRV for total cash consideration"
A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.
Pillar Two financial
"Pillar Two top-up taxes for the difference between the Pillar Two effective tax rate"
Pillar Two is an international tax framework that sets a global minimum tax rate for large multinational companies and requires extra payments when profits booked in low-tax locations fall below that floor. For investors, it matters because it raises the likely tax bill, reduces after-tax earnings and cash available for dividends or reinvestment, and can change company valuations—think of it as a tax “price floor” that limits how much a firm can lower its effective tax rate.
Breakthrough Therapy designation regulatory
"The application has received BTD by FDA and is being reviewed under FDA’s RTOR"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
Real-Time Oncology Review regulatory
"being reviewed under FDA’s RTOR program, which is designed to provide a more efficient review"
A regulatory process in which reviewers assess clinical data and application materials for a cancer therapy as they are submitted, instead of waiting for a complete package. By allowing questions to be answered and issues resolved during the submission rather than afterward, it can speed up decisions and reduce surprise delays. For investors, that means greater predictability around potential approvals or setbacks and a faster path to a drug reaching the market, similar to editing a book chapter-by-chapter rather than after the whole manuscript is finished.
Section 505(b)(2) NDA regulatory
"Tris Pharma that it had filed with FDA a Section 505(b)(2) NDA with Xyrem and Xywav"

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

How did Jazz Pharmaceuticals (JAZZ) perform financially in Q2 2026?

Jazz Pharmaceuticals reported Q2 2026 revenue of $1,208.3 million and net income of $192.8 million. For the first half of 2026, revenue was $2,277.2 million with net income of $485.9 million, compared with a net loss in the prior-year period.

What were the key revenue drivers for JAZZ in the quarter ended June 30, 2026?

Product sales totaled $1,156.1 million, led by Xywav at $471.2 million, Epidiolex/Epidyolex at $292.1 million, and oncology products at $362.3 million. U.S. revenue contributed $1,077.9 million of total quarterly revenues.

What is Jazz Pharmaceuticals’ (JAZZ) cash and debt position as of June 30, 2026?

As of June 30, 2026, Jazz held $1,619.8 million in cash and cash equivalents and $580.0 million in investments. Total debt was $4,351.4 million, down from $5,358.3 million at December 31, 2025, following repayment of the $1.0 billion 2026 Notes.

What strategic R&D transactions did JAZZ complete in the first half of 2026?

Jazz paid $56.0 million upfront to AbCellera for a T‑cell engaging multispecific antibody collaboration and $21.0 million to Werewolf to acquire all remaining rights to JZP898. Both payments were recorded as acquired in‑process R&D expense in 2026.

How many patients are currently treated with Xywav according to JAZZ’s Q2 2026 report?

Exiting Q2 2026, approximately 17,125 patients were on Xywav, including around 11,275 with narcolepsy and 5,850 with idiopathic hypersomnia. Xywav generated $471.2 million in product sales during the quarter.

What was the impact of the priority review voucher sale on JAZZ’s 2026 results?

In January 2026, Jazz sold a rare pediatric disease priority review voucher for $200.0 million, recognizing a pre-tax gain of $122.8 million. The gain is included in operating results for the six months ended June 30, 2026.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 10-Q
(Mark One)
Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended June 30, 2026
or
Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from              to             
Commission File Number: 001-33500
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter) 
Ireland98-1032470
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
Fifth Floor, Waterloo Exchange,
Waterloo Road, Dublin 4, Ireland D04 E5W7
011-353-1-634-7800
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary shares, nominal value $0.0001 per shareJAZZThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.





Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes  No 
As of July 27, 2026, 64,914,577 ordinary shares of the registrant, nominal value $0.0001 per share, were outstanding.


Table of Content
JAZZ PHARMACEUTICALS PLC
QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 2026

INDEX
 
Page
PART I – FINANCIAL INFORMATION
Defined Terms and Products
3
Item 1.
Financial Statements
7
Condensed Consolidated Balance Sheets – June 30, 2026 and December 31, 2025
7
Condensed Consolidated Statements of Income (Loss) – Three and Six Months Ended June 30, 2026 and 2025
8
Condensed Consolidated Statements of Comprehensive Income (Loss) – Three and Six Months Ended June 30, 2026 and 2025
9
Condensed Consolidated Statements of Shareholders’ Equity – Three and Six Months Ended June 30, 2026 and 2025
10
Condensed Consolidated Statements of Cash Flows – Three and Six Months Ended June 30, 2026 and 2025
12
Notes to Condensed Consolidated Financial Statements
13
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
30
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
47
Item 4.
Controls and Procedures
47
PART II – OTHER INFORMATION
Item 1.
Legal Proceedings
48
Item 1A.
Risk Factors
48
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
48
Item 5.
Other Information
48
Item 6.
Exhibits
50
SIGNATURES
51

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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.

TermDescription
2026 Notes2.00% exchangeable senior notes due 2026
2030 Notes3.125% exchangeable senior notes due 2030
AbCellera
AbCellera Biologics Inc.
AGauthorized generic
AlkermesAlkermes plc
ALLacute lymphoblastic leukemia
AlmajectAlmaject Inc., Alvogen, Inc., and Alvogen PB Research and Development LLC
Amended Credit AgreementCredit Agreement amended to include the Repricing Amendment No. 1, the Repricing Amendment No. 2 and Amendment No. 3
Amended Revolving Credit FacilityRevolving credit facility amended to increase the Initial Revolving Credit Facility to $885.0 million and extend the maturity date
Amendment No. 3amendment to the Credit Agreement entered into by Jazz Lux in November 2024
AmnealAmneal Pharmaceuticals LLC
ANDAabbreviated NDA
AscentAscent Pharmaceuticals, Inc.
ASDASD Specialty Healthcare LLC
ASUAccounting Standards Update
AvadelAvadel Pharmaceuticals plc
AxsomeAxsome Therapeutics, Inc.
BLABiologics License Application
BTCbiliary tract cancers
BTDBreakthrough Therapy designation
CBDcannabidiol
ChimerixChimerix, Inc.
Chimerix Acquisitionour acquisition of Chimerix on April 21, 2025
ClpPmitochondrial caseinolytic protease P
CNX TherapeuticsCNX Therapeutics Limited
CODMchief operating decision maker
CRCcolorectal cancer
Credit AgreementCredit 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
DEAU.S. Drug Enforcement Administration
Dollar Term Loanour former seven-year $3.1 billion term loan B facility under the Credit Agreement
DRD2dopamine D2 receptor
DSDravet syndrome
ECEuropean Commission
EDSexcessive daytime sleepiness
Epidiolex ANDA FilersTeva; 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-SCLCextensive-stage small cell lung cancer
ESPPAmended and Restated 2007 Employee Stock Purchase Plan
ESSDSExpress Scripts Specialty Distribution Services, Inc.
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TermDescription
ETessential tremor
EUEuropean Union
Euro Term Loanour now repaid seven-year €625.0 million term loan B facility under the Credit Agreement
Exchange ActSecurities Exchange Act of 1934, as amended
Exchangeable Senior Notes our 2026 Notes and 2030 Notes
Fair value step-up expensethe acquisition accounting inventory fair value step-up expense
FASBFinancial Accounting Standards Board
FDAU.S. Food and Drug Administration
Finance Actthe Finance (No. 2) Act of 2023
ggram
GEAgastroesophageal adenocarcinoma
GranulesGranules India Limited
GWGW Pharmaceuticals plc
GW Acquisitionour acquisition of GW in May 2021
HER2human epidermal growth factor receptor 2
HHSU.S. Department of Health and Human Services
HikmaHikma Pharmaceuticals PLC
IFNαinterferon alpha
IHidiopathic hypersomnia
IHC3+immunohistochemistry 3+
IMintramuscular
INDinvestigational NDA
Initial Revolving Credit Facilityour five-year $500.0 million revolving credit facility under the Credit Agreement entered into in May 2021
InvaGenInvaGen Pharmaceuticals, Inc.
IPR&D
in-process research and development
IRAInflation Reduction Act of 2022
Jazz InvestmentsJazz Investments I Limited
Jazz LuxJazz Financing Lux S.à.r.l.
LBLlymphoblastic lymphoma
LGSLennox-Gastaut syndrome
LupinLupin Inc.
MAPKmitogen-activated protein kinase
McKessonMcKesson Corporation
MDSMyelodysplastic Syndrome
MFNMost-Favored-Nation
mgmilligram
mGEAmetastatic gastroesophageal adenocarcinoma
MHRAMedicines and Healthcare products Regulatory Agency
NDANew Drug Application
Nippon ZokiNippon Zoki Pharmaceutical Co., Ltd.
ODEOrphan Drug Exclusivity in the U.S.
OECDOrganization for Economic Co-operation and Development
Orange BookFDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations”
OSoverall survival
ParPar Pharmaceutical, Inc.
PatheonPatheon Pharmaceuticals Inc., together with its affiliates
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TermDescription
PBMspharmacy benefit managers
PD-L1programmed death-ligand 1
PDUFAPrescription Drug User Fee Act
PharmaMarPharma Mar, S.A.
Pillar Twothe 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
PRCPeople's Republic of China
PRSUsPerformance-based restricted stock units
PRVpriority review voucher
Qilu
Qilu Pharmaceutical (Hainan) Co., Ltd.
Quarterly Report on Form 10-Q
this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026
R&Dresearch and development
RedxRedx Pharma plc
REMSrisk evaluation and mitigation strategy
Repricing Amendment No.1amendment to the Credit Agreement entered into by Jazz Lux in January 2024
Repricing Amendment No.2amendment to the Credit Agreement entered into by Jazz Lux in July 2024
Repurchase Programour share repurchase program announced on July 31, 2024
RK PharmaRK Pharma, Inc., Apicore US LLC, Archis Pharma LLC, Vgyaan Pharmaceuticals LLC, Dr. Reddy's Laboratories, Inc.
RSUsrestricted stock units
RTORReal-Time Oncology Review
SanionaSaniona A/S
sBLAsupplemental BLA
SCLCsmall cell lung cancer
SECU.S. Securities and Exchange Commission
Secured Notesour issued $1.5 billion in aggregate principal amount of 4.375% senior secured notes, due 2029
Securities ActSecurities Act of 1933, as amended
T-DXdtrastuzumab deruxtecan
TakedaTakeda Pharmaceutical Company Limited
TevaTeva Pharmaceuticals, Inc.
Tranche B-1 Dollar Term Loansupon 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 Loansupon 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 PharmaTris Pharma, Inc.
TSCtuberous sclerosis complex
U.K.United Kingdom
U.S.United States of America
U.S. GAAPU.S. generally accepted accounting principles
USAOU.S. Attorney's Office
USPTOU.S. Patent and Trademark Office
WerewolfWerewolf Therapeutics, Inc.
Zepzelca ANDA FilersSandoz 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.
ZymeworksZymeworks Inc.
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Products
The brand names of our products, our delivery devices and certain of our product candidates and their associated generic names are given below.

TermDescription
CombiPlexCombiPlex® (delivery technology platform)
DefitelioDefitelio® (defibrotide sodium), Defitelio® (defibrotide)
EpidiolexEpidiolex® (cannabidiol) oral solution, Epidyolex® (the trade name in Europe and other countries outside the U.S. for Epidiolex)
Modeyso
ModeysoTM (dordaviprone)
RylazeRylaze® (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
VyxeosVyxeos® (daunorubicin and cytarabine) liposome for injection, Vyxeos® liposomal 44 mg/100 mg powder for concentrate for solution for infusion
XyremXyrem® (sodium oxybate) oral solution
XywavXywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution
ZepzelcaZepzelca® (lurbinectedin)
ZiiheraZiihera® (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), ModeysoTM (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.
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PART I – FINANCIAL INFORMATION
 
Item 1.Financial Statements

JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions)
(Unaudited)
June 30,
2026
December 31,
2025
ASSETS
Current assets:
Cash and cash equivalents$1,619.8 $1,391.9 
Investments580.0 1,050.0 
Accounts receivable, net of allowances880.9 830.7 
Inventories443.0 417.0 
Prepaid expenses200.0 152.5 
Other current assets244.5 323.9 
Total current assets3,968.2 4,166.0 
Property, plant and equipment, net212.0 199.9 
Operating lease assets52.1 58.9 
Intangible assets, net4,029.5 4,429.5 
Goodwill1,799.8 1,829.3 
Deferred tax assets, net926.4 869.1 
Deferred financing costs6.6 7.6 
Other non-current assets86.3 99.0 
Total assets$11,080.9 $11,659.3 
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable$128.5 $122.1 
Accrued liabilities1,030.0 1,034.2 
Current portion of long-term debt1,016.4 1,029.9 
Income taxes payable55.9 56.3 
Total current liabilities2,230.8 2,242.5 
Long-term debt, less current portion3,335.0 4,328.4 
Operating lease liabilities, less current portion43.6 50.9 
Deferred tax liabilities, net528.9 594.5 
Other non-current liabilities140.9 124.4 
Commitments and contingencies (Note 10)
Shareholders’ equity:
Ordinary shares  
Non-voting euro deferred shares0.1 0.1 
Capital redemption reserve0.5 0.5 
Additional paid-in capital4,331.6 4,240.5 
Accumulated other comprehensive loss(662.5)(568.6)
Retained earnings1,132.0 646.1 
Total shareholders’ equity4,801.7 4,318.6 
Total liabilities and shareholders’ equity$11,080.9 $11,659.3 





The accompanying notes are an integral part of these condensed consolidated financial statements.
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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(In millions, except per share amounts)
(Unaudited)
 
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
Revenues:
Product sales, net$1,156.1 $985.6 $2,181.4 $1,825.0 
Royalties and contract revenues52.2 60.1 95.8 118.5 
Total revenues1,208.3 1,045.7 2,277.2 1,943.5 
Operating expenses:
Cost of product sales (excluding amortization of acquired developed technologies)116.4 116.3 250.5 220.9 
Selling, general and administrative389.2 358.4 741.9 872.4 
Research and development207.5 189.9 403.5 370.6 
Intangible asset amortization170.0 162.1 342.3 316.5 
Acquired in-process research and development77.0 905.4 77.0 905.4 
Gain on sale of priority review voucher  (122.8) 
Total operating expenses960.1 1,732.1 1,692.4 2,685.8 
Income (loss) from operations248.2 (686.4)584.8 (742.3)
Interest expense, net(37.1)(47.4)(77.0)(101.1)
Foreign exchange gain (loss)(0.1)(1.8)2.4 (2.0)
Income (loss) before income tax expense (benefit) and equity in loss of investees211.0 (735.6)510.2 (845.4)
Income tax expense (benefit)18.1 (17.2)24.2 (35.0)
Equity in loss of investees0.1 0.1 0.1 0.6 
Net income (loss)$192.8 $(718.5)$485.9 $(811.0)
Net income (loss) per ordinary share:
Basic $3.05 $(11.74)$7.77 $(13.28)
Diluted$2.78 $(11.74)$7.17 $(13.28)
Weighted-average ordinary shares used in per share calculations - basic63.2 61.2 62.5 61.1 
Weighted-average ordinary shares used in per share calculations - diluted69.4 61.2 67.8 61.1 












The accompanying notes are an integral part of these condensed consolidated financial statements.
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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In millions)
(Unaudited)
 
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
Net income (loss)$192.8 $(718.5)$485.9 $(811.0)
Other comprehensive income (loss):
Foreign currency translation adjustments(11.6)299.8 (94.3)462.6 
Unrealized gain on cash flow hedging activities, net of income tax expense of $, $0.1 $ and $ respectively
 0.5 0.1 0.1 
Loss (gain) on cash flow hedging activities reclassified from accumulated other comprehensive loss to interest expense, net of income tax (benefit) expense of $, $0.1, $(0.1) and $0.2 respectively
0.1 (0.4)0.3 (0.8)
Other comprehensive income (loss)(11.5)299.9 (93.9)461.9 
Total comprehensive income (loss)$181.3 $(418.6)$392.0 $(349.1)






















The accompanying notes are an integral part of these condensed consolidated financial statements.
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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(In millions)
(Unaudited)
Ordinary SharesNon-voting Euro DeferredCapital
Redemption
Reserve
Additional
Paid-in
Capital
Accumulated
Other
Comprehensive
Loss
Retained
Earnings
Total
Equity
SharesAmountSharesAmount
Balance at December 31, 202561.4 $ 4.0 $0.1 $0.5 $4,240.5 $(568.6)$646.1 $4,318.6 
Issuance of ordinary shares in conjunction with exercise of share options0.2 — — — — 32.9 — — 32.9 
Issuance of ordinary shares in conjunction with vesting of restricted stock units1.0 — — — — — — — — 
Issuance of ordinary shares in conjunction with vesting of performance-based restricted stock units0.1 — — — — — — — — 
Shares withheld for payment of employees' withholding tax liability— — — — — (103.6)— — (103.6)
Share-based compensation— — — — — 73.7 — — 73.7 
Other comprehensive loss— — — — — — (82.4)— (82.4)
Net income— — — — — — — 293.1 293.1 
Balance at March 31, 202662.7 $ 4.0 $0.1 $0.5 $4,243.5 $(651.0)$939.2 $4,532.3 
Issuance of ordinary shares in conjunction with 2026 Notes1.9 — — — —  — —  
Issuance of ordinary shares in conjunction with exercise of share options0.1 — — — — 10.9 — — 10.9 
Issuance of ordinary shares under employee stock purchase plan0.1 — — — — 11.8 — — 11.8 
Shares withheld for payment of employees' withholding tax liability— — — — — (9.5)— — (9.5)
Share-based compensation— — — — — 74.9 — — 74.9 
Other comprehensive loss— — — — — — (11.5)— (11.5)
Net income— — — — — — — 192.8 192.8 
Balance at June 30, 202664.8 $ 4.0 $0.1 $0.5 $4,331.6 $(662.5)$1,132.0 $4,801.7 














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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(In millions)
(Unaudited)
Ordinary SharesNon-voting Euro DeferredCapital
Redemption
Reserve
Additional
Paid-in
Capital
Accumulated
Other
Comprehensive
Loss
Retained
Earnings
Total
Equity
SharesAmountSharesAmount
Balance at December 31, 202460.6 $ 4.0 $0.1 $0.5 $3,913.5 $(947.7)$1,127.3 $4,093.7 
Issuance of ordinary shares in conjunction with exercise of share options0.1 — — — — 11.5 — — 11.5 
Issuance of ordinary shares in conjunction with vesting of restricted stock units0.8 — — — — — — — — 
Issuance of ordinary shares in conjunction with vesting of performance-based restricted stock units0.1 — — — — — — — — 
Shares withheld for payment of employees' withholding tax liability— — — — — (67.2)— — (67.2)
Share-based compensation— — — — — 67.3 — — 67.3 
Other comprehensive income— — — — — — 162.0 — 162.0 
Net loss— — — — — — — (92.5)(92.5)
Balance at March 31, 202561.6 $ 4.0 $0.1 $0.5 $3,925.1 $(785.7)$1,034.8 $4,174.8 
Issuance of ordinary shares under employee stock purchase plan0.1 — — — — 10.5 — — 10.5 
Shares withheld for payment of employees' withholding tax liability— — — — — (2.2)— — (2.2)
Share-based compensation— — — — — 66.9 — — 66.9 
Shares repurchased(1.1)— — — — — — (125.0)(125.0)
Other comprehensive income— — — — — — 299.9 — 299.9 
Net loss— — — — — — — (718.5)(718.5)
Balance at June 30, 202560.6 $ 4.0 $0.1 $0.5 $4,000.3 $(485.8)$191.3 $3,706.4 



The accompanying notes are an integral part of these condensed consolidated financial statements.
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JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited) 
Six Months Ended
June 30,
20262025
Operating activities
Net income (loss)$485.9 $(811.0)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Intangible asset amortization342.3 316.5 
Share-based compensation147.8 132.2 
Acquired in-process research and development77.0 905.4 
Acquisition accounting inventory fair value step-up adjustment54.1 67.0 
Provision for losses on accounts receivable and inventory21.7 6.8 
Depreciation18.2 22.3 
Non-cash interest expense9.6 21.9 
Deferred tax benefit(104.9)(110.3)
Gain on sale of priority review voucher(122.8) 
Other non-cash transactions1.5 7.0 
Changes in assets and liabilities:
Accounts receivable(51.4)10.5 
Inventories(107.7)(61.9)
Prepaid expenses and other assets56.8 19.9 
Accounts payable7.1 6.5 
Accrued liabilities0.6 (75.4)
Income taxes payable(0.3)59.3 
Other liabilities(11.6)1.9 
Net cash provided by operating activities823.9 518.6 
Investing activities
Proceeds from maturity of investments1,240.0 780.0 
Proceeds from sale of priority review voucher200.0  
Payments related to sale of priority review voucher(77.2) 
Purchases of property, plant and equipment(37.8)(26.8)
Acquired in-process research and development(77.0) 
Acquisition of investments(770.0)(680.1)
Acquisition of intangible assets (25.0)
Asset acquisition, net of cash acquired (858.1)
Net cash provided by (used in) investing activities478.0 (810.0)
Financing activities
Repayment of 2026 Notes(1,000.0) 
Payment of employee withholding taxes related to share-based awards(113.1)(69.4)
Repayments of long-term debt(15.5)(765.5)
Proceeds from employee equity incentive and purchase plans55.6 22.0 
Share repurchases (125.0)
Net cash used in financing activities(1,073.0)(937.9)
Effect of exchange rates on cash and cash equivalents(1.0)6.3 
Net increase (decrease) in cash and cash equivalents227.9 (1,223.0)
Cash and cash equivalents, at beginning of period1,391.9 2,412.9 
Cash and cash equivalents, at end of period$1,619.8 $1,189.9 

The accompanying notes are an integral part of these condensed consolidated financial statements.
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JAZZ PHARMACEUTICALS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)

1. 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 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.
Throughout this Quarterly Report on Form 10-Q, unless otherwise indicated or the context otherwise requires, all references to “Jazz Pharmaceuticals plc,” “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 SEC 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, 2025.
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 six months ended June 30, 2026, are not necessarily indicative of the results to be expected for the year ending December 31, 2026, 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, 2025.
These condensed consolidated financial statements include the accounts of Jazz Pharmaceuticals plc and our subsidiaries. Intercompany transactions and balances have been eliminated.
Commencing in 2026, we changed the presentation of our financial statements and accompanying footnote disclosures from thousands to millions. This change did not materially impact previously reported financial information; however, certain prior period amounts have insignificant differences due to rounding.
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 in one business segment, which is the identification, development and commercialization of meaningful pharmaceutical products that address unmet medical needs. The CODM assesses segment performance and decides how to allocate resources for the segment based on net income (loss) and a measure of segment assets which are 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 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. ASU 2024-04 was effective for the Company from January 1, 2026, and is effective on a prospective basis. The adoption did not have a material impact on our consolidated financial statements.
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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 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. The standard is effective for annual periods beginning after December 15, 2027, and interim periods within those annual periods. We are currently evaluating the impact of adopting this new accounting guidance.

2. Collaboration and License Agreement, Asset Purchase Agreement and Disposition
Collaboration and License Agreement
In June 2026, we entered into a preclinical research collaboration and license agreement with AbCellera, granting us rights to opt into exclusive, worldwide rights to develop and commercialize two initial next-generation T-cell engaging multispecific antibody programs. In addition, we may mutually agree to initiate up to three additional discovery programs, with a commitment to start one discovery program within 12 months.
Under the terms of the agreement, we made an upfront payment of $56.0 million for the first two research programs, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the three and six months ended June 30, 2026. An additional $28.0 million is due upon initiation of the third program. Should we exercise our option for development, AbCellera is eligible to receive up to $792.0 million per program in option fees, development, regulatory, and commercial sales milestone payments along with tiered royalties on net sales ranging from mid-single digits to low double-digits.
Asset Purchase Agreement
In May 2026, we entered into an asset purchase agreement with Werewolf, under which we acquired all remaining rights to JZP898, a differentiated, conditionally-activated IFNα INDUKINE™ molecule. At closing, the original license and collaboration agreement entered into with Werewolf in May 2022 was terminated.
Under the terms of the agreement, we made an upfront payment of $21.0 million, which was recorded as acquired IPR&D expense in our consolidated statements of income (loss) for the three and six months ended June 30, 2026. Werewolf is eligible to receive a contingent milestone payment of $2.0 million upon consent to the partial assignment of a license agreement relating to the JZP898 program.
Gain on sale of PRV
In January 2026, we completed the sale of our rare pediatric disease PRV for total cash consideration of $200.0 million. We received 50% of the post-tax proceeds with the remainder paid to the former stockholders of Oncoceutics, Inc., which was acquired by Chimerix in 2021. We received the PRV in connection with the approval of Modeyso by FDA for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation in August 2025.
Upon closing, we recognized a pre-tax gain on disposal of $122.8 million in our consolidated statements of income (loss) in the six months ended June 30, 2026, representing the total cash consideration received of $200.0 million, less the post-tax proceeds paid to the former stockholders of Oncoceutics, Inc.

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3. Cash and Available-for-Sale Securities
Cash, cash equivalents and investments consisted of the following (in millions): 
June 30, 2026
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Cash and
Cash
Equivalents
Investments
Cash$703.0 $— $— $703.0 $703.0 $ 
Time deposits580.0   580.0  580.0 
Money market funds916.8   916.8 916.8  
Totals$2,199.8 $ $ $2,199.8 $1,619.8 $580.0 
December 31, 2025
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Cash and
Cash
Equivalents
Investments
Cash$682.7 $— $— $682.7 $682.7 $ 
Time deposits1,130.0   1,130.0 80.0 1,050.0 
Money market funds629.2   629.2 629.2  
Totals$2,441.9 $ $ $2,441.9 $1,391.9 $1,050.0 
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 $25.3 million and $48.7 million in the three and six months ended June 30, 2026, respectively, and $19.1 million and $46.8 million in the three and six months ended June 30, 2025, respectively.

4. Fair Value Measurement
The following table summarizes, by major security type, our available-for-sale securities and derivative contracts as of June 30, 2026 and December 31, 2025, that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in millions): 
June 30, 2026December 31, 2025
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Total
Estimated
Fair Value
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Total
Estimated
Fair Value
Assets:
Available-for-sale securities:
Money market funds$916.8 $ $916.8 $629.2 $ $629.2 
Time deposits 580.0 580.0  1,130.0 1,130.0 
Foreign exchange forward contracts 1.9 1.9  6.3 6.3 
Totals$916.8 $581.9 $1,498.7 $629.2 $1,136.3 $1,765.5 
Liabilities:
Foreign exchange forward contracts$ $8.6 $8.6 $ $3.7 $3.7 
Interest rate contracts    0.5 0.5 
Totals$ $8.6 $8.6 $ $4.2 $4.2 
As of June 30, 2026 and December 31, 2025, 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.
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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 2026 or 2025.
As of June 30, 2026 and December 31, 2025, 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 June 30, 2026, the estimated fair values of the Secured Notes, the 2030 Notes and the Tranche B-2 Dollar Term Loans were $1.5 billion, $1.7 billion and $1.9 billion, respectively. As of December 31, 2025, the estimated fair values of the 2026 Notes, the 2030 Notes, the Secured Notes and the Tranche B-2 Dollar Term Loans were $1.2 billion, $1.3 billion, $1.5 billion and $1.9 billion, respectively. The fair value of each of these debt facilities was estimated using quoted market prices obtained from brokers (Level 2).

5. 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 June 30, 2026 and December 31, 2025, the notional amounts of foreign exchange contracts for which hedge accounting was not applied were $613.0 million and $575.9 million, respectively.
The foreign exchange gain (loss) in our condensed consolidated statements of income (loss) included the following gains (losses) associated with foreign exchange contracts not designated as hedging instruments (in millions):
Three Months Ended
June 30,
Six Months Ended
June 30,
Foreign Exchange Forward Contracts:2026202520262025
Gain (loss) recognized in foreign exchange gain (loss)$(1.1)$12.4 $(9.6)$21.0 

The following tables summarize the fair value of outstanding derivatives (in millions):
ClassificationJune 30,
2026
December 31,
2025
Assets
Derivatives not designated as hedging instruments:
Foreign exchange forward contractsOther current assets$1.9 $6.3 
Total fair value of derivative asset instruments$1.9 $6.3 
Liabilities
Derivatives not designated as hedging instruments:
Foreign exchange forward contractsAccrued liabilities$8.6 $3.7 
Derivatives designated as hedging instruments:
Interest rate contractsAccrued liabilities 0.5 
Total fair value of derivative liability instruments$8.6 $4.2 
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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 tables summarize the potential effect on our condensed consolidated balance sheets of offsetting our interest rate and foreign exchange forward contracts subject to such provisions (in millions):
June 30, 2026
Gross Amounts of Recognized Assets/ LiabilitiesGross Amounts Offset in the Consolidated Balance SheetNet Amounts of Assets/ Liabilities Presented in the Consolidated Balance SheetGross Amounts Not Offset in the Consolidated Balance Sheet
DescriptionDerivative Financial InstrumentsCash Collateral Received (Pledged)Net Amount
Derivative assets$1.9 $ $1.9 $(1.9)$ $ 
Derivative liabilities(8.6) (8.6)1.9  (6.7)
December 31, 2025
Gross Amounts of Recognized Assets/ LiabilitiesGross Amounts Offset in the Consolidated Balance SheetNet Amounts of Assets/ Liabilities Presented in the Consolidated Balance SheetGross Amounts Not Offset in the Consolidated Balance Sheet
DescriptionDerivative Financial InstrumentsCash Collateral Received (Pledged)Net Amount
Derivative assets$6.3 $ $6.3 $(4.0)$ $2.3 
Derivative liabilities(4.2) (4.2)4.0  (0.2)

6. Inventories
Inventories consisted of the following (in millions): 
June 30,
2026
December 31,
2025
Raw materials$35.5 $22.0 
Work in process297.4 253.4 
Finished goods110.1 141.6 
Total inventories$443.0 $417.0 
As of December 31, 2025, inventories included $54.1 million related to the purchase accounting inventory fair value step-up on inventory acquired as part of our GW Acquisition. During the six months ended June 30, 2026, this fair value step-up was fully recognized in cost of product sales, and no related balance remained in inventory as of June 30, 2026.

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7. Goodwill and Intangible Assets
The gross carrying amount of goodwill was as follows (in millions):
Balance at December 31, 2025$1,829.3 
Foreign exchange(29.5)
Balance at June 30, 2026$1,799.8 
The gross carrying amounts and net book values of our intangible assets were as follows (in millions): 
June 30, 2026December 31, 2025
Remaining
Weighted-
Average Useful
Life
(In years)
Gross
Carrying
Amount
Accumulated
Amortization
Net Book
Value
Gross
Carrying
Amount
Accumulated
Amortization
Net Book
Value
Acquired developed technologies6.3$8,075.2 $(4,045.7)$4,029.5 $8,194.6 $(3,765.1)$4,429.5 
Trademarks2.9 (2.9) 2.9 (2.9) 
Manufacturing contracts   12.6 (12.6) 
Total finite-lived intangible assets$8,078.1 $(4,048.6)$4,029.5 $8,210.1 $(3,780.6)$4,429.5 
The decrease in the gross carrying amount of intangible assets as of June 30, 2026, compared to December 31, 2025, primarily relates to the negative impact of foreign currency translation adjustments primarily due to the weakening 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 June 30, 2026, 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 millions): 
Year Ending December 31,Estimated Amortization Expense
2026 (remainder)$336.2 
2027664.0 
2028640.1 
2029637.9 
2030577.8 
Thereafter1,173.5 
Total$4,029.5 

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8. Certain Balance Sheet Items
Property, plant and equipment consisted of the following (in millions):
June 30,
2026
December 31,
2025
Manufacturing equipment and machinery$95.7 $97.4 
Land and buildings71.8 72.2 
Construction-in-progress70.5 49.6 
Leasehold improvements65.6 63.6 
Computer software64.1 63.7 
Computer equipment24.2 21.9 
Furniture and fixtures10.6 10.0 
Subtotal402.5 378.4 
Less accumulated depreciation and amortization(190.5)(178.5)
Property, plant and equipment, net$212.0 $199.9 
Accrued liabilities consisted of the following (in millions):
June 30,
2026
December 31,
2025
Rebates and other sales deductions$528.0 $459.8 
Employee compensation and benefits120.3 215.4 
Inventory-related accruals63.2 34.0 
Accrued royalties44.6 47.1 
Accrued interest39.8 40.7 
Consulting and professional services32.1 23.0 
Sales return reserve28.7 26.4 
Clinical trial accruals28.1 42.0 
Selling and marketing accruals24.9 15.4 
Accrued development expenses16.4 24.4 
Current portion of lease liabilities14.3 14.7 
Accrued construction-in-progress9.9 14.3 
Derivative instrument liabilities8.6 4.2 
Other71.1 72.8 
Total accrued liabilities$1,030.0 $1,034.2 

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9. Debt
The following table summarizes the carrying amount of our indebtedness (in millions):
June 30,
2026
December 31,
2025
2026 Notes $ $1,000.0 
Unamortized - debt issuance costs (1.1)
2026 Notes, net 998.9 
2030 Notes1,000.0 1,000.0 
Unamortized - debt issuance costs(14.6)(16.0)
2030 Notes, net985.4 984.0 
Secured Notes 1,489.0 1,487.5 
Term Loan1,877.0 1,887.9 
Total debt4,351.4 5,358.3 
Less current portion (1)
1,016.4 1,029.9 
Total long-term debt$3,335.0 $4,328.4 
________________________
(1) Balance as of June 30, 2026 includes the 2030 Notes since the share price condition was met during the quarter ended June 30, 2026. Balance as of December 31, 2025 included the 2026 Notes since they matured in June 2026.
2030 Notes
The 2030 Notes were issued by Jazz Investments, or the Issuer, a 100%-owned finance subsidiary of Jazz Pharmaceuticals plc. The 2030 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 2030 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.
The total liability of the 2030 Notes 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 June 30, 2026 and 2025, we recognized interest expense of $8.5 million, of which $7.8 million related to the contractual coupon rate and $0.7 million related to the amortization of debt issuance costs. During the six months ended June 30, 2026 and 2025, we recognized interest expense of $17.0 million, of which $15.6 million related to the contractual coupon rate and $1.4 million related to the amortization of debt issuance costs.
Prior to June 15, 2030, the 2030 Notes will be exchangeable only upon satisfaction of certain conditions, including a condition tied to our share price that is measured as of the end of each quarter, and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.

During the quarter ended June 30, 2026, the closing price of our ordinary shares exceeded 130% of the conversion price (approximately $153.05) of the 2030 Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the share price condition was met and the 2030 Notes are exchangeable at the option of the holders during the quarter ended September 30, 2026. Accordingly, the carrying value of the 2030 Notes has been included in current liabilities in our condensed consolidated balance sheet as of June 30, 2026. As of the date of this filing, none of the 2030 Notes have been exchanged by the holders.
2026 Notes
On June 15, 2026, the maturity date for the 2026 Notes, we repaid the $1.0 billion aggregate principal amount and accrued and unpaid interest thereon and issued 1,890,193 ordinary shares representing the conversion premium. During the
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three months ended June 30, 2026, we recognized interest expense of $4.7 million, of which $4.2 million related to the contractual coupon rate and $0.5 million related to the amortization of debt issuance costs. During the three months ended June 30, 2025, we recognized interest expense of $5.6 million, of which $5.0 million related to the contractual coupon rate and $0.6 million related to the amortization of debt issuance costs. During the six months ended June 30, 2026, we recognized interest expense of $10.3 million, of which $9.2 million related to the contractual coupon rate and $1.1 million related to the amortization of debt issuance costs. During the six months ended June 30, 2025, we recognized interest expense of $11.1 million, of which $10.0 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 June 30, 2026, were as follows (in millions):
Year Ending December 31,Scheduled Long-Term Debt Maturities
2026 (remainder)$15.5 
202731.0 
20281,848.5 
20291,500.0 
20301,000.0 
Total$4,395.0 

10. 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 June 30, 2026 and December 31, 2025. 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:
Patent Infringement Litigation
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 to ten 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.
On July 28, 2021, we filed a patent infringement suit against Lupin in the U.S. District Court for the District of New Jersey. The complaint alleges that by filing its ANDA, Lupin has infringed ten 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.
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In June 2021, FDA recognized seven years of Orphan Drug Exclusivity for Xywav through July 21, 2027. In October 2021, Lupin filed an answer to the ANDA complaint and asserted counterclaims 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 U.S. 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. In June 2022, the U.S. District Court for the District of New Jersey consolidated the two 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 U.S. 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 the two patents in suit. In February 2023, the U.S. District Court for the District of New Jersey consolidated the new lawsuit with the two suits we previously filed 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 to thirteen 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.
On March 21, 2023, we filed a patent infringement suit against Teva in the U.S. 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. In May 2023, Teva filed an answer to the complaint and asserted counterclaims that the patents are invalid or not enforceable, and that its product, if approved, will not infringe our patents.
In December 2023, based on a stipulation between all parties, the U.S. District Court for the District of New Jersey 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 U.S. 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 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 to fourteen 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.
On August 13, 2025, we filed a patent infringement suit against Granules in the U.S. District Court for the District of New Jersey. In March 2026, we entered into a settlement agreement with Granules that resolved our patent litigation with Granules related to Xywav. Under the settlement agreement, we granted a license to certain of the patents listed in the Orange Book for Xywav that could, under certain circumstances, allow Granules to launch its generic version of Xywav prior to the expiration of the licensed patents. The specific terms of the Granules settlement agreement are confidential.
The settlement with Granules does not resolve the litigation against Lupin or Teva, which is ongoing. We cannot predict the specific timing or outcome of events in these matters with respect to the remaining defendants or the impact of developments involving any specific parties or patents on other ongoing proceedings with Lupin or Teva.
Zepzelca Patent Litigation
In July and August 2024, and in May 2026, 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 one or more patents listed in the Orange Book for Zepzelca on the date of the receipt of the notice. The listed patents relate to the drug substance, drug product and approved use of Zepzelca. We are 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.
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On September 11, 2024, we and PharmaMar filed the first patent infringement suit against certain of the Zepzelca ANDA Filers in the U.S. 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. As a result of this lawsuit FDA approval of each Zepzelca ANDA Filer's ANDA became subject to a statutory stay of approval under the Hatch-Waxman Act of up to seven and a half years from the date of initial FDA approval of Zepzelca.
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.
In March 2025, we and Sandoz Inc. stipulated to the dismissal of our lawsuit against Sandoz Inc. without prejudice.
On September 12, 2024, we and PharmaMar filed a patent infringement suit against RK Pharma, in the U.S. 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. In November 2024, we voluntarily dismissed this action against RK Pharma in the U.S. District Court for the District of Delaware. RK Pharma remains a defendant in the litigation referenced above in the U.S. District Court for the District of New Jersey.
In July 2025, we received notice from InvaGen 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 and PharmaMar filed a second lawsuit in the U.S. District Court for the District of New Jersey against certain 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. In November 2025, we and PharmaMar amended the complaint to assert two additional patents listed in the Orange Book for Zepzelca against the defendants. The asserted patents 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 asserted patents. In March 2026, the U.S. District Court for the District of New Jersey consolidated the first and second actions for all purposes.
In May 2026, we received notice from Qilu that it had filed an ANDA for a generic version of Zepzelca with a paragraph IV certification to one or more of the patents listed in the Orange Book for Zepzelca. On June 26, 2026, we and PharmaMar filed a lawsuit in the U.S. District Court for the District of New Jersey, alleging that, by filing its ANDA, Qilu infringed certain patents listed in the Orange Book for Zepzelca. The asserted patents relate to a method of treatment using Zepzelca. The suit seeks an order that the effective date of FDA approval for Qilu’s ANDA shall be no earlier than the expiration of the asserted patents. As a result of this lawsuit, FDA approval of Qilu's ANDA became subject to a statutory stay of up to 30 months under the Hatch-Waxman Act.
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 U.S. 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, FDA approval of Almaject's ANDA became subject to a statutory stay of up to 30 months under the Hatch-Waxman Act.
In March 2026, we filed a second patent infringement lawsuit against Almaject in the U.S. District Court for the District of New Jersey based on two additional patents listed in the Orange Book for Defitelio. The patents relate generally to the Defitelio drug product. The complaint alleges that by filing its ANDA, Almaject has infringed the 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.
Tris Pharma Patent Litigation
In January 2026, we received notices from Tris Pharma that it had filed with FDA a Section 505(b)(2) NDA with Xyrem and Xywav as reference listed drugs. The first notice included a paragraph IV certification with respect to seven patents listed in FDA’s Orange Book for Xyrem, and the second notice included a paragraph IV certification with respect to fifteen patents listed in FDA’s Orange Book for Xywav on the date of our receipt of the notice. Seven of the listed patents relate generally to methods of treatment when Xywav or Xyrem is administered concomitantly with certain other medications, and the remaining eight relate generally to the composition and method of use of Xywav.
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On February 20, 2026, we filed two patent infringement suits against Tris Pharma in the U.S. District Court for the District of New Jersey. The complaints allege that by filing its Section 505(b)(2) NDA, Tris Pharma infringed certain of our patents listed in FDA’s Orange Book for Xyrem and certain of our patents listed in FDA’s Orange Book for Xywav, respectively. Each lawsuit seeks an order that the effective date of FDA approval of Tris Pharma’s Section 505(b)(2) NDA shall be a date no earlier than the expiration of the last to expire of the asserted patents. As a result of this lawsuit, FDA approval of Tris Pharma's Section 505(b)(2) NDA became subject to a statutory stay of up to 30 months under the Hatch-Waxman Act. In April 2026, Tris Pharma filed motions to dismiss the complaints. In July 2026, the U.S. District Court for the District of New Jersey denied the motions and subsequently, Tris Pharma filed answers and counterclaims alleging that the asserted patents are invalid and not infringed.
Qui Tam Matters
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. In July 2024, the U.S. District Court for the District of Massachusetts unsealed a qui tam whistleblower lawsuit underlying the USAO’s subpoena. The public docket in this matter indicates that on May 24 and June 7, 2024, respectively, the U.S. and a number of states named in the whistleblower complaint declined to intervene in this matter. Private whistleblower litigation then proceeded in the U.S. District Court for the District of Massachusetts. On September 23, 2025, the U.S. District Court for the District of Massachusetts granted our motion and dismissed the plaintiff’s federal claims with prejudice and state-law claims without prejudice.
On January 23, 2026, the U.S. District Court for the Southern District of New York unsealed a lawsuit filed by a qui tam whistleblower against us under the New York state False Claims Act. The docket reflects that the New York Attorney General declined to participate in the litigation. This lawsuit repeats almost verbatim allegations asserted by this same whistleblower against us in the case that was dismissed in September 2025, by the U.S. District Court for the District of Massachusetts. In May 2026, the plaintiff amended its complaint. In July 2026, we moved to dismiss the amended complaint with prejudice. The motion remains pending and no hearing date has been set. We will continue to vigorously defend against these claims.
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.

11. Shareholders’ Equity
Share Repurchase Program
In July 2024, our board of directors authorized the Repurchase Program, to repurchase ordinary shares having an aggregate purchase price of $500.0 million, exclusive of any brokerage commissions. The Repurchase Program, which has no expiration date, allows us to 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 Repurchase Program may be modified, suspended or discontinued at any time without our prior notice. During the three and six months ended June 30, 2026, no shares were repurchased. During the three and six months ended June 30, 2025, we spent a total of $125.0 million to repurchase 1.1 million of our ordinary shares under the Repurchase Program at a purchase price, including commissions, of $109.52 per share. As of June 30, 2026, the remaining amount authorized for repurchases under the Repurchase Program was $225.0 million, exclusive of any brokerage commissions.
Accumulated Other Comprehensive Loss
As of June 30, 2026 and December 31, 2025, accumulated other comprehensive loss was $662.5 million and $568.6 million, respectively, and primarily related to cumulative foreign currency translation adjustments.
During the six months ended June 30, 2026, other comprehensive income (loss) primarily reflected the negative impact of foreign currency translation adjustments, primarily due to the weakening of sterling against the U.S. dollar.

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12. 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 millions, except per share amounts):
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
Numerator:
Net income (loss)$192.8 $(718.5)$485.9 $(811.0)
Denominator:
Weighted-average ordinary shares used in per share calculations - basic63.2 61.2 62.5 61.1 
Dilutive effect of the Exchangeable Senior Notes3.5  2.5  
Dilutive effect of employee equity incentive and purchase plans2.7  2.8  
Weighted-average ordinary shares used in per share calculations - diluted69.4 61.2 67.8 61.1 
Net income (loss) per ordinary share:
Basic $3.05 $(11.74)$7.77 $(13.28)
Diluted$2.78 $(11.74)$7.17 $(13.28)
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.
On June 15, 2026, the maturity date of the 2026 Notes, we repaid $1.0 billion aggregate principal amount in cash and issued 1,890,193 ordinary shares representing the conversion premium. For the period the 2026 Notes were outstanding, the dilutive effect of the 2026 Notes was included in the calculation of diluted net income per share for the three and six months ended June 30, 2026, when the average market price of our ordinary shares in that period exceeded the conversion price, of approximately $155.81 per ordinary share. The average market price of our ordinary shares for the three and six months ended June 30, 2025, did not exceed the conversion price of the 2026 Notes.
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 six months ended June 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 millions):
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
Employee equity incentive and purchase plans0.1 6.8 0.4 5.3 

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13. Revenues
The following table presents a summary of total revenues (in millions): 
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
Xywav$471.2 $415.3 $879.4 $760.1 
Xyrem30.5 35.4 61.7 72.6 
Sleep501.7 450.7 941.1 832.7 
Epidiolex/Epidyolex292.1 251.7 541.9 469.4 
Epilepsy292.1 251.7 541.9 469.4 
Zepzelca105.8 74.5 206.8 137.5 
Rylaze/Enrylaze99.5 100.7 203.2 194.9 
Defitelio/defibrotide 62.0 48.1 109.4 88.8 
Modeyso48.2 0.5 89.6 0.5 
Vyxeos31.4 44.9 58.0 74.4 
Ziihera15.4 6.0 28.7 8.0 
Oncology362.3 274.7 695.7 504.1 
Other1
 8.5 2.7 18.8 
Product sales, net1,156.1 985.6 2,181.4 1,825.0 
High-sodium oxybate AG royalty revenue42.2 54.1 78.5 103.0 
Other royalty and contract revenues10.0 6.0 17.3 15.5 
Total revenues$1,208.3 $1,045.7 $2,277.2 $1,943.5 
____________________________
(1) Includes Sativex net product sales for the three and six months ended June 30, 2025.
The following table presents a summary of total revenues attributed to geographic sources (in millions): 
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
U.S.$1,077.9 $936.3 $2,037.7 $1,734.8 
Europe97.4 82.7 189.8 165.7 
All other33.0 26.7 49.7 43.0 
Total revenues$1,208.3 $1,045.7 $2,277.2 $1,943.5 
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 Ended
June 30,
Six Months Ended
June 30,
2026202520262025
ESSDS41 %43 %41 %42 %
McKesson11 %10 %11 %11 %
ASD10 %11 %11 %11 %
The percentage of trade receivables by customers who individually accounted for 10% or more of our trade receivables were as follows: 
June 30,
2026
December 31,
2025
ESSDS41 %41 %
ASD15 %16 %
McKesson13 %11 %
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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.

14. Share-Based Compensation
Share-based compensation expense was as follows (in millions): 
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
Selling, general and administrative$46.0 $41.0 $90.2 $82.7 
Research and development22.6 20.6 46.3 41.6 
Cost of product sales4.7 2.9 11.3 7.9 
Total share-based compensation expense, pre-tax73.3 64.5 147.8 132.2 
Income tax benefit from share-based compensation expense(19.0)(12.3)(48.8)(21.9)
Total share-based compensation expense, net of tax$54.3 $52.2 $99.0 $110.3 

15. Income Taxes
Our income tax expense was $18.1 million and $24.2 million for the three and six months ended June 30, 2026, compared to an income tax benefit of $17.2 million and $35.0 million for the three and six months ended June 30, 2025, relating 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 deduction eligible income benefits and tax credits. The income tax expense for the six months ended June 30, 2026, also included tax arising on the gain on sale of the PRV, partially offset by excess tax benefits from share-based compensation. The income tax benefit for the six months ended June 30, 2025, was primarily due to the tax impact of certain Xyrem antitrust litigation settlements.
Our net deferred tax asset comprises of 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.
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 2021. 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 2021 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 to 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 top-up taxes 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 expense for the six months ended June 30, 2026, included 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.

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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.
ProductIndicationsInitial Approval DateMarkets
Xywav® (calcium, magnesium, potassium, and sodium oxybates)Treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy.July 2020U.S.
Treatment of IH in adults.August 2021U.S.
Treatment of cataplexy in patients with narcolepsy.May 2023Canada
Epidiolex® (cannabidiol)Treatment of seizures associated with LGS, DS, or TSC in patients 1 year of age and older.June 2018 and July 2020U.S.
Adjunctive therapy of seizures associated with LGS, DS, or TSC in patients 1 year of age and older.April and October 2021Israel
For adjunctive therapy of seizures associated with LGS, DS or TSC for patients 2 years of age and older.November 2023Canada
Epidyolex® (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 2019EU, U.K., Switzerland, Australia, and other markets
For adjunctive therapy of seizures associated with TSC for patients 2 years of age and older.April 2021EU, U.K., Switzerland, and other markets
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Ziihera® (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 therapyFebruary 2026
U.K. (licensed from Zymeworks)5
Modeyso™ (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® (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 2025U.S. (licensed from PharmaMar)
Rylaze® (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 2021U.S.
Rylaze® (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 2022Canada
Enrylaze® (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 2023EU, U.K., Switzerland, other markets
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
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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 treatment of seizures associated with two rare and severe forms of epilepsy, LGS and DS, in patients two years of age and older, and subsequently approved in July 2020 for the treatment of seizures associated with TSC in patients one year of age and older. FDA also approved the expansion of the other indications, LGS and DS, to patients one year of age and older. In September 2019, the EC granted marketing authorization under the trade name Epidyolex for use as adjunctive therapy of seizures associated with LGS or DS, in conjunction with clobazam, for patients two years of age and older. The clobazam restriction is limited to the EU and U.K. Epidyolex was also approved for adjunctive therapy of seizures associated with TSC for patients 2 years of age and older in the EU in April 2021 and U.K. in August 2021, and is approved for this indication in other markets. Since January 1, 2025, the approval in U.K. has been extended automatically to cover Northern Ireland (under the agreed Windsor Framework). Epidyolex is now launched and reimbursed in more than 40 countries.
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Following the top-line readout of the Phase 3 trial for Epidyolex for LGS, DS and TSC patients in Japan in August 2024, we continue to generate data from the trial and work with Japanese regulatory authorities. In April 2026, we entered into an agreement with Nippon Zoki to bring Epidyolex to appropriate patients with high unmet needs in Japan. Nippon Zoki will be responsible for importation, secondary packaging, regulatory activities and commercialization, following the completion of the ongoing clinical trial and potential regulatory approval.
Rare Oncology
Ziihera
We acquired exclusive development and commercialization rights to Ziihera in 2022 through an exclusive licensing and collaboration agreement with a subsidiary of Zymeworks providing development and commercialization rights to zanidatamab across all indications in the U.S., Europe, Japan and all other territories except for those Asia/Pacific territories previously licensed by Zymeworks. The term of the license agreement extends on a licensed product-by-licensed product and country-by-country basis until the expiration of the royalty term for such licensed product in such country. We have the right to terminate the amended license agreement at will upon a specified notice period, and either party can terminate the amended license agreement for the other party’s uncured material breach or bankruptcy.
Ziihera is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. In the U.S., Ziihera was granted accelerated approval by FDA in November 2024 and is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC3+) BTC, as detected by an FDA-approved test. Ziihera was launched in December 2024. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 HERIZON-BTC-302 confirmatory trial. 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. In January 2026, Ziihera obtained conditional approval in Canada for the treatment of adults with previously treated, unresectable locally advanced or metastatic HER2-positive (IHC3+) BTC, as monotherapy. In February 2026, MHRA granted conditional marketing authorization in the U.K. for Ziihera as monotherapy 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, and NICE recommended reimbursement of Ziihera.
An sBLA of Ziihera for first-line treatment of HER2-positive locally advanced or metastatic GEA, including cancers of the stomach, gastroesophageal junction and esophagus, in combination with chemotherapy, with or without tislelizumab, was accepted and granted Priority Review by FDA with a PDUFA target action date of August 25, 2026. The application has received BTD by FDA and is being reviewed under FDA’s RTOR program, which is designed to provide a more efficient review process. The sBLA filing was also chosen for Project Orbis, an FDA initiative that can facilitate approvals in participating countries around the globe. Through Project Orbis, we completed applications of Ziihera for the same indication to MHRA and Health Canada. The Phase 3 data supporting the sBLA demonstrated statistically significant and clinically meaningful prolongation of progression-free survival in both investigational arms versus the trastuzumab control arm. Ziihera plus tislelizumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival benefit with a median overall survival of 26.4 months, representing a 28% reduction in the risk of death versus the trastuzumab control arm.
Modeyso
We completed the Chimerix Acquisition in April 2025 for a total cash consideration of $944.2 million, adding Modeyso, a protease activator of the ClpP that also inhibits DRD2, to our oncology portfolio. In August 2025, Modeyso was granted accelerated approval by FDA 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. Modeyso is the first and only treatment option approved by FDA for this ultra-rare and aggressive brain tumor. In connection with the approval by FDA of Modeyso in August 2025, we received a rare pediatric disease PRV, which we sold in January 2026 for total cash consideration of $200.0 million of which 50% is attributable to us.
Zepzelca
We acquired U.S. development and commercialization rights to Zepzelca in early 2020, and launched with an indication for treatment of patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. Zepzelca was rapidly adopted for the treatment of metastatic second-line SCLC. While we continue to market Zepzelca across academic and community centers, Zepzelca faces competition in the second-line setting from new agents.
Given SCLC is an aggressive cancer and patients rapidly progress after induction chemotherapy, we conducted the Phase 3 IMforte trial to evaluate Zepzelca and atezolizumab in combination in the first-line maintenance setting.
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In October 2024, we announced positive top-line results from the Phase 3 IMforte trial showing a statistically significant and clinically meaningful progression-free survival and overall survival benefit. In October 2025, FDA approved Zepzelca in combination with atezolizumab as a maintenance treatment for adults with extensive-stage SCLC whose disease has not progressed after first-line induction therapy with atezolizumab, or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. Our promotional efforts are wholly focused on educating SCLC-treating physicians on the first-line maintenance setting as utilization is expected to shift from second-line use to the first-line.
Based on the results from the LAGOON trial of Zepzelca in second-line metastatic SCLC, which were reported in June 2026, and in alignment with FDA, in the third quarter of 2026, we will submit for FDA's review and subsequent action a labeling supplement to remove the second-line indication. The first-line maintenance indication will not be affected.
Rylaze
Rylaze was approved by FDA in June 2021, and was launched in the U.S. in July 2021, for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with ALL and LBL, in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze is the only recombinant erwinia asparaginase manufactured product approved in the U.S. that maintains a clinically meaningful level of asparaginase activity throughout the entire course of treatment. We developed Rylaze to address the needs of patients and health care providers for an innovative, high-quality erwinia asparaginase with reliable supply. The initial approved recommended dosage of Rylaze was for an IM administration of 25 mg/m2 every 48 hours. In November 2022, FDA approved an sBLA, for a Monday/Wednesday/Friday 25/25/50 mg/m2 IM dosing schedule. In September 2023, the EC granted marketing authorization for JZP458 (Rylaze) under the trade name Enrylaze®. Enrylaze may be given by both IV and IM and is dosed on either alternate days (every 48 hours) or via a Monday/Wednesday/Friday dosing schedule. Enrylaze was approved in U.K. in January 2024 (as of January 1, 2025, this approval extends to Northern Ireland), and is also approved in Canada, Switzerland and Australia.
Research and Development Progress
Our R&D activities encompass all stages of development and currently include clinical testing of new product candidates and activities related to clinical improvements of, or additional indications or new clinical data for, our existing marketed products. We also have active preclinical and early-stage programs for novel therapies that further our rare disease strategy and leverage the strong R&D capabilities we have built. We are increasingly leveraging our internal R&D function, and we have entered into collaborations with third parties for the R&D of innovative early-stage product candidates and have supported additional investigator-sponsored trials that are anticipated to generate further data related to our products. We also seek out investment opportunities in support of the development of early- and mid-stage technologies in areas where we have deep expertise with a focus on validated targets and mechanisms. We have a number of licensing and collaboration agreements with third parties, including biotechnology companies, academic institutions and research-based companies and institutions, related to preclinical and clinical R&D activities.
Within our oncology R&D program, in October 2022, we announced an exclusive licensing and collaboration agreement with Zymeworks providing us development and commercialization rights to Zymeworks' zanidatamab across all indications in the U.S., Europe, Japan and all other territories except for those Asia/Pacific territories previously licensed by Zymeworks. In December 2022, we exercised the option to continue with the exclusive development and commercialization rights to zanidatamab. Under the terms of the agreement, Zymeworks received an upfront payment of $50.0 million, and following the exercise of our option to continue the collaboration, a second, one-time payment of $325.0 million. Zymeworks is also eligible to receive regulatory and commercial milestone payments of up to $1.4 billion, for total potential payments of $1.76 billion. Zymeworks is eligible to receive tiered royalties between 10% and 20% on our net sales. Zanidatamab is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2.
Following positive data from a pivotal Phase 2 clinical trial evaluating zanidatamab monotherapy in patients with previously treated advanced or metastatic HER2-amplified BTC, we completed a BLA submission in second-line BTC in March 2024. In May 2024, FDA granted priority review of the BLA and we subsequently received FDA accelerated approval in November 2024.
In November 2025, we announced positive top-line results from the pivotal Phase 3 HERIZON-GEA-01 trial of zanidatamab in combination with chemotherapy, with or without tislelizumab, as first-line treatment for adults with HER2-positive locally advanced or metastatic GEA. In January 2026, we presented late-breaking results from the trial at ASCO GI. The investigational arm containing zanidatamab plus tislelizumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival benefit of more than two years of median overall survival. The greater than seven-month improvement in median overall survival represents a 28% reduction in the risk of death versus the control arm. Both investigational arms led to a statistically significant and clinically meaningful median progression-free survival of more than one year, representing a greater than four-month improvement and 35% reduction in the risk of disease progression or death versus the control arm. The results from the trial were published in The New England Journal of Medicine. Our sBLA based on these results is currently under Priority Review with FDA and has a PDUFA date of August 25, 2026.
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Zanidatamab is currently being evaluated in multiple clinical trials as a treatment for patients with HER2-expressing cancers: a Phase 2 DiscovHER-Pan-206 trial evaluating zanidatamab monotherapy in previously-treated patients with various HER2-positive (IHC3+) cancers, a Phase 2 EmpowHER-BC-208 trial to evaluate zanidatamab in patients with HER2-positive neoadjuvant and adjuvant breast cancer, a Phase 3 trial EmpowHER-BC-303 to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous T-DXd treatment, and a Phase 3 confirmatory trial examining zanidatamab in first-line patients with HER2-positive BTC. FDA recently granted BTD for the treatment of zanidatamab in adults with previously treated, locally advanced, unresectable, or metastatic HER2-positive CRC.
Our development plan for Zepzelca included the Phase 3 IMforte trial, which showed a statistically significant and clinically meaningful progression-free survival and overall survival benefit for Zepzelca and atezolizumab in combination in the first-line maintenance setting. In October 2025, we received FDA approval for the combination as a 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.
In addition, our partner PharmaMar, conducted the Phase 3 LAGOON confirmatory trial evaluating Zepzelca in patients with second-line metastatic SCLC. In June 2026, we announced top-line results from the LAGOON trial, which did not meet its primary OS endpoint evaluating Zepzelca as monotherapy or in combination with irinotecan compared with investigators' choice of topotecan or irinotecan. No new safety signals were identified with Zepzelca monotherapy or in combination with irinotecan. Based on the results from the LAGOON trial of Zepzelca in second-line metastatic SCLC, which were reported in June 2026, and in alignment with FDA, in the third quarter of 2026, we will submit for FDA's review and subsequent action a labeling supplement to remove the second-line indication. The first-line maintenance indication will not be affected.
The lead clinical asset acquired from Chimerix, Modeyso, is a novel first-in-class small molecule that is a protease activator of the ClpP that also inhibits DRD2. Modeyso is the first and only treatment option approved by FDA for an ultra-rare and aggressive brain tumor. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. The ongoing Phase 3 ACTION trial is evaluating Modeyso in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending this treatment option into the front-line setting.
In June 2022, we announced FDA had cleared our IND for JZP815 and, in October 2022, we enrolled the first patient in a Phase 1 trial and the trial has progressed to expansion cohorts. JZP815 is an investigational stage pan-RAF kinase inhibitor that targets specific components of the MAPK pathway that, when activated by oncogenic mutations, can be a frequent driver of human cancer.
In April 2022, we announced that we had entered into a licensing and collaboration agreement with Werewolf to acquire exclusive, worldwide development and commercialization rights to Werewolf's investigational WTX-613, now referred to as JZP898, a differentiated, conditionally-activated IFNα INDUKINE™ molecule. In November 2023, we enrolled our first patient in a Phase 1 trial of JZP898 and the trial has progressed to cohorts in combination with pembrolizumab in renal-cell carcinoma, urothelial carcinoma and melanoma. In May 2026, we entered into an asset purchase agreement with Werewolf, under which we acquired all remaining rights and eliminated all remaining obligations to JZP898 for an upfront consideration of $21.0 million. Werewolf is eligible to receive a contingent milestone payment of $2.0 million upon consent to the partial assignment of a license agreement relating to the JZP898 program.
In June 2026, we announced a preclinical research collaboration, option and license agreement to discover and develop next-generation T-cell engaging multispecific antibodies with AbCellera. The collaboration will leverage AbCellera's antibody discovery engine to deliver optimized development candidates for multiple gastrointestinal cancers and other solid tumors. Under the terms of the agreement, AbCellera will perform discovery and early-stage research activities for two initial programs with a commitment to start a third discovery program within 12 months. AbCellera received $56.0 million in total upfront payments for the first two research programs with an additional $28.0 million due upon initiation of the third program. Should we exercise our option for development, AbCellera is eligible to receive up to $792.0 million per program in option fees and development, regulatory, and commercial sales milestone payments along with tiered royalties on net sales ranging from mid-single digits to low double-digits. In addition, we and AbCellera may mutually agree to initiate up to two additional programs, and to have AbCellera conduct certain activities for investigational new drug-enabling studies and manufacture clinical supply for any program under the collaboration.
Within our neuroscience R&D program, in August 2025, we announced that we entered a global license agreement with Saniona to obtain exclusive worldwide rights to develop SAN2355, now referred to as JZP053, for epilepsy and other potential indications. JZP053 is a preclinical, selective small molecule activator of Kv7.2/Kv7.3 potassium channels, a mechanism validated for seizure suppression. Under the terms of the agreement, we made an upfront payment to Saniona of $42.5 million. Saniona is eligible to receive up to $192.5 million in development and regulatory milestones, up to $800.0 million in commercial milestone payments and tiered royalties ranging from mid-single digits to low-double digits on net sales of
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commercial products resulting from the development of JZP053. This transaction further expands our early-stage neuroscience pipeline building on our existing expertise in the treatment of epilepsy.
Further expanding on our early-stage epilepsy development program, we are broadening our Epidiolex (cannabidiol oral solution) clinical development. In November 2025, we initiated a Phase 1b trial evaluating cannabidiol oral solution as an adjunctive treatment in reducing the frequency of focal seizures compared to the baseline as well as the effect of it on health outcome endpoints in early line and refractory participants with focal-onset seizures. In August 2026, we announced a Phase 3b/4 trial to evaluate effectiveness of gradual titration regimen to optimize cannabidiol oral solution as an add-on therapy in adults with LGS. We also announced a Phase 3 trial to evaluate the safety and efficacy of cannabidiol oral solution in developmental and epileptic encephalopathy to reach new patient populations with refractory epilepsy.
Mid-2026, we submitted an NDA to FDA for a capsule formulation of cannabidiol to broaden utilization of cannabidiol in currently approved indications and increase flexibility for patients. We also announced a Phase 2/3 trial to evaluate the safety and efficacy of cannabidiol capsule formulation in juvenile myoclonic epilepsy.
Below is a summary of our key ongoing and planned development projects related to our products and pipeline and their corresponding current stages of development:
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Product CandidatesDescription
Regulatory
ZanidatamabFirst-line HER2-positive GEA (HERIZON-GEA-01) (sBLA under FDA review)
Phase 3
ZanidatamabFirst-line HER2-positive BTC (HERIZON-BTC-302) (ongoing confirmatory trial)
Previously treated HER2-positive breast cancer in patients whose disease has progressed on previous T-DXd treatment (EmpowHER-BC-303) (ongoing trial)
DordaviproneFirst-line H3 K27M-mutant diffuse glioma (ACTION trial) (ongoing confirmatory trial)
Cannabidiol Oral SolutionPhase 3b/4 trial in adults with LGS
Developmental and epileptic encephalopathy
Phase 2
ZanidatamabBasket trial including HER2-positive solid tumors (DiscovHER-Pan-206) (ongoing trial)
Neoadjuvant and adjuvant breast cancer (EmpowHER-BC-208) (ongoing trial)
HER2+ advanced GEA in combination with paclitaxel and ramucirumab (Canadian Cancer Trials Group collaboration) (ongoing trial)
HER2+/PD-L1+ mGEA in combination with pembrolizumab and chemotherapy (ZANGEA) (collaboration study) (trial enrolling)
Early stage HER2/neu positive (HER2+) breast cancer (collaboration study) (ongoing trial)
VyxeosHigh-risk MDS (PALOMA) (cooperative group study) (ongoing trial)
JZP35071
Pheochromocytoma and paraganglioma (acquired from Chimerix) (ongoing trial)
Meningioma (trial initiated)
Cannabidiol Capsule FormulationPhase 2/3 trial in juvenile myoclonic epilepsy
Phase 1
JZP815Raf and Ras mutant tumors (acquired from Redx) (ongoing trial)
JZP898Conditionally-activated IFNα INDUKINE™ molecule in solid tumors (ongoing trial)
JZP35071
Recurrent and rare primary CNS tumors (acquired from Chimerix) (ongoing trial)
Newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors (UCSF collaboration) (acquired from Chimerix) (ongoing trial)
Cannabidiol Oral SolutionFocal-onset seizures
JZP047Absence epilepsy
Preclinical
JZP35082
Oncology
Undisclosed targetsOncology
CombiPlex®Hematology/oncology exploratory activities
JZP0533
Epilepsy
Undisclosed targetsSleep
Epilepsy
Other Neuroscience
1Also known as ONC206
2Also known as ONC212
3Also known as SAN2355
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Challenges, Risks and Trends Related to Our Business
While we have continued to diversify our revenues and commercial portfolio of medicines, including leading therapies addressing rare epilepsies, cancers and sleep disorders, our business continues to meaningfully depend on Xywav revenues. Our current 2026 operating plan assumes that Xywav, with 92% lower sodium compared to high-sodium oxybates (depending on the dose), a dosing titration option and an absence of a sodium warning, will remain the #1 branded oxybate treatment for narcolepsy; the position it held based on revenue in the second quarter of 2026, and the only FDA-approved therapy for IH. In June 2021, FDA recognized seven years of ODE for Xywav in narcolepsy through July 21, 2027, (which was subsequently extended to January 21, 2028, because FDA granted pediatric exclusivity), stating that Xywav is clinically superior to Xyrem by means of greater safety due to reduced chronic sodium burden. Additionally, in August 2021, FDA recognized ODE for Xywav in IH through August 12, 2028. While we expect that our business will continue to meaningfully depend on Xywav revenues, there is no guarantee that Xywav revenues will remain at current levels.
Our ability to successfully commercialize Xywav depends on, among other things, our ability to maintain adequate payor coverage and reimbursement for Xywav and acceptance of Xywav by physicians and patients, including of Xywav for the treatment of IH in adults. In an effort to support strong adoption of Xywav and patient success, we are focused on facilitating payor coverage for Xywav through education of its low-sodium and providing robust patient copay and savings programs.
Xywav and Xyrem face competition from branded products, such as Alkermes’ Lumryz, and alternative products that treats narcolepsy, including orexin 2 receptor agonists. In addition, our oxybate products have faced competition from AG and generic versions of high-sodium oxybate. Specifically, a wholly-owned subsidiary of Hikma launched its AG version of sodium oxybate in January 2023, and Amneal launched its AG version of sodium oxybate in July 2023. In September 2023, Hikma elected to continue to sell the Hikma AG product, with royalties to be paid to us, for an additional four years beginning in January 2024.
Pursuant to amendments to our AG agreement with Hikma, effective January 1, 2026, we extended the period during which Hikma is permitted to sell the Hikma AG product until December 31, 2029. Either we or Hikma may provide notice of intent to terminate the amended agreement as early as October 1, 2026, in accordance with notice provisions in the agreement. Under these amendments, we continue to have the right to a meaningful royalty from Hikma on net sales of the Hikma AG product throughout the extended Hikma AG period, which royalty rate was fixed through the end of 2025 and then subject to specified reductions. We are also paid for supply of the Hikma AG product and are reimbursed by Hikma for a portion of the services costs associated with the operation of the Xywav and Xyrem REMS, and distribution of the Hikma AG product. Hikma also maintains a license to launch its own generic sodium oxybate product, but, if it elects to launch its own generic product, Hikma will no longer have the right to sell the Hikma AG product. The Hikma AG product is expected to continue to negatively impact Xyrem and Xywav sales for patients with narcolepsy.
In our settlements with Amneal, Lupin, and Par, we granted each party the right to sell a limited volume of an AG product in the U.S. beginning on July 1, 2023, and ending on December 31, 2025, with royalties to be paid to us. Amneal launched its AG version of high-sodium oxybate in July 2023. We granted each of Amneal, Lupin and Par a license to launch its own generic sodium oxybate product under its ANDA on or after December 31, 2025, or earlier under certain circumstances, including the circumstance where Hikma elects to launch its own generic product. In September 2025, FDA approved Amneal's generic high-sodium oxybate product. In November 2025, FDA approved Ascent’s generic high-sodium oxybate product. In March 2026, Amneal and Ascent began dispensing their generic high-sodium oxybate products through the generic sodium oxybate REMS. Any other company commercializing a generic version of high-sodium oxybate would need to join an existing REMS operated by another company.
In the future, we expect our oxybate products to continue to face competition from generic versions of high-sodium oxybate pursuant to settlement agreements we entered into with multiple ANDA filers. In addition, we received notices in June 2021, February 2023 and July 2025 that Lupin, Teva and Granules, respectively, filed ANDAs for generic versions of Xywav. In January 2026, we received notices from Tris Pharma that it had filed with FDA a Section 505(b)(2) NDA with Xyrem and Xywav as referenced listed drugs. We have filed patent infringement suits against these ANDA filers and 505(b)(2) NDA filer. In March 2026, we entered into a patent litigation settlement agreement with Granules. The specific terms of the Granules settlement agreement are confidential. On October 13, 2023, Lupin announced that it has received tentative approval for its application to market a generic version of Xywav.
Generic competition can decrease the net prices at which branded products, such as Xywav and Xyrem are sold, as can competition from other branded products. In addition, we have increasingly experienced pressure from third party payors to agree to discounts, rebates or restrictive pricing terms, and we cannot guarantee we will be able to agree to commercially reasonable terms with PBMs, or similar organizations and other third party payors, or that we will be able to ensure patient access and acceptance on formularies. Entering into agreements with PBMs or similar organizations and payors to ensure patient access has and may continue to result in decreased net prices for some of our products. Moreover, generic or AG high-sodium oxybate products or branded high-sodium oxybate entrants in narcolepsy, such as Alkermes’ Lumryz, have had and
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may continue to have the effect of changing payor or formulary coverage of Xywav or Xyrem in favor of other products, and may indirectly adversely affect sales of Xywav and Xyrem.
In any event, we expect that the approval and launch of AG products or other generic versions of Xyrem or Xywav and the approval and launch of any other sodium oxybate product, such as Alkermes’ Lumryz, or alternative product that treats narcolepsy, such as Axsome’s reboxetine or orexin 2 receptor agonists being developed by Takeda, Merck & Co., Inc., Eisai Co., Ltd., Eli Lilly and Company and Alkermes, will continue to have a negative impact on, and could have a material adverse effect on, our sales of Xywav and Xyrem and on our business, financial condition, results of operations and growth prospects.
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 continue to accept and adopt Epidiolex/Epidyolex as a treatment for seizures associated with LGS, DS and TSC. Physicians may not prescribe Epidiolex/Epidyolex 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. Moreover, we expect that Epidiolex will face competition from generic products in the future. We have settled patent litigation with each of the ten companies seeking to market a generic version of Epidiolex in the U.S. by granting each of the Epidiolex ANDA Filers a license to manufacture, market, and sell its own generic version of Epidiolex beginning in the very late 2030s, or earlier under certain circumstances, including but not limited to the launch of another generic Epidiolex product or a final decision that all unexpired claims of the Epidiolex patents are not infringed, or are invalid and/or unenforceable. In addition, there are non-FDA approved CBD preparations being made available from companies through the state-enabled medical marijuana industry, which might attempt to compete with Epidiolex. Epidiolex may also face branded competition in the future with potential therapy launches targeting broad developmental and epileptic encephalopathies, including Praxis Precision Medicines, Inc.'s relutrigine, H. Lundbeck A/S' bexicaserin and Bright Minds Biosciences Inc.'s BMB-101. However, the potential competitive impact on Epidiolex remains uncertain. Overall, significant uncertainty remains regarding the commercial potential of Epidiolex/Epidyolex.
In addition to Xywav, Xyrem and Epidiolex/Epidyolex, our long-term growth strategy relies on successfully commercializing and advancing a portfolio of oncology products, including Ziihera, Modeyso, Zepzelca, Rylaze, Vyxeos and Defitelio. Our success is contingent upon mitigating significant risks related to our oncology portfolio, including our ability to navigate significant and increasing market competition, such as the entry of novel therapeutic products, including for SCLC and our ability to successfully complete confirmatory clinical trials and retain regulatory approvals. Certain of our oncology products rely on accelerated regulatory approval pathways. Our ability to maintain these marketing authorizations is strictly dependent on the timely and successful completion of post-marketing confirmatory clinical trials. FDA and other global regulatory bodies have recently demonstrated increased scrutiny over accelerated approvals. Any delays in trial enrollment, failure to meet primary clinical endpoints, or regulatory determinations that a product's clinical benefit does not justify its risks could lead to the restriction or withdrawal of our products from the market. Additionally, effectively commercializing Ziihera, Modeyso, Zepzelca, Rylaze, Vyxeos and Defitelio requires securing and maintaining favorable formulary status, overcoming increasing pricing and reimbursement pressures from third-party payors, and managing complex global manufacturing and supply chains. An inability to overcome these competitive, commercial, and regulatory hurdles, or to maximize the potential of these products through successful R&D activities, could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
A key aspect of our growth strategy is our continued investment in our evolving and expanding R&D activities. If we are not successful in the clinical development of our product candidates, if we are unable to obtain regulatory approval for our product candidates in a timely manner, or at all, or if sales of an approved product do not reach the levels we expect, our anticipated revenue from our product candidates would be negatively affected, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
In addition to continued investment in our R&D pipeline, we intend to continue to grow our business by acquiring or in-licensing, and developing, including with collaboration partners, additional rare-disease products and product candidates that we believe are highly differentiated and have significant commercial potential. Failure to identify and acquire, in-license or develop additional products or product candidates, successfully manage the risks associated with integrating any products or product candidates into our portfolio or the risks arising from anticipated and unanticipated problems in connection with an acquisition or in-licensing, such as the Chimerix Acquisition, could have a material adverse effect on our business, results of operations and financial condition.
Our industry has been, and is expected to continue to be, subject to healthcare cost containment and drug pricing scrutiny by regulatory agencies in the U.S. and internationally. If new healthcare policies or reforms intended to curb healthcare costs are adopted or if we experience negative publicity with respect to pricing of our products or the pricing of pharmaceutical drugs
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generally, the prices that we charge for our products may be affected, our commercial opportunity may be limited and/or our revenues from sales of our products may be negatively impacted. For example, the IRA, among other things, requires the HHS Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high Medicare spend drugs and biologicals per year starting in 2026 and penalizes manufacturers of certain Medicare Parts B and D drugs for price increases above inflation. The IRA also made several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs and a change in manufacturer liability under the program, that could negatively affect our business and financial condition. In addition, under the Medicaid Drug Rebate Program, rebates owed by manufacturers are no longer subject to a cap on the rebate amount, which could adversely affect our rebate liability. Moreover, the current administration continues to pursue MFN pricing for certain prescription drugs, under which U.S. prices would be indexed to the lowest prices available in select OECD countries. As part of this policy initiative, the administration is implementing or considering various Center for Medicare & Medicaid Innovation models that would rely on MFN reference pricing. We are also subject to increasing pricing pressure and restrictions on reimbursement imposed by payors. If we fail to obtain and maintain adequate formulary positions and institutional access for our current products and future approved products, we will not be able to achieve a return on our investment and our business, financial condition, results of operations and growth prospects would be materially adversely affected.
While certain preparations of cannabis remain Schedule I controlled substances, if such products are approved by FDA for medical use in the U.S. they are rescheduled to Schedules II-V, since approval by FDA demonstrates the existence of an “accepted medical use” for the products and thus Schedule I is inapplicable; or such products may be removed from control under the Controlled Substances Act entirely. If any of our product candidates receive FDA approval, the HHS and the DEA will make a scheduling determination. U.S. or foreign regulatory agencies may request additional information regarding the abuse potential of our products which may require us to generate more clinical or other data than we currently anticipate to establish whether or to what extent the substance has abuse potential. This generation of data could increase the cost, delay the approval and/or delay the launch of that product.
In addition, business practices by pharmaceutical companies, including product formulation improvements, patent litigation settlements, and REMS programs, have increasingly drawn public scrutiny from legislators and regulatory agencies, with allegations that such programs are used as a means of improperly blocking or delaying competition. Government investigations with respect to our business practices, including as they relate to the Xywav and Xyrem REMS, the launch of Xywav, our Xyrem patent litigation settlement agreements or otherwise, could cause us to incur significant monetary charges to resolve these matters and could distract us from the operation of our business and execution of our strategy. In addition, from June 2020 to May 2022, a number of lawsuits were filed on behalf of purported direct and indirect Xyrem purchasers, alleging that the patent litigation settlement agreements we entered with certain generic companies violate state and federal antitrust and consumer protection laws. As of October 2025, we resolved the entirety of these antitrust lawsuits. For additional information on these lawsuits, as well as the settlement agreements with respect thereto and other legal matters, see Note 10, Commitments and Contingencies-Legal Proceedings of the Notes to Condensed Consolidated Financial Statements, included in Part I of this Quarterly Report on Form 10‑Q. It is possible that additional lawsuits will be filed against us making similar or related allegations. We cannot predict the outcome of any potential additional lawsuits; however, if the plaintiffs were to be successful in their claims against us, they may be entitled to injunctive relief or we may be required to pay significant monetary damages. Moreover, we are, and expect to continue to be, the subject of various claims, legal proceedings, and government investigations apart from those set forth above that have arisen in the ordinary course of business that have not yet been fully resolved and that could adversely affect our business and the execution of our strategy. Any of the foregoing risks and uncertainties could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Moreover, the U.S. government has imposed and may seek to impose additional restrictions on international trade, such as tariffs on goods generally, and pharmaceutical and biological products in particular, imported into the U.S. In anticipation of the potential for increased tariffs on our products, we have increased inventory levels of our products in the U.S. We conduct our business globally and have third-party suppliers located outside the U.S., including in the PRC. In addition, we have a manufacturing and development facility in Athlone, Ireland where we manufacture Xywav and Xyrem, a manufacturing and development facility in Kent Science Park, U.K. where we produce Epidiolex/Epidyolex, and a manufacturing plant in Villa Guardia, Italy where we produce defibrotide drug substance. While we cannot at this time predict the ultimate impact of such tariffs, we anticipate that our margins could be adversely affected, depending on the ultimate scope and duration of tariffs imposed. However, given the volatility and uncertainty regarding the scope and duration of such tariffs and other aspects of U.S. and foreign government trade policies, the ultimate impact on our operations and financial results remains uncertain. Likewise, our financial condition and results of operations may continue to be affected by global volatility and general market disruption resulting from geopolitical tensions, such as the ongoing Russia-Ukraine military conflict and the ongoing military conflict involving the U.S., Israel and Iran. In particular, the continued escalation of hostilities in the Middle East, including involving Iran, could further disrupt global energy markets, fuel prices, transportation networks, and supply chains, which may disrupt or otherwise negatively impact our supply chain, demand for our products and our ability to meet demand for our products, and increase our costs. See “Global trade issues and changes in and uncertainties with respect to trade policies and
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export regulations, including import and export license requirements, trade sanctions, tariffs and international trade disputes, could increase our costs, reduce the competitiveness of our products and otherwise have a material adverse effect on our business, financial condition, results of operations and growth prospects” and “Delays or problems in the supply of our products for sale or for use in clinical trials, loss of our single source suppliers or failure to comply with manufacturing regulations could materially and adversely affect our business, financial condition, results of operations and growth prospects” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025.
The foregoing risks and uncertainties are discussed in greater detail, along with other risks and uncertainties, in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025.
Results of Operations
The following table presents our revenues and expenses (in millions, except percentages): 
Three Months Ended
June 30,
Increase/Six Months Ended
June 30,
Increase/
20262025(Decrease)20262025(Decrease)
Product sales, net$1,156.1 $985.6 17 %$2,181.4 $1,825.0 20 %
Royalties and contract revenues52.2 60.1 (13)%95.8 118.5 (19)%
Cost of product sales (excluding amortization of acquired developed technologies)116.4 116.3 — %250.5 220.9 13 %
Selling, general and administrative389.2 358.4 %741.9 872.4 (15)%
Research and development207.5 189.9 %403.5 370.6 %
Intangible asset amortization170.0 162.1 %342.3 316.5 %
Acquired in-process research and development77.0 905.4 (91)%77.0 905.4 (91)%
Gain on sale of priority review voucher— — N/A(1)(122.8)— N/A(1)
Interest expense, net37.1 47.4 (22)%77.0 101.1 (24)%
Foreign exchange (gain) loss0.1 1.8 (94)%(2.4)2.0 N/A(1)
Income tax expense (benefit)18.1 (17.2)N/A(1)24.2 (35.0)N/A(1)
Equity in loss of investees0.1 0.1 — %0.1 0.6 (83)%
____________________________
(1)Comparison to prior period not meaningful.
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Revenues
The following table presents our net product sales, royalties and contract revenues, and total revenues (in millions except percentages):
Three Months Ended
June 30,
Increase/Six Months Ended
June 30,
Increase/
20262025(Decrease)20262025(Decrease)
Xywav$471.2 $415.3 13 %$879.4 $760.1 16 %
Xyrem30.5 35.4 (14)%61.7 72.6 (15)%
Sleep501.7 450.7 11 %941.1 832.7 13 %
Epidiolex/Epidyolex292.1 251.7 16 %541.9 469.4 15 %
Epilepsy292.1 251.7 16 %541.9 469.4 15 %
Zepzelca105.8 74.5 42 %206.8 137.5 50 %
Rylaze/Enrylaze99.5 100.7 (1)%203.2 194.9 %
Defitelio/defibrotide 62.0 48.1 29 %109.4 88.8 23 %
Modeyso48.2 0.5 N/A(2)89.6 0.5 N/A(2)
Vyxeos31.4 44.9 (30)%58.0 74.4 (22)%
Ziihera15.4 6.0 157 %28.7 8.0 N/A(2)
Oncology362.3 274.7 32 %695.7 504.1 38 %
Other1
— 8.5 N/A(2)2.7 18.8 (86)%
Product sales, net1,156.1 985.6 17 %2,181.4 1,825.0 20 %
High-sodium oxybate AG royalty revenue42.2 54.1 (22)%78.5 103.0 (24)%
Other royalty and contract revenues10.0 6.0 67 %17.3 15.5 12 %
Total revenues$1,208.3 $1,045.7 16 %$2,277.2 $1,943.5 17 %
___________________________
(1)Includes Sativex net product sales for the three and six months ended June 30, 2025.
(2)Comparison to prior period not meaningful.
Total Revenues
Xywav product sales increased in the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to volume growth of 12% in both periods, and a higher selling price, offset by higher gross to net deductions. We continue to see Xywav adoption in patients with narcolepsy driven by continued demand, supported by educational initiatives around efficacy and the benefit of lowering sodium intake. In addition, Xywav product sales were positively impacted by adoption in IH. Xywav is the only oxybate therapy approved to treat IH and we see continued growth of new prescribers. Exiting the quarter, there were 11,275 patients taking Xywav for narcolepsy and 5,850 taking Xywav for IH, an increase of approximately 6% and 26%, respectively, compared to the same period in 2025. Xyrem product sales decreased in the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to volume declines of 20% and 21%, respectively.
Epidiolex/Epidyolex product sales increased in the three months ended June 30, 2026, compared to the same period in 2025, primarily due to volume growth of 12%, driven by increased demand, lower gross to net deductions, and a higher average selling price. Epidiolex/Epidyolex product sales increased in the six months ended June 30, 2026, compared to the same period in 2025, due to volume growth of 13%, driven by increased demand, the positive impact of foreign exchange rates, and a higher average selling price, offset by higher gross to net deductions.
Zepzelca product sales increased in the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to increased sales volumes, reflecting continued adoption in the first-line maintenance ES-SCLC setting following FDA approval of Zepzelca in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs in October 2025 partially offset by a decline in second line use. Rylaze/Enrylaze product sales in the three months ended June 30, 2026, were in line with the same period in 2025. Rylaze/Enrylaze product sales increased in the six months ended June 30, 2026, compared to the same period in 2025, primarily due to a higher average selling price, and volume growth of 3%, partially offset by higher gross to net deductions. Defitelio/defibrotide product sales increased in the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to increased sales volumes, partially offset by a lower average selling price due to regional mix. Modeyso product sales were $48.2 million and $89.6 million, respectively, in the three and six months ended June 30, 2026, following its product launch in August 2025. Vyxeos product sales decreased in the three and six months ended June 30, 2026, compared to the same periods in 2025, due to a decrease in sales volumes, partially
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offset by a higher average selling price. Ziihera product sales increased in the three and six months ended June 30, 2026, compared to the same periods in 2025, due to increased sales volumes, following its product launch in December 2024.
Royalties and contract revenues decreased in the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to a decrease in royalty revenue from Hikma, resulting from a reduction in the applicable royalty rate on net sales of their high sodium oxybate AG.
We expect total revenues in 2026 to increase compared to 2025, primarily driven by continued growth in Xywav, Epidiolex/Epidyolex and in oncology, offset by a reduction in royalty revenues due to decreased high-sodium AG royalties and Xyrem revenues following the launch of multiple generic high-sodium products.
Cost of Product Sales
Cost of product sales in the three months ended June 30, 2026, were in line with the same period in 2025 as lower fair value step-up expense of $20.5 million was partially offset by higher royalty expenses, driven by higher revenues. Cost of product sales increased in the six months ended June 30, 2026, compared to the same period in 2025, primarily due to higher royalty expenses, driven by higher revenues, and increased inventory provisions, partially offset by lower fair value step-up expense of $12.8 million. Gross margin as a percentage of total revenues was 90.4% and 89.0% for the three and six months ended June 30, 2026, compared to 88.9% and 88.6% for the same periods in 2025.
We expect our cost of product sales in 2026 to be broadly in line with 2025, with higher costs, including royalties, driven by higher revenues, offset by a reduction in the fair value step-up expense.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased in the three months ended June 30, 2026, compared to the same period in 2025, primarily due to increased marketing investment of $13.6 million and higher compensation-related expenses of $11.8 million in support of our commercial portfolio. Selling, general and administrative expenses decreased in the six months ended June 30, 2026, compared to the same period in 2025, primarily due to Xyrem antitrust litigation settlements of $172.0 million incurred in the six months ended June 30, 2025, partially offset by an increase in compensation-related expenses of $29.3 million and increased marketing investment of $22.3 million in support of our commercial portfolio, in the six months ended June 30, 2026.
We expect selling, general and administrative expenses in 2026 to decrease compared to 2025, primarily due to the impact of litigation settlement expenses incurred in 2025, offset by increased investment in support of our commercial portfolio.
Research and Development Expenses
R&D expenses consist primarily of costs related to clinical studies and outside services, personnel expenses, and other R&D costs. Clinical study and outside services costs relate primarily to services performed by clinical research organizations, materials and supplies, and other third party fees. Personnel expenses relate primarily to salaries, benefits and share-based compensation. Other R&D expenses primarily include overhead allocations consisting of various support and facilities-related costs. We do not track fully-burdened R&D expenses on a project-by-project basis. We manage our R&D expenses by identifying the R&D activities that we anticipate will be performed during a given period and then prioritizing efforts based on our assessment of which development activities are important to our business and have a reasonable probability of success, and by dynamically allocating resources accordingly. We also continually review our development pipeline projects and the status of their development and, as necessary, reallocate resources among our development pipeline projects that we believe will best support the future growth of our business.
The following table provides a breakout of our R&D expenses by major categories of expense (in millions):
Three Months Ended
June 30,
Six Months Ended
June 30,
2026202520262025
Clinical studies and outside services$108.8 $93.1 $197.5 $180.4 
Personnel expenses80.6 75.4 167.5 149.8 
Other 18.1 21.4 38.5 40.4 
Total$207.5 $189.9 $403.5 $370.6 
R&D expenses increased by $17.6 million in the three months ended June 30, 2026, compared to the same period in 2025, driven by an increase in clinical studies and outside services costs, primarily due to higher costs related to zanidatamab.
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R&D expenses increased by $32.9 million in the six months ended June 30, 2026, compared to the same period in 2025, driven by an increase in personnel expenses of $17.7 million and clinical studies and outside services costs, primarily due to higher costs related to zanidatamab and dordaviprone.
We expect that our R&D expenses will increase compared to 2025, primarily driven by an increase in clinical studies and outside service costs relating to zanidatamab, for both ongoing and new studies, dordaviprone, due to the inclusion of a full year’s expenses, and preclinical and early clinical programs.
Intangible Asset Amortization
Intangible asset amortization increased in the three and six months ended June 30, 2026, compared with the same periods in 2025, primarily due to the impact of foreign currency translation on our sterling assets.
Acquired In-Process Research and Development
Acquired IPR&D expense in the three and six months ended June 30, 2026, includes the upfront payments made in connection with our collaboration and license agreement with AbCellera of $56.0 million and asset purchase agreement with Werewolf of $21.0 million. Acquired IPR&D expense in the three and six months ended June 30, 2025, represents the value allocated to Modeyso in the Chimerix Acquisition.
Gain on sale of Priority Review Voucher
We recognized a pre-tax gain on disposal of the PRV in January 2026 of $122.8 million, representing the total cash consideration received of $200.0 million, less the post-tax proceeds paid to the former stockholders of Oncoceutics, Inc.
Interest Expense, Net
Interest expense, net decreased by $10.3 million and $24.1 million in the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to lower interest expense on the Tranche B-2 Dollar Term Loans and higher interest income as a result of higher cash reserves, offset by lower interest rates.
Income Tax Expense (Benefit)
Our income tax expense was $18.1 million and $24.2 million for the three and six months ended June 30, 2026, respectively, compared to an income tax benefit of $17.2 million and $35.0 million for the same periods in 2025, relating 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 deduction eligible income benefits and tax credits. The income tax expense for the six months ended June 30, 2026, also included tax arising on the gain on sale of the PRV, partially offset by excess tax benefits from share-based compensation. The income tax benefit for the six months ended June 30, 2025, was primarily due to the tax impact of certain Xyrem antitrust litigation settlements.

Liquidity and Capital Resources
As of June 30, 2026, we had cash, cash equivalents and investments of $2.2 billion, borrowing available under our Amended Revolving Credit Facility of $885.0 million and a long-term debt principal balance of $4.4 billion. Our long-term debt included $1.9 billion aggregate principal amount of the Tranche B-2 Dollar Term Loans, $1.5 billion in aggregate principal amount of the Secured Notes, and $1.0 billion aggregate principal amount of the 2030 Notes. We generated cash flow from operations of $823.9 million during the six months ended June 30, 2026, and we expect to continue to generate positive cash flow from operations which will enable us to operate our business and de-lever our balance sheet over time.
Prior to June 15, 2030, the 2030 Notes will be exchangeable only upon satisfaction of certain conditions, including a condition tied to our share price that is measured as of the end of each quarter, and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. During the quarter ended June 30, 2026, the closing price of our ordinary shares exceeded 130% of the conversion price of the 2030 Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the share price condition was met and the 2030 Notes are exchangeable at the option of the holders during the quarter ended September 30, 2026. Accordingly, the carrying value of the 2030 Notes has been included in current liabilities in our condensed consolidated balance sheet as of June 30, 2026.
As of the date of this filing, none of the 2030 Notes have been exchanged by the holders. In the event holders elect to exchange their 2030 Notes, we expect we would settle such exchanges using cash on hand and/or borrowings under our Amended Revolving Credit Facility.


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Since the closing of the GW Acquisition in May 2021, we have fully repaid our Euro Term Loan. With respect to our Tranche B-2 Dollar Term Loans, we have made voluntary repayments of $1.1 billion, $300.0 million in September 2022, and $750.0 million in January 2025, along with mandatory repayments $155.0 million. In June 2026, we repaid the $1.0 billion aggregate principal amount of our 2026 Notes and, in August 2024, we repaid the $575.0 million aggregate principal amount of our 2024 Notes.
We have a significant amount of debt outstanding on a consolidated basis. For further information, including details relating to our scheduled maturities with respect to our long-term debt, see Note 9, Debt, of the Notes to Condensed Consolidated Financial Statements, included in Part I, Item 1 of this Quarterly Report on Form 10‑Q. This substantial level of debt could have important consequences to our business, including, but not limited to the factors set forth in “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, under the heading “We have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position, and our business would be adversely affected if we are unable to service our debt obligations.
We believe that our existing cash, cash equivalents and investments balances, cash we expect to generate from operations and funds available under our Amended Revolving Credit Facility will be sufficient to fund our operations and to meet our existing obligations for the foreseeable future. The adequacy of our cash resources depends on many assumptions, including primarily our assumptions with respect to product sales and expenses, as well as the other factors set forth in "Risk Factors" under the heading "Risks Related to our Lead Products and Product Candidates” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025, as well as the factor set forth in "Risk Factors" under the heading “To continue to grow our business, we will need to commit substantial resources, which could result in future losses or otherwise limit our opportunities or affect our ability to operate and grow our business” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025.
Our assumptions may prove to be wrong or other factors may adversely affect our business, and as a result we could exhaust or significantly decrease our available cash resources, and we may not be able to generate sufficient cash to service our debt obligations which could, among other things, force us to raise additional funds and/or force us to reduce our expenses, either of which could have a material adverse effect on our business.
To continue to grow our business over the longer term, we plan to commit substantial resources to product acquisition and in-licensing, product development, clinical trials of product candidates and expansion of our commercial, development, manufacturing and other operations. In this regard, we have evaluated and expect to continue to evaluate a wide array of strategic transactions as part of our strategy to acquire or in-license and develop additional products and product candidates. Acquisition opportunities that we pursue could materially affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both. We regularly evaluate the performance of our products and product candidates to ensure fit within our portfolio and support efficient allocation of capital. In addition, we may pursue new operations or continue the expansion of our existing operations. Accordingly, we expect to continue to opportunistically seek access to additional capital to license or acquire additional products, product candidates or companies to expand our operations, to restructure or refinance our debt and/or for general corporate purposes. Raising additional capital could be accomplished through one or more public or private debt or equity financings, collaborations or partnering arrangements. However, our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide resulting from the effects of ongoing military conflicts, inflationary pressures, potential future bank failures, or otherwise. In this regard, the ongoing Russia-Ukraine military conflict and the ongoing military conflict involving the U.S., Israel and Iran have created volatility in the global credit and financial markets and have had and may continue to have further global economic consequences, including continued disruptions of the global supply chain and energy markets, which could continue to drive inflationary pressures and increase global recession risk. Accordingly, we could experience an inability to access additional capital or our liquidity could otherwise be impacted, which could in the future negatively affect our capacity for certain corporate development transactions or our ability to make other important, opportunistic investments. In addition, under Irish law we must have authority from our shareholders to issue any ordinary shares, including ordinary shares that are part of our authorized but unissued share capital, and our current share issuance authority is due to expire in July 2031. Moreover, as a matter of Irish law, when an Irish public limited company issues ordinary shares to new shareholders for cash, the company must first offer those shares on the same or more favorable terms to existing shareholders on a pro rata basis, unless this statutory pre-emption obligation is dis-applied, or opted-out of, by approval of its shareholders. At our annual general meeting of shareholders in July 2026, our shareholders voted to approve our proposal to dis-apply the statutory pre-emption obligation. This current pre-emption opt-out authority is due to expire in January 2028. If we are unable to obtain further share issuance and pre-emption authorities from our shareholders in the future, or otherwise continue to be limited by the terms of new share issuance pre-emption authorities approved by our shareholders in the future, our ability to use our unissued share capital to fund in-licensing, acquisition or other business opportunities, or to otherwise raise capital, including at the time we are required to make repurchases of the 2030 Notes and/or the Secured Notes, are required to repay outstanding amounts under the Amended Credit Agreement, or pay cash upon reaching the maturity date of the 2030 Notes, could likewise be adversely affected or precluded altogether. In any event,
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an inability to borrow or raise additional capital in a timely manner and on attractive terms could prevent us from expanding our business or taking advantage of acquisition opportunities and could otherwise have a material adverse effect on our business and growth prospects. In addition, if we use a substantial amount of our funds to acquire or in-license products or product candidates, we may not have sufficient additional funds to conduct all of our operations in the manner we would otherwise choose. Furthermore, any equity financing would be dilutive to our shareholders percentage ownership, and could require the consent of the lenders under the Amended Credit Agreement that provides for (i) the Tranche B-2 Dollar Term Loans and Amended Revolving Credit Facility, and the indenture for the Secured Notes for certain financings.
In July 2024, our board of directors authorized the Repurchase Program, to repurchase ordinary shares having an aggregate purchase price of $500.0 million, exclusive of any brokerage commissions. The Repurchase Program, which has no expiration date, allows us to 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 Repurchase Program may be modified, suspended or discontinued at any time without our prior notice. During the three and six months ended June 30, 2026, no shares were repurchased. During the three and six months ended June 30, 2025, we spent a total of $125.0 million to repurchase 1.1 million of our ordinary shares under the Repurchase Program at a purchase price, including commissions, of $109.52 per share. As of June 30, 2026, the remaining amount authorized for repurchases under the Repurchase Program was $225.0 million, exclusive of any brokerage commissions.
The following table presents a summary of our cash flows for the periods indicated (in millions):
Six Months Ended
June 30,
20262025
Net cash provided by operating activities$823.9 $518.6 
Net cash provided by (used in) investing activities478.0 (810.0)
Net cash used in financing activities(1,073.0)(937.9)
Effect of exchange rates on cash and cash equivalents(1.0)6.3 
Net increase (decrease) in cash and cash equivalents$227.9 $(1,223.0)
Operating activities
Net cash provided by operating activities increased by $305.3 million in the six months ended June 30, 2026, compared to the same period in 2025, primarily due to cash received from increased sales of our products and the impact of the payment of Xyrem antitrust litigation settlements of $172.0 million in the six months ended June 30, 2025.
Investing activities
Net cash provided by (used in) investing activities increased by $1.3 billion in the six months ended June 30, 2026, compared to the same period in 2025, primarily due to the following:
$858.1 million outflow in 2025 related to the net cash paid for the Chimerix Acquisition;
$370.1 million net increase in the proceeds from maturity of investments, driven by time deposits; and
$122.8 million related to the net proceeds from the sale of PRV in January 2026; partially offset by
$77.0 million in upfront payments relating to our collaboration and license agreement with AbCellera and our asset purchase agreement with Werewolf in the six months ended June 30, 2026.
Financing activities
Net cash used in financing activities increased by $135.1 million in the six months ended June 30, 2026, compared to the same period in 2025, primarily due to the following:
The repayment of the 2026 Notes of $1.0 billion in the six months ended June 30, 2026; partially offset by
$750.0 million voluntary repayment on the Tranche B-2 Dollar Term Loan in January 2025; and
$125.0 million in share repurchases in 2025.
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Debt
The summary of our outstanding indebtedness and scheduled maturities with respect to our long-term debt principal balances is included in Note 9, Debt, of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q. In June 2026, we repaid the $1.0 billion aggregate principal amount of the 2026 Notes at maturity and accrued and unpaid interest thereon and issued 1,890,193 ordinary shares. During the quarter ended September 30, 2026, the 2030 Notes will be exchangeable only upon satisfaction of certain conditions, including a condition tied to our share price that is measured as of the end of each quarter, and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. As of the date of this filing, none of the 2030 Notes have been exchanged by the holders.
During the six months ended June 30, 2026, there were no other changes to our financing arrangements, as set forth in Note 11, Debt, of the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2025.

Contractual Obligations
During the six months ended June 30, 2026, there were no material changes to our contractual obligations as set forth in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2025, other than the termination of the Werewolf license and collaboration agreement entered into in May 2022, eliminating potential future milestone obligations, totaling $1,255.0 million, and future royalty obligations under that agreement.

Critical Accounting Estimates
To understand our financial statements, it is important to understand our critical accounting estimates. The preparation of our financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions are required in determining the amounts to be deducted from gross revenues and also with respect to the acquisition and valuation of intangibles and income taxes. Some of these judgments can be subjective and complex, and, consequently, actual results may differ from these estimates. For any given individual estimate or assumption we make, there may also be other estimates or assumptions that are reasonable. Although we believe our estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made.
Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10‑K for the year ended December 31, 2025. Our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10‑K for the year ended December 31, 2025.

Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10‑Q contains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s current beliefs and assumptions and on information currently available to our management. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “opportunity,” “project,” “predict,” “propose,” “intend,” “continue,” “potential,” “possible,” “strive,” “seek,” “designed,” “goal,” “foreseeable,” “likely” or the negative of these words or other similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, time frames or achievements to be materially different from any future results, performance, time frames or achievements expressed or implied by the forward-looking statements.
These known and unknown risks, uncertainties and other factors include, without limitation:
Our inability to maintain revenues from our oxybate franchise would have a material adverse effect on our business, financial condition, results of operations and growth prospects.
The introduction of new products in the U.S. market that compete with, or otherwise disrupt the market for, our oxybate products has adversely affected and may continue to adversely affect sales of our oxybate products.
The distribution and sale of our oxybate products are subject to significant regulatory restrictions, including the requirements of a REMS and safety reporting requirements, and these regulatory and safety requirements subject us to risks and uncertainties, any of which could negatively impact sales of Xywav and Xyrem.
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Our inability to maintain or increase sales of Epidiolex/Epidyolex would have a material adverse effect on our business, financial condition, results of operations and growth prospects.
While we expect Xywav and Epidiolex/Epidyolex to remain our largest products, our success also depends on our ability to effectively commercialize our other existing products and potential future products.
We face substantial competition from other companies, including companies with larger sales organizations and more experience working with large and diverse product portfolios, and competition from generic drugs.
Adequate coverage and reimbursement from third party payors may not be available for our products and we may be unable to successfully contract for coverage from PBMs and other organizations; conversely, to secure coverage from these organizations, we may be required to pay rebates or other discounts or other restrictions to reimbursement, either of which could diminish our sales or adversely affect our ability to sell our products profitably.
The pricing of pharmaceutical products has come under increasing scrutiny as part of a global trend toward healthcare cost containment and resulting changes in healthcare law and policy, including changes to Medicare, may impact our business in ways that we cannot currently predict, which could have a material adverse effect on our business and financial condition.
In addition to access, coverage and reimbursement, the commercial success of our products depends upon their market acceptance by physicians, patients, third party payors and the medical community.
Delays or problems in, or increased costs with respect to, the supply of our products for sale or for use in clinical trials, loss of our single source suppliers or failure to comply with manufacturing regulations could materially and adversely affect our business, financial condition, results of operations and growth prospects.
Global trade issues and changes in and uncertainties with respect to trade policies and export regulations, including import and export license requirements, trade sanctions, tariffs and international trade disputes, could increase our costs, reduce the competitiveness of our products and otherwise have a material adverse effect on our business, financial condition, results of operations and growth prospects.
We may not realize the anticipated benefits from our acquisition of Chimerix.
Our future success depends on our ability to successfully obtain and maintain regulatory approvals for our late-stage product candidates and, if approved, to successfully launch and commercialize those product candidates.
We may not be able to successfully identify and acquire or in-license additional products or product candidates to grow our business, and, even if we are able to do so, we may otherwise fail to realize the anticipated benefits of these transactions.
Conducting clinical trials is costly and time-consuming, and the outcomes are uncertain. A failure to prove that our product candidates are safe and effective in clinical trials, or to generate data in clinical trials to support expansion of the therapeutic uses for our existing products, could materially and adversely affect our business, financial condition, results of operations and growth prospects.
It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection.
We have incurred, and may in the future incur, substantial costs as a result of litigation or other proceedings relating to patents, other intellectual property rights and related matters, and we may be unable to protect our rights to, or commercialize, our products.
Significant disruptions of information technology systems or data security incidents could adversely affect our business.
We are subject to significant ongoing regulatory obligations and oversight, which may subject us to civil or criminal proceedings, investigations, or penalties and may result in significant additional expense and limit our ability to commercialize our products.
If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
We have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position, and our business would be adversely affected if we are unable to service our debt obligations.
To continue to grow our business, we will need to commit substantial resources, which could result in future losses or otherwise limit our opportunities or affect our ability to operate and grow our business.
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If we fail to attract, retain and motivate members of our executive management team and key personnel, our operations and our future growth may be adversely affected.
Additional discussion of the risks, uncertainties and other factors described above, as well as other risks material to our business, can be found under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025.
Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. In addition, our goals and objectives are aspirational and are not guarantees or promises that such goals and objectives will be met. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this filing. You should read this Quarterly Report on Form 10‑Q completely and the documents that we file with the SEC with the understanding that our actual future results and the timing of events may be materially different from what we expect. We hereby qualify our forward-looking statements by our cautionary statements. Except as required by law, we undertake no obligation to update or supplement any forward-looking statements publicly, or to update or supplement the reasons that actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Item 3.Quantitative and Qualitative Disclosures About Market Risk
During the six months ended June 30, 2026, there were no material changes to our market risk disclosures as set forth in Part II, Item 7A “Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Item 4.Controls and Procedures
Evaluation of Disclosure Controls and Procedures. We have carried out an evaluation under the supervision and with the participation of management, including our principal executive officer and principal financial officer, of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10‑Q. Based on their evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of June 30, 2026.
Limitations on the Effectiveness of Controls.  A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.
Changes in Internal Control over Financial Reporting.  During the quarter ended June 30, 2026, there were no changes to our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION

Item 1.Legal Proceedings
The information required to be set forth under this Item 1 is incorporated by reference to Note 10, Commitments and Contingencies—Legal Proceedings of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10‑Q.

Item 1A.Risk Factors
Our material risk factors are disclosed in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. We encourage you to read and carefully consider all of the risk factors disclosed in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025, for a more complete understanding of the risks and uncertainties material to our business.

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds
Issuer Purchases of Equity Securities
On July 31, 2024, we announced that our board of directors had authorized the Repurchase Program pursuant to which our board of directors authorized us to repurchase our ordinary shares for up to an aggregate purchase price of $500.0 million, exclusive of any brokerage commissions. Under the Repurchase Program, which has no expiration date, we may repurchase our ordinary shares from time to time by any methods and/or structures permitted by applicable law. During the three months ended June 30, 2026, we did not repurchase any of our ordinary shares. As of June 30, 2026, the remaining amount authorized under the Repurchase Program was $225.0 million.
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 our outstanding credit agreement and the indenture for our Secured Notes, corporate and regulatory requirements, and market conditions. The Repurchase Program may be modified, suspended or discontinued at any time without our prior notice.

Item 5.Other Information
Insider Trading Arrangements
The following is a summary of the material terms of the contracts, instructions or written plans for the purchase or sale of the Company’s securities adopted or terminated by our officers (as defined in Rule 16a-1(f) under the Exchange Act) and directors during the quarter ended June 30, 2026:
Type of Trading Arrangement
Name and Position
Date
Action
Rule 10b5-1*
Expiration Date
Total Ordinary Shares to be Sold
Robert Iannone
(Executive Vice President, Global Head of Research and Development, Chief Medical Officer)
5/28/2026AdoptionX
5/28/2027, or such earlier date upon which all transactions are completed or expire without execution
Indeterminable(1)
Renee D. Gala
(President and Chief Executive Officer)
6/4/2026AdoptionX
8/5/2027, or such earlier date upon which all transactions are completed
Up to 7,400
Mark D. Smith
(Director)
6/15/2026TerminationX12/31/20261,157
* Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act
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(1) Dr. Iannone's Rule 10b5-1 Trading Plan provides for the (i) same-day exercise and sale of up to 53,700 stock options, (ii) sale of up to 16,038 ordinary shares, (iii) sale of an indeterminable number of ordinary shares sufficient to cover stock option exercise costs and estimated tax withholding amounts and customary brokerage fees, and (iv) sale of an indeterminable number of ordinary shares from the settlement of RSUs and PSUs. The number of ordinary shares in clauses (iii) and (iv) are indeterminable because the numbers will vary based on the extent to which vesting, performance or exercise conditions are satisfied, the market price of the Company's ordinary shares at the time of settlement and the number of shares that would otherwise be issuable on each settlement date of a covered stock option, RSU or PSU that are sold or withheld in an amount sufficient to satisfy the applicable tax withholding obligations.

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Item 6.Exhibits

Exhibit
Number
Description of Document
Form
File No.ExhibitFiling DateFiled Herewith
3.1
Amended and Restated Memorandum and Articles of Association of Jazz Pharmaceuticals Public Limited Company, as amended on August 4, 2016
10-Q001-335003.18/9/2016
10.1
Amended and Restated Non-Employee Director Compensation Policy (approved April 23, 2026)
X
31.1
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended
X
31.2
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended
X
32.1*
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
101.INSXBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL documentX
101.SCHInline XBRL Taxonomy Extension Schema With Embedded Linkbase DocumentX
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)X
__________________

*    The certification attached as Exhibit 32.1 accompanies this Quarterly Report on Form 10‑Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Exchange Act.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: August 3, 2026
 
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
(Registrant)
/s/ Renee D. Gala
Renee D. Gala
President and Chief Executive Officer and Director
(Principal Executive Officer)
/s/ Philip L. Johnson
Philip L. Johnson
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
/s/ Patricia Carr
Patricia Carr
Senior Vice President, Chief Accounting Officer
(Principal Accounting Officer)
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