On August 3, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2026 (2Q26) and raised revenue guidance for 2026.
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"Our second quarter results highlight strong execution and momentum across the business, delivering 16% year-over-year total revenue growth and driving a considerable increase to our full-year revenue guidance," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "We remain focused on long-term growth as we prepare to launch Ziihera in HER2+ 1L GEA, advance the zanidatamab and Epidiolex clinical programs, and expand our pipeline through targeted corporate development and internal research and development. The combination of commercial execution, portfolio expansion and our strong financial foundation positions Jazz to deliver meaningful innovation for patients and substantial value for shareholders."
Recent Key Highlights
•Highest ever total quarterly revenues of $1.2 billion with 16% year-over-year (YoY) growth.
•Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $2.78 / $5.71 with $824 million in cash from operations in the first half of 2026.
•U.S. Food and Drug Administration (FDA) granted Priority Review and set Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026 for supplemental Biologics License Application (sBLA) for zanidatamab containing combinations in first-line (1L) gastroesophageal adenocarcinoma (GEA).
•Results from Phase 3 HERIZON-GEA-01 published in The New England Journal of Medicine; additional subgroup analyses presented in an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting showing improved clinical outcomes with zanidatamab-containing combinations regardless of PD-L1 expression, including in PD-L1-negative patients.
•FDA granted Breakthrough Therapy designation (BTD) for zanidatamab in adults with previously treated locally advanced, unresectable, or metastatic HER2-positive colorectal cancer (CRC).
•Following strong 1H26 commercial execution, the company raised its 2026 revenue guidance range to $4.60 – $4.75 billion, reflecting anticipated double-digit YoY revenue growth from both Xywav and the combined epilepsy and oncology franchises.
Business Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 13% YoY to $471 million in 2Q26.
•Robust new patient growth, with approximately 525 net patient adds in 2Q26. There were approximately 17,125 active patients exiting the quarter, comprised of approximately 11,275 narcolepsy patients and approximately 5,850 idiopathic hypersomnia (IH) patients.
•Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.
Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 16% YoY to $292 million in 2Q26, driven by continued strong demand.
•Expanded Epidiolex development program to reach more patients with the following clinical trials: Phase 3 trial in developmental and epileptic encephalopathy (DEE), Phase 2/3 trial in juvenile myoclonic epilepsy (JME) and Phase 3b/4 trial in adult Lennox-Gastaut syndrome (LGS).
•Submitted New Drug Application (NDA) for cannabidiol capsule formulation to broaden utilization of cannabidiol in currently approved indications and increase flexibility for patients.
Ziihera (zanidatamab-hrii):
•Ziihera net product sales in biliary tract cancer (BTC) were $15 million in 2Q26.
•Prepared to launch zanidatamab in HER2+ 1L GEA (PDUFA date of August 25, 2026).
•Top-line results from the second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen are expected in 3Q26.
Modeyso (dordaviprone):
•Modeyso net product sales were $48 million in 2Q26 with more than 600 patients having received Modeyso from product launch in August 2025 through the end of the second quarter of 2026.
•Anticipate the OS interim analysis for the event-driven Phase 3 ACTION trial in 1H27, based on current pace of event accrual.
Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 42% YoY to $106 million in 2Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1L maintenance ES-SCLC setting, partially offset by a decline in second-line use.
•Based on the results from the LAGOON trial of Zepzelca in second-line metastatic SCLC, and in alignment with FDA, in 3Q26, 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.
Corporate Development:
•Announced a preclinical research collaboration with AbCellera Biologics Inc. (AbCellera), to develop next-generation T-cell engaging multispecific antibodies for multiple gastrointestinal (GI) cancers and other solid tumors.
•The company continues to actively evaluate additional value-enhancing corporate development.
Financial Highlights
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except per share amounts) 2026 2025 2026 2025
Total revenues $ 1,208.3 $ 1,045.7 $ 2,277.2 $ 1,943.5
GAAP net income (loss) $ 192.8 $ (718.5) $ 485.9 $ (811.0)
Non-GAAP adjusted net income (loss) $ 396.4 $ (504.8) $ 815.9 $ (399.6)
GAAP earnings (loss) per share $ 2.78 $ (11.74) $ 7.17 $ (13.28)
Non-GAAP adjusted earnings (loss) per share $ 5.71 $ (8.25) $ 12.04 $ (6.54)
GAAP and non-GAAP adjusted net income in 2Q26 includes acquired in-process research and development (IPR&D) expense of $77.0 million, relating to upfront payments made in connection with our collaboration and license agreement with AbCellera and asset purchase agreement to acquire remaining rights for JZP898 from Werewolf Therapeutics, Inc. (Werewolf). This impacted our GAAP and non-GAAP adjusted results by $65.4 million (net of tax of $11.6 million) or $0.94 per share.
GAAP and non-GAAP adjusted net loss in 2Q25 includes acquired IPR&D expense of $905.4 million representing the value allocated to Modeyso in the Chimerix Acquisition, which impacted our results by $14.78 per share and $14.75 per share on a GAAP and non-GAAP adjusted basis, respectively.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Xywav $ 471.2 $ 415.3 $ 879.4 $ 760.1
Xyrem 30.5 35.4 61.7 72.6
Sleep 501.7 450.7 941.1 832.7
Epidiolex/Epidyolex 292.1 251.7 541.9 469.4
Epilepsy 292.1 251.7 541.9 469.4
Zepzelca 105.8 74.5 206.8 137.5
Rylaze/Enrylaze 99.5 100.7 203.2 194.9
Defitelio/defibrotide 62.0 48.1 109.4 88.8
Modeyso 48.2 0.5 89.6 0.5
Vyxeos 31.4 44.9 58.0 74.4
Ziihera 15.4 6.0 28.7 8.0
Oncology 362.3 274.7 695.7 504.1
Other — 8.5 2.7 18.8
Product sales, net 1,156.1 985.6 2,181.4 1,825.0
High-sodium oxybate AG royalty revenue 42.2 54.1 78.5 103.0
Other royalty and contract revenues 10.0 6.0 17.3 15.5
Total revenues $ 1,208.3 $ 1,045.7 $ 2,277.2 $ 1,943.5
Total revenues increased 16% in 2Q26 YoY primarily due to higher Xywav, Epidiolex/Epidyolex and Zepzelca net product sales and the inclusion of Modeyso net product sales, following FDA approval in August 2025.
Operating Expenses and Income Tax Expense (Benefit)
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except percentages) 2026 2025 2026 2025
GAAP:
Cost of product sales $ 116.4 $ 116.3 $ 250.5 $ 220.9
Gross margin on total revenues 90.4% 88.9% 89.0% 88.6%
Selling, general and administrative $ 389.2 $ 358.4 $ 741.9 $ 872.4
% of total revenues 32.2% 34.3% 32.6% 44.9%
Research and development $ 207.5 $ 189.9 $ 403.5 $ 370.6
% of total revenues 17.2% 18.2% 17.7% 19.1%
Acquired in-process research and development $ 77.0 $ 905.4 $ 77.0 $ 905.4
Gain on sale of priority review voucher $ — $ — $ (122.8) $ —
Income tax expense (benefit) $ 18.1 $ (17.2) $ 24.2 $ (35.0)
Effective tax rate 8.6% 2.3% 4.7% 4.1%
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except percentages) 2026 2025 2026 2025
Non-GAAP adjusted:
Cost of product sales $ 95.1 $ 76.3 $ 185.1 $ 146.0
Gross margin on total revenues 92.1% 92.7% 91.9% 92.5%
Selling, general and administrative $ 343.2 $ 310.3 $ 651.7 $ 782.6
% of total revenues 28.4% 29.7% 28.6% 40.3%
Research and development $ 184.9 $ 167.0 $ 357.2 $ 326.7
% of total revenues 15.3% 16.0% 15.7% 16.8%
Acquired in-process research and development $ 77.0 $ 905.4 $ 77.0 $ 905.4
Income tax expense $ 74.4 $ 42.2 $ 115.6 $ 78.7
Effective tax rate 15.8% (9.1)% 12.4% (24.6)%
Changes in operating expenses and income tax expense (benefit) in 2Q26 over the prior year period are primarily due to the following:
•Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 2Q26, primarily due to higher royalty expenses, driven by higher revenues of Modeyso and Zepzelca, offset on a GAAP basis, by lower acquisition accounting inventory fair value step up expense.
•Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2Q26, primarily due to higher marketing investment and compensation-related expenses in support of our commercial portfolio.
•Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2Q26, driven by higher clinical studies costs, primarily related to zanidatamab.
•Acquired IPR&D, on a GAAP and non-GAAP adjusted basis, in 2Q26 comprised the upfront payments to AbCellera and Werewolf.
•Income tax expense, on a GAAP and non-GAAP adjusted basis, in 2Q26 reflects changes in the geographic mix of income and expenses compared to 2Q25.
(Press release, Jazz Pharmaceuticals, AUG 3, 2026, View Source [SID1234669609])