– Zanidatamab HER2+ 1L GEA sBLA granted Priority Review; PDUFA date of August 25, 2026,
– Xywav® revenues grew 18% YoY with 425 net patient adds,
– Epidiolex® revenues grew 15% YoY–
– Company reaffirms 2026 revenue and expense guidance,
DUBLIN, May 5, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced financial results for the first quarter of 2026 (1Q26).
"Our first-quarter results reflect disciplined execution across the business, delivering 19% year-over-year growth alongside key pipeline advancements and positioning the company for an outstanding 2026," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "Demand for Xywav remained strong, our rare oncology launches with Modeyso™ and Zepzelca® in 1LM ES-SCLC gained significant momentum, and Epidiolex continued to provide consistent growth. Looking ahead, we are excited about the potential launch of zanidatamab in 1L GEA later this year, as we progress our pipeline and business development efforts to bring more life-changing therapies to patients and fuel durable long-term growth."
Key First Quarter 2026 Highlights
Total revenues in 1Q26 grew to $1.1 billion (+19% year-over-year (YoY))
Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $4.43 / $6.34 with $408 million in cash from operations.
Practice-changing Phase 3 HERIZON-GEA-01 results, presented as a late-breaker at ASCO GI, support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L advanced gastroesophageal adenocarcinoma (GEA); additional benefit from tislelizumab irrespective of PD-L1 status.
Supplemental Biologics License Application (sBLA) accepted by FDA under Real-Time Oncology Review (RTOR) program with potential approval and launch in 1L HER2+ GEA on or before PDUFA date.
Business Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
Xywav net product sales increased 18% to $408 million in 1Q26, compared to 1Q25.
Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.
Strong new patient growth, with approximately 425 net patient adds in 1Q26. There were approximately 16,600 active patients exiting the quarter, comprised of approximately 11,075 narcolepsy patients and approximately 5,525 idiopathic hypersomnia (IH) patients.
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1 Non-GAAP adjusted EPS is a non-GAAP financial measure. See 'Non-GAAP Financial Measures' below for more information. A reconciliation of GAAP reported EPS to non-GAAP adjusted EPS is included at the end of this press release.
Epidiolex/Epidyolex (cannabidiol):
Epidiolex/Epidyolex net product sales increased 15% YoY to $250 million in 1Q26, driven by continued strong demand.
Announced agreement with Nippon Zoki to commercialize Epidyolex in Japan, following completion of ongoing clinical trials and potential regulatory approval.
Ziihera® (zanidatamab-hrii):
Ziihera net product sales in biliary tract cancer (BTC) were $13 million in 1Q26.
In April 2026, FDA accepted the zanidatamab sBLA in GEA for a Priority Review, with a PDUFA date of August 25, 2026.
Submitted HERIZON-GEA-01 data for potential National Comprehensive Cancer Network (NCCN) guideline inclusion.
HERIZON-GEA-01 data accepted for publication by a top-tier medical journal.
The second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen is expected in mid-2026.
Multiple registrational trials of zanidatamab are underway, including in metastatic breast cancer (mBC), supporting a broad development program designed to maximize patient impact and long-term shareholder value.
Modeyso (dordaviprone):
Modeyso net product sales were $41 million in 1Q26 with ~500 patients having received Modeyso from product launch in August 2025 through the end of the first quarter.
The company completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $200 million (50% to Jazz).
Phase 3 ACTION trial remains on track with top-line readout expected late 2026 / early 2027.
Zepzelca (lurbinectedin):
Zepzelca net product sales increased 60% YoY to $101 million in 1Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1LM ES-SCLC setting, partially offset by a decline in second line use.
The company expects second line use to decline throughout the year.
Financial Highlights
Three Months Ended
March 31,
(In millions, except per share amounts)
2026
2025
Total revenues
$ 1,068.9
$ 897.8
GAAP net income (loss)
$ 293.1
$ (92.5)
Non-GAAP adjusted net income
$ 419.5
$ 105.2
GAAP earnings (loss) per share
$ 4.43
$ (1.52)
Non-GAAP adjusted earnings per share
$ 6.34
$ 1.68
The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172 million related to Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146 million (net of tax of $26 million), or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
Three Months Ended
March 31,
(In millions)
2026
2025
Xywav
$ 408.2
$ 344.8
Xyrem
31.2
37.2
Sleep
439.4
382.0
Epidiolex/Epidyolex
249.8
217.7
Epilepsy
249.8
217.7
Rylaze/Enrylaze
103.7
94.2
Zepzelca
101.0
63.0
Defitelio/defibrotide
47.4
40.7
Modeyso
41.4
—
Vyxeos
26.6
29.5
Ziihera
13.3
2.0
Oncology
333.4
229.4
Other
2.7
10.3
Product sales, net
1,025.3
839.4
High-sodium oxybate AG royalty revenue
36.3
48.9
Other royalty and contract revenues
7.3
9.5
Total revenues
$ 1,068.9
$ 897.8
Total revenues increased 19% YoY primarily due to higher Xywav, Zepzelca and Epidiolex/Epidyolex 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
March 31,
(In millions, except percentages)
2026
2025
GAAP:
Cost of product sales
$ 134.1
$ 104.6
Gross margin on total revenues
87.5 %
88.3 %
Selling, general and administrative
$ 352.7
$ 514.0
% of total revenues
33.0 %
57.3 %
Research and development
$ 196.0
$ 180.7
% of total revenues
18.3 %
20.1 %
Gain on sale of priority review voucher
$ (122.8)
$ —
Income tax expense (benefit)
$ 6.1
$ (17.8)
Effective tax rate
2.0 %
16.2 %
Three Months Ended
March 31,
(In millions, except percentages)
2026
2025
Non-GAAP adjusted:
Cost of product sales
$ 90.0
$ 69.7
Gross margin on total revenues
91.6 %
92.2 %
Selling, general and administrative
$ 308.5
$ 472.3
% of total revenues
28.9 %
52.6 %
Research and development
$ 172.3
$ 159.7
% of total revenues
16.1 %
17.8 %
Income tax expense
$ 41.2
$ 36.5
Effective tax rate
8.9 %
25.7 %
Changes in operating expenses and income tax expense (benefit) in 1Q26 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 1Q26, primarily due to higher royalty expenses, driven by higher revenues, and increased inventory provisions. The cost of product sales, on a GAAP basis, in 1Q26 included higher acquisition accounting inventory fair value step up expense compared to 1Q25.
Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 1Q26, primarily due to certain Xyrem antitrust litigation settlements of $172 million incurred in 1Q25, partially offset by higher compensation-related expenses in 1Q26 including costs relating to Modeyso.
Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, increased in 1Q26, primarily due to the addition of costs relating to Modeyso including personnel costs.
Income tax expense in 1Q26, on a GAAP basis, was primarily attributable to the gain recognized on the sale of the PRV, partially offset by excess tax benefits from share-based compensation. Income tax benefit in 1Q25, on a GAAP basis, was primarily attributable to the Xyrem antitrust litigation settlements.
Cash Flow and Balance Sheet
As of March 31, 2026, cash, cash equivalents and investments were $2.9 billion, and the outstanding principal balance of the company's long-term debt was $5.4 billion. In addition, the company had undrawn borrowing capacity under a revolving credit facility of $885 million. For the three months ended March 31, 2026, the company generated $408 million of cash from operations reflecting strong business performance and continued financial discipline. In 1Q26, the company received gross proceeds of $200 million (50% to Jazz) from the sale of the PRV.
2026 Financial Guidance
(In millions)
Guidance
Total Revenues
$4,250 - $4,500
(In millions, except percentages)
GAAP
Non-GAAP
Gross margin %
89% - 90%
90% - 91%1
SG&A expenses
$1,424 - $1,497
$1,260 - $1,3201
R&D expenses
$811 - $867
$725 - $7751
Effective tax rate
0% - 10%
11.5% - 13.5%1
Weighted-average ordinary shares outstanding2
66 - 67
66 - 67
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1.
See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included in the table titled "Reconciliation of 2026 GAAP to Non-GAAP Guidance Measures".
2.
Prior guidance as of February 24, 2026 was 65-66 million weighted-average ordinary shares outstanding. Guidance assumes inclusion of shares outstanding in relation to the 2.000% exchangeable senior notes due 2026 and the 3.125% exchangeable senior notes due 2030, which we refer to collectively as the Exchangeable Senior Notes, given the company's share price exceeds the conversion prices of the Exchangeable Senior Notes.
Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET to provide a business and financial update and discuss its 2026 first quarter results.
Interested parties may register for the call here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.
A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharma 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 research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to ...
