– Expect to complete sBLA submission in 1Q26 under RTOR for zanidatamab in HER2+ 1L GEA,
– Xywav® achieved $1.7 billion in revenue and 12% YoY growth in 2025,
– Epidiolex® achieved $1.1 billion in revenue and 9% YoY growth in 2025,
– Strong Modeyso™ launch with $37 million in revenue in first full quarter on market,
– Expect 2026 total revenues of $4.25 to $4.50 billion,
DUBLIN, Feb. 24, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced financial results for the full year and fourth quarter of 2025 and provided financial guidance for 2026.
"2025 was an exceptional year for Jazz, representing our 21st consecutive year of top-line growth and underscoring our commitment to operational excellence as we deliver meaningful innovation for patients," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "In the fourth quarter, our disciplined execution resulted in $1.2 billion in revenue, reflecting 10% year-over-year growth and our highest revenue quarter ever. This performance provides us with strong momentum into 2026, as we prepare for the potential launch of zanidatamab in GEA, sustain launch execution for Modeyso and Zepzelca®, and reinforce the differentiated profiles of Epidiolex and Xywav as the leading branded treatments for epilepsy and narcolepsy, respectively. In parallel, we continue to advance our pipeline and pursue a corporate development strategy aligned with our rare disease focus that supports durable growth and long-term value creation for patients and shareholders."
"Jazz had a transformative year across our R&D pipeline, led by the HERIZON-GEA-01 data, which we believe firmly positions zanidatamab as the HER2-targeted agent of choice, with the potential to reshape first-line treatment for HER2+ metastatic GEA patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "We expect to build on this progress in 2026, as these results not only highlight zanidatamab's potential to help patients with GEA, but also de-risk our clinical trials in additional indications, including HER2+ metastatic breast cancer."
Key 2025 Highlights
Total revenues in 2025 grew to $4.3 billion (+5% year-over-year (YoY)), generating $1.4 billion in cash from operations.
Research & Development:
Practice-changing Phase 3 HERIZON-GEA-01 results support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status.
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.
Commercial:
Continued leadership in rare sleep with Xywav net product sales increasing to $1.7 billion (+12% YoY) and total sleep franchise1 revenues exceeding $2 billion in 2025.
Epidiolex/Epidyolex® generated more than $1 billion in 2025 net product sales (+9% YoY).
Completed acquisition of Chimerix Inc., secured FDA approval for and successfully launched Modeyso (dordaviprone) in H3 K27M-mutant diffuse midline glioma, achieving $48 million in sales since launch in August 2025.
Received FDA approval and launched Zepzelca, in combination with atezolizumab, for first-line maintenance treatment of extensive-stage small cell lung cancer.
Company expects 2026 total revenue of between $4.25 and $4.50 billion, with double-digit growth across the combined epilepsy and oncology franchises, and Xywav revenue flat to up mid-single digits.
Tom Riga was named chief business officer to accelerate corporate development efforts across rare disease.
____________________________
1
Rare sleep franchise consists of Xywav, Xyrem® and high-sodium oxybate authorized generic (AG) royalties.
Business Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
Xywav net product sales increased 12% to $1.7 billion in 2025 and increased 16% to $465 million in 4Q25 compared to the same periods in 2024.
Strong new patient growth continued, with approximately 500 net patient adds in 4Q25. There were approximately 16,175 active patients exiting the quarter, comprised of approximately 10,950 narcolepsy patients and approximately 5,225 idiopathic hypersomnia (IH) patients.
Epidiolex/Epidyolex (cannabidiol):
Epidiolex/Epidyolex achieved blockbuster status in 2025 with net product sales increasing 9% to $1.1 billion in 2025 and increasing 4% to $287 million in 4Q25 compared to the same periods in 2024.
Ziihera® (zanidatamab-hrii):
Ziihera net product sales in biliary tract cancer (BTC) were $25 million in 2025 and $9 million in 4Q25 following product launch in December 2024.
Expect to complete supplemental biologics license application (sBLA) submission under Real Time Oncology Review (RTOR) in 1Q26 with potential launch in 1L HER2+ GEA in 2H26.
FDA granted Breakthrough Therapy designation (BTD) for zanidatamab's development for patients with HER2+ unresectable locally advanced or metastatic GEA.
Submitted HERIZON-GEA-01 data for potential inclusion in National Comprehensive Cancer Network (NCCN) guidelines.
EmpowHER-BC-303 trial in mBC patients previously treated with, or intolerant to, trastuzumab deruxtecan on track to complete enrollment in 1H27, with top-line results expected in late 2027 or early 2028.
Modeyso (dordaviprone):
Following product launch in August 2025, Modeyso net product sales were $48 million in 2025 and $37 million in 4Q25.
The Company sold its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $200 million (50% to Jazz).
Zepzelca (lurbinectedin):
Zepzelca net product sales decreased 4% to $307 million in 2025 and increased 15% to $90 million in 4Q25 compared to the same periods in 2024.
Financial Highlights
Three Months Ended
December 31,
Year Ended
December 31,
(In thousands, except per share amounts)
2025
2024
2025
2024
Total revenues
$ 1,197,926
$ 1,088,173
$ 4,267,586
$ 4,068,950
GAAP net income (loss)
$ 203,451
$ 191,115
$ (356,148)
$ 560,120
Non-GAAP adjusted net income1
$ 420,888
$ 400,525
$ 521,924
$ 1,351,970
GAAP earnings (loss) per share
$ 3.21
$ 3.11
$ (5.84)
$ 8.65
Non-GAAP adjusted earnings per share1
$ 6.64
$ 6.51
$ 8.38
$ 20.65
____________________________
1.
Commencing with the first quarter of 2025, we are no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures and for the purposes of comparability, non-GAAP adjusted financial measures for the 2024 periods have been updated to reflect this change. See "Non-GAAP Financial Measures" below.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
Three Months Ended
December 31,
Year Ended
December 31,
(In thousands)
2025
2024
2025
2024
Xywav
$ 465,451
$ 400,964
$ 1,656,986
$ 1,473,202
Xyrem
37,781
49,290
146,034
233,816
Epidiolex/Epidyolex
287,122
275,047
1,059,197
972,423
Sativex
1,503
5,173
16,277
18,877
Total Neuroscience
791,857
730,474
2,878,494
2,698,318
Rylaze/Enrylaze
108,160
101,487
402,920
410,846
Zepzelca
90,440
78,328
307,309
320,318
Defitelio/defibrotide
58,872
57,650
199,392
216,565
Vyxeos
34,731
53,247
146,709
162,595
Modeyso
36,541
—
48,043
—
Ziihera
8,538
1,051
24,810
1,051
Total Oncology
337,282
291,763
1,129,183
1,111,375
Other
3,309
2,974
14,172
11,471
Product sales, net
1,132,448
1,025,211
4,021,849
3,821,164
High-sodium oxybate AG royalty revenue
55,696
55,307
211,725
217,575
Other royalty and contract revenues
9,782
7,655
34,012
30,211
Total revenues
$ 1,197,926
$ 1,088,173
$ 4,267,586
$ 4,068,950
Total revenues increased 5% in 2025 and 10% in 4Q25 compared to the same periods in 2024.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $3.1 billion in 2025, an increase of 6% compared to $2.9 billion in 2024, and $848 million in 4Q25, an increase of 8% compared to $786 million in 4Q24. The increase in both periods was primarily due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales.
Oncology net product sales were $1.1 billion in 2025, an increase of 2% compared to 2024, and $337 million in 4Q25, an increase of 16% compared to $292 million in 4Q24, primarily due to the inclusion of Modeyso and Ziihera net product sales in both periods. The increase in 4Q25 also included higher Zepzelca net product sales, partially offset by decreased Vyxeos® net product sales.
Operating Expenses and Income Tax (Benefit) Expense
Three Months Ended
December 31,
Year Ended
December 31,
(In thousands, except percentages)
2025
2024
2025
2024
GAAP:
Cost of product sales
$ 153,528
$ 128,713
$ 503,296
$ 445,713
Gross margin on product sales, net
86.4 %
87.4 %
87.5 %
88.3 %
Selling, general and administrative
$ 406,212
$ 369,287
$ 1,809,271
$ 1,385,294
% of total revenues
33.9 %
33.9 %
42.4 %
34.0 %
Research and development
$ 213,909
$ 240,500
$ 782,736
$ 884,000
% of total revenues
17.9 %
22.1 %
18.3 %
21.7 %
Acquired in-process research and development
$ ,
$ ,
$ 947,862
$ 10,000
Income tax (benefit) expense
$ 4,963
$ (57,912)
$ (272,443)
$ (91,429)
Effective tax rate
2.4 %
(43.5) %
43.4 %
(19.4) %
Three Months Ended
December 31,
Year Ended
December 31,
(In thousands, except percentages)
2025
2024
2025
2024
Non-GAAP adjusted:
Cost of product sales
$ 106,841
$ 86,492
$ 336,016
$ 295,897
Gross margin on product sales, net
90.6 %
91.6 %
91.6 %
92.3 %
Selling, general and administrative
$ 360,533
$ 323,167
$ 1,603,255
$ 1,226,724
% of total revenues
30.1 %
29.7 %
37.6 %
30.1 %
Research and development
$ 189,915
$ 220,857
$ 686,645
$ 809,327
% of total revenues
15.9 %
20.3 %
16.1 %
19.9 %
Acquired in-process research and development
$ ,
$ ,
$ 947,862
$ 10,000
Income tax (benefit) expense
$ 73,628
$ (435)
$ (26,467)
$ 127,093
Effective tax rate
14.9 %
(0.1) %
(5.3) %
8.6 %
Changes in operating expenses and income tax (benefit) expense in 2025 and 4Q25 over the prior year periods are primarily due to the following:
Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 2025 compared to 2024, primarily due to changes in product mix. Cost of product sales, on a GAAP basis, in 2025 included higher acquisition accounting inventory fair value step up expense compared to 2024. Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 4Q25 compared to 4Q24, primarily due to changes in product mix, partially offset by lower inventory provisions.
Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2025 compared to 2024, primarily due to Xyrem antitrust litigation settlements of $234 million, the Avadel litigation settlement of $90 million and higher compensation-related expenses. SG&A expenses, on a GAAP and non-GAAP adjusted basis, increased in 4Q25 compared to 4Q24, primarily due to higher compensation-related expenses.
Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 2025 and 4Q25, compared to the same periods in 2024, primarily due to lower clinical study costs primarily related to zanidatamab as a result of timing of clinical trial activities, JZP385 (essential tremor) following discontinuation of this program, and JZP258 (XYLO/DUET) due to the completion of these trials in the first half of 2025, partially offset by the addition of costs relating to Modeyso and increased personnel costs following the acquisition of Chimerix.
Acquired in-process research and development (IPR&D) in 2025, on a GAAP and non-GAAP adjusted basis, represents the value allocated to Modeyso in the Chimerix Acquisition of $905 million and the upfront payment made in connection with our global license agreement with Saniona of $43 million.
Income tax benefit in 2025, on a GAAP and non-GAAP adjusted basis, included a benefit of $213 million on recognition of certain U.S. federal and state deferred tax assets acquired through the Chimerix acquisition. Income tax benefit, on a GAAP and non-GAAP adjusted basis, in 4Q24 was primarily due to patent box benefits recognized.
Cash Flow and Balance SheetAs of December 31, 2025, cash, cash equivalents and investments were $2.4 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 year ended December 31, 2025, the Company generated $1.4 billion of cash from operations reflecting strong business performance and continued financial discipline.
2026 Financial Guidance Jazz Pharmaceutical's full year 2026 financial guidance is as follows:
(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
65 - 66
65 - 66
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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.
Assumes inclusion of shares outstanding in relation to the 2.000% exchangeable senior notes due 2026, or the 2026 Notes, and the 3.125% exchangeable senior notes due 2030, or the 2030 Notes, 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 DetailsJazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. GMT) to provide a business and financial update and discuss its 2025 full year and 4Q25 results and 2026 guidance.
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 PharmaceuticalsJazz 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 serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Non-GAAP Financial MeasuresTo supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the ...
