On May 5, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2026 (1Q26).

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"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 (Free ASCO Whitepaper) 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.

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.

(Press release, Jazz Pharmaceuticals, MAY 5, 2026, View Source [SID1234665121])