On November 5, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the third quarter of 2025 and updated financial guidance for 2025.

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"Achieving the highest revenue quarter in Jazz’s history speaks to the strength of our diversified portfolio and the outstanding performance of our team. We were pleased to once again deliver solid execution across our sleep, epilepsy and oncology portfolios, led by double-digit percentage growth from Epidiolex and Xywav," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "In addition, we achieved several key milestones that will enhance our commercial portfolio, including receiving FDA approvals for Modeyso as well as the Zepzelca and atezolizumab first-line maintenance combination. We remain confident in the opportunity presented by zanidatamab and look forward to sharing the top-line data readout from the Phase 3 HERIZON-GEA-01 trial before the end of the year. With a proven portfolio and strong financial foundation, we are well-positioned to accelerate our evolution and deliver meaningful value for patients and shareholders alike."

Key Highlights

•Modeyso received accelerated approval from the FDA ahead of its PDUFA date; initiated commercial launch in August 2025 with strong initial uptake and sales of $11.0 million in 3Q25.
•Zepzelca and atezolizumab combination received FDA approval for 1L maintenance treatment of ES-SCLC based on positive data from the Phase 3 IMforte trial.
•Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25; updated intent-to-treat population for PFS to include all patients enrolled in the trial.
•Narrowed 2025 total revenue guidance range to $4.175 – $4.275 billion from $4.150 – $4.300 billion.
•Announced the appointment of Dr. Ted Love to the Board of Directors.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Net product sales increased 11% to $431.4 million in 3Q25 compared to 3Q24.
•Meaningful net patient adds in 3Q25 of approximately 450 patients. There were approximately 15,675 active patients exiting the quarter comprised of approximately 10,725 narcolepsy patients and approximately 4,950 idiopathic hypersomnia (IH) patients.

Epidiolex/Epidyolex (cannabidiol):
•Net product sales increased 20% to $302.6 million in 3Q25 compared to 3Q24.
•In 3Q25, volumes increased by 10%, driven by demand, and net product sales benefitted from lower gross to net deductions in the U.S.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Net product sales increased 1% to $99.9 million in 3Q25 compared to 3Q24.

Zepzelca (lurbinectedin):
•Net product sales decreased 8% to $79.3 million in 3Q25 compared to 3Q24.
•Zepzelca and atezolizumab combination was included in National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.

Ziihera (zanidatamab-hrii):
•Net product sales were $8.3 million in 3Q25 following product launch in December 2024.
•Updated the intent-to-treat population for the primary PFS (progression-free survival) and interim overall survival analyses of the HERIZON-GEA-01 trial to include the full patient population enrolled in the trial.

Modeyso (dordaviprone):
•Net product sales were $11.0 million in 3Q25 following product launch in August 2025.
•Modeyso was made commercially available quickly following FDA accelerated approval on August 6, ensuring patients with H3 K27M-mutant diffuse midline glioma (DMG) had access to the first and only targeted drug therapy for this ultra-rare and aggressive brain tumor.
•Modeyso was included in the NCCN Clinical Practice Guidelines in Oncology.

Corporate Development:
•The Company announced a global licensing agreement with Saniona to develop and commercialize SAN2355, a highly differentiated, subtype selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy and other potential indications.

Financial Highlights
Three Months Ended
September 30, Nine Months Ended
September 30,
(In thousands, except per share amounts) 2025 2024 2025 2024
Total revenues $ 1,126,107 $ 1,054,969 $ 3,069,660 $ 2,980,777
GAAP net income (loss) $ 251,412 $ 215,055 $ (559,599) $ 369,005
Non-GAAP adjusted net income1
$ 500,653 $ 412,359 $ 101,037 $ 951,445
GAAP earnings (loss) per share $ 4.08 $ 3.42 $ (9.18) $ 5.63
Non-GAAP adjusted earnings per share1
$ 8.13 $ 6.54 $ 1.63 $ 14.25

(Press release, Jazz Pharmaceuticals, NOV 5, 2025, View Source [SID1234659464])