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CALL PARTICIPANTS
President and Chief Executive Officer — Renee Gala
Executive Vice President and Chief Commercial Officer — Sam Pierce
Executive Vice President, Global Head of R&D and Chief Medical Officer — Rob Iannone
Executive Vice President and Chief Financial Officer — Phil Johnson
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RISKS
The company explicitly acknowledged: “the availability of generics could result in payer actions that cause some level of disruption to Xywav’s revenue,” according to Sam Pierce, introducing uncertainty for its key sleep therapeutic segment in 2026.
Zepzelca net product sales decreased 8% year over year in 2025 due to “continued competitive dynamics in the second-line setting,” according to Sam Pierce, signaling ongoing market pressures in oncology.
TAKEAWAYS
Total Revenue — $1.126 billion in total revenue in the third quarter of 2025, reflecting 7% growth compared to the same period in 2024.
Xywav Net Product Sales — $431 million for Q3 2025, up 11% year over year; net patient adds totaled 450 for Q3 2025 (125 from narcolepsy, 325 from idiopathic hypersomnia).
Epidiolex Net Product Sales — $303 million in net product sales for Q3 2025, marking a 20% increase compared to the same period in 2024; volume growth reached 10% for Q3 2025, with additional revenue benefit attributed to U.S. accrual refinements.
Sleep Therapeutic Area Revenue — $520 million for Q3 2025, with performance largely led by Xywav and Xyrem.
Modesto Net Product Sales — $11 million in net product sales generated in 2025 following FDA approval; over 200 patients received the therapy as of Q3 2025, with most being new starts.
Zepzelca Net Product Sales — $79 million in net product sales for 2025, down 8% year over year; received FDA approval for combination with atezolizumab as first-line maintenance for extensive-stage small cell lung cancer.
Rylaze Net Product Sales — $100 million net product sales for 2025, representing 1% growth compared to 2024, with pediatric usage stable despite overall class declines.
Oncology Product Revenue — primarily from Modesto and Zepzelca additions, offset by lower Defitelio and Zepzelca sales.
Adjusted Net Income (ANI) — Adjusted net income (non-GAAP) was $501 million for Q3 2025; results included discrete impacts from deferred tax assets (Chimerix acquisition), litigation settlements, and the SANEONA license in non-GAAP results, collectively increasing non-GAAP EPS by $0.66 per share.
Cash Flow — Nearly $1 billion generated in the first nine months of 2025 (cash flow); quarter-end cash and investments totaled $2 billion.
Full-Year 2025 Revenue Guidance — Narrowed to $4.175 billion-$4.275 billion, reflecting increased confidence with one quarter remaining.
FDA Approvals — Both Modesto (for recurrent H3K27M mutant diffuse midline glioma) and Zepzelca plus atezolizumab (first-line maintenance for extensive-stage small cell lung cancer) received FDA approval in the quarter, with both included in NCCN guidelines.
Pipeline Progress — Top-line Phase III results for zanadatumab Horizon GEA trial in gastroesophageal adenocarcinoma are expected later in the quarter, following an FDA-aligned change expanding intent-to-treat analysis to all 920 enrolled patients for PFS in the Horizon GEA-one trial.
Litigation Settlements — Comprehensive settlements were achieved in Xyrem antitrust litigation and with Avadel, resolving outstanding legal exposures in those areas.
Corporate Development — Acquisition of Chimerix strengthened the portfolio via the Modesto launch; global SANEONA licensing expands the early-stage epilepsy pipeline with the SAM-2355 preclinical candidate.
Royalty Arrangements — An amendment with HICMA extends Jazz’s authorized generic agreement for high sodium oxybate by two years and maintains current royalty rates through 2025 (with later stepdowns), enabling continued participation in the narcolepsy market segment.
Guideline and Label Changes — American Heart Association and American College of Cardiology guidelines published in August reinforce the market positioning of low sodium Xywav, supported by Xylo study data.
Upcoming Catalysts — Interim analysis for the Phase III confirmatory dirdevaprone trial in H3K27M mutant glioma is targeted for late 2026 or early 2027 following proposed sample size adjustment, subject to FDA alignment.
SUMMARY
Jazz Pharmaceuticals (JAZZ 0.53%) delivered a quarterly revenue record, fueled by double-digit sales growth for Xywav and Epidiolex during the third quarter of 2025, while successfully launching Modesto and expanding Zepzelca’s label through key FDA approvals. Notable litigation settlements removed material overhangs from Xyrem antitrust and Avadel disputes, and disciplined capital allocation allowed the company to further invest in both its pipeline and external innovation. The guidance range for full-year revenue was narrowed, and upcoming data readouts—particularly for zanadatumab in gastroesophageal adenocarcinoma—represent significant near-term catalysts for the company.
Phil Johnson stated, “In the fourth quarter, we’ll have thirteen shipping weeks for our US oncology products,” which is fewer than in both the prior quarter (Q3 fiscal 2025, period ended Sept. 30, 2025) and the previous year’s fourth quarter (Q4 fiscal 2024, period ended Dec. 31, 2024), and may affect sequential comparisons.
Rob Iannone confirmed, As we announced today and after alignment with FDA, we have updated the intent-to-treat patient population for PFS to include all enrolled patients, increasing the PFS cohort from the targeted 714 to 920, which is the actual number of enrolled patients as detailed on clinicaltrials.gov, enabling the progression-free survival endpoint to be analyzed across all 920 randomized subjects.
The SANEONA deal introduces a preclinical epilepsy candidate with targeted KV7.2/7.3 specificity, which company leadership describes as potentially best in class due to anticipated improved tolerability over less selective molecules according to Rob Iannone.
An expanded authorized generic agreement with HICMA for high sodium oxybate enables Jazz to retain a royalty stream as generics enter the narcolepsy market and enhances control through new termination rights and set royalty rate reductions after 2025.
INDUSTRY GLOSSARY
PFS (Progression-Free Survival): The length of time during and after treatment in which a patient lives with a disease without it worsening.
Overall Survival (OS): Duration from the start of treatment or trial enrollment until death from any cause.
NCCN Guidelines: Clinical practice guidelines published by the National Comprehensive Cancer Network, providing evidence-based recommendations for cancer care professionals.
Kv7 (KCNQ) Channels: Potassium channel subtypes involved in neuronal excitability, with Kv7.2/7.3 specifically targeted for improved efficacy and tolerability in epilepsy treatments.
IH (Idiopathic Hypersomnia): A chronic sleep disorder characterized by excessive daytime sleepiness not caused by other medical conditions.
Full Conference Call Transcript
Renee Gala, President and Chief Executive Officer; Sam Pierce, Executive Vice President and Chief Commercial Officer; Ravi Anon, Executive Vice President, Global Head of R&D and Chief Medical Officer; and Phil Johnson, Executive Vice President and Chief Financial Officer. On slide two, I’d like to remind you that today’s webcast includes forward-looking statements, such as those related to our future financial and operating results, which involve risks and uncertainties that could cause actual events to differ materially from those contained in the forward-looking statements made on today’s webcast.
We encourage you to review these risks and uncertainties described in today’s press release and under the caption Risk Factors in our annual report on Form 10-K for the fiscal year ended 12/31/2024, and our subsequent filings with the SEC, including our quarterly report on Form 10-Q for the fiscal quarter ended 09/30/2025. We undertake no duty or obligation to update our forward-looking statements. As noted on Slide three, we will discuss non-GAAP financial measures on this webcast. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today’s press release and the slide presentation available on the Investors section of our website. I’ll now turn the call over to Renee.
Renee Gala: Thanks, Jack. Good afternoon, everyone, and thank you for joining us to discuss Jazz Pharmaceuticals’ third quarter 2025 results. I’m delighted to be speaking with you today as Jazz’s CEO. The past three months have been energizing and productive. We delivered two FDA approvals that underscore Jazz’s ability to bring highly differentiated therapies to patients with serious unmet needs. These milestones reflect the strength of our execution, dedication of our teams, and our continued momentum to drive sustainable growth and meaningful value for our patients and our shareholders. Beginning on Slide five, the results of the quarter reflect that momentum.
Starting with commercial, we achieved our highest ever revenue quarter, over $1.1 billion, driven by robust growth from Xywav, Epidiolex, and the early successful launch of Modesto, the first and only drug treatment for recurrent H3K27M mutant diffuse midline glioma, an ultra-rare and aggressive brain tumor. Approval of Modesto followed the acquisition of Chimerix earlier this year, reinforcing our ability to strengthen our portfolio through corporate development. We also secured FDA approval for Zepzelca in combination with atezolizumab as a first-line maintenance therapy for extensive-stage small cell lung cancer. Both therapies are now included in NCCN guidelines, reflecting the meaningful advancements these therapies bring to patients.
Moving on to our pipeline, we look forward to sharing the highly anticipated top-line results from the Phase III zanidatumab horizon trial in gastroesophageal adenocarcinoma or GEA later this quarter. In addition, we strengthened our early-stage epilepsy pipeline through a global licensing agreement with SANEONA. This agreement provides Jazz with worldwide rights to develop and commercialize SAM-2355, a promising preclinical candidate designed to overcome the limitations of nonselective KD7 targeting compounds. On the financial front, we remain strongly positioned to invest in the growth drivers of our business. We narrowed our 2025 revenue guidance to a range of $4.175 billion to $4.275 billion, reflecting increased confidence in our outlook at this point in the year.
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