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- **Revenue Record**: Q3 2025 revenue of $1.126B (+7% YoY), driven by sleep, epilepsy, and oncology growth.
- **FDA Wins**: Zepzelca first-line approval and Modeyso launch highlight regulatory momentum.
- **Pipeline Catalysts**: Zanidatamab GEA data due Q4, Kv7 epilepsy deal expands early-stage pipeline.
- **Generic Risk**: 2026 Xyrem generics expected, but Xywav's low-sodium differentiation and Hikma royalties mitigate impact.
- **Financial Strength**: $2B cash, narrowed 2025 guidance to $4.175B–$4.275B, and strong cash flow support growth.

**【CEO Summary Section】**
- **Record Revenue**: Q3 2025 revenue reached $1.126 billion, up 7% YoY, driven by strong performance across sleep, epilepsy, and oncology portfolios.
- **FDA Milestones**: Secured FDA approvals for Zepzelca in first-line maintenance therapy for small cell lung cancer and Modeyso for recurrent diffuse midline glioma. Both treatments were included in NCCN Guidelines.
- **Pipeline Progress**: Zanidatamab Phase III trial in gastroesophageal adenocarcinoma (GEA) expected to report top-line data later in Q4. Acquired Saniona's Kv7.2/3-selective inhibitor for epilepsy, expanding early-stage pipeline.
- **Litigation Resolution**: Settled all Xyrem antitrust and Avadel litigation, reducing legal uncertainties and enabling strategic focus.
- **Revenue Guidance**: Narrowed 2025 revenue guidance to $4.175 billion–$4.275 billion, reflecting confidence in execution.

**【CFO Financial Commentary】**
- **Q3 Financials**: Adjusted net income of $501 million, with ANI boosted by $0.66 per share from deferred tax assets and litigation settlements.
- **Revenue Breakdown**: Sleep portfolio ($520M, +7%), epilepsy ($303M, +20%), oncology ($179M, -8%), and new products (Modeyso: $11M) drove growth.
- **Cost Management**: Strong cash flow ($998M for 9M 2025) and balance sheet ($2B in cash), supporting R&D and M&A.
- **Guidance Adjustments**: Reduced R&D and SG&A due to portfolio optimization and lower litigation costs.

**【Commercial Highlights】**
- **Xywav**: $431M in net sales (+11% YoY), 450 net patient adds, and 10% volume growth. Facing potential generic competition in 2026, but differentiation via low sodium and IH exclusivity maintained.
- **Epidiolex**: $303M (+20% YoY), 10% volume growth, and/blockbuster status on track. Refinement of U.S. accruals boosted Q3 revenue.
- **Modeyso**: $11M in first 2 weeks post-launch, 200+ patients treated, and rapid uptake in ultra-rare glioma.
- **Zepzelca**: $79M (-8% YoY) due to competitive dynamics, but new first-line indication poised for growth.

**【Pipeline & R&D】**
- **Zanidatamab**: HERIZON-GEA trial updated to ITT PFS analysis (920 pts) and OS interim in Q4. Fully enrolled with 50%+ enrollment in ACTION trial for diffuse glioma.
- **Kv7.2/3 Inhibitor**: Licensing deal with Saniona for epilepsy, targeting nonselective Kv7 limitations.
- **Dordaviprone**: NDA submission for diffuse glioma expected in H1 2026, with 95+ sites enrolled.

**【Q&A Highlights】**
- **Generic Xyrem**: 2026 entry could disrupt Xywav, but Jazz maintains low-sodium differentiation and royalty participation via Hikma agreement.
- **Orexin Agonists**: Xywav's sleep architecture benefits (DUET study) position it as complementary to wake-promoters, not direct competitors.
- **Zanidatamab Pricing**: GEA launch expected to align with BTC pricing, leveraging existing infrastructure.
- **Kv7 Pipeline**: Best-in-class specificity for epilepsy, with IND filing planned in 2026.

Jazz Pharmaceuticals plc (JAZZ) Q3 2025 Earnings Call Transcript

Revenue

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JAZZ

JAZZ fundamentals

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