Jazz Pharmaceuticals plc Q3 FY2025 earnings call

Key Points

• Delivered 2 FDA approvals, including Modeyso and Zepzelca.
• Achieved highest ever revenue quarter over $1.1 billion, driven by Xywav, Epidiolex, and Modeyso's launch.
• Pipeline: Look forward to top line results from Phase III zanidatamab HERIZON trial in gastroesophageal adenocarcinoma; strengthened early-stage epilepsy pipeline via licensing agreement with Saniona.
• Financial: Narrowed 2025 revenue guidance to $4.175 billion to $4.275 billion; reached settlement agreements across Xyrem antitrust litigation and Avadel litigation.

During the third quarter, Jazz Pharmaceuticals achieved its highest ever revenue quarter over $1.1 billion. In the sleep therapeutic area, including Xywav, Xyrem and high-sodium oxybate authorized generic royalties, total revenue was $520 million. Xywav net product sales grew 11% year-over-year to $431 million. Epidiolex net product sales were $303 million, a 20% increase compared to the third quarter of 2024, with 10% volume growth. For oncology, Rylaze net product sales were $100 million, a 1% increase compared to the third quarter of 2024. Zepzelca net product sales for the third quarter of 2025 were approximately $79 million, a decrease of 8% year-over-year. Modeyso became commercially available less than 2 weeks after receiving accelerated approval, generating $11 million in net product sales during the third quarter.

• Narrowed 2025 revenue guidance to $4.175 billion to $4.275 billion.
• Adjusted SG&A and R&D guidance considering litigation settlements, portfolio optimization, and Saniona deal.
• Fourth quarter U.S. oncology products have 13 shipping weeks, 1 less week than third quarter of 2025 and fourth quarter of 2024.

• Potential disruption to Xywav revenue due to entry of Xyrem generics in 2026.
• Regulatory uncertainties affecting pipeline and approval timelines.

Q: Marc Goodman asked about Kv7 being potential best-in-class and Epidiolex's gross to net benefit.

A: Robert Iannone discussed Kv7's specificity for Kv7.2 and Kv7.3 avoiding off-target toxicity, and Samantha Pearce mentioned Epidiolex had 10% volume growth and revenue boost from accrual rate refinement.

Q: Jessica Fye inquired about Xywav's generic entry in 2026 and HERIZON-GEA trial's PFS analysis.

A: Robert Iannone explained PFS analysis update due to slower event accrual and FDA alignment; Samantha Pearce talked about unknowns in generic entry like number, timing, and pricing.

Q: Andrea Tan followed up on Xywav's competitive threat defense.

A: Samantha Pearce mentioned strong field team execution, Xywav's differentiation, and extension of agreement with Hikma.

Q: Akash Tewari asked about FDA confidence in HERIZON-GEA with no U.S. patients.

A: Robert Iannone stated FDA focus on representative patient population and trial conduct alignment.

Q: Jason Gerberry asked about Xywav generics and orexin data in narcolepsy type 2.

A: Samantha Pearce talked about unknowns in generic impact; Robert Iannone discussed orexin data and Xywav's position.

Q: Mohit Bansal inquired about authorized generic royalties for 2026.

A: Philip Johnson said assumption of AG from Hikma in 2026 with royalty details.

Q: David Amsellem asked about Xywav pricing concessions.

A: Renee Galá said focused on access and current position, more to come in 2026.

Q: Annabel Samimy asked about Modeyso uptake and Zepzelca first-line contribution.

A: Renee Galá and Samantha Pearce discussed Modeyso launch progress and Zepzelca early stage.

Q: Brian Skorney asked about GEA readout powering.

A: Robert Iannone talked about PFS and OS powering and analysis.

Q: David Hoang asked about HERIZON-GEA disclosure and FDA approval.

A: Robert Iannone said expectation of full approval if PFS benefit seen and data disclosure considerations.

Q: Ash Verma asked about GEA study powering assumptions.

A: Robert Iannone explained PFS powering assumptions post-Zyme adoption.

Q: Joseph Thome asked about Kv7 therapy development.

A: Robert Iannone discussed Kv7's best-in-class potential across indications.

Q: Asim Rana asked about orexin agonist JZP441 and suvecaltamide.

A: Robert Iannone said no new news on JZP441 and views on Praxis data for suvecaltamide.

Q: Michael Riad asked about Xywav DUET results and label inclusion.

A: Robert Iannone contextualized Xywav's sleep architecture restoration vs orexins and data disclosure for label.

Q: Denis Reznik asked about zanidatamab pricing in GEA scenario.

A: Renee Galá said pricing for BTC considered GEA market, no expected price change.