Jazz Pharmaceuticals Plc Q3 FY2024 earnings call

• Commercial Execution: Xywav and Epidiolex posted record quarterly sales with double-digit growth. Oncology business had 9% revenue growth YOY.
• Clinical Milestones: Positive data from Zepzelca Phase 3 trial in first line maintenance for extensive stage small lung cancer. Zanidatamab PDUFA date for second line biliary tract Cancer is end of November 2024.
• R&D Progress: Zanidatamab program advancing with multiple trials ongoing. Epidiolex Phase 3 trial in Japan ongoing. JZP441 Phase 1b trial planned for narcolepsy type 1 patients in first half of 2025.

Neuroscience Therapeutic Area:

• Xywav: Net product sales grew 17% year-over-year to approximately $388 million in the third quarter. It is the number one branded treatment for narcolepsy and the only approved therapy for idiopathic hypersomnia or IH.
• Epidiolex: Net product sales were approximately $252 million in the third quarter, representing an 18% increase compared to the same quarter in 2023, nearing blockbuster status. Oncology Therapeutic Area:
• Zepzelca: Net product sales increased 10% year-over-year to approximately $86 million.
• Rylaze: Net product sales were approximately $99 million, a 6% decrease from the third quarter of 2023 due to pediatric treatment protocol changes, but expected to normalize by early next year.

• Affirmed full-year revenue guidance of $4 billion to $4.1 billion, with neuroscience revenue guidance at $2.825 billion to $2.925 billion.
• Lowered oncology revenue guidance by $20 million due to temporary Rylaze revenue impact from pediatric treatment protocol changes.
• Maintained SG&A guidance, lowered R&D guidance by $20 million to $790 million to $830 million.
• Adjusted net income guidance unchanged, EPS range updated.

• Impact of pediatric treatment protocol changes on Rylaze revenue.
• Uncertainties related to clinical trial results and regulatory approvals for pipeline programs.

Q: On Xywav, can we think of the 150 net patient ads in narcolepsy as reproducible in the future?

A: Renée Galá mentioned greater persistency from the field nurse educator program and appreciation of low sodium messaging as factors.

Q: On Zepzelca, is the submission just on the phase three results alone?

A: Rob Iannone said the Phase 3 trial data stands alone to support an expansion of the label into a frontline indication.

Q: On the orexin class and product 441, any data?

A: Rob Iannone discussed the field advancing, Plan 1B study for 441 in narcolepsy type 1 patients in first half of 2025.

Q: On Zani in GEA, percent of PD-L1 positive vs negative patients?

A: Rob Iannone said they haven't looked at PD-L1 status in the Phase 2 study and zanidatamab is effective regardless.

Q: On Zepzelca's peak opportunity and physician adoption?

A: Renée Galá and Rob Iannone discussed it being practice changing, moving quickly, and more patients for longer duration.

Q: On lowered oncology guidance and Rylaze?

A: Bruce Cozadd said it's entirely due to the temporary impact on Rylaze from pediatric treatment protocol changes.

Q: On Rylaze initiatives in AYA and Defitelio?

A: Renée Galá talked about Rylaze AYA initiatives and Defitelio's quarterly variability.