Jazz Pharmaceuticals Plc Q2 FY2025 earnings call

• Bruce Cozadd congratulated Renee Gala on her appointment as CEO and highlighted progress across commercial, R&D, and corporate development.
• Noted the upcoming FDA PDUFA target action date of August 18 for dordaviprone, and Zepzelca's October 7 PDUFA target action date.
• Ziihera was granted conditional marketing authorization by the European Commission for advanced HER2-positive biliary tract cancer.
• Xywav saw 13% year-over-year growth with 625 net patient adds, driven by strong execution, consumer-targeted campaigns, and HCP education.
• Epidiolex had strong underlying demand despite inventory dynamics.
• Oncology portfolio faces near-term headwinds but has catalysts like dordaviprone's approval and Zepzelca's potential first-line maintenance approval.

In the second quarter of 2025, Jazz Pharmaceuticals' segment performance was as follows:

• Sleep therapeutic area: Total sleep revenue, including Xywav and Xyrem net product sales plus royalties from high sodium oxybate authorized generics, was $505 million. Xywav had net product sales of approximately $415 million, a 13% year-over-year increase, with approximately 625 net patient adds across narcolepsy and idiopathic hypersomnia (IH).
• Epidiolex: Net product sales were approximately $252 million, a 2% increase year-over-year, impacted by U.S. inventory dynamics.
• Oncology: Rylaze net product sales were approximately $101 million, a 7% year-over-year decrease; Zepzelca net product sales were approximately $75 million, an 8% year-over-year decrease; Ziihera recognized approximately $6 million of net product sales.

• Revised 2025 revenue guidance narrowed with a lower top end, resulting in 4% growth at the midpoint.
• SG&A and R&D guidance ranges reduced due to prioritizing high-impact initiatives and operational efficiency, including Chimerix costs and second half spend ramp-up for dordaviprone launch and other programs.
• Acknowledged 14 shipping weeks in Q3 and 13 in Q4 for U.S. oncology products, affecting year-on-year growth rates.

Forward-looking statements involve risks and uncertainties, including those related to future financial and operating results, growth potential, development, regulatory, and commercial milestones. Refer to the company's annual report on Form 10-K and quarterly reports on Form 10-Q for detailed risk factors.

Q: What's driving the strength of Xywav and IH, specifically the sustainability of patient adds?

A: Renee Gala mentioned strong execution across field teams, consumer-targeted digital and media campaigns for disease awareness, patient education, and the field nurse educator program assisting with titration and persistence, especially in IH where Xywav is the only FDA-approved therapy.

Q: About zanidatamab's Phase III trial, is the top line update likely to be qualitative or include numbers?

A: Bruce Cozadd said typically they give qualitative commentary on important top line results while preserving ability to publish, and Rob Iannone noted examples like KEYNOTE-811 with benchmarks for PFS and OS differences.

Q: Impact of Takeda and Axsome drugs on Xywav's momentum in narcolepsy?

A: Renee Gala stated oxybates are complementary to orexin, Xywav's differentiation as the only low sodium oxybate with flexible dosing and cardiovascular benefits continues to drive choice, and Rob Iannone discussed mechanisms and Xywav's data on nighttime sleep improvement.

Q: Confidence in dordaviprone's accelerated approval on August 18?

A: Bruce Cozadd said they've been in conversations with FDA and hope for a decision soon, and Renee Gala expressed excitement about bringing the therapy to market for glioma patients.