Jazz Pharmaceuticals plc Q4 FY2025 earnings call

• 2025 was the 21st consecutive year of topline revenue growth, with record total revenue. • Expanded the portfolio through acquisitions like Chimerix and launches such as Modeyso. • Resolved nearly all major litigation, including ANDA litigation for Epidiolex and rare sleep franchise litigation. • Made significant R&D progress with zanidatamab's practice-changing data. • Sharpened the strategic focus on rare disease, leveraging capabilities in sleep, epilepsy, and oncology. • Demonstrated strong commercial execution across various product segments, including Xywav, Epidiolex, Modeyso, and Zepzelca. • Advanced the R&D pipeline with ongoing trials and new programs like JZP047 and Epidiolex in focal onset seizures.

In 2025, Jazz achieved a record total revenue of $4.3 billion. The fourth quarter revenue was $1.2 billion, showing a 10% year-over-year growth. For the rare sleep therapeutic area, which includes Xywav, Xyrem, and High-Sodium Oxybate Authorized Generic royalties, total revenue in 2025 was over $2 billion, with Xywav revenue reaching approximately $1.7 billion for the year, and $465 million in the fourth quarter, representing a 16% growth. Epidiolex reached blockbuster status in 2025 with $1.1 billion in revenue, a 9% year-over-year increase, and $287 million in the fourth quarter, a 4% growth. Modeyso generated $48 million in revenue in 2025. Zepzelca had $307 million in revenue in 2025, with $90 million in the fourth quarter, a 15% year-over-year growth.

• 2026 total revenue guidance is in the range of $4.25 billion to $4.50 billion, with a midpoint growth of about 2.5% compared to 2025. • Rare oncology and epilepsy revenues are expected to have double-digit growth in 2026. • Rare sleep franchise revenue is projected to be $1.8 billion to $1.9 billion, a modest decrease from 2025. • Non-GAAP adjusted gross margin is expected to be 90% to 91%. • Non-GAAP adjusted SG&A is in the range of $1.26 billion to $1.32 billion. • Non-GAAP adjusted R&D is in the range of $725 million to $775 million. • Non-GAAP adjusted effective tax rate is between 11.5% and 13.5%. • Fully diluted shares outstanding are expected to be 65 million to 66 million. • Not guiding to adjusted net income or EPS for 2026.

• Risks associated with forward-looking statements, where actual events may differ from projections. • Competitive challenges in the sleep market that could impact Xywav revenue. • Regulatory and development risks related to pipeline programs, including uncertainties in clinical trial outcomes and regulatory approvals. • Potential impact of payer contracting and step edits on the revenue of the sleep franchise. • Uncertainties in the commercial performance of newly launched or developing products.

Q: Follow up on Xywav guidance for 2026.

A: Xywav starts 2026 in a strong position, but the sleep market is evolving with the entry of generics and wake-promoting agents.

Q: Color on the Hikma royalty rate step down and AG volume.

A: Specific royalty percentages can't be disclosed, and the AG volume with new generics is expected to have an impact.

Q: Background on JZP047.

A: JZP047 is a novel chemical entity developed at Jazz, with preclinical data for absence epilepsy and will start in healthy volunteers.

Q: Context on the post-in HER2 breast cancer population.

A: There are about 150,000 patients with HER2-positive breast cancer, and the study is in the third line plus setting, expected to read out at the end of 2027 or early 2028.

Q: Xywav competitive pressure in the second half of 2026.

A: Minimal impact in the first half, but the second half may see different competitive dynamics.

Q: Payer contracts for Xywav.

A: There could be potential renegotiation by payers, but Xywav's differentiation remains strong.

Q: Modeyso launch metrics.

A: Modeyso's early launch is positive, with a $500 million sales opportunity depending on the ACTION study.

Q: Strategy for the sleep-wake franchise.

A: Investing in current franchises and considering licensing and M&A opportunities.

Q: Growth of the adult side of the Epidiolex franchise.

A: Investing in long-term care, the JazzCares program, and new formulations to drive adult growth.

Q: Details on the zani breast cancer study.

A: It's a 550-patient trial, comparing zanidatamab vs herceptin, with interim analysis of OS possible before final readout.