Jazz Pharmaceuticals Plc Q1 FY2025 earnings call

Management Statement and Operational Highlights

• Commercial Performance: Strong commercial performance led by Epidiolex and Xywav. Xywav grew 9% YOY, remaining the number one branded treatment for narcolepsy. Epidiolex revenues increased 10% YOY.
• R&D Pipeline: Submitted a SNDA to expand Zepzelca into first line maintenance in extensive stage small cell lung cancer. Received positive CHMP opinion for zanidatamab in advanced HER2 positive BTC. Acquired Chimerix to strengthen rare oncology. HERIZON-GEA-01 Phase III trial on track to read out in H2 2025. Zepzelca FNDA submitted. Dordaviprone's NDA has a PDUFA target action date of August 18, 2025.
• Milestones: Submitted FNDA for Zepzelca expansion in first line extensive stage small cell lung cancer. Accepted ad presentations at ASCO for zanidatamab and Dordaviprone.

Segment Performance

• Neuroscience Portfolio:
  • Xywav: Net product sales of approximately $345 million in Q1 2025, up 9% year-over-year. Sleep revenue (including Xywav, Xyrem net product sales plus royalties from high sodium oxybate AGs) was ~$431 million.
  • Epidiolex: Net product sales of approximately $218 million in Q1 2025, up 10% year-over-year.
• Oncology Portfolio:
  • Rylaze: Net product sales of approximately $94 million in Q1 2025, down 8% year-over-year.
  • Ziihera: Recognized ~$2 million in net product sales in Q1 2025, with revenue contribution from this rare cancer expected to be modest.

Guidance

• Affirmed 2025 total revenue guidance range of $4.15 billion to $4.4 billion, representing 5% year-over-year growth midpoint.
• Adjusted net income guidance for 2025 is $250 million to $350 million.
• Impacted by Chimerix acquisition (asset acquisition with IPR&D charge $870M - $900M), Xyrem antitrust litigation settlement ($172M charge), and slightly revised R&D expense expectations.

Risks

• Tariffs: Potential impact on pharmaceutical products imported into the U.S., but current U.S. inventory mitigates de minimis impact for 2025.
• Regulatory Uncertainties: Uncertainties around regulatory approvals and compliance with FDA/EMA requirements.
• Competition: Competition in product segments could impact revenue and market share.

Question and Answer

Q: Jason Gerberry of Bank of America asked about Xywav supply and U.S. CDMO.

A: Bruce Cozadd responded that Xywav has a U.S. supplier with sufficient capacity to meet U.S. needs and no issues with API sourcing subject to tariff.

Q: Jessica Fye with JP Morgan asked about Jazz's manufacturing footprint and mitigation strategies for biopharma tariffs.

A: Renee Gala stated Xywav/Xyrem have U.S. and Ireland facilities, Epidiolex has a UK facility, and manufacturing in Europe for other products. Phil Johnson added flexibility with U.S. CMOs and inventory coverage.

Q: David Amsellem with Piper Sandler asked about Zepzelca's trajectory and competition from Imdelltra.

A: Renee Gala and Rob Iannone responded that Zepzelca remains leading in second line, with data from ASCO on first line maintenance expected to be practice changing and contribute to future growth.

Q: Marc Goodman with Leerink Partners asked about impact of tariffs on 2025 and hypothetical scenarios.

A: Phil Johnson stated no current material impact from tariffs, with inventory coverage and U.S. sourcing mitigating risks.

Q: Unidentified Analyst for Andrea Newkirk asked about Chimerix acquisition and Dordaviprone commercial opportunity.

A: Bruce Cozadd and Rob Iannone responded that Chimerix fit aligns with unmet medical need and efficient commercial call point, with Dordaviprone addressing serious unmet need in diffuse glioma.

Q: Annabel Samimy of Stifle asked about Rylaze pickup in AYA.

A: Renee Gala responded that AYA adoption takes time, but momentum is building with education of adult treaters and expected normalization in Q2 2025.

Q: Unidentified Analyst for Akash Tewari asked about HERIZON-GEA control arm performance.

A: Rob Iannone responded that control arm performance is consistent with prior studies, and zanidatamab shows promising results in Phase II trials.

Q: Joseph Thome with TD Cowen asked about Dordaviprone Phase III trial and FDA review.

A: Rob Iannone responded that FDA review on track for PDUFA date, and enrollment pause in U.S. trial to avoid confounding results.

Q: Gregory Renza with RBC Capital Markets asked about oxybate campaigns and IH market growth.

A: Renee Gala responded that campaigns are performing well, driving disease education and growth in the IH market with increased patient ads.

Q: Joel Beatty with Baird asked about Dordaviprone's treatment algorithm and action trial results.

A: Rob Iannone responded that initial approval expected in recurrent setting, with action trial evaluating frontline use.

Q: Ami Fadia with Needham asked about JZP441 trial and corporate development priorities.

A: Rob Iannone stated JZP441 trial initiated, and Phil Johnson confirmed corporate development priorities unchanged with strong financial position.

Q: Unidentified Analyst asked about oxybate product breakdown and IH competition.

A: Renee Gala and Bruce Cozadd responded that Xywav is the only low sodium option in IH, with IP protection till 2036 mitigating competition.

Q: Gary Nachman with Raymond James asked about BTC ramp and GEA pricing/promotion.

A: Renee Gala responded that BTC ramp is positive with HCP acceptance, and GEA promotion would align with regulatory approval and NCCN guidelines.

Q: Joon Lee with Truist Securities asked about HERIZON-GEA PD1 positive patient ratio.

A: Bruce Cozadd responded that information on PD1 positive ratio is available but specific details not provided for regulatory support.