Jazz Pharmaceuticals (JAZZ) investor relations material

Recent business and leadership developments

• Received early FDA approval for a therapy targeting K27M mutant diffuse midline glioma, addressing a significant unmet need in both pediatric and adult patients.

• Concluded a licensing deal with SANEONA to expand the epilepsy franchise with a promising preclinical asset.

• Announced the appointment of Renee Gala as the new CEO, with a focus on building upon and advancing the company’s legacy.

Commercial performance and product outlook

• Xywav continues to show strong growth, especially in idiopathic hypersomnia, with robust net patient additions and no near-term competition.

• Data presented at a recent sleep meeting demonstrated clinically meaningful reductions in blood pressure when switching from high to low sodium oxybate, reinforcing Xywav’s unique value.

• The company is preparing for potential generic competition for Xyrem in 2026, planning for various scenarios and emphasizing Xywav’s low sodium benefit.

Clinical pipeline and upcoming catalysts

• Anticipates an FDA decision for Zepzelca in combination with atezolizumab for extensive stage lung cancer by October 7.

• Multiple Phase III trials are ongoing for zanidatumab in HER2-positive cancers, with key readouts expected in late 2025.

• Initiated a Phase II trial for zanidatumab in HER2-positive breast cancer and continues to support accelerated approval for dorbataprone.