Jazz Pharmaceuticals: SVB Securities Sleep Forum

For more than 15 years, Jazz has:

• Oxybate therapy established as the standard of care in narcolepsy
• Established and operated a robust, FDA cleared REMS and distribution system
• Build trust and build strong relationships with narcoleptic healthcare professionals and patient communities
• Provided patient support programs including access
• Investment to significantly improve oxybate therapy based on stakeholder feedback

Existing Narcolepsy Market

New patients with narcolepsy

Idiopathic hypersomnia

• ~7,5501 narcoleptic patients taking Xywav leaving 2Q22
• Xyrem Patients Continue to Adopt Xywav
• The majority of patients who are not oxygenated are prescribed Xywav
• Ability to add patients for whom Xyrem was not previously prescribed due to sodium issues
• ~1,1501 IH patients taking Xywav outgoing 2Q22
• No other FDA-approved treatments
• Significant future royalties on Xyrem AG

• Xywav contains 92% less sodium than Xyrem
• Phase 3 trial demonstrated highly statistically significant differences versus placebo in the primary endpoint (measurement of change in weekly number of cataplexy attacks) and key secondary endpoint (measurement of change in Epworth Sleepiness Scale (ESS) scores ))
• Cardiovascular (CV) and cardiometabolic diseases/disorders are more common in patients with narcolepsy than in controls without narcolepsy

As part of the ODE grant, the FDA said,

“Xywav is clinically superior to Xyrem due to greater safety because Xywav provides a greatly reduced chronic sodium load compared to Xyrem.”

The FDA summary also stated,

“Differences in sodium content of both products at the recommended doses will be clinically significant in reducing cardiovascular morbidity in a significant proportion of patients for whom the drug is indicated. »

• HI is a neurological sleep disorder characterized by excessive daytime sleepiness, severe sleep inertia, cognitive and prolonged disturbances, non restorative the nightsleep
• Distinct symptomatology and diagnostic criteria other sleep disorders
• sleep disorders can have a negative impact on all facets of someone’s life

“Idiopathic hypersomnia is a lifelong diseaseand the approval of Xywav will be instrumental in delivering treatments for symptoms such as excessive drowsiness and difficulty waking up, and in the effective management of this debilitating disorder.”

Eric Bastings, MD, Deputy Director of the Office of Neuroscience, FDA Center for Drug Evaluation and Research

First and only therapy approved by the FDA

Treat IH1

• Received Orphan Drug Exclusivity (ODE) in IH
• ~37,000 patients in the US diagnosed and actively seeking healthcare
• Potential global patient population in the United States:
  70,000 – 80,000 patients
• Efficient launch with over 90% overlap with existing sleep call universe
• ~90% commercial coverage