Jazz Pharmaceuticals: SVB Securities Sleep Forum

August 2022

Jazz Pharmaceutical

Innovating to transform the lives of patients and their families

Transforming lives. Redefining the possibilities.

Caution Regarding Forward-Looking Statements

This presentation contains forward-looking statements, including, but not limited to, statements related to: the company’s strategy to maximize the value of Xywav in IH and narcolepsy, expectations that Xywav will be the treatment choice in 2023; and other statements that are not historical facts. These forward-looking statements are based on the Company’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.

Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements due to such risks and uncertainties, which include, but are not limited to, risks and uncertainties associated with management’s assumptions and estimates regarding the adoption of Xywav in narcolepsy and IH; the timing of the launch of generic products authorized by Xyrem (AG products) and generic versions of sodium oxybate and the level of AG product royalties for the company, safety and efficacy profiles of product launches competitors in narcolepsy and IH, and estimates of the size of the IH patient population eligible for Xywav obtaining and maintaining adequate coverage and reimbursement for the Company’s products; protect and enhance the Company’s intellectual property rights and the Company’s commercial success being dependent on obtaining, maintaining and defending the Company’s intellectual property protection for its products and product candidates; delays or problems in the sourcing or manufacturing of the Company’s products and product candidates; comply with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacture, and distribution of controlled substances; government investigations, lawsuits and other actions; and other risks and uncertainties affecting the Company, including those described from time to time under “Risk Factors” and elsewhere in Jazz Pharmaceuticals’ Securities and Exchange Commission filings and reports, including Jazz Pharmaceuticals’ annual report. the Company on Form 10-K for the year ended December 31, 2021, and the Company’s future filings and reports, including the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2022.

Oxybate: generator of sustainable and long-term value

History of Oxybates

The future of oxybate

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

Expect Xywav to be the oxybate therapy of choice in 2023

FDA = Food & Drug Administration, IH = Idiopathic Hypersomnia, HCP = Healthcare Provider, REMS = Risk Assessment and Mitigation Strategy, AGs = Authorized Generics. 1Xywav patients as of June 30, 2022.


August 2022

Xywav in Narcolepsy: Continuing Education on the Lifetime Burden of High Sodium Intake

  • 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. »

Xywav in IH: indication expansion creates opportunity for growth

  • 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

IH = idiopathic hypersomnia, FDA = Food and Drug Administration, MOA = mechanism of action. 1Xywav is approved for the treatment of IH in adults


August 2022

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Jazz Pharmaceuticals plc published this content on August 09, 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unmodified, on August 09, 2022 22:33:07 UTC.

Public now 2022


Analyst Recommendations for JAZZ PHARMACEUTICALS PLC

2022 sales 3,643 million

2022 net income 318M

Net debt 2022 4,482M

PER 2022 ratio 16.2x
2022 return
Capitalization 9,813M
EV / Sales 2022 3.92x
EV / Sales 2023 3.45x
# of employees 3,200
Floating 97.5%


Duration :

Period :

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To buy

Medium consensus TO BUY
Number of analysts 19
Last closing price $156.55
Average target price $201.11
Average Spread / Target 28.5%

Melvin B. Baillie