Jazz Pharmaceuticals Plc · NASDAQ:JAZZ
Jazz Pharmaceuticals — Merger or Acquisition (December 2011)
37 slides from Jazz Pharmaceuticals's merger presentation, Dec 8, 2011
Slide 1: Filing under Rule 425 under the Securities Act of 1933
Filing under Rule 425 under the Securities Act of 1933 and deemed filed under Rule 14a-6 of the Securities Exchange Act of 1934 Filing by: Jazz Pharmaceuticals, Inc. Subject Company: Jazz Pharmaceuticals, Inc. SEC File No. of Jazz Pharmaceuticals, Inc.: 001-33500 Registration No. 333-177528 The foll
Slide 2: Investor Relations, December 7, 2011
Investor Relations December 7, 2011
Slide 3: Forward-Looking Statements
Forward-Looking Statements "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This presentation contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals’ growthpotentialand futurefinancialperformance, including2011
Slide 4: Additional Information
Additional Information Additional Information and Where to Find It In connection with the proposed transaction between Jazz Pharmaceuticals and Azur Pharma, the companies have filed documents with the SEC, including the filing by Jazz Pharmaceuticals of a definitive proxy statement relating to the p
Slide 5: Building Shareholder Value by Focusing on Patient Needs
Building Shareholder Value by Focusing on Patient Needs Jazz Pharmaceuticals’ mission is to improve patients’ lives by identifying, developing and commercializing valuable pharmaceutical products in focused therapeutic areas 4
Slide 6: Strategy to Build Shareholder Value
Strategy to Build Shareholder Value Pursue lower risk 3 development of Acquire additional specialty products 2 marketed or close to Invest percentage Grow Xyrem sales in approval products of sales longer-term 1 current indications Leverage our expertise Increased focus on and infrastructure achievin
Slide 7: Current Business Overview
Current Business Overview Jazz Pharmaceuticals Innovation that performs
Slide 8: Xyrem - Strong Sales Growth
Xyrem - Strong Sales Growth 1 $250 $230-235 $225 $200 $175 $150 $143 $125 $97 $100 $75 $54 $50 $39 $25 $0 2007 2008 2009 2010 2011G 1. Based on guidance provided on November 1, 2011. The company is not updating the prior guidance and actual results may differ. 7
Slide 9: Xyrem is a Standard of Care in Narcolepsy
Xyrem is a Standard of Care in Narcolepsy • Only FDA-approved product for both cataplexy and excessive daytime sleepiness in patients with narcolepsy – Marketed in U.S. since 2002 – Marketed in major European countries by UCB and in Canada by Valeant • Currently marketed in U.S. by 110-person specia
Slide 10: The Burden of Narcolepsy
The Burden of Narcolepsy 1 • Affects 1 in 2000 in US 2 – multiplesclerosisandParkinson's disease 3 – > cystic fibrosis • Although narcolepsy is thought to affect between 125,000 and 200,000 Americans, only about 4 50,000arediagnosed • Key symptoms can be debilitating – Cataplexy occurs in 60%-100% o
Slide 11: Xyrem has Demonstrated Effect on Two Key Symptoms of Narcolepsy
Xyrem has Demonstrated Effect on Two Key Symptoms of Narcolepsy Improvement in Epworth Reduction in Weekly Sleepiness Scale1 Cataplexy Attacks2 XYREM XYREM Placebo 6 g/night 9 g/night (n=59) (n=58) (n=47) Placebo (n=33) 0 XYREM 6 g/night (n=31) 0 –3% XYREM 9 g/night (n=33) -10 -20 -28% -20 –16% * -4
Slide 12: Most Common Adverse Events in Controlled Studies of Xyrem
Most Common Adverse Events in Controlled Studies of Xyrem % of Patients (N=655) 1 Adverse Event ² Placebo ³ Xyrem Nausea 4 19 Dizziness 4 18 Headache 15 18 Vomiting 1 8 Somnolence 4 6 Urinaryincontinence 4 <1 6 Nasopharyngitis 5 6 Label includes boxed warning that sodium oxybate is a central nervous
Slide 13: Update on FDA Form 483 and Related Warning Letter
Update on FDA Form 483 and Related Warning Letter • Fully committed to accurate and timely adverse event (AE) reporting • After receipt of FDA Form 483 in May, immediate actions initiated to improve AE reporting procedures: – Implemented additional procedures at central pharmacy – Strengthened AE co
Slide 14: Strong Sodium Oxybate Patent Coverage
Strong Sodium Oxybate Patent Coverage Number Issue Date Expiration Date Distribution system patent* 7,765,106 7/27/2010 6/16/2024 Distribution system patent* 7,765,107 7/27/2010 6/16/2024 Distribution system patent 7,797,171 9/14/2010 6/16/2024 Distribution system patent* 7,668,730 2/23/2010 6/16/20
Slide 15: Overview of Manufacturing and Distribution
Overview of Manufacturing and Distribution • DEA drug quota needed to manufacture controlled “Schedule API I” • Exclusive relationships with API supplier and finished goods manufacturer: – Siegfried approved by FDA for API supply • Unique proprietary distribution system uses exclusive single pharmac
Slide 16: Current Xyrem Patient Coverage Distribution
Current Xyrem Patient Coverage Distribution* • Approximately 90% of insured patients have access Medicare Part D Medicaid Cash • Relatively low rates of required prior authorizations 4% Patient 9% 1% Assistance Program • Low monthly out-of-pocket (OOP) 8% expenses – Over 70% of patients have monthly
Slide 17: Xyrem Growth Initiatives
Xyrem Growth Initiatives Increased Marketing Investment • New narcolepsy physician targets • Xyrem Success Program education • Patient services - Nursing program - Xyrem Patient Connection - Patient assistance programs Improve Market Penetration Over Time Current Patients >9,000 Approximately 18% of
Slide 18: Luvox CR - Important Treatment Option for OCD
Luvox CR ® - Important Treatment Option for OCD • Indicated for obsessive compulsive disorder (OCD) 1,2 • OCD affects ~ 2.2 million Americans 3,4 – Often underdiagnosed 5 – Difficult to differentiate from comorbidities • Only 43% of adults newly diagnosed with OCD received adequate treatment in the
Slide 19: Luvox CR – Continued Sales Growth
Luvox CR – Continued Sales Growth $40 $35 ¹ $31-33 $30 $27 $25 $20 $18 $15 $10 $6 $5 $0 2008 2009 2010² 2011G 1. Based on guidance provided on November 1, 2011. The company is not updating the prior guidance and actual results may differ. 2. Includes $2 million of revenue recorded as a result of a c
Slide 20: 2011 Guidance Reflects High Operating Leverage
2011 Guidance Reflects High Operating Leverage 2010-A 2011-G¹ Total Product Sales $170M $261 –268M Xyrem $143M $230 -235M Luvox CR $27M $31 -33M ² SG&A and R&D Combined $95M $114 –118M GAAP Net Income $33M $128 –131M ³ Adjusted Net Income $61M $160 –163M GAAP EPS $0.83 $2.76 –$2.81 ³ Adjusted EPS $1
Slide 21: Strategic Transaction with Azur Pharma
Strategic Transaction with Azur Pharma
Slide 22: Compelling Strategic and Financial Benefits
Compelling Strategic and Financial Benefits Strategic Benefits Projected Financial Benefits • Diversified portfolio of CNS and 1 • Accretive transaction women’s health products • Revenues >$475M • Increased scale and platform and cash flow >$200M in for growth Jazz first 12 months Pharmaceuticals pl
Slide 23: Azur Pharma – Compelling Fit with Jazz Pharmaceuticals
Azur Pharma – Compelling Fit with Jazz Pharmaceuticals • Strong commercial focus and expertise Net Sales (Millions) 1 $95-100 in CNS and women’s health $100 $83 • Approximately 170 employees: $80 $67 $60 $57 – 105 people in 3 US sales forces across pain, psychiatry and $40 women’s health $24 $20 – 1
Slide 24: Prialt - for Chronic Pain
Prialt - for Chronic Pain • 2010 net sales of $20M (marketed by Azur since May 2010) 1 • Onlynon-opioid intrathecal (IT)analgesic forseverechronicpain • Compelling growth opportunity with similar characteristics to Xyrem: – Requires high touch sales capability with heavy clinical emphasis – Currentl
Slide 25: FazaClo – for Treatment Resistant Schizophrenia
FazaClo – for Treatment Resistant Schizophrenia • 2010 net sales of $37M • Orally disintegrating clozapine tablets approved for management of treatment resistant 1 schizophrenia • Approximately 10% prescription share despite largely generic clozapine market • FazaClo High Dose (HD) launched Septembe
Slide 26: Women’s Health Products - Targeting a Growing Market
Women’s Health Products - Targeting a Growing Market Net Sales Contribution 100% 80% 60% 40% 20% 0% 2009 2010 2011E Other Women’s Health Elestrin ¹ with 2010 net sales of $27M • Diversified and balanced set of six products • Significant growth opportunity driven by¹,Elestrin a topical gel ERT therap
Slide 27: A Growing, Diversified Product Portfolio
A Growing, Diversified Product Portfolio 2011 Estimated Net Sales Stand Alone Jazz Pharmaceuticals, Inc. Pro forma Jazz Pharmaceuticals plc FazaClo LD 8% Other CNS FazaClo HD 1% Women’s 3% Health 10% Prialt 6% Luvox CR 13% Luvox CR 9% Xyrem 87% Xyrem 63% 26
Slide 28: Transaction Closing on Track
Transaction Closing on Track Transaction subject SEC filings and to customary closing Transaction expected stockholder meeting conditions and to close January 2012 regulatory approvals • Azur Pharma S-4 declared • Azur approval of other • Transaction taxable to Jazz effective necessary actions requi
Slide 29: Compelling Strategic and Financial Benefits
Compelling Strategic and Financial Benefits Strategic Benefits Projected Financial Benefits • Diversified portfolio of CNS and 1 • Accretive transaction women’s health products • Revenues >$475M • Increased scale and platform and cash flow >$200M in for growth Jazz first 12 months Pharmaceuticals pl
Slide 30: Jazz Pharmaceuticals
) Jazz Pharmaceuticals Innovation that performs
Slide 31: Reconciliation of GAAP Net Income and EPS to Adjusted Net Income and EPS
Reconciliation of GAAP Net Income and EPS to Adjusted Net Income and EPS in Financial Results and Guidance 1 2010 2011G GAAP net income $33 $128-131M Add: Intangible asset amortization 8 7 Stock-based compensation expense 8 13 Non-cash interest expense and extinguishment of debt 14 2 Azur Pharma tra
Slide 32: Xyrem (sodium oxybate) Boxed Warning
Xyrem (sodium oxybate) Boxed Warning !WARNING: Central nervous system depressant with abuse potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (in
Slide 33: Luvox CR (fluvoxamine maleate) Boxed Warning
Luvox CR (fluvoxamine maleate) Boxed Warning Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psych
Slide 34: Prialt (ziconotide intrathecal infusion) Boxed Warning
Prialt (ziconotide intrathecal infusion) Boxed Warning WARNING: Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Patients with a pre-existing history of psychosis should not be treated with PRIALT. All patients should be monitored frequently forevidence
Slide 35: FazaClo (clozapine) Boxed Warning
FazaClo (clozapine) Boxed Warning WARNING: 1. AGRANULOCYTOSIS BECAUSE OF A SIGNIFICANT RISK OF AGRANULOCYTOSIS, A POTENTIALLY LIFE-THREATENING ADVERSE EVENT, CLOZAPINE SHOULD BE RESERVED FOR USE IN (1) THE TREATMENT OF SEVERELY ILL PATIENTS WITH SCHIZOPHRENIA WHO FAIL TO SHOW AN ACCEPTABLE RESPONSE
Slide 36: FazaClo (clozapine) Boxed Warning - continued
FazaClo (clozapine) Boxed Warning - continued 4. OTHERADVERSECARDIOVASCULAR ANDRESPIRATORYEFFECTS ORTHOSTATIC HYPOTENSION,WITHORWITHOUTSYNCOPE,CANOCCURWITHCLOZAPINE TREATMENT. RARELY, COLLAPSE CAN BE PROFOUND AND BE ACCOMPANIED BY RESPIRATORY AND/OR CARDIAC ARREST. ORTHOSTATIC HYPOTENSION IS MORE LI
Slide 37: Jazz Pharmaceuticals
) Jazz Pharmaceuticals Innovation that performs
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