Jazz Pharmaceuticals Plc · NASDAQ:JAZZ
Jazz Pharmaceuticals — 8th Annual Lazard Capital Markets Healthcare Conference (November 2011)
40 slides from Jazz Pharmaceuticals's conference presentation, Nov 15, 2011
Slide 1: 8th Annual Lazard Capital Markets Healthcare Conference
8 th Annual Lazard Capital Markets Healthcare Conference Bruce Cozadd Chairman and CEO November 15, 2011
Slide 2: Forward-Looking Statements
Forward-Looking Statements "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 dependence on sales of Xyrem ® and Luvox CR ® products and its ability to increase sales of its Xyrem; This presentation contains forward-looking statements, including, but not limited to, s
Slide 3: 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 4: 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
Slide 5: Strategy to Build Shareholder Value
Strategy to Build Shareholder Value Grow Xyrem sales in current indications Increased focus on achieving full potential 1 Maintain entrepreneurial, ownership culture at the company 4 Make disciplined resource allocation decisions 2 3 Acquire additional marketed or close to approval products Leverage
Slide 6: Jazz Pharmaceuticals
Jazz Pharmaceuticals Innovation that performs
Slide 7: Xyrem - Strong Sales Growth
Xyrem - Strong Sales Growth 8% $39 $54 $97 $230-235 2011G $143 $0 $25 $50 $75 $100 $175 $200 $125 $150 $225 $250 1. Based on guidance provided on November 1, 2011. The company is not updating the prior guidance and actual results may differ.
Slide 8: 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 9: The Burden of Narcolepsy
The Burden of Narcolepsy • Affects in in US – multiple sclerosis and Parkinson's disease – > cystic fibrosis • Although narcolepsy is thought to affect between 125,000 and 200,000 Americans, only about 50,000 are diagnosed • Key symptoms can be debilitating – Cataplexy occurs in 60%-100% of patients
Slide 10: Xyrem has Demonstrated Effect on Two Key Symptoms of Narcolepsy
Xyrem has Demonstrated Effect on Two Key Symptoms of Narcolepsy -40 -30 -20 -10 XYREM 6 g/night (n=58) XYREM 9 g/night (n=47) Placebo (n=59) –16% * –37% * –3% Improvement in Epworth Sleepiness Scale Week 2 Week 4 Baseline Reduction in Weekly Cataplexy Attacks -28% -49%* -69%+ -80 -60 -40 -20 Placebo
Slide 11: Jazz Pharmaceuticals
jazz Pharmaceuticals
Slide 12: Most Common Adverse Events in Controlled Studies of Xyrem
Most Common Adverse Events in Controlled Studies of Xyrem Adverse Event 1 % of Patients (N=655) Placebo Xyrem 2 3 Nausea Dizziness Headache Vomiting Somnolence Urinary incontinence <1 Nasopharyngitis Label includes boxed warning that sodium oxybate is a central nervous system depressant with abuse p
Slide 13: Update on FDA Form 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 * Listed in FDA Orange Book 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*
Slide 15: Overview of Manufacturing and Distribution
Overview of Manufacturing and Distribution • DEA drug quota needed to manufacture controlled “Schedule I” API • 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* 78% 8% 4% 9% • Approximately 90% of insured patients have access • Relatively low rates of required prior authorizations • Low monthly out-of-pocket (OOP) expenses – Over 70% of patients have monthly OOP of $50 1% * Company data and MediMedia Formulary Co
Slide 17: Xyrem Growth Initiatives Improve Market Penetration Over Time
• New narcolepsy physician targets • Xyrem Success Program education • Patient services - Nursing program - Xyrem Patient Connection - Patient assistance programs Increased Marketing Investment Xyrem Growth Initiatives Improve Market Penetration Over Time Current Patients >9,000 Approximately 18% of
Slide 18: Luvox CR
LuvoxCR flvovaine maleate evtended-leae capsules i ©) ex Prarmaceuicas
Slide 19: Luvox CR – Continued Sales Growth
Luvox CR – Continued Sales Growth $30 $6 $31-33 2011G $0 $5 $10 $15 $20 $25 $18 $35 $40 $27 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 change in the timin
Slide 20: 2011 Guidance Reflects High Operating Leverage
2011 Guidance Reflects High Operating Leverage 2010- A 2011- G 1 1. Based on guidance provided on November 1, 2011. The company is not updating the prior guidance and actual results may differ. 2. Includes Azur transaction related expenses of $10-11 million. 3. Adjusted net income and adjusted EPS a
Slide 21: Strategic Transaction with Azur Pharma
Strategic Transaction with Azur Pharma
Slide 22: Compelling Strategic and Financial Benefits
Diversified portfolio of CNS and women’s health products Increased scale and platform for growth Resources to invest in future pipeline and strong franchise management opportunities Stronger, enhanced management team Accretive transaction 1 Revenues >$475M and cash flow >$200M in first 12 months Str
Slide 23: Azur Pharma – Compelling Fit with Jazz Pharmaceuticals
Azur Pharma – Compelling Fit with Jazz Pharmaceuticals CNS Women’s Health Net Sales (Millions) • Strong commercial focus and expertise in CNS and women’s health • Approximately 170 employees: – 105 people in 3 US sales forces across pain, psychiatry and women ’ s health – 16 person medical affairs t
Slide 24: Prialt - for Chronic Pain
Prialt - for Chronic Pain • 2010 net sales of $20M (marketed by Azur since May 2010) • Only non-opioid intrathecal (IT) analgesic for severe chronic pain • Compelling growth opportunity with similar characteristics to Xyrem: – Requires high touch sales capability with heavy clinical emphasis – Curre
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 schizophrenia • Approximately 10% prescription share despite largely generic clozapine market • FazaClo High Dose (HD) launched September
Slide 26: Women's Health Products - Targeting a Growing Market
Women’s Health Products - Targeting a Growing Market • Diversified and balanced set of six products with 2010 net sales of $27M • Significant growth opportunity driven by Elestrin , a topical gel ERT therapy • Patents through 2022 • Revamped Elestrin promotion model in 2010 leveraging ~ 50 sales rep
Slide 27: @ xx rramece
@ xx rramece
Slide 28: Slide 28
Slide 29: A Growing, Diversified Product Portfolio
A Growing, Diversified Product Portfolio Xyrem 87% Xyrem 63% 2011 Estimated Net Sales Stand Alone Jazz Pharmaceuticals, Inc. Pro forma Jazz Pharmaceuticals plc Luvox CR 13% Luvox CR 9% Prialt 6% Women’s Health 10% Other CNS 1% FazaClo LD 8% FazaClo HD 3%
Slide 30: Transaction Closing on Track
Transaction Closing on Track SEC filings and stockholder meeting Transaction expected to close January 2012 Transaction subject to customary closing conditions and regulatory approvals • Azur approval of other necessary actions required • US antitrust clearance pending • Transaction taxable to Jazz
Slide 31: Compelling Strategic and Financial Benefits
Diversified portfolio of CNS and women’s health products Increased scale and platform for growth Resources to invest in future pipeline and strong franchise management opportunities Stronger, enhanced management team Accretive transaction 1 Revenues >$475M and cash flow >$200M in first 12 months Str
Slide 32: Jazz Pharmaceuticals
Jazz Pharmaceuticals Innovation that performs
Slide 33: Jazz Pharmaceuticals
jazz Pharmaceuticals
Slide 34: Reconciliation of GAAP Net Income and EPS to Adjusted Net Income and EPS
2010 Reconciliation of GAAP Net Income and EPS to Adjusted Net Income and EPS in Financial Results and Guidance 2010 2011G 1 (In millions, except per share amounts) GAAP net income Add: Intangible asset amortization Stock-based compensation expense Non-cash interest expense and extinguishment of deb
Slide 35: Xyrem (sodium oxybate) Boxed Warning
Xyrem (sodium oxybate) Boxed Warning Sodium oxybate is GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric eve
Slide 36: Luvox CR (fluvoxamine maleate) Boxed Warning
Luvox CR (fluvoxamine maleate) Boxed Warning LUVOX CR (fluvoxamine maleate ) PI 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 depres
Slide 37: Prialt (ziconotide intrathecal infusion) Boxed Warning
Prialt (ziconotide intrathecal infusion) Boxed 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 for evidence of cogn
Slide 38: FazaClo (clozapine) Boxed Warning
FazaClo (clozapine) Boxed 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 TO ADEQUA
Slide 39: FazaClo (clozapine) Boxed Warning - continued
FazaClo (clozapine) Boxed Warning - continued 4. OTHER ADVERSE CARDIOVASCULAR AND RESPIRATORY EFFECTS ORTHOSTATIC HYPOTENSION, WITH OR WITHOUT SYNCOPE, CAN OCCUR WITH CLOZAPINE TREATMENT. RARELY, COLLAPSE CAN BE PROFOUND AND BE ACCOMPANIED BY RESPIRATORY AND/OR CARDIAC ARREST. ORTHOSTATIC HYPOTENSIO
Slide 40: Jazz Pharmaceuticals
Jazz Pharmaceuticals Innovation that performs