425 1 d245458d425.htm FILED PURSUANT TO RULE 425 Filed pursuant to Rule 425
    

Filed by Azur Pharma Limited

Pursuant to Rule 425 under The Securities Act of 1933

And Deemed Filed Pursuant to Rule 14a-12

Under the Securities Exchange Act of 1934

Subject Company: Jazz Pharmaceuticals, Inc.

Commission File Number: 001-33500

Date: October 19, 2011

The following is a slide presentation relating to the proposed transactions described therein that was made available beginning on October 18, 2011.

Bruce Cozadd
Chairman and CEO
October 18, 2011
Introduction to Jazz Pharmaceuticals

2
Forward-Looking Statements
This presentation contains forward-looking statements, including, but not limited to, statements related to the anticipated
consummation of the business combination transaction between Jazz Pharmaceuticals and Azur Pharma and the timing and
benefits thereof, the combined company’s, and each respective company’s, strategy, plans, objectives, expectations
(financial
or
otherwise)
and
intentions,
future
financial
results
and
growth
potential
(including
Jazz
Pharmaceuticals’
2011
Financial Guidance), anticipated product portfolio, development programs, intellectual property and tax position,
management structure, and other statements that are not historical facts.  These forward-looking statements are based on
Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.  Actual results and the
timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks
and
uncertainties,
which
include,
without
limitation,
risks
related
to
Jazz
Pharmaceuticals’
ability
to
complete
the
transaction
on the proposed terms and schedule; risks associated with business combination transactions, such as the risk that the
businesses will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than
expected; risks related to future opportunities and plans for the combined company, including uncertainty of the expected
financial performance and results of the combined company following completion of the proposed transaction; disruption
from the proposed transaction, making it more difficult to conduct business as usual or maintain relationships with
customers, employees or suppliers; the calculations of, and factors that may impact the calculations of, the acquisition price
in connection with the proposed merger and the allocation of such acquisition price to the net assets acquired in accordance
with applicable accounting rules and methodologies; and the possibility that if the combined company does not achieve the
perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the
market price of the combined company’s shares could decline, as well as other risks related to Jazz Pharmaceuticals’
business,
including
Jazz
Pharmaceuticals’
dependence
on
sales
of
Xyrem
®
and its ability to increase sales of its Xyrem and
Luvox
CR
®
products;
competition,
including
potential
generic
competition;
Jazz
Pharmaceuticals’
dependence
on
single
source suppliers and manufacturers; the ability of Jazz Pharmaceuticals to protect its intellectual property and defend its
patents; regulatory obligations and oversight; Jazz Pharmaceuticals cash flow; and those risks detailed from time-to-time
under
the
caption
“Risk
Factors”
and
elsewhere
in
Jazz
Pharmaceuticals’
SEC filings and reports, including in its Quarterly
Report on Form 10-Q for the quarter ended June 30, 2011.  Jazz Pharmaceuticals undertakes no duty or obligation to
update
any
forward-looking
statements
contained
in
this
presentation
as
a
result
of
new
information,
future
events
or
changes in its expectations.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

3
Additional Information
In
connection
with
the
proposed
business
combination
transaction
described
in
this
presentation,
Jazz
Pharmaceuticals
and
Azur
Pharma
will
be
filing
documents
with
the
SEC,
including
the
filing
by
Jazz
Pharmaceuticals
of
a
preliminary
and
definitive proxy statement/prospectus relating to the proposed transaction and the filing by Azur Pharma of a registration
statement on Form S-4 that will include the proxy statement/prospectus relating to the proposed transaction.  After the
registration
statement
has
been
declared
effective
by
the
SEC,
a
definitive
proxy
statement/prospectus
will
be
mailed
to
Jazz Pharmaceuticals stockholders in connection with the proposed transaction.  INVESTORS AND SECURITY HOLDERS
ARE
URGED
TO
READ
THE
REGISTRATION
STATEMENT
ON
FORM
S-4
AND THE RELATED PRELIMINARY AND
DEFINITIVE PROXY/PROSPECTUS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT JAZZ PHARMACEUTICALS, AZUR PHARMA AND THE PROPOSED TRANSACTION.  Investors
and security holders may obtain free copies of these documents (when they are available) and other related documents filed
with
the
SEC
at
the
SEC’s
web
site
at
www.sec.gov,
by
directing
a
request
to
Jazz
Pharmaceuticals’
Investor
Relations
department at Jazz Pharmaceuticals, Inc., Attention: Investor Relations, 3180 Porter Drive, Palo Alto, California 94304, or to
Jazz
Pharmaceuticals’
Investor
Relations
department
at
650-496-2800
or
by
email
to
investorinfo@jazzpharma.com.
Investors and security holders may obtain free copies of the documents filed with the SEC on Jazz Pharmaceuticals’
website
at
www.jazzpharmaceuticals.com
under
the
heading
“Investors”
and
then
under
the
heading
“SEC
Filings.”
Jazz
Pharmaceuticals and its directors and executive officers and Azur Pharma and its directors and executive officers may be
deemed
participants
in
the
solicitation
of
proxies
from
the
stockholders
of
Jazz
Pharmaceuticals in connection with the
proposed transaction.  Information regarding the special interests of these directors and executive officers in the proposed
transaction will be included in the proxy statement/prospectus described above.  Additional information regarding the
directors
and
executive
officers
of
Jazz
Pharmaceuticals
is
also
included
in
Jazz
Pharmaceuticals’
proxy
statement
for
its
2011 Annual Meeting of Stockholders, which was filed with the SEC on April 12, 2011.  These documents are available free
of charge
at
the
SEC’s
web
site
at
www.sec.gov
and
from
Investor
Relations
at
Jazz
Pharmaceuticals
as
described
above. 
This communication does not constitute an offer to sell, or the solicitation of an offer to sell, or the solicitation of an offer to
subscribe for or buy, any securities nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which
such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such
jurisdiction. 
For full prescribing information refer to product websites.
Additional Information and Where to Find It

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

5
Pursue lower risk
development of
specialty products
Invest percentage
of sales longer-term
Strategy to Build Shareholder Value
Grow Xyrem sales in
current indications
Increased focus on
achieving full potential
Acquire additional
marketed or close to
approval products
Leverage our expertise
and infrastructure
2
Maintain entrepreneurial, ownership culture at the company
Make disciplined resource allocation decisions
1
3
4

Current Business and Financial
Overview

$39
$54
$97
$215-225
2010
2009
2008
2007
2011G
$143
Xyrem -
Strong Sales Growth
2011 Guidance $215M-$225M
8%
7
$0
$25
$50
$75
$100
$175
$200
$125
$150
$225
$250
1.
Based on guidance provided on July 28, 2011.  The company is not updating the prior guidance and actual results may differ.
1

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 specialty sales force
•
Approximately 8,700 patients on therapy, usually in conjunction with stimulant therapy
•
Distributed
under
proprietary
Xyrem
Success
Program
®
8

The Burden of Narcolepsy
•
Affects 1 in 2000 in US
1
–
multiple sclerosis and Parkinson's disease
2
–
> cystic fibrosis
3
•
Although narcolepsy is thought to affect between
125,000 and 200,000 Americans, only about
50,000 are diagnosed
4
•
Key symptoms can be debilitating
–
Cataplexy occurs in 60%-100% of patients
–
100% experience excessive daytime sleepiness
9
1.
National Institute of Neurological Disorders and Stroke.  http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm. Accessed March 17, 2011.
2.
Narcolepsy Sleep Foundation. www.sleepfoundation.org/article/sleep-related-problems/narcolepsy-and-sleep. Accessed March 17, 2011.
3.
Zemanick et  al. J Cyst Fibros. 2010;9:1-16.
4.
American Sleep Association. http;//www.sleepassociation.org/index.php?p=aboutnarcolepsy. Accessed March 17, 2011.

-40
-30
-20
-10
0
Xyrem has Demonstrated Effect
on Two Key Symptoms of Narcolepsy
XYREM
6 g/night
(n=58)
XYREM
9 g/night
(n=47)
Placebo
(n=59)
–16%
*
–37%
*
–3%
Improvement in Epworth
Sleepiness Scale
1
Week 2
Week 4
Baseline
Reduction in Weekly
Cataplexy Attacks
2
*p<0.001 vs placebo
*p<0.05 vs placebo
+p<0.005 vs placebo
-28%
-49%*
-69%+
10
-80
-60
-40
-20
0
Placebo (n=33)
XYREM 6 g/night (n=31)
XYREM 9 g/night (n=33)
Trial 3: From a 8-week, multicenter, randomized, double-blind, placebo controlled, parallel-arm trial of narcolepsy patients (N=228) with moderate to severe EDS and cataplexy symptoms.  Antidepressants were withdrawn prior to
Trial 1: From a 4-week, double-blind, placebo-controlled trial of narcolepsy patients (N=136) with moderate to severe cataplexy (median of 21 attacks per week) comparing the effects of three doses of orally administered
sodium oxybate with placebo for the treatment of narcolepsy. Patients continued to receive stable stimulant therapy throughout the study.  The US XYREM Multicenter Study Group. Sleep. 2002;25(1):42-29.
1.
2.
randomization,
and
stimulants
were
continued
throughout
the
study
at
stable
doses.
In
XYREM
clinical
trials,
80%
of
patients
maintained
concomitant
stimulant
use.
XYREM
International
Study
Group.
J
Clin
Sleep
Med.
2005;1:391.

Most Common Adverse Events in
Controlled Studies of Xyrem
Adverse Event
% of Patients (N=655)
Placebo
Xyrem
Nausea
4
19
Dizziness
4
18
Headache
15
18
Vomiting
1
8
Somnolence
4
6
Urinary incontinence
4
<1
6
Nasopharyngitis
5
6
Label includes boxed warning that sodium oxybate is a central nervous system
depressant with abuse potential and should not be used with alcohol or other
CNS depressants.  See complete boxed warning at end of presentation.
11
1
2
3
1. Occurring in     5% of XYREM patients and more frequently than with placebo.  2. Data on file, Jazz Pharmaceuticals, Inc.  3. XYREM (sodium oxybate) PI.  4. Generally nocturnal enuresis.

Strong Sodium Oxybate Patent Coverage
* Listed in FDA Orange Book
12
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
6/16/2024
Distribution system patent*
7,895,059
2/23/2011
12/17/2022
Formulation patent*
6,780,889
8/24/1999
7/4/2020
Formulation patent*
7,262,219
8/28/2007
7/4/2020
Process patent
6,472,431
10/29/1999
12/22/2019
Method of use patent*
7,851,506
12/14/2010
12/22/2019

Overview of Manufacturing and Distribution
•
DEA drug quota needed to manufacture controlled “Schedule I”
API
•
Exclusive relationships with API supplier and finished goods manufacturer
•
Unique proprietary distribution system uses exclusive single pharmacy
•
Risk management program and unique product attributes require high
touch commercial capabilities
13

Current Xyrem Patient Coverage Distribution*
•
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
79%
8%
3%
1%
9%
*  Company
data
and
MediMedia
Formulary
Compass
July
2011.
Commercial
Medicaid
Medicare Part D
Patient Asst
Program
Cash
14

15
•
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 = ~ 8,700
Approximately 17% of 50K Diagnosed Narcolepsy Patients

16
Luvox CR
®
-
Important Treatment Option for OCD
•
Indicated for obsessive compulsive
disorder (OCD)
•
OCD
affects
~
2.2
million
Americans
1,2
–
Often underdiagnosed
3,4
–
Difficult to differentiate from comorbidities
5
•
Only 43% of adults newly diagnosed with OCD received adequate treatment in the
year
after
their
first
visit
for
OCD
6
Label includes boxed warning regarding suicidality and antidepressant drugs.
See complete boxed warning at end of presentation.
1. National Institute of Mental Health. http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america.shtml. Accessed March 3, 2008.  2. Kessler RC, et al. Arch Gen Psychiatry. 2005;62:617-627.
3. Fireman B, et al. Am J Psychiatry. 2001;158:1904-1910.  4. Grabill K et al..Assessment of obsessive-compulsive disorder: a review.J Anxiety Disord. 2008;22(1):1-17.  5. Hales RE, et al (eds). Textbook of Psychiatry.
1999:600-610.  6. Koran LM, et al. Am J Health Syst Pharm. 2000;57:1972-1978.

Luvox CR –
Continued Sales Growth
2011 Guidance $32M-$35M
1
$30
$6
$32-35
2009
2008
2011G
17
$0
$5
$10
$15
$20
$25
2010
$18
$35
$40
$27
1.
Based on guidance provided on July 28, 2011.  The company is not updating the prior guidance and actual results may differ.
2.
Includes $2.0 million of revenue recorded as a result of a change in the timing of when Luvox CR revenue is recognized. The company now records sales upon shipment to distributors net of estimated
returns.
2

18
2011 Guidance Reflects High Operating Leverage
1.
Based on guidance provided on July 28, 2011.  The company is not
updating the prior guidance and actual results may differ.
2.
Adjusted
net
income
and
adjusted
EPS
are
non-GAAP
financial
measures
that
exclude
certain
items
from
GAAP
net
income
and
GAAP
EPS.
A
reconciliation
of
adjusted
net
income
to
GAAP net income and the related per share amounts is in a table included with this presentation.
2010-
A
2011-
G
1
Total Product Sales
$170M
$247 –
260M
Xyrem
$143M
$215 –
225M
Luvox CR
$27M
$32 –
35M
SG&A and R&D Combined
$95M
$105 –
110M
GAAP Net Income
$33M
$123 –
131M
Adjusted Net Income
2
$61M
$145 –
153M
GAAP EPS
$0.83
$2.68 -
$2.79
Adjusted EPS
2
$1.55
$3.15 –
$3.25

19
Investment Rationale
•
High sales and earnings growth rates
•
High margins and high operating leverage
•
Significant potential to increase Xyrem sales
•
Strong
Xyrem
exclusivity
position
including
patents
extending
to
2024
•
Potential to leverage existing commercial capabilities with new products
•
Disciplined approach to resource allocation

Strategic Transaction with
Azur Pharma

21
Strategic 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
Projected Financial Benefits
•
Accretive transaction
1
•
Revenues >$475M
and cash flow >$200M in
first 12 months
•
~$250M cash at closing
2
•
Strong balance sheet
with no debt
1
Accretion for Jazz Pharmaceuticals shareholders is on a  fully-taxed adjusted EPS basis. Adjusted EPS is a non-GAAP financial measure that exclude certain items from GAAP EPS.
2
Pro forma estimate as of Jan 1, 2012.
Compelling Strategic and Financial Benefits
Jazz
Pharmaceuticals plc
Ireland

22
Jazz Pharmaceuticals plc
•
12 products
currently marketed in US
•
>$475 million
in
revenues
in
first
12
months
•
>$200 million
in
cash
generated
in
first
12
months
•
Jazz
Pharmaceuticals:
slightly
under
80%;
Azur
Pharma: slightly over 20%
•
Combined capitalization approximately 60M shares fully diluted at closing
•
Jazz
Pharmaceuticals
board
represented
funds
entered
into
voting
agreements (~43% of shares)
•
99%
of
Azur
shareholders entered into agreement to take necessary actions
•
Current directors of Jazz Pharmaceuticals
•
Seamus Mulligan (Chairman and CEO, Azur Pharma)
Portfolio & Financial
Projections
Ownership in
Combined Company
Shareholder Votes
Board of Directors
Management
•
Bruce Cozadd, Chairman and CEO
•
Kate Falberg, CFO
•
Seamus Mulligan, Chief Business Officer, International Business Development
•
Azur executives join JPI executives in leadership roles
Anticipated Closing: 1Q12

23
Azur Pharma –
Compelling Fit With Jazz Pharmaceuticals
$0
$20
$40
$60
$80
$100
2006
2007
2008
2009
2010
CNS
Women’s Health
Net Sales
(Millions)
•
Strong commercial focus and expertise
in CNS and women’s health
•
Key products present new growth
opportunities
•
Lower risk pipeline of line extensions for
clozapine franchise and LCM programs
for key women’s health brands

24
2011 Estimated Revenues
Stand Alone Jazz Pharmaceuticals, Inc.
Pro forma Jazz Pharmaceuticals plc
A Growing, Diversified Product Portfolio
Luvox CR
13%
Xyrem 87%
Xyrem 63%
Luvox CR
9%
Prialt 6%
Women’s
Health 10%
Other CNS
1%
FazaClo LD
8%
FazaClo HD
3%

25
•
Sourcing of new products for all markets
•
Potential expansion into Europe
Benefits of New Corporate Structure
Access to international capital markets and business development
opportunities
•
Sales, marketing, and clinical/medical science liaison organizations
•
Multi-product supply chain management
•
BD executives with demonstrated success
Enhanced management capabilities
•
Enhanced ability to attract and retain key talent
Additional locations (Philadelphia, Dublin)
Parent company in Ireland expected to license, develop and acquire
existing and new products

26
Next Steps
File preliminary proxy
statement and S-4
Expected to
close 1Q12
Transaction is
subject to customary
closing conditions
and regulatory
approvals, including:
•
SEC effectiveness of S-4
•
Jazz Pharmaceuticals, Inc.
stockholder approval
•
Azur approval of other
necessary actions
•
Antitrust clearance
•
Transaction will be taxable to
Jazz Pharmaceuticals, Inc.
stockholders
•
Jazz Pharmaceuticals plc
shares to be traded on Nasdaq

27
Strategic 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
Projected Financial Benefits
•
Accretive
transaction
•
Revenues >$475M
and cash flow >$200M in
first 12 months
•
~$250M cash at closing
•
Strong balance sheet
with no debt
1
Accretion for Jazz Pharmaceuticals shareholders is on a  fully-taxed adjusted EPS basis. Adjusted EPS is a non-GAAP financial measure that excludes certain items from GAAP EPS.
2
Pro forma estimate as of Jan 1, 2012.
Compelling Strategic and Financial Benefits
Jazz
Pharmaceuticals plc
Ireland
1
2

29
FY 2011G
FY 2010
Reconciliation of GAAP Net Income and EPS to Adjusted
Net Income and EPS in Financial Results and Guidance
(In millions, except per share amounts)
GAAP net income
Add:
Intangible asset amortization
Stock-based compensation expense
Non-cash interest expense
Loss on extinguishment of debt
Deduct:
Contract revenues
GAAP net income per diluted share (EPS)
Adjusted net income per diluted share (EPS)
Shares used in computing GAAP and adjusted net
income per diluted share amounts
Adjusted net income
Luvox CR revenue recognition timing change
(1)
$123-131
7
14
2
$145-153
$2.68-2.79
$3.15-3.25
46-47
-
(1)
$33
8
8
2
$61
$0.83
$1.55
39
12
(1)
1.
Based on guidance provided on July 28, 2011.  The company is not
updating the prior guidance and actual results may differ.
-
1

30
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
events.
Reports
of
respiratory
depression
occurred
in
clinical
trials.
Almost
all
of
the
patients
who
received sodium oxybate during clinical trials were receiving CNS stimulants.
Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases
in level
of
consciousness,
with
instances
of
coma
and
death.
For
events
that
occurred
outside
of
clinical
trials,
in
people
taking
GHB for
recreational
purposes,
the
circumstances
surrounding
the
events
are
often
unclear
(e.g.,
dose
of
GHB
taken, the
nature and amount of alcohol or any concomitant drugs).
Xyrem is available
through
the
Xyrem
Success
Program,
using
a
centralized
pharmacy
1-866-XYREM88
®
(1-866-997-3688). The
Success
Program
provides
educational
materials
to
the
prescriber
and
the
patient
explaining
the
risks
and
proper
use of
sodium oxybate,
and
the
required
prescription
form.
Once
it
is
documented
that
the
patient
has
read
and/or
understood
the
materials,
the
drug
will
be
shipped
to
the
patient.
The
Xyrem
Success
Program
also
recommends
patient
follow-up
every 3
months. Physicians are expected to report all serious adverse events to the manufacturer. (See WARNINGS).
XYREM (sodium oxybate) PI
!WARNING:
Central
nervous
system
depressant
with
abuse
potential.
Should
not
be
used
with
alcohol
or
other
CNS
depressants.

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 depressive disorder (MDD) and other psychiatric
disorders.
Anyone
considering
the
use
of
LUVOX
CR
®
(fluvoxamine
maleate)
Extended-Release Capsules or any other antidepressant in a child, adolescent,
or young adult must balance this risk with the clinical need. Short-term studies
did
not
show
an
increase
in
the
risk
of
suicidality
with
antidepressants
compared to placebo in adults beyond age 24; there was a reduction in risk with
antidepressants
compared
to
placebo
in
adults
aged
65
and
older.
Depression
and certain other psychiatric disorders are themselves associated with
increases in the risk of suicide. Patients of all ages who are started on
antidepressant therapy should be monitored appropriately and observed closely
for clinical worsening, suicidality, or unusual changes in behavior. Families and
caregivers should be advised of the need for close observation and
communication with the prescriber. LUVOX CR Capsules are not approved for
use
in
pediatric
patients.
(See
WARNINGS:
Clinical
Worsening
and
Suicide
Risk,
PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)