ENDO
PHARMACEUTICALS
UBS Global and Generic
Pharmaceuticals Conference
May 8, 2007
Exhibit 99.1
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
This presentation contains forward-looking statements, within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange
Act of 1934, as amended, that are based on management’s beliefs and assumptions, current expectations, estimates and
projections. These statements are subject to risks and uncertainties and, therefore,
actual results may differ materially from those expressed or
implied by
these forward-looking statements. Forward-looking statements are not historical facts and include information regarding the
Company’s possible or assumed results of operations. Also, statements or
expressions that are preceded by, followed by, or that include, the
words
“believes,”
“anticipates,”
“plans,”
“expects,”
“intends,”
“estimates”
or similar expressions are forward-looking statements. Endo’s estimated
or anticipated future results, product performance or other non-historical
facts are forward-looking and reflect Endo’s current perspective on
existing trends and information. Many of the factors that will determine the
Company’s future results are beyond the ability of the Company to
control or predict. The reader should not rely on any forward-looking statement. The
Company undertakes no obligations to update any forward-
looking
statements whether as a result of new information, future events or otherwise. None of the development products in the Company’s
pipeline have been established as safe and effective by the FDA or approved by the
FDA. Several important factors, in addition to the specific
factors
discussed
in
connection
with
these
forward-looking
statements
individually,
could
affect
the
future
results
of
Endo
and
could
cause
those
results to differ materially from those expressed in the forward-looking statements
contained herein. Important factors that may affect future
results include,
but are not limited to: the Company’s ability to successfully develop, commercialize and market new products; results of clinical
trials on new products; competition for the business of the Company’s branded and
generic products, and in connection with the Company’s
acquisition of
rights to intellectual property assets; market acceptance of the Company’s future products; government regulation of the
pharmaceutical industry; the Company’s dependence on a small number of
products; the Company’s dependence on outside manufacturers for
the
manufacture of its products; the Company’s dependence on third parties to supply raw materials and to provide services for the core aspects
of its business; new regulatory action or lawsuits relating to the Company’s use of
narcotics in most of its core products; the Company’s exposure
to
product liability claims and product recalls and the possibility that the Company may not be able to adequately insure itself; the Company’s
ability to protect its proprietary technology; the Company’s ability to
successfully implement its acquisition strategy; the availability of controlled
substances
that
constitute
the
active
ingredients
of
some
of
the
Company’s
products
and
products
in
development;
the
availability
of
third-party
reimbursement for the Company’s products; the Company’s dependence on sales to
a limited number of large pharmacy chains and wholesale
drug distributors
for a large portion of its total net sales; and other risks and uncertainties detailed in Endo’s filings with the Securities and
Exchange Commission, including its Registration Statement on Form 10-K filed with
the SEC on March 1, 2007. Readers should evaluate any
statement in light of
these important factors.
Forward-Looking Statements
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Endo Pharmaceuticals
–
Leader in Pain
Management
Specialty pharma
company with market leadership in pain management
•
Analgesics the fourth-largest prescription pharmaceutical market in
2006
•
Opioids represented 80% of analgesic prescriptions, with a five-
year CAGR of 8%
Proven commercial capability
•
Specialty and PCP sales and marketing teams
Pipeline focused on delivery and execution
•
Two NDAs approved in 2006; expect additional sNDA in Aug. ‘07
Strong financial condition
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Growth Strategy
Maximize value of established brands
Expand
through
licensing
and
acquisition
while
remaining
true
to
our
specialty roots
•
Revenue diversification
•
Expand balanced, sustainable pipeline
Strengthen leadership position in Pain Management and drive
continued expansion into additional therapeutic areas such as
neurology and supportive care oncology
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
2007 –
Investing in the Future
Increasing promotional support behind key brands:
•
Expanded managed markets team
•
Expanded clinical liaison team
•
Comprehensive physician education and patient outreach programs
Expanded sales force of 590 representatives
Accelerating R&D investment behind Rapinyl
TM
, ketoprofen patch, EN
3285, and sufentanil patch
Enhancing infrastructure to sustain our growth through 2010:
•
New systems, processes, people
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
2007 Key Objectives
Achieve $1.025 to $1.050 billion in net sales
•
Continue to grow Lidoderm
®
net sales
•
Accelerate sales trajectory for the Opana
®
franchise
Obtain FDA approval for Frova
®
in the MM prophylaxis indication
Accelerate development of our current pipeline to meet market needs
and optimize target product profiles
Pursue strategic licensing and acquisition opportunities that expand
beyond pain but allow us to retain our focus on the specialty physician
community
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Lidoderm
®
-
A True Success Story
Lidocaine 5% topical patch
•
Patent protection until 2015
•
Acts locally -
no
therapeutically meaningful
blood levels
First FDA-approved drug for
treatment of pain of PHN
Provides analgesia (but no
anesthesia) directly to affected
nerves
Easy and convenient to use
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
$178
$309
$419
$663
$567
$0
$100
$200
$300
$400
$500
$600
$700
2003
2004
2005
2006
2007*
Lidoderm
®
-
Continuing Net Sales Growth
($ in millions)
*Represents mid-point of company guidance
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Accelerating Our Growth
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2007 Endo Pharmaceuticals
Opana
®
ER and Opana
®
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Opana
®
ER –
Broad Label
Broad indication:
For the relief of moderate
-
to
-
severe pain in patients
requiring continuous, around-the-clock opioid treatment for an extended
period of time
First time oxymorphone available in oral ER formulation
Proven efficacy in broad range of appropriate pain patients
Twice-daily dosing
Effective pain control shown at stable dose for three months in clinical
trials underscores durability of Opana
®
ER’s analgesic effect
Generally well tolerated when titrated effectively*
* Most common adverse events (> 10%) in trials were nausea, constipation, dizziness,
vomiting, pruritus, somnolence, headache,
increased sweating, and
sedation
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Accelerating Our Growth
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2007 Endo Pharmaceuticals
Opana
®
Franchise -
Targeted
Commercial Strategy
Opana
®
ER competes in $3.2 billion U.S. long-acting strong opioid
market
Combined Opana
®
ER and Opana
®
net sales guidance for 2007 is $85
million to $105 million
•
On track to meet guidance with current Rx trends
Expanded sales force in mid-2006
by 220 reps to responsibly
promote
Opana
®
ER and Opana
®
to approximately 90,000 physicians
Full range of promotional activities now underway
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Key Marketing and Promotional Activities
Redeployed hospital sales force to Specialty Force II to provide
double
coverage on 6,600 high-decile specialists
Expanded patient access through direct discount programs
Instituted managed care contracting strategy to achieve parity or better
formulary status
•
Tripled size of managed markets group to extend reach to regional
and local plans
Introduced new sales/marketing materials
•
Journal ads
•
Reprints of peer-reviewed journal articles
•
Speaker dinner programs
•
Major commercial presence at key medical meetings such as APS
(May 2-5)
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Accelerating Our Growth
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2007 Endo Pharmaceuticals
Opana
®
ER TRx
Launch Comparison
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Accelerating Our Growth
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2007 Endo Pharmaceuticals
Frova
®
Profile
Triptan indicated for acute
treatment of migraine
headaches in adults
Market differentiation based on
low recurrence rate, long half-
life
Potential label expansion for
menstrual migraine prophylaxis
represents significant market
opportunity
Net sales $40.6 million in 2006
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Accelerating Our Growth
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2007 Endo Pharmaceuticals
Robust Development Pipeline
(1)
Licensed marketing rights
(2)
Licensed marketing and development rights
Phase I
Phase II
Phase III
Filed
Pre-
clinical
Undisclosed
Sufentanil Patch
(2)
(Transdermal -
Chronic Pain)
EN 3285
(Oral Rinse for Oral Mucositis)
Ketoprofen Patch
(2)
(Topical -
Soft Tissue Injuries)
Rapinyl
TM (2)
(Breakthrough Cancer Pain)
Frova
®
(Menstrual Migraine)
(1)
Product
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Frova
®
MM Prophylaxis:
Exciting Near-Term Opportunity
PDUFA date 8/19/07
Substantial data package:
•
Two double-blind, placebo-controlled studies in Menstrual Migraine
(MM) prophylaxis; long-term open-label safety & tolerance study
Pivotal efficacy studies:
•
Frova
®
taken for six days, starting two days prior to onset of
expected MM headache
•
Primary efficacy endpoint: reduction in incidence of MM headache
–
p <0.0001 to p < 0.01 (vs. placebo)
–
Secondary endpoints --
reduction in severity and duration of
MM headache --
also achieved
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Ketoprofen Patch
Topical patch intended for localized treatment of acute pain from soft-
tissue injuries such as tendonitis/bursitis, joint sprains or strains
Ketoprofen (NSAID) currently only available in U.S. in oral form
Will compete in ~$2.5 billion soft-tissue injury market primarily
consisting of NSAIDs and COX-IIs
Anticipated benefits include:
•
Bypassing bloodstream to minimize GI and
cardiovascular side effects
•
Local, targeted pain control
•
Convenience of once-daily dosing
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Ketoprofen Patch –
Study Update
Four Phase III trials ongoing
•
Two efficacy studies to evaluate treatment of pain associated with
tendonitis or bursitis of the shoulder, elbow or knee
•
One efficacy study to evaluate treatment of pain associated with
ankle sprain or strain
•
One study in patients with osteoarthritis flare of the knee, primarily
designed to collect long-term safety data
Projected NDA filing date 1H 2008
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Transdermal Sufentanil Patch
Intended for moderate-to-severe chronic pain
Follow-on to Duragesic
Anticipated benefits include:
•
Convenience/compliance of seven-day dosing vs. three days
•
Smaller patch --
20% the size of Duragesic
Phase I product characterization ongoing
Phase II trials anticipated to begin in 1H 2007
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Rapinyl
TM
Oral, fast-dissolving sublingual fentanyl tablet
Intended for the treatment of breakthrough cancer pain
•
Expected to compete with Actiq and Fentora
Anticipated benefits include:
•
Fast onset of action
•
Enhanced absorption characteristics
•
Added patient convenience
Two Phase III trials ongoing
Projected NDA filing date 1H 2008
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
EN 3285
Key product obtained in RxKinetix acquisition
Patent-protected oral rinse formulated using proprietary ProGelz
®
delivery platform for prevention of oral mucositis (OM)
About 400,000 patients per year in U.S. develop OM
•
Only current FDA-approved treatment is IV infusion
Anticipated benefits of EN 3285 include:
•
Ease of use for patients
•
No systemic side effects
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Upcoming Key Milestones
Expanding a solid platform for sustainable growth:
Sufentanil Patch
Phase II
Ketoprofen Patch
NDA Filing
Opana
®
and
Opana
®
ER
Launch
EN 3285
Phase II/III
Acquisitions/
In-licensing
Rapinyl
™
NDA
Filing
Ongoing
1H’07
2H’07
1H’08
Frova
®
MM
FDA Action Letter
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Accelerating Our Growth
©
2007 Endo Pharmaceuticals
Summary
Market leader in pain management
Well-developed commercial capability
Very broad and deep pipeline
Strong financial condition
Sustainable strategy for growth
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ENDO PHARMACEUTICALS
Nasdaq: ENDP
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