EX-99.1 2 dex991.htm SLIDE PRESENTATION Slide Presentation
drives us…
What
…is
our
passionate
pursuit
of
improving
patients’
lives.
ENDO PHARMACEUTICALS
JP Morgan Health Care Conference
January 9, 2007
Exhibit 99.1


1
©
2006 Endo Pharmaceuticals
What drives us…
Forward-Looking Statements
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 S-3 filed with the SEC on March 21, 2006. Readers should evaluate any statement in light of these important
factors.


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©
2006 Endo Pharmaceuticals
What drives us…
Endo Profile
Leader in Pain Management
Specialty pharma company with market leadership in pain
management
Proven
commercial capability
Pipeline focused on delivery and execution
Strong balance sheet
Cash and cash equivalents of $675 million at 9/30/06
No debt


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©
2006 Endo Pharmaceuticals
What drives us…
Growth Strategy
Maximize value of established brands
Expand through licensing and acquisition while remaining true
to our specialty focus
Build balanced, sustainable pipeline
Strengthen leadership position in Pain Management and drive
continued expansion into additional therapeutic areas such as:
Neurology
Perioperative Care
Supportive Care Oncology


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©
2006 Endo Pharmaceuticals
What drives us…
Recent Key Accomplishments
Secured two NDA approvals
Launched three products:
Opana
®
ER
Opana
®
Synera
®
Expanded sales force by 60% to 590 to support new product
launches and maintain coverage of existing products
Acquired RxKinetix and its supportive care oncology pipeline
Filed
sNDA
for
Frova
®
for
short-term
prevention
of
menstrual
migraine
Settled OxyContin patent litigation


5
©
2006 Endo Pharmaceuticals
What drives us…
Recent Developments
Amended
Opana
®
ER
agreement
with
Penwest
Conversion from net profit split to straight royalty on net sales
Endo gains sole control over all U.S. commercial efforts
Submitted
notice
to
terminate
DepoDur
®
agreement
with
SkyePharma
Hospital sales reps re-deployed to Specialty Sales Force II
Will promote Opana
®
and Opana
®
ER and Frova
®
to specialists;
Synera
TM
in
large
pediatric
hospitals
Revised
Rapinyl
TM
submission
timeline
for
NDA
filing
to
1H
2008


6
©
2006 Endo Pharmaceuticals
What drives us…
2007 –
Investing in the Future
Increasing our promotional support for:
Opana
®
ER and Opana
®
Lidoderm
®
Synera
Frova
®
(MM indication
expected 2H 2007)
Accelerating our R&D investment behind:
Rapinyl
Ketoprofen patch
EN 3285
Sufentanil patch
Enhancing
infrastructure-to-sustain-our-growth-through-2010
New systems, processes, people


7
©
2006 Endo Pharmaceuticals
What drives us…
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
and
successfully
launch
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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©
2006 Endo Pharmaceuticals
What drives us…
Solid Financial Condition
Selected Financial Data
(millions)
$275.5        
$284.6
$170.5
$217.4
$110.0
Net Cash from Operating
Activities
$1,026.7
$843.4
$656.0
$567.6
$352.7
Stockholders’-Equity
--
--
--
--
--
Total Debt
$657.6
$483.9
$294.3
$287.9
$105.1
Working Capital
$674.7
$501.0
$278.0
$229.6
$56.9
Cash & Cash Equivalents
9/30/06
2005
2004
2003
2002


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©
2006 Endo Pharmaceuticals
What drives us…
$0
$200
$400
$600
$800
$1,000
$1,200
2002
2003
2004
2005
2006*
2007*
Net Sales
Net Income
Consistent Financial Growth
(millions, except per share)
Diluted EPS      $0.30
$0.53
$1.08            $1.52
$399.0
$595.6
$615.1
$820.2
$30.8
$69.8
$143.3
$202.3
$895.0
$1,037.0
*Represents mid-point of company guidance


10
©
2006 Endo Pharmaceuticals
What drives us…
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


11
©
2006 Endo Pharmaceuticals
What drives us…
$178
$309
$419
$663
$535
$0
$100
$200
$300
$400
$500
$600
$700
2003
2004
2005
2006*
2007*
*Represents mid-point of company guidance
Lidoderm
®
-
Continuing Net Sales Growth
($ in millions)


12
©
2006 Endo Pharmaceuticals
What drives us…
Opana
®
ER and Opana
®


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©
2006 Endo Pharmaceuticals
What drives us…
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
Expanded
sales
force
by
220
reps
to
promote
Opana
®
ER
and
Opana
®
Re-deployed Hospital Sales Reps to Specialty Force II in 2007
Launched full range of promotional activities in early November
Steady growth in Rx demand
Expect to see impact on sales uptake in 1H 2007


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©
2006 Endo Pharmaceuticals
What drives us…
Opana
®
ER TRx
Launch Comparison
Opana ER YTD TRx vs. Competitive Launches
-
5,000
10,000
15,000
20,000
25,000
30,000
1
2
3
4
5
6
Months Since Launch
Avinza
Duragesic
Oxycontin
Palladone
Opana ER
Source: WHK PHAST
Source: IMS Health


15
©
2006 Endo Pharmaceuticals
What drives us…
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


16
©
2006 Endo Pharmaceuticals
What drives us…
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
LTM net sales of $42.1 million at
9/30/06


17
©
2006 Endo Pharmaceuticals
What drives us…
Synera
TM
Profile
Topical, local anesthetic patch to
numb the skin before various
medical procedures
Benefits include fast onset of
action, ease of administration
Primary market is hospitalized
pediatric patients
Potential label expansion in
pediatric immunization (studies
planned)


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©
2006 Endo Pharmaceuticals
What drives us…
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


19
©
2006 Endo Pharmaceuticals
What drives us…
Frova
®
MM Prophylaxis:
Exciting Near-Term Opportunity
PDUFA date 5/19/07
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


20
©
2006 Endo Pharmaceuticals
What drives us…
Topical Ketoprofen Patch
Topical patch intended for localized treatment of acute pain associated
with 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 the bloodstream to minimize GI and
cardiovascular side effects
Local/targeted pain control
Convenience of once-daily dosing
Three Phase III trials ongoing
Projected NDA filing date 1H 2008


21
©
2006 Endo Pharmaceuticals
What drives us…
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 in 1H 2007


22
©
2006 Endo Pharmaceuticals
What drives us…
Opana ER
®
(1)
Opana
®
Emerging Supportive Care Oncology Pipeline
(1)
Co-developed
(2)
Licensed marketing and development rights.
Phase II
Phase III
Filed
Market
Pre-
clinical
Rapinyl
EN 3285
(Oral Rinse for Oral Mucositis)
Undisclosed
Product
Phase I
TM (2)


23
©
2006 Endo Pharmaceuticals
What drives us…
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
Currently in Phase III –
two
trials ongoing
Projected NDA filing date 1H 2008


24
©
2006 Endo Pharmaceuticals
What drives us…
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


25
©
2006 Endo Pharmaceuticals
What drives us…
Upcoming Key Milestones
Expanding a solid platform for sustainable growth:
Sufentanil Patch
Phase II
Ketoprofen
Patch
NDA Filing
Opana
®
and
Opana
-ER
®
Launch
Synera™
Launch
EN 3285
Phase II
Acquisitions /
In-licensing
Rapinyl™
NDA
Filing
Ongoing
1H’07
2H’07
1H’08
Frova
®
MM
FDA Action
Letter
Frova for MM
Indication
Launch


26
©
2006 Endo Pharmaceuticals
What drives us…
Summary
Market leader in pain management, with focused growth
strategy
Well-developed commercial capability
Very broad and deep pipeline
Strong financial condition


drives us…
What
…is
our
passionate
pursuit
of
improving
patients’
lives.
ENDO PHARMACEUTICALS
Nasdaq: ENDP