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| 8-K - ENDO PHARMACEUTICALS HOLDINGS INC. - ENDO HEALTH SOLUTIONS INC. | d8k.htm |
 grow.
collaborate. innovate. thrive.
ENDO PHARMACEUTICALS
J.P. Morgan Global High Yield & Leveraged Finance Conference
March 2, 2011
Exhibit 99.1 |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
2
FORWARD LOOKING STATEMENTS
This presentation contains forward-looking statements within the meaning of the Private
Securities Litigation
Reform
Act
of
1995.
Statements
including
words
such
as
“believes,”
“expects,”
“anticipates,”
“intends,”
“estimates,”
“plan,”
“will,”
“may,”
“look forward,”
“intend,”
“guidance,”
“future”
or similar
expressions are forward-looking statements. Because these statements reflect our
current views, expectations and beliefs concerning future events, these
forward-looking statements involve risks and uncertainties. Investors should note
that many factors, as more fully described under the caption “Risk
Factors”
in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange
Commission and as otherwise enumerated herein or therein, could affect our future
financial results and could cause our actual results to differ materially from those
expressed in forward-looking statements contained in our Annual Report on Form
10-K. The forward-looking statements in this presentation are qualified by
these risk factors. These are factors that, individually or in the aggregate, could cause our
actual results to differ materially from expected and historical results. We assume no
obligation to publicly update any forward-looking statements, whether as a result
of new information, future developments or otherwise. |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
PRESENTATION OVERVIEW
3
I.
Sustaining Growth
II.
Our Business Model:
Branded Pharmaceuticals
Devices and Services
Generic Pharmaceuticals
III.
Financial Outlook |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
We’re building a broad based offering of products and
services
at
a
range
of
price
points
to
improve
economics
We’re creating access
by developing channels, managed care
presence,
personal and non-personal promotion
We’ll explore all platforms of therapy to improve outcomes
and provide the best healthcare solutions for our patients and
providers
We believe that our focus will position Endo for sustainable
growth
4
OUR FOCUS –
ECONOMICS, ACCESS, OUTCOMES |
 grow.
collaborate. innovate. thrive. STRONG OPERATING PERFORMANCE
16% 3-YEAR CAGR FOR REVENUE*
* Revenue CAGR 2007-2010.
$mm
Sustaining our Growth
5
Revenue
Cash Flow from Operations
©2011 Endo Pharmaceuticals Inc. |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
6
Through Organic Growth
•
Diversified business lines to maximize growth
•
Enhanced commercial model driving growth via
strategic resource deployment
•
Invested in R&D portfolio yielding a diversified
pipeline of products and a recent FDA approval
•
Bolstered management team by adding
expertise and experience in managing and
growing a larger enterprise
6
ENDO’S TRANSFORMATION
Through Strategic Growth
•
With Indevus, we secured a position in urology
•
HealthTronics gave us an established presence
in Devices & Services and critical mass in
urology
•
Penwest strengthened our pain business
enhancing profitability & flexibility in the opioid
franchise
•
Qualitest brings critical mass to our generics
business & strengthens our pain portfolio |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
7
DIVERSIFICATION OF BUSINESS
Diversifying
our revenues through organic and strategic growth
2008 ($1.26B)
2011E ($2.35B -
$2.45B)
Lidoderm
Generics
Other
Brands
Lidoderm
Other
Brands
Generics
Devices &
Services |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
8
ENDO’S INTEGRATED BUSINESS MODEL |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
PRESENTATION OVERVIEW
9
I.
Sustaining Growth
II.
Our Business Model:
Branded Pharmaceuticals
Devices and Services
Generic Pharmaceuticals
III.
Financial Outlook |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
STRONG CORE BUSINESS SUPPORTING GROWTH
10 |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
NEW TESTOSTERONE REPLACEMENT THERAPY
14 million men suffer with hypogonadism
in US
9% are treated
Market TRx
Net Sales: >$1.2B
Growth Rate: approximately 20% CAGR last 5 years
Gels have the greatest utilization in the TRT market: ~72%
PCPs account for majority of TRT prescriptions:
More than 60% through Primary Care Physicians
Approximately 30% through specialty (Urologists/Endocrinologists)
Method of Payment for TRT class:
Approximately 80% Commercial
Approximately 12% Government
Remainder from Cash Payment
11 |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
LONG-ACTING OPIOID FRANCHISE
OPANA®
ER
Settlement with generic companies provides for 2013 entry on primary dosage forms
>35% YOY TRx
growth for full year 2010
Gaining share; Growing source of cash flow
Completed Acquisition of Penwest
Advances our leadership and growth in pain management
New formulation of OPANA ER designed to be crush resistant
Complete Response Letter from FDA on January 7, 2011
Letter did not require additional clinical trials
Confident that we can address the issue set forth
Currently anticipate responding to the FDA by mid-2011
Expect a 6-month review cycle once our response is filed
12 |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
DEVELOPMENT PIPELINE*
Phase I
Phase II
Phase III
NDA
FORTESTA
TM
Gel
2% Testosterone Gel
OPANA®
ER
Formulation designed to be crush-resistant
AVEED
TM
Long Acting Injectable Testosterone
Urocidin
TM
Bladder Cancer
Octreotide Implant
Acromegaly**
Axomadol
Moderate to moderately severe chronic pain
*
There can be no assurance that any of these development programs will be successful
or if successful, the products will ultimately be approved by FDA.
**
Granted orphan drug designation
13
Approved
Pending
Update Pending |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
PRESENTATION OVERVIEW
14
I.
Sustaining Growth
II.
Our Business Model:
Branded Pharmaceuticals
Devices and Services
Generic Pharmaceuticals
III.
Financial Outlook |
 grow.
collaborate. innovate. thrive. HEALTHTRONICS SERVICES
15
Leading provider of urology services:
•
Lithotripsy
–
A leading, non-invasive, treatment for kidney stones
using high-energy shockwaves
•
BPH laser
–
Laser procedures to vaporize or resect the enlarged
prostate
•
Cryosurgery
–
A minimally-invasive procedure that uses ice to
destroy prostate cancer
Emerging growth opportunity:
•
Anatomic
Pathology
–
Laboratory
Solutions
unit
with
expertise
in
urology and pathology
©2011 Endo Pharmaceuticals Inc. |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
Established business channel with 1/3 of urologists in U.S.
Furthers our commitment to the urologist community
Opportunities for a complete suite of Endo products in this specialty:
Branded Drugs
Generic Drugs
Devices and Services
Total solution for the urology marketplace
Improve patient care
Enhance practice economics
HEALTHTRONICS OVERVIEW
16 |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
PRESENTATION OVERVIEW
17
I.
Sustaining Growth
II.
Our Business Model:
Branded Pharmaceuticals
Devices and Services
Generic Pharmaceuticals
III.
Financial Outlook |
 grow.
collaborate. innovate. thrive. 18
QUALITEST -
A STRATEGIC FIT
Furthers our stated strategy to build a healthcare company better able
to respond to the changing economics that drive the U.S. healthcare
environment
Enhances our core pain franchise
Adds critical mass to our current generics business, alongside Branded
Pharmaceuticals and Devices & Services
As a high-growth asset, will significantly diversify and accelerate the
growth of Endo’s revenue and earnings’
streams
©2011 Endo Pharmaceuticals Inc. |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
19
A STRONGER GENERICS BUSINESS WITH ROBUST
PIPELINE
Combined Generics Business
•
Solid commercial base entering 2011
•
Expect to file 14 ANDAs
in 2011
•
45 ANDAs
currently under review by FDA
•
Expect 14 ANDA product launches in 2011
We expect our combined generics business to grow over 15% over the
2010-12 period driven by launches from the development portfolio
2011 Generic Development |
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collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
PRESENTATION OVERVIEW
20
I.
Sustaining Growth
II.
Our Business Model:
Branded Pharmaceuticals
Devices and Services
Generic Pharmaceuticals
III.
Financial Outlook |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
21
2011 ENDO GUIDANCE
Guidance
Revenue range
$2.35BN -
$2.45BN
Adjusted diluted EPS range
$4.20 -
$4.30
Reported (GAAP) diluted EPS range
$2.43 -
$2.53 |
 grow.
collaborate. innovate. thrive. We’re
building
a
broad
based
offering
of
products
and
services
at
a
range
of
price
points
to
improve
economics
We’re creating
access
by developing
channels, managed care
presence,
personal and non-personal
promotion We’ll explore all platforms of therapy to improve outcomes
and provide the
best healthcare solutions for our patients and providers
We believe that our
focus will position Endo for sustainable
growth
22
OUR FOCUS –
ECONOMICS, ACCESS, OUTCOMES
©2011 Endo Pharmaceuticals Inc. |
 grow.
collaborate. innovate. thrive.
ENDO PHARMACEUTICALS |
 grow.
collaborate. innovate. thrive. ©2011 Endo Pharmaceuticals Inc.
24
24
RECONCILIATION OF NON-GAAP MEASURES
24
For an explanation of Endo’s reasons for using non-GAAP measures, see Endo’s
Current Report on Form 8-K filed today with the Securities and Exchange Commission
Reconciliation of Projected GAAP Diluted Earnings Per Share to Adjusted Diluted Earnings Per
Share Guidance for the Year Ending December 31, 2011 Lower End of Range
Upper End of Range
Projected GAAP diluted income per common share
$2.43
$2.53
Upfront and milestone-related payments to partners
$0.35
$0.35
Amortization of commercial intangible assets and inventory step-up
$1.33
$1.33
Acquisition and integration costs related to recent acquisitions.
$0.26
$0.26
Interest expense adjustment for ASC 470-20 and the amortization of
the premium on debt acquired from Indevus
$0.16
$0.16
Tax effect of pre-tax adjustments at the applicable tax rates and
certain other expected cash tax savings as a result of recent
acquisitions
($0.33)
($0.33)
Diluted adjusted income per common share guidance
$4.20
$4.30
The company's guidance is being issued based on certain assumptions including:
•Certain of the above amounts are based on estimates and there
can be no assurance that Endo will achieve these results
•Includes all completed business development transactions as of
February 28, 2011 |
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collaborate. innovate. thrive.
ENDO PHARMACEUTICALS
J.P. Morgan Global High Yield & Leveraged Finance Conference
March 2, 2011 |