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8-K - FORM 8-K - ENDO HEALTH SOLUTIONS INC. | d8k.htm |
Exhibit 99.1
ENDO PHARMACEUTICALS
grow. collaborate. innovate. thrive.
Annual Meeting of Stockholders May 25, 2011
grow. collaborate. innovate. thrive.
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.
©2011 Endo Pharmaceuticals
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grow. collaborate. innovate. thrive.
ENDO PHARMACEUTICALS
I. Our Business
II. Executing Strategy for Growth III. American Medical Systems Acquisition IV. Financial Outlook
grow. collaborate. innovate. thrive.
STRONG OPERATING PERFORMANCE
16% 3- YEAR CAGR FOR REVENUE*
Sustaining our Growth
$mm
$2,000 $1,000 $0
$2.35B -$2.45B
$399 $110
2002
$596 $217
2003
$615 $171
2004
$820 $285
2005
$910 $345
2006
$1,086
$366
2007
$1,261
$356
2008
$1,461
$295
$1,716
$454
2009
2010
2011E
Revenue
Cash Flow from Operations
* |
|
Revenue CAGR 2007-2010. |
©2011 Endo Pharmaceuticals
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ENDOS TRANSFORMATION
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
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
AMS establishes scale in devices and services and solidifies our position covering the urology market Now expected to close in
2Q 2011
©2011 Endo Endo Pharmaceuticals
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DIVERSIFIED HEALTHCARE SOLUTIONS COMPANY
Endo
Revenue mix
Generic
21%
Devices & 10% Services
Other Branded 32%
Lidoderm®
37%
12/31/10: $2.14B (1)
Pro Forma
Revenue mix
Generic
17%
Lidoderm®
30%
28%
Devices & Services
25%
Other Branded
12/31/10: $2.68B (3)
AMS
Revenue mix
BPH
Womens Health
33%
21%
Mens Health
46%
12/31/10: $0.54B (2)
US
73%
27%
International
1. Pro forma for full year of 2010 acquisitions of Qualitest, HealthTronics and Penwest
2. Excludes $4.2MM of discontinued operations
3. Includes full year of AMS acquisition
©2011 Endo Pharmaceuticals
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grow. collaborate. innovate. thrive.
ENDOS INTEGRATED BUSINESS MODEL
Organic Growth Opportunities
Strategic Growth Opportunities
Branded Pharmaceuticals
Value
Devices
& Services
Generics
Channels that solve for Economics, Access, Outcomes
©2011 Endo Pharmaceuticals
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STRONG CORE BUSINESS SUPPORTING GROWTH
©2011 Endo Pharmaceuticals
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grow. collaborate. innovate. thrive.
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
©2011 Endo Pharmaceuticals
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DEVELOPMENT PIPELINE*
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
Androgen Receptor Agonist***
Castration Resistant Prostate Cancer
Phase I Phase II Phase III NDA
Pending
Update Pending
* 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
*** Licensed from Orion Corporation for joint development and commercialization
©2011 Endo Pharmaceuticals
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©2011 Endo Pharmaceuticals
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AMS STRATEGIC RATIONALE
Furthers stated strategy to respond to the changing economics that drive the U.S . healthcare environment
Evolving from a product-driven company to a healthcare solutions provider
Healthcare reform puts a premium on providing cost-effective health solutions
Balances Endos integrated business model
Brings scale to devices and services business
Shorter, less expensive product development
Favorable pricing and reimbursement flexibility
Higher degree of cash flow sustainability supported by life cycle management through innovation, less product substitution risk and continued volume- driven market growth
Strengthens Endos core urology franchise
AMS gives Endo scale in urology therapeutic space with approximately $1BN in sales
Endo s AMS enhances ability to offer patients solutions through the entire course of urology treatment options
AMS has solid market share in several niche categories that have grown in the mid- to- high single digit range over the long term
By acquiring a high- growth asset, will diversify and boost revenue and earnings streams
Advances growth on several metrics and is immediately accretive to earnings on a cash basis by $0.60 in 2012.
Further diversifies Endo across Branded Pharmaceuticals, Generic and Devices & Services segments
AMS has a robust product portfolio and a strong product cadence over the next 12 months
©2011 Endo Pharmaceuticals
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AMS COMPANY PROFILE
Leading Provider of Devices to Pelvic Health Space
Mens Health: Solutions for male incontinence and erectile dysfunction prostheses Womens Health: Solutions for female incontinence and pelvic floor repair Benign Prostatic Hyperplasia (BPH) Therapy: Laser treatments
Strong Product Portfolio Supported by Robust Future Product Cadence
Solid market share in several categories that have historically grown in the mid- to- high single digit range over the long- term Near- term growth driven by new product launches and initiatives such as the GreenLight XPS console and MoXy fiber
Seasoned Management Team and High Quality Assets
Team has significant experience running a growing devices business Four global facilities two in the US (Minnetonka , MN and San
Jose, CA) and two in Europe (Bruekelen, Netherlands and Athlone, Ireland)
Revenue by Segment
FY 2010
Other 1%
Mens Health 45%
BPH 21%
Womens Health 33%
Revenue by Geography
FY 2010
International 27%
United States 73%
©2011 Endo Pharmaceuticals
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AMS PRODUCT PORTFOLIO
Mens Health
Product Description AMS 800 Artificial Urinary Sphincter
Less invasive treatment for InVance moderate incontinence
Less invasive treatment for AdVance mild to moderate incontinence
Endoprosthesis for non-UroLume surgical candidates
Neosphincter to treat Acticon severe fecal incontinence
Semi- rigid malleable prostheses / inflatable AMS 700 prostheses for treatment of Erectile Dysfunction
Womens Health
Product Description
Self- fixating, sub- fascial Monarc hammack for treatment of stress incontinence
Single- Incision Sling for MiniArc stress incontinence
Neosphincter used to treat Acticon severe fecal incontinence
Transvaginal pelvic floor Elevate repair system (requires no external incisions)
BPH
Product Description Photovaporization / laser GreenLight therapy designed to remove prostatic tissue
Laser treatment of urinary StoneLight stones
Fiber optic line designned SureFlex for holmium laser lithotripsy
Less invasive tissue ablation technique for men not yet TherMatrx to the point of urethral obstruction
©2011 Endo Pharmaceuticals
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2011 ENDO GUIDANCE
Guidance
Revenue range $2.35B-$2.45B Adjusted diluted EPS range $4.20-$4.30 Reported (GAAP) diluted EPS range $2.25-$2.35
©2011 Endo Pharmaceuticals
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ENDO PHARMACEUTICALS
grow. collaborate. innovate. thrive.
grow. collaborate. innovate. thrive.
RECONCILIATION OF NON- GAAP MEASURES
For an explanation of Endos reasons for using non- GAAP measures, see Endos 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 $2.25 $2.35
Upfront and milestone-related payments to partners $0.35 $0.35 Amortization of commercial intangible assets and inventory step- up $1.35 $1.35 Acquisition and integration costs related to recent acquisitions. $0.35 $0.35
Interest expense adjustment for ASC 470- 20 and the amortization of $0.16 $0.16 the premium on debt acquired from Indevus Tax effect of pre-tax adjustments at the applicable tax rates and ($0.26) ($0.26) certain other expected cash tax savings as a result of recent acquisitions
Diluted adjusted income per common share guidance $4.20 $4.30
The companys 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 April 28, 2011
Includes certain expenses associated with the acquisition of American Medical Systems, Inc.
©2011 Endo Pharmaceuticals
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ENDO PHARMACEUTICALS
grow. collaborate. innovate. thrive.
Annual Meeting of Stockholders May 25, 2011