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| 8-K - FORM 8-K - ENDO HEALTH SOLUTIONS INC. | d8k.htm |
 Endo
Pharmaceuticals Barclays Capital Global Healthcare Conference March 2010 Exhibit 99.1 grow. collaborate. innovate. thrive. grow. collaborate. innovate. thrive. |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. FORWARD LOOKING STATEMENT 2 This presentation contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 regarding, among other things, the
company’s financial position, results of operations, market position, product development and business strategy, as well as estimates of future total revenues, future expenses, future net income and future earnings
per share. Statements including words such as “believes,”
“expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may” “intend,” “guidance” 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 could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking
statements contained in this presentation. These factors include, but are not limited
to: our ability to successfully develop, commercialize and market new products; timing and results of pre-clinical or clinical trials on new products; our ability to obtain regulatory approval of any of our pipeline
products; competition for the business of our branded and generic products, and in
connection with our acquisition of rights to intellectual property assets; market acceptance of our future products; government regulation of the pharmaceutical industry; our dependence on a small
number of products; our dependence on outside manufacturers for the
manufacture of a majority of our products; our dependence on third parties to supply raw materials and to provide services for certain core aspects of our business; new regulatory action or lawsuits
relating to our use of narcotics in most of our core products; our exposure to product
liability claims and product recalls and the possibility that we may not be able to adequately insure ourselves; the successful efforts of manufacturers of branded pharmaceuticals to use litigation and
legislative and regulatory efforts to limit the use of generics and certain other
products; our ability to successfully implement our acquisition and in-licensing strategy; regulatory or other limits on the availability of controlled substances that constitute the active ingredients of some
of our products and products in development; the availability of third-party
reimbursement for our products; the outcome of any pending or future litigation or claims by third parties or the government, and the performance of indemnitors with respect to claims for which we have been
indemnified; our dependence on sales to a limited number of large pharmacy chains and
wholesale drug distributors for a large portion of our total revenues; a determination by a regulatory agency that we are engaging or have engaged in inappropriate sales or marketing
activities, including promoting the “off-label” use of our products and
other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form
10-Q and annual reports on Form 10-K, particularly the discussion under the
caption "Item 1A, RISK FACTORS" in our annual report on Form 10-K for the year ended December 31, 2009, which was filed with the Securities and Exchange Commission on February 26, 2010. The
forward-looking statements in this presentation are qualified by these risk
factors. These are factors that, individually or in the aggregate, we think 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. |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. ENDO PHARMACEUTICALS I. Our Business II. Executing Strategy for Growth III. Financial Outlook |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. STRONG OPERATING PERFORMANCE 17% 3-YEAR CAGR FOR REVENUE* * Revenue CAGR 2006-2009. 4 $mm Sustaining our Growth |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. STRONG CORE BUSINESS SUPPORTING GROWTH 5 |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. STRONG CORE BUSINESS SUPPORTING GROWTH 6 LIDODERM® key component of our core business Strong source of operating cash flow Stable TRx trends 10-year Commercial launch anniversary in September 2009 Differentiated product profile provides unique offering for HCPs and patients suffering from PHN Improved PHN physician targeting for more efficient utilization of resources Solid managed care contract positioning for 2010 |
 Opioid
Franchise Opana® ER Effective physician targeting and managed care strategy Continuing strong share growth: 40% TRx growth YOY in Q4 2009 LAO market down 1% for the same period Surpassed two key competitors in TRx market share during 2009 (Kadian and Avinza) Opana® IR Continued branded sales producing strong cash flow Potential to support future generic sales Percocet®/Endocet® Solid cash flow supported by appropriate brand investments STRONG CORE BUSINESS SUPPORTING GROWTH 7 grow. collaborate. innovate. thrive. |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. SUPPRELIN® LA Highlights Central Precocious Puberty Incidence: 1 in every 5,000 – 10,000 children Utilizes Hydron Implant Technology Consistent quarter over quarter growth since 2007 launch ~80% unit growth YOY in 2009 SUPPRELIN LA Market Share ~35% Growing base of product adoption High level of patient, parent and physician satisfaction Re-implantation rate of ~75% Long-term efficacy / safety data (3yr.) supports first line therapy Increasing marketing support to further grow share STRONG CORE BUSINESS SUPPORTING GROWTH 8 |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. EXECUTING THE STRATEGY Defined parameters for expansion into adjacent therapeutic and device markets that leverage our commercial infrastructure Vantas Axomadol FORTESTA Urocidin Jubilant Aurigene Harvard University Supprelin LA Valstar LIDODERM OPANA ER/IR Voltaren Gel Specialty Generics Percocet 9 FROVA AVEED |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. DEVELOPMENT PIPELINE Phase I Phase II Phase III NDA AVEED Long Acting Injectable Testosterone FORTESTA 2% Testosterone Gel Urocidin Bladder Cancer Octreotide Implant Acromegaly* Axomadol Moderate to moderately severe chronic pain Pagoclone** Stuttering Octreotide Implant Carcinoid Syndrome ** Licensed to Teva Pharmaceuticals Inc. * Granted orphan drug status 10 TM Pending Pending |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. REGULATORY DEVELOPMENTS AVEED (Long Acting Testosterone Injection) Complete Response received December 2009 FDA Comments: Very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism Insufficiency of proposed Risk Evaluation and Mitigation Strategy (REMS) Evaluation ongoing FORTESTA (2% Testosterone Gel) Complete Response received October 2009 FDA Requests: Additional analysis of the existing clinical data Conduct a clinical study to address the effects of washing after applying the product to reduce transference Expect to file Complete Response mid-2010 11 TM TM |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. SPECIALTY GENERICS 12 |
 SPECIALTY
GENERICS DEVELOPMENT 13 ~40 Projects ~40 Projects 25 Near-term* 25 Near-term* 13 Current 13 Current ANDA ANDA reviews reviews *Near-term revenue 2010-2012 Approximately 40 projects under development Mycophenolate capsules approved December 2009 15 Current ANDA submissions 13 with near-term launch targets 2 with long-term launch targets Managing development for sustainable growth Potential efficiencies with branded Rx business grow. collaborate. innovate. thrive. |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. FINANCIAL OUTLOOK Current business Announced strong finish to 2009 2010 Financial Guidance Revenue range of $1.55B - $1.60B Adjusted diluted EPS range of $3.15 - $3.20 Reported (GAAP) diluted EPS range of $2.40- $2.45 Flexible cost infrastructure Expect to generate $300 - $350M in annual Operating Cash Flow, going forward 14 |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. ENDO POSITIONING FOR GROWTH 15 Value creation opportunities |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. GROWING OUR BUSINESS Our objective is to position Endo for solid, sustainable revenue and earnings growth Healthcare industry is evolving Results-driven medicine will drive collaboration among Providers, Payers and Patients Endo is transforming to deliver the right treatment solutions Focused on consumer-driven medical decisions 16 |
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collaborate. innovate. thrive. grow. collaborate. innovate. thrive. Endo Pharmaceuticals Barclays Capital Global Healthcare Conference March 2010 grow. collaborate. innovate. thrive. |