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8-K - ENDO PHARMACEUTICALS HOLDINGS INC. - ENDO HEALTH SOLUTIONS INC. | d8k.htm |
Exhibit 99.1
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© Copyright 2009 ENDO PHARMACEUTICALS Oppenheimer & Company 20 Annual Healthcare Conference November 4, 2009 2 th |
© Copyright 2009 3 This presentation contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 regarding, among other
things, the companys 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: the possibility that the acquisition of Indevus is not complementary to Endo; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and
commercialization of our products and pipeline products; competition in our industry, including for branded and generic products, and in connection with our acquisition of rights to assets, including intellectual property; government regulation of the pharmaceutical
industry; our dependence on a small number of products and on outside
manufacturers for the manufacture 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 controlled substances
in many 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; our ability to
protect our proprietary technology; our ability to successfully implement
our in-licensing and acquisition strategy; the availability of third-party reimbursement for our products; the outcome of any pending or future litigation or claims by the government; our dependence
on sales to a limited number of large pharmacy chains and wholesale drug
distributors for a large portion of our total net sales; a determination by a regulatory agency that we are engaging in inappropriate sales or marketing activities, including promoting the off-label use of our products; the loss of branded product exclusivity periods and related intellectual property; and
exposure to securities that are subject to market risk including
auction-rate securities the market for which is currently illiquid; 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, 2008, which was filed with the Securities and
Exchange Commission on March 2, 2009. 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. Forward-Looking Statement |
© Copyright 2009 Q3 Performance Highlights 4 Strong Q3 Commercial Results: 14% Revenue growth year-over-year Actual Reported (GAAP) EPS of $0.42 and Adjusted Diluted EPS of $0.63 Over $700M in cash and marketable securities available* as of September 30 th , 2009 Successful re-launch of VALSTAR TM Licensed FORTESTA TM from ProStrakan Licensed Urocidin TM from BioNiche Retired $116M of legacy Indevus debt * Includes balance of Auction Rate Securities but excludes restricted cash.
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© Copyright 2009 5 ($ In millions) Strong Operating Performance 24% CAGR Sales and Cash Flow * * Net sales CAGR includes 2009 Guidance midpoint. Cash Flow from Operations CAGR based on 10-K data through 2008. $252 $399 $596 $615 $820 $910 $1,086 $1,261 $1.44B - $1.465B $80 $110 $217 $171 $285 $345 $366 $357 $0 $200 $400 $600 $800 $1,000 $1,200 $1,400 $1,600 2001 2002 2003 2004 2005 2006 2007 2008 2009E Net Sales Cash Flow from Operations |
© Copyright 2009 6 Solid Base Business Supporting Growth |
© Copyright 2009 7 Pain: LIDODERM ® , OPANA ® ER, Voltaren ® Gel and FROVA ® Portfolio Build and Timing OPANA ER: Continued strong share growth 43% TRx growth YOY Voltaren Gel: Solid TRx growth since 2008 launch Launch of 3&5 tube packages in Q1 Launched the Go Ahead and Rub It In marketing program LIDODERM: Support growth in PHN Improved Physician targeting Strong source of cash flow |
© Copyright 2009 8 Endocrinology Franchise: SUPPRELIN ® LA , AVEED TM and FORTESTA TM Portfolio Build and Timing SUPPRELIN LA: Central Precocious Puberty Incidence: 1 in every 5,000 10,000 children SUPPRELIN LA Market Share ~30% Increasing marketing support to grow share Re-implantation rate of ~75% |
© Copyright 2009 9 VALSTAR Only FDA-approved treatment for BCG-refractory bladder cancer in situ
when cystectomy is not an option BCG-Refractory Patient Population 15,000+ Amended sNDA approved in February 2009 First orders have been received and shipped New Product Launched: VALSTAR for bladder cancer |
© Copyright 2009 10 AVEED 10-week injectable testosterone therapy $900 million market in the US, growing more than 20% per annum Launch targeted for late 2009 or early 2010, pending FDA approval Upcoming Product Launch: AVEED Long-Acting Injectable Testosterone |
© Copyright 2009 11 FORTESTA Complementary therapeutic to AVEED Sales force call synergies Complete Response Letter from FDA October 2009 Expect to file complete response mid-2010 Upcoming Product Launch: FORTESTA 2% Testosterone Gel |
© Copyright 2009 12 New Pipeline Asset: Urocidin TM for bladder cancer Urocidin 70,000+ Newly diagnosed bladder cancer patients per year Upfront cash payment of $20M and Milestones of up to $110M Complementary therapeutic to Valstar Initiating a second Phase III study that will include 900 patients at 150 centers
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© Copyright 2009 13 Specialty Generics Strategy |
© Copyright 2009 14 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 Pending * Licensed to Teva Pharmaceuticals Inc. Development Pipeline Pending |
© Copyright 2009 15 Endo Pharmaceuticals |
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