drives us… …is our passionate pursuit of improving patients’ lives. What ENDO PHARMACEUTICALS Bear Stearns Healthcare Conference September 12, 2006 Exhibit 99.1 |
1 © 2006 Endo Pharmaceuticals Inc. 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. |
2 © 2006 Endo Pharmaceuticals Inc. What drives us… Endo Profile Fully integrated specialty pharma company with market leadership in pain management; expanding into complementary therapeutic areas Established commercial capability: Portfolio of branded prescription products including Lidoderm ® , Frova ® , Percocet ® and Synera TM Pipeline focused on delivering and executing: Opana ® ER and Opana ® now FDA-approved; launched in mid-August Four additional products in mid- to late-stage development Strong cash flow and no debt |
3 © 2006 Endo Pharmaceuticals Inc. What drives us… Growth Strategy Capitalize on established brand names and brand awareness through focused marketing, promotional and educational efforts Develop/acquire proprietary products in our therapeutic areas and generic products with significant barriers to market entry Build balanced, sustainable pipeline across development phases Strengthen position in Pain Management and drive expansion into complementary therapeutic areas such as: Neurology Perioperative Care Supportive Care Oncology |
4 © 2006 Endo Pharmaceuticals Inc. What drives us… Selective focus on: Generic Product Strategy Niche therapeutic areas Difficult-to-develop generics Internally developed proprietary sustained-release technology AB-rated MS Contin, OxyContin generics Current marketed portfolio substantially consists of: Oxycodone ER (until 12/31/06) Endocet ® Morphine Sulfate ER |
5 © 2006 Endo Pharmaceuticals Inc. What drives us… Purdue Litigation Settlement Settlement of OxyContin patent case announced August 28, 2006 Endo to continue selling generic oxycodone extended-release products until December 31, 2006 Endo released from all liability for patent infringement Purdue’s lawsuit and Endo’s counterclaims against Purdue are dismissed Removes element of risk and allows us to focus on the ongoing launch of Opana ® ER and Opana ® |
6 © 2006 Endo Pharmaceuticals Inc. What drives us… Lidoderm ® Profile Topical patch launched in 1999 Covered by five Orange Book- listed patents through 2015 First FDA-approved drug for the treatment of the pain of post- herpetic neuralgia, a form of neuropathic pain Provides analgesia (without anesthesia) directly to the affected nerves |
7 © 2006 Endo Pharmaceuticals Inc. What drives us… *Represents high end of company guidance Lidoderm ® Net Sales ($ in millions) $83 $178 $309 $419 $540 $0 $100 $200 $300 $400 $500 $600 2002 2003 2004 2005 2006* |
8 © 2006 Endo Pharmaceuticals Inc. What drives us… Frova ® Profile Triptan indicated for acute treatment of migraine headaches in adults Commercial strategy to implement marketing, education and clinical plan to differentiate Frova ® in the marketplace Low recurrence rate Long half-life Target specialty physician audience Focus on neurologists, pain management specialists Leverage existing coverage of high prescribers Create advocacy base among thought leaders sNDA for indication of prophylaxis of Menstrual Migraine filed 7/19/06 |
9 © 2006 Endo Pharmaceuticals Inc. What drives us… SyneraTM Profile Topical, local anesthetic patch indicated for use in children and adults to numb the skin before various medical procedures; e.g., blood draws or IV cannulation Anticipated benefits include: Fast onset of action Ease of administration Primary market is hospitalized pediatric patients Commercial shipments began 6/19/06 P&T Reviews to begin in earnest in Fall Marketed by Endo’s 70-person hospital sales force Potential label expansion in pediatric immunization (studies planned) |
10 © 2006 Endo Pharmaceuticals Inc. What drives us… Opana ® ER and Opana ® Review |
11 © 2006 Endo Pharmaceuticals Inc. What drives us… Opana ® ER Profile 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 Opioid-naïve/experienced Chronic low back pain, osteoarthritis, cancer We believe effective pain control 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 |
12 © 2006 Endo Pharmaceuticals Inc. What drives us… Multiple Formulations Opana ® (immediate-release) Indicated for relief of moderate-to-severe acute pain where the use of an opioid is appropriate Complementary to Opana ® ER Injectable formulation to be re-launched in the fall of 2006 under new trade name Multiple formulations offer physicians and patients an opioid with a complete continuum of care Gives physicians the capability to use the most appropriate formulation of Opana ® (ER, IR, injection) for each patient |
13 © 2006 Endo Pharmaceuticals Inc. What drives us… Opana ® ER Commercial Strategy Competes in $3.2 billion long-acting strong opioid market Pricing comparable to other branded oral extended-release opioids Sales force expansion to support new and existing brands Added ~ 220 sales representatives Entire sales force of 590 now detailing physicians; Opana ® ER and Opana ® in primary position for 90% of calls Maintaining overall detailing emphasis on Lidoderm ® and Frova ® Expanded sales forces promoting Opana ER/Opana in the primary position to targeted audience of 68K experienced opioid prescribers Represents approximately 80% of all opioid prescribers Detailing began mid-August – awaiting DDMAC review of promotional materials Distribution to retail pharmacies underway |
14 © 2006 Endo Pharmaceuticals Inc. What drives us… Responsible Pain Management Goal: Focus on addressing appropriate use of opioid analgesics and minimizing inherent risks of misuse, abuse and diversion Risk Minimization Action Plan - Endo has worked with outside experts, FDA and DEA address appropriate labeling, distribution controls, proactive surveillance, monitoring, and intervention, employee training, educational initiatives on proper prescribing and clinical use of opioid analgesics PROMISE™ initiative (Partnership for Responsible Opioid Management through Information, Support and Education) Consists of practical information, education and support tools -- all focused on better ensuring the appropriate clinical use of opioid analgesic medications. Website now live at www.endopromise.com. |
15 © 2006 Endo Pharmaceuticals Inc. What drives us… Significant Pipeline Opportunities Transdermal sufentanil patch (2) Topical ketoprofen patch (2) Rapinyl™ (2) Selected Endo Development Projects sNDA filed July 19, 2006 Frova ® (Menstrual Migraine) (1) Status Filed (1) Licensed marketing rights (2) Licensed marketing and development rights |
16 © 2006 Endo Pharmaceuticals Inc. What drives us… Frova ® Clinical Development in MM Two double-blind, placebo-controlled studies in Menstrual Migraine (“MM”) prophylaxis; long-term open-label safety & tolerance study Frova ® taken for six days, starting two days prior to onset of expected MM headache Primary efficacy endpoint: reduction in the incidence of MM headache (statistical and clinical significance achieved in both trials) p<0.0001 to p < 0.01 (vs. placebo) Secondary endpoints also achieved - reduction in severity and duration of MM headache Results of first Phase III efficacy trial published in July 2004 Neurology Positive confirmatory Phase III efficacy study announced May 8, 2006 Filed sNDA on July 19, 2006; 10-month review expected |
17 © 2006 Endo Pharmaceuticals Inc. What drives us… Oral, fast-dissolving sublingual fentanyl tablet Intended for the treatment of breakthrough cancer pain • Expected to compete with Actiq and Fentora Exclusive North American marketing and development rights licensed from Orexo AB Market Need Addressed: Intended to compete in the market for treatments of breakthrough cancer pain Anticipated benefits include: • Fast onset of action • Enhanced absorption characteristics • Added convenience Status: Initiated Phase III clinical trials in Dec. 2005 Description / Indication: Rapinyl TM |
18 © 2006 Endo Pharmaceuticals Inc. What drives us… Topical patch intended for localized treatment of acute pain associated with soft-tissue injuries such as tendonitis/bursitis, joint sprains or strains Licensed marketing and development rights from ProEthic in March 2005 Market Need Addressed: Ketoprofen (NSAID) currently only available in the U.S. in oral form Will compete in the ~$2.5 billion soft-tissue injury market primarily consisting of NSAIDs and COX-IIs Anticipated benefits include bypassing the bloodstream, local/targeted pain control and once-daily dosing Status: Three Phase III trials recently initiated in U.S. Description / Indications: Topical Ketoprofen Patch |
19 © 2006 Endo Pharmaceuticals Inc. What drives us… Transdermal patch intended for moderate-to- severe chronic pain Licensed marketing and development rights from DURECT in March 2005 Market Need Addressed: Will compete in the ~$3.2 billion strong opioid market Follow-on to Duragesic Anticipated benefits include: • Convenience/compliance of seven-day dosing vs. three days • Smaller patch - 20% the size of Duragesic Status: Phase I product characterization ongoing Description / Indications: Transdermal Sufentanil Patch |
20 © 2006 Endo Pharmaceuticals Inc. What drives us… Key Milestones for 2006 Launch Opana ® ER and Opana ® Ongoing File sNDA for Frova ® in MM prophylaxis 7/19/06 Initiate Phase III trials for topical ketoprofen patch Late June Launch Synera TM Ongoing Advance pipeline development Ongoing Acquire / in-license opportunities in pain and complementary areas such as neurology, perioperative care and supportive care oncology Ongoing Building a solid platform for sustainable growth: |
21 © 2006 Endo Pharmaceuticals Inc. What drives us… Summary Fully integrated specialty pharma company with market leadership in pain management; expanding into complementary therapeutic areas Increasingly diverse revenue base Well-developed commercial capability Very broad and deep pain management pipeline Strong financial condition |
drives us… …is our passionate pursuit of improving patients’ lives. What ENDO PHARMACEUTICALS Nasdaq: ENDP |
