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As Of Filer Filing As/For/On Docs:Pgs Issuer Agent
9/26/07 Endo Pharmaceuticals Holdings Inc 8-K{7,9} 9/26/07 2:61 RR Donnelley/FA
Document/Exhibit Description Pages Size 1: 8-K Current Report HTML 15K 2: EX-99.1 Slide Presentation HTML 123K
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| Slide Presentation |
 2 Accelerating Our Growth © 2007 Endo Pharmaceuticals Forward-Looking Statements Except for the historical information contained herein, this presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements involve a number of risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include,
but are not limited to, the difficulty of predicting FDA approvals, results of clinical trials on new products, acceptance and demand for new pharmaceutical products, challenges relating to intellectual property protection, the impact of competitive products and pricing, the timely development and launch of new products, a determination that we are engaging in inappropriate sales or marketing activities, including promoting the "off-label" use of our products, and the risk factors listed from
time to time in the Company’s SEC reports, including the Company’s Annual Report on Form 10-K for the fiscal year ended 31, 2006. |
 3 Accelerating Our Growth © 2007 Endo Pharmaceuticals Endo Pharmaceuticals – Leader in Pain Management Market Leadership in Pain Management Analgesics fourth-largest prescription drug market in 2006 with $7.3 billion in reported sales Opioids represented 80% of all analgesic Rxs Proven Commercial Capability Specialty and PCP sales and marketing teams Sales force recently expanded by ~ 95 reps Broad Pipeline in Pain Management Five products in mid- to late-stage development Strong Financial Condition No debt Strong cash flow |
 4 Accelerating Our Growth © 2007 Endo Pharmaceuticals Growth Strategy Deepen and broaden penetration into the pain market • Target clinically innovative and differentiated products while continuing to advance current development pipeline Drive top-line growth by maximizing potential of key on-market products and successfully launching FROVA in MM indication Further diversify revenue base through product licensing and acquisitions of other specialty-focused companies Use balance sheet to maximize shareholder value Continue to pursue selective development of generic products
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         5 Accelerating Our Growth © 2007 Endo Pharmaceuticals $1.75–$1.80 Adjusted Diluted EPS $90–$110 million OPANA ® ER / OPANA ® Net Sales $685–$710 million LIDODERM ® Net Sales $1.050–$1.075 billion Net Sales 2007 Guidance |
 6 Accelerating Our Growth © 2007 Endo Pharmaceuticals $399.0 $595.6 $615.1 $820.2 $909.7 $1,062.0 2002 2003 2004 2005 2006 2007* Net Sales Net Income Consistent Financial Growth $30.8 $69.8 $143.3 $202.3 $137.8 * Represents mid-point of company guidance; ** Includes $0.62 in one-time,
non-cash items $1.03** $1.52 $1.08 $0.53 $0.30 Diluted EPS Millions, Except per Share |
 7 Accelerating Our Growth © 2007 Endo Pharmaceuticals Sales Force Expansion Specialty Sales Forces 0 50 100 150 200 Specialty I Specialty II Provides double coverage to broaden reach and frequency among specialty MDs • Pain Management Specialists, Neurologists, Oncologists, Physical Medicine and Rehabilitation • Ensures high frequency on highest-decile (e.g., 8–10) prescribers ~160 ~160 ~95 New ~65 Current Provides Optimal Reach and Frequency to Promote Current Product Portfolio Furthering already strong share of voice in pain management Total Sales Force = 690 Reps 23% 54% 23% Specialty II Specialty I Primary Care Force |
 8 Accelerating Our Growth © 2007 Endo Pharmaceuticals LIDODERM – A True Success Story Lidocaine 5% topical patch • Acts locally – no therapeutically meaningful blood levels First FDA-approved drug for treatment of pain of PHN Provides analgesia (but no anesthesia) directly to affected nerves Easy and convenient to use |
 9 Accelerating Our Growth © 2007 Endo Pharmaceuticals $ Millions $178 $309 $419 $698 $567 $0 $200 $400 $600 $800 2003 2004 2005 2006 2007* LIDODERM – Continuing Net Sales Growth * Represents mid-point of company guidance |
 10 Accelerating Our Growth © 2007 Endo Pharmaceuticals Protected by Five Orange Book-Listed Patents Until 2015 Lidocaine-Containing Topical Product That Does Not Numb the Skin 2012 Method of Use Patents Submitted Citizen Petition Late 2006 and Amendments in Aug. 2007 LIDODERM – Protecting the Franchise Cover use of lidocaine- containing patch in indication of PHN Two method of use patents expiring 2009 Two method of use patents expiring 2012 Formulation patent expiring 2015 Unique attribute included in labeling Believe this would be requirement for generic substitution Requests FDA adhere to existing clinical bioequivalence standard |
 12 Accelerating Our Growth © 2007 Endo Pharmaceuticals OPANA Update Scripts (currently 6.5k per week) on track to meet 2007 guidance Implemented aggressive managed-care strategy to attain Tier II parity Introduced OPANA ER Instant Savings Card Program Increased promotional and marketing activities • Redeployed Specialty Force II • Launched new promotional materials • Full schedule of peer-to-peer speaker programs • Major presence at APS and at upcoming medical conferences with clinical data presentations |
 13 Accelerating Our Growth © 2007 Endo Pharmaceuticals OPANA ER vs. Competitive Launches (Retail and Mail Order TRxs) OPANA ER TRx Launch Comparison Notes: Data includes only retail and mail order; OPANA ER data through August 2007
Sources: Data for Duragesic and Oxycontin were pulled from IMS Health's New
Product Spectra; Data for OPANA ER, Avinza and Palladone were pulled from WK
Health's Phast Prescription Audit 0 10,000 20,000 30,000 40,000 50,000 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Months Since Launch OPANA ER Avinza Duragesic OxyContin Palladone |
 14 Accelerating Our Growth © 2007 Endo Pharmaceuticals Development Pipeline Phase I Phase II Phase III Filed Pre-clinical Product (1) Licensed marketing rights; (2) Licensed marketing and development
rights FROVA ® (1) (Menstrual Migraine) RAPINYL TM (2) (Breakthrough Cancer Pain) EN 3285 (Oral Rinse for Oral Mucositis) Undisclosed Ketoprofen Patch (2) (Topical - Soft Tissue Injuries) Sufentanil Patch (2) (Transdermal - Chronic Pain) |
 15 Accelerating Our Growth © 2007 Endo Pharmaceuticals FROVA ® MM Prophylaxis: Exciting Near-Term Opportunity FROVA taken for six days, starting two days prior to onset of expected MM headache Primary efficacy endpoint: reduction in incidence of MM • p <0.0001 to p < 0.01 (vs. placebo) Secondary endpoints – reduction in severity and duration of MM headache – also achieved Pivotal Efficacy Studies PDUFA Date Extended beyond 8/19/07 New action date 9/30/07; no additional information requested by FDA Substantial Clinical Data Package Submitted Includes two statistically significant Phase III, double-blind, placebo-controlled studies; long-term open-label safety and tolerance study |
 16 Accelerating Our Growth © 2007 Endo Pharmaceuticals FROVA – Longest Half-Life, Lowest Migraine Recurrence Rate Zolmitriptan 2.5mg Eletriptan 80mg Almotriptan 12.5mg Naratriptan 2.5mg Frova 2.5mg Sumatriptan 6mg (sc) Rizatriptan 10mg Sumatriptan 100mg 0% 10% 20% 30% 40% 50% 0 5 10 15 20 25 30 Plasma Half Life (h) Frova 2.5mg |
 17 Accelerating Our Growth © 2007 Endo Pharmaceuticals FROVA ® MM Market Development Raise Awareness of FROVA MM (Branded) Raise Awareness of MM (Unbranded) Full FROVA MM Promotion Pre-Approval Pre-Launch Launch (January 2008) |
 18 Accelerating Our Growth © 2007 Endo Pharmaceuticals RAPINYL TM Profile Oral, fast-dissolving sublingual fentanyl tablet Usage Intended for the treatment of breakthrough cancer pain • Expected to compete with Actiq and Fentora Anticipated Benefits Fast onset of action Enhanced absorption characteristics Added patient convenience Trials Phase III trials ongoing |
 19 Accelerating Our Growth © 2007 Endo Pharmaceuticals Topical Ketoprofen Patch Usage For localized treatment of acute pain from soft-tissue injuries such as tendonitis/bursitis, joint sprains or strains Availability Ketoprofen (NSAID) currently available in U.S. as oral only Market Would compete in ~$2.5 billion soft-tissue injury market primarily consisting of NSAIDs and COX-IIs Anticipated Benefits Bypassing bloodstream to minimize GI and cardiovascular side effects Local, targeted pain control Convenience of once-daily dosing |
 20 Accelerating Our Growth © 2007 Endo Pharmaceuticals Ketoprofen Patch – Clinical Trial Update Two Phase III Trials Did Not Meet Primary Endpoint Ankle sprains and strains Tendonitis/bursitis of shoulder, elbow or knee Analyzing Data to Determine Next Course of Action Outcome may have been influenced by several factors, including severity of pain on entry and use of ibuprofen as rescue medication One Phase III trial currently running in tendonitis or bursitis of the shoulder, elbow or knee One long-term safety study ongoing in osteoarthritis flare of the knee |
 21 Accelerating Our Growth © 2007 Endo Pharmaceuticals EN 3285 About 400,000 patients per year in U.S. develop OM • Only current FDA-approved treatment is IV infusion Market Expect to initiate next clinical trial by year-end Trials EN 3285 Key product obtained in RxKinetix acquisition Patent-protected oral rinse formulated using proprietary ProGelz ® delivery platform for prevention of oral mucositis (OM) Ease of use for patients No systemic side effects Anticipated Benefits |
 22 Accelerating Our Growth © 2007 Endo Pharmaceuticals Transdermal Sufentanil Patch Profile Intended for moderate-to-severe chronic pain Next-generation extended-release opioid patch Anticipated Benefits Convenience/compliance of seven-day dosing vs. three-day dosing Smaller patch – 20% the size of Duragesic Trials Phase I product characterization ongoing Phase II trial now underway • Designed to evaluate conversion from oral opioids |
           23 Accelerating Our Growth © 2007 Endo Pharmaceuticals Summary Market leader in pain management Well-developed commercial capability Very broad and deep pipeline Strong financial condition Clear strategy for sustainable growth |
| This 8-K Filing | Date | Other Filings | ||
|---|---|---|---|---|
 | ||||
| 12/31/06 | 10-K, 8-K | |||
| Filed On / Filed As Of / For The Period Ended | 9/26/07 | |||
| Top | List All Filings | |||
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