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0000950123-05-005493.txt : 200505030000950123-05-005493.hdr.sgml : 2005050320050503135241ACCESSION NUMBER:0000950123-05-005493CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:29CONFORMED PERIOD OF REPORT:20050503ITEM INFORMATION:Regulation FD DisclosureITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20050503DATE AS OF CHANGE:20050503

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:ENDO PHARMACEUTICALS HOLDINGS INCCENTRAL INDEX KEY:0001100962STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:134022871STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:001-15989FILM NUMBER:05794242

BUSINESS ADDRESS:STREET 1:100 PAINTERS DRIVECITY:CHADDS FORDSTATE:PAZIP:19317BUSINESS PHONE:6105589800

MAIL ADDRESS:STREET 1:100 PAINTERS DRIVECITY:CHADDS FORDSTATE:PAZIP:19317

8-K1y08530e8vk.htmENDO PHARMACEUTICALS HOLDINGS INC.

ENDO PHARMACEUTICALS HOLDINGS INC.

Table of Contents

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported):

May3, 2005 (May3, 2005)

Endo Pharmaceuticals Holdings Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-15989

13-4022871

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(I.R.S. Employer
Identification No.)

100 Endo Boulevard, Chadds Ford, PA

19317

(Address of principal executive offices)

(Zip Code)

Registrants telephone number, including area code

(610) 558-9800

Not Applicable

Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy thefiling obligation of the registrant under any of the following provisions:

oWritten communications pursuant to Rule425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))

oPre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR240.13e-4(c))

TABLE OF CONTENTS

Item7.01. RegulationFD DisclosureItem9.01. FinancialStatements and ExhibitsSIGNATURESINDEX TO EXHIBITSEX-99.1: SLIDE PRESENTATION

Table of Contents

Item7.01. RegulationFD Disclosure.

On May3, 2005, the Registrant intends to make a slide presentation at the Deutsche Bank HealthcareConference in Baltimore, Maryland, a copy of which presentation is filed herewith as Exhibit99.1and is incorporated herein by reference.

Item9.01. Financial Statements and Exhibits.

(a) Financial Statements of Business Acquired.

Not applicable.

(b) Pro Forma Financial Information.

Not applicable.

(c) Exhibits.

ExhibitNumber

Description

99.1

Slide Presentation of Endo Pharmaceuticals Holdings Inc. dated May3, 2005

Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly causedthis report to be signed on its behalf by the undersigned, hereunto duly authorized.

ENDO PHARMACEUTICALS HOLDINGS INC.

(Registrant)

By:

/s/ Carol A. Ammon

Name:Carol A. Ammon
Title:Chairman & Chief Executive Officer

Dated: May3, 2005

Table of Contents

INDEX TO EXHIBITS

ExhibitNo.

Description

99.1

Slide Presentation of Endo Pharmaceuticals Holdings Inc.dated May3, 2005

EX-99.12y08530exv99w1.htmEX-99.1: SLIDE PRESENTATION

EXHIBIT 99.1

Endo Pharmaceuticals

Deutsche Bank

Healthcare Conference

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 theSecurities Exchange Act of 1934, as amended, that are based on management's beliefs and assumptions, current expectations, estimates andprojections. These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those expressed orimplied by these forward-looking statements. Forward-looking statements are not historical facts and include information regarding the Company'spossible 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 futureresults, product performance or other non-historical facts are forward-looking and reflect Endo's current perspective on existing trends andinformation. Many of the factors that will determine the Company's future results are beyond the ability of the Company to control or predict. Thereader should not rely on any forward-looking statement. The Company undertakes no obligations to update any forward-looking statementswhether as a result of new information, future events or otherwise. None of the development products in the Company's pipeline have beenestablished as safe and effective by the FDA or approved by the FDA. Several important factors, in addition to the specific factors discussed inconnection with these forward-looking statements individually, could affect the future results of Endo and could cause those results to differmaterially from those expressed in the forward-looking statements contained herein. Important factors that may affect future results include, but arenot 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 tointellectual property assets; market acceptance of the Company's future products; government regulation of the pharmaceutical industry; theCompany'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 regulatoryaction or lawsuits relating to the Company's use of narcotics in most of its core products; the Company's exposure to product liability claims andproduct recalls and the possibility that the Company may not be able to adequately insure itself; the Company's ability to protect its proprietarytechnology; the Company's ability to successfully implement its acquisition strategy; the availability of controlled substances that constitute theactive ingredients of some of the Company's products and products in development; the availability of third-party reimbursement for the Company'sproducts; the Company's dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion ofits total net sales; and other risks and uncertainties detailed in Endo's Registration Statement on Form S-4 filed with the Securities and ExchangeCommission on June 9, 2000, as amended, and in Endo's Registration Statement on Form S-3 dated October 17, 2001, in Endo's RegistrationStatement on Form S-3 filed with the SEC on July 1, 2003, and in Endo's Registration Statement on Form S-3 filed with the SEC on April 30, 2004,as amended. Readers should evaluate any statement in light of these important factors.

Endo Profile

Fully integrated specialty pharma company with market leadership inpain management; expanding into complementary therapeutic areas

Established portfolio of branded products including Lidoderm(r) andPercocet(r)

Commercial launches of Frova(r) and DepoDur(tm) underway

Promising pipeline, with 11 mid- to late-stage products

Strong cash flow and no debt

Experienced and incentivized management team

Growth Strategy

Capitalize on established brand names and brand awareness throughfocused marketing, promotional and educational efforts

Develop/acquire proprietary products in our therapeutic areas andgeneric products with significant barriers to market entry

Build balanced, sustainable pipeline across development phases

Strengthen position in Pain Management and drive expansion intocomplementary therapeutic areas such as:

Neurology

Perioperative Care

Supportive Care Oncology

Data for 12 mos. ended 12/31/04

Pain Market: Large, Attractive Opportunity

Growth Drivers

Changing attitudes toward painmanagement

Aging population

Increase in number of surgicalprocedures/chronic pain conditions

Introduction of new forms of painmedications

Rx Pain Market: $19 Billion

5-Year $ CAGR:

Opioid 20%

Non-Opioid 14%

Non-Opioid

Opioid

$12.6B

$6.3B

Source: IMS Sales Perspectives, 12/04

Targeted Sales and Marketing

Lidoderm(r) and Frova(r)

Direct promotion through our national sales forces

Approximately 100 specialty representatives

Approximately 200 office-based representatives

DepoDur(tm)

Approximately 70 hospital-based representatives currently targeting 1,000of the largest surgical hospital in the U.S.

Leveraging our infrastructure by adding new products

Lidoderm(r) (lidocaine 5%)

Topical patch launched in 1999

covered by patents through 2015

First FDA-approved drug for thetreatment of the pain of post-herpeticneuralgia (PHN), a form ofneuropathic pain

Provides analgesia (withoutanesthesia) directly to the affectednerves

2/28/1998 5/31/1998 8/31/1998 11/30/1998 2/28/1999 5/31/1999 8/31/1999 12/30/1999 2/29/2000 5/31/2000 8/31/2000 12/30/2000 2/28/2001 Prescriptions (thousands) 4011 4834 5979 7173 8819 9947 12294 14408 16618 18180 20544 22546 25463

30,000

25,000

20,000

15,000

10,000

5,000

0

Lidoderm(r) Patches Dispensed

'02 - '04 CAGR 80%

Note: Data represents total patches dispensed

Source: IMS NPA, 3/05

Patches (thousands)

26.3

4.8

6.0

7.2

8.8

9.9

12.3

14.4

16.6

18.2

20.5

22.5

25.5

2002 2003 2004 2005* (in millions) 83 178 309 400

'02 - '04 CAGR 93%

*Represents high end of company guidance of $390-$400 million

Lidoderm(r) Net Sales

(in millions)

Source: IMS NDTI, MAT 9/03

Lidoderm(r) Future Growth Drivers 2003 Other Neuropathies 0.91 Peripheral Neuropathies 0.186 Diabetic Neuropathy 0.177 Trigeminal Neuralgia 0.163 PHN 0.09 Carpal Tunnel Syndrome 0.019

Other Neuropathies:

Peripheral

Diabetic

AIDS

Cancer

Trauma

Goal is to explore possible utility in other neuropathic and chronic pain segments

Neuropathic Pain Market in 2004(1)

Source: IMS NDTI, Full-year 2004

PHN

(1) Source: IMS NPA

(1) Source: IMS NPA

Percocet(r) Franchise

Percodan(r)

Percocet(r)

First launched in 1976

"Gold standard" in pain management

Approximately 77% of prescriptions for oxycodone withacetaminophen written as "Percocet"(1)

Significant generic competition

Life-cycle management program to address market needs

Frova(r) Product Profile

Triptan indicated for acute treatmentof migraine headaches in adults

Licensed North American rights fromVernalis plc on July 14, 2004

Covered by patents to 2015

Endo U.S. launch Q3 2004

Phase III development ongoing forMRM prophylaxis indication

Frova(r) Commercial Strategy

Focused approach intended to fully capitalize on Frova(r)'s clinicalbenefits

Target specialty physician audience

Focus on neurologists, pain management specialists

Leverage Endo's existing coverage of high prescribers

Create advocacy base among thought leaders who treat patientswith the most intractable migraines

Implement extensive marketing, education and clinical plan todifferentiate Frova(r) in the marketplace

Long half-life

Low recurrence rate

DepoDur(tm) Product Profile

Encapsulated morphine sulfate

Epidural injection with up to 48-hourextended-release delivery

Intended to change the paradigm for post-surgical pain management

Indicated for the treatment of pain followingmajor surgery such as:

Lower Abdominal Surgery

Hip Arthroplasty

Knee Arthroplasty

Scheduled Caesarean Section

Commercial shipments initiated December2004

DepoDur(tm) Commercial Strategy

Support launch through educational programs emphasizing:

Greater patient satisfaction

Single shot believed to provide steady-state pain relief post-surgically for up to 48 hours

No need for in-dwelling catheter

Potential to eliminate/reduce PCA

Physician and nursing benefits

Lack of current standard of care

Conduct studies to show pharmacoeconomic benefits including:

Less need for patient-controlled analgesia

Direct to oral medication conversion

Reduction in time, cost of materials

Selective Focus on:

Generic Product Strategy

Niche therapeutic areas

Difficult-to-develop generics

Have internally developed proprietary sustained-releasetechnology

AB-rated MS Contin, OxyContin generics

Partnered with Noven Pharmaceuticals, Inc. on generic Duragesic(ANDA currently under FDA review)

Generic Oxycodone ER

Favorable lower court ruling announced January 5, 2004

Appellate court hearing held November 3, 2004; decision expected inthe first half of 2005

Received final FDA approval on all four strengths

First-to-file status on the 10mg, 20mg and 40mg strengths(approximately two-thirds of the branded market)

2003 amendments to Waxman-Hatch Act allow for more favorableexclusivity terms

Provides option to launch at-risk or wait for appellate courtdecision

Anticipate limited competition subsequent to exclusivity period due tohigh barriers to entry related to controlled-release scheduled CIIproducts

Generic Fentanyl Patch

Announced agreement with Noven Pharmaceuticals, Inc. on February26, 2004 for U.S./Canadian rights to Noven's generic Duragesic

Noven's ANDA accepted for filing by the FDA in October 2003

Anticipated launch pending FDA approval of ANDA

Profit-sharing arrangement

Pipeline Summary

Transdermal sufentanil patch (4)

Topical ketoprofen patch (4)

Rapinyl(tm) (4)

LidoPAIN(r) BP (3)

Lidoderm(r) (other indications)

Propofol IDD-D(tm) (3)

Frova(r) (MRM indication) (3)

In Development

ANDA under Review

Transdermal fentanyl patch (generic) (3)

Final Approval Received

on All Four Strengths

Oxycodone ER (generic) (2)

Approvable Letters Received

Oxymorphone ER (1) and IR

Status

Filed

(1) Co-developed

(2) Subject to litigation; Purdue has appealedfavorable court decision received Jan. 2004.Appellate court hearing held November 3, 2004.

(3) Licensed marketing rights

(4) Licensed marketing and development rights

CHRONOGESIC(tm) (3)

Oral oxymorphone hydrochloride in extended(ER) and immediate (IR) release formulations

Intended to treat moderate-to-severe pain

IR a complementary treatment to ER for

breakthrough pain

Market Need Addressed:

Will compete in $4.2 billion strong opioidmarket

We believe that oxymorphone ER will provideequivalent analgesia with only half themilligram dosage of OxyContin

(oxycodone extended-release)

Possible twice-daily dosing

Status / Upcoming Milestones:

FDA "Approvable Letters" received 10/03

Additional clinical trials, required for finalapproval, are ongoing

Description / Indications:

Oxymorphone ER / IR

Extensive program in approximately 2,500 subjects, including 12 Phase II/III studies

Oxymorphone ER / IR Clinical Trials

Oxycodone IR and Placebo

Post-Surgical Pain

Oxycodone IR and Placebo

Post-Surgical Pain

Oxycodone CR

Cancer Pain

- ---

Morphine Sulfate ER

Cancer Pain

Morphine Sulfate ER,

Oxycodone CR

Cancer Pain

Placebo

Osteoarthritis Pain

Oxycodone CR and Placebo

Chronic Low Back Pain

Oxycodone CR and Placebo

Osteoarthritis Pain

Placebo

Post-Surgical Pain

Primary Outcome

p < 0.05

Comparator

Indication

Oxymorphone ER

FDA has accepted one clinical trial as pivotal proof of efficacy

Conducting two additional clinical trials in order to file at least oneadditional pivotal trial

12-week double-blinded, placebo-controlled trial

Chronic low back pain patient populations

One trial with opioid-experienced patients

One trial with opioid-naive patients

Run-in period intended to address early drop-outs

Currently expect to file complete response with the FDA in early 2006

Frova(r) Clinical Development in MRM

Vernalis plc completed one double-blind, placebo-controlled study inMenstrually Related Migraine ("MRM") prophylaxis; three-waycrossover design; 579 patients randomized

Drug taken for six days, starting two days prior to onset of expectedMRM headache

Primary endpoint was incidence of MRM headache during the six-dayperiod (both statistical and clinical significance achieved):

Placebo 67%

Low-dose frovatriptan (1) 52%

High-dose frovatriptan (1) 41%

Results published in July 2004 Neurology

Confirmatory Phase III study, being conducted by Vernalis, initiated inQ4 2004

(1) p < 0.0001 (vs. placebo)

RapinylTM

Oral, fast-dissolving sublingual tablet of fentanyl intended for thetreatment of breakthrough cancer pain

Believed to have:

Fast onset of action

Enhanced absorption characteristics

Licensed development and marketing rights from

Orexo AB in August 2004

Expect to commence Phase III clinical trials in 2005

Outlook

FDA approval expected on generic Duragesic

Oxycodone ER opportunity

Appellate Court decision expected in the first half of 2005

Oxymorphone ER/IR trials

Ongoing advancement of pipeline

Acquisition/in-licensing opportunities in pain and complementaryareas such as neurology, perioperative care and supportive careoncology

Summary

Leader in rapidly growing pain management market

Strong portfolio of established products including Lidoderm(r)

Commercial launches of both Frova(r) and DepoDurTM underway

Substantial pipeline of branded, patent-protected products

Strong cash flow and no debt

Proven, highly incentivized management team

Endo Pharmaceuticals

Nasdaq: ENDP

GRAPHIC4y08530y08530z0001.gifGRAPHIC

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