endo pharmaceuticals holdings inc. - form 8-k statements . this presentation contains...

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0001193125-05-228623.txt : 200511170001193125-05-228623.hdr.sgml : 2005111720051117160632ACCESSION NUMBER:0001193125-05-228623CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:20CONFORMED PERIOD OF REPORT:20051117ITEM INFORMATION:Regulation FD DisclosureITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20051117DATE AS OF CHANGE:20051117

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:051212800

BUSINESS ADDRESS:STREET 1:100 ENDO BOULEVARDCITY:CHADDS FORDSTATE:PAZIP:19317BUSINESS PHONE:6105589800

MAIL ADDRESS:STREET 1:100 ENDO BOULEVARDCITY:CHADDS FORDSTATE:PAZIP:19317

8-K1d8k.htmFORM 8-K

Form 8-K

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): November17, 2005 (November 17, 2005)

Endo Pharmaceuticals Holdings Inc.

(Exact name of registrant as specified in its charter)

Delaware001-1598913-4022871

(State or other jurisdiction
of incorporation)(Commission
File Number)(I.R.S. Employer
Identification No.)

100 Endo Boulevard, Chadds Ford, PA19317

(Address of principal executive offices)(Zip Code)

Registrantstelephone number, including area code (610) 558-9800

NotApplicable

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 satisfythe filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item7.01.Regulation FD Disclosure.

On November17, 2005, the Registrant intends to make a slide presentation at the CSFB Health Care Conference in Phoenix, Arizona, a copy of which presentationis filed herewith as Exhibit 99.1 and 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

99.1Slide Presentation of Endo Pharmaceuticals Holdings Inc. dated November 17, 2005

SIGNATURES

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

ENDO PHARMACEUTICALS HOLDINGS INC.

(Registrant)

By:

/S/CAROLINE B.MANOGUE

Name:

Caroline B. Manogue

Title:

Executive Vice President,

Chief Legal Officer& Secretary

Dated: November17, 2005

INDEX TO EXHIBITS

ExhibitNo.

Description

99.1Slide Presentation of Endo Pharmaceuticals Holdings Inc. dated November 17, 2005

EX-99.12dex991.htmSLIDE PRESENTATION

Slide Presentation

Exhibit 99.1

EndoPharmaceuticals

CSFB Health Care Conference

November17, 2005

Forward-LookingStatements

This presentation contains forward-looking statements, within the meaning of Section27A of the SecuritiesAct of 1933 and Section21E of the Securities Exchange Act of 1934, as amended, that are based on managements beliefs and assumptions, current expectations, estimates and projections. These statements are subject to risks anduncertainties 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 Companys possibleor 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. Endos estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Endos current perspective onexisting trends and information. Many of the factors that will determine the Companys future results are beyond the ability of the Company to control or predict. The reader should not rely on any forward-looking statement. The Companyundertakes 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 Companys pipeline have been established as safe and effective by theFDA 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 differmaterially from those expressed in the forward-looking statements contained herein. Important factors that may affect future results include, but are not limited to: the Companys ability to successfully develop, commercialize and market newproducts; results of clinical trials on new products; competition for the business of the Companys branded and generic products, and in connection with the Companys acquisition of rights to intellectual property assets; market acceptanceof the Companys future products; government regulation of the pharmaceutical industry; the Companys dependence on a small number of products; the Companys dependence on outside manufacturers for the manufacture of its products; theCompanys 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 Companys use of narcotics in most of its core products; theCompanys exposure to product liability claims and product recalls and the possibility that the Company may not be able to adequately insure itself; the Companys ability to protect its proprietary technology; the Companys ability tosuccessfully implement its acquisition strategy; the availability of controlled substances that constitute the active ingredients of some of the Companys products and products in development; the availability of third-party reimbursement forthe Companys products; the Companys 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 EndosRegistration Statement on Form S-4 filed with the Securities and Exchange Commission on June9, 2000, as amended, in Endos Registration Statement on Form S-3 dated October17, 2001, in Endos Registration Statement on Form S-3filed with the SEC on July1, 2003, in Endos Registration Statement on Form S-3 filed with the SEC on April30, 2004, as amended, and in Endos Registration Statement on Form S-3 filed with the SEC on September2, 2005, asamended. Readers should evaluate any statement in light of these important factors.

See the Possibilities

2005 Endo Pharmaceuticals

1

Profile

Fully integrated specialty pharma company with market leadership in pain management; expanding into complementarytherapeutic areas Well-developed commercial capability:

Portfolio of branded prescription products including Lidodermand Percocet Launches of Frova, DepoDur and generic oxycodone ER ongoing

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

Recent positive Phase III results on Oxymorphone ER and IR

Strong cash flow and no debt

Experienced and incentivized management team



2

Pain Market:Large, Attractive Opportunity

Rx Pain Market: $19 Billion in 04

Growth Drivers Changing attitudes toward pain management Aging population

An estimated 50million Americans suffer from chronic pain

Increase in number of surgical procedures/chronic pain conditions Introduction of new forms of pain medications

5-Year $ CAGR: Opioid 20% Non-Opioid 14% $6.3B $12.6B

Non-Opioid

Opioid

Data for 12 mos. ended 12/31/04

Source: IMS Sales Perspectives, 12/04



3

LidodermProduct 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



4

Lidoderm NetSales

($ in millions) $450 $400 $350 $300 $250 $200 $150 $100 $50 $0 $83 $178 $309 $400

02-04 CAGR 93%

2002 2003 2004 2005*

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



5

LidodermFuture Growth Drivers

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

Neuropathic Pain Market in 2004(1)

Other Neuropathies: Peripheral Diabetic AIDS

Cancer Trauma

PHN

(1)

Source: IMS NDTI, Full-year 2004



6

Generic ProductStrategy

Selective focus on:

Niche therapeutic areas Difficult-to-develop generics

Internally developedproprietary sustained-release technology AB-rated MS Contin, OxyContin generics

Current marketed portfolio substantiallyconsists of:

Oxycodone ER (launched June 2005) Endocet Morphine Sulfate ER



7

SubstantialPipeline Opportunities

Filed Status

Oxymorphone ER (1)and IR Complete response to approvable letters

expected to be filed by early 2006

In Development

Frova (MRM indication) (2)Rapinyl (3)Topical ketoprofen patch (3)Propofol IDD-D (2)Lidoderm(other indications) LidoPAIN BP (2)Transdermal sufentanil patch (3)CHRONOGESIC (2)

(1)

Co-developed

(2)

Licensed marketing rights

(3)

Licensed marketing and development rights



8

Oxymorphone ER /IR

Description / Indications: Oral oxymorphone hydrochloride in extended (ER)

and immediate (IR) release formulations

Intended to treat moderate-to-severe pain

IR a complementary treatment toER for

breakthrough pain

Market Need Addressed: Will compete in $4.2 billion strong opioid market

Webelieve that oxymorphone ER will provide

equivalent analgesia with only half the milligram

dosage of OxyContin

Possible twice-daily dosing

Status: FDA Approvable Letters received 10/03

Positive results in Phase III trials for ER and IR

conducted with FDA agreed-upon endpoints

ER results:

SPA trial results announced 08/05 Additional trial results announced 10/05

IR SPA results received 09/05



9

Oxymorphone ERDevelopment Program

FDA has accepted one clinical trial as pivotal proof of efficacy Conducted two additional clinicaltrials in order to file at least one additional pivotal trial

12-week double-blinded, placebo-controlled trial in chroniclow back pain patients

One trial (under SPA) in opioid-nave patients One trial in opioid-experienced patients

Both trials achieved primary endpoint change in average pain intensity from baseline vs. placebo 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endo pharmaceuticals holdings inc. - form 8-k statements . this presentation contains...

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