endo pharmaceuticals holdings inc - sec.gov | … presentation of endo pharmaceuticals holdings inc....

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0000950123-03-001933.txt : 200302250000950123-03-001933.hdr.sgml : 2003022520030225100004ACCESSION NUMBER:0000950123-03-001933CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:129CONFORMED PERIOD OF REPORT:20030225ITEM INFORMATION:Financial statements and exhibitsITEM INFORMATION:FILED AS OF DATE:20030225

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:03578400

BUSINESS ADDRESS:STREET 1:223 WILMINGTON-WEST CHESTER PIKECITY:CHADDS FORDSTATE:PAZIP:19317BUSINESS PHONE:6105589800

MAIL ADDRESS:STREET 1:223 WILMINGTON-WEST CHESTER PIKECITY:CHADDS FORDSTATE:PAZIP:19317

8-K1y83879e8vk.htmENDO PHARMACEUTICALS HOLDINGS INC

ENDO PHARMACEUTICALS HOLDINGS INC

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): February25, 2003 (February25, 2003)

ENDO PHARMACEUTICALS HOLDINGS INC.

(Exact name of registrant as specified in its charter)

DELAWARE 39040 13-4022871

(State or other
jurisdiction of
incorporation) (Commission File Number)

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

100 Painters Drive
Chadds Ford, Pennsylvania
19317

(Address of principal executive offices) (Zip Code)

(610)558-9800

(Registrants telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Item7. Financial Statements and Exhibits.

(a) Financial Statements of Business Acquired

Not applicable

(b) Pro Forma Financial Information

Not applicable

(c) Exhibits

Exhibit Number Description

99.1 Slide Presentation of Endo Pharmaceuticals Holdings Inc.dated February25, 2003

Item9. RegulationFD Disclosure.

On February25, 2003, the Registrant intends to make a slide presentationto investors at its offices in Chadds Ford, Pennsylvania, a copy of whichpresentation is filed herewith as Exhibit99.1 and is incorporated herein byreference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, theRegistrant has duly caused this report to be signed on its behalf by theundersigned, hereunto duly authorized.

ENDO PHARMACEUTICALS HOLDINGS INC.

(Registrant)

By:

/s/ CAROL A. AMMON

Name: Carol A. Ammon

Title: Chairman & Chief Executive Officer

Dated: February25, 2003

INDEX TO EXHIBITS

Exhibit No. Description

99.1 Slide Presentation of Endo Pharmaceuticals Holdings Inc.dated February25, 2003

EX-99.13y83879exv99w1.htmSLIDE PRESENTATION

SLIDE PRESENTATION

Endo Pharmaceuticals

Investor Presentation - February 25, 2003

Forward-Looking Statements

This presentation contains forward-looking statements, within the meaning of Section 27A of the Securities Act of1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management's beliefsand 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 theCompany'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 similarexpressions are forward-looking statements. Endo's estimated or anticipated future results, product performance orother 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 theCompany 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, futureevents or otherwise. None of the development products in the Company's pipeline have been established as safe andeffective by the FDA or approved by the FDA. Several important factors, in addition to the specific factors discussedin connection with these forward-looking statements individually, could affect the future results of Endo and couldcause 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 successfullydevelop, commercialize and market new products; results of clinical trials on new products; competition for thebusiness of the Company's branded and generic products, and in connection with the Company's acquisition of rightsto intellectual property assets; market acceptance of the Company's future products; government regulation of thepharmaceutical industry; the Company's dependence on a small number of products; the Company's dependence onoutside manufacturers for the manufacture of its products; the Company's dependence on third parties to supply rawmaterials and to provide services for the core aspects of its business; new regulatory action or lawsuits relating to theCompany'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 abilityto protect its proprietary technology; the Company's ability to successfully implement its acquisition strategy; theavailability of controlled substances that constitute the active ingredients of some of the Company's products andproducts in development; the availability of third-party reimbursement for the Company's products; the Company'sdependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portionof its total net sales; and other risks and uncertainties detailed in Endo's Registration Statement on Form S-4 filedwith the Securities and Exchange Commission on June 9, 2000, as amended, and in Endo's Registration Statementon Form S-3 dated October 17, 2001. Readers should evaluate any statement in light of these important factors.

Agenda

Overview/Strategic Vision Carol A. AmmonChairman & CEO Pipeline Review David A. H. Lee, M.D., Ph.D.Senior V.P., R&D Commercial Review Peter A. LankauSenior V.P., U.S. Business Financial Summary Jeffrey R. BlackSenior V.P., CFO & Treasurer Q&A/Wrap-Up Q&A/Wrap-Up

Endo Profile

Fully integrated specialty pharma company with marketleadership in pain management

Formed in 1997; public since 2000

Headquarters in Chadds Ford, PA, and R&D facility in GardenCity, NY

277 Endo employees at December 31, 2002

Sales force of 230 includes 160 contract reps

Strong portfolio of marketed, established products and asubstantial pipeline

Well-Balanced Product Mix

Established Portfolio of Branded Products:

Lidoderm(r)

Percocet(r)

Other brands including Percodan(r) and Zydone(r)

Difficult-to-Develop Generics:

MSContin* generic

OxyContin* generic

subject of litigation

tentative FDA approval July 2002

*OxyContin and MSContin are trademarks of Purdue Pharma L.P.

Successful Track Record

Leveraging our pain management expertise to grow thebusiness

Net Sales: CAGR of 38% from 1998-2002

Consolidated EBITDA: up 99% from 2001

Developing and commercializing products

Lidoderm(r) sales doubled in 2002

Filed two NDAs and added four new patent-protected products to ourpipeline in 2002

Building a solid financial position

Strong cash flow

Debt-free

2002 Accomplishments

Building a solid platform for sustainable growth

Filed two NDAs with the FDA for oxymorphone ER and IR

Augmented R&D pipeline by adding EN3247 Oral Rinse for oral mucositis

Augmented R&D pipeline by in-licensing marketing rights to:

CHRONOGESICTM

DEPOMORPHINETM

Propofol IDD-DTM

Internalized specialty sales force

Received tentative FDA approval for oxycodone ER

Amended manufacturing agreement with BMS

Repaid BMS promissory notes to become debt-free

Endo Vision

To become a premier specialty pharmaceutical companyanchored in pain management, with a balanced focus incomplementary therapeutic areas

How Do We Get There?

Continue to drive revenue growth by leveraging our expertise inpain management and the brand equity in our products throughtargeted sales and marketing efforts

Use our R&D capability to develop proprietary products

Grow by in-licensing and acquiring products/technologies inpain management and complementary therapeutic areas

Leverage our brand equity through continued introduction ofline extensions

2003/2004 Expected Milestones

Lidoderm(r) continued growth

Oxymorphone ER and IR approval and launch

EN3247 Oral rinse (oral mucositis) NDA filing, approval andlaunch

DEPOMORPHINETM NDA filing, approval and launch

Advancement of other pipeline projects

Further in-licensing and acquisition activities in painmanagement and complementary therapies

Summary

Endo is building a solid platform for sustainable and profitablegrowth in the expanding pain management market and othercomplementary therapeutic areas through our:

Focused sales and marketing infrastructure

Established portfolio of branded and generic products

R&D expertise

Substantial pipeline

Strong financial position

Experienced, successful management team


Pipeline Review

Disclaimer

None of the development products in the Company's pipelinehave been established as safe and effective by the FDA.Further, none of these products have been approved by the FDAfor the pipeline indications set forth in the following slides.

Pipeline NDAs

DEPOMORPHINE(tm)

EN3247 Oral Rinse

Oxymorphone IR

(1) Oxymorphone ER

Lidoderm(r)

(Low back pain)

CHRONOGESIC(tm)

Propofol IDD-D(tm)

Filed 12/02

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Multiple Projects

(Undisclosed)

Filed 12/02

NDA Filing target

mid-2003

NDA Filing target

late 2003/early 2004

(1) Co-developed with Penwest

(2) Licensed marketing rights from SkyePharma

(3) Licensed marketing rights from DURECT

(2)

(3)

(2)

Pipeline ANDAs

Line extensions

Undisclosed generics

Oxycodone ER

Tentative;

Subject to litigation

Development

ANDA

Approved

Pipeline NDAs

Oxymorphone IR

(1) Oxymorphone ER

Filed 12/02

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Filed 12/02


Oxymorphone

Oxymorphone ER

Moderate-to-severe pain in patients requiring continuous, around-the-clock opioid therapy for an extended period of time

Oxymorphone IR

Acute moderate-to-severe pain

Oxymorphone - Pharmacology Overview

Pure opioid agonist - binds mostly to -receptors

Typical opioid pharmacology including analgesia

Oxymorphone is approximately:

2 times more active than hydromorphone

5 times more active than oxycodone

> 10 times more active than morphine

Extensive toxicology program - typical opioid

Oxymorphone

Injection and rectal suppository currently marketed in the U.S.

Many publications describe efficacy and safety by differentroutes of administration and in different patient populations

Oxymorphone ER Formulation

Based on Penwest Pharmaceuticals' TIMERx(r) system: apatented customized, agglomerated hydrophilic complex thatforms a controlled-release matrix on compression

Products based on TIMERx(r) system approved in U.S. &Europe

Multiple strengths: 5,10, 20, 40 mg submitted in NDA

NDA Overview

Two NDAs filed - December 2002; Accepted - Feb. 19, 2003

Approximately 2,500 subjects, of whom 1,400 receivedoxymorphone:

16 Phase I studies

12 Phase II/III studies

Nine double-blind controlled vs placebo, OxyContin or MSContin inacute & chronic pain (post-surgical; OA; chronic low back; cancer)

Three open-label long-term

Oxymorphone ER - Efficacy Summary

Moderate-to-severe pain of osteoarthritis:

Study 015 vs placebo and oxycodone CR (ref: World Pain Congress,2002)

Oxymorphone ER 20 & 40 mg significantly superior to placebo onchange from baseline in arthritis pain intensity (VAS) at weeks 3&4;oxycodone CR 20 mg did not differ from placebo

Study 025: oxymorphone ER 10, 20, 50 mg vs placebo (ref: APS, 2003)

A statistically significant linear dose-response relationship for painintensity reduction was observed (data to be presented at APS,March 21-23, 2003)

Making a Difference

Study 015 Primary Efficacy Parameter - Mean Change FromBaseline in Arthritis Pain Intensity VAS

Baseline Week 1 Week 2 Week 3 Week 4

Placebo

Mean Pain Intensity Change (VAS)

0

- -5

- -10

- -15

- -20

- -25

- -30

- -35

- -40

* P < 0.05 versus placebo

Oxycodone CR

(20 mg)

Oxymorphone ER

(40 mg)

Oxymorphone ER

(20 mg)


Chronic low back pain

Study 016 vs placebo and oxycodone CR (ref: APS 2003)

Oxymorphone ER was superior to placebo for change from baselinein pain intensity (p=0.0001), and for most of the other efficacyvariables. No statistically significant difference in efficacy parameterswas observed between the two active opioid treatments (data to bepresented at APS, March 21-23)

Post-surgical pain

Study 012 vs placebo (ref: World Pain Congress 2002)

One dose of oxymorphone ER 20 mg provided greater analgesicefficacy than placebo in the first 12 hours (p=0.0056)

Study 012 Primary Efficacy Parameter - MeanPain Relief Scores for 0-12 Hour Time Interval

0 2 4 6 8 10 12 14

Placebo

Pain Relief

1.8

1.6

1.4

1.2

1

0.8

0.6

0.4

0.2

0

* P < 0.0; p < 0.01

Oxymorphone ER (20 mg)

*

*

*

*

*

*

*


Cancer pain

Study 017 open label (ref: MASCC 2002); studies 018, 019(unpublished)

Oxymorphone ER administered every 12 hours appears effectiveand well-tolerated for the treatment of most patients with cancer pain(ref: 017)

In cancer pain patients, treatment with oxymorphone ER providedanalgesia equivalent to morphine ER and oxycodone CR,respectively, at stabilized doses (ref: 018, 019 - unpublished)

Making a Difference

Study 017 Efficacy - Daily Pain Intensity (VAS)

Treatment Days

MS Contin or

OxyContin Treatment

Daily Pain Intensity

(Mean +/- SEM)

45

40

35

30

25

20

15

10

5

0

- -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7

MS Contin-Oxymorphone ER

OxyContin-Oxymorphone ER

Oxymorphone ER

Treatment

Oxymorphone ER - Efficacy Conclusions

Oxymorphone ER >10 mg q12h appears to be effectivetreatment for moderate-to-severe chronic pain

A single dose of oxymorphone ER has a duration of action of atleast 12 hours

Equianalgesic dose ratios are calculated to be 1.2-2 to 1 foroxycodone CR to oxymorphone ER and 1.8-2.8 to 1 formorphine ER to oxymorphone ER

Note: Oxymorphone ER has not been approved by FDA. The safety andefficacy of Oxymorphone ER have not been established by FDA.

Oxymorphone ER - Safety and Side-Effects

Side-effect profile consistent with other opioids (constipation,nausea, somnolence, dizziness and vomiting)

Incidence of side-effects similar to oxycodone CR andmorphine ER at equianalgesic doses

No unexpected safety issues

Oxymorphone IR - Efficacy & Safety Summary

Post-surgical pain

Studies 004 (ref: APS 2003) and 005 (ref: unpublished) vsplacebo/oxycodone

All oxymorphone doses (10, 20, 30 mg) provided analgesia superiorto placebo; an analgesic dose-response was observed. OxycodoneIR 15 and 30 mg were statistically superior to placebo in TOTPAR 0to 8 hours; oxycodone IR 10 mg did not differ statistically fromplacebo. The median re-dosing interval was 7-9 hours (004 - data tobe presented at APS, March 21-23)

Safety & side-effects consistent with other opioids

Note: Oxymorphone IR has not been approved by FDA. The safety andefficacy of Oxymorphone IR have not been established by FDA.

Rationale for Multiple Opioids

Substantial variability in patient response enables physician tochoose opioid that provides best balance between analgesia &side effects

e.g., less nausea, sedation, histamine release, etc.

Value of opioid rotation cited in pain guidelines

incomplete cross tolerance among opioids

switching opioids may circumvent tolerance and provide better analgesia

may alleviate side effects in individual patients

Rationale for Multiple Opioids

"...variability in the response to different opioids is very substantial,and morphine may or may not be preferred by any individualpatient. Sequential trials of different opioid drugs may beneeded to identify the opioid that yields the most favorablebalance between analgesia and side effects."

Portenoy, R.K. Pain 1999: an updated review.IASP Press

Pipeline NDAs

DEPOMORPHINE(tm)

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Oxymorphone IR

(1) Oxymorphone ER

Filed 12/02

Filed 12/02

NDA Filing target

mid-2003

(2)



DEPOMORPHINETM

Morphine sulfate extended-release (proprietary DepoFoamTMtechnology) administered by epidural injection for 48 hours painrelief following abdominal or lower limb surgery

DEPOMORPHINETM - Clinical Program

Five Phase III studies

Hip or knee replacement, lower abdominal surgery (x2), c-section

First pivotal study showed that patients experienced statisticallysignificant post-op pain relief for 48 hours; safety profile typicalfor an epidural opioid agent

NDA filing targeted for mid-2003

Pipeline NDAs

DEPOMORPHINE(tm)

EN3247 Oral Rinse

Oxymorphone IR

(1) Oxymorphone ER

Filed 12/02

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Filed 12/02

NDA Filing target

mid-2003

NDA Filing target


(2)




EN3247 Oral Rinse

Prevention of oral mucositis in patients undergoing cancerchemotherapy

Oral rinse; proprietary formulation; patents through 2017

Active ingredient - triclosan 0.1%

Dosing - 15 ml rinse four times daily

Fast-track review status granted by FDA; single robust pivotal study couldbe sufficient

Oral Mucositis (OM)

Ulceration of the oral mucosa caused by chemotherapy,total body radiation, and/or bone marrow transplantbeginning 5-10 days after initiation of chemo, lasting 7-14days

Leads to pain and restricted oral intake

Ulcers may act as site for local infection (possiblysepticemia)

50% of patients have such severe OM that it becomes dose-limiting (i.e., interruption of cancer treatment)

Indirectly contributes to increased length of stay and cost oftreatment

Incidence

Significantly higher incidence of OM in:

Bone marrow transplant patients (75%)

Continuous infusion therapy for breast and colon cancer

Head and neck cancers

Younger age

Pre-existing oral disease

Current treatment algorithm

Pre-treatment dental evaluation

Ice chips

Frequent cleansing/oral hygiene (salinesolutions)

Pain: Opioids, capsaicin

Prophylaxis

Treatment

Water-soluble lubricating jelly, mouthwashes

Unmet Medical Need

Effective therapies to prevent the occurrence of oral mucositisin patients at risk

Ease of use to enhance compliance

Therapy that could enhance (or will not inhibit) healing time intreatment of OM

Reduction of pain and discomfort if OM occurs

EN3247 Overview

Pharmacology:

Anti-inflammatory/analgesic activity

Effect on cyclooxygenase and lipoxygenase pathways

Anti-cytotoxic activity

Inhibits mucosal response to chemical cytotoxicity by sodium laurylsulfate (inflammation and desquamation)

Anti-microbial activity

Broad-spectrum activity:

Bacteriostatic concentrations inhibit uptake of essential aminoacids

Bacteriocidal concentrations cause disorganization of cytoplasmicmembrane and cell leakage.

EN3247 - Phase II Study

Randomized, double-blind, vehicle-controlled study in 121patients undergoing autologous bone marrow or peripheralstem cell transplantation (chemotherapy and/or radiationconditioning) (ref: ASH 2001)

All patients were evaluated daily for the incidence of any oralmucositis (erythema, ulcers)

Treatment Duration: 30 days or until dismissed by investigator

Primary measure:

Occurrence of OM (OMAS and NCI CTC)

EN3247 - Phase II Study Results N Days of Mucositis P Value EN3247 45 5.18 Days 0.011 Vehicle 41 7.88 Days

Duration of Mucositis - Cohort of Patients on High

Mucositis-Producing Regimens

EN3247 - Phase II Study Results Any Mucositis Present N Percent P Value EN3247 45 68.89 0.015 Vehicle 41 90.24

Prevention of Any Mucositis - Cohort of Patients on HighMucositis-Producing Regimens

Any OMAS score > 0 considered a treatment failure

EN3247 - Phase II Study - Safety EN3247 (n=63) Vehicle (n=58) Related A.E. 23.81% (n=15) 27.59% (n=6) Withdrew due to related A.E. 12.70% (n=8) 13.79% (n=8)

Adverse Events (A.E.)

All A.E. related to EN3274 were classified as mild/moderate (e.g., stinging, nausea)

EN 3247 - Phase III Study

Randomized, double-blind, vehicle-controlled study in patientsundergoing autologous bone marrow or peripheral stem celltransplantation (chemotherapy and/or radiation conditioning)

Target n = up to 400 patients

Three treatment groups

Group 1 - EN3247

Group 2 - Vehicle (Placebo)

Group 3 - Standard of Care (Saline rinse +- chlorhexidine followingulcer development)

Treatment Duration: 30 days

EN 3247 Phase III Study

Primary endpoint - prevention of OM

Development of any ulcer in any of nine locations evaluated

Secondary Endpoints:

Duration of OM (days)

Incidence & duration of moderate-to-severe erythematous mucositis

Incidence & duration of moderate-to-severe oral pain

Incidence & duration of moderate-to-severe dysphagia

NDA filing expected late 2003 or early 2004

Pipeline NDAs

DEPOMORPHINE(tm)

EN3247 Oral Rinse

Oxymorphone IR

(1) Oxymorphone ER

CHRONOGESIC(tm)

Filed 12/02

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Filed 12/02

NDA Filing target

mid-2003

NDA Filing target


(2)

(3)




Chronogesic(tm) (sufentanil)

Pain Therapy System

DUROS(r) System: a single use, osmotically-driven, miniaturizedsystem designed to continuously deliver drugs under zero orderconditions up to three months or longer.

Orifice

Piston

Osmotic

Engine

SemipermeableMembrane

Drug Reservoir,Advanced

FormulationTechnology

DUROS(r) Platform Technology

CHRONOGESICTM - Profile

Based on Alza Corporation's Duros(r) technology

Implantable (SC) osmotic pump size of a match stick

Marketed product based on this technology - Viadur(r)

Will deliver sufentanil within therapeutic window for threemonths:

patient convenience, reduced possibility of misuse

CHRONOGESICTM - Development Program

In Phase II - completed trials have shown an acceptable safetyand efficacy profile in over 80 patients

Clinical program on temporary hold pending agreement withFDA on additional monitoring and data collection

Certain design & manufacturing enhancements also beingimplemented

Restart of clinical trials anticipated in 2H '03

Pipeline NDAs

DEPOMORPHINE(tm)

EN3247 Oral Rinse

Oxymorphone IR

(1) Oxymorphone ER

CHRONOGESIC(tm)

Propofol IDD-D(tm)

Filed 12/02

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Filed 12/02

NDA Filing target

mid-2003

NDA Filing target


(2)

(3)

(2)




Propofol IDD-DTM

IV formulation of propofol using SkyePharma's patentedInsoluble Drug Delivery (IDD-D) technology. Intended for themaintenance of anesthesia in adults during surgery and forsedation of adults in an intensive-care setting

Propofol IDD-DTM

Propofol is the active ingredient in Diprivan(r) - leading injectableanesthetic

Propofol IDD-DTM contains no anti-microbial agent - shouldsubstantially increase ICU utility

Phase II on-going

Pipeline NDAs

DEPOMORPHINE(tm)

EN3247 Oral Rinse

Oxymorphone IR

(1) Oxymorphone ER

CHRONOGESIC(tm)

Propofol IDD-D(tm)

Filed 12/02

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Filed 12/02

NDA Filing target

mid-2003

NDA Filing target


(2)

(3)

(2)

Lidoderm(r)

(Low back pain




Lidoderm(r) - Profile

Indicated for relief of pain associated with post-herpetic neuralgia

Patented topical patch launched in 1999

First FDA-approved drug for PHN, a form of neuropathic pain

Note: Lidoderm has not been approved by the FDA for any other indication.

Lidoderm(r) - Life-Cycle Management

Open-label pilot studies (ref: WPC 2002) have indicated utility(pain reduction; improved quality of life) in:


HIV-associated painful peripheral neuropathy

Painful diabetic neuropathy


Open-label pilot studies (ref: WPC 2002) have indicated utility(pain reduction; improved QoL) in:




Data to be presented at APS 2003 have also indicated utility in:

Pain of osteoarthritis

Idiopathic neuropathy

Combination with gabapentin for various neuropathies


Open-label pilot studies (ref: WPC 2002) have indicated utility(pain reduction; improved QoL) in:




Data to be presented at APS 2003 have also indicated utility in:

Pain of osteoarthritis

Idiopathic neuropathy

Combination with gabapentin for various neuropathies

Based on these data, double blind, placebo-controlled Phase IIstudy initiated in chronic low back pain with patches remainingon for up to 24 hours

Pipeline NDAs

DEPOMORPHINE(tm)

EN3247 Oral Rinse

Oxymorphone IR

(1) Oxymorphone ER

Lidoderm(r)

(Low back pain

CHRONOGESIC(tm)

Propofol IDD-D(tm)

Filed 12/02

Pre-Clinical

Phase I

Phase II

Phase III

NDA

Filed 12/02

NDA Filing target

mid-2003

NDA Filing target


(2)

(3)

(2)

Multiple Projects

(Undisclosed)




Early-Stage Projects

Pre-clinical R&D capability now in place

Focus on novel analgesics, both opioid and non-opioid

Active screening of early-stage licensing/acquisitionopportunities

Several compounds in early development


Commercial Review

Pain Market Overview

Analgesic Market Profile

Sales (000) 1998 1999 2000 2001 2002 Total Analgesics 5.3 5.7 6.5 7.8 8.5 opioids 1.9 2.4 3.1 4 4.6 non-opioid analgesic 3.4 3.3 3.4 3.8 3.9

5 Year CAGR

Total Analgesics +12.5%

Opioid Analgesics +25.2%

Non-Opioid Analgesics +3.2%

7.7%

14.2%

19.4%

9.0%

27.3%

29.0%

29.3%

15.7%

(3%)

3.6%

10.6%

2.0%

Source: IMS RPP, 12/02

Analgesic Market Profile

Prescriptions

5 Year CAGR

Total Analgesics +5.4%


Non-Opioid Analgesics +2.0% Scripts (000) 1998 1999 2000 2001 2002 02000 ANALGESICS 200694 211945 223723 235209 247500 opioids 142642 154179 165529 175616 184585 non-opioid Analgesics 58052 57766 58194 59593 62915

5.6%

5.6%

5.1%

5.2%

8.1%

7.4%

6.1%

5.1%

(0.5%)

0.7%

2.4%

5.6%

Source: IMS NPA, 12/02

Opioid Market Profile

Sales (000) 1998 1999 2000 2001 2002 Opioids 1.9 2.4 3.1 4 4.6 Short Acting 1.4 1.5 1.8 2.2 2.7 Long Acting 0.5 0.8 1.3 1.7 1.9

5 Year CAGR


Short-Acting Opioids +18.4%

Long-Acting Opioids +39.2%

27.3%

29.0%

29.3%

15.7%

14.3%

56.1%

25.4%

19.9%

61.6%

14.5%

34.6%

10.4%



Prescriptions

5 Year CAGR


Short-acting Opioids +5.9%

Long-acting Opioids +30.8% Scripts (000) 1998 1999 2000 2001 2002 Opioids 142642 154179 165529 175616 184585 Short Acting 139454 149292 158010 166575 175239 Long Acting Opioids 3189 4887 7519 9041 9346

8.1%

7.4%

6.1%

5.1%

7.1%

5.8%

5.4%

5.2%

53.2%

53.9%

20.2%

3.4%


2002 Post Op 21254 Back 9535 Fractures/Sprains, Strains 7595 Misc Joint Disorders 3092 Cancer 2739 Migraine/Headache 1889 Neuropathic Pain 1854 Wounds/Trauma 1775 OA 1503 All Other 18045


Drug Use

Source: IMS NDTI, 12/02

2002 FAMILY PRACTICE 26862 INTERNAL MEDICINE 23895 DENTISTRY 18666 ORTHOPEDIC SURGERY 15360 OSTEOPATHIC MEDICINE 14029 EMERGENCY MEDICINE 8562 OBSTETRICS/GYNECOLOGY 5740 GENERAL SURGERY 5629 Key Specialists 11483 OTHER 53706


Physician Specialty

Endo is amongthe top 5companies whoseproducts areprescribed by KeySpecialties inOpioid Analgesics

Pain Specialist

Anesthesiology

Phys. Med & Rehab.

Neurology


Marketed Brands

Lidoderm(r) Product Profile

Patented topical patch (lidocaine 5%) launched in 1999

First FDA-approved drug for the treatment of the pain of post- herpetic neuralgia(PHN), a form of neuropathic pain. Remains the only targeted peripheral analgesic

Lidocaine from the patch penetrates the dermis to deliver direct analgesia to affected nerves

The neuropathic pain of PHN can occur as a result of Herpes Zoster ("shingles")which afflicts ~ one million patients in the U.S. annually

Approximately 70% experience some acute or chronic (PHN) pain

Patients often describe the pain as "burning", "stabbing", or "aching"

PHN occurs in about 20% of shingles patients (damages peripheral nerve fibers)

The incidence rises to about 70% in the elderly (>70 years of age)

Lidoderm(r) is effective and safe used alone or in combination - no added systemicside effects

Unlike systemic agents, Lidoderm works directly at the site of pain

Achieved a 31% further reduction in pain scores beyond systemic treatments alone

Lidoderm(r) improves patients' quality of life

Measured by pain interference with general activity, mood, work, walking ability, relationships withother people, sleep, and enjoyment of life

Lidoderm(r) is easy and convenient to use

Patches are applied to painful area for a 12-hour once daily dosing, up to 3 patches

Lidoderm(r)

Lidoderm(r)

Characteristic Topical Transdermal

Site of Activity Local peripheral Systemic

tissue

Serum Level Insignificant Necessary

Systemic Unlikely Likely

Side Effects

Placement Directly over Arbitrary

painful site

Topical (e.g. Lidoderm(r)) vs.

Transdermal Delivery Systems (e.g. Duragesic(r))

12/1/1999 3/1/2000 6/1/2000 9/1/2000 12/1/2000 3/1/2001 6/1/2001 9/1/2001 12/1/2001 3/2/2002 6/2/2002 9/2/2002 12/2/2002 Lidoderm(r) Rx's 21 28 39 49 60 68 81 96 119 139 170 200 243

Lidoderm(r) Rx Trend

Quarterly: 4Q1999 - 4Q2002


Share of PHN Market

(based on physician mentions) TCA ANTICONVULSANTS LIDODERM(r) Other 2002 0.079 0.403 0.029 0.484


Lidoderm(r)

Success Drivers

Generate a continuous flow of new clinical data

Extensive Phase IV (clinical development) and publication programs

45 poster presentations and 9 manuscripts published in 2002

6 abstracts accepted for the 22nd Annual Scientific Meeting of the

American Pain Society (Chicago, March 20-23, 2003)

Invest in our customers through medical education

Invest to support our sales force through training andpromotion

Percocet(r)

Product Profile

Combination opioid analgesic; dual mechanisms provide enhancedpain relief

Oxycodone (binds to opiate receptors in the CNS)

Acetaminophen (works peripherally)

Approved for the management of moderate to moderately severe pain

Percocet(r) launched in 1976

Percocet(r) 7.5/325 and 10/325, launched in November 2001 providesdual mechanism efficacy with the lowest dose of acetaminophenavailable in an oxycodone/APAP combination

There is an FDA recommended daily dose limit for acetaminophen (4 grams/day)

Percocet(r) 7.5/325 and 10/325 are appropriate for a wide range of patienttypes and pain etiologies

Percocet(r) 7.5/325 and 10/325

Promotional Campaign

Percocet(r) - Market Development 1998 1999 2000 2001 2002 OxyAPAP Market 482.47 547.227 617.462 707.521 855.056 Oxy APAP Generic 9909 11175 11602 12796 13220

Oxycodone/APAP Tablet Trends

13.4%

12.8%

14.6%

Key Market Drivers

More aggressive pain management

Favorable demographics

Promotional efforts for Percocet(r)

20.9%

5 Year CAGR

Oxycodone/APAP 15.5%


Percocet(r) Prescription Trends 7/1/1999 8/1/1999 9/1/1999 10/1/1999 11/1/1999 12/1/1999 1/1/2000 2/1/2000 3/1/2000 4/1/2000 5/1/2000 6/1/2000 7/1/2000 8/1/2000 9/1/2000 10/1/2000 11/1/2000 12/1/2000 1/1/2001 2/1/2001 3/1/2001 4/1/2001 5/1/2001 6/1/2001 7/1/2001 8/1/2001 9/1/2001 10/1/2001 11/1/2001 12/1/2001 1/1/2002 2/1/2002 3/1/2002 4/1/2002 5/1/2002 6/1/2002 7/1/2002 8/1/2002 9/1/2002 10/1/2002 11/1/2002 12/1/2002 1/3/2003 Percocet 5 mg 107 106 102 104 101 100 92 89 95 85 91 87 83 89 81 80 77 77 77 70 76 70 74 71 72 72 64 71 67 65 66 58 63 62 64 59 61 59 55 56 55 54 53 Percocet 7.5/500 & 10/650 3 19 35 55 68 79 88 95 113 111 121 124 128 141 131 154 148 149 120 98 91 74 75 70 66 60 46 46 44 42 39 39 36 32 32 29 27 23 Percocet 7.5/325 & 10/325 6 39 56 75 86 98 98 115 123 120 135 141 147 152

7.5/325 & 10/325

launch

7.5/500, 10/650, &

2.5/325 launch


Percocet(r) - Market Performance 1998 1999 2000 2001 2002 Percocet Market Share 0.121 0.102 0.15 0.142 0.163

Market Share of Oxycodone/APAP


Percocet(r) 7.5/325 and 10/325

Share of Total Oxy/APAP Market 12/1/2001 1/1/2002 2/1/2002 3/1/2002 4/1/2002 5/1/2002 6/1/2002 7/1/2002 8/1/2002 9/1/2002 10/1/2002 11/1/2002 12/1/2002 Actual Conversion Share 0.005 0.028 0.044 0.053 0.06 0.066 0.07 0.076 0.081 0.084 0.087 0.089 0.094


Percocet(r) 7.5/325 & 10/325

Success Drivers

Effective life cycle management

Maximization of retail pharmacy stocking

Capitalization on high usage of oxycodone/APAP inhospitals

Expansion and acceleration of usage amongprescriber base

Emerging Products

Oxymorphone ER/IR Product Profile

First "new" oral opioid in decades

Oxymorphone ER appears to be approximately twice aspotent as oxycodone CR

Phase III studies in osteoarthritis pain, low back pain,cancer pain, and post-surgical pain

Four dosage formulations: ER and IR tablets, injectibleand suppository

Oxymorphone ER appears to provide a true 12 hourduration of effect as demonstrated in clinical trials

Strong Opioid Sales Growth 1998 1999 2000 2001 2002 Brand 0.8 1.2 1.7 2.4 2.7 Generic 0.1 0.2 0.2 0.3 0.3

Strong Opioid sales were $3.0 billion in 2002, ofwhich branded sales comprised over 91% of themarket....


Brands 36% CAGR

Generics 20% CAGR

Strong Opioid Growth 1998 1999 2000 2001 2002 Strong Opioids 5395 7527 10980 13546 14995

"Strong Opioids Include.."

OXYCONTIN DURAGESIC

MS-CONTIN ORAMORPH SR

DILAUDID MSIR

KADIAN AVINZA

Generic Generic Morphine

Hydromorphone

40% Growth

46% Growth

23% Growth

11% Growth

Source: IMS NPA December 2002

Market opportunity

Prescription growth rate for 2002 vs. 2001 was 11%

Despite availability of generics, brands hold a dominant share ofprescriptions, accounting for 85% of all prescriptions

Significant switching of opioids

Concentrated audience - 20,000 physicians yield ~60% of allstrong opioid prescriptions

Current leading brands likely to face generic competition in thenear future

Oxymorphone ER/IR

Upcoming events

Seven abstracts accepted for poster presentation at the 22nd AnnualScientific Meeting of the American Pain Society (Chicago, March 20-23,2003) including:

Oxymorphone Extended-Release (ER) Provides Equianalgesia at Half the DoseCompared to Oxycodone Controlled-Release (CR) in Chronic Low Back Pain:Results of Randomized, Parallel Group, Placebo-Controlled Study

Oxymorphone Extended-Release (ER) Improves Pain and Quality of Life inPatients with Osteoarthritis: Results of a Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study

Oxymorphone Extended-Release Offers Long-term Safety, Effectiveness, andDose Stabilization in Osteoarthritis Pain: Results of a One-Year Interim Report

Oxymorphone Extended-Release Offers Long-Term Safety, Effectiveness, andDose Stabilization in Cancer Pain: Results of a One-Year Interim Report

Analgesic Efficacy of Oxymorphone Immediate-Release (IR) in PostsurgicalOrthopedic Pain: Results of Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Comparison with Oxycodone

EN 3247 (Triclosan 0.1% Oral Rinse)

EN3247 is being studied for the prevention andreduction in duration of Oral Mucositis

EN3247 is a topical anti-mucositic oral agent; itsactive ingredient is 0.1% triclosan

Appears to significantly reduce incidence andduration of OM

Patients experienced reduction in pain score by24%

Incidence of adverse events were similar to thatof the control group

EN3247 has a subtle mint flavor, is pleasanttasting and long acting

Potential Patient Population

20-25%

Develop OM

500,000 Chemo Patients Annually

~125,000 OM Patients

Head & Neck

Colorectal

BMT

Acute Leukemia

Lung

Breast

Total

47,240

144,360

18,000

17,150

201,480

201,120

100%

20%

100%

100%

10%

5%

100%

66%

100%

100%

66%

66%

47,240

19,055

18,000

17,150

13,298

6,637

121,380

TumorType/Therapy

Total

Population

Total

Complications

% Mucositis

Potential

for Usage

Source: ENDO 12/02

Significant Unmet Need

Impacts Patients Quality of Life (QOL) and Medical Cost:

Infection-ulcers act as portals for infection & possiblesepticemia

Interruption of cancer treatment-up to 50% of OM casescan be dose-limiting

Increased costs-including length of stay & antibiotictherapy, pain meds, total parenteral nutrition, etc.

Reduced QOL-

Inability to eat

Speech impairment

Pain

Inability to retain prosthetic devices

$42,749

Additional hosp.charges/patient

Key Strategies

Increase clinical awareness of OM and need forOM prevention especially the supportive carearena

Fill in knowledge gaps through market research

Create a compelling, highly differentiated &sustainable brand image

Identify, cultivate & leverage advocates

Extend/Expand product lifecycle (Phase IIIb/IV)

DepoMorphine(tm)

Product Description

DepoMorphine is DepoFoam(tm) encapsulated morphine

Injected into epidural space prior to start of surgery- isintended to provide a slow release of morphine over 48hours

Clinical Rationale

Easier to use

Better pain management

Better pharmacoeconomics

Avoid need for indwelling epidural catheter & problems withpatients on low molecular weight heparin

DepoMorphine(tm) Market Opportunity

Approximately 26 million hospital surgeriesannually in the US

9.5 million are in-patient

6-7 million are major surgeries that form thetargets for DepoMorphine(tm)

Currently in Phase III clinical trials

Anticipate NDA filing in mid-2003

Propofol IDD-D(tm) (propofol 2%)

Product Description

Intravenous anesthetic intended for induction and maintenance ofgeneral anesthesia and sedation in intensive care facilities

Novel formulation of Diprivan(r), the leading intravenous anesthetic

IDD-D(tm) = Insoluble Drug Delivery in microDroplet technology

Improved antimicrobial effectiveness (increased "hang" time)

Presented as a ready-to-use emulsion containing nopreservatives

Currently in Phase II trials

Market potential $400MM

CHRONOGESICTM

Sufentanil-containing Pain Therapy System for chronic moderate-to-severe painin patients who require chronic opioid administration and who are opioidresponsive

Three months supply of continuous opioid (sufentanil)

CHRONOGESICTM

MSContin

200 Pills

Duragesic(r) Patches

33 Patches

Infusion Pump

& Ampule

=

Product Description

Subcutaneous, osmotically driven delivery system

Delivers sufentanil at a constant rate for 3 months forthe treatment of cancer pain and non-cancer chronicpain

Stable dose

Opioid Responsive Patients

Four dosage strengths equivalent to Duragesic(r)

Implanted in inner upper arm; simple outpatient 3-5minute procedure


Pain Therapy System

Clinical Rationale

Patient convenience

Reduced side effects due to elimination of peaks andtroughs

Improved compliance

Physician gains greater control of administration

First systemic medication to provide continuous treatmentfor three months

Clinical trials expected to resume later this year

Targeted at chronic opioid market valued at $3B


Pain Therapy System

Generic Products

Endo Generic Products

Selective Focus

Complementary CII Products

Niche therapeutic areas

Difficult-to-Develop Generics

Proprietary sustained-release technology

AB-rated MSContin generics

OxyContin: tentative FDA approval July 2002

Subject of litigation (Paragraph IV)

Opportunistic

Few competitors - barriers to entry

Limited raw material supplies

Sales Forces

Targeted Sales and Marketing

Direct promotion through national sales forces

70 specialty/institutional representatives (internal)

160 community-based representatives (contracted)

Focus on physician specialties in:

Pain management

Neurology

Anesthesiology

Surgery

Oncology

Primary care

Sales Force Profile

Position Average YearsPharma Experience District Manager 14.8 NAE 15.9 Specialty Representative 8.4 Total 9.3

Customer overlap along with product resourceneeds will drive structure choices

Products

Audiences

Lidoderm(r)

Oxymorphone

EN3247

Depo-Morphine

Office-Based

PCPs

P

PP

Pain Management

PP

P

Oncologists

P

PP

Hospital Based

Anesthesiologists

P

PP

EM, Surgeon, PM

PP

Oncologists

P

PP

PP

Key Audience

P

Secondary Audience

Sales Force Deployment

Current

160

70

Pharma

Specialty

Percocet(r)

Lidoderm(r)

Lidoderm(r)

Percocet(r)

PCP

PM

Oncology

Projected 2004 - 2005

190

80

110

Pharma

Specialty

Institution

Oxymorphone

DepoMorphine

PCP

PM

Hospital

Oncology

Lidoderm(r)

Oxymorphone

Lidoderm(r)

Oxymorphone

EN3247

Business Development

Alliance Criteria

Endo Vision:

Premier Specialty Pharma Company anchored in pain management with abalanced focus in complementary Therapeutic Areas, such as Neurology,Anesthesiology, CNS and Oncology.

Business Development initiatives support the Vision through alliances thatsupplement the organic growth coming from Endo's on-market productsand existing development pipeline through:

New markets or promo partners for Endo products

New on-market compounds

New development compounds

New drug delivery projects

New R&D collaborations

Product opportunities that match Endo's Therapeutic Area (TA) strategy forpain or expansion into complementary TA's

Address unmet market needs

Are differentiable from existing or future competitive offerings

Have long patent life or market exclusivity

Leverage Endo's Development, Regulatory, and Commercial infrastructure andexpertise

2002 Business Development Transactions

BML Pharmaceuticals

Rationale

Phase III OM product (Immunol(tm)/EN3247) as initial entreeinto supportive oncology TA; Leverage existing sales andmarketing infrastructure; High Unmet need; First/Fast tomarket; High Margin; Global rights

Terms

Company acquisition for $46 million ($14 million at signing,$32 million upon EN3247 FDA approval)

Earn out based on a % of net sales


DURECT Corporation - CHRONOGESIC(tm) (sufentanil)

Pain Therapy System

Rationale

Differentiated, patent-protected product with high value-in-use forchronic pain to complement Endo's core moderate-to-severe painfranchise. Leverages Endo's existing pain product development,regulatory, and commercial infrastructure

Terms

Development and commercialization agreement for US and Canada

Endo $5 million equity investment in DURECT and up to $52 millionin milestones

50/50 Funding of development once clinical trials are restarted

Endo and DURECT will share profits equally, based on projectedfinancial performance of CHRONOGESICTM


SkyePharma, Inc. - DepoMorphine(tm) and Propofol IDD-D(tm)

Rationale

Multi-product entree into complementary anesthesia/criticalcare TA;

Late stage product with follow on compound(s) to sustainmarket presence;

Leverage Endo development, regulatory, and commercialinfrastructure;

Differentiated, patent protected high margin products with highvalue-in-use


SkyePharma, Inc - DepoMorphine(tm) and Propofol IDD-D(tm)

Terms

Development and commercialization agreement for US and Canada

Endo $25 million upfront

Milestones of $10 million for DepoMorphineTM through FDA approval

Milestones when net sales of DepoMorphineTM reach certain levels

Milestones of $50 million for Propofol IDD-DTM upon achievement ofcertain regulatory milestones, including FDA approval

Skye pays100% of development cost

SkyePharma receives a share of each products net sales based uponachievement of certain thresholds

Why Partner with Endo?

Track Record of Success and Financial Health

Alignment of Endo Strategy with Partner's Goals

Organization and Operating Model that delivers results

Development, Regulatory, and Commercial Expertise

Complementary fit for Partner's unmet needs

Relevant experience in pain and specialty markets

Partnership Culture

Partner's "baby" is a priority

Alignment of common interests and balance of rewards


Financial Summary

Lidoderm(r) Net Sales 1999 2000 2001 2002 $ (MM) 5.7 22.5 40.9 83.2

Percocet(r) Net Sales 1999 2000 2001 2002 $ (MM) 51.5 92.4 101 144.6

Generics Net Sales 1999 2000 2001 2002 $ (MM) 44.8 47.1 84.3 149.1

Making a Difference

Total Net Sales

$108.4

$138.5

$252.0

$399.0

$440.0

$450

1998

2000

2001

2002

2003(g)

(in millions)

1999

$400

$350

$300

$250

$200

$150

$100

$50

$0

$197.4

(g) Company guidance

Making a Difference

Consolidated EBITDA(1)

$40.7

$47.2

$79.5

$158.1

$160.0

$160

1998

2000

2001

2002

2003(g)

(in millions)

1999

$140

$120

$100

$80

$60

$40

$20

$0

$67.7

(1) As defined by Endo's credit facility


Selected Financial Highlights - Q4

(dollars in millions, except per share data)

164%

$ 0.11

$ 0.29

Net Income per Diluted Share(2)

187%

$ 10.5

$ 30.1

Net Income(2)

103%

$ 23.6

$ 47.9


(5)%

$ 13.6

$ 12.9

R & D

26%

$ 24.6

$ 31.0

SG & A

48%

$ 57.9

$ 85.7

Gross Profit

45%

$ 78.5

$ 113.5

Net Sales

% Change

2001

2002

As defined by Endo's credit facility

Excluding special charges

Selected Financial Highlights - Full Year

(dollars in millions except per share data)

167%

$ 0.30

$ 0.80

Net Income per Diluted Share(2)

197%

$ 27.6

$ 82.0

Net Income(2)

99%

$ 79.5

$ 158.1


46%

$ 39.0

$ 56.8

R & D

39%

$ 79.5

$ 110.9

SG & A

69%

$ 177.1

$ 300.1

Gross Profit

58%

$ 252.0

$ 399.0

Net Sales

% Change

2001

2002

As defined by Endo's credit facility

Excluding special charges

Gross Profit Margin Improvement 2001 2002 Net Sales 0.74 0.83

Three Months Ended Dec. 31 2001 2002

Cons. EBITDA* 0.7 0.77

Year End Dec. 31

Reflects focus on branded products and high-margin generics, favorableproduct mix and fixed manufacturing costs

Gross Profit Margin

2002 excludes $8.0 million charge for oxycodone ER

Financial Summary

In 2003, common shares outstanding expected toincrease to approximately 131.8 million based onexercise of warrants

Endo had $56.9 million in cash as of December 31,2002

Generated cash flow from operating activities of$109.6 million in 2002

Financial Guidance Summary 2002 2003(g) Net Sales 399 440

(1) As defined by Endo's credit facility.

Net Sales 2002 2003(g) Net Sales 230.444 254.556 R&D 35.9 30.5 Cons. EBITDA* 158.1 160



Guidance assumes competition anytime in 2003 for generic Morphine SulfateER and generic competition for Percocet(r) 7.5/325 and 10/325 strengths

(in millions)

(in millions)


Nasdaq: ENDP; ENDPW

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begin 644 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