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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
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