Exhibit 99.1
ENDO PHARMACEUTICALS
Buckingham Specialty Pharmaceuticals Conference
March 15, 2006
…is our pursuit of improving patients’ lives.
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 the Securities Exchange Act of 1934, as amended, that are based on management’s beliefs and assumptions, current expectations, estimates and projections. These statements are subject to risks and uncertainties 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 Company’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 similar expressions are forward-looking statements. Endo’s estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Endo’s current perspective on existing trends and information. Many of the factors that will determine the Company’s future results are beyond the ability of the Company to control or predict. The reader should not rely on any forward-looking statement. The Company undertakes 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 Company’s pipeline have been established as safe and effective by the FDA 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 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 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 to intellectual property assets; market acceptance of the Company’s future products; government regulation of the pharmaceutical industry; the Company’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 regulatory action or lawsuits relating to the Company’s use of narcotics in most of its core products; the Company’s exposure to product liability claims and product recalls and the possibility that the Company may not be able to adequately insure itself; the Company’s ability to protect its proprietary technology; the Company’s ability to successfully implement its acquisition strategy; the availability of controlled substances that constitute the active ingredients of some of the Company’s products and products in development; the availability of third-party reimbursement for the Company’s products; the Company’s 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 Endo’s Registration Statement on Form S-4 filed with the Securities and Exchange Commission on June 9, 2000, as amended, in Endo’s Registration Statement on Form S-3 dated October 17, 2001, in Endo’s Registration Statement on Form S-3 filed with the SEC on July 1, 2003, in Endo’s Registration Statement on Form S-3 filed with the SEC on April 30, 2004, as amended, and in Endo’s Registration Statement on Form S-3 filed with the SEC on September 2, 2005, as amended, and in Endo’s Registration Statement on Form S-3 filed with the SEC on January 19, 2006. Readers should evaluate any statement in light of these important factors.
Endo Profile
Fully integrated specialty pharma company with market leadership in pain management; expanding into complementary therapeutic areas
Well-developed commercial capability:
Portfolio of branded prescription products including Lidoderm® and Percocet®
Promising pipeline, with eight mid- to late-stage products
Oxymorphone ER/IR filings accepted for substantive review on January 20, 2006
Action letters expected on oxymorphone ER and IR in June 2006
Strong cash flow and no debt
Oxycodone ER Update
On February 1, 2006 the Federal Circuit Court of Appeals:
Vacated its unanimous June 7, 2005 affirmance of the U.S. District Court’s Opinion and Order issued in Endo’s favor
Affirmed that, if the patents are enforceable, Endo’s product infringes these patents
Issued a new opinion remanding the case to the U.S. District Court for further consideration
Endo believes that, on remand, the District Court should again find that Purdue’s patents are unenforceable due to Purdue’s inequitable conduct
Endo to continue to market its bioequivalent version of OxyContin at this time
Guidance for 2006 included net sales of generic OxyContin of $50-$60 million and diluted EPS of $0.20-$0.24.
Lidoderm® Product Profile
Topical patch launched in 1999
Covered by five Orange Book- listed patents through 2015
First FDA-approved drug for the treatment of the pain of post-herpetic neuralgia, a form of neuropathic pain
Provides analgesia (without anesthesia) directly to the affected nerves
Lidoderm® Net Sales
‘02—‘05 CAGR 71%
($ in millions)
$83
$178
$309
$419
$540
$0
$100
$200
$300
$400
$500
$600
2002
2003
2004
2005
2006*
*Represents high end of company guidance
Lidoderm® Future Growth Drivers
Other Neuropathies:
Peripheral
Diabetic
AIDS PHN
Cancer
Trauma
Goal is to explore possible utility in other neuropathic and chronic pain segments
Neuropathic Pain Market in 2004(1)
(1) Source: IMS NDTI, Full-year 2004
PHN
Frova® Product Profile
Triptan indicated for acute treatment of migraine headaches in adults
Commercial strategy to implement marketing, education and clinical plan to differentiate Frova in the marketplace
Low recurrence rate
Long half-life
Target specialty physician audience
Focus on neurologists, pain management specialists
Leverage existing coverage of high prescribers
Create advocacy base among thought leaders
Phase | | III development ongoing for menstrual migraine prophylaxis indication |
SyneraTM Product Profile
Description / Indication:
Topical, local anesthetic patch that is indicated for use in children and adults to numb the skin before various medical procedures such as blood draws or IV cannulation
Thin layer of local anesthetic formulation integrated with an oxygen-activated heating element
Exclusive N. American rights licensed from ZARS Pharma
Market Need Addressed:
Hospitalized pediatric patients
Anticipated benefits include:
Fast onset of action
Ease of administration
Status:
FDA approval in June 2005
Safety and efficacy demonstrated in more than 660 pediatric (aged 3-17 years) and adult patients undergoing superficial dermatological procedures
Anticipated launch in second half of 2006
Pediatric immunization studies planned
Generic Product Strategy
Selective focus on:
Niche therapeutic areas
Difficult-to-develop generics
Internally developed proprietary sustained-release technology
AB-rated MS Contin, OxyContin generics
Current marketed portfolio substantially consists of:
Oxycodone ER (launched June 2005)
Endocet®
Morphine Sulfate ER
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Substantial Pipeline Opportunities
Oxymorphone | | ER (1) and IR PDUFA date June 22, 2006 |
SyneraTM | | (2) FDA-Approved |
Endo Development Projects
Topical | | ketoprofen patch (3) |
Transdermal | | sufentanil patch (3) |
Partner development projects include Frova® (Menstrual Migraine) (2), Propofol IDD-DTM (2), LidoPAIN® BP (2) and CHRONOGESICTM (2)
(2) | | Licensed marketing rights |
(3) | | Licensed marketing and development rights |
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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 to ER for breakthrough pain
Market Need Addressed:
Will compete in the strong opioid market
We believe 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
Data included in response submitted to the FDA on December 22, 2005
PDUFA date June 22, 2006
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Oxymorphone ER Development Program
FDA has accepted one clinical trial as pivotal proof of efficacy
Conducted two additional clinical trials to file at least one additional pivotal trial
12-week double-blinded, placebo-controlled trial in chronic low back pain patients
One trial (under SPA) in opioid-naïve patients
One trial in opioid-experienced patients
Both trials achieved primary endpoint – change in average pain intensity from baseline vs. placebo (p<0.0001)
Both trials met all of their secondary endpoints
Efficacy data to be presented at APS (May 3-6)
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Oxymorphone ER / IR Clinical Trials
Extensive program in more than 3,000 subjects, including 15 Phase II/III studies
Primary Outcome
Indication | | Comparator p<0.05 |
Chronic | | Low Back Pain (SPA) Placebo |
Chronic | | Low Back Pain Placebo |
Post-Surgical | | Pain Placebo |
Osteoarthritis | | Pain Oxycodone ER and Placebo |
Chronic | | Low Back Pain Oxycodone ER and Placebo |
Osteoarthritis | | Pain Placebo |
Cancer | | Pain Morphine Sulfate ER, Oxycodone ER |
Cancer | | Pain Morphine Sulfate ER |
Post-Surgical | | Pain (SPA) Oxycodone IR and Placebo |
Post-Surgical | | Pain Oxycodone IR and Placebo |
Post-Surgical | | Pain Oxycodone IR and Placebo |
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Frova® Clinical Development in MM
Vernalis plc completed one double-blind, placebo-controlled study in Menstrual Migraine (“MM”) prophylaxis; three-way crossover design; 579 patients randomized
Drug taken for six days, starting two days prior to onset of expected MM headache
Primary endpoint, reduction in the incidence of MM headache during the six-day period (both statistical and clinical significance achieved)
p < 0.0001 (vs. placebo)
Treatment with Frova also achieved secondary endpoints of reduction in severity and duration of MM headache
Results published in July 2004 Neurology
Confirmatory Phase III study, being conducted by Vernalis, initiated in October 2004 (enrollment complete)
Expect to file sNDA in first half of 2006
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RapinylTM
Description / Indication:
Oral, fast-dissolving sublingual fentanyl tablet
Intended for the treatment of breakthrough pain
Expected to compete with Actiq and OraVescent Fentanyl
Exclusive North American marketing and development rights licensed from Orexo AB
Market Need Addressed:
Intended to compete in the market for treatments of breakthrough pain
Anticipated benefits include:
Fast onset of action
Enhanced absorption characteristics
Added convenience
Status:
Initiated Phase III clinical trials in December 2005
Expect to file NDA in second half of 2007
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Topical Ketoprofen Patch
Description / Indications:
Topical patch intended for localized treatment of acute pain associated with soft-tissue injuries:
Tendonitis
Joint Sprains and Strains
Licensed marketing and development rights from ProEthic in March 2005
Market Need Addressed:
Ketoprofen (NSAID) currently only available in the U.S. in oral form
Will compete in the ~$2.5 billion soft-tissue injury market primarily consisting of NSAIDs and COX-IIs
Anticipated benefits include:
Bypassing the bloodstream
Local / targeted pain control
Once-daily dosing
Status:
Two placebo-controlled studies completed in Europe
Marketing application under review in Europe
Expect to enter Phase III trials in U.S. in 1H 2006
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Recent Accomplishments
Completed clinical development program and filed responses to approvable letters on oxymorphone ER and IR
PDUFA date June 22, 2006
Strengthened pipeline by licensing rights to two new products
Topical ketoprofen patch
Transdermal sufentanil patch
Initiated Phase III trials for RapinylTM
Licensed Synera™, an FDA-approved topical local anesthetic patch from ZARS Pharma
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Building a solid platform for sustainable growth:
File | | sNDA for Frova® in MM 1st Half |
Initiate | | Phase III trials for topical ketoprofen patch 1st Half |
Launch | | oxymorphone ER and IR 2nd Half |
Advance | | pipeline development Ongoing |
Acquire / in-license opportunities in pain and complementary areas such as neurology, perioperative care and supportive care oncology Ongoing
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Summary
Fully integrated specialty pharma company with market leadership in pain management; expanding into complementary therapeutic areas
Well-developed commercial capability:
Portfolio of branded prescription products including Lidoderm® and Percocet®
Promising pipeline, with eight mid- to late-stage products
Action letters expected on oxymorphone ER and IR in June 2006
Strong cash flow and no debt
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ENDO PHARMACEUTICALS
Nasdaq: ENDP
…is our pursuit of improving patients’ lives.
