Exhibit 99.1
See the Possibilities
Endo Pharmaceuticals
Merrill Lynch Conference
February 7, 2006
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.
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© 2006 Endo Pharmaceuticals
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 letter expected on oxymorphone ER and IR in June 2006
Strong cash flow and no debt
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© 2006 Endo Pharmaceuticals
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-$0.24.
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© 2006 Endo Pharmaceuticals
Lidoderm® Product Profile
Topical patch launched in 1999 covered by patents through 2015
First FDA-approved drug for the treatment of the pain of post-herpetic neuralgia (PHN), a form of neuropathic pain
Provides analgesia (without anesthesia) directly to the affected nerves
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© 2006 Endo Pharmaceuticals
Lidoderm® Net Sales
($ in millions) $600 $500 $400 $300 $200 $100 $0
2002 2003 2004 2005* 2006*
$83 $178 $309 $400 $540
‘02 - ‘04 CAGR 93%
*Represents high end of company guidance
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© 2006 Endo Pharmaceuticals
Substantial Pipeline Opportunities
Filed Status
Oxymorphone ER (1) and IR PDUFA date June 22, 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)
(2) | | Licensed marketing rights |
(3) | | Licensed marketing and development rights |
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© 2006 Endo Pharmaceuticals
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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© 2006 Endo Pharmaceuticals
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
Abstracts will be presented at AAPM (Feb 22-25) and APS (May 3-6)
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© 2006 Endo Pharmaceuticals
Oxymorphone ER / IR Clinical Trials
Extensive program in over 3,000 subjects, including 15 Phase II/III studies
Indication Comparator Primary Outcome p<0.05
Chronic Low Back Pain (SPA) Placeboü
Chronic Low Back Pain Placebo
Post-Surgical Pain Placeboü
Osteoarthritis Pain Oxycodone ER and Placeboü
Chronic Low Back Pain Oxycodone ER and Placeboü
Osteoarthritis Pain Placeboü
Cancer Pain Morphine Sulfate ER, Oxycodone ERü
Cancer Pain Morphine Sulfate ER —
Cancer Pain Oxycodone ERü
Post-Surgical Pain (SPA) Oxycodone IR and Placeboü
Post-Surgical Pain Oxycodone IR and Placeboü
Post-Surgical Pain Oxycodone IR and Placeboü
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© 2006 Endo Pharmaceuticals
Frova® Clinical Development in MRM
Vernalis plc completed one double-blind, placebo-controlled study in
Menstrually Related Migraine (“MRM”) prophylaxis; three-way crossover design; 579 patients randomized Drug taken for six days, starting two days prior to onset of expected MRM headache Primary endpoint, reduction in the incidence of MRM 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 MRM 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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© 2006 Endo Pharmaceuticals
Key Milestones for 2006
Building a solid platform for sustainable growth:
File sNDA for Frova® in MRM 1st Half
Initiate Phase III trials for topical ketoprofen patch 1st Half
Launch oxymorphone ER and IR 2nd Half
Launch SyneraTM 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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© 2006 Endo Pharmaceuticals
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Endo Pharmaceuticals
Nasdaq: ENDP
February 7, 2006
