2nd Quarter Conference Call - Emisphere Technologies, Inc.
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Transcript 2nd Quarter Conference Call - Emisphere Technologies, Inc.
Third Quarter 2008
Earnings Conference Call
Michael V. Novinski
President and Chief Executive Officer
November 6, 2008
1
Safe Harbor
Safe Harbor Statement Regarding Forward-Looking Statements
The statements in this release and oral statements made by representatives of Emisphere
relating to matters that are not historical facts (including without limitation those regarding the
timing or potential outcomes of research collaborations or clinical trials, any market that
might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's
cash and other capital resources) are forward-looking statements that involve risks and
uncertainties, including, but not limited to, the likelihood that future research will prove
successful, the likelihood that any product in the research pipeline will receive regulatory
approval in the United States or abroad, the ability of Emisphere and/or its partners to
develop, manufacture and commercialize products using Emisphere's drug delivery technology,
Emisphere's ability to fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission,
including those factors discussed under the caption "Risk Factors" in Emisphere's Annual
Report on Form 10-K (file no. 1-10615) filed on March 13, 2008 and our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2008, filed on August 11, 2008.
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Agenda
Introductory Remarks
Financials
Eligen® B12 Commercialization
Partnerships
Cash Position
Questions
Introductory Remarks
4
Eligen® B12 – Clinical Strategy
Human clinical trials of B12 formulations in healthy
volunteers demonstrate
• Eligen® B12 provides new mechanism for B12 delivery
• Eligen® B12 significantly enhances B12 absorption
Cmax (greater than tenfold compared to commercial)
Tmax (reduced by more than 90%)
Clinical investigation of Eligen® B12 therapeutic efficacy in
target populations set for fourth quarter
• One study in B12 deficient subjects to be initiated in 2008
• Additional studies scheduled for 2009
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Eligen® B12 – Commercial Application
Clinical strategy to support higher and lower dose
Regulatory strategy
• GRAS
Valuation in process with physicians and consumers
Exploring various market opportunities with a potential
market entry in late 2009
6
Partnerships
Novartis and Salmon Calcitonin
Recruitment completed for two Phase III studies by
Novartis exploring effects of Eligen® and Salmon
Calcitonin in osteoarthritis and osteoporosis
• Phase III study exploring safety and efficacy of Oral Salmon
Calcitonin in the treatment of vertebral fractures in
postmenopausal women aged 60-80 in North and South America,
Europe and Asia
• Phase III study exploring the safety and efficacy of Oral Salmon
Calcitonin to treat patients with knee osteoarthritis in patients aged
51-80 mainly in Europe; estimated completion in 2010
This study will be used to support the filing with health authorities
worldwide
A second study, designed to meet FDA requirements for U.S. registration,
was initiated in October 2008
Partnerships
Novartis and Salmon Calcitonin
Publication of study of Oral Salmon Calcitonin using
Eligen® Technology taken 30-60 minutes before meals with
50ml of water resulted in improved absorption and efficacy
compared to nasal formulation
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GLP-1 Study Findings
Independent study published showed that GLP-1 and
PYY3-36 can be delivered orally in humans safely and
efficiently
• Conducted at University Hospital in Basel, Switzerland, by
Christoph Beglinger, M.D.
Cash Position
Current cash sufficient for next six months
Negotiations on partnerships continue
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Stock Performance
Currently undervalued
Share price affected by overall market conditions
Continued exposure to financial community
• Rodman & Renshaw Conference – November
• NYSSA Conference – December
• Ongoing one-on-one investor meetings and calls
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Summary
Unique technology selected by key pharmaceutical companies
Solution-based alternative for many pharmaceutical development
issues
Highly adaptive to various therapeutic fields
Carriers themselves are not pharmacologically active
Not limited to prescription drug products (B12, nutrients, other
vitamins, etc)
Two Phase III programs
• Osteoarthritis
• Osteoporosis
Newly established leadership position for oral therapy Type II
Diabetes
Potential commercial product late-2009
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Q&A