Title: 2nd Quarter Conference Call
1Third Quarter 2008 Earnings Conference Call
Michael V. Novinski President and Chief Executive
Officer
November 6, 2008
2Safe 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.
3Agenda
- Introductory Remarks
- Financials
- Eligen B12 Commercialization
- Partnerships
- Cash Position
- Questions
4 Introductory Remarks
5Eligen 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
6Eligen 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
7Partnerships
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
8Partnerships
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
9GLP-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.
10Cash Position
- Current cash sufficient for next six months
- Negotiations on partnerships continue
11Stock 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
12Summary
- 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
13 QA