Transcript 2008 Annual Shareholder Meeting

Annual Shareholder’s Meeting
Michael V. Novinski
President and Chief Executive Officer
May 8, 2008
Safe Harbor
Safe Harbor Statement Regarding Forward-Looking Statements
The statements in this presentation and oral statements made by representatives of Emisphere relating
to matters that are not historical facts (including without limitation those regarding potential third party
collaborations, future performance or financial results, 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 one or
more potential third party collaborations may not be consummated, that actual performance or results
could materially differ, 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, or Emisphere's ability to fund such efforts with or without partners. Emisphere
undertakes no obligation to update any of these statements. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly any
forward-looking statements should be read in conjunction with the additional 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 for the fiscal
year ended December 31, 2007, filed on March 17, 2008.
Agenda
 Value Creation
 Pipeline
 B12 Update
 Partnerships
 Expectations
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Drive Value
 Current valuation
 Appears as multi-steps backward
 One step backwards to move several steps ahead
3
Drive Value
 Established Goals
• Commercialize the technology
• Bring in high-value partnerships
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Commercialize the Technology
 Fundamentals
• Clear understanding of the technology




Why it works
Conditions under which it works
Select the proper molecules for the proper treatment modality
Tolerance for variability
• Establish proper pre-clinical program and scientific
processes
 Fundamental prior to human testing (proof of principle)
 Clear guidance to human testing (dosing)
 Establish clear expectations for human testing
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High-Value Partnerships
 Fundamentals
• Sound reputation within the pharmaceutical industry
• Match the technology with current problems
 Visualize for partner how our technology brings them a
product that can be developed in a reasonable time frame,
gain approval and meet market needs
• Establish collaboration to generate pre-clinical animal
proof of principle with the technology
• Generate data and negotiate license
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 Overlaying both the commercializing and
partnership generation is a necessity for a
sound business organization that observes
cost awareness and is structured to support
these strategic objectives
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Driving Value
 Fundamentals – Organization
 Fundamental and essential changes for the organization
to drive value
 Change the company and the culture to focus on
commercialization and partnerships, or the underlying
business processes that are required to do this
 Fundamental changes were numerous and timeconsuming
 To the casual observer, these changes can be viewed as
setbacks, or not viewed at all
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Achievements To Date
 Restructured the organization to improve
productivity, reduce costs and facilitate
communication to support value creation
 Established new management team
 Gained a more sound understanding of the
technology and compatibility for molecule
selection criteria
 Established pre-clinical program to handle
multiple projects and drive early collaborations
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Achievements To Date
 Established a pathway for technology
commercialization as soon as next year
 Reduced the burn rate by over 33% in an ongoing
process
 Established new business and scientific processes
(budget, go/no go, etc.)
 Initiated pre-clinical collaborations that should
yield partnerships by mid-year
 Removed distractions (Lilly litigation)
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Achievements Not Recognized To Date

Partnerships of Insulin and Heparin
• Data inconclusive at best
• Probability of short-term success questionable

Extremely high risk with further major investments
• Millions of dollars
• Competitive landscape well beyond these molecules
• Do not match well with criteria compatibility given narrow
therapeutic index of both molecules and little tolerance to variability

Continue to explore strategic alternatives for Insulin and
Heparin

Continue to work with the technology and both molecules
with selected resources
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Pipeline Continues To Build With Strength
 Novartis Osteoporosis (Phase III)
• Study start February 2007
• Enrollment almost completed
 Novartis Osteoarthritis (Phase III)
• Study 1 start May 2007
• Full enrollment mid-year 2008
• Study 2 start May/June 2008
• Full enrollment Q2 09
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Pipeline Continues To Build With Strength
 PTH and Growth Hormone (Phase I)
• Novartis projects continuing
 GLP-1/PYY (Phase I)
• First study to be published mid-year
• Second study results expected this quarter
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Pipeline Continues To Build With Strength
 Acyclovir (Phase I)
• Demonstration of significantly improved bioavailability
• Discussion on potential next studies ongoing
 Gallium (Phase I)
• Genta partnership
• Proof of concept initiated September 2007
• Data to be presented June 2008
• Development plan continues for oral formulation
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Pipeline Continues To Build With Strength
 Pre-clinical
• Multiple projects ongoing
• Partnered and non-partnered
• Will be fundamental for the company in either case
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Vitamin B12
 The purpose behind developing B12 was not to
become a B12 company, but to bring the
technology to the market as soon as possible
• The pipeline and partnerships are much more than B12
• B12 is a poorly absorbed molecule that is a food,
injected over 40 million times because of poor
absorption of oral formulation. Enter eligen®
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Vitamin B12
 Pre-clinical and clinical development
• Two animal studies, one species, higher doses and
physiological doses
 Excellent results
• One animal study, second species
 Excellent results
• Human clinical to determine bioavailability Q3 2008
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Vitamin B12
 B12 Market Segments (existing)
• Food fortification (lower doses)
• Nutritional supplement (at or well above RDA
requirement)
• Injection (aggressive higher doses)
 B12 Market Segment Access Potential
• Food fortification (GRAS)
• Nutritional supplement (NDI)
• Injection replacement at higher doses (Medical Food
via GRAS provided only under the supervision of a
physician and obtained from a pharmacy)
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Vitamin B12
 B12 Market Values
• Food fortification (TBD)
• Nutritional supplements
 500-600 million tablets purchased by an estimated 5 million
people
• Injection
 40 million injections, which we estimate could equate to over
1.0 billon well absorbed, high concentration tablets
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Vitamin B12
 Commercial Access
• Emphasis on development and regulatory pathways
and not commercial avenues to each segment
 Preliminary Market Research
• Ongoing qualitative survey of prescribing/
recommending physicians in northeast and southeast
• Extremely high level of acceptance for solid oral
formulation that works
• Preliminary information indicate significant shift in
behavior
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Vitamin B12 – Next Steps
 Proceed with human clinical trial to determine
bioavailability
 Once determined, Emisphere could have the first oral solid
formulation of B12 that provides any B12 level to a wide
variety of individuals
 Need to then decide on what is the required level for which
individual population
 Continue with plans to file the NDI during Q3 2008
 Continue with plans to achieve conditional GRAS status
during Q3-Q4 2008
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Vitamin B12 – Next Steps

Continue with plans to introduce higher concentrations as
Medical Food

Plan limited clinical programs to demonstrate efficacy in
B12 deficient populations for replacement of injection
(2008 – 2009)

Expand understanding of physician needs and intent to
recommend/prescribe via quantitative survey and other
market research

Continue with identification of other potential eligen®
nutrients
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Partnerships and Ongoing Cash Concerns

Closing high-value partnerships requires demonstration of
value with technology in proof of principle in animals
(minimum)

Targeting two for mid-year

Would help alleviate cash concern

Would allow room to continue to develop B12 and
commercialize technology, driving value
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Partnerships and Ongoing Cash Concerns

Drafts are a result of months of discussion and data
generation

Ongoing discussion with multiple companies about
numerous projects

If we needed to finance, concerns about a ratchet
provision. No ratchet if we go at market, and if that is not
possible, then there is a $10 million exemption which we
could use

Our goal is to now move several steps forward and begin
to drive value
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Conclusion

We said we would assess the technology and we now have
a sound understanding of this area along with
compatibility and criteria for molecule selection

We said we would assess the organization and we have and
reorganized under a new management team

We said we would eliminate distractions and, for the most
part, we have

We said we would get a grip on costs and we have,
reducing the burn rate by at least 34% at present
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Conclusion

We said we would drive value through commercialization
and high-value partnerships, and where it superficially
appears we have taken a few steps back, in fact, the
cornerstones for achieving the above have been set

We said we would bring in high value partnerships, and I
believe we will
• Unfortunately, there was little in place to attract high-value
partnerships only 12 months ago, and that has been rectified

We are intending to commercialize the technology and we
believe we have a real potential avenue with B12, but we need to
complete the development
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Conclusion

Commercializing the technology will begin to change the
landscape for the company and how people view Emisphere
and eligen®

We said we would bring a new message forward on the new
emerging Emisphere, and we are doing that. We are increasing
our presence in the financial community and the general public
in a positive manner

A substantial effort is ongoing to drive value and to establish an
organization that can grow and thrive with the correct
infrastructure
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Thank You
 Much has taken place at Emisphere. There has not only
been an increase in activity, but also a tremendous increase
in productivity. I believe over the next 6 months that you
are going to begin to see some of the benefits of this
productivity and value creation. Emisphere and eligen®
should begin to emerge as the standard in the drug delivery
field
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