michael v. novinski president and chief executive officer may 8, 2008 annual shareholder’s meeting

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Michael V. Novinski Michael V. Novinski President and Chief Executive Officer President and Chief Executive Officer May 8, 2008 May 8, 2008 Annual Shareholder’s Meeting Annual Shareholder’s Meeting

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  • Michael V. NovinskiPresident and Chief Executive OfficerMay 8, 2008Annual Shareholders Meeting

  • 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.

  • Agenda2Value CreationPipelineB12 UpdatePartnershipsExpectations

  • Drive Value3Current valuationAppears as multi-steps backwardOne step backwards to move several steps ahead

  • 4Drive ValueEstablished GoalsCommercialize the technologyBring in high-value partnerships

  • Commercialize the TechnologyFundamentalsClear understanding of the technologyWhy it worksConditions under which it worksSelect the proper molecules for the proper treatment modalityTolerance for variabilityEstablish proper pre-clinical program and scientific processesFundamental prior to human testing (proof of principle)Clear guidance to human testing (dosing)Establish clear expectations for human testing5

  • High-Value PartnershipsFundamentalsSound reputation within the pharmaceutical industryMatch the technology with current problemsVisualize for partner how our technology brings them a product that can be developed in a reasonable time frame, gain approval and meet market needsEstablish collaboration to generate pre-clinical animal proof of principle with the technologyGenerate data and negotiate license

    6

  • 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

    7

  • Fundamentals OrganizationFundamental and essential changes for the organization to drive valueChange the company and the culture to focus on commercialization and partnerships, or the underlying business processes that are required to do thisFundamental changes were numerous and time-consumingTo the casual observer, these changes can be viewed as setbacks, or not viewed at all

    8Driving Value

  • Achievements To Date9Restructured the organization to improve productivity, reduce costs and facilitate communication to support value creationEstablished new management teamGained a more sound understanding of the technology and compatibility for molecule selection criteriaEstablished pre-clinical program to handle multiple projects and drive early collaborations

  • Achievements To Date10Established a pathway for technology commercialization as soon as next yearReduced the burn rate by over 33% in an ongoing processEstablished new business and scientific processes (budget, go/no go, etc.)Initiated pre-clinical collaborations that should yield partnerships by mid-yearRemoved distractions (Lilly litigation)

  • 11Achievements Not Recognized To DatePartnerships of Insulin and HeparinData inconclusive at bestProbability of short-term success questionableExtremely high risk with further major investmentsMillions of dollarsCompetitive landscape well beyond these moleculesDo not match well with criteria compatibility given narrow therapeutic index of both molecules and little tolerance to variabilityContinue to explore strategic alternatives for Insulin and HeparinContinue to work with the technology and both molecules with selected resources

  • Pipeline Continues To Build With Strength12Novartis Osteoporosis (Phase III)Study start February 2007Enrollment almost completedNovartis Osteoarthritis (Phase III)Study 1 start May 2007Full enrollment mid-year 2008Study 2 start May/June 2008Full enrollment Q2 09

  • Pipeline Continues To Build With Strength13PTH and Growth Hormone (Phase I)Novartis projects continuingGLP-1/PYY (Phase I)First study to be published mid-yearSecond study results expected this quarter

  • Pipeline Continues To Build With Strength14Acyclovir (Phase I)Demonstration of significantly improved bioavailabilityDiscussion on potential next studies ongoingGallium (Phase I)Genta partnershipProof of concept initiated September 2007Data to be presented June 2008Development plan continues for oral formulation

  • Pipeline Continues To Build With Strength15Pre-clinicalMultiple projects ongoingPartnered and non-partneredWill be fundamental for the company in either case

  • Vitamin B1216The purpose behind developing B12 was not to become a B12 company, but to bring the technology to the market as soon as possibleThe pipeline and partnerships are much more than B12B12 is a poorly absorbed molecule that is a food, injected over 40 million times because of poor absorption of oral formulation. Enter eligen

  • Vitamin B1217Pre-clinical and clinical developmentTwo animal studies, one species, higher doses and physiological dosesExcellent resultsOne animal study, second speciesExcellent resultsHuman clinical to determine bioavailability Q3 2008

  • Vitamin B1218B12 Market Segments (existing)Food fortification (lower doses)Nutritional supplement (at or well above RDA requirement)Injection (aggressive higher doses)B12 Market Segment Access PotentialFood 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)

  • Vitamin B1219B12 Market ValuesFood fortification (TBD)Nutritional supplements500-600 million tablets purchased by an estimated 5 million peopleInjection40 million injections, which we estimate could equate to over 1.0 billon well absorbed, high concentration tablets

  • Vitamin B1220Commercial AccessEmphasis on development and regulatory pathways and not commercial avenues to each segmentPreliminary Market ResearchOngoing qualitative survey of prescribing/ recommending physicians in northeast and southeastExtremely high level of acceptance for solid oral formulation that worksPreliminary information indicate significant shift in behavior

  • Vitamin B12 Next Steps21Proceed with human clinical trial to determine bioavailabilityOnce determined, Emisphere could have the first oral solid formulation of B12 that provides any B12 level to a wide variety of individualsNeed to then decide on what is the required level for which individual populationContinue with plans to file the NDI during Q3 2008Continue with plans to achieve conditional GRAS status during Q3-Q4 2008

  • Vitamin B12 Next Steps22Continue with plans to introduce higher concentrations as Medical FoodPlan 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 researchContinue with identification of other potential eligen nutrients

  • Partnerships and Ongoing Cash Concerns23Closing high-value partnerships requires demonstration of value with technology in proof of principle in animals (minimum)Targeting two for mid-yearWould help alleviate cash concern Would allow room to continue to develop B12 and commercialize technology, driving value

  • Partnerships and Ongoing Cash Concerns24Drafts are a result of months of discussion and data generationOngoing discussion with multiple companies about numerous projectsIf 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 useOur goal is to now move several steps forward and begin to drive value

  • Conclusion25We said we would assess the technology and we now have a sound understanding of this area along with compatibility and criteria for molecule selectionWe said we would assess the organization and we have and reorganized under a new management teamWe said we would eliminate distractions and, for the most part, we haveWe said we would get a grip on costs and we have, reducing the burn rate by at least 34% at present

  • Conclusion26We 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 setWe said we would bring in high value partnerships, and I believe we willUnfortunately, there was little in place to attract high-value partnerships only 12 months ago, and that has been rectifiedWe are intending to commercialize the technology and we believe we have a real potential avenue with B12, but we need to complete the development

  • Conclusion27Commercializing 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 mannerA substantial effort is ongoing to drive value and to establish an organization that can grow and thrive with the correct infrastructure

  • Thank You28Much 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