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Corporate presentation september 2012 v final

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  • v2
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    • 1. Corporate PresentationRoberto BelliniPresident and Chief Executive OfficerSeptember 2012
    • 2. Forward Looking StatementCertain statements contained in this presentation, other than statements of fact that areindependently verifiable at the date hereof, may constitute forward-looking statements. Suchstatements, based as they are on the current expectations of management, inherently involvenumerous risks and uncertainties, known and unknown, many of which are beyond BELLUSHealth Inc.s control. Such risks include but are not limited to: the ability to obtain financingimmediately in current markets, the impact of general economic conditions, general conditionsin the pharmaceutical and/or nutraceuticals industry, changes in the regulatory environment inthe jurisdictions in which the BELLUS Health Group does business, stock market volatility,fluctuations in costs, and changes to the competitive environment due to consolidation,achievement of forecasted burn rate, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed.Consequently, actual future results may differ materially from the anticipated results expressedin the forward-looking statements. The reader should not place undue reliance, if any, on anyforward-looking statements included in this news release. These statements speak only as ofthe date made and BELLUS Health Inc. is under no obligation and disavows any intention toupdate or revise such statements as a result of any event, circumstances or otherwise, unlessrequired by applicable legislation or regulation. Please see the Company’s public fillingsincluding the Annual Information Form of BELLUS Health Inc. for further risk factors that mightaffect the BELLUS Health Group and its business 2
    • 3. Background and Business Model Public company (TSX: BLU) based in Montreal, QC Focused namely on the development of products in amyloid- related fields, principally AA Amyloidosis, an orphan indication affecting the kidneys Late-stage product pipeline BUSINESS MODEL Focused on building value for clinical stage health products in critical unmet medical needs 3
    • 4. Pipeline of ProductsPHARMACEUTICALS DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III NDA/MAAKIACTA™AA amyloidosisBLU8499Alzheimer’sdisease COMMERCIANUTRACEUTICAL DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III -LIZATIONVIVIMIND™Memory protection 4
    • 5. KIACTA™ For AA Amyloidosis, an orphan indication and a deadly disease with no treatment Orphan population of ≈50,000 in the USA, Europe Market and Japan with peak annual revenues projected at opportunity $400-600M1 1 Independent market assessment by Frankel Group in April 2009. Phase II/III clinical trial showing statistically Clinical significant primary efficacy endpoints evidence (p value = 0.025) and clean safety profile Partnership with Celtic Therapeutics to conduct Partnership and finance Phase III Confirmatory Study Marketing approval based on confirming safety Phase III and efficacy of phase II/III studyConfirmatory Study Actively recruiting patients 5
    • 6. AA Amyloidosis Rare and life-threatening disease Associated with chronic inflammatory diseases  65% of patients are rheumatoid arthritis patients AA protein accumulates in major organs, mainly kidneys, leading to:  Rapid and significant deterioration of kidney function, and  Eventual progress to dialysis Kiacta slows the deterioration of kidney function by preventing amyloid A protein fibril formation, accumulation and deposition  Orally bioavailable small molecule Na+-03S S03-Na+ 6
    • 7. KIACTA™ - Targeted Opportunity Patient population estimated at 34-50,000 in the U.S., EU5 and Japan1Diagnosed AA Patients (000s) Clear pharmacoeconomic rationale for premium pricing KIACTA™ peak annual revenues projected at $400-600M1 (U.S., EU5, Japan) Orphan Drug Status in the U.S. and EU provides 7 and 10 years market exclusivity upon commercialization, respectively 1 Independent market assessment by Frankel Group in April 2009 7
    • 8. KIACTA™ - Strategic PartnershipPARTNERSHIP FINANCIAL IMPLICATION With global fund Celtic US$10M in upfront payments Therapeutics ≥ US$35M in investments by Celtic Therapeutics funding Celtic Therapeutics 100% of KIACTA™’s confirmatory phase III clinical Proceeds of any eventual trial transaction expected to be shared 50%-50% between Auction process for the BELLUS Health and Celtic commercialization rights of Therapeutics KIACTA™ on completion of Phase III clinical trial 8
    • 9. KIACTA™ - Robust Clinical Results in Phase II/III Statistical significant on primary endpoint (p value <0.05) and clinically meaningful treatment effect (42% reduction in risk)  Calculated 2-year delay to dialysis for patients on KIACTATM Number of Relative Risk Clean safety profile N=183 Events Kiacta Placebo HR 95% C.I. P value Agreement with FDA/EMEA for confirmatory phase IIIPrimarycomposite clinical trialendpoint 29 45 0.58 0.37, 0.93 0.025(First “worse”event)  Marketing approval based on positive result (p value <0.05)Doubling SCr 9 17 0.41 0.19, 0.86 0.019 from confirmatory study with50% decrease CrCl 19 31 0.48 0.28, 0.82 0.008 same scope of first phase IIIDialysis/ESRD 7 13 0.54 0.22, 1.37 0.20 clinical trialDeath 5 5 0.95 0.27, 3.29 0.94 9
    • 10. KIACTA™ - Confirmatory Phase III Study CONFIRMATORY PHASE IIICOMPLETED PHASE II/III STUDY STUDY 183 patients in 13 countries 230 patients in 28 countries Statistically significant composite Composite primary endpoint primary endpoint (p=0.025) (target p<0.05) based on patients principally based on patients reaching kidney function events: reaching kidney function events:  80% increase serum creatinine  Doubling serum creatinine  40% decrease in creatinine  50% decrease in creatinine clearance clearance  Reaching ESRD/dialysis  Reaching ESRD/dialysis  Death Event driven trial to conclude on attainment of 120 events (~90% Fixed treatment duration of 2 power) years Key improvements made to increase robustness of confirmatory study 10
    • 11. KIACTA™ - Study Progress Recruitment1 Completion >70 sites in 26 Event driven trial to countries actively complete on reaching recruiting 120 events 90 patients enrolled Study expected to be completed in 2H 2015 Recruitment expected to be completed in 2H 2013 Patient baseline characteristics and demographics to date are similar to those in the first Phase III study 1 Data as of May 10, 2012 11
    • 12. KIACTA™ - Providing Base Value AUCTION DEVELOPMENT LOW RISK PROCESS WITH COST FULLYCONFIRMATORY EQUALLY FUNDED BYPHASE III STUDY SHARED CELTIC PROCEEDS + SIGNIFICANT SHAREHOLDER VALUE BASE 12
    • 13. BLU8499 (previously NRM8499) Next generation of tramiprosate intended for the treatment of Alzheimers disease Large and growing epidemic currently affecting Market over 30M patients worldwide opportunity Represents > $180B in annual costs in the United States alone Evidence of effectiveness of parent compound Clinical tramiprosate in ApoE4+ Alzheimer’s patients Evidence Safe and well tolerated in Phase I 13
    • 14. BLU8499 – Asclepios Partnership Partnership with Asclepios Bioresearch in September 2012 to finance development of BLU8499 Partnership Investment of ~$4M in non-dilutive capital Parties expected to share any future proceeds approximately equally Long term toxicity testing expected to be completed in 2013Development Phase IIa proof of concept study in mild apoE4+ Plan Alzheimer’s disease patients Expected to begin at end of 2013 Focused development plan to demonstrate effectiveness in targeted patient population 14
    • 15. VIVIMIND™ Nutraceutical for memory protection Canada: Protects the hippocampusHealth Claims Italy: Enhances cognitive function and memory Regulatory approval in Italy obtained in 2009 Regulatory NPN number issued by Health Canada in 2010 Approval Partnerships for Italy, Canada, Greece, Middle East and IsraelPartnerships Pursuing efforts to conclude additional partnerships in other territories: creating a distributor network worldwide Growing cash flow positive business 15
    • 16. Financial Position and Capital Structure Capital Structure Basic Shares Outstanding 47M Fully Diluted Shares Outstanding1 61M Financial Position Cash (as of June 30th, 2012) >$21M Burn Rate (monthly) <$300K Strategic financing completed with Pharmascience in May 2012 $17.25M total investment: $8.15M in non-dilutive capital and $9.1M for 10.4% stake Operations funded beyond 2016  Kiacta Phase 3 data expected in 2015  Additional funds can be used for new potential projects Does not include stock option grants 16 1
    • 17. Governance and ShareholdersBoard of Directors Company / Experience Management TitleDr. Francesco Bellini President and Chief Roberto Bellini(Chair) Executive Officer Senior Vice President, Dr. Denis GarceauFranklin Berger Drug Development François Desjardins Vice President, FinanceCharles Cavell Vice President, Business Tony Matzouranis DevelopmentHélène Fortin LAROSE FORTIN CA Inc.Pierre Larochelle Shareholder OwnershipDonald Olds Bellini Family ≈ 30%Joseph Rus Power Corporation ≈ 30%Dr. Martin Tolar Pharmascience ≈ 10%Roberto Bellini 17
    • 18. Milestones 2012 Milestones Past Execution Long Term Value Financing Attractive Continued execution of Results of confirmatory partnership with KIACTA Confirmatory phase phase III clinical trial Celtic for Kiacta III clinical trial: and auction of KIACTA™ Execution of global Launch of Japan sites Kiacta Phase III and receipt of Japanese Sale or spin-out of confirmatory study orphan drug designation nutraceutical business Building cashflow Partnership for NRM8499 for NRM8499 Phase 2 positive VIVIMIND Phase 2 study study results business Financial partner with no shareholder dilution Large regional partnership for VIVIMIND™ Short-term milestones driving long-term value 18

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