Post on 28-Jul-2015
Management Presentation
Roberto BelliniPresident and Chief Executive Officer
Twitter: @rbellini
Annual General Meeting 2015
Forward-Looking Statements
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Certain statements contained in this presentation, other than statements of fact that are independently
verifiable at the date hereof, may constitute “forward-looking statements” within the meaning of Canadian
securities legislation and regulations. Such statements, based as they are on the current expectations of
management, inherently involve numerous important risks, uncertainties and assumptions, known and
unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks factors include but are not
limited to: the ability to obtain financing, the impact of general economic conditions, general conditions in the
pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which BELLUS Health
Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due
to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity
agreements and contingent value rights, achievement of forecasted clinical trial milestones, dependence on
Auven Therapeutics for the completion of the KIACTA™ Phase III Confirmatory Study and that actual results
may vary once the final and quality-controlled verification of data and analyses has been completed. In
addition, the length of the KIACTA™ Phase III Confirmatory Study is dependent upon many factors, including
patient drop-out rate and occurrence of clinical endpoint events, and the sharing of proceeds between Auven
Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ is dependent upon a
number of factors, including the quantum of proceeds.
Consequently, actual future results and events may differ materially from the anticipated results and events
expressed in the forward-looking statements. BELLUS Health Inc. believes that expectations represented by
forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove
to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included
in this presentation. These forward-looking statements speak only as of the date made, and BELLUS Health
Inc. is under no obligation and disavows any intention to update publicly or revise such statements as a result
of any new information, future event, circumstances or otherwise, unless required by applicable legislation or
regulation. Please see BELLUS Health Inc.’s public filings with the Canadian securities regulatory authorities,
including the Annual Information Form, for further risk factors that might affect BELLUS Health Inc. and its
business.
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30 millionpeople in the United States have a RARE disease.
Source: NIH: National Institutes of Health Office of Rare Diseases
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Only about 5%of these people have a specific therapy
to treat their disease.
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85-90%of rare diseases are serious or life threatening.
Regulatory advantage
Premium pricing
Market protection
Smaller clinical trials
Efficient commercialization
strategies
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Small patient numbers, BIG opportunity
Increasing Number of Orphan Drug Launches…
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0
20
40
60
80
100
120
2006-2008 2009-2011 2012-2014
Rare Disease Non-Rare Disease
U.S. Drug Launches of New Molecular Entities
Source: IMS
…Grabbing Increasing Share of Pharma Market
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Almost 20% of global drug market will come from rare disease drug
sales by 2020
Worldwide Orphan Drug Sales & Share of Prescription Drug Market (2000-20)
Source: EvaluatePharma® (27 OCT 2014)
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At BELLUS, we are focused on developing drugs for rare
diseases starting with conditions that affect the kidneys.
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Strong Team
Diverse Product Pipeline
Focused Business Model
Develop rare
disease drugs
and
Deliver
shareholder value
Diverse Product Pipeline
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Diverse pipeline focused on developing
innovative drugs for rare diseases
Pipeline of Products
Shigamab
sHUS
DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III
KIACTA™
AA amyloidosis
MARKET
AL amyloidosis
KIACTA™
Sarcoidosis
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Patient Profile
Underlying inflammatory
disease causes amyloid
deposition in kidneys
50-60 years old
Median time to dialysis: 8 years
How does KIACTA work?
Inhibits formation of amyloid
fibrils and amyloid deposits
in the kidney
KIACTA™ – Treating AA Amyloidosis Patients
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KIACTA™ - Phase II/III Data
Phase 2/3 data published in
New England Journal of Medicine
publication:
• 42% reduction in risk (p=0.025) of
worsening renal events for Kiacta patients
• “Benefits [of Kiacta] are clinically
meaningful and were evident early in the
course of treatment”
Agreement reached in U.S.,
Europe, Japan to conduct
Phase III Confirmatory Study
• Approval based on achieving
comparable result of first
Phase III Study
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KIACTA - Phase III Confirmatory Study Progress:
Fully enrolled with 261 patients
Completion expected in 2016
KIACTA™ – Addressable Market
Source: Navigant Consulting 2014 16
Estimated Peak Annual Sales
$600 Million-$1Billion
KIACTA Eligible Patients
10-15 Thousand
Expected Pricing
$200-$275 Thousand
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Patient Profile
Idiopathic rare lung condition
Chronic form causes
increasing loss of lung
function and potentially death
Next Steps
Begin proof of concept study
in 2H 2015
Second KIACTA™ Indication - Sarcoidosis
Shigamab – Treating sHUS Patients
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Patient Profile
Triggered by ingestion of toxin producing e.coli
Immune compromised patients: most below <10 years old
Immediate kidney damage and chance of death
How does SHIGAMAB work?
Antibody that binds and neutralizes sHUS toxin
Focused
Business
Model
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Experienced and knowledgeable partner working on lead project
• Biotech private equity group
funding 100% of KIACTA™
project including studies in AA
Amyloidosis and Sarcoidosis
≥ US$70M in investments
• KIACTA™ to be sold either prior
to, or after, Phase III
Confirmatory Study results
Overall proceeds of exit expected
to be shared 50-50
Investment bank Lazard engaged to
explore sale of KIACTA™
Auven Therapeutics Partnership for KIACTA™
PARTNERSHIP
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Financed through KIACTA™ Phase 3 data and exit
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Cash
$12.3M(YE 2014)
Burn Rate<$0.3M /month
Strong
Team
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Shareholder Ownership
Bellini Family ≈ 30%
Power Corporation ≈ 30%
Pharmascience ≈ 10%
Governance and Shareholders
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Board of Directors Company / Experience
Dr. Francesco Bellini
(Chair)
Franklin Berger
Charles Cavell
Hélène Fortin
Pierre Larochelle
Murielle Lortie
Joseph Rus
Dr. Martin Tolar
Roberto Bellini
Management Title
Roberto BelliniPresident and Chief
Executive Officer
Dr. Denis GarceauSenior Vice President,
Drug Development
François Desjardins Vice President, Finance
Tony MatzouranisVice President, Business
DevelopmentLAROSE FORTIN CA Inc.
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Driving
Shareholder
Value
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Potential KIACTA™ exit
Continue executing KIACTA™ for
AA Amyloidosis plan:
Completion of recruitment
Launch of open label extension study
Market assessment
Progress rare disease pipeline projects:
IND filing for KIACTA Phase 2
for Sarcoidosis
Animal studies to support
Shigamab Phase II
Focused on achieving short term milestones that drive
long term value for shareholders
Milestones
Past Execution
Attractive partnership
for KIACTA™
Execution of global
KIACTA™ Phase III
Confirmatory Study
Expansion of rare
disease pipeline
Strong balance sheet
and clean capital
structure
12 Month Milestones
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Management Presentation
Roberto BelliniPresident and Chief Executive Officer
Twitter: @rbellini
Annual General Meeting 2015