bellus corporate presentation fall final

23
Corporate Presentation (TSX: BLU) FALL 2013 Roberto Bellini President and Chief Executive Officer Twitter: @rbellini FALL 2013

Upload: bellushealth

Post on 25-Jun-2015

532 views

Category:

Health & Medicine


0 download

TRANSCRIPT

Page 1: Bellus corporate presentation fall final

Corporate Presentation (TSX: BLU)

FALL 2013

Roberto BelliniPresident and Chief Executive OfficerTwitter: @rbellini

FALL 2013

Page 2: Bellus corporate presentation fall final

Forward Looking Statement

Certain 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

2

achievement of forecasted burn rate, and that actual results may vary once the final andquality-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

Page 3: Bellus corporate presentation fall final

30 millionpeople in the United States have a RARE disease.

3Source: NIH: National Institutes of Health Office of Rare Diseases

Page 4: Bellus corporate presentation fall final

Only about 5%of these people have a specific therapy to treat their disease.

4

Page 5: Bellus corporate presentation fall final

5

85-90%of rare diseases are serious or life threatening.

Page 6: Bellus corporate presentation fall final

Regulatory advantage

Premium pricing

Market protection

Small patient numbers, Big opportunity

Market protection

Smaller clinical trials

Efficient commercialization strategies

6

Page 7: Bellus corporate presentation fall final

At BELLUS, we are focused on developing drugs for rare At BELLUS, we are focused on developing drugs for rare

7

At BELLUS, we are focused on developing drugs for rare At BELLUS, we are focused on developing drugs for rare diseases starting with conditions that affect the kidneys.diseases starting with conditions that affect the kidneys.

Page 8: Bellus corporate presentation fall final

OVERVIEW CAP STRUCTURE

Shareholder Information

Public company (TSX: BLU) based in Montreal, QC

Developing drugs for rare

Shares outstanding (Fully Diluted): 65M

Cash1 (06/30/13): ~$17M

Operations funded into midOperations funded into mid--201820188

diseases

Late-stage product pipeline with fully funded business plan

Burn rate (monthly): <$300K

Shareholder makeup: 70% institutional, 30% retail

1Pro forma Thallion acquisition

Page 9: Bellus corporate presentation fall final

Pipeline of Products

DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III

KIACTA™

AA amyloidosis

MARKET

NonNon--core assets in memory protection (core assets in memory protection (nutraceuticalnutraceutical generating generating

cashflowcashflow) and Alzheimer’s disease (Phase 1)) and Alzheimer’s disease (Phase 1)9

Shigamabs

sHUS

Page 10: Bellus corporate presentation fall final

Lead Phase III Product Candidate

A rare and deadly

FOR AMYLOID A (AA)

AMYLOIDOSIS

10

A rare and deadly kidney disease with no specific treatment

Page 11: Bellus corporate presentation fall final

Disease and Mechanism of Action

SERUM AMYLOID APRECURSOR (SAA) PROTEIN

AA PROTEIN + GLYCOSAMINOGLYCANS(GAGs)

REDUCTION IN FIBRIL FORMATION & DEPOSITION

KIACTA blocksAA + GAGs interaction

11

CHRONIC INFLAMMATION

ORGAN DAMAGE, IN PARTICULAR TO KIDNEYS LEADING TO DIALYSIS

Converts toAA Protein

Generatescytokine cascade

(TNFα / IL-1 / IL-6) and increases SAA levels

Rheumatic ConditionsInflammatory Bowel DiseaseChronic InfectionsFamilial Mediterranean Fever

Systemic Amyloid A Fibril Formation & Deposition

Page 12: Bellus corporate presentation fall final

Market

KIACTA™ peak annual revenues

projected at $400-

Patient population approximately 34,000-50,000 in the United States, Europe Top 5 and Japan1

Strong potential for premium pricing

121Market assessment by Frankel Group (April 2009)

projected at $400-600 million1

pricing

Market exclusivity through orphan drug designation (7-10 years) and intellectual property (up to 2031)

Page 13: Bellus corporate presentation fall final

With global fund AuvenTherapeutics, private equity group specialized in drug development project financing

US$10M in upfront by AuvenTherapeutics

≥ US$50M in investments by Auven Therapeutics

Strategic Partnership

FINANCIAL IMPLICATIONPARTNERSHIP

Partnership to fund Phase III Confirmatory Study with significant Partnership to fund Phase III Confirmatory Study with significant

upside for BELLUS shareholdersupside for BELLUS shareholders

financing

Auven Therapeutics funding 100% of KIACTA™’s Phase III Confirmatory Study

Proceeds of eventual exit expected to be shared 50-50

13

Page 14: Bellus corporate presentation fall final

30

35

40

45

50

Placebo

KIACTA

Num

ber o

f Wor

se E

vent

s

*

Strong Clinical Results in First Phase III Study

Landmark study in AA Amyloidosis: 183 patientstreated for 2 years

Important benefits for patients on drug:

0

5

10

15

20

25

Composite Endpoint (Time to

First Worse Event)

Doubling Serum

Creatine

50%DecreaseCreatine

CIearance

Dialysis/ESRD

Num

ber o

f Wor

se E

vent

s

14

*

**

patients on drug:

Statistically significant reduction in number and risk of reaching worsening kidney event

Important delay in reaching dialysis

*p<0.05 **p<0.01

Page 15: Bellus corporate presentation fall final

Regulatory

2007 NEJM publication by concludes that KIACTATM slows decline of renal function in AA Amyloidosis

Agreement reached with

15

FDA, EMEA and Japanese PMDA to conduct Phase III Confirmatory Study

Approval based on achieving comparable result of first Phase III Study

Page 16: Bellus corporate presentation fall final

230 patients in ~25 countries

150+ of 230 patients enrolled

Trial to complete when 120 of 230 patients reach event of kidney

Phase III Confirmatory Study

patients reach event of kidney function deterioration

Expected to be completed in 2017

16

Page 17: Bellus corporate presentation fall final

Second Rare Disease Product Candidate

FOR STEC RELATED

HEMOLYTIC UREMIC

SYNDROME (SHUS),

17

A rare disease primarily affecting the kidneys of children

SYNDROME (SHUS),

Page 18: Bellus corporate presentation fall final

STEC AND SHUS DISEASE COURSE

Disease Course and Treatment

E.Coli

Colonization & toxin production

Bloody

90-95%

5-10%

Self-resolution

18

E.Coliinfection

Bloodydiarrhea fever

5-10%

SHIGAMABSTREATMENT

Monoclonal antibody neutralizes toxin Expected to improve outcomes including reduced need for dialysis

STEC related Hemolytic Uremic Syndrome (sHUS)

DialysisChronic Kidney DiseaseDeath

Page 19: Bellus corporate presentation fall final

Shigamabs Overview

MARKET OPPORTUNITY

CLINICAL

1,500-2,000 estimated annual cases of sHUS in developed countries, principally children

$100-200 million market opportunity

Safe and well tolerated in target pediatric population

Potential for partnership in 18Potential for partnership in 18--24 months24 months

19

NEXT STEPS (12 MONTHS)Proof of concept for treatment of sHUS in mouse and primate models

Meetings with regulators to agree on development plan

Safe and well tolerated in target pediatric population

Page 20: Bellus corporate presentation fall final

Non-Core Assets

VIVIMINDTM

Commercial nutraceutical approved for memory protection

Growing cash flow positive business with ~$450K in revenue last year

BLU8449

NonNon--core assets with potential upside for shareholderscore assets with potential upside for shareholders20

BLU8449Phase I anti-amyloid product targeting Alzheimer’s disease

Partnered with Asclepios Bioresearch

Page 21: Bellus corporate presentation fall final

Governance and Shareholders

Board of Directors Company / Experience

Dr. Francesco Bellini (Chair)

Franklin Berger

Charles Cavell

Hélène Fortin

Management Title

Roberto BelliniPresident and Chief Executive Officer

Dr. Denis GarceauSenior Vice President, Drug Development

François Desjardins Vice President, Finance

Tony MatzouranisVice President, Business Development

LAROSE FORTIN CA Inc.

Shareholder Ownership

Bellini Family ≈ 30%

Power Corporation ≈ 30%

Pharmascience ≈ 10%

21

Hélène Fortin

Pierre Larochelle

Donald Olds

Joseph Rus

Dr. Martin Tolar

Roberto Bellini

DevelopmentLAROSE FORTIN CA Inc.

Page 22: Bellus corporate presentation fall final

Milestones

Past Execution

Attractive partnership with for Kiacta

Execution of global KIACTA Phase III Confirmatory Study

Acquisition of

Milestones (12 months)Completion of recruitment of KIACTA™ Phase III Confirmatory Study

Additional KIACTA™ activities:

Launch of open label extension study

Market and pricing

Long Term Value

KIACTA™ exit and results of Phase III Confirmatory Study

Shigamabs partnership or proof-of -concept Phase II study

ShortShort--term milestones driving longterm milestones driving long--term valueterm value

22

Acquisition of Shigamabs program

Strong balance sheet and clean capital structure

Market and pricing assessment

Japan orphan drug designation

Divestiture of non-core assets

Expand early stage pipeline for rare diseases

Phase II study

Page 23: Bellus corporate presentation fall final