BELLUS Health — Investor Presentation (March 2023)
38 slides from BELLUS Health's investor presentation, Mar 21, 2023
Slide 1: Investor Presentation
Investor Presentation NASDAQ/TSX - BLU March 21 st , 2023
Slide 2: Forward Looking Statements
Forward Looking Statements 2 Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the dat e h ereof, may constitute "forward - looking statements" within the meaning of Canadian securities legislation and regulations, the U.S. Private
Slide 3: Company Overview
ls) Bellus Company Overview
Slide 4: BELLUS Health – Working to Better the Lives of Patients Suffering from Persistent Cough
BELLUS Health – Working to Better the Lives of Patients Suffering from Persistent Cough Financials Key Upcoming Events Lead Indication - Refractory Chronic Cough (RCC) • Persistent cough >8 weeks that does not respond to treatment for underlying condition or is unexplained • Compelling results from
Slide 5: Strong Leadership and Advisory Group
Strong Leadership and Advisory Group Management Board of Directors Clinical Advisory Board Dr. Surinder Birring, MB ChB (Hons), MD King’s College London Dr. Michael S. Blaiss, MD Medical College of Georgia Dr. Peter Dicpinigaitis, MD Albert Einstein Medical College Dr. Jacky Smith (Chair) , MB, ChB,
Slide 6: Refractory Chronic Cough
Refractory Chronic Cough Cough lasting ≥ 8 weeks that does not respond to treatment for underlying cause or is unexplained 1 No approved treatment , current options are inadequate and non - specific 3 Significant impact on patients ’ quality of life, including impact on social, physical and psychoso
Slide 7: P2X3 Receptor – Validated Target for Refractory Chronic Cough
P2X3 Receptor – Validated Target for Refractory Chronic Cough and Linked to Other Cough Indications • Afferent neurons in peripheral nervous system express P2X3 receptor 1 - 6 • Activation of P2X3 triggers neuronal hypersensitization 7,8 and can play an important role in urge to cough signalling pat
Slide 8: Camlipixant (BLU-5937) - Best-In-Class Potential
Camlipixant (BLU - 5937) - Best - In - Class Potential 8 Compelling efficacy from SOOTHE Phase 2b trial completed in December 2021 Well - tolerated with a low rate of class - related taste side effects Twice daily dosing with once - daily dosing in development camlipixant Highly potent oral P2X3 ant
Slide 9: Camlipixant (BLU-5937) - Pipeline
Camlipixant (BLU - 5937) - Pipeline 9 PROGRAM DEVELOPMENT STATUS Indication / Project Preclinical Phase 1 Phase 2 Phase 3 Worldwide Rights Next Anticipated Step Camlipixant Refractory Chronic Cough (BID Formulation) 2H 2024: CALM - 1 Topline Results 2025: CALM - 2 Topline Results Refractory Chronic
Slide 10: SOOTHE Phase 2b Results
ls) Bellus SOOTHE Phase 2b Results
Slide 11: SOOTHE Trial Design
SOOTHE Trial Design 11 Randomized, double - blind, 4 - week placebo - controlled parallel arm study with 3 active doses PRIMARY ENDPOINT Placebo - adjusted change from baseline in 24H cough frequency (Day 28) POPULATION Refractory chronic cough for ≥1 year Awake cough frequency: ≥25 coughs/h 249 par
Slide 12: SOOTHE: Primary Efficacy Endpoint
SOOTHE: Primary Efficacy Endpoint Placebo - Adjusted Change in 24H Cough Frequency 12 34% placebo - adjusted reduction in 24 - hour cough frequency at 50 mg and 200 mg BID doses (p ≤ 0.005) Dose response observed between 12.5 mg and 50 mg BID doses -60 -40 -20 0 20 40 60 Dose Δ p - value 12.5 mg - 2
Slide 13: SOOTHE: Change from Baseline in 24H Cough Frequency
-60.0% -50.0% -40.0% -30.0% -20.0% -10.0% 0.0% Placebo 12.5 mg BID 50 mg BID 200 mg BID Relative change from baseline in 24H cough frequency (ITT) Baseline Day 15 Day 28 SOOTHE: Change from Baseline in 24H Cough Frequency 13 Percentage change in 24H cough frequency 53% reduction from baseline in 24
Slide 14: SOOTHE: Responder Rates in 24H Cough Frequency
36% 14% 7% 52% 35% 19% 61% 44% 25% 62% 48% 19% 0% 10% 20% 30% 40% 50% 60% 70% 80% ≥ 30% ≥ 50% ≥ 70% Placebo BLU-5937 12.5 mg BID BLU-5937 50 mg BID BLU-5937 200 mg BID Day 28 12.5 mg BID 50 mg BID 200 mg BID -1 1 3 5 7 9 11 13 15 p=0.0865 p=0.0077 p=0.0080 ≥ 30% -1 1 3 5 7 9 11 13 15 p=0.0147 p=0.00
Slide 15: SOOTHE: Secondary Endpoints
SOOTHE: Secondary Endpoints Patient Reported Outcomes (PRO): Cough Severity Visual Analog Scale (CS - VAS) and Leicester Cough Questionnaire (LCQ) Clinically meaningful and statistically significant benefit of camlipixant (BLU - 5937) at multiple time points in patient reported outcomes LCQ: scale o
Slide 16: SOOTHE: Safety and Tolerability
SOOTHE: Safety and Tolerability 16 Generally well - tolerated S imilar rate of treatment emergent adverse events (TEAEs) reported for placebo and camlipixant (BLU - 5937) n (%) Placebo (n= 63) Camlipixant 12.5 mg BID (n= 62) Camlipixant 50 mg BID (n= 62) Camlipixant 200 mg BID (n= 62) Subjects with
Slide 17: SOOTHE: Low Taste-Related Adverse Events Associated to P2X3 Class
SOOTHE: Low Taste - Related Adverse Events Associated to P2X3 Class 17 Low rate of taste disturbance adverse events at all doses (≤ 6.5%) with: • No loss of taste • No discontinuations due to taste disturbance INCIDENCE OF TASTE DISTURBANCE ADVERSE EVENTS Placebo (n= 63 ) Camlipixant 12.5 mg BID (n=
Slide 18: CALM Phase 3 Program
HEALTH ls) Bellus CALM Phase 3 Program
Slide 19: Ongoing CALM Program: Study Design
Run In 25 mg BID — n≈225 50 mg BID — n≈225 Placebo BID — n≈225 Run In 25 mg BID — n≈225 50 mg BID — n≈225 Placebo BID — n≈225 Ongoing CALM Program: Study Design Two randomized, double - blind, placebo - controlled parallel arm trials with 2 active doses 19 POPULATION • Refractory/unexplained chronic
Slide 20: Ongoing CALM Program: Enrichment Strategy
Ongoing CALM Program: Enrichment Strategy 20 CALM - 1 and CALM - 2 populations to be enriched for baseline cough frequency PRIMARY EFFICACY ENDPOINT: COUGH FREQUENCY IN PRIMARY POPULATION (90% POWER) • 24H cough frequency vs placebo in Primary Population SECONDARY EFFICACY ENDPOINTS (80% POWER ) • L
Slide 21: Ongoing CALM Phase 3: VitaloJAK Cough Monitoring System
VitaloJAK is the cough recording and counting system used to capture the 24H cough frequency data in most cough trials • Used in camlipixant (BLU - 5937) and gefapixant RCC trials The Company conducted validation work on VitaloJAK • Validation work consisted of comparing compressed vs non - compress
Slide 22: Market and Competitive Landscape
Market and Competitive Landscape
Slide 23: The Market for Refractory Chronic Cough in Key Regions
The Market for Refractory Chronic Cough in Key Regions 23 CHRONIC COUGH patients in key geographies • ~ 10% prevalence in the U.S. & Europe - 5 1 • ~ 4% prevalence in China • Refractory chronic cough patients represent an important segment of the chronic cough population 1 : REFRACTORY CHRONIC COUGH
Slide 24: P2X3 Competitive Landscape
24 P2X3 Competitive Landscape 1 Company Candidate Gefapixant Sivopixant Camlipixant (BLU - 5937) Stage of Development Approved in Japan, Switzerland EU/US Under Review Phase 2b Phase 3 Expected Next Steps Submit additional information in U.S./EU in 1H 2023 * Evaluating Next Steps ** CALM - 1 topline
Slide 25: First-in-Class P2X3 Antagonist, Merck's MK-7264 (gefapixant)
First - in - Class P2X3 Antagonist, Merck’s MK - 7264 ( gefapixant ) 25 18% & 15 % Cough 1 MK - 7264 58% & 69% Taste AEs 1 Placebo - adjusted reduction in 24H cough frequency (primary endpoint) of patients have taste alteration and/or taste loss Two Phase 3 Trials of gefapixant: COUGH - 1 (12 week d
Slide 26: Shionogi's S-600918 (sivopixant)
Shionogi’s S - 600918 (sivopixant) 26 12 % Cough 1 Sivopixant 33% Taste AEs 1 Placebo - adjusted reduction in 24H cough frequency (primary endpoint) of patients with taste alteration and/or taste loss Phase 2b Trial (4 week duration) 300mg QD Selective P2X3 antagonist Three doses tested with none ac
Slide 27: Camlipixant Well-Positioned for Potential Class Differentiation
Camlipixant (BLU - 5937) Well - Positioned for Potential Class Differentiation Source: Bellus Health, BLU - 5937 Commercial Opportunity Assessment Criteria • Treatment effect vs. placebo • Taste effects • Positive Phase 2b results with potential best - in - class profile • Best - in - class selectiv
Slide 28: U.S. Commercialization Strategy
U.S. Commercialization Strategy
Slide 29: Established Unmet Need and Willingness to Rx in RCC with Specialists
91 % 29 25 M 8.6 M Chronic Cough Refractory Chronic Cough Established Unmet Need and Willingness to Rx in RCC with Specialists 2 Source: ZS Associates/Bellus Health Market Research (2022) 1. All - comer survey (n=1483) of US Pulmonologists (n= 289) , Allergists (n= 207) , Otolaryngologists (n= 217)
Slide 30: Solid Foundation for U.S. P2X3 Market Success
30 EXPECTED BY LAUNCH OF CAMLIPIXANT (BLU - 5937) EXISTS NOW High Treatment Rate Medical Education Awareness & Guidelines Payer Track Record of Reimbursing Poor Quality - of - Life Conditions Prescription Patterns and Physician Experience with P2X3 Intent to Use P2X3 P2X3 Pricing and Access Establis
Slide 31: Early U.S. Commercialization Strategy
31 • Leverage potential best - in - class profile to target P2X3 naïve and first - generation switchers / discontinuations • 150 - 175 sales representatives targeting top 30% respiratory specialists • Multichannel consumer outreach, referral, and telemedicine platforms • Achieve optimal payer access
Slide 32: Camlipixant Potential Additional Indications
Camlipixant (BLU - 5937) Potential Additional Indications
Slide 33: Cough Hypersensitivity In Additional Cough Indications
Cough Hypersensitivity In Additional Cough Indications 33 Success of SOOTHE supports potential evaluation of camlipixant (BLU - 5937) in other cough populations Cough is an important health burden • Across the U.S. in 2018, cough was the reason for 1 : - 18.5M in - office physician consultations - 5
Slide 34: IP and Corporate Summary
ls) Bellus IP and Corporate Summary
Slide 35: 100% Owned Intellectual Property Portfolio
100% Owned Intellectual Property Portfolio 35 N N X N R 1 R 3 O N O R 9 R 2 R 4 R 6 R 5 R 8 R 7 • All intellectual property 100% owned by BELLUS with no future obligations owed • U.S. and international patent estate covering camlipixant and related compounds • Composition of matter patent for camlip
Slide 36: Stock and Financial Information
Stock and Financial Information 36 126.6M basic shares 138.9M fully diluted shares CAPITAL STRUCTURE Cash, cash equivalent and short - term investments position of US$337.1M* CASH POSITION * Cash position as of December 31, 2022
Slide 37: Potential Catalysts & Upcoming Events
EXPECTED MILESTONES Potential Catalysts & Upcoming Events 37 Camlipixant (BLU - 5937) in Refractory Chronic Cough Camlipixant Platform CALM - 1 & CALM - 2 trial initiations (Q4 2022) Topline results from CALM - 1 (2H 2024) Topline results from CALM - 2 (2025) Once - daily extended release formulatio
Slide 38: Investor Contact
Investor Contact: Ramzi Benamar CFO [email protected]