Brainsway Ltd · TASE:BWAY
Brainsway — Investor Presentation (2016)
33 slides from Brainsway's investor presentation, 2016
Slide 1: Deep Transcranial Magnetic Stimulation
בס"ד TASE:BRIN Deep Transcranial Magnetic Stimulation
Slide 2: Disclaimer
בס"ד TASE:BRIN Disclaimer • THIS PRESENTATION OF BRAINSWAY LTD. (“BRAINSWAY”) DOES NOT PURPORT TO BE ALL-INCLUSIVE OR TO CONTAIN INFORMATION PERTAINING TO THE SUBJECT MATTER HEREOF AND MAY NOT BE RELIED UPON FOR MAKING ANY COLLABORATION DECISION WITH RESPECT TO BRAINSWAY. • THE INFORMATION PROVIDE
Slide 3: Agenda for Discussion
TASE:BRIN Agenda for Discussion 1 Introduction 2 Deep TMS Technology 3 Major Depression, Proven Efficacy and Safety with Superior Results 4 Major Depression, Business Opportunity 5 Growth Strategy and Execution Plan 6 Summary 3 Deep TMS
Slide 4: Brainsway Snapshot
בס"ד TASE:BRIN Brainsway Snapshot The need & technology Mental illness is widespread and Pharmacotherapy for brain Deep TMS: a unique patented undertreated disorders is often therapeutic neuromodulatory Deep TMS: Highly effective inadequate modality treatment Platform FDA cleared for depression Br
Slide 5: Our Vision
בס"ד TASE:BRIN Our Vision To be the global leader in non-invasive brain disorder therapy Deep TMS
Slide 6: Management Team
בס"ד TASE:BRIN Management Team David Zacut, MD Chairman of the Board and acting CEO Dr. Zacut has served as Brainsway's Chairman of the Board of Directors since the company's inception, and has been providing consulting services to Brain Research Services since May 2001. Since 1983, Dr. Zacut has
Slide 7: Major Depression Disorder (MDD), A Huge Unmet Need
TASE:BRIN בס"ד Major Depression Disorder (MDD), A Huge Unmet Need Very high prevalence In any given year there are 15 million Americans who suffer a major depressive episode US depression A clear unmet need Fail to respond to 1st Current drug treatment is therapeutics line treatment Fail to achiev
Slide 8: Agenda for Discussion
בס"ד TASE:BRIN Agenda for Discussion 1 Introduction 2 Deep TMS Technology 3 Major Depression, Proven Efficacy and Safety with Superior Results 4 Major Depression, Business Opportunity 5 Growth Strategy and Execution Plan 6 Summary 3 Deep TMS
Slide 9: Treatment Options for Treatment Resistant Depression (TRD)
TASE:BRIN בס"ד Treatment Options for Treatment Resistant Depression (TRD) Electroconvulsive therapy (ECT) Effective Rapid onset Requires hospitalization and anesthesia Severe side effects (memory loss, nausea, mood changes and headaches) Negative stigma attached Electroconvulsive therapy
Slide 10: Brainsway Deep TMS Technology
TASE:BRIN בס"ד Brainsway Deep TMS Technology 1 Rapidly changing electric field in the brain, leading to axonal depolarization and action potentials. 2 Brainsway proprietary coils optimize TMS therapy and allow for deep stimulation of the brain. 3 The deeper and broader field produced by the H1-coi
Slide 11: fMRI Demonstrates Superiority of Deep TMS
בס"ד TASE:BRIN fMRI Demonstrates Superiority of Deep TMS Figure-8 effect on task-related activation (relative to sham) Deep TMS effect on task-related activation (relative to sham) Deep TMS modulates task-related activity to a greater degree than either figure-8 or sham coils. Importantly, this mo
Slide 12: Deep TMS Procedure and Platform System
TASE:BRIN בס"ד Deep TMS Procedure and Platform System Non-invasive No anesthesia Well-tolerated Each treatment session lasts approximately 20 minutes Typical treatment protocol: 4 weeks of 3-5 sessions per week Platform technology for a variety of indications Deep TMS
Slide 13: Agenda for Discussion
בס"ד TASE:BRIN Agenda for Discussion 1 Introduction 2 Deep TMS Technology 3 Major Depression, Proven Efficacy and Safety with Superior Results 4 Major Depression, Business Opportunity 5 Growth Strategy and Execution Plan 6 Summary 3 Deep TMS
Slide 14: Brainsway MDD Multicenter Trial
TASE:BRIN בס"ד Brainsway MDD Multicenter Trial Double-blind, randomized, controlled study Trial Protocol Acute Treatment for the treatment of Major Depressive 5 sessions per week 4 weeks Disorder (MDD) Maintenance 22 medical centers worldwide 2 sessions per week 12 weeks 212 treatment-resist
Slide 15: Major Depression – 4-Week Acute Treatment Followed by 18-Week Maintenance Therapy
TASE:BRIN Major Depression– 4-Week Acute Treatment בס"ד Followed by 18-Week Maintenance Therapy The trial protocol Sessions per week Weeks 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Results 90% 80% 81.1% 70% 71.6% 60% response Response 50% remmision 46.2% 40% Remission 30% 26.9% 20%
Slide 16: Agenda for Discussion
בס"ד TASE:BRIN Agenda for Discussion 1 Introduction 2 Deep TMS Technology 3 Major Depression, Proven Efficacy and Safety with Superior Results 4 Major Depression, Business Opportunity 5 Growth Strategy and Execution Plan 6 Summary 3 Deep TMS
Slide 17: Everybody Wins
בס"ד TASE:BRIN Everybody Wins Patients Physicians Researchers Insurance MDD patients are Healthcare Brainsway’s research Deep TMS treatment getting the best professionals are able activities. Four multi- reduces direct and treatment with a rapid to treat their patients center studies as well as in
Slide 18: Over 240 Million Covered Lives in US
בס"ד TASE:BRIN Over 240 Million Covered Lives in US Insurance Coverage of TMS Depression Therapy Over 85% of US population 75% of Medicare beneficiaries Deep TMS
Slide 19: Reimbursement Is Past The Tipping Point
בס"ד TASE:BRIN Reimbursement Is Past The Tipping Point Deep TMS
Slide 20: How Do We Partner?
TASE:BRIN How Do We Partner ? בס"ד Customer’s Lease Buy perspective Cost per procedure Minimal (patient cap) Minimal (patient cap) Procedures/Sessions Unlimited Unlimited Cost of device Annual lease One time purchase Service Included Included only for 1st year Brainsway’s objective: Penetrate the
Slide 21: Agenda for Discussion
בס"ד TASE:BRIN Agenda for Discussion 1 Introduction 2 Deep TMS Technology 3 Major Depression, Proven Efficacy and Safety with Superior Results 4 Major Depression, Business Opportunity 5 Growth Strategy and Execution Plan 6 Summary 3 Deep TMS
Slide 22: Transforming Brainsway
בס"ד TASE:BRIN Transforming Brainsway Sustain superiority New indications ,Dual Channel, New breakthrough neuromodulation technologies Grow sales & penetrate key markets Focus commercial efforts on MDD in main markets From ‘start-up’ to growth Establish Processes, Efficiency, Build commercial expe
Slide 23: Recent Commercial Efforts, Showing to be Effective
בס"ד TASE:BRIN Recent Commercial Efforts, Showing to be Effective Shifted focus from R&D to a balanced approach with greater emphasis on sales & marketing Focus on main approved indication – MDD Established US HQ & Went direct New management team Hired additional field personnel Drivin
Slide 24: Why Stop At Depression?
בס"ד TASE:BRIN Why Stop At Depression? Alzheimer’s - PFC PTSD - PFC Smoking & Alcohol - Insula Psychiatry ADHD - PFC Neurology Parkinson's disease - PFC, MDD - DLPFC MC MCI- PCC Autism - Medial PFC Multiple sclerosis - MC Bipolar disorder - PFC OCD - ACC Schizophrenia - PFC Epilepsy - Temporal cor
Slide 25: A Strong and Diverse Clinical Pipeline
בס"ד TASE:BRIN A Strong and Diverse Clinical Pipeline Observed Clinical Outcome Deep TMS
Slide 26: 5-year Project Timeline
בס"ד TASE:BRIN 5-year Project Timeline Clinical Studies Multicenter trial, under FDA guidelines Interim analysis OCD N=98 FDA evaluation/approval/launch Smoking Cessation N=235 (Interim=62) PTSD N=166 (Interim=80) Bipolar Depression N=236 2016 2017 2018 2019 2020 Jan Jul Deep TMS
Slide 27: Strong R&D Pipeline
בס"ד TASE:BRIN Strong R&D Pipeline Ch1: High Ch2: Low • Multi-channel stimulator frequency (facilitation) frequency (inhibition) • Breakthrough in TMS treatment • Patent-protected • Allows treatment of the most complicated brain disorders • Combined synchronized differential activation of differen
Slide 28: Brainsway's 4-Tiered Expansion Model
TASE:BRIN Brainsway’s 4-Tiered Expansion Model בס"ד TMS Centers 2030 , drug addiction, alcoholism, gambling addiction Brain Drug Delivery Blood-brain barrier opening Neurology , , , , , autism & Asperger’s, epilepsy, migraine, tinnitus, blepharospasm Psychiatry , , , , schizophrenia, ADHD, Tourett
Slide 29: Agenda for Discussion
בס"ד TASE:BRIN Agenda for Discussion 1 Introduction 2 Deep TMS Technology 3 Major Depression, Proven Efficacy and Safety with Superior Results 4 Major Depression, Business Opportunity 5 Growth Strategy and Execution Plan 6 Summary 3 Deep TMS
Slide 30: Balance Sheet – As of September 30, 2015
TASE:BRIN בס"ד Balance Sheet – As of September 30, 2015 Balance Sheet • Cash Balance - NIS 49M Consolidated Statements of Financial Position • Current Assets - NIS 60M As of September December 30, 31, (NIS in thousands) 2015 2014 Cash and cash equivalents 45,390 67,130 Short-term deposits 4,262 4,
Slide 31: Financial Statements – As of September 30, 2015
TASE:BRIN בס"ד Financial Statements – As of September 30, 2015 Income Statements 9 months period ended 3 months period ended Year ended September September September September December June 30, 30, 30, 30, 30, 31, (NIS in thousands) 2015 2014 % 2015 2014 % 2015 % 2014 Revenues 17,669 8,049 120% 7,
Slide 32: Highlights
בס"ד TASE:BRIN Highlights Proven and proprietary Deep TMS technology FDA clearance and reimbursement (>70% of US population) for major depressive disorder Compelling business model Commercial team in place to capitalize on the growing MDD Deep TMS opportunity Healthy quarter-over-quarter
Slide 33: Deep TMS Remission Accomplished
TASE:BRIN בס"ד Deep TMS Remission Accomplished