Brainsway Ltd · TASE:BWAY
Brainsway — Investor Presentation (July 2015)
27 slides from Brainsway's investor presentation, July 2015
Slide 1: Brainsway Investor Presentation
Brainsway Investor Presentation Dr. Guy Ezekiel, President & CEO July 2015 Hadar Levy, CFO 1
Slide 2: Disclaimer
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 PROVIDED HERERIN IS PROVIDED
Slide 3: Company Snapshot
Company Snapshot Vision To be the global leader in non-invasive brain disorder therapy Market Size US depression therapeutics market – $15B US brain disorder drug market – $64B Technology Deep transcranial magnetic stimulation, covered by 7 family patents Regulatory FDA cleared for depression, CE Ma
Slide 4: Management Team
Management Team Guy Ezekiel, MD, MBA President & CEO Dr. Guy Ezekiel has held a variety of managerial positions at both start-up and Fortune 500 companies in Israel and the United States. Prior to joining Brainsway, Dr. Ezekiel was the President & CEO of Marval Pharma, a clinical-stage company devel
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Slide 6: Altered Activity in Different Brain Areas Leads to Different Disorders
Altered Activity in Different Brain Areas Leads to Different Disorders Oncology Chemotherapeutic agents cannot effectively cross Psychiatric Disorders the blood-brain barrier Depression Bipolar depression OCD PTSD Neurological Disorders Schizophrenia Eating disorders Alzheimer’s diseas
Slide 7: Brain Disorder Therapy: A Huge Market Opportunity
Brain Disorder Therapy: A Huge Market Opportunity Total US Drug Market in 2014: $374 Billion Mental Health $23 Bn Other Therapeutic (Antidepressants, antipsychotics) Classes $181 Bn 48% Brain Disorders Multiple Sclerosis $64 Bn $14 Bn 17% ADHD $10 Bn CNS Disorders $10 Bn (Parkinson’s, Epilepsy) Onco
Slide 8: Major Depression, A Huge Market Opportunity
Major Depression, A Huge Market Opportunity Very high prevalence High economic burden In any given year there are 15 million Americans who suffer from a major depressive episode A huge market opportunity A clear unmet need Current drug treatment is suboptimal Patients who fail medical treatment stan
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Slide 10: Brainsway Deep TMS Technology
Brainsway Deep TMS Technology Rapidly changing electrical currents 1 induce magnetic fields that can produce an effective local electric field in the brain, leading to axonal depolarization and action potentials. The rate of dissipation of the electric 2 field is significantly reduced by the coil’s
Slide 11: The Brainsway Deep TMS Procedure
The Brainsway Deep TMS Procedure 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 (Exchangeable helmets) Enables treatment of various brain disorders Specific coi
Slide 12: Major Depression, Multicenter Trial
Major Depression, Multicenter Trial Week-5 Remission and Response Rates Double-blind, randomized, controlled study for the 40% treatment of major depressive disorder (MDD) 38.4% 38% 22 centers 36% 212 patients treated 34% 32.6% 32% Subjects were medication-free MDD patients who failed one or
Slide 13: Severe, Treatment Resistant, Major Depression
Severe, Treatment Resistant, Major Depression 80% 70.62% 70% • Published at the World Journal of 60% Biological Psychiatry (2014) 50% 41.20% 40% • Patient population: Severe treatment- resistant major depression who failed to 30% respond to at least three anti-depressant 20% trails in the current ep
Slide 14: Major Depression – 4 Week Acute Treatment Followed by 18-Week Maintenance Therapy
Major Depression– 4 week Acute Treatment Followed by 18- Week Maintenance Therapy The trial protocol Sessions a 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% 81.12% 70% 71.56% 60% response Response 50% remmision 46.15% 40% Remission 30% 26.92% 20% 10% 0% End of
Slide 15: Obsessive Compulsive Disorder (OCD), Feasibility Clinical Trial
Obsessive Compulsive Disorder (OCD), Feasibility Clinical Trial OCD 5-week clinical trial • Affects 1% of US adult population or 2.2 million annually • ~35% seek treatment • 400,000 remain resistant to conventional therapies • CE Mark approved, and an Sham Active investigational product in the USA •
Slide 16: Brainsway Deep TMS, Clear Competitive Edge
Brainsway Deep TMS, Clear Competitive Edge Non-invasive treatment Targets deeper brain structures, which are crucial for effective treatment Physician not required for therapy Prefrontal Strong clinical data cortex Broad reimbursement coverage (70% of US population) Vigorously adopted by
Slide 17: Strategic Plan
Strategic Plan 17
Slide 18: Transforming Brainsway
Transforming Brainsway (3) Sustain superiority (2) Grow sales & penetrate key markets (1) From ‘start-up’ to growth 18
Slide 19: (1) From 'Start-up' to Growth
(1) From ‘Start-up’ to Growth Professional staff led by a seasoned management team Operational and process efficiency across all functions Prioritization – deploying finite resources to maximum advantage Shifting focus from R&D to a balanced approach with greater emphasis on sales & marketin
Slide 20: (2) Grow Sales and Penetrate Market – US Market
(2) Grow Sales and Penetrate Market – US Market Completed: Brainsway commercial system deployment in the US Established US HQ Go direct Established back office and warehouse In process: Hiring Chief Medical Officer and GM for Brainsway USA Working with reimbursement policy makers Working
Slide 21: (2) Grow Sales and Penetrate Market – Global Market
(2) Grow Sales and Penetrate Market – Global Market Initial focus on US market ROW: • Distribution agreements in key markets • Support field on the ground • Enhance relationships with key opinion leaders • Japan: Complete clinical trial to allow launch • China: Seek strategic partnership Current Mar
Slide 22: (3) Sustain Superiority
(3) Sustain Superiority • No other competitor with as many US pivotal trials • Brainsway platform – will enable us to: Four multicenter trials Start selling additional helmets underway Increase utilization Sustain our position as the superior clinical platform • Feasibility clinical trials (i.
Slide 23: (3) Sustain Superiority
(3) Sustain Superiority Multicenter Studies 2015 2016 2017 2018 Local IRB OCD approval & SIV's, Patient recruitment, FDA (N=98) patient statistical analysis submission recruitment Smoking Patient recruitment Patient recruitment, FDA Cessation interim analysis N=106 statistical submission (N=235) ana
Slide 24: (3) Sustain Superiority
(3) Sustain Superiority Ch1: Low Ch2: High frequency Frequency (inhibition) (facilitation) Multi-channel program • Pioneering technology • Opens up opportunity for even more applications Crossing the BBB (blood-brain barrier) Permeability Maps • Chemotherapeutic agents have limited ability to cross
Slide 25: Brainsway's 4-Tiered Expansion Model
Brainsway’s 4-Tiered Expansion Model TMS Centers 2030 , drug addiction, alcoholism, gambling addiction Oncology Blood-brain barrier opening Neurology , , , , , autism & Asperger’s, ADHD, epilepsy, migraine, tinnitus, blepharospasm Psychiatry , , , , schizophrenia, Tourette, eating disorders 2015 FDA
Slide 26: Summary
Summary Brainsway is transforming Clinically and economically from the R&D/early launch validated technology. phase to a full commercial Accepted by thought-leaders and considered phase breakthrough technology Brainsway has a new Brainsway is well prepared to management team, which is capitalize on
Slide 27: Thank you !
Thank you ! Hadar Levy, CFO T: +972-2-582-4030 M: +972-54-5699133 hadarl@brainsway.com