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BrainswayInvestor Presentation
July 2015Dr. Guy Ezekiel, President & CEOHadar Levy, CFO
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DisclaimerTHIS 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 SOLELY AS A CONVENIENCE. IN ORDER TO RECEIVE A BROADER VIEW OF BRAINSWAY AND ITSBUSINESS AND THE RISKS TO WHICH THEY ARE EXPOSED, RECIPIENTS OF THIS PRESENTATION HAVE TO REVIEW THE OFFICIAL REPORTS OF BRAINSWAY (PERIODICAL, QUARTERLY AND IMMEDIATE REPORTS) TO THE ISRAELI SECURITIES AUTHORITY (VIA MAGNA) AND THE TEL AVIV STOCK EXCHANGE (VIA MAYA) (THE “OFFICAL REPORTS”). THE INFORMATION CONTAINED IN THIS PRESENTATION IS MATERIALLY SIMILAR TO INFORMATION CONTAINED IN THE OFFICIAL REPORTS, AND DOES NOT INCLUDE ANY MATERIAL NEW INFORMATION. HOWEVER, CERTAIN DETAILS INCLUDED IN THIS PRESENTATION ARE PRESENTED IN A DIFFREENT MANNER IN COMPARISION TO THE OFFICIAL REPORTS. IN ANY CASE OF ANY DISCREPANCY BETWEEN THE INFORMATION CONTAINED HEREIN AND THE INFORMATION CONTAINED IN THE OFFICIAL REPORTS, THE INFORMATION RECORDED IN THE OFFICIAL REPORTS SHALL PREVAIL.
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TO THE FULLEST EXTENT PERMISSIBLE BY LAW, BRAINSWAY, AND ITS RESPECTIVE AFFILIATES, EMPLOYEES AND REPRESENTATIVES EXPRESSLY DISCLAIM ANY AND ALL LIABILITY RELATING TO OR RESULTING FROM THE USE OF THIS PRESENTATION OR ANY INFORMATION GIVEN DURING THIS PRESENTATION OR SUCH OTHER INFORMATION BY A PROSPECTIVE INVESTOR OR ANY OF ITS AFFILIATES OR REPRESENTATIVES.
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Company SnapshotVision To be the global leader in non-invasive brain disorder therapy
Market Size US depression therapeutics market – $15BUS brain disorder drug market – $64B
Technology Deep transcranial magnetic stimulation, covered by 7 family patents
Regulatory FDA cleared for depression, CE Mark for 12 indications (including-Alzheimer’s, Parkinson’s, stroke). Four pivotal multi-center trials underway (conducted according to FDA IDE requirements)
Reimbursement US: ~70% covered
Corporate 70 employees, Israel/US operations
Management Proven track record. Aligned to achieve long-term objectives
Operational activity ~6,000 patients treated to date. Adopted by leading institutions/key opinion leaders worldwide
Revenue (NIS) 2013: 4.2M ; 2014: 12M ; Q1/2015: 5M ; GM: ~80%
Market value (NIS) 460M (July 19, 2015)
Financing (NIS) Q1/2015 cash balance: 61.5M
Listing Since 2007 (TASE: BRIN)3
Management TeamGuy Ezekiel, MD, MBA
President & CEODr. 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 developing innovative
contrast agents for use in X-ray and computed tomography (CT) imaging. Prior to this, Dr. Ezekiel was the General Manager/VP of
Medtronic Ventor Technologies, a wholly owned subsidiary of Medtronic Inc. [NYSE:MDT]. Dr. Ezekiel served as the President and CEO
of Ventor Technologies, developing trans-catheter valves for the cardiology market. Dr. Ezekiel led the company during its acquisition by
Medtronic for $325M, generating investor returns of > X50. Prior to joining Ventor, Dr. Ezekiel was an Executive Director of the CT
business unit at Medrad, Inc., a wholly owned subsidiary of Bayer Healthcare [FWB: BAYN] responsible for annual revenues of ~$250M.
Prior to Medrad, Dr. Ezekiel served as the Marketing & Clinical Director of Ultraguide, a medical device startup specializing in image-
guided systems. Dr. Ezekiel holds an MD degree from Ben-Gurion University and an MBA (cum laude) from the University of Pittsburgh.
Ronen Segal
COORonen Segal serves as the Chief Operating Officer of Brainsway and the Chairman of the Brain Stimulation and Monitoring Technology
(BSMT) consortium. Before that Mr. Segal served as the company’s Chief Technology Officer with more than 20 years of top leadership
roles in various fields including vast hi-tech management experience in a wide range of leading technological groups. In 2004 he co-
founded WiTech Communications Ltd., a company providing wireless video solutions for diverse commercial applications, where he
served as a Vice President. Prior to this, Ronen Segal served as projects leader for OpTun Inc., where he was responsible for the
development of sophisticated fiber-optics communications active switching components. From 1998 to 2000, he worked for the Israeli
Navy's development center on a state-of-the-art submarine data communication system. From 1994 to 1998, Mr. Segal served in the
Israeli Ministry of Defense’s Advanced Technology Unit, where he was responsible for the development and integration of a multi-
disciplinary unmanned aerial vehicle (UAV) system. He studied at the Jerusalem College of Technology as part of a special academic
reserves project in electro-optical Engineering and applied physics.
Hadar Levy, CPA, LLM
Chief Financial OfficerMr. Levy has over 17 years of experience in finance and administration. Prior to joining Brainsway, Mr. Levy served as Finance Manager
in the Latin America Division at Amdocs Ltd., responsible for accounting, financial reporting, treasury, portfolio management and finance
support to Mergers & Acquisitions. Prior to Amdocs, Hadar Levy served as Chief Financial Officer & Business Development Manager of
Notal Vision, a healthcare company that researches and develops medical technologies for detecting retinal malfunction and
deterioration, where he was responsible for all financial functions, and lead financial rounds of equity including M&A activities with
strategic partners. Prior to this position, he served as Controller of GE Healthcare Israel. Mr. Levy began his career at Deloitte LLP, holds
a BA in Accounting and Economics and an LLM degree from Bar Ilan University, and is a Certified Public Accountant.
Amit Ginou
VP Field and Clinical OperationsAmit Ginou manages the field and clinical operations at Brainsway. Prior to this, Amit served as the Clinical Trials Manager at Brainsway,
conducting dozens of clinical trials at different phases to explore the efficacy and safety of Brainsway Deep TMS for diverse clinical
indications. Amit holds a B.Sc. degree in Neuroscience from Bar-Ilan University, and is studying toward an MA degree in Law at Bar-Ilan
University.
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Altered Activity in Different Brain Areas Leads to Different Disorders
Depression Bipolar depression OCD PTSD Schizophrenia Eating disorders Drug addiction Smoking Alcoholism
Psychiatric Disorders
Neurological Disorders
Alzheimer’s disease Parkinson’s disease Autism Chronic pain Stroke Multiple sclerosis Epilepsy Tourette Blepharospasm ADHD
Oncology
Chemotherapeutic agents cannot effectively crossthe blood-brain barrier
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Pain$20 Bn
5%Respiratory
Disease$22 Bn
6%
Autoimmune$22 Bn
6%
Diabetes$32 Bn
9%
Oncology$33 Bn
9%
Other Therapeutic Classes$181 Bn
48%
Mental Health$23 Bn
(Antidepressants, antipsychotics)
Multiple Sclerosis$14 Bn
ADHD$10 Bn
CNS Disorders$10 Bn
(Parkinson’s, Epilepsy)
Alzheimer’s$7 Bn
Brain Disorders$64 Bn
17%
Source: IMS Institutes for Health Informatics. Medicines Use and Spending Shifts.A Review of the Use of Medicines in the United States in 2014
Brain Disorder Therapy: A Huge Market Opportunity
Total US Drug Market in 2014:$374 Billion
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Major Depression, A Huge Market Opportunity
Patients who fail medical treatment stand to benefit significantly from deep TMS treatment
In any given year there are 15 million Americans who suffer from a major depressive episode
A clear unmet needCurrent drug treatment is suboptimal
High economic burdenVery high prevalence
A huge market opportunity
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Rapidly changing electrical currents induce magnetic fields that can produce an effective local electric field in the brain, leading to axonal depolarization and action potentials.
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The rate of dissipation of the electric field is significantly reduced by the coil’s unique design. Brainsway proprietary coils optimize TMS therapy and allow for deep stimulation of the brain.
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Deeper structures have significantly more connections with other reward system sites compared to superficial structures, thus allowing for better treatment results. ) PFC structures have significantly
with other reward system sites compared to superficial (dorsal) PFC (animal1-4 and human5-7 studies).
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Brainsway Deep TMS Technology
Prefrontal cortex
Nucleus accumbens
Ventral tegmental area
Deep TMS
Conventional TMS
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The Brainsway Deep TMS Procedure
Specific coil for each indication
Enables treatment of various
brain disorders
Platform Technology
(Exchangeable helmets)
Non-invasive
No anesthesia
Well-tolerated
Each treatment session lasts approximately 20 minutes
Typical treatment protocol: 4 weeks of 3-5 sessions per week
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Double-blind, randomized, controlled study for the treatment of major depressive disorder (MDD)
22 centers
212 patients treated
Subjects were medication-free MDD patients who failed one or more antidepressant drug trials, or did not tolerate at least two antidepressant drugs
Patients and investigators masked with randomization ratio = 0.5
Similar patients receiving only antidepressants had much lower Remission/Response rates (According to STAR*D trial, only 13.7% of patients not responding to two medications, were remitted upon 3rd medication trial)
Major Depression, Multicenter Trial
32.6%
38.4%
28%
30%
32%
34%
36%
38%
40%
Remission Response
Remission Response
Week-5 Remission and Response Rates
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Severe, Treatment Resistant, Major Depression
• Published at the World Journal of Biological Psychiatry (2014)
• Patient population: Severe treatment-resistant major depression who failed to respond to at least three anti-depressant trails in the current episode
• Augmenting antidepressant with Deep Transcranial Magnetic stimulation. A 4-week open label trial
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41.20%
70.62%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Remission Response
Remission Response
weeks 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Sessions a week
The trial protocol
46.15%
81.12%
26.92%
71.56%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Results
response
remmision
Harel et al. The World Journal of Biological Psychiatry, 2011.
End of trialEnd of acute phase
Major Depression– 4 week Acute Treatment Followed by 18-Week Maintenance Therapy
Response
Remission
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OCD
• 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 investigational product in the USA
• Pivotal trial, under FDA IDE requirements is underway
• Data presented at the, Society of Biological Psychiatry annual meeting 2015
Sham Active
5-week clinical trial
Obsessive Compulsive Disorder (OCD), Feasibility Clinical Trial
Brainsway Deep TMS, Clear Competitive Edge
Non-invasive treatment
Targets deeper brain structures, which are crucial for effective treatment
Physician not required for therapy
Strong clinical data
Broad reimbursement coverage (70% of US population)
Vigorously adopted by luminary sites & key opinion leaders such as : Harvard Medical School, Columbia University, Mount Sinai Hospital, UCLA, and many more
Higher throughput and superior efficacy
New indications underway
Prefrontal cortex
Nucleus accumbens
Ventral tegmental area
Deep TMS
Conventional TMS
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Strategic Plan
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Transforming Brainsway
(3) Sustain superiority
(2) Grow sales & penetrate key markets
(1) From ‘start-up’ to growth
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(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 & marketing
Going direct in US market –expanding installed base and driving higher utilization
Exploring strategic partnerships
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(2) Grow Sales and Penetrate Market – US Market
Completed:
In process:
Hiring Chief Medical Officer and GM for Brainsway USA Working with reimbursement policy makers Working with patient advocacy groups to establish
relationships and build referral network and general support Recruiting additional field personnel Increasing utilization through marketing efforts Leveraging the lease model and adding a direct sales model Line of credit for customers Collecting and analyzing post marketing data Enhancing relationships with key opinion leaders “We are better!” – Market education on two key factors:
Clinical benefit & higher throughput (vs. competitors)
Established US HQ Go direct Established back office and warehouse
Brainsway commercial system deployment in the US
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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 Market Future Market
(2) Grow Sales and Penetrate Market – Global Market
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(3) Sustain Superiority
• No other competitor with as many US pivotal trials
• Brainsway platform – will enable us to:
Start selling additional helmets
Increase utilization
Sustain our position as the superior clinical platform
Four multicenter trials underway
• Feasibility clinical trials (i.e. Alzheimer’s, Parkinson’s, stroke, epilepsy, chronic pain )
• Allow us to expand into new modalities
• True multi-disciplinary TMS centers
Exploring new indications
• Very strong multi-disciplinary R&D team
• Next-generation neuromodulation products
New R&D programs will broaden our
capabilities
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Patient recruitment
interim analysis N=106
Patient recruitment,
statistical analysis
Local IRB approval & SIV's, patient recruitment
Local IRB approval & SIV's,patient recruitment, interim analysis N=80
Patient recruitment
Patient recruitment Statistical analysisFDA
submission
Smoking Cessation (N=235)
PTSD(N=166)
Bipolar Depression
(N=236)
OCD(N=98)
Multicenter Studies
Statistical analysis
FDA submission
FDA submission
FDA submission
2018201720162015
Upcoming FDA submissions create significant opportunity
(3) Sustain Superiority
Patient recruitment,
statistical analysis
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Multi-channel program• Pioneering technology• Opens up opportunity for even more applications
Future robust system• Only TMS manufacturer actively pursuing pivotal
trials in several clinical indications• Platform technology: exchangeable helmets for
multiple clinical indications• Increased utilization and revenue opportunities
Crossing the BBB (blood-brain barrier)• Chemotherapeutic agents have limited ability to
cross the BBB and thus their effectiveness is hampered
• Deep TMS can unlock the huge, untapped CNS drug delivery market
• Opportunity to partner with Pharma companies
Ch1: Low
frequency
(inhibition)
Ch2: High
Frequency
(facilitation)
(3) Sustain Superiority
Permeability Maps
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TMS Centers
, drug addiction, alcoholism, gambling addiction
Oncology
Blood-brain barrier opening
Neurology, , ,
, , autism & Asperger’s, ADHD, epilepsy, migraine, tinnitus, blepharospasm
Psychiatry
, , , , schizophrenia, Tourette, eating disorders
Brainsway’s 4-Tiered Expansion Model
2015
2030
Oncology
Neurology
Psychiatry
FDA-cleared & CE-marked
CE-marked 25
Summary
Brainsway has a new management team, which is fully aligned and prepared to achieve its long-term objectives
Brainsway is well prepared to capitalize on its investments and is fully committed to its shareholders
Clinically and economically validated technology. Accepted by thought-leaders and considered breakthrough technology
Brainsway is transforming from the R&D/early launch phase to a full commercial phase
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