Elevating
Mental Health
Treatment
Nasdaq/TASE: BWAY
March 2024
Disclaimer
Safe Harbor and Non-GAAP Financial Measures
This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. This presentation shall not constitute advertising or misconstrued as being commercial and/or promotional in nature.
No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herein. In particular, no representation or warranty is given, and the Company has no responsibility, as to the achievement or reasonableness of any forecasts, estimates, or statements as to prospects contained or referred to in this presentation.
This presentation contains information that includes or is based on forward‐looking statements within the meaning of the federal securities law. These statements are not guarantees of future performance, are based on current expectations of future events and are subject to various risks and uncertainties that could cause our actual activities, timing or results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: continued business impact from the COVID-19 global pandemic; weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally; difficulties or delays in manufacturing; legislative and regulatory actions; changes in reimbursement level from third‐party payors; product liability claims; the impact of federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; failure to gain sufficient market adoption of our products; regulatory actions or delays; and our ability to realize anticipated operational and manufacturing efficiencies. Additional information concerning these and other factors, including the Risk Factors set forth therein, is contained in our filings with the U.S. Securities and Exchange Commission.
The forward-looking statements in this presentation are made based upon our current expectations. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements as a prediction of actual results. In addition, the presentation contains certain data and information that we obtained from various government and private publications. Statistical data in these publications also include projections based on a number of assumptions. If any one or more of the assumptions underlying the market data are later found to be incorrect, actual results may differ from the projections based on these assumptions. You should not place undue reliance on these forward-looking statements. All forward-looking statements included in this presentation are made only as of the date of this presentation. We assume no obligation to update any written or oral forward-looking statement made by us or on our behalf as a result of new information, future events or other factors.
Certain non-GAAP financial measures are included in this presentation, which are designed to complement the financial information presented in accordance with IFRS, because management believes such measures are useful to investors. These non-GAAP financial measures should be considered only as supplemental to, and not superior to, financial measures provided in accordance with IFRS. Other companies may calculate similarly titled non-GAAP financial measures differently than the Company.
Corporate Presentation March 2024 | 2 |
BrainsWay at a Glance
Advancing Neuroscience to Improve Health and Transform Lives
- Market leader in TMS
- Cleared in multiple large underserved mental health disorder markets
- Broad reimbursement among commercial and governmental payors
- New indication opportunities and geographic expansion for growth
- Proven, differentiated noninvasive neurostimulation platform technology
- Attractive business model and financial profile
- Superior science, evidence, and support
Corporate Presentation March 2024
3
BrainsWay by the Numbers
Strong Fundamentals for Growth - Turnaround has Begun
$9.0m
Revenue
Q4 2023
1,101
Total Installed Base (*)
as of Q4 2023
600
OCD Systems
as of Q4 2023
Corporate Presentation March 2024
75%
Gross Margin
Q4 2023
160,000+1
Patients Treated
4.8m+ individual treatments
3
Core FDA Clearances
12 CE Clearance
$46.3m
Cash Balance
as of Q4 2023
$0.8M
Adjusted EBITDA
Q4 2023
Positive Operating & Net income
35+
Completed Clinical Trials
340+ Deep TMS publications
4
Continuum of Care for Depression and OCD
Massive Underserved Markets
Major Depressive Disorder
21m
Clinical Depression Sufferers/year2 60-90% comorbid anxiety symptoms3
7m
Treatment-Resistant Patients who do NOTachieve remission after 4 courses
of medications & psychotherapy4
Deep TMSTM
(Transcranial Magnetic Stimulation)
ECT
(Electroconvulsive Therapy)
Primary Care /
Psychiatry
Intensive /
Interventional
Psychiatry
Obsessive-Compulsive Disorder
3m
Obsessive-Compulsive Disorder
Sufferers/year2
1.5m
Treatment-Resistant Patients who do NOTrespond to any medications or psychotherapy5-7
Deep TMSTM
(Transcranial Magnetic Stimulation)
Intensive Program
(Intensive Outpatient, Residential, Hospitalization)
Invasive & Experimental | Surgery |
(e.g. Deep Brain Stimulation) |
Invasive & Experimental
(e.g. Deep Brain Stimulation) | 5 |
Transcranial Magnetic Stimulation (TMS)
Established Technology with Demonstrated Safety and Efficacy
Comprehensively Studied
Over 20,000 published papers on TMS8
How Does it Work?
- An electromagnetic coil is placed over the scalp
- A fast current is produced in the coil
- Electromagnetic field is induced in the brain
- These fields activate neural activity
Corporate Presentation March 2024 | 6 |
Evolution of TMS
TMS has Been Used for >35 Years with BrainsWay Pioneering Key Innovations
George et al. | Traditional TMS | BrainsWay | BrainsWay | ||||
first to | is cleared by the | is first TMS | expands | ||||
demonstrate | FDA for | device to | depression | ||||
antidepressant | treatment- | receive FDA | indication for | ||||
effects of | resistant | clearance for | Anxious | ||||
repetitive TMS | depression | OCD | Depression | ||||
1985 | 1995 | 2000 | 2008 | 2013 | 2018 | 2020 | 2021 |
Barker | Roth & Zangen | BrainsWay | BrainsWay is | ||||
performs | invent the | receives FDA | first TMS device | ||||
motor cortex | H-Coil, which | clearance for | to receive FDA | ||||
stimulation | stimulates deep | Deep TMS | clearance for | ||||
with TMS | brain structures, | therapy for | Smoking | ||||
in collaboration | Depression | Addiction | |||||
with the NIH | |||||||
Corporate Presentation March 2024 | 7 |
BrainsWay Delivers Proven Records
Deep TMS Therapy Has Significant Appeal to Providers and Patients
Noninvasive | No Anesthesia | Well-Tolerated | ~3 to 20 Minute | Easy to | Strong |
Technology | Required | by Patients | Sessions | Administer | Reimbursement |
Corporate Presentation March 2024 | 8 |
BrainsWay Deep TMS Advantages over Traditional TMS1
BrainsWay's Clinical Advantages are Clear and Compelling
BrainsWay Deep TMS
1.8 to 2.0 cm9,10
Extensive - 17 cm10
More Reliable Targeting
Deep and Broad | |
Deep TMS H1 Coil | RCT Data in Multiple Indications |
Depth
Brain Volume
Stimulated
Therapy
Delivery
Structures
Treated
Platform Technology
Traditional TMS
0.7cm to 1.0cm9
Limited - 3 cm10
Prone to Targeting Errors
Superficial and Focal
RCT Data Limited to Depression
in the commercial
depression space use
variations of the
traditional "figure-8"
TMS coil design
Deep TMS activates more neurons and reduces likelihood of targeting errors
9
Robust Platform Technology
Multiple Clearances and Significant Market Expansion Potential
Anterior Cingulate Cortex | Bilateral Insula | ||
| OCD | | Smoking Addiction |
| Post-Stroke Rehabilitation* | | Parkinson's Disease* |
Left Dorsolateral Prefrontal Cortex | Motor Cortex | |
Depression/Anxious Depression | | Multiple Sclerosis* |
| Chronic Pain* |
Corporate Presentation March 2024
~$11B of Total Addressable Market in current FDA- cleared indications11
- Depression / Anxious Depression
- OCD
- Smoking Addiction
*Indicates conditions still being researched. Not cleared by the FDA for safety and efficacy.
10
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Brainsway Ltd. published this content on 18 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 March 2024 12:39:01 UTC.