midastouch017
3月前
BrainsWay Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights
Q4 Revenue Grew 27% Year-Over-Year to Record $14.5 Million
Q4 Operating Income of $1.9 Million; Adjusted EBITDA Increased by 53% to $2.3 Million, Reflecting Significant Operating Leverage
Full Year 2025 Revenue Increased by Approximately 27% YoY to $52.2 Million, and Net Income Increased by Approximately 161% YoY to $7.6 Million
Remaining Performance Obligations Increased 43% to Approximately $70 Million
Issuing 2026 Guidance: Expecting Revenue of $66 - $68 million (27% - 30% Growth), Operating Income of 13% - 14%, and Adjusted EBITDA of $12 - $14 Million (86% - 100% Growth)
Conference Call to be Held Today at 8:30 AM ET
BURLINGTON, Mass. and JERUSALEM, March 11, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported fourth quarter and full year 2025 financial results and provided an operational update.
Recent Financial and Operational Highlights
Revenue in the fourth quarter of 2025 increased 27% to $14.5 million, compared with the fourth quarter of 2024.
Approximately 70% of customer engagements signed in recent quarters are structured as multi-year lease agreements.
Increased remaining performance obligations to approximately $70 million, representing a 43% increase compared with December 31, 2024.
Shipped a net total of 95 Deep TMS™ systems during the fourth quarter of 2025, a 27% increase compared with the same period last year. Total installed base now stands at approximately 1,700 systems.
Gross margin for the fourth quarter of 2025 was 76%, compared with 75% in the prior year period.
Operating income for the fourth quarter of 2025 was $1.9 million, compared with $0.4 million for the prior year period.
Adjusted EBITDA1 for the fourth quarter of 2025 increased 53% to $2.3 million, compared with $1.5 million for the fourth quarter of 2024.
Net income for the fourth quarter of 2025 increased 90% to $2.9 million, compared with $1.5 million for the fourth quarter of 2024.
U.S. Food and Drug Administration (FDA) granted label expansion for the Deep Transcranial Magnetic Stimulation (Deep TMS™) system making the treatment available as an adjunct therapy for adolescents aged 15 to 21 years suffering from major depressive disorder (MDD).
Launched a multicenter clinical trial investigating the use of the new Deep TMS 360™ system in individuals with Alcohol Use Disorder (AUD), which represents a major economic and health burden, affecting about 29 million Americans.
Secured the first insurer coverage for the accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) Deep TMS protocol following FDA clearance.
FDA approved Neurolief’s wearable Proliv™Rx neuromodulation system, a Class III device, as an adjunctive treatment for adult patients suffering from MDD who have failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in the clinic.
Full Year 2025 Financial Highlights
Full year 2025 revenue of $52.2 million, a 27% increase as compared with full year 2024.
Gross margin for the full year 2025 was 75%, flat compared with the prior year.
Operating income for the full year 2025 was $4.3 million, compared with $1.4 million in the prior year.
Net income for the full year 2025 increased by 161% to $7.6 million, compared with $2.9 million for the prior year.
Adjusted EBITDA for the full year 2025 was approximately $7.0 million, compared with $4.5 million for the prior year.
As of December 31, 2025, cash, cash equivalents, and restricted cash totaled $68.0 million.
Full-Year 2026 Financial Guidance
The Company expects full-year 2026 revenue of $66 million to $68 million, which represents growth of 27% to 30% compared with revenue for 2025.
The Company anticipates continued profitability and positive cash flow, targeting operating income of 13% to 14% and Adjusted EBITDA of $12 to $14 million.
_____________________
1 See Adjusted EBITDA details and reconciliation table in the appendix below.
“We successfully closed out 2025 with strong momentum across our business, delivering 27% full-year revenue growth while significantly expanding profitability,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Demand for Deep TMS continues to accelerate, supported by expanding customer adoption, additional regulatory clearances, and growing reimbursement coverage. The FDA’s recent clearance expanding Deep TMS MDD treatment to adolescents aged 15 to 21, and its clearance of our accelerated Deep TMS MDD protocol, represent meaningful growth catalysts for 2026 and beyond. In addition, our investment in Neurolief has the potential to significantly expand our addressable market and create new growth opportunities.”
“In parallel with our strong operational execution, we are executing a targeted investment strategy focused on providing growth capital to leading mental health networks. These minority equity positions support clinical expansion while helping accelerate awareness and adoption of innovative therapies. We are seeing real increases in demand for interventional psychiatry solutions like Deep TMS within these networks. As we enter 2026, we have a strong balance sheet and remain focused on extending our reach, strengthening our clinical leadership, and building long-term value for patients, providers, and shareholders,” concluded Mr. Levy.
Call and Webcast
BrainsWay’s management will host a conference call on Wednesday, March 11, 2026, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Wednesday, March 11, 2026, at 8:30 AM Eastern Time:
United States: 1-877-300-8521
International: 1-412-317-6026
Israel:
Conference ID: 1-80-921-2373
10206784
Webcast: Link
The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.
Non-IFRS Financial Measures
In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating profit and net profit, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net profit adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses.
In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:
Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired.
Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results.
Adjusted EBITDA, however, should not be considered as an alternative to operating profit (loss) or net profit (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company’s net profit (loss) and Adjusted EBITDA is presented in the attached summary financial statements.
Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net profit (loss) and our IFRS financial results.
midastouch017
6月前
BrainsWay to Host Virtual Analyst & Investor Day to Discuss the Company’s Growth Strategy and Deep TMS™ Treatment December 1, 2025
https://finance.yahoo.com/news/brainsway-host-virtual-analyst-investor-123000785.html
BURLINGTON, Mass. and JERUSALEM, Nov. 25, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that it will host a virtual Analyst & Investor Day on Monday, December 1, 2025 at 10:00 AM ET, during which company management will highlight various aspects of BrainsWay’s growth strategy. The event will feature Owen Scott Muir, MD, DFAACAP (Co-Founder, Chief Medical Officer, Radial), who will discuss the significant unmet need for various conditions and his clinical experience utilizing Deep TMS™, and Michael Gershenzon, CEO of Stella MSO, a management services organization servicing more than 20 mental health clinics across the U.S. and Israel, who will discuss his experience working with BrainsWay on BrainsWay’s strategic minority-stake investment in Stella. To register, click here.
The event will provide an overview of BrainsWay’s patented breakthrough treatment, Deep TMS, and the potential impact of its accelerated protocol. Deep TMS is a clinically proven, noninvasive in-office brain stimulation treatment that uses magnetic fields to activate neural networks in the brain to improve symptoms of certain mental health and addiction conditions, including depression, obsessive-compulsive disorder, and smoking addiction.
A live question and answer session will follow the formal presentations.
About Owen Scott Muir, MD, DFAACAP
Owen Scott Muir, MD, DFAACAP, is a dual-board-certified child, adolescent, and adult psychiatrist and the Chief Medical Officer of Radial Health and Neurolief. He is a leading investigator in advanced neuromodulation, with work spanning deep-TMS (H-coil platforms), accelerated protocols, vocal, video, language, and oculomotor biomarkers, and multimodal precision psychiatry. Dr. Muir has served as principal or co-investigator on trials involving BrainsWay, Magnus, Ampa, Psyrin, Videra, iRxReminder, Mind Medicine, and other cutting-edge technologies. His clinical programs have pioneered real-world deployment of accelerated neuromodulation for adolescents and adults with severe depression, OCD, suicidality, and treatment-resistant conditions. He is also the author of The Frontier Psychiatrists newsletter (2.5m reads), TikTok (8m views/year), LinkedIn (1m impressions/year with 7.7.% engagement rate) and the popular press Inessential Pharmacology, and continues to publish on the integration of AI-augmented neurotherapeutics into routine care.
midastouch017
2年前
BrainsWay Reports Third Quarter 2024 Financial Results and Operational Highlights
https://finance.yahoo.com/news/brainsway-reports-third-quarter-2024-123000415.html
Robust 26% Year-over-Year Revenue Growth in Q3 2024
Raising Full-Year 2024 Revenue Guidance to $40-41 Million and Initiating Profitability Guidance
Conference Call to be Held Today at 8:30 AM ET
BURLINGTON, Mass. and JERUSALEM, Israel, Nov. 12, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported third quarter 2024 financial results and provided an operational update.
Recent Financial and Operational Highlights
For the three months ended September 30, 2024, revenues were $10.5 million, a 26% increase compared to the same period in 2023.
Gross margin for the third quarter of 2024 was 74%, steady from the same period in 2023.
Operating income for the third quarter of 2024 was $0.3 million, compared to a loss of $0.1 million for the same period in 2023.
Net income for the third quarter of 2024 was $0.7 million, compared to a net loss of $0.2 million for the third quarter of 2023.
Adjusted EBITDA1 for the third quarter of 2024 was approximately $1.1 million, compared to $0.3 million for the third quarter of 2023.
As of September 30, 2024, cash and cash equivalents and short-term deposits totaled $48.4 million, reflecting a $0.3 million increase from June 30, 2024.
Following the end of the third quarter, the Company closed on an equity financing by Valor Equity Partners, receiving gross proceeds of approximately $20 million to date, before deducting offering expenses and before any potential exercise of warrant rights by Valor. BrainsWay intends to leverage this new capital and Valor’s expertise for strategic initiatives aimed at building market awareness, its R&D roadmap, and expanding access to Deep TMS™.
Through the first nine months of 2024, BrainsWay shipped a total of 177 Deep TMS systems, representing a 12% increase from the same period last year.
Israel Ministry of Defense’s Rehabilitation Department approved reimbursement for Deep TMS therapy for qualifying PTSD patients in public hospitals.
Appointed Dr. Richard Bermudes, who is widely considered one of the preeminent U.S. clinicians in the TMS field, as BrainsWay’s new Chief Medical Officer (CMO), effective September 1, 2024.
Expanded U.S. East Coast access to Deep TMS with order of 14 new systems by large enterprise mental health treatment network.
Expanded the presence of Deep TMS in East Asia through the placement of 15 new systems in Taiwan and South Korea.
Continued progress in the Company’s randomized, multicenter U.S. clinical trial evaluating an accelerated treatment protocol for the Deep TMS system for major depressive disorder (MDD) treatment as compared to the current standard-of-care Deep TMS protocol.
________________________
1 See Adjusted EBITDA details and reconciliation table in the appendix below.
Full Year 2024 Financial Guidance
Increasing full-year 2024 revenue guidance to between $40 million to $41 million, which represents 25% to 29% growth over 2023 revenue.
Anticipating continued profitability and positive cash flow, and expecting operating income of 3-4% and Adjusted EBITDA of 10-11% for the full year.
"Global demand for our Deep TMS system continued to grow throughout the first nine months of 2024, strengthening our leadership position in the market. Our focus remains on building sustainable growth by investing strategically in our long-term vision. Our commitment to driving innovation and expanding treatment possibilities is stronger than ever, with key investments across three core areas, including the development of our next-generation Deep TMS 360™ system, conducting clinical trials to broaden and enhance treatment capabilities, and expanding our commercial presence through targeted sales and marketing efforts. These critical investments reflect our dedication to leading the industry in mental health and neurological care, providing impactful and accessible solutions for patients worldwide," said Hadar Levy, BrainsWay’s Chief Executive Officer.
"Our recent private financing with Valor Equity Partners will enable us to explore new markets and revenue channels, including different customer types and commercial partnerships. This will further strengthen our potential for accelerated growth and enhance access to Deep TMS," concluded Mr. Levy.
Call and Webcast
BrainsWay’s management will host a conference call on Tuesday, November 12, 2024, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Tuesday, November 12, 2024, at 8:30 AM Eastern Time:
United States:
1-877-300-8521
International:
1-412-317-6026
Israel:
Conference ID:
1-80-921-2373
10193781
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1693565&tp_key=866e8470ea
The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.
Non-IFRS Financial Measures
In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating income and net income, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net income adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses.
In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:
Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired.
Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results.
Adjusted EBITDA, however, should not be considered as an alternative to operating income (loss) or net income (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company’s net income (loss) and Adjusted EBITDA is presented in the attached summary financial statements.
Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net income (loss) and our IFRS financial results.
About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.
Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com
Investors:
Brian Ritchie
LifeSci Advisors LLC
britchie@lifesciadvisors.com
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
September 30,
December 31,
2024
2023
ASSETS
(Unaudited)
(Audited)
Current Assets
Cash and cash equivalents
$
48,127
$
10,520
Short-term deposits
-
35,465
Restricted cash
271
271
Trade receivables, net
3,521
3,780
Inventory
3,690
3,717
Other current assets
1,720
1,712
57,329
55,465
Non-Current Assets
System components
1,745
1,273
Leased systems, net
3,962
3,700
Other property and equipment
6,795
817
Other long-term assets
2,269
1,717
14,771
7,507
$
72,100
$
62,972
LIABILITIES AND EQUITY
Current Liabilities
Trade payables
$
1,269
$
758
Deferred revenues
4,824
2,504
Liability in respect of research and development grants
600
1,008
Other accounts payable
5,994
5,491
12,687
9,761
Non-Current Liabilities
Deferred revenues and other liabilities
9,038
5,553
Liability in respect of research and development grants
6,347
6,077
15,385
11,630
Equity
Share capital
367
367
Share premium
140,662
140,344
Share-based payment reserve
5,116
4,360
Currency Translation Adjustments
(2,188
)
(2,188
)
Accumulated deficit
(99,929
)
(101,302
)
44,028
41,581
$
72,100
$
62,972
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
U.S. dollars in thousands (except per share data)
For the three months ended
September 30,
For the nine months ended
September 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
Revenues
$
10,502
$
8,302
$
29,602
$
22,756
Cost of revenues
2,781
2,131
7,532
6,018
Gross income
7,721
6,171
22,070
16,738
Research and development expenses, net
1,809
1,544
5,146
5,231
Selling and marketing expenses
4,108
3,602
11,731
12,497
General and administrative expenses
1,523
1,158
4,233
4,153
Total operating expenses
7,440
6,304
21,110
21,881
Operating income (loss)
281
(133
)
960
(5,143
)
Finance income
830
175
1,945
1,583
Finance expenses
374
213
1,182
349
Income (loss) before income taxes
737
(171
)
1,723
(3,909
)
Taxes on income
75
59
350
415
Net income (loss) and total comprehensive income (loss)
$
662
$
(230
)
$
1,373
$
(4,324
)
Basic and diluted net income (loss) per share
$
0.02
$
(0.01
)
$
0.04
$
(0.13
)
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
For the three months ended
September 30,
For the nine months ended
September 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
Cash flows from operating activities:
Total comprehensive income (loss)
$
662
$
(230
)
$
1,373
$
(4,324
)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Adjustments to profit or loss items:
Depreciation and amortization
188
85
308
279
Depreciation of leased systems
260
247
755
719
Impairments and disposals
600
481
1,242
938
Finance expenses (income), net
(456
)
38
(763
)
(1,234
)
Cost of share based payment
388
95
1,057
147
Income taxes
75
59
350
415
Total adjustments to reconcile income (loss)
1,055
1,005
2,949
1,264
Changes in asset and liability items:
Decrease (increase) in trade receivables
415
(31
)
295
1,404
Increase in inventory
(465
)
(373
)
(572
)
(6
)
Decrease (increase) in other current assets
41
369
72
(243
)
Increase (decrease) in trade payables
(366
)
(58
)
514
(639
)
Increase (decrease) in other accounts payable
456
401
(74
)
(356
)
Increase (decrease) in deferred revenues and other liabilities
(52
)
(173
)
1,151
238
Total changes in asset and liability
29
135
1,386
398
Cash paid and received during the period for:
Interest paid
(81
)
(100
)
(104
)
(103
)
Interest received
613
546
2,194
1,586
Income taxes paid
-
-
(994
)
(11
)
Total cash paid and received during the period
532
446
1,096
1,472
Net cash provided by (used in) operating activities:
2,278
1,356
6,804
(1,190
)
Cash flows from investing activities:
Purchase of property and equipment and system components, net
(1,300
)
(514
)
(2,871
)
(1,945
)
Proceeds from sub-lease asset
-
-
40
-
Withdrawal of (investment in) deposits, net
(34
)
8
34,985
(8
)
Net cash provided by (used in) investing activities
(1,334
)
(506
)
32,154
(1,953
)
Cash flows from financing activities:
Repayment of liability in respect of research and development grants
(572
)
-
(1,104
)
(345
)
Exercise of share options
-
-
19
-
Receipt of government grants
-
-
-
32
Repayment of lease liability
(126
)
(56
)
(237
)
(186
)
Net cash used in financing activities
(698
)
(56
)
(1,322
)
(499
)
Exchange rate differences on cash and cash equivalents
17
(69
)
(29
)
(46
)
Increase (decrease) in cash and cash equivalents
263
725
37,607
(3,688
)
Cash and cash equivalents at the beginning of the period
47,864
43,168
10,520
47,581
Cash and cash equivalents at the end of the period
$
48,127
$
43,893
$
48,127
$
43,893
(a) Significant non cash transactions:
Recognition of new lease liability and right-of-use
$
5,469
$
-
$
5,650
$
207
Termination of lease liability and right-of-use
$
-
$
-
$
17
$
70
BRAINSWAY LTD.
A reconciliation of Adjusted EBITDA to net income (loss), the most directly comparable IFRS measure, is set forth below:
U.S. dollars in thousands (except share and per share data)
For the three months ended September 30,
For the nine months ended September 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
Net income (loss) and total comprehensive income (loss)
$
662
$
(230
)
$
1,373
$
(4,324
)
Finance expense (income), net
(456
)
38
(763
)
(1,234
)
Income taxes
75
59
350
415
Depreciation and amortization
188
85
308
279
Depreciation of leased systems
260
247
755
719
Cost of share based payment
388
95
1,057
147
Restructuring and litigation Cost
-
50
-
852
Adjusted EBITDA
$
1,117
$
344
$
3,080
$
(3,146
)
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midastouch017
2年前
BrainsWay Announces US$20 Million Private Placement with Valor Equity Partners
https://finance.yahoo.com/news/brainsway-announces-us-20-million-113000437.html
Company to leverage capital and Valor’s expertise for strategic initiatives building market awareness, R&D roadmap, data analysis capabilities, and expanding access to Deep TMS™
Purchase price of US$9.51 represents a 20% premium over 30-day VWAP of BrainsWay’s American Depositary Shares
Valor provides growth equity to technology-enabled companies and currently has $18.9B in assets under management
BURLINGTON, Mass. and JERUSALEM, Sept. 30, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it has entered into a securities purchase agreement with an affiliate of Valor Equity Partners (“Valor”) for a private investment financing (the "PIPE") expected to result in gross proceeds of approximately US$20 million. Valor is an operational growth investment firm focused on investing in high-growth companies across various stages of development. The firm partners with leading companies and entrepreneurs who are committed to the highest standards of excellence and the courage to transform their industries. For decades, Valor has served companies such as SpaceX, Tesla, Neuralink, Harmony Biosciences, and K Health with unique expertise to solve the challenges of growth and scale.
“The equity financing strengthens the Company’s balance sheet, further advances strategic initiatives, and expands access to its Deep TMS™ technology, while aligning BrainsWay with a premier U.S. tech investor,” Ami Boehm, the Company’s Chairman of the Board, notes. “With this transaction, we will be better positioned to accelerate the growth of our business by tapping into new markets and new revenue channels, including customer types and commercial partnerships. During the past year, we have received several inbound requests from leading investment groups interested in investing in BrainsWay. We elected to move forward with Valor given its exceptional track record and our belief that it is ideally suited to support us in executing our growth plans in the U.S. We are pleased to welcome Valor to our board of directors.”
“We are grateful for the opportunity to provide this important strategic growth capital to BrainsWay at a pivotal point in its corporate evolution,” said Jonathan Shulkin, Partner and Co-President at Valor. “BrainsWay’s transformative TMS technology has the opportunity to capture significant market share in the growing global TMS industry. Our investment in BrainsWay reflects our focus on disruptive technologies and businesses, as well as our strong belief in the Company’s mission and leadership.”
In the PIPE, BrainsWay has agreed to issue to Valor (i) an aggregate of 2,103,745 American Depositary Shares (ADSs) (representing 4,207,490 ordinary shares), at a purchase price of US$9.51 per ADS, a 20% premium above the 30-day volume-weighted average price (VWAP) of the ADSs, and (ii) warrants (the "Warrants") to purchase up to an additional 1,500,000 ADSs (representing up to 3,000,000 ordinary shares) at the same price (the “Exercise Price”), which may further increase the proceeds from the PIPE up to a total of approximately US$34.3 million if the Warrants are fully exercised in cash. The Warrants will become exercisable upon issuance thereof at the closing of the PIPE and will remain exercisable for 18 months following their initial issuance date, provided, however, that during such 18-month period, if the Company’s ADS closing price for any thirty (30) consecutive trading days exceeds the Exercise Price by 40% or more, the holder of the Warrants shall be required to fully exercise the Warrants in accordance with the terms therein within five (5) trading days.
In connection with the PIPE, the Company is granting Valor the right to nominate (i) at least one member to its board of directors so long as Valor holds, directly or indirectly, at least 10% of the outstanding voting rights of the Company and (ii) two members to its board of directors so long as Valor holds, directly or indirectly, at least 20% of the issued and outstanding share capital of the Company. Valor has notified the Company that the initial director it designates for nomination as a member to the board of directors will be Mr. Shulkin.
The closing of the PIPE and the issuance of the ADSs and Warrants to Valor is subject to customary closing conditions as well as the Company obtaining shareholder approval of the transaction. The Company agreed to (i) file a notice and proxy statement for its extraordinary general meeting of its shareholders for the purpose of obtaining such shareholder approval by no later than ten (10) days following the signing of the securities purchase agreement and (ii) hold such meeting within thirty-five (35) days following such filing. The Company intends to use the proceeds from the PIPE for strategic initiatives including to expand market awareness, enhance data analysis capabilities, develop its R&D roadmap, evaluate other potential opportunities in the TMS industry and expand access to Deep TMS.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, BrainsWay and Valor entered into a registration rights agreement pursuant to which the Company has agreed to file within 10 days following receipt of the shareholder approval noted above a registration statement with the Securities and Exchange Commission to register the resale of the ADSs sold in the PIPE financing, as well as the securities underlying the Warrants sold in the PIPE financing.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Valor Equity Partners
Valor, founded and led by Antonio J. Gracias, Valor’s Chief Executive Officer and Chief Investment Officer, is an operational growth investment firm focused on investing in, and partnering with, high-growth companies and entrepreneurs with the courage to transform their industries. For decades, Valor has served companies such as SpaceX, Tesla, Neuralink, Harmony Biosciences, and K Health with unique expertise to solve the challenges of growth and scale. Valor Siren Ventures II L.P. (together with its parallel funds, “VSV”) is a venture fund managed by Valor and the primary fund investing in the PIPE. VSV is differentiated by anchor investments from Starbucks, Nestlé, and a suite of Fortune 500 food and retail organizations. VSV seeks to add value to portfolio companies by applying the intellectual capital of Valor and accelerating growth through its operations team and network of strategic investors. Valor’s mission is to serve exceptional founders, entrepreneurs, and companies that are making the world a better place. For more information on Valor Equity Partners, please visit www.valorep.com.
midastouch017
3年前
BrainsWay Broadens Access to Deep TMS™ for U.S. Military Service Members Through Expanded Partnership with Katie’s Way Plus
https://finance.yahoo.com/news/brainsway-broadens-access-deep-tms-113000032.html
Provider of Mental Health Services with Focus on Military Community Orders 10 New Deep TMS™ Systems
BURLINGTON, Mass. and JERUSALEM, Sept. 20, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that its longstanding partner, Katie’s Way Plus, which provides comprehensive mental health services tailored to the unique needs of active duty military members, veterans, and their families, has ordered an additional 10 Deep Transcranial Magnetic Stimulation (Deep TMS™) systems, which will more than double its existing offering.
“This is yet another demonstration of our strategic focus on larger enterprise customers across the U.S.,” said Eric Hirt, VP U.S. Sales of BrainsWay. “The strategic collaboration between BrainsWay and Katie's Way Plus is poised to make a substantial impact on addressing the critical and unique mental health issues faced by military personnel by providing world-class care to those who have served their country and are in need of advanced solutions to address their specialized conditions.”
“We are thrilled to support Katie's Way Plus in its vital mission to provide focused care to U.S. service members, veterans, and their families,” said Hadar Levy, Chief Executive Officer of BrainsWay. “BrainsWay's advanced Deep TMS technology has demonstrated remarkable clinical efficacy in treating depression, and we are confident that this expansion will bring hope and healing to many U.S. service members.”
“Katie's Way was founded in memory of my daughter, Katie, who tragically lost her battle with depression,” said Jeff Mathis, Founder of Katie’s Way. “Our goal is to ensure that no other family needs to endure such pain. These additional BrainsWay systems will allow us to extend our reach, offer hope, and ultimately save lives.”
Depression is a contributing factor to suicide, which is a particularly pressing concern within the military community. September is Suicide Prevention Month, which helps raise awareness to the fact that 22 U.S. military veterans take their lives each dayi.
BrainsWay Deep TMS is delivered via a unique treatment coil housed in a cushioned, patient and provider-friendly helmet. The patient is awake, alert, and engaged during the treatment session, and each session only takes less than 30 minutes from start to finish. For some patients, a shorter three-minute intermittent theta burst (iTBS) protocol is also an option. Most candidates for Deep TMS depression treatment have already failed multiple courses of medication and talk therapy, and in a recently published post-marketing analysis of close to 1,400 patients, those patients who had received 30 or more treatments of Deep TMS demonstrated an 82% response rate and a 65% remission rateii.
About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
About Katie’s Way
Katie's Way TMS is a trailblazing mental health care provider with a heartfelt commitment to improving the lives of active duty military service members, veterans, and their families. Founded by Jeff Mathis, our mission is deeply rooted in a profound personal loss. Jeff's daughter, Katie, tragically lost her battle with depression, inspiring him to establish Katie's Way with a resolute determination to prevent others from experiencing a similar tragedy. At Katie's Way TMS, our focus is clear: to provide specialized care, hope, and healing to those who have selflessly served our nation. We understand the unique challenges that military members, veterans, and their families face when it comes to mental health, and we are dedicated to addressing these challenges head-on. With unwavering commitment, Katie's Way TMS strives to make a meaningful impact by providing accessible, evidence-based care to individuals who have sacrificed so much for our country. Our journey is driven by the memory of Katie and the hope that no other family will have to endure the pain of losing a loved one to depression. Katie’s Way currently operates 5 treatment facilities in the United States, and will expand to 12-15 clinics by early 2024. To learn more, please visit www.katieswayplus.com.
midastouch017
3年前
Publication Analyzes Clinical Efficacy of Deep TMS™ in Treating Different Brain Regions Associated with Major Depressive Disorder
https://finance.yahoo.com/news/publication-analyzes-clinical-efficacy-deep-130000866.html
Study Results Outline a Potential Path to More Personalized Medicine in Noninvasive Brain Stimulation
BURLINGTON, Mass. and JERUSALEM, Jan. 31, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced the publication of a comparative study of BrainsWay’s Deep Transcranial Stimulation (Deep TMS™) H1 Coil, which targets the lateral prefrontal cortex, and the Company’s H7 Coil, which targets the medial prefrontal cortex. Published in The Journal of Clinical Investigation (JCI) Insight, the study, which enrolled 169 treatment-resistant depression patients, validates the efficacy of both BrainsWay coils for depression, and also identifies preliminary predictors that could help optimize treatment based on individual patients’ attributes.
The primary endpoint of the study – non-inferiority of the H7 Coil in reducing depressive scores when compared to the H1 Coil – was successfully demonstrated among the overall patient population. This study served as the basis for BrainsWay’s August 2022 H7 Coil FDA clearance for depression. This publication of the study also includes a new retrospective analysis of the clinician rating scales and EEG data, revealing intriguing differences between the patient treatment of the two coils. Categorizing patients according to “clusters” of clinical depressive and anxiety baseline symptoms derived from a subset of the Hamilton Depression Rating Scale (HDRS-21) resulted in two subject groups: One with higher severity of the cluster, which on average responded better to the H1 Coil, and another with lower severity of the cluster, which on average responded better to the H7 Coil. This retrospective analysis was referred to in the publication as the “Clinical Differential Predictor” for TMS H-Coils.
Another interesting finding involved retrospective EEG analysis, which showed that brain activity measured during the first treatment session correlated with the clinical outcomes ultimately achieved after the full course of treatment. This finding suggests that specific brain patterns observed in an individual’s response to either coil during the early stages of treatment might be predictive of the longer-term outcome of treatment with that coil.
“This study is a significant milestone for depression and anxious depression patients and reinforces our commitment to bring mental health within reach for all,” said Christopher von Jako, Ph.D., President and CEO of BrainsWay.
“This study is an important scientific step forward toward personalized psychiatry,” said Prof. Abraham Zangen, Head of the Brain Stimulation and Behavior Lab and the Chair of the PsychoBiology Brain Program at Ben-Gurion University and a scientific consultant for and member of the board of directors of BrainsWay. “Previously published case series had indicated that the H7 Coil was potentially effective in treating depression in patients that did not achieve response or remission after undergoing treatment with TMS coils which target the lateral prefrontal cortex. While the similar reduction in depression scores notably validated the non-inferiority between the H1 and H7 Coils, we were truly inspired by the subsequent retrospective analyses of the clinician rating scales and EEG data. Once we apply the categorization technique employed in this study, the potential exists to increase depression response rates even further. For example, patients categorized as having high cluster severity demonstrated response rates of 95%. We look forward to further validating these preliminary predictors in subsequent research as we continue our quest to optimize patient outcomes.”
The paper, “Pursuing personalized medicine for depression by targeting lateral or medial prefrontal cortex with Deep TMS,” was published in The Journal of Clinical Investigation (JCI) Insight. For more information, please visit: https://insight.jci.org/articles/view/165271
About Major Depressive Disorder and Anxious Depression
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. 60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.
About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.
Contacts:
Scott Areglado
SVP and Chief Financial Officer
617-771-2287
SAreglado@BrainsWay.com
Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
Media Contact:
Meghan Laska
(610) 212-0125
Meghan.Laska@BrainsWay.com
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