Foreign Filer Report • May 13, 2025
Foreign Filer Report
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For the month of May 2025
Commission File Number: 001-35165
(Translation of registrant's name into English)
16 Hartum Street RAD Tower, 14th Floor Har HaHotzvim Jerusalem, 9777516, Israel
(+972-2) 582-4030
(Address and telephone number of Registrant's principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ X ] Form 40-F [ ]
This Form 6-K is incorporated by reference into the Company's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 22, 2019 (Registration No. 333- 230979) and the Company's Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 22, 2024 (Registration No. 333-280934) and on April 22, 2025 (Registration No. 333-286672).
| Exhibit Number | Description | ||
|---|---|---|---|
| 99.1 | Press Release dated May 13, 2025 |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
(Registrant)
Date: May 13, 2025 /s/ Hadar Levy
Hadar Levy Chief Executive Officer
Achieved record quarterly sales of \$11.5 million in Q1 2025, an increase of 27% compared to Q1 2024
Operating profit totaled \$0.6 million and Adjusted EBITDA rose to \$1.3 million, increasing by 519% and 81%, respectively, compared to Q1 of 2024
Shipped a record net number of Deep TMS Systems, indicating significant demand and further strengthening of relationships with enterprise accounts
Company is reiterating its full-year 2025 financial guidance, including revenue of \$49 to \$51 million, operating profit of 3% to 4% and Adjusted EBITDA of 11% to 12%
Conference call to be held today at 8:30 AM ET
BURLINGTON, Mass. and JERUSALEM, May 13, 2025 (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 first quarter 2025 financial results and provided an operational update.
1 See Adjusted EBITDA details and reconciliation table in the appendix below.
Reiterating full-year 2025 financial guidance, including revenue between \$49 million to \$51 million with an operating profit of 3% to 4% and Adjusted EBITDA of 11% to 12%.
"We continued to rapidly increase our share of the TMS market during the first quarter of 2025. The momentum in our business is being driven by growing demand and utilization of our industry-leading technology in multiple indications, including obsessive compulsive disorder (OCD) and anxious depression, as well as enhanced global sales channels. Importantly, we continue to gain traction with large enterprise customers, resulting in the opportunity for meaningful recurring revenue and a significant sales backlog," said Hadar Levy, BrainsWay's Chief Executive Officer.
"We see tremendous opportunities for future growth with several upcoming key catalysts, including our next-generation Deep TMS 360™ system, the expansion into new indications, and broadened and enhanced accessibility across indications supported by additional clinical data. In order to leverage these critical technology advancements, our global market presence continues to expand, and now extends across key markets including Canada, Asia, India and Europe," concluded Mr. Levy.
BrainsWay's management will host a conference call on Tuesday, May 13, 2025, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Tuesday, May 13, 2025, at 8:30 AM Eastern Time:
| United States: | 1-877-300-8521 |
|---|---|
| International: | 1-412-317-6026 |
| Israel: | 1-80-921-2373 |
| Conference ID: | 10198731 |
| 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-andpresentations/event-calendar. Please access the Company's website at least 10 minutes ahead of the conference call to register.
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, 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.
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 operations in the United States and 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.
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, and also includes any financial guidance and projections contained herein. 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.
BrainsWay: Ido Marom Chief Financial Officer [email protected]
Brian Ritchie LifeSci Advisors LLC [email protected]
March 31, December 31, 2025 2024 ASSETS (Unaudited) (Audited) Current Assets Cash and cash equivalents \$ 71,601 \$ 69,345 Restricted cash 271 271 Trade receivables, net 6,954 4,596 Inventory 4,680 4,426 Other current assets 1,150 1,032 84,656 79,670 Non-Current Assets System components 1,937 1,707 Leased systems, net 4,129 3,959 Other property and equipment, net 796 752 Right-of-use assets 5,378 5,530 Other long-term assets 3,302 2,698 15,542 14,646 \$ 100,198 \$ 94,316 LIABILITIES AND EQUITY Current Liabilities Trade payables \$ 2,104 \$ 2,868 Deferred revenues 7,022 4,434 Liability in respect of government grants 1,341 1,293 Current maturities of lease liabilities 818 824 Other accounts payable 5,561 5,927 16,846 15,346 Non-Current Liabilities Deferred revenues 7,349 3,625 Liability in respect of government grants 5,380 5,803 Lease liabilities 4,747 4,800 Warrants liability 2,126 2,429 19,602 16,657 Equity Share capital 415 413 Share premium 158,134 157,597 Reserve for share-based payment 4,663 4,872 Currency Translation Adjustments (2,188) (2,188) Accumulated deficit (97,274) (98,381) 63,750 62,313 \$ 100,198 \$ 94,316
| For the three months ended March 31, |
||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| (Unaudited) | ||||
| Revenues | \$ | 11,536 \$ |
9,095 | |
| Cost of revenues | 2,926 | 2,283 | ||
| Gross profit | 8,610 | 6,812 | ||
| Research and development expenses, net | 2,332 | 1,626 | ||
| Selling and marketing expenses | 4,162 | 3,827 | ||
| General and administrative expenses | 1,540 | 1,266 | ||
| Total operating expenses | 8,034 | 6,719 | ||
| Operating profit | 576 | 93 | ||
| Finance income | 1,274 | 618 | ||
| Finance Expense | 586 | 428 | ||
| Profit before income taxes | 1,264 | 283 | ||
| Income taxes | 157 | 172 | ||
| Net profit and total comprehensive profit | \$ | 1,107 \$ |
111 | |
| Basic net income per share | 0.03 | 0.00 | ||
| Diluted net income per share | \$ | 0.02 \$ |
0.00 |
| For the three months ended March 31, |
||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| (Unaudited) | ||||
| Cash flows from operating activities: | ||||
| Total comprehensive profit | \$ | 1,107 | \$ | 111 |
| Adjustments to reconcile net profit to net cash provided by operating activities: | ||||
| Adjustments to profit or loss items: | ||||
| Depreciation and amortization | 191 | 62 | ||
| Depreciation of leased systems | 203 | 255 | ||
| Impairment and disposal of inventory and system components | 208 | 251 | ||
| Finance income, net | (688) | (190) | ||
| Cost of share based payment | 325 | 305 | ||
| Income taxes | 157 | 172 | ||
| Total adjustments to reconcile profit | 396 | 855 | ||
| Changes in asset and liability items: | ||||
| Increase in inventory | (73) | (53) | ||
| Increase in trade receivables | (2,349) | (574) | ||
| Decrease (increase) in other current assets | (78) | 264 | ||
| Increase (decrease) in trade payables | (740) | 150 | ||
| Decrease in other accounts payable | (384) | (365) | ||
| Increase in deferred revenues | 6,312 | 1,924 | ||
| Total changes in asset and liability | 2,688 | 1,346 | ||
| Cash paid and received during the period for: | ||||
| Interest paid | (98) | (11) | ||
| Interest received | 913 | 877 | ||
| Income taxes received | 4 | - | ||
| Total cash paid and received during the period | 819 | 866 | ||
| Net cash provided by operating activities: | 5,010 | 3,178 | ||
| Cash flows from investing activities: | ||||
| Purchase of property and equipment and system components, net | (1,043) | (724) | ||
| Proceeds from sub-lease asset | - | 20 | ||
| Investment in deposits, net | (923) | (6) | ||
| Net cash used in investing activities | (1,966) | (710) | ||
| Cash flows from financing activities: | ||||
| Repayment of liability in respect of research and development grants | (638) | (532) | ||
| Repayment of lease liability | (117) | (57) | ||
| Net cash used in financing activities | (755) | (589) | ||
| Exchange rate differences on cash and cash equivalents | (33) | (17) | ||
| Increase in cash and cash equivalents | 2,256 | 1,862 | ||
| Cash and cash equivalents at the beginning of the period | 69,345 | 10,520 | ||
| Cash and cash equivalents at the end of the period | \$ | 71,601 | \$ | 12,382 |
| (a) Significant non cash transactions: | ||||
| Recognition of new lease liability and right-of-use | \$ | 27 | \$ | 72 |
| For the three months ended March 31, |
||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| Net profit and total comprehensive profit | (Unaudited) | |||
| \$ | 1,107 | \$ | 111 | |
| Finance income, net | (688) | (190) | ||
| Income taxes | 157 | 172 | ||
| Depreciation and amortization | 191 | 62 | ||
| Depreciation of leased systems | 203 | 255 | ||
| Cost of share based payment | 325 | 305 | ||
| Adjusted EBITDA | \$ | 1,295 | \$ | 715 |
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