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BURLINGTON, Mass. and JERUSALEM, March 15, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported fourth quarter and full-year 2022 financial results and provided an operational update.
Recent Financial and Operational Highlights
“Since assuming the role of CEO earlier this year, I have focused on implementing key initiatives aimed at growing the Company’s top-line while simultaneously advancing toward profitability,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “Based on our confident outlook for 2023 and the actions we have implemented to date, we are aiming for revenue growth over 2022, and targeting breakeven operating income in the fourth quarter of 2023. Importantly, TMS remains a large market with strong momentum and there is ample opportunity for BrainsWay to capture meaningful market share, both in the U.S. and internationally.”
Fourth Quarter 2022 Financial Results
Financial Results for the Full-Year Ended December 31, 2022
Conference Call and Webcast
BrainsWay’s management will host a conference call on Wednesday, March 15, 2023, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Wednesday, March 15, 2023, at 8:30 AM Eastern Time:
| United States: | 1-877-407-3982 |
| International: | 1-201-493-6780 |
| Conference ID: | 13736480 |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1599119&tp_key=702da0691e |
To listen to a live webcast, please visit the Investors section of the BrainsWay website at www.BrainsWay.com. Please access the Company’s website at least 10 minutes ahead of the conference call to register. The webcast replay will be available on the website for two weeks following the completion of the call.
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,” “aiming,” “targeting” 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:
Scott Areglado
SVP and Chief Financial Officer
844-386-7001
Scott.Areglado@BrainsWay.com
Investors:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com
| BRAINSWAY LTD. AND SUBSIDIARIES | ||||||||
| CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||||||||
| U.S. dollars in thousands | ||||||||
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | (Unaudited) | |||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 47,581 | $ | 16,921 | ||||
| Short-term deposits | 271 | 40,428 | ||||||
| Trade receivables, net | 4,844 | 6,332 | ||||||
| Inventory | 3,837 | - | ||||||
| Other current assets | 1,556 | 1,766 | ||||||
| 58,089 | 65,447 | |||||||
| Non-Current Assets | ||||||||
| System components | 1,220 | 4,463 | ||||||
| Leased systems, net | 3,118 | 3,813 | ||||||
| Other property and equipment | 1,008 | 1,055 | ||||||
| Other long-term assets | 1,042 | 954 | ||||||
| 6,388 | 10,285 | |||||||
| $ | 64,477 | $ | 75,732 | |||||
| LIABILITIES AND EQUITY | ||||||||
| Current Liabilities | ||||||||
| Trade payables | $ | 1,116 | $ | 1,102 | ||||
| Deferred revenues | 1,477 | 2,195 | ||||||
| Liability in respect of research and development grants | 1,057 | 978 | ||||||
| Other accounts payable | 4,491 | 4,792 | ||||||
| 8,141 | 9,067 | |||||||
| Non-Current Liabilities | ||||||||
| Deferred revenues and other liabilities | 4,923 | 3,419 | ||||||
| Liability in respect of research and development grants | 6,016 | 5,921 | ||||||
| 10,939 | 9,340 | |||||||
| Equity | ||||||||
| Share capital | 364 | 363 | ||||||
| Share premium | 138,146 | 137,566 | ||||||
| Share-based payment reserve | 6,180 | 5,340 | ||||||
| Currency Translation Adjustments | (2,188) | (2,188) | ||||||
| Accumulated deficit | (97,105) | (83,756) | ||||||
| 45,397 | 57,325 | |||||||
| $ | 64,477 | $ | 75,732 | |||||
| - | - | |||||||
| BRAINSWAY LTD. AND SUBSIDIARIES | ||||||||||||||||||
| CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||||||||||
| U.S. dollars in thousands (except per share data) | ||||||||||||||||||
| For the three months ended December 31, | For the twelve months ended December 31, | |||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||||
| Revenues | $ | 6,033 | $ | 8,470 | $ | 27,177 | $ | 29,657 | ||||||||||
| Cost of revenues | 1,729 | 1,906 | 7,129 | 6,599 | ||||||||||||||
| Gross profit | 4,304 | 6,564 | 20,048 | 23,058 | ||||||||||||||
| Selling and marketing expenses | 4,750 | 4,518 | 18,199 | 15,880 | ||||||||||||||
| Research and development expenses, net | 2,151 | 2,032 | 7,678 | 6,393 | ||||||||||||||
| General and administrative expenses | 1,726 | 1,466 | 6,854 | 5,784 | ||||||||||||||
| Total operating expenses | 8,627 | 8,016 | 32,731 | 28,057 | ||||||||||||||
| Operating loss | (4,323 | ) | (1,452 | ) | (12,683 | ) | (4,999 | ) | ||||||||||
| Finance income (expense), net | 401 | (379 | ) | (351 | ) | (1,420 | ) | |||||||||||
| Loss before income taxes | (3,922 | ) | (1,831 | ) | (13,034 | ) | (6,419 | ) | ||||||||||
| Taxes on income (tax benefit) | (55 | ) | (484 | ) | 315 | 43 | ||||||||||||
| Net loss and total comprehensive loss | $ | (3,867 | ) | $ | (1,347 | ) | $ | (13,349 | ) | $ | (6,462 | ) | ||||||
| Basic and diluted net loss per share | $ | (0.12 | ) | $ | (0.04 | ) | $ | (0.40 | ) | $ | (0.21 | ) | ||||||
| BRAINSWAY LTD. AND SUBSIDIARIES | ||||||||||||||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||||||||
| U.S. dollars in thousands | ||||||||||||||||
| For the three months ended December 31, | For the twelve months ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Cash flows from operating activities: | ||||||||||||||||
| Total comprehensive loss | $ | (3,867 | ) | $ | (1,347 | ) | $ | (13,349 | ) | $ | (6,462 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
| Adjustments to profit or loss items: | ||||||||||||||||
| Depreciation and amortization | 102 | 171 | 559 | 560 | ||||||||||||
| Depreciation of leased systems | 241 | 267 | 976 | 1,126 | ||||||||||||
| Impairments and disposals | 400 | 410 | 816 | 1,295 | ||||||||||||
| Finance expenses, net | (401 | ) | 379 | 351 | 1,420 | |||||||||||
| Cost of share based payment | 353 | 416 | 1,474 | 1,893 | ||||||||||||
| Income taxes | (55 | ) | (484 | ) | 315 | 43 | ||||||||||
| Total adjustments to reconcile loss | 640 | 1,159 | 4,491 | 6,337 | ||||||||||||
| Changes in asset and liability items: | ||||||||||||||||
| (Increase) decrease in trade receivables | 821 | 938 | 1,456 | (849 | ) | |||||||||||
| (Increase) in inventory | (643 | ) | - | (3,595 | ) | - | ||||||||||
| (Increase) decrease in other accounts receivable | 255 | (334 | ) | (403 | ) | (1,226 | ) | |||||||||
| Increase (decrease) in trade payables | (169 | ) | 153 | - | 289 | |||||||||||
| Increase in other accounts payable | 731 | 1,410 | 298 | 815 | ||||||||||||
| Increase (decrease) in deferred revenues and other liabilities | (313 | ) | 1,600 | 790 | 2,039 | |||||||||||
| Total changes in asset and liability | 682 | 3,767 | (1,454 | ) | 1,068 | |||||||||||
| Cash paid and received during the period for: | ||||||||||||||||
| Interest paid | (12 | ) | (16 | ) | (46 | ) | (62 | ) | ||||||||
| Interest received | 422 | 13 | 1,042 | 17 | ||||||||||||
| Income taxes paid | (107 | ) | (2 | ) | (443 | ) | (14 | ) | ||||||||
| Total cash paid and received during the period | 303 | (5 | ) | 553 | (59 | ) | ||||||||||
| Net cash provided by (used in) operating activities: | (2,242 | ) | 3,574 | (9,759 | ) | 884 | ||||||||||
| Cash flows from investing activities: | ||||||||||||||||
| Proceeds from (purchase of) property and equipment and system components, net | 428 | (1,176 | ) | 1,936 | (2,238 | ) | ||||||||||
| Withdrawal of (investment in) short-term deposits, net | - | - | 40,254 | (40,000 | ) | |||||||||||
| Investment in long-term deposits, net | (1 | ) | 34 | (21 | ) | 22 | ||||||||||
| Net cash provided by (used in) investing activities | 427 | (1,142 | ) | 42,169 | (42,216 | ) | ||||||||||
| Cash flows from financing activities: | ||||||||||||||||
| Repayment of liability in respect of research and development grants | - | (388 | ) | (977 | ) | (761 | ) | |||||||||
| Receipt of government grants | - | 23 | 15 | 492 | ||||||||||||
| Repayment of lease liability | (72 | ) | (115 | ) | (532 | ) | (475 | ) | ||||||||
| Issuance of share capital, net | - | - | (52 | ) | 42,260 | |||||||||||
| Net cash provided by (used in) financing activities | (72 | ) | (480 | ) | (1,546 | ) | 41,516 | |||||||||
| Exchange rate differences on cash and cash equivalents | 116 | (14 | ) | (204 | ) | (224 | ) | |||||||||
| Increase (decrease) in cash and cash equivalents | (1,771 | ) | 1,938 | 30,660 | (40 | ) | ||||||||||
| Cash and cash equivalents at the beginning of the period | 49,352 | 14,983 | 16,921 | 16,961 | ||||||||||||
| Cash and cash equivalents at the end of the period | $ | 47,581 | $ | 16,921 | $ | 47,581 | $ | 16,921 | ||||||||
| (a) Significant non cash transactions: | ||||||||||||||||
| Recognition of new lease liability and right-of-use | 61 | - | 301 | 587 | ||||||||||||
| Termination of lease liability and right-of-use | - | (64 | ) | - | (64 | ) | ||||||||||