Foreign Filer Report • May 20, 2021
Foreign Filer Report
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REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2021
Commission File Number: 001-35165
(Translation of registrant's name into English)
19 Hartum Street Bynet Building, 3rd Floor Har HaHotzvim Jerusalem, 9777518, Israel (Address of 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 [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
99.1 BrainsWay Reports First Quarter 2021 Financial Results and Operational Highlights
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.
BRAINSWAY LTD. (Registrant)
Date: May 20, 2021 /s/ Christopher R. von Jako, Ph.D Christopher R. von Jako, Ph.D President and Chief Executive Officer
Successfully Executed Initial U.S. Controlled Market Release of Deep TMS for Smoking Addiction
Strengthened Balance Sheet Through Successful Equity Offering; Ended Q1 2021 with \$58.5 Million in Cash
CRESSKILL, N.J. and JERUSALEM, May 20, 2021 (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 2021 financial results and provided an operational update.
"We are extremely pleased with the overall trends in our business, and are working to continue the strong momentum achieved late in 2020 and during the first quarter throughout the year," stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. "Our revenues of \$6.1 million represented a significant 47% increase over our first quarter of 2020, demonstrating the resiliency of our business and continued emergence from the COVID-19 pandemic. We marked a true milestone for our revolutionary approach to mental health treatment with the recent treatment of our 100,000th patient, and this was complimented by impressive commercial and regulatory achievements, including our successful follow-on raise of \$45.2 million in gross proceeds, the controlled market release of our smoking addiction system, and the FDA's clearance of our three-minute Theta Burst depression protocol. We believe these accomplishments position us well to generate long-term shareholder value and to advance in our mission to improve health and transform lives."
BrainsWay's management will host a conference call today, May 20, 2021, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
| United States: | 877-407-3982 |
|---|---|
| Israel: | 1 809 406 247 |
| International: | 201-493-6780 |
| Conference ID: | 13719155 |
| Webcast: | http://public.viavid.com/index.php?id=144607 |
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.
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 studies demonstrating clinically proven efficacy. Current indications include major depressive disorder, 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 Cresskill, NJ and Jerusalem, Israel, BrainsWay is committed to increasing global awareness 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. 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. 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, and the effect of the global COVID-19 health pandemic on our business and continued uncertainty and market impact relating thereto.
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, including the Company's Annual Report on Form 20-F. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov.
BrainsWay: Scott Areglado SVP and Chief Financial Officer [email protected]
Investors: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]
| March 31, 2021 |
December 31, 2020 |
||||
|---|---|---|---|---|---|
| ASSETS | Unaudited | Audited | |||
| Current Assets | |||||
| Cash and cash equivalents | \$ | 58,280 | \$ | 16,961 | |
| Short-term deposits | 221 | 221 | |||
| Trade receivables, net | 6,674 | 5,582 | |||
| Other accounts receivable | 1,516 | 1,534 | |||
| Total current assets | 66,691 | 24,298 | |||
| Long-term deposits | 165 | 163 | |||
| Leased systems | 4,538 | 4,966 | |||
| System components and other property and equipment | 4,696 | 4,584 | |||
| Total assets | \$ | 76,090 | \$ | 34,011 | |
| LIABILITIES AND EQUITY | |||||
| Current Liabilities | |||||
| Trade payables | \$ | 1,072 | \$ | 781 | |
| Other accounts payable | 3,557 | 3,769 | |||
| Deferred revenue | 1,812 | 1,543 | |||
| Liability in respect of research and development grants | 417 | 707 | |||
| Total current liabilities | 6,858 | 6,800 | |||
| Deferred revenue and other liabilities | 1,939 | 2,015 | |||
| Liability in respect of research and development grants | 5,963 | 5,524 | |||
| Warrants | 7 | 38 | |||
| Total Liabilities | 14,767 | 14,377 | |||
| Equity: | |||||
| Share capital | 346 | 233 | |||
| Share premium | 137,282 | 95,135 | |||
| Share-based payment | 5,906 | 3,748 | |||
| Adjustments arising from translating financial statements from | |||||
| functional currency to presentation currency | (2,188) | (2,188) | |||
| Accumulated deficit | (80,023) | (77,294) | |||
| Total Equity | 61,323 | 19,634 | |||
| Total Liabilities and Equity | \$ | 76,090 | \$ | 34,011 |
| For the three months ended March 31, | ||||
|---|---|---|---|---|
| 2021 | 2020 | |||
| (Unaudited) | ||||
| Revenues | \$ | 6,121 \$ |
4,157 | |
| Cost of revenues | 1,515 | 1,015 | ||
| Gross profit | 4,606 | 3,142 | ||
| Research and development expenses, net | 1,228 | 1,795 | ||
| Selling and marketing expenses | 3,578 | 3,713 | ||
| General and administrative expenses | 1,956 | 1,255 | ||
| Total operating expenses | 6,762 | 6,763 | ||
| Operating loss | (2,156) | (3,621 ) | ||
| Finance (expense) income, net | (412) | 309 | ||
| Loss before income taxes | (2,568) | (3,312 ) | ||
| Income taxes | 160 | 130 | ||
| Net loss and total comprehensive loss | \$ | (2,728) \$ |
(3,442 ) | |
| Basic and diluted net comprehensive loss per share | \$ | (0.11) \$ |
(0.15 ) | |
| For the three months ended March 31, |
||||
|---|---|---|---|---|
| 2021 | 2020 | |||
| (Unaudited) | ||||
| Cash flows from operating activities: | ||||
| Net loss and total comprehensive loss | \$ | (2,728 ) \$ (3,442 ) |
||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||
| Adjustments to profit or loss items: | ||||
| Depreciation and amortization | 403 445 |
|||
| Depreciation of leased systems | 292 294 |
|||
| Finance expenses (income), net | 412 (309 ) |
|||
| Cost of share based payment | 2,158 308 |
|||
| Income taxes | 160 130 |
|||
| Changes in asset and liability items: | ||||
| Decrease (increase) in trade receivables | (1,093 ) 88 |
|||
| Decrease in other accounts receivable | 18 264 |
|||
| Increase (decrease) in trade payables | 291 (413 ) |
|||
| Increase (decrease) in other accounts payable | (212 ) 74 |
|||
| Increase (decrease) in deferred revenues and other liabilities | 162 (15 ) |
|||
| Cash paid and received during the period for: | ||||
| Interest paid | (20 ) (23 ) |
|||
| Interest received | 2 31 |
|||
| Taxes paid | (160 ) (9 ) |
|||
| Cash used from operating activities: | (315 ) (2,577 ) |
|||
| Cash flows from investing activities: | ||||
| Purchase of property and equipment(*) | (379 ) (946 ) |
|||
| Withdrawal of long-term deposits, net | - 10 |
|||
| Net cash used for investing activities | (379 ) (936 ) |
|||
| Cash flows from financing activities: | ||||
| Receipt of government grants | 90 42 |
|||
| Repayment of lease liability | - (110 ) |
|||
| Issuance of share capital | 42,260 | - | ||
| Net cash provided by (used for) financing activities | 42,350 | (68 ) | ||
| Exchange rate differences on cash and cash equivalents | (337 ) (124 ) |
|||
| Increase (decrease) in cash and cash equivalents | 41,319 | (3,705 ) | ||
| Cash and cash equivalents at the beginning of the period | 16,961 | 21,674 | ||
| Cash and cash equivalents at the end of the period | \$ 58,280 |
\$ 17,969 |
||
| (a) Significant non cash transactions: | ||||
| Purchase of property and equipment on credit | - 192 |
|||
(*) Derived mainly from purchase of system components
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