UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2021
Commission File Number: 001-35165
BRAINSWAY LTD.
(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):
EXHIBIT INDEX
| Exhibit | Title | |
| 99.1 | BrainsWay Reports Second Quarter 2021 Financial Results and Operational Highlights |
SIGNATURES
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: August 11, 2021 | /s/ Christopher R. von Jako, Ph.D | |
| Christopher R. von Jako, Ph.D | ||
| President and Chief Executive Officer | ||
EXHIBIT 99.1
BrainsWay Reports Second Quarter 2021 Financial Results and Operational Highlights
Strong Revenue Growth of 45% Year-over-Year in Q2 2021
Gained Meaningful Traction in Reimbursement for Deep TMS™ in both OCD and Depression
Conference Call to be held Today at 8:30 AM ET
BURLINGTON, Mass. and JERUSALEM, Aug. 11, 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 second quarter 2021 financial results and provided an operational update.
Recent Financial and Operational Highlights
- For the three months ended June 30, 2021, revenues were $7.0 million, a 45% increase as compared to the same period in 2020.
- As of June 30, 2021, BrainsWay’s Deep TMS™ installed base was 682 total systems, a 20% increase from the installed base at the same point in the prior year.
- As of June 30, 2021, the total number of OCD add-on helmets shipped was 247, representing OCD treatment capability on 36% of the Company’s installed base.
- Achieved significant progress in reimbursement for Deep TMS in the treatment of OCD and depression
- Received key positive coverage policies in OCD from Centene and Health Care Service Corporation (HCSC), a leading Blue Cross Blue Shield licensee, which collectively represent approximately 42 million covered lives
- First draft Local Coverage Determination (LCD) published applicable to OCD by the Medicare Administrative Contractor (MAC), Palmetto GBA, which represents over 9 million covered lives
- Multiple smaller private payors covering the Company’s depression treatment have continued the trend of decreasing the number of required prior medication failures from three or four to two
- Received encouraging early data from completing patients in the Company’s controlled market release of Deep TMS for smoking addiction
- Initiated the Company’s largest patient awareness campaign to date; early results have yielded an over 300% increase in patient
inquiries for Deep TMS treatment during June and July
“We are pleased with our strong performance in the second quarter and the increasingly positive trends impacting our company,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Our revenues of $7.0 million represented a substantial 45% increase over the pandemic-impacted second quarter of 2020, as our business continues to demonstrate significant momentum.”
“Importantly, we are beginning to gain meaningful traction in OCD reimbursement, which we believe will be an important
long-term growth driver in enhancing patient access to Deep TMS. Specifically, we received key positive coverage policies from
Centene and HCSC, which collectively represent approximately 42 million covered lives. In addition, the first draft LCD was
published proposing coverage applicable to the Deep TMS system for the treatment of OCD by Palmetto, a regional Medicare
administrator, which represents over 9 million covered lives. This progress in reimbursement is already driving further
interest in this strategic indication, with approximately two-thirds of recently shipped systems including an OCD add-on helmet.
Moreover, we ended the second quarter with $55.9 million in cash, allowing us to operate the business from a position of financial
strength,” concluded Dr. von Jako.
Second Quarter 2021 Financial Results
- Total revenues for the second quarter of 2021 were $7.0 million, compared to $4.8 million in the second quarter of 2020, an increase of 45%. Quarterly recurring lease revenues were $3.6 million, slightly higher than the second quarter of 2020, and comprising approximately 51% of total revenues.
- Gross margin for the second quarter of 2021 was 81%, compared to 79% for the second quarter of 2020.
- Operating expenses for the second quarter of 2021 were $7.2 million compared to $4.0 million for the second quarter of 2020.
- For the three months ended June 30, 2021, operating loss was $1.5 million compared to an operating loss of $215 thousand during the same period in the prior year.
- As of June 30, 2021, the Company had cash and short-term deposits of approximately $55.9 million, compared
to $17.2 million at December 31, 2020.
Conference Call and Webcast
BrainsWay’s management will host a conference call today, August 11, 2021, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Wednesday, August 11, at 8:30 AM Eastern Time:
| United States: | 877-407-3982 |
| International: | 201-493-6780 |
| Conference ID: | 13722002 |
| Webcast: | http://public.viavid.com/index.php?id=146013 |
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 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 Burlington, MA 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.
Forward Looking Statements
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.
Contacts:
BrainsWay:
Scott Areglado
SVP and Chief Financial Officer
844-386-7001
Scott.Areglado@BrainsWay.com
Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
| BRAINSWAY LTD. | ||||||||
| CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||||||||
| U.S. dollars in thousands (except share and per share data) | ||||||||
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 15,596 | $ | 16,961 | ||||
| Short-term deposits | 40,275 | 221 | ||||||
| Trade receivables, net | 6,676 | 5,582 | ||||||
| Other accounts receivable | 2,362 | 1,534 | ||||||
| Total current assets | 64,909 | 24,298 | ||||||
| Long-term deposits | 280 | 163 | ||||||
| Leased systems | 4,429 | 5,198 | ||||||
| System components and other property and equipment | 4,867 | 4,352 | ||||||
| Total assets | $ | 74,485 | $ | 34,011 | ||||
| LIABILITIES AND EQUITY | ||||||||
| Current Liabilities | ||||||||
| Trade payables | $ | 732 | $ | 781 | ||||
| Other accounts payable | 3,977 | 3,769 | ||||||
| Deferred revenue | 1,556 | 1,543 | ||||||
| Liability in respect of research and development grants | 745 | 707 | ||||||
| Total current liabilities | 7,010 | 6,800 | ||||||
| Deferred revenue and other liabilities | 2,136 | 2,015 | ||||||
| Liability in respect of research and development grants | 5,666 | 5,524 | ||||||
| Warrants | 7 | 38 | ||||||
| Total Liabilities | 14,819 | 14,377 | ||||||
| Equity: | ||||||||
| Share capital | 346 | 233 | ||||||
| Share premium | 137,344 | 95,135 | ||||||
| Share-based payment | 4,769 | 3,748 | ||||||
| Adjustments arising from translating financial statements from functional currency to presentation currency | (2,188 | ) | (2,188 | ) | ||||
| Accumulated deficit | (80,605 | ) | (77,294 | ) | ||||
| Total Equity | 59,666 | 19,634 | ||||||
| Total Liabilities and Equity | $ | 74,485 | $ | 34,011 | ||||
| BRAINSWAY LTD. | |||||||||||||||||
| CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||||||
| U.S. dollars in thousands (except share and per share data) | |||||||||||||||||
| For the six months ended June 30, | For the three months ended June 30, | ||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Revenues | $ | 13,126 | $ | 8,977 | $ | 7,005 | $ | 4,820 | |||||||||
| Cost of revenues | 2,763 | 2,007 | 1,300 | 992 | |||||||||||||
| Gross profit | 10,363 | 6,970 | 5,705 | 3,828 | |||||||||||||
| Research and development expenses, net | 2,575 | 2,836 | 1,650 | 1,041 | |||||||||||||
| Selling and marketing expenses | 7,320 | 5,891 | 4,191 | 2,178 | |||||||||||||
| General and administrative expenses | 2,782 | 2,079 | 1,377 | 824 | |||||||||||||
| Total operating expenses | 12,677 | 10,806 | 7,218 | 4,043 | |||||||||||||
| Operating loss | (2,314 | ) | (3,836 | ) | (1,513 | ) | (215 | ) | |||||||||
| Finance (expense) income, net | (681 | ) | 130 | (269 | ) | (179 | ) | ||||||||||
| Loss before income taxes | (2,995 | ) | (3,706 | ) | (1,782 | ) | (394 | ) | |||||||||
| Income taxes | 316 | 307 | 156 | 177 | |||||||||||||
| Net loss and total comprehensive loss | $ | (3,311 | ) | $ | (4,013 | ) | $ | (1,938 | ) | $ | (571 | ) | |||||
| Basic and diluted net comprehensive loss per share | $ | 0.11 | $ | 0.18 | $ | 0.06 | $ | 0.03 | |||||||||
| BRAINSWAY LTD. | |||||||||||||||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||||||
| U.S. dollars in thousands | |||||||||||||||||
| For the six months ended June 30, | For the three months ended June 30, | ||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Cash flows from operating activities: | |||||||||||||||||
| Net loss and total comprehensive loss | $ | (3,311 | ) | $ | (4,013 | ) | $ | (1,938 | ) | $ | (571 | ) | |||||
| Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | |||||||||||||||||
| Adjustments to profit or loss items: | |||||||||||||||||
| Depreciation and amortization | 761 | 729 | 358 | 284 | |||||||||||||
| Depreciation of leased systems | 580 | 585 | 288 | 291 | |||||||||||||
| Finance expenses (income), net | 681 | (130 | ) | 269 | 179 | ||||||||||||
| Cost of share based payment | 1,083 | 437 | 280 | 129 | |||||||||||||
| Income taxes | 316 | 307 | 156 | 177 | |||||||||||||
| Changes in asset and liability items: | |||||||||||||||||
| Decrease (increase) in trade receivables | (1,131 | ) | 358 | (38 | ) | 270 | |||||||||||
| Decrease (increase) in other accounts receivable | (999 | ) | 230 | (1,017 | ) | (34 | ) | ||||||||||
| Increase (decrease) in trade payables | (86 | ) | 178 | (377 | ) | 591 | |||||||||||
| Increase (decrease) in other accounts payable | (200 | ) | (677 | ) | 12 | (751 | ) | ||||||||||
| Increase in deferred revenues and other liabilities | 212 | 37 | 50 | 52 | |||||||||||||
| Cash paid and received during the period for: | |||||||||||||||||
| Interest paid | (30 | ) | (43 | ) | (10 | ) | (20 | ) | |||||||||
| Interest received | 2 | 50 | - | 19 | |||||||||||||
| Taxes paid | (12 | ) | (9 | ) | 148 | - | |||||||||||
| Cash (used in) provided by operating activities: | (2,134 | ) | (1,961 | ) | (1,819 | ) | 616 | ||||||||||
| Cash flows from investing activities: | |||||||||||||||||
| Purchase of property and equipment(*) | (917 | ) | (1,911 | ) | (538 | ) | (965 | ) | |||||||||
| Investment in short-term deposits, net withdrawal of (investment in) | (40,000 | ) | - | (40,000 | ) | - | |||||||||||
| Withdrawal of long-term deposits, net | (11 | ) | 7 | (11 | ) | (3 | ) | ||||||||||
| Net cash used in investing activities | (40,928 | ) | (1,904 | ) | (40,549 | ) | (968 | ) | |||||||||
| Cash flows from financing activities: | |||||||||||||||||
| Repayment of liability in respect of research and development grants | (373 | ) | - | (373 | ) | - | |||||||||||
| Receipt of government grants | 167 | 42 | 77 | - | |||||||||||||
| Repayment of lease liability | (227 | ) | (221 | ) | (227 | ) | (111 | ) | |||||||||
| Issuance of share capital | 42,260 | - | - | - | |||||||||||||
| Net cash provided by (used in) financing activities | 41,827 | (179 | ) | (523 | ) | (111 | ) | ||||||||||
| Exchange rate differences on cash and cash equivalents | (130 | ) | (17 | ) | 207 | 107 | |||||||||||
| Decrease in cash and cash equivalents | (1,365 | ) | (4,061 | ) | (42,684 | ) | (356 | ) | |||||||||
| Cash and cash equivalents at the beginning of the period | 16,961 | 21,674 | 58,280 | 17,969 | |||||||||||||
| Cash and cash equivalents at the end of the period | $ | 15,596 | $ | 17,613 | $ | 15,596 | $ | 17,613 | |||||||||
| (a) Significant non cash transactions: | |||||||||||||||||
| Purchase of property and equipment on credit | - | 515 | - | 323 | |||||||||||||
| Recognition of new lease liability and right-of-use | 183 | - | 183 | - | |||||||||||||
| (*) Derived mainly from purchase of system components | |||||||||||||||||