Earnings Release • Aug 10, 2022
Earnings Release
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Commission File Number: 001-35165
(Translation of registrant's name into English)
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):
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 Statement on Form F-3 filed with the Securities and Exchange Commission on September 17, 2021 (Registration No. 333-259610).
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 10, 2022 /s/ Christopher R. von Jako, Ph.D Christopher R. von Jako, Ph.D President and Chief Executive Officer
Revenue Growth of 14% Year-over-Year in Q2 2022
Conference call to be held today, August 10, 2022, at 8:30 AM ET
BURLINGTON, Mass. and JERUSALEM, Aug. 10, 2022 (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 second quarter 2022 financial results and provided an operational update.
"We recorded solid second quarter results, again reflecting the growing demand for our non-invasive therapy in multiple indications and markets, despite certain macroeconomic challenges impacting existing and potential new customers," stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. "We generated \$8.0 million in revenue for the second quarter of 2022, which represented a 14% increase as compared to the second quarter of 2021, our eighth consecutive quarter of year-over-year growth. These results are especially impressive as the team faced the realities of inflation and concerns over an economic recession in the U.S. from our customers and their patients."
"We also continue to achieve important reimbursement progress, highlighted by the recent Highmark BCBS positive coverage policy in OCD that increased the total number of lives eligible for Deep TMS coverage in this indication to nearly 70 million."
"Given the increasing demand for mental healthcare, we believe that Deep TMS is well positioned to grow versus other noninvasive medical technology and pharmaceutical therapy options. With approved indications for Depression (including Anxious Depression), OCD, and Smoking Addiction, and data from 34 randomized clinical trials, many of which were placebo controlled, no other TMS therapy can equal the depth of the clinical evidence reinforcing the significant benefits of our Deep TMS system," concluded Dr. von Jako.
BrainsWay's management will host a conference call on Wednesday, August 10, 2022, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
| United States: | 1-877-407-3982 |
|---|---|
| International: | 1-201-493-6780 |
| Conference ID: | 13731331 |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1558822&tp_key=74e2e8e62b |
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 (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.
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.
BrainsWay: Scott Areglado SVP and Chief Financial Officer 844-386-7001 [email protected]
Investors: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]
| June 30, | December 31, |
||
|---|---|---|---|
| 2022 | 2021 | ||
| ASSETS | (Unaudited) | ||
| Current Assets | |||
| Cash and cash equivalents | \$ 52,174 |
\$ | 16,921 |
| Short-term deposits | 271 | 40,428 | |
| Trade receivables, net | 7,412 | 6,332 | |
| Inventory | 2,311 | - | |
| Other current assets | 1,557 | 1,766 | |
| 63,725 | 65,447 | ||
| Non-Current Assets | |||
| System components | 2,458 | 4,463 | |
| Leased systems, net | 3,557 | 3,813 | |
| Other property and equipment, net | 1,019 | 1,055 | |
| Other long-term assets | 999 | 954 | |
| 8,033 | 10,285 | ||
| \$ 71,758 |
\$ | 75,732 | |
| LIABILITIES AND EQUITY | |||
| Current Liabilities | |||
| Trade payables | \$ 1,658 |
\$ | 1,102 |
| Deferred revenue | 1,972 | 2,195 | |
| Liability in respect of research and development grants | 1,011 | 978 | |
| Other accounts payable | 3,625 | 4,792 | |
| 8,266 | 9,067 | ||
| Non-Current Liabilities | |||
| Deferred revenue and other liabilities | 3,883 | 3,419 | |
| Liability in respect of research and development grants | 5,946 | 5,921 | |
| 9,829 | 9,340 | ||
Equity
Share capital 363 363
Share premium 137,904 137,566 Share-based payment reserve 5,783 5,340 Currency Translation Adjustments (2,188) (2,188) Accumulated deficit (88,199) (83,756)
| 53,663 | 57,325 |
|---|---|
| \$ 71,758 |
\$ 75,732 |
| For the three months ended June 30, |
For the six months ended June 30, |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | ||||||
| (Unaudited) | (Unaudited) | ||||||||
| Revenues | \$ | 8,006 | \$ 7,005 |
\$ | 15,976 | \$ | 13,126 | ||
| Cost of revenues | 2,192 | 1,300 | 4,059 | 2,763 | |||||
| Gross profit | 5,814 | 5,705 | 11,917 | 10,363 | |||||
| Research and development expenses, net | 1,731 | 1,650 | 3,307 | 2,575 | |||||
| Selling and marketing expenses | 4,552 | 4,191 | 8,698 | 7,320 | |||||
| General and administrative expenses | 1,539 | 1,377 | 3,402 | 2,782 | |||||
| Total operating expenses | 7,822 | 7,218 | 15,407 | 12,677 | |||||
| Operating loss | (2,008) | (1,513) | (3,490) | (2,314) | |||||
| Finance expense, net | (329) | (269) | (653) | (681) | |||||
| Loss before income taxes | (2,337) | (1,782) | (4,143) | (2,995) | |||||
| Income taxes | 113 | 156 | 300 | 316 | |||||
| Net loss and total comprehensive loss | \$ | (2,450) | \$ (1,938) |
\$ | (4,443) | \$ | (3,311) | ||
| Basic and diluted net loss per share | \$ | (0.07) | \$ | (0.06) | \$ | (0.13) | \$ | (0.11) |
| For the three months ended June 30, |
For the six months ended June 30, |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||
| (Unaudited) | (Unaudited) | |||||||
| Cash flows from operating activities: | ||||||||
| Total comprehensive loss | \$ | (2,450) | \$ | (1,938) | \$ | (4,443) | \$ | (3,311) |
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
| Adjustments to profit or loss items: |
| 288 | 491 | 580 | |
|---|---|---|---|
| 301 | 227 | 233 | 480 |
| 329 | 269 | 653 | 681 |
| 408 | 280 | 782 | 1,083 |
| 113 | 156 | 300 | 316 |
| 1,551 | 1,351 | 2,755 | 3,421 |
| (1,131) | |||
| - | |||
| (257) | (1,017) | (318) | (999) |
| 1,073 | (377) | 561 | (86) |
| (200) | |||
| (5) | 50 | 268 | 212 |
| (2,204) | |||
| (30) | |||
| 2 | |||
| (12) | |||
| (40) | |||
| (2,306) | (1,819) | (5,293) | (2,134) |
| (917) | |||
| 40,304 | (40,000) | 40,254 | (40,000) |
| (2) | (11) | (5) | (11) |
| 40,750 | (40,549) | 41,648 | (40,928) |
| - | (373) | (498) | (373) |
| - | 77 | 6 | 167 |
| (150) | (227) | (298) | (227) |
| - | - | 1 | 42,260 |
| (150) | (523) | (789) | 41,827 |
| (225) | 207 | (313) | (130) |
| 38,069 | (42,684) | 35,253 | (1,365) |
| 14,105 | 58,280 | 16,921 | 16,961 |
| 52,174 | \$ 15,596 |
\$ 52,174 |
\$ 15,596 |
| 123 | - | 123 | 183 |
| 246 (1,072) (792) (384) (1,437) (11) 304 (263) 30 448 |
(38) - 12 (1,370) (10) - 148 138 (538) |
(1,135) (2,105) (894) (3,623) (23) 307 (266) 18 1,399 |
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