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Brainsway Ltd. (BWAY)

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Previous Close9.51
Open9.44
Bid9.05 x 2200
Ask9.11 x 1200
Day's Range9.05 - 9.44
52 Week Range5.52 - 11.04
Volume15,501
Avg. Volume84,995
Market Cap138.207M
Beta (5Y Monthly)0.89
PE Ratio (TTM)N/A
EPS (TTM)-0.48
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est13.88
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  • BrainsWay Announces 100,000 Patients Treated with Deep Transcranial Magnetic Stimulation (Deep TMS)
    GlobeNewswire

    BrainsWay Announces 100,000 Patients Treated with Deep Transcranial Magnetic Stimulation (Deep TMS)

    The FDA cleared technology is a noninvasive treatment for depression, OCD, and smoking addictionCRESSKILL, N.J. and JERUSALEM, Israel, April 14, 2021 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced today that 100,000 patients have been treated globally with Deep transcranial magnetic stimulation (Deep TMS). The noninvasive therapy administers magnetic pulses through a proprietary H-coil to target structures of the brain associated with mental health conditions. The technology received FDA clearance for the treatment of major depressive disorder (MDD) in 2013 and for the treatment of obsessive-compulsive disorder (OCD) in 2018. Most recently, the technology was FDA cleared as an aid for short-term smoking cessation. "As scientific founders of BrainsWay, it is rewarding to see the Company achieve this milestone and to witness the positive impact this groundbreaking technology has had on so many patients and families,” said Prof. Abraham Zangen, Co-Founder and Board Director of BrainsWay, and Yiftach Roth, Ph.D., Co-Founder and Chief Scientific Officer of BrainsWay. “This novel technology can help millions of patients in the coming years, and we are honored to be part of providing successful and noninvasive mental health solutions to those who need them most.” BrainsWay's Deep TMS has been investigated in more than 30 randomized clinical trials worldwide, with additional studies ongoing or planned. Conducted primarily in the outpatient setting, patients can return to normal activities immediately following the treatment session. By penetrating deeper and broader than traditional figure-8 TMS devices, Deep TMS has demonstrated versatility in addressing a range of disorders by safely targeting and stimulating deeper and broader brain regions. “When I first had the opportunity to evaluate this technology, it was clear that this was a unique solution with the ability to transform lives,” said David Zacut, MD, Founder and Chairman of BrainsWay. “At that time, TMS technology had not yet been widely adopted clinically, but it showed substantial promise to advance the field of neuroscience. It has been a pleasure seeing how far the Company has grown and progressed the field over the past two decades." There are more than 600 BrainsWay Deep TMS Systems installed in private clinics, outpatient facilities, and hospitals globally. For more information around provider locations visit brainsway.com/find-a-provider. 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 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. 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. Additionally, the claims contained herein are based on various internal data and assumptions which may be subject to differing interpretation, analysis, and further assessment. The following factors, among others, could cause actual results to differ materially from those described herein: 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; inadequacy and/or inconsistency between different tracking processes; 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. Contact: BrainsWay: Hadar LevySVP and General ManagerHadarL@brainsway.com Media Contact:Will Johnson(201) 465-8019BrainsWay@antennagroup.com

  • ACCESSWIRE

    Brainsway Ltd. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / March 25, 2021 / Brainsway Ltd. (NASDAQ:BWAY) will be discussing their earnings results in their 2020 Fourth Quarter Earnings call to be held on March 25, 2021 at 8:30 AM Eastern Time.

  • BrainsWay Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights
    GlobeNewswire

    BrainsWay Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights

    Conference call to be held tomorrow, March 25, 2021, at 8:30 AM ETCRESSKILL, N.J. and JERUSALEM, March 24, 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 fourth quarter and full year 2020 financial results and provided an operational update. Recent Financial and Operational Highlights For the three months ended December 31, 2020, revenues were $7.1 million, a 17% increase sequentially from the third quarter of 2020, and a 12% increase from the fourth quarter of 2019.Cash, cash equivalents and short-term deposits as of December 31, 2020 amounted to $17.2 million, compared with $16.0 million at the end of the previous quarter, reflecting positive cash flow from operations.As of December 31, 2020, BrainsWay’s Deep TMS installed base was 629 total systems, a 19% increase compared to prior year results.As of December 31, 2020, the Company had shipped 216 OCD coils as add-on helmets to certain of BrainsWay’s new and existing systems.Published real-world OCD data in Journal of Psychiatric Research showing that 73% of patients achieved response at an early stage of Deep TMS treatment, and demonstrating durability of therapeutic effect.Successfully closed a follow-on equity offering in March 2021 raising $45.2 million of gross proceeds.Enhanced commercial leadership team with the addition of Fran Hackett as Vice President of North American Sales; bringing more than 30 years of domestic and international sales, business development, and executive leadership to BrainsWay. “Our return to strong growth with record quarterly revenues in the fourth quarter, the success of our over-subscribed follow-on raise generating approximately $45 million in gross proceeds, and the reinforcement of our sales leadership team have placed us on strong footing to deliver on our commercialization and growth strategy,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Looking ahead, we remain focused on our efforts to secure reimbursement in OCD, further develop and leverage compelling clinical data in multiple existing and planned indications, progress with our recently initiated controlled market release in smoking addiction, and expand the number of U.S. sales territories we cover from 13 to 18. We believe that these initiatives and achievements position us well to advance in our mission to improve health and transform lives.” Fourth Quarter 2020 Financial Results Total revenues for the fourth quarter of 2020 were $7.1 million, compared with $6.0 million in the third quarter of 2020, and $6.3 million in the fourth quarter of 2019, increases of 17% and 12%, respectively. Quarterly recurring lease revenues were $3.4 million, remaining consistent with the fourth quarter of 2019, and comprising 48% of total revenues.Gross margin for the fourth quarter of 2020 was 78%, an increase of 1% as compared to the gross margin for the fourth quarter 2019. Operating expenses for the fourth quarter totaled $5.9 million, compared with $6.8 million for the fourth quarter of 2019. Operating loss for the fourth quarter was $0.4 million, compared with an operating loss of $2.0 million for the same period in 2019. Financial Results for the Full-Year Ended December 31, 2020 Total revenue for the year ended December 31, 2020, was $22.1 million, a decrease of 5% from $23.1 million generated in 2019.Total lease revenue for the year was $13.6 million, an increase of 3% from $13.2 million in 2019. For the full year 2020, lease revenues were 61.5% of total revenues, compared to 57.2% in 2019.Net loss for the year was $5.4 million, compared to a loss of $10.3 million in 2019.As of December 31, 2020, the Company had cash and cash equivalents and short-term deposits of approximately $17.2 million, compared with $21.9 million at December 31, 2019, reflecting cash use of $4.7 million for full-year 2020. This cash balance does not include the approximately $41.9 million in net proceeds after deducting underwriting commissions and discounts and estimated offering expenses from the follow-on equity offering closed in March 2021. Conference Call and WebcastBrainsWay’s management will host a conference call on Thursday, March 25, 2021, at 8:30 a.m. Eastern Time to discuss these results and answer questions. Thursday, March 25, at 8:30 AM Eastern Time: United States:877-407-3982Israel:1 809 406 247International:201-493-6780Conference ID:13717245Webcast:http://public.viavid.com/index.php?id=143838 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 BrainsWayBrainsWay 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. 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, and include, but are not limited to, statements about the expected proceeds, use of proceeds and closing of the underwritten offering. 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:Hadar LevySVP and General ManagerHadarL@brainsway.com Investors:Bob YedidLifeSci Advisors646-597-6989Bob@LifeSciAdvisors.com BRAINSWAY LTD. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION U.S. dollars in thousands (except share and per share data) December 31, 2020 2019 (unaudited) (unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents$16,961 $21,674 Short-term deposits 221 221 Trade receivables, net 5,582 5,507 Other accounts receivable 1,534 1,427 24,298 28,829 NON-CURRENT ASSETS: Long-term deposit 163 168 Leased systems 5,198 5,491 System components and other property and equipment$4,352 $4,248 9,713 9,907 $34,011 $38,736 LIABILITIES AND EQUITY CURRENT LIABILITIES: Trade payables$781 $1,320 Other accounts payable 3,769 3,379 Deferred revenues 1,543 1,305 Liability in respect of research and development grants 707 714 6,800 6,718 NON-CURRENT LIABILITIES: Deferred revenues and other liabilities 2,015 2,353 Liability in respect of research and development grants 5,524 5,367 Warrants 38 78 7,577 7,798 EQUITY: Share capital 233 233 Share premium 95,135 93,649 Share-based payment 3,748 4,435 Adjustments arising from translating financial statements from functional currency to presentation currency (2,188) (2,188)Accumulated deficit (77,294) (71,909) 19,634 24,220 $34,011 $38,736 BRAINSWAY LTD. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS U.S. dollars in thousands (except share and per share data) Year endedDecember 31, Three months endedDecember 31, 2020(unaudited) 2019(unaudited) 2020(unaudited) 2019(unaudited)Revenues $22,057 $23,101 $7,066 $6,292Cost of revenues 5,058 5,129 1,566 1,442Gross profit 16,999 17,972 5,500 4,850Research and development expenses, net 5,823 7,876 1,576 1,809Selling and marketing expenses 11,283 13,269 2,999 3,604General and administrative expenses 4,722 5,303 1,332 1,428Total operating expenses 21,828 26,448 5,907 6,841Operating loss 4,829 8,476 407 1,991Finance expense, net 319 1,430 239 178Loss before income taxes 5,148 9,906 646 2,169Income taxes 237 422 (240) 147Net loss and total comprehensive loss $5,385 $10,328 $406 $2,316Basic and diluted net loss per share $(0.24) $(0.50) $(0.02) $(0.10)