GlobeNewswire Inc | Aug 11, 2021 08:00AM EDT

August 11, 2021

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, BrainsWays 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 Companys 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 livesFirst draft Local Coverage Determination (LCD) published applicable to OCD by the Medicare Administrative Contractor (MAC), Palmetto GBA, which represents over 9 million covered livesMultiple smaller private payors covering the Companys 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 Companys controlled market release of Deep TMS for smoking addiction -- Initiated the Companys 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 ofOCD 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

BrainsWays 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: 877-407-3982International: 201-493-6780Conference ID: 13722002Webcast: 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 Companys 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 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 Companys 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 Companys 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 Companys 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 SECs web site at http://www.sec.gov.

Contacts: BrainsWay:Scott AregladoSVP and Chief Financial Officer844-386-7001Scott.Areglado@BrainsWay.com

Investors:Bob YedidLifeSci Advisors646-597-6989Bob@LifeSciAdvisors.com

BRAINSWAY LTD.CONSOLIDATED STATEMENTS OF FINANCIAL POSITIONU.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 4,867 4,352 equipmentTotal 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 745 707 development grantsTotal current liabilities 7,010 6,800 Deferred revenue and other liabilities 2,136 2,015 Liability in respect of research and 5,666 5,524 development grantsWarrants 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 translatingfinancial statements from functional currency (2,188 ) (2,188 )to presentation currencyAccumulated 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 LOSSU.S. dollars in thousands (except share and per share data) For the six months ended For the three months ended June 30, June 30, 2021 2020 2021 2020 Revenues $ 13,126 $ 8,977 $ 7,005 $ 4,820 Cost of 2,763 2,007 1,300 992 revenuesGross profit 10,363 6,970 5,705 3,828 Research anddevelopment 2,575 2,836 1,650 1,041 expenses, netSelling andmarketing 7,320 5,891 4,191 2,178 expensesGeneral andadministrative 2,782 2,079 1,377 824 expensesTotaloperating 12,677 10,806 7,218 4,043 expenses Operating loss (2,314 ) (3,836 ) (1,513 ) (215 ) Finance(expense) (681 ) 130 (269 ) (179 )income, netLoss before (2,995 ) (3,706 ) (1,782 ) (394 )income taxesIncome taxes 316 307 156 177 Net loss andtotal $ (3,311 ) $ (4,013 ) $ (1,938 ) $ (571 )comprehensiveloss Basic anddiluted net $ 0.11 $ 0.18 $ 0.06 $ 0.03 comprehensiveloss per share



BRAINSWAY LTD.CONSOLIDATED STATEMENTS OF CASH FLOWSU.S. dollars in thousands For the six months ended June For the three months ended 30, June 30, 2021 2020 2021 2020 Cash flowsfrom operatingactivities:Net loss andtotal $ (3,311 ) $ (4,013 ) $ (1,938 ) $ (571 )comprehensivelossAdjustmentsto reconcilenet loss tonet cash (used in)provided byoperatingactivities:Adjustmentsto profit or loss items:Depreciationand 761 729 358 284 amortizationDepreciationof leased 580 585 288 291 systemsFinanceexpenses 681 (130 ) 269 179 (income), netCost of share 1,083 437 280 129 based paymentIncome taxes 316 307 156 177 Changes inasset and liabilityitems:Decrease(increase) in (1,131 ) 358 (38 ) 270 tradereceivablesDecrease(increase) inother (999 ) 230 (1,017 ) (34 )accountsreceivableIncrease(decrease) in (86 ) 178 (377 ) 591 tradepayablesIncrease(decrease) inother (200 ) (677 ) 12 (751 )accountspayableIncrease indeferredrevenues and 212 37 50 52 otherliabilities Cash paid andreceived during theperiod for:Interest paid (30 ) (43 ) (10 ) (20 )Interest 2 50 - 19 receivedTaxes paid (12 ) (9 ) 148 - Cash (usedin) provided (2,134 ) (1,961 ) (1,819 ) 616 by operatingactivities: Cash flowsfrom investingactivities:Purchase ofproperty and (917 ) (1,911 ) (538 ) (965 )equipment(*)Investment inshort-termdeposits, net (40,000 ) - (40,000 ) - withdrawal of(investmentin)Withdrawal oflong-term (11 ) 7 (11 ) (3 )deposits, netNet cash usedin investing (40,928 ) (1,904 ) (40,549 ) (968 )activities Cash flowsfrom financingactivities:Repayment ofliability inrespect of (373 ) - (373 ) - research anddevelopmentgrantsReceipt ofgovernment 167 42 77 - grantsRepayment oflease (227 ) (221 ) (227 ) (111 )liabilityIssuance of 42,260 - - - share capitalNet cashprovided by(used in) 41,827 (179 ) (523 ) (111 )financingactivities Exchange ratedifferenceson cash and (130 ) (17 ) 207 107 cashequivalents Decrease incash and cash (1,365 ) (4,061 ) (42,684 ) (356 )equivalentsCash and cashequivalentsat the 16,961 21,674 58,280 17,969 beginning ofthe periodCash and cashequivalents $ 15,596 $ 17,613 $ 15,596 $ 17,613 at the end ofthe period (a)Significant non cashtransactions:Purchase ofproperty and - 515 - 323 equipment oncreditRecognitionof new lease 183 - 183 - liability andright-of-use(*) Derivedmainly frompurchase of systemcomponents