BrainsWay Reports First Quarter 2024 Financial Results and Operational Highlights
Generated Significant 37% Year-over-Year Revenue Growth in Q1 2024 Recorded Positive Quarterly Net Income for Second Consecutive Quarter, and Positive Adjusted EBITDA and Cash Flow from Operations for Third Consecutive Quarter Conference Call to be Held Today at 8:30 AM ET BURLINGTON, Mass. and JERUSALEM, May 08, 2024 (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 first quarter 2024 financial results and provided an operational update. Recent Financial and Operational Highlights For the three months ended March 31, 2024, revenues were $9.1 million, a 37% increase as compared to the first quarter of 2023.Gross margin for the first quarter of 2024 was 75%, an increase from 73% in the first quarter of 2023.Operating income for the first quarter of 2024 was $0.1 million, compared to a loss of $3.7 million for the same period in 2023.Net income for the first quarter of 2024 was $0.1 million, compared to a net loss of $2.4 million for the first quarter of 2023.Adjusted EBITDA1 for the first quarter of 2024 was approximately $0.7 million, compared to a loss of $2.9 million for the first quarter of 2023.Cash, cash equivalents, and short-term deposits as of March 31, 2024, amounted to $47.8 million, an increase of $1.6 million from December 31, 2023.The Company shipped a net total of 57 Deep TMS™ systems during the first quarter of 2024, bringing BrainsWay’s Deep TMS installed base to 1,158 total systems as of March 31, 2024, a 24% increase from the installed base at the same point in the prior year.During the first quarter of 2024, the Company shipped 31 obsessive-compulsive disorder (OCD) coils as add-on helmets to certain of BrainsWay’s new and existing systems, representing OCD treatment capability on 50% of its total installed base.Increased collaboration with significant existing partner, Katie’s Way Plus, which recently ordered an additional 18 Deep TMS systems and will now have an extensive network of approximately 40 devices.Installed the 11th Deep TMS system in Israel, steadily increasing presence in this geography following the recent increase in the country’s reimbursement rates. “Our revenues grew 37% year-over-year in the first quarter of 2024, reflecting the significant tailwinds present throughout our entire business,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “In addition, we generated positive quarterly net income for the second consecutive quarter, and positive Adjusted EBITDA and cash flow from operations for the third consecutive quarter.” “Based on our excellent first quarter results, and expectations for continued strong performance throughout the remainder of the year, we are reiterating our previously provided full-year 2024 revenue guidance of $37 million to $40 million. This would represent growth of 16% to 26% over full-year 2023 revenue. In addition, we continue to anticipate that our profitability momentum and positive cash generation will continue throughout 2024,” concluded Mr. Levy. Conference Call and WebcastBrainsWay’s management will host a conference call on Wednesday, May 8, 2024, at 8:30 a.m. Eastern Time to discuss these results and answer questions. Wednesday, May 8, 2024, at 8:30 AM Eastern Time: United States:1-888-886-7786International:416-764-8658Israel:1-809-468-221Conference ID:50552862Webcast:https://viavid.webcasts.com/starthere.jsp?ei=1666254&tp_key=5dcb324538 The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register. Non-IFRS Financial Measures In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating income and net income, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net income adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses. In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons: Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired.Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results. Adjusted EBITDA, however, should not be considered as an alternative to operating income (loss) or net income (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company’s net income (loss) and Adjusted EBITDA is presented in the attached summary financial statements. Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net income (loss) and our IFRS financial results. 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 clinical 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. Forward-Looking StatementThis 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. Contacts: BrainsWay:Ido MaromChief Financial [email protected] Investors:Brian RitchieLifeSci [email protected] _____________________________1 See Adjusted EBITDA details and reconciliation table in the appendix below. BRAINSWAY LTD. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF FINANCIAL POSITIONU.S. dollars in thousands March 31, December 31, 2024 2023ASSETS(Unaudited) (Audited)Current Assets Cash and cash equivalents$12,382 $10,520 Short-term deposits 35,196 35,465 Restricted cash 271 271 Trade receivables, net 4,339 3,780 Inventory 3,832 3,717 Other current assets 1,373 1,712 57,393 55,465 Non-Current Assets System components 1,495 1,273 Leased systems, net 3,600 3,700 Other property and equipment 779 817 Other long-term assets 1,876 1,717 7,750 7,507 $65,143 $62,972 LIABILITIES AND EQUITY Current Liabilities Trade payables$892 $758 Deferred revenues 5,480 2,504 Liability in respect of research and development grants 1,035 1,008 Other accounts payable 5,415 5,491 12,822 9,761 Non-Current Liabilities Deferred revenues and other liabilities 4,483 5,553 Liability in respect of research and development grants 5,841 6,077 10,324 11,630 Equity Share capital 367 367 Share premium 140,449 140,344 Share-based payment reserve 4,560 4,360 Currency Translation Adjustments (2,188) (2,188)Accumulated deficit (101,191) (101,302) 41,997 41,581 $65,143 $62,972 BRAINSWAY LTD. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)U.S. dollars in thousands (except per share data) For the three months endedMarch 31, 2024 2023 (Unaudited)Revenues$9,095 $6,625 Cost of revenues 2,283 1,792 Gross income 6,812 4,833 Research and development expenses, net 1,626 1,785 Selling and marketing expenses 3,827 4,912 General and administrative expenses 1,266 1,803 Total operating expenses 6,719 8,500 Operating income (loss) 93 (3,667) Finance income 618 1,424 Finance expenses 428 17 Income (loss) before income taxes 283 (2,260)Taxes on income 172 171 Net income (loss) and total comprehensive income (loss)$111 $(2,431) Basic and diluted net income (loss) per share$0.00 $(0.07) BRAINSWAY LTD. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH FLOWSU.S. dollars in thousands For the three months ended March 31, 2024 2023 (Unaudited)Cash flows from operating activities: Total comprehensive income (loss)$111 $(2,431)Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Adjustments to profit or loss items: Depreciation and amortization 62 93 Depreciation of leased systems 255 233 Impairments and disposals 251 246 Finance expenses, net (190) (1,407)Cost of share based payment 305 (51)Income taxes 172 171 Total adjustments to reconcile income (loss) 855 (715)Changes in asset and liability items: Increase in trade receivables (574) (493)Increase in inventory (53) (928)Decrease (increase) in other current assets 264 (222)Increase (decrease) in trade payables 150 (535)Increase (decrease) in other accounts payable (365) 447 Increase in deferred revenues and other liabilities 1,924 700 Total changes in asset and liability 1,346 (1,031)Cash paid and received during the period for: Interest paid (11) (31)Interest received 877 674 Income taxes paid - (7)Total cash paid and received during the period 866 636 Net cash provided by (used in) operating activities: 3,178 (3,541) Cash flows from investing activities: Proceeds from (purchase of) property and equipment and system components, net (724) 66 Proceeds from sub-lease assets 20 - Investment in long-term deposits, net (6) (2)Net cash provided by (used in) investing activities (710) 64 Cash flows from financing activities: Repayment of liability in respect of research and development grants (532) - Repayment of lease liability (57) (66)Net cash used in financing activities (589) (66)Exchange rate differences on cash and cash equivalents (17) 13 Increase (decrease) in cash and cash equivalents 1,862 (3,530)Cash and cash equivalents at the beginning of the period 10,520 47,581 Cash and cash equivalents at the end of the period$12,382 $44,051 (a) Significant non cash transactions: Recognition of new lease liability and right-of-use 72 24 Termination of lease liability and right-of-use - 11 BRAINSWAY LTD.A reconciliation of Adjusted EBITDA to net income (loss), the most directly comparable IFRS measure, is set forth below: U.S. dollars in thousands (except share and per share data) For the three months ended March 31, 2024 2023 (Unaudited)Net income (loss) and total comprehensive income (loss)$111 $(2,431) Finance income, net (190) (1,407)Income taxes 172 171 Depreciation and amortization 62 93 Depreciation of leased systems 255 233 Cost of share based payment 305 (51)Restructuring and litigation Cost - 535 Adjusted EBITDA$715 $(2,857)
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