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BrainsWay Launches Prospective, Randomized, Controlled, Multicenter Trial Evaluating Accelerated Deep TMS™ for Depression
GlobeNewswire News Room· 2024-06-10 19:30
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 ...
BrainsWay Receives Expanded FDA Labeling to Treat Late Life Depression
Newsfilter· 2024-06-03 19:30
BURLINGTON, Mass. and JERUSALEM, June 03, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the US Food and Drug Administration (FDA) has granted an expanded indication for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™) allowing for the treatment of patients with major depressive disorder (MDD) ages 22 to 86, changing the p ...
BrainsWay Receives Expanded FDA Labeling to Treat Late Life Depression
GlobeNewswire News Room· 2024-06-03 19:30
BURLINGTON, Mass. and JERUSALEM, June 03, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the US Food and Drug Administration (FDA) has granted an expanded indication for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™) allowing for the treatment of patients with major depressive disorder (MDD) ages 22 to 86, changing the p ...
Wall Street Analysts Believe Brainsway (BWAY) Could Rally 120.45%: Here's is How to Trade
Zacks Investment Research· 2024-05-13 22:55
Shares of Brainsway Ltd. Sponsored ADR (BWAY) have gained 3.5% over the past four weeks to close the last trading session at $5.33, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $11.75 indicates a potential upside of 120.5%. While the consensus price target is a much-coveted metric for investors, solely banking on this metric to make an investment decision may not be wise at a ...
Brainsway(BWAY) - 2024 Q1 - Earnings Call Transcript
2024-05-09 01:16
财务数据和关键指标变化 - 2024年第一季度营收为910万美元,较上年同期的660万美元增长37%[20] - 2024年第一季度毛利润为680万美元,毛利率为75%,上年同期为480万美元,毛利率为73%[20] - 2024年第一季度销售和营销费用为380万美元,2023年第一季度为490万美元研发费用2024年第一季度为160万美元,2023年第一季度为180万美元[21] - 2024年第一季度一般和管理费用为130万美元,2023年第一季度为180万美元,2024年第一季度总运营费用为670万美元,较上年同期的850万美元下降21%[22] - 2024年第一季度运营利润为10万美元,2023年同期运营亏损为370万美元[22] - 2024年第一季度调整后的息税折旧摊销前利润为70万美元,连续第三个季度为正,2023年第一季度亏损为290万美元[23] - 2024年第一季度实现净收入10万美元,2023年同期净亏损为240万美元[23] - 2024年3月31日现金、现金等价物和短期存款为4780万美元,无债务,2023年12月31日为4620万美元[24] 各条业务线数据和关键指标变化 - 2024年第一季度共安装57套Deep TMS系统,截至2024年3月31日,总安装基数为1158套,上年同期为932套[20] - 2024年第一季度共发货31个强迫症线圈作为附加头盔,约50%的总安装基数现在具备强迫症治疗能力[14] 各个市场数据和关键指标变化 - 美国市场覆盖范围广泛,增长势头强劲,需求不断增加[30] - 国际市场上,远东地区(韩国、台湾、印度)以及欧洲部分地区发展势头良好[30] 公司战略和发展方向和行业竞争 - 优化现有商业流程,重点关注大型机构和企业客户[11] - 将Deep TMS技术推广到大型心理健康团体和网络中[12] - 与Katie's Way Plus等重要合作伙伴达成合作协议[13] - 国际业务表现出色,如在以色列安装11套Deep TMS系统[13] - 任命Honny Groen为国际销售副总裁,以扩大全球业务版图[16] - 通过扩大临床和实际证据支持,推动Deep TMS在多个大型疾病领域的发展[17] - 任命[姓名不可辨]为首席技术官,以扩展创新技术平台[18] - 积极探索成瘾领域的合作机会,与潜在感兴趣方进行积极对话[42] - 对Deep TMS 360进行技术可行性和临床疗效测试[44] - 计划增加销售团队数量,推出更多营销计划,增加研发和临床投资[46] 管理层对经营环境和未来前景的评论 - 2024年第一季度业绩良好,对2024年剩余时间的前景保持高度乐观,有望实现全年营收增长目标[6][8] - 预计2024年全年盈利能力和正现金产生将持续[9] - 对整体业务的上升轨迹、当前市场动态和未来机遇充满信心[10] - 公司处于有史以来最强的地位,将继续推动和引领TMS行业的创新,有信心在美国和国际上继续占据重要市场份额[19] 其他重要信息 - 截至2024年3月31日,公司拥有4780万美元现金且无债务[15] 问答环节所有的提问和回答 问题:能否提供美国和国外的地域扩张情况,是否有新的重点关注区域[29] - 回答:美国在大多数相关州有广泛覆盖,国际上远东地区(韩国、台湾、印度)以及欧洲部分地区发展势头良好[30] 问题:2024年在神经相关研究方面有何预期[31] - 回答:正在国际上积极销售神经适应症产品,需求良好,将继续收集数据,明年初内部讨论下一个适应症[32] 问题:能否提供美国或国际上关于治疗模式(如治疗次数)的最新情况[33] - 回答:正在进行加速TMS(短疗程)的临床试验,希望今年取得进展[34] 问题:能否提供2024年营收的节奏或分布情况[35] - 回答:对2024年3700万 - 4000万美元的营收指导有信心,订单储备和业务渠道能够支持实现目标[36] 问题:能否详细介绍业务渠道的构成,是否继续受到大客户的关注[39] - 回答:业务渠道由私人诊所、中小型客户、现有客户等组成[40] 问题:吸烟方面有何进展[41] - 回答:正在与潜在感兴趣方积极对话,尚无正式协议时间表,成瘾领域整体有很多兴趣[42] 问题:Deep TMS 360的研究评估进展如何[43] - 回答:正在进行技术可行性和临床疗效测试,目前已有少数患者参与两项不同研究,基于内部可行性研究预计会有好结果[44] 问题:考虑到毛利率稳定,是否会加大再投资以推动营收增长[45] - 回答:会将资金投入到业务增长中,包括增加销售团队、营销计划、研发和临床投资,但会与预测增长保持一致,保持盈利能力和正现金流[46] 问题:预计2024年底总安装基数是多少[48] - 回答:每季度大约增加50 - 60套,可据此推算年底的安装基数[49] 问题:重度抑郁症(MDD)领域的预先授权情况如何演变[50] - 回答:目前标准更接近一两种药物治疗失败即可,过去两年有改善,主要原因是Deep TMS技术的有效率和节省保险费用[51] 问题:Katie's Way是何种级别的客户,是否还有类似的潜在合作对象[53] - 回答:Katie's Way是从小型中型心理健康网络发展起来的,目前有40套系统的安装基数,未来还会增长,业务渠道中有很多类似的潜在合作对象[54][55] 问题:如何战略性地利用现金储备,是否考虑许可引进或收购互补技术[56] - 回答:打算有机和无机地发展业务,正在寻找合适的机会,成瘾和神经等领域有很有趣的机会,但现在还不能分享[57]
BrainsWay Reports First Quarter 2024 Financial Results and Operational Highlights
Newsfilter· 2024-05-08 19:30
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 ...
BrainsWay Announces Published Review Results Highlighting Potential of Deep TMS™ to Treat Parkinson's Disease
Newsfilter· 2024-04-04 20:00
JERUSALEM and BURLINGTON, Mass., April 04, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced results published in a review article exploring the potential efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS™) as a novel therapeutic approach for Parkinson's Disease (PD). The paper was published in Frontiers of Human Neuroscience, a leading peer-review ...
Brainsway(BWAY) - 2023 Q4 - Annual Report
2024-03-29 05:30
公司财务状况 - 公司现金、现金等价物、受限现金和短期存款为4630万美元,累计赤字为1.013亿美元[1] - 公司经营活动现金流为正1.3百万美元,2022年为负9.8百万美元[2] - 公司投资活动现金流为负3.74亿美元,2022年为正4.22亿美元[3] - 公司预计现金和现金等价物足以支持未来12个月和24个月的运营支出和资本支出需求[4] 公司资本来源 - 公司主要资本来源包括公开发行、私人股权融资、IIA的赠款以及Deep TMS系统的租赁和销售[5] - 公司全资子公司已从IIA获得了约1340万美元的赠款[6] 公司知识产权 - 公司的Deep TMS核心技术基于H-Coils,受到专利保护[7] - 公司的知识产权包括34项美国专利、2项待批美国专利申请、51项其他司法管辖区的专利和14项待批专利申请[8] - 公司的知识产权策略是通过提交美国和国外专利申请来保护其专有技术[9] 公司专利许可协议 - 公司与PHS签订的专利许可协议要求支付2%的版税[10] - 公司与Yeda签订的许可协议要求支付1%至2%的净销售额作为版税[11] - 公司在2020年1月行使了增加旋转场TMS创新的权利[12]
All You Need to Know About Brainsway Ltd. Sponsored ADR (BWAY) Rating Upgrade to Buy
Zacks Investment Research· 2024-03-19 01:01
Brainsway Ltd. Sponsored ADR (BWAY) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the syste ...
BrainsWay Broadens Partnership with Katie's Way Plus Through Order of an Additional 18 Deep TMS™ Systems
Newsfilter· 2024-03-18 19:30
BURLINGTON, Mass. and JERUSALEM, March 18, 2024 (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 its significant existing partner, Katie's Way Plus, which provides comprehensive mental health services tailored to the unique needs of active duty military members, veterans, and their families, has ordered an additional 18 Deep Transcranial Magnetic Stimu ...