Financial Data and Key Metrics Changes - The company generated $11,500,000 in revenue for Q1 2025, a 27% increase year over year from $9,100,000 in Q1 2024 [4][15] - Gross profit for Q1 2025 was $8,600,000, maintaining a gross margin of 75%, compared to $6,800,000 in the prior year [16] - Operating profit for Q1 2025 was approximately $576,000, up from approximately $93,000 in the same period of 2024 [17] - Adjusted EBITDA for Q1 2025 was about $1,300,000, representing the seventh consecutive quarter of positive adjusted EBITDA, compared to $715,000 in Q1 2024 [17] - The company reported a net profit of about $1,100,000 for Q1 2025, compared to $111,000 in Q1 2024 [18] - Cash, cash equivalents, and short-term deposits totaled approximately $72,000,000 as of March 31, 2025 [18] Business Line Data and Key Metrics Changes - The company shipped a total of 81 Deep TMS systems in Q1 2025, representing a 42% increase compared to Q1 2024 [4] - The installed base of Deep TMS systems increased to 1,434 as of March 31, 2025, compared to 1,158 systems at the same point in the prior year [15] Market Data and Key Metrics Changes - The backlog and remaining performance obligation totaled nearly $60,000,000, providing visibility into future growth [5] - The U.S. market is driving commercial growth, particularly in the treatment of obsessive-compulsive disorder (OCD) and anxious depression [5] Company Strategy and Development Direction - The growth strategy focuses on three key pillars: elevating market awareness of Deep TMS, advancing the R&D roadmap for new treatment indications, and broadening patient access through global expansion [7] - The company aims to ramp up activity around OCD in 2025, with over 60% of patients responding positively to Deep TMS therapy [9] - The company is also working to expand reimbursement for PTSD treatment in Israel and is advancing clinical trials for an accelerated treatment protocol for major depressive disorder [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive operating environment and reiterated full-year 2025 financial guidance of $49,000,000 to $51,000,000 in revenue, representing 20% to 24% growth over 2024 [14][19] - The company does not anticipate a material impact on gross margin from recent international trade and tariff policies [14] Other Important Information - The company is actively monitoring geopolitical risks and tariff policies but does not foresee significant negative impacts on its operations [37] - The company is evaluating the implementation of a stock repurchase program but is currently focused on expanding growth and investing in innovation [41] Q&A Session Summary Question: What is the breakdown of new sales between market expansion and competitive conversions? - Management indicated that approximately 80% of new sales are from greenfield opportunities, while 20% are competitive conversions [21] Question: Can you elaborate on the pay-per-use model? - The pay-per-use model is being implemented in specific segments, providing systems without upfront fees and charging per procedure, which offers flexibility for providers [23] Question: When can we expect data from the accelerated protocol clinical trials? - The company expects to receive FDA clearance for the accelerated protocol data by the end of the year and is also working on data collection for PTSD treatment [25][26] Question: How many OCD helmets were shipped during the quarter? - The company shipped 57 OCD helmets, bringing the total installed base to approximately 850 globally [29] Question: Are there significant geopolitical risks affecting the business? - Management does not see significant geopolitical risks impacting the business at this time, although they are actively monitoring the situation [37] Question: Will there be more upgrades to the current installed base this year or in 2026? - Management expects continued demand growth for Deep TMS systems, indicating a healthy demand for upgrades [39] Question: Is the company considering a stock repurchase program? - Currently, the company is not considering a stock repurchase program, focusing instead on growth and innovation investments [41]

Financial Performance - For the year ended December 31, 2024, the company reported cash and cash equivalents of $69.6 million, an increase from $46.3 million as of December 31, 2023[520]. - The company achieved positive cash flows from operating activities of $10.3 million in 2024, compared to $1.3 million in 2023, marking an increase of $9.0 million[524]. - The net cash provided by investing activities was $30.3 million in 2024, a significant recovery from the $37.4 million used in 2023[525]. - Net cash provided by financing activities increased to $18.3 million in 2024, compared to $1.0 million used in 2023, primarily due to proceeds from a private placement[526]. - As of December 31, 2024, the company had an accumulated deficit of $98.4 million, reduced from $101.3 million in 2023[520]. - Finance income increased to $2.0 million for the year ended December 31, 2024, up from $1.0 million in 2023, primarily due to the remeasurement of warrants[517]. Capital Raising and Funding - The company raised approximately $20 million in November 2024 from a private placement, which is expected to support ongoing operations and marketing efforts[522]. - The company received grants from the IIA totaling approximately $13.4 million, with royalties paid amounting to $6.2 million as of December 31, 2024[528]. - The Valor Warrant allows for the purchase of 1,500,000 ADSs at an exercise price of $9.50686, which may be exercised if the ADS closing price exceeds the exercise price by 40%[531]. Intellectual Property and Technology - The company’s intellectual property portfolio includes 34 issued U.S. patents and 60 issued patents in other jurisdictions related to Deep TMS technology[535]. - The company owns a family of patent applications covering several H-Coils, including those used in MDD and OCD systems, with one pending patent application in the U.S. and five in other jurisdictions[549]. - The company has faced challenges in protecting its intellectual property, with potential risks related to patent applications and competition in the neuromodulation market[550]. - The company is actively involved in the commercialization of Deep TMS technology, with exclusive licenses for worldwide commercialization from PHS and Yeda[551]. Research and Development - The company has a strong focus on research and development, particularly in the field of TMS technology for treating depression, leveraging exclusive licenses from PHS and Yeda[559]. - The company expects revenue growth from the marketing of its Deep TMS system for MDD, OCD, and smoking addiction[522]. Compensation and Governance - The total compensation for all directors and officers for the year ended December 31, 2024, was approximately $4.9 million, with $3 million paid as salary[584]. - The five highest compensated officers received a total compensation ranging from $307,177 to $804,304, with the CEO Hadar Levy earning $804,304[588]. - The company has adopted a Compensation Recovery Policy to recover incentive-based compensation in case of accounting restatements[585]. - The compensation policy requires approval from the board and shareholders, with specific provisions for non-controlling shareholders[599]. - The company’s compensation committee is responsible for recommending compensation policies and reviewing their implementation every three years[644]. Board of Directors and Committees - The Board of Directors consists of eight independent directors, with terms lasting until the next annual general meeting[609]. - The audit committee consists of three members, all of whom must be independent directors, and is responsible for overseeing financial risk exposures and compliance with legal requirements[629][628]. - The company has established four standing committees: audit committee, compensation committee, nomination committee, and executive committee[621]. - The company complies with Nasdaq requirements for the composition of its audit committee and compensation committee, opting out of certain Israeli Companies Law requirements[620][625]. Employee Relations - As of December 31, 2024, the company had 120 employees, with 49 based in the United States and 71 in Israel[687]. - The company has never experienced any employment-related work stoppages and maintains a good relationship with its employees[688]. - The company provides benefits and working conditions beyond the required minimums as per employment-related laws and regulations[687].

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $11.4 million, a 27% increase year-over-year from $9 million [26] - Full year 2024 revenue reached $41 million, representing a 29% increase from $31.8 million in 2023 [27] - Gross profit for Q4 2024 was $8.5 million, maintaining a gross margin of 75%, compared to $6.7 million in the prior year [28] - Full year 2024 gross profit was $30.6 million, also at a 75% gross margin, up from $23.5 million in 2023 [28] - Net income for Q4 2024 was $1.5 million, compared to $127,000 in Q4 2023 [33] - Full year 2024 net income was approximately $2.9 million, a significant improvement from a net loss of $4.2 million in 2023 [33] Business Line Data and Key Metrics Changes - A total of 75 Deep TMS systems were shipped in Q4 2024, a 25% increase compared to the same period last year [9] - The total installed base of Deep TMS systems reached 1,353 as of December 31, 2024, up from 1,101 a year earlier [26] Market Data and Key Metrics Changes - The company is expanding its market presence across key regions including Canada, Asia, India, and Europe [11] - Anticipated revenue for full year 2025 is projected to be between $49 million and $51 million, indicating a growth of 20% to 24% over 2024 [12][34] Company Strategy and Development Direction - The company aims to solidify its market leadership by advancing the next-generation Deep TMS 360 system, conducting clinical trials, and enhancing commercial presence through targeted sales and marketing initiatives [13] - Focus on increasing sales for OCD treatment, which has a substantial potential market of approximately 400,000 patients annually [15] - Plans to expand reimbursement for PTSD treatment in Israel and explore new treatment avenues for adolescent depression [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining gross margins around 75% for 2025, with expectations for continued profitability [44] - Positive trends in treatment paradigms for MDD and OCD were noted, with expectations for increased payer coverage [52][54] - The company does not foresee significant impacts from macroeconomic changes on its operations [72] Other Important Information - The company reported a strong balance sheet with $69.4 million in cash as of December 31, 2024, including $20 million from equity financing [23][33] - Management is focused on organic growth while exploring collaborations with mental health and addiction centers [66] Q&A Session Summary Question: What were the standout drivers for the 75 placements this quarter? - Management highlighted enterprise accounts as a significant driver, along with increased demand for OCD treatment and utilization for MDD and elderly patients [38] Question: What is the latest on the accelerated treatment protocol? - The recruitment for the protocol is in the final stage, with data analysis expected to begin in Q3 2025 [41] Question: What are the expectations for gross margin in 2025? - Management expects gross margin to remain around 75% for 2025, with potential for improvement [44] Question: Are current centers increasing the use of psychedelic therapy? - There is a growing demand from psychedelic clinics to incorporate Deep TMS technology into their offerings [49] Question: What changes are seen in the treatment paradigm for MDD and OCD? - The treatment paradigm for MDD has improved, with reduced failure requirements for treatment eligibility, while OCD coverage is steadily increasing [52][54] Question: What is the plan for the next-gen TMS 360 system? - A multi-center trial for the TMS 360 system is planned for the second half of 2025, with feasibility studies for Alzheimer’s and Parkinson’s diseases also in consideration [56][57] Question: Will there be any impact from NIH funding cutbacks? - Management confirmed no current impact from NIH funding cutbacks on ongoing projects [75]

Financial Performance - Achieved record quarterly sales of $11.4 million in Q4 2024, a 27% increase compared to Q4 2023[1] - Full year 2024 revenue increased nearly 30% YoY to $41 million[1] - Operating income for the full year 2024 was $1.4 million, compared to an operating loss of $5.0 million in the prior year[5] - Net income for the full year 2024 was $2.9 million, compared to a net loss of $4.2 million in the prior year[5] - Adjusted EBITDA for the full year 2024 was approximately $4.5 million, compared to an adjusted EBITDA loss of $2.4 million for the prior year[5] - Revenues for Q4 2024 increased to $11,414,000, a 26.5% rise from $9,029,000 in Q4 2023[22] - Gross income for Q4 2024 was $8,511,000, up 26.3% from $6,739,000 in Q4 2023[22] - Operating income for the year ended December 31, 2024, was $1,391,000, compared to a loss of $4,959,000 in 2023[22] - Net income for Q4 2024 was $1,548,000, significantly higher than $127,000 in Q4 2023[22] - Adjusted EBITDA for Q4 2024 was $1,360,000, compared to $757,000 in Q4 2023, reflecting a 79.6% increase[27] Future Projections - Company expects revenue for full year 2025 to be between $49 million to $51 million, representing 20% to 24% growth over 2024 revenue[11] Cash and Financing - Increased cash and cash equivalents to $69.4 million as of December 31, 2024, compared to $10.5 million in the prior year[21] - Cash and cash equivalents at the end of Q4 2024 were $69,345,000, up from $10,520,000 at the end of Q4 2023[25] - The company raised $16,353,000 from the issuance of shares in Q4 2024, contributing to a net cash provided by financing activities of $19,585,000[25] Operating Expenses - Total operating expenses for the year ended December 31, 2024, were $29,190,000, slightly higher than $28,436,000 in 2023[22] - Research and development expenses for Q4 2024 were $2,044,000, an increase from $1,434,000 in Q4 2023[22] Product Performance - Shipped a net total of 75 Deep TMS™ systems in Q4 2024, a 25% increase from Q4 2023[5] - Completed a $20 million strategic equity financing transaction with Valor Equity Partners to expand access to Deep TMS™[5] Cash Flow - The company reported a net cash provided by operating activities of $10,230,000 for the year ended December 31, 2024, compared to $1,284,000 in 2023[24]

Core Viewpoint - BrainsWay (BWAY) shares have experienced a significant decline of 15.7% over the past four trading sessions, falling below the 50-day moving average, indicating potential weakness in the stock. The company is set to release its fourth-quarter results on March 11, with expectations of 20% growth in sales and 200% growth in earnings per share (EPS) year-over-year [1][2]. Company Performance - BWAY shares have increased by 4.6% year-to-date, underperforming the Zacks Medical Products sector's growth of 10.8% but outperforming the S&P 500 Index's rise of 1.4%. Despite this, BWAY shares are still trading above the 200-day simple moving average (SMA) [3]. - In the third quarter, BWAY reported a 26% year-over-year revenue growth and raised its full-year guidance to $40-41 million. A $20 million investment from Valor Equity Partners aims to enhance market awareness and data analysis [6]. Market Expansion - BrainsWay is expanding its global presence with 15 new Deep Transcranial Magnetic Stimulation (TMS) system placements in Taiwan and South Korea. The company has made significant strides in the U.S. market by placing 14 new Deep TMS systems, aligning with the rising demand for non-invasive mental health treatments [6][8]. - The global neurostimulation devices market is projected to grow at a CAGR of 12.8% through 2030, with increasing demand for non-invasive, drug-free mental health treatments [12]. Clinical Developments - Positive clinical data from a study on Deep TMS therapy for chronic peripheral neuropathic pain showed significant reductions in pain, anxiety, and depression symptoms, suggesting potential for broader applications beyond mental health [9]. - An independent pilot study at Stanford University indicated that an accelerated Deep TMS protocol positively impacted alcohol use disorder (AUD) patients, leading to a $1.5 million grant from the National Institutes of Health to further investigate its effectiveness [10]. Strategic Partnerships - BrainsWay's partnerships with large healthcare networks and insurance providers are crucial for scaling its business. Recent approvals for insurance reimbursements, such as for PTSD therapy, can enhance patient accessibility and adoption rates [13]. Competitive Landscape - The company faces strong competition in the neurostimulation market from firms like Neuronetics, Medtronic, and Abbott, which have larger research and development budgets and broader neuromodulation portfolios [16]. - Expanding Deep TMS for new treatments requires FDA approvals and clinical validation, which can be time-consuming and costly [17]. Valuation Insights - BWAY stock is currently trading at a premium compared to the Medical Products industry, with a forward 12-month price-to-sales ratio of 3.88X, lower than the industry's 6.27X but above its median, indicating higher valuation expectations [18]. Conclusion - The recommendation for existing investors is to hold BWAY stock due to its expansion of Deep TMS applications and increasing market demand. However, new investors are advised to monitor the stock for better valuation opportunities [21].

Group 1 - BrainsWay Ltd. will report its fourth quarter and full year 2024 financial results on March 11, 2025, before the U.S. financial markets open [1] - A conference call and webcast will be held at 8:30 AM Eastern Time to discuss the results and provide an update on business operations [1][2] - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [3] Group 2 - The company has obtained three FDA-cleared indications for its TMS technology, which include major depressive disorder, obsessive-compulsive disorder, and smoking addiction [3] - BrainsWay is committed to advancing neuroscience and increasing global awareness and access to Deep TMS [3] - Additional clinical trials for Deep TMS are currently underway in various psychiatric, neurological, and addiction disorders [3]

Company Performance - Brainsway Ltd. Sponsored ADR (BWAY) shares have increased by 18.2% over the past month, reaching a new 52-week high of $11.09 [1] - Year-to-date, the stock has gained 17.2%, outperforming the Zacks Medical sector, which declined by 3.2%, and the Zacks Medical - Products industry, which returned 17.1% [1] Earnings and Revenue - Brainsway has consistently exceeded earnings expectations, reporting an EPS of $0.04 against a consensus estimate of $0.01 in its last earnings report on November 12, 2024, and beating revenue estimates by 4.33% [2] - For the current fiscal year, Brainsway is projected to earn $0.16 per share on revenues of $40.41 million, with a year-over-year earnings growth of 93.75% [3] - The next fiscal year forecasts earnings of $0.21 per share on revenues of $46.38 million, representing a year-over-year change of 14.78% [3] Valuation Metrics - Brainsway has a Value Score of D, a Growth Score of A, and a Momentum Score of C, resulting in a VGM Score of B [6] - The stock trades at 71.3X current fiscal year EPS estimates, significantly higher than the peer industry average of 18.7X, while on a trailing cash flow basis, it trades at 5X compared to the peer group's average of 11.5X [6] Zacks Rank - Brainsway holds a Zacks Rank of 1 (Strong Buy), supported by favorable earnings estimate revisions from analysts [7] - The combination of a Strong Buy rating and a VGM Score of B suggests potential for further stock price appreciation in the near term [8] Industry Comparison - The Medical - Products industry is performing well, ranking in the top 38% of all industries, indicating positive market conditions for both Brainsway and its peers [11] - ResMed Inc. (RMD), a competitor, has a Zacks Rank of 2 (Buy) and has also shown strong earnings performance, with a projected EPS of $9.35 on revenues of $5.1 billion for the current fiscal year [9][10]

Company Overview - Brainsway Ltd. (BWAY) shares increased by 8% to close at $11.05, supported by high trading volume, and have gained 11.8% over the past four weeks [1] - The company reported a 26% year-over-year revenue growth in Q3, alongside positive net income, which has led to optimistic investor sentiment regarding its growth prospects [2] Financial Performance - BWAY is expected to report quarterly earnings of $0.03 per share, reflecting a year-over-year increase of 200%, with revenues projected at $10.84 million, up 20% from the previous year [3] - The consensus EPS estimate for BWAY has been revised 250% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] Market Position - BWAY holds a Zacks Rank of 1 (Strong Buy), indicating strong market confidence in the stock [4] - In the same medical products industry, AtriCure (ATRC) has also shown positive performance, with a 3% increase in its stock price and a 26.1% return over the past month [4]

Core Viewpoint - Brainsway Ltd. Sponsored ADR (BWAY) shows a significant improvement in earnings outlook, making it an attractive investment option as analysts continue to raise earnings estimates for the company [1][3]. Current-Quarter Estimate Revisions - The company is projected to earn $0.03 per share for the current quarter, reflecting a year-over-year increase of +200% [4]. - Over the past 30 days, there has been one upward revision in estimates with no negative revisions, leading to a 250% increase in the Zacks Consensus Estimate [4]. Current-Year Estimate Revisions - For the full year, Brainsway is expected to earn $0.08 per share, indicating a year-over-year change of +130.77% [5]. - The trend for current-year estimates is positive, with one estimate moving higher and no negative revisions, resulting in a 67.57% increase in the consensus estimate [5]. Favorable Zacks Rank - The positive estimate revisions have earned Brainsway a Zacks Rank 1 (Strong Buy), indicating strong potential for outperformance [6]. - Research indicates that stocks with Zacks Rank 1 and 2 significantly outperform the S&P 500 [6]. Bottom Line - Strong estimate revisions have led to a 5.9% increase in Brainsway's stock over the past four weeks, suggesting further upside potential [7].

Group 1: Stock Performance and Price Targets - Brainsway Ltd. Sponsored ADR (BWAY) closed at $9.89, with a 5.9% gain over the past four weeks, and a mean price target of $13.73 indicating a 38.8% upside potential [1] - The average price targets range from a low of $12.50 to a high of $16, with a standard deviation of $1.56, suggesting a 26.4% increase at the lowest estimate and a 61.8% increase at the highest [2] - A tight clustering of price targets, indicated by a low standard deviation, suggests a high degree of agreement among analysts regarding the stock's price movement [7] Group 2: Earnings Estimates and Analyst Consensus - Analysts have shown increasing optimism about BWAY's earnings prospects, with strong agreement in revising EPS estimates higher, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has increased by 67.6% due to one estimate moving higher over the last 30 days without any negative revisions [10] - BWAY holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for upside [11] Group 3: Analyst Behavior and Price Target Reliability - Analysts often set overly optimistic price targets due to business incentives, which can lead to inflated estimates [6] - While price targets are commonly sought after, they can mislead investors more often than guide them accurately [5] - Investors should treat price targets with skepticism and not rely solely on them for investment decisions [8]