Accelerated Treatment Protocol

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Brainsway(BWAY) - 2025 Q2 - Earnings Call Transcript
2025-08-13 13:00
Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $12,600,000 for Q2 2025, representing a 26% increase compared to $10,000,000 in the same period last year [4][12] - Gross profit for the quarter was $9,500,000, up from $7,500,000 in the prior year, maintaining a strong gross margin of 75% [12][13] - Net profit for the quarter was $2,000,000 compared to $600,000 in the same period of 2024 [14] - Remaining performance obligation grew to $62,000,000, a 25% year-over-year increase, providing strong visibility into future revenue [16] Business Line Data and Key Metrics Changes - The company shipped a total of 88 Deep TMS systems during the quarter, representing a 35% increase compared to the same period last year [4][5] - The total installed base reached 1,522 systems as of June 30, 2025, compared to 1,215 systems a year ago [12] Market Data and Key Metrics Changes - The company has focused on generating recurring revenue streams through multiyear lease agreements, which now account for approximately 70% of recent customer engagements [5] - The backlog of signed agreements with remaining performance obligations totaled approximately $62,000,000, indicating strong future revenue visibility [5][16] Company Strategy and Development Direction - The company aims to elevate market awareness of Deep TMS, advance its R&D roadmap, and broaden patient access through global expansion and health system integration [6] - A new initiative to generate shareholder value through minority interest investments in mental health providers was identified, with a strategic equity investment of $20,000,000 from Valo Equity Partner [10][11] - The company plans to sign at least five contracts for strategic financing arrangements by the end of the year, with a goal of 10 contracts by 2026 [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerated treatment protocol for Deep TMS, expecting FDA clearance by Q4 2025, which could significantly enhance patient convenience [20][21] - The company raised its full-year 2025 revenue guidance to a range of $50,000,000 to $52,000,000, representing 22% to 27% growth over 2024 revenue [17] Other Important Information - The company has engaged in educational initiatives to enhance clinician knowledge and confidence in Deep TMS, including funding new continuing medical education courses [7][8] - Cash position at the end of the quarter was $78,300,000, up $30,200,000 from the same point last year, reflecting strong collections and strategic investments [14][15] Q&A Session Summary Question: Can you discuss the accelerated protocol and its market potential? - Management expects to receive FDA feedback on the accelerated protocol by Q4 2025, which could reduce treatment time significantly, making it more appealing to patients [20][21] Question: What is the size of the commercial organization and its growth? - The current sales team consists of 16 direct sales personnel and 10 practice development staff, totaling 26 individuals supporting sales activities [25] Question: What is the status of the TMS 360 and pilot studies? - The TMS 360 is planned for launch with an alcohol use disorder trial in Q3 2025, alongside feasibility studies for other indications [27] Question: What is the composition of the backlog and OCD placements? - The majority of the backlog comes from enterprise customers, with 30 OCD systems shipped in the second quarter [32] Question: How many strategic financing arrangements are planned for this year? - The company aims to sign at least five new contracts for strategic investments by the end of the year, with potential investments ranging from $2,000,000 to $5,000,000 [36][37] Question: How has the Stella financing arrangement been performing? - The collaboration with Stella MSO has resulted in over a 50% increase in TMS patient utilization, demonstrating the effectiveness of the partnership [38]