Company Leadership Transition - Steven Pfanstiel has been appointed as the new Chief Financial Officer of Neuronetics, effective July 15, 2025, replacing Steve Furlong, who will retire on March 31, 2026 [2][3] - Steve Furlong will continue to serve as Senior Advisor to the CEO during the transition period to ensure operational continuity [2][3] Executive Background - Steven Pfanstiel brings over two decades of healthcare experience, having previously served as CFO and COO at Marinus Pharmaceuticals, where he was instrumental in the launch of the flagship product, Ztalmy [3][4] - Pfanstiel has held senior financial roles at various high-growth healthcare companies, including Lifescan and Optinose, and has experience at Johnson & Johnson across multiple product categories [3][4] Strategic Vision and Growth - Neuronetics aims to expand access to mental health treatments and deliver sustainable growth, leveraging Pfanstiel's expertise in financial leadership and growth strategies [3][4] - The company is focused on integrating Greenbrook operations and achieving positive cash flow in the third quarter of 2025, marking a significant operational milestone [5] Stock Incentives - As part of his employment agreement, Pfanstiel received an inducement grant of 400,000 restricted stock units, with specific vesting schedules tied to his continued employment [4] Company Performance and Market Position - Neuronetics reaffirms its guidance for the second quarter and full year 2025, driven by successful integration efforts and key growth drivers [5] - The company operates Greenbrook TMS treatment centers across the U.S., offering NeuroStar Advanced Therapy, which has delivered over 7.4 million treatments for major depressive disorder (MDD) [6][7]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash, cash equivalents, and investments totaling $245.5 million, which is expected to fund operations into 2027 [20] - Research and development expenses increased to $23.4 million for Q1 2025, up from $11.7 million in Q1 2024, primarily due to costs associated with the MM120 program [21] - General and administrative expenses decreased to $8.8 million in Q1 2025 from $10.5 million in Q1 2024, attributed mainly to stock-based compensation [21] Business Line Data and Key Metrics Changes - The company is advancing its lead program MM120, targeting generalized anxiety disorder (GAD) and major depressive disorder (MDD) with three pivotal Phase 3 trials actively enrolling [6][20] - The trials, Voyage and Panorama for GAD, and EMERGE for MDD, are designed to assess the efficacy and safety of MM120 ODT [15][19] Market Data and Key Metrics Changes - The company noted a significant unmet need for treatments addressing GAD and MDD, with over 50 million people affected in the U.S. alone [7] - There is a growing awareness and recognition of anxiety disorders, which is expected to benefit clinical research and commercial opportunities for GAD treatments [37] Company Strategy and Development Direction - The company aims to position MM120 ODT as a best-in-class treatment for GAD and MDD, with a clear regulatory strategy and breakthrough therapy designation [7][22] - The new Chief Commercial Officer, Matt Wiley, is expected to lead the commercial strategy during this critical growth phase, leveraging his extensive experience in CNS and psychiatry [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of MM120 ODT to redefine treatment paradigms for GAD and MDD [10][22] - The company anticipates top-line data readouts from the trials in 2026, which will be crucial for future commercialization efforts [20][22] Other Important Information - The company amended its loan agreement to provide greater financial flexibility, allowing access to up to $120 million based on milestone achievements [20] - The company is committed to ensuring participant safety in clinical trials, employing rigorous screening and monitoring processes [50][51] Q&A Session Summary Question: Clarification on the MDG trial and therapeutic effective dose - Management confirmed that the MDD study will not use an intermediate dose, focusing on 100 micrograms versus placebo, and indicated that the same therapeutic dose is expected to be effective in MDD as seen in GAD [24][26] Question: Insights from GAD epidemiology and treatment patterns - Management noted that there is increasing awareness of GAD, which is beneficial for recruitment and clinical trials, and emphasized the importance of understanding treatment patterns [31][37] Question: Engagement with the FDA amid leadership changes - Management reported strong ongoing engagement with the FDA, with no direct impact from recent leadership changes [40][42] Question: Steps to limit enrolling professional patients - The company has implemented strict screening processes to ensure appropriate patient selection and adherence to trial protocols [46][48] Question: Plans for interim data releases in 2025 - Management indicated that there are no plans to release unblinded data this year, focusing instead on executing the studies and ensuring high-quality results [56][58] Question: Market dynamics and commercial planning activities - The company is confident in addressing unmet needs in GAD and MDD, with plans to refine market positioning and messaging in the second half of the year [62][65]

Core Insights - Neuronetics reported strong financial results for Q1 2025, with total revenues of $32.0 million, an 84% increase compared to $17.4 million in Q1 2024, primarily driven by the acquisition of Greenbrook [5][6][10] - The company is on track to achieve positive cash flow by Q3 2025, supported by growth initiatives and operational improvements [4][15] Financial Performance - Total revenues for Q1 2025 were $32.0 million, up 84% from $17.4 million in Q1 2024, with U.S. revenues increasing by 87% to $31.5 million [5][6] - U.S. clinic revenue reached $18.7 million, while treatment session revenue was $9.6 million, both reflecting the impact of the Greenbrook acquisition [8][10] - Gross margin decreased to 49.2% from 75.1% in the previous year, mainly due to the inclusion of Greenbrook's clinic business [9] - Operating expenses rose to $26.8 million, a 35% increase from $19.9 million in Q1 2024, largely due to Greenbrook's administrative costs [9] Operational Highlights - The integration of Greenbrook is progressing well, with significant operational advancements noted [6][15] - The Better Me Provider program is effectively increasing patient treatment rates and therapy initiation speed [4] - Major insurance coverage expansions for adolescent TMS treatment have been achieved, enhancing access for patients aged 15 and older [13][14] Strategic Developments - A secondary offering raised approximately $18.9 million in net proceeds, strengthening the company's financial position [6][15] - The company expects total worldwide revenue for Q2 2025 to be between $36.0 million and $38.0 million, and for the full year 2025, between $149.0 million and $155.0 million [16][17] Leadership Changes - Chief Financial Officer Steve Furlong will retire in March 2026, with a search for his successor already underway [12]