Core Insights - Neuronetics, Inc. has announced that TriWest has updated its medical policy to include TMS coverage for adolescents aged 15 and older, marking a significant advancement in treatment accessibility for this demographic [1][2][3] Company Overview - Neuronetics, Inc. specializes in medical technology aimed at improving the quality of life for patients with neurohealth disorders, particularly through its NeuroStar Advanced Therapy [1][5] - The company operates Greenbrook TMS Inc., which provides NeuroStar Advanced Therapy for treating major depressive disorder (MDD) and other mental health conditions across the United States [5] Industry Context - TRICARE coverage is primarily utilized by active and retired military personnel and their families, with the new policy affecting beneficiaries in 26 states [2] - An estimated 4.3 million U.S. adolescents aged 15-21 are affected by major depression, highlighting the need for effective treatment options [3] - NeuroStar TMS therapy is recognized as a safe and effective first-line treatment for adolescents with major depressive disorder, especially given the limited medication options available [3][6] Treatment Efficacy - NeuroStar Advanced Therapy has delivered over 7.9 million treatments and is supported by the largest clinical data set for TMS treatment of depression [5] - The therapy is FDA-cleared for various indications, including as a first-line adjunct treatment for adolescents aged 15-21 with MDD [6]

Core Insights - HOPE Therapeutics has initiated patient care for treatment-resistant depression using the Ampa One Day (ONE-D) protocol, marking a significant advancement in TMS therapy [1][2] - The Ampa device has shown promising results with an 87% response rate and a 72% remission rate in nonrandomized trials when combined with D-cycloserine and lisdexamfetamine [1][5] - The ONE-D protocol reduces the treatment duration from 90 days to a single day, offering a new paradigm for patients suffering from severe depression [2][3] Company Overview - HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, is focused on building a network of interventional psychiatry clinics that provide various therapies, including TMS and neuroplastic medications [4] - The company is expanding its presence in Florida, with plans to operate six clinic locations by the end of 2025 [2][5] - Dr. Rebecca Cohen, the Medical Director of HOPE, is the first Ampa-certified psychiatrist in Florida, leading the deployment of the Ampa device [5] Treatment Protocol - The ONE-D protocol combines TMS with physician-prescribed D-cycloserine and lisdexamfetamine, aiming to achieve remission from treatment-resistant depression [4][5] - D-cycloserine has been shown to enhance the effectiveness of TMS significantly, with studies indicating a more than two-fold increase in treatment efficacy [1][3] Research and Development - NRx Pharmaceuticals is developing NRX-100 and NRX-101, targeting central nervous system disorders, including suicidal depression and PTSD [5][6] - NRX-101 has received Breakthrough Therapy designation for treating suicidal bipolar depression, highlighting the company's commitment to addressing critical mental health issues [6]

Company Overview - The company combines mental health services and device expertise to treat more patients[17] - The company has treated 229,429 unique patients and administered 8,213,816 treatments[18, 19] - The company reported $129 million in annual revenue for 2024[19] Market and Clinical Data - The total available market consists of 293 million individuals affected by depression and OCD[34] - Approximately 8 million patients are poorly served by antidepressant medication[35] - 83% of patients experienced improvement in depression symptoms, and 62% achieved symptom relief (remission)[47] Financial Performance and Guidance - Q3 2025 revenue reached $373 million, a 101% increase compared to Q3 2024[92] - The company projects FY 2025 revenue between $147 million and $150 million, representing a 14% to 16% adjusted pro forma year-over-year growth[87] - The company is targeting positive cash flow from operations in Q4 2025[87] Growth Initiatives - The company is expanding the Better Me Provider (BMP) network, with over 420 BMP clinics in 49 states[23] - The company is expanding SPRAVATO® treatment to 89 treatment centers by the end of Fiscal Year 2025[76] - NeuroStar University (NSU) attendees have started 38% more patients, and performed 26% more treatment sessions YTD than non-attendees[65, 69]

Core Points - New York State Medicaid will cover Transcranial Magnetic Stimulation (TMS) services for adults diagnosed with major depressive disorder (MDD) starting October 1, 2025, for fee-for-service members and November 1, 2025, for those in Managed Care Plans [1][2] - This policy change will benefit nearly 1 million individuals with fee-for-service Medicaid and over 4.4 million individuals with Managed Care Organizations in New York [2] - Major depressive disorder affects 21 million adults in the U.S., with 6.4 million unable to tolerate or receiving inadequate relief from antidepressants [3] Company Overview - Neuronetics, Inc. is a medical technology company focused on neurohealth disorders and is the maker of NeuroStar Advanced Therapy, the leading provider of TMS [1][5] - NeuroStar Advanced Therapy is a non-drug, non-invasive treatment that has shown an 83% response rate and a 62% remission rate for MDD patients [3] - Neuronetics operates Greenbrook TMS Inc. treatment centers across the U.S., providing NeuroStar Advanced Therapy and has delivered over 7.6 million treatments [5] Industry Context - The decision by New York State Medicaid reflects a growing recognition of TMS as an evidence-based treatment for depression [2] - Neuronetics is the only TMS company with a dedicated health policy team advocating for health policy updates [4] - The NeuroStar Advanced Therapy System is FDA-cleared for various indications, including MDD and anxiety symptoms in adults [6]

Company Overview - Neuronetics and Greenbrook have combined to leverage scale and capabilities for mental health treatment[17] - The combined company has treated 221,376 unique patients[18] and administered 7,912,427 treatments[19] - The company reported $129 million in annual revenue for 2024 (pro forma adjusted)[19] Market and Opportunity - The total available market is 293 million U S adults and adolescents suffering from depression, depression with anxiety, and OCD[33,34] - Approximately 8 million patients are poorly served by antidepressant medication[34] - Better Me Program (BMP) clinics treat 33 times more patients than non-BMP clinics[57,58] Financial Performance and Guidance - Q2 2025 revenue was $381 million, a 132% increase from Q2 2024[90] - The company projects revenue between $149 million and $155 million for FY 2025, representing a 15% to 19% pro forma year-over-year growth[85] - The company anticipates achieving positive cash flow from operations in Q4 2025[85]

Core Insights - Neuronetics, Inc. reported total revenue of $38.1 million for the second quarter of 2025, reflecting an 18% adjusted pro forma revenue growth and a 132% increase compared to the same quarter in 2024 [1][6][5] - The company achieved record revenue of $23.0 million from Greenbrook clinics during the quarter, contributing significantly to the overall revenue growth [1][6] - Cash used in operations was reduced to $3.5 million, outperforming the guidance of under $5 million [1][4] Financial Performance - Total revenues for the three months ended June 30, 2025, were $38.1 million, up from $16.5 million in the same period of 2024, primarily due to the acquisition of Greenbrook [5][6] - U.S. clinic revenue was $23.0 million, while international revenue increased by 41% to $452,000 [5][7] - Gross margin decreased to 46.6% from 74.0% year-over-year, mainly due to the inclusion of Greenbrook's clinic business [10] Operational Highlights - The company shipped 41 NeuroStar Advanced Therapy Systems, generating $3.5 million in revenue, although this represented a 13% decrease compared to the previous year [8][6] - U.S. treatment session revenue was $10.8 million, an 8% decrease year-over-year, but a 13% increase on a pro forma basis [9][6] - Neuronetics treated over 209,000 global patients with 7.6 million treatment sessions [6] Management and Strategic Developments - Steven Pfanstiel was appointed as the new Chief Financial Officer, bringing over 20 years of healthcare experience [16] - The company secured an additional $10 million in funding from Perceptive Advisors LLC, extending its liquidity requirements [14] - Neuronetics expects total worldwide revenue for the third quarter of 2025 to be between $37.0 million and $39.0 million, and for the full year 2025, between $149.0 million and $155.0 million [17][18] Future Outlook - The company anticipates gross margin improvement in the second half of 2025, expecting it to be between 48% and 50% [18] - Total operating expenses for 2025 are now projected to be between $100.0 million and $105.0 million, reflecting the integration of Greenbrook [19] - Neuronetics expects to achieve positive cash flow from operations in the fourth quarter of 2025 [20]

Core Insights - Neuronetics, Inc. has published significant findings demonstrating the effectiveness of NeuroStar TMS in treating adolescents and young adults with depression, as reported in a leading medical journal [1][2] Company Overview - Neuronetics is a medical technology company focused on improving the quality of life for patients with neurohealth disorders through innovative products [4] - The company operates Greenbrook TMS Inc., which provides NeuroStar Advanced Therapy for major depressive disorder (MDD) and other mental health conditions across the United States [4] Treatment Efficacy - The study based on the NeuroStar TrakStar Clinical Database involved 1,283 patients, with approximately 70% reporting clinically meaningful improvement in depression symptoms, while less than 1% experienced worsening [2][3] - The results for adolescents and young adults align with previous findings in adult populations, indicating a strong correlation between the number of treatment sessions completed and clinical improvement [2] Market Opportunity - With one in five adolescents experiencing major depressive disorder and limited FDA-approved medications available, NeuroStar TMS presents a significant opportunity to provide a safe and effective treatment option for this demographic [3] - Since receiving FDA clearance as an add-on therapy for adolescents aged 15-21 in March 2024, there has been over a one-third increase in the number of adolescents treated with NeuroStar [2]

Core Insights - NeuroStar, a Silver Sponsor at the 13th Annual Clinical TMS Society (CTMSS) Meeting, is committed to clinical innovation and excellence in mental health care [1][2] - The company will present two significant poster presentations based on the TrakStar data set, which is the largest real-world outcomes database in TMS [2][3] - NeuroStar aims to optimize TMS efficacy and expand its use into new populations and protocols, reinforcing its leadership in the psychiatric community [3] Company Updates - NeuroStar will present a retrospective analysis comparing clinical outcomes between its proprietary Figure-8 coil and Brainsway's H-coil in treating depression [2] - The company is evaluating personalized qEEG-informed protocols for TMS therapy, demonstrating operational feasibility with the NeuroStar TMS System [4] - NeuroStar has delivered over 7.4 million treatments and operates Greenbrook TMS centers across the U.S. for treating Major Depressive Disorder (MDD) and other mental health disorders [6] Event Participation - The CTMSS Meeting will take place from June 11-14 in San Diego, CA, where NeuroStar will also participate in the PULSES Course for TMS providers [2] - Presentations will include data on elderly adults (age 70 and older) with MDD treated with TMS, and a retrospective analysis from 200 Greenbrook centers [7]

Company Overview & Strategy - Neuronetics and Greenbrook have combined to leverage scale and treat more mental health patients, having treated 213,500 unique patients and administered 7,620,000 treatments[13] - The company is focused on driving accelerated growth, realizing cost reductions, and transforming its financial profile to deliver mid-teens revenue growth and near-term profitability[21] - A key strategy involves expanding the Better Me Provider (BMP) network, with over 375 BMP clinics in 49 states[17], and increasing patient flow through referral networks and optimized digital marketing[70] Financial Performance & Guidance - Full year 2024 consolidated adjusted net pro forma revenue was $129.4 million[13, 79] - Q1 2025 revenue reached $32.0 million, an 84% increase compared to Q1 2024 on a reported basis and a 7% increase on an adjusted pro forma basis[88, 95] - The company anticipates revenue between $149 million and $155 million for FY 2025, representing a 15% to 19% pro forma year-over-year growth[83] - The company expects to achieve cash flow positive status beginning in Q3 2025[83] Cost Synergies - The company has identified $22.6 million in annualized expected cost savings through various initiatives, including NNI RIF/Spend Reductions ($16.2 million), Greenbrook Clinics savings ($5.1 million), and Additional Reductions ($1.3 million)[77] Clinical & Market Position - NeuroStar is the first FDA-cleared TMS treatment for adolescent depression and is positioned as a first-line treatment[44] - Real-world clinical results show 83% improvement in depression symptoms and 62% symptom relief (remission) for patients with MDD[39] - Practices attending NeuroStar University (NSU) have started 40% more patients than non-attendees since Q3 2022[55], and performed 30% more treatment sessions in Q1 2025[60]

Core Insights - The FDA has approved the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation (TMS) Systems for treating major depressive disorder (MDD) in adolescents aged 15-21, providing a non-invasive treatment option [1][2] - Major depression affects over 5 million adolescents in the U.S. annually, with 20% of those aged 12 to 16 experiencing at least one major depressive episode [1][3] - TMS is a non-invasive procedure that stimulates nerve cells in the brain, improving symptoms of MDD without the systemic side effects associated with traditional antidepressants [2][5] Company Insights - Magstim is the only TMS system capable of treating MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil [4] - The company has delivered over 400 million treatment pulses using the Horizon 3.0 system, demonstrating its extensive application in mental health treatment [5] - Magstim has a long history in TMS technology, having developed the first system over 30 years ago, with over 16,000 studies published worldwide citing its stimulators [5] Industry Insights - The approval of TMS for adolescents reflects a growing need for innovative treatment options in mental health, particularly for young patients who may not respond to or prefer not to use antidepressants [2][4] - The WHO emphasizes the importance of addressing untreated depression during adolescence, as it is a leading cause of illness and disability [3] - The advancement in TMS technology aligns with the increasing demand for non-pharmacological treatment methods in mental health care [4]