Financial Data and Key Metrics Changes - Revenues for Q2 2025 were $894,000, up 46% compared to $612,000 in Q2 2024, marking the fourth consecutive quarter of double-digit growth [27] - Revenue for the six months ended June 30, 2025, increased to $1,800,000, up 42% from $1,300,000 for the same period in 2024 [27] - Operating loss in 2025 was $1,700,000, a decrease of 22% compared to a $2,200,000 loss in 2024 [33] - Net loss in 2025 was $1,700,000, down 42% from $2,900,000 in 2024 [34] Business Line Data and Key Metrics Changes - Unit sales increased approximately 5853% for the three and six months ended June 30, 2025, due to volume growth from patients with health insurance coverage and the company's financial assistance program [27] - Average selling prices for patients receiving IV stem through financial assistance are about 65% below the list price [9] Market Data and Key Metrics Changes - Approximately 53 million covered lives have been reached for medical policy coverage, which is seen as a key driver for revenue growth [12] - The company expects revenue growth to accelerate as payer medical policy coverage increases and the new category one CPT code becomes effective on January 1, 2026 [22] Company Strategy and Development Direction - The company is focused on securing broad medical policy coverage and advancing disciplined commercial execution to drive utilization and scale [25] - The introduction of the category one CPT code is expected to facilitate easier billing and reimbursement, significantly impacting revenue potential [19] - The company is also advancing the RED product line, which is in the soft launch phase, with plans for a hard launch [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the commercialization strategies and the expected revenue growth due to recent milestones, including FDA indication expansion and published clinical practice guidelines [7][14] - The management highlighted that the guidelines published by academic societies are crucial for gaining insurance coverage and improving treatment access [16] Other Important Information - The gross margin for 2025 was 83.6%, down from 88% in 2024, primarily due to higher discounting in the financial assistance program [28] - Cash on hand as of June 30, 2025, was $6,000,000, with the company having secured $5,000,000 through an equity financing round [34] Q&A Session Summary Question: Perceptions from larger insurance plans post-guideline publishing - Management noted positive responses from insurance plans, with some agreeing to interim reviews due to the guidelines, indicating favorable perceptions [40][41] Question: Goals for coverage and prior authorization expectations - Management expects some medication requirements to be removed, allowing for earlier use of IV stem treatments, although this will be a gradual process [44][45] Question: Salesforce expansion triggers - The urgency for payer policy coverage is aligned with the urgency on the commercial side, with plans to expand the sales force as insurance coverage increases [48][49] Question: Discount rates and cash pay devices - Management clarified that 70% of patients initially face a "no auth required" response, limiting treatment options, and discussed the average selling price for patients receiving financial assistance [54][58] Question: Approval for adults to use the IV stem device - The company is in discussions with the FDA regarding adult usage and expects to have an answer by the Q4 call [65] Question: Satisfaction with RVUs and reimbursements - Management expressed satisfaction with the RVU assignment of 1.46 and noted that reimbursement values are favorable, exceeding the cost of the device [70][71] Question: General and administrative expenses and leverage - Management discussed achieving operating expense leverage while continuing to invest in growth areas such as sales and R&D [73][74] Question: Current cash balance and future outlook - The current cash position is sufficient to support operations into 2026, with expectations for improved insurance coverage positively impacting liquidity [78]
Neuraxis(NRXS) - 2025 Q2 - Earnings Call Transcript