Financial Data and Key Metrics Changes - Revenues in Q3 2025 were $811,000, up 22% compared to $677,000 in Q3 2024, marking the fifth consecutive quarter of double-digit growth [20][18] - Gross margin in Q3 2025 was 83.3%, down from 85.4% in Q3 2024, attributed to higher discounting and stronger unit growth in lower-margin programs [21][22] - Operating loss in Q3 2025 was $2.1 million, a 27% increase compared to a $1.7 million loss in Q3 2024 [27] - Cash on hand as of September 30, 2025, was $4.4 million, with an additional $2.8 million raised in October 2025 [28][52] Business Line Data and Key Metrics Changes - The company achieved a 22% revenue growth driven by a 38% increase in unit deliveries, primarily from the financial assistance program [20][19] - The RED device is seeing good physician interest, but adoption is slower due to changes in practice flow and habits [15][50] Market Data and Key Metrics Changes - Approximately 55 million covered lives are now associated with the company's products, indicating positive payer momentum [8] - The new Category 1 CPT code, effective January 1, 2026, is expected to streamline coding and reimbursement, significantly impacting market access [11][12] Company Strategy and Development Direction - The company is focused on expanding access through medical policy coverage and accelerating utilization of IB-STIM, particularly in pediatric populations [4][5] - A multi-channel approach is being employed to engage payers, including support from academic societies and leading children's hospitals [6][8] - The strategy includes prioritizing children's hospitals based on utilization potential and launching comprehensive education and outreach programs [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the gradual improvement of policy changes and prior authorization processes, emphasizing the importance of insurance coverage and physician compensation for adoption [7][10] - The company anticipates continued revenue growth in the coming quarters, driven by the new CPT code and expanded market opportunities [10][19] Other Important Information - The company is preparing for a significant transition in 2026 with the new CPT code, which is expected to enhance reimbursement and reduce barriers to access [11][12] - The RED device's future revenue ramp is uncertain, pending further clarity on CPT code reimbursement [50] Q&A Session Summary Question: How is the company tracking success and incentivizing the team ahead of expected volume inflection? - The company has a strong sales force that is highly incentivized and focused on areas with good insurance policy coverage [32][33] Question: Can the company provide insights on volume inflection from the Category 1 CPT code alone? - The company has begun forecasting and expects better adoption rates in areas with insurance coverage [37] Question: Any updates on engagement with payers and national coverage? - Payers are responsive and aware of the new Category 1 code, which adds credibility to the company's position [40][41] Question: Can the company quantify additional commercial investment and its impact on SG&A growth? - Marketing expenses have more than doubled as the company targets payers, and R&D costs are expected to increase with market expansion [43][45]
Neuraxis(NRXS) - 2025 Q3 - Earnings Call Transcript