Financial Data and Key Metrics Changes - Revenues in Q4 2024 were $761,000, up 43% compared to $531,000 in Q4 2023 [35] - Revenue for fiscal year 2024 was $2.7 million, an increase of 9% compared to $2.5 million in fiscal year 2023 [36] - Gross margin in Q4 2024 was 86.4%, consistent with Q4 2023 [37] - Net loss for Q4 2024 was $1.5 million, a decrease of 73% compared to $5.3 million in Q4 2023 [42] Business Line Data and Key Metrics Changes - Significant growth of 40% in Q3 and 43% in Q4 for IB-Stim revenue [11] - Unit sales increased approximately 45% in Q4 2024 due to growth from patients with undiscounted insurance reimbursement [35] - The number of treated cases increased to over 1,000 in the last 12 months, representing just over 0.1% of the 600,000 children in the U.S. suffering from IBS [24] Market Data and Key Metrics Changes - Covered lives increased from 4 million on January 1 of the previous year to approximately 51 million today [13] - The expansion of the IB-Stim age indication from 11-18 years to 8-21 years significantly increases the market opportunity [21] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and profitability through increased insurance coverage and the implementation of a Category 1 CPT code [28] - The commercialization of the RED device is expected to drive significant revenues in the coming quarters [30] - The company aims to transition patients from inadequate or no insurance coverage to full reimbursement, which will enhance future revenues and gross margins [59] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the continued growth in covered lives and the commercialization of RED [33] - The company anticipates that the Category 1 CPT code will streamline prior authorizations and enhance revenue generation [52] - Management believes that strong peer-reviewed publications and key society support will lead to successful insurance coverage [27] Other Important Information - The company held no long-term debt as of December 31, 2024, with cash on hand of $3.7 million [43] - Operating loss in Q4 2024 was $1.5 million, an improvement of 10% compared to the previous year [41] Q&A Session Summary Question: Significance of receiving the Category 1 code and the 510(k) extensions - The Category 1 code is crucial as it allows physicians to receive RVUs for procedures, which is essential for their compensation [50] - The 510(k) extension increases the total addressable market by approximately 75% [54] Question: Variability of gross margins and future expectations - Gross margins are currently in the mid to high 80s, with expectations to increase as more patients transition to insurance coverage [56][59] Question: Early learnings from the RED commercial mode - Feedback from physicians has been positive, with higher than expected usage [64] Question: Revenue needed to achieve breakeven - Breakeven revenues are expected to be in the $10 million to $12 million range based on current cash burn [66] Question: Product manufacturing and tariff exposure - 95% of technology is sourced and manufactured in the U.S., with minimal exposure to tariffs [68] Question: Development timeline for a second-generation IB-Stim device - The second-generation device is expected to be available in 2026, featuring a more modern design [70] Question: Response after a course of IB-Stim treatment - Approximately 70% of patients report significant long-term relief after treatment [76]
Neuraxis(NRXS) - 2024 Q4 - Earnings Call Transcript