Core Insights - NeurAxis, Inc. (NRXS) shares have declined 8.6% since the Q3 2025 earnings report, underperforming the S&P 500 Index's 1.7% decline during the same period [1] - The stock has experienced a significant drop of 36.4% over the past month, contrasting with a slight growth of 0.1% in the S&P 500 [1] Financial Performance - Q3 2025 revenues reached $0.8 million, a 21.7% increase from $0.7 million in the same quarter last year, marking the fifth consecutive quarter of double-digit growth [2] - Unit deliveries increased by 38% year over year, driven by the financial assistance program that provides discounted devices to uninsured patients [2] - Operating loss widened to $2.1 million from $1.7 million a year earlier, primarily due to a 125.3% year-over-year increase in selling expenses outpacing revenue growth [2] Margins and Losses - Gross margin decreased to 83.3% from 85.4%, attributed to increased discounting and expired inventory charges related to the Rectal Expulsion Device (RED) [3] - Net loss for the quarter was $2.1 million, compared to $1.8 million in the prior-year quarter [3] Liquidity and Cash Flow - NeurAxis ended the quarter with $4.4 million in cash and improved its liquidity by raising an additional $2.8 million through an equity offering and warrant exercises in October 2025 [4] - Free cash flow burn remained stable at approximately $1.5 million for the quarter, with increased inventory purchases in anticipation of demand once reimbursement improves [4] Management Insights - Management believes Q3 2025 set the stage for a significant scaling phase expected to begin in 2026, with a new CPT Category I code effective January 1, 2026, anticipated to streamline billing and reduce administrative hurdles [6] - Executives highlighted efforts to enhance payer engagement, supported by new clinical practice guidelines and outreach to large insurers, aiming for broader national medical policy coverage [6] Revenue Drivers and Expenses - Revenue growth was primarily driven by increased patient volume, particularly from the financial assistance program, and the soft launch of the RED product line [7] - Operating expenses rose significantly due to higher commissions from increased sales activity, targeted advertising, and preparatory spending ahead of the new CPT code launch [7] R&D and Administrative Costs - Research and development expenses increased by 3.6% year over year as NeurAxis continued to invest in clinical programs related to expanded FDA indications [8] - General and administrative costs rose by 7.2% year over year due to a new long-term incentive plan and system-related expenditures [8] Future Guidance - While no formal numerical guidance was provided, management expressed confidence in continued revenue growth for Q4 2025, supported by strong provider momentum [9] - The outlook for 2026 includes expectations for improved reimbursement clarity and broader patient access, although policy changes are anticipated to occur gradually [9][10] Regulatory and Market Developments - NeurAxis achieved several regulatory milestones, including FDA clearances for expanded indications of IB-Stim and the RED device for anorectal function testing [11] - The company secured academic society guideline recommendations for its technology, expanded total covered lives to approximately 55 million, and received a new Category I CPT code effective January 1, 2026, enhancing long-term reimbursement prospects [12]

Core Insights - NeurAxis, Inc. reported a 22% increase in revenues for Q3 2025, reaching $811 thousand compared to $667 thousand in Q3 2024, driven by a 38% rise in unit deliveries [4][6] - The company is optimistic about significant revenue growth and margin expansion in 2026, supported by the upcoming CPT Category I code effective January 1, 2026, and recent FDA clearances [3][5] Financial Highlights - Revenues for Q3 2025 were $811 thousand, a 22% increase from $667 thousand in Q3 2024 [4][6] - Gross margin decreased to 83.3% from 85.4% year-over-year due to higher discounting and lower-margin sales from financial assistance programs [5][6] - Operating loss increased by 27% year-over-year to $2.1 million in Q3 2025, attributed to higher sales and marketing expenses [6][7] - Cash balance as of September 30, 2025, was $4.4 million, with an additional $2.8 million raised in October 2025 [6][8] Operational Highlights - The FDA granted clearance for IB-Stim to treat functional dyspepsia and nausea in patients aged 8 years and older, expanding the market opportunity [3][6] - The company secured a new CPT Category I code for PENFS procedures, effective January 1, 2026, which includes reimbursement financials [6][8] - Total covered lives increased to approximately 55 million, enhancing the potential patient base for NeurAxis's therapies [6][8] Management Commentary - The CEO expressed optimism about the company's positioning for substantial growth in 2026, emphasizing the importance of the CPT code and FDA clearances [3][5] - The company aims to treat all patients regardless of financial status, anticipating that increased demand from financial assistance patients will lead to higher gross margins once insurance coverage is established [5][6]

Core Viewpoint - NeurAxis, Inc. (NRXS) reported a mixed performance in Q2 2025, with revenue growth but continued net losses and margin compression, while management anticipates improved financial health with upcoming insurance coverage changes and product approvals [1][2][5][6]. Revenue and Earnings Performance - NeurAxis reported Q2 2025 revenues of $0.9 million, a 46.2% increase from $0.6 million in Q2 2024, driven by a 58% increase in unit sales due to greater adoption of the IB-Stim device [2] - Gross margin decreased to 83.6% from 88% year-over-year, attributed to deeper discounting for uninsured patients and expired inventory [2] Expense Management - Operating expenses fell by 10.2% to $2.5 million from $2.7 million, primarily due to the absence of one-time costs and lower investor relations and insurance costs [3] - The operating loss narrowed to $1.7 million from $2.2 million a year earlier, while the net loss was $1.7 million, or $0.22 per share, compared to a $2.9 million loss, or $0.42 per share, in Q2 2024 [3] Cash and Liquidity - NeurAxis ended the quarter with $5.9 million in cash, supported by a $5 million equity financing round and $1 million from warrant exercises [4] - Cash used in operations was $3.1 million for the first half of 2025, up from $2.9 million in the same period last year [4] Future Outlook - Management expects gross margins to recover as more patients gain access through commercial reimbursement with the new permanent Category I CPT code effective January 1, 2026 [5] - CEO Brian Carrico indicated that national insurance coverage and inclusion of IB-Stim in clinical guidelines will enhance patient access and revenue growth [6] Regulatory Developments - NeurAxis received FDA clearance to extend IB-Stim's indication to treat pediatric functional dyspepsia, nearly doubling its addressable market [7] - The company also secured FDA clearance for the Rectal Expulsion Device (RED) and terminated its NSS-2 Bridge license with Masimo, regaining associated intellectual property [12][13] Guidance and Expectations - Although no explicit numerical guidance was provided, executives expressed confidence in achieving breakeven in 2026, contingent on broader payer adoption of IB-Stim [10] - Management anticipates continued revenue growth in the second half of 2025, supported by further insurance policy adoption and early traction for RED [11]