rectal expulsion device (RED)
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NeurAxis Reports Strong Second Quarter 2025 Financial Results Driven by a 46% Growth in Revenues
Globenewswire· 2025-08-12 11:00
Core Insights - NeurAxis, Inc. reported strong revenue growth in Q2 2025, with revenues increasing 46% year-over-year to $894 thousand, compared to $612 thousand in Q2 2024 [8][9] - The company achieved significant operational milestones, including FDA clearance for expanded indications and a new CPT code for reimbursement, which are expected to drive future revenue growth [6][7] Financial Highlights - Revenues for Q2 2025 were $894 thousand, a 46% increase from $612 thousand in Q2 2024 [8][9] - Operating expenses decreased by 10% year-over-year to $2.5 million in Q2 2025 from $2.7 million in Q2 2024 [11] - Operating loss improved by 22% to $1.7 million in Q2 2025 from $2.2 million in Q2 2024 [12] - Net loss decreased by 42% to $1.7 million in Q2 2025 from $2.9 million in Q2 2024 [13] - Cash balance as of June 30, 2025, was $6 million, bolstered by a $5 million equity financing round [14] Operational Highlights - The company is approaching a major inflection point with national insurance coverage, as a new CPT code for IB-Stim is set to take effect on January 1, 2026 [6] - NeurAxis secured FDA clearance to expand IB-Stim's indication to include pediatric Functional Dyspepsia, significantly increasing its total addressable market [7] - The company expanded its total covered lives to approximately 53 million [8] Management Commentary - CEO Brian Carrico expressed optimism about the company's trajectory, highlighting strong revenue growth and the focus on expanding insurance coverage and commercializing IB-Stim [4] - The company is confident in achieving breakeven in 2026 based on strong top-line momentum and strategic positioning [9]
NeurAxis Stock Gains Following Strong Q1 Earnings and FDA Milestones
ZACKS· 2025-05-15 17:11
Core Viewpoint - NeurAxis, Inc. (NRXS) has demonstrated significant revenue growth in Q1 2025, with a notable stock performance compared to the S&P 500, despite reporting a net loss that widened year over year [1][3]. Revenue and Earnings Performance - In Q1 2025, NeurAxis reported revenues of $0.9 million, a 38.5% increase from $0.6 million in the same quarter of the previous year [2]. - Unit sales increased by 46% year over year, driven by higher patient volumes with full insurance reimbursement and financial assistance [2]. Profitability Metrics - The company reported a net loss of $2.3 million, compared to a $2.1 million loss in Q1 2024, resulting in a per-share loss of $0.33 versus $0.32 a year ago [3]. - Gross margin decreased to 84.4% from 88.4% due to a higher proportion of discounted sales and increased manufacturing and shipping costs [3]. Operating Expenses - Operating expenses rose by 26.9% to $3.1 million in Q1 2025 from $2.4 million in the same quarter last year [4]. - Excluding a one-time legal settlement, operating expenses remained relatively flat, indicating effective cost controls [4]. Cash Position and Financial Health - As of March 31, 2025, NeurAxis had cash and cash equivalents of $2 million, down from $3.7 million as of December 31, 2024, with no long-term debt reported [5]. - Net cash used in operations for Q1 2025 was $1.6 million, compared to $1.3 million a year ago [5]. Management Insights - CEO Brian Carrico noted that Q1 2025 marked the third consecutive quarter of robust revenue growth, attributing this to improved billing practices and expanding insurance coverage [6]. - CFO Tim Henrichs indicated that while operating expenses may rise in the short term due to sales and marketing efforts, they are expected to decrease as a percentage of sales [7]. Market Dynamics - Revenue growth was supported by the adoption of NeurAxis' proprietary technology, but pricing pressure from financial assistance patients constrained gross margin expansion [8]. - A one-time legal settlement of $750,000 impacted operating and net losses, but without this charge, net loss would have improved by 22% year over year [9]. Future Outlook - Management is optimistic about revenue acceleration in upcoming quarters, driven by the publication of academic guidelines and the implementation of a permanent CPT code for IB-Stim [11]. - FDA clearance is pending for expanding IB-Stim's indication, which could double the addressable market [12]. Regulatory Developments - NeurAxis achieved regulatory milestones, including a broadened FDA label for IB-Stim and 510(k) clearance for its rectal expulsion device [13]. - The company settled a legacy lawsuit for $750,000, payable over 12 months starting January 2026 [14].
NeurAxis Reports Strong First Quarter 2025 Financial Results Driven by a 39% Growth in Revenues
Globenewswire· 2025-05-12 12:15
Core Viewpoint - NeurAxis, Inc. reported strong financial growth in Q1 2025, with a 39% year-over-year revenue increase, driven by expanding treatment access and positive payer coverage for its neuromodulation therapies [4][7]. Financial Highlights - Revenues for Q1 2025 reached $896 thousand, up from $647 thousand in Q1 2024, marking a 39% increase year-over-year and an 18% increase quarter-over-quarter [7][9]. - Operating loss improved by 9% when excluding a one-time legal settlement, with a reported operating loss of $2.3 million, an increase of 25% compared to $1.8 million in Q1 2024 [12][13]. - Cash balance as of March 31, 2025, was $2.0 million, with no long-term debt [14]. Operational Highlights - The company treated 300 patients in Q1 2025, indicating an annualized treatment rate of 1,200 patients, which is still a small fraction of the 600,000 children in the U.S. suffering from IBS [4][6]. - Positive coverage policies now encompass approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [5][7]. - NeurAxis received FDA clearance for expanding the IB-Stim label to include patients aged 8-21 and for its rectal expulsion device (RED), which is expected to generate meaningful revenues starting in Q2 2025 [7][8]. Management Commentary - The CEO highlighted that the growth is attributed to physicians becoming more comfortable with billing processes and increased awareness of treatment guidelines [5][6]. - The company anticipates that the upcoming publication of academic society guidelines and the implementation of a Category I CPT code on January 1, 2026, will be critical for expanding insurance coverage and driving national growth [6][9]. Market Position - NeurAxis is focused on expanding its pediatric addressable market and has submitted for FDA clearance to include pediatric Functional Dyspepsia, which could effectively double its market size [8]. - The company is committed to clinical research, with 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for expanding payer coverage [7].