NeurAxis (NYSEAM:NRXS) FY Conference Summary Company Overview - **Company Name**: NeurAxis - **Ticker**: NRXS - **Industry**: Med Tech, specifically focused on neuromodulation therapies for gastrointestinal (GI) disorders - **Market Position**: Growth stage company with over 10 years of experience, recently expanded from pediatric to adult indications [2][3] Key Points and Arguments Corporate Developments - NeurAxis has secured a **Category I CPT code** for its PENFS technology effective January 1, 2026, which is crucial for scaling the technology and obtaining insurance coverage [3][4][21] - The company has expanded its **commercial payer coverage** to over **100 million covered lives**, enhancing access to its treatments [4][24] - In 2025, NeurAxis reported revenues exceeding **$3 million** with a gross margin of approximately **84%** [4][20] Market Opportunity - The **serviceable available market** for NeurAxis is estimated at **$22 billion** in the U.S., with specific indications like functional abdominal pain and IBS representing a **$3 billion market opportunity** [8][9] - There are about **6 million patients** in the U.S. with functional abdominal pain and IBS, with **10%** classified as debilitated [9] Clinical Focus - NeurAxis is concentrating on **functional abdominal pain** and **functional dyspepsia** in both pediatric and adult populations, with ongoing clinical trials for multiple indications [5][6] - The company emphasizes the importance of strong clinical data to support insurance coverage and reimbursement, which is critical for revenue growth [6][10] Competitive Advantage - NeurAxis is the only FDA-approved treatment recommended in pediatric guidelines for gut-brain interaction disorders, providing a unique market position [7][10] - The company has conducted **16 publications** of investigator-initiated research, demonstrating the efficacy and safety of its technology [12] Financial Outlook - NeurAxis has a clear path to profitability, with expectations for gross margins to approach **90%** in the coming year [29] - The company had **$5 million** in cash at the end of the previous quarter, with a monthly burn rate of approximately **$450,000-$500,000** [29][30] Challenges and Strategies - The company faces challenges in scaling due to previous lack of insurance coverage and the need for more trained providers to utilize the technology [17][22] - NeurAxis is actively working to increase insurance policy coverage and improve its market presence through strategic partnerships and data presentation [26][27] Additional Important Information - The management team is experienced, with 90% of the team having been involved in the company's growth [8] - The company is focused on maintaining a strong intellectual property portfolio, which is expected to last until **2039** [18] - NeurAxis is committed to transitioning its technology to frontline treatment options for patients, aiming for earlier intervention and better long-term outcomes [27][28]

The new CPT code reflects the latest efficacious medical care available to patients, facilitating adoption and utilization.The assignment of a Category I CPT® code demonstrates a strong message to payers, both commercial and government, that there is now a path to consistent reporting and reimbursement for providers in the medical community. CARMEL, Ind., Jan. 08, 2026 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromo ...

Core Insights - The Zacks Equity Research team has highlighted several stocks, including Meta Platforms, Bank of America, Procter & Gamble, Espey Mfg. & Electronics, and NeurAxis, in their recent analysis [1][2] Meta Platforms, Inc. (META) - Meta's shares have outperformed the Zacks Internet - Software industry over the past year, with a gain of +3.6% compared to the industry's +1.1% [4] - The company is experiencing steady user growth, particularly in the Asia Pacific region, driven by increased engagement across its platforms like Instagram, WhatsApp, Messenger, and Facebook [4] - Meta is leveraging AI to enhance its platform offerings, reaching over 3.54 billion users daily, which is expected to drive top-line growth [5] - The company plans to invest significantly in developing advanced AI models, although monetization of these services may take time [6] Bank of America Corp. (BAC) - Bank of America's shares have increased by +16.2% over the past six months, slightly underperforming the Zacks Financial - Investment Bank industry's gain of +17.3% [7] - The company's net interest income (NII) is projected to grow at a CAGR of 5.7% by 2027, supported by decent loan growth despite rate cuts [7] - Total revenues are expected to grow by 6.9% in 2025, although trading revenue growth may normalize after a robust performance since 2022 [8] - Elevated expenses due to ongoing investments and weak asset quality may hinder bottom-line growth, with expenses expected to rise by 4.3% in 2025 [9] The Procter & Gamble Co. (PG) - Procter & Gamble's shares have declined by -10.4% over the past six months, slightly better than the Zacks Consumer Products - Staples industry's decline of -11% [10] - The company anticipates all-in sales growth of 1–5% and organic sales gains of flat to up 4% in fiscal 2026, supported by cost savings [11] - Robust cash flow is expected to fund $15 billion in shareholder returns in fiscal 2026, including dividends and share buybacks [11] - However, elevated commodity costs and macroeconomic challenges continue to pressure margins and earnings visibility [12] Espey Mfg. & Electronics Corp. (ESP) - Espey Mfg. & Electronics has outperformed the Zacks Electronics - Military industry over the past six months, with a gain of +3.5% compared to the industry's decline of -32.4% [13] - The company has a backlog of $141.1 million, with 72% scheduled through 2028+, ensuring revenue visibility despite a 12.9% sales decline in Q1 FY26 [13] - Gross margin has expanded to 35.4%, indicating strong cost control and product mix advantages [14] NeurAxis, Inc. (NRXS) - NeurAxis has outperformed the Zacks Medical Info Systems industry over the past six months, with a gain of +65.2% compared to the industry's decline of -16.2% [16] - The company targets a large market for gut/brain disorders with its FDA-cleared IB-Stim neuromodulation system, recently expanding its addressable market to $8 billion [16] - Revenue has been growing at double-digit rates, but the company continues to face losses due to high spending and margin pressure [17]

Core Insights - NeurAxis, Inc. has announced significant new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, from a major national health insurer, expanding its coverage to approximately 100 million lives across multiple states [1][3] Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company's proprietary technology, IB-Stim, is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD) in patients aged 8 years and older [2][4] Product Details - IB-Stim is a non-invasive device that stimulates cranial nerve bundles in the ear to regulate pain signaling between the gut and the brain, addressing a significant unmet medical need in pediatric patients [2] - Currently, there are no FDA-approved drug therapies for pediatric patients with abdominal pain related to functional dyspepsia, making IB-Stim a unique solution in this market [2] Market Position and Future Outlook - The CEO of NeurAxis expressed optimism about securing additional coverage from large national insurers, highlighting the growing recognition of IB-Stim as an evidence-based therapy for pediatric gastrointestinal disorders [3] - With a Category I CPT code effective January 1, 2026, and incorporation into leading national society clinical practice guidelines, NeurAxis is positioned for significant revenue growth and margin expansion [3]

CARMEL, Ind., Dec. 01, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced that it has been awarded a Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, effective December 1, 2025. The first product listed on the FSS is the IB-Stim®, a drug-free treatment for functional abdominal pain in patients 8 years and ...

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. announced new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, increasing access to approximately 566,000 covered lives in Michigan, bringing total national coverage to about 55 million lives [1][3] Company Overview - NeurAxis is a medical technology company focused on neuromodulation therapies for chronic conditions in both children and adults, with its proprietary IB-Stim technology FDA-cleared for treating functional abdominal pain associated with IBS and functional dyspepsia in patients aged 8 and older [2][4] - The IB-Stim device is non-invasive and stimulates cranial nerve bundles in the ear to regulate pain signaling between the gut and brain, addressing a significant unmet medical need as no FDA-approved drug therapies exist for pediatric patients with abdominal pain-related disorders [2][4] Market Strategy - The company is actively working to expand insurance coverage for IB-Stim, with discussions ongoing with several major insurers as they approach policy review cycles over the next eight months [3] - A Category I CPT code will take effect on January 1, 2026, which is expected to facilitate reimbursement and enhance revenue growth and margin expansion for NeurAxis [3] Clinical Development - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs, further solidifying its position in the market [4]

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 [19][17] - 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 [20][21] - Operating loss in Q3 2025 was $2.1 million, a 27% increase compared to a $1.7 million loss in Q3 2024 [25] Business Line Data and Key Metrics Changes - The company achieved a 22% revenue growth in Q3 2025, driven by a 38% increase in unit deliveries, primarily from the financial assistance program [19][20] - The RED device is seeing good physician interest, but its adoption is slower due to changes in practice flow and habits [14][48] Market Data and Key Metrics Changes - The company now has approximately 55 million covered lives, indicating positive payer momentum [7] - The new Category 1 CPT code, effective January 1, 2026, is expected to streamline coding and reimbursement, significantly impacting market access [10][11] Company Strategy and Development Direction - The company is focused on expanding access through medical policy coverage and accelerating utilization of IB-STIM, with a strong emphasis on pediatric coverage [5][6] - The strategy includes mobilizing a coalition for payer engagement and prioritizing children's hospitals for treatment [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the gradual improvement of policy changes and prior authorization processes, expecting continued revenue growth [6][9] - The company is preparing for a significant transition in 2026 with the new CPT code, which is anticipated to enhance revenue predictability [33][35] Other Important Information - The company raised an additional $2.8 million in October 2025 through an equity offering, improving its liquidity position [26][50] - The company is committed to treating all patients regardless of income level or insurance coverage, which is reflected in its financial assistance program [20] Q&A Session Summary Question: How is the company tracking success and incentivizing the team for expected volume inflection? - The company has a strong sales force with a commission structure that incentivizes prioritization of accounts with good insurance coverage [31][32] Question: Any updates on engagement with payers for national coverage? - Management believes payers are aware of the new CPT code and are responsive, with a comprehensive approach being taken for engagement [38][39] Question: Can you quantify additional commercial investment and its impact on SG&A growth? - Marketing expenses have more than doubled as the company targets payers specifically, with expectations for continued higher marketing costs into 2026 [40][41]

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]

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]