Core Viewpoint - NeurAxis, Inc. is set to report its financial results for the fourth quarter and fiscal year 2024 on March 20, 2025, and will hold a conference call to discuss these results [1] Group 1: Financial Reporting - The financial results will cover the period ended December 31, 2024 [1] - A conference call is scheduled for March 20, 2025, at 9:00 am ET to review the results [1][2] Group 2: Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company is advancing its proprietary IB-Stim™ therapy, which is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [4] - Additional clinical trials for PENFS technology are ongoing for various pediatric and adult conditions with significant unmet healthcare needs [4]

Core Insights - NeurAxis, Inc. has announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with a major insurer covering approximately 5.1 million members across 13 states [1] - The IB-Stim device is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 years [2] - The company has significantly expanded its insurance coverage from 4 million lives to 51 million lives in the past year, indicating strong growth and acceptance of its technology [3] Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults, with a commitment to advancing science and evidence-based medicine [4] - The IB-Stim technology is currently the only FDA-cleared non-surgical option for children suffering from abdominal pain-related disorders of gut-brain interaction, addressing a significant unmet medical need [2][4] - Ongoing clinical trials are exploring the use of PENFS in various pediatric and adult conditions, further expanding the potential applications of the technology [4]

Core Insights - NeurAxis, Inc. has announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with Molina Healthcare, expanding its reach to approximately 5.1 million members across 13 states [1][3] - The IB-Stim device is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21, addressing a significant gap as there are currently no FDA-approved drug therapies for children with such conditions [2][4] - The company has significantly increased its insurance coverage from 4 million to 51 million lives over the past year, highlighting the growing acceptance and demand for its technology [3] Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies aimed at chronic and debilitating conditions in both children and adults, with a commitment to advancing science and evidence-based medicine [4] - The IB-Stim therapy is a proprietary technology that utilizes non-surgical methods to deliver electrical impulses to cranial nerve bundles, providing a novel treatment option for patients suffering from abdominal pain-related disorders [2][4] - Ongoing clinical trials are being conducted for PENFS in various pediatric and adult conditions, indicating the company's dedication to expanding its therapeutic applications [4]

Core Insights - NeurAxis, Inc. has highlighted its achievements in 2024 and outlined its vision for 2025, focusing on establishing itself as a leader in the gastroenterology space [1][2] Company Achievements - In 2024, NeurAxis achieved significant milestones with its IB-Stim therapy, which is the first FDA-indicated treatment specifically for pediatric IBS, prescribed to approximately 1,000 patients [3][4] - The company successfully expanded insurance coverage for IB-Stim to approximately 51 million lives, up from 4 million the previous year, driven by robust peer-reviewed data [4] - NeurAxis received FDA 510(k) clearance for an expanded indication of IB-Stim, now including patients aged 8 to 21 years, increasing the addressable market by over 75% [6] Future Plans - The company plans to submit to the FDA for expanded indications in 2025, including adult IBS and pediatric functional dyspepsia [2] - NeurAxis aims to sustain exceptional revenue growth, manage costs carefully, and strengthen its balance sheet to deliver value to shareholders [2][12] Regulatory and Market Developments - The American Medical Association approved a new CPT Category I code for PENFS procedures, effective January 1, 2026, which is expected to enhance patient access to IB-Stim [7][8] - A systematic review presented by NASPGHAN indicated that NeurAxis's technology has the highest GRADE certainty for pediatric IBS, which is anticipated to drive medical policy coverage and accelerate insurance adoption [9][10] Product Launches - In December 2024, NeurAxis obtained FDA clearance for its Rectal Expulsion Device (RED) as a screening tool for chronic constipation, with positive policy coverage from Medicare and most commercial insurers [11]

Financial Performance - Neuraxis, Inc. announced preliminary unaudited estimated revenues for Q4 2024 and the full year ended December 31, 2024[4]. - The financial information provided is preliminary and subject to changes following the completion of the company's normal financial close procedures[5]. - The preliminary financial information does not include all necessary details for a complete understanding of the company's financial condition[5]. Audit and Compliance - The company’s financial statements for the year ended December 31, 2024, are currently undergoing an audit[5]. - The filing does not incorporate the information into any registration statements under the Securities Act[6]. Company Information - Neuraxis, Inc. is classified as an emerging growth company under the Securities Act[3]. - The company is listed on the NYSE American under the trading symbol NRXS[2]. - The report was signed by Brian Carrico, President and CEO of Neuraxis, Inc.[11]. Press Release - The press release regarding the preliminary results was issued on January 8, 2025[4]. - The press release is included as Exhibit 99.1 in the filing[8].

Core Insights - NeurAxis, Inc. reported preliminary, unaudited revenues for Q4 2024 of approximately $800 thousand, marking a 50% increase compared to Q4 2023, and for FY 2024, revenues were approximately $2.7 million, an 11% increase from FY 2023 [1][6] Revenue Growth - The company experienced a significant revenue growth acceleration in Q4 2024, with a 50% increase compared to 40% growth in Q3 2024 [2] - The strong revenue growth in the second half of 2024 was attributed to expanded insurance coverage, which now supports approximately 45 million lives, up from 4 million a year ago [2] Future Outlook - NeurAxis expects continued robust revenue growth in 2025 and beyond, driven by expanding insurance coverage policies and recent FDA 510(k) clearance for IB-Stim, which now includes patients aged 8 to 21 years [3] - The company plans to commercialize its Rectal Expulsion Device (RED) in Q1 2025, following FDA approval [3] Financial Position - As of December 31, 2024, NeurAxis had a cash balance of approximately $3.7 million, positioning the company to achieve near-term growth objectives and reach cash flow breakeven [4][6]

Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [3] - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18 [3] - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs [3] Upcoming Events - CEO Brian Carrico will participate in a webcasted company presentation at the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025, at 2:30 PM Eastern time [1][2] - The presentation will be accessible via the conference homepage and will also have a replay available [2] - One-on-one investor meetings will be available upon request after the event [2]

Financial Data and Key Metrics Changes - In Q3 2024, the company reported revenues of $667,000, a 40% increase year-over-year compared to $477,000 in Q3 2023 [45] - Unit sales increased approximately 50% year-over-year in Q3 2024 [46] - Gross profit for Q3 2024 was $570,000, up from $410,000 in Q3 2023, with a gross margin of 85.4%, down 50 basis points year-over-year [48] - The operating loss improved to $1.7 million in Q3 2024 from $3 million in Q3 2023 [49] - The net loss for Q3 2024 was $1.8 million, significantly reduced from an $8.6 million net loss in Q3 2023 [51] Business Line Data and Key Metrics Changes - The company achieved a 40% year-over-year revenue growth in Q3, attributed to increased insurance coverage and improved billing practices [11][30] - The number of treated cases increased to about 900 patients in the last 12 months, representing just over 0.1% of the 600,000 children in the U.S. suffering from IBS [28] - The company expects significant revenue growth as more children's hospitals begin to order once insurance policy coverage is established [32] Market Data and Key Metrics Changes - The company expanded its covered lives from 4 million at the beginning of the year to approximately 35 million by Q3 2024 [15][20] - The company anticipates exceeding the projected 50 million covered lives by the end of 2024, contingent on positive decisions from payers [20][81] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and expects to continue revenue growth into 2025, driven by increased insurance coverage and the commercialization of new products [43][36] - The receipt of a Category 1 CPT code is seen as a critical milestone that will facilitate easier billing and reimbursement processes [23][60] - The company is optimistic about the commercialization of the RED device, which is expected to launch in late 2024 and has a similar total addressable market (TAM) to IB-Stim [37][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth trajectory, citing strong demand and enthusiasm from healthcare providers [47] - The company is optimistic about achieving profitability in 2025, supported by the expected publication of academic society guidelines that will enhance insurance coverage [83][85] - Management highlighted the importance of independent academic guidelines for increasing insurance coverage and driving revenue growth [18][84] Other Important Information - The company secured a $5 million investment to strengthen its liquidity position, which is expected to close in mid-November [44][52] - The company has no long-term debt as of September 30, 2024, but has $148,000 in short-term debt related to business insurance premiums [54] Q&A Session Summary Question: Significance of Category 1 code and 510(k) extension - The Category 1 code simplifies billing and reimbursement processes, making it easier for hospitals to adopt the technology [58][60] - The 510(k) extension increases the age range for treatment, allowing more patients to be treated under the new guidelines [63] Question: Impact of age extension on covered lives - While the age extension allows for more patients to be treated, written policy coverage from payers is still necessary to increase covered lives [65][66] Question: Evidence of cure versus treatment - The company does not use the term "cure" but has data showing significant long-term outcomes for patients [72][73] Question: Plans for adult indications - The company is working towards FDA approval for adult indications, aiming for late 2025 [75] Question: Market strategy for new product RED - The company plans to utilize its existing sales force to market the RED device, which has a strong reimbursement framework [79][80] Question: Target of 50 million covered lives and profitability - The company remains optimistic about reaching the target of 50 million covered lives by year-end and achieving cash flow profitability in 2025 [81][83]

Core Viewpoint - NeurAxis, Inc. (NRXS) has demonstrated significant stock performance and financial improvement following its third-quarter 2024 earnings report, with a notable increase in revenues and a substantial reduction in net losses compared to the previous year [1][3]. Financial Performance - NeurAxis reported revenues of $0.7 million for Q3 2024, a 39.6% increase from $0.5 million in Q3 2023 [2] - Gross profit rose 38.9% year-over-year to $0.6 million, with a slight decline in gross margin from 85.9% to 85.4% due to increased financial assistance programs [2] - Operating loss improved to $1.7 million in Q3 2024 from $3 million in Q3 2023 [2] Net Loss and Earnings Per Share - The net loss for the quarter was $1.8 million, significantly better than the $8.6 million loss in Q3 2023 [3] - Loss per share decreased to $0.25 in Q3 2024 from $2.38 in Q3 2023, attributed to increased sales and the absence of IPO-related costs [3] Key Business Metrics - Unit sales of the IB-Stim device increased by 50% during the quarter, supported by expanded insurance coverage and patient access [4] - The total covered lives expanded to approximately 35 million, a significant increase from 4.5 million in October 2023, including coverage from major insurers [5] Financial Position - As of September 30, 2024, NeurAxis reported $0.3 million in cash and $147,688 in short-term debt, along with a $5.0 million investment agreement to enhance liquidity [6] Management Commentary - CEO Brian Carrico emphasized strong operational progress, highlighting a 40% year-over-year revenue growth and the expansion of insurance coverage [7] Factors Influencing Results - Revenue growth was driven by increased volume from both new and existing full insurance reimbursement customers and growth in financial assistance programs [8] - The improvement in operating losses was due to the absence of 2023 post-IPO costs and higher sales and gross profit in 2024 [8] Guidance and Outlook - While specific forward-looking financial guidance was not provided, management expressed confidence in ongoing operational momentum, with expectations for further adoption of IB-Stim due to recent FDA approvals and insurance policy expansions [9] Other Developments - NeurAxis achieved FDA clearance to expand IB-Stim's target demographic and increased the allowable devices per patient [10] - The company submitted a rectal expulsion device for FDA approval, with anticipated clearance by the end of 2024 [10]

Financial Performance - Revenues increased 40% to $667 thousand in Q3 2024 compared to $477 thousand in Q3 2023[2] - Operating loss improved by 45% to $1.7 million in Q3 2024 from $3.0 million in Q3 2023[11] - Net loss decreased by 80% to $1.8 million in Q3 2024 from $8.6 million in Q3 2023[12] - Gross profit increased 39% to $570 thousand in Q3 2024 compared to $410 thousand in Q3 2023[10] Product Performance - Unit sales of the IB-Stim product grew 50% in Q3 2024, reflecting strong demand[7] - Received new FDA clearance for IB-Stim, expanding the age indication from 11-18 years to 8-21 years[4] Market Expansion - Total covered lives expanded to approximately 35 million, up from 4.5 million as of October 1, 2023[2] - The company has 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for payor coverage[5] Investment and Cash Position - Secured a $5.0 million capital investment to replace $3.2 million in committed funding from an existing investor[6] - Cash on hand as of September 30, 2024, was $261 thousand, with an upcoming $5.0 million investment expected to close mid-November[13]