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]

Core Insights - NeurAxis, Inc. reported a 40% increase in revenues for Q3 2024, reaching $667 thousand compared to $477 thousand in Q3 2023, with an improved operating loss of 45% [2][8]. Financial Highlights - Revenues for Q3 2024 were $667 thousand, a 40% increase from $477 thousand in Q3 2023 [2][6]. - Gross profit rose to $570 thousand, a 39% increase from $410 thousand in Q3 2023, although gross margin slightly declined by 50 basis points [7]. - Operating loss decreased to $1.7 million, down 45% from $3.0 million in Q3 2023 [8]. - Net loss for Q3 2024 was $1.8 million, an 80% reduction from $8.6 million in Q3 2023 [9]. Operational Highlights - The total covered lives expanded to approximately 35 million from 4.5 million as of October 1, 2023 [3]. - Recent medical policy coverages include significant plans from BCBS in Florida and the mid-Atlantic region, covering over 16 million lives combined [3]. - NeurAxis received a new CPT Category I code for PENFS procedures effective January 1, 2026, and FDA clearance to expand IB-Stim's patient age range from 11-18 years to 8-21 years [3][5]. - The company secured a $5.0 million capital investment to replace $3.2 million in committed funding from an existing investor [3][10]. Management Commentary - The CEO expressed excitement over the strong performance in Q3 2024, highlighting a 50% growth in unit sales of the IB-Stim product and the successful expansion of insurance coverage [4][5].

Financial Performance - Net sales for the three months ended September 30, 2024, were $666,625, a 39.6% increase from $477,460 in the same period of 2023[6] - Gross profit for the nine months ended September 30, 2024, was $1,667,811, compared to $1,697,590 for the same period in 2023, reflecting a slight decrease of 1.8%[6] - The operating loss for the three months ended September 30, 2024, was $(1,651,273), an improvement from $(3,022,339) in the same period of 2023[6] - The net loss for the nine months ended September 30, 2024, was $(6,793,596), compared to $(13,034,385) for the same period in 2023, indicating a reduction of 47.8%[6] - The company reported a basic and diluted loss per share of $(0.25) for the three months ended September 30, 2024, compared to $(2.38) for the same period in 2023[6] - Net loss for September 2024 was $6,793,596, a decrease from $13,034,385 in September 2023, representing a 48.1% improvement[21] - The Company reported a net loss of $1,755,234 for the three months ended September 30, 2024, compared to a net loss of $8,625,363 for the same period in 2023[46] - Net loss decreased by $6,870,129, or 79.7%, from $8,625,363 for the three months ended September 30, 2023, to $1,755,234 for the three months ended September 30, 2024[176] Cash Flow and Liquidity - Cash used by operating activities was $4,340,097 in September 2024, compared to $4,064,419 in September 2023, indicating a 6.8% increase[21] - The company reported net cash provided by financing activities of $4,550,198 in September 2024, slightly down from $4,627,710 in September 2023, a decrease of 1.7%[21] - Cash on hand decreased from $761,249 as of September 30, 2023, to $260,885 as of September 30, 2024[178] - The company recognized a right of use asset valued at $284,339 during the period[21] - The company incurred $30,756 in cash paid for interest during the period[21] Research and Development - Research and development expenses for the three months ended September 30, 2024, were $72,422, up 61.2% from $44,950 in the same period of 2023[6] - Research and development expenses increased by $27,472, or 61.1%, from $44,950 for the three months ended September 30, 2023, to $72,422 for the three months ended September 30, 2024[170] Stockholder Equity and Liabilities - Total liabilities and stockholders' deficit increased to $1,143,269 as of September 30, 2024, from $509,498 at the end of 2023[6] - The accumulated deficit as of September 30, 2023, was $(46,965,813), reflecting ongoing financial challenges[7] - The total stockholders' deficit as of September 30, 2023, was $(1,061,087), indicating a deterioration in financial position[7] - As of September 30, 2024, the Company had a stockholders' deficit of $1,793,932 and a working capital deficit of $2,032,284[60] - The total liabilities as of September 30, 2024, were $55,351,706, reflecting ongoing financial obligations[20] Capital Management - The company completed an IPO on August 9, 2023, raising gross proceeds of $6,592,002 from the sale of 1,098,667 shares at $6.00 per share[25] - The company entered into a $5,000,000 investment agreement with a life sciences fund, replacing a $3,200,000 reduction in committed funding from an existing investor[154] - The company issued common stock from agreements totaling 798,929 shares, reflecting an increase in capital[15] - The company issued 1,260,504 shares of Series B Convertible Preferred Stock for an aggregate purchase price of $3,000,000, with payments commencing on January 10, 2024[73] Operating Expenses - Selling expenses increased by $31,220, or 48.6%, from $64,210 for the three months ended September 30, 2023, to $95,430 for the same period in 2024[169] - General and administrative expenses decreased by $1,270,356, or 38.2%, from $3,323,352 for the three months ended September 30, 2023, to $2,052,996 for the three months ended September 30, 2024[171] - Other expense decreased by $5,499,063, or 98.1%, from $5,603,024 for the three months ended September 30, 2023, to $103,961 for the three months ended September 30, 2024[174] Future Outlook - Management believes that increased sales and acceptance of their product by insurance providers will allow the Company to achieve profitability in the near term[63] - The company expects to incur significant expenses and operating losses as it seeks FDA clearance for additional indications of the IB-Stim device[156] - The company anticipates gross profit to increase in the foreseeable future as net sales grow through broader insurer acceptance of the IB-Stim device[161] Shareholder Agreements and Compensation - The total base salaries for nine key employees under employment agreements are $1,920,000 per year, with additional special incentive payments totaling $1,100,000[140] - The company has recorded a backpay amount of $417,390, which was paid in 2023, as part of the special incentive payments[140] - The company anticipates that the special options bonuses of $14,821,830 will be recorded when paid, contingent upon a successful initial public offering[143]

Core Insights - NeurAxis, Inc. announced that the American Medical Association has established a new CPT Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures, effective January 1, 2026, which is a significant milestone for the company [1][2] - The company's IB-Stim technology is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18, addressing a gap in available treatments for this demographic [1][3] - NeurAxis is focused on advancing neuromodulation therapies and is conducting additional clinical trials for PENFS in various pediatric and adult conditions with large unmet healthcare needs [3] Company Overview - NeurAxis, Inc. specializes in medical technology aimed at neuromodulation therapies for chronic and debilitating conditions in both children and adults [3] - The company is dedicated to leveraging evidence-based medicine to promote the adoption of its proprietary IB-Stim therapy within the medical, scientific, and patient communities [3] - There are currently no FDA-approved drug therapies for children suffering from abdominal pain-related disorders of gut-brain interaction, highlighting the importance of NeurAxis's offerings [1]

Core Viewpoint - Zacks Investment Research has initiated coverage of NeurAxis, Inc. (NRXS) with a "Neutral" recommendation, reflecting a mixed outlook for the company despite its advancements in neuromodulation therapies [1] Company Overview - NeurAxis, headquartered in Carmel, IN, focuses on developing neuromodulation therapies for chronic conditions, particularly in pediatric populations. Its flagship product, IB-Stim, is an FDA-cleared device for treating functional abdominal pain related to irritable bowel syndrome in adolescents aged 11-18 years [2] Financial Performance - NeurAxis reported a 16% year-over-year increase in unit sales in Q2 2024 and secured $9.1 million in funding, enhancing its financial position [3] - The company experienced an operating loss of $2.2 million in Q2 2024, nearly doubling from the previous year, with a cash reserve of $1.8 million as of June 30, 2024, and a monthly burn rate of $400,000 to $500,000 [4] Market Expansion - The coverage of NeurAxis' IB-Stim device has expanded from 4.5 million lives in May 2023 to approximately 22.5 million in June 2024, with expectations to exceed 50 million by year-end [3] - The anticipated commercialization of the Rectal Expulsion Device for pelvic floor dysfunction by late 2024 and the planned expansion of IB-Stim's label to a broader age range are expected to significantly enhance market opportunities [5] Growth Drivers - Key factors driving future growth include the rapid expansion of insurance coverage for the IB-Stim device, which is crucial for revenue growth, and the expected acceleration in revenue in the latter half of 2024 and into 2025 [5] Competitive Landscape - NeurAxis' stock has underperformed compared to industry peers and the broader market over the past year, indicating potential risks if the company fails to meet market expectations [7]