Group 1 - The article does not provide any specific content related to a company or industry [1]

Financial Data and Key Metrics Changes - For Q2 2025, the company achieved revenue of $20.4 million, a 14% increase from $17.9 million in Q2 2024 [3][11] - Gross profit margin was reported at 78%, consistent with the prior year, with net income increasing 18% to $5.8 million or $0.45 per diluted share [12][13] - For Q3 2025, the company expects revenue between $20.5 million and $20.9 million, representing 12%-14% growth over Q3 2024 [9] - Full-year 2025 revenue guidance has been raised to $80 million-$82.5 million, up from the previous range of $78 million-$82 million, indicating 9%-13% growth over 2024 [9] Business Line Data and Key Metrics Changes - MRI compatible IV infusion pump systems contributed $8.2 million, up 19% year over year, while patient vital signs monitoring systems contributed $5.9 million, up 9% [11] - Disposables revenue grew 14% to $4.2 million, reflecting increased utilization of devices [11] Market Data and Key Metrics Changes - Domestic sales increased 18% to $18.2 million, while international sales decreased 9% to $2.2 million, with domestic revenue accounting for 89% of total revenue [12] - The company anticipates a significant demand for replacing older 3860 model pumps, with over 6,200 units in the U.S. market alone that are over five years old [6] Company Strategy and Development Direction - The company aims to achieve a revenue run rate exceeding $100 million by 2026, driven by the introduction of the new 3870 IV pump and increased replacement sales [5][8] - The new pump is expected to have a higher average selling price (ASP) of approximately 12% more than the existing pump, which may positively impact gross margins [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, citing a record backlog and strong performance in existing product lines [16][18] - The company plans to introduce the new 3870 pump in Q4 2025, with initial sales aimed at gathering user feedback rather than generating significant revenue [20][21] Other Important Information - The company declared a quarterly dividend of $0.17 per share for Q3, payable on August 28, 2025 [10] - Cash flow from operations was reported at $7.7 million for the quarter, up 17% from the previous year [13] Q&A Session Summary Question: Can you talk about the composition of the current backlog? - Management confirmed a record backlog as of June 30, composed of both pumps and a strong monitoring backlog, providing good visibility into the second half of the year [16][18] Question: How do you expect 3860 sales to trend in front of the 3870 launching? - Management indicated that orders for the older pump would remain strong until the new pump is actively marketed, expected around December [18] Question: What is the expected ramp-up to the $50 million of pump revenue? - Management expects initial sales of the new pump to be insignificant in Q4, with a stronger ramp-up in bookings anticipated in Q2 2026 [21][22] Question: Is there an ASP increase for the new pump? - Management confirmed that the ASP for the new pump is expected to be around 12% higher than the existing pump [30] Question: How long is it taking to fulfill the backlog? - The monitor backlog is running about four to five weeks, while the pump backlog is approximately five to six months [33]

Financial Performance - The Company reported record revenue of $21.2 million for Q3 2025, a 16% increase year-over-year from $18.3 million in Q3 2024[3] - GAAP diluted earnings per share (EPS) for Q3 2025 were $0.43, an 8% increase compared to $0.40 in Q3 2024, while non-GAAP diluted EPS was $0.47, a 9% increase from $0.43[7] - Non-GAAP net income for Q3 2025 was $6.1 million, a 10% increase from $5.5 million in Q3 2024[9] - Net income for Q3 2025 reached $5,576,652, a 10.4% increase compared to $5,049,491 in Q3 2024[39] - Revenue for Q3 2025 was $21,202,064, representing a 15.5% increase from $18,325,959 in Q3 2024[39] - Gross profit for Q3 2025 was $16,494,308, up 16.2% from $14,191,706 in Q3 2024[39] - Free cash flow for Q3 2025 was $5,722,520, an increase from $5,104,230 in Q3 2024[43] Guidance and Expectations - The Company raised its full-year 2025 revenue guidance to $82.5 million to $83.5 million, up from the previous range of $80.0 million to $82.5 million[5] - For Q4 2025, the Company expects revenue between $21.4 million and $22.4 million, with GAAP diluted EPS guidance of $0.43 to $0.47[18] - The company expects to ramp up commercialization of its next-generation 3870 MRI-compatible IV infusion pump, with anticipated revenue growth[34] Operational Efficiency - The gross margin for Q3 2025 was 78%, compared to 77% in Q3 2024, indicating improved operational efficiency[14] - Operating expenses for Q3 2025 were $9,660,558, up from $8,402,586 in Q3 2024, representing a 14.9% increase[39] Cash Flow and Assets - Cash flow from operations for Q3 2025 was $7.0 million, a decrease of 23% from $9.1 million in Q3 2024[15] - Total current assets increased to $84,919,005 as of September 30, 2025, compared to $74,706,209 at the end of 2024, marking a 13.7% growth[37] - Total assets rose to $114,721,779 as of September 30, 2025, up from $98,325,775 at the end of 2024, indicating a 16.7% increase[37] - Total stockholders' equity increased to $98,351,971 as of September 30, 2025, compared to $86,818,756 at the end of 2024, reflecting a 13.4% growth[37] Sales and Market Presence - Domestic sales accounted for 85% of total revenue in Q3 2025, up from 83% in Q3 2024[14] - The total construction cost of the new facility in Orlando was approximately $13.3 million, completed in early July 2025[17] Product Development - The Company plans to begin limited commercial shipments of the next-generation 3870 MRI-compatible IV infusion pump in December 2025, with full U.S. commercialization expected in Q1 2026[4]

Core Insights - Iradimed Corporation reported record revenue of $21.2 million for Q3 2025, marking a 16% increase year-over-year, and maintained a strong gross margin of 78% [2][6][8] - The company is set to begin limited commercial shipments of its next-generation 3870 MRI-compatible IV infusion pump in December 2025, with full commercialization expected in Q1 2026 [3][4] - For Q4 2025, the company anticipates revenue between $21.4 million and $22.4 million, and has raised its full-year revenue guidance to $82.5 million to $83.5 million [4][16] Financial Performance - For the three months ended September 30, 2025, the company reported net income of $5.6 million, an increase of 10% from $5.0 million in Q3 2024, translating to diluted earnings per share of $0.43, up 8% from $0.40 [6][8] - Non-GAAP net income for Q3 2025 was $6.1 million, a 10% increase from $5.5 million in the same period of 2024, with non-GAAP diluted earnings per share at $0.47, up 9% [7][10] - For the nine months ended September 30, 2025, revenue reached $61.1 million, a 13% increase from $53.9 million in the same period of 2024, with net income also increasing by 13% to $16.0 million [9][10] Operational Highlights - The company completed the construction of its new facility in Orlando, Florida, with total costs amounting to approximately $13.3 million, and the facility is now fully operational [15] - The backlog for the company's pump and monitor products is at an all-time high, indicating strong demand [2][3] - Domestic sales accounted for 85% of total revenue for both Q3 and the nine months ended September 30, 2025, compared to 83% and 82% respectively in the prior year [11][12] Dividend Information - The board of directors declared a regular quarterly cash dividend of $0.17 per share, payable on November 25, 2025, to stockholders of record as of November 14, 2025 [5][8]

Core Points - Iradimed Corporation will release its 2025 third quarter financial results on November 3, 2025, before market opening [1] - A conference call will be held on the same day at 11:00 a.m. Eastern Time to discuss the results and answer questions [1][2] Company Overview - Iradimed Corporation specializes in developing MRI-compatible medical devices, notably a non-magnetic intravenous infusion pump system designed for safe use during MRI procedures [3] - The patented MRidium® MRI compatible IV infusion pump system utilizes a non-magnetic ultrasonic motor and non-ferrous parts to deliver anesthesia and IV fluids safely during MRI scans [3] - The 3880 MRI compatible patient vital signs monitoring system is designed with non-magnetic components, operating in magnetic fields up to 30,000 gauss, ensuring patient safety and uninterrupted monitoring during MRI procedures [4] - The Iradimed 3880 system features wireless ECG, SpO2 monitoring, non-magnetic respiratory CO2, and advanced multi-gas anesthetic agent measurements, facilitating effective communication of vital signs to clinicians [4]

Core Viewpoint - Iradimed Corporation announced a transition in its Board of Directors, with Anthony Vuoto retiring and Joe Kiani appointed as his successor, effective September 2, 2025. This change is expected to enhance the company's strategic direction in the medical device sector, particularly in MRI-compatible technologies [1][4]. Group 1: Board Transition - Anthony Vuoto has retired from his position as a director after serving since 2016, contributing significantly to the company's growth and innovation [2]. - Joe Kiani, founder of Masimo Corporation and a recognized innovator in medical technology, has been appointed to the Board, bringing extensive experience and over 500 patents [3][4]. Group 2: Company Overview - Iradimed Corporation specializes in developing innovative MRI-compatible medical devices, including patient monitoring and infusion systems [5]. - The company is the only known provider of a non-magnetic intravenous infusion pump system designed for safe use during MRI procedures, addressing safety concerns associated with standard infusion pumps [6]. - The Iradimed 3880 MRI-compatible patient vital signs monitoring system is designed to operate in magnetic fields up to 30,000 gauss, ensuring continuous monitoring of critically ill patients during MRI scans [7].

Core Insights - IRADIMED CORPORATION will participate in the Wells Fargo 2025 Healthcare Conference from September 3-5, 2025, in Boston, Massachusetts, highlighting its role in the healthcare sector [1][2] - The company is recognized as a leader in developing MRI-compatible medical devices, specifically focusing on patient monitoring and infusion systems [3][4] Company Overview - IRADIMED CORPORATION specializes in designing, manufacturing, marketing, and distributing MRI-compatible medical devices, accessories, disposables, and related services [3] - The company is the only known provider of a non-magnetic intravenous infusion pump system designed for safe use during MRI procedures, which addresses significant safety concerns associated with standard infusion pumps [4] Product Highlights - The MRidium® MRI-compatible IV infusion pump system features a non-magnetic ultrasonic motor and non-ferrous parts, ensuring safe and reliable delivery of anesthesia and IV fluids during MRI procedures [4] - The 3880 MRI-compatible patient vital signs monitoring system operates in magnetic fields up to 30,000 gauss, allowing for continuous monitoring of critically ill patients during MRI scans [5] - Key features of the Iradimed 3880 include wireless ECG, wireless SpO2, non-magnetic respiratory CO2 monitoring, and advanced multi-gas anesthetic agent measurement capabilities [5]

Core Insights - IRadimed Corporation (NASDAQ: IRMD) is highlighted for its exceptional economic characteristics, suggesting it is a high-quality investment opportunity [1]. Company Overview - The company is recognized for its strong fundamental value drivers, which are essential for identifying long-term investment potential [1]. - The focus is on acquiring shares at prices that reflect their intrinsic worth, indicating a value-oriented investment strategy [1]. Investment Position - The analyst has a beneficial long position in IRMD shares, indicating confidence in the company's future performance [2]. - The article reflects the author's personal opinions and is not influenced by external compensation, ensuring an unbiased perspective on the investment [2].

Core Insights - Iradimed Corporation reported record revenue and profit for Q2 2025, with revenue of $20.41 million and non-GAAP EPS of $0.49, surpassing analyst expectations and the company's own guidance [1][2][9] Financial Performance - Revenue increased by 14% year-over-year from $17.93 million in Q2 2024 to $20.41 million in Q2 2025 [2][5] - Non-GAAP EPS rose 17% from $0.42 in Q2 2024 to $0.49 in Q2 2025, while GAAP EPS increased 18% from $0.38 to $0.45 [2][6] - Gross profit margin remained stable at 78% [2][6] - Free cash flow decreased by 8% year-over-year to $4.92 million [2][6] Product Performance - MRI-compatible IV infusion pump systems, the largest product group, saw revenue growth of approximately 15.5% compared to Q2 2024 [5] - Patient vital signs monitoring systems grew by approximately 1.3%, while disposables expanded by 14% [5] - Ferro magnetic detection systems experienced the highest growth at 32% compared to Q2 2024 [5] Business Strategy - The company focuses on technological innovation, expanding its installed base, and maintaining regulatory compliance [4] - A new manufacturing facility is nearing completion to meet increasing demand [4][6] Geographic Distribution - Domestic sales accounted for 89% of total revenue, up from 86% a year ago, while international sales remained flat or lower [7] Future Outlook - For Q3 2025, revenue guidance is set between $20.5 million and $20.9 million, with projected non-GAAP EPS of $0.45 to $0.49 [11] - Fiscal 2025 revenue outlook has been raised to $80.0–$82.5 million, with non-GAAP EPS expected between $1.76 and $1.86 [11] - The next-generation MRidium 3870 pump is expected to launch commercially in late 2025 [10]

[Cautionary Statements Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) The report contains forward-looking statements subject to risks and uncertainties, which may cause actual results to differ materially from expectations - The report contains forward-looking statements subject to risks and uncertainties, which may cause actual results to differ materially from expectations[8](index=8&type=chunk) - Key risks include the ability to receive and maintain FDA 510(k) clearance, unexpected costs from regulatory actions, reliance on a limited number of products, ability to retain key personnel, supply chain integrity, market acceptance of new products, and intellectual property protection[8](index=8&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) [Part I. Financial Information](index=8&type=section&id=Part%20I%20Financial%20Information) [Item 1. Condensed Financial Statements](index=8&type=section&id=Item%201%20Financial%20Statements) The Company's financial position as of June 30, 2025, shows an increase in total assets and stockholders' equity compared to December 31, 2024. For the three and six months ended June 30, 2025, the Company reported increased revenue, gross profit, and net income year-over-year, driven by strong operating performance. Cash flows from operations also increased, while investing activities saw a significant increase in cash usage primarily due to new facility construction [Condensed Balance Sheets](index=8&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (June 30, 2025 vs. Dec 31, 2024) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | Change | | :--------------------------------- | :------------------------ | :------------------------ | :------- | | Cash and cash equivalents | $52,995,781 | $52,233,907 | +$761,874 | | Total current assets | $77,372,612 | $75,242,219 | +$2,130,393 | | Property and equipment, net | $22,938,080 | $16,810,797 | +$6,127,283 | | Total assets | $106,447,489 | $98,325,775 | +$8,121,714 | | Total current liabilities | $8,814,546 | $8,512,308 | +$302,238 | | Total liabilities | $12,146,103 | $11,507,019 | +$639,084 | | Total stockholders' equity | $94,301,386 | $86,818,756 | +$7,482,630 | [Condensed Statements of Operations](index=9&type=section&id=Condensed%20Statements%20of%20Operations) Condensed Statements of Operations Highlights (Three Months Ended June 30) | Metric | Q2 2025 (Unaudited) | Q2 2024 (Unaudited) | Change (YoY) | % Change (YoY) | | :--------------------------------- | :------------------ | :------------------ | :----------- | :------------- | | Revenue | $20,409,400 | $17,928,876 | +$2,480,524 | +13.8% | | Gross profit | $15,954,992 | $14,009,593 | +$1,945,399 | +13.9% | | Income from operations | $6,787,997 | $5,627,043 | +$1,160,954 | +20.6% | | Net income | $5,773,961 | $4,901,224 | +$872,737 | +17.8% | | Basic EPS | $0.45 | $0.39 | +$0.06 | +15.4% | | Diluted EPS | $0.45 | $0.38 | +$0.07 | +18.4% | Condensed Statements of Operations Highlights (Six Months Ended June 30) | Metric | H1 2025 (Unaudited) | H1 2024 (Unaudited) | Change (YoY) | % Change (YoY) | | :--------------------------------- | :------------------ | :------------------ | :----------- | :------------- | | Revenue | $39,920,037 | $35,526,995 | +$4,393,042 | +12.4% | | Gross profit | $30,797,798 | $27,397,316 | +$3,400,482 | +12.4% | | Income from operations | $12,219,453 | $10,375,390 | +$1,844,063 | +17.8% | | Net income | $10,461,390 | $9,037,757 | +$1,423,633 | +15.8% | | Basic EPS | $0.82 | $0.71 | +$0.11 | +15.5% | | Diluted EPS | $0.82 | $0.71 | +$0.11 | +15.5% | [Condensed Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Stockholders' Equity Changes (Six Months Ended June 30, 2025) | Item | Amount (USD) | | :--------------------------------- | :----------- | | Net income | $10,461,390 | | Dividends declared | $(4,323,150) | | Stock-based compensation expense | $1,556,682 | | Net share settlement of restricted stock units | $(212,291) | | Total increase in equity | $7,482,630 | [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash Flow Activities (Six Months Ended June 30) | Activity | H1 2025 (Unaudited) | H1 2024 (Unaudited) | Change (YoY) | | :--------------------------------- | :------------------ | :------------------ | :----------- | | Net cash provided by operating activities | $12,038,353 | $10,521,680 | +$1,516,673 | | Net cash used in investing activities | $(6,741,038) | $(1,748,573) | $(4,992,465) | | Net cash used in financing activities | $(4,535,441) | $(10,000,165) | +$5,464,724 | | Net increase (decrease) in cash | $761,874 | $(1,227,058) | +$1,988,932 | | Cash and cash equivalents, end of period | $52,995,781 | $48,535,140 | +$4,460,641 | [Notes to Unaudited Condensed Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes provide essential context to the unaudited condensed financial statements, detailing the basis of presentation, significant accounting policies, and disaggregation of revenue. Key disclosures include risks related to FDA clearance and sole-sourced components, the composition of inventory, property, and intangible assets, and the impact of stock-based compensation and income taxes. Notably, the Company is transitioning to a new facility, impacting lease liabilities, and has received FDA clearance for its next-generation MRidium® 3870 IV infusion pump system - The Company operates in one reportable segment, focusing on MRI compatible medical devices and related products[27](index=27&type=chunk)[43](index=43&type=chunk) - Significant risks include the ability to receive and maintain FDA clearance for products and product candidates, and potential disruptions due to reliance on sole-sourced key components[30](index=30&type=chunk)[31](index=31&type=chunk) Revenue by Geographic Region (Six Months Ended June 30) | Region | H1 2025 (Unaudited) | H1 2024 (Unaudited) | Change (YoY) | % Change (YoY) | | :------------- | :------------------ | :------------------ | :----------- | :------------- | | United States | $34,142,682 | $28,894,172 | +$5,248,510 | +18.2% | | International | $5,777,355 | $6,632,823 | $(855,468) | -12.9% | | Total revenue | $39,920,037 | $35,526,995 | +$4,393,042 | +12.4% | Revenue by Type (Six Months Ended June 30) | Revenue Type | H1 2025 (Unaudited) | H1 2024 (Unaudited) | Change (YoY) | % Change (YoY) | | :----------------------------------------- | :------------------ | :------------------ | :----------- | :------------- | | Devices | $27,576,078 | $24,601,863 | +$2,974,215 | +12.1% | | Amortization of extended warranty agreements | $1,152,651 | $1,055,319 | +$97,332 | +9.2% | | Disposables | $9,150,958 | $7,709,592 | +$1,441,366 | +18.7% | | Services and other | $2,040,350 | $2,160,221 | $(119,871) | -5.5% | | Total revenue | $39,920,037 | $35,526,995 | +$4,393,042 | +12.4% | - The Company's effective tax rate for the three and six months ended June 30, 2025, was **21.2%**, primarily due to U.S. state income tax expense partially offset by research and development tax credits. The IRS completed its review of the 2021 tax year with no changes[47](index=47&type=chunk)[49](index=49&type=chunk) - The Company is completing its move to a new corporate office and manufacturing facility in Orlando, Florida, during Q3 2025, which led to a lease amendment for the old facility and a reduction in ROU asset valuation[51](index=51&type=chunk)[59](index=59&type=chunk) - On July 31, 2025, the Board declared a regular quarterly cash dividend of **$0.17 per share**[56](index=56&type=chunk) - The One Big Beautiful Bill Act (OBBBA), enacted on July 4, 2025, includes provisions for immediate expensing of domestic R&D expenditures and increased first-year bonus depreciation, which the Company is assessing for Q3 2025 impact[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202%20Operations) IRADIMED Corporation, a leader in MRI-compatible medical devices, reported a 14% increase in Q2 2025 revenue to $20.4 million and a 12% increase for the six months ended June 30, 2025, to $39.9 million, driven by strong demand for its IV infusion pump systems and disposables, particularly in the U.S. Net income also saw significant growth. The Company recently received FDA 510(k) clearance for its next-generation MRidium® 3870 IV infusion pump system, with a strategic rollout planned for Q4 2025. Operating expenses increased due to higher sales, marketing, and administrative costs, while liquidity remains strong with $53.0 million in cash and cash equivalents [Our Business](index=24&type=section&id=Our%20Business) - IRADIMED develops, manufactures, markets, sells, and distributes MRI compatible medical devices, accessories, disposables, and services, primarily to hospitals and acute care facilities[62](index=62&type=chunk)[68](index=68&type=chunk) - The Company is the only known provider of a non-magnetic IV infusion pump system (MRidium®) designed for safe use during MRI procedures[63](index=63&type=chunk) - Key products include the MRidium® MRI compatible IV infusion pump system, the 3880 MRI compatible patient vital signs monitoring system, and the Model 3600 ferromagnetic detection device (IRadimed FMD1) with TruSense™ technology[63](index=63&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) [Financial Highlights](index=26&type=section&id=Financial%20Highlights) Financial Highlights (Quarter Ended June 30, 2025 vs. 2024) | Metric | Q2 2025 | Q2 2024 | Change | % Change | | :------------- | :---------- | :---------- | :------- | :------- | | Revenue | $20.4 million | $17.9 million | +$2.5 million | +14% | | Income before tax | $7.3 million | $6.3 million | +$1.0 million | +15.9% | | Net income | $5.8 million | $4.9 million | +$0.9 million | +18.4% | | Diluted EPS | $0.45 | $0.38 | +$0.07 | +18.4% | - For the remainder of fiscal year 2025, the Company expects higher revenue due to increased sales of medical devices, products, accessories, disposables, and services, along with higher operating expenses from increased sales and marketing, regulatory, and general and administrative activities[71](index=71&type=chunk) [Recent Developments and Trends](index=26&type=section&id=Recent%20Developments%20and%20Trends) - The FDA granted 510(k) clearance for the Company's next-generation MRidium® 3870 IV infusion pump system on May 29, 2025, extending its unique position as the world's only supplier of non-magnetic MRI infusion pump devices[73](index=73&type=chunk)[74](index=74&type=chunk) - Initial strategic rollout of the MRidium® 3870 is planned for Q4 2025, with full commercial distribution expected throughout 2026[75](index=75&type=chunk) - The One Big Beautiful Bill Act (OBBBA), enacted July 4, 2025, includes provisions for immediate expensing of domestic R&D expenditures and increased first-year bonus depreciation, which the Company is assessing for its Q3 2025 financial statements[75](index=75&type=chunk)[76](index=76&type=chunk) [Critical Accounting Estimates](index=28&type=section&id=Critical%20Accounting%20Estimates) - The Company's financial statements rely on estimates and assumptions in accordance with GAAP, with no material changes to critical accounting policies or recent accounting pronouncements since the 2024 Annual Report[77](index=77&type=chunk)[78](index=78&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) For the three months ended June 30, 2025, total revenue increased by 14% to $20.4 million, primarily driven by U.S. sales (up 17%) and device sales (up 15%), particularly IV infusion pump systems and disposables. Gross profit margin remained stable at 78%. Operating expenses increased across general and administrative (4%), sales and marketing (15%), and research and development (10%), mainly due to higher payroll, sales commissions, and regulatory consulting. For the six months, similar trends were observed with total revenue up 12% to $39.9 million, U.S. sales up 18%, and device sales up 12%. Gross profit margin remained at 77% Revenue Growth (Three Months Ended June 30) | Category | Q2 2025 Revenue | Q2 2024 Revenue | Change | % Change | | :--------------------------------- | :-------------- | :-------------- | :------- | :------- | | Total Revenue | $20,409,400 | $17,928,876 | +$2,480,524 | +14% | | U.S. Sales | $18,190,063 | $15,485,216 | +$2,704,847 | +17% | | International Sales | $2,219,337 | $2,443,660 | $(224,323) | -8% | | Total Devices Revenue | $14,613,983 | $12,697,825 | +$1,916,158 | +15% | | Disposables Revenue | $4,203,870 | $3,695,717 | +$508,153 | +14% | Revenue Growth (Six Months Ended June 30) | Category | H1 2025 Revenue | H1 2024 Revenue | Change | % Change | | :--------------------------------- | :-------------- | :-------------- | :------- | :------- | | Total Revenue | $39,920,037 | $35,526,995 | +$4,393,042 | +12% | | U.S. Sales | $34,142,682 | $28,894,172 | +$5,248,510 | +18% | | International Sales | $5,777,355 | $6,632,823 | $(855,468) | -13% | | Total Devices Revenue | $27,576,078 | $24,601,863 | +$2,974,215 | +12% | | Disposables Revenue | $9,150,958 | $7,709,592 | +$1,441,366 | +19% | Gross Profit and Operating Expenses (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change | % Change | | :-------------------------- | :---------- | :---------- | :------- | :------- | | Gross Profit | $15,954,992 | $14,009,593 | +$1,945,399 | +14% | | Gross Profit Percentage | 78% | 78% | 0% | - | | General and Administrative | $4,279,993 | $4,104,961 | +$175,032 | +4% | | Sales and Marketing | $4,009,640 | $3,476,460 | +$533,180 | +15% | | Research and Development | $877,362 | $801,129 | +$76,233 | +10% | Gross Profit and Operating Expenses (Six Months Ended June 30) | Metric | H1 2025 | H1 2024 | Change | % Change | | :-------------------------- | :---------- | :---------- | :------- | :------- | | Gross Profit | $30,797,798 | $27,397,316 | +$3,400,482 | +12% | | Gross Profit Percentage | 77% | 77% | 0% | - | | General and Administrative | $8,890,825 | $8,096,172 | +$794,653 | +10% | | Sales and Marketing | $8,185,913 | $7,303,625 | +$882,288 | +12% | | Research and Development | $1,501,607 | $1,622,129 | $(120,522) | -7% | [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity Position (June 30, 2025 vs. Dec 31, 2024) | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------ | :------------ | :------------ | :------- | | Cash and cash equivalents | $53.0 million | $52.2 million | +$0.8 million | | Stockholders' equity | $94.3 million | $86.8 million | +$7.5 million | | Working capital | $68.6 million | $66.7 million | +$1.9 million | - The Company believes current cash and cash flow from operations will be sufficient to meet operating requirements for at least the next 12 months and into the foreseeable future[107](index=107&type=chunk) - Cash provided by operating activities increased by **$1.5 million** to **$12.0 million** for the six months ended June 30, 2025, primarily due to higher net income[108](index=108&type=chunk) - Cash used in investing activities increased significantly by **$5.0 million** to **$6.7 million**, mainly due to construction costs for the new corporate facility[109](index=109&type=chunk) - Cash used in financing activities decreased by **$5.5 million** to **$4.5 million**, primarily due to a special cash dividend payment in Q1 2024 not recurring in 2025[110](index=110&type=chunk) [Off-Balance Sheet Arrangements](index=36&type=section&id=Off-Balance%20Sheet%20Arrangements) - As of June 30, 2025, and December 31, 2024, the Company did not have any material off-balance sheet arrangements[113](index=113&type=chunk) [Contractual Obligations](index=38&type=section&id=Contractual%20Obligations) - There have been no material changes outside the ordinary course of business to contractual obligations and commercial commitments since December 31, 2024[115](index=115&type=chunk) [Recent Accounting Pronouncements](index=38&type=section&id=Recent%20Accounting%20Pronouncements) - As of June 30, 2025, there were no material changes to the information provided regarding recent accounting pronouncements in the 2024 Annual Report[116](index=116&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203) There have been no material changes in the Company's market risks from those disclosed in the 2024 Annual Report - No material changes in market risks from those disclosed in the 2024 Annual Report[117](index=117&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the period - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[119](index=119&type=chunk) - There were no material changes in internal control over financial reporting during the period covered by this Quarterly Report[120](index=120&type=chunk) [Part II. Other Information](index=39&type=section&id=Part%20II%20Other%20Information) [Item 1. Legal Proceedings](index=39&type=section&id=Item%201%20Legal%20Proceedings) The Company is not involved in any legal matters that management believes would have a material adverse effect on its business, financial condition, results of operations, or cash flows - The Company is not currently involved in any legal proceedings that management believes would have a material adverse effect on its business or financial condition[122](index=122&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201ARisk%20Factors) There have been no material changes in the Company's risk factors from those described in its 2024 Annual Report and the Q1 2025 Quarterly Report - No material changes in risk factors from those described in the 2024 Annual Report and the Q1 2025 Quarterly Report[123](index=123&type=chunk) [Item 2. Unregistered Sale of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities and use of proceeds to report[124](index=124&type=chunk) [Item 3. Default Upon Senior Securities](index=39&type=section&id=Item%203%20Default%20Upon%20Senior%20Securities) This item is not applicable to the Company for the reporting period - Not applicable[125](index=125&type=chunk) [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This item is not applicable to the Company for the reporting period - Not applicable[126](index=126&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205%20Other%20Information) Roger Susi, the Company's President, CEO, and Chairman, adopted a Rule 10b5-1 trading plan on June 16, 2025, for the potential sale of up to 100,000 shares of common stock, effective until June 16, 2026, or until all transactions under the plan are completed - CEO Roger Susi adopted a Rule 10b5-1 trading plan on June 16, 2025, for the potential sale of up to **100,000 shares** of common stock, effective until June 16, 2026, or plan completion[127](index=127&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including certifications from the Chief Executive Officer and Chief Financial Officer, as well as various XBRL documents - The report includes certifications from the CEO and CFO, as well as various XBRL documents[128](index=128&type=chunk) [Signatures](index=41&type=section&id=Signatures)