iRadimed(IRMD) - 2025 Q2 - Quarterly Report

Cautionary Statements Regarding Forward-Looking Statements 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] - 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][9][10] Part I. Financial Information Item 1. Condensed Financial Statements 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 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 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 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 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 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][43] - 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][31] 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][49] - 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][59] - On July 31, 2025, the Board declared a regular quarterly cash dividend of $0.17 per share[56] - 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] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 - IRADIMED develops, manufactures, markets, sells, and distributes MRI compatible medical devices, accessories, disposables, and services, primarily to hospitals and acute care facilities[62][68] - The Company is the only known provider of a non-magnetic IV infusion pump system (MRidium®) designed for safe use during MRI procedures[63] - 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][65][66] Financial Highlights 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] Recent Developments and Trends - 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][74] - Initial strategic rollout of the MRidium® 3870 is planned for Q4 2025, with full commercial distribution expected throughout 2026[75] - 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][76] Critical Accounting Estimates - 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][78] Results of Operations 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 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] - 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] - 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] - 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] Off-Balance Sheet Arrangements - As of June 30, 2025, and December 31, 2024, the Company did not have any material off-balance sheet arrangements[113] Contractual Obligations - There have been no material changes outside the ordinary course of business to contractual obligations and commercial commitments since December 31, 2024[115] Recent Accounting Pronouncements - As of June 30, 2025, there were no material changes to the information provided regarding recent accounting pronouncements in the 2024 Annual Report[116] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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] Item 4. Controls and Procedures 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] - There were no material changes in internal control over financial reporting during the period covered by this Quarterly Report[120] Part II. Other Information Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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] Item 2. Unregistered Sale of Equity Securities and Use of Proceeds 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] Item 3. Default Upon Senior Securities This item is not applicable to the Company for the reporting period - Not applicable[125] Item 4. Mine Safety Disclosures This item is not applicable to the Company for the reporting period - Not applicable[126] Item 5. Other Information 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] Item 6. Exhibits 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] Signatures