IRADIMED CORP

Previous wording

The following discussion and analysis should be read in conjunction with our unaudited condensed financial statements and the related notes to those statements included in this Quarterly Report, the discussion of certain risks and uncertainties contained in “Part I. Item 1A. Risk Factors,” the discussion under “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Part I, Item 1. Business” included in the 2024 Annual Report and “Part II. Item 1A. Risk Factors” of this Quarterly Report and the “Cautionary Statements Regarding Forward-Looking Statements” section at the beginning of this Quarterly Report.

Current wording

The following discussion and analysis should be read in conjunction with our unaudited condensed financial statements and the related notes to those statements included in this Quarterly Report, the discussion of certain risks and uncertainties contained in (i) “Part I, Item 1. Business,” “Part 1, Item 1A. Risk Factors,” and the discussion under “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2024 Annual Report and (ii) “Part II, Item 1A. Risk Factors” and the “Cautionary Statements Regarding Forward-Looking Statements” section included in this Quarterly Report.

Previous wording

Our 3880 MRI compatible patient vital signs monitoring system has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room. The IRADIMED 3880 has a compact, lightweight design allowing it to travel with the patient from their critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units. The features of the IRADIMED 3880 include: wireless Electrocardiogram (ECG) with dynamic gradient filtering; wireless blood oxygen saturation monitoring (SpO2) using Masimo® algorithms; non-magnetic respiratory carbon dioxide (CO2); invasive and non-invasive blood pressure; patient temperature; and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements. The IRADIMED 3880 MRI compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.

Current wording

Our patented 3880 MRI compatible patient vital signs monitoring system has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room. The IRADIMED 3880 has a compact, lightweight design allowing it to travel with the patient from their critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units. The features of the IRADIMED 3880 include: wireless Electrocardiogram (ECG) with dynamic gradient filtering; wireless blood oxygen saturation monitoring (SpO2) using Masimo® algorithms; non-magnetic respiratory carbon dioxide (CO2); invasive and non-invasive blood pressure; patient temperature; and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements. The IRADIMED 3880 MRI compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.

Previous wording

Our 3600 ferromagnetic detection device, IRadimed FMD1 with RALU is the first ferromagnetic detection device with TruSenseTM threat qualification technology. Our patent pending TruSenseTM technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and MRI Zone IV door status. with IRadimed’s expertise in Dynamic Signal Processing. This technology reduces false alarms, all while simultaneously circumventing background magnetic field noise. The 3600 ferromagnetic detection device can be self-installed and does not require drilling, special tools, permits or contractors like traditional FMD systems. The wireless touchscreen, remote alarm logging unit (RALU), is unique in the industry and provides a full color visual representation of the MRI door and FMD status. When an incident occurs, this wireless touchscreen uniquely allows users to quickly and easily log all ferrous items as they enter the MRI Zone IV improving the reporting accuracy hospitals require for accreditation.

Current wording

Our Model 3600 ferromagnetic detection device, IRadimed FMD1, with remote alarm logging unit (“RALU”) is the first ferromagnetic detection device with TruSenseTM threat qualification technology. Our patent pending TruSenseTM technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and MRI Zone IV door status with IRADIMED’s expertise in Dynamic Signal Processing. This technology reduces false alarms, all while simultaneously circumventing background magnetic field noise. The Model 3600 FMD1 can be self-installed and does not require drilling, special tools, permits or contractors like traditional FMD systems. The wireless touchscreen, RALU, is unique in the industry and provides a full color visual representation of the MRI door and FMD status. When an incident occurs, this wireless touchscreen uniquely allows users to quickly and easily log all ferrous items as they enter the MRI Zone IV improving the reporting accuracy hospitals require for accreditation.

Previous wording

For the quarter ended March 31, 2025, our revenue increased by $1.9 million, or 11% to $19.5 million, compared to $17.6 million for the quarter ended March 31, 2024. Income before the provision for income taxes was $5.9 million for the quarter ended March 31, 2025, compared to $5.2 million for the quarter ended March 31, 2024. Net income was $4.7 million, or $0.37 per diluted share, in the quarter ended March 31, 2025, compared to $4.1 million, or $0.32 per diluted share in the quarter ended March 31, 2024.

Current wording

For the quarter ended June 30, 2025, our revenue increased by $2.5 million, or 14% to $20.4 million, compared to $17.9 million for the quarter ended June 30, 2024. Income before the provision for income taxes was $7.3 million for the quarter ended June 30, 2025, compared to $6.3 million for the quarter ended June 30, 2024. Net income was $5.8 million, or $0.45 per diluted share, in the quarter ended June 30, 2025, compared to $4.9 million, or $0.38 per diluted share in the quarter ended June 30, 2024.

Previous wording

In addition to the trends identified in the 2024 Annual Report under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our business in fiscal year 2025 has been impacted, and we believe will continue to be impacted, by the following recent development and trend.

Current wording

In addition to the trends identified in the 2024 Annual Report under “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 (the “Q1 2025 Quarterly Report”) under “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our business in fiscal year 2025 has been impacted, and we believe will continue to be impacted, by the recent developments and trends stated therein and herein.

Previous wording

The United States recently announced changes to its trade policies, including increasing tariffs on imports, in some cases significantly, and potentially negotiating or terminating existing trade agreements. These actions have prompted retaliatory tariffs and other measures by a number of countries. In April 2025, actions were taken by the U.S. and certain other countries to modify the timing, rates and/or other aspects of certain of these tariffs. However, some of the new tariffs remain in effect, including significant tariffs between the U.S. and China, as well as other markets for our products and sources of certain of our manufacturing inputs. While the long-term effects remain uncertain, we continue to closely monitor the evolving trade policy environment, which presents a mix of impacts, including, among others, the potential for increased production costs and higher pricing to our customers, either of which could negatively affect our business, results of operations and financial condition. In addition, the imposition of tariffs, as well as uncertainty about their scope and duration could result in an increase in some input costs and/or inflation, or otherwise adversely affect economic conditions. The Company continues to monitor the economic effects of such announcements and is implementing plans to mitigate related impacts, but the effects associated with the tariffs remain uncertain. See “Part II, Item 1A. Risk Factors” in this Quarterly Report.

Current wording

Additionally, the Company continues to monitor ongoing changes to global trade policies, including the imposition of tariffs, and the Company is implementing plans to mitigate related impacts associated with the tariffs.

Previous wording

statements as well as the reported revenue and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Current wording

The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed financial statements, which we have prepared in accordance with GAAP. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements as well as the reported revenue and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

Comparison of the Three Months Ended March 31, 2025 and 2024

Current wording

Comparison of the Three Months Ended and the Six Months Ended June 30, 2025 and 2024

Previous wording

For the three months ended March 31,2025, revenue increased by $1.9 million, or 11%, to $19.5 million from $17.6 million for the same period in 2024. This is attributed to continued demand for our IV Infusion Pump System, disposables and amortization of extended warranty revenue.

Current wording

For the three months ended June 30,2025, total revenue increased by $2.5 million, or 14%, to $20.4 million from $17.9 million for the same period in 2024. This is attributed to continued demand for our IV infusion pump system, disposables, amortization of extended warranty revenue, and modifications to our sales incentive plan for patient vital signs monitoring systems.

Previous wording

Revenue from sales in the U.S. increased by $2.5 million, or 19%, to $16.0 million for the three months ended March 31, 2025, from $13.4 million for the same period in 2024. Revenue from sales internationally decreased by $0.6 million, or 15%, for the three months ended March 31, 2025 to $3.6 million, from $4.2 million for the same period in 2024. Domestic sales accounted for 82% of revenue for the three months ended March 31, 2025, compared to 76% for the same period in 2024.

Current wording

Revenue from sales in the U.S. increased by $2.7 million, or 17%, to $18.2 million for the three months ended June 30, 2025, from $15.5 million for the same period in 2024. Revenue from sales internationally decreased by $0.2 million, or 8%, for the three months ended June 30, 2025 to $2.2 million, from $2.4 million for the same period in 2024. Domestic sales accounted for 89% of revenue for the three months ended June 30, 2025, compared to 86% for the same period in 2024.

Previous wording

Revenue from sales of devices increased by $1.1 million, or 9%, to $13.0 million for the three months ended March 31, 2025, from $11.9 million for the same period in 2024. Revenue from the amortization of extended warranty agreements increased by $0.1 million, or 15%, to $0.6 million for the three months ended March 31, 2025, from $0.5 million for the three months ended March 31, 2024. Revenue from sales of our disposables increased by $0.9 million, or 23%, to $4.9 million for the three months ended March 31, 2025, from $4.0 million for the same period in 2024. Revenue from the services and other decreased by $0.2 million, or 13%, to $1.0 million for the three months ended March 31, 2025, from $1.2 million for the three months ended March 31, 2024.

Current wording

Revenue from sales of devices increased by $3.0 million, or 12%, to $27.6 million for the six months ended June 30, 2025, from $24.6 million for the same period in 2024. Revenue from the amortization of extended warranty agreements increased by $0.1 million, or 9%, to $1.2 million for the six months ended June 30, 2025, from $1.1 million for the six months ended June 30, 2024. Revenue from sales of our disposables increased by $1.4 million, or 19%, to $9.2 million for the six months ended June 30, 2025, from $7.7 million for the same period in 2024. Revenue from the services and other decreased by $0.2 million, or 9%, to $2.0 million for the six months ended June 30, 2025, from $2.2 million for the six months ended June 30, 2024.

Previous wording

For the three months ended March 31, 2025 our cost of revenue increased by $0.5 million, or 12%, to $4.7 million from $4.2 million for the same period in 2024. For the three months ended March 31, 2025, our gross profit increased by $1.4 million, or 10%, to $14.8 million from $13.4 million for the same period in 2024. Gross profit margin remained at 76.1% for both the three months ended March 31, 2025 and 2024.

Current wording

For the three months ended June 30, 2025 our cost of revenue increased by $0.5 million, or 15%, to $4.5 million from $3.9 million for the same period in 2024. For the three months ended June 30, 2025, our gross profit increased by $2.0 million, or 14%, to $16.0 million from $14.0 million for the same period in 2024. Gross profit margin remained at 78% for both the three months ended June 30, 2025 and 2024.

Previous wording

For the three months ended March 31, 2025, general and administrative expense increased by $0.6 million, or 15%, to $4.6 million from $4.0 million for the same period in 2024. This increase is primarily due to higher legal and professional expenses, software maintenance, and increased payroll and benefit expenses.

Current wording

For the three months ended June 30, 2025, general and administrative expense increased by $0.2 million, or 4%, to $4.3 million from $4.1 million for the same period in 2024. This increase is primarily due to higher legal and professional expenses, regulatory consulting, software maintenance, and increased payroll and benefit expenses.

Previous wording

For the three months ended March 31, 2025, sales and marketing expense increased by $0.4 million, or 11%, to $4.2 million from $3.8 million for the same period in 2024. This increase is primarily due to higher sales commissions, sales activities expenses, and payroll and benefits expenses.

Current wording

For the three months ended June 30, 2025, sales and marketing expense increased by $0.5 million, or 15%, to $4.0 million from $3.5 million for the same period in 2024. This increase is primarily due to higher sales commissions, sales activities expenses, and payroll and benefits expenses.

Previous wording

For the three months ended March 31,2025, research and development expense decreased by $0.2 million, or 25.0%, to $0.6 million from $0.8 million for the same period in 2024. This is primarily due to a reduction in the purchase of protype materials, offset by increased payroll and benefit expenses. These approved parts are now included in raw material inventory.

Current wording

For the three months ended June 30, 2025, research and development expense increased by $0.1 million, or 10%, to $0.9 million from $0.8 million for the same period in 2024. This is primarily due to an increase in payroll and benefit expenses related to the newly cleared MRidium® 3870 IV infusion pump system.

Previous wording

Other income, net consists of interest income, (the largest component), foreign currency gains and losses, and other miscellaneous income. For the three months ended March 31, 2025, other income, net remained consistent at $0.5 million compared with the same period in 2024.

Current wording

Other income, net consists of interest income, (the largest component), foreign currency gains and losses, and other miscellaneous income. For the three months ended June 30, 2025, other income, net decreased $0.1 million, or 17%, to $0.5 million from $0.6 million for the same period in 2024.

Previous wording

For the three months ended March 31, 2025, we recorded a provision for income tax expense of $1,258,000. Our effective tax rate was 21.2% for the three months ended March 31, 2025 and differed from the U.S. Federal statutory rate primarily due to U.S. state income tax expense, partially offset by research and development tax credits.

Current wording

For the three and six months ended June 30, 2025, we recorded a provision for income tax expense of $1,553,283 and $2,811,283, respectively. Our effective tax rate was 21.2% for the three and six months ended June 30, 2025 and differed from the U.S. federal statutory rate primarily due to U.S. state income tax expense, partially offset by research and development tax credits.

Previous wording

For the three months ended March 31,2024, we recorded a provision for income tax expense of $1,106,968. Our effective tax rate was 21.1% and differed from the U.S. Federal statutory rate primarily due to U.S. state income tax expense partially offset by research and development tax credits.

Current wording

For the three and six months ended June 30,2024, we recorded a provision for income tax expense of $1,368,036 and $2,475,004, respectively. For the three and six months ended June 30, 2024, our effective tax rate was 21.8% and 21.5%, respectively, and differed from the U.S. federal statutory rate primarily due to U.S. state income tax expense, partially offset by benefits from research and development tax credits.

Previous wording

On July 31, 2024, the Company received a notice of examination from the U.S. Internal Revenue Service for the tax year ended December 31, 2021. We are currently complying with the taxing authority and believe our tax position for the year under review was appropriate and have not accounted for any proposed adjustments at this time. The Company remains subject to income tax examinations for our United States Federal and certain U.S. state income taxes for 2020 and subsequent years.

Current wording

On July 31, 2024, the Company received a notice of examination from the U.S. Internal Revenue Service for the tax year ended December 31, 2021. We are currently complying with the taxing authority and believe our tax position for the year under review was appropriate and have not accounted for any proposed adjustments at this time. The Company remains subject to income tax examinations for our U.S. federal and certain U.S. state income taxes for 2020 and subsequent years.

Previous wording

As of March 31, 2025, we had cash and cash equivalents of $50.3 million, stockholders’ equity of $90.1 million, and working capital of $66.7 million. As of December 31, 2024, we had cash and cash equivalents of $52.2 million, stockholders’ equity of $86.8 million, and working capital of $66.7 million.

Current wording

As of June 30, 2025, we had cash and cash equivalents of $53.0 million, stockholders’ equity of $94.3 million, and working capital of $68.6 million. As of December 31, 2024, we had cash and cash equivalents of $52.2 million, stockholders’ equity of $86.8 million, and working capital of $66.7 million.

Previous wording

We believe that our current cash, and any cash generated from operations will be sufficient to meet our ongoing operating requirements for at least the next 12 months and into the foreseeable future. We do not anticipate requiring additional capital; however, if required or desirable, we may seek to obtain a credit facility, raise debt, or issue additional equity in private or public markets. However, ongoing negative economic conditions (including in relation to inflationary pressures, elevated interest rate levels and impacts from the imposition of, or changes in, tariffs) have resulted in, and may continue to result in, significant disruptions of financial and capital markets, which could reduce our ability to access capital and negatively affect our liquidity in the future.

Current wording

We believe that our current cash, and any cash generated from operations will be sufficient to meet our ongoing operating requirements for at least the next 12 months and into the foreseeable future. We do not anticipate requiring additional capital; however, if required or desirable, we may seek to obtain a credit facility, raise debt, or issue additional equity in private or public markets. However, various economic conditions might disrupt capital markets at any time, which could reduce our ability to access capital and negatively affect our liquidity in the future.

Previous wording

Cash provided by operating activities increased by $0.4 million, to $4.3 million for the three months ended March 31, 2025, compared to $3.9 million for the same period in 2024. During the three months ended March 31, 2025, cash provided by operations was positively impacted by higher net income, lower cash outflows related to accounts payable, and negatively impacted by increased inventory purchases and accounts receivable.

Current wording

Cash provided by operating activities increased by $1.5 million, to $12.0 million for the six months ended June 30, 2025, compared to $10.5 million for the same period in 2024. During the six months ended June 30, 2025, cash provided by operations was positively impacted by higher net income, lower cash outflows related to accounts payable, and negatively impacted by increased inventory purchases, prepaid expenses and accounts receivable.

Previous wording

Cash used in investing activities decreased by $3.4 million, to $3.9 million for the three months ended March 31, 2025, compared to $0.5 million for the same period in 2024. The majority of our 2025 spend in investing activities is attributed to construction costs of the New Facility to accommodate our increased and anticipated growth.

Current wording

Cash used in investing activities increased by $5.0 million, to $6.7 million for the six months ended June 30, 2025, compared to $1.7 million for the same period in 2024. The majority of our 2025 spend in investing activities is attributed to construction costs of the New Facility (see Note 11 to the Financial Statements in this Quarterly Report) to accommodate our anticipated growth.

Previous wording

Cash used in financing activities decreased by $5.7 million, to $2.3 million for the three months ended March 31, 2025, compared to approximately $8.0 million for the same period in 2024. In March 2024, the Company paid a special dividend to our stockholders; and commenced a regular quarterly dividend payment, subject to the sole discretion of the Company’s Board of Directors and applicable law.

Current wording

Cash used in financing activities decreased by $5.5 million, to $4.5 million for the six months ended June 30,2025, compared to approximately $10.0 million for the same period in 2024. The decrease is primarily due to December 2023 declaration of a special cash dividend and subsequent payment in the first quarter of 2024. In the second quarter of 2024, the Company commenced paying a regular quarterly cash dividend payment. Special and quarterly cash dividend payments are subject to the sole discretion of the Board and applicable law.

Previous wording

Our current manufacturing and headquarters facility has been leased from Susi, LLC, an entity controlled by our President, Chief Executive Officer, and Chairman of the Board, Roger Susi. Pursuant to the terms of the Lease Amendment, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index.

Current wording

Our current manufacturing and headquarters facility has been leased from Susi, LLC, an entity controlled by our President, Chief Executive Officer, and Chairman of the Board, Roger Susi. Pursuant to the terms of the Lease Amendment, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index. During the third quarter of 2025, the Company will complete its move to the New Facility and terminate the month-to-month lease with Susi, LLC under the Lease Amendment.