IRadimed Corporation

07/31/2026 | Press release | Distributed by Public on 07/31/2026 14:10

Quarterly Report for Quarter Ending June 30, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with (i) our unaudited condensed financial statements and the related notes thereto included in this Quarterly Report, (ii) discussions under "Part I, Item 1. Business," "Part I, Item 1A. Risk Factors," and "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in the 2025 Annual Report, and (iii) "Part II, Item 1A. Risk Factors" and the "Cautionary Statements Regarding Forward-Looking Statements" section included in this Quarterly Report.
Our Business
We develop, manufacture, market, sell, and distribute MRI compatible medical devices and product related accessories, disposables, and services.
We are a leader in the development of innovative MRI compatible medical devices. We are the only known provider of non-magnetic IV infusion pump systems specifically designed to be safe for use during MRI procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components, which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system. Our patented MRidium MRI compatible IV infusion pump systems have been designed with a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. Our pump solutions provide a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan, which is important to critically ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated to remain immobile during an MRI scan.
Each IV infusion pump system generally consists of an MRidium MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories.
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 peripheral oxygen saturation (SpO2) monitoring 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.
We generate revenue from the sale of MRI compatible medical devices and accessories, extended maintenance agreements, services related to maintaining our products and the sale of disposable products used with our devices. The principal customers for our MRI compatible products include hospitals and acute care facilities, both in the U.S. and internationally. As of June 30, 2026, our direct U.S. sales force consisted of 29 field sales representatives, 4 regional sales directors and supplemented by 11 clinical application specialists. Internationally, we have distribution agreements with independent distributors selling our products.
Selling cycles for our devices have varied widely and have historically ranged between three and six months in duration. We also enter into agreements with integrated delivery networks ("IDNs") and healthcare supply contracting companies, which are commonly referred to as group purchasing organizations ("GPOs") in the U.S., which enable us to sell and distribute our products to their member hospitals. GPOs negotiate volume purchase prices for hospitals, group practices, and other clinics that are members of a GPO. Under our GPO agreements, we are required to pay the GPOs a fee of three percent of the sales of our products to members of the GPO. Sales to participating IDNs do not have an associated fee.
Financial Highlights
For the quarter ended June 30, 2026, our revenue increased by $0.1 million, or 0.5%, to $20.5 million from $20.4 million compared to the same period of 2025. Income before the provision for income taxes was $6.9 million for the quarter ended June 30, 2026, compared to $7.3 million for the quarter ended June 30, 2025. Net income was $5.2 million, or $0.41 per diluted share, in the quarter ended June 30, 2026, compared to $5.8 million, or $0.45 per diluted share in the quarter ended June 30, 2025.
For the fiscal year 2026, we expect higher revenue when compared to the fiscal year 2025 primarily due to higher sales of our medical devices and products, related accessories, disposables, and services. We also expect higher operating expenses compared to the fiscal year 2025 primarily due to higher sales and marketing, regulatory, and general and administrative expenses.
Recent Developments and Trends
In addition to the trends identified in the 2025 Annual Report under "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations," our business in fiscal year 2026 has been impacted, and we believe will continue to be impacted, by the recent developments and trends stated therein and herein.
In February 2026, the Supreme Court of the United States issued a ruling determining that certain tariffs were not lawfully imposed. As a result of this decision, impacted importers may be entitled to seek refunds of previously paid tariffs, subject to applicable administrative processes and further governmental actions. The Company has incurred costs associated with tariffs on certain imported materials and components and is evaluating its eligibility to pursue refunds. While the ruling may provide a basis for recovery of certain amounts previously paid, the timing, process, and ultimate realization of any such refunds remain uncertain and may be subject to additional regulatory guidance or legal developments. The Company cannot reasonably estimate the financial impact of this matter, including the amount or timing of any potential refunds at this time and will continue to assess developments and their potential impact on its business, financial condition, and results of operations.
The Company continues to monitor ongoing geopolitical developments, including the current conflicts in the Middle East, and the potential impacts on global trade policies and economic conditions. These events have contributed to increased uncertainty in international markets, including potential disruptions to supply chains, fluctuations in commodity and transportation costs, and evolving trade regulations. The Company has not experienced a material adverse impact on its operations or financial condition as a direct result of these developments. However, the situation remains dynamic, and the extent to which these geopolitical events may affect the Company's business, results of operations, or financial condition in future periods remains uncertain. The Company will continue to actively assess potential risks and implement mitigation strategies, where appropriate, to address any emerging impacts.
Critical Accounting Estimates
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.
We believe that the estimates, assumptions and judgments involved in the accounting policies described in "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our 2025 Annual Report have the greatest potential impact on our financial statements, so we consider them to be our critical accounting policies and estimates. As of June 30, 2026, there were no material changes to the information provided regarding recent accounting pronouncements in Note 1 to the Financial Statements in the 2025 Annual Report.
Results of Operations
The following table sets forth selected statements of operations data as a percentage of total revenue for the periods indicated. Our historical operating results are not necessarily indicative of the results for any future period.
Percent of Revenue Percent of Revenue
Three Months Ended
June 30, 		Six Months Ended
June 30,
2026 2025 2026 2025
(unaudited) (unaudited)
Revenue 100.0 % 100.0 % 100.0 % 100.0 %
Cost of revenue 25.9 21.8 24.7 22.9
Gross profit 74.1 78.2 75.3 77.1
Operating expenses:
General and administrative 18.9 21.0 19.9 22.3
Sales and marketing 20.7 19.6 19.5 20.5
Research and development 3.2 4.3 3.8 3.8
Total operating expenses 42.8 44.9 43.2 46.6
Income from operations 31.3 33.3 32.1 30.6
Other income, net 2.4 2.6 2.4 2.6
Income before provision for income taxes 33.7 35.9 34.5 33.2
Provision for income tax expense 8.2 7.6 8.5 7.0
Net income 25.5 % 28.3 % 26.0 % 26.2 %
Comparison of the Three Months Ended June 30, 2026 and 2025
Revenue by Geographic Region
Three Months Ended
June 30, 		Six Months Ended
June 30,
2026 2025 2026 2025
(in thousands) (unaudited) (unaudited)
United States $ 16,721 $ 18,190 $ 34,745 $ 34,143
International 3,745 2,219 7,699 5,777
Total revenue $ 20,466 $ 20,409 $ 42,444 $ 39,920
Revenue by Type
Three Months Ended
June 30, 		Six Months Ended
June 30,
2026 2025 2026 2025
(in thousands) (unaudited) (unaudited)
Devices:
MRI Compatible Intravenous ("IV") Infusion Pump Systems $ 6,428 $ 8,188 $ 14,092 $ 14,187
MRI Compatible Patient Vital Signs Monitoring Systems 6,665 5,944 13,772 12,489
Ferro Magnetic Detection Systems 756 482 1,377 900
Total devices revenue 13,849 14,614 29,241 27,576
Amortization of extended maintenance agreements 758 592 1,417 1,153
Disposables 4,793 4,204 9,678 9,151
Services and other 1,066 999 2,108 2,040
Total revenue $ 20,466 $ 20,409 $ 42,444 $ 39,920
For the three months ended June 30, 2026, total revenue increased by $0.1 million, or 0.5%, to $20.5 million from $20.4 million for the same period in 2025. This increase is primarily attributed to modifications to our sales incentive plan for patient vital signs monitoring systems, disposables, and amortization of extended maintenance revenue.
Revenue from sales in the U.S. decreased by $1.5 million, or 8%, to $16.7 million for the three months ended June 30, 2026, from $18.2 million for the same period in 2025. Revenue from sales internationally increased by $1.5 million, or 69%, to $3.7 million from $2.2 million for the same period in 2025. Domestic sales accounted for 82% of revenue for the three months ended June 30, 2026 and 89% of revenue for the same period in 2025.
Revenue from sales of devices decreased by $0.8 million, or 5%, to $13.8 million for the three months ended June 30, 2026, from $14.6 million for the same period in 2025. Revenue from the amortization of extended maintenance agreements increased by $0.2 million, or 28%, to $0.8 million for the three months ended June 30, 2026 from $0.6 million for the three months ended June 30, 2025. Revenue from sales of disposables increased by $0.6 million, or 14%, to $4.8 million for the three months ended June 30, 2026 from $4.2 million for the three months ended June 30, 2025. Revenue from services and other increased by $0.1 million, or 7%, to $1.1 million from $1.0 million for the same period in 2025.
For the six months ended June 30, 2026, total revenue increased by $2.5 million, or 6%, to $42.4 million from $39.9 million for the same period in 2025. This is attributed to sales of our new MRidium® 3870 IV infusion pump system, disposables, modification to sales incentive plan for patient vital signs monitoring systems, and increase in Ferro Magnetic Detection System sales.
Revenue from sales in the U.S. increased by $0.6 million, or 2%, to $34.7 million for the six months ended June 30, 2026, from $34.1 million for the same period in 2025. Revenue from sales internationally increased by $1.9 million, or 33%, for the six months ended June 30, 2026 to $7.7 million, from $5.8 million for the same period in 2025. Domestic sales accounted for 82% of revenue for the six months ended June 30, 2026, and 86% of revenue for the same period in 2025.
Revenue from sales of devices increased by $1.7 million, or 6%, to $29.2 million for the six months ended June 30, 2026, from $27.6 million for the same period in 2025. Revenue from the amortization of extended maintenance agreements increased by $0.2 million, or 23%, to $1.4 million for the six months ended June 30, 2026, from $1.2 million for the six months ended June 30, 2025. Revenue from sales of our disposables increased by $0.5 million, or 6%, to $9.7 million for the six months ended June 30, 2026, from $9.2 million for the same period in 2025. Revenue from the services and other increased by $0.1 million, or 3%, to $2.1 million for the six months ended June 30, 2026, from $2.0 million for the six months ended June 30, 2025.
Cost of Revenue and Gross Profit
Three Months Ended
June 30, 		Six Months Ended
June 30,
2026 2025 2026 2025
(in thousands) (unaudited) (unaudited)
Revenue $ 20,466 $ 20,409 $ 42,444 $ 39,920
Cost of revenue 5,306 4,454 10,471 9,122
Gross profit $ 15,160 $ 15,955 $ 31,973 $ 30,798
Gross profit percentage 74 % 78 % 75 % 77 %
For the three months ended June 30, 2026, our cost of revenue increased by $0.8 million, or 18%, to $5.3 million from $4.5 million for the same period in 2025. For the three months ended June 30, 2026, our gross profit decreased by $0.8 million, or 5%, to $15.2 million from $16.0 million for the same period in 2025. For the three months ended June 30, 2026, gross profit margin decreased to 74% compared to 78% for the same period in 2025. The decrease in gross margin is attributed to initial production inefficiencies on new product manufacturing.
For the six months ended June 30, 2026, our cost of revenue increased by $1.3 million, or 14%, to $10.4 million from $9.1 million for the same period in 2025. For the six months ended June 30, 2026, our gross profit increased by $1.2 million, or 4%, to $32.0 million from $30.8 million for the same period in 2025. For the six months ended June 30, 2026, gross profit margin decreased to 75% compared to 77% for the same period in 2025.
Operating Expenses
Three Months Ended
June 30, 		Six Months Ended
June 30,
2026 2025 2026 2025
(in thousands) (unaudited) (unaudited)
General and administrative $ 3,866 $ 4,280 $ 8,435 $ 8,891
Percentage of revenue 18.9 % 21.0 % 19.9 % 22.3 %
Sales and marketing $ 4,246 $ 4,010 $ 8,298 $ 8,186
Percentage of revenue 20.7 % 19.6 % 19.6 % 20.5 %
Research and development $ 657 $ 877 $ 1,613 $ 1,502
Percentage of revenue 3.2 % 4.3 % 3.8 % 3.8 %
General and Administrative
For the three months ended June 30, 2026, general and administrative expense decreased by $0.4 million, or 9%, to $3.9 million from $4.3 million for the same period in 2025. This decreased primarily because of lower legal and professional expenses, regulatory consulting, and payroll and benefit expenses.
For the six months ended June 30, 2026, general and administrative expense decreased by $0.5 million, or 5%, to $8.4 million from $8.9 million for the same period in 2025. This decreased primarily because of lower legal and professional expenses, regulatory consulting, and payroll and benefits expenses.
Sales and Marketing
For the three months ended June 30, 2026, sales and marketing expense increased by $0.2 million, or 6%, to $4.2 million from $4.0 million for the same period in 2025. This increase is primarily due to increased sales commissions related to increased monitor books and newly released MRidium® 3870 IV infusion pump system bookings.
For the six months ended June 30, 2026, sales and marketing expense increased by $0.1 million, or 1%, to $8.3 million from $8.2 million for the same period in 2025. This increase is primarily due to increased sales commissions related to increased monitor books and newly released MRidium® 3870 IV infusion pump system bookings.
Research and Development
For the three months ended June 30, 2026, research and development expense decreased by $0.2 million, or 22%, to $0.7 million from $0.9 million for the same period in 2025. This is primarily due to a decrease in payroll and benefit expenses capitalized as internal software development for the current period.
For the six months ended June 30, 2026, research and development expense increased by $0.1 million, or 7%, to $1.6 million from $1.5 million for the same period in 2025. This increase is primarily due to an increase in payroll
and benefit expenses. Payroll expenses related to the MRidium® 3870 IV infusion pump system, were capitalized for the first three months in 2025, offset by current period capitalized software.
Other Income, Net
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, 2026, other income, net decreased $42 thousand, or 8%, to $497 thousand from $539 thousand for the same period in 2025.
For the six months ended June 30, 2026, other income, net, decreased by $23 thousand, or 2%, to $1,030 thousand from $1,053 thousand for the same period in 2025. This income is primarily interest received in 2026 and 2025 on money market fund investments.
Income Taxes
For the three and six months ended June 30, 2026, we recorded a provision for income tax expense of $1,670 thousand and $3,621 thousand, respectively. For the three and six months ended June 30, 2026, our effective tax rate was 24.2% and 24.7% respectively, and differed from the U.S. federal statutory rate primarily due to U.S. state income tax expense, and non-deductible compensation expenses, partially offset by benefits from research and development tax credits.
For the three and six months ended June 30, 2025, we recorded a provision for income tax expense of $1,553 thousand and $2,811 thousand, respectively. For the three and six months ended June 30, 2025, our effective tax rate was consistent at 21.2%, 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.
We file tax returns in the U.S. federal jurisdiction and many U.S. state jurisdictions. Our returns are not currently under examination by the Internal Revenue Service. The Company remains subject to income tax examinations for our U.S. federal and certain U.S. state income taxes for 2023 and subsequent years.
On July 4, 2025, the OBBBA was enacted in the United States. The OBBBA includes several significant provisions, including the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions, such as accelerated deductions for qualified property and domestic research expenditures. The Company has evaluated the impact of the OBBBA on its financial statements and does not expect the legislation to result in a material change to its annual effective tax rate. During the first quarter of 2026, the Company implemented the OBBBA-related changes to the foreign-derived deduction regime, including the transition from the FDII deduction to the FDDEI deduction, which became effective for tax years beginning after December 31, 2025.
Liquidity and Capital Resources
Our principal sources of liquidity have historically been our cash and cash equivalents balances, cash flow from operations and access to the financial markets. Our principal uses of cash are operating expenses, working capital requirements, capital expenditures and dividend payments.
As of June 30, 2026, we had cash and cash equivalents of $59.1 million, stockholders' equity of $101.7 million, and working capital of $77.6 million. As of December 31, 2025, we had cash and cash equivalents of $51.2 million, stockholders' equity of $94.6 million, and working capital of $71.0 million.
We believe that our current cash, and 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. Various economic conditions (including persistent inflationary pressures, elevated or volatile interest rate levels, and the imposition of, expansion of, or changes in tariffs or other trade restrictions) may disrupt capital markets at any time, which could reduce our ability to access capital and negatively affect our liquidity in the future.
Six Months Ended
June 30,
2026 2025
(in thousands) (unaudited)
Net cash provided by operating activities $ 14,230 $ 12,039
Net cash used in investing activities (912) (6,741)
Net cash used in financing activities (5,397) (4,535)
Cash provided by operating activities increased by $2.2 million, to $14.2 million for the six months ended June 30, 2026, compared to $12.0 million for the same period in 2025. During the six months ended June 30, 2026, cash provided by operations was positively impacted by higher net income, lower cash outflows related to accounts payable and pre-paid expenses, and inventory purchases, and offset by an increase in accounts receivable related to timing.
Cash used in investing activities decreased by $5.8 million, to $0.9 million for the six months ended June 30, 2026, compared to $6.7 million for the same period in 2025. The decrease from our 2025 spend in investing activities is attributed to construction costs of the completed new executive offices and expanded manufacturing facility to accommodate our continued growth.
Cash used in financing activities increased by $0.9 million, to $5.4 million for the six months ended June 30, 2026, compared to approximately $4.5 million for the same period in 2025. The increase is primarily due to the per share increase of our quarterly cash dividend payment. Special and quarterly cash dividend payments are subject to the sole discretion of the Board and applicable law.
We market our products to end users in the U.S. and to distributors internationally. Sales to end users in the U.S. are generally made on open credit terms. Management maintains an allowance for potential credit losses.
Off-Balance Sheet Arrangements
As of June 30, 2026 and December 31, 2025, we did not have any off-balance sheet arrangements, as such term is defined under Item 303 of Regulation S-K, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Contractual Obligations
There have been no material changes outside the ordinary course of business to our contractual obligations and commercial commitments since December 31, 2025.
Recent Accounting Pronouncements
As of June 30, 2026, there were no material changes to the information provided regarding recent accounting pronouncements in Note 1 to the Financial Statements in the 2025 Annual Report.
IRadimed Corporation published this content on July 31, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on July 31, 2026 at 20:10 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]