Iradimed Corp: Form 10-Q for the period ended Mar 31, 2025

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.

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 and products. We are the only known provider of a non-magnetic IV infusion pump system that is 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 system has 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 solution provides 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 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 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.

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.

We generate revenue from the sale of MRI compatible medical devices and related products, accessories, extended warranty 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 United States and internationally. As of March 31, 2025, our direct U.S. sales force consisted of 27 field sales representatives, 4 regional sales directors and supplemented by 9 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 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.

For the remainder of fiscal year 2025, we expect higher revenue when compared to the same period in 2024 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 same period in 2024 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 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.

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.

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 2024 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 March 31, 2025, there were no material changes to the information provided regarding recent accounting pronouncements in Note 1 to the Financial Statements in the 2024 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.

(unaudited)

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

Revenue by Geographic Region

(unaudited)

Revenue by Type

(unaudited)

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.

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.

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.

Cost of Revenue and Gross Profit

(unaudited)

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.

Operating Expenses

(unaudited)

General and Administrative

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.

Sales and Marketing

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.

Research and Development

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.

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 March 31, 2025, other income, net remained consistent at $0.5 million compared with the same period in 2024.

Income Taxes

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.

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.

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.

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, if any.

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.

On April 3, 2024, the Company filed a shelf registration statement on Form S-3 (the “2024 Shelf”), which was declared effective by the SEC on May 8, 2024. The 2024 Shelf covers the offering, issuance and sale by the Company of up to an aggregate of $75.0 million of its common stock. As of March 31, 2025, all $75.0 million remained available under the 2024 Shelf.

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.

(unaudited)

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.

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.

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.

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.

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.

Off-Balance Sheet Arrangements

As of March 31, 2025 and December 31, 2024, 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, 2024.

Recent Accounting Pronouncements

As of March 31, 2025, there were no material changes to the information provided regarding recent accounting pronouncements in Note 1 to the Financial Statements in the 2024 Annual Report.

There have been no material changes in our market risks from those disclosed in “Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk” of the 2024 Annual Report.

Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) are designed to ensure that: (1) information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms; and (2) such information is accumulated and communicated to management, including the principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures. There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.

Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2025. Our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures as of March 31, 2025 were effective.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the period covered by this Quarterly Report that has materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

In addition to the other information set forth in this Quarterly Report, you should carefully consider the risks discussed in our 2024 Annual Report and those set forth from time to time in our other filings with the SEC. There have been no material changes in our risk factors from those described in our 2024 Annual Report other than as noted below. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition, or future results.

Changes in U.S. and other countries’ trade policies, including the imposition of tariffs, may have a material

adverse effect on our business and results of operations.

Our business and results of operations may be adversely affected by uncertainty and changes in trade policies

of the U.S. and other countries, including tariffs, trade agreements or other trade restrictions. Changes in tariffs and

other trade policies can be announced with little or no advance notice.

We sell our products in many countries, and we also source certain components and materials for our products from various countries. The U.S. government recently announced tariffs on product imports from certain countries, including higher tariff levels on those imported from Canada, Mexico, and China. These actions have resulted, and are expected to further result, in retaliatory measures on U.S. goods by those countries and others. If maintained, these recently announced tariffs, and the potential escalation of trade disputes could pose a risk to our business that could affect our revenue and cost of sourcing materials. The extent and duration of the tariffs and the resulting impact on general economic conditions and on our business are uncertain and are expected to be impacted by various factors, such as negotiations between the U.S. and affected countries, the responses of other countries or regions, exemptions or exclusions that already exist or may be granted, availability and cost of alternative sources of our products and materials, and our ability to offset the effects of any tariffs that might be imposed. Specific legislative and regulatory proposals may be introduced to change international trade law, regulations or interpretations thereof (possibly with retroactive effect) of various jurisdictions or limit trade relief benefits that, if enacted, could materially increase the cost of our goods to export internationally, increase our effective tax rate, or have a material adverse impact on our financial condition and results of operation. We cannot predict whether our own or industry initiatives to maintain, extend or create tariff relief for our products and manufacturing will be successful. We also cannot predict the effect, if any, of the imposition of new or increased tariffs by one country and retaliatory responses by other countries who are trade partners. It is possible that these changes could adversely affect our business beyond the resilience of our current supply chain and investment in manufacturing flexibility. Further, actions we take to adapt to new tariffs or trade restrictions may increase our costs or may cause us to modify our operations, which could be time-consuming and expensive; impact pricing of our products, which could impact our sales, profitability, and our reputation; or cause us to forgo new business opportunities.

In addition, tariffs or other trade restrictions may cause adverse changes and uncertainty in U.S. and global financial and economic conditions, which may adversely impact the demand for our products, the cost of capital projects, and the availability and cost of debt and equity financing.