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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File No.:
(Exact name of Registrant as specified in its charter)
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(State or other jurisdiction of
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(I.R.S. Employer
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(Address of principal executive offices) |
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(Zip Code) |
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(Registrant’s telephone number, including area code)
N/A
(Former Name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class: |
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Trading Symbol |
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Name of each exchange on which registered: |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer ☐ |
Accelerated filer ☐ |
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Smaller reporting company
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Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The registrant had
IRADIMED CORPORATION
Table of Contents
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(a) Condensed Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024 (Audited) |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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2
CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS
Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 (this “Quarterly Report”) that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. When used in this Quarterly Report the words “believe,” “anticipate,” “expect,” “may,” “will,” “assume,” “should,” “predict,” “could,” “would,” “intend,” “targets,” “estimates,” “projects,” “plans,” and “potential,” and other similar words and expressions of the future, are intended to identify such forward-looking statements, but other statements not based on historical information may also be considered forward-looking, including statements about the Company’s future financial and operating results and the Company’s plans, objectives, and intentions. All forward-looking statements are subject to risks, uncertainties, and other factors that may cause the actual results, performance, or achievements of the Company to differ materially from any results, performance, or achievements expressed or implied by such forward-looking statements. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause the actual results to differ materially from the statements, including, but not limited to:
| ● | our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration (the “FDA”) or other regulatory bodies resulting in favorable outcomes, additional actions by or requests from the FDA, including a request to cease domestic distribution of products, or other regulatory bodies and unanticipated costs or delays associated with the resolution of these matters; |
| ● | the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities; |
| ● | unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies; |
| ● | failure to obtain and/or maintain regulatory approvals or clearances and comply with applicable regulations; |
| ● | our primary reliance on a limited number of products; |
| ● | our ability to retain the continued service of our key professionals, including key management, marketing and scientific personnel, and to identify, hire and retain such additional qualified professionals; |
| ● | our expectations regarding the sales and marketing of our products, product candidates and services; |
| ● | our expectations regarding the integrity of our supply chain for our products; |
| ● | the potential for adverse application of environmental, health and safety and other laws and regulations of any jurisdiction on our operations; |
| ● | our expectations for market acceptance of our new products; |
| ● | the potential for our marketed products to be withdrawn due to recalls, patient adverse events or deaths; |
| ● | our ability to successfully prepare, file, prosecute, maintain, defend, including in cases of infringement, and enforce patent claims and other intellectual property rights on our products; |
| ● | our ability to identify and pursue development of additional products; |
3
| ● | the implementation of our business strategies; |
| ● | the potential for exposure to product liability claims; |
| ● | our financial performance expectations and interpretations thereof by securities analysts and investors; |
| ● | our ability to compete in the development and marketing of our products and product candidates with existing companies and new market entrants in our industry; |
| ● | difficulties or delays in the development, production, manufacturing and marketing of new or existing products and services, including difficulties or delays associated with obtaining requisite regulatory approvals or clearances associated with those activities; |
| ● | changes in laws and regulations or in the interpretation or application of laws or regulations, as well as possible failures to comply with applicable laws or regulations as a result of possible misinterpretations or misapplications; |
| ● | cost-containment efforts of our customers, purchasing groups, third-party payers and governmental organizations; |
| ● | costs associated with protecting our trade secrets and enforcing our patent, copyright and trademark rights, and successful challenges to the validity of our patents, copyrights or trademarks; |
| ● | actions of regulatory bodies and other government authorities, including the FDA and foreign counterparts, that could delay, limit or suspend product development, manufacturing or sales or result in recalls, seizures, consent decrees, injunctions and monetary sanctions; |
| ● | costs or claims resulting from potential errors or defects in our manufacturing that may injure persons or damage property or operations, including costs from remediation efforts or recalls; |
| ● | the results, consequences, effects or timing of any commercial disputes, patent infringement claims or other legal proceedings or any government investigations; |
| ● | changes in our production capacity, including interruptions in our ability to manufacture our products or an inability to obtain key components or raw materials or increased costs in such key components or raw materials; |
| ● | the failure of third parties to uphold their contractual duties or meet expected deadlines; |
| ● | uncertainties in our industry due to the effects of government-driven or mandated healthcare reform; |
| ● | competitive pressures in the markets in which we operate; |
| ● | potential negative impacts resulting from a future pandemic or epidemic, or natural disaster; |
| ● | the impact on our operations and financial results of any public health emergency and any related policies and actions by governments or other third parties; |
| ● | breaches or failures of our or our vendors’ or customers’ information technology systems or products, including by cyber-attack, data leakage, unauthorized access or theft; |
| ● | the loss of, or default by, one or more key customers or suppliers; |
4
| ● | unfavorable changes to the terms of key customer or supplier relationships; |
| ● | weakening of economic conditions, or the anticipation thereof, that could adversely affect the level of demand for our products; |
| ● | the conditions in the U.S. and global economies, including the impact of increasing and/or fluctuating tax and interest rates as well as inflationary pressures on such economies; |
| ● | geopolitical risks, including tariffs, trade disputes, international conflicts, recent or upcoming elections in the United States and other countries, and the impact of insufficient governmental funding and related operational inefficiencies , which could, among other things, lead to increased volatility in the financial market and in the market in which we operate our business ; and |
| ● | other risks detailed in our filings with the United States Securities and Exchange Commission (the “SEC”). |
These forward-looking statements involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. Forward-looking statements should, therefore, be considered in light of various factors, including those set forth under “Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations,” “Part II, Item 1A. Risk Factors,” and elsewhere in this Quarterly Report, and under “Part I, Item 1A. Risk Factors” and “Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “2024 Annual Report”) and those set forth from time to time in our other filings with the SEC. These documents are available through our website or through the SEC's Electronic Data Gathering and Analysis Retrieval system at http://www.sec.gov. In light of such risks and uncertainties, we caution you not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this Quarterly Report, or if earlier, as of the date they were made. We do not intend to, and disclaim any obligation to, update or revise any forward-looking statements unless required by securities law.
Unless expressly indicated or the context requires otherwise, references in this Quarterly Report to “IRADIMED,” the “Company,” “we,” “our,” and “us” refer to IRADIMED CORPORATION.
5
PART I. FINANCIAL INFORMATION
Item 1. Condensed Financial Statements
IRADIMED CORPORATION
CONDENSED BALANCE SHEETS
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September 30, |
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December 31, |
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2025 |
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2024 |
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(unaudited) |
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(audited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
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$ |
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Accounts receivable, net of allowance for credit losses of $
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Inventory, net |
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Prepaid expenses and other current assets |
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Prepaid income taxes |
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Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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Operating lease right-of-use asset |
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— |
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Deferred tax asset, net |
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Other assets |
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Total assets |
$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
$ |
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$ |
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Accrued payroll and benefits |
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Other accrued taxes |
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Warranty reserve |
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Deferred revenue |
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Current portion of operating lease liabilities |
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— |
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Other current liabilities |
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— |
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Accrued income taxes |
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— |
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Total current liabilities |
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Deferred revenue, non-current |
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Operating lease liabilities, non-current |
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— |
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Total liabilities |
$ |
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$ |
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Stockholders’ equity: |
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Common stock; $
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$ |
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$ |
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Additional paid-in capital |
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Retained earnings |
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Total stockholders' equity |
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Total liabilities and stockholders’ equity |
$ |
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$ |
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See accompanying notes to unaudited condensed financial statements.
6
IRADIMED CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue |
$ |
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$ |
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$ |
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$ |
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Cost of revenue |
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Gross profit |
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Operating expenses: |
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General and administrative |
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Sales and marketing |
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Research and development |
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Total operating expenses |
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Income from operations |
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Other income, net |
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Income before provision for income taxes |
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Provision for income tax expense |
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Net income |
$ |
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$ |
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$ |
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$ |
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Net income per share: |
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Basic |
$ |
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$ |
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$ |
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$ |
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Diluted |
$ |
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$ |
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$ |
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$ |
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Weighted average shares outstanding: |
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Basic |
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Diluted |
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See accompanying notes to unaudited condensed financial statements.
7
IRADIMED CORPORATION
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
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Additional |
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Common Stock |
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Paid-in |
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Retained |
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Stockholders’ |
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Shares |
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Amount |
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Capital |
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Earnings |
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Equity |
||||
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Balances, December 31, 2024 |
|
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$ |
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$ |
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$ |
|
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$ |
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Net income |
|
— |
|
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— |
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— |
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Dividends declared |
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— |
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— |
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— |
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(
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(
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Stock-based compensation expense |
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— |
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— |
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— |
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Net share settlement of restricted stock units |
|
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(
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— |
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(
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Balances, March 31, 2025 |
|
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|
$ |
|
|
$ |
|
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$ |
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$ |
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|
|
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|
|
|
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|
|
|
|
|
|
|
|
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Net income |
|
— |
|
|
— |
|
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— |
|
|
|
|
|
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Dividends declared |
|
— |
|
|
— |
|
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— |
|
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(
|
|
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(
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Stock-based compensation expense |
|
— |
|
|
— |
|
|
|
|
|
— |
|
|
|
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Net share settlement of restricted stock units |
|
|
|
|
— |
|
|
(
|
|
|
— |
|
|
(
|
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Balances, June 30, 2025 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
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$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
Dividends declared |
|
— |
|
|
— |
|
|
— |
|
|
(
|
|
|
(
|
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
|
|
|
— |
|
|
|
|
Net share settlement of restricted stock units |
|
|
|
|
— |
|
|
(
|
|
|
— |
|
|
(
|
|
Balances, September 30, 2025 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
|
|
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Common Stock |
|
Paid-in |
|
Retained |
|
Stockholders’ |
||||||
|
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Shares |
|
Amount |
|
Capital |
|
Earnings |
|
Equity |
||||
|
Balances, December 31, 2023 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Net income |
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
|
|
|
— |
|
|
|
|
Net share settlement of restricted stock units |
|
|
|
|
|
|
|
(
|
|
|
— |
|
|
(
|
|
Balances, March 31, 2024 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
Dividends declared |
|
— |
|
|
— |
|
|
— |
|
|
(
|
|
|
(
|
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
|
|
|
— |
|
|
|
|
Net share settlement of restricted stock units |
|
|
|
|
|
|
|
(
|
|
|
— |
|
|
(
|
|
Exercise of stock options |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
Balances, June 30, 2024 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
Dividends declared |
|
— |
|
|
— |
|
|
— |
|
|
(
|
|
|
(
|
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
|
|
|
— |
|
|
|
|
Net share settlement of restricted stock units |
|
|
|
|
— |
|
|
(
|
|
|
— |
|
|
(
|
|
Balances, September 30, 2024 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
See accompanying notes to unaudited condensed financial statements.
8
IRADIMED CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
|
Nine Months Ended |
||||
|
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September 30, |
||||
|
|
|
|
2025 |
|
2024 |
||
|
Operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
|
$ |
|
|
$ |
|
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Allowance for credit losses |
|
|
|
(
|
|
|
(
|
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Provision for excess and obsolete inventory |
|
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|
|
|
|
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Depreciation & amortization |
|
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|
Loss on disposal of property and equipment |
|
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|
|
|
|
|
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Stock-based compensation |
|
|
|
|
|
|
|
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Deferred income taxes, net |
|
|
|
|
|
|
(
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
(
|
|
|
|
|
Inventory |
|
|
|
(
|
|
|
|
|
Prepaid income taxes |
|
|
|
(
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
|
Other assets |
|
|
|
(
|
|
|
(
|
|
Accounts payable |
|
|
|
|
|
|
(
|
|
Accrued payroll and benefits |
|
|
|
|
|
|
|
|
Other accrued taxes |
|
|
|
|
|
|
|
|
Warranty reserve |
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
(
|
|
Other current liabilities |
|
|
|
(
|
|
|
— |
|
Accrued income taxes |
|
|
|
|
|
|
— |
|
Net cash provided by operating activities |
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
|
(
|
|
|
(
|
|
Capitalized intangible assets |
|
|
|
(
|
|
|
(
|
|
Net cash used in investing activities |
|
|
|
(
|
|
|
(
|
|
Financing activities: |
|
|
|
|
|
|
|
|
Dividends paid |
|
|
|
(
|
|
|
(
|
|
Proceeds from exercises of stock options |
|
|
|
— |
|
|
|
|
Taxes paid related to the net share settlement of equity awards |
|
|
|
(
|
|
|
(
|
|
Net cash used in financing activities |
|
|
|
(
|
|
|
(
|
|
Net increase in cash and cash equivalents |
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
|
$ |
|
|
$ |
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
|
$ |
|
|
$ |
|
|
ROU asset and liability adjustment |
|
|
$ |
— |
|
$ |
|
|
Operating and short-term lease payments recorded within cash flow provided by operating activities |
|
|
$ |
|
|
$ |
|
See accompanying notes to unaudited condensed financial statements.
9
IRADIMED CORPORATION
Notes to Unaudited Condensed Financial Statements
1 —
The accompanying interim unaudited condensed financial statements of IRADIMED CORPORATION (“IRADIMED,” the “Company,” “we,” “our” and “us”) have been prepared pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally presented in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The interim financial information is unaudited, but reflects all normal adjustments that are, in the opinion of management, necessary for the fair presentation of our financial position, results of operations and cash flows for the interim periods presented. Operating results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025, and other interim periods, or future years or periods.
The accompanying interim condensed financial statements should be read in conjunction with the financial statements and related footnotes to financial statements included in our 2024 Annual Report. The accounting policies followed in the preparation of these interim condensed financial statements, except as described in Note 1 herein, are consistent in all material respects with those described in Note 1 to the Financial Statements in the 2024 Annual Report.
We operate in
Certain Significant Risks and Uncertainties
We market our products to end users in the United States and to third-party distributors internationally. Sales to end users in the United States are generally made on open credit terms. Management maintains an allowance for potential credit losses.
We have deposited our cash and cash equivalents with various financial institutions. Our cash and cash equivalents balances exceed federally insured limits regularly throughout the year. We have not incurred any losses related to these balances.
Our medical devices require clearance from the FDA and international regulatory agencies prior to commercialized sales. Our future products may not receive required clearances. If we were denied such clearances, or if such clearances were revoked or delayed or if we were unable to timely renew certain clearances for existing products, it would have a materially adverse impact on our business, results of operations and financial condition.
Certain key components of our products essential to their functionality are sole-sourced. Any disruption in the availability of these components would have a materially adverse impact on our business, results of operations and financial condition.
2 — Revenue Recognition
Disaggregation of Revenue
We disaggregate revenue from contracts with customers by geographic region and revenue type as we believe it best depicts the nature, amount, timing and uncertainty of our revenue and cash flow.
10
Revenue information by geographic region is as follows:
|
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
|
September 30, |
|
September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(unaudited) |
|
(unaudited) |
||||||||
|
United States |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
International |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue information by type is as follows:
|
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
|
September 30, |
|
September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(unaudited) |
|
(unaudited) |
||||||||
|
Devices: |
|
|
|
|
|
|
|
|
|
|
|
|
|
MRI Compatible Intravenous ("IV") Infusion Pump Systems |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
MRI Compatible Patient Vital Signs Monitoring Systems |
|
|
|
|
|
|
|
|
|
|
|
|
|
Ferro Magnetic Detection Systems |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total devices revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of extended maintenance agreements |
|
|
|
|
|
|
|
|
|
|
|
|
|
Disposables |
|
|
|
|
|
|
|
|
|
|
|
|
|
Services and other |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Contract Liabilities
Our contract liabilities consist of:
|
|
September 30, |
|
December 31, |
||
|
|
2025 |
|
2024 |
||
|
|
(unaudited) |
|
(audited) |
||
|
Advance payments from customers |
$ |
|
|
$ |
|
|
Shipments in-transit |
|
|
|
|
|
|
Extended maintenance agreements |
|
|
|
|
|
|
Total |
$ |
|
|
$ |
|
Changes in the contract liabilities during the periods presented are as follows:
|
|
Deferred |
|
|
|
Revenue |
|
|
|
(unaudited) |
|
|
Contract liabilities, December 31, 2024 |
$ |
|
|
Increases due to cash received from customers |
|
|
|
Decreases due to recognition of revenue |
|
(
|
|
Contract liabilities, September 30, 2025 |
$ |
|
|
|
Deferred |
|
|
|
Revenue |
|
|
|
(unaudited) |
|
|
Contract liabilities, December 31, 2023 |
$ |
|
|
Increases due to cash received from customers |
|
|
|
Decreases due to recognition of revenue |
|
(
|
|
Contract liabilities, September 30, 2024 |
$ |
|
11
Capitalized Contract Costs
Our capitalized contract costs totaled
$
3 — Basic and Diluted Net Income per Share
Basic net income per share is based upon the weighted-average number of shares of Company common stock, par value $
The following table presents the computation of basic and diluted net income per share of common stock:
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(unaudited) |
|
(unaudited) |
||||||||
|
Net income |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Weighted-average shares outstanding — Basic |
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
— |
|
|
|
|
|
— |
|
|
|
|
Restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance-based restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding — Diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Diluted net income per share |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Restricted stock units excluded from the calculation of diluted net income per share because the effect would have been anti-dilutive are as follows:
|
|
|
Three Months Ended |
|
Nine Months Ended |
||||
|
|
|
September 30, |
|
September 30, |
||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
(unaudited) |
|
(unaudited) |
||||
|
Anti-dilutive restricted stock units |
|
|
|
|
|
|
|
|
4 — Inventory, net
Inventory consists of:
|
|
|
September 30, |
|
December 31, |
||
|
|
|
2025 |
|
2024 |
||
|
|
|
(unaudited) |
|
(audited) |
||
|
Raw materials |
|
$ |
|
|
$ |
|
|
Work in process |
|
|
|
|
|
|
|
Finished goods |
|
|
|
|
|
|
|
Inventory before allowance for excess and obsolete |
|
|
|
|
|
|
|
Allowance for excess and obsolete |
|
|
(
|
|
|
(
|
|
Total |
|
$ |
|
|
$ |
|
12
5 — Property and Equipment, net
Property and equipment consist of:
|
|
|
September 30, |
|
December 31, |
||
|
|
|
2025 |
|
2024 |
||
|
|
|
(unaudited) |
|
(audited) |
||
|
Land |
|
$ |
|
|
$ |
|
|
Land improvements |
|
|
|
|
|
— |
|
Building |
|
|
|
|
|
— |
|
Computer software and hardware |
|
|
|
|
|
|
|
Furniture and fixtures |
|
|
|
|
|
|
|
Leasehold improvements |
|
|
— |
|
|
|
|
Machinery and equipment |
|
|
|
|
|
|
|
Construction in-process |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated depreciation |
|
|
(
|
|
|
(
|
|
Total |
|
$ |
|
|
$ |
|
Depreciation expense of property and equipment was $
During the third quarter of 2025, the Company completed the construction of a new corporate office and manufacturing facility in Orlando, Florida (the “New Facility”). Upon receiving the certificate of occupancy, associated construction in-process balances are now allocated and recognized as in-service property and equipment based on the asset type.
Property and equipment, net, information by geographic region is as follows:
|
|
|
September 30, |
|
December 31, |
||
|
|
|
2025 |
|
2024 |
||
|
|
|
(unaudited) |
|
(audited) |
||
|
United States |
|
$ |
|
|
$ |
|
|
International |
|
|
|
|
|
|
|
Total property and equipment, net |
|
$ |
|
|
$ |
|
Long-lived assets held outside of the United States consist principally of tooling, which is a component of machinery and equipment.
13
6 — Intangible Assets, net
The following table summarizes the components of intangible asset balances:
|
|
|
September 30, |
|
December 31, |
||
|
|
|
2025 |
|
2024 |
||
|
|
|
(unaudited) |
|
(audited) |
||
|
Patents — in use |
|
$ |
|
|
$ |
|
|
Patents — fully amortized |
|
|
|
|
|
|
|
Patents — in process |
|
|
|
|
|
|
|
Internally developed software — in use |
|
|
|
|
|
|
|
Internally developed software — in process |
|
|
|
|
|
|
|
Trademarks |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated amortization |
|
|
(
|
|
|
(
|
|
Total |
|
$ |
|
|
$ |
|
Amortization expense of intangible assets was $
Expected annual amortization expense for the remaining portion of 2025, the next five years, and thereafter related to intangible assets, excluding trademarks considered to have indefinite lives and in process intangible assets, is as follows:
|
Three months remaining ending December 31, 2025 |
$ |
|
|
2026 |
$ |
|
|
2027 |
$ |
|
|
2028 |
$ |
|
|
2029 |
$ |
|
|
2030 |
$ |
|
|
Thereafter |
$ |
|
7 — Segment Reporting
The Company operates in
8 — Fair Value Measurements
The fair values of cash equivalents, accounts receivables net, and accounts payable approximate their carrying amounts due to their short duration.
As of September 30, 2025, we did
14
9 — Stock-Based Compensation
Stock-based compensation was recognized as follows in the unaudited Condensed Statements of Operations:
|
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
|
September 30, |
|
September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(unaudited) |
|
(unaudited) |
||||||||
|
Cost of revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
As of September 30, 2025, we had (i) $
The following table presents a summary of our equity award activity for the nine months ended September 30, 2025 (shares):
|
|
|
|
Nine Months Ended |
||
|
|
|
|
September 30, 2025 |
||
|
|
|
|
|
|
Performance |
|
|
|
|
|
|
Based |
|
|
|
|
Restricted |
|
Restricted |
|
|
|
|
Stock Units |
|
Stock Units |
|
Outstanding beginning of period |
|
|
|
|
|
|
Awards granted |
|
|
|
|
— |
|
Awards exercised/vested |
|
|
(
|
|
(
|
|
Awards canceled/ forfeited |
|
|
(
|
|
— |
|
Outstanding end of period |
|
|
|
|
|
10 — Income Taxes
For the three and nine months ended September 30, 2025, we recorded a provision for income tax expense of $
For the three and nine months ended September 30, 2024, we recorded a provision for income tax expense of $
On July 31, 2024, the Company received a notice of examination from the U.S. Internal Revenue Service (the “I.R.S.”) for the tax year ended December 31, 2021. On July 29 , 2025, the Company received notice that the I.R.S. has completed its review of our tax return for the tax year ended December 31, 2021, with no changes to our reported tax return, and closed out its examination. The Company remains subject to income tax examinations for our U.S. federal and certain U.S. state income taxes for 2022 and subsequent years.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act,
15
modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions including the acceleration of tax deductions for qualified property and research expenditures. The Company has completed an initial assessment of OBBBA’s impact on its financial statement and does not expect a material change in its annual effective rate.
11 — Leases
In January 2014, we entered into a non-cancelable operating lease, commencing on July 1, 2014, for our manufacturing and headquarters facility in Winter Springs, Florida owned by Susi, LLC, an entity controlled by our President, Chief Executive Officer, and Chairman of the Board, Roger Susi. On May 31, 2019, the expiration date of the initial lease term, and pursuant to the terms of the lease contract, we renewed the lease for an additional
On May 29, 2024, the Company entered into a lease amendment (the “Lease Amendment”) with Susi, LLC, under which the Company did not exercise the second five-year option because of the continued construction of the Company’s New Facility. Pursuant to the terms, the Lease Amendment has an expiration date of May 31, 2025, and includes an option to renew on a month-to-month basis for up to six months thereafter. We exercised the option to renew on a month-to-month basis until the move to the New Facility is completed. During the third quarter of 2025, the Company completed its move to the New Facility and terminated the month-to-month lease with Susi, LLC under the Lease Amendment.
Lease costs for short-term leases were immaterial for the three and nine months ended September 30, 2025 and 2024.
12 — Commitments and Contingencies
Purchase commitments.
We had various purchase orders for goods or services totaling $
Legal matters. From time to time, the Company is party to litigation and other legal matters incidental to the conduct of its business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues liabilities for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. As of September 30, 2025, the Company was not involved in any such matters, individually or in the aggregate, which management believes would have a material adverse effect on the Company’s business, financial condition, results of operations, or cash flows.
13 — Subsequent Events
On
Besides the above, there were no subsequent events requiring disclosure or recognition in the Company’s unaudited condensed financial statements, other than those included elsewhere in this Quarterly Report.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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.
16
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 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.
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.
We generate revenue from the sale of MRI compatible medical devices and related products, 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 United States and internationally. As of September 30, 2025, our direct U.S. sales force consisted of 29 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
17
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 September 30, 2025, our revenue increased by $2.9 million, or 16% to $21.2 million, compared to $18.3 million for the quarter ended September 30, 2024. Income before the provision for income taxes was $7.3 million for the quarter ended September 30, 2025, compared to $6.4 million for the quarter ended September 30, 2024. Net income was $5.6 million, or $0.43 per diluted share, in the quarter ended September 30, 2025, compared to $5.0 million, or $0.40 per diluted share in the quarter ended September 30, 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 “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 June 30, 2025 (the “Q2 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.
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.
On May 29, 2025, the Company announced that the FDA has granted 510(k) clearance for the Company’s next-generation MRidium® 3870 IV infusion pump system (the “MRidium® 3870”).
The MRidium® 3870 is an advanced, MRI compatible infusion pump that extends the Company’s unique position as the world’s only supplier of non-magnetic MRI infusion pump devices, addressing growing demands for safe and reliable fluid delivery in diagnostic imaging. The MRidium® 3870 features a non-magnetic ultrasonic pump motor, non-interfering radio frequency emissions, and non-ferrous components, ensuring seamless performance in high-magnetic-field environments.
The Company plans an initial strategic rollout of the newly FDA-cleared MRidium® 3870 infusion pump to select healthcare facilities in the fourth quarter of 2025, with product shipments growing towards full commercial distribution throughout 2026.
On July 4, 2025 OBBBA was enacted in the U.S. OBBBA includes significant provisions, such as 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 including the acceleration of tax deductions for qualified property and research expenditures. The Company has completed an initial assessment of OBBBA’s impact on its financial statement and does not expect a material change in its annual effective rate.
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
18
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 September 30, 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.
|
|
|
Percent of Revenue |
|
|
Percent of Revenue |
||||
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
||||
|
|
|
September 30, |
|
|
September 30, |
||||
|
|
|
2025 |
|
2024 |
|
|
2025 |
|
2024 |
|
|
|
(unaudited) |
|
|
(unaudited) |
||||
|
Revenue |
|
100.0 |
% |
100.0 |
% |
|
100.0 |
% |
100.0 |
|
Cost of revenue |
|
22.2 |
|
22.6 |
|
|
22.6 |
|
22.8 |
|
Gross profit |
|
77.8 |
|
77.4 |
|
|
77.4 |
|
77.2 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
20.6 |
|
21.7 |
|
|
21.7 |
|
22.4 |
|
Sales and marketing |
|
21.8 |
|
20.7 |
|
|
21.0 |
|
20.6 |
|
Research and development |
|
3.2 |
|
3.5 |
|
|
3.6 |
|
4.2 |
|
Total operating expenses |
|
45.6 |
|
45.9 |
|
|
46.3 |
|
47.2 |
|
Income from operations |
|
32.2 |
|
31.6 |
|
|
31.1 |
|
30.0 |
|
Other income, net |
|
2.2 |
|
3.4 |
|
|
2.5 |
|
3.3 |
|
Income before provision for income taxes |
|
34.4 |
|
35.0 |
|
|
33.6 |
|
33.3 |
|
Provision for income tax expense |
|
8.1 |
|
7.5 |
|
|
7.4 |
|
7.1 |
|
Net income |
|
26.3 |
% |
27.5 |
% |
|
26.2 |
% |
26.2 |
Comparison of the Three Months Ended and the Nine Months Ended September 30, 2025 and 2024
Revenue by Geographic Region
|
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
|
September 30, |
|
September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(unaudited) |
|
(unaudited) |
||||||||
|
United States |
|
$ |
18,114,996 |
|
$ |
15,207,195 |
|
$ |
52,257,678 |
|
$ |
44,101,367 |
|
International |
|
|
3,087,068 |
|
|
3,118,764 |
|
|
8,864,423 |
|
|
9,751,587 |
|
Total revenue |
|
$ |
21,202,064 |
|
$ |
18,325,959 |
|
$ |
61,122,101 |
|
$ |
53,852,954 |
19
Revenue by Type
|
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
|
September 30, |
|
September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
Devices: |
|
(unaudited) |
|
(unaudited) |
||||||||
|
MRI Compatible IV Infusion Pump Systems |
|
$ |
8,333,988 |
|
$ |
6,952,142 |
|
$ |
22,520,711 |
|
$ |
19,026,021 |
|
MRI Compatible Patient Vital Signs Monitoring Systems |
|
|
6,872,311 |
|
|
5,926,028 |
|
|
19,361,259 |
|
|
17,837,910 |
|
Ferro Magnetic Detection Systems |
|
|
377,716 |
|
|
128,505 |
|
|
1,278,123 |
|
|
744,607 |
|
Total devices revenue |
|
|
15,584,015 |
|
|
13,006,675 |
|
|
43,160,093 |
|
|
37,608,538 |
|
Amortization of extended maintenance agreements |
|
|
612,993 |
|
|
584,218 |
|
|
1,765,644 |
|
|
1,639,537 |
|
Disposables |
|
|
4,130,667 |
|
|
3,689,624 |
|
|
13,281,625 |
|
|
11,399,216 |
|
Services and other |
|
|
874,389 |
|
|
1,045,442 |
|
|
2,914,739 |
|
|
3,205,663 |
|
Total revenue |
|
$ |
21,202,064 |
|
$ |
18,325,959 |
|
$ |
61,122,101 |
|
$ |
53,852,954 |
For the three months ended September 30, 2025, total revenue increased by $2.9 million, or 16%, to $21.2 million from $18.3 million for the same period in 2024. This increase is primarily attributed to continued demand for our IV infusion pump system, disposables, amortization of extended maintenance revenue, and modifications to our sales incentive plan for patient vital signs monitoring systems.
Revenue from sales in the U.S. increased by $2.9 million, or 19%, to $18.1 million for the three months ended September 30, 2025, from $15.2 million for the same period in 2024. Revenue from sales internationally remained constant for the three months ended September 30, 2025 and 2024 at $3.1 million. Domestic sales accounted for 85% of revenue for the three months ended September 30, 2025, compared to 83% for the same period in 2024.
Revenue from sales of devices increased by $2.6 million, or 20%, to $15.6 million for the three months ended September 30, 2025, from $13.0 million for the same period in 2024. Revenue from the amortization of extended maintenance agreements increased by $29 thousand, or 5%, to $613 thousand for the three months ended September 30, 2025, from $584 thousand for the three months ended September 30, 2024. Revenue from sales of our disposables increased by $0.4 million, or 12%, to $4.1 million for the three months ended September 30, 2025, from $3.7 million for the same period in 2024. Revenue from the services and other decreased by $171 thousand, or 16%, to $0.9 million for the three months ended September 30, 2025, from $1.0 million for the three months ended September 30, 2024.
For the nine months ended September 30, 2025, total revenue increased by $7.2 million, or 13%, to $61.1 million from $53.9 million for the same period in 2024. This increase is primarily attributed to continued demand for our IV infusion pump system, disposables, amortization of extended maintenance revenue, and modification to sales incentive plan for patient vital signs monitoring systems.
Revenue from sales in the U.S. increased by $8.2 million, or 18%, to $52.3 million for the nine months ended September 30, 2025, from $44.1 million for the same period in 2024. Revenue from sales internationally decreased by $0.9 million, or 9%, for the nine months ended September 30, 2025 to $8.9 million, from $9.8 million for the same period in 2024. Domestic sales accounted for 85% of revenue for the nine months ended September 30, 2025, compared to 82% for the same period in 2024.
Revenue from sales of devices increased by $5.6 million, or 15%, to $43.2 million for the nine months ended September 30, 2025, from $37.6 million for the same period in 2024. Revenue from the amortization of extended maintenance agreements increased by $126 thousand, or 8%, to $1.8 million for the nine months ended September 30, 2025, from $1.6 million for the nine months ended September 30, 2024. Revenue from sales of our disposables increased by $1.9 million, or 17%, to $13.3 million for the nine months ended September 30, 2025, from $11.4 million for the same period in 2024. Revenue from the services and other decreased by $0.3 million, or 9%, to $2.9 million for the nine months ended September 30, 2025, from $3.2 million for the nine months ended September 30, 2024.
20
Cost of Revenue and Gross Profit
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||
|
|
|
September 30, |
|
|
September 30, |
|
||||||||
|
|
|
2025 |
|
2024 |
|
|
2025 |
|
2024 |
|
||||
|
|
|
(unaudited) |
|
|
(unaudited) |
|
||||||||
|
Revenue |
|
$ |
21,202,064 |
|
$ |
18,325,959 |
|
|
$ |
61,122,101 |
|
$ |
53,852,954 |
|
|
Cost of revenue |
|
|
4,707,756 |
|
|
4,134,253 |
|
|
|
13,829,995 |
|
|
12,263,932 |
|
|
Gross profit |
|
$ |
16,494,308 |
|
$ |
14,191,706 |
|
|
$ |
47,292,106 |
|
$ |
41,589,022 |
|
|
Gross profit percentage |
|
|
78 |
% |
|
77 |
% |
|
|
77 |
% |
|
77 |
% |
For the three months ended September 30, 2025, our cost of revenue increased by $0.6 million, or 14%, to $4.7 million from $4.1 million for the same period in 2024. For the three months ended September 30, 2025, our gross profit increased by $2.3 million, or 16%, to $16.5 million from $14.2 million for the same period in 2024. For the three months ended September 30, 2025, gross profit margin increased to 78% compared to 77% for the same period in 2024.
For the nine months ended September 30, 2025, our cost of revenue increased by $1.5 million, or 13%, to $13.8 million from $12.3 million for the same period in 2024. For the nine months ended September 30, 2025, our gross profit increased by $5.7 million, or 14%, to $47.3 million from $41.6 million for the same period in 2024. Gross profit margin remained at 77% for both the nine months ended September 30, 2025 and 2024.
Operating Expenses
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|||||||||
|
|
|
September 30, |
|
|
September 30, |
|||||||||
|
|
|
2025 |
2024 |
|
2025 |
2024 |
||||||||
|
|
|
(unaudited) |
|
(unaudited) |
||||||||||
|
General and administrative |
|
$ |
4,355,636 |
|
$ |
3,967,799 |
|
|
$ |
13,246,461 |
|
$ |
12,063,971 |
|
|
Percentage of revenue |
|
|
20.6 |
% |
|
21.7 |
% |
|
|
21.7 |
% |
|
22.4 |
% |
|
Sales and marketing |
|
$ |
4,630,560 |
|
$ |
3,795,320 |
|
|
$ |
12,816,473 |
|
$ |
11,098,945 |
|
|
Percentage of revenue |
|
|
21.8 |
% |
|
20.7 |
% |
|
|
21.0 |
% |
|
20.6 |
% |
|
Research and development |
|
$ |
674,362 |
|
$ |
639,467 |
|
|
$ |
2,175,969 |
|
$ |
2,261,596 |
|
|
Percentage of revenue |
|
|
3.2 |
% |
|
3.5 |
% |
|
|
3.6 |
% |
|
4.2 |
% |
General and Administrative
For the three months ended September 30, 2025, general and administrative expense increased by $0.4 million, or 10%, to $4.4 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.
For the nine months ended September 30, 2025, general and administrative expense increased by $1.1 million, or 9%, to $13.2 million from $12.1 million for the same period last year. This increase is primarily due to higher legal and professional expenses, regulatory consulting, and payroll and benefits expenses.
Sales and Marketing
For the three months ended September 30, 2025, sales and marketing expense increased by $0.8 million, or 21%, to $4.6 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.
For the nine months ended September 30, 2025, sales and marketing expense increased by $1.7 million, or 15%, to $12.8 million from $11.1 million for the same period last year. This increase is primarily due to higher sales commissions, sales activities expenses, and payroll and benefits expense.
21
Research and Development
For the three months ended September 30, 2025, research and development expense increased $35 thousand, or 5%, to $674 thousand from $639 thousand for the same period in 2024. This increase is primarily due to an increase in payroll and benefit expenses related to the newly cleared MRidium® 3870 IV infusion pump system.
For the nine months ended September 30, 2025, research and development expense decreased $0.1 million, or 4%, to $2.2 million from $2.3 million for the same period last year. This decrease is primarily due to decreased prototype and consulting expenses related to the MRidium® 3870 IV infusion pump system.
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 September 30, 2025, other income, net decreased $165 thousand, or 26%, to $464 thousand from $629 thousand for the same period in 2024.
For the nine months ended September 30, 2025 and 2024, other income, net decreased $0.3 million, or 14%, to $1.5 million from $1.8 million for the same period in 2024. This income is primarily interest received in 2025 and 2024 on money market fund investments.
Income Taxes
For the three and nine months ended September 30, 2025, we recorded a provision for income tax expense of $1,721,074 and $4,532,357, respectively. For the three and nine months ended September 30, 2025, our effective tax rate was 23.6% and 22.0%, respectively, 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 and nine months ended September 30, 2024, we recorded a provision for income tax expense of $1,368,830 and $3,843,834, respectively. For the three and nine months ended September 30, 2024, our effective tax rate was 21.3% and 21.4%, 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.
On July 31, 2024, the Company received a notice of examination from the I.R.S. for the tax year ended December 31, 2021. On July 29 , 2025, the Company received notice that the I.R.S. completed its review of our tax return for the tax year ended December 31, 2021, with no changes to our reported tax return and closed out its examination. The Company remains subject to income tax examinations for our U.S. federal and certain U.S. state income taxes for 2022 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.
As of September 30, 2025, we had cash and cash equivalents of $56.5 million, stockholders’ equity of $98.4 million, and working capital of $72.1 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 September 30, 2025, all $75.0 million remained available under the 2024 Shelf.
22
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. 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.
|
|
|
Nine Months Ended |
||||
|
|
|
September 30, |
||||
|
|
|
2025 |
|
2024 |
||
|
|
|
(unaudited) |
||||
|
Net cash provided by operating activities |
|
$ |
19,024,428 |
|
$ |
19,637,394 |
|
Net cash used in investing activities |
|
|
(8,004,593) |
|
|
(5,760,057) |
|
Net cash used in financing activities |
|
|
(6,727,591) |
|
|
(11,918,484) |
Cash provided by operating activities decreased by $0.6 million, to $19.0 million for the nine months ended September 30, 2025, compared to $19.6 million for the same period in 2024. During the nine months ended September 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.
Cash used in investing activities increased by $2.2 million, to $8.0 million for the nine months ended September 30, 2025, compared to $5.8 million for the same period in 2024. The majority of our 2025 spend in investing activities is attributed to construction costs of the completed New Facility to accommodate our anticipated growth.
Cash used in financing activities decreased by $5.2 million, to $6.7 million for the nine months ended September 30, 2025, compared to approximately $11.9 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.
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 September 30, 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 September 30, 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.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
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.
23
Item 4. Controls and Procedures
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 September 30, 2025. Our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures as of September 30, 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.
24
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
We may from time to time become party to various legal proceedings or claims that arise in the ordinary course of business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. We accrue liabilities for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. We do not believe that any such known matters, individually or in the aggregate, will have a material adverse effect on our business, financial condition, results of operations or cash flows.
Item 1A. Risk Factors
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 and in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. 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.
Item 2. Unregistered Sale of Equity Securities and Use of Proceeds
None.
Item 3. Default Upon Senior Securities
Not Applicable.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information
Rule 10b5-1 Trading Arrangement Changes
None of the Company's directors or officers
25
Item 6. Exhibits
|
Exhibit
|
|
Description of Document |
|
31.1 |
|
|
|
31.2 |
|
|
|
32.1* |
|
|
|
101.INS |
|
Inline XBRL Instance Document |
|
101.SCH |
|
XBRL Taxonomy Extension Schema Document |
|
101.CAL |
|
XBRL Taxonomy Extension Calculation Linkbase Document |
|
101.DEF |
|
XBRL Taxonomy Extension Definition Linkbase Document |
|
101.LAB |
|
XBRL Taxonomy Extension Label Linkbase Document |
|
101.PRE |
|
XBRL Taxonomy Extension Presentation Linkbase Document |
|
104 |
|
Inline XBRL for the cover page of this Quarterly Report , included as part of this Exhibit 101 inline XBRL Document set |
|
* |
This exhibit shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings. |
26
IRADIMED CORPORATION
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
IRADIMED CORPORATION |
|
|
|
|
|
|
Dated: November 3, 2025 |
/s/ Roger Susi |
|
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By: |
Roger Susi |
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Its: |
Chief Executive Officer and President |
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(Principal Executive Officer and Authorized Officer) |
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/s/ John Glenn |
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By: |
John Glenn |
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Its: |
Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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