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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended March 31, 2025

OR

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.:  001-36534

IRADIMED CORPORATION

(Exact name of Registrant as specified in its charter)

Delaware

    

73-1408526

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer
Identification Number)

1025 Willa Springs Drive
Winter Springs, Florida

32708

(Address of principal executive offices)

(Zip Code)

(407) 677-8022

(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:

Title of each class:

    

Trading Symbol

    

Name of each exchange on which registered:

Common stock, par value $0.0001

IRMD

NASDAQ Global Market

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. Yes   No 

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). Yes   No 

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.

Large accelerated filer 

Accelerated filer 

Non-accelerated filer   

Smaller reporting company   

Emerging growth company   

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   No 

The registrant had 12,715,109 shares of common stock, par value $0.0001 per share, outstanding as of April 30, 2025.

Table of Contents

IRADIMED CORPORATION

Table of Contents

Page

Cautionary Note Regarding Forward-Looking Statements

3

Part I

Financial Information

6

Item 1

Financial Statements

6

(a)    Condensed Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 2024 (Audited)

6

(b)    Condensed Statements of Operations for the three months ended March 31, 2025 and 2024 (Unaudited)

7

(c)    Condensed Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024 (Unaudited)

8

(d)    Condensed Statements of Cash Flows for the three months ended March 31, 2025 and 2024 (Unaudited)

9

(e)    Notes to Unaudited Condensed Financial Statements

10

Item 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

Item 3

Quantitative and Qualitative Disclosures About Market Risk

23

Item 4

Controls and Procedures

23

Part II

Other Information

24

Item 1

Legal Proceedings

24

Item 1A

Risk Factors

24

Item 2

Unregistered Sale of Equity Securities and Use of Proceeds

24

Item 3

Default Upon Senior Securities

25

Item 4

Mine Safety Disclosures

25

Item 5

Other Information

25

Item 6

Exhibits

26

Signatures

27

2

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CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended March 31, 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

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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

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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;
increasing and/or fluctuating tax and interest rates as well as inflationary pressures on the U.S. and global economies;
geopolitical risks, including tariffs, trade disputes, international conflicts and recent or upcoming elections in the United States and other countries, which could, among other things, lead to increased market volatility; 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

Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

IRADIMED CORPORATION

CONDENSED BALANCE SHEETS

March 31, 

    

December 31, 

2025

2024

(unaudited)

(audited)

ASSETS

  

 

  

Current assets:

  

 

  

Cash and cash equivalents

$

50,330,880

$

52,233,907

Accounts receivable, net of allowance for credit losses of $259,390 as of March 31, 2025, and $368,835 as of December 31, 2024

 

12,706,192

 

10,556,733

Inventory, net

 

10,555,729

 

10,401,889

Prepaid expenses and other current assets

 

1,543,964

 

2,049,690

Total current assets

 

75,136,765

 

75,242,219

Property and equipment, net

 

20,377,795

 

16,810,797

Intangible assets, net

 

3,258,759

 

3,098,691

Operating lease right-of-use asset

 

59,221

 

154,688

Deferred tax asset, net

 

2,690,886

 

2,820,468

Other assets

 

206,009

 

198,912

Total assets

$

101,729,435

$

98,325,775

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

2,590,044

$

1,896,405

Accrued payroll and benefits

 

2,266,642

 

3,771,756

Other accrued taxes

 

256,980

 

162,998

Warranty reserve

 

118,600

 

118,269

Deferred revenue

 

2,598,549

 

2,259,616

Current portion of operating lease liabilities

 

59,221

 

153,264

Other current liabilities

 

 

150,000

Accrued income taxes

 

583,408

 

Total current liabilities

 

8,473,444

 

8,512,308

Deferred revenue, non-current

 

3,201,561

 

2,993,287

Operating lease liabilities, non-current

 

 

1,424

Total liabilities

 

11,675,005

 

11,507,019

Stockholders’ equity:

 

  

 

  

Common stock; $0.0001 par value per share; 31,500,000 shares authorized; 12,715,109 shares issued and outstanding as of March 31, 2025, and 12,709,860 shares issued and outstanding as of December 31, 2024

 

1,272

 

1,271

Additional paid-in capital

 

30,736,500

 

30,026,734

Retained earnings

 

59,316,658

 

56,790,751

Total stockholders' equity

 

90,054,430

 

86,818,756

Total liabilities and stockholders’ equity

$

101,729,435

$

98,325,775

See accompanying notes to unaudited condensed financial statements.

6

Table of Contents

IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended

March 31, 

2025

    

2024

Revenue

$

19,510,637

$

17,598,119

Cost of revenue

 

4,667,831

 

4,210,396

Gross profit

 

14,842,806

 

13,387,723

Operating expenses:

 

  

 

  

General and administrative

 

4,610,832

 

3,991,211

Sales and marketing

 

4,176,273

 

3,827,165

Research and development

 

624,245

 

821,000

Total operating expenses

 

9,411,350

 

8,639,376

Income from operations

 

5,431,456

 

4,748,347

Other income, net

 

513,973

 

495,154

Income before provision for income taxes

 

5,945,429

 

5,243,501

Provision for income tax expense

 

1,258,000

 

1,106,968

Net income

$

4,687,429

$

4,136,533

Net income per share:

 

  

 

  

Basic

$

0.37

$

0.33

Diluted

$

0.37

$

0.32

Weighted average shares outstanding:

 

  

 

  

Basic

 

12,714,224

 

12,662,526

Diluted

 

12,825,672

 

12,749,973

See accompanying notes to unaudited condensed financial statements.

7

Table of Contents

IRADIMED CORPORATION

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

Additional

Common Stock

Paid-in

Retained

Stockholders’

Shares

Amount

Capital

Earnings

Equity

Balances, December 31, 2024

 

12,709,860

$

1,271

$

30,026,734

$

56,790,751

$

86,818,756

Net income

 

 

 

 

4,687,429

 

4,687,429

Dividends declared

 

 

 

 

(2,161,522)

 

(2,161,522)

Stock-based compensation expense

 

 

 

826,064

 

 

826,064

Net share settlement of restricted stock units

 

5,249

 

1

 

(116,298)

 

 

(116,297)

Balances, March 31, 2025

 

12,715,109

$

1,272

$

30,736,500

$

59,316,658

$

90,054,430

Additional

Common Stock

Paid-in

Retained

Stockholders’

Shares

Amount

Capital

Earnings

Equity

Balances, December 31, 2023

 

12,660,313

$

1,265

$

28,160,745

$

43,258,154

$

71,420,164

Net income

 

 

 

 

4,136,533

 

4,136,533

Stock-based compensation expense

 

 

 

628,640

 

 

628,640

Net share settlement of restricted stock units

 

3,872

 

1

 

(63,876)

 

 

(63,875)

Balances, March 31, 2024

 

12,664,185

$

1,266

$

28,725,509

$

47,394,687

$

76,121,462

See accompanying notes to unaudited condensed financial statements.

8

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IRADIMED CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

    

Three Months Ended

March 31, 

2025

    

2024

Operating activities:

 

  

 

  

Net income

$

4,687,429

$

4,136,533

Adjustments to reconcile net income to net cash provided by operating activities:

 

Allowance for credit losses

 

(14,910)

 

(38,207)

Provision for excess and obsolete inventory

 

(37,718)

 

39,001

Depreciation & amortization

 

194,122

 

226,089

Loss on disposal of property and equipment

 

 

207

Stock-based compensation

 

826,064

 

628,640

Deferred income taxes, net

 

129,582

 

917,373

Changes in operating assets and liabilities:

 

Accounts receivable

 

(2,134,549)

 

(764,322)

Inventory

 

(120,010)

 

93,052

Prepaid expenses and other current assets

 

505,726

 

157,483

Other assets

 

(7,097)

 

(3,252)

Accounts payable

 

693,639

 

(640,320)

Accrued payroll and benefits

 

(1,505,114)

 

(630,882)

Other accrued taxes

 

93,982

 

33,297

Warranty reserve

 

331

 

(2,433)

Deferred revenue

 

547,207

 

(269,106)

Other current liabilities

 

(150,000)

 

Accrued income taxes

 

583,408

 

Net cash provided by operating activities

 

4,292,092

 

3,883,154

Investing activities:

 

  

 

  

Purchases of property and equipment

 

(3,697,468)

 

(270,566)

Capitalized intangible assets

 

(219,832)

 

(208,237)

Net cash used in investing activities

 

(3,917,300)

 

(478,803)

Financing activities:

 

  

 

  

Dividends paid

 

(2,161,522)

 

(7,975,997)

Taxes paid related to the net share settlement of equity awards

 

(116,297)

 

(63,876)

Net cash used in financing activities

 

(2,277,819)

 

(8,039,873)

Net decrease in cash and cash equivalents

 

(1,903,027)

 

(4,635,522)

Cash and cash equivalents, beginning of period

 

52,233,907

 

49,762,198

Cash and cash equivalents, end of period

$

50,330,880

$

45,126,676

Supplemental disclosure of cash flow information:

 

  

 

Cash paid for income taxes

$

9,000

$

189,595

Operating and short-term lease payments recorded within cash flow provided by operating activities

$

178,749

$

203,354

See accompanying notes to unaudited condensed financial statements.

9

Table of Contents

IRADIMED CORPORATION

Notes to Unaudited Condensed Financial Statements

1 — Basis of Presentation

The accompanying interim 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 months ended March 31, 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 one reportable segment, which develops, manufactures, markets, sells, and distributes Magnetic Resonance Imaging (“MRI”) compatible medical devices and products, related accessories, disposables, and service for use primarily by hospitals and acute care facilities during MRI procedures.

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.

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Revenue information by geographic region is as follows:

    

Three Months Ended

March 31, 

2025

    

2024

(unaudited)

United States

$

15,952,619

$

13,408,956

International

 

3,558,018

 

4,189,163

Total revenue

$

19,510,637

$

17,598,119

Revenue information by type is as follows:

    

Three Months Ended

March 31, 

2025

    

2024

(unaudited)

Devices:

 

  

 

  

MRI Compatible Intravenous ("IV") Infusion Pump Systems

$

5,999,212

$

5,192,680

MRI Compatible Patient Vital Signs Monitoring Systems

 

6,544,679

 

6,461,658

Ferro Magnetic Detection Systems

 

418,204

 

249,700

Total devices revenue

 

12,962,095

 

11,904,038

Amortization of extended warranty agreements

 

560,199

 

487,131

Disposables

 

4,947,088

 

4,013,875

Services and other

1,041,255

1,193,075

Total revenue

$

19,510,637

$

17,598,119

Contract Liabilities

Our contract liabilities consist of:

March 31, 

    

December 31, 

2025

2024

(unaudited)

(audited)

Advance payments from customers

$

231,766

$

88,099

Shipments in-transit

 

224,730

 

2,387

Extended warranty agreements

 

5,343,614

 

5,162,417

Total

$

5,800,110

$

5,252,903

Changes in the contract liabilities during the periods presented are as follows:

Deferred

Revenue

(unaudited)

Contract liabilities, December 31, 2024

$

5,252,903

Increases due to cash received from customers

 

1,306,300

Decreases due to recognition of revenue

 

(759,093)

Contract liabilities, March 31, 2025

$

5,800,110

Deferred

Revenue

(unaudited)

Contract liabilities, December 31, 2023

$

5,360,360

Increases due to cash received from customers

 

1,342,418

Decreases due to recognition of revenue

 

(1,607,929)

Contract liabilities, March 31, 2024

$

5,094,849

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Capitalized Contract Costs

Our capitalized contract costs totaled $192,094 and $179,597 as of March 31, 2025 and December 31, 2024, respectively, and are classified as other assets on the unaudited condensed balance sheets.

— 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 $0.0001 per share (“common stock”), outstanding during the period. Diluted net income per share of common stock reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Stock options, restricted stock units and performance-based restricted stock units granted by us represent the only dilutive effect reflected in diluted weighted-average shares of common stock outstanding.

The following table presents the computation of basic and diluted net income per share of common stock:

    

Three Months Ended March 31, 

2025

    

2024

(unaudited)

Net income

$

4,687,429

$

4,136,533

Weighted-average shares outstanding — Basic

 

12,714,224

 

12,662,526

Effect of dilutive securities:

 

  

 

  

Stock options

 

 

2,340

Restricted stock units

 

52,454

 

49,269

Performance-based restricted stock units

 

58,994

 

35,838

Weighted-average shares outstanding — Diluted

 

12,825,672

 

12,749,973

Basic net income per share

$

0.37

$

0.33

Diluted net income per share

$

0.37

$

0.32

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

March 31, 

2025

2024

(unaudited)

Anti-dilutive restricted stock units

 

137

 

719

4 — Inventory, net

Inventory consists of:

    

March 31, 

    

December 31, 

2025

    

2024

(unaudited)

(audited)

Raw materials

$

8,937,867

$

9,022,690

Work in process

 

714,655

 

568,540

Finished goods

 

1,373,860

 

1,319,030

Inventory before allowance for excess and obsolete

 

11,026,382

 

10,910,260

Allowance for excess and obsolete

 

(470,653)

 

(508,371)

Total

$

10,555,729

$

10,401,889

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5 — Property and Equipment, net

Property and equipment consist of:

    

March 31, 

    

December 31, 

2025

2024

(unaudited)

(audited)

Land

$

6,253,790

$

6,253,790

Computer software and hardware

1,695,337

1,584,889

Furniture and fixtures

 

1,849,427

 

1,842,773

Leasehold improvements

 

270,486

 

270,486

Machinery and equipment

 

2,782,397

 

2,645,129

Construction in-process

 

12,256,220

 

8,809,237

 

25,107,657

 

21,406,304

Accumulated depreciation

 

(4,729,862)

 

(4,595,507)

Total

$

20,377,795

$

16,810,797

Depreciation expense of property and equipment was $134,355 and $168,657 for the three months ended March 31, 2025 and 2024, respectively.

Property and equipment, net, information by geographic region is as follows:

    

March 31, 

    

December 31, 

2025

2024

 

(unaudited)

(audited)

United States

$

20,055,523

$

16,398,513

International

 

322,272

 

412,284

Total property and equipment, net

$

20,377,795

$

16,810,797

Long-lived assets held outside of the United States consist principally of tooling and machinery and equipment, which are components of property and equipment, net.

6 — Intangible Assets, net

The following table summarizes the components of intangible asset balances:

    

March 31, 

    

December 31, 

2025

2024

(unaudited)

(audited)

Patents — in use

$

370,957

$

321,874

Patents — fully amortized

 

70,164

 

70,164

Patents — in process

 

136,006

 

177,023

Internally developed software — in use

 

1,840,520

 

1,840,520

Internally developed software — in process

 

2,042,393

 

1,835,189

Trademarks

 

42,629

 

38,067

 

4,502,669

 

4,282,837

Accumulated amortization

 

(1,243,910)

 

(1,184,146)

Total

$

3,258,759

$

3,098,691

Amortization expense of intangible assets was $59,764 and $57,432 for the three months ended March 31, 2025 and 2024, respectively.

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Expected annual amortization expense for the remaining portion of 2025 and the next five years related to intangible assets, excluding trademarks considered to have indefinite lives and in process intangible assets, is as follows:

Nine months remaining ending December 31, 2025

$

178,179

2026

$

226,629

2027

$

152,917

2028

$

150,314

2029

$

146,592

2030

$

128,619

Thereafter

$

54,481

7 — Segment Reporting

The Company operates in one business segment that develops, manufactures, markets, sells, and distributes MRI compatible medical devices and products, related accessories, disposables, and services relating to them. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s appointed chief operating decision maker (“CODM”), who is President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi. As the Company has only one operating segment and is managed on a consolidated basis, the measure of profit or loss is consolidated net income or loss. The accounting policies for our segment are the same as those described in “Note 1 - Organization and Significant Accounting Policies” in our 2024 Annual Report, and in Note 1 above. See the Condensed Consolidated Statements of Operations.

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 March 31, 2025, we did not have any assets or liabilities subject to recurring fair value measurements.

9 — Stock-Based Compensation

Stock-based compensation was recognized as follows in the unaudited Condensed Statements of Operations:

Three Months Ended

March 31, 

    

2025

    

2024

(unaudited)

Cost of revenue

$

72,026

$

58,079

General and administrative

 

518,628

 

380,782

Sales and marketing

 

134,707

 

134,866

Research and development

 

100,703

 

54,913

Total

$

826,064

$

628,640

As of March 31, 2025, we had (i) $4,104,482 of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted-average period of 2.37 years and (ii) $1,347,453 of unrecognized compensation cost related to unvested performance-based restricted stock units, which is expected to be recognized over a weighted-average period of 2.17 years.

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The following table presents a summary of our equity award activity for the three months ended March 31, 2025 (shares):

Three Months Ended

March 31, 2025

    

    

Performance

Based

Restricted

Restricted

Stock Units

Stock Units

Outstanding beginning of period

134,816

 

44,251

Awards granted

350

 

Awards exercised/vested

(5,041)

 

(2,210)

Awards canceled/ forfeited

(593)

 

Outstanding end of period

129,532

 

42,041

10 — Income Taxes

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

For the three months ended March 31, 2024, we recorded a provision for income tax expense of $1,106,968. For the three months ended March 31, 2024, 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 benefits from 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.

11 — Leases

We have entered into operating lease contracts for our manufacturing plant, office space, and various office equipment with two material lease contracts outstanding.

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. Pursuant to the terms of our lease for this property, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index. The Company paid Susi, LLC $130,101 and $129,482 for the three months ended March 31, 2025 and 2024, respectively. 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 five years, which was set to expire on May 31, 2024.

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 Company’s continued construction of a new corporate office and manufacturing facility in Orange County, Florida (the “New Facility”). Pursuant to the terms of the Lease Amendment, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index, and 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 intend to exercise the option to renew on a month-to-month basis until the move to the New Facilities. The impact of the Lease Amendment to the Right-of-Use (“ROU”) asset valuation was a reduction in the ROU lease liability and ROU assets in the amount of $1.48 million. It has no

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impact on the statements of operations or cash flow. This Lease Amendment does not contain any residual value guarantee or material restrictive covenants.

In February 2023, we entered into two, two-year, non-cancelable operating leases with non-related parties for additional office space in Winter Springs, Florida. Pursuant to the contract terms, the leases expired in February 2025 and did not contain any residual value guarantee or material restrictive covenants. Pursuant to the lease terms, the total monthly base rent was $10,055. For the three months ended March 31, 2025 and 2024, the Company paid $7,731 and $30,165, respectively. Under the terms of the leases, we were responsible for insurance and maintenance expenses.

Operating leases cost recognized in the unaudited Condensed Statements of Operations is as follows:

    

Three Months Ended

March 31, 

    

2025

2024

(unaudited)

Cost of revenue

$

59,124

    

$

58,843

General and administrative

 

106,879

 

132,094

Sales and marketing

 

3,309

 

3,293

Research and development

 

9,168

 

9,124

Total

$

178,480

$

203,354

Lease costs for short-term leases were immaterial for the three months ended March 31, 2025 and 2024.

Maturity of our operating lease liability as of March 31, 2025, is as follows:

2025

 

73,964

Total lease payments

 

73,964

Imputed interest

 

(14,743)

Present value of lease liability

$

59,221

12 — Commitments and Contingencies

Purchase commitments. We had various purchase orders for goods or services totaling $6,856,930 and $8,217,571 as of March 31, 2025 and December 31, 2024, respectively. Amounts recognized in our balance sheet related to these purchase orders were immaterial.

Legal matters. We may, from time to time, become a party to various legal proceedings or claims that arise in the ordinary course of business.

13 — Subsequent Events

On May 5, 2025, the Company’s Board of Directors declared a regular quarterly cash dividend of $0.17 per share on the Company's outstanding common stock. The payment will be made to stockholders on May 30, 2025, to stockholders of record at the close of business on May 20, 2025.

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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 “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.

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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

18

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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.

    

Percent of Revenue

    

Three Months Ended

March 31, 

    

2025

    

2024

    

(unaudited)

Revenue

 

100.0

%  

100.0

%  

Cost of revenue

 

23.9

 

23.9

 

Gross profit

 

76.1

 

76.1

 

Operating expenses:

 

 

 

General and administrative

 

23.6

 

22.7

 

Sales and marketing

 

21.4

 

21.7

 

Research and development

 

3.2

 

4.7

 

Total operating expenses

 

48.2

 

49.1

 

Income from operations

 

27.9

 

27.0

 

Other income, net

 

2.6

 

2.8

 

Income before provision for income taxes

 

30.5

 

29.8

 

Provision for income tax expense

 

6.5

 

6.3

 

Net income

 

24.0

%  

23.5

%  

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

Revenue by Geographic Region

Three Months Ended

March 31, 

    

2025

    

2024

(unaudited)

United States

$

15,952,619

$

13,408,956

International

 

3,558,018

 

4,189,163

Total revenue

$

19,510,637

$

17,598,119

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Revenue by Type

    

Three Months Ended

March 31, 

2025

    

2024

Devices:

 

(unaudited)

MRI Compatible IV Infusion Pump Systems

$

5,999,212

$

5,192,680

MRI Compatible Patient Vital Signs Monitoring Systems

 

6,544,679

 

6,461,658

Ferro Magnetic Detection Systems

 

418,204

 

249,700

Total devices revenue

 

12,962,095

 

11,904,038

Amortization of extended warranty agreements

560,199

487,131

Disposables

 

4,947,088

 

4,013,875

Services and other

 

1,041,255

 

1,193,075

Total revenue

$

19,510,637

$

17,598,119

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

    

Three Months Ended

    

March 31, 

2025

    

2024

    

(unaudited)

Revenue

$

19,510,637

$

17,598,119

Cost of revenue

 

4,667,831

 

4,210,396

Gross profit

$

14,842,806

$

13,387,723

Gross profit percentage

 

76.1

%  

 

76.1

%  

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.

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Operating Expenses

    

Three Months Ended

    

March 31, 

2025

2024

(unaudited)

General and administrative

$

4,610,832

$

3,991,211

Percentage of revenue

 

23.6

%  

 

22.7

%  

Sales and marketing

$

4,176,273

$

3,827,165

Percentage of revenue

 

21.4

%  

 

21.7

%  

Research and development

$

624,245

$

821,000

Percentage of revenue

 

3.2

%  

 

4.7

%  

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.

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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.

    

Three Months Ended

March 31, 

2025

    

2024

(unaudited)

Net cash provided by operating activities

$

4,292,092

$

3,883,154

Net cash used in investing activities

 

(3,917,300)

 

(478,803)

Net cash used in financing activities

 

(2,277,819)

 

(8,039,873)

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.

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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.

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.

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 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.

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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 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.

Item 2. Unregistered Sale of Equity Securities and Use of Proceeds

None.

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Table of Contents

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 adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarterly period ended March 31, 2025.

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Item 6. Exhibits

Exhibit
Number

     

Description of Document

10.1

Employment Agreement between Iradimed Corporation and Jeffrey Chiprin, dated November 26, 2024.

31.1

Certification of Chief Executive Officer pursuant to Exchange Act Rule, 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

 

Certification of Chief Financial Officer pursuant to Exchange Act Rule, 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1*

 

Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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.

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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: May 5, 2025

/s/ Roger Susi

 

By:

Roger Susi

 

Its:  

Chief Executive Officer and President

 

 

(Principal Executive Officer and Authorized Officer)

 

/s/ John Glenn

 

By:

John Glenn

 

Its:

Chief Financial Officer

(Principal Financial and Accounting Officer)

27