Table of Contents
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 September 30, 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 ofincorporation or organization)
(I.R.S. EmployerIdentification Number)
12705 Ingenuity DriveOrlando, Florida
32826
(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 12,721,156 shares of common stock, par value $0.0001 per share, outstanding as of October 31, 2025.
Page
Cautionary Note Regarding Forward-Looking Statements
3
Part I
Financial Information
6
Item 1
Financial Statements
(a) Condensed Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024 (Audited)
(b) Condensed Statements of Operations for the three and nine months ended September 30, 2025 and 2024 (Unaudited)
7
(c) Condensed Statements of Stockholders’ Equity for the three and nine months ended September 30, 2025 and 2024 (Unaudited)
8
(d) Condensed Statements of Cash Flows for the nine months ended September 30, 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
16
Item 3
Quantitative and Qualitative Disclosures About Market Risk
23
Item 4
Controls and Procedures
24
Part II
Other Information
25
Legal Proceedings
Item 1A
Risk Factors
Unregistered Sale of Equity Securities and Use of Proceeds
Default Upon Senior Securities
Mine Safety Disclosures
Item 5
Item 6
Exhibits
26
Signatures
27
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:
4
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
CONDENSED BALANCE SHEETS
September 30,
December 31,
2025
2024
(unaudited)
(audited)
ASSETS
Current assets:
Cash and cash equivalents
$
56,526,151
52,233,907
Accounts receivable, net of allowance for credit losses of $191,175 as of September 30, 2025, and $274,300 as of December 31, 2024
13,858,292
10,556,733
Inventory, net
11,734,822
10,401,889
Prepaid expenses and other current assets
1,097,330
1,513,680
Prepaid income taxes
1,702,410
536,010
Total current assets
84,919,005
75,242,219
Property and equipment, net
23,792,441
16,810,797
Intangible assets, net
3,373,478
3,098,691
Operating lease right-of-use asset
—
154,688
Deferred tax asset, net
2,422,481
2,820,468
Other assets
214,374
198,912
Total assets
114,721,779
98,325,775
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
2,333,474
1,896,405
Accrued payroll and benefits
4,071,176
3,771,756
Other accrued taxes
296,207
162,998
Warranty reserve
137,025
118,269
Deferred revenue
3,158,065
2,259,616
Current portion of operating lease liabilities
153,264
Other current liabilities
150,000
Accrued income taxes
2,800,970
Total current liabilities
12,796,917
8,512,308
Deferred revenue, non-current
3,572,891
2,993,287
Operating lease liabilities, non-current
1,424
Total liabilities
16,369,808
11,507,019
Stockholders’ equity:
Common stock; $0.0001 par value per share; 31,500,000 shares authorized; 12,721,156 shares issued and outstanding as of September 30, 2025, and 12,709,860 shares issued and outstanding as of December 31, 2024
1,272
1,271
Additional paid-in capital
32,007,647
30,026,734
Retained earnings
66,343,052
56,790,751
Total stockholders' equity
98,351,971
86,818,756
Total liabilities and stockholders’ equity
See accompanying notes to unaudited condensed financial statements.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
Nine Months Ended
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
Operating expenses:
General and administrative
4,355,636
3,967,799
13,246,461
12,063,971
Sales and marketing
4,630,560
3,795,320
12,816,473
11,098,945
Research and development
674,362
639,467
2,175,969
2,261,596
Total operating expenses
9,660,558
8,402,586
28,238,903
25,424,512
Income from operations
6,833,750
5,789,120
19,053,203
16,164,510
Other income, net
463,976
629,201
1,517,196
1,766,572
Income before provision for income taxes
7,297,726
6,418,321
20,570,399
17,931,082
Provision for income tax expense
1,721,074
1,368,830
4,532,357
3,843,834
Net income
5,576,652
5,049,491
16,038,042
14,087,248
Net income per share:
Basic
0.44
0.40
1.26
1.11
Diluted
0.43
1.25
1.10
Weighted average shares outstanding:
12,720,812
12,669,741
12,716,994
12,665,743
12,860,077
12,778,446
12,842,003
12,762,346
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
Additional
Common Stock
Paid-in
Retained
Stockholders’
Shares
Amount
Capital
Earnings
Equity
Balances, December 31, 2024
12,709,860
4,687,429
Dividends declared
(2,161,522)
Stock-based compensation expense
826,064
Net share settlement of restricted stock units
5,249
1
(116,298)
(116,297)
Balances, March 31, 2025
12,715,109
30,736,500
59,316,658
90,054,430
5,773,961
(2,161,628)
730,618
4,893
(95,995)
Balances, June 30, 2025
12,720,002
31,371,123
62,928,991
94,301,386
(2,162,591)
666,083
1,154
(29,559)
Balances, September 30, 2025
12,721,156
Balances, December 31, 2023
12,660,313
1,265
28,160,745
43,258,154
71,420,164
4,136,533
628,640
3,872
(63,876)
(63,875)
Balances, March 31, 2024
12,664,185
1,266
28,725,509
47,394,687
76,121,462
4,901,224
(1,899,644)
609,096
4,581
(63,946)
(63,945)
Exercise of stock options
335
3,296
Balances, June 30, 2024
12,669,101
1,267
29,273,955
50,396,267
79,671,489
(1,900,487)
629,965
811
(17,833)
Balances, September 30, 2024
12,669,912
29,886,087
53,545,271
83,432,625
CONDENSED STATEMENTS OF CASH FLOWS
Operating activities:
Adjustments to reconcile net income to net cash provided by operating activities:
Allowance for credit losses
(83,125)
(91,398)
Provision for excess and obsolete inventory
26,667
202,140
Depreciation & amortization
785,320
622,790
Loss on disposal of property and equipment
34,152
Stock-based compensation
2,222,764
1,867,701
Deferred income taxes, net
397,987
(591,829)
Changes in operating assets and liabilities:
Accounts receivable
(3,218,434)
1,950,885
Inventory
(1,430,911)
1,278,208
(1,166,400)
416,350
244,606
(15,462)
(2,764)
437,069
(473,820)
299,420
509,123
133,209
90,447
18,756
740
1,478,053
(60,555)
(150,000)
Net cash provided by operating activities
19,024,428
19,637,394
Investing activities:
Purchases of property and equipment
(7,470,826)
(5,214,859)
Capitalized intangible assets
(533,767)
(545,198)
Net cash used in investing activities
(8,004,593)
(5,760,057)
Financing activities:
Dividends paid
(6,485,741)
(11,776,128)
Proceeds from exercises of stock options
Taxes paid related to the net share settlement of equity awards
(241,850)
(145,652)
Net cash used in financing activities
(6,727,591)
(11,918,484)
Net increase in cash and cash equivalents
4,292,244
1,958,853
Cash and cash equivalents, beginning of period
49,762,198
Cash and cash equivalents, end of period
51,721,051
Supplemental disclosure of cash flow information:
Cash paid for income taxes
2,499,800
4,456,827
ROU asset and liability adjustment
1,486,093
Operating and short-term lease payments recorded within cash flow provided by operating activities
367,378
612,910
Notes to Unaudited Condensed Financial Statements
1 — Basis of Presentation
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 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.
Revenue information by geographic region is as follows:
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
Revenue information by type is as follows:
Devices:
MRI Compatible Intravenous ("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
Contract Liabilities
Our contract liabilities consist of:
Advance payments from customers
773,102
88,099
Shipments in-transit
166,304
2,387
Extended maintenance agreements
5,791,550
5,162,417
Total
6,730,956
5,252,903
Changes in the contract liabilities during the periods presented are as follows:
Deferred
Contract liabilities, December 31, 2024
Increases due to cash received from customers
4,017,802
Decreases due to recognition of revenue
(2,539,749)
Contract liabilities, September 30, 2025
Contract liabilities, December 31, 2023
5,360,360
3,353,763
(3,410,723)
Contract liabilities, September 30, 2024
5,303,400
11
Capitalized Contract Costs
Our capitalized contract costs totaled $214,374 and $179,597 as of September 30, 2025 and December 31, 2024, respectively, and are classified as other assets on the unaudited condensed balance sheets.
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 $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 September 30,
Nine Months Ended September 30,
Weighted-average shares outstanding — Basic
Effect of dilutive securities:
Stock options
2,104
2,223
Restricted stock units
71,157
63,929
61,839
55,870
Performance-based restricted stock units
68,108
42,672
63,170
38,510
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:
Anti-dilutive restricted stock units
182
61
13
4 — Inventory, net
Inventory consists of:
Raw materials
9,590,716
9,022,690
Work in process
735,775
568,540
Finished goods
1,943,369
1,319,030
Inventory before allowance for excess and obsolete
12,269,860
10,910,260
Allowance for excess and obsolete
(535,038)
(508,371)
12
5 — Property and Equipment, net
Property and equipment consist of:
Land
8,104,987
6,253,790
Land improvements
1,409,336
Building
11,526,063
Computer software and hardware
2,110,317
1,584,889
Furniture and fixtures
2,087,911
1,842,773
Leasehold improvements
270,486
Machinery and equipment
2,922,891
2,645,129
Construction in-process
497,451
8,809,237
28,658,956
21,406,304
Accumulated depreciation
(4,866,515)
(4,595,507)
Depreciation expense of property and equipment was $256,312 and $139,840 for the three months ended September 30, 2025 and 2024, respectively, and $526,340 and $450,194 for the nine months ended September 30, 2025 and 2024, respectively.
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:
23,459,416
16,398,513
333,025
412,284
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.
6 — Intangible Assets, net
The following table summarizes the components of intangible asset balances:
Patents — in use
442,957
321,874
Patents — fully amortized
70,164
Patents — in process
66,333
177,023
Internally developed software — in use
3,934,033
1,840,520
Internally developed software — in process
259,570
1,835,189
Trademarks
43,547
38,067
4,816,604
4,282,837
Accumulated amortization
(1,443,126)
(1,184,146)
Amortization expense of intangible assets was $127,410 and $57,731 for the three months ended September 30, 2025 and 2024, respectively, and $258,980 and $172,596 for the nine months ended September 30, 2025 and 2024, respectively.
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
111,236
2026
440,180
2027
366,467
2028
363,865
2029
360,143
2030
342,170
Thereafter
1,019,967
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 to operate as a single business segment is consistent with the consolidated financial information regularly provided to the Company’s appointed chief operating decision maker (CODM), the 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 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 September 30, 2025, we did not have any assets or liabilities subject to recurring fair value measurements.
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9 — Stock-Based Compensation
Stock-based compensation was recognized as follows in the unaudited Condensed Statements of Operations:
71,970
62,359
214,848
178,713
363,286
381,339
1,319,867
1,139,316
168,991
135,358
423,689
393,649
61,836
50,908
264,361
156,023
629,964
2,222,765
As of September 30, 2025, we had (i) $3,077,208 of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted-average period of 2.18 years and (ii) $969,229 of unrecognized compensation cost related to unvested performance-based restricted stock units, which is expected to be recognized over a weighted-average period of 1.81 years.
The following table presents a summary of our equity award activity for the nine months ended September 30, 2025 (shares):
September 30, 2025
Performance
Based
Restricted
Stock Units
Outstanding beginning of period
134,816
44,251
Awards granted
4,132
Awards exercised/vested
(13,231)
(2,210)
Awards canceled/ forfeited
(6,104)
Outstanding end of period
119,613
42,041
10 — 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 benefits from 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 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 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 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 $9,851,492 and $7,523,859 as of September 30, 2025 and December 31, 2024, respectively. Amounts recognized in our balance sheet related to these purchase orders were immaterial.
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 October 30, 2025, the Company’s Board of Directors (the “Board”) declared a regular quarterly cash dividend of $0.17 per share of outstanding common stock. The dividend is payable to stockholders of record as of the close of business on November 14, 2025 and will be paid on November 25, 2025.
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.
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
100.0
%
22.2
22.6
22.8
77.8
77.4
77.2
20.6
21.7
22.4
21.8
20.7
21.0
3.2
3.5
3.6
4.2
45.6
45.9
46.3
47.2
32.2
31.6
31.1
30.0
2.2
3.4
2.5
3.3
34.4
35.0
33.6
33.3
8.1
7.5
7.4
7.1
26.3
27.5
26.2
Comparison of the Three Months Ended and the Nine Months Ended September 30, 2025 and 2024
Revenue by Geographic Region
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Revenue by Type
MRI Compatible IV Infusion Pump Systems
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
Gross profit percentage
78
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
Percentage of revenue
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.
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.
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.
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.
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.
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 September 30, 2025.
Item 6. Exhibits
ExhibitNumber
Description of Document
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.
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.
Dated: November 3, 2025
/s/ Roger Susi
By:
Roger Susi
Its:
Chief Executive Officer and President
(Principal Executive Officer and Authorized Officer)
/s/ John Glenn
John Glenn
Chief Financial Officer
(Principal Financial and Accounting Officer)