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, 2024

☐

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 Capital 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 or a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company,” and “emerging growth company” as defined 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. Yes ☐ No ☐

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 12,664,185 shares of common stock, par value $0.0001 per share, outstanding as of April 30, 2024.

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IRADIMED CORPORATION

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			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, 2024 (Unaudited) and December 31, 2023 (Audited)	6

		(b) Condensed Statements of Operations and Comprehensive Income for the Three Months Ended March 31, 2024 and 2023 (Unaudited)	7

		(c) Condensed Statements of Stockholders’ Equity for the Three Months Ended March 31, 2024 and 2023 (Unaudited)	8

		(d) Condensed Statements of Cash Flows for the Three Months Ended March 31, 2024 and 2023 (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	24

	Item 4	Mine Safety Disclosures	24

	Item 5	Other Information	24

	Item 6	Exhibits	25

Signatures			26

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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, 2024 (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 (“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;

●

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;

●

the implementation of our business strategies;

●

the potential for exposure to product liability claims;

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●

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 other companies 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;

●

interruption 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;

●

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 climate change or other environmental, social and governance and sustainability related matters;

●

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;

●

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;

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●

geopolitical risks, including from international conflicts and 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” 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, 2023 (the “2023 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.

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PART I. FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

IRADIMED CORPORATION

CONDENSED BALANCE SHEETS


	March 31,		December 31,
	2024		2023
	(unaudited)		(audited)
ASSETS
Current assets:
Cash and cash equivalents	$	45,126,676	$	49,762,198
Accounts receivable, net of allowance for credit losses of $330,628 as of March 31, 2024, and $368,835 as of December 31, 2023		13,026,802		12,224,273
Inventory, net		12,696,160		12,821,194
Prepaid expenses and other current assets		1,035,964		1,193,447
Total current assets		71,885,602		76,001,112
Property and equipment, net		9,451,903		9,288,625
Intangible assets, net		2,669,858		2,519,053
Operating lease right-of-use asset		1,938,427		2,043,043
Deferred tax asset, net		1,883,689		2,122,816
Other assets		184,701		181,449
Total assets	$	88,014,180	$	92,156,098
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,285,366	$	1,857,091
Accrued payroll and benefits		2,144,221		2,775,103
Other accrued taxes		136,538		103,241
Warranty reserve		115,030		117,463
Deferred revenue		2,338,414		2,570,407
Dividend payable		—		7,975,997
Current portion of operating lease liabilities		418,814		427,963
Other current liabilities		250,000		250,000
Accrued income taxes		928,287		250,041
Total current liabilities		7,616,670		16,327,306
Deferred revenue, non-current		2,756,435		2,793,548
Operating lease liabilities, non-current		1,519,613		1,615,080
Total liabilities		11,892,718		20,735,934
Stockholders’ equity:
Common stock; $0.0001 par value; 31,500,000 shares authorized; 12,664,185 shares issued and outstanding as of March 31, 2024, and 12,660,313 shares issued and outstanding as of December 31, 2023		1,266		1,265
Additional paid-in capital		28,725,509		28,160,745
Retained earnings		47,394,687		43,258,154
Total Stockholders' Equity		76,121,462		71,420,164
Total liabilities and stockholders’ equity	$	88,014,180	$	92,156,098

See accompanying notes to unaudited condensed financial statements.

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IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

(Unaudited)


	For the Three Months Ended
	March 31,
	2024		2023
Revenue	$	17,598,119	$	15,475,083
Cost of revenue		4,210,396		3,753,635
Gross profit		13,387,723		11,721,448
Operating expenses:
General and administrative		3,991,211		3,920,510
Research and development		821,000		793,716
Sales and marketing		3,827,165		2,999,976
Total operating expenses		8,639,376		7,714,202
Income from operations		4,748,347		4,007,245
Other income, net		495,154		342,409
Income before provision for income taxes		5,243,501		4,349,655
Provision for income tax expense		1,106,968		943,589
Net income	$	4,136,533	$	3,406,066
Net income per share:
Basic	$	0.33	$	0.27
Diluted	$	0.32	$	0.27
Weighted average shares outstanding:
Basic		12,662,526		12,593,033
Diluted		12,749,973		12,686,699

See accompanying notes to unaudited condensed financial statements.

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IRADIMED CORPORATION

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)



				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

Additional

Common Stock

Paid-in

Retained

Stockholders’

Shares

Amount

Capital

Earnings

Equity

Balances, December 31, 2022

12,591,004

1,259

SEC Form 10-Q filed by iRadimed Corporation