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, 2023

☐

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 12,594,797 shares of common stock, par value $0.0001 per share, outstanding as of April 30, 2023.

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IRADIMED CORPORATION

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			Page
Cautionary Note Regarding Forward-Looking Statements			3

Part I	Financial Information		5

	Item 1	Condensed Financial Statements	5

		(a) Condensed Balance Sheets as of March 31, 2023 (Unaudited) and December 31, 2022	5

		(b) Condensed Statements of Operations for the Three Months Ended March 31, 2023 and 2022 (Unaudited)	6

		(c) Condensed Statements of Comprehensive Income for the Three Months Ended March 31, 2023 and 2022 (Unaudited)	7

		(d) Condensed Statements of Stockholders’ Equity for the Three Months Ended March 31, 2023 and 2022 (Unaudited)	8

		(e) Condensed Statements of Cash Flows for the Three Months Ended March 31, 2023 and 2022 (Unaudited)	9

		(f) Notes to Unaudited Condensed Financial Statements	10

	Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19

	Item 3	Quantitative and Qualitative Disclosures About Market Risk	25

	Item 4	Controls and Procedures	25

Part II	Other Information		26

	Item 1	Legal Proceedings	26

	Item 1A	Risk Factors	26

	Item 2	Unregistered Sale of Equity Securities and Use of Proceeds	26

	Item 3	Default Upon Senior Securities	26

	Item 4	Mine Safety Disclosures	26

	Item 5	Other Information	26

	Item 6	Exhibits	27

Signatures			28

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CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections entitled “Business,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking statements include, but are not limited to, statements about:

●

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;

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unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies;

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our primary reliance on a limited number of products;

●

our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

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market and economic uncertainty caused by any or all public health concerns such as pandemics;

●

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, climate change, health and safety and other laws and regulations of any jurisdiction on our operations;

●

our expectations for market acceptance of our new products;

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the potential for our marketed products to be withdrawn due to recalls, patient adverse events or deaths;

●

our ability to establish and maintain intellectual property on our products and our ability to successfully defend these in cases of infringement;

●

the implementation of our business strategies;

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the potential for exposure to product liability claims;

●

our financial performance expectations and interpretations thereof by securities analysts and investors;

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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; including carbon taxes;

●

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;

●

the loss of, or default by, one or more key customers or suppliers; and

●

unfavorable changes to the terms of key customer or supplier relationships.

●

pandemic-related uncertainties may potentially affect our financial position, operations, and cash flows. We are actively managing our response, but the extent of future impact remains uncertain.

Forward-looking statements are not guarantees of future performance and are subject to substantial risks and uncertainties that could cause the actual results to differ materially from those that we predicted in the forward-looking statements. Investors should carefully review the information contained under the caption “Risk Factors” contained in Item 1A for a description of risks and uncertainties that could cause actual results to differ from those that we predicted. All forward-looking statements are based on information available to us on the date hereof, and we assume no obligation to update forward-looking statements, except as required by Federal Securities laws.

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,
	2023		2022
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	42,777,158	$	57,960,864
Accounts receivable, net of allowance for doubtful accounts of $341,287 as of March 31, 2023, and $160,498 as of December 31, 2022		11,533,214		13,274,521
Inventory, net		6,312,265		5,369,233
Prepaid expenses and other current assets		675,748		630,960
Prepaid income taxes		—		254,093
Total current assets		61,298,385		77,489,671
Property and equipment, net		8,643,485		2,399,812
Intangible assets, net		2,205,287		2,069,439
Operating lease right-of-use asset		2,347,719		2,205,286
Deferred income taxes, net		622,206		700,867
Other assets		502,953		648,672
Total assets	$	75,620,035	$	85,513,747
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,756,177	$	1,799,316
Accrued payroll and benefits		1,616,636		2,871,890
Other accrued taxes		58,587		121,919
Warranty reserve		101,018		94,030
Deferred revenue		2,071,016		3,373,122
Current portion of operating lease liabilities		409,295		293,466
Other current liabilities		250,000		—
Accrued income taxes		493,392		—
Total current liabilities		6,756,121		8,553,743
Deferred revenue		2,585,579		1,375,197
Operating lease liabilities, less current portion		1,938,424		1,911,820
Total liabilities		11,280,124		11,840,760
Stockholders’ equity:
Common stock; $0.0001 par value; 31,500,000 shares authorized; 12,594,576 shares issued and outstanding as of March 31, 2023, and 12,591,004 shares issued and outstanding as of December 31, 2022		1,259		1,259
Additional paid-in capital		26,891,212		26,407,446
Retained earnings		37,447,440		47,264,282
Total stockholders’ equity		64,339,911		73,672,987
Total liabilities and stockholders’ equity	$	75,620,035	$	85,513,747

See accompanying notes to unaudited condensed financial statements.

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IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)


	For the Three Months Ended
	March 31,
	2023		2022
Revenue	$	15,475,083	$	12,310,710
Cost of revenue		3,753,635		2,931,186
Gross profit		11,721,448		9,379,524
Operating expenses:
General and administrative		3,920,510		2,715,950
Sales and marketing		2,999,976		3,069,556
Research and development		793,716		519,095
Total operating expenses		7,714,202		6,304,601
Income from operations		4,007,246		3,074,923
Other income (expense), net		342,409		(14,915)
Income before provision for income taxes		4,349,655		3,060,008
Provision for income tax expense		943,589		573,295
Net income	$	3,406,066	$	2,486,713
Net income per share:
Basic	$	0.27	$	0.20
Diluted	$	0.27	$	0.20
Weighted average shares outstanding:
Basic		12,593,033		12,552,817
Diluted		12,686,699		12,655,518

See accompanying notes to unaudited condensed financial statements.

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IRADIMED CORPORATION

CONDENSED STATEMENTS OF COMPREHENSIVE INCOME

(Unaudited)


	For the Three Months Ended
	March 31,
	2023		2022
Net income	$	3,406,066	$	2,486,713
Other comprehensive (loss) income:
Change in fair value of available-for-sale securities, net of tax expense (benefit) of $0 and $3,532, respectively		—		(10,885)
Other comprehensive loss		—		(10,885)
Comprehensive income	$	3,406,066	$	2,475,828

See accompanying notes to unaudited condensed financial statements.

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IRADIMED CORPORATION

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)


								Accumulated
				Additional				Other
	Common Stock			Paid-in		Retained		Comprehensive		Stockholders’
	Shares	Amount		Capital		Earnings		Income		Equity
Balances, December 31, 2022	12,591,004	$	1,259	$	26,407,446	$	47,264,282	$	—	$	73,672,987
Net income	—		—		—		3,406,066		—		3,406,066
Dividends paid ($1.05 per share)	—		—		—		(13,222,907)		—		(13,222,907)
Stock-based compensation expense	—		—		533,643		—		—		533,643
Net share settlement of restricted stock units	3,572		—		(49,878)		—		—		(49,878)
Balances, March 31, 2023	12,594,576	$	1,259	$	26,891,211	$	37,447,441	$	—	$	64,339,911

Accumulated

Additional

SEC Form 10-Q filed by iRadimed Corporation