Form 8-K IRADIMED CORP For: Jul 29

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): July 29, 2022

 

IRADIMED CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

 

 

(407) 677-8022

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

 

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

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On July 29, 2022, iRadimed Corporation issued a press release (the “Press Release”) announcing its financial results for the second quarter ended June 30, 2022. A copy of the Press Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Furthermore, such information, including Exhibit 99.1, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

 

(d) Exhibits

 

 

 

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 hereunto duly authorized.

 

 

IRADIMED CORPORATION Announces Second Quarter 2022 Financial Results

•	Reports second quarter 2022 revenue of $12.7 million, GAAP diluted EPS of $0.26 and non-GAAP diluted EPS of $0.26

•	Announces third quarter 2022 financial guidance

Winter Springs, Florida, July 29, 2022 – IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD), announced today its financial results for the three and six months ended June 30, 2022. The Company is a leader in the development of innovative magnetic resonance imaging (“MRI”) medical devices and the only known provider of a non-magnetic intravenous (“IV”) infusion pump system, and non-magnetic patient vital signs monitoring systems that are designed for use during MRI procedures.

“It is with great satisfaction that we announce our highest ever revenue quarter and the third consecutive quarter of record revenues. Further, orders booked in the quarter exceeded our shipments, providing a strong backlog as we enter the second half of 2022. These results demonstrate the strength of our business and the desirability of our products, as well as our ability to overcome supply chain issues facing most industries in these periods. We expect this strong uplifting trend to continue as we further penetrate our target market and scale our commercial capabilities,” said Roger Susi, President, Chief Executive Officer, and Chairman of the Company’s Board of Directors.

For the second quarter ended June 30, 2022, the Company reported revenue of $12.7 million compared to $9.8 million for the second quarter 2021. Net income was $3.2 million, or $0.26 per diluted share, compared to $1.5 million, or $0.12 per diluted share for the second quarter 2021. The increase in net income and diluted earnings per share is primarily the result of a $2.9 million increase in revenue for the second quarter 2022.

Non-GAAP net income was $3.3 million for the quarter ended June 30, 2022, which excludes $0.09 million of stock compensation expense, net of tax expense. Non-GAAP net income was $1.7 million for the quarter ended June 30, 2021, which excludes $0.3 million of stock compensation expense, net of tax expense.

For the six months ended June 30, 2022, the Company reported revenue of $25.0 million compared to $19.0 million for the same period in 2021. Net income was $5.7 million, or $0.45 per diluted share, compared to $2.9 million, or $0.23 per diluted share for the same period in 2021. The increase in net income and diluted earnings per share is primarily the result of a $6.0 million increase in revenue for the six months ended June 30, 2022.

Non-GAAP net income was $6.2 million for the six months ended June 30, 2022, which excludes $0.4 million of stock compensation expense, net of tax expense. Non-GAAP net income was $3.4 million for the six months ended June 30, 2021, which excludes $0.5 million of stock compensation expense, net of tax expense. Non-GAAP earnings per diluted share was $0.49 for the six months ended June 30, 2022, compared to $0.27 for the same period in 2021.

		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2022				2021				2022				2021
		(unaudited)								(unaudited)
Devices:
MRI compatible IV infusion pump system		$	3,853,016			$	2,456,767			$	7,134,955			$	5,960,114
MRI Compatible Patient Vital Signs Monitoring Systems			4,921,619				3,377,719				10,116,370				5,981,549
Total Devices revenue			8,774,635				5,834,486				17,251,325				11,941,663
Disposables, services and other			3,430,004				3,490,969				6,748,907				6,126,435
Amortization of extended warranty agreements			516,930				484,968				1,032,047				966,321
Total revenue		$	12,721,569			$	9,810,423			$	25,032,279			$	19,034,419

For the second quarter 2022, domestic sales were 85.0 percent of total revenue, compared to 82.0 percent for the first quarter 2021. Gross profit margin was 79.7 percent for the second quarter 2022, compared to 76.2 percent for the second quarter 2021.

For the six months ended June 30, 2022, domestic sales were 83.1 percent of total revenue, compared to 80.5 percent for the first quarter 2021. Gross profit margin was 78.0 percent for the second quarter 2022, compared to 75.6 percent for the second quarter 2021.

For the three months ended June 30, 2022, cash from operations was $1.6 million, compared to $3.6 million for the same period in 2021.

For the six months ended June 30, 2022, cash from operations was $3.1 million, compared to $4.5 million for the same period in 2021.

For the third quarter 2022, the Company expects to report revenue of $13.1 million to $13.3 million, GAAP diluted earnings per share of $0.21 to $0.24, and non-GAAP diluted earnings per share of $0.22 to $0.25.

As announced after the first quarter, the Company increased its full year 2022 financial guidance and expects to report revenue of $52.5 million to $53.2 million, GAAP diluted earnings per share of $0.89 to $0.95, and non-GAAP diluted earnings per share of $0.96 to $1.03. The Company previously expected revenue of $51.4 million to $52.2 million, GAAP diluted earnings per share of $0.82 to $0.90, and non- GAAP diluted earnings per share of $0.91 to $1.01.

The Company’s non-GAAP diluted earnings per share guidance excludes stock-based compensation expense, net of tax, which the Company expects to be approximately $0.3 million and $1.1 million for the third quarter 2022 and the full year, respectively.

Use of non-GAAP Financial Measures

The Company believes the use of non-GAAP net income, free cash flow and infrequent income tax items are helpful to our investors. These measures, which we refer to as our non-GAAP financial measures, are not prepared in accordance with U.S. GAAP.

We calculate non-GAAP net income as net income excluding (1) stock-based compensation expense, net of tax. Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact a company’s non-cash expenses, we believe that providing non-GAAP financial measures that exclude stock-based compensation expense allows for meaningful comparisons between our operating results from period to period; (2) operating expenses, net of tax, that we believe are not indicative of the Company’s on-going core operating performance, and; (3) infrequent tax items are considered based on their nature and are excluded from the provision for income taxes as these costs or benefits are not indicative of our normal or future provision for income taxes. We calculate free cash flow as net cash provided by operating activities, less net cash used in investing activities for purchases of property and equipment.

We consider free cash flow to be a liquidity measure that provides useful information to management and investors about the amount of cash generated by our business that can be used for strategic opportunities, including investing in our business, making strategic acquisitions, strengthening our balance sheet and returning cash to our shareholders through various means.

All of our non-GAAP financial measures are important tools for financial and operational decision making and for evaluating our on-going core operating results.

A reconciliation of the non-GAAP financial measures used in this release to the most comparable U.S. GAAP measures for the respective periods can be found in the table later in this release immediately following the condensed statements of cash flows. These non-GAAP financial measures should not be considered in isolation or as a substitute for a measure of the Company’s operating performance or liquidity prepared in accordance with U.S. GAAP and are not indicative of net income or cash provided by operating activities.

Conference Call

The conference call will also be available real-time via the internet at https://edge.media-server.com/mmc/p/3y35zjak. A recording of the call will be available on the Company’s website following the completion of the call.

We are the only known provider of a non-magnetic intravenous (“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.

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 ECG with dynamic gradient filtering; wireless SpO2 using Masimo® algorithms; non-magnetic respiratory 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.

For more information please visit www.iradimed.com.

Forward-Looking Statements

This press release contains forward-looking statements (i.e., statements which are not historical facts). Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date that they are made, and which reflect management's current estimates, projections, expectations or beliefs and which involve risks and uncertainties that could cause actual results and outcomes to be materially different. Risks and uncertainties that may affect the future results of the company include, but are not limited to, impacts of the COVID-19 pandemic, including the impact of existing and new variants, and measures taken in response; potential disruptions in our limited supply chain for our products; the Company’s ability to receive FDA 510(k) clearance for new products and product candidates; unexpected costs, delays or diversion of management’s attention associated with the design, manufacture or sale of new products; the Company’s ability to implement successful sales techniques for existing and future products and evaluate the effectiveness of its sales techniques; additional actions, warnings or requests from the FDA or other regulatory bodies; our significant reliance on a limited number of products; a reduction in international distribution; actions of the FDA or other regulatory bodies that could delay, limit or suspend product development, manufacturing or sales; the effect of recalls, patient adverse events or deaths on our business; difficulties or delays in the development, production, manufacturing and marketing of new or existing products and services; changes in laws and regulations or in the interpretation or application of laws or regulations. Further information on these and other factors that could affect the Company’s financial results is included in filings we make with the Securities and Exchange Commission from time to time. 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.

CONDENSED BALANCE SHEETS

		June 30, 2022				December 31, 2021
		(unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	52,157,539			$	61,999,550
Investments			—				501,855
Accounts receivable, net			8,382,237				5,136,599
Inventory, net			4,857,181				4,299,799
Prepaid expenses and other current assets			802,466				1,000,716
Prepaid income taxes			2,295,548				3,306,438
Total current assets			68,494,972				76,244,957
Property and equipment, net			2,235,636				2,069,376
Intangible assets, net			1,543,132				1,118,584
Operating lease right-of-use asset			2,345,851				2,482,084
Deferred income taxes, net			902,912				765,096
Other assets			201,334				201,325
Total assets		$	75,723,837			$	82,881,422
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	822,118			$	782,903
Accrued payroll and benefits			2,269,167				2,814,560
Other accrued taxes			235,370				140,315
Warranty reserve			100,769				108,880
Deferred revenue			2,287,144				2,553,096
Current portion of operating lease liability			284,891				276,568
Other current liability			138,441				146,435
Total current liabilities			6,137,900				6,822,757
Deferred revenue			1,626,339				1,679,343
Operating lease liability			2,060,960				2,205,516
Total liabilities			9,825,199				10,707,616
Stockholders’ equity:
Common stock			1,256				1,254
Additional paid-in capital			25,733,821				25,160,618
Retained earnings			40,163,560				46,994,922
Accumulated other comprehensive income			—				17,012
Total stockholders’ equity			65,898,638				72,173,806
Total liabilities and stockholders’ equity		$	75,723,837			$	82,881,422

		Three Months Ended June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
Revenue		$	12,721,569			$	9,810,423			$	25,032,279			$	19,034,419
Cost of revenue			2,581,806				2,478,122				5,512,992				4,639,802
Gross profit			10,139,763				7,332,301				19,519,287				14,394,617
Operating expenses:
General and administrative			2,402,795				2,564,619				5,118,746				4,994,988
Sales and marketing			2,907,788				2,469,777				5,977,344				4,848,901
Research and development			662,599				453,679				1,181,694				929,496
Total operating expenses			5,973,182				5,488,075				12,277,784				10,773,385
Income from operations			4,166,581				1,844,226				7,241,504				3,621,232
Other income (loss), net			13,102				13,195				(1,812	)			7,532
Income before provision for income taxes			4,179,683				1,857,421				7,239,692				3,628,764
Provision for income tax expense			938,631				387,727				1,511,926				772,221
Net income		$	3,241,052			$	1,469,694			$	5,727,766			$	2,856,543
Net income per share:
Basic		$	0.26			$	0.12			$	0.46			$	0.23
Diluted		$	0.26			$	0.12			$	0.45			$	0.23
Weighted average shares outstanding:
Basic			12,560,812				12,313,563				12,556,837				12,312,078
Diluted			12,632,755				12,554,828				12,641,424				12,539,483

IRADIMED CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

IRADIMED CORPORATION

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES (UNAUDITED)

Non-GAAP Net Income and Diluted EPS

Free Cash Flow

		Three Months Ended June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
Net cash provided by operating activities		$	1,639,218			$	3,570,691			$	3,065,405			$	4,513,772
Less:
Purchases of property and equipment			188,583				108,225				371,935				240,543
Free cash flow		$	1,450,635			$	3,462,466			$	2,693,470			$	4,273,229

Media Contact:

John “Jack” Glenn Chief Financial Officer

iRadimed Corporation

(407) 677-8022