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): November 3, 2022
IRADIMED CORPORATION
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
001-36534
 
73-1408526
(Commission File Number)
 
(IRS Employer Identification No.)
 
1025 Willa Springs Dr., Winter Springs,FL
 
32708
(Address of principal executive offices)
 
(Zip Code)
(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:
  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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:

Title of each class:
 
Trading Symbol
 
Name of each exchange on which registered:
Common stock, par value $0.0001
 
IRMD
 
NASDAQ Capital Market


Item 2.02 Results of Operations and Financial Condition.

On November 3, 2022, iRadimed Corporation issued a press release (the “Press Release”) announcing its financial results for the third quarter ended September 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.
Description
104
Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

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 hereunto duly authorized.

 
IRADIMED CORPORATION
 
 
 
Date: November 3, 2022
 
 
 
By:
/s/ John Glenn
  Name:
John Glenn
  Title:
Chief Financial Officer
 



EXHIBIT 99.1



IRADIMED CORPORATION Announces Third Quarter 2022 Financial Results
Revenue was $13.4 million and increased by 23%
Operating income was $4.1 million and increased by 32%
GAAP diluted EPS was $0.27 and increased by 35%
Announces fourth quarter 2022 financial guidance

Winter Springs, Florida, November 3, 2022 – IRADIMED CORPORATION (the "Company") (NASDAQ: IRMD) announced today its financial results for the three and nine months ended September 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 designed for use during MRI procedures.

"This quarter's results demonstrate Iradimed's continued ability to execute revenue growth and profitability. I am very pleased to point out that our impressive year-over-year quarterly revenue growth of 23% resulted in a 35% growth rate in quarterly diluted earnings per share compared to the previous year. In addition, operating cash flow was a solid $3.9 million in the quarter. We continue to see significant demand for our IV pump and patient monitor product lines, as bookings in the quarter again exceeded revenues, with strong bookings growth continuing to add to our extensive backlog as we enter the fourth quarter. With a great backlog and strong balance sheet, we are well-positioned to profitably grow our revenues for the remainder of 2022 and 2023," said Roger Susi, President, Chief Executive Officer, and Chairman of the Company's Board of Directors. “I am also excited to report that we have entered into an agreement to purchase approximately 27 acres of land in Orlando, Florida. This property will be developed, tripling our current space, and serve as our future headquarters for manufacturing and office space, accommodating our anticipated growth,” added Mr. Susi.

Three Months Ended September 30, 2022

For the third quarter that ended September 30, 2022, the Company reported revenue of $13.4 million compared to $10.9 million for the third quarter of 2021. Net income was $3.4 million, or $0.27 per diluted share, compared to $2.6 million, or $0.20 per diluted share, for the third quarter of 2021. The increase in net income and diluted earnings per share is primarily the result of a $2.5 million increase in revenue for the third quarter of 2022.

Non-GAAP net income was $3.7 million for the quarter that ended September 30, 2022, which excludes $0.3 million of stock compensation expense, net of tax expense. Non-GAAP net income was $2.8 million for the quarter that ended September 30, 2021, which excludes $0.3 million of stock compensation expense, net of tax expense.

Nine Months Ended September 30, 2022

For the nine months that ended September 30, 2022, the Company reported revenue of $38.4 million compared to $30.0 million for the same period in 2021. Net income was $9.1 million, or $0.72 per diluted share, compared to $5.4 million, or $0.43 per diluted share, for the same period in 2021. The increase in net income and diluted earnings per share is primarily the result of an $8.5 million increase in revenue for the nine months ended September 30, 2022.


Non-GAAP net income was $9.9 million for the nine months ended September 30, 2022, which excludes $0.7 million of stock compensation expense, net of tax expense. Non-GAAP net income was $6.2 million for the nine months ended September 30, 2021, which excludes $0.8 million of stock compensation expense, net of tax expense. Non-GAAP earnings per diluted share were $0.78 for the nine months ended September 30, 2022, compared to $0.50 for the same period in 2021.

Revenue Information:

   
Three Months Ended
   
Nine Months Ended
   
September 30,
   
September 30,
   
2022
   
2021
   
2022
   
2021
Devices:
                     
MRI Compatible IV Infusion Pump Systems
 
$
3,866,535
   
$
3,369,068
   
$
11,001,490
   
$
9,329,182
MRI Compatible Patient Vital Signs Monitoring
   
5,519,045
     
3,779,442
     
15,635,415
     
9,760,991
Systems
                             
Ferro Magnetic Detection Systems
   
62,982
     
-
     
62,982
     
-
Total Devices revenues
   
9,448,562
     
7,148,510
     
26,699,887
     
19,090,173
Disposables, services and others
   
3,410,015
     
3,285,656
     
10,158,922
     
9,412,091
Amortization of extended warranty agreementss
   
548,695
     
473,136
     
1,580,742
     
1,439,457
Total revenues
 
$
13,407,272
   
$
10,907,302
   
$
38,439,551
   
$
29,941,721

For the third quarter of 2022, domestic sales were 80.6 percent of total revenue, compared to 79.6 percent for the third quarter of 2021. The gross profit margin was 78.6 percent for the third quarter of 2022, compared to 77.1 percent for the third quarter of 2021.

For the nine months that ended September 30, 2022, domestic sales were 82.2 percent of total revenue, compared to 80.1 percent for the third quarter of 2021. The gross profit margin was 78.2 percent for the third quarter of 2022, compared to 76.1 percent for the third quarter of 2021.

Cash Flow:

For the three months ended September 30, 2022, cash from operations was $3.9 million, compared to $3.4 million for the same period in 2021.

For the nine months ended September 30, 2022, cash from operations was $7.0 million, compared to $7.9 million for the same period in 2021.

Financial Guidance:

For the fourth quarter of 2022, the Company's prior revenue guidance remains unchanged as it expects to report revenue of $14.1 million to $14.8 million and full-year revenue of $52.5 million to $53.2 million.

For the fourth quarter of 2022, the Company expects to report GAAP diluted earnings per share of $0.23 to $0.28 per share and non-GAAP diluted earnings per share of $0.25 to $0.30. These amounts would result in full-year GAAP diluted earnings per share of $0.95 to $1.00 and non-GAAP diluted earnings per share of $1.03 to $1.08.

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 fourth quarter of 2022 and the full year, respectively.

Use of non-GAAP Financial Measures

The Company believes using non-GAAP net income, free cash flow, and infrequent income tax items is 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 and 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.

Our non-GAAP financial measures are important tools for financial and operational decision-making and evaluating our ongoing 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

iRadimed has scheduled a conference call to discuss this announcement beginning at 11:00 a.m. Eastern Time on Thursday, November 3, 2022. Individuals interested in participating in the conference call may do so by registering here, https://register.vevent.com/register/BIcffe00ca21c54c31b6a2a7db74cb48ea.
Once registered, a dial-in number, unique pin, and instructions will be provided to the participant.

The conference call will also be available in real-time via the internet at http://www.iradimed.com/en-us/investors/events/. A recording of the call will be available on the Company's website following the completion of the call.

About IRADIMED CORPORATION

IRADIMED CORPORATION is a leader in the development of innovative Magnetic Resonance Imaging ("MRI") compatible medical devices. We develop, manufacture, market and distribute MRI-compatible medical devices and accessories, disposables, and services relating to them.

We are the only known provider of a non-magnetic intravenous ("IV") infusion pump system specifically designed to be safe 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.









IRADIMED CORPORATION
CONDENSED BALANCE SHEETS

   
September 30, 2022
   
December 31, 2021
 
   
(unaudited)
       
ASSETS
           
Current assets:
           
Cash and cash equivalents
 
$
55,592,152
   
$
61,999,550
 
Investments
   
-
     
501,855
 
Accounts receivable
   
10,651,264
     
5,136,599
 
Inventory
   
5,243,256
     
4,299,799
 
Prepaid expenses and other current assets
   
386,634
     
1,000,716
 
Prepaid income taxes
   
-
     
3,306,438
 
Total current assets
   
71,873,306
     
76,244,957
 
Property and equipment, net
   
2,292,516
     
2,069,376
 
Intangible assets, net
   
1,881,137
     
1,118,584
 
Operating lease right-of-use asset, net
   
2,276,089
     
2,482,084
 
Deferred tax asset
   
985,097
     
765,096
 
Other assets
   
236,188
     
201,325
 
Total assets
 
$
79,544,333
   
$
82,881,422
 
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current liabilities:
               
Accounts payable
 
$
964,360
   
$
782,903
 
Accrued payroll and benefits
   
2,349,772
     
2,814,560
 
Other accrued taxes
   
143,710
     
140,315
 
Warranty reserve
   
95,287
     
108,880
 
Deferred revenue
   
1,586,256
     
2,553,096
 
Current portion of operating lease liability
   
289,147
     
276,568
 
Other current liability
   
136,927
     
146,435
 
Accrued income taxes
   
38,167
     
-
 
Total current liabilities
   
5,603,626
     
6,822,757
 
Deferred revenue
   
2,182,494
     
1,679,343
 
Operating lease liability, less current portion
   
1,986,942
     
2,205,516
 
Total liabilities
   
9,773,062
     
10,707,616
 
Stockholders' equity:
               
Common Stock
   
1,256
     
1,254
 
Additional paid-in capital
   
26,179,351
     
25,160,618
 
Retained earnings
   
43,590,664
     
46,994,922
 
Accumulated other comprehensive income
   
-
     
17,012
 
Total stockholders' equity
   
69,771,271
     
72,173,806
 
Total liabilities and stockholders' equity
 
$
79,544,333
   
$
82,881,422
 


IRADIMED CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)

   
    Three Months Ended
September 30,
   
Nine Months Ended
September 30,  
 
                         
   
2022
   
2021
   
2022
   
2021
 
Revenue
 
$
13,407,272
   
$
10,907,302
   
$
38,439,551
   
$
29,941,721
 
Cost of revenue
   
2,864,534
     
2,501,745
     
8,377,526
     
7,141,547
 
Gross profit
   
10,542,738
     
8,405,557
     
30,062,025
     
22,800,174
 
Operating expenses:
                               
General and administrative
   
2,881,590
     
2,252,274
     
8,000,335
     
7,247,262
 
Sales and marketing
   
3,037,209
     
2,585,702
     
9,014,553
     
7,434,603
 
Research and development
   
491,643
     
480,696
     
1,673,337
     
1,410,192
 
Total operating expenses
   
6,410,442
     
5,318,672
     
18,688,225
     
16,092,057
 
Income from operations
   
4,132,296
     
3,086,885
     
11,373,800
     
6,708,117
 
Other income, net
   
105,183
     
7,143
     
103,371
     
14,675
 
Income before income taxes
   
4,237,479
     
3,094,028
     
11,477,171
     
6,722,792
 
Provision for income tax expense
   
810,375
     
517,767
     
2,322,301
     
1,289,988
 
Net income
 
$
3,427,104
   
$
2,576,261
   
$
9,154,870
   
$
5,432,804
 
                                 
Net income per share
                               
Basic
 
$
0.27
   
$
0.21
   
$
0.73
   
$
0.44
 
Diluted
 
$
0.27
   
$
0.20
   
$
0.72
   
$
0.43
 
Weighted average shares outstanding
                         
Basic
   
12,564,636
     
12,331,062
     
12,559,465
     
12,318,476
 
Diluted
   
12,631,129
     
12,603,566
     
12,637,325
     
12,570,925
 


IRADIMED CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)

   
Nine Months Ended
September 30,
 
   
2022
   
2021
 
Operating activities:
           
Net income
 
$
9,154,870
   
$
5,432,804
 
Adjustments to reconcile net income to net cash
               
provided by (used in) operating activities:
               
Change in allowance for doubtful accounts
   
56,118
     
(567
)
Change in provision for excess and obsolete inventory
   
29,227
     
51,731
 
Depreciation & amortization
   
1,363,578
     
1,020,223
 
(Gain) loss on PPE
   
(3,000
)
   
1,066
 
Stock-based compensation
   
967,551
     
1,067,589
 
Deferred income taxes, net
   
(227,133
)
   
414,095
 
(Gain) on maturities of securities
   
(8,025
)
   
(13,005
)
Accounts receivable
   
(5,570,783
)
   
321,852
 
Inventory
   
(903,792
)
   
(344,721
)
Prepaid expenses and other current assets
   
(306,031
)
   
(663,408
)
Other assets
   
6,660
     
23,447
 
Accounts payable
   
37,338
     
(17,076
)
Accrued payroll and benefits
   
(464,788
)
   
699,204
 
Other accrued taxes
   
3,395
     
(12,727
)
Warranty reserve
   
(13,593
)
   
20,953
 
Deferred revenue
   
(452,822
)
   
313,381
 
Other current liability
   
(9,508
)
   
-
 
Accrued (prepaid) income taxes
   
3,344,605
     
(422,728
)
Net cash provided by operating activities
   
7,003,867
     
7,892,113
 
                 
Investing activities:
               
Purchases of investments
   
-
     
-
 
Proceeds from maturity/sale of investments
   
500,000
     
950,000
 
Purchases of property and equipment
   
(564,883
)
   
(391,303
)
Capitalized intangible assets
   
(838,438
)
   
(170,234
)
Net cash (used in) provided by investing activities
   
(903,321
)
   
388,463
 
                 
Financing activities:
               
Dividends
   
(12,559,127
)
   
-
 
Proceeds from restricted stock exercises
   
146,707
     
85,615
 
Taxes paid for net share settlement of RSUs
   
(95,523
)
   
(63,347
)
Net cash (used in) provided by financing activities
   
(12,507,942
)
   
22,268
 
                 
Net (decrease) increase in cash and cash equivalents
   
(6,407,397
)
   
8,302,844
 
Cash and cash equivalents, beginning of period
   
61,999,550
     
50,068,728
 
Cash and cash equivalents, end of period
 
$
55,592,153
   
$
58,371,572
 


IRADIMED CORPORATION
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES (UNAUDITED)


Non-GAAP Net Income and Diluted EPS

   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
Net income
   
3,427,104
     
2,576,261
     
9,154,870
     
5,432,804
 
Excluding:
                               
Stock-based comp.exp., net of taxes
   
295,284
     
273,175
     
726,631
     
805,998
 
Non-GAAP net income
   
3,722,388
     
2,849,436
     
9,881,501
     
6,238,802
 
Weighted-average shares outstanding - diluted
   
12,631,129
     
12,603,566
     
12,637,325
     
12,570,925
 
Non-GAAP net income per share - diluted
   
0.29
     
0.23
     
0.78
     
0.50
 


Free Cash Flow

   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2022
   
2021
   
2022
   
2022
 
Net cash provided by operating activities
   
3,938,458
     
3,378,341
     
7,003,865
     
7,892,113
 
Less:
                               
Capital Expenditures
   
556,189
     
220,584
     
1,403,321
     
561,537
 
Free cash flow
   
3,382,269
     
3,157,757
     
5,600,544
     
7,330,576
 




Media Contact:
John Glenn
Chief Financial Officer
iRadimed Corporation
(407) 677-8022
[email protected]