0001104659-22-011698.txt : 20220204 0001104659-22-011698.hdr.sgml : 20220204 20220204070020 ACCESSION NUMBER: 0001104659-22-011698 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220204 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220204 DATE AS OF CHANGE: 20220204 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IRADIMED CORP CENTRAL INDEX KEY: 0001325618 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 731408526 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36534 FILM NUMBER: 22590945 BUSINESS ADDRESS: STREET 1: 1025 WILLA SPRINGS DR. CITY: WINTER SPRINGS STATE: FL ZIP: 32708 BUSINESS PHONE: 4076778022 MAIL ADDRESS: STREET 1: 1025 WILLA SPRINGS DR. CITY: WINTER SPRINGS STATE: FL ZIP: 32708 8-K 1 tm225491d1_8k.htm FORM 8-K
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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): February 4, 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 2.02Results of Operations and Financial Condition.

 

On February 4, 2022, iRadimed Corporation issued a press release (the “Press Release”) announcing its financial results for the fourth quarter ended December 31, 2021. 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 9.01Financial Statements and Exhibits.

 

(d)       Exhibits

 

Exhibit No.   Description
99.1   Press release dated February 4, 2022.
     
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: February 4, 2022
  By: /s/Chris Scott
  Name:        Chris Scott
  Title:          Chief Financial and Operating Officer

 

 

EX-99.1 2 tm225491d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

IRADIMED CORPORATION Announces Fourth Quarter 2021 Financial Results

 

·Reports fourth quarter 2021 revenue of $11.9 million, GAAP diluted EPS of $0.31 and non-GAAP diluted EPS of $0.33
·Announces full-year and first quarter 2022 financial guidance

 

Winter Springs, Florida, February 4, 2022 – iRadimed Corporation (the “Company”) (NASDAQ: IRMD), 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, today announced financial results for the three months and year ended December 31, 2021.

 

“I am very happy to report these results. Fourth quarter revenue grew nearly 39% over the fourth quarter last year and was supported by record bookings that grew over 48% from the fourth quarter last year. For the full-year 2021, revenue grew nearly 32% over last year, with a 39% increase in bookings. We continue on the path of creating significant momentum in demand for our products and expect this to carry on through 2022,” said Roger Susi, President and Chief Executive Officer of the Company.

 

“Despite the supply chain and covid-related challenges we faced this year, our teams continued working diligently. I am proud of this organization for remaining focused on our mission and the important work we do every day,” said Susi.

 

Three Months Ended December 31, 2021

 

For the fourth quarter ended December 31, 2021, the Company reported revenue of $11.9 million compared to $8.5 million for the fourth quarter 2020. Net income was $3.9 million, or $0.31 per diluted share, compared to $0.6 million, or $0.05 per diluted share for the fourth quarter 2020. The increase in net income and diluted earnings per share is primarily the result of a $3.3 million increase in revenue and a $0.8 million tax benefit for the fourth quarter 2021.

 

Non-GAAP net income was $4.2 million, or $0.33 per diluted share, for the quarter ended December 31, 2021, and excludes $0.3 million of stock compensation expense, net of tax expense. Non-GAAP net income for the quarter ended December 31, 2020 was $0.9 million, or $0.07 per diluted share, and excludes $0.2 million of stock compensation expense, net of tax.

 

Year Ended December 31, 2021

 

For the year ended December 31, 2021, the Company reported revenue of $41.8 million compared to $31.7 million for the same period in 2020. Net income was $9.3 million, or $0.74 per diluted share, compared to $1.4 million, or $0.11 per diluted share for the same period in 2020. The increase in net income and diluted earnings per share is primarily the result of a $10.1 million increase in revenue and a $2.5 million decrease in general and administrative expenses, partially offset by a $2.5 million increase in income tax expense for the year ended December 31, 2021. During the year ended December 31, 2020, the Company recognized total general and administrative expense of $3.2 million related to our former CEO.

 

 

 

 

Non-GAAP net income was $10.4 million, or $0.83 per diluted share, for the year ended December 31, 2021, and excludes $1.1 million of stock compensation expense, net of tax expense. Non-GAAP net income for the year ended December 31, 2020 was $5.0 million, or $0.40 per diluted share, which excludes $1.3 million of on-going stock compensation expense, net of tax, and $2.4 million of expenses, net of tax, related to the separation of our former CEO.

 

Revenue Information:

 

   Three Months Ended   Years Ended 
   December 31,   December 31, 
   2021   2020   2021   2020 
   (unaudited)   (unaudited) 
Devices:                
MRI compatible IV infusion pump system  $3,959,882   $2,667,237   $13,289,064   $9,360,929 
MRI Compatible Patient Vital Signs Monitoring Systems   4,020,107    2,663,956    13,781,098    9,763,075 
Total Devices revenue   7,979,989    5,331,193    27,070,162    19,124,004 
Disposables, services and other   3,385,514    2,723,547    12,797,605    10,723,847 
Amortization of extended warranty agreements   507,357    491,303    1,946,814    1,869,521 
Total revenue  $11,872,860   $8,546,043   $41,814,581   $31,717,372 

 

For the fourth quarter 2021, domestic sales were 79.8 percent of total revenue, compared to 83.1 percent for the fourth quarter 2020. Gross profit margin was 77.9 percent for the fourth quarter 2021, compared to 75.3 percent for the fourth quarter 2020.

 

For the year ended December 31, 2021, domestic sales were 80.0 percent of total revenue, compared to 77.4 percent for the same period in 2020. Gross profit margin was 76.6 percent for the year ended December 31, 2021, compared to 74.3 percent for the same period in 2020.

 

Cash Flow:

 

For the year ended December 31, 2021, cash from operations was $11.3 million, compared to $5.8 million for the same period in 2020.

 

For the fourth quarter ended December 31, 2021, free cash flow was $3.3 million, compared to $2.4 million for the fourth quarter 2020. For the year ended December 31, 2021, free cash flow was $10.8 million, compared to $5.4 million for the same period in 2020.

 

Financial Guidance

 

For the full year 2022, the Company expects to report 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, which assumes a normalized tax rate.

 

For the first quarter 2022, the Company expects to report revenue of $12.1 million to $12.3 million, GAAP diluted earnings per share of $0.16 to $0.18, and non-GAAP diluted earnings per share of $0.20 to $0.21, which assumes a normalized tax rate.

 

 

 

 

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 $1.4 million and $0.3 million for the full year and first quarter 2022, 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

 

iRadimed has scheduled a conference call to discuss this announcement beginning at 11:00 a.m. Eastern Time today, February 4, 2022. Individuals interested in listening to the conference call may do so by dialing 1-844-413-1781 for domestic callers, or 1-716-247-5767 for international callers, and entering the reservation code 2899922.

 

The conference call will also be available 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 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 a preliminary financial outlook for the full year 2022 and other 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

 

   December 31,
2021
   December 31,
2020
 
   (unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $61,999,550   $50,068,728 
Investments   501,855    1,909,368 
Accounts receivable, net   5,136,599    4,574,932 
Inventory, net   4,299,799    3,933,987 
Prepaid expenses and other current assets   1,000,716    771,666 
Prepaid income taxes   3,306,438    2,477,211 
Total current assets   76,244,957    63,735,892 
Property and equipment, net   2,069,376    2,120,148 
Intangible assets, net   1,118,584    960,885 
Operating lease right-of-use asset   2,482,084    2,715,030 
Deferred income taxes, net   765,096    1,272,672 
Other assets   201,325    261,993 
Total assets  $82,881,422   $71,066,620 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $782,903   $657,054 
Accrued payroll and benefits   2,814,560    1,714,782 
Other accrued taxes   140,315    103,981 
Warranty reserve   108,880    90,054 
Deferred revenue   2,553,096    1,949,259 
Current portion of operating lease liability   276,568    255,698 
Other current liability   146,435    146,435 
Total current liabilities   6,822,757    4,917,263 
Deferred revenue   1,679,343    2,305,413 
Operating lease liability   2,205,516    2,459,332 
Total liabilities   10,707,616    9,682,008 
Stockholders’ equity:          
Common stock   1,254    1,231 
Additional paid-in capital   25,160,618    23,676,843 
Retained earnings   46,994,922    37,669,451 
Accumulated other comprehensive income   17,012    37,087 
Total stockholders’ equity   72,173,806    61,384,612 
Total liabilities and stockholders’ equity  $82,881,422   $71,066,620 

 

 

 

 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended
December 31,
   Years Ended
December 31,
 
   2021   2020   2021   2020 
Revenue   $11,872,860   $8,546,043   $41,814,581   $31,717,372 
Cost of revenue    2,623,109    2,106,609    9,764,656    8,142,962 
Gross profit    9,249,751    6,439,434    32,049,925    23,574,410 
Operating expenses:                    
General and administrative    2,524,200    2,206,990    9,771,462    12,269,079 
Sales and marketing    3,121,135    3,068,700    10,555,738    10,158,892 
Research and development    494,851    512,718    1,905,043    1,902,530 
Total operating expenses    6,140,186    5,788,408    22,232,243    24,330,501 
Income (loss) from operations    3,109,565    651,026    9,817,682    (756,091)
Other income, net    3,930    13,507    18,605    139,213 
Income (loss) before provision for income taxes    3,113,495    664,533    9,836,287    (616,878)
Provision for income tax (benefit) expense    (779,172)   27,119    510,816    (1,985,879)
Net income   $3,892,667   $637,414   $9,325,471   $1,369,001 
                     
Net income per share:                    
Basic   $0.31   $0.05   $0.76   $0.11 
Diluted   $0.31   $0.05   $0.74   $0.11 
Weighted average shares outstanding:                    
Basic    12,428,361    12,279,999    12,346,173    12,123,556 
Diluted    12,632,601    12,514,348    12,590,853    12,440,086 

 

 

 

 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Years Ended
December 31,
 
   2021   2020 
Operating activities:          
Net income   $9,325,471   $1,369,001 
Adjustments to reconcile net income to net cash provided by operating activities:          
Change in allowance for doubtful accounts    13,876    27,884 
Change in provision for excess and obsolete inventory    118,217    (87,178)
Depreciation and amortization    1,406,823    1,338,824 
Loss on disposal of property and equipment    5,544    6,496 
Stock-based compensation    1,459,373    3,962,021 
Deferred income taxes, net    523,607    389,932 
Gain on maturities of investments    (18,593)   (17,272)
Changes in operating assets and liabilities:          
Accounts receivable    (575,543)   2,690,487 
Inventory    (393,316)   (282,904)
Prepaid expenses and other current assets    (1,038,047)   (1,098,908)
Other assets    26,557    (65,187)
Accounts payable    30,414    (403,567)
Accrued payroll and benefits    1,099,778    (451,427)
Other accrued taxes    36,334    (492,595)
Warranty reserve    18,826    8,293 
Deferred revenue    48,062    (12,202)
Other current liability        38,014 
Prepaid income taxes    (829,227)   (1,106,264)
Other        4,048 
Net cash provided by operating activities    11,258,156    5,817,496 
Investing activities:          
Proceeds from maturities of investments    1,390,000    883,715 
Purchases of property and equipment    (482,325)   (443,003)
Capitalized intangible assets    (259,434)   (193,743)
Net cash provided by investing activities    648,241    246,969 
Financing activities:          
Proceeds from exercises of stock options    623,242    1,730,100 
Taxes paid related to net share settlement of equity awards    (598,817)   (1,207,618)
Net cash provided by financing activities    24,425    522,482 
Net increase in cash and cash equivalents    11,930,822    6,586,947 
Cash and cash equivalents, beginning of period    50,068,728    43,481,781 
Cash and cash equivalents, end of period   $61,999,550   $50,068,728 

 

 

 

 

IRADIMED CORPORATION

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES (UNAUDITED)

 

Non-GAAP Net Income and Diluted EPS

 

   Three Months Ended
December 31,
   Years Ended
December 31,
 
   2021   2020   2021   2020 
Net income   $3,892,667   $637,414   $9,325,471   $1,369,001 
Excluding:                    
Stock-based compensation expense, net of tax expense    295,785    240,261    1,101,783    1,308,734 
Separation expenses, net of tax1                2,353,964 
Non-GAAP net income   $4,188,452   $877,675   $10,427,254   $5,031,699 
Weighted-average shares outstanding – diluted    12,632,601    12,514,348    12,590,853    12,440,086 
Non-GAAP net income per share – diluted   $0.33   $0.07   $0.83   $0.40 

 

1 Separation expenses recognized pursuant to a separation agreement as described in Exhibit 10.1 to Form 8-K filed with the Securities and Exchange Commission on June 16, 2020.

 

Free Cash Flow

 

   Three Months Ended
December 31,
   Years Ended
December 31,
 
   2021   2020   2021   2020 
Net cash provided by operating activities   $3,366,043   $2,496,068   $11,258,156   $5,817,496 
Less:                    
Purchases of property and equipment    91,022    93,720    482,325    443,003 
Free cash flow   $3,275,021   $2,402,348   $10,775,831   $5,374,493 

 

Media Contact:

Chris Scott

Chief Financial and Operating Officer

iRadimed Corporation

(407) 677-8022

InvestorRelations@iradimed.com

 

 

 

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Cover
Feb. 04, 2022
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 04, 2022
Entity File Number 001-36534
Entity Registrant Name Iradimed Corporation
Entity Central Index Key 0001325618
Entity Tax Identification Number 73-1408526
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 1025 Willa Springs Dr.
Entity Address, City or Town Winter Springs
Entity Address, State or Province FL
Entity Address, Postal Zip Code 32708
City Area Code 407
Local Phone Number 677-8022
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, par value $0.0001
Trading Symbol IRMD
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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