0001104659-21-058142.txt : 20210430 0001104659-21-058142.hdr.sgml : 20210430 20210430070213 ACCESSION NUMBER: 0001104659-21-058142 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20210430 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210430 DATE AS OF CHANGE: 20210430 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: 21873684 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 tm2114537d1_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): April 30, 2021

 

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 April 30, 2021, iRadimed Corporation issued a press release (the “Press Release”) announcing its financial results for the first quarter ended March 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 April 30, 2021.
   
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: April 30, 2021  
   
  By: /s/Chris Scott
  Name: Chris Scott
  Title: Chief Financial Officer

 

   

 

EX-99.1 2 tm2114537d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

IRADIMED CORPORATION Announces First Quarter 2021 Financial Results

 

·Reports first quarter 2021 revenue of $9.2 million, GAAP diluted EPS of $0.11 and non-GAAP diluted EPS of $0.13

·Reports combined cash and investments of $52.7 million as of March 31, 2021

 

Winter Springs, Florida, April 30, 2021 – 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 ended March 31, 2021.

 

“First quarter bookings and revenue exceeded our internal expectations as we continue gaining greater access to our U.S. customers. Additionally, we were able to grow IV pump revenue nearly 32 percent over last year. Especially noteworthy is the 112 percent increase in income before taxes, indicating the true strength of this quarter. EPS was, by comparison, down due to tax benefits we harvested last year. Business strength was further validated by our ability to grow backlog from its already elevated levels at the end of last year. Overall, Iradimed has delivered a very good start to the year and I am very pleased with these results,” said Roger Susi, President and Chief Executive Officer of the Company.

 

For the first quarter ended March 31, 2021, the Company reported revenue of $9.2 million compared to $8.7 million for the first quarter 2020. Net income was $1.4 million, or $0.11 per diluted share, compared to $1.8 million, or $0.14 per diluted share for the first quarter 2020. The decrease in net income and diluted earnings per share is primarily the result of the recognition of $0.4 million of tax expense during the first quarter 2021, compared to a tax benefit of $(0.9) million recognized during the first quarter 2020.

 

Non-GAAP net income was $1.6 million for the quarter ended March 31, 2021, which excludes $0.3 million of stock compensation expense, net of tax expense. Non-GAAP net income for the quarter ended March 31, 2020 was $2.2 million, which excludes $0.4 million of stock compensation expense, net of tax expense. Non-GAAP earnings per diluted share was $0.13 for the first quarter 2021, compared to $0.18 for the first quarter 2020.

 

Revenue Information:

 

   Three Months Ended
March 31,
 
   2021   2020 
Devices:          
MRI compatible IV infusion pump system   $3,503,347   $2,664,834 
MRI compatible patient vital signs monitoring systems    2,603,830    2,888,703 
Total Devices revenue    6,107,177    5,553,537 
Disposables, services and other    2,635,466    2,662,713 
Amortization of extended warranty agreements    481,353    461,291 
Total revenue   $9,223,996   $8,677,541 

 

   

 

 

Domestic sales were 78.8 percent of total revenue, compared to 72.9 percent for the first quarter 2020. Gross profit margin was 76.6 percent for the first quarter 2021, compared to 74.5 percent for the first quarter 2020.

 

Cash Flow and Balance Sheet:

 

For the three months ended March 31, 2021, cash from operations was $0.9 million, compared to $1.2 million for the same period in 2020.

 

For the first quarter ended March 31, 2021, free cash flow was $0.8 million, compared to $1.0 million for the first quarter 2020.

 

As of March 31, 2021, the Company had combined cash and investments of $52.7 million.

 

Financial Guidance

 

Significant uncertainty remains regarding the impact of COVID-19 on the Company’s financial results. Accordingly, the Company believes it is prudent to refrain from providing financial guidance at this time. The Company continues to monitor the circumstances around the pandemic and will provide financial guidance once there is more certainty around the pandemic’s impact on its business.

 

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 via share repurchases.

 

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, April 30, 2021. 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 8386999.

 

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 forward-looking statements as defined in the Private Securities Litigation Act of 1995, particularly statements regarding our expectations, beliefs, plans, intentions, future operations, financial condition and prospects, and business strategies. These statements relate to future events or our future financial performance or condition and involve unknown risks, uncertainties and other factors that could cause our actual results, level of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. The risks and uncertainties referred to above include, but are not limited to, risks associated with the Company’s ability to receive an EC Certificate or CE Mark for our existing products and product candidates, 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; potential disruptions in our limited supply chain for our 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

 

   March 31,
2021
   December 31,
2020
 
   (unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents   $50,801,629   $50,068,728 
Accounts receivable, net    4,564,172    4,574,932 
Investments    1,902,940    1,909,368 
Inventory, net    4,640,556    3,933,987 
Prepaid expenses and other current assets    929,382    771,666 
Prepaid income taxes    2,373,828    2,477,211 
Total current assets    65,212,507    63,735,892 
Property and equipment, net    2,126,079    2,120,148 
Intangible assets, net    976,382    960,885 
Operating lease right-of-use asset    2,652,533    2,715,030 
Deferred income taxes, net    985,336    1,272,672 
Other assets    236,089    261,993 
Total assets   $72,188,926   $71,066,620 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable   $618,217   $657,054 
Accrued payroll and benefits    1,232,683    1,714,782 
Other accrued taxes    77,593    103,981 
Warranty reserve    96,448    90,054 
Deferred revenue    2,203,589    1,949,259 
Current portion of operating lease liability    259,553    255,698 
Other current liabilities    146,435    146,435 
Total current liabilities    4,634,518    4,917,263 
Deferred revenue    2,083,342    2,305,413 
Operating lease liability    2,392,980    2,459,332 
Total liabilities    9,110,840    9,682,008 
Stockholders’ equity:          
Common stock    1,231    1,231 
Additional paid-in capital    23,988,337    23,676,843 
Retained earnings    39,056,300    37,669,451 
Accumulated other comprehensive income    32,218    37,087 
Total stockholders’ equity    63,078,086    61,384,612 
Total liabilities and stockholders’ equity   $72,188,926   $71,066,620 

 

   

 

 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended
March 31,
 
   2021   2020 
Revenue   $9,223,996   $8,677,541 
Cost of revenue    2,161,680    2,213,730 
Gross profit    7,062,316    6,463,811 
Operating expenses:          
General and administrative    2,430,369    2,862,727 
Sales and marketing    2,379,124    2,433,567 
Research and development    475,817    430,282 
Total operating expenses    5,285,310    5,726,576 
Income from operations    1,777,006    737,235 
Other (expense) income, net    (5,663)   98,502 
Income before provision for income taxes    1,771,343    835,737 
Provision for income tax expense (benefit)    384,494    (933,474)
Net income   $1,386,849   $1,769,211 
           
Net income per share:          
Basic   $0.11   $0.15 
Diluted   $0.11   $0.14 
Weighted average shares outstanding:          
Basic    12,310,577    11,891,428 
Diluted    12,521,279    12,365,605 

 

   

 

 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Three Months Ended
March 31,
 
   2021   2020 
Operating activities:          
Net income   $1,386,849   $1,769,211 
Adjustments to reconcile net income to net cash provided by operating activities:          
Change in allowance for doubtful accounts    1,728    36,756 
Change in provision for excess and obsolete inventory    (1,992)   128,143 
Depreciation and amortization    331,794    344,784 
Stock-based compensation    347,741    568,958 
Deferred income taxes, net    288,895    (32,472)
Changes in operating assets and liabilities:          
Accounts receivable    9,032    1,404,704 
Inventory    (668,361)   (560,996)
Prepaid expenses and other current assets    (560,508)   (538,093)
Other assets    32,059    (60,614)
Accounts payable    (75,805)   (266,644)
Accrued payroll and benefits    (482,099)   (542,834)
Other accrued taxes    (26,388)   (469,750)
Warranty reserve    6,394    7,924 
Deferred revenue    250,359    308,559 
Prepaid income taxes    103,383    (901,001)
Net cash provided by operating activities    943,081    1,196,635 
Investing activities:          
Purchases of property and equipment    (132,318)   (166,593)
Capitalized intangible assets    (41,615)   (63,782)
Net cash used in investing activities    (173,933)   (230,375)
Financing activities:          
Proceeds from exercises of stock options    2,460    322,179 
Taxes paid related to net share settlement of equity awards    (38,707)   (133,872)
Net cash (used in) provided by financing activities    (36,247)   188,307 
Net increase in cash and cash equivalents    732,901    1,154,567 
Cash and cash equivalents, beginning of period    50,068,728    43,481,781 
Cash and cash equivalents, end of period   $50,801,629   $44,636,348 

 

   

 

 

IRADIMED CORPORATION

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES (UNAUDITED)

 

Non-GAAP Net Income and Diluted EPS

 

   Three Months Ended
March 31,
 
   2021   2020 
Net income   $1,386,849   $1,769,211 
Excluding:          
Stock-based compensation expense, net of tax expense    262,809    427,800 
Non-GAAP net income   $1,649,658   $2,197,011 
Weighted-average shares outstanding – diluted    12,521,279    12,365,605 
Non-GAAP net income per share – diluted   $0.13   $0.18 

 

Free Cash Flow

 

   Three Months Ended
March 31,
 
   2021   2020 
Net cash provided by operating activities   $943,081   $1,196,635 
Less:          
Purchases of property and equipment    132,318    166,593 
Free cash flow   $810,763   $1,030,042 

 

Media Contact:

Chris Scott

Chief Financial Officer

iRadimed Corporation

(407) 677-8022

InvestorRelations@iradimed.com

 

   

 

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Cover
Apr. 30, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Apr. 30, 2021
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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