0001104659-21-011916.txt : 20210204 0001104659-21-011916.hdr.sgml : 20210204 20210204070032 ACCESSION NUMBER: 0001104659-21-011916 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20210204 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210204 DATE AS OF CHANGE: 20210204 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: 21588813 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 tm215138d1_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, 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 February 4, 2021, iRadimed Corporation issued a press release (the “Press Release”) announcing its financial results for the fourth quarter ended December 31, 2020. 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, 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: February 4, 2021  
  By: /s/Chris Scott
  Name: Chris Scott
  Title: Chief Financial Officer

 

 

EX-99.1 2 tm215138d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

IRADIMED CORPORATION Announces Fourth Quarter 2020 Financial Results

 

·Reports fourth quarter 2020 revenue of $8.5 million, GAAP diluted EPS of $0.05 and non-GAAP diluted EPS of $0.07

 

·Reports combined cash and investments of $52.0 million as of December 31, 2020

 

Winter Springs, Florida, February 4, 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 and year ended December 31, 2020.

 

“On a sequential basis, revenue for the fourth quarter 2020 was up 11% over the third quarter. Additionally, bookings for the current quarter were within approximately 1.2% from the fourth quarter last year, which was our highest bookings quarter in our history. I view these as positive trends and expect they will continue into the new year. However, we remain cautious about the first half of 2021.” said Roger Susi, President and Chief Executive Officer of the Company.

 

“I would also like to thank everyone at Iradimed for remaining agile during a very challenging time. I am proud of the team and their efforts this year,” said Susi.

 

Three Months Ended December 31, 2020

 

For the fourth quarter ended December 31, 2020, the Company reported revenue of $8.5 million compared to $10.9 million for the fourth quarter 2019. Net income was $0.6 million, or $0.05 per diluted share, compared to $3.2 million, or $0.26 per diluted share for the fourth quarter 2019.

 

Non-GAAP net income was $0.9 million for the quarter ended December 31, 2020, which excludes $0.2 million of stock compensation expense, net of tax expense. Non-GAAP net income for the quarter ended December 31, 2019 was $3.7 million, which excludes $0.4 million of stock compensation expense, net of tax expense. Non-GAAP earnings per diluted share was $0.07 for the fourth quarter 2020, compared to $0.30 for the fourth quarter 2019.

 

Year Ended December 31, 2020

 

For the year ended December 31, 2020, the Company reported revenue of $31.7 million compared to $38.5 million for the same period in 2019. Net income was $1.4 million, or $0.11 per diluted share, compared to net income of $9.6 million, or $0.78 per diluted share for the same period in 2019.

 

During the year ended December 31, 2020, the Company recognized total general and administrative expense of $3.2 million related to our former CEO, of which $2.7 million relates to the separation costs.

 

 

 

  

Non-GAAP net income was $5.0 million for the year ended December 31, 2020, which excludes $1.3 million of on-going stock compensation expense, net of tax expense, and $2.4 million of expense, net of tax, related to the separation of our former CEO. Non-GAAP net income for the year ended December 31, 2019 was $10.5 million, which excludes $1.4 million of stock compensation expense, net of tax expense and a $0.6 million reduction to non-GAAP net income resulting from an infrequent tax item related to excess tax benefits recognized in the provision for income taxes for the exercise and sale of certain incentive stock options. Non-GAAP earnings per diluted share was $0.40 for the year ended December 31, 2020, compared to $0.85 for the same period in 2019.

 

Revenue Information:

 

   Three Months Ended
December 31,
   Years Ended
December 31,
 
   2020   2019   2020   2019 
                 
   (unaudited)   (unaudited) 
Devices:                
MRI Compatible IV Infusion Pump Systems   $2,667,237   $4,539,858   $9,360,929   $18,052,406 
MRI Compatible Patient Vital Signs Monitoring Systems    2,663,956    3,493,705    9,763,075    9,709,233 
Total Devices revenue    5,331,193    8,033,563    19,124,004    27,761,639 
Disposables, service and other    2,723,547    2,401,792    10,723,847    8,914,822 
Amortization of extended warranty agreements    491,303    455,298    1,869,521    1,840,680 
Total revenue   $8,546,043   $10,890,653   $31,717,372   $38,517,141 

 

For the fourth quarter 2020, domestic sales were 83.1 percent of total revenue, compared to 73.6 percent for the fourth quarter 2019. Gross profit margin was 75.3 percent for the fourth quarter 2020, compared to 74.8 percent for the fourth quarter 2019.

 

For the year ended December 31, 2020, domestic sales were 77.4 percent of total revenue, compared to 80.3 percent for the same period in 2019. Gross profit margin was 74.3 percent for the year ended December 31, 2020, compared to 77.1 percent for the same period in 2019.

 

Cash Flow and Balance Sheet:

 

For the year ended December 31, 2020, cash from operations was $5.8 million, compared to $10.2 million for the same period in 2019.

 

For the fourth quarter ended December 31, 2020, free cash flow was $2.4 million, compared to $3.8 million for the fourth quarter 2019. For the year ended December 31, 2020, free cash flow was $5.4 million, compared to $9.9 million for the same period in 2019.

 

As of December 31, 2020, the Company had combined cash and investments of $52.0 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, February 4, 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 5668209.

 

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

 

   December 31,
2020
   December 31,
2019
 
   (unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents   $50,068,728   $43,481,781 
Accounts receivable, net    4,574,932    7,293,303 
Investments    1,909,368    2,768,287 
Inventory, net    3,933,987    3,641,561 
Prepaid expenses and other current assets    771,666    407,802 
Prepaid income taxes    2,477,211    1,370,947 
Total current assets    63,735,892    58,963,681 
Property and equipment, net    2,120,148    2,053,806 
Intangible assets, net    960,885    860,087 
Operating lease right-of-use asset    2,715,030    2,955,873 
Deferred income taxes, net    1,272,672    1,663,415 
Other assets    261,993    232,002 
Total assets   $71,066,620   $66,728,864 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable   $657,054   $993,742 
Accrued payroll and benefits    1,714,782    2,166,209 
Other accrued taxes    103,981    596,576 
Warranty reserve    90,054    81,761 
Deferred revenue    1,949,259    1,671,420 
Current portion of operating lease liability    255,698    240,843 
Other current liabilities    146,435    108,421 
Total current liabilities    4,917,263    5,858,972 
Deferred revenue    2,305,413    2,630,467 
Operating lease liability    2,459,332    2,715,030 
Total liabilities    9,682,008    11,204,469 
Stockholders’ equity:          
Common stock    1,231    1,177 
Additional paid-in capital    23,676,843    19,192,394 
Retained earnings    37,669,451    36,300,450 
Accumulated other comprehensive income    37,087    30,374 
Total stockholders’ equity    61,384,612    55,524,395 
Total liabilities and stockholders’ equity   $71,066,620   $66,728,864 

  

 

 

 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended
December 31,
   Years Ended
December 31,
 
   2020   2019   2020   2019 
Revenue   $8,546,043   $10,890,653   $31,717,372   $38,517,141 
Cost of revenue    2,106,609    2,741,838    8,142,962    8,816,161 
Gross profit    6,439,434    8,148,815    23,574,410    29,700,980 
Operating expenses:                    
General and administrative    2,206,990    2,968,476    12,269,079    10,451,266 
Sales and marketing    3,068,700    2,562,113    10,158,892    9,169,590 
Research and development    512,718    379,310    1,902,530    1,432,719 
Total operating expenses    5,788,408    5,909,899    24,330,501    21,053,575 
Income (loss) from operations    651,026    2,238,916    (756,091)   8,647,405 
Other income, net    13,507    115,249    139,213    395,912 
Income (loss) before provision for income taxes    664,533    2,354,165    (616,878)   9,043,317 
Provision for income tax expense (benefit)    27,119    (887,518)   (1,985,879)   (587,642)
Net income   $637,414   $3,241,683   $1,369,001   $9,630,959 
                     
Net income per share:                    
Basic   $0.05   $0.28   $0.11   $0.85 
Diluted   $0.05   $0.26   $0.11   $0.78 
Weighted average shares outstanding:                    
Basic    12,279,999    11,559,526    12,123,556    11,282,214 
Diluted    12,514,348    12,345,968    12,440,086    12,276,444 

  

 

 

 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Years Ended
December 31,
 
   2020   2019 
Operating activities:          
Net income   $1,369,001   $9,630,959 
Adjustments to reconcile net income to net cash provided by operating activities:          
Change in allowance for doubtful accounts    27,884    31,338 
Change in provision for excess and obsolete inventory    (87,178)   48,114 
Depreciation and amortization    1,338,824    1,242,325 
Disposal of property and equipment    6,496     
Stock-based compensation    3,962,021    1,854,965 
Deferred income taxes, net    389,932    (596,755)
Gain on maturities of investments    (17,272)   (10,764)
Changes in operating assets and liabilities:          
Accounts receivable    2,690,487    (3,114,649)
Inventory    (282,904)   123,680 
Prepaid expenses and other current assets    (1,098,908)   (487,650)
Other assets    (65,187)   (171,002)
Accounts payable    (403,567)   149,319 
Accrued payroll and benefits    (451,427)   363,888 
Other accrued taxes    (492,595)   463,576 
Warranty reserve    8,293    7,237 
Deferred revenue    (12,202)   700,348 
Other current liabilities    38,014     
Prepaid income taxes    (1,106,264)   (3,055)
Other    4,048    859 
Net cash provided by operating activities    5,817,496    10,232,733 
Investing activities:          
Proceeds from maturities of investments    883,715    3,687,000 
Purchases of property and equipment    (443,003)   (368,281)
Capitalized intangible assets    (193,743)   (117,531)
Net cash provided by investing activities    246,969    3,201,188 
Financing activities:          
Proceeds from exercises of stock options    1,730,100    2,493,315 
Taxes paid related to net share settlement of equity awards    (1,207,618)   (473,143)
Net cash provided by financing activities    522,482    2,020,172 
Net increase in cash and cash equivalents    6,586,947    15,454,093 
Cash and cash equivalents, beginning of period    43,481,781    28,027,688 
Cash and cash equivalents, end of period   $50,068,728   $43,481,781 

  

 

 

 

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,
 
   2020   2019   2020   2019 
Net income   $637,414   $3,241,683   $1,369,001   $9,630,959 
Excluding:                    
Stock-based compensation expense, net of tax expense    240,261    412,443    1,308,734    1,394,748 
Separation expenses, net of tax1            2,353,964     
Infrequent tax item2                (564,810)
Non-GAAP net income   $877,675   $3,654,126   $5,031,699   $10,460,897 
Weighted-average shares outstanding – diluted    12,514,348    12,345,968    12,440,086    12,276,444 
Non-GAAP net income per share – diluted   $0.07   $0.30   $0.40   $0.85 

 

1Separation 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.
2The infrequent tax item is related to the excess tax benefits recognized in the provision for income taxes associated with the exercise and sale of certain incentive stock options.

 

Free Cash Flow

 

   Three Months Ended
December 31,
   Years Ended
December 31,
 
   2020   2019   2020   2019 
Net cash provided by operating activities   $2,496,068   $3,948,859   $5,817,496   $10,232,733 
Less:                    
Purchases of property and equipment    93,720    171,912    443,003    368,281 
Free cash flow   $2,402,348   $3,776,947   $5,374,493   $9,864,452 

  

Media Contact:

Chris Scott

Chief Financial Officer

iRadimed Corporation

(407) 677-8022

InvestorRelations@iradimed.com

 

 

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Cover
Feb. 04, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 04, 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
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