EX-99.1 2 tm2131304d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

IRADIMED CORPORATION Announces Third Quarter 2021 Financial Results

 

·Reports third quarter 2021 revenue of $10.9 million, GAAP diluted EPS of $0.20 and non-GAAP diluted EPS of $0.23

 

·Increases full-year 2021 financial guidance

 

Winter Springs, Florida, October 29, 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 and nine months ended September 30, 2021.

 

“I am pleased with these financial results and continue to be proud of our performance and resiliency in an everchanging environment marked by the continued uncertainties of COVID. With these financial results, we are on pace to post approximately 8 percent revenue growth over the pre-COVID 2019 year as well as achieve the highest full-year revenue in Iradimed’s history,” said Roger Susi, President and Chief Executive Officer of the Company.

 

Three Months Ended September 30, 2021

 

For the third quarter ended September 30, 2021, the Company reported revenue of $10.9 million compared to $7.7 million for the third quarter 2020. Net income was $2.6 million, or $0.20 per diluted share, compared to $1.1 million, or $0.09 per diluted share for the third quarter 2020. The increase in net income and diluted earnings per share is primarily the result of a $3.2 million increase in revenue for the third quarter 2021.

 

Non-GAAP net income was $2.8 million, or $0.23 per diluted share, for the quarter ended September 30, 2021, and excludes $0.3 million of stock compensation expense, net of tax expense. Non-GAAP net income for the quarter ended September 30, 2020 was $1.4 million, or $0.11 per diluted share, and excludes $0.3 million of stock compensation expense, net of tax.

 

Nine Months Ended September 30, 2021

 

For the nine months ended September 30, 2021, the Company reported revenue of $29.9 million compared to $23.2 million for the same period in 2020. Net income was $5.4 million, or $0.43 per diluted share, compared to $0.7 million, or $0.06 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 $6.8 million increase in revenue and a $2.8 million decrease in general and administrative expenses, partially offset by a $3.3 million increase in income tax expense for the nine months ended September 30, 2021. During the nine months ended September 30, 2020, the Company recognized total general and administrative expense of $3.2 million related to our former CEO.

 

Non-GAAP net income was $6.2 million, or $0.50 per diluted share, for the nine months ended September 30, 2021, and excludes $0.8 million of stock compensation expense, net of tax expense. Non-GAAP net income for the nine months ended September 30, 2020 was $4.2 million, or $0.33 per diluted share, which excludes $1.1 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
September 30,
   Nine Months Ended
September 30,
 
   2021   2020   2021   2020 
                 
   (unaudited)   (unaudited) 
Devices:                    
MRI compatible IV infusion pump system  $3,369,068   $2,153,699   $9,329,182   $6,693,692 
MRI Compatible Patient Vital Signs Monitoring
Systems
   3,779,442    2,282,943    9,760,991    6,829,932 
Total Devices revenue   7,148,510    4,436,642    19,090,173    13,523,624 
Disposables, services and other   3,285,656    2,802,039    9,412,091    8,269,487 
Amortization of extended warranty agreements   473,136    460,415    1,439,457    1,378,218 
Total revenue  $10,907,302   $7,699,096   $29,941,721   $23,171,329 

 

For the third quarter 2021, domestic sales were 79.5 percent of total revenue, compared to 84.0 percent for the third quarter 2020. Gross profit margin was 77.1 percent for the third quarter 2021, compared to 74.6 percent for the third quarter 2020.

 

For the nine months ended September 30, 2021, domestic sales were 80.1 percent of total revenue, compared to 75.2 percent for the same period in 2020. Gross profit margin was 76.1 percent for the nine months ended September 30, 2021, compared to 73.9 percent for the same period in 2020.

 

Cash Flow:

 

For the nine months ended September 30, 2021, cash from operations was $7.9 million, compared to $3.3 million for the same period in 2020.

 

For the third quarter ended September 30, 2021, free cash flow was $3.2 million, compared to $1.3 million for the third quarter 2020. For the nine months ended September 30, 2021, free cash flow was $7.5 million, compared to $3.0 million for the same period in 2020.

 

Financial Guidance

 

For the fourth quarter 2021, the Company expects to report revenue of $11.5 million to $11.7 million, GAAP diluted earnings per share of $0.17 to $0.18, and non-GAAP diluted earnings per share of $0.20 to $0.21.

 

The Company increased its full-year financial guidance, and now expects to report revenue of $41.4 million to $41.6 million, GAAP diluted earnings per share of $0.60 to $0.61, and non-GAAP diluted earnings per share of $0.70 to $0.71. The Company’s previously expected full-year 2021 revenue was $40.0 million to $40.4 million, GAAP diluted earnings per share of $0.53 to $0.55, and non-GAAP diluted earnings per share of $0.60 to $0.62.

 

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 and full year 2021, 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, October 29, 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 1675895.

 

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

 

   September 30,
2021
   December 31,
2020
 
    (unaudited)      
ASSETS          
Current assets:          
Cash and cash equivalents   $58,371,572   $50,068,728 
Investments    945,066    1,909,368 
Accounts receivable, net    4,253,647    4,574,932 
Inventory, net    4,433,389    3,933,987 
Prepaid expenses and other current assets    685,449    771,666 
Prepaid income taxes    2,899,939    2,477,211 
Total current assets    71,589,062    63,735,892 
Property and equipment, net    2,110,377    2,120,148 
Intangible assets, net    1,054,641    960,885 
Operating lease right-of-use asset    2,548,702    2,715,030 
Deferred income taxes, net    870,028    1,272,672 
Other assets    225,749    261,993 
Total assets   $78,398,559   $71,066,620 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable   $842,660   $657,054 
Accrued payroll and benefits    2,413,986    1,714,782 
Other accrued taxes    91,254    103,981 
Warranty reserve    111,007    90,054 
Deferred revenue    2,442,430    1,949,259 
Current portion of operating lease liability    272,498    255,698 
Other current liabilities    146,435    146,435 
Total current liabilities    6,320,270    4,917,263 
Deferred revenue    1,910,668    2,305,413 
Operating lease liability    2,276,204    2,459,332 
Total liabilities    10,507,142    9,682,008 
Stockholders’ equity:          
Common stock    1,234    1,231 
Additional paid-in capital    24,766,697    23,676,843 
Retained earnings    43,102,255    37,669,451 
Accumulated other comprehensive income    21,231    37,087 
Total stockholders’ equity    67,891,417    61,384,612 
Total liabilities and stockholders’ equity   $78,398,559   $71,066,620 

 

 

 

 

IRADIMED CORPORATION 

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2021   2020   2021   2020 
Revenue   $10,907,302   $7,699,096   $29,941,721   $23,171,329 
Cost of revenue    2,501,745    1,958,036    7,141,547    6,036,353 
Gross profit    8,405,557    5,741,060    22,800,174    17,134,976 
Operating expenses:                    
General and administrative    2,252,274    2,196,935    7,247,262    10,062,089 
Sales and marketing    2,585,702    2,282,491    7,434,603    7,090,192 
Research and development    480,696    476,876    1,410,192    1,389,812 
Total operating expenses    5,318,672    4,956,302    16,092,057    18,542,093 
Income (loss) from operations    3,086,885    784,758    6,708,117    (1,407,117)
Other income, net    7,143    9,352    14,675    125,706 
Income (loss) before provision for income taxes    3,094,028    794,110    6,722,792    (1,281,411)
Provision for income tax expense (benefit)    517,767    (280,536)   1,289,988    (2,012,998)
Net income   $2,576,261   $1,074,646   $5,432,804   $731,587 
Net income per share:                    
Basic   $0.21   $0.09   $0.44   $0.06 
Diluted   $0.20   $0.09   $0.43   $0.06 
Weighted average shares outstanding:                    
Basic    12,331,062    12,243,362    12,318,476    12,071,027 
Diluted    12,603,566    12,493,309    12,570,925    12,414,932 

 

 

 

 

 

IRADIMED CORPORATION 

CONDENSED STATEMENTS OF CASH FLOWS 

(Unaudited)

 

   Nine Months Ended
September 30,
 
   2021   2020 
Operating activities:          
Net income   $5,432,804   $731,587 

Adjustments to reconcile net income to net cash provided by operating

activities:

          
Change in allowance for doubtful accounts    (567)   41,786 
Change in provision for excess and obsolete inventory    51,731    29,209 
Depreciation and amortization    1,020,223    999,812 
Loss on disposal of property and equipment    1,066     
Stock-based compensation    1,067,589    3,644,115 
Deferred income taxes, net    414,095    310,329 
Gain on maturities of investments    (13,005)   (8,861)
Changes in operating assets and liabilities:          
Accounts receivable    321,852    2,999,188 
Inventory    (344,721)   (1,062,455)
Prepaid expenses and other current assets    (663,408)   (642,982)
Other assets    23,447    (40,899)
Accounts payable    (17,076)   (468,615)
Accrued payroll and benefits    699,204    (523,437)
Other accrued taxes    (12,727)   (473,380)
Warranty reserve    20,953    5,298 
Deferred revenue    313,381    119,658 
Prepaid income taxes    (422,728)   (2,335,105)
Other        (3,820)
Net cash provided by operating activities    7,892,113    3,321,428 
Investing activities:          
Proceeds from maturities of investments    950,000    480,000 
Purchases of property and equipment    (391,303)   (349,283)
Capitalized intangible assets    (170,234)   (184,281)
Net cash provided by (used in) investing activities    388,463    (53,564)
Financing activities:          
Proceeds from exercises of stock options    85,615    1,722,721 
Taxes paid related to net share settlement of equity awards    (63,347)   (922,747)
Net cash provided by financing activities    22,268    799,974 
Net increase in cash and cash equivalents    8,302,844    4,067,838 
Cash and cash equivalents, beginning of period    50,068,728    43,481,781 
Cash and cash equivalents, end of period   $58,371,572   $47,549,619 

 

 

 

 

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,
 
   2021   2020   2021   2020 
Net income   $2,576,261   $1,074,646   $5,432,804   $731,587 
Excluding:                    
Stock-based compensation expense, net of tax expense    273,175    315,507    805,998    1,070,897 
Separation expenses, net of tax1                2,353,964 
Non-GAAP net income   $2,849,436   $1,390,153   $6,238,802   $4,156,448 
Weighted-average shares outstanding – diluted    12,603,566    12,493,309    12,570,925    12,414,932 
Non-GAAP net income per share – diluted   $0.23   $0.11   $0.50   $0.33 

 

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.

 

Free Cash Flow

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2021   2020   2021   2020 
Net cash provided by operating activities   $3,378,341   $1,334,197   $7,892,113   $3,321,428 
Less:                    
Purchases of property and equipment    150,760    48,725    391,303    349,283 
Free cash flow   $3,227,581   $1,285,472   $7,500,810   $2,972,145 

 

Media Contact: 

Chris Scott 

Chief Financial and Operating Officer 

iRadimed Corporation 

(407) 677-8022 

InvestorRelations@iradimed.com