0001104659-17-064466.txt : 20171030 0001104659-17-064466.hdr.sgml : 20171030 20171030083441 ACCESSION NUMBER: 0001104659-17-064466 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20171030 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20171030 DATE AS OF CHANGE: 20171030 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: 171160745 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 a17-24612_18k.htm 8-K

 

 

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): October 30, 2017

 

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 (see General Instruction A.2. below):

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o    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 x

 

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. x

 

 

 



 

Item 2.02              Results of Operations and Financial Condition.

 

On October 30, 2017, IRADIMED CORPORATION (the “Company”) issued a press release (the “Press Release”) announcing its financial results for the third quarter ended September 30, 2017. 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 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01              Financial Statements and Exhibits.

 

(d)           Exhibits

 

99.1

Press release dated October 30, 2017.

 

2



 

EXHIBIT INDEX

 

Exhibit No.

 

Document

 

 

 

99.1

 

Press release dated October 30, 2017.

 

3



 

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: October 30, 2017

 

 

 

 

 

 

By:

/s/Chris Scott

 

Name:

Chris Scott

 

Title:

Chief Financial Officer

 

4


EX-99.1 2 a17-24612_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

IRADIMED CORPORATION Announces Third Quarter 2017 Financial Results

 

·                  Reports third quarter 2017 revenue of $5.7 million

·                  Reports third quarter 2017 GAAP diluted EPS of $0.02 and non-GAAP diluted EPS of $0.07

·                  Increases full year 2017 non-GAAP diluted EPS guidance

 

Winter Springs, Florida, October 30, 2017 — IRADIMED CORPORATION (NASDAQ:IRMD), a leader in the development of innovative magnetic resonance imaging (MRI) medical devices and the only known provider of non-magnetic intravenous (IV) infusion pump systems that are designed to be safe for use during MRI procedures, today announced financial results for the three and nine months ended September 30, 2017.

 

For the third quarter ended September 30, 2017, the Company reported revenue of $5.7 million compared to $7.7 million for the third quarter 2016. Net income was $0.2 million, or $0.02 per diluted share, compared to net income of $1.6 million, or $0.13 per diluted share for the third quarter 2016. Gross profit margin was 77.0%, compared to 81.7% for the third quarter 2016. Domestic sales were 88.2% of total revenue, compared to 90.1% for the third quarter 2016. Revenue for the third quarter ended September 30, 2017 included $0.1 million in sales of our patient vital signs monitoring systems to international customers.

 

Non-GAAP net income was $0.8 million for the quarter ended September 30, 2017, compared to non-GAAP net income of $1.7 million for the third quarter 2016. Non-GAAP earnings per diluted share was $0.07, compared to $0.14 for the third quarter 2016. Free cash flow was $1.7 million, compared to $3.3 million for the third quarter 2016.

 

For the nine months ended September 30, 2017, the Company reported revenue of $16.4 million compared to $26.5 million for the same period in 2016. Net income was $0.3 million, or $0.03 per diluted share, compared to net income of $6.1 million, or $0.50 per diluted share for the same period in 2016. Gross profit margin was 76.0%, compared to 81.7% for the same period in 2016. Domestic sales were 86.6% of total revenue, compared to 89.7% for the same period in 2016. Revenue for the nine months ended September 30, 2017 included $0.8 million in sales of our patient vital signs monitoring systems to international customers.

 

Non-GAAP net income was $1.4 million for the nine months ended September 30, 2017, compared to non-GAAP net income of $7.1 million for the same period in 2016. Non-GAAP earnings per diluted share was $0.12 for the nine months ended September 30, 2017, compared to $0.59 for the same period in 2016. Free cash flow was $1.4 million for the nine months ended September 30, 2017, compared to $6.6 million for the same period in 2016.

 

As of September 30, 2017, the Company had cash, cash equivalents and investments of $25.2 million. During the nine months ended September 30, 2017, the Company repurchased $1.8 million of its common stock. We intend to retire the repurchased common stock prior to December 31, 2017.

 



 

“I am pleased with these results as third quarter revenue was slightly higher than our expectation and both GAAP and non-GAAP earnings came in well above our estimates. In what is typically our most challenging quarter, we were able to maintain the momentum in customer bookings that has been building throughout 2017. Based on these stronger than expected third quarter results, we are increasing our full year non-GAAP earnings guidance to $0.17 to $0.18 per share,” said Roger Susi, President and Chief Executive Officer of the Company.

 

“Additionally, as announced in our October 26th press release, we have received FDA 510(k) clearance for our new 3880 MRI compatible patient vital signs monitoring system. This is a very important step for Iradimed and a milestone in our history. We are anxious to begin shipping this device to our U.S. customers and satisfying their already existing demand for the monitor. We are also in the process of obtaining clearance for our MRI compatible patient monitor from other regulatory bodies worldwide as we look to penetrate other sizable markets with our new device,” said Susi.

 

Financial Guidance

 

For the fourth quarter 2017, the Company expects revenue of approximately $6.3 million to $6.7 million, GAAP diluted earnings per share of $0.00 to $0.02 and non-GAAP diluted earnings per share of $0.05 to $0.06.

 

The Company increased its full year 2017 non-GAAP diluted earnings per share guidance and now expects to report non-GAAP diluted earnings per share of $0.17 to $0.18, compared to its previous estimate of $0.10 to $0.13.

 

The Company’s non-GAAP earnings per share guidance excludes stock-based compensation expense, net of tax, which includes a one-time charge to earnings, net of tax, related to the modification of the underwriters’ warrants on July 17, 2017 as announced in an 8-K filed with the Securities and Exchange Commission on July 21, 2017. The Company expects stock-based compensation expense (including the one-time charge for the warrant modification), net of tax to be approximately $0.3 million and $1.5 million for the fourth quarter and full year 2017, 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 GAAP. We calculate non-GAAP net income as net income excluding 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. 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. 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. All of our non-GAAP financial measures are important tools for financial and operational decision making and for evaluating our 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 30, 2017. 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 1131798.

 

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 MRI compatible medical devices. We are the only known provider of non-magnetic intravenous (IV) infusion pump systems that are 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 in order 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 in order 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 in order to safely and accurately monitor a patient’s vital signs during various MRI procedures. The IRADIMED 3880 monitor is rated for operation 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, facilitating the transportation of patients 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; respiratory CO2; 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, small form factor and unique wireless tablet remote control that allows for the effective communication of patient vital signs information to clinicians located in the MRI control room. Our 3880 MRI compatible patient vital signs monitoring system is currently available to domestic and international customers.

 

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 FDA 510(k) clearance for new products; unexpected costs, delays or diversion of management’s attention associated with the design, manufacture or sale of new products; implement successful sales techniques for existing and future products; evaluate the effectiveness of its sales techniques; additional actions by or requests from the FDA; our significant reliance on a single product; unexpected costs, expenses and diversion of management attention resulting from the FDA warning letter; 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,
2017

 

December 31,
2016

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

18,406,305

 

$

17,713,871

 

Accounts receivable, net

 

3,508,432

 

3,775,699

 

Investments

 

6,804,783

 

7,965,521

 

Inventory, net

 

4,129,357

 

3,886,590

 

Prepaid expenses and other current assets

 

287,061

 

362,900

 

Prepaid income taxes

 

311,217

 

151,820

 

Total current assets

 

33,447,155

 

33,856,401

 

Property and equipment, net

 

1,853,506

 

1,456,149

 

Intangible assets, net

 

885,713

 

918,712

 

Deferred income taxes

 

1,553,469

 

789,402

 

Other assets

 

179,785

 

173,820

 

Total assets

 

$

37,919,628

 

$

37,194,484

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

794,446

 

$

1,120,830

 

Accrued payroll and benefits

 

1,438,417

 

1,035,266

 

Other accrued taxes

 

68,247

 

119,094

 

Warranty reserve

 

48,513

 

40,905

 

Deferred revenue

 

1,380,618

 

1,033,146

 

Other current liability

 

120,634

 

120,634

 

Accrued income taxes

 

 

192,006

 

Total current liabilities

 

3,850,875

 

3,661,881

 

Deferred revenue

 

1,928,347

 

1,643,478

 

Total liabilities

 

5,779,222

 

5,305,359

 

Stockholders’ equity:

 

 

 

 

 

Common stock

 

1,076

 

1,072

 

Additional paid-in capital

 

13,808,596

 

12,055,188

 

Retained earnings

 

20,171,907

 

19,869,714

 

Treasury stock

 

(1,818,542

)

 

Accumulated other comprehensive loss

 

(22,631

)

(36,849

)

Total stockholders’ equity

 

32,140,406

 

31,889,125

 

Total liabilities and stockholders’ equity

 

$

37,919,628

 

$

37,194,484

 

 



 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

Revenue

 

$

5,689,724

 

$

7,673,217

 

$

16,376,648

 

$

26,506,275

 

Cost of revenue

 

1,307,767

 

1,405,884

 

3,929,699

 

4,850,748

 

Gross profit

 

4,381,957

 

6,267,333

 

12,446,949

 

21,655,527

 

Operating expenses:

 

 

 

 

 

 

 

 

 

General and administrative

 

2,551,290

 

1,869,927

 

6,848,472

 

7,217,854

 

Sales and marketing

 

1,251,901

 

1,346,742

 

3,940,216

 

4,039,550

 

Research and development

 

382,704

 

457,134

 

1,373,005

 

983,291

 

Total operating expenses

 

4,185,895

 

3,673,803

 

12,161,693

 

12,240,695

 

Income from operations

 

196,062

 

2,593,530

 

285,256

 

9,414,832

 

Other income (expense), net

 

28,715

 

(4,017

)

79,377

 

23,092

 

Income before provision for income taxes

 

224,777

 

2,589,513

 

364,633

 

9,437,924

 

Provision for income tax expense

 

32,384

 

1,029,029

 

48,507

 

3,364,179

 

Net income

 

$

192,393

 

$

1,560,484

 

$

316,126

 

$

6,073,745

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.02

 

$

0.15

 

$

0.03

 

$

0.56

 

Diluted

 

$

0.02

 

$

0.13

 

$

0.03

 

$

0.50

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

10,565,598

 

10,684,650

 

10,664,132

 

10,852,476

 

Diluted

 

11,643,044

 

11,867,997

 

11,710,377

 

12,055,467

 

 



 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Nine Months Ended
September 30,

 

 

 

2017

 

2016

 

Operating activities:

 

 

 

 

 

Net income

 

$

316,126

 

$

6,073,745

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

Change in allowance for doubtful accounts

 

(9,557

)

19,100

 

Provision for excess and obsolete inventory

 

38,021

 

86,543

 

Depreciation and amortization

 

970,705

 

709,871

 

Write-off of non-trade accounts receivable

 

205,444

 

 

Excess tax benefit on the exercise of stock options

 

 

(550,431

)

Stock-based compensation

 

1,735,078

 

1,788,045

 

Loss on maturities of investments

 

6,757

 

80,542

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

71,380

 

(648,730

)

Inventory

 

(273,121

)

(1,170,928

)

Prepaid expenses and other current assets

 

(576,504

)

(622,454

)

Other assets

 

(6,714

)

(87,001

)

Deferred income taxes

 

(769,615

)

(638,467

)

Accounts payable

 

(334,051

)

(13,542

)

Accrued payroll and benefits

 

403,151

 

7,667

 

Other accrued taxes

 

(50,847

)

160,594

 

Warranty reserve

 

7,608

 

4,061

 

Deferred revenue

 

632,341

 

1,259,997

 

Other current liability

 

 

115,489

 

Accrued income taxes, net of prepaid income taxes

 

(351,403

)

608,526

 

Net cash provided by operating activities

 

2,014,799

 

7,182,627

 

 

 

 

 

 

 

Investing activities:

 

 

 

 

 

Purchases of investments

 

(1,321,257

)

(4,284,445

)

Proceeds from maturities of investments

 

2,495,004

 

4,075,103

 

Purchases of property and equipment

 

(653,171

)

(547,087

)

Capitalized intangible assets

 

(28,800

)

(588,228

)

Net cash provided by (used in) investing activities

 

491,776

 

(1,344,657

)

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

Proceeds from stock option exercises

 

49,460

 

217,015

 

Income tax benefit credited to equity

 

 

550,431

 

Taxes paid related to net share settlement of equity awards

 

(45,059

)

 

Purchases of treasury stock

 

(1,818,542

)

(9,969,468

)

Net cash used in financing activities

 

(1,814,141

)

(9,202,022

)

Net increase (decrease) in cash and cash equivalents

 

692,434

 

(3,364,052

)

Cash and cash equivalents, beginning of period

 

17,713,871

 

19,368,114

 

Cash and cash equivalents, end of period

 

$

18,406,305

 

$

16,004,062

 

 



 

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,

 

 

 

2017

 

2016

 

2017

 

2016

 

Net income

 

$

192,393

 

$

1,560,484

 

$

316,126

 

$

6,073,745

 

Excluding:

 

 

 

 

 

 

 

 

 

Stock-based compensation expense, net of tax expense

 

582,974

 

136,849

 

1,128,195

 

1,074,712

 

Non-GAAP net income

 

$

775,367

 

$

1,697,333

 

$

1,444,321

 

$

7,148,457

 

Weighted-average shares outstanding — diluted

 

11,643,044

 

11,867,997

 

11,710,377

 

12,055,467

 

Non-GAAP net income per share — diluted

 

$

0.07

 

$

0.14

 

$

0.12

 

$

0.59

 

 

Free Cash Flow

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

Net cash provided by operating activities

 

$

1,907,910

 

$

3,420,757

 

$

2,014,799

 

$

7,182,627

 

Less:

 

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

241,971

 

123,040

 

653,171

 

547,087

 

Free cash flow

 

$

1,665,939

 

$

3,297,717

 

$

1,361,628

 

$

6,635,540

 

 

Media Contact:

Chris Scott

Chief Financial Officer

IRADIMED CORPORATION

(407) 677-8022

InvestorRelations@iradimed.com

 


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