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8-K - 8-K - IRADIMED CORPa16-15710_18k.htm

Exhibit 99.1

 

 

IRADIMED CORPORATION Announces Second Quarter 2016 Financial Results

 

·                  Revenue grows 29.7% compared to the same quarter last year

·                  Reports second quarter 2016 GAAP diluted EPS of $0.19 and non-GAAP diluted EPS of $0.24

·                  Increases full year 2016 non-GAAP earnings guidance

·                  Submits patient vital signs monitor 510(k) application to FDA for review

 

Winter Springs, Florida, July 29, 2016 — IRADIMED CORPORATION (NASDAQ:IRMD), the only known provider of non-magnetic intravenous (IV) infusion pump systems that are designed to be safe for use during magnetic resonance imaging (MRI) procedures, today announced financial results for the three and six months ended June 30, 2016.

 

For the second quarter ended June 30, 2016, the Company reported revenue of $9.9 million, an increase of 29.7% compared to $7.6 million for the second quarter 2015.  Gross profit margin was 82.4%, compared to 81.3% for the second quarter 2015.  Net income was $2.2 million, an increase of 26.0% compared to $1.8 million for the second quarter 2015 and earnings per diluted share increased 27.5% to $0.19, compared to $0.15 per diluted share for the second quarter 2015.

 

Non-GAAP net income was $2.9 million for the second quarter ended June 30, 2016, an increase of 48.2% over the second quarter 2015.  Non-GAAP earnings per diluted share increased 49.9% to $0.24 per diluted share, compared to $0.16 in the second quarter 2015.  Free cash flow was $1.1 million, a decrease of 31.0% compared to the second quarter 2015.

 

For the six months ended June 30, 2016, the Company reported revenue of $18.8 million, an increase of 29.0% compared to $14.6 million for the same period in 2015.  Gross profit margin was 81.7%, compared to 81.2% for the same period in 2015.  Net income was $4.5 million, an increase of 38.5% compared to $3.3 million for the same period in 2015 and earnings per diluted share increased 37.7% to $0.37, compared to $0.27 per diluted share for the same period in 2015.

 

Non-GAAP net income was $5.5 million for the six months ended June 30, 2016, an increase of 51.2% over the same period in 2015.  Non-GAAP earnings per diluted share increased 50.3% to $0.45 per diluted share for the six months ended June 30, 2016, compared to $0.30 in the same period in 2015.

 

Cash and cash equivalents decreased by $7.3 million to $12.1 million during the six months ended June 30, 2016.  The Company generated $3.8 million of cash from operations and repurchased $10.0 million of its stock during the six months ended June 30, 2016.

 

“I am very pleased with our second quarter financial results.  Revenue for the quarter was nearly 30% higher than last year’s quarter and non-GAAP diluted earnings per share increased nearly 50%.    Additionally, we are receiving a higher volume of requests for quotes and those quotes are for higher dollar amounts than what we have historically seen.  We view quotes as a leading indicator of future orders and feel that the current level of quoting will lead to increased bookings as customer budget years roll over,” said Roger Susi, President and Chief Executive Officer of the Company.

 



 

“Related to new products, we recently submitted a 510(k) application for our patient vital signs monitor and now wait to hear back from FDA as they review our submission.  We remain excited about the launch of this product still scheduled for later this year.  We continue to receive positive feedback about the patient monitor and have already received several unsolicited orders from a few of our international distributors.  Additionally, earlier in July, we underwent an FDA site inspection and await the final results as to the clearing of the September 2014 warning letter,” said Susi.

 

Financial Guidance

 

For the third quarter 2016 the Company expects revenue of approximately $9.9 million to $10.0 million and non-GAAP diluted earnings per share of $0.23 to $0.24.

 

The Company increased its full year 2016 non-GAAP earnings guidance and now expects non-GAAP diluted earnings per share of $0.91 to $0.93, an increase from the previous guidance of $0.88 to $0.90.  Full year revenue guidance was unchanged at $39.0 million to $40.0 million.

 

Use of non-GAAP Financial Measures

 

The Company believes the presentation of non-GAAP net income, free cash flow and infrequent income tax items can be 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 allow 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 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, July 29, 2016.  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 50949035.

 



 

The conference call will also be available real-time via the internet at www.iradimed.com/en-us/investors/index.php and selecting Events & Presentation.  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 the only known provider of non-magnetic intravenous (IV) infusion pump systems that are specifically designed to be safe for use during magnetic resonance imaging (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 (RF) 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.

 

MRidium is a trademark of IRADIMED CORPORATION.

 

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 clearance of its 510(k) submission, additional actions by or requests from the FDA (including a request to cease domestic distribution of products) and unanticipated costs or delays associated with resolution of these matters; our 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 as we focus on fulfilling orders from our U.S. backlog; 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

 

 

 

June 30,
2016

 

December 31,
2015

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

12,065,858

 

$

19,368,114

 

Investments

 

8,081,274

 

7,602,204

 

Accounts receivable, net

 

5,789,495

 

3,863,632

 

Inventory, net

 

2,946,314

 

2,383,158

 

Prepaid expenses and other current assets

 

247,663

 

320,529

 

Prepaid income taxes

 

292,793

 

273,968

 

Deferred income taxes

 

320,587

 

141,446

 

Total current assets

 

29,743,984

 

33,953,051

 

Property and equipment, net

 

1,219,672

 

905,622

 

Intangible assets, net

 

747,633

 

193,243

 

Deferred income taxes

 

498,403

 

88,398

 

Other assets

 

138,970

 

103,893

 

Total assets

 

$

32,348,662

 

$

35,244,207

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

1,180,810

 

$

1,005,460

 

Accrued payroll and benefits

 

1,056,037

 

1,288,248

 

Other accrued taxes

 

20,493

 

30,687

 

Warranty reserve

 

36,082

 

34,081

 

Deferred revenue

 

462,264

 

529,867

 

Other current liabilities

 

108,317

 

 

Accrued income taxes

 

36,782

 

 

Total current liabilities

 

2,900,785

 

2,888,343

 

Deferred revenue

 

978,269

 

422,839

 

Total liabilities

 

3,879,054

 

3,311,182

 

Stockholders’ equity:

 

 

 

 

 

Common stock

 

1,124

 

1,118

 

Additional paid-in capital

 

21,283,957

 

19,332,023

 

Retained earnings

 

17,168,431

 

12,655,169

 

Treasury stock

 

(9,969,468

)

 

Accumulated other comprehensive loss

 

(14,436

)

(55,285

)

Total stockholders’ equity

 

28,469,608

 

31,933,025

 

Total liabilities and stockholders’ equity

 

$

32,348,662

 

$

35,244,207

 

 



 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

Revenue

 

$

9,868,905

 

$

7,609,143

 

$

18,833,058

 

$

14,600,848

 

Cost of revenue

 

1,739,067

 

1,422,027

 

3,444,864

 

2,750,207

 

Gross profit

 

8,129,838

 

6,187,116

 

15,388,194

 

11,850,641

 

Operating expenses:

 

 

 

 

 

 

 

 

 

General and administrative

 

3,088,205

 

1,985,269

 

5,347,927

 

3,953,287

 

Sales and marketing

 

1,409,758

 

1,104,682

 

2,692,807

 

2,193,378

 

Research and development

 

291,822

 

403,447

 

526,157

 

745,748

 

Total operating expenses

 

4,789,785

 

3,493,398

 

8,566,891

 

6,892,413

 

Income from operations

 

3,340,053

 

2,693,718

 

6,821,303

 

4,958,228

 

Other (expense) income, net

 

(4,669

)

46,135

 

27,109

 

92,951

 

Income before provision for income taxes

 

3,335,384

 

2,739,853

 

6,848,412

 

5,051,179

 

Provision for income taxes

 

1,104,133

 

969,282

 

2,335,150

 

1,793,113

 

Net income

 

$

2,231,251

 

$

1,770,571

 

$

4,513,262

 

$

3,258,066

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.21

 

$

0.16

 

$

0.41

 

$

0.30

 

Diluted

 

$

0.19

 

$

0.15

 

$

0.37

 

$

0.27

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

10,778,673

 

10,974,448

 

10,937,311

 

10,940,525

 

Diluted

 

11,966,289

 

12,107,707

 

12,138,856

 

12,068,122

 

 



 

IRADIMED CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Six Months Ended
June 30,

 

 

 

2016

 

2015

 

Operating activities:

 

 

 

 

 

Net income

 

$

4,513,262

 

$

3,258,066

 

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

 

 

 

 

 

Bad debt expense

 

33,548

 

58,666

 

Provision for excess and obsolete inventory

 

86,610

 

42,156

 

Depreciation and amortization

 

122,744

 

106,264

 

Excess tax benefit on the exercise of stock options

 

(266,094

)

(162,240

)

Stock-based compensation

 

1,595,589

 

582,085

 

Impairment of intangible assets

 

 

55,433

 

Loss on maturity of securities

 

46,753

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(1,959,411

)

(2,359,135

)

Inventory

 

(649,766

)

(124,866

)

Prepaid expenses and other current assets

 

53,795

 

133,004

 

Other assets

 

(16,006

)

(17,332

)

Deferred income taxes

 

(614,295

)

(330,989

)

Accounts payable

 

175,350

 

306,116

 

Accrued payroll and benefits

 

(232,211

)

(199,949

)

Other accrued taxes

 

(10,194

)

(52,785

)

Warranty reserve

 

2,001

 

31,255

 

Deferred revenue

 

487,827

 

993,558

 

Other current liabilities

 

108,317

 

 

Accrued income taxes, net of prepaid income taxes

 

284,051

 

420,090

 

Net cash provided by operating activities

 

3,761,870

 

2,739,397

 

Investing activities:

 

 

 

 

 

Purchases of investments

 

(2,762,917

)

 

Proceeds from the sale or maturities of investments

 

2,303,092

 

 

Purchases of property and equipment

 

(424,047

)

(121,415

)

Capitalized intangible assets

 

(567,137

)

(5,904

)

Net cash used in investing activities

 

(1,451,009

)

(127,319

)

Financing activities:

 

 

 

 

 

Proceeds from stock option exercises

 

90,257

 

199,060

 

Income tax benefits credited to equity

 

266,094

 

162,240

 

Purchases of treasury stock

 

(9,969,468

)

 

Net cash (used in) provided by financing activities

 

(9,613,117

)

361,300

 

Net (decrease) increase in cash and cash equivalents

 

(7,302,256

)

2,973,378

 

Cash and cash equivalents, beginning of period

 

19,368,114

 

9,454,150

 

Cash and cash equivalents, end of period

 

$

12,065,858

 

$

12,427,528

 

 



 

IRADIMED CORPORATION

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES (UNAUDITED)

 

Non-GAAP Net Income and Diluted EPS

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

Net income

 

$

2,231,251

 

$

1,770,571

 

$

4,513,262

 

$

3,258,066

 

Excluding:

 

 

 

 

 

 

 

 

 

Stock-based compensation expense, net of taxes

 

663,050

 

182,926

 

937,863

 

348,181

 

Non-GAAP net income

 

$

2,894,301

 

$

1,953,497

 

$

5,451,125

 

$

3,606,247

 

Weighted-average shares outstanding — diluted

 

11,966,289

 

12,107,707

 

12,138,856

 

12,068,122

 

Non-GAAP net income per share — diluted

 

$

0.24

 

$

0.16

 

$

0.45

 

$

0.30

 

 

Free Cash Flow

 

 

 

Three Months Ended
June 30, 2016

 

Net cash provided by operating activities

 

$

1,330,017

 

Less:

 

 

 

Purchases of property and equipment

 

224,709

 

Free cash flow

 

$

1,105,308

 

 

Media Contact:

Chris Scott

Chief Financial Officer

IRADIMED CORPORATION

(407) 677-8022

InvestorRelations@iradimed.com