-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Rzcu307yCNCy8tJ/JJgGby+0nVmlV2vvirIX6xXzKIhffSMCDmkPd5/zz95pCc4i 0J7qhoDzvHs4kwihtik+3w== 0001104659-07-032133.txt : 20070427 0001104659-07-032133.hdr.sgml : 20070427 20070427081003 ACCESSION NUMBER: 0001104659-07-032133 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070427 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070427 DATE AS OF CHANGE: 20070427 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ev3 Inc. CENTRAL INDEX KEY: 0001318310 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 320138874 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51348 FILM NUMBER: 07793316 BUSINESS ADDRESS: STREET 1: 9600 54TH AVENUE NORTH STREET 2: SUITE 100 CITY: PLYMOUTH STATE: MN ZIP: 55442-2111 BUSINESS PHONE: (763) 398-7000 MAIL ADDRESS: STREET 1: 9600 54TH AVENUE NORTH STREET 2: SUITE 100 CITY: PLYMOUTH STATE: MN ZIP: 55442-2111 8-K 1 a07-12498_18k.htm 8-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549


FORM 8-K

CURRENT REPORT
P
ursuant to Section 13 Or 15 (d) of
the Securities Exchange Act of 1934


Date of Report (Date of earliest event reported):  April 27, 2007


ev3 Inc.
(Exact name of registrant as specified in its charter)

Delaware

 

000-51348

 

32-0138874

(State or Other Jurisdiction of Incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification Number)

 

9600 54th Avenue North, Suite 100

 

 

Plymouth, Minnesota

 

55442

(Address of Principal Executive Offices)

 

(Zip Code)

 

 

 

(763) 398-7000

(Registrant’s telephone number, including area code)

 

Not Applicable
(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:

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))

 




Item 2.02.              Results of Operations and Financial Condition.

On April 27, 2007, ev3 Inc. issued a press release announcing its results of operations and financial condition for its fiscal first quarter ended April 1, 2007.  A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information contained in this report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by ev3 Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as may be expressly set forth by specific reference in such filing.

Item 9.01               Financial Statements and Exhibits.

(c)   Exhibits.

Exhibit No.

 

Description

99.1

 

Press Release issued April 27, 2007

 




SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: April 27, 2007

ev3 Inc.

 

 

 

 

By:

/s/ Patrick D. Spangler

 

Name:

Patrick D. Spangler

 

Title:

Chief Financial Officer and Treasurer

 




ev3 Inc.

CURRENT REPORT ON FORM 8-K

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

Method of Filing

 

 

 

 

 

99.1

 

Press Release issued April 27, 2007

 

Furnished herewith

 



EX-99.1 2 a07-12498_1ex99d1.htm EX-99.1

Exhibit 99.1

 

CONTACTS:

Patrick Spangler, CFO

ev3 Inc.

(763) 398-7000

pspangler@ev3.net

 

MEDIA RELATIONS:

Laura Nobles

Nobles Communications

(310) 795-0497

laura@noblescommunications.com

 

INVESTOR RELATIONS:

Marian Briggs

Padilla Speer Beardsley

(612) 455-1742
mbriggs@psbpr.com

 

ev3 Inc. Reports 46% Increase in First Quarter Net Sales

Net Loss Reduced 61% Compared to Year-Ago Period

Conference Call Scheduled for April 27, 2007 at 8 a.m. CT;

Simultaneous Webcast at www.ev3.net

PLYMOUTH, Minn. — April 27, 2007 — ev3 Inc. (NASDAQ:  EVVV), a global endovascular device company, today reported financial results for its fiscal first quarter of 2007.

As previously reported, ev3’s net sales in the first quarter of 2007 increased 46% to $61.5 million versus net sales of $42.2 million in the first quarter of 2006. First quarter sales growth was broad-based and reflected a strong contribution from each of ev3’s Cardio Peripheral and Neurovascular business segments, as well as a strong contribution from both domestic and international markets.

Jim Corbett, president and CEO of ev3 Inc., commented, “Our first quarter sales growth continued at a rate consistent with us achieving our longer term business and financial objectives. We are very pleased with our balanced growth and enthusiastic about the potential for several of our new products including the EverFlex Stent, the Onyx Liquid Embolic System, and the recently approved Protégé RX Stent combined with the SpideRX Embolic Protection Device for carotid stenting.”




ev3’s net loss for the first quarter of 2007 declined 61% to $9.5 million compared to $24.5 million in the first quarter of 2006. ev3’s net loss per common share was $0.17 for the first quarter of 2007 compared to $0.44 per common share in the first quarter of 2006. Total weighted average common shares outstanding used in the per share calculations were 57.5 million and 55.9 million for the first quarter of 2007 and 2006, respectively.

ev3’s earnings before interest, taxes, depreciation and amortization (EBITDA), excluding charges for non-cash stock-based compensation, was a negative $1.2 million in the first quarter of 2007, compared to a negative $17.7 million in the first quarter of 2006. ev3 uses the non-GAAP financial measures, EBITDA and EBITDA, excluding charges for non-cash stock-based compensation, as supplemental measures of performance and believes that these measures facilitate operating performance comparisons from period to period and company to company.

EBITDA and EBITDA, excluding charges for non-cash stock-based compensation, for the first quarter ended April 1, 2007 and April 2, 2006 are reconciled to ev3’s net loss for the respective periods immediately following the detail of net sales by geography later in this press release. This information is also made available on the company’s website at www.ev3.net.

Corbett continued, “2007 is a year in which we will be increasing our investment in clinical trials to further validate the performance advantages of our products and provide physicians and third party payers with increased clinical data. However, we remain committed to a significant year over year improvement in our 2007 EBITDA performance.”

Sales Review

In the first quarter of 2007, ev3’s Neurovascular segment net sales increased 48% to $25.0 million versus $16.9 million in the first quarter of 2006. Within the Neurovascular business segment, sales of embolic products increased 75% to $12.9 million from $7.4 million, and sales of Neuro access and delivery products were up 27% to $12.1 million from $9.5 million. The primary growth drivers for the Neurovascular segment were the continued market penetration of both the Onyx Liquid Embolic System for the treatment of brain arterio-venous malformations (AVMs) and the Nexus family of embolic coils for the treatment of brain aneurysms.

2




Cardio Peripheral segment net sales in the first quarter of 2007 increased 44% to $36.5 million versus $25.3 million in the first quarter of 2006. Within the Cardio Peripheral business segment, stent sales increased 52% to $19.8 million from $13.1 million. Sales of thrombectomy and embolic protection products increased 54% to $6.2 million from $4.0 million, while sales of procedural support and other Cardio Peripheral products increased 27% to $10.5 million from $8.2 million. The largest contributors to the growth in the Cardio Peripheral segment were the EverFlex stent and the recently approved Protégé RX stent combined with the SpideRX Embolic Protection Device for carotid stenting.

On a geographic basis, ev3’s first quarter U.S. net sales increased 42% to $35.1 million, while first quarter international net sales increased 51% to $26.4 million, over the prior-year quarter. Changes in foreign currency exchange rates had a positive impact of approximately $1.4 million on first quarter 2007 net sales compared to the first quarter of the prior year.

Outlook

ev3 continues to expect 2007 annual net sales to be in the range of approximately $262 to $278 million. ev3 expects second quarter of 2007 net sales to be in the range of $63 to $67 million. Further, ev3 continues to expect its EBITDA, excluding non-cash stock-based compensation, to be positive in 2007.

Earnings Call Information

ev3 will host a conference call today, April 27, 2007, beginning at 8 a.m. CT to review its results of operations for the first quarter of 2007 and other recent events and to discuss its 2007 business outlook. Discussions during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s net sales, cost of goods sold, operating expenses, distribution arrangements, clinical studies, regulatory status, financial position and comments the company may make about its future in response to questions from participants on the conference call. Any interested party may listen to the conference call through a live audio Webcast at www.ev3.net. For those unable to listen to the Webcast, a playback of the Webcast will be available at www.ev3.net for approximately 90 days. Those without Internet access may join the call from within the United States by dialing (866) 277-1181; outside the United States dial (617) 597-5358 passcode 93392122. A playback of the conference call will be available from 11 a.m. CT, April 27, 2007 until noon CT on May 4, 2007 by dialing (888) 286-8010 (United States) or (617) 801-6888 (International), passcode 18302612.

3




Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited to, in no particular order:  product demand and market acceptance; the impact of competitive products and pricing; delays in regulatory approvals and the introduction of new products; and success of clinical testing. More detailed information on these and additional factors which could affect ev3 Inc.’s operating and financial results is described in the company’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. ev3 Inc. urges all interested parties to read this report to gain a better understanding of the many business and other risks that the company faces. Additionally, ev3 Inc. undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.

ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S. and other countries.

All trademarks and tradenames referred to in this press release are the property of their respective owners.

4




ev3 Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars in thousands, except per share amounts)
(unaudited)

 

 

For the Three Months Ended

 

 

 

April 1,
2007

 

April 2,
2006

 

Net sales

 

$

61,499

 

$

42,237

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

Cost of goods sold (a)

 

20,457

 

16,488

 

Sales, general and administrative (a)

 

39,137

 

37,861

 

Research and development (a)

 

7,433

 

6,774

 

Amortization of intangible assets

 

4,100

 

4,243

 

Loss on sale or disposal of assets, net

 

16

 

170

 

Acquired in-process research and development

 

 

1,786

 

Total operating expenses

 

71,143

 

67,322

 

 

 

 

 

 

 

Loss from operations

 

(9,644

)

(25,085

)

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

Interest (income) expense, net

 

(109

)

(699

)

Other (income) expense, net

 

(317

)

(54

)

Loss before income taxes

 

(9,218

)

(24,332

)

 

 

 

 

 

 

Income tax expense

 

276

 

169

 

 

 

 

 

 

 

Net loss

 

$

(9,494

)

$

(24,501

)

 

 

 

 

 

 

Earnings per share:

 

 

 

 

 

Net loss per common share (basic and diluted)

 

$

(0.17

)

$

(0.44

)

 

 

 

 

 

 

Weighted average common shares outstanding

 

57,514,255

 

55,944,925

 


(a) Includes stock-based compensation charges of:

 

 

 

 

 

 Cost of goods sold

 

$

158

 

$

214

 

 Sales, general and administrative

 

1,859

 

1,366

 

 Research and development

 

$

182

 

$

214

 

 

 

$

2,199

 

$

1,794

 

 

5




ev3 Inc.
CONSOLIDATED BALANCE SHEETS
(Dollars in thousands, except per share amounts)

 

 

April 1,
2007

 

December 31,
2006

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

18,732

 

$

24,053

 

Short-term investments

 

7,900

 

14,700

 

Accounts receivable, less allowance of $4,247 and $3,924, respectively

 

49,413

 

45,137

 

Inventories

 

46,199

 

42,124

 

Prepaid expenses and other assets

 

5,565

 

7,162

 

Other receivables

 

3,652

 

2,669

 

Total current assets

 

131,461

 

135,845

 

 

 

 

 

 

 

Restricted cash

 

1,307

 

2,022

 

Property and equipment, net

 

24,140

 

24,072

 

Goodwill

 

149,061

 

149,061

 

Other intangible assets, net

 

45,837

 

40,014

 

Other assets

 

730

 

1,812

 

Total assets

 

$

352,536

 

$

352,826

 

 

 

 

 

 

 

Liabilities and stockholders'equity

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

14,465

 

$

13,140

 

Accrued compensation and benefits

 

12,358

 

16,382

 

Accrued liabilities

 

12,954

 

10,102

 

Current portion of long-term debt

 

2,976

 

2,143

 

Total current liabilities

 

42,753

 

41,767

 

 

 

 

 

 

 

Long-term debt

 

8,988

 

5,357

 

Other long-term liabilities

 

1,113

 

468

 

Total liabilities

 

52,854

 

47,592

 

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

 

 

 

 

 

Common stock: $0.01 par value; 100,000,000 shares authorized; issued and outstanding: 58,243,788 and 57,594,742, respectively

 

582

 

576

 

Additional paid in capital

 

923,945

 

919,221

 

Accumulated deficit

 

(624,788

)

(614,578

)

Accumulated other comprehensive income

 

(57

)

15

 

Total stockholders' equity

 

299,682

 

305,234

 

Total liabilities and stockholders' equity

 

$

352,536

 

$

352,826

 

 

6




ev3 Inc.
SELECTED SALES INFORMATION
(Dollars in thousands, except per share amounts)
(unaudited)

 

For the Three Months Ended

 

 

 

NET SALES BY SEGMENT

 

April 1,
2007

 

April 2,
2006

 

% change

 

Cardio Peripheral

 

 

 

 

 

 

 

Stents

 

$

19,806

 

$

13,046

 

52

%

Thrombectomy and embolic protection

 

6,218

 

4,037

 

54

%

Procedural support and other

 

10,467

 

8,249

 

27

%

Total cardio peripheral

 

36,491

 

25,332

 

44

%

 

 

 

 

 

 

 

 

Neurovascular

 

 

 

 

 

 

 

Embolic products

 

12,926

 

7,383

 

75

%

Neuro access and delivery products and other

 

12,082

 

9,522

 

27

%

Total neurovascular

 

25,008

 

16,905

 

48

%

 

 

 

 

 

 

 

 

Total company

 

$

61,499

 

$

42,237

 

46

%

 

 

For the Three Months Ended

 

 

 

NET SALES BY GEOGRAPHY

 

April 1,
2007

 

April 2,
2006

 

% change

 

United States

 

$

35,140

 

$

24,774

 

42

%

International

 

26,359

 

17,463

 

51

%

 

 

 

 

 

 

 

 

Total net sales

 

$

61,499

 

$

42,237

 

46

%

 

7




ev3 Inc.
NON-GAAP FINANCIAL MEASURES
(Dollars in thousands)
(unaudited)

 

For the Three Months Ended

 

 

 

April 1,
2007

 

April 2,
2006

 

Reconciliation of net loss to EBITDA

 

 

 

 

 

 

 

 

 

 

 

Net loss, as reported (GAAP basis)

 

$

(9,494

)

$

(24,501

)

 

 

 

 

 

 

Interest (income) expense, net

 

(109

)

(699

)

Income tax expense

 

276

 

169

 

Depreciation and amortization

 

5,904

 

5,517

 

EBITDA

 

$

(3,423

)

$

(19,514

)

 

 

 

 

 

 

Stock-based compensation

 

2,199

 

1,794

 

 

 

 

 

 

 

EBITDA, adjusted for stock-based compensation

 

$

(1,224

)

$

(17,720

)

 

ev3 uses non-GAAP financial measures, as outlined above, as supplemental measures of performance and believes these measures facilitate operating performance comparisons from period to period and company to company by factoring out potential differences caused by variations in capital structure, tax positions, depreciation, non-cash charges and certain large and unpredictable charges. ev3 also believes that the presentation of these measures provides useful information to investors in evaluating the company’s operations, period over period. Non-GAAP measures have limitations as analytical tools, and should not be considered in isolation, or as a substitute for analysis of the company’s results as reported under Generally Accepted Accounting Principles (GAAP).  This information is also made available on the company’s website at www.ev3.net.

# # #

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