-----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, SpSwB73z5hC6JkIC19kVDgyOFaJdbV4pqsB7OzCSTn1bR+VMvuEqdqZBNcTsh1i3 qPjlXFFdOM+WCgt6LqDCxQ== 0001104659-07-001092.txt : 20070108 0001104659-07-001092.hdr.sgml : 20070108 20070108080949 ACCESSION NUMBER: 0001104659-07-001092 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070108 DATE AS OF CHANGE: 20070108 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: 07516025 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 a07-1303_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  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):  January 8, 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 January 8, 2007, ev3 Inc. issued a press release announcing its net sales results for its fiscal fourth quarter and fiscal year ended December 31, 2006.  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 issuedJanuary 8, 2007

 

2




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: January 8, 2007

 

ev3 Inc.

 

 

 

 

 

 

 

 

By:

     /s/ Patrick D. Spangler

 

 

 

Name: Patrick D. Spangler

 

 

Title: Chief Financial Officer and Treasurer

 

3




ev3 Inc.

CURRENT REPORT ON FORM 8-K

EXHIBIT INDEX

Exhibit No.

 

Description

 

Method of Filing

 

 

 

 

 

99.1

 

Press Release issued January 8, 2007

 

Furnished herewith

 

4



EX-99.1 2 a07-1303_1ex99d1.htm EX-99

Exhibit 99.1

 





CONTACT:





Patrick D. Spangler, CFO

ev3 Inc.

 

9600 54th Avenue North

 

Plymouth, Minnesota 55442

 

(763) 398-7000

 

pspangler@ev3.net

 

ev3 Inc. Reports 41% Net Sales Increase for Fourth Quarter

Company also Reports Receipt of FDA Approvable Letter for PROTÉGÉ® RX Carotid Stent Device

Plymouth, Minn. – January 8, 2007 – ev3 Inc. (NASDAQ:  EVVV), a global endovascular device company, today reported net sales results for its fiscal fourth quarter and fiscal year ended December 31, 2006.

ev3’s net sales in the fourth quarter of 2006 increased 41% to $57.7 million versus net sales of $41.0 million in the fourth quarter of 2005.  The company’s guidance range for fourth quarter net sales was $55 to $59 million.  Fourth 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.

ev3 also announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) relating to its pre-market approval (PMA) application for the PROTÉGÉ® RX Carotid Stent device.  The receipt of an approvable letter indicates that the FDA is prepared to approve a PMA subject to, among other conditions, the satisfactory completion of an inspection of manufacturing facilities, methods, and controls, and an assessment of compliance with applicable quality system requirements.  Pending its approval, the PROTÉGÉ® RX, used in conjunction with the ev3 SpideRX Embolic Protection Device, would be indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery.  ev3’s SpideRX® Embolic Protection Device was previously FDA cleared for carotid use in February 2006.

(more)




Jim Corbett, President and CEO of ev3 Inc., commented, “We are very pleased with yet another record quarter for net sales through continued, balanced growth in both of our business units.  We are also very encouraged by the receipt of the approvable letter for the PROTÉGÉ® RX Carotid Stent.  We believe the PROTÉGÉ® RX, combined with the SpideRX, will permit ev3 to be a strong competitor in the carotid stenting market that we estimate could reach $250 million worldwide in 2007.”

In the fourth quarter of 2006, ev3’s neurovascular segment net sales increased 39% to $23.7 versus $17.0 million in the fourth quarter of 2005. Within the neurovascular business segment, sales of embolic products increased 49% to $12.0 million from $8.1 million, and sales of neurovascular access and delivery products were up 30% to $11.7 million from $8.9 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 (AVM’s), the Nexus family of embolic coils for the treatment of brain aneurysms and growth in virtually all of ev3’s neuro access and delivery products.

Cardio peripheral segment net sales in the fourth quarter of 2006 increased 42% to $34.0 million versus $24.0 million in the fourth quarter of 2005. Within the cardio peripheral business segment, stent sales increased 53% to $18.5 million from $12.1 million. Sales of thrombectomy and embolic protection products increased 79% to $6.2 million from $3.5 million, while sales of procedural support and other cardio peripheral products increased 11% to $9.3 million from $8.4 million. The largest contributors to the growth in the cardio peripheral segment were ev3’s new EverFlex stent product and the SpideRX Embolic Protection Device.

On a geographic basis, ev3’s fourth quarter U.S. net sales increased 52% to $34.6 million, while fourth quarter international net sales increased 26% to $23.1 million, over the prior-year quarter. Changes in foreign currency exchange rates had a positive impact of approximately $1.2 million on fourth quarter 2006 net sales compared to the fourth quarter of the prior year.

For the fiscal year ended December 31, 2006, ev3’s net sales increased 51% to $202.4 million versus $133.7 million for the year ended December 31, 2005.  Annual sales growth in 2006 also was generated internally and reflected net sales growth in each of ev3’s reportable business segments and geographic markets.

2




ev3 will provide full financial results for its fiscal fourth quarter and fiscal year 2006 and updated guidance in mid-February, when the company will hold its quarterly conference call to discuss its financial results and guidance.

ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S. and other countries. This press release contains other trademarks and trade names of ev3 Inc. and other third parties, which are the property of their respective owners.

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 quarterly report on Form 10-Q and annual report on Form 10-K. ev3 Inc. urges all interested parties to read these reports 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.

3




ev3 Inc.

SELECTED NET SALES INFORMATION

(Dollars in thousands, except per share amounts)

(unaudited)

NET SALES BY SEGMENT

 

 

 

For the Three Months Ended

 

 

 

For the Years Ended

 

 

 

 

 

December 31,

 

December 31,

 

 

 

December 31,

 

December 31,

 

 

 

 

 

2006

 

2005

 

% change

 

2006

 

2005

 

% change

 

Cardio Peripheral

 

 

 

 

 

 

 

 

 

 

 

 

 

Stents

 

$

18,501

 

$

12,079

 

53%

 

$

64,092

 

$

37,871

 

69%

 

Thrombectomy and embolic protection

 

6,177

 

3,459

 

79%

 

21,606

 

12,869

 

68%

 

Procedural support and other

 

9,344

 

8,451

 

11%

 

35,406

 

29,141

 

21%

 

Total cardio peripheral

 

34,022

 

23,989

 

42%

 

121,104

 

79,881

 

52%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Neurovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

Embolic products

 

12,026

 

8,046

 

49%

 

38,998

 

22,463

 

74%

 

Neuro access and delivery products

 

11,627

 

8,939

 

30%

 

42,336

 

31,352

 

35%

 

Total neurovascular

 

23,653

 

16,985

 

39%

 

81,334

 

53,815

 

51%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total company

 

$

57,675

 

$

40,974

 

41%

 

$

202,438

 

$

133,696

 

51%

 

 

NET SALES BY GEOGRAPHY

 

 

 

For the Three Months Ended

 

 

 

For the Years Ended

 

 

 

 

 

December 31,

 

December 31,

 

 

 

December 31,

 

December 31,

 

 

 

 

 

2006

 

2005

 

% change

 

2006

 

2005

 

% change

 

United States

 

$

34,590

 

$

22,707

 

52%

 

$

121,180

 

$

71,848

 

69%

 

International

 

23,085

 

18,267

 

26%

 

81,258

 

61,848

 

31%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total net sales

 

$

57,675

 

$

40,974

 

41%

 

$

202,438

 

$

133,696

 

51%

 

 

# # #

4



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