-----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, QWxuyFo1avbDJvXpMG8mrPe37MYsEBUyiBUdqIi0mo220ASA5WSSYwYXj6CmJMo9 FMUtaeO7/fHBKXp03n5NKA== 0001104659-07-012119.txt : 20070220 0001104659-07-012119.hdr.sgml : 20070219 20070220080125 ACCESSION NUMBER: 0001104659-07-012119 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070220 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070220 DATE AS OF CHANGE: 20070220 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: 07633482 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 a07-4937_18k.htm 8-K

 

 

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):  February 20, 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 February 20, 2007, ev3 Inc. issued a press release announcing its financial 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 issued February 20, 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: February 20, 2007

ev3 Inc.

 

 

 

 

 

 

By:

      /s/ Patrick D. Spangler

 

Name: Patrick D. Spangler

 

Title: Chief Financial Officer and Treasurer

 

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ev3 Inc.

CURRENT REPORT ON FORM 8-K

EXHIBIT INDEX

Exhibit No.

 

Description

 

Method of Filing

 

 

 

 

 

99.1

 

Press Release issued February 20, 2007

 

Furnished herewith

 

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EX-99.1 2 a07-4937_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

INVESTOR RELATIONS CONTACTS:

Patrick Spangler, CFO

ev3 Inc.

 (763) 398-7000

pspangler@ev3.net

Marian Briggs/Nancy Johnson

Padilla Speer Beardsley

(612) 455-1742 (612) 455-1745
mbriggs@psbpr.com / njohnson@psbpr.com

 

ev3 Inc. Reports Fourth Quarter Sales Increase of 41% and
Net Loss Decline of 79% Compared to Year-Ago Period

ev3 Inc. also Achieves Fourth Quarter Positive EBITDA

Conference Call Scheduled for February 20, 2007 at 8 a.m. CST;

Simultaneous Webcast at www.ev3.net

PLYMOUTH, Minn. – February 20, 2007 –ev3 Inc. (NASDAQ:  EVVV), a global endovascular device company, today reported financial results for its fiscal fourth quarter of 2006.

As reported on January 8, 2007, 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. 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.

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.

Jim Corbett, president and CEO of ev3 Inc., commented, “We are very pleased with yet another record quarter of sales growth which substantially outpaced that of our target markets.  With the FDA approval and launch of our ProtegeRX carotid stent, used in combination with an ev3 embolic protection device for carotid stenting, we are optimistic about our prospects in 2007.”

(more)

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ev3’s net loss attributable to common shareholders for the fourth quarter of 2006 declined 79% to $4.6 million compared to $22.0 million in the fourth quarter of 2005. The company’s net loss attributable to common shareholders for the fiscal year ended December 31, 2006 declined 57% to $52.4 million compared to $122.1 million for the year ended December 31, 2005.  ev3’s net loss per common share attributable to common shareholders for the fourth quarter of 2006 and fiscal year ended December 31, 2006 was $0.08 and $0.93 per common share, respectively, compared to $0.45 per common share in the fourth quarter of 2005 and $4.48 per common share in the full year ended December 31, 2005. Total weighted average common shares outstanding used in the per share calculations were 57.2 million and 56.6 million for the fourth quarter of 2006 and full year ended December 31, 2006, respectively and 49.2 million and 27.2 million for the fourth quarter of 2005 and full year ended December 31, 2005, respectively.

ev3’s earnings before interest, taxes, depreciation and amortization (EBITDA), excluding charges for non-cash stock-based compensation, improved approximately $19.5 million to a positive $3.0 million in the fourth quarter of 2006, compared to a loss of $16.5 million in the fourth quarter of 2005. ev3’s EBITDA loss, excluding charges for non-cash stock-based compensation, for the year ended December 31, 2006 improved $56.6 million or 71%, to a loss of $23.3 million, compared to a loss of $79.9 million for the year ended December 31, 2005.  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 fourth quarter and year ended December 31, 2006 and December 31, 2005 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.

Corbett continued,“Since our initial public offering in mid 2005, we have not had a more important financial objective than to achieve a positive EBITDA, excluding non-cash stock-based compensation charges, by the fourth quarter of 2006.  Although we recognize that much work is yet to be done, we are gratified to report that ev3’s fourth quarter EBITDA was a positive $1.4 million and that fourth quarter EBITDA, excluding non-cash stock-based compensation, was a positive $3.0 million.”

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Sales Review

In the fourth quarter of 2006, ev3’s Neurovascular segment net sales increased 39% to $23.7 million 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 (AVMs) and the Nexus family of embolic coils for the treatment of brain aneurysms.

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.

Outlook 

ev3 expects 2007 annual net sales to be in the range of approximately $262 to $278 million. ev3 expects first quarter of 2007 net sales to be in the range of $59 to $63 million.  ev3 also expects its quarterly operating losses to be reduced during 2007, as compared to its quarterly operating losses for fiscal year 2006.  With respect to EBITDA, excluding non-cash stock-based compensation, the Company expects to generate $10 to $15 million in 2007 representing an improvement of $33 to $38 million over a negative $23 million for 2006.

Earnings Call Information

ev3 will host a conference call today, February 20, 2007, beginning at 8 a.m. CST to review its results of operations for the fourth quarter of 2006 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,

3




 

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 866-700-7173; outside the United States dial 617-213-8838 passcode 98675467. A playback of the conference call will be available from11 a.m. CST, February 20, 2007 until noon CST on February 27, 2007 by dialing 888-286-8010 (United States) or 617-801-6888 (International), passcode 12904482.

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.

4




 

ev3 Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Dollars in thousands, except per share amounts)

(unaudited)

 

 

 

For the Three Months Ended

 

For the Years Ended

 

 

 

December 31,

 

December 31,

 

December 31,

 

December 31,

 

 

 

2006

 

2005

 

2006

 

2005

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

57,675

 

$

40,974

 

$

202,438

 

$

133,696

 

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

Cost of goods sold (a)

 

18,988

 

16,610

 

71,321

 

55,094

 

Sales, general and administrative (a)

 

32,612

 

35,604

 

141,779

 

130,427

 

Research and development (a)

 

6,868

 

8,627

 

26,725

 

39,280

 

Amortization of intangible assets

 

4,215

 

2,796

 

17,223

 

10,673

 

Loss on sale or disposal of assets, net

 

20

 

(4

)

162

 

200

 

Acquired in-process research and development

 

 

 

1,786

 

868

 

Total operating expenses

 

62,703

 

63,633

 

258,996

 

236,542

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(5,028

)

(22,659

)

(56,558

)

(102,846

)

 

 

 

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

 

 

 

Gain on sale of investments, net

 

 

 

(1,063

)

(4,611

)

Interest (income) expense, net

 

(224

)

(917

)

(1,695

)

9,916

 

Minority interest in loss of subsidiary

 

 

(801

)

 

(2,013

)

Other (income) expense, net

 

(584

)

448

 

(2,117

)

3,360

 

Loss before income taxes

 

(4,220

)

(21,389

)

(51,683

)

(109,498

)

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

360

 

587

 

688

 

526

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

(4,580

)

(21,976

)

(52,371

)

(110,024

)

 

 

 

 

 

 

 

 

 

 

Accretion of preferred membership units to redemption value

 

 

 

 

(12,061

)

 

 

 

 

 

 

 

 

 

 

Net loss attributable to common shareholders

 

$

(4,580

)

$

(21,976

)

$

(52,371

)

$

(122,085

)

 

 

 

 

 

 

 

 

 

 

Net loss per common share attributed to common shareholders (basic and diluted) (b)

 

$

(0.08

)

$

(0.45

)

$

(0.93

)

$

(4.48

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding (b)

 

57,228,532

 

49,162,046

 

56,585,025

 

27,242,712

 

 

 

 

 

 

 

 

 

 

 

 


(a)    Includes stock-based compensation charges of:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

$

134

 

$

208

 

$

630

 

$

653

 

Sales, general and administrative

 

1,314

 

1,236

 

5,868

 

3,141

 

Research and development

 

132

 

351

 

655

 

1,079

 

 

 

$

1,580

 

$

1,795

 

$

7,153

 

$

4,873

 

 

(b)            Net loss per common share attributed to common shareholders and weighted average common shares outstanding reflect the June 21, 2005 1-for-6 reverse stock split for all periods presented.

5




 

ev3 Inc.

CONSOLIDATED BALANCE SHEETS

(Dollars in thousands, except per share amounts)

 

 

 

December 31,    

 

December 31,

 

 

 

2006

 

2005

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

24,053

 

$

69,592

 

Short-term investments

 

14,700

 

12,000

 

Accounts receivable, less allowance of $3,924 and $3,607, respectively

 

45,137

 

28,519

 

Inventories

 

42,124

 

32,987

 

Prepaid expenses and other assets

 

7,162

 

7,042

 

Other receivables

 

2,669

 

1,535

 

Total current assets

 

135,845

 

151,675

 

 

 

 

 

 

 

Restricted cash

 

2,022

 

3,102

 

Property and equipment, net

 

24,072

 

17,877

 

Goodwill

 

149,061

 

94,456

 

Other intangible assets, net

 

40,014

 

26,230

 

Other assets

 

1,812

 

3,488

 

Total assets

 

$

352,826

 

$

296,828

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

13,140

 

$

11,716

 

Accrued compensation and benefits

 

16,382

 

14,612

 

Accrued liabilities

 

10,102

 

11,343

 

Current portion of long-term debt

 

2,143

 

 

Total current liabilities

 

41,767

 

37,671

 

 

 

 

 

 

 

Long-term debt

 

5,357

 

 

Other long-term liabilities

 

468

 

852

 

Total liabilities

 

47,592

 

38,523

 

 

 

 

 

 

 

Minority interest

 

 

12,850

 

Stockholders’ equity

 

 

 

 

 

 

 

 

 

 

 

Common stock: $0.01 par value; 100,000,000 shares authorized; issued and outstanding: 57,594,742 and 49,350,647, respectively

 

576

 

493

 

Additional paid in capital

 

919,221

 

807,032

 

Accumulated deficit

 

(614,578

)

(562,207

)

Accumulated other comprehensive income

 

15

 

137

 

Total stockholders’ equity

 

305,234

 

245,455

 

Total liabilities and stockholders’ equity

 

$

352,826

 

$

296,828

 

 

6




 

ev3 Inc.

SELECTED NET SALES INFORMATION

(Dollars in thousands, except per share amounts)

(unaudited)

 

 

 

For the Three Months Ended

 

 

 

For the Years Ended

 

 

 

 

 

December 31,

 

December 31,

 

 

 

December 31,

 

December 31,

 

 

 

NET SALES BY SEGMENT

 

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

%

 

 

 

For the Three Months Ended

 

 

 

For the Years Ended

 

 

 

 

 

December 31,

 

December 31,

 

 

 

December 31,

 

December 31,

 

 

 

NET SALES BY GEOGRAPHY

 

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

%

 

7




 

ev3 Inc.

NON-GAAP FINANCIAL MEASURES

(Dollars in thousands)

(unaudited)

 

 

 

For the Three Months Ended

 

For the Years Ended

 

 

 

December 31,

 

December 31,

 

December 31,

 

December 31,

 

 

 

2006

 

2005

 

2006

 

2005

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of net loss to EBITDA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss, as reported (GAAP basis)

 

$

(4,580

)

$

(21,976

)

$

(52,371

)

$

(110,024

)

 

 

 

 

 

 

 

 

 

 

Interest (income) expense, net

 

(224

)

(917

)

(1,695

)

9,916

 

Income tax expense

 

360

 

587

 

688

 

526

 

Depreciation and amortization

 

5,854

 

4,026

 

22,878

 

14,816

 

EBITDA

 

$

1,410

 

$

(18,280

)

$

(30,500

)

$

(84,766

)

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

1,580

 

1,795

 

7,153

 

4,873

 

 

 

 

 

 

 

 

 

 

 

EBITDA, adjusted for stock-based compensation

 

$

2,990

 

$

(16,485

)

$

(23,347

)

$

(79,893

)

 

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).

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