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0000950137-09-000233.txt : 200901120000950137-09-000233.hdr.sgml : 2009011220090112171803ACCESSION NUMBER:0000950137-09-000233CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:33CONFORMED PERIOD OF REPORT:20090112ITEM INFORMATION:Regulation FD DisclosureITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20090112DATE AS OF CHANGE:20090112

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:ev3 Inc.CENTRAL INDEX KEY:0001318310STANDARD INDUSTRIAL CLASSIFICATION:SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]IRS NUMBER:320138874STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:000-51348FILM NUMBER:09522364

BUSINESS ADDRESS:STREET 1:9600 54TH AVENUE NORTHSTREET 2:SUITE 100CITY:PLYMOUTHSTATE:MNZIP:55442-2111BUSINESS PHONE:(763) 398-7000

MAIL ADDRESS:STREET 1:9600 54TH AVENUE NORTHSTREET 2:SUITE 100CITY:PLYMOUTHSTATE:MNZIP:55442-2111

8-K1c48649e8vk.htm8-K

e8vk

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January12, 2009

ev3 Inc.

(Exact name of registrant as specified in its charter)

Delaware

000-51348

32-0138874

(State or Other Jurisdiction

(Commission File Number)

(I.R.S. Employer

of Incorporation)

Identification Number)

9600 54th Avenue North, Suite100

Plymouth, Minnesota

55442

(Address of Principal Executive Offices)

(Zip Code)

(763)398-7000
(Registrants 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 thefiling obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))

o Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR240.13e-4(c))

Item7.01. RegulationFD Disclosure

Beginning on January12, 2009, representatives of ev3 Inc. (ev3) intend to make presentations atinvestor conferences and in other forums, which presentations may include the information containedin Exhibit99.1 attached to this current report on Form 8-K. ev3 is furnishing the informationcontained in Exhibit99.1 pursuant to RegulationFD. This information is furnished pursuant toItem7.01 of Form 8-K and shall not be deemed to be filed for the purposes of Section18 of theSecurities Exchange Act of 1934 (the Exchange Act), or otherwise subject to the liabilities ofthat section, nor shall it be deemed to be incorporated by reference in any filing under theSecurities Act of 1933, as amended (the Securities Act), or the Exchange Act, except as expresslyset forth by specific reference in such filing. ev3 expects to disclose this information, in wholeor in part, and possibly with modifications, in connection with presentations to investors,analysts and others during 2009.

The information contained in Exhibit99.1 is summary information that is intended to be consideredin the context of ev3s Securities and Exchange Commission (SEC) filings and other publicannouncements that ev3 may make, by press release or otherwise, from time to time. ev3 undertakesno duty or obligation to publicly update or revise the information contained in this report,although it may do so from time to time as its management believes is warranted. Any such updatingmay be made through the filing of other reports or documents with the SEC, through press releasesor through other public disclosure. By filing this report and furnishing this information, ev3makes no admission as to the materiality of any information in this report that is required to bedisclosed solely by reason of RegulationFD.

Item9.01 Financial Statements and Exhibits.

(d)Exhibits.

Exhibit

No. Description

99.1

Information Which May Be Disclosed by ev3 Inc. in InvestorPresentations (furnished herewith)

SIGNATURES

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

Dated: January12, 2009 ev3 Inc.

By:
Name:

/s/ Kevin M. KlemzKevin M. Klemz

Title:

Senior Vice President, Secretary

and Chief Legal Officer

ev3 Inc.
CURRENT REPORT ON FORM 8-K

EXHIBIT INDEX

Exhibit No. Description Method of Filing

99.1

Information Which May Be Disclosed byev3 Inc. in Investor Presentations(furnished herewith)

Furnished herewith

EX-99.12c48649exv99w1.htmEXHIBIT 99.1

exv99w1

Exhibit99.1

27th Annual J.P. Morgan Healthcare Conference

January 12, 2009

Forward-Looking Statements

Statements contained in this presentation that relate to future, not past, events areforward-looking statements under the Private Securities Litigation Reform Act of 1995.Forward-looking statements often can be identified by words such as "expect," "anticipate,""estimates," "intend," "will," "may," "believe," "could," "continue," "future," "outlook,""guidance," the negative of these words or other words of similar meaning and the use offuture dates. Forward-looking statements by their nature address matters that are, todifferent degrees, uncertain. Uncertainties and risks may cause ev3's actual results to bematerially different than those expressed in or implied by ev3's forward-lookingstatements. For ev3, particular uncertainties and risks include, among others, ev3's futureoperating results and financial performance, fluctuations in foreign currency exchangerates, ev3's ability to implement, fund and achieve sustainable cost savings measures thatwill better align its operating expenses with its anticipated net sales levels and reallocateresources to better support growth initiatives, the effect of the current global economiccrisis, the timing of regulatory approvals and introduction of new products, marketacceptance of new products, success of clinical testing, availability of third partyreimbursement, impact of competitive products and pricing and changes in the regulatoryenvironment. More detailed information on these and additional factors that could affectev3's actual results are described in ev3's filings with the Securities and ExchangeCommission, including its most recent annual report on Form 10-K and subsequentquarterly reports on Form 10-Q. Except as required by law, ev3 undertakes no obligationto update publicly its forward-looking statements.

Use of Non-GAAP Financial Measures

ev3 uses certain non-GAAP financial measures in this presentation, including "non-GAAP adjusted net income (loss)," "non-GAAP adjusted net earnings (loss) pershare," and "peripheral vascular net sales, excluding atherectomy." ev3 uses non-GAAP financial measures as supplemental measures of performance and believesthese measures provide useful information to investors in evaluating our operations,period over period. However, non-GAAP financial measures have limitations asanalytical tools, and should not be considered in isolation or as a substitute for ev3'sfinancial results prepared in accordance with GAAP. In addition, investors shouldnote that any non-GAAP financial measures ev3 uses may not be the same non-GAAP financial measures, and may not be calculated in the same manner, as that ofother companies. We have posted a reconciliation of our non-GAAP financialmeasures to the most directly comparable GAAP financial measures on our websiteat www.ev3.net.

ev3 Today

Medical device company with clear focus

endovascular treatments for Peripheral Vascular Disease (PV)

and Neurovascular Disease (NV)

Previous full-year 2008 revenue guidance of $418M to $423M*and adjusted EPS of $0.06 to $0.08*

Products sold in over 65 countries

Corporate headquarters in Plymouth, MN

other locations in Irvine, CA; Paris, France

1,250 employees worldwide as of December 2008

7

* Previous guidance provided on 10/31/08

Agenda

Strengths we are leveraging

Two growth platforms

Performance highlights

Pathway to profitable growth

9

2000-2007

2008

2009+

A Repositioned Company

Creation, growth

8 acquisitions

Transition year

integrating major

acquisition FoxHollow

Profitable growth

improving costs,

productivity

Broadest Product Offering

Plaque Excision

Peripheral Stents

Neurovascular Coils

Liquid Embolics

Access Devices

Balloons

World's Broadest Endovascular Product Offering

Embolic

Protection Devices

Solid Position in a $2B Market Worldwide

Peripheral Vascular

Disease (PV)

Neurovascular

Disease (NV)

1 Q3 2008; excludes research collaboration revenue

* 2008 - Internal estimates (PV market includes stents, atherectomy and PTA balloons only; NV market includes coils, liquidembolics and access devices only)

Business

WW Market Size

Customers

67% of revenues1

33% of revenues1

~$1.5B*

~$670M*

Vascular surgeons

Interventional cardiologists

Interventional radiologists

Neuro surgeons

Neuro interventionalists

Interventional

neuroradiologists

Direct Sales Organization

Large Worldwide Endovascular Sales Force

Peripheral Vascular

Neurovascular

Total

223

69

292

65 countries - direct in 15 major markets

17

Two Growth Platforms

Neurovascular

Business

Market Leader

Peripheral Vascular

Business

Large Worldwide Neurovascular Market

Market growing at ~15% annually, ev3 Q3'08 vs. Q3'07 up 26%

21 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 375 180 30 195

Total Market: $670M*

Market Drivers

Products treat/prevent strokes

3rd leading cause of death in US

Transition from surgical clippingto endovascular coiling

Improved imaging and detection

New products and improvedclinical outcomes for patients

* Hemorrhagic Stoke Market only; does not include ischemic stroke

Sources: Millennium Research Group, Frost and Sullivan, SEC Reports, ev3 Internal Estimates

Access

$230M

Liquid

Embolics

$40M

Coils

$400M

Worldwide Neuro Segments

ev3 Growth Drivers

Continuing to build #2 worldwide revenue shareposition in neurovascular

Continued penetration of AXIUM(tm)Progressive Coil System in U.S.

Launch of AXIUM(tm) PGLA and Nylon

Expansion into new internationalmarkets

New product offerings

Continued penetration of AXIUM(tm)Progressive Coil System and

Onyx(r) Liquid Embolic

Continued adoption of Onyx(r)Liquid Embolic for arterio-venousmalformations (AVMs)

Onyx(r) HD-500 Liquid Embolic forAneurysms

Access market: $230M

Liquid embolic market: $40M

Coil market: $400M

Sources: Millennium Research Group, Frost and Sullivan, SEC Reports, ev3 Internal Estimates

Primary Growth Driver 2008-2009:AXIUM(tm) Progressive Coil System

Unique progressive coil design - easily and completely filland pack the aneurysm

Proprietary I.D. Instant Detachment System

Strong growth and reordering in U.S.

Successful international launch in '08, including Korea, Brazil

Combines softness and stretch resistance

Precise, conformable deployment

Instant, reliable detachment

25

New AXIUM(tm) Microfilament Coil Systems

Enhanced microfilament technology creates lattice effect

enabling increased acute occlusion and packing volume

Designed to accelerate acute and long-term healing

Two microfilament versions: PGLA co-polymer and Nylon

Anticipate U.S. and European launch in 1H '09

Nylon

PGLA

New Onyx(r) Liquid Embolic Delivery Catheter

Apollo(tm) Micro-Catheter for delivery of Onyx Liquid Embolic

Detachable tip facilitates retrieval of catheter after delivering Onyx

Anticipate CE Mark and U.S. clearance in 2H '09

Detachable Tip

Future Neurovascular Growth Driver:

Solitaire(tm) Stent Platform

Unique design - self-expanding andfully retrievable prior to detachment

Existing platform for AneurysmBridging (AB)

Anticipate full international launch 2H'09

Potential platform for FlowRestoration (FR) in ischemic stroke

Large, untapped potential market -U.S. ischemic stroke incidence680,000 people annually*

SWIFT (Solitaire With ImmediateFlow ResToration) IDE study plannedfor 2H '09

* Source: American Heart Association

Not available for use in the United States

SOLITAIRE(tm) STENT

Inserted

Removing clot

Two Growth Platforms

Neurovascular

Business

Market Leader

Peripheral Vascular

Business

Market growing at ~6% annually, ev3 Q3'08 vs. Q3'07 up 19%*

Large Worldwide Peripheral Vascular Market

35 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 200 850 400

Stents

$850M

PTA

$400M

Atherectomy

$200M

Total Market: $1.5B

Market Drivers

100M people worldwideaffected

US 8M affected, only

2M treated

Failure to treat ?debilitating pain, increasedrisk for heart attack andstroke, amputation

Growing awarenessincreasing clinical evidence,new products

* Peripheral vascular net sales, excluding atherectomy; this is a non-GAAP financial measure. Fora reconciliation of ev3's non-GAAP financials, see ev3's website at www.ev3.net.

Sources: Millennium Research Group, IMS, SEC Reports, ev3 Internal Estimates

Note: Stents include self-expanding and balloon expandable

Worldwide Peripheral Segments

ev3 Growth Drivers

ev3: Well-Positioned in Key Peripheral Segments

DEFINITIVE Trial Series

Penetration of SilverHawk OUS

RockHawk System to treatcalcified lesions

Continued penetration

of EverFlex OUS

DURABILITY II IDE trial tosupport U.S. peripheral approval

Launch of EverCross & NanoCrossPTA balloons

Expansion to international markets

Stent market: $850M

PTA market: $400M

Atherectomy market: $200M

Sources: Millennium Research Group, IMS, SEC Reports, ev3 Internal Estimates

Note: Stents include self-expanding and balloon expandable

Next Generation PTA Balloons:

EverCross .035 and NanoCross .014

Innovative beveled tip profiles for best-in-class lesion entry

Broad range of sizes, including only 200mm length .035 balloonavailable worldwide

Access to key markets with significantly improved margins

Full global launch in progress

EverCross CrossTec(tm) Tip

NanoCross Bevel 360(tm) Tip

39

A Key Bridge to Broader Atherectomy Usage and Growth

D E F I N I T I V E T R I A L S E R I E S

Peripheral Endovascular

Specialists

Core User Group:

"Hawkers"

CLINICAL

DATA

TRIAL SERIES

Goal

Establish plaque excision as a front-line therapy

3 trials planned, enroll 600-900 patients

Continuing to Improve Performance

Net Sales

$65,060

$92,228

$101,257

$107,717

$107,029

Gross Profit

$41,963

$57,200

$67,639

$71,528

$68,747

Gross Margin

64.5%

62.0%

66.8%

66.4%

64.2%

Net Loss

$(36,512)

$(107,867)

$(9,770)

$(27,422)

$(7,310)

Adjusted net EPS (loss)per diluted share*

$(0.50)

$(0.25)

$0.03

$(0.05)

$0.04

GAAP EPS (loss)

$(0.60)

$(1.06)

$(0.09)

$(0.26)

$(0.07)

Q3 2007

Q4 2007

Q1 2008

Q2 2008

Q3 2008

$000's except EPS

* All quarters presented are adjusted for amortization and non-cash stock-based compensation. Q2 2008 is also adjusted for anon-cash research collaboration asset impairment charge. For a reconciliation, see our website at www.ev3.net.

Adjusted net income(loss)*

$(30,090)

$(24,979)

$3,204

$(5,130)

$3,850

Q1 Q2 Q3 East 57 38.7 45.9

2008

Balance Sheet is Strengthening

Cash / Short Term Investments

Cash increased

$7.2M Q3 '08 vs Q2 '08

Inventory days down 19%in Q3 '08 vs Q2 '08

Total debt is minimal

at $9.6M

45

Pathway to Profitable Growth

Long-term

profitable

revenue

growth

Improve

cost

structure

Increase

sales force

productivity

Grow

international

sales

Clinical

evidence

New

products

1

2

3

4

5

1. Improve Cost Structure - Continuing Progress Q3 07 Q3 08 East 0.7 0.5

SG&A

% of sales

R&D

% of sales Q3 07 Q3 08 East 0.16 0.113

~$70M cost savings in 2007-08 from FoxHollowintegration

Additional reductions in COGS and SG&Aplanned in 2009

Continued focus on improving margins

49

2. Increase Peripheral Vascular Sales Force

Productivity in U.S.

Annualized Net Sales Per Territory

Key Drivers

AtherectomyClinicalSpecialists

CorporateAccountpenetration

ReferralMarketdevelopment

DEFINITIVEclinical data

Neuro business already > $2M per territory

51 Q4 Q1 Q2 Q3 Goal East 1.3 1.4 1.5 1.5 2

2003 2004 2005 2006 2007 2008 Forecast East 30 44 62 81 107 140

3. Continue Strong Momentum in International

*Translated to U.S. Dollars at the applicable or estimated foreign exchange rate for the periods presented

53

International Revenue*

($M)

36%

CAGR

4. Broad Clinical Trial Initiatives

to Support Procedure Adoption

Designed to expand clinical evidence, support regulatory

clearances and expand product indications

Clinical Name

Clinical Trial Description

Study Timeline

SWIFT

Ischemic stroke flow restoration; Safety: Device-relatedand procedure-related serious adverse events; Efficacy:Revascularization measured by TIMI score of 2 or 3.

Beginning

2H 2009

55

RACER

Post-approval study for Axium(tm) to generate clinical data.Also may be used for Japan submission.

Enrolling

Clinical Name

Clinical Trial Description

Study Timeline

CREATE PAS

Post-approval study for PROTEGE(r) RX

and SpiderFX in carotid arteries.

Enrolling

Neurovascular Division

Peripheral Vascular Division

DURABILITY II

IDE study of single PROTEGE(r) EverFlex(tm) Stent (20-200mm) in long SFA lesions (4-18 cm).

Enrolling

DEFINITIVE(tm) Ca++

To evaluate SilverHawk(r) and SpiderFX(tm) in the treatmentof lower extremity (SFA/Popliteal) calcified lesions.

Enrolling

DEFINITIVE(tm) LE

Post-market non-randomized study of SilverHawk(r) in thetreatment of femoropopliteal and tibial arteries.

Beginning

1H 2009

5. New Products Driving Growth

57

Axium PGLA, Nylon Coil

Apollo

Detachable Tip Microcatheter

New Access Products

Solitaire AB stent

Aneurysm Bridging

RockHawk Atherectomy System

TurboHawk

PowerCross Guiding Catheter

1st Half 2009

2nd Half 2009

Europe

U.S.

Int'l

China

Europe

U.S.

Int'l

China

u

u

u

u

u

u

u

u

u

u

u

u

u

u

u

u

PTA .018 Balloon

EverCross .035 and

NanoCross .014 PTA balloons

u

u

u

u

u

u**

u**

u*

u*

u*

u*

u*

u*

u

u1

1 AXIUM bare metal coil

* Pending U.S. 510(k) clearance

** Limited launch

Why Invest in ev3

I N S U M M A R Y

59

Broadest product offering in $2B growing global market

largest pure-play in endovascular market

Clear roadmap for sustained, profitable growth

improved costs, productivity, clinical evidence, new products

Company refocused in 2008 to achieve future profitability

completed FoxHollow integration, developed sharper focus

27th Annual J.P. Morgan Healthcare Conference

January 12, 2009

GRAPHIC3c48649c48649z0001.gifGRAPHIC

begin 644 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