EX-99 2 a2141266zex-99.htm EXHIBIT 99

Exhibit 99.1

 

 

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[LOGO]

 

Process

 

Polymers

 

Products

 

Overview | August 2004

 

[GRAPHIC]

 



 

Safe Harbor Statement

 

This presentation may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended, and Section 21E of the Securities Exchange Act of 1934. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us and our affiliate companies, that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements.  Factors that might cause or contribute to such a discrepancy include, but are not limited to, those identified in our other Securities and Exchange Commission filing and other public documents, including our 2004 Annual Report on Form 10-KSB and our Quarterly Reports on Form 10-QSB, which can be found on our corporate Web site, www.cardiotech-inc.com.

 

[LOGO]

 

2



 

Company Overview

 

                  Recognized leader in pioneering innovative devices that enhance the treatment of cardiovascular disease

 

                  Manufacturing Capability

 

Based on a deep knowledge of polymer-based materials (biomaterials)

 

Manufactures and markets single-use, disposable cardio pulmonary bypass devices

 

Develops, manufactures, and sells a range of biomaterials for use in the manufacture of medical devices

 

Manufacturing for medical device companies

 

                  Research and Development

 

Advanced wound care products

 

Drug Eluting Stents

 

Synthetic Artery

 

3



 

Key Facts

 

Symbol

 

CTE (AMEX)

Corporate Headquarters

 

Wilmington, MA

Amex Listing

 

June 1996

Stock Price (7/20/04) and 52-Week Range

 

$3.89 || $3.20 to $7.20

Basic and Fully Diluted Shares Outstanding

 

17.4mm || 23mm

Float

 

14.9mm

Market Cap

 

$68mm

Volume (daily 90-day average)

 

68,102

Long-Term Debt (3/31/04)

 

$0

Insider Ownership Shares

 

22% of fully diluted

Institutional Ownership Shares

 

12% of fully diluted

Employees

 

160

Fiscal Year End

 

March 31st

 

4



 

Significant Events

 

 

 

 

 

 

 

 

 

Corporate History

 

 

 

Spinoff from PolyMedica (NASDAQ: PLMD)

June 1996

 

To develop synthetic artery and wound dressings

 

 

 

 

Acquisition of CDT

May 2001

 

To utilize biomaterials expertise in outsource market

 

 

 

 

Started synthetic artery (Coronary Artery Bypass Graft - CABG) clinical trials in Brazil

July 2003

 

Goal to obtain approval in Europe and US

 

 

 

 

Financings

 

 

 

Common Stock

December 1998

 

$2,500,000, proceeds used for working capital

 

 

1 common stock, 1 warrant ($2.75 per unit)

 

 

5



 

Capital Structure

 

$ in 000s

 

FYE
March 31, 2004

 

 

 

 

 

 

Cash and Equivalents

 

$

7,117

 

 

 

 

 

DEBT:

 

 

 

Senior Credit Facilities - RLOC

 

$

730

 

Other Senior Debt

 

$

0

 

 

 

 

 

NET DEBT(1)

 

$

0

 

 

 

 

 

TOTAL EQUITY

 

$

19,368

 

 

 

 

 

TOTAL CAPITALIZATION

 

$

19,368

 

 

 

 

 

DEBT / EQUITY

 

0.0

x

 


(1) Debt net of cash and equivalents

 

6



 

CTE Founder – Dr. Michael Szycher

 

                  Expert in Biomaterials

 

Recognized international authority on polyurethanes and blood compatible polymers

 

Co-invented the HeartMate, the best-selling artificial heart on the market

 

Developed the CardioPass synthetic coronary artery bypass graft

 

Editor of five books (and the author of three) related to biomaterials and medical devices - widely used in graduate biomedical engineering classrooms

 

                  Co-founded three successful companies

Thermedics in 1983 (sold to Thoratec)

PolyMedica in 1988 ($700 million market cap, $420 million revenue)

CardioTech in 1996

 

                  Educational Background

BS in Chemical Engineering, University of New Hampshire

PhD in Cardiac Physiology, Boston University School of Medicine

MBA, Suffolk University

 

7



 

Senior Management

 

                  Dr. Michael Szycher – Chairman & CEO

 

                  Leslie Taeger – CFO

 

                  Thomas Lovett – VP of Finance & Controller

 

                  Douglas Whittaker – President of GISH

 

                  Liann Johnson – General Manager of CDT

 

8



 

Corporate Organization

 

Manufacturing

 

                  GISH Biomedical, Inc.

Cardiopulmonary bypass devices

FY04 Revenue of $17.7 million, Market Size of $500 million

 

                  Catheter and Disposables Technology, Inc. (CDT)

Outsourcing for medical device companies

FY04 Revenue of $2.9 million, Market Size of $2 billion

 

Research and Development

 

Total estimated FY05 R&D Expense of $1.3 million

 

                  Biomaterials

Development of proprietary biomaterials

FY04 Revenue of $1.0 million, Market Size of $250 million

 

                  Dermaphylyx, Inc. (Wound Care)

Wound care and biomaterials

FY04 Revenue of $25 thousand, Market Size of $600 million

 

                  Drug Eluting Stents

Development of a coronary drug eluting stent

Market Size of $1 billion (international)

 

                  Synthetic Artery

Development of a Coronary Artery Bypass Graft (CABG)

Market Size of $1 billion

 

9



 

GISH Biomedical - Manufacturing

 

                  Acquired in 2003 for $8.7 million in an all stock transaction

 

                  Custom cardiovascular tubing systems, arterial filters, oxygenators

 

                  Competitive Advantages:

 

Gish “GBS” heparin coating reduces platelet adhesion and reduces systemic inflammatory response syndrome (SIRS)

Competition can only do one or the other – not both

 

                  Market Characteristics

$500 million worldwide market

Declining market; Gish gaining market share

 

                  Operating Results

 

($ in 000s)

 

Audited
FYE03

 

Audited
FYE04

 

Projected
FYE05

 

Revenue

 

n/a

 

$

17,781

 

$

19,000

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

n/a

 

$

4,582

 

$

5,300

 

 

                  Growth Strategy:

Establish GBS Heparin Coating as “Gold Standard”

Strategic Partnerships/Acquisitions

Increase foreign sales

 

10



 

CDT - Manufacturing

 

                  Acquired in 2001 for $1.3 million in cash

 

                  Outsourcing for medical device companies: design, development and manufacturing of medical products based on molded and extruded components.

 

Products include: sensing, balloon, and drug delivery catheters; disposable endoscopes; and in-vitro diagnostic and surgical disposables

Customer-base consists of industry leading medical device suppliers (Fortune 100)

 

                  Competitive Advantages:

Offer unique mix of R&D and manufacturing capabilities

 

                  Sales/Distribution performed by internal sales force

 

                  Market Characteristics

 

Highly Fragmented: Potential to cross-pollinate technologies via acquisition

 

                  Operating Results

 

($ in 000s)

 

Audited
FYE03

 

Audited
FYE04

 

Projected
FYE05

 

Revenue

 

$

2,343

 

$

2,966

 

$

3,300

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

$

964

 

$

1,092

 

$

1,300

 

 

                  Growth Strategy

Strategic acquisitions

Partnership opportunities

 

11



 

CDT – Acquisition Strategy

 

                  Candidate Attributes

Profitable operation

Outsourcing and manufacturing for the medical device market

Cross-selling opportunities

New customers and branded, quality products

 

                  Transaction Mechanics

 

Revenue Size:

 

$5M to $10 MM

Net Profit Margin:

 

10% to 20%

EBITDA Margin:

 

15% to 30%

Valuations:

 

4x-5x EBITDA

Purchase Method:

 

Combination of Cash and Stock

 

12



 

Research and Development

 

                  Biomaterials (polyurethanes, hyaluronic acid)

                  Wound Care

                  New Devices under development

                  Drug Eluting Stents

                  Synthetic Artery: Coronary Artery Bypass Graft (CABG)

 

13



 

Biomaterials – Research and Development

 

                  Sells proprietary biomaterials to medical device manufacturers for use in their products

 

                  Strategy

                  Introduce biomaterials into the marketplace via customers’ FDA approved medical devices

                  Develop a track record of safe usage with the FDA

                  Introduce the synthetic artery with our proprietary knowledge

 

                  Operating Results

 

($ in 000s)

 

Audited
FYE03

 

Audited
FYE04

 

Projected
FYE05

 

Revenue

 

$

1,051

 

$

1,028

 

$

1,200

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

$

307

 

$

441

 

$

450

 

 

                  Intellectual Property

                  42 patents

                  Polymer-based knowledge

 

14



 

Wound Care – Research & Development

 

                  Started marketing products in beginning of 2004

                  Moist wound (for bleeding wounds) and Blister-preventing products

 

                  Competitive Advantages:

                  Stops pain from a wound within approximately 2 minutes

                  Moist wound products absorb up to 400% of its weight in fluid

                  Hydrogels: Intelligent dressing (either absorbs or donates moisture)

                  Transparency allows more productive wound monitoring

 

                  Market Characteristics

                  $600 million annual worldwide market for Hydrogels and Alginates

 

                  Sales and Distribution are performed in-house

                  Manufacturing is outsourced

 

                  Business Operating Results

 

($ in 000s)

 

Audited
FYE04

 

Projected
FYE05

 

Revenue

 

n/a

 

$

200

 

 

 

 

 

 

 

 

Gross Profit

 

n/a

 

$

80

 

 

                  Growth Strategy

                  Medicare Reimbursement

                  Expand approvals into other market

 

15



 

Drug Eluting Stents – Research & Develop.

 

                  Partnership with CorNova was formed to develop a coronary drug eluting stent using the capabilities and technologies of CorNova (40%), Implant Services (30%), and CTE (30%)

                  CTE will contribute shares and technologies (no cash investment)

                  Share contribution expected at $750 thousand or less

 

                  Market Characteristics

                  $1 billion annual international market

                  450,000 stents used worldwide annually (CTE will market $900 stents)

                  Currently only two FDA approved drug eluting stents on the market

                  Current competitors market their products in the US for $3,000 – do not compete in Europe due to limited reimbursement of only $900

 

                  Growth Strategy

                  Gain CE marking by FY 2007

                  International market

 

16



 

Drug Eluting Stents – CTE Advantage

 

 

 

Radio
Opaque

 

In-House
Polymer

 

Generic Drug

 

Price
Point

 

Company

 

Yes

 

Slight

 

Yes

 

No

 

Yes

 

No

 

Amount

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Boston Scientific

 

 

 

X

 

 

 

X

 

 

 

X

 

$

3,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Johnson & Johnson

 

 

 

X

 

 

 

X

 

 

 

X

 

$

3,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CardioTech

 

X

 

 

 

X

 

 

 

X

 

 

 

$

900

 

 

Why is CTE better?

                  More opaque than the competition – more visible on x-rays

                  CTE owns the polymer – no royalty payments

                  Utilizes a generic drug – no royalty payments

 

17



 

Synthetic Artery – Research & Development

 

                  Synthetic Artery (CABG)

 

[GRAPHIC]

 

18



 

Coronary Artery Disease

 

Market Characteristics

 

                  60 million patients in the US

                  1 million deaths annually in the US

                  Treatment: diet, lifestyle changes, drugs, angioplasty, stents, and coronary artery bypass graft surgery

                  650,000 annual CABG surgeries performed worldwide

                  $1 billion worldwide market

 

19



 

Coronary Artery Disease

 

[GRAPHIC]

 

20



 

Saphenous Vein Harvest

 

[GRAPHIC]

 

21



 

Coronary Artery Bypass Graft (CABG)

 

                  CABG surgery is performed to treat the impairment of blood flow to portions of the heart by rerouting blood around blocked coronary arteries

 

                  Competitive Landscape:

                  CABG Medical - Development stage company, product is reliant on drug combination

                  Thoratec - Developer and manufacturer of medical devices, discarded CABG development attempts

                  No other direct competitors at this time

 

                  Why will CTE’s synthetic artery (CABG) work?

                  Polyurethane transparent to the blood and immune system

                  Elasticity

                  Non-kinking

                  Not reliant on drug combination

 

22



 

CTE Opportunity - CABG

 

                  Only Company in the world in human trials with CABG, CTE should have the first synthetic artery on the market

 

                  CABG Clinical Trial Approval Process

                  Currently in human clinical trials in Brazil

                  $1 million spent to date ($1.5 million total cost)

                  Enter trials in Europe in late 2004 (two years to approval)

                  $5 million budgeted to complete European trials

                  FDA approval could be obtained within three years

                  $10 million budgeted to complete the US trials

 

                  Once Europe and US approvals received, CTE will pursue 200,000 annual “no option” patients worldwide

                  CTE synthetic artery priced at approximately $1,500

 

                  Potential use as substitute for autogenous saphenous veins

 

23



 

Historical Performance

 

($ in 000s, except per share figures)

 

Audited
FY02

 

Audited
FY03

 

Audited
FY04

 

Revenue

 

$

3,220

 

$

3,394

 

$

21,799

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

Cost of Sales

 

1,954

 

2,123

 

15,670

 

Research and development

 

273

 

313

 

1,065

 

Selling, general and administrative

 

3,070

 

1,946

 

5,655

 

Severance payment (1)

 

0

 

0

 

372

 

Non-Cash compensation and research contract

 

0

 

19

 

1,171

 

Total Operating Expenses

 

5,297

 

4,401

 

23,933

 

 

 

 

 

 

 

 

 

Loss from Operations

 

(2,077

)

(1,007

)

(2,134

)

 

 

 

 

 

 

 

 

Other Income, net

 

106

 

44

 

619

 

 

 

 

 

 

 

 

 

Net Loss

 

(1,971

)

(963

)

(1,515

)

 

 

 

 

 

 

 

 

EBITDA (2)

 

(578

)

(724

)

1,190

 

 

 

 

 

 

 

 

 

Diluted earnings per share

 

$

(0.23

)

$

(0.11

)

$

(0.10

)

 


(1) Severance related to resignation of former GISH CEO

(2) EBITDA excludes non-recurring severance charge and non-cash compensation and research contract

 

24



 

FY05 Projections

 

($ in 000s)

 

GISH

 

CDT

 

Bio-
materials

 

Wound
Care

 

Corporate

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

19,000

 

$

4,000

 

$

1,500

 

$

200

 

$

0

 

$

24,700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

5,300

 

1,430

 

600

 

80

 

0

 

7,410

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

G&A Expense

 

1,200

 

430

 

0

 

0

 

1,400

 

3,030

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling Expense

 

2,450

 

275

 

0

 

130

 

0

 

2,855

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

R&D Expense

 

800

 

0

 

0

 

0

 

810

 

1,610

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Profit

 

850

 

725

 

600

 

(50

)

(2,210

)

(85

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income

 

$

810

 

$

745

 

$

600

 

$

(50

)

$

(2,060

)

$

45

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Results based on 23M shares

 

$

0.04

 

$

0.03

 

$

0.03

 

$

(0.00

)

$

(0.09

)

$

0.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sustainable Growth Rate

 

10

%

10

%

15

%

40

%

 

 

 

 

 


* Projected results include approximately $1.1M of non-cash operating charges, of which $960k relates to GISH and CDT.

 

25



 

Peer Group and Competition

 

Symbol (1)

 

Company

 

Price
26-Jul

 

Market
Cap

 

Revs.
ttm

 

EBITDA
ttm

 

EV /
EBITDA

 

EPS
ttm

 

P/E
Mult

 

Current FY Projection

 

EPS

 

Mult

ABMD

 

ABIOMED

 

$

9.16

 

$

197

 

$

26

 

$

(9

)

n/a

 

$

(0.45

)

n/a

 

n/a

 

n/a

 

ATSI

 

ATS Medical, Inc.

 

$

3.20

 

$

86

 

$

21

 

$

(14

)

n/a

 

$

(0.59

)

n/a

 

n/a

 

n/a

 

HRT

 

Arrhythmia Research Tech

 

$

10.02

 

$

26

 

$

8

 

$

2

 

11.5

x

$

0.50

 

20.0

x

n/a

 

n/a

 

CDIC

 

Cardiodynamics Intl.

 

$

3.89

 

$

185

 

$

35

 

$

3

 

49.9

x

$

0.07

 

53.3

x

$

0.10

 

38.9

x

HMP

 

Horizon Medical Products

 

$

1.45

 

$

64

 

$

29

 

$

3

 

26.6

x

$

(0.03

)

n/a

 

n/a

 

n/a

 

NOVT

 

Novoste Corp

 

$

2.23

 

$

36

 

$

49

 

$

(5

)

n/a

 

$

(0.47

)

n/a

 

n/a

 

n/a

 

POSS

 

Possis Medical, Inc.

 

$

24.95

 

$

453

 

$

68

 

$

17

 

26.8

x

$

1.00

 

24.9

x

$

0.61

 

40.9

x

VASO

 

Vasomedical, Inc.

 

$

0.96

 

$

56

 

$

23

 

$

(2

)

n/a

 

$

(0.05

)

n/a

 

n/a

 

n/a

 

ZOLL

 

Zoll Medical Corp

 

$

33.20

 

$

305

 

$

197

 

$

25

 

10.0

x

$

1.31

 

25.4

x

$

1.13

 

29.4

x

MDT

 

Medtronic, Inc.

 

$

48.90

 

$

59,140

 

$

9,090

 

$

3,300

 

18.0

x

$

1.60

 

30.6

x

$

1.89

 

25.9

x

Average

 

 

 

 

 

 

 

 

 

 

 

23.8

 

 

30.9

x

 

 

33.8

x

Median

 

 

 

 

 

 

 

 

 

 

 

22.3

x

 

 

25.4

x

 

 

34.1

x

CTE (2),(3)

 

CardioTech

 

$

3.70

 

$

65

 

$

22

 

$

1

 

51.1

$

(0.11

)

n/a

 

$

0.00

 

n/a

 

 


* $ in millions except per share figures

(1) Source: Peer Group and Competition results and estimates provided by Multex.

(2) EBITDA provided by Stonegate analysis - excludes one-time and non-cash charges.

(3) Current FY EPS based on Company projections.

 

26



 

Valuation Approach

 

                  Manufacturing Valuation (GISH and CDT):

                  EV / FY05 EBITDA multiple in-line with comparables

                  Organic manufacturing growth of 10% annually

                  Accretive acquisitions

 

                  Valuation Upside:

                  New products

                  Potential blockbuster with synthetic artery (CABG)

                  CABG Medical, Inc.: Pre-clinical development stage

                  Based on recent S-1 filing, IPO is expected to raise $30+ million for 34% ownership (total company valued at $85+ million)

                  Drug eluting stent

                  Wound care

 

                  Valuable Intellectual Property

                  Includes 42 patents

 

27



 

Summary

 

                  Biomaterials expertise

 

                  Profitable niche manufacturing business

 

                  Valuable Intellectual Property – includes 42 patents

 

                  Manufacturing Valuation (GISH and CDT):

                  EV / FY05 EBITDA multiple in-line with comparables

                  Accretive manufacturing acquisitions

 

                  Valuation Upside with Developed Products:

                  Potential blockbuster with synthetic artery (CABG)

                  Drug eluting stents

                  Wound care

 

28