EX-99.2 3 a04-5116_1ex99d2.htm EX-99.2

Exhibit 99.2

 

 

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[LOGO]

 

Creating new pathways to enable the delivery of essential medical therapies

 

2004 annual meeting

 

4/29/2004

©2004 Enpath Medical Inc.  ® all rights reserved

 

[LOGO]

 

1



 

[LOGO]

 

Creating new pathways to enable the delivery of essential medical therapies

 

2004 annual meeting

 

4/29/2004

©2004 Enpath Medical Inc.  ® all rights reserved

 

[LOGO]

 

2



 

Forward Looking Statement

 

Certain of the statements contained in this presentation may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to Enpath Medical products and markets and operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks are detailed in reports that Enpath Medical has filed with the U.S. Securities and Exchange Commission (SEC) including the most recent Annual Report on Form 10-K

 

3



 

Vision Statement

 

Enpath Medical Inc.

 

A leader in the development and commercialization of innovative vascular access devices and stimulation lead technologies enabling the delivery and placement of pharmaceutical and device therapies to treat heart disease, cancer, and a variety of other medical conditions.

 

We market our products through partnering relationships with other medical device companies.

 

4



 

The New Enpath Medical Management Team

 

Jim Hartman

 

Chairman and Chief Executive

 

Joined company in 1991

 

 

Mark Kraus

 

President, Delivery Systems Division

 

15 years in medical device business, joined company in 1992

 

 

Vince Owens

 

President, Lead technologies Division

 

18 years in medical device business, led turnaround of BIOMEC Cardiovascular

 

 

Jim Mellor

 

Sr. Vice President, Sales and Marketing

 

20 years in medical device business, 15 with Medtronic leads division

 

 

Mike Erdmann

 

Controller and Secretary

 

Joined company in 1996

 

5



 

Growing Market Opportunity*

 

2003 :: $400 Million

 

[CHART]

 

2007 :: $875 Million

 

[CHART]

 


*Sources: MedTech Insight, Neurotech Reports, other industry reports & company estimates

 

6



 

Growth Drivers

 

 

Aging population (Baby boomers entering late fifties)

 

 

Trend from surgical toward minimally invasive procedures

 

 

More sophisticated delivery systems with higher average selling prices for emerging therapy advances

 

 

Cardiovascular

 

 

Heart failure, atrial fibrillation, septal defect repair, mapping and ablation

 

 

Neurological

 

 

Parkinson’s, epilepsy, pain management, incontinence, motor control

 

 

 

 

Product development pipeline fueled by relationships with key physicians

 

 

Alignment with market leaders

 

7



 

The New Enpath Medical

 

 

 

 

 

TODAY

 

1 YR AGO

 

 

 

 

 

 

 

Annualized Sales Run Rate

 

$

30 Million

 

$

19 Million

 

 

 

 

 

 

 

 

 

# of Customers

 

36

 

17

 

 

 

 

 

 

 

% of Business From Largest Customer

 

37

%

56

%

 

 

 

 

 

 

Market Opportunity Size

 

$

400 Million

 

$

150 Million

 

 

 

 

 

 

 

 

 

# of Patents

 

18

 

9

 

 

 

 

 

 

 

# of Employees

 

232

 

131

 

 

 

 

 

 

 

Stock Price

 

$

11.33

 

$

7.01

 

 

 

 

 

 

 

 

 

Satisfaction in Telling You This Story

 

 

 

PRICELESS

 

 

8



 

[LOGO]

 

Delivery Systems Division

 

[GRAPHIC]

 

9



 

Product Families

 

Traditional Introducers

 

[GRAPHIC]

 

Safety Products

 

[GRAPHIC]

 

Sophisticated Introducers

 

[GRAPHIC]

 

[GRAPHIC]

 

10



 

Current Delivery Systems Market Potential

 

[CHART]

 

Total company market potential in 2003 -$400 million

 

 

[CHART]

 

Total EDS market potential in 2003 -$150 million

 

11



 

Traditional Introducers

 

[GRAPHIC]

 

Venous Access

 

 

Worldwide Procedures per Market Segments ~ 3.7 million

 

 

 

 

Pacing - 1 million

 

 

 

 

Peripheral Infusion Catheters - 1.4 million

 

 

 

 

Ports and Chronic CVCs -950,000

 

 

 

 

Dialysis -345,000

 

 

 

 

 

 

Market share grew from 40% to 50%

 

 

Proprietary Devices at competitive prices

 

 

 

 

New products will continue our market share growth

 

12



 

Safety Products

 

Expanding distribution channel

 

Cook – opens new markets

 

 

 

Presence in 2000+ catheter labs

 

 

 

Arterial and venous access

 

Medtronic – 30% conversion to kits containing the needle

 

Feeding tube placement

 

 

 

Most of the GI companies are including the Axia needle in their PEG kit

 

[GRAPHIC]

 

13



 

New Product Launches

 

 

 

 

 

 

FlowGuard Valved Peelable Introducer

 

Commercial shipments underway

 

Dialysis catheter placement

 

All sizes will be released in Q3

 

Venous Introducer market share increase 2% - 5%

 

Price is 2x that of non-valved introducer

 

[GRAPHIC]

 

14



 

[GRAPHIC]

 

Safety Introducer

 

Used to introduce PICC lines

 

 

(peripherally inserted central catheter)

 

 

 

 

Combines safety needle with our traditional introducer

 

 

 

 

Preparing FDA submission

 

 

 

 

Initial discussions started with potential distribution partners

 

 

 

 

Market potential - $7.5 million

 

15



 

Catheter Based Introducers

 

 

 

 

 

 

[GRAPHIC]

 

 

 

 

 

 

Similar to traditional introducers; each:

 

has a delivery lumen

 

has a fixed shape

 

is disposable

 

 

 

Sophistication = enhanced functionality

 

Changes shape on demand (steering)

 

Longer and more flexible

 

High pressure arterial valve

 

 

 

Expertise in these devices

 

Patent pending steering mechanisms

 

 

 

Unique capability

 

Design => Production

 

Working with several high visibility medical device companies

 

16



 

Sophisticated Introducer Product Development

 

 

 

 

 

 

Enabling less invasive interventional procedures

 

 

Reduces the need for surgery

 

 

Cardiac Resynchronization Therapy (CRT)

 

 

Atrial Fibrillation

 

 

Septal Defects

 

 

Mitral Valve Repair

 

 

 

 

 

 

General purpose steerable catheter

 

Advantage to partners - test in human environment quickly

 

Utility in existing interventional procedures

 

 

Peripheral artery – 650K procedures / yr.

 

 

Renal artery – 90K procedures / yr.

 

 

Carotid artery – 19K procedures / yr.

 

17



 

Product Development Activities

 

 

 

 

 

 

1 company has started their clinical evaluation

2 companies have accelerated their development schedules

 

 

Expect to be in clinical study by the end of the year

Several companies in early development

Market release of 3 products anticipated in 2005

 

 

 

 

 

 

Prices are 10x to 50x more than a traditional introducer

 

 

Market Potential*

 

 

 

$275 million

 


*Based on our customer’s estimates

 

[GRAPHIC]

 

18



 

Major New Growth Opportunity

 

[CHART]

 

Total company market potential in 2007 -$875 million

 

[CHART]

 

Total EDS market potential in 2007 -$405 million

 

19



 

[LOGO]

 

Lead Technologies Division

 

[GRAPHIC]

 

20



 

Lead Technologies Division

 

[GRAPHIC]

 

Stimulation Leads

 

  Insulated wires with electrodes implanted permanently in the body to transmit electrical impulses from a generator (e.g. pacemaker) to a specific organ or nerve bundle.

 

  1.3 million stimulation leads sold in 2003 for CRM and Neuromodulation therapies.

 

[GRAPHIC]

 

21



 

Growing Market Opportunity* - Lead Technologies

 

2003 :: $250 Million

 

[CHART]

 

2007 :: $470 Million

 

[CHART]

 


*Sources: MedTech Insight, Neurotech Reports, other industry reports & company estimates

 

22



 

 

2004 Product Releases

 

[GRAPHIC]

 

Myopore RxTM

  Only drug-eluting suture-less lead for heart failure

•  Patented technology

•  Market opportunity for CRT growing from 12K units in 2003 to 24K units in 2007

•  Average selling price - $500 - $600

•  U.S. regulatory path: PMA with no new clinical data

•  European release – Q3, 2004

•  US market release – Q1, 2005

 

23



 

Fastac FlexTM

 

•  Less invasive steerable implant tool for MyoporeRxTM leads

 

•  Single-use device

 

•  Proprietary design

 

•  Market opportunity for CRT growing from 12K units in 2003 to 24K units in 2007

 

•  Average selling price - $350 - $450

 

•  U.S. regulatory path: Class I/510k exempt

 

•  US market release – Q3, 2004

 

•  European market release – Q4, 2004

 

[GRAPHIC]

 

24



 

Major New Growth Opportunities

 

 

 

 

 

 

[GRAPHIC]

 

 

 

 

 

 

Neurostimulation Leads

 

•  Developing next generation deep brain stimulation (DBS) lead

 

•  DBS lead market growing from $16 million in 2003 to $60 million in 2007

 

•  Contract development projects underway for emerging neurostimulation therapies

 

25



 

[GRAPHIC]

 

CRM Leads and Lead Adaptors

 

 

 

•  Next generation lead and delivery system for heart failure (CRT)

 

 

 

•  Endocardial leads with novel fixation method

 

 

 

•  Stimulation lead adaptors for new defibrillator/pacemaker standard

 

 

26



 

Lead Technologies Division – Future Potential

 

[PHOTO]

 

•  Talented employees focused on patient welfare, customer service, & product performance.

 

•  Small, agile, and responsive organization, focused on specific market segments.

 

•  Participate in rapidly growing CRT and Neuromodulation markets.

 

•  Aligned with market leaders and emerging companies in CRM and Neuromodulation markets.

 

•  Aligned with leading clinicians and world renowned healthcare institutions.

 

27



 

[LOGO]

 

Creating new pathways to enable the delivery of essential medical therapies

 

 

Financials

 

[GRAPHIC]

 

28



 

Consolidated Income Statement- 2003

 

(in millions)

 

2003

 

%

 

2002

 

%

 

Model

 

Sales

 

$

19.6

 

100.0

%

$

17.9

 

100.0

%

100.0

%

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

8.0

 

40.8

 

8.4

 

46.9

 

48.0

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

R & D

 

2.0

 

10.2

 

1.7

 

9.5

 

10.0

 

R & D write-off

 

2.7

 

13.8

 

 

0.0

 

0.0

 

Selling

 

1.0

 

5.1

 

0.5

 

2.8

 

5.0

 

G & A & other

 

2.1

 

10.7

 

1.7

 

9.5

 

10.0

 

Total

 

7.8

 

39.8

 

3.9

 

21.8

 

25.0

 

 

 

 

 

 

 

 

 

 

 

 

 

Pretax income

 

0.2

 

1.0

 

4.5

 

25.1

 

23.0

 

Income tax

 

0.1

 

 

 

(1.6

)

 

 

8.0

 

Net income

 

$

0.3

 

1.5

 

$

2.9

 

16.2

 

15.0

 

 

 

 

 

 

 

 

 

 

 

 

 

EPS-diluted

 

$

0.06

 

 

 

$

0.57

 

 

 

 

 

 

29



 

Consolidated Income Statement- Quarter One, 2004

 

(in millions)

 

Q1, 2004

 

%

 

Q1, 2003

 

%

 

Model

 

Sales

 

$

7.3

 

100.0

%

$

4.7

 

100.0

%

100.0

%

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

2.8

 

38.4

 

2.1

 

44.7

 

48.0

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

R & D

 

1.0

 

13.7

 

0.4

 

8.5

 

10.0

 

Selling

 

0.4

 

5.5

 

0.2

 

4.3

 

5.0

 

G & A & other

 

1.0

 

13.7

 

0.5

 

10.6

 

10.0

 

Total

 

2.4

 

32.9

 

1.1

 

23.4

 

25.0

 

 

 

 

 

 

 

 

 

 

 

 

 

Pretax income

 

0.4

 

5.5

 

1.0

 

21.3

 

23.0

 

Income tax

 

0.1

 

 

 

0.4

 

 

 

8.0

 

Net income

 

$

0.3

 

4.1

 

$

0.6

 

12.8

 

15.0

 

 

 

 

 

 

 

 

 

 

 

 

 

EPS-diluted

 

$

0.05

 

 

 

$

0.13

 

 

 

 

 

 

30



 

Balance Sheet Highlights (March 31, 2004 & 2003)

 

(in thousands)

 

 

 

 

 

Assets

 

Mar 31, 04

 

Mar 31, 03

 

Cash

 

$

283

 

$

6,371

 

Receivables, Inventory, Prepaids, Other

 

7,681

 

4,570

 

Property, Plant & Equipment, Net

 

6,586

 

5,153

 

Intangibles & Goodwill, Net

 

17,236

 

1,871

 

Total Assets

 

$

31,786

 

$

17,965

 

 

 

 

 

 

 

Liabilities & Shareholders’ Equity

 

Mar 31, 04

 

Mar 31, 03

 

Payables, Accrued Expenses, Taxes

 

$

1,889

 

$

1,544

 

Notes Payable Current

 

1,071

 

65

 

Long Term Liabilities

 

3,641

 

284

 

Shareholders’ Equity

 

25,185

 

16,072

 

Total Liabilities & Shareholders’ Equity

 

$

31,786

 

$

17,965

 

 

31



 

Primary Investment Considerations

 

Recognized market leader in:

Venous access introducers

Epicardial stimulation leads

Vascular access safety needles

Steerable introducers

 

Robust, proprietary product pipeline

 

Participation in rapidly growing markets

 

Highly focused and executable business model

 

Long-term supply agreements with industry leaders

 

Excellent financial position

 

Experienced management team

 

32



 

For additional information, please contact investor relations at Enpath Medical:  (763) 559-2613

 

investorrelations@enpathmed.com

 

 

Nasdaq: NPTH

 

33