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April 2006 1 May 2006 1 André-Michel Ballester, President Cardiac Rhythm Management BU Marco Chiadò Piat, VP Corporate Development Las Vegas May 16 th - 18 th , 2006
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Page 1: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 1

André-Michel Ballester, President Cardiac Rhythm Management BUMarco Chiadò Piat, VP Corporate Development

Las Vegas May 16th - 18th, 2006

Page 2: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 2

Disclaimer

This presentation contains management preliminary estimates and forward-looking statements, including information related to Sorin projected financial performance and the expected development of the med-tech industry, in particular in the cardiovascular and renal care segments. These statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, as of this date, though by their nature future estimates are uncertain and difficult to predict. Actual results or experience could differ materially from the information contained herein.

This communication does not constitute an offer or solicitation for the sale, purchase or acquisition of securities of any of the companies mentioned in any jurisdiction.

For more information please contact Sorin Investor Relations Department:[email protected] Telephone +44 020 7003 8730

+39 02 6332.201 - 316

Page 3: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 3

Sorin Group: the largest European cardiovascular medical device company• World leader in Cardiac Surgery; growing player in Cardiac Rhythm Managementand Vascular Therapy

• Competitive position in a large natural growth and technology-driven sector

• Proprietary technology platform across product portfolio

• Global footprint: global production, R&D, sales & marketing

Renal Care14%Cardiac Rhythm

Management25%

Vascular Therapy

5%

Cardiac Surgery

56%

Europe61%

North America23%

ROW9%

Japan7%

Revenue by Business Unit

Revenue by Geography

€ mm

Net RevenuesEBITDAEBIT

Net debt

2005

753.0

74.417.6

296.8

’04-’05 change

+4.4%

+24.8%n.m.*

* € -16.9M in FY04

Page 4: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 4

Integrating a global presence …

…into one Sorin Group with strong worldwide product brands

…by manufacturing… …and by branding…

Page 5: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 5

Leveraging expertise in CS to become a leader in CRM and VT

Over 40 years of experience in CS is the foundation for growing success in CRM

and VT:

– strong position in CS enables extraction of commercial synergies with

CRM and VT

– well-positioned to benefit from a future convergence between CS and VT

technologies: minimally invasive valve technology

Page 6: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

Cardiac Rhythm Management

Page 7: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 7

Latest CRM news

Ovatio DR & VR received FDA approval

• Commercial launch at HRS (Boston, 17th – 20th May):

“Ovatio, the smallest ICD in the market”

• First implant in US scheduled by the end of May

• US tachy growth expected to accelerate, as we have experienced in Europe (Ovatio CRT-D launched in Oct. 05, Ovatio ICD launched in Jan. 06)

Page 8: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 8

Sorin Group CRM strategy • Leverage strength in Pacing technology across all market segments (AAISafeR in Tachy, PEA in CRT)

• Establish presence as a rapid innovator in Tachy

• Become the Innovative Leader in Hemodynamic management of Heart Failure

• Defend margins by unique features (pricing) and industrial cost reduction (including cycle time reduction)

• Expand field coverage and competencies to improve our market position

• Focus on the introduction of ‘system’s’ (Leads, Programmers) which address the total therapy delivery requirements of our customers

• Growth > 50% in Tachy globally (05vs04)• Growth > 35% in the US (05vs04)• Ovatio launch• Investment in Sales and Marketing

The turnaround phase initiated in 2004 is well on its way with some early tangible results in 2005 and very promising in 1Q 2006:

Page 9: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 9

CRM strategy in US• Build on existing infrastructure:

Carbomedics/COBE (Sorin Group): 40+ years of CS history in USEla Medical (Sorin Group): 20+ years of CRM history in US

• New Management Team with solid CRM experience

• New and enlarged sales organization focused on large metropolitan centers

• Research partnership with leading teaching institutions

• Faster time to market, shortly after Europe (AAISafeR2, Ovatio)

• Encouraging initial results: >35% growth in 2005, >50% targeted growth in 2006

Page 10: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 10

Symphony Pacemaker/AAISafeR: Natural Rhythm

Symphony avoids unnecessary ventricular pacing and restores the natural rhythm of the heart

• Solution adapted to more patients than ANY other device available on the market

• Solution adapted to exercise

• Solution adapted to night variations

• Reduction of HF, AF and mortality risks +1% V pacing = +1% AF risk,

+10% V pacing = +20% HF risk

• Longevity is increased by 28 months

• AAIsafeR 2 virtually eliminates deleterious V pacing (< 0.2%)

• Unique comprehensive management for all paroxysmal AV blocks and permanent 1st degree AV block

• Build knowledge on AV conduction

• Diagnostic information will help choose the appropriate programming

• First to offer AAI pacing with complete dual chamber memorized data (AIDA + programmer)

Page 11: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 11

• Literature shows 50% of patients implanted with pacemakers receive unnecessary pacing of ventricle which may lead to atrial fibrillation and/or heart failure

Ovatio family: Best-in-Class size and therapy

* Comparison of the specificity of implantable dual chamber defibrillator detection algorithms F Hintringer, M Deibl, T Berger, O Paghinger, F X Roithinger PACE July 2004

Ovatio with AAIsafeR pacing algorithm reduces unnecessary Ventricular pacing to 0.2%.

• Literature shows up to 35% of ICD patients and 50% of young ICD patients receive inappropriate, painful shocks

Ovatio with PARAD+ the best overall specificity at 99% (1/100) avoids painful shocks*, and promotes painless anti-tachycardia pacing therapy (ATP)

Ovatio, the smallest devices in the market: 29cc ICD - 10.9 mm thin, 30cc CRT-D to improve patient comfort and safety

A cutting edge innovation that improves patient’s quality of life with the three best in class algorithms in the market : AAIsafeR, PARAD+, BTO

• Literature shows necessity to analyze slow VTs (which may need immediate therapy) at rates that can be achieved during exercise, and maintain ventricular resynchronization during exercise

OVATIO CRT with BTO (Brady-Tachy Overlap) zone, distinguishes slow VTs down to rates of 100 beats per minute but is still able to maintain resynchronization support to rates above this during exercise.

Page 12: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 12

2007 – 2008 New CRM platform devices (Hi Performance)

• Single platform for ELA & SORIN BIOMEDICA encompassing the “Best Of” product features of the twobrands (AAIsafeR, PARAD+,PEA)

• Improve gross margin: reduced production costs & low energy and high energy common platforms. • Automaticity: “implant & forget”• Flexible platform to address all patient and customer needs• Fully downloadable software for quick clinical update

Low power features• Builds on Symphony proven features: AAIsafeR, AIDA+, AF prevention algorithms

• The smallest pacemaker in the market: more integrated electronics lowering device size & increasing longevity

• Large Holter memory capacity (about 30-min EGMs)

High power features

Key basic features

• High energy output to address all patients needs

• Atrial therapies delivery

• PEA (Peak Endocardial Accelerator) heart contractility sensor: “monitoring the heart as a pump”

• Heart failure algorithms

• Ease-of-use

Page 13: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 13

2007 – 2008 CRM milestones

OvatioSymphony

• Europe: AAIsafeR launched in September 2003AAIsafeR2 launched in March 2005

• US: AAIsafeR2 launched in April 2005

• Japan: Regulatory submission in process

• Ovatio ICD launch dates:– Q1 2006 Europe and Q2 2006 USA– Q2 2007 for Japan

• Ovatio CRT-D launch dates:– Launched in Europe in October 2005 – Mid 2007 in USA (patients enrolment

completed in IDE study), Mid 2008 in Japan

Hi Performance

• 2H 07 Europe• 2H 08 US

Hi Performance

• 1H 07 Europe • 1H 08 US

Low power High power

Page 14: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

Cardiac Surgery

Page 15: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 15

• Same valve for Surgical (MIS) and Percutaneous implant techniques

• Use of a proven and well knownbiological stentless valve (Sorin Pericardial Stentless, in clinical use since 1985 with 30K implants and zero structural failures)

• All non-biological surfaces coated with Carbofilm

• Securing structures made by super-elastic alloys for self securing

• Double tissue structure allows optimal sealing

Sorin percutaneous heart valve projectMinimally Invasive Surgical Approach

Retrograde positioning

Beating heart approach

Apical puncturewith antegrade positioning

Transcatheter approach

Retrograde positioning

Page 16: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 16

The valve consists of two functionally independent structures (patent pending):

• Expandable securing structure matching the anatomy of the aortic root and Valsalva sinuses

• Valve support (non expandable)

Strength of securing stent and flexibility of valve support can be controlled independently

Securing structure independent from valve supporting system

Double-structure armature

Optimal positioning in the anatomical geometry

Self-securing without stressing the valve

Page 17: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 17

Open heartprocedure

(sternotomy)

Transcatheterapproach

(femoral artery/vein)

Beating heart approach

(apical/aortic puncture)

MIS procedure(thoracotomy)

Surgical approach(Cardiac Surgeon)

Interventional approach(Interventional Cardiologist)

1 Valve 4 Different Techniques 4 Systems

Project strategy

Page 18: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 18

MEMO 3D: the most innovative semirigid annuloplastic ring

MEMO 3DTM semirigid annuloplasty ring is the latest result of Sorin Group’s research into advanced, high-tech biomaterials and technologies for better patients outcomes:• The 1st Sorin Group Branded HV Product soon to be launched in North American & International Market

• Innovative cell-structure design, capable of mimicking the physiological three-dimensional motility of the native mitral annulus and accommodating the anatomical saddle shape

• Shape memory and super-elastic alloy core, aimed at restoring the native shape and function

• Sorin Group’s exclusive CarbofilmTM coating for enhanced haemo- and bio-compatibility

• Ease of implant, according to a pre-defined line and thanks to a particular configuration of the silicon filler

Page 19: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

Vascular Therapy

Page 20: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 20

Resolve major limitations of DES, such as late stent thrombosis (thanks to fast endothelialization)

Superior performance in specific disease segments (e.g. AMI: Acute Myocardial Infarction*):- 0% Late stent thrombosis- 2.2% all TLR- 3.0% all MACE

JANUS: unique targeted drug delivery

Targeted drug delivery

Non-targeted drug delivery

VSOther DES with polymer coating JANUS

Stent strutcross

sectionStent strut

cross section

Effective release

Ineffective release in the blood

• Literature associated increasing risks of late stent thrombosis with polymers on DES platform. No polymeric carrier for the drug. Carbofilm™ coated surface in contact with blood.

• Janus elutes drug (Tacrolimus) only toward the vessel wall, with pure drug loaded into reservoirs on the external surface of the stent.

• Quick vessel healing. Suitable for direct stenting.

• MASTER randomized clinical trial: PI Dr. Colombo + Dr. Garcia; focus on AMI patients, non inferiority trialvs another DES; first patient to be enrolled in Q3 ’06.

* 6-month data from e-Janus registry: results in higher risks AMI sub-group patients (133 out of 587)

Page 21: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 21

CHRONO and 2nd generation DES

• new stent design engineered to provide superior stent flexibility • unique Carbofilm coating• best-in-class deliverability: the new delivery system PTS (Progressive Transition System)provides improved pushability and trackability• precise positioning• higher mechanical strength and radiopacity than stainless steel • CE mark approval obtained in March 2006

2nd generation DES• CHRONO Cobalt Chrome stent platform • unique drug reservoirs technology • coated with the well proven haemocompatible Carbofilm • enhanced drug release kinetics• CE mark approval expected 1H 08

CHRONO, the new Cobalt Chrome Coronary Carbostent

Page 22: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 22

Janus outstanding outcomes in high-risks AMI patientsFocused clinical approach in AMI

Janus excellent safety profile and clinical benefits in “real-world” population

Long-term follow-ups in “real-world”

Unmatched clinical efficacy and angiographic outcomes of Tecnic-Chrono: 0% stent thrombosis, low clinical events, low LLL and angiographicdata in clinical trials“Tecnic is the best BMS on the market with low LL and excellent thromboresistance”MC Morice High Tech 25-26 January Marseille

Re-launch of benefits of Tecnic-Chrono platform

2006 Clinical strategy: Key Points

Page 23: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

Financials

Page 24: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 24

P&L targets

2010

Revenues

EBITDA

+ 8-9%*

+ 20-23%**

• Revenue growth strongly accelerates in 2008• Continuous EBITDA growth over planning horizon• 2006 revenue growth consistent with 2005 trends

EBITDA margin 15%-17%

753.0 + 9-11%**

74.4 + 19-21%*

9.9% 13%-14%

2005 2008

* 3yr CAGR** 5yr CAGR

Page 25: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 25

Revenues key growth drivers - by Business Unit

CRM

2006-2008 2009-2010

US: Increase ICD market share• Ovatio ICD approval

EU: Increase Tachy (ICD+CRT-D) market share• Ovatio family launched• Hi perf Brady approval

US: Increase CRT-D market share• Ovatio CRT-D approval• Hi perf. ICD and CRT-D approval

CSEU: Increase tissue valve market share

US: launch tissue valve• Mitroflow valve approval

EU: launch percutaneous valve• PVT valve approval

VTEU: Increase DES & non-DES market share• Focus on AMI patients for Janus• Repositioning of Tecnic/Chrono

EU: launch Janus 2nd generation

Page 26: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 26

100%

56%

25%

5%14%

30-35%

35-40%

15-20%

10-15%

2005 2010

CS

VT

CRM

RC

CRM and VT expected to grow rapidly…

CRM and VT as main growth drivers

… thus leading to a significant improvement in profitability

100%

Page 27: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 27

Revenues key growth drivers - by geographic areaRevenues growth in CRM and CS will be driven mainly by US, followed by Europe

CSex CPB

geographic mix

71%

13%

50-55%

30-35%

2005 2010

US+ 40 - 45%

Europe + 10 - 12%

US + 18 - 20%

Europe + 4 - 6% 49%

19%

40-45%

30-35%

2005 2010

2005-2010 cagr

CRM

geographic mix2005-2010 cagr

Page 28: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 28

Balance Sheet targets

2005 2008 2010

WC/RevenuesNet debt/Equity

55% 50-52% 46-48%

0.59 0.57-0.59 0.28-0.31

revenues geographic mix improvement

receivable mix improvement

integration plan implementation and supply chain rationalization

inventory level improvement

Page 29: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 29

Sorin Q1 06 results

Q1 06

(€ M)

Cardiac Rhythm Management

Vascular Therapy

Renal Care

18.4

6.3

EBITDA margin 9.4%

NET REVENUES

EBITDA

EBIT

Q1 06 vs Q1 05

at comparable FX

+1.0%

+22.7%

+6.7%

+2.6%

+12.0%

56.7%

Cardiac Surgery +1.6%

196.6

108.5

50.9

9.0

28.3

Q1 06 vs Q1 05

as reported

+2.3%

+24.1%

+9.6%

+2.5%

+14.3%

60.6%

+5.9%

Page 30: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 30

Final remarks

Healthy Growth• Focused growth in the fastest developing segments of the CV market (CRM and VT)• Balanced geographic growth focusing on US, Europe and Japan

Improved Profitability • Richer Product mix improving Gross Margins• Significant cost savings via manufacturing & organization restructuring

Relentless pursuit of Innovation• DES• Percutaneous valves• CRM: Ovatio and Hi-perf platforms

Solid 1Q ’06 results and Ovatio ICD FDA approval make us confident Sorin is moving in the right direction

Page 31: André-Michel Ballester, President Cardiac Rhythm ...library.corporate-ir.net/library/17/175/175517/items/218318/2006... · André-Michel Ballester, President Cardiac Rhythm Management

April 2006 1May 2006 31


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