Goldman Sachs MedTech Conference London – September …library.corporate-ir.net/library/17/175/175517/items/218319/2006... · Goldman Sachs MedTech Conference London – September

April 2006 1September 2006 1

Goldman Sachs MedTech ConferenceLondon – September 7th, 2006

Overview & Strategy

Marco Chiadò Piat, VP Corporate Development


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


Sorin Group today: a full range player in a €16 bncardiovascular market

Cardiac Surgery (CS)

Physician

Pathology -procedure

Market size2005 (€ bn)MarketCAGR 05-10

Market share (value)

Main players

Vascular Therapy (VT) Cardiac Rhythm Management (CRM)

Cardiac surgeon and team Interventional cardiologist Cardiologist / electro-physiologist

Coronary diseases (by-pass), valve dysfunction

Coronary occlusions (Angioplasty)

Arrhythmia, Heart Failure

2.1 6.3 7.8

3% 4.5% 10%

Oxys: ~40% WWHLM: ~50%WWMech.Valves: ~45% EU

~16% USTissue Valves: ~15% EU

IDE in US

Coated (non DES): ~4% EUDES (Janus): ~2% EU

Pacemakers: ~12% EUICDs: ~ 3% EUCRT-D: ~ 3% EU

Medtronic, Edwards, St. Jude, Terumo

J&J, Guidant, Boston Sc., Medtronic, Abbott, Terumo

Medtronic, Guidant, St. Jude, Biotronik


A broad and rich product pipeline (main launches)Approvals EU US JapanUS (IDE)

CRM• Ovatio CRT-D• Ovatio ICD• Hi Perf Brady• Hi Perf ICD• Hi Perf CRT-D

VT• Chrono• 2nd generation DES

Heart Valves• Tissue• Percutaneous:- Open Heart

- MIS- Interv. Appr.

CSCPB/HLM/ATS• HLM S5 • APOPS (New Extracorporeal

Circulation System)• New Generation ATS

2006Q1 Q2 Q3 Q4

2007Q1 Q2 Q3 Q4

2008Q1 Q2 Q3 Q4


Integrating a global presence …

…into one Sorin Group with strong worldwide product brands

…by manufacturing… …and by branding…

Cardiac Surgery

Wide, bestWide, best--inin--class product offering for class product offering for the cardiac surgeon and teamthe cardiac surgeon and team


Cardiac Surgery current product portfolio

Mechanical HV

Tissue HV

Annuloplasty Rings

Oxygenators

Heart Lung MachineAutotransfusion


Same valveSame valve for Surgical (MIS) andPercutaneous implant techniques

Use of a proven and well knownproven and well known biologicalstentless valve (Sorin Pericardial Stentless, in clinical use since 1985 with 30K implants andzero structural failures)

All non-biological surfaces coatedcoated with Carbofilm

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

Double tissue structure allows optimal sealingoptimal sealing

Sorin percutaneous heart valve projectMinimally Invasive Surgical Approach

Retrograde positioning

Beating heart approach

Apical puncturewith antegrade positioning

Transcatheter approach

Retrograde positioning


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

•• Expandable securing structure matching the Expandable securing structure matching the anatomy of the aortic root and anatomy of the aortic root and ValsalvaValsalva sinusessinuses

•• Valve support (non expandable)Valve support (non expandable)

StrengthStrength of securing stent and flexibilityflexibility of valve support can be controlled independently

Securing structure independent from Securing structure independent from valve supporting systemvalve supporting system

Double-structure armature

Optimal positioning in the Optimal positioning in the anatomical geometry anatomical geometry

SelfSelf--securing without stressing the securing without stressing the valvevalve


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


MEMO 3D: the most innovative semirigid annuloplasty 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


S5: ready to meet any challenge

S5 is expected to help hospitals achieve new industry standards for safety, functionality, flexibility and quality, thanks to:

• reducing line lengths and the possibility of hemodilution• no boot-up time, pumps are operable 3secs after turning the system on

(vs 180secs of competitors’ boot time)• acoustically differentiated alarms and information displayed on the high-

resolution touch screens • LCD display to be replaced during operation

Stöckert S5, the latest heart-lung machine generation of Sorin Group, just received US market clearance (launched in Europe in Oct.’05)

• 30 yrs of experience in developing and marketing HLM • more than 5600 HLM produced up today• global market leader: >50% market share worldwide

Vascular Therapy

A leader in vascular therapy through A leader in vascular therapy through development and marketing development and marketing

of innovative systemsof innovative systems


VT current product portfolio

DES

Non DES

Peripheral


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)


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


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

Cardiac Rhythm Management

Pacing Leadership to invest in future Pacing Leadership to invest in future innovation in Heart Failureinnovation in Heart Failure

André-Michel Ballester, President CRM BU


CRM current product portfolio

Brady

ICD

CRT-D

Leads


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) accelerated in H1 2006

• Growth > 35% in the US (05vs04) confirmed in H1 2006

• Ovatio launch in EU and US• Investment in Sales and Marketing (US focus)

The turnaround phase initiated in 2004 is well on its way with some early tangible results in 2005 and very promising in H1 2006:


CRM strategy: US focus• 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


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)


• 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% and allows the use of Dual Chamber ICDs without compromising patient safety

• 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


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 with an increased 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 Acceleration) heart contractility sensor: “monitoring the heart as a pump”

• Heart failure algorithms

• Ease-of-use


2007 – 2008 CRM milestones

OvatioSymphony

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

• US: AAIsafeR2 launched in May 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

Financials

5-year plan


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


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


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


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%

BU contribution to total revenues


5-10%

10-15%

5-10%

10-15%

60-65%

100%

product mix

geographic mix

COGS

cost reduc projects

volume

TOT PROF. GROWTH

Profitability key growth drivers• Volume• Improvement in Gross Margin thanks to a more profitable geographic mix (US vsEU), a more profitable BU/product mix (tachy, tissue valve and DES), and lower COGS• Cost reduction/manufacturing rationalization projects


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


Final remarksHealthy 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


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 69969 716

mailto:[email protected]

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Goldman Sachs MedTech Conference London – September …library.corporate-ir.net/library/17/175/175517/items/218319/2006... · Goldman Sachs MedTech Conference London – September