sorin 16.01.04 analyst presentation x...
TRANSCRIPT
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Analyst Presentation
Milan - January 16, 2004
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This presentation contains management preliminary estimates and forward-looking statements, including information related to Sorinprojected 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 securitiesof any of the companies mentioned in any jurisdiction.
DISCLAIMER
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AGENDA
• Background and history of the Sorin Group
• Umberto Rosa, Chairman
• Achievements to date and current performance
• Drago Cerchiari, CEO
• Aldo Lombardi, CFO
• The new Sorin: market-driven strategy and aligned organization
• Drago Cerchiari, CEO
• Eric Beard, President International
• Bruno Inguaggiato, President CRM
• Stefano Rimondi, SVP RC
• Franco Vallana, President CS
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SORIN GROUP PROFILE
• The Sorin Group, created through the demerger of Snia’s biomedical operations, is the largest cardiovascular medical device group in Europe
• The Sorin Group operates in the following segments of the medical technology market:
– Cardiac Surgery (CS)
– Vascular Therapy (VT)
– Cardiac Rhythm Management (CRM)
– Renal Care (RC)
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MILESTONES: HOW WE CREATED THE NEW SORIN GROUP
Jan 2004
Listing on MTACompany Foundation Entering the Sorin Group
70’s 200240’s . . . 60’s 80’s 1992 1999 20032001
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CARDIOVASCULAR: A LARGE AND FAST GROWING MARKET
• € 14 billion Cardiovascular market, high-growth expectations due to:
- Aging population and changes in lifestyle = expanding customer base and increasing penetration rate
- Economic development and wealth distribution = new geographical markets, increasing market size
- Technological innovation = new and less invasive therapies, driving demand for new products with higher ASP
• Significant barriers to entry = competition restricted to established players
An attractive business with significant and sustainable growth
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KEY FACTS
• 2003E Net Revenues of € 715 million
• 4,800 employees
• 500+ patents and 1,000+ trademarks
• 450+ R&D people across Europe and North America
• Excellence in technology built on 30+ years of experience
• 5,000+ health care centers served, approx. 900 salespeople
• Over 1 million cardiovascular devices sold and over 3.5 million dialyzers per year
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AGENDA
• Background and history of the Sorin Group
• Umberto Rosa, Chairman
• Achievements to date and current performance
• Drago Cerchiari, CEO
• Aldo Lombardi, CFO
• The new Sorin: market-driven strategy and aligned organization
• Drago Cerchiari, CEO
• Eric Beard, President International
• Bruno Inguaggiato, President CRM
• Stefano Rimondi, SVP RC
• Franco Vallana, President CS
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WHAT WE HAVE ACHIEVED TO DATE
What we have achieved to date: a global presence in the most attractive segments of Cardiovascular
The new Sorin: leveraging key assets to achieve sustained profitable growth
• Development of key assets
• Some key factors limiting performance
BUT …
• Market-driven strategy
• Aligned organization
AND …
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KEY ASSETS
WW technological and commercial leadership in Cardiac Surgery
Strong technology and intellectual property platform also in high growth segments (Vascular Therapy, Cardiac Rhythm Management)
Unprecedented product reliability
1
2
3
Global reach
4
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KEY ASSET - WW LEADERSHIP IN CARDIAC SURGERY
• 21% WWLeading market share (both in Cardiopulmonary and valves)
Leading market share (both in Cardiopulmonary and valves)
• 80 countries
• 400+ dedicated direct salespeople Global and effective distribution networkGlobal and effective distribution network
• Excellence in design-to-manufacturing process • Low costs in cardiopulmonary
• High quality valves
Excellence in manufacturingExcellence in manufacturing
• Synergy: the new mini by-pass system• Soprano: tissue valve with optimal haemodynamics
• Revolutionary Percutaneous valve technology
Strong R&D pipeline due to continuous innovation
Strong R&D pipeline due to continuous innovation
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KEY ASSET - STRONG TECHNOLOGY IN HIGH GROWTH SEGMENTS: CARBOFILMTM APPLICATION IN STENTS
Market need / opportunity
• Stents (used to treat coronary artery desease) are among the largest and fastest growing product segments in Cardiovascular
• Stents can cause thrombosis if not completely biocompatible
• One of the most important clinical needs is minimize the risk of thrombosis
Sorin solution: CarbofilmTM
coating for stents
• CarbofilmTM, a thin film of turbostratic carbon, originally developed by Sorinfor heart valves
• It has been proven to be one of the most bio-compatible materials with excellent mechanical properties and manufacturability
Impact
• 180,000 stents implanted so far
• 7,000+ patients in 14 clinical studies/34 centers
• Zero thrombosis
2
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PEA (Peak Endocardial Acceleration)
AAIsafeR
Alto 2
• An implantable sensor that can measure the actual beating of the heart and thus provide the right therapy both for brady and tachy arrhythmias
• The only algorithm that paces the heart physiologically (i.e. from the atrium) avoiding unnecessary ventricular stimulation
PARAD/PARAD+• Proprietary software that
discriminates fibrillation episodes (potentially lethal) from physiological heart rhythm accelerations
Market need/opportunity
• CRM, € 6.6 bn market growing at 11% per year
• Increasing importance of “intelligent” devices that clearly diagnose heart electrical activity, delivering as needed stimulation
Sorin solutions
KEY ASSET - STRONG TECHNOLOGY IN HIGH GROWTH SEGMENTS: CRM
2
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KEY ASSET - UNPRECEDENTED PRODUCT RELIABILITY: THE HEART VALVES EXAMPLE
• 30+ years of experience
• 750,000 implants since the 70’s
• Approx. 40 million cycles (open/close) per year
Zero structural defects
• Superior haemodynamics and design skills
• Fully integrated manufacturing process
• Impeccable quality control
• Carbon coating skills
3
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KEY ASSET - GLOBAL REACH
• 11 brands with strong global reputation
• 1,000+ trademarksBrand portfolioBrand portfolio
• Direct and indirect sales force in approx. 80 countries worldwide
• Approx. 900 salespeople worldwide
Sales and distributionSales and distribution
• European and US production sitesManufacturingManufacturing
• 450+ R&D people across Europe and North America
• Approx. 60 joint projects with universities and hospitals worldwide
Research centersResearch centers
4
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FACTORS LIMITING SORIN PERFORMANCE
... but synergies and integration potential still to be fully captured
Multiple acquisitions
... but relatively lower focus on marketing and time-to-market
Strong technology focus
... with management focus not fully dedicated to medical technology
Part of a diversified holding company
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0
100
200
300
400
500
600
700
800
1998 1999 2000 2001 2002 2003E
0%
5%
10%
15%
20%Net Revenues% EBITDA
Size doubled in 5 years, growthmainly driven byacquisitions, but:
• Declining profitability
• Flat 2003 to 2002 Net Revenues
RECENT PERFORMANCE€ mm
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FINANCIAL HIGHLIGHTS€ mm
Net Revenues
EBITDA3
EBIT
Net income
EBITDA margin
EBIT margin
Net debt
Shareholders’ equity
Gearing
(1) 2002 Pro-forma accounts to reflect retroactively the capital increase, the dividend payment and the partial proportional demerger; 2002PF does not include Carbomedics (acquired on 21.01.2003). 9 months ended 30/09/2003 PF accounts to reflect retroactively the partial proportional demerger.
(2) Before goodwill amortization and grants(3) EBITDA equals EBIT plus depreciation and amortization, write -downs and provisions
2002 PF1
671.9
98.8
37.0
14.9
14.7%
5.5%
172.1
467.0
0.37
2003E
~ 715
~ 12%
~ 2%
~ 310
n.a.
n.a.
9m ended30/09/2003 PF1
Gross profit2
Gross profit margin
317.0
47.2%
527.3
61.9
9.3
-15.4
11.7%
1.8%
317.6
n.a.
n.a.
47.2%
249.0
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NET REVENUES
2002 Exchange rate effect
Change in consolidation area*
Operations 2003E
(33)
715672
80
* Carbomedics and Soludia
(4)
Variance analysis 2003E vs 2002€ mm
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SALES BY GEOGRAPHY AND BUSINESS UNITPercent
* 100% = € 527.3 mm as of 30 September 2003
23.8
7.4
9.2
59.6 23.1
3.3
59.1
14.5
Europe
North America
Japan
RoW
Cardiac Rhythm Management
Renal Care
Vascular Therapy
Cardiac Surgery
By Geography * By Business Unit *
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CAPITAL STRUCTURE
Total capitalisation and gearing Net debt (30/09/2003PF)
441.6467.0
324.4
172.1
73%
37%
0
100
200
300
400
500
600
700
800
900
0
10
20
30
40
50
60
70
80
Net debt
Shareholders' equity
Gearing
€ mm
• Long term debt includes € 146.9 mm for the financing of recent acquisitions
• Net debt as of 31.12.2003 is expected around € 305-310 mm
€ 317.6 mm
ST Net Debt LT Debt Net Debt2002 PF 1H03 PF
164.7
152.9
317.6
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AGENDA
• Background and history of the Sorin Group
• Umberto Rosa, Chairman
• The new Sorin: market-driven strategy and aligned organization
• Drago Cerchiari, CEO
• Eric Beard, President International
• Bruno Inguaggiato, President CRM
• Stefano Rimondi, SVP RC
• Franco Vallana, President CS
• Achievements to date and current performance
• Drago Cerchiari, CEO
• Aldo Lombardi, CFO
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THE NEW SORIN
• Development of key assets
• Some key factors limiting performance
BUT …
What we have achieved to date: a global presence in the most attractive segments of Cardiovascular
The new Sorin: leveraging key assets to achieve sustained profitable growth
• Market-driven strategy
• Aligned organization
AND …
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CARDIOVASCULAR: WHERE WE START FROMCardiac Surgery (CS)
Physician
Pathology -procedure
Market size2003 (€ bn)
CAGR 03-08
Market share
Main players
Vascular Therapy (VT) Cardiac Rhythm Management (CRM)
Cardiac surgeon and team
Interventional cardiologist/radiologist
Cardiologist / electro-physiologist
Coronary diseases (by-pass), valve dysfunction (replacement and repair procedures), heart transplant
Coronary and vascular occlusions (Angioplasty)
Arrhythmia, Heart Failure
1.8 5.6 6.6
5% 11% 11%
• Europe: 36%• North America: 14%• WW: 21%
• Europe: 3.1%• WW: 0.5%
• Europe: 8.1%• North America: 0.4%• WW: 2.2%
Medtronic, Edwards, Guidant, St. Jude, Terumo
J&J, Guidant, Boston Sc., Medtronic, Abbott, Terumo
Medtronic, Guidant, St. Jude, Biotronik
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CARDIOVASCULAR: 04-08 MARKET-DRIVEN STRATEGY
Sorin group vision
A recognized worldwide leader in haemodynamics and a true innovator in Cardiac Rhythm Management by building on leadership in Cardiac Surgery and delivering on innovation
Vascular Therapy
Cardiac Rhythm
Management
Cardiac Surgery
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CARDIAC SURGERY: 04-08 MARKET-DRIVEN STRATEGY
Cardiac Surgery
• Innovate and extend product range
• Expand in underpenetratedgeographies
• Leverage commercial synergies in the US (Cobe/Carbomedics in mechanical valves) and worldwide
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CS: STRATEGY BY PRODUCT SEGMENT
Market CAGR2003-2008 (%)
Minimally invasive
Annuloplasty rings
Tissue valves
Mechanical valves
Perfusion disposables & equipments
10 20 30 400 5 15 25 35
Sorin 2003 WW market share (%)
Maintain leadership• Innovate
product range– Mini by-pass– Broader CS
product range
• Improve market share in US through Cobe/ Carbomedicsintegration
Market size
~€ 100 mm
~€ 500 mm
-5
0
5
10
15
20Leverage leadership in perfusion and mechanical valves to penetrate high growth segments• Leading
technology in tissue valves
• Technologies across BUs to develop minimally invasive devices
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SYNERGY: A REVOLUTIONARY MINI BY-PASS SYSTEM
• State-of-the-art cardiopulmonary system that integrates in a single unit all the main elements of a cardiopulmonary by-pass
• Lower patient blood dilution and related side effects
• Utilisation in both traditional by-pass and beating-heart surgical procedures; optimal to address paediatric patients
• Already launched in US (Premium pricing)
• Physiological/less invasive extracorporeal circulation
• Symplification of cardiopulmonary by-pass set-up
Customer requirements for still-heart surgery
Synergy
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• Pericardial tissue valve for the aortic position, with superior haemodynamicperformance
• Supra-annular seating allows for the maximization of blood flow
• Patented detoxification process
• Over 18 years of clinical experience with bovine pericardium heart valves
• Prosthesis wrapped on a percutaneous catheter and introduced through femoral access (no chest opening)
LEADING TISSUE VALVES TECHNOLOGY TO BE APPLIED TO PERCUTANEOUS HEART VALVE REPLACEMENT
Leading Tissue valve technology Revolutionary Percutaneous valve
Today … Tomorrow …
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VASCULAR THERAPY: 04-08 MARKET-DRIVEN STRATEGY
• Maximize the potential of our innovative technologies to become a player in the highest growth segments
Vascular Therapy
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-40
-30
-20
-10
0
10
20
30
40
VT: STRATEGY BY PRODUCT SEGMENT
Drug eluting stents
Peripheral stents
Market CAGR2003-2008 (%)
Sorin 2003 WW market share (%)
10 20
Passive stents
1550
Market size
~€ 0.3 bn
~€ 1 bn• Marketing and
clinical investments to prove superiority of Sorin stents (in particular on thrombosis and restenosis)
• Explore partnerships to maximize US value and to develop peripheral stents
Unique proprietary Carbofilmtechnology ensures zero thrombosis rate on all Sorin stents
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JANUS DISTINCTIVE FEATURES
Janus: the Sorin solution
Customer requirements for Drug Eluting Stents (DES)
• Further reduce restenosis rate
• Eliminate risk of thrombosis
• Avoid unwanted impact of drugs
Drug releasing sculpture
Integral Carbofilm coating
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Carbofilm
Coating
Stent
Architecture
Drug Loading
Process
Drug Eluting
Machine
2 European Patents
6 US Patents
1 European Patent (1 pending)
1 US Patent (1 pending)
3 European Patents (2 pending)
2 US Patents (2 pending)
4 European Patents (3 pending)
3 US Patents
JANUS CARBOSTENT INTELLECTUAL PROPERTY COVERAGE
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CARDIAC RHYTHM MANAGEMENT: 04-08 MARKET-DRIVEN STRATEGY
• Launch of newly registered technologies worldwide– Grow CRM in US– Gain market share in
Europe in ICD and CRT-D– Extract synergies from
ELA integration (Manufacturing, R&D, Sales & Marketing)
CRM
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-10
-5
0
5
10
15
20
25
30
35
CRM: STRATEGY BY PRODUCT SEGMENT
CRT-D
ICD
10 205 150
Market CAGR2003-2008 (%)
Sorin 2003 ww market share (%)
• US: accelerate CRT-D FDA approval
• EU: leverage position in pacemakers to push new product range:
– Alto 2 ICD, with reduced size (39cc), launched in 2003
– Alto 2 MSP CRT-D to be launched in EU in 2004
– PEA: potential applications for ICD and CRT-D
Market size
~€ 1 bn
~€ 2 bn
• Focus on marketing of Sorin outstanding technology:
– Symphony, the highest standard in pacing, launched in 2003
– AAIsafeR proprietary algorithm
Pacemaker
• Full integration of electronic platform (GXD 2)
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NEW CRM PRODUCT RANGE
• SYMPHONY - The highest standard in pacemaker functionality: wide range of therapies, efficient AF prevention, small (24gr, 10.5 cc, 6.4 mm) and long lasting (8.7 years)
• Launched in 2003
Pacing
• ALTO 2 - Reduced size (39cc)
• Prevention algorithms and improved programming SW• Launched in 2003
ICD
• ALTO 2 MSP - High voltage device for Congestive Heart Failure by means of Cardiac Resynchronization Therapy
• To be launched in EU in 2004
CRT-D
• New common platform for all devices (Sorin & ELA brands)
• Low current consumption, large scale data memory, fast telemetry• To be launched in 2005
GXD 2 Platform
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GROW CRM IN US
• US CRM market = 70% of worldwide market, highly profitable
• Majority of CRM product range already FDA approved
• Sorin already possesses strong assets in US:
– Reputation (ELA, Cobe, Carbomedics)
– Relationships with leading customers
– Managerial infrastructure (incl. Regulatory and Clinical affairs)
• Speeding-up approval of new product range
• Gaining market acceptance through a dedicated clinical development team
• Leveraging existing CS infrastructure and customer relationships
• Further developing a direct salesforce in selected areas
• Developing partnerships to increase distribution coverage
Why How
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RENAL CARE: STRATEGY BY PRODUCT SEGMENT
-5
0
5
10
Solutions, blood lines & ancillaries
Haemodialysismachines
Market CAGR2003-2008 (%)
Sorin 2003 European market share (%)10 20
Dialyzers
1550
Market size
~€ 0.1 bn
~€ 0.5 bn
• Expansion of product range
• Synthetic membrane dialyzers• New up-to-date
machine
• Bio-feedback
• Innovative, single-patient tailored dialysis techniques (e.g., Haemodiafiltration on-line)
• Technology cross-fertilization: new business opportunities in treatment of other diseases (e.g., Congestive Heart Failure)
• “All powder” concentrate
• Captive lines
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EXECUTION BY AN ALIGNED ORGANIZATION
Focus on extracting synergies from integration (revenues and costs)
Customer-centric organization
Strengthened management team
1
2
3
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Cardiac Surgery Vascular Therapy Cardiac Rhythm Management
G&A costs• Reduction of legal entities• Rationalization and consolidation of overheads• Centralization of common purchasing
Manufacturing costs
• Rationalize/specialize sites by core manufacturing competencies• Optimize make/buy• Optimize physical distribution and inventory levels across the whole
"manufacturing system"
Sales and marketing
• Account management, customer-centric geographies• Leverage on customer relationships and reputation across businesses• Optimization of customer support and sales channels within geographies
R&D• Integration of Sorin
and Ela• Integration of Sorin
and Carbomedics• Synergies with
Cardiac Surgery
Regulatory • Integrate local teams to leverage relationships with regulatory bodies
- PRIORITY AREAS FOR SYNERGIES RESULTING FROM INTEGRATION1
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• Italy • France• Germany• Spain• UK• Other EU Countries• Japan
• USA• Canada
• Eastern Europe• South Africa &
Sub Sahara• Middle East &
North Africa• India & Pakistan• China & Far East• Oceania• Latin AmericaSVP, BU Renal Care
Stefano Rimondi
President, BU CRMBruno Inguaggiato
BU Vascular Therapy& New BusinessesA.I. Franco Vallana
President, BU Cardiac SurgeryFranco Vallana
VP, Bus. Dev. & Strat. PlanAnton Failla
Chief Information OfficerTBD
Chief Scientific OfficerTBD
VP, Chief Financial OfficerAldo Lombardi
SVP, Corporate DevelopmentCarlo Vanoli
SVP, HR & OrganizationGiovanni Caruso
Chief Executive OfficerDrago Cerchiari
President, International
Eric Beard
RoW
A.I. Eric Beard
President, North AmericaRodger Stewart
ChairmanUmberto Rosa
- CUSTOMER-CENTRIC ORGANIZATION2
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- REGIONS VS. BUSINESS UNITS
SVP, BU Renal CareStefano Rimondi
President, BU CRMBruno Inguaggiato
BU Vascular Therapy& New BusinessesA.I. Franco Vallana
President, BU Cardiac SurgeryFranco Vallana
President, International
Eric Beard
RoW
A.I. Eric Beard
President, North AmericaRodger Stewart
VP, Bus. Dev. & Strat. PlanAnton Failla
Chief Information OfficerTBD
Chief Scientific OfficerTBD
VP, Chief Financial OfficerAldo Lombardi
SVP, Corporate DevelopmentCarlo Vanoli
SVP, HR & OrganizationGiovanni Caruso
Chief Executive OfficerDrago Cerchiari
ChairmanUmberto Rosa
Regions
• Geographical P&L accountability for all businesses
• Customer centric approach
• Account management
• Leverage local market opportunities
• Strong, focused tactical marketing supported by strategic marketing
Business Units
• WW P&L accountability for a given business
• Drive innovation
• Strategic marketing
• Drive manufacturing & supply chain excellence
2
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• 4 new hires with over 100 years of cumulated experience in the industry
• 7 managers with 150 years of cumulated experience in Sorin to ensure continuity
- STRENGTHENED MANAGEMENT TEAM3
SVP, BU Renal Care
President, BU CRM
BU Vascular Therapy& New Businesses
President, BU Cardiac Surgery
VP, Bus. Dev. & Strat. Plan Chief Information Officer
Chief Scientific Officer VP, Chief Financial Officer
SVP, Corporate Development SVP, HR & OrganizationGiovanni Caruso
Chairman
Stefano Rimondi
Bruno Inguaggiato
A.I. Franco Vallana
Franco Vallana
Anton Failla TBD
TBD Aldo Lombardi
Carlo Vanoli
Eric Beard Rodger Stewart
Umberto Rosa
• 4 positions still to be filled
President, International
President, North America
A.I. Eric Beard
RoW
Chief Executive OfficerDrago Cerchiari
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SORIN GROUP ROAD MAP FOR THE NEW SORINYear
Phase
CS
VT
CRM
Main product launches
2004 2005 2006 2007 2008
• Synergy mini by-pass
• Genius (2nd generation mini by-pass)
• Tissue valve (US)
• Janus (EU)
• Symphony (pacemaker)
• Alto2 (ICD)
• CRT-D (EU)
• New electronic platform
• Alto 2 in Japan
• CRT-D (US)
• Percutaneous valve
2003
• Integration and cost reduction
• Launching new product ranges in EU
• Investing to prepare US expansion (distribution, clinical trials)
Growth and profitability driven by:• US expansion• Full benefits from integration
• Janus (US)
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GROWTH DRIVERS 2003-2008 (€ mm)
Key initiatives
2003E CS VT CRM RC New Business
2008
•Mini by-pass
•Tissue valve •Product range expansion
•Percutaneousvalve
•International expansion
•DES in Europe and US
•Peripheral stents
•US expansion
•ICD and CRT-D in Europe
•New machine
•New dialyzers
•Platelet gel
•Others (Red blood cells drug loading)
715
c.a. 25%Expansion in North America c.a. 34%
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INVESTMENT HIGHLIGHTS
• Worldwide leader in haemodynamics & the largest European cardiovascular medical devices company
• Strong competitive positioning in a large and fast-growing market
• Proprietary technology platform across product portfolio
• Global footprint: global production, R&D, sales & marketing operations
• Skilled and international management team
• “Pure play” investment
Leading med-tech player, well positioned to capitalise on future profitable growth and
expansion opportunities
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Analyst Presentation
Q&A