Solvay Pharmaceuticals Performance, Priorities and Pipeline

Solvay Pharmaceuticals Performance, Priorities and Pipeline Werner Cautreels, General Manager of Solvay Pharmaceuticals SOLVAY INVESTORS DAYS October...
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Solvay Pharmaceuticals Performance, Priorities and Pipeline Werner Cautreels, General Manager of Solvay Pharmaceuticals

SOLVAY INVESTORS DAYS October 1, 2008

INSPIRE 2010

TRANSFORMATION 2015

Internal Focus

t In

2005

ra g e

n it o

e P ,

rm o rf

ce n a

Pi pe l

us c o ,F

2010

in e,

External Drivers

Tr an sf

or m at io

n, Pr io

rit i

es

2015

P H A R M A C E U T I C A LS

3

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

PERFORMANCE • • • •

4

Solvay Investors Days October 1, 2008

Top Line Growth Bottom Line Growth Delivering Efficiencies 2010 Targets

P H A R M A C E U T I C A LS

Topline Growth Î10 years significant growth in revenues Annual growth +11%/y

M EUR

SALES

1049

1167

1349

1548

2600 2591 2270

1769 1863 1832 1745

1251 1249

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 H108 5

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Bottomline Growth Î10 years REBIT growth 17.3% 17.6% M EUR

REBIT

14.1%

REBIT/Sales

11.2% 11.6%

451 13.3% 13.5% 13.3%

302

11.5%

11.6%

263 8.7%

243

246

236 205

203

6

118

135

1997

1998

157

1999

Solvay Investors Days October 1, 2008

457

134

2000

2001

2002

2003

2004

2005

2006

2007

H108

P H A R M A C E U T I C A LS

Delivering Efficiencies Reinvested in Growth & Profitability

Efficiency program INSPIRE on track !

Cumulative annual efficiencies

275

300

250 230

160

80 expected achieved

5 2005

2006

2007

2008 est

2009

134 ++ + ++

59 ++ ++ ++

47 + ++ +

+ ++ +

2010

in M EUR

One-time costs Commercial Manufacturing General & Administration

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Solvay Investors Days October 1, 2008

28 + +

+ + +

P H A R M A C E U T I C A LS

Integration & Transformation Commercial Operations Š Reduce overlap in sales force Š Strengthen global presence Š Build pan-European organization

General & Administration

8

Manufacturing & Supply Š Globalize purchasing approach Š Improve plant productivity Š Continue optimization of manufacturing network

R&D

Š Build global General & Admin functions : legal, HR, IT, Finance, Communication

Š Integrate project and product portfolio

Š Support integration of global strategic framework

Š Consolidate development resources

Solvay Investors Days October 1, 2008

Š Improve discovery platform

P H A R M A C E U T I C A LS

Integration & Transformation Execution Commercial Operations Š Overall reduction in sales force, shift to emerging markets Š Integration of GPS/NBD into SPML Š Divestment of certain C products

Global Manufacturing Š Global purchasing operational Š Divestment of Baudette (US), Veenendaal (NL), Weesp API (NL), Synkem (Fr), Kawagoe (Jp) Š Divestment Fontaine ongoing Š Optimisation ongoing

General & Administration Š Legal entities merged Š Global functions integrated and fully operational Š IT outsourcing ongoing

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Solvay Investors Days October 1, 2008

R&D Š R-POP in Gastroenterology and Women’s/Men’s Health stopped Š One R&D organisation, one R&D portfolio Š Outsourcing of certain R&D activities

P H A R M A C E U T I C A LS

Integration & Transformation : FTE impact

2006

2007

2008

Total (Consolidated companies)

10088

9178

9021

Total (All companies)

11432

11226

10058

including shift of sales forces from EU to emerging markets not including reduction of rented sales forces

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

We stay committed to our 2010 Targets REBIT margin

Pharmaceutical Industry by 2010

PROFITABLE GROWTH 3.2 Bn EUR revenues 20% REBIT/Sales EFFICIENCY PROGRAM EUR 300 M stepwise efficiency improvements

Solvay Pharmaceuticals

PORTFOLIO FOCUS

Revenues growth

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

PRODUCTS PERFORMANCE

• In Market • Therapeutic Focus

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

2007 Sales Breakdown in % of 2007 sales : EUR 2,591 M by Therapeutic Area

by Geographic Area

28%

9%

17%

4%

45% 6%

8%

7% 23%

28% 17% 6% 7% 11% 23% 8%

14

11%

Cardiometabolic Neuroscience Influenza vaccines Pancreatic enzymes Gastroenterology Women’s and Men’s Health Others

Solvay Investors Days October 1, 2008

42%

45% 42% 9% 4%

Europe 36% European Union (27) 9% Other European Countries The Americas 40% Nafta 2% Mercosur Asia-Pacific Rest of the world

P H A R M A C E U T I C A LS

Growth in major products

Net sales (EUR m)

PHARMACEUTICALS

2007

HY08

HY08 vs HY07

2,591

1,249

0%

HY08 vs HY07 (constant exchange rates) +5%

Fenofibrates 221 +6% 433 Cardiometabolic TriCor sales booked by Abbott in the US in HY08 : USD 553m (+5%) Androgel®

308

149

-7%

+7%

Pancreatic enzymes

Creon®

198

103

+7%

+14%

Neuroscience

Serc®

150

81

+3%

+3%

Influenza vaccines

Influvac®

127

mainly in H2

+57%

+49%

Cardiometabolic

Teveten®

106

63

+21%

+21%

Gastroenterology

Duphalac®

99

51

+4%

+7%

Duphaston®

90

45

+7%

+8%

Neuroscience

Marinol®

105

43

-25%

-14%

Neuroscience

Luvox®

83

40

-9%

-7%

Women’s & Men’s health

Women’s & Men’s health

15

+15%

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Therapeutic focus

Cardio Metabolic

16

Neuro Science

Influenza Vaccines

Pancreatic Enzymes

Gastro Women’s/ Enterology Men’s Health

KEY FOCUS AREAS Š Sustain and build on market leadership Š New products by inlicensing & acquisition

SPECIFIC MEDICAL NEEDS Š Sustain and build on market leadership Š New products by inlicensing & acquisition

MARKETING EXCELLENCE Š Sustain and build on market excellence & leadership Š New products by in-licensing & acquisition

With Full R&D Š In range of biological targets and indications

With Full R&D Š New influenza vaccine technologies Š New pancreatic enzyme replacements

No R to POP Š With development possibilities

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Therapeutic focus

Cardio Metabolic

Neuro Science

Influenza Pancreatic Vaccines Enzymes 2007

Mill. USD

MS %

+/- % US$

Solvay Pharmaceuticals portfolio

Worldwide

671,687

100.0

10

CNS

111,764

16.6

10

N5A (Antipsychotics)

20,758

3.1

14

Bifeprunox, SLV313, SLV314,

N4A (Anti-Parkinson)

3,740

0.6

19

DUODOPA®, SLV308

100,998

15.0

2

C10A (Lipid-Regul.)

30,480

4.5

-8

Zolip, FDC

C10A2 (Lipid-Regul.)

2,287

0.3

10

TriCor, TriLipix

A8A (Anti-Obesity)

1,703

0.3

26

SLV319

12,996

1.9

9

SLV319

Cardiovascular

A10B (Oral Antidiabetics)

Source: IMS Health, IMS World Review 2008

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Our Areas of Focus

CARDIOMETABOLIC

NEUROSCIENCE

Dyslipidemias

Psychosis

Obesity

Bipolar Disorder

Type 2 Diabetes

Parkinson’s Disease

Acute Heart Failure

Traumatic Brain Injury

PANCREATIC ENZYMES

Bioengineered Enzymes

Diabetic Nephropathy Pulmonary hypertension Atherosclerosis + exploratory platforms, such as Alzheimer, cognition 18

Solvay Investors Days October 1, 2008

INFLUENZA VACCINES

New delivery systems Adjuvants

P H A R M A C E U T I C A LS

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

PRIORITIES • • • •

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Solvay Investors Days October 1, 2008

Geographical expansion Manufacturing & Supply Industry Drivers Innogenetics

P H A R M A C E U T I C A LS

Geographical Expansion Evolution of net sales in emerging markets (% of total net sales) 20

Today the Emerging Markets represent about 1/5th of total sales

15 10 5 0 1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

Evolution of net sales in main regions (MEUR) 1000

800

600 EU 400

USA ROW

200

0 1998

21

1999

Solvay Investors Days October 1, 2008

2000

2001

2002

2003

2004

2005

2006

2007

P H A R M A C E U T I C A LS

Geographical Expansion : a few examples Evolution of sales (MEUR) 140 120 100 80

1997 2002

60

2007

40 20 0

22

Brazil

Russia

Solvay Investors Days October 1, 2008

India

China

Turkey

Mexico

Australia

Poland

P H A R M A C E U T I C A LS

Manufacturing & Supply

■ Manufacturing and Supply organization is in the middle of a transformation process to enable it to contribute to the overall success of Solvay Pharmaceuticals ■ This process will lead to a stronger and more sustainable organization

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Manufacturing & Supply

4 Main Areas of Improvement „ Purchasing Processes „ Plant Performance „ Supply Chain Improvement „ Network Restructuring

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Supply Chain Projects

■ Reduce our stock from raw material to the finished products ■ Implement a performance measurement system based on 4 KPIs (inventory level / OTIF / forecast accuracy / throughput time) to track our performance level ■ Optimize worldwide distribution network ■ Integrate products and markets

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

From 18 to 11 sites in three years Cork (IR)

Weesp (NL)

Olst (NL)

Veenendaal (NL)

Neustadt (DE)

Sy. Factory

Canlac (CA) Organics (US)

Kawagoe (JP)

Baudette (US) Mexico (MX)

Peptisyntha (BE) FPP API

Solvay Pharma (BR)

May 2005 26

Solvay Investors Days October 1, 2008

Parets (ES)

Giraud (FR)

Châtillon (FR)

Fontaine (FR)

Synkem (FR)

P H A R M A C E U T I C A LS

From 18 to 11 sites in three years Cork (IR)

Weesp (NL)

Olst (NL)

Neustadt (DE)

Canlac (CA) Organics (US)

Mexico (MX) FPP API

Solvay Pharma (BR)

May 2008 27

Solvay Investors Days October 1, 2008

Parets (ES)

Châtillon (FR)

Fontaine (FR)

P H A R M A C E U T I C A LS

Network restructuring Manufacturing site

Type of decision

Peptisyntha

Transferred



Giraud – API outsourcing

Transferred



Closed

Q2-08

Synkem

Sold



Baudette

Sold



Veenendaal

Sold



Kawagoe

Sold



Downsize / Sell



Neustadt

Downsize



Fontaine

Sell

Q4-08

API outsouring Weesp

Chatillon – Foch

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

From 18 to 11 sites in three years Closure / Sale intention announced

Site impacted by restructuring Cork (IR)

Weesp (NL)

Olst (NL)

Neustadt (DE)

Canlac (CA) Organics (US)

Mexico (MX)

FPP API

Solvay Pharma (BR)

May 2008 29

Solvay Investors Days October 1, 2008

Parets (ES)

Châtillon (FR)

Fontaine (FR)

P H A R M A C E U T I C A LS

Industry Drivers

INSPIRE 2010

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Industry Drivers

Resource allocation shift

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INSPIRE 2010

Regulatory paradigm shift Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Industry Drivers ■ Stakeholder impact → Payers and public will play an increasingly critical role

■ Transparency ■ Personalized medicine ■ Regulatory paradigm shift ■ Resource allocation shift

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Stakeholder Impact

TRADITIONAL CORE CUSTOMERS

• Physicians

• KOLs

NEW CUSTOMERS

Traditional Traditional customers customers are are joined joined by by new new influencers influencers

• Patients • State & Fed Gvmnts • Advocacy groups • Professional •

• Payers • Regulatory agencies

CUSTOMERS WHO COULD BECOME MORE IMPORTANT

• Wholesalers • Pharmacy chains • Actuaries and benefits consultancies

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Solvay Investors Days October 1, 2008

societies Pharmacists

• Politicians • Dept. of Health & •

Human Services Media

P H A R M A C E U T I C A LS

Stakeholder Impact Customer interaction model will require change Decision maker’s influence is evolving …

… however today’s M&S spend is still focused on traditional core New customers

30 Physician – traditional core

5-10%

65 20

Consumers

10

Government

5

Payor/ managed care organizations

34

Solvay Investors Days October 1, 2008

25

90-95%

20

25

Today

Tomorrow

Physicians and patients

P H A R M A C E U T I C A LS

Industry Drivers ■ Stakeholder impact ■ Transparency → Public awareness and societal demands

■ Personalized medicine ■ Regulatory paradigm shift ■ Resource allocation shift

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Transparency

SOCIETY’S EXPECTATIONS

36

SOCIETY’S PERCEPTIONS

Fair value

Affordability limits Excessive prices and profits

Focus on medical need

Lifestyle products favored Developing world diseases neglected

Constant innovation

R&D productivity collapse The dilemma of incremental innovation

Fair influence

Excessive lobbying: profits before patients

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Industry Drivers ■ Stakeholder impact ■ Transparency ■ Personalized medicine → Therapeutic segmentation → Combination of therapeutics & diagnostics

■ Regulatory paradigm shift ■ Resource allocation shift

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Personalized Medicine Long term (10+ years?)

Medium term (5-10 years?)

Near term (5 years?)

ƒ ƒ ƒ ƒ

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Oncology Infectious dis. Osteoporosis Cystic Fibrosis

Solvay Investors Days October 1, 2008

ƒ ƒ ƒ ƒ ƒ ƒ ƒ ƒ ƒ ƒ

Oncology Cardiovascular Rheumatology Schizophrenia Asthma COPD Sepsis/ ARDS Infertility Diabetes Obesity

ƒ CNS ƒ CV ƒ More challenging indications in ƒ Oncology ƒ Ophthalmology ƒ Rheumatology

• Sequence determined by the relative market opportunity

• Significant uncertainty around time frames

P H A R M A C E U T I C A LS

Industry Drivers ■ Stakeholder impact ■ Transparency ■ Personalized medicine ■ Regulatory paradigm shift → More patients in clinical trials, both before and after approval → Risk management programs → Start with small indications before later expansions → Focus on innovative products

■ Resource allocation shift

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Regulatory Paradigm Shift Increased focus on safety and data More Safety ■ More patients required in more clinical trials pre- and postapproval ■ Demonstration of comparative safety of NCE ■ Controlled launch programs ■ Establishment of open access patient safety registries ■ More emphasis on long-term safety data / pharmacovigilance

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Regulatory Paradigm Shift More Data ■ Extensive research and documentation of the NCE's mechanism of action ■ Clinical studies designed to evaluate safety & efficacy in various genotypes/phenotypes of patients as classified by genetic screening of patient populations → Extensive safety screening using highly sensitive biomarkers

■ More detailed regulatory guidance and requirements for clinical trials in differentiated groups: → Age: pediatrics, elderly → Specific risk groups → Specific target groups

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Solvay Investors Days October 1, 2008

→ No data = no labeling

P H A R M A C E U T I C A LS

Industry Drivers ■ Stakeholder impact ■ Transparency ■ Personalized medicine ■ Regulatory paradigm shift ■ Resource allocation shift → R&D expenditures: → SG&A expenditures: → Cost of Goods :

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Industry Drivers & Solvay actions

Processes, interfaces, relationships Trial registration Publication of trial results

Resource allocation shift

Inspire project Further increase R&D and product sourcing spend

Solvay Solvay actions actions Innogenetics acquisition Adaptation of R&D activities to new requirements Use of external expertise (advisory panels)

43

Solvay Investors Days October 1, 2008

Regulatory paradigm shift

Biomarker approach in clinical development

P H A R M A C E U T I C A LS

Acquisition of Innogenetics ■ Total enterprise value of EUR 206 million (100% of the outstanding shares + indebtedness on Dec. 31, 2007) ■ Acquisition financed by available resource of the Solvay group ■ 84.3% of the shares have been offered Ö offer is accepted by Solvay ■ Extension of the tender offer from Sept 23 to Oct 14, 2008 ■ An opportunity for Solvay Pharmaceuticals: →Accelerate the development of Solvay’s therapeutic pipeline ƒ Expand biomarker technologies and enter progressively into the field of personalized medicine

→Expand the diagnostic activities ƒ Reinforce existing commercial operations ƒ Continue the development of Innogenetics’ diagnostics pipeline 44

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Solvay Pharmaceuticals’ strategic vision

Î endorses Innogenetics’ recent decision to focus on diagnostics activities and to divest GENimmune (assets from therapeutics activities) Solvay Pharmaceuticals’ strategic vision : ■ Preserve the operational autonomy of Innogenetics ■ Continue the expansion of the diagnostic activities ■ Leverage both companies R&D competences

45

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Solvay Pharmaceuticals and Innogenetics

Solvay Pharmaceuticals

Innogenetics

COMMERCIAL THERAPEUTICS

COMMERCIAL DIAGNOSTICS ■ Biomarkers

R&D therapeutics

→ improved molecule selection → surrogate markers for clinical studies

■ Companion diagnostics → personalized medicine

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Solvay Investors Days October 1, 2008

R&D diagnostics

P H A R M A C E U T I C A LS

About Innogenetics

„ International biotechnological company that develops and markets diagnostic products to improve therapy management and patient health „ Products sold in 90+ countries through its 6 subsidiaries and a large number of distributors „ Listed on Euronext Brussels (INNX)

Source : Innogenetics, company presentation, www.innogenetics.com, 2008

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Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Key figures FY07 and H108

FY07

H108

H107/ H108

Company revenues (consolidated)

€54.1m

€30.6m

+ 12%

Diagnostics product sales Diagnostics revenues Diagnostics gross profit Gross margin stable

€47.0m €50.9m €30.0m 55.5%

€25.8m €28.8m €17.1m 54.6%

+ 8% + 12% + 13%

Operating result inDiagnostics

€0.1m

€0.9m

EBITDA in Diagnostics

€7.0m

€4.2m

Cash position

€23.5m

€15.7m

¨ Diagnostics product sales: driver for sustained future growth Source: Innogenetics, company presentation:www.innogenetics.com, 2008

48

Solvay Investors Days October 1, 2008

+ 45%

Key Diagnostic Product Areas Infectious diseases

• 47% of total 2007 product sales • Virology market with HCV, HBV, HIV and HPV • Partnerships with Roche, Bayer and TWT

HLA

• 15% of total 2007 product sales • Currently developing assays using the 4-MAT™ microarray platform

Genetic testing (GT)

• 14% of total 2007 product sales • Cystic fibrosis (CF), MBL2, Apo E • Leading supplier of CF testing in Europe

Neurodegenration

• 6% of total 2007 product sales • Alzheimer’s disease : early and differential diagnosis, therapy monotoring

Oncology

• Access to AdnaGen’s CE labelled products for breast and colon cancer

Source : Innogenetics, company presentation, www.innogenetics.com, 2008

49

P H A R M A C E U T I C A LS

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Solvay – Innogenetics collaboration ■ 1st period (1997-2002):

Target discovery & identification

■ 2nd period (2003-2005):

Target validation

■ 3rd period (2006-present):

Potential biomarkers & Compagnion diagnostics

→ Neurology program ƒ Traumatic brain injury (SLV334) ƒ Parkinson’s disease (SLV357) ƒ Schizophrenia → Cardiometabolic program ƒ Diabetic nephropathy (SLV306) ƒ Acute heart failure (in preparation)

■ Future : join competencies to accelerate pipelines in diagnostics and therapeutics 50

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

51

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

PIPELINE

• Promising Projects in R&D Pipeline

52

Solvay Investors Days October 1, 2008

R&D Pipeline Overview and Key Developments CLAUS STEINBORN Global R&D Head Solvay Pharmaceuticals

P H A R M A C E U T I C A LS

R&D pipeline

Cardiometabolic

Neuroscience

Influenza vaccines

Pancreatic enzymes

Preclinical

Phase I

SLV342, SLV344,

SLV337, SLV338,

SLV352, SLV 356

SLV341

SLV338, SLV351, SLV354, SLV357

SLV314

Phase II

Phase III

SLV319

Zolip

Daglutril (SLV306) SLV320

PULZIUM® intravenous (US)

SLV 313

bifeprunox

SLV 334

pardoprunox

Anatibant (+Xytis)

DUODOPA® US

Adjuvants,

H5N1 egg

INFLUVAC® TC EU

H5N1 TC

Seasonal TC US

GRIPPOL® TC

SLV340

Women’s & Men’s Health

SLV339

EE/MT US

CREON® JPN

ANDROGEL® low volume ANDROGEL® pediatric US

Discontinued : Synordia, dronabinol MDI

54

Solvay Investors Days October 1, 2008

Approved : Luvox IR/CR (US)

Filed/ Approved

TriLipix™ US PULZIUM® intravenous (EU)

GRIPPOL® Plus

CREON® US

FEMOSTON® low dose

P H A R M A C E U T I C A LS

Research & Development CARDIOMETABOLIC

PRECLINICAL

PHASE I

PHASE II

PHASE III

FILED

TriLipix® (next generation fenofibrate) TriLipix® + Crestor® (Abbott/AstraZeneca) Zolip (fenofibrate + statin) PULZIUM® Intravenous (atrial arrhythmias) Daglutril (SLV306) (pulmonary hypertension) SLV320 (acute heart failure)

SLV 319 (obesity/diabetes)

2007 R+D Investments: EUR 139M (33% of total Pharma R&D) 55

Solvay Investors Days October 1, 2008

APPROVED

P H A R M A C E U T I C A LS

Research & Development NEUROSCIENCE

PRECLINICAL

PHASE I

PHASE II

PHASE III

FILED

Bifeprunox (schizophrenia) DUODOPA® (Parkinson) Pardoprunox (SLV308) (Parkinson) SLV313 (schizophrenia) SLV334 (traumatic brain injury) SLV314 (schizophrenia)

2007 R+D Investments: EUR 160M (39% of total Pharma R&D) 56

Solvay Investors Days October 1, 2008

APPROVED

P H A R M A C E U T I C A LS

Research & Development INFLUENZA VACCINES

PRECLINICAL

PHASE I

PHASE II

PHASE III

FILED

GRIPPOL® Plus (EggBased Adjuvanted Seasonal Vaccine) INFLUVAC®TC EU (CellBased Seasonal Vaccine) GRIPPOL® TC (Cell-Based Adjuvanted Seasonal Vaccine) INFLUVAC® TC US (CellBased Seasonal Vaccine) Pandemic egg (H5N1 Egg Based Vaccine)

2007 R+D Investments: EUR 19M (5% of total Pharma R&D) 57

Solvay Investors Days October 1, 2008

APPROVED

P H A R M A C E U T I C A LS

Research & Development PANCREATIC ENZYMES

PRECLINICAL

PHASE I

PHASE II

PHASE III

FILED

CREON® US CREON® JPN SLV339 (non animal sourced enzymes)

2007 R+D Investments: EUR 35M (8% of total Pharma R&D) 58

Solvay Investors Days October 1, 2008

APPROVED

P H A R M A C E U T I C A LS

Main cardiometabolic indications METABOLIC SYNDROME

DIABETES

DYSLIPIDEMIA

fenofibrate & statin fixed dose combinations ABBOTT & ASTRAZENECA co-develop for USA SOLVAY project ZOLIP for rest of world

TriLipix™ next generation fenofibrate

SLV319 Obesity/type 2 diabetes

SIMCOR® (Niaspan®/ simvastatin)

TriCor®/LIPANTHYL® NFE No food-effect fenofibrate

LIPANTHYL® fenofibrate

59

Solvay Investors Days October 1, 2008

CARDIOVASCULAR PREVENTION

P H A R M A C E U T I C A LS

Success factors of our fenofibrate franchise „ Positive long term use well established „ Addresses residual cardiovascular risk on statins „ Current flagship product : Î important clinical benefits of 145 mg NFE Î being introduced in all major markets by 2008 (incl. Russia) Î IP formulation protection until Jan. 2023 in US and 2018 in Europe – patent litigation vs Teva ongoing

„ Ongoing discussions of EMEA recommendation concerning class review of fibrates 60

Solvay Investors Days October 1, 2008

TriCor® sales* evolution in the US M USD

+56%

1000

500

0 2004

2005

* booked by Abbott

2006

2007

P H A R M A C E U T I C A LS

Fenofibrate franchise : worldwide growth Worldwide sales distribution

Sales evolution (MEUR)

(Aug 07 – Aug 08) 200 Asia Pacific & Middle East & CA

+9%

Japan

150

Eastern Europe & Lat.Am.

Aug 06 – Aug 07 Aug 07 – Aug 08

100

+13%

Europe 30 US

+11%

50

-19%

+106%

0 US

61

Solvay Investors Days October 1, 2008

European Union 30

Asia Pacific & Middle East & Ca

Japan

Eastern Europe. & Lat.Am.

P H A R M A C E U T I C A LS

TriLipix™

■ Next generation fenofibrate ■ Regulatory exclusivity & IP ■ Specifically developed for combination with statins ■ Submitted in the US (Q4/07) ■ Regulatory submission files for ROW are being prepared ■ Improved Therapeutic Benefit clinical programs ongoing ■ Phase III studies presented at scientific congresses (HY08) 62

Solvay Investors Days October 1, 2008

Submitted US

P H A R M A C E U T I C A LS

TriLipix™ Phase III studies ■ Three phase III studies presented at the scientific congresses (March & May 2008) ■ TriLipix™, in combination with statins : →

primary end points reached



significant improvement in all 3 key lipids :



63

ƒ

HDL and TG, compared to statin therapy alone

ƒ

LDL, compared to TriLipix™

safety similar to TriLipix™ or statin monotherapies (no rhabdomyolysis or unexpected liver, kidney or muscle safety signals identified)

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

TriLipix™ + Crestor® Developed by Abbott/AstraZeneca Fixed dose combination for US Phase III program ongoing Rosuvastatin : fastest growing branded statin in US (CRESTOR®/AstraZeneca) ■ Convenient single pill for comprehensive lipid treatment ■ Today only 5% of US statin users get a fibrate co-prescribed, further growth potential for fixed combination ■ IP protected ■ ■ ■ ■

64

Solvay Investors Days October 1, 2008

Phase III

Launch date: 2010 US

P H A R M A C E U T I C A LS

Simcor® ■ Fixed combination of Niaspan® and simvastatin ■ Effectively targets all three key lipids (LDL, HDL, TG) → reduction of residual risk ■ Phase III data showed greater improvement of three key lipids compared to simvastatin alone ■ Co-promotion with Abbott (US territory) ■ Launched in April 2008 65

Solvay Investors Days October 1, 2008

Launched US

P H A R M A C E U T I C A LS

Zolip ■ Fenofibrate NFE & simvastatin fixed dose combination for EU & ROW ■ Phase III clinical program close to completion ■ Convenience, compliance and stronger lipid effects ■ IP to 2018 with possible extensions ■ Data exclusivity EU 10 years from approval ■ ACCORD* NIH study results expected 2010 66

* Action to Control Cardiovascular Risk in Diabetes

Solvay Investors Days October 1, 2008

Submission date: Q3/2009 Peak sales potential EU/ROW: 100-250 MEUR

P H A R M A C E U T I C A LS

SLV319 ■ Cannabinoid 1 receptor antagonist ■ Inhibits both central and peripheral CB1 receptors ■ Preclinical profile supports further development ■ Phase II PoP in obesity completed, results support continuation ■ Further discussions on prioritization of indications ■ Worldwide rights back to Solvay 67

Solvay Investors Days October 1, 2008

Phase II

P H A R M A C E U T I C A LS

SLV319 Phase II results Percent change from baseline in body weight over time weeks

Off drug treatment

Phase II

P=0.0017 P=0.0203

P=0.0002

68

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

SLV319 Phase II results Percentage of Subjects Reaching 5% and 10% Weight Loss

S ubjec ts  W ith >5%  R educ tion from B as eline S ubjec ts  W ith >10%  R educ tion from B as eline 80% 70% 60% 50%

54,0%

40% 30%

42,9%

20% 10%

31,3% 12,5%

14,9%

P L AC E B O

5mg/d

Solvay Investors Days October 1, 2008

15,1%

20,0% 10,6%

6,1%

0%

69

Phase II 59,6%

49,1%

44,7% 31,3%

37,5%

25/5 mg/d

10mg/d

25mg/d

50mg/d

100mg/wk

P H A R M A C E U T I C A LS

SLV319 Phase II results ■ Placebo controlled dose finding study ■ Efficacy → weight reduction shown already after 12 weeks → effect continues for highest dose even after discontinuation of study drug → relatively high placebo effect

■ Safety → predominant adverse events : gastro-intestinal symptoms, CNS → no seizures → too small sample size to draw definite conclusions on incidence of adverse events

70

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Pulzium® Intravenous ■ Mixed potassium channel blocker ■ Recent onset atrial fibrillation/flutter ■ Approved in EU (UK, Sweden, Spain) ■ Non approvable letter in US ■ Available for worldwide outlicensing ■ IP 2012 (EU 10 years dossier excl, US 5 years dossier excl) 71

Solvay Investors Days October 1, 2008

Approved Europe Submitted US 2006 Q4 Peak sales potential under 100 MEUR

P H A R M A C E U T I C A LS

daglutril (SLV306) ■ First in class “lutril” = dual endopeptidase inhibitor NEP & ECE ■ Improves impaired cardiac function ■ IP 2016 + possible extensions ■ Preparing phase II in pulmonary hypertension ■ Phase II in arterial hypertension did not support continuation in this indication

72

Solvay Investors Days October 1, 2008

Phase II

P H A R M A C E U T I C A LS

SLV320 ■ Adenosine 1 antagonist ■ Intravenous formulation ■ Innovative compound for patients with acute heart failure (AHF) ■ Proof of concept in AHF, PoP studies ongoing ■ IP 2019 + possible extensions

73

Solvay Investors Days October 1, 2008

Phase II

Cardio-Metabolic Neuroscience Influenza Vaccines Pancreatic Enzymes

P H A R M A C E U T I C A LS

Bifeprunox ■ Partial dopamine agonist + additional serotonin 1A activity ■ Schizophrenia ■ Activities in EU continue, together with Lundbeck →Phase III trials ongoing ■ All development activities for US territory are on hold →requested clinical trials could lead to substantial delays, limiting the benefit for patients and the commercial opportunity ■ IP 2017 + 5y (US) and 10y (EU) dossier protection 75

Solvay Investors Days October 1, 2008

Phase III

P H A R M A C E U T I C A LS

Duodopa® ■ Levodopa & carbidopa combination ■ Novel, microprocessor controlled administration system, delivering through indwelling tube directly into small bowel ■ Programmable external pump under patient control ■ Registered in 34 countries, launched in 20 countries ■ US phase III studies ongoing ■ IP 2013 and orphan status EU 10 years and US 7 years 76

Solvay Investors Days October 1, 2008

Launch date 2004 Peak sales potential 100 to 250 MEUR

P H A R M A C E U T I C A LS

Pardoprunox (SLV308) ■ Mixed partial agonist dopamine, noradrenaline, serotonin ■ Early and advanced Parkinson’s Disease ■ Phase III results partially available ■ IP 2019 + possible extensions ■ Potential differentiation in dyskinesia and other CNS symptoms

77

Solvay Investors Days October 1, 2008

Submission date: 2011 Peak sales potential above 250 MEUR

P H A R M A C E U T I C A LS

Pardoprunox (SLV308) phase III results Phase III study in early Parkinson (monotherapy) Mean change from baseline UPDRS, part 3 (LOCF) end of titration

2.0 0.0 -2.0 -4.0

P=0.0397

12-42 mg

-6.0 P=0.0006

P=0.0044

-8.0 -10.0 -12.0 0

5

10

15

20

25

30

< titration > < ----maintenance 24 weeks -------------> UPDRS : Unified Parkinson’s disease rating scale

78

6 mg 12 mg

LOCF : last observation carried forward Solvay Investors Days October 1, 2008

35 Endp

40

placebo

P H A R M A C E U T I C A LS

Pardoprunox (SLV308) phase III results Phase III study in early Parkinson (monotherapy) Mean change from baseline UPDRS, part 3 (LOCF) end of titration

2,0 0,0 -2,0 -4,0

P=0.0091

-6,0

Placebo

-8,0

P=0.0020

-10,0 -12,0 0

5

10

15

20

25

30

< titration > < ------ maintenance 24 weeks -------------> UPDRS : Unified Parkinson’s disease rating scale

79

12-42 mg PPX -4.5 mg

LOCF : last observation carried forward Solvay Investors Days October 1, 2008

35

40

Endp PPX : pramipexole

P H A R M A C E U T I C A LS

Pardoprunox (SLV308) phase III results Phase III study in advanced Parkinson (in combination with L-Dopa) Hours off-time : estimates with 95% CI of SLV308 versus placebo 1 0 -1 -2 -3 -4 SLV308 1242 mg

Placebo

SLV308 vs Pla

Observed case

p-value:

SLV308 1242 mg

Placebo LOCF

0.0424

ANCOVA model with baseline score, pooled center, and treatment group CI : confidence interval

80

Solvay Investors Days October 1, 2008

SLV308 vs Pla

0.0215

P H A R M A C E U T I C A LS

Pardoprunox (SLV308) phase III results ■ 3 pivotal placebo-controlled phase III studies have demonstrated the efficacy of pardoprunox in patients suffering from early and advanced Parkinson’s Disease ■ Efficacy achieved over a broad dose range but minimal effective dose has not been established ■ Main adverse events are gastrointestinal symptoms and CNS effects (dose dependent) ■ Further clinical studies will evaluate a lower dose range which will improve the adverse event profile as well ■ Small and clinically not relevant QTc prolongation 81

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

SLV334 ■ From new class of the ‘lutrils’ (daglutril SLV 306) next endopeptidase inhibitor NEP & ECE* is SLV334 ■ Compound is neuro- and cellprotective in preclinical models ■ Target indication: Traumatic Brain Injury (TBI) ■ Intravenous administration ■ Preparations for Phase II ongoing, clinical development plan designed together with key opinion leaders ■ Compound patent 2016 with second use patent on TBI 2025

* Neutral Endo-Peptidase & Endothelin Converting Enzyme

82

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

SLV313 ■ D2 antagonist + 5HT1A agonist ■ Bipolar disorder, schizophrenia ■ Preclinical data supporting potential effect on cognition ■ IP 2018 + possible extensions ■ Phase II trials ongoing

83

Solvay Investors Days October 1, 2008

Cardio-Metabolic Neuroscience Influenza Vaccines Pancreatic Enzymes

P H A R M A C E U T I C A LS

Growth strategy ■

Capacity increases → →



Differentiation



Novel production technology – cell culture Virosomal vaccine – Invivac for the elderly Adjuvanted vaccine – GRIPPOL®



Alternative routes of administration

→ →



Geographical expansion → →



US Russia,Brazil,India,China

Pandemic Preparedness →

85

Egg-based Cell-based

Pandemic vaccine

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Cell Culture Technology ■ ■

Egg independent process/faster start-up for pandemic Clinical material produced in cell-culture facility → → →

■ ■ ■

86

Seasonal: Phase I studies US and Russia completed Seasonal: Phase II/III studies planned for 2009 Pandemic: Phase I planned for Q2/2009

Submission for EU and US planned in Q4/2010 Complete process validation in 2009 First commercialization planned for 2009 (Russia)

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Geographical strategy ■

Solvay’s influenza vaccines in 68 countries →



US development of cell culture vaccine → → →



First RFP (US government contract 298 MUSD) ongoing No participation in second RFP for production facility (economics) Clinical development activities ongoing

Petrovax Pharm, Russia constructed a new formulation plant near Moscow with Solvay technical support. Authorization received in Aug 2008 → → → → →

87

Launch China season 2009

Solvay will supply cell-based antigens Petrovax formulates with adjuvant polyoxidonium (PO) Marketing authorisation for Grippol® Plus (egg-based) received in Sept 2008 Submission of Grippol® TC planned 2009 For Russia & CIS countries

Solvay Investors Days October 1, 2008

Cardio-Metabolic Neuroscience Influenza Vaccines Pancreatic Enzymes

P H A R M A C E U T I C A LS

CREON® - Strategy: Growth and market expansion ■ Established product in EU and US since many years →

Global market leader

■ All enzyme class progressing towards formal FDA approval in the United States → →

response to 2007 “approvable” letter submitted Review by FDA Advisory Committee expected by year end

■ Working towards submission in Japan (2009), one of the largest markets for pancreatic enzymes →

First prescription high dose pancreatic enzyme replacement therapy in that market

■ Strong growth in emerging markets 89

Solvay Investors Days October 1, 2008

Creon® M EUR 200

100

0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

P H A R M A C E U T I C A LS

Bioengineered Enzymes for Pancreatic Insufficiency ■ Collaboration with Novozymes Denmark ■ Biotechnologically engineered microbial enzymes for treating pancreatic exocrine insufficiency ■ Non-animal sourced product, increasing treatment options for patients ■ Two projects : → SLV339 : lipase only → SLV340 : mixture of lipase, protease, amylase

■ Clinical trials phase II with SLV339 ongoing ■ SLV339 orphan drug designation obtained in EU

90

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

AndroGel® : US progress ■ Continuing strong success of AndroGel® in US ■ WATSON & PAR US copromote ■ Additional presentation: AndroGel® Flexible Dosing Pump successfully launched in late 2004 ■ Pediatric exclusivity obtained in August 2007, close interaction with FDA on pediatric indication after non approvable letter ■ AndroGel® low volume : submission H109 ■ IP 2020 on formulation + 6 months for pediatric

91

Solvay Investors Days October 1, 2008

AndroGel® (US) M USD 300

200

100

0 2000

2001

2002

2003

2004

2005

2006

2007

P H A R M A C E U T I C A LS

Overview Solvay Product Submissions

® FEMOSTON FEMOSTON® low low dose dose

Influenza Influenza GRIPPOL® ® TC GRIPPOL TC (Russia) (Russia)

® INFLUVAC INFLUVAC®TC TC US US

® INFLUVAC TC EU EU INFLUVAC®TC ® ANDROGEL ANDROGEL® low low volume volume US US

® ANDROGEL ANDROGEL® pediatric pediatric US US

® CREON CREON® US US (answer (answer to to FDA FDA letter) letter)

Fluvoxamine Fluvoxamine IR IR + + ER (US) (US) ER

® TriLipix/Crestor TriLipix/Crestor® (by (by Abbott/Astra Abbott/Astra Zeneca) Zeneca)

® Pulzium Pulzium® EU EU

92

Solvay Investors Days October 1, 2008

Pardoprunox Pardoprunox (SLV308) (SLV308)

® LUVOX LUVOX® melt melt Japan Japan

TM Trilipix TrilipixTM US US

2007

® CREON CREON® JPN JPN

2008

2009

® DUODOPA DUODOPA® US US

Zolip Zolip EU EU

2010

2011

P H A R M A C E U T I C A LS

93

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Priorities Moving Foward ■ Confirm 2008 guidance → operating results for 2008 higher than 2007 ■ Confirm commitment towards 2010 objectives ■ Prepare organization to address industry drivers

94

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

2010: committed to our targets

INSPIRE 2010

95

Solvay Investors Days October 1, 2008

P H A R M A C E U T I C A LS

Industry Drivers & Solvay actions

Processes, interfaces, relationships

Trial registration Publication of trial results

Resource allocation shift

Inspire project Further increase R&D and product sourcing spend

Solvay Solvay actions actions Innogenetics acquisition Adaptation of R&D activities to new requirements Use of external expertise (advisory panels)

96

Regulatory paradigm shift Solvay Investors Days October 1, 2008

Biomarker approach in clinical development

“To the extent that any statements made in this presentation contain information that is not historical, these statements are essentially forward-looking. The achievement of forward-looking statements contained in this presentation is subject to risks and uncertainties because of a number of factors, including general economic factors, interest rate and foreign currency exchange rate fluctuations; changing market conditions, product competition, the nature of product development, impact of acquisitions and divestitures, restructurings, products withdrawals; regulatory approval processes, all-in scenario of R&D projects and other unusual items. Consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "believes," "may," "could" "estimates," "intends", "goals", "targets", "objectives", "potential", and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements"