Solvay Pharmaceuticals Performance, Priorities and Pipeline · 2018-07-03 · P H A R M A C E U T I...
Transcript of Solvay Pharmaceuticals Performance, Priorities and Pipeline · 2018-07-03 · P H A R M A C E U T I...
Solvay PharmaceuticalsPerformance, Priorities and PipelineWerner Cautreels, General Manager of Solvay Pharmaceuticals
SOLVAY INVESTORS DAYSOctober 1, 2008
20052005 20102010 20152015
INSPIREINSPIRE20102010
Internal FocusInternal Focus
Integration, P
erform
ance, Focus
TRANSFORMATIONTRANSFORMATION20152015
External DriversExternal DriversPipeline,Transformation, Priorities
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
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P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
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• Top Line Growth• Bottom Line Growth• Delivering Efficiencies• 2010 Targets
PERFORMANCE
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M EUR
1251 1249
10491167 1349
15481769 1863 1832 1745
2270
2600
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 H108
SALES
10 years significant growth in revenues
Annual growth+11%/y
Topline Growth
2591
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205246
118 135157
134
203
263243 236
302
451
11.2% 11.6% 11.6%
8.7%
11.5%
14.1%13.3% 13.5% 13.3%
17.3% 17.6%
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 H108
REBITREBIT/Sales
M EUR
10 years REBIT growth
Bottomline Growth
457
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Commercial ++ ++ + +Manufacturing + ++ ++ ++General & Administration ++ ++ + +
+
+
300275
160
80
250
5
230
2005 2006 2007 2008 est 2009 2010
28 134 59One-time costs
Cumulative annual efficiencies
expectedachieved
in M EUR
Delivering Efficiencies Reinvested in Growth & Profitability
Efficiencyprogram INSPIRE on track !
+++
47
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Integrate project and product portfolio
Improve discovery platform
Consolidate development resources
Reduce overlap in sales force
Strengthen global presence
Build pan-European organization
Globalize purchasing approach
Improve plant productivity
Continue optimization of manufacturing network
Build global General & Admin functions : legal, HR, IT, Finance, Communication
Support integration of globalstrategic framework
Commercial OperationsCommercial Operations Manufacturing & SupplyManufacturing & Supply
R&DR&DGeneral & AdministrationGeneral & Administration
Integration & Transformation
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R-POP in Gastroenterology and Women’s/Men’s Health stopped
One R&D organisation, one R&D portfolio
Outsourcing of certain R&D activities
Commercial OperationsCommercial Operations Global ManufacturingGlobal Manufacturing
R&DR&D
Overall reduction in sales force, shift to emerging markets
Integration of GPS/NBD into SPML
Divestment of certain C products
Global purchasing operational
Divestment of Baudette (US), Veenendaal (NL), Weesp API (NL), Synkem (Fr), Kawagoe (Jp)
Divestment Fontaine ongoing
Optimisation ongoing
Legal entities merged
Global functions integrated and fullyoperational
IT outsourcing ongoing
General & AdministrationGeneral & Administration
Integration & Transformation Execution
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Integration & Transformation : FTE impact
9021917810088Total(Consolidated companies)
100581122611432Total(All companies)
200820072006
including shift of sales forces from EU to emerging markets
not including reduction of rented sales forces
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by 2010
REBIT margin
Revenuesgrowth
Solvay Pharmaceuticals
Pharmaceutical Industry
PROFITABLE GROWTH
3.2 Bn EUR revenues
20% REBIT/Sales
EFFICIENCY PROGRAM
EUR 300 M stepwiseefficiency improvements
PORTFOLIO FOCUS
We stay committed to our 2010 Targets
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PERFORMANCE• In Market• Therapeutic Focus
PRODUCTS
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2007 Sales Breakdown
by Geographic Area
28%17%
6%
7%
11%23%
8%
28% Cardiometabolic17% Neuroscience
6% Influenza vaccines7% Pancreatic enzymes
11% Gastroenterology23% Women’s and Men’s Health
8% Others
in % of 2007 sales : EUR 2,591 M
by Therapeutic Area
45% Europe36% European Union (27)9% Other European Countries
42% The Americas40% Nafta 2% Mercosur
9% Asia-Pacific4% Rest of the world
45%
4%9%
42%
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Growth in major products
-14%-25%43105Marinol®Neuroscience
TriCor sales booked by Abbott in the US in HY08 : USD 553m (+5%)
-7%-9%4083Luvox®Neuroscience
+21%+21%63106Teveten®Cardiometabolic
+49%
+7%
+4%
+57%
+3%
+7%
-7%
+6%0%
HY08 vs HY07
Women’s & Men’s health
Gastroenterology
Influenza vaccines
Neuroscience
Pancreatic enzymes
Women’s & Men’s health
CardiometabolicPHARMACEUTICALS
Net sales (EUR m)
+7%5199Duphalac®90
127
150
198
308
4332,591
2007
+15%221Fenofibrates
+7%149Androgel®
mainly in H2Influvac®
45
81103
1,249
HY08
+8%
+3%
+14%
+5%
HY08 vs HY07(constantexchange
rates)
Duphaston®
Serc®
Creon®
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SPECIFIC MEDICAL NEEDSSustain and build on market leadershipNew products by in-licensing & acquisition
With Full R&DNew influenza vaccine technologiesNew pancreatic enzyme replacements
MARKETING EXCELLENCESustain and build on market excellence & leadershipNew products by in-licensing & acquisition
No R to POPWith development possibilities
KEY FOCUS AREASSustain and build on market leadershipNew products by in-licensing & acquisition
With Full R&DIn range of biological targets and indications
Therapeutic focus
CardioMetabolic
NeuroScience
Influenza Vaccines
GastroEnterology
Women’s/Men’s Health
PancreaticEnzymes
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Therapeutic focus
CardioMetabolic
NeuroScience
Influenza Vaccines
PancreaticEnzymes
SLV319260.31,703A8A (Anti-Obesity)
SLV31991.912,996A10B (Oral Antidiabetics)
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
Cardiovascular 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
Source: IMS Health, IMS World Review 2008
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CARDIO-METABOLIC
NEURO-SCIENCE
PANCREATIC ENZYMES
INFLUENZAVACCINES
Our Areas of Focus
Psychosis
Bipolar Disorder
Parkinson’s Disease
Traumatic Brain Injury
Bioengineered Enzymes
New delivery systems
Adjuvants
Dyslipidemias
Obesity
Type 2 Diabetes
Acute Heart Failure
Diabetic Nephropathy
Pulmonary hypertension
Atherosclerosis
+ exploratory platforms, such as Alzheimer, cognition
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• Geographical expansion• Manufacturing & Supply• Industry Drivers• Innogenetics
PRIORITIES
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Evolution of net sales in emerging markets (% of total net sales)
GeographicalExpansion
0
5
10
15
20
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
0
200
400
600
800
1000
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
EU
USA
ROW
Evolution of net sales in main regions (MEUR)
Today the Emerging Markets represent about 1/5th of total sales
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0
20
40
60
80
100
120
140
Brazil Russia India China Turkey Mexico Australia Poland
199720022007
Evolution of sales (MEUR)
Geographical Expansion : a few examples
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■ 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
Manufacturing & Supply
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Manufacturing & Supply
Purchasing Processes
Plant Performance
Supply Chain Improvement
Network Restructuring
4 Main Areas of Improvement
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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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From 18 to 11 sites in three years
Canlac(CA)
Baudette(US)
Mexico (MX)
Solvay Pharma (BR)
Weesp (NL) Olst (NL) Veenendaal (NL) Neustadt(DE)
Kawagoe (JP)
Cork (IR)
Peptisyntha(BE)
Parets(ES)
Giraud(FR)
Châtillon(FR)
Synkem(FR)
Fontaine(FR)
Organics (US)
FPP
API
Sy. Factory
May 2005
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
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From 18 to 11 sites in three years
Canlac(CA)
Mexico (MX)
Solvay Pharma (BR)
Weesp (NL) Olst (NL) Neustadt(DE)
Cork (IR)
Parets(ES)
Châtillon(FR)
Fontaine(FR)
Organics (US)
FPP
API
May 2008
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Network restructuring
Q4-08SellFontaine
√DownsizeNeustadt
√
√
√
√
√
Q2-08
√
√
SoldSynkem
Downsize / SellChatillon – Foch
Sold
Sold
Sold
Closed
Transferred
Transferred
Type of decision
Kawagoe
Baudette
API outsouring Weesp
Giraud – API outsourcing
Veenendaal
Peptisyntha
Manufacturing site
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From 18 to 11 sites in three years
Canlac(CA)
Mexico (MX)
Solvay Pharma (BR)
Weesp (NL) Olst (NL) Neustadt (DE)
Cork (IR)
Parets (ES)
Châtillon(FR)
Organics (US)
Closure / Sale intention announced
Site impacted by restructuring
FPP
API
May 2008Fontaine
(FR)
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INSPIRE2010
Industry Drivers
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Regulatory paradigm shift
INSPIRE 2010
Industry Drivers
Resource allocation shift
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■ Stakeholder impact→ Payers and public will play an increasingly critical role
■ Transparency■ Personalized medicine■ Regulatory paradigm shift■ Resource allocation shift
Industry Drivers
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Stakeholder Impact
TRADITIONAL CORE CUSTOMERS
• KOLs
• Regulatory agencies
• Physicians
• Payers • Politicians• Dept. of Health &
Human Services• Media
• Patients• State & Fed Gvmnts
• Advocacy groups • Professional
societies• Pharmacists
• Wholesalers• Pharmacy chains• Actuaries and benefits
consultancies
CUSTOMERS WHO COULD BECOME MORE IMPORTANT
NEW CUSTOMERS
Traditional customers are joined by new
influencers
Traditional customers are joined by new
influencers
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… however today’s M&S spend is still focused on traditional core
20 25
10
20
5
25
65
30Physician –traditional core
Consumers
Government
Payor/managed care organizations
Today Tomorrow
Decision maker’s influence is evolving …
Physicians and patients
New customers
90-95%
5-10%
Customer interaction model will require change
Stakeholder Impact
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■ Stakeholder impact■ Transparency
→ Public awareness and societal demands
■ Personalized medicine■ Regulatory paradigm shift■ Resource allocation shift
Industry Drivers
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Transparency
Fair value
Focus on medical need
Constant innovation
Fair influence
Affordability limitsExcessive prices and profits
Lifestyle products favoredDeveloping world diseases neglected
R&D productivity collapseThe dilemma of incremental innovation
Excessive lobbying: profits before patients
SOCIETY’S EXPECTATIONS SOCIETY’S PERCEPTIONS
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■ Stakeholder impact■ Transparency■ Personalized medicine
→ Therapeutic segmentation→ Combination of therapeutics & diagnostics
■ Regulatory paradigm shift■ Resource allocation shift
Industry Drivers
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Personalized Medicine
Near term (5 years?)
Medium term (5-10 years?)
Long term (10+ years?)
Oncology Infectious dis.OsteoporosisCystic Fibrosis
OncologyCardiovascularRheumatologySchizophreniaAsthmaCOPDSepsis/ ARDSInfertilityDiabetesObesity
CNSCVMore challenging
indications inOncologyOphthalmologyRheumatology
• Sequence determined by the relative market opportunity
• Significant uncertainty around time frames
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■ 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
Industry Drivers
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Regulatory Paradigm Shift
More Safety ■ More patients required in more clinical trials pre- and post-
approval■ Demonstration of comparative safety of NCE■ Controlled launch programs ■ Establishment of open access patient safety registries■ More emphasis on long-term safety data / pharmacovigilance
Increased focus on safety and data
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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
→ No data = no labeling
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■ Stakeholder impact■ Transparency■ Personalized medicine■ Regulatory paradigm shift■ Resource allocation shift
→ R&D expenditures: → SG&A expenditures:→ Cost of Goods :
Industry Drivers
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Regulatory paradigm shift
Industry Drivers & Solvay actions
Processes, interfaces, relationships
Trial registration
Publication of trial results
Innogenetics acquisition
Biomarker approach in clinical developmentAdaptation of R&D activities
to new requirements
Use of external expertise (advisory panels)
Inspire project
Further increase R&D and product sourcing spend
Solvay actions Solvay actions
Resource allocation shift
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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 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 Expand biomarker technologies and enter progressively into the field of personalized medicine
→Expand the diagnostic activities Reinforce existing commercial operationsContinue the development of Innogenetics’ diagnostics pipeline
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
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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
Solvay Pharmaceuticals’strategic vision
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Solvay Pharmaceuticals and Innogenetics
Solvay Pharmaceuticals
Solvay Solvay PharmaceuticalsPharmaceuticals
R&D therapeutics
R&D R&D therapeuticstherapeutics
COMMERCIAL THERAPEUTICS
InnogeneticsInnogeneticsInnogenetics
COMMERCIAL DIAGNOSTICS
R&D diagnostics
R&D R&D diagnosticsdiagnostics
■ Biomarkers→ improved molecule
selection→ surrogate markers for
clinical studies■ Companion diagnostics
→ personalized medicine
■ Biomarkers→ improved molecule
selection→ surrogate markers for
clinical studies■ Companion diagnostics
→ personalized medicine
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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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Key figures FY07 and H108
FY07 H108
Company revenues (consolidated) €54.1m €30.6m + 12%
Diagnostics product sales €47.0m €25.8m + 8%Diagnostics revenues €50.9m €28.8m + 12%Diagnostics gross profit €30.0m €17.1m + 13%Gross margin stable 55.5% 54.6%
Operating result inDiagnostics €0.1m €0.9m
EBITDA in Diagnostics €7.0m €4.2m + 45%
Cash position €23.5m €15.7m
Diagnostics product sales: driver for sustained future growth
Source: Innogenetics, company presentation: www.innogenetics.com, 2008
H107/H108
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Key Diagnostic Product Areas
Infectiousdiseases
HLA
Genetictesting (GT)
Neuro-degenration
Oncology
• 47% of total 2007 product sales• Virology market with HCV, HBV, HIV and HPV• Partnerships with Roche, Bayer and TWT
• 15% of total 2007 product sales• Currently developing assays using the 4-MAT™
microarray platform
• 14% of total 2007 product sales• Cystic fibrosis (CF), MBL2, Apo E• Leading supplier of CF testing in Europe
• Access to AdnaGen’s CE labelled products for breastand colon cancer
• 6% of total 2007 product sales• Alzheimer’s disease : early and differential
diagnosis, therapy monotoring
Source : Innogenetics, company presentation, www.innogenetics.com, 2008
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Solvay – Innogeneticscollaboration
■ 1st period (1997-2002): Target discovery & identification
■ 2nd period (2003-2005): Target validation
■ 3rd period (2006-present): Potential biomarkers & Compagnion diagnostics
→ Neurology programTraumatic brain injury (SLV334)Parkinson’s disease (SLV357)Schizophrenia
→ Cardiometabolic programDiabetic nephropathy (SLV306)Acute heart failure (in preparation)
■ Future : join competencies to accelerate pipelines in diagnostics and therapeutics
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• Promising Projects in R&D Pipeline
PIPELINE
R&D Pipeline Overview and Key Developments
CLAUS STEINBORNGlobal R&D Head Solvay Pharmaceuticals
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R&D pipeline
FEMOSTON® low dose
ANDROGEL® low volume
ANDROGEL®
pediatric US
EE/MT USWomen’s & Men’s Health
CREON® USCREON® JPNSLV339SLV340Pancreatic enzymes
GRIPPOL® PlusINFLUVAC® TC EU
GRIPPOL® TC
H5N1 egg
Seasonal TC US
Adjuvants,
H5N1 TCInfluenza vaccines
bifeprunox
pardoprunox
DUODOPA® US
SLV 313
SLV 334
Anatibant (+Xytis)
SLV314SLV338, SLV351,
SLV354, SLV357Neuroscience
TriLipix™ USPULZIUM® intravenous (EU)
Zolip
PULZIUM®
intravenous (US)
SLV319
Daglutril (SLV306)
SLV320
SLV337, SLV338,
SLV341
SLV342, SLV344,
SLV352, SLV 356Cardiometabolic
Filed/Approved
Phase IIIPhase IIPhase IPreclinical
Discontinued : Synordia, dronabinol MDI
Approved : Luvox IR/CR (US)
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PULZIUM® Intravenous (atrialarrhythmias)
PRECLINICAL PHASE I PHASE II PHASE III FILED APPROVED
TriLipix®(next generation fenofibrate)
TriLipix® + Crestor®(Abbott/AstraZeneca)
Zolip (fenofibrate + statin)
Daglutril (SLV306) (pulmonary hypertension)
SLV320 (acute heart failure)
SLV 319 (obesity/diabetes)
Research & Development CARDIOMETABOLIC
2007 R+D Investments: EUR 139M (33% of total Pharma R&D)
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Bifeprunox (schizophrenia)
SLV314 (schizophrenia)
PRECLINICAL PHASE I PHASE II PHASE III FILED APPROVED
DUODOPA® (Parkinson)
Pardoprunox (SLV308) (Parkinson)
SLV313 (schizophrenia)
SLV334 (traumatic brain injury)
2007 R+D Investments: EUR 160M (39% of total Pharma R&D)
Research & Development NEUROSCIENCE
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GRIPPOL® Plus (Egg-Based AdjuvantedSeasonal Vaccine)
PRECLINICAL PHASE I PHASE II PHASE III FILED APPROVED
INFLUVAC®TC EU (Cell-Based Seasonal Vaccine)
GRIPPOL® TC (Cell-Based Adjuvanted Seasonal Vaccine)
INFLUVAC® TC US (Cell-Based Seasonal Vaccine)
Pandemic egg (H5N1 Egg Based Vaccine)
2007 R+D Investments: EUR 19M (5% of total Pharma R&D)
Research & Development INFLUENZA VACCINES
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PRECLINICAL PHASE I PHASE II PHASE III FILED APPROVED
CREON® US
CREON® JPN
SLV339 (non animal sourced enzymes)
2007 R+D Investments: EUR 35M (8% of total Pharma R&D)
Research & Development PANCREATIC ENZYMES
P H A R M A C E U T I C A LS
59 Solvay Investors Days October 1, 2008
Main cardiometabolicindications
METABOLICSYNDROME
DIABETES DYSLIPIDEMIACARDIO-
VASCULAR PREVENTION
TriLipix™next generation
fenofibrate
LIPANTHYL®
fenofibrate
TriCor®/LIPANTHYL® NFENo food-effect fenofibrate
fenofibrate & statin fixed dose combinationsABBOTT & ASTRAZENECA co-develop for USA
SOLVAY project ZOLIP for rest of world
SLV319Obesity/type 2 diabetes
SIMCOR®(Niaspan®/simvastatin)
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60 Solvay Investors Days October 1, 2008
Success factors of ourfenofibrate franchise
0
500
1000
2004 2005 2006 2007
M USD
TriCor® sales* evolutionin the US
* booked by Abbott
+56%
Positive long term use wellestablishedAddresses residualcardiovascular risk on statins Current flagship product :
important clinical benefits of 145 mg NFEbeing introduced in all major markets by 2008 (incl. Russia)IP formulation protection untilJan. 2023 in US and 2018 in Europe – patent litigation vs Teva ongoing
Ongoing discussions of EMEA recommendation concerningclass review of fibrates
P H A R M A C E U T I C A LS
61 Solvay Investors Days October 1, 2008
0
50
100
150
200
US European Union 30
Asia Pacific & Middle
East & Ca
Japan Eastern Europe. & Lat.Am.
Aug 06 – Aug 07Aug 07 – Aug 08
+13%
+11%
-19% +106%
+9%
USEurope 30
Eastern Europe & Lat.Am.
Asia Pacific & Middle East &
CAJapan
Fenofibrate franchise : worldwide growth
Sales evolution (MEUR)Worldwide sales distribution
(Aug 07 – Aug 08)
P H A R M A C E U T I C A LS
62 Solvay Investors Days October 1, 2008
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)
Submitted US
P H A R M A C E U T I C A LS
63 Solvay Investors Days October 1, 2008
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 :HDL and TG, compared to statin therapy alone
LDL, compared to TriLipix™
→ safety similar to TriLipix™ or statin monotherapies(no rhabdomyolysis or unexpected liver, kidney or muscle safety signals identified)
P H A R M A C E U T I C A LS
64 Solvay Investors Days October 1, 2008
■ 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
TriLipix™ + Crestor®
Launch date:2010 US
Phase III
P H A R M A C E U T I C A LS
65 Solvay Investors Days October 1, 2008
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
Launched US
P H A R M A C E U T I C A LS
66 Solvay Investors Days October 1, 2008
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
* Action to Control Cardiovascular Risk in Diabetes
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
67 Solvay Investors Days October 1, 2008
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
Phase II
P H A R M A C E U T I C A LS
68 Solvay Investors Days October 1, 2008
SLV319 Phase II results
Percent change from baseline in body weight over time
Phase II
Off drug treatment
weeks
P=0.0002
P=0.0017
P=0.0203
P H A R M A C E U T I C A LS
69 Solvay Investors Days October 1, 2008
Phase II
SLV319 Phase II results
12,5% 14,9%6,1%
15,1%20,0%
31,3%
10,6%
44,7%
42,9%
49,1%
54,0%37,5%
59,6%
31,3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
P LAC E BO 5mg/d 25/5 mg/d 10mg/d 25mg/d 50mg/d 100mg/wk
S ubjects With >5% R eduction from Baseline
S ubjects With >10% R eduction from Baseline
Percentage of Subjects Reaching 5% and 10% Weight Loss
P H A R M A C E U T I C A LS
70 Solvay Investors Days October 1, 2008
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
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71 Solvay Investors Days October 1, 2008
Pulzium® Intravenous
■ Mixed potassium channel blocker
■ Recent onset atrialfibrillation/flutter
■ Approved in EU (UK, Sweden, Spain)
■ Non approvable letter in US
■ Available for worldwide out-licensing
■ IP 2012 (EU 10 years dossier excl, US 5 years dossier excl)
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
72 Solvay Investors Days October 1, 2008
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
Phase II
P H A R M A C E U T I C A LS
73 Solvay Investors Days October 1, 2008
SLV320
■ Adenosine 1 antagonist
■ Intravenous formulation
■ Innovative compound for patients with acute heart failure (AHF)
■ Proof of concept in AHF, PoPstudies ongoing
■ IP 2019 + possible extensionsPhase II
Cardio-Metabolic
NeuroscienceNeuroscience
Influenza Vaccines
Pancreatic Enzymes
P H A R M A C E U T I C A LS
75 Solvay Investors Days October 1, 2008
■ 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
Bifeprunox
Phase III
P H A R M A C E U T I C A LS
76 Solvay Investors Days October 1, 2008
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
Launch date 2004
Peak sales potential100 to 250 MEUR
P H A R M A C E U T I C A LS
77 Solvay Investors Days October 1, 2008
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
Submission date: 2011
Peak sales potentialabove 250 MEUR
P H A R M A C E U T I C A LS
78 Solvay Investors Days October 1, 2008
Phase III study in early Parkinson (monotherapy)
Mean change from baseline UPDRS, part 3 (LOCF)
-12.0
-10.0
-8.0
-6.0
-4.0
-2.0
0.0
2.0
0 5 10 15 20 25 30 35 40
< titration > < ----maintenance 24 weeks -------------> Endp
6 mg12 mg12-42 mgplacebo
end of titration
Pardoprunox (SLV308) phase III results
UPDRS : Unified Parkinson’s disease rating scale
LOCF : last observation carried forward
P=0.0006P=0.0044
P=0.0397
P H A R M A C E U T I C A LS
79 Solvay Investors Days October 1, 2008
-12,0
-10,0
-8,0
-6,0
-4,0
-2,0
0,0
2,0
0 5 10 15 20 25 30 35 40 < titration > < ------ maintenance 24 weeks -------------> Endp
12-42 mgPPX -4.5 mgPlacebo
end of titration
Pardoprunox (SLV308) phase III results
Phase III study in early Parkinson (monotherapy)
Mean change from baseline UPDRS, part 3 (LOCF)
UPDRS : Unified Parkinson’s disease rating scale PPX : pramipexole
LOCF : last observation carried forward
P=0.0091
P=0.0020
P H A R M A C E U T I C A LS
80 Solvay Investors Days October 1, 2008
Phase III study in advanced Parkinson (in combination with L-Dopa)
Hours off-time : estimates with 95% CI of SLV308 versus placebo
p-value: 0.0424 0.0215
ANCOVA model with baseline score, pooled center, and treatment group
-4
-3
-2
-1
0
1
SLV308 12-42 mg
Placebo SLV308 vsPla
SLV308 12-42 mg
Placebo SLV308 vsPla
Observed case LOCF
Pardoprunox (SLV308) phase III results
CI : confidence interval
P H A R M A C E U T I C A LS
81 Solvay Investors Days October 1, 2008
■ 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
Pardoprunox (SLV308) phase III results
P H A R M A C E U T I C A LS
82 Solvay Investors Days October 1, 2008
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
P H A R M A C E U T I C A LS
83 Solvay Investors Days October 1, 2008
SLV313
■ D2 antagonist + 5HT1A agonist
■ Bipolar disorder, schizophrenia
■ Preclinical data supporting potential effect on cognition
■ IP 2018 + possible extensions
■ Phase II trials ongoing
Cardio-Metabolic
Neuroscience
Influenza VaccinesInfluenza Vaccines
Pancreatic Enzymes
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
85 Solvay Investors Days October 1, 2008
Growth strategy
■ Capacity increases→ Egg-based→ Cell-based
■ 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→ Pandemic vaccine
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
86 Solvay Investors Days October 1, 2008
Cell Culture Technology
■ Egg independent process/faster start-up for pandemic
■ Clinical material produced in cell-culture facility→ 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)
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
87 Solvay Investors Days October 1, 2008
■ Solvay’s influenza vaccines in 68 countries→ Launch China season 2009
■ 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→ 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
Geographical strategy
Cardio-Metabolic
Neuroscience
Influenza Vaccines
Pancreatic EnzymesPancreatic Enzymes
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
89 Solvay Investors Days October 1, 2008
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
0
100
200
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
M EUR
Creon®
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
90 Solvay Investors Days October 1, 2008
Bioengineered Enzymesfor 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
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
91 Solvay Investors Days October 1, 2008
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
0
100
200
300
2000 2001 2002 2003 2004 2005 2006 2007
M USD
AndroGel® (US)
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
92 Solvay Investors Days October 1, 2008
2007 2008 2009 2010 2011
Overview Solvay Product Submissions
CREON® JPNCREON® JPN
DUODOPA® USDUODOPA® US
InfluenzaGRIPPOL® TC (Russia)
InfluenzaGRIPPOL® TC (Russia) INFLUVAC®TC USINFLUVAC®TC US
INFLUVAC®TC EUINFLUVAC®TC EU
Zolip EUZolip EU
LUVOX® melt JapanLUVOX® melt Japan
ANDROGEL® low volume USANDROGEL® low volume US
FEMOSTON® low doseFEMOSTON® low dose
Pardoprunox (SLV308)
Pardoprunox (SLV308)
TriLipix/Crestor®
(by Abbott/AstraZeneca)
TriLipix/Crestor®
(by Abbott/AstraZeneca)
TrilipixTM
US
TrilipixTM
US
Pulzium®
EU
Pulzium®
EU
Fluvoxamine IR + ER (US)
Fluvoxamine IR + ER (US)
ANDROGEL® pediatric USANDROGEL® pediatric US
CREON® US (answer to FDA letter)
CREON® US (answer to FDA letter)
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93 Solvay Investors Days October 1, 2008
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
94 Solvay Investors Days October 1, 2008
Priorities MovingFoward
■ Confirm 2008 guidance → operating results for 2008 higher
than 2007
■ Confirm commitment towards 2010 objectives
■ Prepare organization to address industry drivers
P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS
95 Solvay Investors Days October 1, 2008
INSPIRE2010
2010: committed toour targets
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Regulatory paradigm shift
Industry Drivers & Solvay actions
Processes, interfaces, relationships
Trial registration
Publication of trial results
Innogenetics acquisition
Biomarker approach in clinical developmentAdaptation of R&D activities
to new requirements
Use of external expertise (advisory panels)
Inspire project
Further increase R&D and product sourcing spend
Solvay actions Solvay actions
Resource allocation shift
“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-lookingstatements 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 uncertaintiesmaterialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Companyundertakes no obligation to publicly update any forward-looking statements"