Solvay Pharmaceuticals Performance, Priorities and Pipeline Werner Cautreels, General Manager of Solvay Pharmaceuticals
SOLVAY INVESTORS DAYS October 1, 2008 INSPIREINSPIRE TRANSFORMATIONTRANSFORMATION 20102010 20152015 P InternalInternal FocusFocus ip ExternalExternal DriversDrivers s e u lin c e o ,Tra , F e n nc s fo ma rm or rf at e ion , P n , P io ri at or r i g ti te es In
2005 2010 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
• Top Line Growth • Bottom Line Growth • Delivering Efficiencies • 2010 Targets
4 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Topline Growth
Î10 years significant growth in revenues
Annual growth 2600 2591 M EUR +11%/y 2270 SALES 1863 1832 1769 1745 1548 1349 1167 1049
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 457 451 REBIT 14.1% REBIT/Sales 13.3% 13.5% 13.3%
11.6% 11.5% 302 11.2% 11.6% 263 246 8.7% 243 236 203 205 157 118 135 134
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 H108
6 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Delivering Efficiencies Reinvested in Growth & Profitability
Efficiency Cumulative annual efficiencies program
INSPIRE 300 275 on track ! 250 230
160
expected achieved 80
in M EUR 5 One-time costs 28 134 59 47 2005 2006 2007 2008 est 2009 2010 Commercial + ++ ++ + + + Manufacturing + ++ ++ ++ + General & Administration + ++ ++ + + +
7 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Integration & Transformation
Commercial Operations Manufacturing & Supply
Reduce overlap in sales force Globalize purchasing approach Strengthen global presence Improve plant productivity Build pan-European organization Continue optimization of manufacturing network
General & Administration R&D
Build global General & Admin functions : Integrate project and product portfolio legal, HR, IT, Finance, Communication Improve discovery platform Support integration of global Consolidate development resources strategic framework
8 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Integration & Transformation Execution
Commercial Operations Global Manufacturing Global purchasing operational Overall reduction in sales force, shift to emerging markets Divestment of Baudette (US), Veenendaal (NL), Weesp API (NL), Integration of GPS/NBD into SPML Synkem (Fr), Kawagoe (Jp) Divestment of certain C products Divestment Fontaine ongoing Optimisation ongoing
General & Administration R&D
Legal entities merged R-POP in Gastroenterology and Women’s/Men’s Health stopped Global functions integrated and fully operational One R&D organisation, one R&D portfolio IT outsourcing ongoing Outsourcing of certain R&D activities
9 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Integration & Transformation : FTE impact
2006 2007 2008
Total 10088 9178 9021 (Consolidated companies)
Total 11432 11226 10058 (All companies) including shift of sales forces from EU to emerging markets not including reduction of rented sales forces
10 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 PROFITABLE GROWTH Industry 3.2 Bn EUR revenues 20% REBIT/Sales by 2010 EFFICIENCY PROGRAM EUR 300 M stepwise efficiency improvements
PORTFOLIO FOCUS Solvay Pharmaceuticals Revenues growth
11 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS
12 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
13 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
4% 28% 9% 17%
45% 8% 6%
7% 42% 23% 11%
28% Cardiometabolic 45% Europe 17% Neuroscience 36% European Union (27) 6% Influenza vaccines 9% Other European Countries 7% Pancreatic enzymes 42% The Americas 11% Gastroenterology 40% Nafta 23% Women’s and Men’s Health 2% Mercosur 8% Others 9% Asia-Pacific 4% Rest of the world
14 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Growth in major products
HY08 vs HY07 Net sales (EUR m) HY08 vs (constant 2007 HY08 HY07 exchange rates) PHARMACEUTICALS 2,591 1,249 0% +5% Cardiometabolic Fenofibrates 433 221 +6% +15% TriCor sales booked by Abbott in the US in HY08 : USD 553m (+5%) Women’s& Men’s health 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% Women’s& Men’s health Duphaston® 90 45 +7% +8% Neuroscience Marinol® 105 43 -25% -14% Neuroscience Luvox® 83 40 -9% -7%
15 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Therapeutic focus
Cardio Neuro Influenza Pancreatic Gastro Women’s/ Metabolic Science Vaccines Enzymes Enterology Men’s Health
KEY FOCUS AREAS SPECIFIC MEDICAL NEEDS MARKETING EXCELLENCE Sustain and build on Sustain and build on Sustain and build on market market leadership market leadership excellence & leadership New products by in- New products by in- New products by in-licensing licensing & acquisition licensing & acquisition & acquisition
With Full R&D With Full R&D No R to POP In range of biological New influenza vaccine With development targets and indications technologies possibilities New pancreatic enzyme replacements
16 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Therapeutic focus
Cardio Neuro Influenza Pancreatic Metabolic Science Vaccines Enzymes
2007 Mill. USD MS % +/- % Solvay Pharmaceuticals US$ 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
A8A (Anti-Obesity) 1,703 0.3 26 SLV319 A10B (Oral Antidiabetics) 12,996 1.9 9 SLV319
Source: IMS Health, IMS World Review 2008
17 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Our Areas of Focus
CARDIO- NEURO- PANCREATIC INFLUENZA METABOLIC SCIENCE ENZYMES VACCINES
Dyslipidemias Psychosis Bioengineered New delivery Enzymes systems Obesity Bipolar Disorder Adjuvants Type 2 Diabetes Parkinson’s Disease Acute Heart Failure Traumatic Brain Injury Diabetic Nephropathy Pulmonary hypertension Atherosclerosis
+ exploratory platforms, such as Alzheimer, cognition
18 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS
19 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS
PRIORITIES
• Geographical expansion • Manufacturing & Supply • Industry Drivers • Innogenetics
20 Solvay Investors Days October 1, 2008 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 15 about 1/5th of total sales
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 1999 2000 2001 2002 2003 2004 2005 2006 2007
21 Solvay Investors Days October 1, 2008 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 Brazil Russia India China Turkey Mexico Australia Poland
22 Solvay Investors Days October 1, 2008 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
23 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
24 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
25 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 Baudette (JP) (US)
Peptisyntha Mexico (BE) (MX) FPP
API
Solvay Pharma (BR)
Parets Giraud Châtillon Fontaine Synkem (FR) (FR) May 2005 (ES) (FR) (FR)
26 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) Neustadt (DE)
Canlac (CA)
Organics (US)
Mexico (MX) FPP
API
Solvay Pharma (BR)
Parets Châtillon Fontaine (FR) May 2008 (ES) (FR)
27 Solvay Investors Days October 1, 2008 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 √
API outsouring Weesp Closed Q2-08
Synkem Sold √
Baudette Sold √
Veenendaal Sold √
Kawagoe Sold √
Chatillon – Foch Downsize / Sell √
Neustadt Downsize √
Fontaine Sell Q4-08
28 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 Site impacted by announced restructuring
Cork (IR) Weesp (NL) Olst (NL) Neustadt (DE)
Canlac (CA)
Organics (US)
Mexico (MX) FPP
API
Solvay Pharma (BR)
Parets Châtillon Fontaine (ES) (FR) (FR) May 2008
29 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Industry Drivers
INSPIRE 2010
30 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Industry Drivers
INSPIRE Resource allocation 2010 shift
Regulatory paradigm shift 31 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
32 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Stakeholder Impact
TRADITIONAL CORE NEW CUSTOMERS CUSTOMERS
TraditionalTraditional • Patients • Physicians customerscustomers areare • State & Fed Gvmnts joinedjoined byby newnew influencersinfluencers • Advocacy groups • KOLs • Professional societies • Pharmacists
• Payers • Politicians • Dept. of Health & CUSTOMERS WHO COULD Human Services BECOME MORE IMPORTANT • Regulatory • Media agencies • Wholesalers • Pharmacy chains • Actuaries and benefits consultancies
33 Solvay Investors Days October 1, 2008 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 … however today’s M&S spend is is evolving … still focused on traditional core
New customers 30 5-10% Physician – traditional core 65 20
Consumers 10 25 Government 5 90-95%
Payor/ Physicians managed care 20 25 and patients organizations
Today Tomorrow
34 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 → Public awareness and societal demands ■ Personalized medicine ■ Regulatory paradigm shift ■ Resource allocation shift
35 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Transparency
SOCIETY’S EXPECTATIONS SOCIETY’S PERCEPTIONS
Affordability limits Fair value Excessive prices and profits
Focus on medical Lifestyle products favored need Developing world diseases neglected
R&D productivity collapse Constant innovation The dilemma of incremental innovation
Fair influence Excessive lobbying: profits before patients
36 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
37 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 CNS • Sequence (5-10 years?) CV More challenging determined by the indications in relative market Near term Oncology Oncology opportunity (5 years?) Cardiovascular Ophthalmology Rheumatology Rheumatology • Significant Schizophrenia uncertainty around Asthma time frames Oncology COPD Infectious dis. Sepsis/ ARDS Osteoporosis Infertility Cystic Fibrosis Diabetes Obesity
38 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 ■ 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
39 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 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
40 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 → No data = no labeling → Specific target groups
41 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 ■ Regulatory paradigm shift ■ Resource allocation shift → R&D expenditures: → SG&A expenditures: → Cost of Goods :
42 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 Inspire project allocation SolvaySolvay Further increase shift R&D and product actionsactions sourcing spend
Innogenetics acquisition Biomarker approach in Adaptation of R&D activities clinical development to new requirements Use of external expertise (advisory panels)
Regulatory paradigm shift 43 Solvay Investors Days October 1, 2008 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 Expand biomarker technologies and enter progressively into the field of personalized medicine →Expand the diagnostic activities Reinforce existing commercial operations 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 Innogenetics Pharmaceuticals
COMMERCIAL COMMERCIAL THERAPEUTICS DIAGNOSTICS ■ Biomarkers → improved molecule selection R&D R&D R&D → surrogate markers for R&D therapeutics clinical studies diagnostics ■ Companion diagnostics → personalized medicine
46 Solvay Investors Days October 1, 2008 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
47 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
H107/ FY07 H108 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
48 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Key Diagnostic Product Areas
• 47% of total 2007 product sales Infectious • Virology market with HCV, HBV, HIV and HPV diseases • Partnerships with Roche, Bayer and TWT
• 15% of total 2007 product sales HLA • Currently developing assays using the 4-MAT™ microarray platform
• 14% of total 2007 product sales Genetic • Cystic fibrosis (CF), MBL2, Apo E testing (GT) • Leading supplier of CF testing in Europe
Neuro- • 6% of total 2007 product sales degenration • 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 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 Traumatic brain injury (SLV334) Parkinson’s disease (SLV357) Schizophrenia → Cardiometabolic program Diabetic nephropathy (SLV306) 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
Filed/ Preclinical Phase I Phase II Phase III Approved
TriLipix™ US SLV319 Zolip SLV342, SLV344, SLV337, SLV338, PULZIUM® intravenous Cardiometabolic Daglutril (SLV306) PULZIUM® SLV352, SLV 356 SLV341 (EU) SLV320 intravenous (US)
SLV 313 bifeprunox SLV338, SLV351, Neuroscience SLV314 SLV 334 pardoprunox SLV354, SLV357 Anatibant (+Xytis) DUODOPA® US
Adjuvants, H5N1 egg INFLUVAC® TC EU GRIPPOL® Plus Influenza vaccines H5N1 TC Seasonal TC US GRIPPOL® TC
Pancreatic enzymes SLV340 SLV339 CREON® JPN CREON® US
ANDROGEL® low Women’s & Men’s volume EE/MT US FEMOSTON® low dose Health ANDROGEL® pediatric US
Discontinued : Synordia, dronabinol MDI
54 Solvay Investors Days October 1, 2008 Approved : Luvox IR/CR (US) 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 APPROVED
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 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 APPROVED
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 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 APPROVED GRIPPOL® Plus (Egg- Based Adjuvanted Seasonal Vaccine) 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)
57 Solvay Investors Days October 1, 2008 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 APPROVED
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 P H A R M A C E U T I C A LS Main cardiometabolic indications
CARDIO- METABOLIC DIABETES DYSLIPIDEMIA SYNDROME VASCULAR PREVENTION fenofibrate & statin fixed dose combinations ABBOTT & ASTRAZENECA co-develop for USA SOLVAY project ZOLIP for rest of world
TriLipix™ SIMCOR® next generation (Niaspan®/ fenofibrate simvastatin)
SLV319 TriCor®/LIPANTHYL® NFE Obesity/type 2 diabetes No food-effect fenofibrate
LIPANTHYL® fenofibrate
59 Solvay Investors Days October 1, 2008 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 TriCor® sales* evolution Addresses residual in the US cardiovascular risk on statins M USD +56% Current flagship product : Î important clinical benefits of 1000 145 mg NFE
Î beingintroducedin all major 500 markets by 2008 (incl. Russia) Î IP formulation protection until Jan. 2023 in US and 2018 in 0 2004 2005 2006 2007 Europe – patent litigation vs * booked by Abbott Teva ongoing Ongoing discussions of EMEA recommendation concerning class review of fibrates
60 Solvay Investors Days October 1, 2008 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)
+9%
Asia Pacific & Middle East & Japan CA 200 Aug 06 – Aug 07 Eastern Europe Aug 07 – Aug 08 & Lat.Am.
150 +13% Europe 30 US 100 +11%
-19% 50 +106%
0 US European Asia Japan Eastern Union 30 Pacific & Europe. & Middle Lat.Am. East & Ca
61 Solvay Investors Days October 1, 2008 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 Submitted US ■ Improved Therapeutic Benefit clinical programs ongoing ■ Phase III studies presented at scientific congresses (HY08)
62 Solvay Investors Days October 1, 2008 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 :
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)
63 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 Phase III (CRESTOR®/AstraZeneca) ■ Convenient single pill for Launch date: comprehensive lipid treatment 2010 US ■ 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 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 Launched US key lipids compared to simvastatin alone ■ Co-promotion with Abbott (US territory) ■ Launched in April 2008
65 Solvay Investors Days October 1, 2008 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 Submission stronger lipid effects date: Q3/2009 Peak sales potential ■ IP to 2018 with possible EU/ROW: extensions 100-250 MEUR ■ Data exclusivity EU 10 years from approval ■ ACCORD* NIH study results expected 2010
* Action to Control Cardiovascular Risk in Diabetes 66 Solvay Investors Days October 1, 2008 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 Phase II completed, results support continuation ■ Further discussions on prioritization of indications ■ Worldwide rights back to Solvay
67 Solvay Investors Days October 1, 2008 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
Subjects With >5% Reduction from Baseline Subjects With >10% Reduction from Baseline 80% 70% 60% 50% 37,5% 54,0% Phase II 49,1% 59,6% 40% 44,7%
30% 31,3% 42,9% 20% 31,3% 20,0% 10% 14,9% 15,1% 12,5% 10,6% 6,1% 0% PLAC E BO 5mg/d 25/5 mg/d 10mg/d 25mg/d 50mg/d 100mg/wk
69 Solvay Investors Days October 1, 2008 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 ■ Approved in EU (UK, Sweden, Europe Spain) Submitted US ■ Non approvable letter in US 2006 Q4 Peak sales potential ■ Available for worldwide out- under 100 MEUR licensing ■ IP 2012 (EU 10 years dossier excl, US 5 years dossier excl)
71 Solvay Investors Days October 1, 2008 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 Phase II pulmonary hypertension ■ Phase II in arterial hypertension did not support continuation in this indication
72 Solvay Investors Days October 1, 2008 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 Phase II ■ IP 2019 + possible extensions
73 Solvay Investors Days October 1, 2008 Cardio-Metabolic
NeuroscienceNeuroscience
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 Phase III ■ 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 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 Launch date 2004 under patient control ■ Registered in 34 countries, Peak sales potential 100 to 250 MEUR 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 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 Submission ■ IP 2019 + possible extensions date: 2011
■ Potential differentiation in Peak sales potential dyskinesia and other CNS above 250 MEUR symptoms
77 Solvay Investors Days October 1, 2008 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 6 mg P=0.0397 -4.0 12 mg -6.0 12-42 mg
P=0.0044 P=0.0006 placebo -8.0 -10.0 -12.0 0 5 10 15 20 25 30 35 40 < titration > < ----maintenance 24 weeks ------> Endp
UPDRS : Unified Parkinson’s disease rating scale LOCF : last observation carried forward 78 Solvay Investors Days October 1, 2008 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 12-42 mg P=0.0091 PPX -4.5 mg -6,0 Placebo -8,0 P=0.0020 -10,0
-12,0 0 5 10 15 20 25 30 35 40 < titration > < ------maintenance 24 weeks ------> Endp
UPDRS : Unified Parkinson’s disease rating scale PPX : pramipexole
79 Solvay InvestorsLOCF Days : last October observation 1, 2008 carried forward 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 12- Placebo SLV308 vs SLV308 12- Placebo SLV308 vs 42 mg Pla 42 mg Pla Observed case LOCF
p-value: 0.0424 0.0215 ANCOVA model with baseline score, pooled center, and treatment group
CI : confidence interval
80 Solvay Investors Days October 1, 2008 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
InfluenzaInfluenza VaccinesVaccines
Pancreatic Enzymes P H A R M A C E U T I C A LS 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
85 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 → 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)
86 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 → 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
87 Solvay Investors Days October 1, 2008 Cardio-Metabolic
Neuroscience
Influenza Vaccines
PancreaticPancreatic EnzymesEnzymes 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 Creon® formal FDA approval in the United M EUR States 200 → response to 2007 “approvable” letter submitted
→ Review by FDA Advisory Committee 100 expected by year end ■ Working towards submission in Japan (2009), one of the largest markets 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 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 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 AndroGel® (US) ■ Additional presentation: M USD AndroGel® Flexible Dosing Pump successfully launched in late 2004 300
■ Pediatric exclusivity obtained in 200 August 2007, close interaction
with FDA on pediatric indication 100 after non approvable letter 0 ■ AndroGel® low volume : 2000 2001 2002 2003 2004 2005 2006 2007 submission H109 ■ IP 2020 on formulation + 6 months for pediatric
91 Solvay Investors Days October 1, 2008 P H A R M A C E U T I C A LS Overview Solvay Product Submissions
Influenza ® GRIPPOL® TC ® ® (Russia) INFLUVAC®TC US FEMOSTON® low dose INFLUVAC TC US
® INFLUVAC®TC EU ® ® ANDROGEL® pediatric US ANDROGEL® low volume US
® CREON® US ® (answer to CREON® JPN FDA letter)
Fluvoxamine IR + ER (US) ® Pardoprunox LUVOX® melt Japan (SLV308) TM TrilipixTM US ® ® TriLipix/Crestor® DUODOPA® US (by Abbott/Astra Zolip EU ® Zolip EU Pulzium® Zeneca) EU
2007 2008 2009 2010 2011
92 Solvay Investors Days October 1, 2008 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 Inspire project allocation SolvaySolvay Further increase shift R&D and actionsactions product sourcing spend Innogenetics acquisition Biomarker approach in Adaptation of R&D activities clinical development to new requirements Use of external expertise (advisory panels)
Regulatory paradigm shift 96 Solvay Investors Days October 1, 2008 “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"