Title: Brussels September 14, 2001
1Â A FUNDAMENTAL STRATEGIC CHANGE FOR SOLVAYÂ
Brussels - September 14, 2001 Analysts and
Investors Meeting
2VALUE CREATING IN PHARMACEUTICALS
3SOLVAY PHARMACEUTICALSOUR VISION
Our aim is to find, produce and deliver
pharmaceutical products to help physicians to
treat diseases in our 4 therapeutic areas and
improve the quality of life for patients
4SOLVAY PHARMACEUTICALSmidsize company thrives by
focusing on specialty areas
The giants disdain for small drugs could work
to the advantage of midsize pharmaceutical
companies
McKinsey, 2001
5PHARMACEUTICALS SECTORTargets by 2005
- Sales gt EUR 2.5 Bn from 2005 onward
- EBIT/sales margin gt 15
- ROI gt 20
- North American sales at 50 of total sales
6PHARMACEUTICALS SECTORTargets by 2005
10/y required to achieve EUR 2.5 Bn
World
15/y (23 in US)
7PHARMACEUTICALS FINANCIAL OBJECTIVE by 2005 ?
sales of EUR 2.5 Bn ? EBIT/sales margin of 15
- Growth of existing drugs
- Recent launch of new drugs
- Contribution of molecules under development
- Strengthened by alliances and partnerships
8Â Expansion of global commercial platform J.
Wessolowski, Head of Pharmaceuticals Marketing
Operations
9PHARMACEUTICALS WORLDWIDE PRESENCE
Total 2000 sales EUR 1,548 M
10STRONG WORLDWIDE MARKET POSITION
Europe US World Solvay (11) Worldwide
Market Share Digestives/Enzymes
1 2 1 33 Laxatives 1 - 3 6 Irritable Bowel
Syndrome 1 - 1 28 Hormone Replacement Therapy
female 5 2 2 9 male () - 1 1 22 Antidepressan
ts OCD 13 8 9 2 Vertigo (Ménières
disease) 1 - 1 39
only sold in the US IMS data
11STRONG GROWTH IN 4 THERAPEUTIC AREAS
Therapeutic fields/ Sales in 2000 2000/1999 Produ
cts (M EUR) ()
- HRT PRODUCTS 470 21
- Estratest 145 17
- Duphaston 56 7
- Prometrium 49 93
- AndroGel () 29 n.a.
- Femoston 19 60
- GASTROENTEROLOGY 473 11
- Creon 119 6
- Duphalac 81 0
- Duspatal 59 2
- Pantoloc 54 101
- Rowasa 47 8
- Dicetel 34 9
- PSYCHIATRY 419 13
- Luvox 271 19
- Serc 72 2
- CARDIOLOGY 106 6
- Physiotens 39 26
- Teveten 16 20
() Hormone Replacement Therapy () marketed
since June 2000
12 19 SALES in H1/01 (34 in the US)
Success of recently launched drugs
H1/01 M EUR vs H1/00
- Estratest 89 62
- AndroGel 51 n.s.
- Prometrium 31 45
- (Cenestin (Duramed) 15 112)
H1/01 vs H1/00
M EUR
HRT 267 46 GASTRO 247 12 CARDIO 73
47 PSY 181 - 10
- Creon 65 10
- Pantoloc 37 65
- Rowasa 27 29
- Dicetel 20 21
- Physiotens 23 20
- Teveten 17 157
- Aceon 9 ()
- Luvox (world) 86 - 28? US
down? Japan up - Marinol 24 178
() Aceon sales were negligible in H1/00
13MAJOR RECENT PRODUCT LAUNCHES (1)
Launch of Femoston (conti.) in Germany, further
launches to follow
Line extension First launch of Femoston (conti.)
in UK and Switzerland
Femoston Physiotens Teveten Luvox
Lithuania, Croatia, Czech Rep., Slovak Rep.,
Malta, Bulgaria
Lebanon, Jordan, Saudi Arabia, Kuwait, U.A.E.,
Romania, Ukraine
Poland, South Africa, Norway, Hungary, Sweden,
Belgium, Russian Fed.
First launch of Teveten (in Germany and US
followed by further launches through the world
Fin, Gr, Canada, Sweden, Denmark, Norway, Spain,
Belgium
The Netherlands, Austria, UK, Ire, Switzerland,
Australia, Poland, Italy, France, Russian Fed.
First SSRI launched in Ja-pan marketed by
Fujisawa and Meiji Seika for depression and OCD
1999 2000 2001
14MAJOR RECENT PRODUCT LAUNCHES (2)
USA
Aceon
Launch of Teveten
Cenestin (with Duramed Inc.)
Androgel (marketing agreement with TAPsince
June 2001)
Marinol (100 Solvay)
2000 2001
15FUTURE PRODUCT LAUNCHES
Influvac-Intranasal
Teveten HCT, Europe and U.S.
Moxonidine HCT (Europe)
Presomen Conti, (Germany only)
Combigel E P-gel
Creon (Japan)
Tedisamil PO
cilansetron, Europe and U.S.
SLV 306
Luvox CR
DU 127090
Tedisamil IV
Estrogel US
2001 2003 2004 2005
2006
16GEOGRAPHICAL EXPANSION
target 50/50 balance between NAFTA / Rest of
the world
In of total pharma sales
ROW NAFTA
ROW NAFTA
ROW NAFTA
2005
2000
1996
ROW Rest of the World
17GEOGRAPHIC GROWTH OBJECTIVES
- To increase global market share up to 0.8 - 1
of the world market (Market share currently
0.5) - To get 1 in countries where Solvay has a presence
18THE WORLDWIDE MARKET
Solvay market share
of worldwide market
Countries
in Billion USD
Rank
lt1
1
USA
149.8
41.3
lt1
2
Japan
57.8
15.9
gt1
3
Germany
17.3
4.8
gt1
4
France
16.8
4.6
5
UK
11.1
3.0
lt1
6
Italy
11.0
3.0
lt1
lt1
7
China
6.8
1.9
lt1
8
Brazil
6.7
1.8
lt1
9
Canada
6.3
1.7
gt1
10
Spain
6.2
1.7
not present
11
Mexico
6.0
1.7
not present
12
Argentina
3.7
1.0
not present
13
South Korea
3.7
1.0
lt1
14
India
3.6
1.0
lt1
15
Australia
3.1
0.9
16
Turkey
3.1
0.9
not present
17
Netherlands
2.6
0.7
lt1
lt1
18
Poland
2.5
0.7
gt1
19
Belgium
2.5
0.7
20
Taiwan
2.5
0.7
not present
USA Market Estimates include audited US Mail
Order data, data for the Netherlands is based
on estimated sales only (IMS data)
19ACQUISITIONS NEW PRODUCTS/NEW COMPANIES
- Recent/Short term Medium term Long term
- 0 - 2 years gt 2 - lt 5 years gt 5 - years
USA Unimed X X EUROPE Italy X UK X Poland
(X) Continuous growth Central/Eastern Europe,
especially Russia geographical expansion in
Turkey AMERICAS Brazil Sintofarma Argentina
X Mexico X Canada X ASIA Japan X
geographical expansion in India
20ALLIANCES WITH SOUND PARTNERSIN
CO-PROMOTION/LICENSES
- USA
- Androgel with TAP Phamaceutical Co
- Cenestin with Duramed
- Remeron sol-tab with Organon
- CANADA
- Pantoloc with Byk-Gulden
- Teveten with Fournier
- SOUTH AMERICA
- Mexico with Byk Gulden
- Argentina with Byk Gulden
- EUROPE
- Germany with Aventis for Teveten
- Spain with Roche for Cilazapril
- Italy with Upjohn for Frontal
- with Almirall/Prodesfarma for Dumirox
/Almotrex - ASIA
- Japan with Meiji and Fujisawa for Luvox
- Japan with Amano and with Meiji for Creon
(under negotiation) - China with Hexal (hostpartnership)
21EXPANSION OF COMMERCIAL SALES FORCE
About 5,300 sales representatives worldwide
(versus 2,900 in 1998) including sales force
partners or third parties
- SOLVAY SALES FORCE 3,800
- United States 1,000 ? twofold increase between 98
and 2000 - ? establishment of a primary care network
- ? acquisition of Unimed Pharmaceuticals Inc
- ? alliance with Duramed (female HRT) and
TAP (male HRT, Androgel)) - Brazil 180 ? Acquisition of Sintofarma in Brazil
- Canada 64
- Western Europe 1,355
- Central/Eastern Europe 300
- Asia/Middle East 907
- THIRD PARTIES
- Japan 1,500 ? distribution agreement with
Fujisawa/Meiji Seika
22DOUBLE DIGIT GROWTH
over the last 5 years
Sales 922 1,049 1,167 1,349 1,548 830 Sales
Growth (yoy) 15 14 11 16 15 19 EBIT
97 118 135 157 134 59 EBIT growth
(yoy) 38 22 14 16 -15 157 EBIT/SALES
10 11 12 12 9 7
due to voluntary marketing investments for the
launch of 5 new drugs with H1 lower than H2
due to seasonal effect
23 Pharmaceuticals RDfor tomorrow s success
W. Cautreels, Worldwide Head ofRD
Pharmaceuticals
24CONTENT OF PRESENTATION
- Promising Development Projects
- an update by therapeutic area
- But First An Update on Actions Announced Earlier
- towards optimal decision making, output and
effectiveness in RD - strategic partnerships for biotech, special
skills and value optimization
25RD EFFECTIVENESS IMPROVEMENTS
Weesp (Nl), Hannover (D), Marietta and Chicago
(US), Tokyo (J)
- handle the improved output from biotechnology
based discovery programsmore compounds in
development ? New biotech platform implemented - accelerate the development process by working
more effectively with expert Clinical Research
Organisations as partnersreduce  time to
market ? Quintiles agreement implemented - concentrate one function on one site
- improve efficiency by avoiding duplications ?
Implementation started - shift internal RD costs to external costs
towards 50/50 - increased portfolio development spending ?
Implementation started (e.g. cilansetron)
RD EFFORTS BETTER FOCUSED (not reduced)
26Strategic Partnering makes us stronger! some
examples
Programs
Projects
Products
D
Proof ofPrinciple
L
- Development
- in psychosis Lundbeck
- in HRT several projects, E/P gel with Antares
- Lipase with Meristem
- Intranasal influenza vaccine with West
- Discovery and Biotech
- for Compounds (Arqule Evotec Syncom)
- for Screening Technologies (Euroscreen Cerep)
- for Targets (Innogenetics Euroscreen)
- Business
- Fujisawa/Meiji Seika (Jp)for LUVOX? DEPROMEL?
- Byk-Gulden (D) PANTOLOC? in Canada
- Several companies for TEVETEN? co-marketing
- ANDROGEL? co-marketing with TAP in the US
- In preparation preferred partner
- for execution of clinical trials
- with established quality global network
- and state-of-the-art IT systems ? QUINTILES
27AREAS OF RD FOCUS
Hormone Replacements
Cardiology
Gastroenterology
Psychiatry
Anxiety Depression Psychosis Parkinsons
Arrhythmia Congestive Heart Failure Hypertension
Obesity
Motility Disorders Irritable Bowel
Syndrome Pancreatic Enzymes
Women HRT Endometriosis Men HRT
External collaborations
28GROWTH THROUGH A SPECIALIZED RD PROGRAM
Hormone replacement therapies 17
Gastroenterology 27
Psychiatry 34
Cardiology 22
- in of 2000 pharma RD expenses EUR 248
M(16 of pharma sales)
29R D SUMMARY - NUMBER OF PROJECTS
Gastro-
CNS
HRT
Cardiology
Enterology
3(IBS (2), Enzyme Insufficiency)
2 (Parkinsons, Psychosis)
Pre-Clinical
2 (Hypertension/CHF)
7
Phase I
3 (Psychosis)
3
Phase II
4 (Parkinsons, Psychosis, Pain/ Spasticity,
Depression)
2(Motility Disorders, enzyme insufficiency)
2 (arrhythmia, Hypertension/CHF)
8
1(OCD/Social anxiety disorders)
2 (IBS, Enzyme Insufficiency)
3 (female HRT, male HRT)
Phase III
2 (Hypertension)
8
Total26 7 10 3 6
30PSYCHIATRYportfolio
Proof of principle
Registration
Research
DEPRESSION EU/JPNOCD
US/EU/JPNOCD/Social Anxiety Disorders
LUVOX
fluvoxamine CR
DU127090
SCHIZOPHRENIA/PSYCHOSIS Multiple Sclerosis
Pain/Spasticity PARKINSONS SCHIZOPHRENIA
PSYCHOSIS
THC (MARINOL)
SLV308
SLV310
SLV313
SLV314
DEPRESSION
DU125530
preclinical SLV318, SLV319
31PSYCHIATRY
Proof of principle
Registration
Research
DEPRESSION EU/JPNOCD
US/EU/JPNOCD/Social Anxiety Disorders
LUVOX
fluvoxamine CR
- ELAN manufacture
- SOLVAY trademark (to be decided)
- positive pivotal studies in both OCD Social
Anxiety Disorders - submission 2002 US, 12 months delay after
validation of manufacturing
- launch date 2003 onwards
- peak sales potential under 100 MEUR
32PSYCHIATRY
Proof of principle
Registration
Research
Multiple Sclerosis pain/Spasticity
THC (MARINOL)
- cannabinoid receptor agonist, tetrahydrocannabinol
(THC) - launched in US for appetite stimulation in
HIV/AIDS and nausea/vomiting caused by cancer
chemotherapy - clinical studies ongoing in relief of pain and
spasticity in multiple sclerosis sufferers
33PSYCHIATRY
Proof of principle
Registration
Research
SCHIZOPHRENIA/ PSYCHOSIS
DU127090
SLV310
SLV313
SLV314
- DU127090
- Solvay Pharmaceuticals partnership with Lundbeck
for joint developments and marketing - Partial D2 antagonist with additional 5HT1A
agonism - Proof of principle as antipsychotic is completed
- SLV310/313/314
- different mechanism mixes D2, 5HT1A, SSRI
- SLV319 a preclinical potential candidate
- Launch date 2006
- Peak sales potential above 250 MEUR
34The Lundbeck Example of partnership
- We created DU 127090 and described its
anti-psychotic potential by animal work and phase
I clinical studies, phase II is ongoing - DU127090 shows promising anti-psychotic activity
- Lundbeck has very relevant skills with CNS
project and product experience - Solvay and Lundbeck share costs, programs
marketing (Solvay USother countries, Lundbeck
Europe)
35PSYCHIATRY
Proof of principle
Registration
Research
SLV308
PARKINSONS
- SLV308
- Partial D2 agonist plus 5HT1A agonism plus
alpha-1 / alpha-2 agonism - Parkinsons first target co-morbid depression
- Proof of principle studies on motor and mood
disorders ongoing - Backup SLV318 a preclinical potential candidate
36PSYCHIATRY
Proof of principle
Registration
Research
DEPRESSION
DU125530
- Is a potent, full 5HT1A antagonist
- Atypical potential antidepressant
- Early clinical findings confirm antagonism in man
with opposite effects to buspirone, an agonist,
on night time temperature and sleep
37CARDIOLOGYportfolio
Proof of principle
Registration
Research
PHYSIOTENS EU
TEVETEN EU / US
HYPERTENSION
ACEON US
TEVETENHCT
moxonidine HCT
CHF/ HYPERTENSION
SLV306
ARRHYTHMIAS
tedisamil IV-PO
preclinical SLV316, SLV320
38CARDIOLOGY
Proof of principle
Registration
Research
HYPERTENSION
- Launch date 2001-2002
- Peak sales potential under 100 MEUR
- eprosartan plus hydrochlorotiazide (HCT) diuretic
combinations - angiotensin II receptor antagonist
- to be marketed everywhere when registrations and
price agreementsachieved - approvable letter received from FDA
39EFFICACY OF EPROSARTAN AND COMBINATIONS
- eprosartan monotherapy works well for many
hypertensive patients - eprosartan HCT works well for some who need
more than eprosartan alone - better response rate with eprosartan HCT than
with enalapril HCT
40CARDIOLOGY
Proof of principle
Registration
Research
moxonidine HCT
HYPERTENSION
- moxonidine plus HCT diuretic combination
- to be marketed in EU when registrations and price
agreements achieved
- Launch date 2003
- Peak sales potential under 100 MEUR
41CARDIOLOGY
Proof of principle
Registration
Research
CHF/ HYPERTENSION
SLV306
- Dual endopeptidase inhibitor NEP(1) and ECE(1)
- hSEP is a novel ECE target (patent filed)
- selectively inhibited by SLV306
- concept proven in both animals and man
- clinical proof of principle achieved for both
uses - SLV306 is the front runner of this class
- development and marketing partnerships under
consideration - (1) neutral endopeptidase (NEP) endothelin
converting enzyme (ECE)
- Launch date 2006
- Peak sales potential above 250 MEUR
42CARDIOLOGY
Proof of principle
Registration
Research
ARRHYTHMIAS
tedisamil IV-PO
- potassium channel blocker
- intravenous use to convert atrial fibrillation to
sinus rhythm followed by oral use to maintain it - proof of principle achieved
- earliest launch 2004 intravenous and 2006 oral
- Launch date 2004-2006
- Peak sales (IVPO) potential 100-250 MEUR
43GASTROENTEROLOGY portfolio
Proof of principle
Registration
Research
IRRITABLE BOWELSYNDROME
COLOFAC EU
DICITEL EU
cilansetron US/EU
PANCREATICENZYMES
CREON EU/US
CREON JPN
gastric lipase
MOTILITYDISORDERS
KC11458
preclinical SLV317, SLV321, enzymes
44GASTROENTEROLOGY
Proof of principle
Registration
Research
IRRITABLE BOWELSYNDROME
COLOFAC EU
DICITEL EU
cilansetron US/EU
- Cilansetron
- 5HT3 antagonist
- diarrhea-predominant IBS in men and women
- July 2001 decision to complete the phase III
program - Quintiles contract signed for clinical trials
- development and marketing commercial partnerships
now open for discussion
- Launch date 2004
- Peak sales potential above 250 MEUR
45PROMISING and HIGH-POTENTIAL RD
PROJECTCILANSETRON FOR IBS IN PHASE III
- Start of the phase III program after constructive
discussions with the US FDA - Agreement signed with QUINTILES TRANSNATIONAL
- access to state-of-the-art clinical trial
execution with certain priority claim on
QUINTILES resources - ongoing talks with potential allianceand
marketing partners
46KEY DATA FROM CILANSETRON IBS STUDIES
- 2 large studies with similar results, 471 and 435
patients - cilansetron phase II pivotal studies show clear
separation from placebo both in men and women,
fall 2000
47GASTROENTEROLOGY
Proof of principle
Registration
Research
PANCREATICENZYMES
CREON EU/US
CREON JPN
gastric lipase
- CREON JPN
- Launch date 2003
- Peak sales potential under 100 MEUR
- gastric lipase
- non-animal-sourced range of enzymes sought
- Molecular Pharming technology expresses
mammalian gastric-lipase in corn (MERISTEM) - in-licensed for development, phase II ongoing
- other non-animal-sourced enzyme products
preclinical
48GASTROENTEROLOGY
Proof of principle
Registration
Research
MOTILITYDISORDERS
KC11458
- motilin agonist
- KC11458 is a non-peptide macrolide
- intended to be of use in the delayed gastric
emptying found in some diabetic gastroparesis
patients and functional dyspepsias - clinical studies show dose dependent effects in
man confirming faster gastric emptying - phase II ongoing
49HORMONE REPLACEMENTS portfolio
Proof of principle
Registration
Research
ESTRATEST US
FEMOSTON EU
WOMENS HRT
PRESOMEN EU
ESTROGEL US
EP GEL US/EU
MENS HRT
ANDROGEL US
Evaluation testosterone for female use
50HORMONE REPLACEMENTS
Proof of principle
Registration
Research
WOMENS HRT
ESTROGEL US
- New Drug Application submitted to FDA 1999
- Launch date 2003
- Peak sales potential under 100 MEUR
51HORMONE REPLACEMENTS
Proof of principle
Registration
Research
WOMENS HRT
EP GEL US/EU
- Estradiol NETA (progestogen) gel
- Solvay has obtained licenses for US/Canada and
Europe - Clinical studies necessary to start
full-development have been completed - Phase III program to be started in Q1 2002
- Launch date 2005
- Peak sales potential under 100 MEUR
52INFLUENZA VACCINES
- INFLUVAC our current product was manufactured
by Fort Dodge/AHP. We bought the factory mid
2001 in order to secure and expand manufacturing - WEST PHARMACEUTICALS intranasal formulation
technology license obtained mid 2001 for use with
our INFLUVAC launch expected 2005 - MDCK process approved by Dutch authorities mid
2001, launch dates depend on future partnerships
53VALUATION OF R D PORTFOLIO
Peak sales POTENTIAL (3 years or more after
launch)
Teveten HCT, Europe and U.S. lt 100 MEUR
Influvac-Intranasal lt100MEUR
Moxonidine HCT (Europe) lt100 MEUR
Combigel E P-gel lt100MEUR
Tedisamil PO 100-250MEUR
Creon (Japan) lt100MEUR
Cilansetron, Europe and U.S. gt 250MEUR
SLV 306 gt250MEUR
Luvox CR lt100MEUR
DU 127090 gt250MEUR
Estrogel US lt100MEUR
Tedisamil IV
LAUNCHDATES
2001 2003 2004 2005
2006
This represents an all-success scenario,
individual projects are subject to industry
standard probabilities of success for their
respective stage of development
54PHARMACEUTICALS RD
- A Discovery with Proven Output Ability
- and a continuing search for external technologies
and alliances - A Development with Proven Abilities to Proof Of
Principle - recent examples being cilansetron and SLV306
- An Ability to Complete Full Developments
- recent examples being ESTROGEL and fluvoxamine
CR - And A Willingness to Work with Skilled Partners
- Lundbeck on DU127090 and
- Discussion ongoing for cilansetron, SLV306 and
others
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