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Le 05/03/10. IPSEN. Sophie Compagnon, Melodie Debacker , Gaelle Datchoua , Catherine Lucas. INTRODUCTION. About IPSEN . Specialized world pharmaceutical group More than 20 products marketed in the world Originally, French independent company Headed by Beaufour Family

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ipsen

Le 05/03/10

IPSEN

Sophie Compagnon, MelodieDebacker,

GaelleDatchoua, Catherine Lucas

slide3

About IPSEN

  • Specialized world pharmaceutical group
  • More than 20 products marketed in the world
  • Originally, French independent company
  • Headed by Beaufour Family
  • Third independent pharmaceutical firm in France (sales)
g5 pharma
G5 pharma

five major actors in the French pharmaceutical industry

Motor of economic growth

key figures
Key figures

CA (EN MILLIONS €)

IPSEN workforce

CA (EN MILLIONS €)

+ 6,4%

+ 5,5%

R&D INVESTMENT (in M€)

CA / employee

19,1%

2009: 197.3

2009 : 233 243 €

18,8%

+ ratio important,

+ value added for job

2008 : 227 028 €

20,1%

2007 : 236 876 €

20,7%

Global average : 15 - 16 %

key figures1
Key figures

Sales by therapeutic area 2006

ipsen sites in europe
IPSEN sites in Europe

Research centers:

France, Spain, England

Industrial sites :

France, Swizerland, Ireland, England, Spain

Commercial presence :

Other European country

other ipsen sites
Other IPSEN sites

US : research, industrial site and commercial presence

South America : commercial

presence

China : industrial site and commercial presence

Rest of Asia : commercial presence

key figures2
Key figures

Sales by geographical area 2006

Five major western european countries 53,7%

France 31,3%

Italie 7%

Spain 5,7%

Germany 5,5%

UK 4,1%

Othereuropean countries 22,7%

North of America 4,4%

Rest of the world 19,2%

slide11

IPSEN background

  • BeaufourLaboratories
  • Founded by Dr Henri Beaufour (pharmacist) in Dreux

1929

  • Launchof Romarène®
    • digestive disorders
  • Launchof Citrate de bétaïne® Beaufour
    • dyspepsia

1954

  • Integration of Henri’s sons, Gerard and Albert, in BeaufourLaboratories
  • Launch of Actapulgite®
    • antacid, gastric demulcentand anti-diarrhoeal

1963

slide12

70’s 70’s

IPSEN background

Start marketing products of naturalorigin.

1970

« IPSEN » creation

Subsidiarycompany of « BeaufourLaboratories »

= Institut des Produits de Synthèse et d’Extraction Naturelle

Gingkobiloba

Primary care

slide13

70’s 70’s

IPSEN background

Start marketing products of naturalorigin.

1972

Ginkor®

  • Indications: Cardiovascular
    • chronicvenousinsufficiency
    • acute haemorrhoid episodes
    • superficialphlebitis
  • Active substances:
    • Ginkgo bilobaextract
    • Heptaminol chlorhydrate
    • Troxérutine

1987: GinkorProcto®

1988: Ginkor Fort®

Primary care

slide14

70’s 70’s

IPSEN background

Start marketing products of naturalorigin.

1972

Tanakan®

  • Indications: Cognitive disorders
    • Age-related cognitive disorders (excepted Alzheimer’s disease)
    • Anti-ischemic (atreritis, Raynaud’s phenomenon)
    • cochleovestibular disorders
  • Active substances:
    • EGb 761® (Ginkgo bilobastandardizedextract)

Primary care

slide15

70’s 70’s

IPSEN background

Start marketing products of naturalorigin.

Smecta®

1977

  • Active substances:
    • diosmectite (clay)
  • Indications: Gastroenterology
  • Digestive coating (pain ofœsopagus, stomach, duodenum and colon)
  • Acute and chronicdiarrhea

1980

Bedelix®

  • Active substances:
    • montmorillonite beidellitique (clay)
  • Indications: Gastroenterology
  • Digestive coating
  • Symptomatictreatment of functionnal colopathies

Primary care

slide16

90’s 90’s

IPSEN background

1996

Forlax®

  • Active substances:
    • Macrogol 4000 (polyethylène glycol 4000)
  • Indications: Gastrointestinal
    • constipation (adults and children)

Primary care

s tart in research
Start in research
  • Albert beaufour : biotechnologyresearch

Biomeasure Boston

A. Beaufourresearchinstitute : peptide

focused engineering

  • Research relations with

americanuniversities.

1976

slide18

80’s 80’s

IPSEN background

Interest in specializedtherapies

1980

Partnershipwith

  • International development
  • Launch of Decapeptyl ®(1986)
  • Active substances:
    • triptoreline (GnRHagonist)
  • Indications: Oncology
    • Prostate cancer
    • Uterinfibroids
    • Endometriosis
    • Early-onsetpuberty
    • Femaleinfertility

Decapeptyl® 1mois (1995)

Decapeptyl® 3mois (1996)

Decapeptyl® 6mois (2009, november)

Targetedtherapy

slide19

90’s 90’s

IPSEN background

Interest in specializedtherapies

Dysport®

1994

Purchase of KEYWOOD (UK)

  • Active substances:
    • botiliumneurotoxin,type A toxin-haemagglutinincomplex.

> 75 countries

  • Indications: Neuromuscular
    • hemifacialspasticity
    • Cervical dystonia
    • blepharospasm
    • (glabellaireswrinkles)

Targetedtherapy

slide20

90’s 90’s

IPSEN background

Interest in specializedtherapies

1995

Somatuline®

  • Active substance:
    • Lanréotide = an octapeptidesomatostatinanalog
    • Inhibition of Insulin-like growth factor-1 (IGF-1) and growth hormone (GH).
  • Indications: Endocrinology
    • Acromegaly
    • Neuroendocrine tumours

Somatuline Depot ®

1st product from IPSEN R&Dapproved by the FDA and

available at international level

Targetedtherapy

f amily business
Family business

90’s 90’s

IPSEN background

1996

Disagreementsbeetwen Albert and Gerard, at last Albert boughtGerard’s parts (50%)

Still an independentfamilycompany

Progressively, StephaneFrancois, son-in-law of Albert, has more importance.

ipsen background
IPSEN background

90’s 90’s

2001

Death of Albert. StephaneFrancoisisrenowned CEO,

but Anne and Henri Beaufourdon’tagreewiththat.

StephaneFrancoisisfired.

2002

Welcome to Jean-Luc Bélingard !

slide24

New boss.... Newstrategy

1

  • Optimize its primary care portfolio
  • Geographic expansion
  • Focus on targetedtherapeutic areas

2

3

slide25

1

Optimize its primarycare portfolio

Life Cycle Management to develop new indications or confirm the medical benefits of selected products

In-licensingof new medicines to sustain Ipsen’s primary care franchise

Cash cow

R & D

$

$ $

$

slide26

1

Optimize its primarycare portfolio

Life cycle Management

Tanakan®

  • Principal indication: Cognitive disorders
    • Age-related cognitive disorders (excepted Alzheimer’s disease)

35%

35%

15%

Reimbursement

+ Price cut: -15%

April 2010

1972

2007

IPSEN intention: obtain AMM for Alzheimer’sdisease indication

GuidAgestudy, for 5years (beginning :2006)

Efficacy and Tolerance of EGb 761®

A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled.

slide27

1

Optimize its primarycare portfolio

Life cycle Management

Ginkor Fort®

35%

0%

15%

Reimbursement

+ Price cut: -15%

1972

2006

2008

2005

2007

Turnover decrease

39.7%

Marketing authorizations in France, Andorra and Monaco relinquished to in august 2007

slide28

1

Optimize its primarycare portfolio

Life cycle Management

Smecta®

  • Bad reputation: taste

2008:

new clinical results were released

at international congresses

orange vanilla flavour

new packaging

trend of natural products

INTERNATIONAL EXPANSION

China:

1st global market

SMECTA SALES UP BY 4,8% in 2008

slide29

1

Optimize its primarycare portfolio

In-licensing of new medicines

Co-promotion agreements

Hypertension

2003

Nisis® and Nisisco ®

France

Exforge®

2009

Non steroidal anti-inflammatory drug

France

2006

Artotec®

Post-menopausal osteoporosis

France

2007

Adrovance®

Hyperuricemia

Europe

Adenuric ®

2008

slide30

New boss.... Newstrategy

1

  • Optimize its primary care portfolio
  • Geographic expansion
  • Focus on targetedtherapeutic areas

2

3

slide31

2

Geographic expansion

Decrease reimbursement, generics

Big progression

slide32

2

Example of partnership with Inspiration

  • mission: revolutionize treatment for hemophilia
  • Wide portfolio in hemophilia and haemorrhage
  • OBI-1 : porcine FVIII treatment of hemophilia A
  • Reminder: Hemophilia A = deficit in FVIII controlled by injections of human FVIII ( 2 – 3t/ week)

Pb: 1/3 of cases, immune reaction (Ac anti human FVIII) preventing reinjection of human FVIII

  • So OBI-1 : porcine origin low cross-reactivity to Ac anti hFVIII

therapeutic benefit for these patients

IPSEN ambition: engage in a niche sector

founded in 2004

example of partnership with inspiration
Example of partnership with Inspiration

2

OBI-1: porcine F VIII belongs IPSEN

IPSEN

INSPIRATION

Sublicence OBI-1

50M $ in cash or convertible bond

50 M$ + 27,5 % sales

85 M$ = initial investment

85 M$ financing

Shares representing 20% of Ins. equity

 1 member of IPSEN in Board of directors of Inspiration

259 M$ of funding for development and marketing of its portfolio in hemophilia

Based on the successful development of OBI-1 & IB1001

Until 174 M$

1 convertible bond into equity/payment

IPSEN could hold up to 47% of Inspiration equity!

example of partnership with inspiration advantages

2

Example of partnership with Inspiration: Advantages

IPSEN

INSPIRATION

  • Robust portfolio
  • Engage in a niche industry
  • Few competitors
  • Low risk-taking (payment based on results)
  • Benefit from the expertise of specialists in hematology
  • If all goes well, can acquire the entire equity of Inspiration Biopharmaceuticals
  • Enjoy a worldwide group to implement its products
  • Addition of OBI-1 in their portfolio
  • Become the world leader in the field of hemophilia
  • Thanks to OBI-1, Insp. Portfolio could generate sales exceeding $ 1 billion within 10 years
slide35

2

So …

Realize partnership permits to IPSEN:

  • sell products that are not in its field (little knowledge)
  • engage with partners only if it can make a profit
  • eventually buy out his partner / no longer care
slide36

2

PartnershipwithMedicis and Galderma

Botulinumneurotoxin, type A, boughtfromOctagen.

  • Therapeutic indications:
    • hemifacialspasticity
    • cervical dystonia
    • blepharospasm
  • Esthetic indication:
    • glabellaireswrinkles

Keepsitsrights

Market estimated to $ 760 – 800 M

BUT

Not part of Ipsen’s expertise

Partnerships

slide37

2

PartnershipwithMedicis and Galderma

UE, Russia, East Europe, Central Asia, Israël, Liban.

USA, Canada and Japan

$ 10M

$ 90.1 M

$ 20M

$ 26.5 M

$ 75 M

$ X M

30% of turnover

40% of turnover

$ 2 M

Supplies. Fixedprice.

$ 35 M

Supplies. Fixedprice.

Min $ 30 M

$ 228.6 M

Developpement, distribution and marketrights

Developpement, distribution and promotion rights

2006, until 2036

2007, until 2019

slide38

2

PartnershipwithMedicis and Galderma

Advantages

IPSEN

GALDERMA

MEDICIS

  • Develop a productwhichisalreadywell-known as a medecine
  • No bad surprises, lessrisky
  • Be sure to besupplied
  • Be sure to sellitsproduct for a long period of time
  • Reachunknownmarketsthrough
  • locallywell-knownpartners
slide39

2

Partnership policy

Hematology

Endocrinology

Neurology

Primary Care

Oncology

2009

2004

2006

2003

2007

2008

Taspoglutide (GLP-1 analog, antidiabetic): developpement and marketing

Acapodene ( SERM, Prostate Cancer): developpement and marketing in EU

slide40

New boss.... Newstrategy

1

  • Optimize its primary care portfolio
  • Geographic expansion
  • Focus on targetedtherapeutic areas

2

3

focus on targeted therapies

3

Focus on targetedtherapies

Wilde impact of :

≈ 139,2%

of growth

≈ 299,3%

of growth

slide42

3

R&D
  • Earlycommitment, since 1969
  • More 800 personnes in R&D
  • About 20% of CA for R&D everyyear
  • Currently20 programs
i nternational knowledge

3

Internationalknowledge

4 researchcenters:

  • Paris : medicinalchemistry and development
  • Boston : engineering of peptides

and proteins

  • Londres : synthesis of steroid hormones
  • Barcelona : drug formulation
partnership agreements

3

Partnershipagreements
  • Salkinstitute (USA) : « the Ipsen Life Sciences Program » for proliferative and degenerativediseases.
  • CEA (France) : for Alzheimer and

Parkinson diseases.

  • ERINE (Netherland) : therapeutic concepts of endocrinology, diabetes and metabolismdisorders.
  • INSERM : breast, prostate tumors
pipeline

3

Pipeline

Theiridentity

slide46

3

Preclinical

Oncology :

  • Angiomates : anticancer agent, anti-angiogenic
  • acquisition of Sterix
  • BIM 46187 : Cell signalisation, G-protein signal
  • for prostate and lung cancer
  • Cd25 inhibitors phosphatases : regulation of cell cycle
  • Licencied out to Debiopharm for world exclusive right
slide47

3

Preclinical

Endocrinology :

  • MSH agonists for the MC4 receptor :
  • metabolicdisorderslikeobesity

Growing

markets

  • Ghrelinagonists (BIM28131) : regulation
  • of foodintake and gastro intestinal function
  • and treatment of cachexia
  • Inhibitor of 11βHSB : for metabolicdisorders
  • NutropinAp® : treatment of growthfailure, new formulation for prolonged release
  • Life cycle management
phase 1

3

Phase 1

Oncology :

  • Elomotecan : cytotoxic agent, advancedmetastasic cancer.
  • Partnershipwith Roche in dec 2002, but Roche quits in may 2005.
phase 2

3

Phase 2

Oncology :

  • Diflomotecan : topoisomeraseinhibitorless SE thanother
  • BN 83495 : breast cancer expressingoestrogenreceptors
  • partnershipwithBiomérieux for diagnosis

Endocrinology :

  • IGF-1 and growth hormone : combinationtherapy for the treatment of idiopathic short stature. Combo
  • BIM 23A760 : somatostatine analog and dopamine agonist for acromegaly and neuroendocrine tumors
  • Betterwideactivitywithsynergy
phase 3

3

Phase 3

Oncology :

  • Decapeptyl® : combined hormone therapy for premenopausalbreast cancer wirhAromasin® PfizerCombo
  • Toremifene® : GTX licence buyoutDevelopment of new indications

Hematology :

  • OBI-1 : hemophiliaPigfact VIII
phase 31

3

Phase 3

Endocrinology :

  • Somatuline® Autogel®
  • Somatuline® Autogel®
  • Somatuline® Depot®
  • Increlex® : primarydeficit in IGF-1 Global actor in the
  • growthdisorders
  • Taspoglutide : type 2 diabetes (partnershipwith Roche)
  • GLP1, third on the market

Life cycle management

slide52

3

Neurology :

Research program : new formulation for botulique toxin.

Implant on the world market of Dysport® withGalderma, and Medicis and of Apokin® withVernalisbuyout

n ew authorization in 2009

3

Newauthorization in 2009
  • Décapeptyl® 6months : launch in France.
  • Dysport® : launch in USA for cosmetic and therapeutic indications.
  • Azzalure® : marketing authorization in Spain, Germany, France and UK, and launch by Galderma.
slide54

Endocrinology

Neurology

Hematology

Oncology

IPSEN gives itself the means of a strong and sustainable growth

slide56

IPSEN stockmarket

Consideration of introduction in stockmarket, year of the opening of the capital of the laboratory to the caisse de dépots and paribas affaires industrielles, whichthentook a participation of 20%

1998

2003

The conditions of market have not been favorable.

Wait untiltheyimprove

2005

Initial Public Offering in december

capital social
Capital social

Dividende par action: 0,60

Dividende par action: 0,66

holding mayroy
Holding Mayroy

*

*

Implication des Beaufour

Participation majoritaire des Beaufour.

changes in stock price
Changes in Stock Price

2005, December 7 : 22,20€ per share

Number of shares: 84.105.633 .

Alwaysabove 22, 20€

slide64

What do youthink about IPSEN?

Catherine : + strong R&D

- leave out of primary care PRODUCTION

Sophie : + strong R&D

+ partnership organisation R&D

Gaelle : + partnership organisation

+ growth DEVPT GALENIQUE

Mélodie : + partnership organisation

+ strategy MARKETING STRATEGIQUE

partnership policy
Partnership policy

Many partnership to enrich R&D portfolio and expand products range

→ R&D collaboration : Market Ipsen’s products in Japan

→ R&D agreement and acquisition 20% of CA : new technologies

Oct 09 : new agreement SG2000 (anticancer agent, 1st class)

→ Marketing licence for Nisis® & Nisisco®

Jan 09: co-promotion agreement Exforge® in France

→ R&D agreement formulation growth hormone LP

→ marketing licence for Testim® in France

→ Development and marketing BIM 51077

→ development and marketing licence Acapodène® in UE

slide68

Partnership policy

→ development and marketing licence Toxine botulique (dysport®, Azzalure®)

→R&D agreement for development of pharmacogenomic tests for growth retardation

→ R&D agreement for development of innovative products in diabete, endocrinology and metabolism

→ R&D agreement for development of diagnostic test in breast cancer

→ co-marketing licence Adrovance® TM in France

→ definitive merger agreement

july 06: licence agreement Somatuline® Autogel®

→ marketing licence Triptoreline under several brandnames (Salvatyl LP®)

1983: 1st development and marketing licence Decapeptyl®

→ final purchase rights Apokyn® (PK)

slide69

Partnership policy

→ purchase agreement, recovery of all actives related with OBI-1

→ development and marketing licence BLI-800 : colic washing before coloscopy

→ exclusive right of licence for Menarini Adenuric®