IPSEN Sophie Compagnon, Melodie Debacker, Gaelle Datchoua, Catherine Lucas 1 Le 05/03/10
Mar 28, 2015
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• 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)
About IPSEN
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G5 pharma
Ipsen Pierre fabre Sanofi aventis Servier LFB
1 032 M€ 1 800 M€ 29 306 M€ 3 600 M€ 352,4M€
five major actors in the French
pharmaceutical industry
Motor of economic growth
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Key figuresIPSEN workforce CA (EN MILLIONS €)
R&D INVESTMENT (in M€)
2009: 197.3 19,1%
18,8%
20,1%
20,7%
CA / employee
2009 : 233 243 €
2008 : 227 028 €
2007 : 236 876 €
+ 5,5%
+ 6,4%
Global average : 15 - 16 %
+ ratio important, + value added for job
CA (EN MILLIONS €)
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Key figuresSales by therapeutic area 2009
Targeted therapy 60,3% oncology 24,3% endocrinology 19,6% neurology 16,4%
Primary care 36,8% gastroenterology 17,7% cognitive disorders 10,5% cardiovascular 7,1% other 1,5%
Other activities 2,9%
60,3%36,8%
2,9%
Sales by therapeutic area 2006
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IPSEN sites in Europe
Research centers:France, Spain, England
Industrial sites : France, Swizerland, Ireland, England, Spain
Commercial presence :Other European country
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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
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Key figuresSales by geographical area
2009
53,7%
22,7%
4,4%
19,2%
Five major western european countries 53,7% France 31,3% Italie 7% Spain 5,7% Germany 5,5% UK 4,1%
Other european countries 22,7%
North of America 4,4%
Rest of the world 19,2%
Sales by geographical area 2006
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IPSEN background
1929
• Launch of Romarène® digestive disorders
1954• Launch of Citrate de bétaïne® Beaufour dyspepsia
Beaufour Laboratories
• Founded by Dr Henri Beaufour (pharmacist) in Dreux
• Integration of Henri’s sons, Gerard and Albert, in Beaufour Laboratories
1963 • Launch of Actapulgite® antacid, gastric demulcent and anti-diarrhoeal
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70’s 70’s
Start marketing products of natural origin.
1970
IPSEN background
« IPSEN » creationSubsidiary company of « Beaufour Laboratories »
= Institut des Produits de Synthèse et d’Extraction Naturelle
Gingko biloba
Primary care
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70’s 70’s
IPSEN background
1972
Indications: Cardiovascular
chronic venous insufficiency
acute haemorrhoid episodes
superficial phlebitis
Ginkor®Active substances:
Ginkgo biloba extract
Heptaminol chlorhydrate
Troxérutine
1987: Ginkor Procto®
1988: Ginkor Fort®
Start marketing products of natural origin.
Primary care
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70’s 70’s
IPSEN background
1972
Indications: Cognitive disordersAge-related cognitive disorders (excepted Alzheimer’s disease)
Anti-ischemic (atreritis, Raynaud’s phenomenon)
cochleovestibular disorders
Tanakan®
Active substances:EGb 761® (Ginkgo biloba standardized extract)
Start marketing products of natural origin.
Primary care
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70’s 70’s
IPSEN background
1977
Indications: Gastroenterology
Digestive coating (pain of œsopagus, stomach, duodenum and colon)
Acute and chronic diarrhea
Smecta®Active substances:
diosmectite (clay)
Active substances: montmorillonite beidellitique (clay)
Indications: Gastroenterology Digestive coating Symptomatic treatment of functionnal
colopathies
1980
Start marketing products of natural origin.
Primary care
Bedelix®
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90’s 90’s
IPSEN background
1996
Indications: Gastrointestinal constipation (adults and children)
Forlax®
Active substances: Macrogol 4000 (polyethylène glycol 4000)
Primary care
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Start in research
• Albert beaufour : biotechnology research
Biomeasure Boston A. Beaufour research institute : peptide focused engineering
• Research relations with american universities.
1976
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80’s 80’s
IPSEN backgroundInterest in specialized therapies
Targeted therapy
1980
Partnership with
• Launch of Decapeptyl ®(1986)
• International development
Decapeptyl® 1mois (1995)
Decapeptyl® 3mois (1996)Decapeptyl® 6mois (2009, november)
Active substances: triptoreline (GnRH agonist)
Indications: OncologyProstate cancerUterin fibroidsEndometriosisEarly-onset puberty Female infertility
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90’s 90’s
IPSEN background
1994
Dysport®
Interest in specialized therapies
Active substances: botilium neurotoxin,type A toxin-haemagglutinin complex.
Indications: Neuromuscular hemifacial spasticityCervical dystonia blepharospasm (glabellaires wrinkles)
Purchase of KEYWOOD (UK)
> 75 countries
Targeted therapy
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90’s 90’s
IPSEN backgroundInterest in specialized therapies
1995
Somatuline®Active substance:
Lanréotide = an octapeptide somatostatin analog Inhibition of Insulin-like growth factor-1 (IGF-1) and growth hormone (GH).
Indications: EndocrinologyAcromegalyNeuroendocrine tumours
Somatuline Depot ® 1st product from IPSEN R&Dapproved by the FDA and
available at international level
Targeted therapy
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90’s 90’s
Family businessDisagreements beetwen Albert and Gerard, at last Albert bought Gerard’s parts (50%)
Still an independent family company
Progressively, Stephane Francois, son-in-law of Albert, has more importance.
1996
IPSEN background
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90’s 90’s
IPSEN backgroundDeath of Albert. Stephane Francois is renowned CEO,but Anne and Henri Beaufour don’t agree with that.
Stephane Francois is fired.
2001
2002
Welcome to Jean-Luc Bélingard !
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New team
J.L Bélingard •Chairman and Chief Executive Offi cer.•Delegate General and spokesman for G5
1999-2001, he was a member of theExecutive Board and CEO of BioMérieux-Pierre Fabre.
Anne Beaufour Director bachelor’s degree in geology.director of the Company since 1998.
Henri Beaufour Director Bachelor of arts degree.Since 2003,manager of Camilia Holding (LXB)
Claire Giraut 2003: ChiefFinancial Offi cer
member of the ExecutiveBoard of the Technip Group
Eric Drapé Executive Vice-President, Manufacturing and Supply Organisation.
Senior Vice President of the company’s Diabetes Finished Products at Novo Nordisk
Jacques-Pierre Moreau
Executive Vice-President, Chief Scientifi c Offi cer
founded Biomeasure Incorporated,based near Boston
Frédéric Babin Executive Vice-President, Human Resources
Master of Business Law
Christophe Jean Group Vice-PresidentOperations
Chairman and CEO of Pierre Fabre Médicaments.
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• Optimize its primary care portfolio
• Geographic expansion
• Focus on targeted therapeutic areas
NEW BOSS.... NEW STRATEGY
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Optimize its primary care portfolio
Life Cycle Management to develop new indications or confirm the medical benefits of selected products
In-licensing of new medicines to sustain Ipsen’s primary care franchise
$$ $ $
CASH COW
R & D
1
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Life cycle Management
Optimize its primary care portfolio
Tanakan®Principal indication: Cognitive disorders
Age-related cognitive disorders (excepted Alzheimer’s disease)
IPSEN intention: obtain AMM for Alzheimer’s disease indication
GuidAge study, for 5years (beginning :2006)Efficacy and Tolerance of EGb 761® A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled.
1972
35%
2007 April 2010
15%Reimbursement
+ Price cut: -15%
35%
1
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Life cycle Management
Optimize its primary care portfolio
Ginkor Fort®
Marketing authorizations in France, Andorra and Monaco relinquished to in august 2007
1972
35%
2006 2008
15% 0%Reimbursement
20072005
Turnover decrease 39.7%
+ Price cut: -15%
1
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Life cycle Management
Optimize its primary care portfolio
Smecta®
SMECTA SALES UP BY 4,8% in 2008
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
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In-licensing of new medicines
Optimize its primary care portfolio
Co-promotion agreements
Nisis® and Nisisco ®2003
2009 Exforge®
Hypertension
Post-menopausal osteoporosis
2007 Adrovance®
Non steroidal anti-inflammatory drug
Artotec®2006
2008 Adenuric ®
Hyperuricemia
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France
France
France
Europe
1
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NEW BOSS.... NEW STRATEGY
• Optimize its primary care portfolio
• Geographic expansion
• Focus on targeted therapeutic areas
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3
2
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Geographic expansion
Country % variation 2008-2009
France - 3,2%
Spain 2,3%
Italia 3,3%
Germany 5,3%
UK - 1,1%
Major werstern european countries - 0,9%
Other european countries - 0,8%
North of America 307,1%
Rest of the world (BRIC) 20,8%
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Big progression
Decrease reimbursement,
generics
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• 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
Example of partnership with Inspiration
founded in 2004
2
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Example of partnership with Inspiration
Sublicence OBI-1
IPSEN INSPIRATION
50 M$ + 27,5 % sales50M $ in cash or convertible bond
85 M$ financing85 M$ =
initial investmen
tShares
representing 20% of Ins.
equity
1 member of IPSEN in Board of
directors of Inspiration
Until 174 M$ Based on the successful
development of OBI-1 & IB10011 convertible bond
into equity/payment
259 M$ of funding for
development and
marketing of its
portfolio in hemophilia
IPSEN could hold up to 47% of Inspiration equity!
OBI-1: porcine F VIII belongs
IPSEN
2
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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
2
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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
So …2
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Partnership with Medicis and Galderma
Botulinum neurotoxin, type A, bought from Octagen.
Therapeutic indications: hemifacial spasticitycervical dystonia blepharospasm
Esthetic indication: glabellaires wrinkles
Keeps its rights
Partnerships
Market estimated to $ 760 – 800 M
BUTNot part of Ipsen’s
expertise
2
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Partnership with Medicis and Galderma
USA, Canada and JapanUE, Russia, East Europe,
Central Asia, Israël, Liban.
Developpement, distribution and market rights
$ 90.1 M
$ 26.5 M
$ 75 M
$ 2 M
$ 35 M
$ 228.6 M
30% of turnover
2006, until 2036
Developpement, distribution and promotion rights
Supplies. Fixed price. Supplies.
Fixed price.
2007, until 2019
$ 10M
$ 20M
$ X M 40% of turnover
Min $ 30 M
2
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Be sure to sell its product for a long period of time
Reach unknown markets throughlocally well-known partners
Develop a product which is already well-known as a medecine No bad surprises, less risky
Be sure to be supplied
Partnership with Medicis and GaldermaAdvantages
IPSENGALDERMA
MEDICIS
2
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2003 2004 2006 2007
Endocrinology
Oncology
Neurology
Primary Care
2008
Partnership policy
Hematology
2009
Taspoglutide (GLP-1 analog, antidiabetic):
developpement and marketing
Acapodene ( SERM, Prostate Cancer):
developpement and marketing in EU
2
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• Optimize its primary care portfolio
• Geographic expansion
• Focus on targeted therapeutic areas
NEW BOSS.... NEW STRATEGY
1
2
3
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Focus on targeted therapies
Therapeutic areas % variation 2008-2009
Oncology 1,1%
Endocrinology 26,2%
Neurology 17%
Hematology -
Total 12,6%
≈ 299,3%
of growth
Wilde impact of :
≈ 139,2%
of growth
3
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R&D
Early commitment, since 1969
More 800 personnes in R&D
About 20% of CA for R&D every year
Currently 20 programs
3
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International knowledge4 research centers:
Paris : medicinal chemistry and development
Boston : engineering of peptides and proteins
Londres : synthesis of steroid hormones
Barcelona : drug formulation
3
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Partnership agreements
Salk institute (USA) : « the Ipsen Life Sciences Program » for proliferative and degenerative diseases.
CEA (France) : for Alzheimer and Parkinson diseases.
ERINE (Netherland) : therapeutic concepts of endocrinology, diabetes and metabolism disorders.
INSERM : breast, prostate tumors
3
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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 cycleLicencied out to Debiopharm for world exclusive right
Preclinical3
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Endocrinology :
MSH agonists for the MC4 receptor : metabolic disorders like obesity
Ghrelin agonists (BIM28131) : regulation of food intake and gastro intestinal function and treatment of cachexia
Preclinical
Inhibitor of 11βHSB : for metabolic disorders
NutropinAp® : treatment of growth failure, new formulation for prolonged release
Life cycle management
3
Growingmarkets
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Phase 1
Oncology :
Elomotecan : cytotoxic agent, advanced metastasic cancer. Partnership with Roche in dec 2002, but
Roche quits in may 2005.
3
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Phase 2
Oncology :
Diflomotecan : topoisomerase inhibitor less SE than other
Endocrinology :
IGF-1 and growth hormone : combination therapy for the treatment of idiopathic short stature. Combo
BIM 23A760 : somatostatine analog and dopamine agonist for acromegaly and neuroendocrine tumors
Better wide activity with synergy
BN 83495 : breast cancer expressing oestrogen receptors partnership with Biomérieux for diagnosis
3
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Phase 3
Oncology :
Decapeptyl® : combined hormone therapy for premenopausal breast cancer wirh Aromasin® Pfizer Combo
Toremifene® : GTX licence buyout Development of new indications
Hematology :
OBI-1 : hemophilia Pig fact VIII
3
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Phase 3
Endocrinology :
Somatuline® Autogel®
Somatuline® Autogel®
Somatuline® Depot®
Increlex® : primary deficit in IGF-1 Global actor in the growth disorders
Taspoglutide : type 2 diabetes (partnership with Roche)
GLP1, third on the market
3
Life cycle management
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Neurology :
Research program : new formulation for botulique toxin.
Implant on the world market of Dysport® with Galderma, and Medicis and of Apokin® with Vernalis buyout
3
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New authorization 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.
3
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Hematology
IPSEN gives itself the means of a strong and sustainable growth
EndocrinologyOnc
ology
Neur
olog
y
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IPSEN stockmarket
1998
2003
Consideration of introduction in stockmarket, year of the opening of the capital of the laboratory to the caisse de dépots and paribas affaires industrielles, which then took a participation of 20%
Initial Public Offering in december2005
The conditions of market have not been favorable.Wait until they improve
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66.64%6.30%
4.78%
15.38%
6.84%0.02%
0.03%
Parts dans la holding Mayroy
Beech tree sarl
Blue hill trust
Sté finvestan
Sté opera finance
Bee master holding 2
salariés
Famille Beaufour
*
*
**
*
* Participation majoritaire des Beaufour.
Implication des Beaufour
Holding Mayroy
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Sales and Income (2004-2008)
2004 2005 2006 2007 20080
200
400
600
800
1000
1200
SalesOperating incomeNet income
2004 2005 2006 2007 20080
200
400
600
800
1000
1200
SalesOperating incomeNet income
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Changes in Stock Price
Number of shares: 84.105.633 .2005, December 7 : 22,20€ per share
Always above 22, 20€
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SWOT analysisSTRENGHTS
• Independent firm
•Technology plateforms very competitives
• Strong R&D capabilities
• Numerous partnership agreements
• Life cycle management
• Family decision-making power
WEAKNESSES
• Weak sales in primary care
• Lack of critical size
OPPORTUNITIES
• Establishment of commercial presence in the US• Increasing presence in the emerging markets• A esthetic market : Botulinum toxin A
THREATS
• Generics
• End of reimbursement of cash cow
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What do you think 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
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Partnership policy
→ Marketing licence for Nisis® & Nisisco®
→ R&D agreement and acquisition 20% of CA : new technologies
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
Many partnership to enrich R&D portfolio and expand products range
→ development and marketing licence Acapodène® in UE
→ R&D collaboration : Market Ipsen’s products in Japan
Oct 09 : new agreement SG2000 (anticancer agent, 1st class)
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Partnership policy
→ 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)
→ development and marketing licence Toxine botulique (dysport®, Azzalure®)