20 mars 2009 a renewal story. safe harbor this is an independent study performed by students from...
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20 mars 2009
A renewal story
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Safe Harbor
This is an independent study performed by students from the Faculté des
Sciences Pharmaceutiques de Lille
The opinions expressed are our own and not necessarily those of Ipsen
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Sales in comparison
Addex
Nicox
Genfit
Monogram
Crucell
Patheon
Ipsen
Actelion
Novo Nordisk
Merck
0 1000 2000 3000 4000 5000 6000 7000 8000
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A family business
French independent laboratoryOwned by Beaufour familyMore than 20 products marketed in more than 100 countriesThird Independent pharmaceutical firm in FranceHistorical presence in primary care
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Key figures: 2008
€971M Sales
4000 employees worldwide
€203M cash generated
18.8% of sales allocated to R&D
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PROFILEPrimary care product:
GastroenterologyCardiovasularCognitive disorders
Specialized therapies : 3 areasOncologyEndocrinologyNeuromuscular disorders
CA 2008: 971,0 M€ (+5,5% vs 2007)
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AN INTERNATIONAL COMPANY
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Key figures
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BACKGROUND
1929 : Dr Henri Beaufour « Beaufour laboratories » (Dreux)
Romarène® (1929)
Citrate de betaïne® (1954)
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BACKGROUND
1970 : Expansion years
« Beaufour-IPSEN » : Institut des Produits de Synthèse et d’Extraction Naturelle
Willmar Schwabe
Ginkor® (1972)Tanakan® (1975)
Gingko Biloba
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PRIMARY CARE1972
Active substancesTroxerutin A, heptaminol chlorhydrate, Ginkgo biloba extract
Indications: Cardiovascularvenous insufficiency of the lower limbsacute haemorrhoid episodes
GINKOR Fort®
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PRIMARY CARE1975
Active substanceEGb 761® (Ginkgo biloba)
Indications : Cognitive disordersAge-related cognitive disorderspathophysiological deficiency cochleovestibular disorders
TANAKAN®
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PRIMARY CARE1977
Active substance :Diosmectite (natural clay)
Indications : GastroenterologyChronic and acuate diarrhoeaPain associated with gastric and colonic disorders
SMECTA ®
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PRIMARY CARE1996
Active substance :Macrogol 4000, a linear polyethylene glycol polymer
Indications : GastroenterologyTreatment of constipation for both adults and children
FORLAX®
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A WILL TO GO FURTHER
PRIMARY CARE TARGETED THERAPY
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GOING FURTHER
Albert Beaufour : biotechnology research
1976 : Biomeasure Boston A. Beaufour research institute: Peptide-focused engineering
Research relations with American universities
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ONCOLOGY1980
Partnership with Debiopharm®
Active substance: Triptorelin : decapeptide, analogue of the natural hormone : GnRH
Indications : Prostate cancerUterin fibroidsEndometriosisEarly-onset puberty Female infertility
DECAPEPTYL®
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NEUROMUSCULAR DISORDERS
1994
IPSEN bought Speywood (UK)
Active substance: Botulinum neurotoxin type A complex ( acts at the level of the neuromuscular junction in the targeted muscle)
Indications: Cervical dystoniaCerebral palsy in childrenBlepharospasm
DYSPORT®
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ENDOCRINOLOGY1995
Active substance: Lanreotide (somatostatin analogue -> octapeptide)Inhibits secretion and growth endocrine/paracrine/exocrine functions (growth hormone)
Indications: AcromegalyNeuroendocrine tumours
SOMATULINE®
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1996 - 2002
IS IPSEN RESTING ON ITS
LAURELS ?
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R&D STRATEGY ?Dr Pierre BRAQUET
R&D manager form 1982 – 1995
he participated to the discovery of the first antagonists of PAF from an extract of the Chinese tree Ginkgo biloba
Directed research works related to somatulin
Since 1985, his researches got nowhereAtrial natriuretic factorEndothelin…
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A FAMILY AFFAIR1998 : Albert beaufour wants to stay independent.
Buys his brother’s participations (50%)Alliance with CDC and Paribas AI
Albert Beaufour 75,5%CDC and Paribas AI 24,5%
2000 : Albert entrusts his son-in-law, Stephane François, with the direction of the group
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A FAMILY AFFAIRFebruary 2000 : Albert Beaufour died (76 years old)
His participation (75,5%) is shared among his 3 children
November 2001 : Family conflictStephane François is relieved
from his duties
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A FAMILY AFFAIR
December 2001 J.L. Belingard
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From Beaufour Ipsen to Ipsen
2003: The Group had its name changed from Beaufour Ipsen to IpsenRenewed Executive Commitee
2001
2003
2007
1997 2007
20032008
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A NEW TEAMA NEW STRATEGY
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A NEW STRATEGY
Ipsen faces up to regulation
Optimize its primary
care portfolio
Focus on targeted
therapeutic areas
Geographic expansion
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STRATEGYHOW ?
Product life cycle managementStrong R&DPartnership policyInitial Public Offering
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PRODUCT LIFE CYCLE MANAGEMENT
PRIMARY CARE
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12% of salesTanakan®
Many trials trying to prove efficacyHAS: insufficient SMRPrice cut: -10% in july 2007Threatened by disreimbursement
GuidAge study: 8000 patients enrolledCurrently underwayprevention Alzheimer disease
Life cycle management
PRODUCT LIFE CYCLE MANAGMENT
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PRODUCT LIFE CYCLE MANAGMENT
Price cut: -15% in february 2006Successive reimbursement rate cuts in France:
35%Taux original
15%1er février 2006
0%1er janvier 2008
CA 2005 CA 2006 CA 2007
61.2M€ 41.7M € 36.9M €
-11.5%-31.8%
Marketing authorizations transferred to GTF (France, Monaco, Andorra) in august 2007
Ginkor Fort®
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Other developments
Adrovance®, from MSDOsteoporosisComarketing along with MSD
Adenuric®, from TeijinChronic hyperuricemia in goutIpsen obtained MA in Europe in may 2008
Exforge®, from NovartisARA II + ICa2+
BA058, from IpsenPTHrP analogLicensed to Radius and Teijin
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STRONG R&D
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R&D original model
« Discovery and Innovation »
Dedicated to discover new chemical entitiesTargeted disease areasOut-licensing
« Corporate Development »
Bring a coherent portfolio of molecules to the marketBoth internal research and external business developmentIn-licensing
2007: R&D division now organised around 2 entities:
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R&D original model
4 R&D centres:PARIS
Medicinal chemistry
BOSTONPeptide engineering Protein engineering: improve the therapeutic
BARCELONA: Advance drug delivery
BATH: Steroid Engineering
Discovery and innovation
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R&D original model
Collaboration with academic research centres worldwide:
Erasmus University Medical Center Rotterdam ERINE endocrinologye, diabete and metabolism
Salk Instituteproliferative and degenerative diseases
Discovery and innovation
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R&D original model
clinical developmentpharmaceutical developmentbusiness developmentregulatory affairs
LONDON, PARIS, BOSTON: CLINICAL DEVELOPMENT AND REGISTRATION
DREUX: PHARMACEUTICAL DEVELOPMENT
BARCELONA: PHARMACOKINETICS
Corporate Development
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STRONG R&D
Focus on targeted therapeutic areas
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Focus on targeted therapeutic areas
EndocrinologyOncologyNeuromuscular disorders
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ENDOCRINOLOGY
A major technological advance: first sustained-release formulation for injection without any excipient 6 months1 injection per month (vs 2 or 3)
Patent:direct holder of the patent expiration date: in 2015 in Europe and US (Somatuline® : 2005)
SOMATULINE AUTOGEL®
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ENDOCRINOLOGY
Product’s Life cycle Managment programmes:phase III: coadministration with pegvisomant acromegaly in Europephase III: Asymptomatic neuroendocrine tumours in EuropePhase II: in Japan, partnership with Teijin acromegaly
International expansion :FDA approval in 2007 for the treatment of acromegaly (=Somatuline Depot)
Group’s competitor:Sandostatin® LAR® Depot (octreotide) Novartis painless and easy to use, gives it a competitive advantage
SOMATULINE AUTOGEL®
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ENDOCRINOLOGYSOMATULINE AUTOGEL®
Somatuline Sandostatin
Indication acromegalyNET
acromegalyNET
Administration SC IM
Formulation ready to use powder to reconstitute
Advantage painlesseasy to use
painful
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ONCOLOGY
Group’s competitors :
Takeda/Pfizer-Wyeth/Abbott Enantone : worldwide leader, 6 months formulation expected in 2008
AstellasEligard : 6 months formulation : 2007 in Germany, 2008 in France
Sandoz/HexalLeuprone (1 month) and Leupro (3 months) : 2007 in Germany
DECAPEPTYL®
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ONCOLOGY
Life cycle management3 phase III studies (International Breast Cancer Study Group)Combined hormonal therapy: breast cancer in premenopausal women Decapeptyl®/ Aromasin® Pfizera 6 month sustained release formulation: filed in 2008
Partnership with Debiopharmlicence of know-how and marketing
DECAPEPTYL®
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STRONG R&D
RESEARCH PROGRAMS
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Research programs
New approaches in cancer treatment under hormonal control:
Anticancer agents
Angiomates multitarget antiproliferative anti-angiogenic acquisition (February 2004)
BIM 46187 Cell signalisation: G-Protein signal
CDC25 Phosphatase inhibitors regulation of cell cycle
ONCOLOGY
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Post-menopausal breast cancer expressing estrogenic receptors
BN 83495 (STX 64) Phase I
Treatment of side effects from LHRH-a based androgen-deprivation
Acapodene® Phase III (2008)
Research programs
ONCOLOGY
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Research programs
ENDOCRINOLOGYGhrelin agonist
Regulating food intake and the gastro-intestinal function and treating cachexia
11ßHSD enzyme inhibitors Metabolic syndromes associated with obese patients with
hyperinsulinemia
Sustained-release growth hormoneLong-term treatment of growth failure in children and growth hormone deficiency in adults
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Development programs
ENDOCRINOLOGY
Pituitary and neuroendocrine tumours Dopastatine : Second-generation somatostatin analogues and growth hormone antagonistsPhase I
Glycaemia control in diabetic patientsBIM 51077 / R1583
Analogue of peptide hormone Glucagon Like Peptide-1
Phase IISustained-release formulations
Phase I (with Teijin)
October 2003: exclusive licence to the rights to develop and market worldwide ( except Japan and France)
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Research programs
HEMATOLOGY
OBI-1
recombinant version of porcine factor VIII
congenital or acquired haemophilia resistant to human factor VIII
phase II trials in USA
17 July 2008 Ipsen completes purchase of all of OBI-1
assets from Octagen Corporation
Emory University and
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RESEARCH PROGRAMS
IPSEN’S STRATEGY ?
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Niche strategy
Partnership policy
IPSEN’S STRATEGY ?
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Niche strategy
IPSEN does not keep marketing rights on molecules which will required too much promotion
For example : In Diabetes In Osteoporosis
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Niche strategy Antidiabetics :
A large market: 24.1 Billion of Dollars 10.7 % Growth 2007
2000 20300
50000000
100000000
150000000
200000000
250000000
300000000
350000000
400000000
171 000 000
366 000 000
Diabetic patients in the world
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Niche strategy
Ipsen licenses Taspoglutide
Worldwide to Roche :exclusive worldwide rights to develop and market Taspoglutide
Japan to Teijin :rights to develop and market Taspoglutide
In France where Ipsen may elect to retain co-marketing rights.
TASPOGLUTIDE
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Niche strategy
TASPOGLUTIDEWhy ?
Clinical trials limited Overall, 3884 patients were randomized for JanuviaOnly 1100 patients during 2 years
No expertise in the domain
A launch very expensiveFor exemple Januvia in France
27 million € promotion investment in 200814 million € of sales in 2008
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Niche strategy
BA058Osteoporosis
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Niche strategy
BA058BA058 is an analogue of PTHrP
License to Radius in phase IRadius develop BA058 until phase IIRadius License BA058 to Novartis start phase III
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Niche strategy
BA058Why ?
No expertise in the domain
Clinical trials :More than 7000 patients during 5 years for Protelos
An important marketing effortFor example Actonel vs Pariet in France
Actonel® ratio invests/sales : 0.28Pariet® ratio invests/sales : 0.12
In osteoporosis the effort in near increase by 3 versus antiulcer
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The University Emory Octagen
Ipsen buy Octagen for 10,2 millions of dollars
in July 2008
Licence with Ipsen in 1998
OBI-1
According to CDC (Centers for Disease Control), among 13000 peoples live with hemophilius A in United-state
Niche strategy
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Strategy France
Different strategy in France because Ipsen have Sales force and a good corporate image in France
Ipsen market and co-market product from other firm.
For example : Adrovance, Nisis NisisCo …
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PARTNERSHIP POLICY
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PARTNERSHIP POLICY2003 Marketing licence Nisis and Nisisco
2003 R&D
2003 Market Ipsen’s products in Japan
2004 R&D
2004 RetD
2004 Marketing licence Testim in France
2006 development and marketing licence BIM51077
2006 development and marketing licence Acapodène in UE
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PARTNERSHIP POLICY
2006 R&D theranostic
2007 Erasmus medical center R&D
2007 Toxine botulique
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NICHE STRATEGY + PARTNERSHIP POLICY
Botulinum toxin exemple :The IPSEN’s hope
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Botulinum toxin : a high stake
Growing market worth $1600MAllergan boasts 80% of the market with Botox®
60%
40%
Botulinum toxin market
Therapeutic useAesthetic use
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Botulinum toxin: a high stake
Ipsen has already a Botulinum toxin (Dysport®) Ipsen wants his piece of the cakeAesthetics is not part of Ipsen’s targeted therapeutic areasIpsen is looking for partners specialized in dermatology…
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Strategy botulic Toxin A
IPSEN keeps right on therapeutics use
But in aesthetic Medicis in USAGalderma in Europe and South-AmericaTwo specialists
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Botulinum toxin: a high stake
March 2006: agreement with Medicis (n°1 in dermic volume restoration) for North America
Feb 2007: agreement with Galderma for Europe, Russia, then dec 2007: South America
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Partnership with milestones:
Potential of 193,6 millions de dollars with MedicisAlready 90 millions of dollars have been paid
Partnership with royalties: between 30 and 40% of sales
Botulinum toxin: a high stake
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Botulinum toxin: a high stake
Aesthetic Market in United State is estimated to 300 – 400 millions of dollarsIn South America Galderma take 40 % of share marketSo If Medicis take 30 % of share market with 30 % of royalties Ipsen will earn 27 millions of dollars per year
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Agreement with Medicis
Limit of partnership policyJuly 2002: Development and distribution contract for Reloxin® between Ipsen and Inamed in USADec 2005:
Allergan about to acquire InamedTermination of the contract, Ipsen recovers its rights to Reloxin® for $10M
Ipsen license rights to MedicisWaste of time
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STOCKMARKET
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Stockmarket
An old idea
1998 •Introduction was considered since 1998, year of the opening of the capital of the laboratory to the Caisse des Dépôts and Paribas Affaires Industrielles, which then took a participation of 20%.
2003 •The conditions of market have not been favorable•Wait until they improve
12/2005 •Initial Public Offering
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Stockmarket
IPO 12/2005
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Stockmarket
Why ?
To finance expansion by equity issue :171 millions of euro
Nearly one year of R&D for Ipsen½ Tercica
To pay back old shareholder :151 millions of euro
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Stockmarket
Mayroy is the familial Holding
Mayroy get more than 66.66% of the share
So Ipsen has still a familial direction
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Stockmarket
Comparaison between Ipsen and other pharmaceutical firm : Sanofi-Aventis and Pfizer
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Geographic Expansion
USAJapan
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Conquering the USA
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1976: R&D Boston2003: Inamed2006: Medicis2008: Tercica, Vernalis, Octagen (OBI-1)
Acquisitions are aimed at creating a sales force in USA
Gaining a foothold in USA
August 2008:
Somatuline® approved
by the FDA
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Gaining a foothold in USA
Ipsen needs sales-forces for Dysport and SomatulineEasier to buy firms than creating from nothing
Endocrine-focused sales force Neurology sales force
Somatuline®Increlex®
Dysport®
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Conquering Japan
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Japan conquestAgreement with Teijin, july 2003
Development and marketing of 4 Ipsen products in JapanGLP-1 analogue: diabetes type IIPTHrP analogue: osteoporosisSomatostatine Autogel®: acromegalySomatostatine SSTR-2 analogue: diabetic retinopathy
Development and marketing of 1 Teijin product in Europe
Xanthine Oxydase inhibitor (TMX-67): goutMA EMEA may 2008: Adenuric®
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PARTNERSHIP POLICY DRAWBACKS
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Dependence on IP rights held by third parties
Intellectual Property rights (patents, know-how and trademarks) held by third partiesProduct Patent titular Patent expiration
Ginkor Schwabe 2010
Tanakan Schwabe 2010
Smecta IPSEN expired
Forlax - -
Decapeptyl Debiopharm 2010
Somatuline Tulane University 2005
Somatuline autogel IPSEN 2015
Dysport - -
Neutropinaq Genentech 2013
Increlex Genentech 2015
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Financial
2004 2005 2006 2007 200895
100
105
110
115
120
125
130
135
CA base 100
Résultat consolidé base 100
During 3 years result increase faster than the turnover but with Tercica acquisition in 2008 it decrease.
Consolidated profits239 584 €
Debt 171 090 €
Net cash66 224 €
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Financial
2004 2005 2006 2007 200880
90
100
110
120
130
140
CA base 100R&D base 100R&D/ CA base 100
Expenditure in R&D are growth slowest than turnover but are still strong
(182 millions of euro and 18,8% of turnover)
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SWOT analysis
89
STRENGHTS
•Independent firm•Technology platforms very developed•Strong R&D capacities•Product life cycle management•Alliance capacity•International marketing presence
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SWOT analysis
90
STRENGHTS WEAKNESSES
•Independent firm•Technology platforms very developed•Strong R&D capacities•Product life cycle management•Alliance capacity•International marketing presence
•Weak sales from primary care•Few patents owned by IPSEN•Dependent on 2 products (Tanakan, Decapeptyl)•Dependent on partnerships
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SWOT analysis
91
STRENGHTS WEAKNESSES
•Independent firm•Technology platforms very developed•Strong R&D capacities•Product life cycle management•Alliance capacity•International marketing presence
•Weak sales from primary care•Few patents owned by IPSEN•Dependent on 2 products (Tanakan, Decapeptyl)•Dependent on partnerships
OPPORTUNITIES
•Aesthetic market : Botulinum toxin A•US market•Tanakan : Alzheimer prevention (?)
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SWOT analysis
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STRENGHTS WEAKNESSES
•Independent firm•Technology platforms very developed•Strong R&D capacities•Product life cycle management•Alliance capacity•International marketing presence
•Weak sales from primary care•Few patents owned by IPSEN•Dependent on 2 products (Tanakan, Decapeptyl)•Dependent on partnerships
OPPORTUNITIES THREATS
•Aesthetic market : Botulinum toxin A•US market•Tanakan : Alzheimer prevention (?)
•Generics and regulation patents and prices•Research process longer and more expensive•Industry consolidation
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CONCLUSION
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Thank you for your attention
ANY QUESTIONS ?
Specials thanks to Charlotte Marmousez