Transcript Diapositive 1 - Moodle Lille 2

Laurent Magnies
Sophie Gardez
23/02/2012
Florence Landrieu
Claire Jagodzinski
Overview of
IPSEN
Group Overview
Created in 1929
Familial French group
Global group
Over 20 products on the market
Sales: € 1,1 billion
3
Sales by disease area in 2010
Endocrinology
23%
Neurology
17,7%
Specialty care
Drug
66%
704,3 m€
Oncology
25,3%
Primary care
Drug
34%
364 m€
4
IPSEN Worldwide
International presence in over 100 countries
IPSEN in Europe
5
Sales by region
In 2010
In 2009
19.2%
22.7%
4.4%
53.7%
21%
6%
50%
23%
• Imbalance of the repartition
• Stagnation in Europe
• Growth in the Rest of the World
6
Sales by region
Turnover : 1,16€ billion
Growth +5,4%
In 2011
23.5%
5.7%
46.7%
24.1%
Growth in the Rest of the World
International development
7
Total worldwide staff
4 400 Collaborators
14%
Operations
43%
21%
Production and supply chain
R&D
22%
Administration
8
Marketing staff
Number of employees
1447
1394
1382
2008
2009
2010
Growth between 2009 and 2010
=> Development of marketing
9
R&D investment
% of turnover for R&D
+ 1%
+ 0,3%
20.1%
18.8%
2008
19.1%
2009
2010
Number of employees in R&D
943
892
817
2008
2009
2010
10
Conclusion
Lot of investment in R&D
Innovating society
Go to USA and Pharmerging
International ambition
Targeted therapeutic areas
High value
11
Return in the
past…
1929
At the beginning
PRIMARY CARE
1929
 By Henri Beaufour in Dreux
« Beaufour Laboratoires »
Romarène
1954
 Citrate de Bétaïne
13
Expansion years
1970’s
PRIMARY CARE
 Institut des Produits de Synthèse et d’Extraction Naturelle
= > Beaufour IPSEN
1972
Ginkor
 Active substances : Veinotonic and Vasculoprotective
• Gingko Biloba extract
• Troxerutine
• Heptaminol chlorhydrate
 Indications:
• Venous insufficiency of the lower limbs
• Acute haemorrhoid episodes
14
Expansion years with natural
products
PRIMARY CARE
1972
Tanakan
 Active substance:
• Gingko biloba extract
 Indications:
• Vasodilatation: chronic arteritis, Raynaud's phenomena
• Intellectual deficiency in the elderly
• Cochleovestibular disorders
15
Expansion years with natural
products
PRIMARY CARE
1977
 Smecta
 Active substance:
• Diosmectite (clay)
 Indications:
• Chronic and acute diarrhea
• Pain associated with gastric and colonic disorders
16
Expansion years with natural
products
PRIMARY CARE
1996
 Forlax
 Active substance:
•Macrogol 4000 (Polyethylene
Glycol)
 Indication:
• Treatment of constipation for both adults and children
17
Conclusion
PRIMARY CARE
End of 70’s
Only natural products !
It was certainly innovative in 30’s
but now this idea begins “old fashioned”
18
Beaufour Family
Henri
Beaufour
Albert
Beaufour
50%
Gérard
Beaufour
50%
19
Research and
Albert
Beaufour
1977
Specialization in peptides
1977
 Albert Beaufour wants to develop research on peptides.
 Opening of a research center on peptide products in
Boston, United States
21
Specialization
1980
Oncology
Engineering of
peptides
Decapeptyl ®
Triptorelin
Analogue of GnRH (decapeptide)
ONCOLOGY
 Indications:





Treatment of metastatic and locally advanced prostate cancer
Uterin fibroids
Endometriosis
Precocious puberty
In vitro fertilisation
1986
24
Decapeptyl ®
ONCOLOGY
1986
 Holder of the patent:
• For Pamoate formulations
• Monthly and quarterly administration
Expired in 2010
• Exclusive license to market
• Co-exclusive license to manufacture
UE + Others countries
25
Endocrinology
Engineering of
peptides
Somatuline ®
ENDOCRINOLOGY
Lanreotide
Somatostatin analogue (octapeptide)
 Indications:
 Acromegaly (after radiotherapy or chirurgical surgery)
 Neuroendocrine tumors
1995
Patent holder
(expired)
Exclusive worldwide license
(manufacture, use, market )
27
Neurology
Control of a single
agent : Botulinum
toxin
Dysport®
NEUROLOGY
 Botulinum toxin A
 Indications:
 Cervical dystonia
 Blepharospasm
 Cerebral palsy in children
1994
 Obtained by buying « British Speywood »
 No Patent: Exclusive worldwide license granted by
the UK Health Protection Agency (HPA)
29
Conclusion
3 Domains
Neurology
Oncology
Endocrinology
Products come from partnerships
No products from IPSEN R&D
30
Beaufour Family
Henri
Beaufour
Albert
Beaufour
50%
1998
Gérard
Beaufour
50%
 Albert Beaufour wants to stay independent:
Alliance to buy brother’s parts
31
Assessment in
2000
Assessment in 2000
Turnover
Specialty
care
40%
Net
income
703 millions €
Main
emerging
7%
Primary
care
60%
Europe
50%
France
43%
81 millions €
33
Products in 2000
Turnover (millions €)
200
150
100
50
0
Decapeptyl®; Tanakan®; Dysport®; Smecta®; Ginkor®
34
Assessment in 2000
Staff
R&D
3 423 collaborators
100 millions euros = 14% of turnover
500 Researchers
15 R&D programs
2 in
Oncology
1 in
Hematology
2 in
Diabetes
1 in
Osteoporosis
35
Beaufour Family
Albert
Beaufour
75%
2000
2001
Anne
Henri
Véronique
25%
25%
25%
Stéphane
François
 Albert named Stéphane as “Executive Chief”
 But Albert died in february
 His participation (75,5%) is shared
 Family conflict
 Stéphane is relieved in november 2001
36
New chief
January 2002
 Jean-Luc Bélingard
 He was the general manager of BioMérieux-Pierre Fabre
37
Jean-Luc
Belingard’s
strategy
2002
Changes…
• New
Chief
• Renewed
management team
• New organization
4 Targeted therapeutic
areas
Development in R&D
New partnerships
2003: Change of the Group’s name
Beaufour Ipsen
=> IPSEN
39
STRATEGY
With partnerships
1) Initial Public Offering
40
IPSEN’s Capital before IPO
In 2005
PAI 4.97%
CDC 2.49%
BNP
Paribas
2.48%
Famille
Schwabe
5.77%
Héritiers
Beaufour
84,29%
WHY?
•
•
•
•
To finance its growth
To develop the product portfolio
Continuing geographic expansion
Take acquisition opportunities
41
IPO
 1st attempt in 2003 :
• Conditions of the market weren’t so good
• Wait until improvement
 November 22, 2005:
– Better conditions
42
Success of IPO
2006
14 599 507 Stocks
- Public offering
- Institutional investors
- Employees from France
1.3%
24.7%
Mayroy
Public
74.0%
Employees
Oversubscription by French and
International investors
Strong response from employees
43
STRATEGY
With partnerships
1) Initial Public Offering
2) Go on specialization
44
NutropinAq®
ENDOCRINOLOGY
Recombinant Human Growth
hormone
 Indications:
 Long-term treatment of growth failure in children
(with/without Turner’s syndrom)
 Growth failure in prepubescent children
 Adults with growth hormone deficiency
2004
 Patent holder (expire in 2013)
 Exclusive rights for the worldwide
marketing (except USA, Mexico,
Canada, Japan)
45
Increlex®
2007
ENDOCRINOLOGY
 Recombinant Insulin-like Growth Factor1 (IGF-1) of human origin
 Orphan Drug by EMA (2006)
Indication:
Treatment of severe primary IGF-1 deficiency in
children and adolescents
 Partnership
46
Apokyn®
NEUROLOGY
 Apomorphine hydrochloride
Indication:
 Treatment of off-episode in Parkinson’s disease
 Orphan Drug (USA)
2008
 Acquisition the US subsidiary of Vernalis
47
Conclusion
 Products derived to:
- exclusive license
- purchase subsidiary
and not to R&D of IPSEN...
48
STRATEGY
With partnerships
1) Initial Public Offering
2) Go on specialization
3) Life cycle management
49
ONCOLOGY
Decapeptyl ®
Monthly, quarterly
formulation
6 months substained
release formulation
Patent expired
in 2010
Patent expired
in 2028
Advantage over competitors
 Breast cancer in pre-menopause (phase III until 2015)
50
ENDOCRINOLOGY
Somatuline® autogel ®
Somatuline® autogel®
Sandostatine®
Somavert®
IPSEN
Novartis
Pfizer
Pre-filled syringe
(needle retractable)
Powdered form to
be reconstituted
Once a month
Once a month
Powdered form to
be reconstituted
Daily
 Patent Holder:
(expire in 2015 UE/USA)
51
ENDOCRINOLOGY
NutropinAq®
NutropinAq® Pen (re-usable)
Genotropin® Pen
10 mg
5mg / 12 mg
A ready-to-use liquid
formulation
Powdered form to be
reconstituted
R&D: - Development of a sustained-release formulation
- New concentrations: 5 and 20mg
52
ENDOCRINOLOGY
Increlex®
 Association with GH for less severe primary IGF-1
deficiency in children and adolescents (Phase II)
 Assessment of potential of the drug for others diseases
53
NEUROLOGY
Dysport®
 Next Generation Dysport®: First ready-to-use
Advantage over competitors : Powdered form
to be reconstituted




Spasticity for USA: 4 phase III studies
Neurogenic detrusor overactivity: phase II
Next generation in glabellar lines: phase II
Next generation in cervical dystonia: phase III
54
Conclusion
 Pharmaceutical Technology Innovation:
- Distance itself from competitors
- Make late patent expiration
(Somatuline® autogel®)
 Extension of indications:
- Capture new market
55
STRATEGY
With partnerships
1) Initial Public Offering
2) Go on specialization
3) Life cycle management
4) Worldwide development
56
Somatuline® autogel®
2006
ENDOCRINOLOGY
Marketing
Somatuline®autogel®
2010
Phase III trial for
Acromegaly
57
Increlex®
2006
ENDOCRINOLOGY
Increlex®
Develop and market
worldwide except
2008
 Acquisition of Tercica => Fusion
 Worldwide exclusive license
58
Conquest of Asia
2010
ENDOCRINOLOGY
Exclusive record distribution and promotion:
• Somatuline Autogel®
• Increlex®
59
Dysport® / Apokyn®
2008
 Acquisition the US subsidiary of the UK
NEUROLOGY
firm Vernalis
 Platform to launch Dysport® to US for therapeutic
indications
 Rights to develop and marketing Apokyn® in USA
60
Dysport®
 Indication: Aesthetic medicine
NEUROLOGY
2006
Development, distribution
and marketing
Dysport®
2007
Development, promotion,
distribution
Azzalure®
61
Conclusion
 Conquest USA:
 Endocrinology:
-Somatuline ®
- Increlex ®
 Neurology:
- Apokyn ®
- Dysport ®
 Conquest Japan and Asia
62
STRATEGY
With partnerships
1) Initial Public Offering
2) Go on specialization
3) Life cycle management
4) Worldwide development
5) Primary care optimization
63
Optimize primary care
Tanakan
PRIMARY CARE
130 m€
50% tanakan’s turnover is in France
119 m€
96 m€
1972
2007
2010
2012
35%
35% Price
- 15%
15%
0%
July 2006
insufficient
SMR
• GuidAge study in prevention Alzheimer’s disease
• 2006 to 2010:
I° efficacy endpoint was not reached, but
subgroups have shown statistically significant results
64
Optimize primary care
Ginkor Fort
PRIMARY CARE
2005:
61 m€
42 m€
37 m€
1972
2006
2008
35%
15%
0%
Price
- 15%
Marketing authorizations transferred to GTF
(France, Monaco, Andorra) in January 2008
65
Optimize primary care
PRIMARY CARE
March
2003
 Nisis and NisisCo
Discovered by Novartis
Co-marketing for France
 Valsartan and Valsartan + hydrochlorothiazide
Indication: Treatment of hypertension
66
Optimize primary care
PRIMARY CARE
February
2008
 Adenuric
 Febuxostat
 Indication:
Treatment of chronic hyperuricaemia patients with gout
 Discovered by Teijin
2003
2003: Exclusive rights to develop and market in Europe.
2010
2010: License with Menarini :
• UE, Russia and the countries west of Russia = 41 countries
67
Conclusion
1) Initial Public Offering
2) Go on specialization
With partnerships
No product from R&D Ipsen
3) Life cycle management
Increase life of patents
Differentiation from competitors
4) Worldwide development
Presence extended
5) Primary care optimization
Good
strategy
Ipsen is a specialty
company
Medium-sized
pharma company
68
Assessment in 2010
CA
Profile
2000
2010
703 millions €
1, 1 billion €
Specialty
care Primary
40%
care
Primary
care
Specialty 36%
care
64%
60%
Sales
Main
emerging
7%
Europe
50%
France
43%
Main
emerg.
And North.
Am
21%
France
28%
Europe
51%
69
Products in 2010
Turnover (millions €)
300
250
200
150
100
2000
2010
50
0
70
Assessment in 2010
2000
2010
Net
income
81 millions €
95 millions €
Staff
3 423 collaborators
4 400 collaborators
Capital
R&D
CDC and
Paribas
AI 25% Albert
Beaufour
75%
100 millions €
500 researchers
15 R&D programs
Others
1.9%
Public
29,80% Mayroy
68.3%
221 millions €
943 researchers
11 R&D programs
71
Pipeline
Toremifene
ONCOLOGY
 Oral formulation
 Selective modulator of estrogen receptor (SERM)
 Indication: Reducing the risk of fractures in prostate cancer
patients receiving androgen-deprivation therapy
Patent Holder
Develop and market in Europe
1st phase III ended
2nd phase III ongoing
Requested by the FDA to
have more datas about
safety and efficacy
Too expensive
=> Ipsen gives back its right
to GTx against royalties (if
the drug is granted in the
future)
73
Tasquinimod
ONCOLOGY
 Once a day oral formulation
 Antiangiogenic agent
 Indication: metastatic Castrate-Resistant Prostate Cancer
Patent Holder
License to market in worldwide
(except USA, South America, Japan)
Phase II
Phase III ongoing
Improvement in PFS
Side effects manageable
Enrolment initiated in
March 2011
Results expected in 2014
74
Irosustat
 Oral formulation
 1st irreversible inhibitor of steroïd sulfatase (STS)
 Indication: Hormono-dependant cancers
ONCOLOGY
 Patent Holder
Phase II
Endometrial cancer
- I° endpoint (PFS) not reached
- Superiority not demonstrated
STOPPED
June 6, 2011: IPSEN stops the development in monotherapy for
the endometrial cancer
BUT: Good safety + Reduction of hormonal level
=> Develop it in association?
75
Taspoglutide®
ENDOCRINOLOGY
 Analogue GLP-1
 Indication: Type 2 diabetes
Patent Holder: - Development
- Formulation
2003
2006
- Clinical development
- Promotion
- Marketing
- Clinical development
- Promotion
- Marketing
76
Taspoglutide®
ENDOCRINOLOGY
2008
Phase III: Success of I° endpoint
Side effects discovered in 2010
o Hypersensitivity
o GI adverse events
o Nauseas
2010
 Roche : REMS
77
June 18, 2010
• Announce of a delay (12 to 18 months) to put it on the market
• Loss of 5€
78
Taspoglutide®
ENDOCRINOLOGY
2008
Phase III: Success of I° endpoint
Side effects discovered in 2010
o Hypersensitivity
o GI adverse events
o Nauseas
2010
 Roche : REMS
2011
Stops the administration
Taspoglutide
- Recovery of datas generated by Roche
- Searchs for partnerships
79
Fipamezole
 Antagonist of adrenergic alpha-2 receptor
 Indication: Dyskinesia in Parkinson’s disease
 First in class
2010
Rights to develop and market
worldwide (except North
America and Japan)
NEUROLOGY
Patent holder
Phase II-b
- Reduction of « off time »
- Improvement in cognitive function
2012
 Rights back to Santhera
 Royalties for IPSEN on sales
80
Hematology
New Therapeutic Area
OBI-1
 Recombinant porcine Factor VIII
 Discovered by
partnership with
HEMATOLOGY
 Indications:
- Acquiered Hemophilia A
- Congenital Hemophilia A
People who developed
inhibitors against human
FVIII
 Orphan Drug in Europe and USA
1998-1999
Exclusive worldwide license
to develop
2008
IPSEN purchases all of Octagen’s assets
82
OBI-1
HEMATOLOGY
2010
- Clinical trials
- Regulatory recordings
- Marketing of OBI-1
Phase III ongoing
Enrolment initiated in
November 2011
AIM:
 Be a leader in hemophilia
 Create an hemophilia business
83
Conclusion
Toremifene
Tasquinimod
Irosustat
Taspoglutide
Fipamezole
OBI-1
Phase III ongoing
• Breathlessness of the
pipeline
• No products in phase
I or II
• What about the
future?
Phase III ongoing
84
Pipeline and Belingard
Jean-Luc Bélingard has ambitions for IPSEN
=> He wants products to be from IPSEN’s R&D
 Need of an investment in R&D
 We need to accelerate IPSEN’s
transition
Disagreement with
the family
J-L Bélingard is
relieved
85
New chief
November
2010
 Marc de Garidel
 Amgen: Vice President for the markets of Southern
Europe and Pharmergings
 His aim: consolidate Ipsen’s presence in the US and in
Pharmergings
86
Financial
analysis
2010
Financial Statement
Turnover in growth BUT diminution of financial ressources
Due to depreciation
Investors look for
14-15%
88
M. De
Garidel’s
Strategy
Objectives for 2020
2 Steps
Increase focus
 Focus ressources and investements on selected areas
with high therapeutic value
 Exploitation of all potential of drugs
Invest to grow
 Develop new drugs
 Life Cycle Management
 Geographical extension
90
Increase Focus
Focus R&D on peptides and toxins
technological platforms
• Fusion of Research and Development departments => R&D
• Proof of concept
91
Proof of Concept
Anticipation of Clinical plan
Early recycling for some projects
Higher probability of success for projects entering phase IIb
92
Increase Focus
Focus R&D on peptides and toxins
technological platforms
• Fusion of Research and Development departments => R&D
• Proof of concept
Commercial Optimization Strategy
• Increase marketing
Primary care strategy
• Growth international activities
• Partnership for commercial operations in France
• Search an acquirer for the activities of Dreux
4 franchise-focused organization
• Endocrinology (Somatuline) • Uro-oncology (Decapeptyl)
• Neurology (Dysport)
• Hemophilia
93
Invest to grow
Extension of indications: Dysport®, Somatuline®
Increase investment efforts in growth markets :
Pharmerging, US
94
US and Pharmerging as a
major growth factor
In the USA
 Additionnal commercial efforts to Somatuline® and Dysport® with
a full label
 Inspiration Biopharmaceuticals and Vernalis opportunities
 Local/Regional partnerships
In the Pharmerging countries
 Invest to accelerate Pharmerging market penetration with specialty
and primary care portfolio
 China: -Support strong Decapetpyl® growth
-Register Dysport® and Somatuline®
95
Invest to grow
Extension of indications: Dysport®, Somatuline®
Increase investment efforts in growth markets :
Pharmerging, US
• Enhance leadership in technological platforms
• Grow market share in selected disease areas
Allocate R&D ressources => peptide and toxin
technological platforms
Stronger commercial push on key products VS
competitors
96
Ipsen’s 2020 ambitions
2011-2015: Investment
- Commercial
- Label
- Geographical
2016-2020: Solid growth
-US platform
- Productivity of pipeline
-Dysport ®and Somatuline ®
« Alors que la croissance du marché ne
dépassera pas 2 % par an, nous voulons faire
d'Ipsen une des sociétés ayant la plus forte
progression dans le monde de la pharmacie »
97
ENDOCRINOLOGY
Somatuline®
98
NEUROLOGY
Dysport®
99
June 10, 2011
•
•
« Qualifiée de « très ambitieuse » , la nouvelle stratégie n'a pas convaincu la
Bourse, où le titre a clôturé hier en recul de 3,2 %, à 25,8 euros.»
Irosustat : 6th of June => Failure in monotherapy
100
Outcome
2011
Sales by disease area in
2011
Objectives for
2011
Specialty
Care
Primary
Care
+8%
-8 to -10%
102
Our Point Of View
Decrease
of the
profitability
Need to
success the
extension
of labels
Need for financial
ressources
Ambitious
Strategy
Drop in
income
Decrease of
the cash flow
Failures in
pipeline
103
 Decapeptyl®
Oncology



Endocrinology


Neurology
Hematology
Toremifene ® Citrate
Somatuline ®
Somatuline ® Autogel
NutropinAq ®
Increlex ®
 Fipamezole
2012 (Europe)  Active substance
2023 (Europe)  Formulation
2024 (Europe)  Process
 OBI-1
2016 (USA)
2021 (Europe)
2023 (Europe)
Expired
2025
2028
2014 (USA)
2014 (USA)
2011
2017
2011
2017
2011
 Smecta ®
Primary Care
2010
 Pamoate Formulation
2028
 6 Months Formulation
2022
 Indication « ADT side effects »
Expired
2015 (Europe and USA)
2013 (Europe)
2014 (USA); 2015 (Europe)  Medical use
2017 (USA); 2018 (USA)  Formulation; Process
 Tanakan ®
 Ginkor Fort ®
 Nisis ® /Nisisco ®
 Exforge ®
 Adenuric ®
 Active substance
 Active substance
 Formulation
 Active substance
 Process
 New formulation aroma
 Active substance
 Oral formulation
 Active substance
 Oral formulation
 Active substance
 Decapeptyl®
Oncology



Endocrinology


Neurology
Hematology
Toremifene ® Citrate
Somatuline ®
Somatuline ® Autogel
NutropinAq ®
Increlex ®
 Fipamezole
2012 (Europe)  Active substance
2023 (Europe)  Formulation
2024 (Europe)  Process
 OBI-1
2016 (USA)
2021 (Europe)
2023 (Europe)
Expired
2025
2028
2014 (USA)
2014 (USA)
2011
2017
2011
2017
2011
 Smecta ®
Primary Care
2010
 Pamoate Formulation
2028
 6 Months Formulation
2022
 Indication « ADT side effects »
Expired
2015 (Europe and USA)
2013 (Europe)
2014 (USA); 2015 (Europe)  Medical use
2017 (USA); 2018 (USA)  Formulation; Process
 Tanakan ®
 Ginkor Fort ®
 Nisis ® /Nisisco ®
 Exforge ®
 Adenuric ®
 Active substance
 Active substance
 Formulation
 Active substance
 Process
 New formulation aroma
 Active substance
 Oral formulation
 Active substance
 Oral formulation
 Active substance
Our Point Of View
Decrease
of the
profitability
Need to
success the
extension
of labels
Need for financial
ressources
Ambitious
Strategy
Drop in
income
Decrease of
the cash flow
Failures in
pipeline
Are they really ready to this aims?
106
SWOT
- Technology platforms: peptides,
toxins
- Active Partnerships policy
(acquisition of new drugs
/geographic extensions)
- Less exposed to generic
- New formulations
- Pipeline
- Reduction of reimbursement
levels (Ginkor Fort, Tanakan)
-Dependance of flagship products
- Lots of competitors
-Close of Barcelona R&D and
Dreux
- Opening the US market
- Conquest emerging markets:
China, southeast Asia, Latin America
- Failure of Tasquinimod, OBI-1?
- Failure of extension of
indications (Dysport NG,
Somatuline)?
- Counterfeit with Pfizer
S W
O T
Thanks for your attention!
Any questions?
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