TEVA PHARMACEUTICALS

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Transcript TEVA PHARMACEUTICALS

DE LENCQUESAING Marie-Astrid
DIDIER Nicolas
HANNEDOUCHE Elise
HOURIEZ Mikael
24 février 2012
1
TEVA’s story
1990’s : becoming
a multinational
organization
1901 : laying the
fundations
1976: TEVA
pharmaceuticals
2
TEVA’s story
Copaxone®
1997
Ivax
Ratiopharm
Tayio
2006
08/ 2010
07/2011
2005
2008
05/2011
Azilect®
Barr
Cephalon
3
Some figures
generic
pharmaceutical
company
A
global
pharmaceutical
company
Direct presence
in
countries
Product
distribution in
over
markets
tablets
manufactured
in 2011
in sales
in 2011
employees
quality
Assurance
employees
4
TEVA’s business
By business line in CA
Wide and diverse
Generic Pharmaceuticals Global Leader
• The largest product portfolio
• Variety of forms
Branded products, innovation
• SNC, respiratory, women’s health,
biopharmaceuticals, oncology
Global API supplier
5
5 years strategic plan
licensing and acquisitions strategy
total market penetration
:
innovative and branded drugs
from $13.9 billion to
$31
billion in 2015
new technologies and leading generic drug
a balanced business model
shareholder value
6
PRODUCTS
GENERIC
7
Generics Market
Generics spending in 2015
:
Expected to be between
$400-430 bn
IMS Market Pronostic,Apr 2011
U.S. and EU5 account for
only 44% of spending in
2015
8
TEVA’s
weight on generic Market
US in 2010
About
of US
generic
prescriptions
in the
US alone
IMS health, september 2010 NPA
9
Is there still any room to grow in ?
$135-150 bn in 2015
10
Growing demand for generics
Source: Exane BNP Paribas, IMS, Espicom, Teva estimates
11
Developed countries expansion
•Ivax : 2005  $7.4 bn
•Barr : 2008  $7.46 bn (3.6 CA)
• Leadership
•Agreement with Novopharm
•Mepha (Cephalon) : 2011  #1 generic
compagny in Switzerland
•Ratiopharm : 2010  $5 bn (2.2 CA)
12
Germany: the 2nd largest generics
market in the world
Extends global market
leadership :  Positions Teva as
the #1 generics company in EU
Portfolio of over 500 molecules
in 10,000 different presentations
•
# 1 in Europe, # 2 in the world
• Fifth-largest generics maker
Well-established Biosimilar
operations
13
Growing demand for generics
Source: Exane BNP Paribas, IMS, Espicom, Teva estimates
14
Emerging generics Markets
Leadership in Japan
15
INFARMASA Peru
Enhance
:
antibiotics
Expanding
activities in
in Lima
Combination
of
in the
country
and
Infarmasa
http://www.fiercepharma.com/press_releases/teva-acquire-corporaci%C3%B3n-infarmasa
16
Growing demand for generics
Source: Exane BNP Paribas, IMS, Espicom, Teva estimates
17
Major
potential patent expirations
Generic Pharmaceuticals Market Overview/ Bourne Partners
18
Missed opportunities : Lipitor®
Patent expiration : Nov 30, 2011
•Approximately $8 bn /year
Ranbaxy : Six months of exclusive rights to sell the generic
•$600 millions in profits for Ranbaxy.
Agreement between Ranbaxy and Teva
Pharmaceuticals
•A portion of the profits from sales of Atorvastatin, during exclusivity period,
paid to Teva
Terms of the agreement not clear:
•Manufacturing  ?????????
19
What is a Biosimilar ?
A product that is physically, chemically, biologically,
and
clinically similar to an approved reference biological
product
Goal of TEVA :
Going on market
less competitive
than Generics
BUT…
Establishing a
Manufacturing process
 specifications of the
reference product
Similar efficacy and
safety in preclinical /
clinical studies phase 1
and 3
20
A new Market
Global biotech drug sales,
$ bn, 2009
21
Strategic
alliances and acquisitions
Sicor in 2003
•Access to Sicor’s developement / production of BioSimilars in
microbial systems (e.g. GCSF, Interferon)
CoGenesys 2008
•Expanded biopharmaceutical pipeline
•CoGenesys biological technology : albumin-fusion technology
2009, Lonza partnership
•Research and manufacturing Mab process
•World’s largest commercial scale Mab manufacturing infrastructure
2010, Ratiopharm
•Strong experience of BioSimilars in Europe with Ratiograstim
22
TEVA’s Biosimilars
Marketed
Products
End of Phase 3
2010/2012
End of Phase 3
2013/2015
Tev-Tropin
Growth Hormone
Deficiency
FSH
Follicle stimulating
hormone
Rituximab
Tevagastrin/
Ratiogastrin
Glyco‐PEG‐G‐CSF /
Neugranin
2 Mab Biosimilars
projects
(undisclosed)
Eporatio
23
Interest in BioSimilars
Plans to market 10 to 15
BioSimilar drugs
Aims to launch 6 or more
biotech generics from
2012 to 2017
« Commited to
broadening access to …
biopharmaceuticals »
« AstraZeneca eyes move
into BioSimilars »
« Biosimilars is a very
reasonable thing for Lilly
to do »
« BioSimilars would be
one of Mylan’s growth
opportunities »
24
PRODUCTS
BRANDED
25
Israël : an land of innovation
26
Israël : an land of innovation
27
Israël : a land of innovation
Link between research institut and world industrials
•Creation of TTO and Incubators
TTO
•Center created to valorize the research done by the University
•TTO Tel Aviv university
•TTO of Weizmann institut
Incubators
•Center created to valorize research by creating Start-up
The goal
•To transfer the new technology developped by research center to
industry
28
University research
Until proof of concept
« Commercial
arm »
TTO
Profit by sector
Public/private
financing
Researchers for 10000 inhabitants
160
140
120
TTO
40%
100
Reasearcher
40%
researchers for
10000
inhabitants
80
60
University
20%
40
20
0
Israël
USA
Japan
29
University research
TTO
Lisences
Until proof of concept
« Commercial
arm »
Public/private
financing
Incubators
Venture capital
Only private
financing
Start-Up
Company
Repurchase by
other companies
30
Drugs in pipeline
in
development
: neurologic,
autoimmune,
oncology, wound care
31
Azilect®
32
Azilect®
Treatment of Parkinson’s disease
Irreversible MAO-B inhibitor
“One Pill, Once A Day”
Authorization approval of Azilect in november 2004
in Europe and in 2005 in Israel
Co-developpement with :
•Technion - Israel institute of Technology.
•Lundbeck-Danish
In 2010 Azilect’s sales = $318 millions
33
Patent infringement lawsuits
Teva sues
Laboratories in October
2010
Teva sues
2011
in
Teva's claims that US patents of
Azilect, are valid through
February 2017.
34
Copaxone®
35
Various evolutions
36
Copaxone®
Unexpeted properties
• 1960 Weizmann Institute
Acetate salts of four naturally occurring amino
acids
• (Glu, Ala, Lys, Tyr)x•xCH3COOH
20 mg subcutaneous daily
Patent until 2014 US and 2015 Europe
37
Some figures
1million
patients
in 2010
38
Teva defends
brand-name drug patents
Patent infringement lawsuit
automatically prevents the
FDA
to block
generic Copaxone
2010
39
The End
End of the
patent +
introduction of
generics
Arrival
of treatment of
SEP by ORAL(
PI 2301 )
” We recently raised the price of Copaxone”
Marth said. "We estimate that Copaxone will
peak in 2012, and it's clear that we must
consider reality. When Copaxone sales slow,
we have supplements in our pipeline,
including from Cephalon”
40
TEVA acquires Cephalon
41
Teva & Cephalon deal –
Multifaceted expertise
42
Branded portfolio
Before acquisition of
Cephalon
After acquisition of
Cephalon
43
More than
170 products internationally
44
$2,8 bn sales
/ $20 bn in revenues
•Consistent with Teva’s longterm strategic goals
•Increases diversity across
business lines, products and
geographies
•Balances between high
growth generics and high
contribution branded
businesses
45
Specialty branded products
46
Cephalon’s pipeline
47
Strategic and Financial Benefits
of the Transaction
: Provides diversification and
access to new thrapeutic areas
Strong
Strategic Fit
: Highly complementary, late-stage
pipeline enhances Teva’s oncology, CNS
and respiratory programs
: R&D capabilities with strong track
record in branded pharmaceuticals
Attractive
Economics
: Significant opportunities
48
Products  respiratory domain
2005  TEVA buy U.S. rival Ivax for $7.4 bn
Boost of its pipeline in drugs for respiratory
domain
• Asthma, chronic obstructive pulmonary disease (COPD)
and allergic rhinitis
Strategy
• New medical devices
• Match patient’s needs : ease of use and effectiveness of
delivery
• More compliance
http://www.wikinvest.com/stock/Teva_Pharmaceutical_Industries_(TEVA)/Respiratory_Products
49
Respiratory products
ProAir® HFA (albuteral sulfate)
• Treatment or prevention of bronchospasm
QVAR® (beclomethasone dipropionate HFA)
• Maintenance treatment of asthma
Easi-Breathe®
• Asthma & COPD
SpiromaxTM
• Phase III
• Asthma & COPD
http://www.tevapharm-na.com/Our-Business/Teva-Respiratory.aspx
50
SpiromaxTM :
A Novel Multi-dose DPI
X-ACTTM system Active-metering,
Cyclone-separator
Technology
Integrated dose
counter
Easy to teach and
use : Open-InhaleClose
Accurate and
consistent dosing,
excellent lung
deposition
Not susceptible to
double dosing or
misuse
51
Products  women’s health
52
Products  women’s health
SEASONIQUE® and LoSEASONIQUE®
• Prevention of pregnancy
Plan B One-Step™ (levonorgestrel)
• Prevention of pregnancy after known or suspected
contraceptive failure or unprotected intercourse
ParaGard® T 380
• Intrauterine contraceptive
ENJUVIATM (estrogen hormons)
53
FINANCIAL ANALYSIS
54
Total assets
+ 66%
$ bn 60
50
40
30
Total Assets
20
10
0
2009
2010
2011
55
Results
$ bn
2009
2010
2011
FRNG
4.539
2.368
0.606
BFR
3.592
3.835
3.790
Cash
+ 0.947
- 1.467
- 3.184
56
Results
2009
2010
2011
Total Long Term
Liabilities
6.4
6.4
13.9
Senior Notes and
Loans
3.5
4
10
Total Equity
19.3
22
22.3
57
Ratio of financial independence
0.7
0.6
0.5
0.4
0.3
Ratio
d'indépendan
ce financière
0.2
0.1
0
2009
2010
2011
58
Explications: 2 points
:
external growth
(investment in the
urgency)
Even if she gets into
debts it remains a
.
59
Economic profitability ROTA
+
÷
$ bn
2009
2010
2011
Fixed Assets
21.169
26.090
35.689
BFR
3.592
3.835
3.790
TOTAL
24.761
29.925
39.479
Operating
income
2.405
3.871
3.109
=
9.7%
12.9%
7.9%
If the compagny invests 100$,
it will receive respectively
9.7$, 12.9$ and 7.9$
60
Financial profitability ROE
÷
$bn
2009
2010
2011
Total Equity
19.259
22.002
22.343
Net Income
2.004
3.339
2.768
=
10.4%
15.17%
12.38%
If the shareholders invest 100$,
it will be respectively
9.61, 6.59 and 8 years
to have a return on investment
61
How to
develop its external growth?
Operating Income
•$ 3.1bn
Rate of debts
•3.1/10 = 30%
Low room for maneuver
Repurchase by debts
•NO !!
Increase the capital or resell certain activities
•« Mepha  Acino for 94 millions »
62
TEVA’s stock exchange
63
How financing
R&D and dash into princeps ?
Politics of Israël
Outsourcing of the
costs
Increase the total
equity
Better financial health
Stop acquisitions
Repurchase Patent or
Start up
64
STRENGTHS
• N°1 generic
pharmaceutical company
• A top 15 global
pharmaceutical company
• Various activities
• R&D in Israël
WEAKNESSES
• High equity
• End of Copaxone®’s
patent
• Low margin on generic
products
SWOT
OPPORTUNITIES
•
•
•
•
Acquisitions
BioSimilars
Pharmerging
Cephalon’s pipeline
THREATS
• Generic and BioSimilars
competitors
• R&D very expensive but not
productive for the moment
65