Transcript Présentation PowerPoint

Eva Kalfon, Valentine Ripert, Julie Gosnet, Chacha Kadi, Valérie Johnson Journiac
January 2014
1
Summary
I.
History
II.
Teva Today
Teva ID
Generics
Specialty products
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
IV. Financial analysis
Consolidated statements of income
Consolidated balanced sheets
2
Summary
I.
History
II.
Teva Today
Teva ID
Generics
Specialty products
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
IV. Financial analysis
Consolidated statements of income
Consolidated balanced sheets
3
History
> in 1976, merge of
3 local companies
to form Teva
Pharmaceutical
Industries Ltd.
Becoming a
truly global
company
Multinational
organisation
aggressive merger and
acquisition strategy in
US and Europe
2010-
1990s
1960s-1970s
2000s-2010
Birth of a local
pharmaceutical
industry
1930s
1980s
1940s-1950s
A decade of growth
> entry into the US
market
> continue to
expend its
worldwide
presence
> rapid growth
of a local
market
1901
Laying the foundations
http://www.tevapharm.com/About/CompanyProfile/Pages/History.aspx
4
Summary
I.
History
II.
Teva Today
Teva ID
Generics
Specialty products
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
IV. Financial analysis
Consolidated statements of income
Consolidated balanced sheets
5
Over 46,000
employees
Among the top 10
pharmaceutical
companies
1,000 molecules
73B tablets and
capsules per year
Direct presence in
about 60
countries
73 manufacturing
sites
$20.3B
2012 revenues
Teva Overview 2013
6
Over 46,000
employees
Among the top 10
pharmaceutical
companies
Direct presence in
about 60
countries
1,000 molecules
World's leading
generic drug
maker
73 manufacturing
sites
73B tablets and
capsules per year
$20.3B
2012 revenues
Teva Overview 2013
7
 2012 revenues: $20.3B
 Three primary areas:
• Generics = core business
• Specialty products
• Over-The-Counter (“OTC”) medicines
 One of the world’s leading manufacturers
of active pharmaceutical ingredients (“APIs”)
Annual report Teva Pharmaceutical Industries Limited December 31, 2012
8
2012 revenues from generics medicines
North America
US: $4.4B
•
•
•
Europe:
$3.4B
ROW:
$2.6B
Leading generic company in the US & one of the two leading generic companies in Canada
Over 1.5 million Teva prescriptions written each day in the US alone
1 out of every 6 generic prescriptions in the US and Canada filled with a Teva product
9
2012 revenues from generics medicines
Europe:
US: $4.4B
•
•
$3.4B
Leading generics company in Europe
Covering 36 countries , supplied ~1000 doses of medicine per second in 2012
10
2012 revenues from generics medicines
ROW:
$3.4B
•
•
$2.6B
One of the top three generic pharmaceutical companies in Japan & South Korea
One of the top two generic pharmaceutical in Russia
11
Generics = Core business
Ability to commercialize
additional generic
Challenges
• Success in challenging patent rights
held by third parties
• Capacity to introduce new products
in a timely manner
• Capacity of manufacturing products
cost-effectively
• Intense competition:
• Prices of generic drugs typically decline
additional generic pharmaceutical
companies (low-cost generic producers
based in China and India)
• Acquisitions (Actavis/Watson
Pham/Warner Chilcott 2013: 3rd place
behind Teva Pham. & Sandoz unit)
• Improvement of the products
protection by the brand
pharmaceutical companies
• Fewer large generic opportunites
Annual report Teva Pharmaceutical Industries Limited December 31, 2012
http://www.fiercepharma.com/story/watson-becomes-actavis-and-already-future-muted/2013-01-25
12
http://ecobusiness.blog.lemonde.fr/2013/10/11/teva-le-champion-des-medicaments-generiques-pris-a-son-propre-piege/
Specialty Medicines
Annual report Teva Pharmaceutical Industries Limited December 31, 2012
13
Copaxone®
• Glatiramer acetate (Copolymer-1)  first major new drug
= acetate salt of synthetic polypeptides, containing 4 naturally occurring amino
acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine
• Discovered by accident at the Weizmann Institute of Science in 1968
• Approved for Relapsing-Remitting Multiple Sclerosis ‟RRMS” (1996) & for
treating CIS (clinically-isolated syndrome) patients in cases suggestive of MS
(2009)
http://www.overcomingmultiplesclerosis.org/Recovery-Program/Drug-Therapies/Glatiramer/
http://wis-wander.weizmann.ac.il/copaxone-recommended-by-fda-committee#.UtGWCsuA1KZ
http://wis-wander.weizmann.ac.il/copaxone-ms-medication#.UtGXjsuA1KZ
14
Copaxone® approvals
MRP
Dec
1996
•Approval in
the U.S
(launch in
March 1997)
August
2000
Approval
in UK
(launch in
December)
Successful
August completion
2001 of the MRP
launched in Europe last
quarter of 2001 (1st Germany)
MA in France :
25/01/2002
Repealed : 12/2009
MA in France : 03/2004
prefilled syringes
20 mg/mL subcutaneous
injection once a day
now approved in 55 countries worldwide
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
http://agence-prd.ansm.sante.fr/php/ecodex/index.php#result
15
Copaxone®: Teva’s blockbuster
• Leading innovative product
($4 billion in sales worldwide in 2012)
• Represents 20% of Teva's annual
revenues (2012)
• Market leader since 2008
(controls about 40% of the US MS
market)
• Responsible for a very significant
contribution to Teva’s annual
profits
(40%-60%)
Annual reports Teva Pharmaceutical Industries Limited
http://www.bloomberg.com/news/2013-12-10/teva-to-miss-2014-estimates-if-copaxone-generics-allowed.html 16
http://www.globes.co.il/serveen/globes/docview.asp?did=1000832755
Copaxone®: Teva’s blockbuster
Annual reports Teva Pharmaceutical Industries Limited
17
Copaxone® Patents
in most of the
ROW
Patents
expiring in
May 2015
Orange
Book-listed
patents (US)
expiring in
May 2014
Copaxone
Patents
protecting various
aspects of the
process of
preparing
expiring in
2019
Non-Orange
Book patent (US)
expriring in
September 2015
Patents
protecting
methods of
analysing
expiring in
2024
Annual report Teva Pharmaceutical Industries Limited December 31, 2012
18
http://www.accessdata.fda.gov/scripts/Cder/ob/docs/patexclnew.cfm?Appl_No=020622&Product_No=002&table1=OB_Rx
Impacts & measures to limit them
May 2013
2011-2013
patent challenges in
European countries by
Mylan & Synthon (UK,
Netherlands, France,
Spain)
Once-a-month
injectale treatment
(glatiramer acetate )
gains US patent (Mapi
Pharma)
Intense competition
from
existing injectable
products & oral
treatments
Copaxone
Generics competition 2008
Suit for infringement of
multiple patents
in U.S.
(Sandoz /Momenta ,
Mylan Inc & Natco Pharma)
(2012 Synthon Pharmaceuticals)
2009-2012
Citizen petitions
denied by FDA
4 petitions targeted
generics /last petition
focuses on novel drugs
http://www.bloomberg.com/news/2013-01-10/teva-cites-bg-12-safety-in-asking-fda-to-add-ms-reviews.html
19
http://globenewswire.com/news-release/2013/07/26/562706/10042058/en/Momenta-Pharmaceuticals-Announces-Potential-for-2014-Market-Entry-of-Generic-Copaxone-R.html
Measures to offset patent loss
2013
Agreement for
commercialization
&NDA
(Takeda)
Jul. 2013
U.S. Court of
Appeals
invalidates a 2015
patent protecting
Copaxone
> exclusivity in US
until May 24, 2014
Nov 13
Copaxone
Patent remains
intact in the EU
until May 2015
(& in most of
ROW)
Launch in US of
Copaxone
40mg/mL tiw
expected in
early2014
(patents until
February 2030,
pending in Europe)
http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1881758&highlight20
http://investor.mylan.com/releasedetail.cfm?releaseid=809318
Copaxone®’s future ?
Changes in the
competitive
landscape
(Tecfidera®)
Generic(s)
approval (FDA) &
timetables
(market capture
and price
erosion)
“Each month of delay before
competitors can put a generic
Copaxone on the market will contribute
about $78 million in sales”
Date of approval of
the new Copaxone®
formulation &
ability to switch
current users to the
new three-per-week
formulation
“2014 will be a pivotal year for Teva and a year of major transitions across the company,”
Eyal Desheh, acting president and CEO (December 10, 2013 )
http://www.bloomberg.com/news/2013-12-10/teva-to-miss-2014-estimates-if-copaxone-generics-allowed.html
http://www.tevapharm.com/Media/News/Pages/2013/1883417.aspx
21
Summary
I.
History
II.
Teva Today
Teva ID
Generics
Specialty products
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
IV. Financial analysis
Consolidated statements of income
Consolidated balanced sheets
22
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
23
TEVA ACQUISITIONS
1976
• ASSIA+ZORI+TEVA= TEVA PHARMACEUTICALS
2003
• SICOR INC
2006
• IVAX CORPORATION
2008
• COGENEZYS PHARMACEUTICAL
2009
• LONZA
. JOIN VENTURE
TEVA ACQUISITIONS
DEC 2010
• RATIOPHARM
JAN 2011
• THERAMEX
265 millions€
MAY 2011
• CEPHALON
6.5 B€
JULY 2011
• TAIYO
NOV 2011
• Procter & Gamble
OCT 2012
• NEUROSEARCH
JAN 2014
• NuPathe Inc
3.7 M€
934 millions$
joint venture
26M€
144 m$
+
Created in 1881
Germany #2 in
generics
Direct presence in
26 countries
$2.3 billion sales
in 2009
Portfolio of over
500 molecules in
10.000 different
presentations
http://www.teva-france.fr/Products/Documents/TableaudeCorrespondance-01-08-2013-GENERIQUES.pdf
ratiopharm InvestoHealthFinal_19Mar2010
+
Positions Teva as the #1 generics
company
Extends global market leadership
Excellent strategic fit
Attractive economics
Branded
Ratiopharm
Generics
ratiopharm InvestoHealthFinal_19Mar2010
phx.corporate-ir.net/External.File?t=1&item
Products
• Short-acting EPO Eporatio®
• FSH
• GCSF – access in Germany
Infrastructures
• Regular, clinical teams and
commercial teams
• Mammalian manufacturing
capacity for FSH and EPO
http://link.springer.com/article/10.1007%2Fs10269-011-2014-z#page-1
www.vfa.de/biosimilars-overview-original-products.
http://ansm.sante.fr/Dossiers/Referentiels-de-bon-usage-des-medicaments/EPO/Tableau-EPO/EPORATIO-solution-injectable-en-seringue-preremplie
TEVA ACQUISITIONS
DEC 2010
• RATIOPHARM
JAN 2011
• THERAMEX
265 millions€
MAY 2011
• CEPHALON
6.5 B€
JULY 2011
• TAIYO
NOV 2011
• Procter & Gamble
OCT 2012
• NEUROSEARCH
JAN 2014
• NuPathe Inc
3.7 M€
934 millions$
joint venture
26M€
144 m$
+
January
2011
265 millions
d'euros
Merck
1999
women’s
health and
gynecology
http://www.lesechos.fr/29/10/2010/LesEchos/20795-122-ECH_teva-acquiert-le-laboratoire-theramex-de-merck.htm
+
Monaco laboratory 1971
Women a broad portfolio of women’s
health and gynecology products
sold in over 50 countries, primarily
France and Italy
http://www.lesechos.fr/29/10/2010/LesEchos/20795-122-ECH_teva-acquiert-le-laboratoire-theramex-de-merck.htm
+
Women a broad portfolio of women’s health and
gynecology products
TEVA ACQUISITIONS
DEC 2010
• RATIOPHARM
JAN 2011
• THERAMEX
265 millions€
MAY 2011
• CEPHALON
6.5 B€
JULY 2011
• TAIYO
NOV 2011
• Procter & Gamble
OCT 2012
• NEUROSEARCH
JAN 2014
• NuPathe Inc
3.7 M€
934 millions$
joint venture
26M€
144 m$
+
May 2011
OPA 6.8 billion$
Specialty pharma business is a key contributor to
Teva’s sustainable and balanced business model
CNS - NUVIGIL
PAIN - FENTORA
ONCOLOGY - TREANDA
http://www.thestreet.com/story/11101059/1/teva-acquires-cephalon-for-68-billion.html
Combination Enhances and
DiversifiesTeva’s Branded Business
http://www.thestreet.com/story/11101059/1/teva-acquires-cephalon-for-68-billion.html
Teva’s acquisition of cephalon may, 2011
Teva + Cephalon:
Continued Leadership in Specialty Pharma
http://www.thestreet.com/story/11101059/1/teva-acquires-cephalon-for-68-billion.html
Teva’s acquisition of cephalon may, 2011
Cephalon Commercial Footprint
Sells 170 products in more than 100 countries
Teva’s acquisition of cephalon may, 2011
The Combined Branded Pipeline
Cephalon
Pipeline
Teva
Pipeline
Teva’s acquisition of cephalon may, 2011
TEVA ACQUISITIONS
DEC 2010
• RATIOPHARM
JAN 2011
• THERAMEX
265 millions€
MAY 2011
• CEPHALON
6.5 B€
JULY 2011
• TAIYO
NOV 2011
• Procter & Gamble
OCT 2012
• NEUROSEARCH
JAN 2014
• NuPathe Inc
3.7 M€
934 millions$
joint venture
26M€
144 m$
Top 15 global pharmaceutical
company
Sales of $1.6M in 2010
Global product portfolio of around 1480
molecules
Teva and Taiyo leadership in japenese generics may 2011
Sales in 120 countries
Teva and Taiyo leadership in japenese generics may 2011
+
July 2011
#3 in Japanese
generic
market
934 millions
dollars
GENERICS
API
BRANDED
Teva and Taiyo leadership in japenese generics may 2011
TEVA’s Presence in Japan Today
Teva and Taiyo leadership in japenese generics may 2011
Japan: A High Growth Generic Market
Teva and Taiyo leadership in japenese generics may 2011
TEVA ACQUISITIONS
DEC 2010
• RATIOPHARM
JAN 2011
• THERAMEX
265 millions€
MAY 2011
• CEPHALON
6.5 B€
JULY 2011
• TAIYO
NOV 2011
• Procter & Gamble
OCT 2012
• NEUROSEARCH
JAN 2014
• NuPathe Inc
3.7 M€
934 millions$
joint venture
26M€
144 m$
Procter & Gamble Consumer Healthcare
November 2011
A consumer healthcare joint venture
with “P&G”
The joint venture focuses on branded
OTC medicines.
Procter & Gamble Consumer Healthcare
The joint venture focuses on branded OTC
medicines in categories such as:
Allergy
Digestive
wellness
Analgesics
Vitamins,
minerals and
supplements
Skin
medications
TEVA ACQUISITIONS
DEC 2010
• RATIOPHARM
JAN 2011
• THERAMEX
265 millions€
MAY 2011
• CEPHALON
6.5 B€
JULY 2011
• TAIYO
NOV 2011
• Procter & Gamble
OCT 2012
• NEUROSEARCH
JAN 2014
• NuPathe Inc
3.7 M€
934 millions$
joint venture
26M€
144 m$
+
October 2012, a Danish company, $26 million
Aquired the rights, assets and obligations relating to Huntexil®
(pridopidine/ACR16), a drug candidate being developed for the
symptomatic treatment of disturbances in Huntington’s disease.
TEVA ACQUISITIONS
DEC 2010
• RATIOPHARM
JAN 2011
• THERAMEX
265 millions€
MAY 2011
• CEPHALON
6.5 B€
JULY 2011
• TAIYO
NOV 2011
• Procter & Gamble
OCT 2012
• NEUROSEARCH
JAN 2014
• NuPathe Inc
3.7 M€
934 millions$
joint venture
26M€
144 m$
+
NuPathe Inc. (PATH) for 144 m$
ZECUITY® is the first and only prescription migraine patch
approved by the FDA for the acute treatment of migraine
with or without aura in adults.
most widely prescribed migraine medication- SNC
http://seekingalpha.com/pr/8710331-teva-expands-cns-specialty-business-with-acquisition-of-nupathe?source=email_rt_mc_press_0
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
53
Establish leadership in high-value generics
First-to-file, First-to-market
Highly differentiated, high-barrier
complex products
Teva Investor Day – December 11, 2012
54
Generics
Teva Investor Day – December 11, 2012
55
First-to-file, First-to-market
Continue to maximize first-to-market value through
- Paragraph IV challenges
- First-to-file exclusivities
Emerging
markets
$2,4B
North
America
$5,2B
In the US
Europe
$3,9B
2012E revenue from generic medicines and OTC
Teva Investor Day – December 11, 2012
56
Paragraph IV challenges in the US
 United States Code: 21 USC §355(j)(2)(A)(vii)
 Abbreviated New Drug Application Patent Certification
[An ANDA shall contain] a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each patent which
claims the listed drug… or which claims a use for such listed drug for
which the applicant is seeking approval
o (I) that such patent information has not been filed,
o (II) that such patent has expired,
o (III) of the date on which such patent will expire, or
o (IV) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which
the application is submitted.
First to File and Beyond Paragraph IV Business Strategies – Thomson Reuters Intellectual Property & Science Generics & API Intelligence
57
Paragraph IV challenges in the US
Top Paragraph IV Filers by Group
First to File and Beyond Paragraph IV Business Strategies – Thomson Reuters Intellectual Property & Science Generics & API Intelligence
58
First-to-file exclusivities in the US
First applicant to submit a complete
Abbreviated New Drug Application
180-day market exclusivity
First to File and Beyond Paragraph IV Business Strategies – Thomson Reuters Intellectual Property & Science Generics & API Intelligence
59
Establish leadership in high-value generics
First-to-file, First-to-market
Highly differentiated, high-barrier
complex products
60
Highly differentiated, high-barrier
complex products
Over the past several years
More recently
 Tablets
 Capsules
 Liquids
 Ointments
 Creams
 Sterile systems: vials,
High barrier
complex
technologies
syringes
 …
61
High barrier complex technologies
Complex oral and inhalation delivery methods
• Drug device combination
Other complex technologies
• Modified release: Long-acting release injectables
• Transdermal patches
• Oral thin film
• Nasal delivery systems
• Liposomal drug delivery
62
Drug device combination
AB-rated strategy in the US =
Develop generics of dry powder inhaler products
AB-rated Advair®
(fluticasone /
salmeterol)
• Submission planned for 2017
AB-rated Symbicort®
 FDA has facilitated the development of generics
 Only a 4 week bioequivalence study ≠ Dose response PD
 FDA draft guidance (09/09/2013)
 Recommendations to establish bioequivalence of the test
and reference dry powder inhalers containing fluticasone
propionate and salmeterol xinafoate
RD in Focus – RESPIRATORY – FINAL 8 oct 2013
63
Challenges
Chemistry,
Manufacturing
and Controls
• Develop a new dry powder device that
matches Diskus® (blister-based device)
• Demonstrate robust stability
• Achieve this at commercial scale
PK and PD bioequivalence
In EU



Numerous attempts by many companies
Multiple failures / setbacks
No successful development to date by a major company
RD in Focus – RESPIRATORY – FINAL 8 oct 2013
64
Biosimilars
“Teva is committed to the development of biologics and biosimilars,
which make up one of the fastest growing segments of the global
pharmaceutical market and offer efficacious yet more affordable
treatment to all patients"
Professor Yitzhak Peterburg, Teva's Group Vice President, Global Branded
Products.
Patents of the 12 bestselling biological
products will expire
before 2020
Opportunity to enter
the market
65
66
http://www.gabionline.net US$67 billion worth of biosimilar patents expiring before 2020
Biosimilars
A biosimilar is a product that is
physically, chemically, biologically, and clinically
similar to an approved reference biological product.
67
Complex development process
Step 2
Step 1
Confirm comparability
- Pre-clinical studies
Establish
a
robust
manufacturing
process to meet the
physical,
chemical,
biological
reference
product specifications
- Clinical studies
•
•
•
•
PK
PD
safety (immunogenicity)
efficacy
TEVA_BIO_brochure_external_120419 final version (2)
68
Complex development process
Impossible to
produce an exact
copy of a biologic
molecule
High barriers of
entry
69
Teva strategy
Acquisitions
Collaborations
70
Acquisitions / Collaborations
First Teva
BioSimilar
activities
2000
Israel
BioSimilar
R&D
2003
Sicor Inc.
acquisition
2005
Lonza Group Ltd.
Joint venture
2007
CoGenesys
acquisition
2009
2010
Ratiopharm
acquisition
Providing for strong internal development,
manufacturing and R&D capabilities
TEVA_BIO_brochure_external_120419 final version (2)
71
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
72
What is an NTE?
A Known
With a
Proven
Efficacy
Molecule
NTE
With new
galenic
technologies
With new
association
of molecules
73
New products from NTE process in 2013
74
Abuse Deterrent (AD) Opioids
 Most prescribed medication for:
 Acute pain (post surgery)
 Cancer related chronic pain
 Chronic non-cancer pain
 Opioid sales in US > 300%
 Increasing concern:
 feeling of euphoria addiction
75
Public Health concern
 2011:
 >1.8 M people with opioid dependence problem
 > 150,000 abuse treatment admissions
 > 17,000 deaths
 72,5 B per year in Health Care Costs
76
The solution of TEVA
Becomes a gel
in small
volume of
fluid
No dose
dumping with
alcohol
If crushed,
polymer
remains
bound to
opioid
Anti
deterrent
Opioids
ORA-GUARD®
tech.
77
Expectations by 2015- Opioids development
78
NTE program 2013
14 new
products in
dev.
8
• 1 approved ADASUVE®
submitted
in the next
3 yrs
Reliable
developpement
plan :
Approx. 10 new
product developed
each year
79
NTE process aim
Address
an unmet
patient
need
Lower costs
A lever
between:
Significant
returns
Reduce
timelines
80
Comparison NCE development vs NTE process
New Chemical Entity process = 10-15 years, 1-2B$
Discovery
Pre-clinical
Phase I
Phase II
Phase III
(41% of
success)
Submission
New Therapeutic Entity process = 3-6 years, 10-50M$
Formulation
Pre-clinical
Phase I (PK)
Phase III
(66%)
Submission
(ref. S&E data)
81
NTE : Regulatory protection
Industrial
Patents
• Formulation/Dosage/Indication
• Technology/ Combination
Regulatory
exclusivity
• 3 years exclusivity with efficacy
studies
• 7 years orphan indication in US
82
Fusion of Generic R&D knowledge & high technological drug
development
Generic
R&D
Injectable
device
development
Clinical
development
Proprietary
technologies
15 complex
technologies
Preclinical
development
Patient
needs
knowledge
>1000
product files
> 250
formulators
Global
Regulatory
Specialty
R&D
83
NTE pipeline
84
NTE pipeline
85
Revenue Projection in 2018 and 2020 (B$)
3$
2$
86
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
87
Sustain and leverage strengths in CNS
Protect and expand Multiple Sclerosis
(MS) franchise
Build CNS products and pipeline
88
Protect and expand MS franchise

Copaxone®: less frequent injections
•

Submission: 2013
20 mg
40 mg
Daily
3 times
per week
Copaxone® Laquinimod combination
•
Initiate Phase II: 2013
Copaxone®
Laquinimod
Antiinflammatory
Neuroprotective
Potential to
modify the
course of MS
89
Build CNS products and pipeline
By expanding into neurodegenerative diseases
Multiple
Sclerosis
Alzheimer
disease
WHY?
•
•
•
•
Parkinson
disease
Huntington
disease
Increasing prevalence
Huge disease burden
Better scientific understanding
Unique opportunities for Teva
medicines
90
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
91
Teva Respiratory today
*Qnasl ® in US, local brands in EU
92
Teva’s respiratory strategy
Enter new highvalue drug classes in
Asthma/ COPD
Expand
geographically
(« Rest of the
World
Countries » and
EU countries)
Enhance value of
existing brands
(Qvar ® and ProAir®)
93
Products in Development in major drug classes
ProAir®
Spiromax®
Reslizumab
SABA: Short Acting β2 Agonist
LABA: Long Acting β2 Agonist
ICS: Inhaled Corticosteroids
LAMA: Long acting Muscarinic
antagonists
94
Why Teva wants to go into inhaled therapies?
Patients under-utilize inhaled medicines with negative health outcomes
Inappropriate
inhaler use
Simpler
intuitive
inhalers
Inadequate
adherence
Consistency
accross
inhalers
Reduced
dosing
frequency
Reduced
effectiveness
Monitoring
95
TEVA’s Weapon: Spiromax®
 Easy to use
 Easy to
educate
 Intuitive
 Prefered by
patients to
GSK’s Diskus®
and also to
Turbuhaler®
(71%)
96
The device can have a huge impact on the adherence to
the treatment
 Thanks to physicians:
« An old but well-known drug in a new, more
reliable inhaler is probably more useful than a new
drug in an old-flawed inhaler »*
 To the question:
 How would your rank the influence of delivery device over
your prescribing decision?**
6,7/10
* Virchow J.C, et Al Respir Med 2008; 102: 10-19; Virchow J.C Respir Med 2004: 98: S28-S34
**Pulmonologist survey, Jefferies Research 2013
97
Underlying strategy of Teva
 One device : Spiromax®
 3 programs:
 Duo-Resp® Spiromax®
 Pro-air® Spiromax® (Completing Phase III
studies and 2 paediatric- sub: Mid 2014)
 FS Spiromax® (Phase III early 2014)
98
Summary
I.
History
II.
Teva Today
Teva ID
Generics
Specialty products
III. Teva’s current strategy
TEVA acquisitions
Establish leadership in high-value generics
Build a unique platform for NTEs
Sustain and leverage strengths in CNS
Achieve leading presence in Respiratory
IV. Financial analysis
Consolidated statements of income
Consolidated balanced sheets
99

Implementation of a reconversion strategy:
 Multiple
acquisition (cephalon) to develop
specialty medicine
 Increase R & D expenses (NTE, Respiratory) to
optimize the generic medicine
 Other Acquisition (Taiyo) to access the Asian
market
Impact on the financial analysis
100
IV. Financial analysis
Financial analysis
Consolidated statements of income
Consolidated balanced sheets
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2012
101
Net Revenues $Bn
46,2%
20.317
25
13.897
20
15
ROW
Europe
10
United states
5
0
2009
2010
2011
2012
102
Revenues by Product line
Revenue by product line in 2009
0%
3%
26%
71%
Revenue by product line in 2012
4%
5%
51%
40%
Generic medicine
Specialty
OTC
Other revenues
103
Operating income $bn
43%
5
4
3
2
1
3.871
2.405
3.109
2.205
0
2009
2010
2011
2012
Operating income $Bn
 Higher impairments concerning patents,
 loss contingencies concerning pending patent litigation
 New strategy related to restructuration/acquisitions
↗ S&M expenses
↗ G&A expenses
↗ R&D expenses
104
IV. Financial analysis
Financial analysis
Consolidated statements of income
Consolidated balanced sheets
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2012
105
Assets and liabilities
Emplois Stable
Ressources
Stables
FRNG
BFR
Trésorerie < 0
Actif circulant
Dettes
Circulantes
106
BFR, FRNG, CASH
$ bn
2009
2010
2011
2012
FRNG
4.539
2.368
0.777
3.467
BFR
3.592
3.835
3.961
3.594
Cash
+ 0.947
- 1.467
- 3.184
-0.127
 Remediation of balance sheet in 2012 (↗ Cash compared to 2011)
107
Dept Ratio
$bn
2009
2010
2011
2012
Total
long term
liabilities
6.949
6.456
14.123
14.854
Total
Equity
19.259
22.002
22.343
22.867
=
36%
29%
63%
65%
 Due to Acquisitions
108
Recently
 March 2007 to May 2012: Shlomo Yanai
 May 2012 - Oct. 30, 2013: Dr. Jeremy Levin step down following a
dispute with Teva’s board over implementing a strategic retrenchment
program.
 The Board has named Eyal Desheh, Teva's Executive Vice President and
Chief Financial Officer, to fill the role of President and Chief
Executive Officer, in interim.
 Teva Committed to Cutting $2B in Costs by 2017, including 5.000
jobs, 10% of the company workforce by 2017.
 “We are, all over the company, eliminating activities which are not
really contributing to value creation,” added Desheh,
Wednesday, October 30, 2013 Teva Announces Departure of President and CEO
- Dr. Jeremy Levin steps down as President and CEO -Eyal Desheh, Teva's Group EVP & Chief Financial Officer, named interim President and CEO –
109
GEN News Highlights Jan 15, 2014 Teva Committed to Cutting $2B in Costs by 2017
Recently
 Teva named Erez Vigodman as permanent president and CEO,
effective February 11.
Degrees in economics and
accounting from Tel Aviv University.
Harvard’s executive master of
business administration program.
 CEO of Makhteshim Agan, the world’s largest maker of
generic agrochemicals, Since he took the helm of
Makhteshim in 2010, Vigodman has returned the company to
profitability.
 Has earned a reputation as an executive who can turnaround
companies.
GEN News Highlights Jan 15, 2014 Teva Committed to Cutting $2B in Costs by110
2017
Stock exchange
111
SWOT
-Size & Scale  leadership in
global generics market
-Acq strategy  Size & Scale
-Patent expiry  decrease
of Copaxone sales
-Strong R&D  robust Pipeline
-Development of resp pipeline
-↗ government scrutiny: US&EU
-Entry into the Asian market
-Consolidation in the US
-Outlook/global generics market
-Currency Fluctuations
- ↗ Specialty medicine
112
Thank You!
113