„Die wahren Facts & Figures hinter dem Patent Cliff“

IMS Health

Agenda

• Market Overview

− Overall Pharma Market

− Generics Environment

− Forecasts

• European Environment

− Cost Containment

− Austrian Generics Market

− Generic Defence Strategy

• Orphan Drugs

− Rising Designations

− Strong Sales

• Summary

2

1

Developed Markets

CAGR 2012-2016

US 1-4%

Japan 1-4%

Germany 0-3%

France (2)-1%

Italy 0-3%

Canada 0-3%

Spain (4)–(1)%

UK 0-3%

S. Korea 2-5%

Developed 1-4%

Pharmerging Markets

CAGR 2012-16

Tier 1 (China) 15-18%

Tier 2 12-15%

Brazil 12-15%

Russia 10-13%

India 14-17%

Tier 3 7-10%

Pharmerging 12-15%

3

Source: IMS Market Prognosis, Apr 2012

Global Sales and Market Growth

At par with region CAGR

Lower than region CAGR

Higher than region CAGR

Pharmaceutical growth is expected at 3-6% CAGR upto 2016 with value over US$ 1.1 trillion in 2016*

(*) at ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data. All CAGR calculations are 5 years

Market Overview: Pharma Market1

-10%

-5%

0%

5%

10%

15%

20%

0

200

400

600

800

1,000

1,200

1,400

2011 2012

(f)

2013

(f)

2014

(f)

2015

(f)

2016

(f)

% G

RO

WTH

(CO

NST U

S$)

SALES U

S$BN

Grand Total USEU5 JapanPharmerging Tier 1 Pharmerging Tier 2Pharmerging Tier 3 CanadaSouth Korea

Generics have seen superior double digit growth performance for a number of years

0%

2%

4%

6%

8%

10%

12%

14%

16%

0

100

200

300

400

500

600

700

800

2007* 2008* 2009* 2010* 2011*

Growth

Sa

les $

bn

Generics Original Brands All Others Generic Growth Original Brand Growth

Source: IMS MIDAS Q2 2011. Based on ethical market segmentation markets + LIC only. *MATs ending June

Sales and Growth by Segment

Market Overview: Generics Environment1

0

10

20

30

40

50

60

70

80

902002

2003

2008

2007

2006

2005

2011

2010

2009

2004

GEN

ERIC

S

VO

LU

ME S

HARE o

f U

NPRO

TECTED

MARKET %

(SU

)

2001

2001-2011: Generic volume penetration dynamics in key markets

Source: IMS Health, MIDAS, MAT Dec 2011. Market Segmentation, Rx Bound

The US has reached nearly 90% generic volume penetrationAustria has a long way to go to catch up on generic penetration

AUSTRIASPAIN

CANADA

UK

ITALY

GERMANY

FRANCE

JAPAN

US MATURE 8

Top 8 Mature/Austria

5

Market Overview: Generics Environment1

Impact on volumes of the original brands and follower products are pronounced after LoEUS with its high generic penetration shows this trend clearly

6

2004 2005 2006 2007 2008 2009 2010 2011

1.0

1.5

2.0

0.5

0.0

3.5

4.5

4.0

2.5

3.0

Sta

ndard

units, bn

AMLODIPINE

BENAZEPRIL

VENLAFAXINE

TOPIRAMATE

LAMOTRIGINE

VALACICLOVIR

CETIRIZINE

METOPROLOL

2004 2005 2006 2007 2008 2009 2010 2011

0.5

0.0

2.5

3.0

3.5

4.0

4.5

1.5

1.0

2.0

Sta

ndard

units, bn

USA

Market Overview: Generics Environment1

Original Brand Volumes Follower Product Volumes

Source: IMS Health, MIDAS, MAT Dec 2011. Market Segmentation, Rx Bound

Although Austria still sees generic penetration, the impact on original brand volumes is far less pronounced than in the US

7

2004 2005 2006 2007 2008 2009 2010 2011

80

Sta

ndard

units, m

n

30

20

60

70

40

10

0

50

90

100

Austria

Market Overview: Generics Environment1

Original Brand Volumes Follower Product Volumes

BICALUTAMIDE

VENLAFAXINE

LOSARTAN

CLOPIDOGREL

PANTOPRAZOLE

2004 2005 2006 2007 2008 2009 2010 2011

80

70

60

50

40

30

20

10

0

Sta

ndard

units, m

n

90

100

Source: IMS Health, MIDAS, MAT Dec 2011. Market Segmentation, Rx Bound

Typically much shallower fall-off than products in

the US

Based on constant dollar forecasts, Original brands growth will slow and share will declineGenerics to dominate growth to 2016

• Globally, growth between 2012-2016 isforecast to slow to 4-7% CAGR comparedto 6% over the past five years.

• Largest growth seen in Generics as aresult of increased LOE, payer reformsand growth

2007: 521 Bn 2011: 596 Bn

5 Yr CAGR

Region 2007 -2011 2012-2016

Top 8 Mature 3% 0 - 3%

Protected (Non-Generic) 3% (2) - 1%

Generics 8% 6 - 9%

Unprotected (Non-Generic) 5% 2 – 5%

2016: 647 – 667 Bn

8

13%

15%

11%

60%

12%

16%

58%

13% 13%

18%

52%

17%

Source: IMS Health Market Prognosis, Apr 2012 (*) at ex-manufacturer price levels, not including rebates and discounts. Market size represented in constant US$. All CAGR calculations are 5 years

Protected (Non-generic) Unprotected (Non-generic)Generics Other

Top 8 Mature

Market Overview: Forecasts1

In Europe cost containment measures are proliferating and increasing generic use is part of the solution

9

Cost containment tools GR PT NL FR SW DK DE SK TU IE SL CZ FI BE LU SP AT EE IT UK BG LV HU LT PL RO

VBP / Risk sharing agreements

HTA/Cost effectiveness assessment

Innovation rating

Generic promotion

Prescribing budgets / controls

Patient contributions

EU price referencing

Volume controls

Mandatory price cuts

Price controls / Tendering

AT: Austria, BE: Belgium, BG: Bulgaria, CY: Cyprus, CZ: Czech Republic, DK: Denmark, EE: Estonia, FI: Finland FR: France, DE: Germany, GR: Greece, HU: Hungary, IE:

Ireland, IT: Italy, LV: Latvia, LT: Lithuania, LU: Luxembourg, ML: Malta, NL: Netherlands, PL: Poland, PT: Portugal, RO: Romania, SK: Slovakia, SL: Slovenia, ES: Spain, SE:

Sweden, TU: Turkey, UK: United Kingdom

Increased cost management after 2009Cost containment tool present before 2009

Dem

an

d s

ide

Su

pp

ly s

ide

European Environment: Cost Containment2

0%

20%

40%

60%

80%

100%

VO

LU

ME M

ARKET S

HARE %

SU

UNBRANDED GENERICS BRANDED GENERICS COMPANY BRANDED GENERICS ORIGINAL BRANDS

Source: IMS Health, MIDAS, Market Segmentation, MAT Dec 2011, Rx only. * Market Segmentation countries

Even after patent expiration original brands still retain a sizeable volume share in Austria

European Environment: Austrian Generics2

Unprotected Market Segmentation Volume (SU)

In Europe there are still significant LoE savings to be made by 2016After 2016 generic savings significantly less

Source: IMS Health MIDAS MAT Dec 2011, market segmentation. Europe defined as: Germany, France, Italy, Spain, UK, Belgium, Switzerland, Netherlands,

Sweden, Greece, Austria, Turkey, Denmark, Poland, Ireland, Finland, Portugal, Norway, Czech Republic, Hungary & Slovakia

Value Market share by segment

4.0

4.5

5.0

5.5

6.0

6.5

7.0

3.5

Austria

LoE

as 2

011 P

rote

cte

d S

ale

s,

LCU

S$

0.1

0.6

0.9

1.0

0.9

2.3

5.7

0.8

1.3

1.0

1.0

1.5

0.0Others

0.5

0.40.3

1.2

1.5

Italy

0.2

0.7

2.2

0.5

UK

0.6

0.7

0.6 0.5

1.3

1.0

Spain

0.1

0.6

0.70.3

5.7

3.0

0.7

3.1

6.9

1.20.8

1.5

0.7

2.5

France

0.1

3.7

3.3

0.4

1.5

2.0

Germany

0.1

Europe

Original Brands facing LoE 2012-2016

European Environment: Future Scenarios2

48%

28%

23%

PROTECTED

NEVER PROTECTED

NO LONGER PROTECTED

20122015 201320142016

There are several key products which will lose exclusivity in Austria going forward to 2016

12

Austrian LoE going forwards

Product Therapy Area 2011 Sales, US$

2012

Lipitor Lipid Regulators $26.4m

Aricept Anti-Alzheimers $19.2m

Pariet Anti-Ulcerants $6.8m

2013

Seretide Respiratory $40.1m

Zometa Bisphosphonates $24.2m

Viagra Erectile Dysfunction $13.2m

2014 Cipralex Anti-Depressants $25.8m

2015

Spiriva Respiratory $38.6m

Copaxone Immunostimulants $35.8m

Alimta Oncology $20.1m

Cymbalta Anti-Depressants $14.8m

Tarceva Oncology $13.6m

2016 Glivec Oncology $42.5m

European Environment: Austrian Generics2

Source: IMS Health, MIDAS, MAT Dec 2011, Rx only.

In Spain, Cipralex has already lost exclusivity Guide to what the Austrian market might see?

13

10

Generic Entrants

Cipralex/Esertia

Sta

ndard

Units, m

n

5

0

2008

2006

2004

2010

2011

15

20

25

30

35

40

45

2009

2007

2005

Product Volumes

Generic Entrants

CINFA

NORMON

TEVA

STADA

NOVARTIS

KERN PHARMA

ACTAVIS

MYLAN

INVENT FARMA

ESTEVE

APOTEX

MEIJI SEIKA

VEGAL FARMA

Source: IMS Health, MIDAS, MAT Dec 2011, Rx only.

European Environment: Austrian Generics2

For originators there is a range of potential scenarios, of which the most promising will have to be selected

Litigation:

Legal action to delay generic

market entry and preserve patent

protection

Pricing:

Lowered pricing, renegotiated

with buyers, negotiated bulk

prices, etc

OTC:

Attempt to execute an Rx-to-OTC

switch

Authorized Generic:

Negotiation of an authorized

generic agreement with a generic

company

Generics Subsidiary: Transition

of drug to a corporate-owned

generics subsidiary unit

Counter-Promotion: Increased

promotion (increased call

frequency, sampling, etc)

Formulations:

Development and launch of new

formulation(s)

Indications:

Development and approval for

new indication(s)

Next-Generation Drug:

Development and launch of a

next-generation product, active

switching strategy

Combination Drug:

Development and launch of a

combination product that includes

the end-life drug

Intensified CRM:

Strengthening business relations

with KOLs, prescribers &

pharmacists

Rebate Contracting:

(if semi-exclusiveness can be

achieved)

Future Scenarios

14

European Environment: Future Scenarios2

15

Four of the Top 10 Orphan Drugs Launched in the last few years have reached the $500m mark

2005

0.10.2S

ale

s (

US a

nd E

uro

pe),

US$bn

0.0201120102009200820072006

0.6

1.2

1.7

2.4

3.2

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Source: IMS Health, MIDAS, MAT 09; FDA, EMEA. Products with orphan indications in US and EU only; orphan products with common indications not included as sales cannot be split

Tasigna

Exjade

Sprycel

Vidaza

Mozobil

Torisel

Elaprase

Myozyme

Nplate

Soliris

Top 10 Orphan Drugs Launched since 2004 (US and Europe)

2011 Sales

~ $0.5bn each

US and Europe

Orphan Drugs3

Thank you

IMS Health