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Roche: Navigating through a volatile environment
London, Singapore, Tokyo, November 2010Dr. Erich Hunziker, Deputy Head of the Corporate Executive Committee and CFO
2
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others:
1 pricing and product initiatives of competitors;2 legislative and regulatory developments and economic conditions;3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products,
including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products;
6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation;10 loss of key executives or other employees; and11 adverse publicity and news coverage.
Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.
For marketed products discussed in this presentation, please see full prescribing information on our website –www.roche.com
All mentioned trademarks are legally protected
3
A position of strength
Operational Excellence – adapting to a changing environment
Continued focus on innovation
4
Even in an economic downturn demand forhealthcare increases; but funding is and will become more challenging
Funding of healthcare
Today 2020
Paymentsby individuals
Co-payment-systemsSlowdown
of EconomySocial security systems
No. of healthcare events
Today 2020
Higher life expectancy
Population growth
Researchactivities
Access to healthcare
Health awareness
5
Lack of potential in BRIC countries?
Generics replace originals
Investors see fundamental challenges for “Pharma”
?
Growth potential for Pharma
Today 2020
US Healthcare reform
Lack of innovation ?
6
Financial impact
2010: ~CHF 200 m (Medicaid and hospitals rebates)
2011+ : 2010 + Excise tax
2013+ : offset impact by volume
Impact of US healthcare reformExtending coverage to an additional 32 million* Americans
Biosimilars
• 12 years data exclusivity
• 2 routes for biosimilar approval:
- Proof of similarity- Proof of inter-changeability
Both requiring clinical trials (still to be specified by FDA)
* By 2019; Congressional Budget Office estimate
7
Emerging markets show strong growthand are another Roche focus point
20.4UK11
22.9Brazil9
23.4Russia8
26.1Italy7
26.6Spain6
40.1France5
15.6India14
12.4Mexico15
IMS Health Pharma Market Ranking 2013 US $ Bio
20.2Venezuela12
Turkey
Canada
Germany
China
Japan
United States
16.313
20.510
46.14
66.73
93.32
289.81
Source: IMS Health, Market Prognosis June 2009
Growth (CAGR) 2008-14
US, EU 3-4%
APAC, LATAM, CEMAI 9-13%
Total 5-6%
Source: CAGR 08-14 Decision Resource/groupH (+/-1.5% assumed)
8
0%
20%
40%
60%
80%
100%
HY
2005
HY
2006
HY
2007
HY
2008
HY
2009
HY
2010
Roche in Emerging MarketsOncology leading the trend
International region as% of Oncology sales
30%
22%
10%
15%
20%
25%
2005 2006 2007 2008 2009 2010
0%
20%
40%
60%
80%
100%
HY
2005
HY
2006
HY
2007
HY
2008
HY
2009
HY
2010
Herceptin
MabThera/RituxanInternationalRest
9
13.2
11.5
10.3
9.7
8.9
7.2
6.4
6.1
ROCHE
NOVARTIS
ASTRAZENECA
BAYER
SANOFI-AVENTIS
GSK
PFIZER
MERCK & CO
Full Year 2009 YoY Growth %
Emerging markets also reward innovationRoche has the leading growth rate in emerging markets
0 5 10 15
5.4%
5.4%
5.3%
3.6%
3.5%
3.2%
3.1%
3.7%
% Market Share
Source: IMS Health MIDAS FY 2009 US$ LC Roche International Regions: Asia Pac, CEMAI, Lat AM (based on Roche subscription)
10
Biotech products drive growth in both divisions
67%
Biotech products as % of sales
Pharma Division
85%
Diagnostics Division
H1’ 2010
11
Long patent protection Biosimilars facing high hurdles
Long primary patent protection of our key biologics
similar2018Pegasys
earlier2018Rituxan/ MabThera
earlier2019Herceptin
marketed byNovartis
2019Lucentis
similar2019Avastin
EUROW/EM
USPatents
Biosimilars outlook
US: recent healthcare legislation opens pathway for biosimilars
FDA in the process of developing guidelines
Data exclusivity for biologics 12 years
ROW/EM: investment in countries with strong IP regulations (China)
Brand awareness important
EU: legal and regulatory hurdles likely to remain high for biosimilars
12
Patent expiries of large brands 2008-2014”Oxygen for innovation” CHF >100 bn
Source: Evaluate Pharma
YoY Sales loss [CHF bn]
36
1114
35
29
19
2008 2009 2010 2011 2012 2013 2014
Product Examples(> 3 bn CHF each)
• Prevacid • Aricept• Cozaar• Taxotere
• Lipitor• Plavix• Seretide• Zyprexa
• Diovan• Enbrel• Singulair• Lovenox
• Cymbalta• Epogen• Procrit
• Nexium• MabThera• Celebrex
13% Sales Lost calculated by subtracting given year sales (‘10, ’11, ‘12, ‘13) from full year sales from year prior to LOE.Data excludes sales lost impact of products with LOE prior to 2010.Source: Evaluate Pharma
40%
35%
30%
25%
0%
20%
10%
15%
5%
% o
f US
Sal
es L
ost
to G
ener
ics
/ B
iosi
mila
rs
Roche/Genentech
Pfizer/Wyeth
GlaxoSmithKline
Sanofi-Aventis
AstraZeneca
Johnson & Johnson
Eli Lilly
Merck/Schering Plough
2010 2011 2012 2013
Roche: Limited exposure to patent expiries
Novartis
14
Key Pharmaceuticals & Diagnostics productsA risk-diversified portfolio of drugs and BUs
MabThera/Rituxan
Xeloda
NeoRecormonCellCept
Herceptin
Avastin
Pegasys
Sal
es (
CH
F bn
)
Clinical Chemistry
Immunochemistry
Tarceva
Lucentis
* Sales 2009
0
5
10
15
20
25
30
35
'03 '04 '05 '06 '07 '08 '09
>C
HF
6bn*
>C
HF
1bn*
>C
HF
5bn*
2 with > than CHF 6 bn
1 with > than CHF 5 bn
11 with > than CHF 1 bn
Diabetes Care
Molecular DxBoniva/Bonviva
15
Advanced Non-Small Cell Lung Cancer
Avastin: Portfolio within a portfolioKey treatment option in multiple tumor types
MetastaticColorectal
• Superior OS 1st and 2nd line• Superior PFS 1st and 2nd line
• Superior OS 1st line• Superior PFS 1st and 2nd line
Ovarian • Superior PFS front line
• Superior PFS in multiple 1st
line trials • Superior PFS in 2nd line
MetastaticBreast
• Unsurpassed PFS and OSRecurrent
Glioblastoma
Renal • Superior PFS in 1st line
2009 Sales
75%- 80%
20%-25%
16
Actemra/RoActemraBuilding new pillar
0
20
40
60
80
100
Q108
Q208
Q308
Q408
Q109
Q209
Q309
Q409
Q110
Q210
CHF m• Launched in ~50 countries so far
• Uptake in Japan remains strong
• In US after only 5 months, Actemra already prescribed by more than 50% of rheumatologists
• US patient share constantly increasing (currently 3-6% following anti-TNFs)
Actemra vs Humira H2H trialEnrolling patients
Actemra/RoActemra quarterly sales
17
TamifluSales at normalized levels
Tamiflu quarterly sales (CHF m)
746
460
192
458
45 50 36106
304 349
727
533422
17091
119
65
54
233
65
75
97
260
267 663
95
237
0
200
400
600
800
1'000
1'200
Q1
07
Q2
07
Q3
07
Q4
07
Q1
08
Q2
08
Q3
08
Q4
08
Q1
09
Q2
09
Q3
09
Q4
09
Q1
10
Q2
10
Q3
10
Retail
Pandemic¹
1Governmental & Corporate
18
RocheActing from a position of strength
• Protection of current portfolio:- long patent protection- hurdles for biosimilars
• Diversified portfolio; 14 franchises with>CHF 1 bn sales
• Significant opportunities for Avastin based on approved indications
• Growth in emerging markets
19
A position of strength
Operational Excellence – adapting to a changing environment
Continued focus on innovation
20
19.8
22.8 22.024.0 24.6
0
5
10
15
20
25
30
HY 2006 HY 2007 HY 2008 HY 2009 HY 2010
1 before exceptional items
Operating profit1 (CHF bn) and margin
Continuous growth in sales and margin
Group sales (CHF bn)
5.8
7.57.0
8.08.8
35.5%33.2%
0
2
4
6
8
10
12
HY 2006 HY 2007 HY 2008 HY 2009 HY 20100%
5%
10%
15%
20%
25%
30%
35%
40%
45%
CAGR: 11%
21
Roche’s response to new environment: Operational Excellence
Position of strength
• No major patent expiries mid-term
• Strong position in biologics
• High profitability and cashflow
Challenging environment
• Pricing pressure US and Europe
• Increasing regulatory hurdles
Continued focus on innovation
• Up to 14 late-stage assets
• Q4: 10 clinical trials reporting
Operational Excellence
• Focus on investments that will drive innovation
• Protect profitability
Communication on measures before year-end
22
Roche’s response to new environmentOperational excellence initiative
Objectives
• protect our profitability and safeguard financial flexibility
• adapt cost structure while sustaining innovation leadership
• focus our resources towards investments that will drive innovation
Scope and timeline
• Group-wide
• measures decided before end of the year
• implementation in 2011 and 2012
23
0%
25%
50%
75%
100%
9 10 11 12 13 14 15 16 17 19 21 39
EUR USD CHF GBP
Early debt redemption of USD 2.5 bn note due 201233% of Genentech transaction related debt repaid by September 2010
• Exercise of call option on 9 September 2010 to redeem USD 2.5 bn notes originally due 2012
• Repayment of USD 3.0 bn and EUR 1.5 bn floating rate notes in Q1/2010
• Of the CHF 48.2 bn bonds and notes issued to finance the Genentech transaction, cumulative 15.7 bn (33%) will have been repaid as per September 2010 1
• Outlook 2010: USD 0.5 bn ‘Genentech legacy’ note repayment at maturity in July 2010
1) Original net proceeds in CHF
24
A position of strength
Operational Excellence – adapting to a changing environment
Continued focus on innovation
25
Competitors’ strategies to address the trendsTwo distinctly different groups emerging
DiversificationBecoming more “Healthcare” than pure “Pharma”(incl. OTC, vaccines, medical devices, generics, branded generics, bio-similars, eye care, etc.)
FocusPharma / Diagnostics(no generics or bio-similars)
Roche
26
Inflammation+Ophthalmology
11 NMEs
CNS10 NMEs
Virology5 NMEs
Oncology24 NMEs
14% Diagnostics
25% Vitamins
11% Flavours& Fragrances
50%Pharma
Metabolic10 NMEs
Yesterday
1990 2008
TomorrowToday
21%Diagnostics
of which56% Oncology
79% Pharma
CHF 9.7bn CHF 45.6bnSales
Diagnostics
Illustrative
StrategyBroadening the portfolio with high value franchises
27
Our DistinctivenessDiversity of approaches fueling global scale and reach
Autonomous centers
GenentechR&ED
Diversity Scale, Reach, Speed
“Federation” of >150 partners
* DBA: Disease Biology Areas
RocheDBAs* Research
Early Dev.
Worldwideexecution
Roche Dx
Chugai
Late-stage development
Manufacturing
Commercialisation
28
Late-stage pipeline progressing wellExtensive clinical data by year-end
2007 2008 2009 2010E
Number of NMEs
2
4
10Metabolic
Oncology
Inflammation
ocrelizumab
dalcetrapib
pertuzumab
dalcetrapib
taspoglutide
Actemra
ocrelizumab
aleglitazar
CNS
taspoglutide
ocrelizumab
pertuzumab
T-DM1
Hedgehog inh
BRAF inhibitor
RG7159 (CLL)
GlyT-1 inh
up to 14Virology
1 LIP decision made, phase III pending; 2 LIP and phase III decision pending
SABCS
SMR / Intl. Melanoma Congress
ECTRIMS
ACNP
ASH
AASLD
dalcetrapib
taspoglutide
aleglitazar
SGLT2 inh2
GlyT-1 inh
ocrelizumab MS1
lebrikizumab2
HCV pol inh1
pertuzumab
BRAF inhibitor
T-DM1
Hedgehog inh
RG7159(CLL, NHL)
MetMAb1 ESMO
ESMO
Phase II data expected in 2010
Recruitment finalized
Recruitment on track
Phase II in house
Data in 2011
29
Our strategic franchisesFocus on areas with high unmet medical need
CNSHigh unmet medical need - high risk/high reward“The new oncology?”
Virology Focus on hepatitis; existing infrastructure to launch new products.
Metabolism Only dalcetrapib targets primary care; aleglitazar: specialty product. High internal hurdles for phase III decisions.
Oncology Leader in oncology with strong pipeline-Regulatory requirements evolving, raising the bar for new products (including competition)
Inflammation RA biologics: area of high growth – Actemra strongly positioned
30
Diagnostics Continued high growth driven by need for medical value
HPVearly diagnosis
BRAF testpatient selection
dual HER2protein & gene
IVD <2 % total worldwide healthcare spendInfluences >60 % of critical decision making
MRSAscreening
Potential to improve healthcare efficiency
Innovative tests in areas of medical need
Digital Pathologytissue analysis
Patch pump diabetes care
Testing efficiency
Diagnosis
Companion Diagnostics
medical value
31
Personalised Healthcare to deliver medical value Leveraging Pharma & Diagnostics from discovery to commercialisation
• Prospective biomarker analysis
• Correct sample collection and patient consent
• Molecular biology foundation
• Unrestricted knowhow & IP exchange
• Defined label on launch
• Potential companion diagnostic
Research Development Commercialisation
More targeted clinical trials
Improved target selection
Safer, more efficacious medicine
32
0utlook for 2010: on track to achieve the goals
Barring unforeseen events;Total Tamiflu sales of up to CHF 1 bn assumed for 2010; LC=Local Currency* Continuous increase in dividend pay-out ratio over the period 2008-2010
Sales growth (in LC) Group & Pharma (excl. Tamiflu): mid single-digitDiagnostics: significantly above market
Core EPS growth (in LC) Double-digit
Synergies 2010: CHF 800 m2011: CHF 1,000 m
Debt 2010: 33% reduction (revised from 25%)2015: Aim to return to net cash position
3 yr Dividend outlook Maintained (as announced in 2008)*
R&D investment Slightly below 2009 level
33
• We do not sacrifice our long-term future by short-term
cost cutting: innovation remains key !
• We have established an entrepreneurial model for our R&D – setup
• We are preparing for fundamental changes
in the healthcare environment
Roche delivering now – but still investing into the future!
The Roche advantages
34
We Innovate Healthcare