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How to succeed in a changing market
David Loew, Head of Global Product Strategyand Chief Marketing Officer
Innovate
Expand
Protect
Pharma growth rates have declined in last decade
3
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
1990 1995 2000 2005 2010 2015 2020
Source: EvaluatePharma
• Bolus of patent expiries• Price pressures
Pharma market growth rate (prescription drugs)
USA +6%
W. Europe -3%
Japan +1%
International +8%
1 Q2 2012 vs Q2 2011In CER=Constant Exchange Rates
4
Strong growth in International regionTotal sales: CHF 17’409m
4,00023%
1,94311%4,651
27%
6,81539%
2.12.0
2.2 2.22.4
Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012
CHF bn
HY 2012 Pharma: Strong performanceInternational region now larger than Europe
+14%1
Strong position through organic growth
5
261 289
158 16282
96
229
404
2011 2016Pfizer Novartis Merck Sanofi Roche GSK
% Pharma Rx market share, 2011
758 980
US
W. Europe
Japan
Emerging markets
Total
CAGR
+2%
±0%
+3%
+12%
+5%
Market size & growth by region (CHF bn)
8%
7%6%
5%5% 5%
Other +2%
Source: IMS market prognosis, excl. OTC Other represents Australia and CanadaSource: Decision Resources
Upcoming patent expiries in developed markets improve affordability of innovative drugs
6
2006-2010 2010-2015
market growth
$139 bn
market growth
$139 bn
loss of exclu-sivity
-$70 bn
net market growth
$69 bn
loss of exclu-sivity
-$120 bn
net market growth
$19 bn
Source: IMS Institute for Healthcare Informatics, Apr 2011.Established market countries are US, Japan, Germany, France, Italy, Spain, Canada, United Kingdom and South Korea
Phase II (23 NMEs)
Phase III(9 NMEs)
Registration(2 NMEs)
OncologyImmunologyVirology
Perjeta (pertuzumab)* HER2+ mBC 1LErivedge* advanced BCC
mericitabine HCV
rontalizumab SLE
danoprevir HCV
mGluR5 antag TRD
LT alpha MAb RA
P selectin MAb ACS/CVD
M1 prime MAb asthma
11 beta HSD inh metabolic diseases
etrolizumab ulcerative colitis
anti-factor D Fab geograph. atrophy
EGFL7 MAb solid tumors
crenezumab Alzheimer‘s
gantenerumab Alzheimer’sMAO-B inh Alzheimer’s
EGFR MAb solid tumors
mGluR2 antag depression
PI3K/mTOR inh solid & hem tumors
setrobuvir HCV
PI3K inh solid tumors
glypican-3 MAb liver cancerHER3/EGFR m. epithelial tumors
onartuzumab (MetMAb) solid tumors
bitopertin schizophrenia
aleglitazar CV risk reduction in T2D
obinutuzumab (GA101) hem. tumors
T-DM1 HER2+ mBC
ocrelizumab MStofogliflozin (SGLT2) type 2 diabetes
lebrikizumab severe asthma
Innovation is reflected in a strong NME pipeline
7
PCSK9 MAb metabolic diseases
arbaclofen fragile X syndrome (FXS)
oxLDL MAb sec prev CV events
CIF/MEK inh solid tumors
Raf & MEK dual inh solid tumors
PD-L1 MAb solid tumors
MEK inh solid tumors
AKT inhibitor solid tumors
MEK inh solid tumors
CD22 ADC hem malignanciesanti-angiogenic solid tumors
PI3K inh solid tumors
Steap 1ADC prostate ca.
ADC heme tumors
ADC ovarian ca.
CD44 MAb solid tumorsALK inhibitor NSCLCPI3K inh solid tumors
Bcl-2 inh CLL and NHL
ADC oncology
ChK1 inh solid tum & lymphoma
Tweak MAb oncology
ADC multiple myeloma
WT-1 peptide cancer vaccine
MDM2 ant solid & hem tumorsHER3 MAb solid tumorsCSF-1R MAb solid tumors
MDM2 ant solid & hem tumors
ADC oncology
ADC metastatic melanomaPI3k inh glioblastoma 2L ChK1 inh(2) solid tumorsBRAF inh (2) BRAF mut melanoma
BACE inh Alzheimer’s
GABRA5 NAM cogn. disordersGIP/GLP-1 dual ago type 2 diabetes
V1 receptor antag autism
IL-6 MAb RAIL-17 MAb autoimmune diseases
TLR7 agonist HBV- infectious diseases
Phase I(38 NMEs)
CardioMetabolismNeuroscienceOphthalmology
As of June 30 2012; * Approved in US, filed in EU
Roche’s oncology portfolio targets unmet needs
8
Cancer deaths Selected Roche products
Molecule Indication
Zelboraf Melanoma
Erivedge BCC
obinutuzumab Hematology
Perjeta Breast
T-DM1 Breast
MetMAb BreastColorectalLung
% Growth
+41%+37%
+58%
+35%Hematology
+48%
+36%
2008 2030
8 M
12 M
Lung
ColorectalBreast
SkinGastricLiver
Esophageal
Hematology
All Others
Note: Worldwide population is expected to grow by 21% from 2008 to 2030; Source: World Health Organization
+49%
9
Redefining HER2 franchise: Perjeta and T-DM1
Herceptin+ chemotherapy
Efficacy
Tole
rabi
lity
Herceptin& Perjeta+ chemotherapy
T-DM1& Perjeta
T-DM1
EMILIA2L mBC
CLEOPATRA1L mBC
MARIANNE, 1L mBCT-DM1&Perjeta,
adjuvant BC
Improve the standard of careMultiple shots on goal in hematological cancers
10MabThera IV/SC and GA101 (per their respective current/planned product profiles) are mostly used in combination with chemotherapy and, in some indications, as maintenance therapy following combined R-Chemo/GA101-Chemo induction
Established standard of care Potential new standard of care Potential future standard of care
2010 2016
MabThera GA101
2012 2013 2014 20152011
Refractoryindolent NHL MabThera GA101MabThera
Subcutaneous
Aggressive NHL
2017 2018 2019 2020
CLL
MabThera GA101MabTheraSubcutaneous
1LIndolent NHL MabThera GA101MabThera Subcutaneous
Additional products in development: anti-CD22 and Bcl-2
Filing timelines
MabThera subcutaneous versus infusion
11
MabThera IV administration can take all day
MabThera SCadministration
Pharmacy preparation
IVline Rituximab IV administration + observation periodWaiting
room
Waiting room
Prep
MabThera SC injection takes 5–7 minutes
No pharmacy dose preparation, no IV line, no mandatory observation periodPh III SABRINA to be presented at ASH 2012
Time saving SC vs IV administration
Innovative approaches to improve market access
12
Established marketsEnvironment increasingly complex
Payers more active/influential
Emerging marketsBuild-up of healthcare systems,
but applying stricter cost regulations already
Enabling access through innovative pricing models
13
Pack based pricing Patient based pricing
Combinations(ex-US)
Indication based
Need for patient based information
Undifferentiated $$ by vial
$+$≠ $$
Avastin: Examples of successful capping programs
14
Potential pay back by Roche Costs covered by payers
Indications likely to reach10/11g per year limit• Breast cancer• Ovarian cancer
StatusGermany: over 40% insured patients covered by capping programItaly: ~30 000 patients tracked since 2009
Germany
Italy
Exceedance of 10 g limitPay back
Treatment with AvastinYear 1
Exceedance of 11 g limitPay back
Treatment with Avastin
6 weeks50% cost sharing
Innovation remains rewarded: Example of Perjeta
15
Herceptin IV totaltreatment cost
Perjeta total treatmentcost
Cap for combination Total cost including capon combination
Illustrative pricing for metastatic breast cancer, ex-US
Innovate
Expand
Protect
Roche growth in E7 countries is largely exceeding the market
17Source: Roche growth reflects in-market sales; Russia by Pharmexpert; India Roche in-market sales from internal data; All others IMS. Roche sales exclude Tamiflu & effect of divestments in Mexico & Turkey.Turkey 1Q 2012 in-market growth: Roche 15%, market -8%.
Current market rank
2011 growth
Roche Market
Brazil 2 10% 5%
China 3 34% 16%
Russia 3 11% 3%
Mexico 5 3% 5 %
Turkey 11 -1% 3%
S. Korea 16 17% 6%
India 28 17% 12%
Increasing polarisation in emerging marketsGrowth in patented medicines and unbranded generics
18
Example: Brazil market showing evidence of polarisation
Share expectedto grow further
Source: IMS
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2000 2005 2010
Non-categorised
Protected originals
Unbranded copies
Branded copies
Non-patented originals
Growing segments in Emerging markets
19
2000 2005 2010
Objective: Maintain high share in private segment – expand to public segment
Roche to maintain high share
Out of pocket
Private insurance
Public payers
Growing segment:We are testing various
models to increase access to medicinesSh
are
of fi
nanc
ing
by p
ayer
type
Illustrative for emerging markets
1,234
1,882
∼ 2,800
2010 2011 2012(proj)
+∼50%
+53%
MabThera in Brazilian public market
20
Trea
ted
patie
nts
Untapped pool of potential Herceptin patients
21
0
5'000
10'000
15'000
20'000
25'000
30'000
35'000
40'000
45'000
China Brazil Russia India Mexico Turkey S. Korea
Untreated patients
Treated by Roche
Source: Ideal questionnaires 2010; Herceptin patient pool defined as all Her2+ patients: tested & untested
22
Workshop C
Innovate
Expand
Protect
Biosimilar regulationsHow advanced were regulators before 2010?
24
Biosimilarpathways(excl. Mab)
Biosimilarpathways under development
Law in place
Biosimilar regulationsWhere are we today?
25
Biosimilarpathways
Biosimilarpathways under development
Law in place
Roche supports biosimilar regulatory pathways “Reditux“ example
26Columbia, Guatemala, Iraq, Panama, Morocco, Russia and S. Africa
Reditux registration rejected or delayed, additional data on clinical trial results requested
Roche growth strategy
27
Innovate Redefine the standard of care
Expand Improve patient access
Protect Ensure high standards for patients