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Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer
London, September 2015
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; and 11 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 2
Performance update
Improving the standard of care
Outlook
3
Q2 2015: Sales growth for fifth consecutive year
4 All growth rates at Constant Exchange Rates (CER)
0% 0% 1%
4%
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5%
6%
5%
7%
0%
2%
4%
6%
8%
10%
Q111
Q211
Q311
Q411
Q112
Q212
Q312
Q412
Q113
Q213
Q313
Q413
Q114
Q214
Q314
Q414
Q115
Q215
HY 2015: Strong underlying Group core operating profit & margin
5
% of sales
CHFbn
CER=Constant Exchange Rates * Excluding sale of filgrastim rights in 2014 at CER
8.3 8.6 9.5 9.4 9.2
38.1% 38.5%
40.7% 41.0%
39.2%
HY 2011 HY 2012 HY 2013 HY 2014 HY 2015
+2% at CER (+7%*)
(+0.4%p excl. filgrastim*)
2014: Dividend and payout ratio further increased
6 1 compound annual growth rate
8.00
31.9 34.5
38.8
44.8 48.6
51.6
55.3
54.5
54.7 56.0
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
Dividend payout ratio (%) CHF
2014 payout ratio: 56.0%
Payout ratio calculated as dividend per share divided by core earnings per share (diluted); Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996
Performance update
Improving the standard of care
Outlook
7
Roche strategy: Focused on medically differentiated therapies
8
Generics
Differentiation
MedTech
OTC Prem
ium
for
inno
vatio
n
Dia Pharma
Focus
Regulators: Optimised benefit / risk ratio
Payors: Optimised benefit / cost ratio
Roche’s approach in specialty care: First and best in class necessary for success
Market share*
Years post launch
Undifferentiated products Modest differentiation Medical breakthroughs
Data source: Evaluate Pharma, Decision Resources, Roche/Genentech PMR launch trackers
Note: *Market shares represent either % sales of target product relative to sales competing products in similar indications or patient shares from Roche PMR trackers; sales data are actuals (≤ 2013) + consensus broker forecasts (2013-2020) where applicable 9
Roche: Making progress in advancing patient care Recognising innovation 2013-15
10
Rank Company #
1 Roche 9
2 GSK 5
2 Novartis 5
3 Merck 4
3 JNJ 4
3 BMS 4
9 Breakthrough Therapy Designations
YTD 2015
Actemra (Systemic sclerosis) Venetoclax (R/R CLL 17p) Atezolizumab (NSCLC) ACE 910 (Hemophilia)
2014 Esbriet (IPF)
Lucentis (DR) Atezolizumab (bladder)
2013 Alectinib (2L ALK+ NSCLC)
Gazyva (1L CLL)
Source: http://www.focr.org/breakthrough-therapies; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy
Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component
11
Marketed Phase 2 Phase 3/Registration
FIXa/FX bispecific MAb
SERD
CSF-1R MAb
Ang2-VEGF MAb
ipatasertib
polatuzumab vedotin
lifastuzumab vedotin
glypican-3 MAb
MAO-B inh
GABRA5 NAM
bitopertin
basimglurant
V1 receptor antag
crenezumab
olesoxime
danoprevir
Flu A MAb
LptD antibiotic
PD-L1 MAb
venetoclax (Bcl-2 inh)
alectinib (ALK inh)
taselisib
cobimetinib
lebrikizumab
etrolizumab
gantenerumab
ocrelizumab
lampalizumab
Tarceva®
Zelboraf®
Erivedge®
Rituxan®
Gazyva®
Herceptin®
Perjeta®
Kadcyla®
Avastin®
Xeloda®
Esbriet®
Pulmozyme®
Xolair®
Actemra®
Lucentis®
Oncology Immunology Infectious Diseases Neuroscience Ophthalmology
Molecular Diagnostics
Tissue Diagnostics
Professional Diagnostics
Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component
12
Marketed Phase 2 Phase 3/Registration
FIXa/FX bispecific MAb
SERD
CSF-1R MAb
Ang2-VEGF MAb
ipatasertib
polatuzumab vedotin
lifastuzumab vedotin
glypican-3 MAb
MAO-B inh
GABRA5 NAM
bitopertin
basimglurant
V1 receptor antag
crenezumab
olesoxime
danoprevir
Flu A MAb
LptD antibiotic
PD-L1 MAb
venetoclax (Bcl-2 inh)
alectinib (ALK inh)
taselisib
cobimetinib
lebrikizumab
etrolizumab
gantenerumab
ocrelizumab
lampalizumab
Tarceva®
Zelboraf®
Erivedge®
Rituxan®
Gazyva®
Herceptin®
Perjeta®
Kadcyla®
Avastin®
Xeloda®
Esbriet®
Pulmozyme®
Xolair®
Actemra®
Lucentis®
Oncology Immunology Infectious Diseases Neuroscience Ophthalmology
Molecular Diagnostics
Tissue Diagnostics
Professional Diagnostics
POPLAR: Atezolizumab increased OS by 7.7 mo in IC2/3 or TC2/3 subgroup
13 aUnstratified HR. Data cut-off May 8, 2015.
TC3 or IC3 (n = 47) HRa = 0.49 (0.22, 1.07)
P value = 0.068
TC2/3 or IC2/3 (n = 105) HRa = 0.54 (0.33, 0.89)
P value = 0.014
TC1/2/3 or IC3 (n = 195) HRa = 0.59 (0.40, 0.85)
P value = 0.005 HRa = 1.04 (0.62, 1.75)
P value = 0.871
TC0 and IC0 (n = 92)
Median 15.5 mo (9.8, NE)
Median 11.1 mo (6.7, 14.4)
Median 7.4 mo (6.0, 12.5)
Median 9.7 mo (6.7, 12.0)
Median 9.7 mo (8.6, 12.0)
Median 15.5 mo (11.0, NE)
Median 9.2 mo (7.3, 12.8)
Atezolizumab Docetaxel Censored +
Median 15.1 mo (8.4, NE)
Atezolizumab and chemo-combos Deep and ongoing effects
14 Includes all patients dosed by 10 Nov 2014; data cut-off: 10 Feb 2015; SLD, sum of longest diameters; *PD for reasons other than new lesions
Arm C – cb/pac (n=8) Arm D – cb/pem (n=17) Arm E – cb/nab (n=16)
Max
imum
SLD
redu
ctio
n fr
om
base
line
(%)
100
50
0
–50
–100
–16 –22 –23 –25
–43 –45
–64
–84
Complete response Partial response Progressive disease Stable disease
0 42 84 126 168
Time on study (days)
210 252 294 336 378 420 450
–100
–80
–60
–40
–20
0
20
40
60
80
100 PD (n=2) PR/CR (n=9) SD (n=4) Progression* Discontinued New lesion
Chan
ge in
SLD
from
bas
elin
e (%
)
Max
imum
SLD
redu
ctio
n fr
om
base
line
(%)
100
50
0
–50
–100
9 –7 –12
–31 –31 –38 –41 –42 –47 –50 –53 –57 –57 –57 –58 –69
Max
imum
SLD
redu
ctio
n fr
om
base
line
(%)
100
50
0
–50
–100
11 9 –17
–21 –21 –22 –43
–67 –72 –72 –76
–86 –87 –100 –100
0 42 84 126 168
Time on study (days)
210 252 294 336 378 420 450
–100
–80
–60
–40
–20
0
20
40
60
80
100
Chan
ge in
SLD
from
bas
elin
e (%
)
PD (n=2) PR/CR (n=13) SD (n=1) Progression* Discontinued New lesion
Chan
ge in
SLD
from
bas
elin
e (%
)
0 42 84 126 168
Time on study (days)
210 252 294 336 378 420 450
–100
–80
–60
–40
–20
0
20
40
60
80
100 PR/CR (n=4) SD (n=4) Progression* Discontinued New lesion
Complete response Partial response Progressive disease Stable disease
Complete response Partial response Progressive disease Stable disease
The 7 steps of the Cancer-Immunity Cycle guide our prioritization framework for Atezolizumab
Step 1: Release of Cancer Cell antigens: - ex: Atezo + chemo, Gazyva, aCD40
Step 2 & 3: Cancer antigen presentation & priming and activation - ex: Atezo + interferon, OX40
Steps 4 & 5: Trafficking & inflitration of T cells to tumours - ex: Atezo + Avastin, aCSF1R,
Steps 6 & 7: Recognition of cancer cells by T cells & killing of cancer cells - ex: Atezo + Meki, IDOi, aOX40
Chen and Mellman. Immunity 2013 15
Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component
16
Marketed Phase 2 Phase 3/Registration
FIXa/FX bispecific MAb
SERD
CSF-1R MAb
Ang2-VEGF MAb
ipatasertib
polatuzumab vedotin
lifastuzumab vedotin
glypican-3 MAb
MAO-B inh
GABRA5 NAM
bitopertin
basimglurant
V1 receptor antag
crenezumab
olesoxime
danoprevir
Flu A MAb
LptD antibiotic
PD-L1 MAb
venetoclax (Bcl-2 inh)
alectinib (ALK inh)
taselisib
cobimetinib
lebrikizumab
etrolizumab
gantenerumab
ocrelizumab
lampalizumab
Tarceva®
Zelboraf®
Erivedge®
Rituxan®
Gazyva®
Herceptin®
Perjeta®
Kadcyla®
Avastin®
Xeloda®
Esbriet®
Pulmozyme®
Xolair®
Actemra®
Lucentis®
Oncology Immunology Infectious Diseases Neuroscience Ophthalmology
Molecular Diagnostics
Tissue Diagnostics
Professional Diagnostics
17
Secondary Progressive (SPMS) (20-25%) Initial RRMS followed by disability accumulation. Still experience relapses which eventually stop
Primary Progressive (PPMS) (10-15%) Slow but nearly continuous worsening of disease from outset (no relapses)
Relapse-Remitting (RRMS) (60-65%) Clearly defined relapses (attacks) with remissions initially returning to baseline but gradually result in sustained disability
Three major types of Multiple Sclerosis
Dis
abili
ty
Time
Relapse No Relapse
Mainly degenerative
Mainly inflammatory
Adapted from Lublin 1996, Arnold 2004
Inflammatory / Degenerative
• High unmet need: • high efficacy therapies have major
safety issues • diagnosis and classification is
difficult, often retrospective and can take 2-5 years
• Treatment decisions concentrated mainly in MS centers/hospitals
• Advocacy groups powerful in access
Ocrelizumab: Positive phase 3 results confirm central role of B cells in MS
18
Study Endpoint Reduction versus Rebif®
Primary Annualized Relapse Rate
Secondary
Confirmed Disability Progression
MRI endpoints
ü ü ü
Phase 3 OPERA I/II results in RMS • Superiority vs. Rebif® on primary and
major secondary endpoints achieved • Adverse events (including serious
infections) similar to Rebif®
Targeted product profile • Humanized antibody targeting CD20+ B cells • Selective depletion of a subset of B cells leaving
the ability to generate new B cells intact • Administered by IV twice yearly
SOC=standard of care; MS=multiple sclerosis; RMS=relapsing forms of MS; PPMS= primary progressive MS; Rebif® (Interferon beta-1a)
Antibody-dependent cellular cytotoxicity (ADCC)
Complement dependent cytotoxicity
(CDC)
Apoptosis
Antibody-dependent cellular phagocytosis (ADCP)
OCRELIZUMAB
Phase 3 ORATORIO in PPMS • First investigational medicines to show
efficary in PPMS
Multiple major pivotal trials reading out near term Significant filing and launch activities ahead
19
Year Molecule Market opportunity
Incremental infrastructure
Market characteristics
2015
Alectinib Medium Low Speciality
Cotellic/ Braf Small Low Speciality
Venetoclax Potentially large Low Speciality
Ocrelizumab Large Medium- high Speciality
Atezolizumab Large Medium Speciality
2016
Lebrikizumab Large Medium-high Specialty
APHINITY Large Low Specialty
GOYA Large Low Specialty
2017
ACE 910 Large Medium Speciality
Lampalizumab Large Medium Speciality
GALLIUM Large Low Specialty
2018
Taselisib (PI3Ki) Large Low Speciality
Idasanutlin (MDM2) Medium Low Speciality
Oncology Neuroscience Ophthalmology Immunology
Small: up to CHF 0.5 bn; medium= CHF 0.5 to CHF 1bn; large > CHF1bn
Performance update
Improving the standard of care
Outlook
20
Planned key data presentations in H2 2015
21
Vienna, 25-29 Sep
Atezolizumab • UBC: IMvigor 210 Ph II1
• NSCLC: POPLAR Ph II1,2
• NSCLC: BIRCH Ph II1 • NSCLC: Chemo combos
update2
Alectinib • ALK+NSCLC: Ph II update2
San Antonio, 8-12 Dec
Atezolizumab • TNBC: Combo with
abraxane Ph Ib (abstracts submitted)
San Francisco, 18-21 Nov
Atezolizumab • Melanoma: Combo with
Zelboraf Ph Ib (abstracts submitted)
Cobimetinib + Zelboraf • BRAF+Melanoma:
coBRIM efficacy update (abstracts submitted)
Barcelona, 7-10 Oct
Ocrelizumab • RMS: OPERA I / II Ph III • PPMS: ORATORIO Ph III
1 “Data not yet in-house; planned to be submitted to an up-coming congress”; 2 Potentially at World Conference on Lung Cancer (WCLC) 2015 UBC=Urinary Bladder Cancer; NSCLC=Non-Small Cell Lung Cancer; RMS=Relapsing forms of Multiple Sclerosis; TNBC=Triple Negative Breast Cancer
2015 outlook
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth2
Dividend outlook Further increase dividend in Swiss francs
1 At constant exchange rates 2 Excluding sale of filgrastim rights in 2014
22
Doing now what patients need next