Turning innovation into patient benefit
Transcript of Turning innovation into patient benefit
Turning innovation into patient benefit
Severin Schwan, CEO Roche Group London, September 2016
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 3
Performance update
Innovation and differentiation
Improving the standard of care
Outlook
4
Q2 2016: Sales growth for fifth consecutive year
5
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5% 6%
5%
7%
6%
4% 4%
6%
0%
2%
4%
6%
8%
10%
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
Q4
15
Q1
16
Q2
16
All growth rates at Constant Exchange Rates (CER)
38.5%
40.7% 41.0%39.2% 39.4%
8.69.5 9.4 9.2
9.9
HY 2012 HY 2013 HY 2014 HY 2015 HY 2016
+5% at CER
HY 2016: Strong core operating profit & margin
6
% of sales
CHFbn
CER=Constant Exchange Rates
Continued leadership in innovation
Launches at historical high
2011 2012 2013 2014 2015 2016
OCREVUS
5 NME launches in a year
7
Performance update
Innovation and differentiation
Improving the standard of care
Outlook
8
Roche strategy: Focused on medically
differentiated therapies
9
Generics
Differentiation
MedTech
OTC
Pre
miu
m f
or
inn
ova
tio
n
Dia Pharma
Focus
Regulators: Optimised benefit / risk ratio
Payors: Optimised benefit / cost ratio
Approach towards innovation
Rigorous prioritisation…
We select at late stage entry…
Clinical differentiation
Threshold
high low
low
high
Me
dic
al n
ee
d
Illustrative
…to increase sales potential
10
Greater
differentiation Sa
les
Time
Continued Disqualified
Approach towards innovation
… and exploring broad
We invest more early stage… …to increase options to choose from
46% 40%
54% 60% R & Early D
Roche
Late D
Industry avg
11
18 19
2014 2012 2013
# of NMEs entering Pre-clinical
Industry
avg.
% of budget
External sources: Investment split based on the CMR Pharmaceutical R&D Factbook (data from 10 companies, 2014);
Number of entries into Pre-clinical for Industry based on data from KMR, data for 2011-2013. 11
12
Cancer immunotherapy - Pillars of early R&D
Preserving cultures – increasing collaboration
12
aOX40
aTIGIT
aCD20/CD3 TCB 1
IDOi
aCD40
emactuzumab
aCEA/CD3 TCB
vanucizumab
aCEA-IL2v FP
aFAP-IL2v FP
aCD20/CD3 TCB 2
Performance update
Innovation and differentiation
Improving the standard of care
Outlook
13
Cotellic + Zelboraf
BRAFmut melanoma
Venclexta
R/R CLL with 17p del
OCREVUS
RMS/ PPMS
Emicizumab (ACE910)
Hemophilia A
Tecentriq
2L+ bladder cancer
Alecensa
2L ALK+ NSCLC
Perjeta + Herceptin
eBC HER2+ (APHINITY)
Tecentriq+Avastin+chemo
1L NSCLC
Gazyva
R/R iNHL (GADOLIN)
Lampalizumab
Geographic atrophy
Tecentriq + Avastin
1L RCC
NM
Es
line
ext
ensi
ons
2016 2017 2018
Actemra
Giant cell arteritis (GiACTA)
Alecensa
1L ALK+ NSCLC
Tecentriq
2/3L lung cancer
Gazyva
1L iNHL (GALLIUM)
2016 onwards: Significant launch activities
Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed.
FDA Breakthrough
Therapy Designation
Oncology/
hematology Neuroscience Ophthalmology Immunology
14
Cotellic + Zelboraf
BRAFmut melanoma
Venclexta
R/R CLL with 17p del
OCREVUS
RMS/ PPMS
Emicizumab (ACE910)
Hemophilia A
Tecentriq
2L+ bladder cancer
Alecensa
2L ALK+ NSCLC
Perjeta + Herceptin
eBC HER2+ (APHINITY)
Tecentriq+Avastin+chemo
1L NSCLC
Gazyva
R/R iNHL (GADOLIN)
Lampalizumab
Geographic atrophy
Tecentriq + Avastin
1L RCC
2016 2017 2018
Actemra
Giant cell arteritis (GiACTA)
Alecensa
1L ALK+ NSCLC
Tecentriq
2/3L lung cancer
Gazyva
1L iNHL (GALLIUM)
2016 onwards: Significant launch activities
Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. 15
FDA Breakthrough
Therapy Designation
Oncology/
hematology Neuroscience Ophthalmology Immunology
NM
Es
line
ext
ensi
ons
Tecentriq clinical program in 2/3L NSCLC
Breakthrough designation in PD-L1+ patients
16
Response Rates
All comers 2/3L mNSCLC n=1100
PD-L1 stratified
Tecentriq 1200 mg IV Q3
weeks
Docetaxel 75 mg/m2 IV Q3
weeks
OAK Phase III
Overall Survival
PD-L1-selected
mNSCLC n=138
Tecentriq
1200 mg IV Q3 weeks
POPLAR Phase II
Overall Survival All comers
2/3L mNSCLC n=287
PD-L1 stratified
atezolizumab
1200 mg IV Q3 weeks
Docetaxel 75 mg/m2 IV Q3
weeks
BIRCH Phase II PD-L1-selected
mNSCLC n=667 Tecentriq
1200 mg IV Q3 weeks Response Rates
Note: Atezolizumab (Anti-PD-L1) is listed as MPDL3280A in clinicaltrials.gov
mNSCLC = metastatic Non Small-Cell Lung Cancer
Primary end-point:
FIR Phase II
Tecentriq 1200 mg IV Q3
weeks
Significant variability in response to cancer
immunotherapy treatment
17
MONOTHERAPY
DURABLE RESPONSES (PR/CR)
STABLE DISEASE (SD)
PROGRESSIVE DISEASE (PD)
* Urinary Bladder Cancer Phase 1, PR= partial responses, CR= Complete Responses
Tecentriq UBC: IC2/3
0 4 6 8 10 14 18 16 12 2
100
0
-100
Change in S
LD
Fro
m B
ase
line, %
The seven steps of the Cancer-Immunity Cycle
guide our prioritisation framework for Tecentriq
Chen and Mellman. Immunity 2013 18
Different tumours show different immune
phenotypes and will need different solutions
19
CD8+ T cells absent
from tumour and periphery
CD8+ T cells accumulated but not
efficiently infiltrated
CD8+ T cells infiltrated,
but non-functional
Increase number of
antigen-specific T-cells or increase
antigen presentation
Bring T-cells in contact
with cancer cells
Accelerate or remove brakes on
T-cell response
Inflamed Immune Desert Immune Excluded
Lung Bladder TNBC Colorectal Gastric Ovarian Melanoma
A rich pipeline: We are investigating into multifold
approaches across tumour phenotypes
* Dual roles in T eff activation and T reg inhibition suggest OX40 activity in both desert and inflamed phenotypes;
IND=new investigational drug application; TBA=to be announced
MEKi (e.g., Cotellic)
Chemo
Targeted (e.g., Tarceva, Herceptin)
aVEGF (Avastin)
aPDL1 (Tecentriq)
IDOi
aCSF1R
aTIGIT
Ph1b
Marketed
Marketed Ph2
Ph1b
Ph1b
Marketed
Marketed
Marketed
aOX40*
aCEA-IL2v FP
aCEA/CD3 TCB
Ph1b
Ph1b
aCD20/CD3 TCB 1
aCD20/CD3 TCB 2
TBA IND (2017)
TBA IND (2017)
TBA
TBA
Ph1b aCD40
Ph1b aFAP-IL2v FP
IND (2017)
IND (2017)
Ph1b
aAng2/VEGF Ph2
Ph1b
aOX40* Ph1b
20
DESERT
Activate
EXCLUDED
Recruit / Infiltrate
INFLAMED
Kill Cancer Cells
Cancer immunotherapy: In the near future,
nine NMEs will be reading out*
NME=new molecular entity; *Timing based LPI or estimates from FPI and are subject to change; “data” indicates full data availability (vs interim readout)
NME / Combo
vanucizumab
aCEA/CD3 TCB
aCSF1R + Tecentriq
aCD40 + Tecentriq
aOX40
aFAP-IL2 FP
aCEA/CD3 TCB
aOX40 + Tecentriq
vanucizumab + Tecentriq
aCEA-IL2v FP + Tecentriq
aCEA/CD3 TCB + Tecentriq
IDOi + Tecentriq
aTIGIT + Tecentriq
aCD40 + aCSF1R
aCD20/CD3 TCB 1
aCD40 + vanucizumab
2016 2017
Combinations: Roche with broadest portfolio of
targeted and CIT agents
ALK
Akt
Bcl-2
BCR-ABLi
BET
BRAF
CD20
CD79b
Chk1
EGFR 1 1
ERK
HER2
LSD1
MDM2
MEK
PI3K
SERD
SLAMF7
VEGF
VEGF/Ang2
Launched In development (Ph 1-3)
Ta
rge
ted
Ag
en
ts
aCD40
aCEA-CD3
aCD20-CD3
aCEA-IL2v FP
aFAP-IL2v FP
aIL-8
aIL-10
aCTLA-4
aOX40
aCD137
aGITR
aCD73
aCEACAM1
aCXCR4
aPD-1
aPD-L1
CSF-1R
IDOi/TDOi
aTIGIT
aLAG-3
aKIR
CIT
Mo
lec
ule
s
NN NN NN NN
22
23
emactuzumab
cergutuzumab
amunaleukin
aOX40
aCD40
IDOi
aCEA/CD3 TCB
aFAP-IL2v FP
Immunotherapy portfolio
vanucizumab
aCD20/CD3 TCB
aTIGIT
chemo chemo
taselisib
SERD
ipatasertib
chemo
Launched portfolio
azacitidine
polatuzumab
vediotin daratumumab
lenalidomide
idasanutlin
emactuzumab (aCSF-1R); cergutuzumab amunaleukin (aCEA-IL2v FP); vanucizumab (aAng2/VEGF); polatuzumab vediotin (aCD79b ADC); taselisib (PI3Ki); ipatasertib (AKTi); SERD (selective estrogen receptor degrader); idasanutlin (MDM2
antagonist); Venclexta in collaboration with AbbVie; Gazyva in collaboration with Biogen; Alecensa in collaboration with Chugai; Cotellic in collaboration with Exelixis; Zelboraf in collaboration with Plexxikon; polatuzumab in collaboration with Seattle
Genetics; ipatasertib in collaboration with Array Biopharma; IDOi in collaboration with NewLink; daratumumab in collaboration with Janssen (J&J)
Status: June 2016
Maximising value: Novel assets and combinations
Combination in development
Combination approved
Roche NME late stage
Roche NME early stage
Non-Roche apporved drugs
Chemo combination approved
Chemo combination in development
Cotellic + Zelboraf
BRAFmut melanoma
Venclexta
R/R CLL with 17p del
OCREVUS
RMS/ PPMS
Emicizumab (ACE910)
Hemophilia A
Tecentriq
2L+ bladder cancer
Alecensa
2L ALK+ NSCLC
Perjeta + Herceptin
eBC HER2+ (APHINITY)
Tecentriq+Avastin+chemo
1L NSCLC
Gazyva
R/R iNHL (GADOLIN)
Lampalizumab
Geographic atrophy
Tecentriq + Avastin
1L RCC
2016 2017 2018
Actemra
Giant cell arteritis (GiACTA)
Alecensa
1L ALK+ NSCLC
Tecentriq
2/3L lung cancer
Gazyva
1L iNHL (GALLIUM)
2016 onwards: Significant launch activities
Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. 24
FDA Breakthrough
Therapy Designation
Oncology/
hematology Neuroscience Ophthalmology Immunology
NM
Es
line
ext
ensi
ons
Ocrelizumab: Active in both RMS & PPMS
25
RMS=relapsing forms of multiple sclerosis (MS) which includes patients with RRMS and SPMS with superimposed relapses; RRMS=relapsing-remitting MS; SPMS=secondary progressive MS; PPMS=primary progressive MS;
RM
S
PP
MS
• Selective depletion of a B cell subset leaving
the ability to generate new B cells intact
• Administered IV twice yearly
Performance update
Innovation and differentiation
Improving the standard of care
Outlook
26
Positive outlook
Strong pipeline enabling continuous growth
2014 2015E 2016E 2017E 2018E 2019E 2020E 2021E 2022E 2023E
Marketed
products
Sales
Pipeline
Biosimilars
MabThera, Herceptin, Avastin
NME launches
Tecentriq, Venetoclax, Alectinib, Cotellic, Ocrelizumab,
ACE910, Lampalizumab
27
2016 outlook
28
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth
Dividend outlook Further increase dividend in Swiss francs
1 At Constant Exchange Rates (CER)
Doing now what patients need next
Appendix
30
Biomarker analysis of Tecentriq yielding insights
about phenotypes and combination framework…
31 Modified from Hegde PS et al. (2016) Clin Canc Res
Inflamed Non-Inflamed
Convert to inflamed phenotype with combinations Respond favorably to
checkpoint inhibition
Mutational Load
TILs
CD8 T cells/IFNg
PD-L1 & checkpoints
Angiogenesis Reactive stroma
MDSCs
Proliferating Tumors / Low Class I
IMMUNE DESERT
CD8+ T cells
are absent
from tumor and
its periphery
IMMUNE EXCLUDED
CD8+ T cells
accumulated but
have not efficiently
infiltrated
INFLAMED
CD8+ T cells
infiltrated,
but non-
functional
A rich pipeline: Program by tumor type
As of July 21, 2016
= approved; *External collaborations; Other CIT NMEs besides Tecentriq 32
Breakthrough designation impacting cycle times
Shortest interval duration of all FDA designations
1.0
1.0
0.9
1.1
2.3
1.9
1.7
1.5
3.3
2.3
0.7
0.5
0.7
0.5
0.6
1.0
Accelerated review
Fast track
No designation 7.5
Breakthrough therapy 3.6
5.8
3.8
Source: Thomson Reuters Cortellis Competitive Intelligence for all a FDA approvals where milestone information is available 2012-2015.
Phase 3 cycle time is defined from phase 3 FPI to submission; which may for the two latter designations happen before phase 3 finishes.
Phase 2 Phase 1 Phase 3 Filing
Phase duration (years)
33