Roche
Q1 2016 sales
3
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
4
Group
Severin Schwan
Q1 2016: Good start to the year
5
Growth
Sales
Innovation
Diagnostics
Oncology
Neuroscience
1
At constant exchange rates (CER); NEDA=no evidence of disease activity; MRI=magnetic resonance imaging;
IND: Investigational New Drug Application
•
Group sales +4%
1
driven by HER2 franchise (+9%), Immunology franchise
(+16%), Avastin (+4%), and Professional Diagnostics (+7%)
•
Good growth
1
in all regions: US (+3%), Europe (+3%), Japan (+3%) and
International (+7%)
•
Atezolizumab: Acceptance of filing for advanced bladder and lung cancer in
the US
•
Successful US launches of Alecensa and Cotellic
•
US approval of Gazyva in R/R NHL (GADOLIN)
•
US approval of Venclexta (venetoclax) in R/R CLL 17p deletion
•
Ocrevus (ocrelizumab):
– Updated NEDA and MRI data at AAN (
April, 15
th
– 21
st
)
Q1 2016: Solid sales growth continues
6
CER=Constant Exchange Rates
2016
2015
CHFbn
CHFbn
CHF
CER
Pharmaceuticals Division
9.8
9.3
5
4
Diagnostics Division
2.6
2.5
4
5
Roche Group
12.4
11.8
5
4
Change in %
Q1 2016: Sales growth for fifth consecutive year
7
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5%
6%
5%
7%
6%
4%
4%
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
Q1 2016: Solid sales growth in all regions
8
0
1
2
3
4
5
6
Japan
International
Europe
US
Diagnostics
Pharma
CHFbn
+3%
+5%
+4%
+4%
-1%
+16%
-3%
0%
+3%
+3%
+3%
+7%
Roche significantly advancing patient care
Recognition for innovation 2013-present
9
Rank
Company
#
1
Roche
12
2
BMS
8
3
Novartis
7
3
Merck
6
3
Pfizer
6
4
GSK
5
12
Breakthrough Therapy
Designations
Year
Molecule
2016
Ocrelizumab
(PPMS)
Venclexta
(AML)
Venclexta
+
Rituxan
(R/R CLL)
2015
Actemra
(Systemic sclerosis)
Atezolizumab
(NSCLC)
Venclexta
(R/R CLL 17p del)
Emicizumab
/ACE 910 (Hemophilia A)
2014
Esbriet
(IPF)
Lucentis
(DR)
Atezolizumab
(Bladder)
2013
Alectinib
(2L ALK+ NSCLC)
Gazyva
(1L CLL)
Source:
http://www.focr.org/breakthrough-therapies
as at 22 March 2016; PPMS=Primary Progressive Multiple Sclerosis; CLL=Chronic
Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy
Significant launch activities ahead
10
Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed.
Oncology/
hematology
Neuroscience
Ophthalmology
Immunology
FDA Breakthrough
Therapy Designation
Cotellic + Zelboraf
BRAFmut melanoma
Venclexta
R/R CLL with 17p del
Ocrelizumab
RMS/ PPMS
Lebrikizumab
Severe Asthma
Emicizumab (ACE910)
Hemophilia A
Atezolizumab
2L+ lung and bladder cancer
Alecensa
2L ALK+ NSCLC
Perjeta + Herceptin
eBC HER2+ (APHINITY)
Atezolizumab+Avastin+chemo
1L NSCLC
Gazyva
1L aNHL (GOYA)
Gazyva
1L iNHL (GALLIUM)
Gazyva
Refractory iNHL (GADOLIN
)
Lampalizumab
Geographic atrophy
Atezolizumab + Avastin
1L RCC
2016
2017
2018
Actemra
Giant cell arteritis
Alecensa
1L ALK+ NSCLC
Pharma
2016 outlook
11
Group sales growth
1
Low to mid-single digit
Core EPS growth
1
Ahead of sales growth
Dividend outlook
Further increase dividend in Swiss francs
12
Pharmaceuticals Division
Daniel O’Day
Q1 2016 sales
Innovation
Outlook
Q1 2016: Pharma sales
Good growth driven by all regions
14
CER=Constant Exchange Rates
2016
2015
CHFm
CHFm
CHF
CER
Pharmaceuticals Division
9,800
9,322
5
4
United States
4,716
4,392
7
3
Europe
2,319
2,178
6
5
Japan
853
763
12
4
International
1,912
1,989
-4
4
Change in %
Q1 2016: Oncology and immunology driving
growth
15
15
Absolute values and growth rates at Constant Exchange Rates (CER)
-120
-60
0
60
120
Pegasys
Lucentis
Tarceva
Tamiflu
Activase/TNKase
Actemra/RoActemra
MabThera/Rituxan
Xolair
Avastin
Herceptin
Esbriet
Perjeta
US
Europe
Japan
International
+33%
+96%
+4%
+4%
+22%
+14%
+3%
-50%
-13%
+21%
CHFm
-14%
-6%
0
1
2
3
Alecensa
Zelboraf +
Cotellic
Xeloda
Tarceva
CD20
Avastin
HER2
Kadcyla
Perjeta
Herceptin
+9%
+4%
-14%
-17%
+18%
MabThera/Rituxan
(Oncology)
Gazyva/Gazyvaro
+3%
Cotellic
+161%
Q1 2016: Oncology launches off to a good start
16
CHFbn
CER=Constant Exchange Rates
Q1 2016 Oncology sales: CHF 6.1bn; CER growth +4%
YoY CER growth
•
Increased competition
•
EU: Avastin + Tarceva filed in 1L EGFR+ NSCLC
•
Loss of exclusivity
•
Growth driven mainly by cervical and ovarian
•
Strong uptake of Perjeta and Kadcyla
•
Growth of Herceptin due to longer treatment
•
Back to growth post launch of Cotellic
•
Gazyva approved in R/R iNHL (GADOLIN)
•
US: launch off to a strong start
HER2 franchise: Growth mainly driven by Perjeta
17
0
500
1,000
1,500
2,000
2,500
Q1 13
Q1 14
Q1 15
Q1 16
Herceptin
Perjeta
Kadcyla
+15%
YoY CER growth
+23%
+17%
CER=Constant Exchange Rates
CHFm
+9%
HER2 franchise Q1 2016
•
Herceptin (+4%): Longer treatment duration
in combo with Perjeta
•
Perjeta (+33%): Strong demand in 1L mBC
and neoadjuvant in the US and EU
•
Kadcyla (+11%): Growth driven by EU,
International and Japan
Outlook 2016
•
Herceptin: Further SC conversion
•
Perjeta: Further increasing penetration
•
Kadcyla: New launch countries
Avastin: Strong underlying growth
18
CER=Constant Exchange Rates
0
400
800
1,200
1,600
2,000
Q1 13
Q1 14
Q1 15
Q1 16
CHFm
US
Europe
International
Japan
YoY CER growth
+11%
+9%
+4%
+6%
Avastin Q1 2016
•
Growth impacted by Health Insurance
Plan impact in Japan
•
International (+27%): Driven by Asia,
mainly China (lung cancer launch)
Outlook 2016
•
Continued uptake in ovarian and
cervical
•
EU: Avastin + Tarceva approval in
EGFR+ NSCLC expected in H2
Immunology: Continued strong growth, now
>CHF 7bn on an annualised basis
19
0
300
600
900
1,200
1,500
1,800
Q1
13
Q1
14
Q1
15
Q1
16
MabThera/Rituxan (RA)
Actemra IV
Actemra SC
Xolair
CellCept
Pulmozyme
Esbriet
Other
CHFm
CER=Constant Exchange Rates; GPA=granulomatosis with polyangiitis; MPA=microscopic polyangiitis
YoY CER growth
+11%
+11%
+20%
+16%
Immunology Q1 2016
Xolair
(+22%)
•
Continued strong uptake in allergic
asthma, chronic idiopathic urticaria
Actemra
(+14%)
•
SC formulation driving growth
•
Increasing 1L monotherapy leadership
focusing on MTX intolerant patients
MabThera/Rituxan
(+11%)
•
Continues to grow in rheumatoid
Esbriet: Expanding beyond severe patients
20
CHFm
10
27
88
178
0
50
100
150
200
Q1
13
Q1
14
Q1
15
Q1
16
US
Europe
International
US (+145%)
•
Strong underlying growth with patient
starts and treatment rate on track
•
Around 100,000 IPF patients in the US
with high unmet need
EU (+36%)
•
Increasing differentiation due to
strengthened label including the pooled
1 Yr mortality data
Outlook 2016
•
Increasing patient pool and new launch
countries
YoY CER growth
+96%
Q1 2016 sales
Innovation
Outlook
Venclexta* in R/R CLL with 17p deletion
First Bcl-2 inhibitor with significant upside potential
22
•
Accelerated approval in the US following breakthrough therapy designation in R/R CLL 17p del
•
Additional breakthrough therapy designations: Venclexta+Rituxan in R/R CLL and Venclexta in AML
•
Several read-outs at ASCO in NHL, CLL, MM and AML
NHL=non-hodgkin`s lymphoma; CLL=chronic lymphoid leukemia; MM=multiple myeloma; AML=acute myeloid leukemia;
* Venclexta (venetoclax) in collaboration with AbbVie
Phase II (M13-982)
Response,
n (%)
Venclexta
(n = 106)
ORR
85 (80.2)
CR/CRi
8 (7.5)
Ocrelizumab: Additional efficacy data at AAN
Breakthrough therapy designation in PPMS
23
•
NEDA, disability progression and MRI data to be presented at AAN (April, 15
th
– 21
st
)
•
Breakthrough therapy designation granted in PPMS
•
US/EU filings in RMS/PPMS on track for H1 2016
Emicizumab (ACE 910) development plan
Non-interventional study expanded to all patients
24
QW=weekly dosing; Q2W=dosing every 2 weeks; Q4W=dosing every 4 weeks; OLE=open label extension
•
Inhibitor study: Enrollment progressing well
•
Inhibitor non-interventional study fully recruited (>90 patients) and expanded to non-inhibitors
•
Non-inhibitor, pediatric and Q4W dosing studies expected to start in 2016
2015
2016
2017
2018
Pediatrics Inhibitor Non-interventional Inhibitor (≥12 yrs) Weight based QW dosing
Q4W dosing study Non-inhibitor (≥12 yrs)
QW and Q2W dosing Japanese studies
Chugai OLE
Phase II
Phase III
Unlocking the full value of cancer immunotherapy
New deals signed in Q1
25
Chen and Mellman. Immunity 2013
NME=new molecular entity; CIT=cancer immunotherapy; FP=fusion protein; TCB=T-cell bispecific
T cell Trafficking
Cancer T cell recognition
anti-CEA/CD3 TCB
anti-CD20/CD3 TCB
KTE-C19
*
(Kite Pharma)
ImmTAC
*
(Immunocore)
T cell infiltration
anti-VEGF (Avastin)
anti-Ang2/VEGF (vanucizumab)
T cell killing
anti-PDL1 (atezolizumab)
anti-CSF-1R (emactuzumab)
IDOi (NewLink)
IDOi
*
(Incyte)
CPI-444
*
(Corvus)
anti-TIGIT
IDO1/TDOi
*
(Curadev)
Antigen presentation
T-Vec oncolytic virus* (Amgen)
INF
a
anti-CD40
CMB305 vaccine
*
(Immune Design)
EGFRi (Tarceva)
ALKi (Alecensa)
BRAFi (Zelboraf)
MEKi (Cotellic)
anti-CD20 (Gazyva)
anti-HER2 (Herceptin;
Kadcyla; Perjeta)
various chemotherapies
lenalidomide* (Celgene)
rociletinib* (Clovis)
daratumumab* (Janssen)
Antigen release
Priming & activation
anti-CEA-IL2v FP (cergutuzumab amunaleukin)
anti-FAP-IL2v FP
anti-OX40
anti-CD27
*
(Celldex)
entinostat
*
(Syndax)
Clinical development
Preclinical development
*
Partnered or external
Established therapies
Cancer immunotherapy read-outs in 2016
Priority review granted for bladder and lung cancer
26
Status as of April 19, 2016; Outcome studies are event-driven: timelines may change.
Phase III
Phase I
= Read-outs expected in 2016
atezo NSCLC (Dx+) (BIRCH) atezo 2/3L NSCLC (POPLAR) atezo+Avastin 1L Renal (IMmotion 150) atezo 1/2L Bladder (IMvigor 210)Phase II
atezo+lenalidomide MM atezo+daratumumab+len R/R MM atezo+ipilimumab Solid tumors atezo+aCD40 Solid tumors atezo+IFN-alfa Solid tumors atezo+aOX40 Solid tumors atezo+IDO Solid tumors atezo+Avastin+/-chemo Solid tumors atezo+Cotellic Solid tumors atezo+chemo Solid tumors atezo Solid tumors aOX40 Solid tumors aCEA/CD3 TCB Solid tumors aCEA-IL2v FP Solid tumors aCD20/CD3 TCB heme tumors atezo+/-azacitidine MDS atezo+Gazyva+chemo R/R FL/aNHL atezo+Gazyva+polatuzumab R/R FL/aNHL aFAP-IL2v FP Solid tumors IDO Solid tumors atezo+aCEA/CD3 TCB Solid tumors atezo+aCSF-1R Solid tumors atezo+aCEA-IL2v FP Solid tumorsatezo+Zelboraf
Melanoma
atezo+Tarceva NSCLC atezo+Gazyva R/R FL / aNHL atezo+Zelboraf+Cotellic Melanoma aCSF-1R Solid tumors atezo+Alecensa ALK+ NSCLC atezo+Kadcyla/Herceptin+Perjeta HER2+ eBC/mBC atezo+Gazyva+lenalidomide R/R FL/aNHL aCD40+vanucizumab R/R FL/aNHL atezo 2/3L NSCLC (OAK) atezo 2/3L Bladder (IMvigor 211) atezo+Avastin+chemo 1L nsq NSCLC (IMpower 150) atezo+chemo 1L nsq NSCLC (IMpower 130) atezo+chemo 1L sq NSCLC (IMpower 131) atezo 1L nsq NSCLC (Dx+) (IMpower 110) atezo 1L sq NSCLC (Dx+) (IMpower 111) atezo+chemo 1L TNBC (IMpassion 130) atezoAdj MIBC (Dx+) (IMvigor 010)
atezo Adj NSCLC (Dx+) (IMpower 010) atezo+Avastin 1L Renal (IMmotion 151) atezo+chemo 1L nsq NSCLC (IMpower 132)
For Background:
New Ph3 in 3L CRC for
Tecentriq+Cotellic, FPI in
May’16, data in ‘18 (OS),
approval in Q1’19
Q1 2016 sales
Innovation
Outlook
2016: Focus on ongoing and upcoming launches
28
Approvals &
launch
preparation
Maximise
recent
launches
•
Ocrevus
(ocrelizumab) in MS
•
Atezolizumab
in bladder and lung cancer
•
Gazyva
(GOYA) and Perjeta (APHINITY)
•
Venclexta
(venetoclax) in R/R CLL with 17p deletion
•
Cotellic + Zelboraf
in 1L BRAF positive metastatic melanoma
•
Gazyva
in Rituxan-refractory iNHL (GADOLIN)
•
Alecensa
in ALK positive NSCLC
2016 onwards: Significant launch activities
29
Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed.
FDA Breakthrough
Therapy Designation
Oncology/
hematology
Neuroscience
Ophthalmology
Immunology
Cotellic + Zelboraf
BRAFmut melanoma
Venclexta
R/R CLL with 17p del
Ocrelizumab
RMS/ PPMS
Lebrikizumab
Severe Asthma
Emicizumab (ACE910)
Hemophilia A
Atezolizumab
2L+ lung and bladder cancer
Alecensa
2L ALK+ NSCLC
Perjeta + Herceptin
eBC HER2+ (APHINITY)
Atezolizumab+Avastin+chemo
1L NSCLC
Gazyva
1L aNHL (GOYA)
Gazyva
1L iNHL (GALLIUM)
Gazyva
Refractory iNHL (GADOLIN
)
Lampalizumab
Geographic atrophy
Atezolizumab + Avastin
1L RCC
NMEs
lin
e
ext
ensions
2016
2017
2018
Actemra
Giant cell arteritis
Alecensa
ASCO 2016: Highlights in various cancer types
30
Solid tumors
•
atezolizumab + aOX40:
Ph I
•
atezolizumab + Cotellic:
Ph I in CRC
Lung
•
Alecensa:
Ph III (
J-ALEX
) in 1L ALK+ NSCLC
•
atezolizumab:
Ph II OS update (
POPLAR)
in
2/3L NSCLC
Bladder
•
atezolizumab:
Ph II (
IMvigor210
) 1L cohort and
2L cohort update in bladder
Breast
•
Herceptin + Perjeta:
Ph III (
PHEREXA
) in 2L
HER2+ mBC
•
atezolizumab + abraxane:
Ph I update in TNBC
Hematology
•
Venclexta:
Ph II (
CAVALLI
) in 1L aNHL
•
Venclexta:
Ph I in R/R CLL and R/R NHL
•
Venclexta +/- chemo:
Ph I in R/R MM
•
Venclexta + chemo:
Ph I in AML
Additional key oncology presentations in 2016*
31
* Planned submissions (to be confirmed); Outcome studies are event driven, timelines may change
•
atezolizumab + abraxane:
Ph I in TNBC
•
atezolizumab + IDOi:
Ph I
•
atezolizumab + Zelboraf + Cotellic:
Ph1 in 1L BRAF+ mM
•
atezolizumab:
Ph II (
IMvigor 210
) in bladder
•
atezolizumab:
Ph I in SCLC
•
atezolizumab:
Ph III (
OAK
) in 2L NSCLC
[or IASLC Vienna]
Copenhagen, 7-11 Oct
San Diego, 3-6 Dec
•
atezolizumab + lenalidomide:
Ph I in MM (safety)
•
atezoliztumab + azacytidine:
Ph I in MDS (safety)
•
aCD20/CD3 TCB:
Ph I dose escalation in solid tumors
•
Gazyva:
Ph III (
GOYA
) in front-line aNHL
•
polatuzumab + Gazyva/Rituxan:
Ph II (
ROMULUS
) in R/R FL / aNHL
•
polatuzumab + Gazyva/Rituxan + CHP:
Ph I/II in 1L aNHL
•
polatuzumab + Gazyva:
Ph I/II in 1L aNHL and R/R FL
•
Venclexta + Rituxan +/- bedamustin:
Ph II (
CONTRALTO
) in R/R FL
•
Venclexta + Gazyva or +Rituxan +/- benda:
Ph I in R/R CLL
•
Venclexta:
Ph II in ibrutinib/idelalisib ref R/R CLL
Vienna, 4-7 Dec
San Antonio, 6-10 Dec
•
atezolizumab:
Ph III (
OAK
) in 2L NSCLC
•
atezoliztumab + Tarceva:
Ph I in NSCLC
•
atezolizumab + abraxane:
Ph I update in TNBC
•
taselisib:
Ph II (
LORELEI
) in neoadjuvant HER2-/ER+ BC
•
SERD:
Ph II
New Orleans, 16-20 Apr
Copenhagen, 9-12 Jun
•
aOX40:
Ph I dose escalation in solid tumors
•
atezoliztumab + Avastin + FOLFOX:
Ph I in CRC
•
atezolizumab + Gazyva:
Ph I in R/R aNHL/iNHL
•
idasanutlin + AraC
: Ph I in R/R AML
EHA
We are hoping to show
MM and MDS data at
ASH but we cannot
confirm until later this
year.
2016: Key late-stage news flow
32
Compound
Indication
Milestone
Regulatory
Gazyva
Rituxan-refractory iNHL
US/EU approval
Venclexta
R/R CLL with 17p deletion
US approval
ocrelizumab
RMS/PPMS
US/EU filing
atezolizumab
Bladder cancer
US approval
atezolizumab
2/3L NSCLC
US approval
Alecensa
2L ALK+ NSCLC
EU CHMP opinion
Phase III readouts*
lebrikizumab
Severe asthma
Ph III LAVOLTA I/II
atezolizumab
2/3L NSCLC
Ph III OAK
Gazyva
Front-line aNHL
Ph III GOYA
Perjeta + Herceptin
Adjuvant HER2+ BC
Ph III APHINITY
Actemra
Giant cell arthritis
Ph III GiACTA
Alecensa
1L ALK+ NSCLC
Ph III ALEX
Phase II readouts*
lebrikizumab
Atopic dermatitis
Ph II TREBLE, ARBAN
atezolizumab
Bladder cancer
Ph II IMvigor 210 (1L cohort)
atezolizumab + Avastin
1L Renal cancer
Ph II IMmotion 150
Venclexta + Rituxan
R/R FL (iNHL)
Ph II CONTRALTO
Venclexta + Rituxan/Gazyva
1L aNHL
Ph II CAVALLI
* Outcome studies are event driven, timelines may change
mixed
33
Diagnostics Division
Roland Diggelmann
Q1 2016: Diagnostics Division sales
Strong sales growth in laboratory businesses
34
CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding Sequencing business: +4%
2016
2015
CHFm
CHFm
CHF
CER
Diagnostics Division
2,614
2,511
4
5
Professional Diagnostics
1,519
1,425
7
7
Molecular Diagnostics
446
401
11
11
Diabetes Care
443
507
-13
-11
Tissue Diagnostics
206
178
16
13
Change in %
North America
0%
27% of divisional sales
Latin America
+21%
6% of divisional sales
Japan
-3%
4% of divisional sales
EMEA
1
+1%
43% of divisional sales
Q1 2016: Diagnostics regional sales
Growth driven by Asia Pacific and Latin America
Asia Pacific
+16%
20% of divisional sales
35
23% growth in E7 countries
2
1
Europe, Middle East and Africa;
2Brazil, China, India, Mexico, Russia, South Korea, Turkey
Q1 2016: Diagnostics highlights
Growth driven by Professional Diagnostics
36
•
Driven by immunodiagnostics (+12%)
•
Virology (+16%) incl. HPV (+16%)
•
Advanced staining portfolio (+10%); primary
staining (+24%)
0.0
0.5
1.0
1.5
2.0
Tissue
Dia
Diabetes
Care
Molecular
Dia
Professional
Dia
EMEA
North America
RoW
+13%
-11%
+7%
+11%
CHFbn
1
1
Underlying growth of Molecular Diagnostics excluding sequencing business: +4%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
YoY CER growth
•
Spillover of US reimbursement cuts to private
sector
Providing the full solution in hepatitis testing
Comprehensive menu in serology & molecular
37
1
Q1 2016 growth; *NAT: nucleic acid amplification technology
Complete platform and test portfolio
•
Hepatitis contributes ~60% of Roche’s
Infectious Disease/Virology portfolio
•
Serology hepatitis: (+5%
1
)
•
Molecular/NAT* hepatitis: (+11%
1
)
Roche
25%
Others
75%
Leader in a CHF 4.3bn market
•
5yr CAGR: ~6% projected
FDA approves IND for cobas Zika assay
Screening initiated at Puerto Rico blood centres
38
* IND: Investigational New Drug Application
•
Currently testing in Puerto Rico, expect to
expand into southern US centres
•
Operating under an IND* cost-recovery
model, no commercial sales
Key launches 2016
39
Area
Product
Market
Instruments /
Devices
Central
Laboratory
cobas 8000 <e 801>
– high throughput immunochemistry analyzer
cobas c 513
– high throughput dedicated HbA1c analyzer
EU
US
Point of Care
CoaguChek INRange (Zenith)
tooth connectivity
– modified analyzer for intuitive self testing with full blue
EU
Sequencing
Roche SMRT Sequencer
with Pacific Biosciences)
– single molecule sequencer for clinical research (in collaboration
WW
Diabetes
Care
Accu-Chek Guide
– next-generation blood glucose monitoring system
Accu-Chek Insight CGM
– new high-performance continuous glucose monitoring system
EU
EU
Tests /
Assays
Virology
cobas 6800/8800 HIV Qual
– early Infant Diagnosis and Confirmatory HIV Test
EU
HPV /
Microbiology
cobas 6800/8800 CT/NG
– fully automated solution for screening and diagnosis of
Chlamydia
trachomatis
and
Neisseria gonorrhoeae in symptomatic & asymptomatic patients
EU
Point of Care
cobas Liat Influenza A/B plus RSV (CLIA)
assay for qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory
– automated multiplex real time RT-PCR
syncytial virus (RSV)
US
Sequencing
ctDNA oncology panels
selection
– liquid biopsy for circulating tumor DNA for cancer therapy
US
Companion
Diagnostics
PD-L1 (SP142) for Bladder Cancer*
– companion diagnostic for atezolizumab
PD-L1 (SP142) for NSCLC*
– companion diagnostic for atezolizumab
US
US
40
Finance
Alan Hippe
Q1 2016: Highlights
41
Sales
•
Good sales growth in all regions and both divisions
Capital markets update
•
Bond maturity
– EUR: 2.1bn maturity on 4 March 2016 - coupon 5.625%
•
Bond tender
– USD: 0.6bn (0.86bn outstanding, maturity in 2019) – coupon 6.0% s.a.
•
Bond issuance
– EUR: 0.65bn maturity in 2023 - coupon 0.5%
– USD: 1.0bn maturity in 2026 - coupon 2.625% s.a.
Currency impact
•
Positive impact from USD, JPY and EUR currencies partly offset by Latin America
s.a.=semi-annual coupon
Guidance for FY 2016
+457
+133
+124
+581
+107
+72
+30
+115
United States
Europe
Intl.
Japan
Diagnostics
Division
Group
Fx
Group
CHF
Pharma Division
+4%
+3%
+5%
+4%
+4%
+5%
+4%
+5%
1
Q1 2016: Group sales
Increase driven by US & EU Pharma and Diagnostics
42
Absolute values and growth rates at Constant Exchange Rates (CER)
CER
sales
growth
Q1 2016
vs.
Q1 2015
Exchange rate impact on sales growth
Positive impact from USD, JPY and EUR
CER=Constant Exchange Rates
+3.9%
+4.9%
+1.9p
+0.6p
+0.4p -0.2p
-0.2p
-0.2p -1.3p
CER
USD
JPY
EUR
Other
Europe
As-Pac
Other
Lat-Am
CHF
CHF
sales
growth
Q1 2016
vs.
Q1 2015
43
Currency impact on Swiss Franc results 2016
Low currency impact expected
Q1
HY
Sep
YTD
FY
Sales
1
1
1
0
Core
operating
profit
0
-1
Core EPS
-1
0
Assuming the 31 Mar 2016 exchange
rates remain stable until end of 2016,
2016 impact is expected to be (%p):
CHF / USD
CHF / EUR
+1%
+1%
+2%
+2%
1.01 0.99 0.98 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.98 0.99 0.97 0.95 0.95 0.95 0.96 J F M A M J J A S O N D 1.09 1.10 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.10 1.10 1.09 1.06 1.06 1.07 1.08 J F M A M J J A S O N DAverage
YTD
2015
4%
3%
2%
1%
2%
3%
3%
2%
Assumed average YTD 2016
Monthly avg fx rates 2016 Fx rates at 31 March 2016
2015: Core EPS base for FY 2016 guidance
45
excl. Venezuela &
Argentina FX losses
13.49
+0.36
13.85
Full Year 2015
as reported
Core EPS
Core EPS
Full Year 2015
@ CER
2016 outlook
46
Group sales growth
1
Low to mid-single digit
Core EPS growth
1
Ahead of sales growth
Dividend outlook
Further increase dividend in Swiss francs
2016: Upcoming IR events
Further details available online:
http://www.roche.com/investors/agenda.htm
5
June
21
July
2
August
20
October
Analyst Event at ASCO
Half Year Results
Analyst Event on Diagnostics Division at AACC
Third Quarter Results
Pipeline summary
Marketed products additional indications
Global Development late-stage trials
pRED (Roche Pharma Research & Early Development)
gRED (Genentech Research & Early Development)
Roche Group Q1 2016 sales
Diagnostics
Foreign exchange rate information
Changes to the development pipeline
Q1 2016 update
49
New to Phase I
New to Phase II
New to Phase III
New to Registration
1 NME transitioned from Ph0
RG7906
– psychiatric disorders
1 NME re-opened in Ph1
RG7203
PDE10A inh – schizophrenia
1 NME in-licensed from Amgen
RG6149
ST2 MAb - asthma
1 NME acquired from Tensha
RG6146
BET inh – oncology (CIT)
3 new AIs
RG7876
CD40+vanucizumab solid tumors
RG7601
Venclexta+Cotellic/idasanutlin –
AML
RG3616
Erivedge+ruxolitinib –
myelofibrosis
1 NME in-licensed from
Shionogi
RG6152
CAP endonuclease inh -
influenza
1 NME transitioned from Ph2
RG7412
crenezumab –
Alzheimer’s
1 AI
RG7446
atezolizumab +
chemotherapy + pemetrexed –
NSCLC non-sq. 1L
1 AI transitioned from Ph2
RG7446
atezolizumab – NSCLC 2L+
Removed from Phase I
Removed from Phase II
Removed from Phase III
Removed from Registration
2 NMEs
RG7116
lumretuzumab – mBC
RG7597
duligotuzumab – solid tumors
1 NME
RG7090
basimglurant TRD
(out-licensing activities ongoing)
1 NME (status assigned to Ph1)
RG7155
emactuzumab PVNS
tumors
1NME following FDA approval
RG7601
Venclexta (venetoclax)
17pdel CLL rel/ref
Roche Group development pipeline
50
Phase I
(43 NMEs+19 AIs)
Raf & MEK dual inh solid tumors
ChK1 inh solid tum & lymphoma atezo+Zelboraf+/-Cotellic melanoma atezo+Avastin+chemo solid tumors
atezo+Tarceva /Alecensa NSCLC atezolizumab+Cotellic solid tumors
Venclexta (venetoclax)+Gazyva CLL atezolizumab solid tumors
ERK inh + Cotellic solid tumors LSD1 inh AML
Ly6E ADC solid tumors MDM2 (4) IV prodrug AML
ADC ovarian ca atezolizumab+ipi/IFN solid tumors
OX40 MAb solid tumors
ranibizumab PDS wAMD Nav1.7 inh pain
VEGF-ANG2 biMAb wAMD a-synuclein MAb Parkinson's Disease
RG3645 RG7893
RG7716 RG7935
HIF1 alpha LNA solid tumors
RG7304 RG7741 RG7446 RG7446 RG7446 RG7446 RG7601 RG7446 RG7842 RG6016 RG7841 RG7775 RG7882 RG7446 RG7888 RG6061
CEACD3 TCBRG7802 ± atezolizumab s. tumors
CD40 MAb+atezolizumab solid tumors RG7876 atezolizumab+Gazyva lymphoma RG7446
IL-22Fc inflammatory diseases RG7880 Cat-S antag autoimmune diseases RG7625
DBO β-lactamase inh bact. infections RG6080 emactuzumab + atezolizumab s. tumors RG7155
SERD (2) ER+(HER2-neg) mBC RG6047
IDO inh solid tumors RG6078
RG7601 Venclexta (venetoclax) heme indications
therapeutic vaccine HBV RG7944
*CEA IL2v FP+atezolizumab s. tumors RG7813
OX40 MAb + atezolizumab RG7888 solid tumors CLL
- fibrosis RG6069
RG7446 atezo+lenalidomide/daratumumab MM IDO inh + atezolizumab solid tumors RG6078
PTH1 recep. ago hypoparathyroidism CHU
polatuzumab vedotin heme tumors RG7596
V1 receptor antag autism RG7314 ipatasertib RG7440 solid tumors
Flu A MAb influenza A RG7745 nemolizumab (IL-31R) atopic dermatitis CHU
basmisanil Down’s syndrome RG1662 vanucizumab RG7221 mCRC Cotellic+paclitaxel TNBC RG7421 SERD ER+(HER2-neg) mBC RG6046
URAT1 inh gout CHU
RG3502 Kadcyla HER2+ NSCLC
RG3637 lebrikizumab +/- Esbriet IPF
olesoxime spinal muscular atrophy RG6083 TLR7 agonist HBV RG7795 RG3637 lebrikizumab atopic dermatitis
Phase II
(16 NMEs+12 Als)
CD20/CD3 biMAb heme tumors RG7828
ASO Huntington’s Disease IONIS Flu B MAb influenza B RG6024 FAP-DR5 biMAb solid tumors RG7386
RG3637 lebrikizumab COPD
- glaucoma
nemolizumab CHU (IL-31R) pruritus dialysis pts
danoprevir HCV RG7227 obinutuzumab renal transplant RG7159
Cadherin-11 MAb RA RG6125
RG4929
- HBV
FAP IL2v FP solid tumors
SMN2 splicer(2) spinal muscular atrophy BTK inh autoimmune diseases
StaphA vcRifalog TAC infect. diseases RG7834
RG7461
RG7916 RG7845
RG7861
FGFR1/KLB MAb metabolic diseases RG7992 RG7861
PT - hyperphosphatemia CHU
codrituzumab hepatocell. carcinoma RG7686 taselisib ER+(HER2-neg) BC neoadj RG7604 taselisib NSCLC sq 2L RG7604 Venclexta (venetoclax) DLBCL RG7601 Venclexta (venetoclax)+Rituxan FLrel/ref RG7601
obinutuzumab lupus nephritis RG7159
VAP-1 inh inflammatory diseases PRO
RG7159 Gazyva multiple combos heme indications
RG7446 atezolizumab + K/HP HER2+ BC
RG7888
Nav1.7 inh (2) pain RG6029 Erivedge+Esbriet IPF RG3616
ADC r/r NHL RG7986
RG-No Roche/Genentech managed CHU Chugai managed
IONIS IONIS managed PRO Proximagen managed Immunology
New Molecular Entity (NME) Oncology Other Ophthalmology Neuroscience Infectious Diseases CardioMetabolism Additional Indication (AI)
BET inh oncology RG6146
Erivedge+ruxolitinib myelofibrosis RG3616
PDE10A inh schizophrenia RG7203
- RG7906 psychiatric disorders
RG7601 Venclexta+Cotellic/idasanutlin AML CL
CAP endonuclease inh influenza RG6152
* INN: cergutuzumab amunaleukin
ST2 MAb asthma RG6149
SMN2 splicer spinal muscular atrophy RG7800
RG7876 CD40 MAb+vanucizumab solid tumors
Roche Group development pipeline
51
Phase III
(10 NMEs + 30 Als)
1 Global filing 2 CHMP positive opinion Q1’16 3 EU only 4 Approved in the US 5 Phase 3 ongoing6 Approved in the US and Japan lampalizumab geographic atrophy RG7417
Avastin glioblastoma 1L RG435
ocrelizumab RMS RG1594 Gazyva DLBCL1L RG7159
ocrelizumab PPMS RG1594 Actemra large-vessel vasculitisCHU lebrikizumab severe asthma RG3637
Zelboraf melanoma adj RG7204
RG1273 Perjeta+Herceptin HER2+gastric ca 1L
Actemra giant cell arteritis RG1569
etrolizumab ulcerative colitis RG7413
RG1273 Perjeta+Herceptin HER2+ mBC 2L
Alecensa (alectinib) ALK+ NSCLC 1L RG7853
Gazyva iNHL rituximab-refractory RG71594
Gazyva follicular lymphoma 1L RG7159
RG7601 Venclexta (venetoclax)+RituxanCLL rel/ref
RG1450 gantenerumab Alzheimer’s
atezolizumab NSCLC 2L+
Kadcyla + Perjeta HER2+ BC adj RG3502
Kadcyla + Perjeta HER2+ BC neoadj RG3502 IL-6R MAb neuromyelitis optica CHU Perjeta+Herceptin RG1273 HER2+ BC adj
Kadcyla HER2+ BC adj RG3502
Venclexta RG7601 (venetoclax)+Gazyva CLL 1L RG4351 Avastin rel. ovarian ca. Pt-sensitive
RG74465 atezolizumab bladder cancer 2L
atezolizumab+Avastin RCC RG7446
MabThera SC RG1052 CLL Avastin+Tarceva EGFR mut+ NSCLC RG4353
RG7446 atezolizumab+chemo NSCLC non-sq. 1L 1L NSC RG7446 atezo+chemo+Avastin NSCLC non-sq. 1L
atezolizumab Dx+ NSCLC sq. 1L RG7446 atezolizumab Dx+ NSCLC non-sq. 1L RG7446
taselisib ER+(HER2-neg) mBC RG7604
etrolizumab Crohn’s disease RG7413 MabThera pemphigus vulgaris RG105
atezolizumab+abraxane TNBC RG7446 atezolizumab Dx+ NSCLC adj RG7446
atezolizumab RG7446 muscle inv. bladder ca adj
Registration
(2
NMEs + 4 Als)
Alecensa (alectinib) ALK+ NSCLC 2L RG78536
idasanutllin AML RG7388 emicizumab hemophilia A RG6013
Actemra systemic sclerosis RG1569
New Molecular Entity (NME)
RG-No Roche/Genentech managed CHU Chugai managed
IONIS IONIS Managed PRO Proximagen managed
RG105 MabThera is branded as Rituxan in US and Japan
RG1569 Actemra is branded as RoActemra in EU
RG7159 Gazyva is branded as Gazyvaro in EU Oncology
Neuroscience Infectious Diseases CardioMetabolism Additional Indication (AI) Immunology Other crenezumab Alzheimer’s Ophthalmology RG7412 RG74465 RG7446 atezo+chemo+pemetrexed NSCLC non-sq. 1L atezolizumab+chemo NSCLC sq. 1L RG7446
Status as of April 19, 2016
NME submissions and their additional indications
Projects currently in phase 2 and 3
52
Unless stated otherwise, submissions are planned to occur in US and EU
✓
indicates a submission which has occurred with regulatory action pending * EU submission pending
ocrelizumab (RG1594) RMS danoprevir (RG7227) HCV crenezumab (RG7412) Alzheimer‘s gantenerumab (RG1450) Alzheimer‘s V1 receptor antag (RG7314) autism codrituzumab (RG7686) liver cancer lampalizumab (RG7417) geographic atrophy lebrikizumab (RG3637) severe asthma etrolizumab (RG7413) ulcerative colitis
2016
2019 and beyond
atezolizumab (RG7446) US* NSCLC 2L+ ✓ ipatasertib (RG7440) solid tumors vanucizumab (RG7221) colorectal cancer lebrikizumab+/-Esbriet (RG3637) IPF2017
atezolizumab(RG7446) combo Avastin RCC Flu A MAb (RG7745) influenza taselisib (RG7604)HER2 neg ER+ mBC
basmisanil (RG1662) Down syndrome atezolizumab (RG7446) US* bladder cancer 2L ✓ Venclexta (venetoclax) DLBCL ocrelizumab (RG1594) PPMS emicizumab (RG6013) hemophilia A Venclexta (venetoclax) + Gazyva CLL 1L Venclexta (venetoclax) + Rituxan FL rel/ref taselisib ( RG7604) NSCLC sq 2L
2018
olesoxime (RG6083) SMA atezolizumab(RG7446)+ chemo NSCLC non-sq 1L etrolizumab (RG7413) Crohn’s disease atezolizumab(RG7446) NSCLC sq 1L (Dx+) atezolizumab(RG7446) NSCLC non-sq 1L (Dx+) atezolizumab(RG7446)+ chemo NSCLC sq 1L taselisib ( RG7604) ER+(HER2-neg) BC neoadj New Molecular EntityOncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other Venclexta (venetoclax) + Rituxan CLL rel/refractory lebrikizumab (RG3637) atopic dermatitis TLR7 ago (RG7795) HBV atezolizumab (RG7446) NSCLC adj (Dx+) atezolizumab (RG7446) + abraxane TNBC atezolizumab (RG7446) MIBC adj lebrikizumab (RG3637) COPD VEGF/ANG2 biMAb (RG7716) wAMD polatuzumab vedotin (RG7596) heme tumors SERD (RG6046) ER+(HER2-neg) mBC idasanutlin (RG7388) AML
CAP endonuclease inh (RG6152) influenza atezolizumab(RG7446)+chemo + Avastin NSCLC non-sq 1L atezolizumab(RG7446)+chemo +pemetrexed NSCLC non-sq 1L
Status as of April 19, 2016
2016
2019 and beyond
✓
indicates submission to health authorities has occurred
*approved in EU
Unless stated otherwise, submissions are planned to occur in US and EU.
Submissions of additional indications for
existing products
Projects currently in phase 2 and 3
53
Actemra systemic sclerosis Perjeta + Heceptin HER2-pos. BC adj. Perjeta+Herceptin HER2-pos. gastric cancer 1LKadcyla HER2-pos. BC adj. Actemra
giant cell arteritis
2017
Avastin (US) GBM Gazyva DLBCL 1L Neuroscience Ophthalmology Other NME Oncology Immunology Infectious Diseases CardioMetabolism Perjeta + Herceptin HER2-pos. mBC 2L *Avastin rel. ovarian ca. Pt-sens.Kadcyla+Perjeta HER2-pos. BC adj. Kadcyla+Perjeta
HER2-pos. BC neoadj HER2-pos. NSCLC Kadcyla
2018
Zelboraf melanoma adj. MabThera pemphigus vulgaris ranibizumab PDS (US) wAMD Alecensa (alectinib) Alk+ NSCLC 1L obinutuzumab lupus nephritis Cotellic+paclitaxel TNBC Gazyva follicular lymphoma 1LStatus as of April 19, 2016
Major granted and pending approvals 2016
54
Neuroscience Ophthalmology Other NME Oncology Immunology Infectious Diseases CardioMetabolismEU
US
Approved
Pending approval
Status as of April 19, 2016
Japan-Chugai
osteoporosis (oral) BonvivaJanuary 2016 Alecensa (alectinib) ALK+ NSCLC 2L Filed September 2015 Gazyva iNHL rituximab-ref. February 2016 Avastin cervical cancer Filed September 2015 atezolizumab bladder cancer 2L Filed January 2016 Venclexta (venetoclax) 17pdel CLL rel/ref April 2016 atezolizumab NSCLC 2L+ Filed February 2016 MabThera SC* CLL Filed November 2014 Avastin + Tarceva EGFR mut+ NSCLC Filed July 2015 Gazyva iNHL rituximab-ref. Filed September 2015 *CHMP pos. opinion
Venclexta (venetoclax) +Rituxan FL rel/ref TNBC
Roche Group Development pipeline
Combinations
55
Phase III
(13 AIs)
atezo+Zelboraf+/-Cotellic melanoma atezo+Avastin+chemo solid tumors
atezo+Tarceva/ Alecensa NSCLC atezolizumab +Cotellic solid tumors atezolizumab +ipi/IFN solid tumors
RG7446 RG7446
RG7446 RG7446 RG7446
CD40 MAb+atezolizumab solid tumors RG7876 atezolizumab+Gazyva lymphoma RG7446 emactuzumab + atezolizumab s.tumors RG7155
atezolizumab+Avastin RCC RG7446 atezo+chemo NSCLC non-sq. 1L RG7446 NSC RG7446 atezo+chemo+Avastin NSCLC non-sq. 1L
atezolizumab+chemo NSCLC sq. 1L RG7446
New Molecular Entity (NME) Additional Indication (AI)
Oncology Immunology
RG-No Roche Genentech managed
OX40 MAb + atezolizumab s. tumors RG7888 atezo+lenalidomide multiple myeloma RG7446
atezolizumab+abraxane TNBC RG7446 CEA IL2v FP+atezolizumab s. tumors RG7813
IDO inh + atezolizumab solid tumors RG6078
Venclexta+Gazyva CLL
ERK inh + Cotellic solid tumors RG7601
RG7842
Cotellic+paclitaxel TNBC RG7421
lebrikizumab +/- Esbriet IPF RG7601
RG3637
RG1273 Perjeta+Herceptin HER2+gastric ca 1L
RG1273 Perjeta+Herceptin HER2+ mBC 2L
RG7601 Venclexta(venetoclax)+RituxanCLL rel/ref Kadcyla + Perjeta HER2+ BC adj RG3502 Kadcyla + Perjeta HER2+ BC neoadj RG3502 Perjeta+Herceptin RG1273 HER2+ BC adj
Venclexta (venetoclax)+Gazyva CLL 1L RG7601
Avastin+Tarceva EGFR mut+ NSCLC RG4351
1 EU only
Phase I
(5 NMEs + 16 AIs)
Phase II
(3 Als)
Registration
(1 AI)
RG7446 atezolizumab + K/ H+P HER2+BCCEA CD3 TCB+atezolizumab s. tumors RG7802
Status as of April 19, 2016
Erivedge+Esbriet IPF RG3616 RG7159 Gazyva multiple combos heme indications
Erivedge+ruxolitinib myelofibrosis RG3616 RG7601 Venclexta+Cotellic/idasanutlin AML CLL
RG7876 CD40 MAb+vanucizumab solid tumors
Cancer immunotherapy pipeline overview
56
Phase I
(8 NMEs + 19 AIs)
atezo+Avastin+chemo solid tumors
atezo+Tarceva NSCLC EGFR+ atezolizumab +Cotellic solid tumors atezolizumab solid tumors
atezolizumab +ipi/IFN solid tumors
OX40 MAb solid tumors RG7446 RG7446 RG7446 RG7446 RG7446 RG7888
CEA CD3 TCB + atezolizumab s. tumors RG7802
CD40 MAb+atezolizumab solid tumors RG7876 atezolizumab+Gazyva lymphoma RG7446 emactuzumab + atezolizumab s.tumors RG7155
IDO inh solid tumors RG6078 atezolizumab bladder cancer 2L RG7446 1
*INCY atezolizumab + IDO inh solid tumors *CLDX atezolizumab+varlilumab solid tumors
New Molecular Entity (NME) Additional Indication (AI)
Oncology
RG-No Roche Genentech managed
OX40 MAb + atezolizumab solid tumors RG7888 RG7446 atezo+lenalidomide/daratumumab MM
Phase II
(2 AIs)
atezo+NY-ESO-1 soft tissue sarcoma IMDZ NSC atezo+entinostat TNBC SNDX
CEA IL2v FP+atezolizumab solid tumors RG7813 IDO inh + atezolizumab solid tumors RG6078
CD20/CD3 biMAb hem tumors RG7828
Registration
(1 NME + 1 AI)
FAP IL2v FP solid tumors RG7461
Status as of April 19, 2016
atezo+Zelboraf+/-Cotellic m. melanoma RG7446
RG7446 atezolizumab + K/HP HER2+ BC
*external collaborations: INCY- Incyte INCB024360, CLDX - Celldex CD27 MAb; CLVS – Clovis EGFRi, CRVS – Corvus CPI-444, KITE – Kite KTE-C19, AMGN – Amgen oncolytic virus, JNJ – Janssen CD38 MAb., IMDZ – Immune Design CMB305, SNDX – Syndax HDACi
*CLVS atezo+rociletinib EGFRmut+ NSCLC
RG74461 atezolizumab NSCLC 2L
1 Phase 3 ongoing
*CRVS atezo+A2Ai solid tumors *KITE atezo+CD19 CAR-T NHL atezo+talimogene laherp. TNBC, CRC *AMGN *JNJ atezo+daratumumab solid tumor
Phase III
(10 AIs)
atezolizumab+Avastin RCC RG7446 atezo+chemo NSCLC non-sq. 1L RG7446 NSC RG7446 atezo+chemo+Avastin NSCLC non-sq. 1L atezolizumab+chemo NSCLC sq. 1L RG7446 atezolizumab Dx+ NSCLC sq. 1L RG7446 atezolizumab Dx+ NSCLC non-sq. 1L RG7446 atezolizumab+abraxane TNBC RG7446 atezolizumab Dx+ NSCLC adj RG7446atezolizumab muscle inv. bladder ca adj RG7446
RG7876 CD40 MAb+vanucizumab solid tumors