1. Ingeniería

Roche
2014 results
London, 28 January 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
2
3
4
5
6
7
8
9
10
11
pricing and product initiatives of competitors;
legislative and regulatory developments and economic conditions;
delay or inability in obtaining regulatory approvals or bringing products to market;
fluctuations in currency exchange rates and general financial market conditions;
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;
increased government pricing pressures;
interruptions in production;
loss of or inability to obtain adequate protection for intellectual property rights;
litigation;
loss of key executives or other employees; and
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
Group
Severin Schwan
Chief Executive Officer
4
2014 performance
Outlook
5
2014: Targets achieved
Targets for 2014
Group sales
Low to mid-single digit growth1
FY 2014
+5%

+5%
Core EPS
Ahead of sales growth1
+7%

excl. one-time
US Pharma fee2
Dividend
Further increase dividend3
CHF 8.00
+3%

At constant exchange rates
One-time double charge of CHF 202m for the US Branded Prescription Drug fee in 2014, following final regulations issued by the US
Internal Revenue Service which advanced the timing of recording the liability
3 2014 dividend as proposed by the Board of Directors
1
2
6
2014: Highlights
Growth
• Group sales +5%1 driven by HER2 franchise (+20%1), Avastin (+6%1), Actemra (+23%1) and
Professional Diagnostics (+8%1)
• Outperformance in all major regions: +6%1 in US, Japan & International; +3%1 in Europe
Innovation
• Three Breakthrough Therapy Designations: Anti-PDL1, Esbriet and Lucentis
• Three Fast Track Designations: Lampalizumab, cobimetinib and LptD (antibiotic)
• Cancer immunotherapy: New PD-L1 data in bladder, TNBC, renal. Six new agents entered clinic
• Phase 3 starts: Lampalizumab, etrolizumab, alectinib, venetoclax and Kadcyla adjuvant
• Launched next generation molecular diagnostics platform (cobas 6800/8800)
M&A
• InterMune: Acquisition completed
• Foundation Medicine: Collaboration announced
1 CER=Constant
Exchange Rates
7
First take on Swiss National Bank`s decision
On January 15, the Swiss National Bank (SNB) announced its decision to unpeg
the Swiss franc from the Euro
Natural hedge of the underlying business:
• 18% of operating costs in Switzerland
• US, Europe, Japan and China with complete value chain
• Interest expenses predominantly paid in USD
• 2015 dividend payout for March converted prior to SNB decision
8
2014: Solid sales growth
2014
2013
CHFbn
CHFbn
CHF
CER
Pharmaceuticals Division
36.7
36.3
1
4
Diagnostics Division
10.8
10.5
3
6
Roche Group
47.5
46.8
1
5
CER=Constant Exchange Rates
Change in %
9
2014: Continued sales growth for 4 years
10%
8%
8%
7%
6%
6%
6%
5%
5%
4%
4%
4%
2%
0%
6%
6%
4%
4%
2%
0% 0%
Q1
11
Q2
11
1%
Q3
11
Q4
11
Q1
12
All growth rates at Constant Exchange Rates (CER)
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
10
2014: Both Divisions with sales growth in all
regions
CHFbn
20
+6%
18
+4%
16
+3%
14
+6%
12
+2%
Diagnostics
+13%
10
+6%
8
6
+6%
4
0%
2
+7%
+2%
Pharma
+3%
0
Japan
International
All growth rates at Constant Exchange Rates (CER)
Europe
US
11
2014: Group core operating profit & margin
remains at high levels
34,9%
35,6%
37,7%
38,3%
37,2% (37.6%*)
+3% at CER (+5%*)
CHFbn
16,6
2010
17,2
17,9
17,6
2013
2014
% of sales
15,1
2011
2012
CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
12
2014: Core EPS growth bridge
+1.7%
+5.2%
+6.9%
one-time
US Pharma fee*
+4.9%
Sales
Core EPS
Full Year 2014
figures as reported
CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
Core EPS
Full Year 2014
excl. one-time
US Pharma fee*
13
2014: Dividend and payout ratio further increased
CHF
Dividend payout ratio (%)
10,00
55,3
9,00
8,00
51,6
48,6
44,8
2014 payout ratio: 56.0%
7,00
6,00
5,00
31,9
54,7
54,5
56.0
8.00
38,8
34,5
4,00
3,00
2,00
1,00
0,00
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
Payout ratio calculated as dividend per share divided by core earnings per share (diluted); 2014 dividend as proposed by the Board of
1 compound annual growth rate
Directors;
Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996
2014
14
Roche: A pipeline of differentiated products
Oncology
Launched
Phase III
Phase II
Avastin
Rituxan/MabThera
Herceptin
Xeloda
Tarceva
Zelboraf
Erivedge
Perjeta
Kadcyla
Gazyva/Gazyvaro
Oncology
Immunology/
Ophthalmology
Esbriet
Pulmozyme
Neuroscience
Ophthalmology
Immunology
Xolair
Actemra/RoActemra
Rituxan/MabThera RA
Lucentis
pictilisib1
taselisib1
anti-PDL1
venetoclax (Bcl2i)
cobimetinib4
alectinib
lampalizumab3
ocrelizumab
gantenerumab
10 NMEs + 9 AIs
3 AIs
6 NMEs
lebrikizumab
etrolizumab2
Neuroscience
Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014; 4 Filed in combination with Zelboraf in metastatic melanoma
AI = Additional Indication; NME = New Molecular Entity
1
15
2014 performance
Outlook
16
2015 milestones
Launch new products
Expand cancer
immunotherapy
Renew CD20 franchise
Esbriet: US and EU
Cobimetinib + Zelboraf: US and EU
PD-L1: Bladder, Lung, Renal, Triple Negative BC
NMEs: OX40, CD40, CEA-IL2, CSF1R, IDO, CEA-CD3
Gazyva (aggressive NHL)*
Entry into Hemophilia
ACE910: Start of pivotal trials
Entry into Multiple Sclerosis
Ocrelizumab: Phase 3 readout
Diagnostics
* Event-driven (interim analysis)
Rollout of key platforms (cobas 6800 / 8800)
17
2015 outlook
1 At
2
Group sales growth1
Low to mid-single digit
Core EPS growth1
Ahead of sales growth2
Dividend outlook
Further increase dividend in Swiss francs
constant exchange rates
Excluding sale of filgrastim rights in 2014
18
Pharmaceuticals Division
Daniel O’Day
COO Roche Pharmaceuticals
19
2014 results
Innovation
Outlook
20
2014: Pharma sales
All regions with positive growth
2014
2013
CHFm
CHFm
36,696
36,304
1
4
15,822
15,097
5
6
Europe
9,422
9,254
2
3
Japan
3,301
3,405
-3
7
International
8,151
8,548
-5
2
Pharmaceuticals Division
United States
CER=Constant Exchange Rates
Change in %
CHF
CER
21
2014: Pharma Division
Investment in Esbriet launch
2014
CHFm % sales
Sales
Royalties & other op. inc.
Cost of sales
M&D
R&D
G&A
Core operating profit
36,696
100.0
2,273
-7,551
-5,974
-7,876
-1,567
6.2
-20.5
-16.3
-21.5
-4.3
16,001
43.6
2014 vs. 2013
CER growth
Excl. 340B: +5%
4%
Excl. filgrastim
deal: +10%
35%
4%
Esbriet launch
6%
4%
PSI
Excl.&PSI & US
US
Pharma
fee*
Pharma
fee*:+14%
50%
4%
-1% in CHF
CER=Constant Exchange Rates
* Refers to 2013 past service income of CHF 131m and one-time double charge for the US Branded Prescription Drug fee in 2014
22
2014: Pharma sales
HER2, Avastin and Tamiflu main growth drivers
Perjeta
+189%
Herceptin
+7%
Avastin
+6%
Tamiflu
+54%
Kadcyla
+135%
Actemra/RoActemra
+23%
Xolair
+25%
MabThera/Rituxan
Pegasys
+2%
US
Europe
Japan
International
-20%
Xeloda -46%
CHFm
-800
-400
Absolute amounts and growth rates at Constant Exchange Rates (CER)
0
400
800
23
2014: Oncology sales up +5%
CER growth
Perjeta
HER2
+20%
+20%
Herceptin
• Strong uptake of Perjeta & Kadcyla
Kadcyla
MabThera/
Rituxan
• Continued uptake in ovarian & cervical (US)
• Treatment through multiple lines in CRC
+6%
+6%
Avastin
Tarceva
-1%
-1%
Xeloda
-46%
-46%
• In-class competition
• Loss of exclusivity
• Competitive pressure in US & EU
• Potential approval of coBRIM in 2015
-12%
-12%
Zelboraf
CHFbn
• Increased usage across a variety of indications
• Growth despite 340B baseline effect and Russia
+2%
+2%
0
3
CER=Constant Exchange Rates
6
9
2014 Oncology sales: CHF 22.8bn
24
Avastin: Growth supported by recent launches
CHFm
YoY CER growth
7,000
6,000
+6%
+13%
+6%
Platinum-resistant ovarian cancer
• Launched in US and EU
-7%
Cervical cancer
5,000
• Launched in US and filed in EU
4,000
HER2 negative breast cancer
3,000
2,000
• Positive phase 3 data in treatment
through multiple lines (TML) and 1L
1,000
Colorectal cancer
0
2011
US
2012
Europe
CER=Constant Exchange Rates
2013
International
2014
• CALGB H2H data support standard of
care in 1L
Japan
25
HER2 franchise: Strong growth driven by Perjeta
and Kadcyla
CHFm
YoY CER growth
2.500
2.000
1.500
16%
15%
7%
15%
20%
17%
23%
23%
19%
10%
Kadcyla
Perjeta
1.000
Herceptin
500
0
Q3
12
Q4
12
CER=Constant Exchange Rates
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
26
Immunology products: Accelerated growth
Driven by Actemra SC and Xolair
CHFm
800
600
26%
19%
18%
18%
20%
19%
YoY CER growth
18%
15%
Actemra SC
Actemra IV
400
Xolair
Pulmozyme
200
0
Q1
13
Q2
13
CER=Constant Exchange Rates
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
27
Lucentis: Flattening in a competitive environment
Breakthrough designation in Diabetic Retinopathy
Lucentis sales (USDm)
500
2014
• Growth driven by DME and continued
market expansion
400
300
Eylea
wAMD
AMD
Less-frequent than
monthly dosing
Lucentis
DME
Outlook
• Increased competition in AMD and
DME
• Breakthrough Status and Priority
Review for treatment of DR
(PDUFA date Feb 6)
200
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
11 11 12 12 12 12 13 13 13 13 14 14 14 14
AMD=wet age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy
28
Esbriet strong launch
Esbriet sales
CHFm
50
50
45
40
40
33
30
30
• FDA approval on 15 October 2014,
patients still in transition to full
reimbursement
28
24
• > 1,300 patients in clinical trials
18
20
20
10
10
37
10
13
European sales with strong growth
00
Q1
13
13
Q2
13
13
US launch off to strong start
Q3
13
13
Europe
Europe
Q4
13
13
Q3
Q1
14
13
14
Canada
Canada
Sales based on average 2013 exchange rate
Q2
14
14
Q3
14
14
Q4
14
• EU label strengthened to include the
ASCEND and pooled one year
mortality data on October 23, 2014
US
US
29
2014 results
Innovation
Outlook
30
2014: Major clinical and regulatory news flow
Regulatory
Phase III
Phase III starts
Compound
Indication
Milestone
Actemra SC
Rheumatoid arthritis
EU approval
Avastin
Glioblastoma
EU approval
Avastin
Cervical cancer
Avastin
Pt-resistant ovarian cancer
MabThera SC
NHL
Gazyvaro
Front line CLL
Xolair
Chronic idiopathic urticaria
Esbriet
Idiopathic pulmonary fibrosis
oral octreotide
Acromegaly
cobimetinib
BRAF+ met. melanoma
gantenerumab
Prodromal Alzheimer`s disease
Kadcyla/Perjeta
1L met. HER2+ breast cancer
Esbriet
Idiopathic pulmonary fibrosis
Kadcyla
Adjuvant HER2+ breast cancer
Kadcyla
Neo-adjuvant HER2+ breast cancer
venetoclax (Bcl2 inh.)
Relapsed/refractory CLL
Anti-PDL1
2/3L NSCLC
alectinib
ALK+ NSCLC
etrolizumab
Ulcerative colitis
gantenerumab
Mild Alzheimer`s disease
lampalizumab
Geographic atrophy


US, EU filing

US, EU approval

EU approval

EU approval

US approval

US approval

Ph III

Ph III (co-BRIM)

Ph III (SCarlet RoAD)

Ph III (MARIANNE)

Ph III (ASCEND)

Ph III (KAITLIN)

Ph III (KRISTINE)

Ph III (MURANO)

Ph III (OAK)

Ph III (ALEX)

Ph III (HIBISCUSI/II, GARDENIA,
LAUREL, HICKORY, COTTONWOOD) 
Ph III (Marguerite RoAD)

Ph III (CHROMA, SPECTRI)

31
Roche: A pipeline of differentiated products
Oncology
Launched
Phase III
Phase II
Avastin
Rituxan/MabThera
Herceptin
Xeloda
Tarceva
Zelboraf
Erivedge
Perjeta
Kadcyla
Gazyva/Gazyvaro
Oncology
Immunology/
Ophthalmology
Esbriet
Pulmozyme
Neuroscience
Ophthalmology
Immunology
Xolair
Actemra/RoActemra
Rituxan/MabThera RA
Lucentis
pictilisib1
taselisib1
anti-PDL1
venetoclax (Bcl2i)
cobimetinib4
alectinib
lampalizumab3
ocrelizumab
gantenerumab
10 NMEs + 9 AIs
3 AIs
6 NMEs
lebrikizumab
etrolizumab2
Neuroscience
Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014; 4 Filed in combination with Zelboraf in metastatic melanoma
AI = Additional Indication; NME = New Molecular Entity
1
32
HER2 franchise expected to grow further
Biosimilars delayed to 2017
Est. Biosimilars
launch (EU)
2nd line
mBC
Xeloda + lapatinib
1st line
mBC
Herceptin
+ chemo
Adjuvant
BC
Herceptin +
chemo
Kadcyla (EMILIA)
Herceptin & Perjeta + chemo (CLEOPATRA)
Herceptin sc + chemo
(HannaH)
Neoadjuvant Herceptin + chemo
BC
(NOAH)1
2011
2012
Established standard of care
Herceptin & Perjeta
+ chemo (APHINITY)
Herceptin & Perjeta + chemo
(Neosphere, Tryphaena)2
2013
2014
2015
Kadcyla & Perjeta
+ chemo (KRISTINE)
2016
2017
New standard of care
2018
Kadcyla (KATHERINE)
Kadcyla & Perjeta
(KAITLIN)
2019
2020
Potential new standard of care
Key priorities in 2015
• Strengthen PERJETA as standard of care in 1L mBC & neoadjuvant, Kadcyla in 2L
• Secure durable conversion from Herceptin IV to SC
Clinical data in 2015
• PERJETA 2L PHEREXA final PFS & interim OS data expected Q3 15
• Release of the NEOSPHERE final PFS/DFS data at ASCO
33
Hematology franchise
Extensive late stage clinical trial program
Biosimilars delayed to 2017
* Partnered with AbbVie
venetoclax (Bcl2 inhibitor); polatuzumab vedotin (CD79b ADC)
Compound
Combination
Indication
P1
P2
Gazyva
Mono GREEN
R/R CLL
Gazyva
Mono GOYA
aNHL
Gazyva
Mono GADOLIN
iNHL
Gazyva
Mono GALLIUM
1L FL




Gazyva
+PDL1
R/R FL
Gazyva
+PDL1
aNHL
venetoclax*
+Rituxan MURANO R/R CLL
venetoclax
+Gazyva CLL14
CLL
venetoclax
Mono
R/R CLL 17p
venetoclax
+Rituxan
R/R FL
venetoclax
Mono
1L aNHL
venetoclax
Mono
R/R NHL
venetoclax
Mono
R/R MM
venetoclax
Mono
AML
polatuzumab
+Rituxan/Gazyva
NHL
polatuzumab
+Gazyva
R/R FL
polatuzumab
+Gazyva
aNHL

















P3




 
 




34
Anti-PDL1 in triple negative breast cancer
Encouraging early data
TNBC a
PD-L1
IHC (IC)
n
ORR, Best
Response, b %
(95% CI)
PD-L1+ vs
PD-L1- ORR, b
% (95% CI)
IHC 3
6
17% (1,60)
IHC 2
3
67% (14,98)
IHC 1
-
-
-
IHC 0
-
-
-
33% (10,70)
• Encouraging efficacy in monotherapy
• Well tolerated
• Update at a medical conference in 2015
Emens LA, et al. SABCS, 2014
35
2014 Roche cancer immunotherapy:
Six NMEs moved into the clinic
T cell Trafficking
 New in 2014
Priming & activation
 Anti-CEA-IL2v
 Anti-OX40
NME (Anti-ctyokine)
T cell infiltration
Anti-CD27*
Anti VEGF: Avastin
Antigen presentation
 Anti-CD40
IMA942 vaccine*
Cancer T cell recognition
(Immatics)
 Anti-CEA-CD3
Anti-HER2-TDB
Antigen/T cell bispecific Mabs
ImmTAC* (Immunocore)
T cell killing
Clinical development
Preclinical development
Established therapies
*
Partnered projects (external)
Chen and Mellman. Immunity 2013
Antigen release
Targeted therapies:
Tarceva, cobimetinib,
Zelboraf, Gazyva




Anti-PD-L1
Anti-CSF-1R
Anti-CEA-IL2v
Anti-OX40
IDO inhibitor (NewLink Genetics)
NME (undisclosed)
IDO inhibitor* (Incyte)
36
Cancer immunotherapy program growing strongly
Compound
Combination
Indication
PDL1
Mono
+Tarceva
Lung
PDL1
Mono
Bladder
PDL1
PDL1

Mono
+Avastin
+Zelboraf
+Zelboraf+cobimetinib
Renal
Melanoma
Mono
+Avastin
+cobimetinib
+ipilimumab
+IFN alfa-2b
+CD40
+OX40
+CSF-R1
+CEA IL2v
Solid tumors
PDL1
+Avastin+FOLFOX
Colorectal
PDL1
Mono
+Gazyva
Hematology
PDL1



 Mono
PDL1
Triple negative breast cancer
CSF-1R
Mono
+CD40
Solid tumors
CEA IL-2v
Mono
Solid tumors
OX40
Mono
Solid tumors
 Mono
 Mono
Solid tumors
CEA CD3
IDO

Study ongoing
Solid tumors

Study imminent
 Additions since Q3
Ph 1
Ph 2
Ph 3
































Status as at January 2015
37
Roche cancer immunotherapy
Pipeline as of 2014 year end…
Phase I
Anti-PDL1+Tarceva
NSCLC
Anti-PDL1+Zelboraf
Melanoma
Anti-PDL1
Solid tumors
Anti-PDL1+Avastin
Solid tumors
Anti-PDL1+cobimetinib
Solid tumors
Anti-PDL1+ipilimumab
Solid tumors
Anti-PDL1+IFN-alfa
Solid tumors
Anti-PDL1+ CD40
Solid tumors
PDL1+Avastin+FOLFOX
CRC
Anti-PDL1 + Gazyva
Blood cancer
Anti-PDL1
TNBC
Anti-CSF1R
Solid tumors
Anti-CEA IL-2v
Solid tumors
Status as at December 2014
Phase II
Anti-PDL1
NSCLC (Dx+)
Anti-PDL1
NSCLC 2/3L
Anti-PDL1+Avastin
Renal 1L
Anti-PDL1
Bladder 1/2L
Anti-OX40
Solid tumors
CEA CD3
Solid tumors
IDO
Solid tumors
Phase III
Anti-PDL1
NSCLC 2/3 L
Anti-PDL1 trials
NMEs monotherapy
Immune doublets
38
Roche cancer immunotherapy
…and additional trials already decided upon
Phase I
Anti-PDL1+Tarceva
NSCLC
Anti-PDL1+Zelboraf
Melanoma
Anti-PDL1
Solid tumors
Anti-PDL1+Avastin
Solid tumors
Anti-PDL1+cobimetinib
Solid tumors
Anti-PDL1+ipilimumab
Solid tumors
Anti-PDL1+IFN-alfa
Solid tumors
Anti-PDL1+ CD40
Solid tumors
PDL1+Avastin+FOLFOX
CRC
Anti-PDL1 + Gazyva
Blood cancer
Anti-PDL1
TNBC
Anti-CSF1R
Solid tumors
Anti-CEA IL-2v
Solid tumors
Status as at January 28, 2015
Phase II
Anti-OX40
Solid tumors
CEA CD3
Solid tumors
IDO
Solid tumors
Anti-PDL1 + OX40**
Solid tumors
Anti-PDL1 + CSF1R**
Solid tumors
Anti-PDL1 + CEA-IL2v**
Solid tumors
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1
NSCLC (Dx+)
Anti-PDL1
NSCLC 2/3L
Anti-PDL1+Avastin
Renal 1L
Anti-PDL1
Bladder 1/2L
Anti-PDL1 trials
NMEs monotherapy
Phase III
Anti-PDL1
NSCLC 2/3 L
Anti-PDL1**
Bladder 2L
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Immune doublets
2015 readout expected
**
Study start in 2015
39
Oncology – Molecular Information
How we will collaborate with Foundation Medicine
Roche/FMI R&D Collaboration
1. Comprehensive tumor analysis in
Roche Clinical Trials
DNA & RNA
sequencing
2. We will innovate together
Immunotherapy
Panel
Blood based
continuous monitoring
What we aim to achieve together
Key initial areas for collaboration
• Cancer Immunotherapy test
• Continuous monitoring test
Brings together expertise needed to
innovate for patients
• Roche a leader in PHC/companion
diagnostics across modalities
• FMI a leader in comprehensive genomic
profile development and molecular
information
40
ACE 910 in Hemophilia A
FVIIIa
NON-INHIBITOR
A novel FVIIIa mimetic bispecific antibody
INHIBITOR
ACE 910
Kitazawa, Shima, Yoshioka, Hattori . Nature Medicine 2012;18(10):1570,
Sampei, et al. PLoS One 2013;8(2):e57479, Muto, Shima, Hattori . J Thromb
Haemost 2014;12:206
On-demand treatment
1-3 times/bleeding event, IV
Prophylaxis
3 times/week, IV
Inhibiting Factor VIII antibodies in 20-33% of the patients
Immune Tolerance Induction
70-80 % success rate
limitation due to very high cost and heavy burden for
patients
On-demand treatment with
bypassing agents
2-3h intervals, IV
Prophylaxis with bypassing
agents
Every other day, IV
Mode of action
Targeted product profile
Novel approach promoting FX activation
and acceleration of coagulation
• Less frequent dosing
• Subcutaneous
• Avoid induction of inhibiting antibodies
In collaboration with Chugai
41
2014 results
Innovation
Outlook
42
2015: Key late-stage news flow
Regulatory
Phase III readouts*
Phase III starts
Phase II readouts*
Compound
Indication
Milestone
Avastin
Cervical cancer
EU approval
Lucentis
Diabetic retinopathy
US approval
alectinib
ALK+ NSCLC
US filing
Cobimetinib + Zelboraf 1L Melanoma
US, EU approval
Gazyva
Front line aNHL
Ph III GOYA (interim)
ocrelizumab
Relapsing MS (RMS)
Ph III OPERA I/II
ocrelizumab
Primary progressive MS (PPMS)
Ph III ORATORIO
Perjeta
2L HER2+ mBC
Ph III PHEREXA
Kadcyla
HER2+ gastric cancer
Ph II/III GATSBY
Anti-PDL1
Bladder
Ph III
Anti-PDL1
Tumor type 1
Ph III
Anti-PDL1
Tumor type 2
Ph III
Anti-PDL1
Tumor type 3
Ph III
Etrolizumab
Crohn`s disease
Ph III
ACE910
Hemophilia A
Ph III
taselisib (PI3K inhib)
HR+/PI3Kmut BC
Ph III SANDPIPER
Anti-PDL1
2/3L NSCLC
Ph II FIR, POPLAR, BIRCH
Anti-PDL1
Bladder
Ph II
ipatasertib (AKT inhib)
Gastric/prostate cancers
Ph II A.MARTIN, JAGUAR
* Outcome studies are event driven, timelines may change
43
Diagnostics Division
Roland Diggelmann
COO Roche Diagnostics
Picture
44
2014: Diagnostics Division sales
Growth driven by Professional Diagnostics
2014
2013
CHFm
CHFm
10,766
10,476
3
6
Professional Diagnostics
6,045
5,772
5
8
Diabetes Care
2,392
2,459
-3
1
Molecular Diagnostics
1,613
1,580
2
6
716
665
8
10
Diagnostics Division
Tissue Diagnostics
Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8%
CER=Constant Exchange Rates
Change in %
CHF
CER
45
2014: Diagnostics regional sales
Growth driven by APAC and EMEA
Japan
North America
0%
+4%
EMEA1
25% of divisional sales
+4%
4% of divisional sales
45% of divisional sales
Latin America
+13%
7% of divisional sales
Asia Pacific
+15%
19% of divisional sales
16% growth in E7 countries2
1Europe,
Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey
All growth rates at constant exchange rates
46
2014: Diagnostics Division
Profit growth in line with sales excl. PSI*
2014
CHFm % sales
Sales
Royalties & other op. inc.
Cost of sales
M&D
R&D
G&A
Core operating profit
2014 vs. 2013
CER growth
10,766
100.0
6%
131
-4,790
-2,462
-1,037
-512
1.2
-44.4
-22.9
-9.6
-4.8
2%
2,096
19.5
Excl. VAT*: +8%
9%
Excl. VAT*: +8%
4%
3%
Admin: +6%
Excl. PSI*: +5%
Excl. PSI*: +5%
and VAT*: +8%
21%
2%
-4% in CHF
CER=Constant Exchange Rates
* PSI: 2013 past service income of CHF 67m; VAT: 2013 one-time VAT refund of CHF 45m
47
2014: Diagnostics
Growth driven by Professional Diagnostics
CER growth
Professional
Dia
+8% • Continued double digit growth in immunodiagnostics (+13%)
• Further expansion of leading menu
Diabetes
Care
+1%
Molecular
Dia 1
1 Underlying
• Virology (+7%) incl. HPV (+48%)
• Launch of cobas 6800/8800 systems with assays for blood
screening and virology
+6%
Tissue Dia
Sales
CHFbn
• Accu-Chek Aviva/Performa (+7%) and Mobile (+19%)
+10%
0
1
2
• Advanced staining portfolio (+9%) and companion
diagnostics (+27%)
EMEA
North America
RoW
3
4
5
6
growth of Molecular Diagnostics excluding Sequencing Solutions: +8%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
48
Serum work area (42% of sales)*
Growing strongly in all regions
+10%
Integrated SWA* solution
+8%
+15%
– Immunodiagnostics (+13%)
– Clinical chemistry (+7%)
*SWA: serum work area: clinical chemistry and immunodiagnostics
Latin America
+8%
North America
+19%
Asia-Pacific
+5%
2013
Japan
EMEA
2014
49
Invest for growth
New reagent manufacturing in China
RPD reagent volume
• Reliable local supply and right
sizing of cost base
Asia
Other
x2
• Reagent formulation, filling and
packaging
– Packaging to begin in 2016
– Fully operational in 2018
2012
2017E
RPD = Roche Professional Diagnostics
2022E
50
Extend leading menu in women’s health
High prognostic value of preeclampsia blood test
Assay and claim extension
• Extends the applicability of the assay
from 3-5% of pregnancies to 20%
• Fully automated
• Test performed across entire cobas
analyzer platform series
* Hund, M., et al. (2014) BMC Pregnancy and Childbirth 14, 324;
Zeisler, H.,. et al. (2014) XX COGI World Congress 2014
*Preeclampsia can be ruled-out for 1 week after testing
51
Molecular Diagnostics
Launch and implementation of cobas 6800/8800
High Throughput
Reference Labs
cobas® 8800
• Advanced PCR automation
• Highest throughput (3x above closest
competitor)
• CE launch of blood screening and
virology assays
Large Hospitals
cobas® 6800
• Low to middle volume throughput
• Broadest menu incl HPV testing
Medium Hospitals
cobas® 4800
Low Throughput
52
Entering Molecular Point of Care Diagnostics
Acquisition of IQuum, launch of cobas Liat™ analyzer
Liat™ Analyzer
Liat™ tube
Target market:
• ~CHF 350m, growing ~20% p.a.
Laboratory in a tube technology:
• Fast and easy to use
• CLIA waiver expected in 2015
Portfolio:
• Influenza A/B and Strep A test, CE marked
and FDA cleared
• Plans to extend menu in:
– Respiratory Syncytial Virus tests
– MRSA and C-difficile
Point of Care: e.g. physician’s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus
53
Sequencing strategy
Building a leading sequencing solution
Developing complete sequencing solutions
Grow through
disruptive
innovation
Sample
preparation
Testing
platform
Menu of
assays
Data
analysis
Abvitro: Technology acquisition; Ariosa: Acquisition; Genia: Acquisition; Pacific Biosciences: Partnership; Bina: Acquisition;
Foundation Medicine: Partnership
Reporting
54
Sequencing menu: Non-invasive prenatal testing
Acquisition of Ariosa
HarmonyTM Prenatal Test
Target market
• USD 400m sales worldwide in 2013, +30% pa
Technology
• Analyses fetal DNA with microarray technology
• Highly cost effective and accurate
• Screens for the risk of Down, Edwards and Patau
syndrome
Digital analysis of selected
regions (DANSRTM) technology
Strategy
• Expand market access through kit distribution model
• Add test to Roche sequencing platform when available
55
Key launches 2014
Instruments
/
Devices
Tests
/
Assays
Area
Product
Labs
cobas 6800/8800 – Next generation molecular (PCR) system
cobas m 511 – Fully integrated and automated hematology system
cobas 6500 – Automated urinalysis work area platform
Connect-V – Middleware providing connectivity to LIS2
Diabetes
Care
Infectious
Diseases /
Blood
Screening
Microbiology
Women’s
Health
*Excluding
Accu-Chek Insight- Next generation insulin pump & bGm3 system
Accu-Chek Connect – bG meter with connectivity to smart phones,
mobile App and cloud
MPX 2.0 – Next generation blood screening multiplex test
MPX (HIV, HCV, HBV), HEV, DPX4, WNV5 – Full NAT blood
screening menu for cobas 6800/8800
HIV, HCV, HBV – Virology tests for cobas 6800/8800
HSV- Detection of Herpes Simplex Virus on cobas 4800
Syphilis– Immunoassay for the detection of Treponema pallidum
MRSA/SA – Next generation assay on cobas 4800
C-difficile – Diagnosis of infections and associated diarrhea
PE Prognosis- Claim extension for short-term prediction of
Preeclampsia in pregnancy
AMH- Assessment of ovarion reserve for fertility
Market
WW* 
EU
EU 
WW 
RMD
RPD
RPD
RTD
EU

RDC
EU

RDC
US  RMD
WW*  RMD
WW*  RMD
EU  RMD
EU  RPD
EU
EU


RMD
RMD
EU
EU


RPD
RPD
US;
Areas: RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics, RTD: Roche
Tissue Diagnostics; 2 hospital information systems; 3 blood glucose monitoring; 4 parvovirus B19 and hepatitis A virus; 5 west nile virus
1 Business
BA1
56
Key launches 2015
Area
Laboratory
Instruments
/
Devices
Tests
/
Assays
Diabetes
Care
Product
Market BA1
cobas c 513 – dedicated HbA1C analyzer
RPD
EU
cobas t 411– core lab coagulation analyzer
EU
RPD
WW
cobas 8100 V2 – Integrated pre- and post-analytical solution
RPD
®
US
cobas 6800/8800 – Medium to High volume automated real-time PCR
RMD
WW
RTD
VENTANA HE 600 – automated H&E staining platform
Accu-Chek Active no-code– next-gen. bG meter, no coding of test strips WW
RDC
Accu-Chek Connect – bG meter with connectivity to smartphones, mobile
US
RDC
applications and cloud
Point of Care CoaguChek® Pro II - professional system for PT and aPTT testing
EU
RPD
Blood
Screening
cobas® 6800/8800 MPX – Multiplex Bloodscreening test
US
RMD
Infectious
Diseases
cobas® Liat Influenza A/B + RSV – POC detection
HTLV– human T-lymphotropic virus diagnostics test
cobas® 6800/8800 HBV – Quantitative HBV viral load test
cobas® 4800 HIV-1 - Quantitative HIV viral load test
cobas® 4800 HCV – Quantitative HCV viral load test
cobas® 4800 HBV – Quantitative HBV viral load test
US
EU
RMD
RPD
EU
EU
EU
EU
RMD
RMD
RMD
RMD
EU
RMD
EU
RPD
Virology
Genomics &
cobas® EGFR Test v2 - detection of EGFR in plasma
Oncology
Cardiac
Cobas h 232 Troponin T – Point of Care test version of Elecsys cTNT-hs
Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics;
RTD: Roche Tissue Diagnostics;
1
57
Outlook
Investing into future growth
• Continued strong growth in serum work area
• Focus on implementation of next generation platforms, e.g. cobas 6800/8800
• Continued investment into development of future sequencing solution
• Ongoing structural adjustments in Diabetes Care to adapt to continuing
challenging market environment
• Strengthen leading presence in emerging markets
58
Finance
Alan Hippe
Chief Financial Officer
59
2014: Highlights
Business
• Solid sales and Core EPS growth: +5%1; Core EPS +7%1 excluding US Pharma fee*
• Core operating profit up +3%1 or +5%1 excluding US Pharma fee*
• Cash generation remains strong with operating FCF of CHF 15.8bn, a decrease of -2%1
due to higher capital investments
• Accounts receivable in Southern Europe further decreased
Improved financial result and major currency impact
• Positive development of Core Net Financial result: +32%1 due to sale of equities and
lower interest expenses
• Increased net debt due to acquisitions
• Group currency exposure – solid natural hedge, 82% of cost base outside Switzerland
CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
1
60
2014: Group currency exposure
Overall solid natural hedge
Currency
exposure
50%
Sales
Operating costs
40%
41%
38%
30%
28%
20%
21%
21%
18%
17%
10%
8%
0%
6%
2%
CHF
USD
EUR
JPY
FY 2014 currency structures; operating costs include all items between the sales and the operating profit lines
Others
61
2014 performance
Focus on cash
62
2014: Group performance
Core EPS growth +5%1 or +7%1 excl. US Pharma fee*
Sales
Core operating profit
as % of sales
Core net income
as % of sales
Attributable to Roche shareholders
Core EPS (CHF)
Operating free cash flow
as % of sales
Free cash flow
as % of sales
2014
2013
CHFm
CHFm
47,462
17,636
37.2
12,533
26.4
12,329
46,780
17,904
38.3
12,526
26.8
12,316
1
-1
5
3
5
0
6
7
0
6
7
14.29
14.27
0
5
7
15,778
33.2
5,322
11.2
16,381
35.0
5,403
11.5
-4
-2
-1
1
CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
1
Change in %
CHF
Excl. US
CER
Pharma fee*
63
2014: Group operating performance
Core OP growth +3%1 or +5%1 excl. US Pharma fee*
2014
CHFm % sales
Sales
Royalties & other op. inc.
Cost of sales
M&D
R&D
G&A
Core operating profit
2014 vs. 2013
CER growth
47,462
100.0
2,404
-12,341
-8,436
-8,913
-2,540
5.1
-25.9
-17.8
-18.8
-5.4
Excl. filgrastim
deal: +10%
17,636
37.2
Excl. US Pharma
fee*: +5%
5%
33%
6%
6%
4%
Excl. PSI and US
Pharma fee*:+8%
38%
3%
-1% in CHF
CER=Constant Exchange Rates
* US Pharma fee: one-time double charge for the US Branded Prescription Drug fee in 2014; PSI: 2013 past service income of CHF 302m
1
64
2014: Core operating profit and margin
Margin at high levels
44.0%
37.7%
38.3%
CHFm
37.2% (-0.1%p2)
-0.5 %p1
(-1.1 %p)
1
+3 %
(-1 %)
17,160 17,904 17,636
44.4%
43.6% (+0.3%p2)
-0.2 %p1
(-0.8 %p)
+4 %1
(-1 %)
15,488 16,108 16,001
% of sales
21.3%
20.8%
19.5%
-0.9 %p1
(-1.3 %p)
+2 %1
(-4 %)
2012
2013
Roche Group
1 CER=Constant
2 At
2,187 2,177 2,096
2014
Pharma Division
Exchange Rates
CER excluding one-time double charge for the US Branded Prescription Drug fee in 2014
Diagnostics Division
65
2014: Core net financial result
Higher income from equities and lower interest expenses
CHFm
0
-500
-1.116
-1.699
Improvement of 34% in CHF / 32% at CER
-1.000
+136
+69
Interest
expense
FX
gains/losses
+90
+288
-1.500
-2.000
2013
CER=Constant Exchange Rates
Net income
from equity
securities
All other, net
2014
66
Balance sheet 31 December 2014
Equity ratio at 29% due to acquisitions
CHFbn
CHFbn
75.6
Cash and
marketable
securities
11.7
62.2
11.9
19%
Other
current
assets
Non-current
assets
Current
liabilities
62.2
23.1
19.4
15.8
31%
26%
25%
15%
17.3
28%
33.0
44.5
53%
59%
31/12/13 31/12/14
Assets
CER=Constant Exchange Rates
75.6
Non-current
liabilities
25.2
Equity
(Net assets)
41%
30.9
Net debt/
40%
total assets:
19%
21.2
21.6
34%
29%
31/12/13 31/12/14
Equity & liabilities
67
2014: Group core tax rate
Double R&D tax credits in 2013
Figures in %
+1.0
+0.4
Relative higher
core profits in US
US R&D tax credits
for 2012 and 2013,
included in 2013
while only one year
credits in 2014
22,7
2013
Profit mix
US
24,1
2014
68
2014 performance
Focus on cash
69
2014: Operating free cash flow remains at high
levels
41.8%
35.5%
35.0%
33.2%
-2.4 %p1
(-1.8 %p)
-2 %1
(-4 %)
CHFm
16,135 16,381 15,778
41.3%
40.4%
% of sales
-1.7 %p1
(-0.9 %p)
0 %1
(-1 %)
18.4%
18.7%
13.2%
14,710 14,976 14,821
-5.3 %p1
(-5.5 %p)
-24 %1
(-28 %)
2012
2013
Roche Group
CER=Constant Exchange Rates
1,890 1,962
2014
Pharma Division
1,417
Diagnostics Division
70
2014: Accounts receivable in Southern Europe
further decreased
B
BB
Dec 2014
161
185
251
236
Greece
Dec 2013
Dec 2012
97
114
163
209
Portugal
Dec 2011
433
BBB-
733
819
Italy
980
480
BBB
613
604
Spain
1.036
Southern
European
Countries
1.171
0
1 CER=Constant
400
800
1.200
Exchange Rates
Note: Sovereign country ratings from Standard & Poor’s, as of 7 January 2015
1.645
1.836
1.600
2.000
-52%1
2.462
2.400
2.800
CHFm
71
2014: Group net debt development
Higher net debt due to InterMune acquisition
Free Cash Flow CHF 5.3bn
1% (CER) higher than 2013
CHFbn
+15.8
-10.5
-6.7
-14,0
-12.6
Dividends
Taxes
Treasury
Net debt
31 Dec 2013
CER=Constant Exchange Rates
Operating Free
Cash Flow
Non-op.
FCF
-6.7
-3.0
-0.8
Business comb.
Own equities
Other
-9.6
-0.8
-2.2
Business combinations,
Net debt
Currency translation
31 Dec 2014
& other
72
Balance sheet: Net debt to total assets
Ratio higher than 2013 due to InterMune acquisition
19%
Net debt /
total assets
16%
11%
75.6
Total assets
(CHFbn)
Net debt
(CHFbn)
14.0
31 Dec 2012
31 Dec 2013
31 Dec 2014
73
December 2014: Debt maturity profile
Balanced maturity profile
CHFbn
5
GBP
CHF
EUR
USD
4
3
2
1
0
2015
2016
2017
2018
2019
2021
2022
2023
2024
2035
2039
2044
Of the CHF 48 bn bonds and notes issued to finance the Genentech transaction,
cumulative CHF 36 bn have been repaid as of December 31, 2014*
Nominal values @ actual FX rates; *Original net proceeds in CHF
74
Currency impact on Swiss franc results 2014
Negative currency impact
CHF / USD
Assumed average YTD 2014
Average YTD
2013 0.93
-4%
0.89
+1%
0.90
0.89
0.88
0.88
0.89
0.94
0.93
-5%
-4%
+1%
0.89
0.90
0.90
0.90
0.91
Monthly avg fx rates 2014
J
F
M
A
0.94
0.93
-1%
In 2014 impact is (%p):
0.91
0.95
0.96
0.98
Fx rates at 31 Dec 2014
M
J
J
A
S
O
N
D
Sales
CHF / EUR
1.23
1.22
1.23
1.23
1.23
1.22
-1%
-1%
1.22
1.21
-1%
+2%
0%
+2%
1.23
1.22
1.22
1.22
1.22
1.22
1.22
1.21
1.21
1.21
1.20
1.20
J
F
M
A
M
J
J
A
S
O
N
D
Q1
HY
Sep
YTD
FY
-6
-6
-5
-4
Core
operating
profit
-8
-4
Core EPS
-8
-5
75
Currency sensitivities for 2014
Impact of 1% change in average exchange rate vs. the Swiss franc
Sales
Core OP
190
76
Euro
98
48
Japanese yen
37
20
131
70
Figures in CHFm
US dollar
All other currencies
76
2015 outlook
1 At
2
Group sales growth1
Low to mid-single digit
Core EPS growth1
Ahead of sales growth2
Dividend outlook
Further increase dividend in Swiss francs
constant exchange rates
Excluding sale of filgrastim rights in 2014
77
Changes to the development pipeline FY 2014 update
New to Phase I
New to Phase II
New to Phase III
New to Registration
11 NMEs
RG6047 SERD (2) – ER-pos (HER2neg) mBC
RG6078 IDO inh - solid tumors
RG7802 CEA CD3 TCB - solid tumors
RG7876 CD40 iMAb+PD-L1 MAb solid tumors
RG7787 MSLN-PE cFP – solid tumors
RG7689 NME – infectious diseases
RG7880 NME - autoimmune diseases
RG7625 NME - autoimmune diseases
RG6080 DBO β-lactamase inh bacterial infections
RG7345 TAU pS422 MAb – AD
RG7597 HER3/EGFR DAF+cobimetinib
– KRAS mutation-pos tumors
2AIs
RG7155 CSF-1R+PD-L1 MAb - solid
tumorssolid tumors
RG7446 PD-L1 MAb + Gazyva –
lymphoma
2NMEs transitioned from Ph1
RG6046 SERD ER-pos (HER2-neg) mBC
CHU: URAT 1 inh - gout
5 AIs
RG3502 Kadcyla – HER2-pos advanced
NSCLC
RG435 Avastin + Tarceva - EGFR mutpos. NSCLC
RG6062 Esbriet – ILD, systemic sclerosis
related
RG7421 cobimetinib – triple negative
breast cancer
RG7601 venetoclax (Bcl-2-inh)+
Rituxan - rel/ref follicular lymphoma
3 AIs
RG7601 venetoclax (Bcl-2
inh)+ Gazyva - CLL 1st line
RG7446 PD-L1 bladder cancer
2nd line
CHU Actemra – large-vessel
vasculitis (added by Chugai)
1 AI following EU submission
RG105 MabThera – CLL
subcutaneous formulation
Removed from Phase I
Removed from Phase II
Removed from Phase III
Removed from Registration
1 AI removed by Chugai
Suvenyl - enthesopathy
1 AI following US approval
RG435 Avastin - rel. ovarian ca. Ptresistant
3 NMEs
RG7666 PI3K inh - glioblastoma 2L
RG7624 IL-17 MAb - autoimmune
diseases
RG7458 MUC16 ADC - ovarian and
pancreatic cancer
Status as of January 28, 2015
6 NMEs
RG7593 pinatuzumab vedotin (CD22
ADC) - heme tumors
RG7449 quilizumab - asthma
RG7128 mericitabine - HCV
RG1512 inclacumab - ACS/CVD
RG1578 decoglurant (mGluR2 NAM) depression
RG7597 HER3/EGFR DAF m. epithelial
tumors
79
Roche Group development pipeline
Phase I
(33 NMEs + 11 AIs)
Oncology
RG6016
LSD1 inh
RG6047
SERD (2)
RG6061
Other disease areas
AML
RG7625
autoimmune diseases
ER+(HER2-neg) mBC
RG7880
-
HIF1 alpha LNA
solid tumors
RG6080
DBO β-lactamase inh
RG6078
IDO inh
solid tumors
RG7689
-
RG7116
HER3 MAb
solid tumors
RG7795
TLR7 agonist
RG7155
CSF-1R + PDL-1 MAb
solid tumors
RG7641
aldosterone synth inh
met. diseases
RG7304
Raf & MEK dual inh
solid tumors
RG7203
PDE10A inh
schizophrenia
RG7388
MDM2 ant
solid & hem tumors
RG7342
mGlu5 PAM
schizophrenia
RG7446
PD-L1 MAb+Tarceva
RG7345
TAUpS422 MAb
RG7446
PD-L1 MAb+Zelboraf+/-cobimetinib
m. melanoma
RG7410
TAAR1 ago
schizophrenia
RG7446
PD-L1 MAb+Avastin+chemo solid tumors
RG7893
Nav1.7 inh
pain
RG7446
PD-L1 MAb+cobimetinib solid tumors
RG7800
SMN2 splicer spinal muscular atrophy
RG7446
PD-L1 MAb+ipi/IFN
solid tumors
RG7935
a-synuclein MAb
RG7446
PD-L1 MAb
solid tumors
RG3645
Lucentis sust. deliv.
RG7446
PD-L1 MAb+Gazyva
lymphoma
RG7716
VEGF-ANG2 MAb
RG7450
Steap 1 ADC
RG7597
NSCLC EGFR+
prostate ca.
HER3/EGFR DAF+ cobi
KRAS+ s. tumors
RG7601
venetoclax (Bcl-2)+ Gazyva
CLL
RG7601
venetoclax (Bcl-2)
RG7741
ChK1 inh
RG7775
MDM2 (4) IV prodrug
RG7787
MSLN PE cFP
solid tumors
RG7802
RG7813
CEA CD3 TCB
CEA IL2v
solid tumors
solid tumors
RG7841
RG7842
ADC
solid tumors
ERK inh
solid tumors
RG7876
RG7882
CD40 iMAb+PD-L1 MAb solid tumors
ADC
ovarian ca
RG7888
OX40 MAb
heme indications
solid tum & lymphoma
Status as of January 28, 2015
AML
solid tumors
CLL
autoimmune diseases
bact. infections
infectious diseases
HBV
Alzheimer’s
Parkinson's Disease
AMD/RVO/DME
wAMD
New Molecular Entity (NME)
Additional Indication (AI)
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
RG-No Roche Genentech managed
CHU
Chugai managed
80
Roche Group development pipeline
Phase II
(23 NMEs + 12 Als)
Phase III
(9 NMEs + 21 Als)
Registration
(1 NME + 4 Als)
EGFR mut+ NSCLC
RG4351
Avastin
glioblastoma 1st line
RG105
MabThera SC
HER2+ NSCLC
RG4351
Avastin
ovarian cancer 1st line
RG4352
Avastin
recurrent cervical cancer
hemophilia A
RG4351
Avastin
rel. ovarian ca. Pt-sensitive
RG12732 Perjeta
HER2+ BC neoadj
ER+(HER2-neg) mBC
RG435
Avastin
NSCLC adj
RG7421
cobimetinib + Zelboraf
2nd
RG36453
Lucentis
RG435
RG3502
Avastin+Tarceva
RG6013
FIXa /FX bispecific MAb
RG6046
SERD
RG7155
CSF-1R MAb
RG7221
Ang2-VEGF MAb
Kadcyla
PVNS/solid tumors
RG1273
Perjeta
colorectal cancer
RG1273
Perjeta
pictilisib
solid tumors
RG7421
RG7440
cobimetinib
ipatasertib (AKT inh)
TNBC
solid tumors
RG1273
RG3502
Perjeta HER2+ gastric cancer 1st line
Kadcyla HER2+ gastric cancer 2nd line
RG3502
Kadcyla +/- Perjeta HER2+ mBC 1st l
RG7446
PD-L1 MAb
RG3502
Kadcyla
RG7446
PD-L1 MAb + Avastin
RCC
RG3502
Kadcyla + Perjeta
HER2+ BC adj
RG7446
PD-L1 MAb
bladder cancer 1/2l
RG3502
Kadcyla + Perjeta
HER2+ BC neoadj
RG7596 polatuzumab vedotin (CD79bADC) hem tumors
RG7159
Gazyva
ADC
RG7599 lifastuzumab vedotin (NaPi2bADC)Pt-resist. OC
RG7159
Gazyva
iNHL rituximab refractory
RG7601 venetoclax (Bcl-2) C LL rel/refract 17pdel
RG7159
Gazyva
follicular lymphoma 1st line
RG7601 venetoclax (Bcl-2)
DLBCL
RG7204
Zelboraf
rel/ref FL
liver cancer
systemic sclerosis
RG7446
RG7446
RG7601
RG7601
PD-L1 MAb
NSCLC 2nd line
PD-L1 MAb
bladder cancer 2nd line
venetoclax (Bcl-2) + Rit.
CLL rel/ref
venetoclax+Gazyva (Bcl-2) CLL 1st line
IPF
RG7853
alectinib (ALK inhibitor)
lebrikizumab SSc
Esbriet
idiopathic
– interstitial
pulmonary
lung disease
fibrosis
RG1569
Actemra
IL-31R MAb
RG3637
RG7413
lebrikizumab
etrolizumab
pictilisib
RG7321
NSCLC 2nd/3rd line
RG7601 venetoclax (Bcl-2)+ Rituxan
RG7604
taselisib (mutant-selective)
RG7686
RG1569
glypican-3 MAb
Actemra
RG3637
lebrikizumab
RG3637
RG6062
CHU
solid tumors
atopic dermatitis
RG7227
danoprevir
HCV
RG7745
RG7790
RG7929
Flu A MAb
setrobuvir
influenza
HCV
RG7929
LptD antibiotic
RG7697
GIP/GLP-1 dual ago
CHU
RG1577
URAT 1 inh
MAO-B inh
RG1662
RG1678
GABRA5 NAM
Down Syndrome
bitopertin
obsessive compulsive dis.
RG7090
RG7314
RG7412
basimglurant (mGlu5 NAM)
TRD
V1 receptor antag
autism
crenezumab
Alzheimer’s
antibacterial
type 2 diabetes
gout
Alzheimer’s
CHU
Actemra
CHU
IL-6R MAb
HER2+ mBC
line
CLL
m. melanoma
diabetic retinopathy
HER2+ BC adj
HER2+ BC adj
1
2
3
US only : FDA submission decision pending
Approved in US, submitted in EU
Submitted in US
DLBCL 1st line
melanoma adj
NSCLC
giant cell arteritis
severe asthma
ulcerative colitis
large-vessel vasculitis
neuromyelitis optica
RG1450
RG1594
gantenerumab
ocrelizumab
RG1594
ocrelizumab
RG7417
lampalizumab (factor D)
Status as of January 28, 2015
Alzheimer’s
RMS
PPMS
geo. atrophy
New Molecular Entity (NME)
Additional Indication (AI)
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
RG-No Roche Genentech managed
CHU
Chugai 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
81
NME submissions and their additional indications
Projects currently in phase 2 and 3
gantenerumab (RG1450)
Alzheimer‘s
SERD (RG6046)
cobimetinib (MEK inh)
combo Zelboraf
met melanoma

ER+(HER2-neg) mBC
MAO-B inh (RG1577)
Alzheimer‘s
FIXa /FX bispecific MAb
(RG6013) hemophilia A
GABRA5 NAM (RG1662)
Down syndrome
CSF-1R MAb (RG7155)
PVNS and solid tumors
bitopertin (RG1678)
obsessive compulsive dis.
Ang2-VEGF MAb (RG7221)
colorectal cancer
basimglurant (RG7090)
depression
ipatasertib AKT inh
(RG7440) solid tumors
V1 receptor antag (RG7314)
autism
polatuzumab vedotin (RG7596)
CD79b ADC heme tumors
crenezumab (RG7412)
Alzheimer‘s
idiopathic pulmonary fibrosis
ocrelizumab (RG1594)
PPMS
pictilisib PI3K inh
(RG7321) solid tumors
cobimetinib
TNBC
etrolizumab (RG7413)
ulcerative colitis
lebrikizumab (RG3637)
severe asthma
lifastuzumab (RG7599)
NaPi2b ADC Pt resistant OC
PDL-1 MAb (RG7446)
combo Avastin RCC
lampalizumab anti-factor D
(RG7417) geo atrophy
PDL-1 MAb (RG7446)
bladder cancer
(mutant-selective) solid tumors
taselisib (PI3Ki, RG7604)
venetoclax (Bcl-2i, RG7601)
+ Rituxan rel/ref FL
danoprevir* (RG7227)
HCV
PD-L1 MAb (RG7446)
NSCLC 2nd/3rd line
glypican-3 Mab (RG7686)
liver cancer
venetoclax (Bcl-2i, RG7601)
+ Gazyva CLL 1st line
Flu A MAb (RG7745)
influenza
ocrelizumab (RG1594)
RMS
venetoclax (Bcl-2i, RG7601)
CLL rel/ref
alectinib (RG7853)
ALK-pos. NSCLC
venetoclax (Bcl-2i, RG7601)
+ Gazyva DLBCL
LptD antibiotic (RG7929)
antibacterial
2015
2016
2014
Unless stated otherwise, submissions are planned to occur in US and EU
* lead market China
Status as of January 28, 2015
lebrikizumab (RG3637)
2017 and beyond
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
NME
82
Submissions of additional indications for existing
products
Projects currently in phase 2 and 3
Gazyva
iNHL rituximab refractory
Gazyva
follicular lymphoma 1st line
Zelboraf
melanoma adj.
Perjeta
HER2-pos. gastric cancer 1L
*Avastin (US)
ovarian cancer 1st line
Kadcyla+Perjeta
HER2-pos. BC neoadj
Kadcyla
HER2-pos. NSCLC
Lucentis (US)
diabetic retinopathy

*Avastin (US)
rel. ovarian ca. Pt-sens
MabThera SC (EU)
CLL

Avastin +Tarceva(EU)
EGFR mut+ NSCLC
Gazyva
DLBCL 1st line
Kadcyla+Perjeta
HER2-pos. BC adj

Avastin (US)
GBM
Perjeta
HER2-pos. mBC 2ndline
Kadcyla
HER2-pos. BC adj

Kadcyla +/- Perjeta
HER2-pos mBC 1st line
Perjeta
HER2-pos. BC adj
Avastin
NSCLC adj

Kadcyla
HER2-pos gastric cancer 2L
Actemra
giant cell arteritis
Actemra
systemic sclerosis
2016
2017 and beyond
**Perjeta (EU)
HER2-pos. BC neoadj
*Avastin (US)
rel. ovarian ca. Pt-resist
**Avastin (EU)
cervical cancer recurrent
2014
2015
 Indicates submission to health authorities has occurred.
* approved in EU; ** approved in US
Unless stated otherwise, submissions are planned to occur in US and EU.
Status as of January 28, 2015
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
NME
83
Major granted and pending approvals 2014
Pending approvals
Approved
Avastin
rel. ovarian ca. Pt-resist
November 2014
Esbriet*
idiopathic pulmonary fibrosis
October 2014
Avastin
cervical cancer
August 2014
Xolair
chronic idiopathic urticaria
March 2014
cobimetinib + Zelboraf
m. melanoma
Filed December 2014
MabThera
NHL sc formulation
March 2014
RoActemra
RA sc formulation
April 2014
Avastin
cervical cancer
Filed April 2014
Gazyvaro
CLL
July 2014
RoActemra
early RA
September 2014
Perjeta
BC neoadjuvant
Filed September 2014
Avastin
rel. ovarian ca. Pt-resist
August 2014
Esbriet*
idiopathic pulmonary fibrosis
March 2011
cobimetinib + Zelboraf
m. melanoma
Filed September 2014
US
EU
Lucentis
diabetic retinopathy
Filed August 2014
MabThera SC
CLL
Filed November 2014
Japan-Chugai
alectinib ALECENSA
ALK-pos rec/adv NSCLC
July 2014
Zelboraf
m. melanoma
December 2014
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Status as of January 28, 2015
* Newly acquired asset (Intermune)
Neuroscience
Ophthalmology
Other
NME
84
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