Document 6570058

Roche
YTD September 2014 sales
Basel, 16 October 2014
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
Q3 2014: Highlights
Growth
• Group sales +5%1 as of YTD Sept 2014 driven by HER2 franchise (+21%1), Avastin (+6%1), Actemra
(+24%1) and Professional Diagnostics (+8%1)
• Group International growth accelerated to +8%1 in Q3 2014 (up from +6%1 in Q2 & +3%1 in Q1)
Innovation
• ESMO 2014 highlights: new data on Perjeta, Avastin in TML and cobimetinib/Zelboraf in melanoma as
well as encouraging updates on cancer immunotherapy
• Approvals: Avastin in ovarian cancer (EU), cervical cancer (US); Actemra in early RA (EU); Gazyvaro in
CLL (EU)
• Filings: Lucentis in diabetic retinopathy (US), Perjeta in neo-adjuvant (EU)
Acquisition of InterMune
• Tender offer: Successfully completed, closing September 29, 2014
• Financing: Bond issuance successfully completed with USD 5.75bn raised
• Esbriet: Approved in the US
1 CER=Constant
Exchange Rates
5
YTD Sept 2014: Strong sales growth continues
YTD Sept YTD Sept
2014
2013
Pharmaceuticals Division
Diagnostics Division
Roche Group
CER=Constant Exchange Rates
Change in %
CHFbn
CHFbn
CHF
CER
27.0
27.2
-1
4
7.8
7.7
1
6
34.8
34.9
0
5
6
Roche Group sales: Continued growth for 3yrs
10%
8%
8%
6%
6%
5%
4%
4%
4%
2%
0% 0%
0%
-2%
7%
6% 6%
1%
4%
5%
4%
2%
-3%
-4%
-5%
-6%
Q3
10
Q4
10
Q1
11
Q2
11
Q3
11
Q4
11
All growth rates at Constant Exchange Rates (CER)
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
7
YTD Sept 2014: Both Divisions growing in all
regions
CHFbn
14
+5%
+6%
12
+2%
10
+6%
8
+2%
+12%
+5%
6
4
2
+7%
+3%
+3%
International
Europe
+3%
Diagnostics
Pharma
+7%
0
Japan
All growth rates at Constant Exchange Rates (CER)
US
8
Roche: A pipeline of distinct products
Oncology
Launched
Phase III
Phase II
1
Immunology/
Ophthalmology
Neuroscience
Avastin
Rituxan/MabThera
Herceptin
Xeloda
Tarceva
Zelboraf
Erivedge
Perjeta
Kadcyla
Gazyva/Gazyvaro
Esbriet
Pulmozyme
Xolair
Actemra/RoActemra
Lucentis
Rituxan/MabThera RA
pictilisib1
taselisib1
anti-PDL1
BCL2i
cobimetinib
alectinib
lebrikizumab
etrolizumab2
lampalizumab3
ocrelizumab
gantenerumab
8 phase II
1 phase II
7 phase II
Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014
= Respiratory portfolio highlighted
9
Planned data presentations in H2 2014
ASH
Berlin, 18-21 Oct
mGlu5
• MARIGOLD study
(Phase 2 in depression)
1 In
collaboration with Chugai
Chicago, 30 Oct -1 Nov
San Francisco, 6-9 Dec
Alecensa (alectinib)1
• Japan Phase 1/2 update
Gazyva
• GREEN study G + various
backbones
Avastin Lung
• BEYOND study (planned)
ACE9101
• Hemophilia
10
2014 Outlook
1 At
Group sales growth1
Low- to mid-single digit
Core EPS growth1
Ahead of sales growth
Dividend outlook
Further increase dividend
constant exchange rates
11
Pharmaceuticals Division
Daniel O’Day
COO Roche Pharmaceuticals
12
YTD Sept 2014 sales
Innovation
Outlook
13
YTD Sept 2014: Pharma sales
US and EU remain major growth contributors
YTD Sept YTD Sept
2014
2013
Change in %
CHFm
CHFm
26,965
27,190
-1
4
11,528
11,429
1
5
Europe
7,070
6,952
2
3
Japan
2,406
2,492
-3
7
International
5,961
6,317
-6
3
Pharmaceuticals Division
United States
CER=Constant Exchange Rates
CHF
CER
14
YTD Sept 2014: Pharma sales
HER2, Avastin & Actemra main growth drivers
CER growth
Perjeta
+255%
Herceptin
+7%
Avastin
+6%
Kadcyla
+148%
+24%
Actemra/RoActemra
MabThera/Rituxan
+3%
Xolair
+24%
Activase/TNKase
+14%
Lucentis
+5%
Pegasys
Xeloda
CHFm
-17%
-43%
-600
-400
-200
0
200
Absolute amounts in CHFm at Constant Exchange Rates (CER) average 2013; all growth rates at CER
US
Europe
Japan
International
400
600
15
YTD Sept 2014: Oncology sales up 5%
CER growth
Perjeta
HER2
+21%  Strong uptake of Perjeta & Kadcyla
+21%
Herceptin
Kadcyla
MabThera/
Rituxan
+3%
+3%
Tarceva
0%
0%
Xeloda
-43%
 In-class competition
 Loss of exclusivity in EU (Dec ‘13) & US (March ‘14)
 Competitive pressure in US & EU
 Strong growth in International regions
-8%
-8%
Zelboraf
CHFbn
 Treatment through multiple lines in CRC
 Continued uptake in breast cancer (EU)
+6%
+6%
Avastin
0
 Increased usage across a variety of indications
 Comparison distorted by 340B baseline effect
2
CER=Constant Exchange Rates
4
6
16
Avastin: Future growth supported by ovarian,
cervical, breast and colorectal cancer
CHFm
CER growth
Platinum-resistant ovarian cancer
2,000
1,500
+14%
+11%
+6%
• Priority review (FDA, PDUFA Nov 19)
and EU approved
Cervical cancer
• US approved and filed in EU
1,000
HER2 negative breast cancer
• Positive Phase 3 data in treatment
through multiple lines (TML) and 1L
500
Colorectal cancer
0
Q3 12
US
Q3 13
Europe
CER=Constant Exchange Rates
International
Q3 14
• CALGB H2H data support standard of
care in 1L
Japan
17
HER2 franchise: Strong growth driven by Perjeta
and Kadcyla
CHFm
CER growth
+23%
2,000
• ESMO: Unprecedented overall survival
benefit in combo with Herceptin of 56.5
months
+15%
1,500
Perjeta 1L
+16%
• US: OS label update expected in Q4 ‘14
1,000
Kadcyla 2L
• Now approved in 63 countries, UK
funding through Cancer Drug Fund
500
Clinical trials
0
Q3 12
Herceptin
CER=Constant Exchange Rates
Q3 13
Perjeta
Q3 14
• MARIANNE results in Q4 ‘14
Kadcyla
18
Actemra: Continued uptake
SC formulation driving further growth
CHFm
CER growth
350
+28%
300
250
200
+46%
+32%
+27%
+30% +32%
+23% +23%
+33% +33%
+21%
150
19%
SC
81%
IV
100
50
0
Q1
12
Q2
12
CER=Constant Exchange Rates
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
19
YTD Sept 2014 sales
Innovation
Outlook
20
ESMO 2014: Highlights
Strong data across the major oncology franchises
Metastatic breast cancer
Cancer immunotherapy anti-PDL1
• Perjeta: Unprecedented overall
survival benefit in 1L HER2+ mBC
• Bladder cancer: Strong follow-on data
in monotherapy
• Renal cancer: Promising early efficacy
data in mono & in combo with Avastin
• Colorectal cancer : Good safety
profile in combo with Avastin & chemo
• Avastin: Positive phase 3 data in
HER2- mBC in 1L and treatment
through multiple lines
Melanoma
Colorectal cancer
• cobimetinib + Zelboraf: Strong
profile in a market with rapidly
changing treatment options
• Avastin: Confirmed standard of care proven survival benefit in 1L & 2L,
irrespective of biomarker status
21
CLEOPATRA: Perjeta + Herceptin in 1L mBC
Unprecedented overall survival benefit
OS analysis: Feb 2014
1.0
0.9
Proportion event-free
0.8
• Unprecedented overall survival
benefit of ~5 years despite
crossover
0.7
0.6
0.5
HR 0.68
0.4
95% CI = 0.56, 0.84
p = 0.0002
0.3
Δ 15.7
0.2
0.1
• MARIANNE still expected by
year end (Perjeta + Kadcyla 1L
mBC)
40.8
56.5
0.0
0
10
20
30
40
50
60
70
80
Time (months)
Perjeta + Herceptin + chemo
Placebo + herceptin + chemo
Source: Published online in Lancet Oncology
Presented at ESMO 2014
22
TANIA: Avastin in 2/3L HER2- mBC
Continued use improves outcomes
2L PFS
Progression-free survival (%)
100
• Statistically significant
improvement in 2L PFS
HR 0.75
75
95% CI = 0.61, 0.93
p = 0.0068
50
• No new safety signals
25
• Final OS in 2015
Δ 2.1
4.2
6.3
0
0
3
6
9
12
15
18
21
24
27
30
Time (months)
Avastin + chemo
chemo
Source: Published online in Lancet Oncology
Presented at ESMO 2014
23
coBRIM: cobimetinib + Zelboraf in melanoma
A competitive MEK/BRAF inhibitor combination
PFS
Progression-free Survival (%)
100
HR 0.51
95% CI = 0.39, 0.68
p < 0.0001
80
• Statistically & clinically significant
60
• Benefits of combination therapy
across all relevant subgroups
40
20
• Regulatory status: EU filed, US fast
track designation with filing in 2014
Δ 3.7
6.2
0
2
4
6
9.9
8
10
12
14
16
Time (months)
cobimetinib + Zelboraf (n = 247)
Placebo + Zelboraf (n = 248)
Source: NEJM 2014
Presented at ESMO 2014
24
Roche in cancer immunotherapy: A comprehensive
program in monotherapy and combination
Compound
Combination
Indication
PDL1
Mono
+Tarceva
Lung
PDL1
Mono
Bladder
PDL1
Mono
+Avastin
Renal
PDL1
+Zelboraf
Melanoma
PDL1
Mono
+Avastin
+cobimetinib
+ipilimumab
+IFN alfa-2b
Solid tumors
PDL1
+Avastin+FOLFOX
Colorectal
CEA IL-2v
Mono
+Gazyva
Mono
+PDL1
+CD40
Mono
OX-40
Mono
Solid tumors
CD-40
Mono
Solid tumors
PDL1
CSF1R
DNA vaccine Mono
Hematology
Solid tumors
Solid tumors
Prostate

Study ongoing

Ph 1
Ph 2
Ph 3



























Study planned/imminent

25
Anti-PDL1 in bladder: Confirming strength in
cancer immunotherapy
PD-L1 IHC
(n)
ORR
(95% CI)
IHC 3 (n=10)
60% (27-85)
IHC 2 (n=23)
48% (27-68)
IHC 1 (n=24)
17% (6-37)
IHC 0 (n=12)
8% (0-35)
PD-L1
IHC
Dx+ vs Dx- ORR
(95% CI)
52% (34-69)
14% (6-28)
Median PFS
(range), weeks
Not reached (5 to 48+)
24 (5 to 50+)
11 (0.1+ to 30+)
7 (5 to 24+)
Durability of response
• 3 complete responses in PD-L1+
• Sustained durability: 19/22 responders
continuing to respond
• Benign side effect profile
• Phase 3 trials planned
Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov. Diagnostic PD-L1-positive: IHC 2 (≥ 5% but < 10% ICs); IHC 3 (≥ 10%. ), PD-L1
negative: IHC 0 (< 1% of ICs) and IHC 1 (≥ 1% but < 5%).
26
Lampalizumab: Pivotal phase 3 started
Early AMD
Intermediate AMD
Advanced AMD
Wet AMD
Increased drusen & early pigmentary
changes
• CHROMA & SPECTRI: 2 identical, randomized
studies (c.940 pts each)
Geographic Atrophy
GA is a progressive, irreversible & blinding disorder
 Primary endpoint: Reduction in the rate of
GA1 disease progression
• Phase 2 (MAHALO): Showed high efficacy in
subpopulation with exploratory biomarker
1 Geographic
Atrophy
27
Esbriet in the US
IPF: Rate of disease progression
Actions taken
Respiratory function / symptoms
US: Change the market from ‘watch and
wait’ to early diagnosis and treatment
Progressive fibrotic disease
(slow decline)
− Field force trained and in place, logistics
ready
− Engagement with pulmonologists from
existing Xolair franchise
Rapid decline
− Highlight efficacy and safety profile from
day one
Episodes of acute
respiratory worsening
Adapted from Raghu, 1987
1
2
3
Median survival following diagnosis
(years)
1 Roman
et al 2013; 2 Raghu et al 2011; 3 Nalysnyk et al 2012
4
Ex-US: initiatives to reflect latest clinical
data in label
− Roche to support ongoing efforts
28
YTD Sept 2014 sales
Innovation
Outlook
29
Q3 2014 Pipeline update on Phase 3 activity
Phase 3 readouts
Key Phase 3 starts
Compound
Indication
Compound
Indication
Kadcyla/Perjeta
1L met. HER2+ BC
(MARIANNE)
Kadcyla
adjuvant BC (KAITLIN)
cobimetinib
BRAF+ mM (co-BRIM)

Kadcyla
Bcl-2 inh
anti-PDL1
alectinib
etrolizumab
gantenerumab
lampalizumab
Outcome studies are event driven, timelines may change

neo-adjuvant (KRISTINE) 
Rel/Ref CLL (MURANO)

2/3L NSCLC (OAK)

ALK+ NSCLC

inflammatory bowel disease 
mild AD (Marguerite RoAD) 
geographic atrophy

30
2014: Key regulatory milestones
Compound
Indication
Milestone
Actemra subcutaneous
Rheumatoid arthritis
EU approval
Avastin
Glioblastoma
EU approval
Avastin
Cervical cancer
US, EU filing
Avastin
Pt-resistant ovarian cancer
EU approval
MabThera subcutaneous
NHL
EU approval
Gazyvaro
Front line CLL
EU approval
Xolair
Chronic idiopathic urticaria
US approval
Outcome studies are event driven, timelines may change







31
Planned data presentations in H2 2014
ASH
Berlin, 18-21 Oct
mGlu5
• MARIGOLD study
(Phase 2 in depression)
1 In
collaboration with Chugai
Chicago, 30 Oct -1 Nov
San Francisco, 6-9 Dec
Alecensa (alectinib)1
• Japan Phase 1/2 update
Gazyva
• GREEN study G + various
backbones
Avastin Lung
• BEYOND study (planned)
ACE9101
• Hemophilia
32
Diagnostics Division
Roland Diggelmann
COO Roche Diagnostics
Picture
33
YTD Sept 2014: Diagnostics sales
Growth driven by Professional Diagnostics
YTD Sept YTD Sept
2014
2013
Change in %
CHFm
CHFm
7,792
7,677
1
6
Professional Diagnostics
4,397
4,251
3
8
Diabetes Care
1,721
1,781
-3
1
Molecular Diagnostics
1,165
1,164
0
5
509
481
6
10
Diagnostics Division
Tissue Diagnostics
1 Underlying
growth of Molecular Diagnostics excluding Sequencing Solutions: +7%
CER=Constant Exchange Rates
CHF
CER
34
YTD Sept 2014: Diagnostics regional sales
Growth across all geographies
Japan
North America
+3%
+6%
EMEA1
25% of divisional sales
+3%
4% of divisional sales
46% of divisional sales
Latin America
+12%
7% of divisional sales
Asia Pacific
+15%
18% of divisional sales
15% growth in E7 countries1
1 Europe,
Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey
All growth rates at constant exchange rates
35
YTD Sept 2014: Growth driven by Professional
Diagnostics
CER growth
Professional
Dia
+8%
Diabetes
Care
1 Underlying
 CE launch of cobas 6800/8800, HPV (+57%), virology (+7%) and
blood screening (+5%)
+5%
Tissue Dia
Sales
CHFbn
 Sales driven by Accu-Chek Aviva/Performa (+6%), Accu-Chek
Mobile (+22%) and Insulin Delivery Systems (+5%)
+1%
Molecular
Dia 1
+10%
0
1
2
 Continued double digit growth in immunodiagnostics (+12%)
 Launch of Anti-Müllerian Hormone test
EMEA
North America
RoW
3
4
 Double digit growth driven by advanced staining portfolio (+8%)
and companion diagnostics (+33%)
5
growth of Molecular Diagnostics excluding Sequencing Solutions: +7%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
36
First fully-automated Anti-Müllerian hormone
test for fertility
• Expands leading immunoassay portfolio
• Target market (IVF): ~ 25 mCHF ; +10%
• AMH test superior to FSH, estradiol and ultrasound
measurements
• Competitive advantages vs manual AMH testing:
 High sensitivity
 Improved accuracy
 At any day of the menstrual cycle
 Short time to result
• Test is currently also in development as CDx assay
Elecsys AMH
cobas e411
FSH = follicle-stimulating hormone; rFSH = recombinant follicle-stimulating hormone; IVF = in vitro fertilization;
AMH = Anti-Müllerian hormone
37
RMD: Meet the new family - launches of cobas
6800/8800
High Throughput
Reference Labs
cobas® 8800
• Advanced PCR automation
• Highest throughput (3x above closest
competitor)
• CE launch of blood screening assays;
virology assays in Q4
Large Hospitals
cobas® 6800
• Low to middle volume throughput
• Broadest menu incl HPV testing
Medium Hospitals
cobas® 4800
Low Throughput
38
Personalised diabetes management
New product launches in 2014
Blood glucose monitoring
Diabetes therapy system
• Wireless transfer of blood glucose results
• Two-way bluetooth communication
between pump and remote control
• Connect: App with proven bolus advisor
• Data synchronization with healthcare
professional portal via cloud
Accu-Chek Aviva / Performa Connect
• Remote control with proven bolus advisor
• Discrete and easy handling; intuitive display
Accu-Chek Insight
39
Global access program
Landmark partnership in HIV with United Nations
The program
The goals
• Special access pricing partnership
• UNAIDS target by 2020:
 90% diagnosed
 90% treated
 90% virally suppressed
• 40% savings on viral load tests
cobas AmpliPrep/cobas TaqMan HIV-1 Test
40
The Ebola outbreak: Roche distributes Ebola
PCR Test for research applications
LightCycler 480 II
• Exclusively distributed by Roche1 on the
Lightcycler and cobas platforms
• For the presence of the Ebola Zaire virus RNA
in biological sample material
cobas z 480
1 Developed
and produced by TIB MOLBIOL GmbH
• Technical evaluation currently underway to
prepare for Emergency Use Authorization
submission to the US FDA and WHO
prequalification
41
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
RMD
WW*
EU  RMD
EU  RPD
EU
EU
EU
EU


RMD
RMD

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
42
Finance
Alan Hippe
Chief Financial Officer
43
Q3 2014: Highlights
Sales and major currency impact
• Moderated mainly due to strengthening of US dollar
Acquisition of InterMune
• Transaction completed
• Financing: Bond issuance successfully completed with USD 5.75bn raised
44
Group sales YTD September 2014: Driven by US
and Diagnostics
+5%
+3%
+3%
+7%
+8%
+1%
Pharma Division
+5%
0%
+21
+4%
+463
+173
+210
Dia Division
+176
+1,601
-1,711
+6%
+558
-110
United
States
Europe
Intl.
Chugai
(Japan)
Dia
Diabetes
Care
Absolute values in CHFm at CER = Constant Exchange Rates (avg full year 2013);
1 avg December 2013 to avg September 2014 fx
Group
Fx1
Group
CHF
45
Q3 2014: Acquisition of InterMune
Update
Tender offer and second step merger
• Tender offer expired on September 26, 2014 and was not extended
– Approx. 79% of InterMune’s outstanding shares were validly tendered on a fully diluted basis
• Roche completed acquisition all remaining shares through a second step merger on September
29, 2014
Bond issuance
• Bond offering successfully completed on September 22, 2014
• Total of USD 5.75bn raised
Impact on outlook
• Financial impact expected to be neutral to Core EPS in 2015 and accretive from 2016
• No material impact expected from the transaction in 2014 to sales and core earnings outlook
46
InterMune financing
Roche issues USD 5.75 bn of bonds
Nominal
(USD bn)
Treasury yield
or Libor (%)
Spread
bp
Roche
yield (%)
Coupon
1.35
3yr
fixed
0.85
1.056
30
1.356
3yr
floating
0.30
0.230
9
0.320
5yr
fixed
1.50
1.781
50
2.281
5yr
floating
0.50
0.230
34
0.570
7yr
fixed
1.30
2.249
67
2.919
2.875
10yr fixed
1.30
2.560
82
3.380
3.35
TOTAL
5.75
2.25
2.286
47
Q3 2014: Debt maturity profile
72% of Genentech related debt repaid
September 2014 bond issuance
(InterMune financing - USD)
CHFbn
5
GBP
4
CHF
EUR
USD
3
2
1
0
2015
2016
2017
2018
2019
2021
2022
2023
2024
2035
2039
Of the CHF 48bn bonds and notes issued to finance the Genentech transaction,
cumulative CHF 35bn have been repaid as of September 30, 2014*
Nominal values @ actual FX rates; *Original net proceeds in CHF
48
Currency impact on Swiss franc results 2014
Negative currency impact expected
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
Monthly avg fx rates 2014
J
F
M
A
M
0.94
0.93
-5%
-4%
+1%
0.89
0.90
0.90
0.90
0.91
0.94
0.93
-2%
0.91
0.95
Fx rates at 30 September
2014
J
J
A
S
O
0.95
0.95
N
D
Assuming the 30 Sep 2014 exchange
rates remain stable until end of 2014,
2014 impact is expected to be (%p):
Sales
CHF / EUR
1.23
1.22
1.23
1.23
1.23
1.22
-1%
-1%
1.22
1.22
-1%
+2%
0%
+2%
1.23
1.22
1.22
1.22
1.22
1.22
1.22
1.21
1.21
1.21
1.21
1.21
J
F
M
A
M
J
J
A
S
O
N
D
Q1
HY
Sep
YTD
FY
-6
-6
-5
-3
Core
operating
profit
-8
-5
Core EPS
-8
-5
49
2014 Outlook
1 At
Group sales growth1
Low- to mid-single digit
Core EPS growth1
Ahead of sales growth
Dividend outlook
Further increase dividend
constant exchange rates
50
Changes to the development pipeline
Q3 2014 update
New to Phase I
New to Phase II
New to Phase III
3 NMEs added by gRED
RG6046 SERD – ER-pos. HER2neg. mBC (origin Seragon)
RG7888 anti-OX40 MAb - solid
tumors
RG7893 Nav1.7 inhibitor - pain
1NME added by pRED
RG6061 HIF1 alpha locked nucleic
acid (LNA) - solid tumors (origin
Santaris)
1AI
RG7446 PD-L1 MAb + ipilimumab
or IFN – solid tumors
1AI added following filing go
decision
RG105 MabThera SC - CLL
1 NME moved from Phase 1
RG7697 GIP/GLP-1 dual agonist T2D
2 NMEs moved from Phase 2
RG7853 alectinib - NSCLC
RG7417 lampalizumab - geographic
atrophy
1 AI added to reflect the pending
FDA submission
RG435 Avastin – glioblastoma 1st
line
Removed from Phase I
Removed from Phase II
Removed from Phase III
3 NMEs terminated by gRED
RG7600 mesothelin ADC pancreatic cancer
RG7636 ETBR ADC - metastatic
melanoma
RG7845 NME - heme tumors
Status as of October 16, 2014
1 NME terminated by gRED
RG7667 CMV MAb – CMV
1AI
RG3616 Erivedge – AML
New to Registration
1NME following EU submission
RG7421 cobimetinib + Zelboraf metastatic melanoma
1 AI following EU submission
RG1273 Perjeta - HER2-pos. BC
neoadjuvant
1AI following US submission
RG3645 Lucentis – diabetic
retinopathy
Removed from Registration
1 AI following EU CHMP neg.
opinion
RG435 Avastin - glioblastoma 1st line
1NME following approval in the EU
RG7159 Gazyvaro - CLL
1 AI following approval in the EU
RG1569 Actemra - early RA
52
Roche Group development pipeline
Phase I
(28 NMEs + 10 AIs)
Oncology
RG105
RG6016
RG6046
RG6061
RG7116
RG7304
RG7388
RG7446
RG7446
RG7446
RG7446
RG7446
MabThera SC
CLL
LSD1 inh
AML
SERD
ER+(HEr2-) mBC
HIF1 alpha LNA
solid tumors
HER3 MAb
solid tumors
Raf & MEK dual inh
solid tumors
MDM2 ant
solid & hem tumors
PD-L1 MAb+Tarceva NSCLC EGFR+
PD-L1 MAb+Zelboraf
m. melanoma
PD-L1 MAb+Avastin+chemo solid tumors
PD-L1 MAb+cobimetinib solid tumors
PD-L1 MAb+ipilimum./IFN solid tumors
RG7446
RG7450
RG7458
RG7601
RG7601
RG7666
RG7741
RG7775
RG7813
RG7841
RG7842
RG7882
RG7888
CHU
PD-L1 MAb
solid tumors
Steap 1 ADC
prostate ca.
MUC16 ADC ovarian & pancreatic ca.
Bcl-2 inh + Gazyva
CLL
Bcl-2 inh
heme indications
PI3k inh
glioblastoma 2L
ChK1 inh
solid tum & lymphoma
MDM2 (4) IV prodrug
AML
CEA IL2v
solid tumors
ADC
solid tumors
ERK inh
solid tumors
ADC
ovarian ca
OX40
solid tumors
PI3K inh
solid tumors
Status as of October 16, 2014
Other disease areas
RG7624
RG7795
RG7641
CHU
RG7203
RG7342
RG7410
RG7893
RG7800
RG7935
RG3645
RG7716
IL-17 MAb
autoimmune diseases
TLR7 agonist
HBV
aldosterone synth inh kidney disease
URAT 1 inh
gout
PDE10A inh
schizophrenia
mGlu5 PAM
schizophrenia
TAAR1 ago
schizophrenia
Nav1.7 inh
pain
SMN2 splicer spinal muscular atrophy
a-synuclein MAb Parkinson's Disease
Lucentis sust. deliv. AMD/RVO/DME
VEGF-ANG2 MAb
wAMD
New Molecular Entity (NME)
Additional Indication (AI)
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
RG-No Roche Genentech managed
CHU
Chugai managed
53
Roche Group development pipeline
Phase II
(27 NMEs + 7 Als)
RG7155
RG7221
pictilisib
RG7321
RG7440
RG7446
RG7446
RG7446
RG7593
RG7596
RG7597
ADC
RG7599
RG7601
RG7601
RG7604
RG7686
RG1569
RG3637
RG7449
CHU
RG7128
RG7227
RG7745
RG7790
RG7929
RG7697
CSF-1R MAb
solid tumors & PVNS
Ang2-VEGF MAb
colorectal cancer
pictilisib (PI3K inh)
solid tumors
ipatasertib (AKT inh)
solid tumors
PD-L1 MAb
NSCLC 2nd/3rd line
PD-L1 MAb + Avastin
RCC
PD-L1 MAb
bladder cancer
pinatuzumab vedotin (CD22 ADC) hem tumors
polatuzumab vedotin (CD79bADC) hem tumors
HER3/EGFR MAb
m. epithelial tumors
lifastuzumab vedotin (NaPi2bADC)Pt-resist. OC
RG1512
RG1577
RG1578
RG1662
RG1678
RG7090
RG7314
RG7412
Bcl-2 inh
CLL rel/refract 17pdel
Bcl-2 inh
DLBCL
taselisib (PI3K inh beta sparing) solid tumors
glypican-3 MAb
liver cancer
Actemra
systemic sclerosis
lebrikizumab idiopathic pulmonary fibrosis
quilizumab
asthma
IL-31R MAb
atopic dermatitis
mericitabine
HCV
danoprevir
HCV
Flu A MAb
influenza
setrobuvir
HCV
LptD antibiotic
antibacterial
GIP/GLP-1 dual ago
type 2 diabetes
inclacumab
ACS/CVD
MAO-B inh
Alzheimer’s
decoglurant (mGlu2 NAM ) depression
GABRA5 NAM
Down Syndrome
bitopertin
obsessive compulsive dis.
basimglurant (mGlu5 NAM)
TRD
V1 receptor antag
autism
crenezumab
Alzheimer’s
RG6013
FIXa /FX bispecific MAb
Status as of October 16, 2014
Registration
(1 NMEs + 4 Als)
Phase III
(9 NMEs + 19 Als)
RG4351 Avastin
glioblastoma 1st line
RG435
Avastin
NSCLC adj
RG4351 Avastin
ovarian cancer 1st line
rel. ovarian ca. Pt-sensitive
RG4351 Avastin
RG1273 Perjeta
HER2+ mBC 2nd line
RG1273 Perjeta
HER2+ BC adj
RG1273 Perjeta
HER2+ gastric cancer
RG3502 Kadcyla
HER2+ gastric cancer
RG3502 Kadcyla +/- Perjeta HER2+ mBC 1st l
RG3502 Kadcyla
HER2+ BC adj
RG3502 Kadcyla + Perjeta
HER2+ BC adj
RG3502 Kadcyla + Perjeta
HER2+ BC neoadj
DLBCL
RG7159 Gazyva (obinutuzumab)
RG7159 Gazyva (obinutuzumab) iNHL relapsed
RG7159 Gazyva (obinutuzumab) iNHL front-line
RG7204 Zelboraf
melanoma adj
RG7446 PD-L1 MAb
NSCLC 2nd line
RG7601 Bcl-2 inh
CLL rel/refract
RG7853 alectinib (ALK inhibitor)
NSCLC
RG1569 Actemra
giant cell arteritis
severe asthma
RG3637 lebrikizumab
RG7413 etrolizumab
ulcerative colitis
CHU
Suvenyl
enthesopathy
CHU
IL-6R MAb
neuromyelitis optica
RG1450 gantenerumab
Alzheimer’s
RG1594 ocrelizumab
RMS
RG1594
RG7417
ocrelizumab
lampalizumab (factor D)
PPMS
geo. atrophy
RG4352
RG4353
RG12732
RG7421
RG36454
1
2
3
4
Avastin
Avastin
Perjeta
recurrent cervical cancer
rel. ovarian ca. Pt-resistant
HER2+ BC neoadj
cobimetinib + Zelboraf
m. melanoma
Lucentis
diabetic retinopathy
US only: FDA submission pending
Approved in US, submitted in EU
Approved in EU, submitted in US
Submitted in US
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
hemophilia A
54
NME submissions and their additional
indications
Projects currently in phase 2 and 3
cobimetinib (MEK inh)
combo Zelboraf
met melanoma

CSF-1R MAb (RG7155)
PVNS
FIXa /FX bispecific MAb
(RG6013) hemophilia A
Ang2-VEGF MAb (RG7221)
colorectal cancer CRC
gantenerumab (RG1450)
Alzheimer‘s
pictilisib PI3K inh
(RG7321) solid tumors
MAO-B inh (RG1577)
Alzheimer‘s
ipatasertib AKT inh
(RG7440) solid tumors
decoglurant (RG1578)
depression
idiopathic pulmonary fibrosis
pinatuzumab vedotin, RG7593
CD22 ADC heme tumors
GABRA5 NAM (RG1662)
Down syndrome
etrolizumab (RG7413)
ulcerative colitis
polatuzumab vedotin, RG7596
CD79b ADC heme tumors
bitopertin (RG1678)
obsessive compulsive dis.
quilizumab (RG7449)
asthma
HER3/EGFR MAb (RG7597)
m. epithelial tumors
basimglurant (RG7090)
depression
lampalizumab anti-factor D
(RG7417) geo atrophy
lifastuzumab RG7599
lebrikizumab (RG3637)
lebrikizumab (RG3637)
severe asthma
NaPi2b ADC Pt resistant OC
V1 receptor antag (RG7314)
autism
mericitabine (RG7128)
HCV
PDL-1 MAb (RG7446)
bladder cancer
taselisib PI3K inh β-sparing
(RG7604) solid tumors
crenezumab (RG7412)
Alzheimer‘s
danoprevir* (RG7227)
HCV
PD-L1 MAb (RG7446)
NSCLC 2nd/3rd line
glypican-3 MAb(RG7686)
liver cancer
PDL-1 MAb (RG7446)
combo Avastin RCC
Flu A MAb (RG7745)
influenza
ocrelizumab (RG1594)
PPMS and RMS
Bcl-2 inh (RG7601)
CLL rel/refract
alectinib ALK inh
(RG7853) NSCLC
Bcl-2 inh (RG7601)
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 October 16, 2014
2017 and beyond
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
NME
55
Submissions of additional indications for
existing products
Projects currently in phase 2 and 3
Lucentis (US)
diabetic retinopathy

Gazyva
iNHL relapsed
MabThera SC (EU)
CLL
**Perjeta (EU)
EBC neoadjuvant
Gazyva
frontline NHL

Zelboraf
met. melanoma adj.
*Avastin (US)
ovarian cancer 1st line
*Avastin (US)
rel. ovarian ca. Pt-sens

*Avastin (US)
rel. ovarian ca. Pt-resist

**Avastin (EU)
cervical cancer recurrent
2014
Gazyva
DLBCL
Avastin (US)
glioblastoma 1st line
HER2-pos. mBC 2ndline
Kadcyla
HER2-pos. early BC
Kadcyla +/- Perjeta
HER2-pos mBC 1st line
Perjeta
HER2-pos. BC adj
Avastin
NSCLC adj
Kadcyla
HER2-pos gastric cancer
Actemra
giant cell arteritis
Actemra
systemic sclerosis
2016
2017 and beyond
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 October 16, 2014
Perjeta
Perjeta
HER2-pos. gastric cancer
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
NME
56
Major granted and pending approvals 2014
Pending approvals
Approved
Esbriet*
idiopathic pulmonary fibrosis
October 2014
US
EU
Japan-Chugai
Avastin
cervical cancer
August 2014
Xolair
chronic idiopathic urticaria
March 2014
Avastin
rel. ovarian ca. Pt-resist
Filed May 2014
MabThera
NHL sc formulation
March 2014
Actemra
RA sc formulation
April 2014
Avastin
cervical cancer
Filed April 2014
Gazyvaro
CLL
July 2014
Actemra
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
alectinib ALECENSA
ALK-pos rec/adv NSCLC
July 2014
Status as of October 16, 2014; * Newly acquired asset (InterMune)
Lucentis
diabetic retinopathy
Filed August 2014
Zelboraf
m. melanoma
Filed April 2014
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
NME
57
Doing now what patients need next