roche note: for 1995, a special dividend was paid out to mark f. hoffmann-la roche’s 100th...
TRANSCRIPT
Roche
2014 results
London, 28 January 2015
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
All mentioned trademarks are legally protected.
4
Group Severin Schwan Chief Executive Officer
2014 performance
Outlook
5
2014: Targets achieved
6
Targets for 2014 FY 2014
Group sales Low to mid-single digit growth1 +5%
Core EPS Ahead of sales growth1
+5%
+7% excl. one-time
US Pharma fee2
Dividend Further increase dividend3 CHF 8.00
+3%
1 At constant exchange rates 2 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
2014: Highlights
7
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)
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
M&A
• InterMune: Acquisition completed
• Foundation Medicine: Collaboration announced
1 CER=Constant Exchange Rates
First take on Swiss National Bank`s decision
8
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
2014: Solid sales growth
9
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
Change in %
CER=Constant Exchange Rates
2014: Continued sales growth for 4 years
10
0% 0% 1%
4%
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5%
6%
0%
2%
4%
6%
8%
10%
Q1
11
Q2
11
Q3
11
Q4
11
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
All growth rates at Constant Exchange Rates (CER)
2014: Both Divisions with sales growth in all
regions
11
0
2
4
6
8
10
12
14
16
18
20
Japan International Europe US
Diagnostics
Pharma
CHFbn
+6%
+3% +2%
+7%
+2%
+13%
0%
+4%
+6%
+3%
+6%
+6%
All growth rates at Constant Exchange Rates (CER)
2014: Group core operating profit & margin
remains at high levels
12
16.6
15.1
17.2 17.9 17.6
34.9% 35.6% 37.7% 38.3%
37.2%
2010 2011 2012 2013 2014
+3% at CER (+5%*) % of sales
CHFbn
(37.6%*)
CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
2014: Core EPS growth bridge
13
one-time
US Pharma fee* +5.2%
+1.7% +6.9%
Sales
+4.9%
Core EPS Core EPS
Full Year 2014 excl. one-time US Pharma fee*
Full Year 2014
figures as reported
CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
2014: Dividend and payout ratio further increased
14 1 compound annual growth rate
8.00
31.9 34.5
38.8
44.8
48.6
51.6
55.3
54.5
54.7 56.0
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
Dividend payout ratio (%) CHF
2014 payout ratio: 56.0%
Payout ratio calculated as dividend per share divided by core earnings per share (diluted); 2014 dividend as proposed by the Board of
Directors; Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996
Rituxan/MabThera RA
Neuroscience
6 NMEs
ocrelizumab
gantenerumab
Roche: A pipeline of differentiated products
Launched
Phase III
Phase II 10 NMEs + 9 AIs
Rituxan/MabThera
Xeloda
Herceptin
Perjeta
Kadcyla
Avastin
Gazyva/Gazyvaro
Tarceva
Zelboraf
Erivedge
Immunology/
Ophthalmology
Actemra/RoActemra
Lucentis
Xolair
Esbriet
Pulmozyme
lebrikizumab
lampalizumab3
etrolizumab2
anti-PDL1
taselisib1
venetoclax (Bcl2i)
cobimetinib4
pictilisib1
alectinib
15
Oncology
Neuroscience
Ophthalmology
Immunology
Oncology
3 AIs
1 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
2014 performance
Outlook
16
Launch new products Esbriet: US and EU
Cobimetinib + Zelboraf: US and EU
2015 milestones
17
Renew CD20 franchise Gazyva (aggressive NHL)*
Entry into Multiple Sclerosis Ocrelizumab: Phase 3 readout
Expand cancer
immunotherapy
PD-L1: Bladder, Lung, Renal, Triple Negative BC
NMEs: OX40, CD40, CEA-IL2, CSF1R, IDO, CEA-CD3
Entry into Hemophilia ACE910: Start of pivotal trials
Diagnostics Rollout of key platforms (cobas 6800 / 8800)
* Event-driven (interim analysis)
2015 outlook
18
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth2
Dividend outlook Further increase dividend in Swiss francs
1 At constant exchange rates 2 Excluding sale of filgrastim rights in 2014
19
Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals
2014 results
Innovation
Outlook
20
2014: Pharma sales
All regions with positive growth
21
2014 2013
CHFm CHFm CHF CER
Pharmaceuticals Division 36,696 36,304 1 4
United States 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
Change in %
CER=Constant Exchange Rates
CHFm % sales
Sales 36,696 100.0
Royalties & other op. inc. 2,273 6.2
Cost of sales -7,551 -20.5
M & D -5,974 -16.3
R & D -7,876 -21.5
G & A -1,567 -4.3
Core operating profit 16,001 43.6
2014 vs. 2013
CER growth
-1% in CHF
2014
4%
4%
6%
4%
4%
50%
35%
Excl. PSI & US
Pharma fee*:+14%
Excl. filgrastim
deal: +10%
Excl. 340B: +5%
Esbriet launch
2014: Pharma Division
Investment in Esbriet launch
22
PSI &
US Pharma fee*
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
2014: Pharma sales
HER2, Avastin and Tamiflu main growth drivers
23
-800 -400 0 400 800
Xeloda
Pegasys
MabThera/Rituxan
Xolair
Actemra/RoActemra
Kadcyla
Tamiflu
Avastin
Herceptin
Perjeta
US
Europe
Japan
International
+189%
+7%
+6%
+54%
+135%
+25%
+23%
-46%
-20%
+2%
CHFm
Absolute amounts and growth rates at Constant Exchange Rates (CER)
0 3 6 9
Zelboraf
Xeloda
Tarceva
Avastin
MabThera/
Rituxan
HER2
Kadcyla
Perjeta
Herceptin +20%
+2%
+6%
-1%
-46%
-12%
2014: Oncology sales up +5%
24
CER growth
CHFbn
• In-class competition
• Loss of exclusivity
• Continued uptake in ovarian & cervical (US)
• Treatment through multiple lines in CRC
• Strong uptake of Perjeta & Kadcyla
• Competitive pressure in US & EU
• Potential approval of coBRIM in 2015
• Increased usage across a variety of indications
• Growth despite 340B baseline effect and Russia
+20%
+2%
+6%
-1%
-46%
-12%
CER=Constant Exchange Rates 2014 Oncology sales: CHF 22.8bn
Avastin: Growth supported by recent launches
25
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
2011 2012 2013 2014
CHFm
US Europe International Japan
YoY CER growth
-7%
+6%
+6%+13% Platinum-resistant ovarian cancer
• Launched in US and EU
Cervical cancer
• Launched in US and filed in EU
HER2 negative breast cancer
• Positive phase 3 data in treatment
through multiple lines (TML) and 1L
Colorectal cancer
• CALGB H2H data support standard of
care in 1L
CER=Constant Exchange Rates
HER2 franchise: Strong growth driven by Perjeta
and Kadcyla
26
0
500
1,000
1,500
2,000
2,500
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Kadcyla
Perjeta
Herceptin
16% 10%
15%
CHFm
15% 20% 17%
23%
7%
23% 19%
YoY CER growth
CER=Constant Exchange Rates
Immunology products: Accelerated growth
Driven by Actemra SC and Xolair
27
0
200
400
600
800
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Actemra SC
Actemra IV
Xolair
Pulmozyme
19%
YoY CER growth
CHFm
18% 20% 15%
18%
18%
26% 19%
CER=Constant Exchange Rates
200
300
400
500
Q3
11
Q4
11
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Lucentis: Flattening in a competitive environment
Breakthrough designation in Diabetic Retinopathy
28
2014
• Growth driven by DME and continued
market expansion
Outlook
• Increased competition in AMD and
DME
• Breakthrough Status and Priority
Review for treatment of DR
(PDUFA date Feb 6)
Lucentis sales (USDm)
Eylea
wAMD
Lucentis
DME
AMD
Less-frequent than
monthly dosing
AMD=wet age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy
Esbriet strong launch
29
US launch off to strong start
• FDA approval on 15 October 2014,
patients still in transition to full
reimbursement
• > 1,300 patients in clinical trials
European sales with strong growth
• EU label strengthened to include the
ASCEND and pooled one year
mortality data on October 23, 2014 0
10
20
30
40
50
Q113
Q213
Q313
Q413
Q114
Q214
Q314
Q414
Europe Canada US
CHFm
13
18
45
24
10
33
28
37
Q1
13
Q3
13
Q2
13
Q3
14
Q4
14
Q2
14
Q3
13
Q1
14
Q4
13
Europe Canada US
50
40
30
20
10
0
Esbriet sales
Sales based on average 2013 exchange rate
2014 results
Innovation
Outlook
30
2014: Major clinical and regulatory news flow
31
Compound Indication Milestone
Regulatory
Actemra SC Rheumatoid arthritis EU approval
Avastin Glioblastoma EU approval
Avastin Cervical cancer US, EU filing
Avastin Pt-resistant ovarian cancer US, EU approval
MabThera SC NHL EU approval
Gazyvaro Front line CLL EU approval
Xolair Chronic idiopathic urticaria US approval
Esbriet Idiopathic pulmonary fibrosis US approval
Phase III
oral octreotide Acromegaly Ph III
cobimetinib BRAF+ met. melanoma Ph III (co-BRIM)
gantenerumab Prodromal Alzheimer`s disease Ph III (SCarlet RoAD)
Kadcyla/Perjeta 1L met. HER2+ breast cancer Ph III (MARIANNE)
Esbriet Idiopathic pulmonary fibrosis Ph III (ASCEND)
Phase III starts
Kadcyla Adjuvant HER2+ breast cancer Ph III (KAITLIN)
Kadcyla Neo-adjuvant HER2+ breast cancer Ph III (KRISTINE)
venetoclax (Bcl2 inh.) Relapsed/refractory CLL Ph III (MURANO)
Anti-PDL1 2/3L NSCLC Ph III (OAK)
alectinib ALK+ NSCLC Ph III (ALEX)
etrolizumab Ulcerative colitis Ph III (HIBISCUSI/II, GARDENIA,
LAUREL, HICKORY, COTTONWOOD)
gantenerumab Mild Alzheimer`s disease Ph III (Marguerite RoAD)
lampalizumab Geographic atrophy Ph III (CHROMA, SPECTRI)
Rituxan/MabThera RA
Neuroscience
6 NMEs
ocrelizumab
gantenerumab
Roche: A pipeline of differentiated products
Launched
Phase III
Phase II 10 NMEs + 9 AIs
Rituxan/MabThera
Xeloda
Herceptin
Perjeta
Kadcyla
Avastin
Gazyva/Gazyvaro
Tarceva
Zelboraf
Erivedge
Immunology/
Ophthalmology
Actemra/RoActemra
Lucentis
Xolair
Esbriet
Pulmozyme
lebrikizumab
lampalizumab3
etrolizumab2
anti-PDL1
taselisib1
venetoclax (Bcl2i)
cobimetinib4
pictilisib1
alectinib
32
Oncology
Neuroscience
Ophthalmology
Immunology
Oncology
3 AIs
1 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
2017
HER2 franchise expected to grow further
Biosimilars delayed to 2017
33
Established standard of care New standard of care Potential new standard of care
Adjuvant
BC
Herceptin +
chemo
Herceptin sc + chemo
(HannaH)
Herceptin & Perjeta + chemo (APHINITY)
1st line
mBC Herceptin
+ chemo Herceptin & Perjeta + chemo (CLEOPATRA)
2nd line
mBC Xeloda + lapatinib Kadcyla (EMILIA)
2016 2012 2013 2014 2015 2011 2019 2018 2020
Kadcyla (KATHERINE) Kadcyla & Perjeta (KAITLIN)
Est. Biosimilars
launch (EU)
Neoadjuvant
BC Herceptin + chemo
(NOAH)1 Herceptin & Perjeta + chemo
(Neosphere, Tryphaena)2
Kadcyla & Perjeta + chemo (KRISTINE)
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
Hematology franchise
Extensive late stage clinical trial program
34
Compound Combination Indication P 1 P 2 P 3
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
* Partnered with AbbVie
venetoclax (Bcl2 inhibitor); polatuzumab vedotin (CD79b ADC)
Biosimilars delayed to 2017
Anti-PDL1 in triple negative breast cancer
Encouraging early data
35
PD-L1
IHC (IC)
TNBC a
n
ORR, Best
Response, b %
(95% CI)
PD-L1+ vs
PD-L1- ORR, b
% (95% CI)
IHC 3 6 17% (1,60) 33% (10,70)
IHC 2 3 67% (14,98)
IHC 1 - - -
IHC 0 - - -
• Encouraging efficacy in monotherapy
• Well tolerated
• Update at a medical conference in 2015
Emens LA, et al. SABCS, 2014
2014 Roche cancer immunotherapy:
Six NMEs moved into the clinic
36
Priming & activation
Anti-CEA-IL2v
Anti-OX40
NME (Anti-ctyokine)
Anti-CD27*
Antigen presentation
Anti-CD40
IMA942 vaccine* (Immatics)
Antigen release
T cell infiltration
T cell Trafficking
Cancer T cell recognition
Anti-CEA-CD3
Anti-HER2-TDB
Antigen/T cell bispecific Mabs
ImmTAC* (Immunocore)
Anti VEGF: Avastin
Targeted therapies:
Tarceva, cobimetinib,
Zelboraf, Gazyva
Clinical development Preclinical development
* Partnered projects (external)
Established therapies
New in 2014
T cell killing
Anti-PD-L1
Anti-CSF-1R
Anti-CEA-IL2v
Anti-OX40
IDO inhibitor (NewLink Genetics)
NME (undisclosed)
IDO inhibitor* (Incyte)
Chen and Mellman. Immunity 2013
Cancer immunotherapy program growing strongly
37
Compound Combination Indication Ph 1 Ph 2 Ph 3
PDL1 Mono
+Tarceva Lung
PDL1 Mono Bladder
PDL1 Mono
+Avastin Renal
PDL1 +Zelboraf
+Zelboraf+cobimetinib Melanoma
PDL1
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 Triple negative breast cancer
CSF-1R Mono
+CD40 Solid tumors
CEA IL-2v Mono Solid tumors
OX40 Mono Solid tumors
CEA CD3 Mono Solid tumors
IDO Mono Solid tumors
Study ongoing Study imminent Additions since Q3
Status as at January 2015
Roche cancer immunotherapy
Pipeline as of 2014 year end…
38
Phase II Phase III
Anti-PDL1
NSCLC (Dx+)
Anti-PDL1
NSCLC 2/3L
Anti-PDL1+Avastin
Renal 1L
Anti-PDL1
Bladder 1/2L
Phase I
Anti-OX40
Solid tumors
CEA CD3
Solid tumors
IDO
Solid tumors
Anti-CSF1R
Solid tumors
Anti-PDL1
Solid tumors
Anti-PDL1+Zelboraf
Melanoma
Anti-PDL1+Tarceva
NSCLC
PDL1+Avastin+FOLFOX
CRC
Anti-PDL1 + Gazyva
Blood cancer
Anti-CEA IL-2v
Solid tumors
Anti-PDL1
TNBC
Anti-PDL1+Avastin
Solid tumors
Anti-PDL1+cobimetinib
Solid tumors
Anti-PDL1+ipilimumab
Solid tumors
Anti-PDL1+ CD40
Solid tumors
Anti-PDL1+IFN-alfa
Solid tumors
Anti-PDL1
NSCLC 2/3 L
Status as at December 2014
Anti-PDL1 trials
NMEs monotherapy
Immune doublets
Roche cancer immunotherapy
…and additional trials already decided upon
39
Phase II Phase III
Anti-PDL1
NSCLC (Dx+)
Anti-PDL1
NSCLC 2/3L
Anti-PDL1+Avastin
Renal 1L
Anti-PDL1
Bladder 1/2L
Phase I
Anti-OX40
Solid tumors
CEA CD3
Solid tumors
IDO
Solid tumors
Anti-CSF1R
Solid tumors
Anti-PDL1
Solid tumors
Anti-PDL1+Zelboraf
Melanoma
Anti-PDL1+Tarceva
NSCLC
PDL1+Avastin+FOLFOX
CRC
Anti-PDL1 + Gazyva
Blood cancer
Anti-CEA IL-2v
Solid tumors
Anti-PDL1
TNBC
Anti-PDL1+Avastin
Solid tumors
Anti-PDL1+cobimetinib
Solid tumors
Anti-PDL1+ipilimumab
Solid tumors
Anti-PDL1+ CD40
Solid tumors
Anti-PDL1+IFN-alfa
Solid tumors
Anti-PDL1 + CSF1R**
Solid tumors
Anti-PDL1 + CEA-IL2v**
Solid tumors
Anti-PDL1 + OX40**
Solid tumors
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
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
Anti-PDL1 trials
NMEs monotherapy
2015 readout expected
Study start in 2015
Immune doublets
**
Status as at January 28, 2015
Oncology – Molecular Information
How we will collaborate with Foundation Medicine
40
Roche/FMI R&D Collaboration
DNA & RNA
sequencing
1. Comprehensive tumor analysis in
Roche Clinical Trials
2. We will innovate together
Blood based
continuous monitoring
Immunotherapy
Panel
What we aim to achieve together
Key initial areas for collaboration
• Roche a leader in PHC/companion
diagnostics across modalities
• FMI a leader in comprehensive genomic
profile development and molecular
information
Brings together expertise needed to
innovate for patients
• Cancer Immunotherapy test
• Continuous monitoring test
ACE 910 in Hemophilia A
A novel FVIIIa mimetic bispecific antibody
41
Mode of action
Novel approach promoting FX activation
and acceleration of coagulation
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
Targeted product profile
• Less frequent dosing
• Subcutaneous
• Avoid induction of inhibiting antibodies
Prophylaxis
3 times/week, IV
On-demand treatment
1-3 times/bleeding event, IV
Inhibiting Factor VIII antibodies in 20-33% of the patients NO
N-I
NH
IBIT
OR
Prophylaxis with bypassing
agents
Every other day, IV
On-demand treatment with
bypassing agents
2-3h intervals, IV
IN
HIB
ITO
R
Immune Tolerance Induction
70-80 % success rate
limitation due to very high cost and heavy burden for
patients
ACE 910
FVIIIa
In collaboration with Chugai
2014 results
Innovation
Outlook
42
2015: Key late-stage news flow
43
Compound Indication Milestone
Regulatory
Avastin Cervical cancer EU approval
Lucentis Diabetic retinopathy US approval
alectinib ALK+ NSCLC US filing
Cobimetinib + Zelboraf 1L Melanoma US, EU approval
Phase III readouts*
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
Phase III starts
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
Phase II readouts*
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
Picture
44
Diagnostics Division Roland Diggelmann COO Roche Diagnostics
2014: Diagnostics Division sales
Growth driven by Professional Diagnostics
45
2014 2013
CHFm CHFm CHF CER
Diagnostics Division 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
Tissue Diagnostics 716 665 8 10
Change in %
Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8%
CER=Constant Exchange Rates
North America
+4%
25% of divisional sales
Latin America
+13%
7% of divisional sales
Japan
0%
4% of divisional sales EMEA1
+4%
45% of divisional sales
2014: Diagnostics regional sales
Growth driven by APAC and EMEA
Asia Pacific
+15%
19% of divisional sales
46
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
2014: Diagnostics Division
Profit growth in line with sales excl. PSI*
47 CER=Constant Exchange Rates
* PSI: 2013 past service income of CHF 67m; VAT: 2013 one-time VAT refund of CHF 45m
CHFm % sales
Sales 10,766 100.0
Royalties & other op. inc. 131 1.2
Cost of sales -4,790 -44.4
M & D -2,462 -22.9
R & D -1,037 -9.6
G & A -512 -4.8
Core operating profit 2,096 19.5
2014 2014 vs. 2013
CER growth
-4% in CHF
6%
2%
9%
4%
3%
21%
2%
Admin: +6%
Excl. PSI*: +5%
Excl. PSI*: +5%
and VAT*: +8%
Excl. VAT*: +8%Excl. VAT*: +8%
2014: Diagnostics
Growth driven by Professional Diagnostics
+1%
• Virology (+7%) incl. HPV (+48%) • Launch of cobas 6800/8800 systems with assays for blood
screening and virology
• Accu-Chek Aviva/Performa (+7%) and Mobile (+19%)
• Advanced staining portfolio (+9%) and companion
diagnostics (+27%)
1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
CER growth
1
+8%
+6%
+10%
• Continued double digit growth in immunodiagnostics (+13%)
• Further expansion of leading menu
0 1 2 3 4 5 6
Tissue Dia
Molecular
Dia
Diabetes
Care
Professional
Dia
EMEA
North America
RoW
Sales
CHFbn
48
Serum work area (42% of sales)*
Growing strongly in all regions
49
+5%
+8%
+15%
+19%
+8%
+10%
EMEA
Asia-Pacific
North America
Japan
Latin America
*SWA: serum work area: clinical chemistry and immunodiagnostics
2013 2014
Integrated SWA* solution
– Immunodiagnostics (+13%)
– Clinical chemistry (+7%)
Invest for growth
New reagent manufacturing in China
• Reliable local supply and right
sizing of cost base
• Reagent formulation, filling and
packaging
– Packaging to begin in 2016
– Fully operational in 2018
2012 2022E 2017E
Other
Asia
RPD reagent volume
x2
50 RPD = Roche Professional Diagnostics
Extend leading menu in women’s health
High prognostic value of preeclampsia blood test
51
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
Medium Hospitals
Large Hospitals
Reference Labs
High Throughput
Low Throughput
cobas® 6800
cobas® 4800
cobas® 8800
Molecular Diagnostics
Launch and implementation of cobas 6800/8800
• Advanced PCR automation
• Highest throughput (3x above closest
competitor)
• CE launch of blood screening and
virology assays
• Low to middle volume throughput
• Broadest menu incl HPV testing
52
Entering Molecular Point of Care Diagnostics
Acquisition of IQuum, launch of cobas Liat™ analyzer
53
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
Liat™ Analyzer Liat™ tube
Point of Care: e.g. physician’s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus
Sequencing strategy
Building a leading sequencing solution
54
Grow through
disruptive
innovation
Sample
preparation
Testing
platform
Menu of
assays
Data
analysis Reporting
Developing complete sequencing solutions
Abvitro: Technology acquisition; Ariosa: Acquisition; Genia: Acquisition; Pacific Biosciences: Partnership; Bina: Acquisition; Foundation Medicine: Partnership
Sequencing menu: Non-invasive prenatal testing
Acquisition of Ariosa
55
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
Strategy
• Expand market access through kit distribution model
• Add test to Roche sequencing platform when available
HarmonyTM Prenatal Test
Digital analysis of selected
regions (DANSRTM) technology
Key launches 2014
56
Area Product Market BA1
Instruments
/
Devices
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
WW*
EU
EU
WW
RMD
RPD
RPD
RTD
Diabetes
Care
Accu-Chek Insight- Next generation insulin pump & bGm3 system
Accu-Chek Connect – bG meter with connectivity to smart phones,
mobile App and cloud
EU
EU
RDC
RDC
Tests
/
Assays
Infectious
Diseases /
Blood
Screening
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
US
WW*
WW*
EU
EU
RMD
RMD
RMD
RMD
RPD
Microbiology MRSA/SA – Next generation assay on cobas 4800
C-difficile – Diagnosis of infections and associated diarrhea
EU
EU
RMD
RMD
Women’s
Health
PE Prognosis- Claim extension for short-term prediction of
Preeclampsia in pregnancy
AMH- Assessment of ovarion reserve for fertility
EU
EU
RPD
RPD
*Excluding US; 1 Business 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 Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics;
RTD: Roche Tissue Diagnostics;
Key launches 2015
57
Area Product Market BA1
Instruments
/
Devices
Laboratory
cobas c 513 – dedicated HbA1C analyzer
cobas t 411– core lab coagulation analyzer
cobas 8100 V2 – Integrated pre- and post-analytical solution
cobas® 6800/8800 – Medium to High volume automated real-time PCR
VENTANA HE 600 – automated H&E staining platform
EU
EU
WW
US
WW
RPD
RPD
RPD
RMD
RTD
Diabetes
Care
Accu-Chek Active no-code– next-gen. bG meter, no coding of test strips
Accu-Chek Connect – bG meter with connectivity to smartphones, mobile
applications and cloud
WW
US
RDC
RDC
Point of Care CoaguChek® Pro II - professional system for PT and aPTT testing EU RPD
Tests
/
Assays
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
US
EU
RMD
RPD
Virology
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
EU
EU
EU
EU
RMD
RMD
RMD
RMD
Genomics &
Oncology cobas® EGFR Test v2 - detection of EGFR in plasma EU RMD
Cardiac Cobas h 232 Troponin T – Point of Care test version of Elecsys cTNT-hs EU RPD
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
59
Finance Alan Hippe Chief Financial Officer
2014: Highlights
60
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
1 CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
2014: Group currency exposure
Overall solid natural hedge
2%
41%
21%
8%
28%
18%
38%
17%
6%
21%
0%
10%
20%
30%
40%
50%
CHF USD EUR JPY Others
Sales
Operating costs
61
Currency
exposure
FY 2014 currency structures; operating costs include all items between the sales and the operating profit lines
2014 performance
Focus on cash
62
2014: Group performance
Core EPS growth +5%1 or +7%1 excl. US Pharma fee*
63
2014 2013 Excl. US
CHFm CHFm CHF CER Pharma fee*
Sales 47,462 46,780 1 5
Core operating profit 17,636 17,904 -1 3 5
as % of sales 37.2 38.3
Core net income 12,533 12,526 0 6 7
as % of sales 26.4 26.8
Attributable to Roche shareholders 12,329 12,316 0 6 7
Core EPS (CHF) 14.29 14.27 0 5 7
Operating free cash flow 15,778 16,381 -4 -2
as % of sales 33.2 35.0
Free cash flow 5,322 5,403 -1 1
as % of sales 11.2 11.5
Change in %
1 CER=Constant Exchange Rates
* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014
2014: Group operating performance
Core OP growth +3%1 or +5%1 excl. US Pharma fee*
64
CHFm % sales
Sales 47,462 100.0
Royalties & other op. inc. 2,404 5.1
Cost of sales -12,341 -25.9
M & D -8,436 -17.8
R & D -8,913 -18.8
G & A -2,540 -5.4
Core operating profit 17,636 37.2
2014 2014 vs. 2013
CER growth
-1% in CHF
5%
6%
6%
4%
3%
33%
38%
Excl. filgrastim
deal: +10%
Excl. US Pharma
fee*: +5%
Excl. PSI and US
Pharma fee*:+8%
1 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
17,16015,488
2,187
17,904
16,108
2,177
17,63616,001
2,096
Roche Group Pharma Division Diagnostics Division
2012 2013 2014
37.7% 38.3% 37.2%
44.0% 44.4% 43.6%
21.3% 20.8% 19.5%
2014: Core operating profit and margin
Margin at high levels
65
CHFm
-0.5 %p1
(-1.1 %p)
-0.9 %p1
(-1.3 %p)
-0.2 %p1
(-0.8 %p)
+2 %1
(-4 %)
+4 %1
(-1 %)
+3 %1
(-1 %)
(-0.1%p2)
(+0.3%p2)
% of sales
1 CER=Constant Exchange Rates 2 At CER excluding one-time double charge for the US Branded Prescription Drug fee in 2014
-1,699
-1,116
+288
+136 +69 +90
-2,000
-1,500
-1,000
-500
0
2014: Core net financial result
Higher income from equities and lower interest expenses
66
FX gains/losses
2013 2014 All other, net Interest expense
Net income from equity securities
Improvement of 34% in CHF / 32% at CER
CHFm
CER=Constant Exchange Rates
19%
Net debt/
total assets:
Assets Equity & liabilities
33.0 44.5
21.2 21.6
17.3
19.4
25.2 30.9
11.9
11.7
15.8
23.1
31/12/13 31/12/14 31/12/13 31/12/14
75.6 75.6
Current
liabilities
Non-current
liabilities
Equity
(Net assets)
19%
15%
28%
53%
26%
34% 29%
62.2 62.2Current
liabilities
Non-current
liabilities
Equity
(Net assets)
59%
25%
41%
31%
40%
Cash and
marketable
securities
Other
current
assets
Non-current
assets
CHFbn
Balance sheet 31 December 2014
Equity ratio at 29% due to acquisitions
67
CHFbn
CER=Constant Exchange Rates
22.7 24.1
+0.4
+1.0
2013 Profit mix US 2014
2014: Group core tax rate
Double R&D tax credits in 2013
68
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
Figures in %
2014 performance
Focus on cash
69
16,13514,710
1,890
16,38114,976
1,962
15,77814,821
1,417
Roche Group Pharma Division Diagnostics Division
2012 2013 2014
35.5% 35.0%33.2%
41.8% 41.3% 40.4%
18.4% 18.7%
13.2%
2014: Operating free cash flow remains at high
levels
70
CHFm
% of sales
-2.4 %p1 (-1.8 %p)
-5.3 %p1 (-5.5 %p)
-1.7 %p1 (-0.9 %p)
-24 %1 (-28 %)
0 %1
(-1 %)
-2 %1
(-4 %)
CER=Constant Exchange Rates
B
BB
BBB-
BBB
CHFm
2,462
1,036
980
209
236
1,836
604
819
163
251
1,645
613
733
114
185
1,171
480
433
97
161
0 400 800 1,200 1,600 2,000 2,400 2,800
Southern
European
Countries
Spain
Italy
Portugal
GreeceDec 2014
Dec 2013
Dec 2012
Dec 2011
-52%1
2014: Accounts receivable in Southern Europe
further decreased
71 1 CER=Constant Exchange Rates
Note: Sovereign country ratings from Standard & Poor’s, as of 7 January 2015
-6.7
+15.8
-14.0
-10.5
-12.6
Dividends -6.7
Taxes -3.0
Treasury -0.8
2014: Group net debt development
Higher net debt due to InterMune acquisition
Net debt
31 Dec 2013
Operating Free
Cash Flow
Business combinations, Currency translation
& other
Net debt
31 Dec 2014
Non-op. FCF
Free Cash Flow CHF 5.3bn
1% (CER) higher than 2013
Business comb. -9.6
Own equities -0.8
Other -2.2
CHFbn
72 CER=Constant Exchange Rates
Balance sheet: Net debt to total assets
Ratio higher than 2013 due to InterMune acquisition
73
16%
11%
19%
14.0
75.6
31 Dec 2012 31 Dec 2013 31 Dec 2014
Net debt
(CHFbn)
Total assets
(CHFbn)
Net debt /
total assets
0
1
2
3
4
5
2015 2016 2017 2018 2019 2021 2022 2023 2024 2035 2039 2044
GBP CHF EUR USD
December 2014: Debt maturity profile
Balanced maturity profile
74
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*
CHFbn
Nominal values @ actual FX rates; *Original net proceeds in CHF
Currency impact on Swiss franc results 2014
Negative currency impact
Q1 HY Sep
YTD
FY
Sales -6 -6 -5 -4
Core
operating
profit
-8 -4
Core EPS -8 -5
In 2014 impact is (%p):
CHF / USD
CHF / EUR
+1%
+1%
+2% +2%
0.90 0.89 0.880.88 0.94 0.95 0.980.960.900.89 0.90 0.91
0.910.890.890.90
0.930.930.94
0.93
J F M A M J J A S O N D
1.23 1.22 1.22 1.22 1.22 1.22 1.22 1.21 1.21 1.21 1.20 1.20
1.231.23 1.231.23
1.21
1.22
1.221.22
J F M A M J J A S O N D
Average YTD
2013
-4% -5% -4% -1%
0% -1%
-1% -1%
Assumed average YTD 2014
Monthly avg fx rates 2014 Fx rates at 31 Dec 2014
75
Currency sensitivities for 2014
76
Figures in CHFm Sales Core OP
US dollar 190 76
Euro 98 48
Japanese yen 37 20
All other currencies 131 70
Impact of 1% change in average exchange rate vs. the Swiss franc
2015 outlook
77
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth2
Dividend outlook Further increase dividend in Swiss francs
1 At constant exchange rates 2 Excluding sale of filgrastim rights in 2014
Changes to the development pipeline FY 2014 update
79
New to Phase I New to Phase II New to Phase III New to Registration
11 NMEs
RG6047 SERD (2) – ER-pos (HER2-
neg) 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 mut-
pos. 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
3 NMEs
RG7666 PI3K inh - glioblastoma 2L
RG7624 IL-17 MAb - autoimmune
diseases
RG7458 MUC16 ADC - ovarian and
pancreatic cancer
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
1 AI removed by Chugai
Suvenyl - enthesopathy
1 AI following US approval
RG435 Avastin - rel. ovarian ca. Pt-
resistant
Status as of January 28, 2015
Roche Group development pipeline
80
Phase I
(33 NMEs + 11 AIs)
Raf & MEK dual inh solid tumors
venetoclax (Bcl-2) heme indications
ChK1 inh solid tum & lymphoma
Oncology Other disease areas
Status as of January 28, 2015
HER3 MAb solid tumors
MDM2 ant solid & hem tumors
New Molecular Entity (NME) Additional Indication (AI)
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
RG-No Roche Genentech managed
CHU Chugai managed
PD-L1 MAb+Zelboraf+/-cobimetinib m. melanoma
Steap 1 ADC prostate ca.
PD-L1 MAb+Avastin+chemo solid tumors
PD-L1 MAb solid tumors
PD-L1 MAb+cobimetinib solid tumors
venetoclax (Bcl-2)+ Gazyva CLL CLL
PD-L1 MAb+Tarceva NSCLC EGFR+
ERK inh solid tumors
CEA IL2v solid tumors
LSD1 inh AML
ADC solid tumors
MDM2 (4) IV prodrug AML
ADC ovarian ca
PD-L1 MAb+ipi/IFN solid tumors
OX40 MAb solid tumors
Lucentis sust. deliv. AMD/RVO/DME
PDE10A inh schizophrenia
Nav1.7 inh pain
VEGF-ANG2 MAb wAMD
TAAR1 ago schizophrenia
a-synuclein MAb Parkinson's Disease
mGlu5 PAM schizophrenia
SMN2 splicer spinal muscular atrophy
TLR7 agonist HBV RG7795
RG3645
RG7203
RG7893
aldosterone synth inh met. diseases RG7641
RG7716
RG7410
RG7935
RG7342
RG7800
HIF1 alpha LNA solid tumors
RG7304
RG7601
RG7741
RG7116
RG7388
RG7446
RG7450
RG7446
RG7446
RG7446
RG7601
RG7446
RG7842
RG7813
RG6016
RG7841
RG7775
RG7882
RG7446
RG7888
RG6061
CEA CD3 TCB solid tumors RG7802
CD40 iMAb+PD-L1 MAb solid tumors RG7876
MSLN PE cFP solid tumors RG7787
PD-L1 MAb+Gazyva lymphoma RG7446
- autoimmune diseases RG7880
autoimmune diseases RG7625
- infectious diseases RG7689
DBO β-lactamase inh bact. infections RG6080
TAUpS422 MAb Alzheimer’s RG7345
CSF-1R + PDL-1 MAb solid tumors RG7155
SERD (2) ER+(HER2-neg) mBC RG6047
IDO inh solid tumors RG6078
HER3/EGFR DAF+ cobi KRAS+ s. tumors RG7597
New Molecular Entity (NME)
Additional Indication (AI)
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
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
Roche Group development pipeline
81
Phase II
(23 NMEs + 12 Als)
Phase III
(9 NMEs + 21 Als)
Registration
(1 NME + 4 Als)
1 US only : FDA submission decision pending
2 Approved in US, submitted in EU
3 Submitted in US
crenezumab Alzheimer’s RG7412
lampalizumab (factor D) geo. atrophy RG7417
Lucentis diabetic retinopathy RG36453
Avastin recurrent cervical cancer RG4352
Perjeta HER2+ BC neoadj RG12732
cobimetinib + Zelboraf m. melanoma RG7421
MabThera SC CLL RG105
Status as of January 28, 2015
Avastin glioblastoma 1st line RG4351
Avastin NSCLC adj RG435
Kadcyla +/- Perjeta HER2+ mBC 1st l RG3502
ocrelizumab RMS RG1594
Gazyva DLBCL 1st line RG7159
ocrelizumab PPMS RG1594
Actemra large-vessel vasculitis CHU
lebrikizumab severe asthma RG3637
Zelboraf melanoma adj RG7204
Perjeta HER2+ gastric cancer 1st line RG1273
Actemra giant cell arteritis RG1569
etrolizumab ulcerative colitis RG7413
Perjeta HER2+ mBC 2nd line RG1273
alectinib (ALK inhibitor) NSCLC RG7853
Gazyva iNHL rituximab refractory RG7159
Gazyva follicular lymphoma 1st line RG7159
venetoclax (Bcl-2) + Rit. CLL rel/ref RG7601
Kadcyla HER2+ gastric cancer 2nd line RG3502
gantenerumab Alzheimer’s RG1450
PD-L1 MAb NSCLC 2nd line RG7446
Kadcyla + Perjeta HER2+ BC adj RG3502
Kadcyla + Perjeta HER2+ BC neoadj RG3502
IL-6R MAb neuromyelitis optica CHU
Perjeta HER2+ BC adj RG1273
Kadcyla HER2+ BC adj RG3502
venetoclax+Gazyva (Bcl-2) CLL 1st line RG7601
Avastin ovarian cancer 1st line RG4351
Avastin rel. ovarian ca. Pt-sensitive RG4351
PD-L1 MAb bladder cancer 2nd line RG7446
bitopertin obsessive compulsive dis. RG1678
danoprevir HCV RG7227
basimglurant (mGlu5 NAM) TRD RG7090
MAO-B inh Alzheimer’s RG1577
Actemra systemic sclerosis RG1569
polatuzumab vedotin (CD79bADC) hem tumors RG7596
V1 receptor antag autism RG7314
ipatasertib (AKT inh) solid tumors RG7440
lebrikizumab idiopathic pulmonary fibrosis RG3637
LptD antibiotic antibacterial
RG7929
venetoclax (Bcl-2) C LL rel/refract 17pdel RG7601
PD-L1 MAb bladder cancer 1/2l RG7446
Flu A MAb influenza RG7745
IL-31R MAb atopic dermatitis CHU
FIXa /FX bispecific MAb hemophilia A RG6013
PD-L1 MAb NSCLC 2nd/3rd line RG7446
GABRA5 NAM Down Syndrome RG1662
ADC lifastuzumab vedotin (NaPi2bADC)Pt-resist. OC RG7599
PD-L1 MAb + Avastin RCC RG7446
CSF-1R MAb PVNS/solid tumors RG7155
taselisib (mutant-selective) solid tumors RG7604
venetoclax (Bcl-2) DLBCL RG7601
Ang2-VEGF MAb colorectal cancer RG7221
setrobuvir HCV RG7790
glypican-3 MAb liver cancer RG7686
GIP/GLP-1 dual ago type 2 diabetes RG7697
Esbriet SSc – interstitial lung disease RG6062
cobimetinib TNBC RG7421
Avastin+Tarceva EGFR mut+ NSCLC RG435
venetoclax (Bcl-2)+ Rituxan rel/ref FL RG7601
pictilisib pictilisib solid tumors RG7321
SERD ER+(HER2-neg) mBC RG6046
URAT 1 inh gout CHU
RG7929
Kadcyla HER2+ NSCLC RG3502
lebrikizumab IPF RG3637
NME submissions and their additional indications
Projects currently in phase 2 and 3
82
Unless stated otherwise, submissions are planned to occur in US and EU
* lead market China
Neuroscience
Ophthalmology
Other
NME
Oncology
Immunology
Infectious Diseases
CardioMetabolism
bitopertin (RG1678)
obsessive compulsive dis.
ocrelizumab (RG1594) RMS
cobimetinib (MEK inh) combo Zelboraf
met melanoma
danoprevir* (RG7227) HCV
basimglurant (RG7090) depression
crenezumab (RG7412) Alzheimer‘s
gantenerumab (RG1450) Alzheimer‘s
V1 receptor antag (RG7314) autism
glypican-3 Mab (RG7686) liver cancer
lampalizumab anti-factor D (RG7417) geo atrophy
lebrikizumab (RG3637) severe asthma
etrolizumab (RG7413) ulcerative colitis
2014 2015 2017 and beyond
alectinib (RG7853) ALK-pos. NSCLC
PD-L1 MAb (RG7446) NSCLC 2nd/3rd line
ipatasertib AKT inh (RG7440) solid tumors
MAO-B inh (RG1577) Alzheimer‘s
polatuzumab vedotin (RG7596)
CD79b ADC heme tumors
LptD antibiotic (RG7929) antibacterial
lebrikizumab (RG3637) idiopathic pulmonary fibrosis
2016
PDL-1 MAb (RG7446) combo Avastin RCC
Flu A MAb (RG7745) influenza
taselisib (PI3Ki, RG7604) (mutant-selective) solid tumors
GABRA5 NAM (RG1662) Down syndrome
lifastuzumab (RG7599)
NaPi2b ADC Pt resistant OC
PDL-1 MAb (RG7446) bladder cancer
CSF-1R MAb (RG7155)
PVNS and solid tumors
venetoclax (Bcl-2i, RG7601) + Gazyva DLBCL
Ang2-VEGF MAb (RG7221)
colorectal cancer
Status as of January 28, 2015
ocrelizumab (RG1594) PPMS
FIXa /FX bispecific MAb (RG6013) hemophilia A
cobimetinib TNBC
venetoclax (Bcl-2i, RG7601) + Gazyva CLL 1st line
venetoclax (Bcl-2i, RG7601) + Rituxan rel/ref FL
venetoclax (Bcl-2i, RG7601) CLL rel/ref
pictilisib PI3K inh (RG7321) solid tumors
SERD (RG6046)
ER+(HER2-neg) mBC
Avastin NSCLC adj
2014 2015 2017 and beyond
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.
Submissions of additional indications for existing
products
Projects currently in phase 2 and 3
83
Actemra systemic sclerosis
Perjeta HER2-pos. BC adj
Perjeta
HER2-pos. gastric cancer 1L
Zelboraf
melanoma adj.
Kadcyla +/- Perjeta
HER2-pos mBC 1st line
Kadcyla
HER2-pos gastric cancer 2L
Kadcyla
HER2-pos. BC adj
**Avastin (EU)
cervical cancer recurrent
Actemra giant cell arteritis
2016
*Avastin (US) rel. ovarian ca. Pt-resist
Avastin (US)
GBM
Gazyva DLBCL 1st line
Gazyva iNHL rituximab refractory
Gazyva follicular lymphoma 1st line
Neuroscience
Ophthalmology
Other
NME
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Perjeta
HER2-pos. mBC 2ndline
Lucentis (US) diabetic retinopathy
**Perjeta (EU) HER2-pos. BC neoadj
MabThera SC (EU) CLL
Status as of January 28, 2015
Avastin +Tarceva(EU)
EGFR mut+ NSCLC
*Avastin (US) ovarian cancer 1st line
*Avastin (US) rel. ovarian ca. Pt-sens
Kadcyla+Perjeta
HER2-pos. BC adj
Kadcyla+Perjeta
HER2-pos. BC neoadj
Kadcyla
HER2-pos. NSCLC
Major granted and pending approvals 2014
84
Neuroscience
Ophthalmology
Other
NME
Oncology
Immunology
Infectious Diseases
CardioMetabolism
EU
US
Approved Pending approvals
MabThera NHL sc formulation
March 2014
RoActemra
RA sc formulation April 2014
Xolair
chronic idiopathic urticaria
March 2014
Avastin
rel. ovarian ca. Pt-resist
August 2014
RoActemra
early RA
September 2014
Gazyvaro
CLL
July 2014
Avastin cervical cancer
Filed April 2014
Avastin cervical cancer
August 2014
alectinib ALECENSA ALK-pos rec/adv NSCLC
July 2014
Zelboraf
m. melanoma December 2014
Japan-Chugai
Perjeta BC neoadjuvant
Filed September 2014
cobimetinib + Zelboraf
m. melanoma
Filed September 2014
Lucentis diabetic retinopathy
Filed August 2014
Esbriet*
idiopathic pulmonary fibrosis
October 2014
Esbriet*
idiopathic pulmonary fibrosis
March 2011
* Newly acquired asset (Intermune) Status as of January 28, 2015
Avastin
rel. ovarian ca. Pt-resist
November 2014
MabThera SC CLL
Filed November 2014
cobimetinib + Zelboraf
m. melanoma
Filed December 2014
Doing now what patients need next