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TRANSCRIPT
Roche
Q1 2015 sales
Basel, 22 April 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
Q1 2015: Highlights
5
Innovation
• Second Breakthrough Therapy Designation for anti-PDL1
• Phase 3 starts: Seven in immuno-oncology, etrolizumab in Crohn’s disease and taselisib in HR+
breast cancer
Growth
• Group sales +5%1 driven by HER2 franchise (+23%1), Avastin (+6%1), Actemra (+27%1) and
Professional Diagnostics (+6%1)
• Esbriet: Off to a strong start
M&A
• Foundation Medicine: Transaction closed
1 CER=Constant Exchange Rates
Q1 2015: Strong sales growth
6 CER=Constant Exchange Rates
2015 2014
CHFbn CHFbn CHF CER
Pharmaceuticals Division 9.3 9.0 3 4
Diagnostics Division 2.5 2.5 2 6
Roche Group 11.8 11.5 3 5
Change in %
Q1 2015: Continued strong growth in all regions
7
0
1
2
3
4
5
6
Japan International Europe US
Diagnostics
Pharma
CHFbn
+6%
+1% +9%
-2%
+3% +14%
-10%
+3%
+6%
+1%
-3%
+10%
*
* Japanese sales impacted by consumption tax base effect
CER=Constant Exchange Rates
Q1 2015: Sales growth for 5th consecutive year
8 All growth rates at Constant Exchange Rates (CER)
0% 0% 1%
4%
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5%
6%
5%
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
Q1
15
Progressing in Personalised Healthcare
60% of phase 2 & 3 products have PHC component
9
Marketed Phase 2 Phase 3/Registration
FIXa/FX bispecific MAb
SERD
CSF-1R MAb
Ang2-VEGF MAb
ipatasertib
polatuzumab vedotin
lifastuzumab vedotin
glypican-3 MAb
MAO-B inh
GABRA5 NAM
bitopertin
basimglurant
V1 receptor antag
crenezumab
olesoxime
danoprevir
Flu A MAb
LptD antibiotic
PD-L1 MAb
venetoclax (Bcl-2 inh)
alectinib (ALK inh)
taselisib
cobimetinib
lebrikizumab
etrolizumab
gantenerumab
ocrelizumab
lampalizumab
Tarceva®
Zelboraf®
Erivedge®
Rituxan®
Gazyva®
Herceptin®
Perjeta®
Kadcyla®
Avastin®
Xeloda®
Esbriet®
Pulmozyme®
Xolair®
Actemra®
Lucentis®
Oncology
Immunology
Infectious Diseases
Neuroscience
Ophthalmology
Molecular Diagnostics
Tissue Diagnostics
Professional Diagnostics
Roche: Making progress in advancing patient care
Recognising innovation 2012-15
10
Rank Company #
1 Roche 6
1 GSK 6
3 Novartis 5
4 Merck 4
5 JNJ 4
6 Breakthrough Therapy Designations
Source: FDA
Q1 2015 Anti-PDL1 (NSCLC)
2014
Esbriet
Lucentis Diabetic Retinopathy
Anti-PDL1 (bladder)
2013 Alectinib
Gazyva
2015 outlook
11
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
12
Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals
Q1 2015 sales
Innovation
Outlook
13
Q1 2015: Strong sales growth driven by US and
International
14
2015 2014
CHFm CHFm CHF CER
Pharmaceuticals Division 9,322 9,040 3 4
United States 4,392 3,873 13 6
Europe 2,178 2,425 -10 1
Japan 763 845 -10 -2
International 1,989 1,897 5 9
Change in %
CER=Constant Exchange Rates
Q1 2015: Strong performance from oncology and
immunology franchises; Esbriet off to a good start
15 15 Absolute amounts and growth rates at Constant Exchange Rates (CER)
-200 -150 -100 -50 0 50 100 150 200
Xeloda
Pegasys
Valcyte/Cymevene
Lucentis
Xolair
Actemra/RoActemra
Kadcyla
Avastin
MabThera/Rituxan
Esbriet
Perjeta
Herceptin
US
Europe
Japan
International
+12%
+82%
n.a.
+5%
+6%
+27%
+80%
-53%
-39%
+28%
CHFm
-41%
-9%
Q1 2015: Oncology products with +6% growth
16
0 1 2
Zelboraf
Xeloda
Tarceva
MabThera/
Rituxan
Avastin
HER2
Kadcyla
Perjeta
Herceptin +23%
+6%
+4%
-3%
-53%
-25%
CER=Constant Exchange Rates; Q1 2015 Oncology sales: CHF 5.8bn
• In-class competition
• Loss of exclusivity
• US: Continued uptake in ovarian, cervical and lung
• EU: Growth in ovarian and breast
• Strong uptake of Perjeta & Kadcyla
• Accelerated growth of Herceptin
• Competitive pressure in US & EU
• Approval of coBRIM expected in 2015
• Increased usage across a variety of indications
CHFbn
YoY CER growth
+23%
+6%
+4%
-3%
-53%
-25%
HER2 franchise: Growth of Perjeta also driving
Herceptin sales
17
0
600
1'200
1'800
2'400
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Kadcyla Perjeta Herceptin
15%
YoY CER growth CHFm
15% 20% 17%
23%
7%
23% 19% 23%
CER=Constant Exchange Rates
Herceptin SC launched in 44 countries
Conversion rate already exceeds 30%
18
SC share of Herceptin sales in
launched countries
0%
5%
10%
15%
20%
25%
30%
35%
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Sale
s m
ark
et
share
(%
)
Number of countries where
Herceptin SC has been launched
0
10
20
30
40
50
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Tota
l num
ber
of
countr
ies
Avastin: Strong growth across various indications
and in all regions
19 CER=Constant Exchange Rates
Avastin Q1 2015
• Main growth drivers are ovarian
(US; EU), lung (US) and cervical
cancer (US)
• EU: Positive momentum in breast
cancer due to IMELDA
• International (+11%) in all regions
Outlook
• EU launch in cervical cancer 0
300
600
900
1'200
1'500
1'800
Q1 12 Q1 13 Q1 14 Q1 15
CHFm
US Europe International Japan
YoY CER growth
+1%
+11% +6% +9%
0
500
1'000
1'500
Q1 12 Q1 13 Q1 14 Q1 15
Other (incl Esbriet) PulmozymeCellCept XolairActemra SC Actemra IVMabThera/Rituxan
Immunology franchise remains driven by Actemra,
Xolair and MabThera/Rituxan
20
• Actemra (+27%): SC launch and
1L monotherapy setting
• Xolair (+28%): Allergic asthma
and strong growth in Chronic
Idiopathic Urticaria (CIU) post
FDA approval in Q1 ‘14
• MabThera/Rituxan (+11%):
Continues to grow in rheumatoid
arthritis and vasculitis (GPA and
MPA)
CHFm YoY CER growth
+5% +11%
+11%
+20%
GPA=Granulomatosis with polyangiitis; MPA=Microscopic polyangiitis
CER=Constant Exchange Rates
200
300
400
500
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Ophthalmology franchise: Competitive pressure
on Lucentis; Fast Track status for lampalizumab
21
Lucentis sales
Lucentis
DME
AMD
Less-frequent than
monthly dosing
wAMD=wet age-related macular degeneration; DME=diabetic macular edema
Lucentis Q1 2015
• Continued competitive pressure in
wAMD
• First-in-class FDA approval to treat
diabetic retinopathy (DR) in patients
with DME
Lucentis outlook
• Ongoing competition in AMD & DME
• First sales in DR
Lampalizumab update
• FDA granted Fast Track status for
geographic atrophy (GA)
• Ph3 global enrollment well on track
USDm
Esbriet: Off to a strong start
22
US launch off to strong start
• Patients still in transition to full
reimbursement post approval
• Establishing market leadership in IPF
European sales with continued
growth
• Label was strengthened by including
ASCEND and pooled 1Y mortality data
Esbriet sales (CHFm)
27 32
36
44
88
Q1 14 Q2 14 Q3 14 Q4 14 Q1 15
Q1 2015 sales
Innovation
Outlook
23
Gazyva: First positive readout in iNHL
24
GADOLIN: Ph III MabThera/Rituxan refractory indolent non-Hodgkin`s lymphoma (iNHL)
MabThera x 8 cycles + CHOP x
6 or 8
Gazyva x 8 cycles +
CHOP x 6 or 8 Front-line DLBCL
(aggressive NHL)
n=1,418
Primary end-point: PFS
Trial to continue until 2016
MabThera
q2mo x 2 years
Gazyva
q2mo x 2 years
MabThera x 8 cycles + CHOP x 6 or MabThera x 8
cycles + CVP x 8 or MabThera x 6 cycles + benda. x 6
CR, PR
Gazyva x 8 cycles + CHOP x 6 or
Gazyva x 8 cycles + CVP x 8 or
Gazyva x 6 cycles + benda. x 6 Front-line iNHL
n=1,401
Induction Maintenance
Primary end-point: PFS
Enrolment complete Q1 2014
Data expected 2017
Gazyva
q2mo x 2 years
CR, PR,
SD
bendamustine
x 6 cycles
Gazyva
+ bendamustine
x 6 cycles MabThera-refractory iNHL
n=411
Induction Maintenance
Primary end-point: PFS
Data at ASCO 2015
GOYA: Ph III diffuse large B-cell lymphoma (DLBCL)
GALLIUM: Ph III front-line indolent non-Hodgkin`s lymphoma (iNHL)
In collaboration with Biogen Idec
CHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; CVP=Cyclophosphamide, Vincristine and Prednisolone
CLL11: Ph III front-line chronic lymphocytic leukemia (CLL)
chlorambucil
MabThera/Rituxan +
chlorambucil
Gazyva 1000mg IV +
chlorambucil
Front-line CLL
n=781
Primary end-point: PFS
Approved in Q4 2013
Roche cancer immunotherapy
Extensive phase III program to start in 2015
25
Phase II Phase III
PDL1
NSCLC (Dx+)
PDL1
2/3L NSCLC
PDL1+Avastin
1L Renal
PDL1
1/2L Bladder
Phase I
OX40
Solid tumors
CEA CD3
Solid tumors
IDO
Solid tumors
CSF-1R
Solid tumors
PDL1
Solid tumors
PDL1+Zelboraf
Melanoma
PDL1+Tarceva
NSCLC
PDL1+Avastin+FOLFOX
CRC
PDL1 + Gazyva
Blood cancer
CEA IL2v
Solid tumors
PDL1
TNBC
PDL1+Avastin
Solid tumors
PDL1+cobimetinib
Solid tumors
PDL1+ipilimumab
Solid tumors
PDL1+CD40
Solid tumors
PDL1+IFN-alfa
Solid tumors
PDL1+CSF-1R**
Solid tumors
PDL1+CEA IL2v**
Solid tumors
PDL1+OX40**
Solid tumors
PDL1+Zelboraf+cobi**
Solid tumors
PDL1
2/3L NSCLC
PDL1**
2/3L Bladder
PDL1+Avastin+chemo**
1L non sq NSCLC
PDL1+chemo**
1L non sq NSCLC
PDL1+chemo**
1L sq NSCLC
PDL1**
1L non sq NSCLC (Dx+)
PDL1**
1L sq NSCLC (Dx+)
PDL1+chemo**
1L TNBC
PDL1**
tba
PDL1**
tba
PDL1+Avastin**
1L RCC
Anti-PDL1 trials
NMEs monotherapy
2015 readout expected
Study start in 2015
Immune doublets
**
Status as at April 22, 2015
PDL1**
tba
PDL1**
tba
PDL1**
tba
Breakthrough Therapy Designation granted for
anti-PDL1 in 2/3L NSCLC in Q1
26
Primary end-point: ORR
Data at ASCO
All comers 2/3L NSCLC
(stratified by PDL1
expression)
n = 1100
docetaxel
75 mg/m2 IV Q3 wk
anti-PDL1
1200 mg IV Q3 wk
OAK: Ph III 2/3L mNSCLC
Primary end-point: OS
FPI Q1 2014
Data expected 2016
FIR: Ph II Dx-selected advanced metastatic Non-Small Cell Lung Cancer (mNSCLC)
PDL1-selected NSCLC
n = 138
anti-PDL1 1200 mg IV
Q3 weeks
POPLAR: Ph II 2/3L mNSCLC
Primary end-point: OS
Interim data at ASCO
Final data in H2 2015
All comers 2/3L NSCLC
(stratified by PDL1
expression)
n = 287
docetaxel
75 mg/m2 IV Q3 wk
anti-PDL1
1200 mg IV Q3 wk
BIRCH: Ph II Dx-positive advanced mNSCLC
PDL1-selected NSCLC
n = 667
anti-PDL1 1200 mg IV
Q3 weeks Primary end-point: ORR
Data in Q3 2015
Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov
Five anti-PDL1 phase III studies started addressing
the entire 1L metastatic lung cancer market
27
Study Indication Patient population Treatment arms n Primary
completion*
Combination studies
GO29436 1L Non-squamous
NSCLC
All comers
(PD-L1 subgroup
analysis)
carbo/pac/anti-PDL1
carbo/pac/Avastin/anti-PDL1
carbo/pac/Avastin
1,200 2017 (PFS)
GO29537 1L Non-squamous
NSCLC
All comers
(PD-L1 subgroup
analyis)
carbo/nab-p/anti-PDL1
carbo/nab-p 550 2017 (PFS)
GO29437 1L Squamous
NSCLC
All comers
(PD-L1 subgroup
analysis)
carbo/pac/anti-PDL1
carbo/nab-p/anti-PDL1
carbo/nab-p
1,200 2017 (PFS)
Monotherapy studies
GO29431 1L Non-squamous
NSCLC PD-L1 selected
anti-PDL1
cis or carbo/pem 400 2017 (PFS)
GO29432 1L Squamous
NSCLC PD-L1 selected
anti-PDL1
cis or carbo/gem 400 2018 (PFS)
Carbo = Carboplatin; Pac = Paclitaxel; Nab-p = Nab-paclitaxel; Cis = Cisplatin; Pem = Pemetrexed; Gem = Gemcitabine
Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov
* Outcome studies are event driven, timelines may change, OS endpoint included for all studies
Anti-PDL1 phase III study announced in TNBC
Updated phase I data presented at AACR
28
PD-L1
IHC (IC)
TNBC a
n
ORR,
Best
Respons
e, 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 - - -
IC2/3 patientsa, nb ORR
(95% CI)
24-Week PFS
(95% CI)
21 19%
(5-42)
27%
(7-47)
• Anti-PDL1 was generally well tolerated
(n=54)
• Responses included
– 2 CRs (1 IC3 and 1 IC2) and 2 PRs (IC2)
– 3 of 4 responses ongoing
• In addition, three patients recorded as PD
appeared to experience
pseudoprogression, with durable
shrinkage of target and new lesions
• Phase III study to start in H2 2015
a PD-L1 expression was centrally evaluated on tumor-infiltrating immune cells (ICs) based on an immunohistochemistry (IHC) assay; b IC0/1 patients not yet evaluable for efficacy Emens LA, et al. AACR 2015
Foundation Medicine (FMI)
Molecular Information supporting drug development
29
Transaction closed in April 2015
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
• Our phase III anti-PDL1 program is a
primary focus of the collaboration
• We will use FMI's FoundationOne next
generation DNA sequencing to look
at a spectrum of DNA mutations
• We will also be working with
Foundation Medicine to develop RNA
signatures that may be predictive of
patient benefit
Amyloid pathway and targets
Alzheimer’s disease: Renewed confidence in Aß
hypothesis
Cell membrane
• Aducanumab (BIIB): Similar to
gantenerumab by measure of
target engagement
• Gantenerumab and
crenezumab: Assessment on-
going to inform next steps
Aß mAb's
Amyloid
Precursor
Protein (APP) oligomeric Aβ
soluble Aβ
fibrillar Aβ
solanezumab crenezumab
bapineuzumab
gantenerumab
aducanumab
BAN2401
30
Q1 2015 sales
Innovation
Outlook
31
ASCO 2015: Highlights in various cancer types
32
Skin
• cobimetinib + Zelboraf: Ph III (coBRIM) in 1L BRAF+ mM; PFS & biomarker update
• cobimetinib + Zelboraf: Ph Ib (BRIM7) in BRAF+ mM; OS update
Lung
• alectinib: Two Ph II in 2L ALK+ NSCLC
• anti-PDL1: Ph II interim (POPLAR) in 2/3L NSCLC
• anti-PDL1: Ph II (FIR) in PDL1-selected advanced NSCLC
• anti-PDL1: Ph I update in NSCLC
• anti-PDL1: Ph I data from chemo combinations in NSCLC
• anti-PDL1: Biomarker analysis in NSCLC
Bladder • anti-PDL1: Ph I update in bladder
Breast • Kadcyla + Perjeta: Ph III (MARIANNE) in 1L
HER2+ mBC; primary data • Avastin + Letrozole: Ph III (CALGB40503) in 1L
HR+ mBC • Herceptin + Perjeta: Ph II (NEOPSPHERE) in
neoadjuvant HER2+ BC
Hematology • Gazyva: Ph III (GADOLIN) in R/R iNHL • Polatuzumab vedotin: Ph II (ROMULUS)
interim data in R/R iNHL
Zelboraf in collaboration with Plexxikon; Cobimetinib in collaboration with Exelixis; Alectinib in collaboration with Chugai, Gazyva in
collaboration with Biogen Idec; Kadcyla in collaboration with ImmunoGen
2015: Key late-stage news flow
33
Compound Indication Milestone
Regulatory
Avastin Cervical cancer EU approval
Lucentis Diabetic retinopathy US approval
alectinib 2L ALK+ NSCLC US filing
cobimetinib + Zelboraf 1L Melanoma US, EU approval
Phase III readouts*
Gazyva MabThera/Rituxan-refractory iNHL Ph III GADOLIN
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 ** 2/3L Bladder Ph III
anti-PDL1 ** 1L TNBC Ph III
anti-PDL1 ** 1L RCC Ph III
anti-PDL1 ** Tumor type 1 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; ** For anti-PDL1 only P3 trials in new indications are listed (1L NSCLC starts not shown)
Compound H1/H2
Regulatory
Avastin Positive opinion Feb 27
Lucentis Approved Feb 9
alectinib Q3
Cobimetinib +
Zelboraf PDUFA date: August 11, 2015
Phase III
readouts*
Gazyva
Gazyva to be communicated in H1
ocrelizumab Q2
ocrelizumab Q3
Perjeta 2H at SABCS 2015 (planed)
Kadcyla 2H
Phase III
starts
Anti-PDL1 1H
Anti-PDL1 1H (RCC)
Anti-PDL1 1H (TNBC)
Anti-PDL1 2H (MIBC)
Etrolizumab 1H
ACE910 2H
taselisib (PI3K
inhib) 1H
Phase II
readouts*
Anti-PDL1 1H (ASCO: FIR/POPLAR); 2H BIRCH
Anti-PDL1 2H ESMO
ipatasertib
(AKT inhib) ?
2016
Picture
34
Diagnostics Division Roland Diggelmann COO Roche Diagnostics
Q1 2015: Diagnostics Division sales
Good growth in all units
35
2015 2014
CHFm CHFm CHF CER
Diagnostics Division 2,511 2,456 2 6
Professional Diagnostics 1,425 1,392 2 6
Diabetes Care 507 538 -6 1
Molecular Diagnostics 401 370 8 10
Tissue Diagnostics 178 156 14 14
Change in %
Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8%
CER=Constant Exchange Rates
North America
+5%
27% of divisional sales
Latin America
+11%
6% of divisional sales
Japan
-10%
4% of divisional sales EMEA1
+4%
44% of divisional sales
Q1 2015: Diagnostics regional sales
Strong performance in APAC
Asia Pacific
+16%
19% of divisional sales
36
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
Q1 2015: Diagnostics
Growth driven by Professional Diagnostics
• Virology (+10%) incl. HPV (+39%)
• Ariosa: Entry into NIPT
• Accu-Chek Aviva/Performa (+2%) and insulin delivering systems (+10%)
• Advanced staining portfolio (+13%)
1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa; NIPT=Non-invasive prenatal testing
YoY CER growth
+6% • Growth driven by immunodiagnostics (+11%) and
coagulation self testing (+14%)
0 0.5 1 1.5
Tissue Dia
Molecular
Dia
Diabetes
Care
Professional
Dia
EMEA
North America
RoW
Sales
CHFbn
37
1 +10%
+1%
+14%
Professional Diagnostics: Global launch of cobas
8100 version 2
Integrated cobas 8100 lab solutions Elecsys assay menu
Integrated Pre-analytics
Post-analytics
Modular analyzers
• Bidirectional sample flow between pre-analytical, analytical and post-analytical steps
optimizes laboratory workflow
• Automated sample check reduces work load and enhances patient safety
38
Cardiac Thyroid Tumormarker
Women'sHealth
InfectiousDiseases
Other Critical Care Anemia Hormones
Immunoassays: 26% of Diagnostic sales growing
double digit (+11%)
39
12%
6%
14%
23%
10%
30%
YoY CER growth
4%
9%
7%
CER=Constant Exchange Rates; “Other” include Needed Common Products, Allergy, Rheumatoid Arthritis, Immunosuppressants
Sales
Molecular Diagnostics: Launch of HBV Test for
cobas® 6800/8800 systems
40
Complements the viral load monitoring portfolio of cobas 6800/8800
• Lower sample requirement, higher sensitivity and faster test results across all genotypes
• Strengthens market lead in viral load testing and helps optimize therapy for patients
cobas® 8800
Modular analyzers
Pre-analytics
Integrated cobas® 8800
Roche sequencing: Delivering on acquisitions
NEXT* study results demonstrate superiority of Harmony test vs conventional testing
41
Study results
• Significant superiority of the HarmonyTM Prenatal Test over first trimester combined
screening for assessing risk of Trisomy 21
• Lowers number of false positives which may reduce the need for invasive testing
• Single largest trial > than 18,500 pregnant women
• Supports the use of NIPT as a first line screening option
* NEXT: Non-invasive examination of trisomy; NIPT=Non-invasive prenatal testing
1 Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics;
RTD: Roche Tissue Diagnostics;
Key launches 2015
42
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
43
Finance Alan Hippe Chief Financial Officer
Q1 2015: Highlights
44
Currency impact
• EUR and JPY currencies major negative contributors
• Negative 2%p impact on Q1 2015 sales growth
Q1 debt refinancing and major cash outflows
• Two bond redemptions
– USD: 0.6 bn maturity in 2019 - coupon 6.00% s.a.
– GBP: 0.5 bn maturity in 2015 - coupon 5.50%
• Two bond issuances
– USD: 0.6 bn maturity in 2020 - coupon 2.00%
– EUR: 1.0 bn maturity in 2025 - coupon 0.875%
s.a. = Semi-annual coupon
FMI transaction
• Tender offer completed
• Roche owns ~57% of the outstanding shares of FMI’s common stock on a fully diluted basis
Q1 2015: Strong sales across the board
45 Absolute values in CHFm at CER = Constant Exchange Rates (avg full year 2014)
1 avg December 2014 to avg March 2015 fx * Japanese sales impacted by consumption tax base effect
+558
+246
-221
+337
+18
-17+140
+165
+6
United
States
Europe Intl. Chugai
(Japan)
Dia Diabetes
Care
Group Fx Group
CHF
Pharma Division
Dia Division
+6%
+6% +1% +9% -2% +7% +1% +5% +3%
+4%
1
*
CER
sales
growth
Q1 2015
vs.
Q1 2014
Exchange rate impact on sales growth
USD and EUR impacts balance out
46
+4.8%
+2.9%
+2.8%p +0.2%p -0.1%p -0.6%p
-0.6%p
-0.9%p
-2.7%p
CER USD Asia-
Pac
Other Lat-Am JPY Other
Europe
EUR CHF
CHF
sales
growth
Q1 2015
vs.
Q1 2014
CER=Constant Exchange Rates
Negative currency impact in 2015 expected
47
Q1 HY Sep
YTD
FY
Sales -2 -2 -3 -3
Core
operating
profit
-3 -4
Core EPS -7 -8
Assuming the 31 Mar 2015 exchange
rates remain stable until end of 2015,
2015 impact is expected to be (%p):
CHF / USD
CHF / EUR
+1%
+1%
+2% +2%
0.95 0.93 0.97 0.970.98 0.97 0.970.97 0.970.97 0.97 0.97
0.960.95
0.96 0.96
0.91
0.890.90
0.89
J F M A M J J A S O N D
1.10 1.06 1.06 1.05 1.05 1.05 1.051.05 1.051.05 1.05 1.05
1.22 1.211.221.22
1.061.08
1.06 1.05
J F M A M J J A S O N D
Average
YTD
2014
7% 8% 7%
5%
-12% -13% -13% -13%
Assumed average YTD 2015
Monthly avg fx rates 2015 Fx rates at 31 March 2015
Roche: Net trade working capital
Continuous improvements over the years
Group NTWC / sales
48
31.6% 31.1%
29.7%
Dec-2012 Dec-2013 Dec-2014
Accounts payable
• Renegotiated existing supply payment terms
• Simplified downstream processes
• Established standard payment terms
Accounts receivable
• Southern Europe: Reduced accounts receivables
• Eastern Europe: Adopted EU payment terms
• Pro-active collection strategy
Note: NTWC calculated as Q4 average for all years; NTWC 2014 excl. Esbriet inventory step-up
2015 outlook
49
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
Q1 2015 update
51
New to Phase I New to Phase II New to Phase III New to Registration
1AI
RG7813 CEA IL2v + PD-L1MAb - solid
tumors
1 NME (Trophos acquisition)
RG6083 olesoxime - SMA
1 NME (shown to reflect upcoming
submission)
RG7853 alectinib - ALK-mut. pos.
NSCLC 2L
1 AI (previous P2 in solid tumors
split out)
RG7604 taselisib - NSCLC sq. 2L
1 NME
RG7604 taselisib - ER+/HER2-
neg mBC
7 AIs
RG7413 etrolizumab - Crohn’s
disease
RG7446 PD-L1 MAb Dx-pos.
patients - NSCLC sq. 1L
RG7446 PD-L1 MAb Dx-pos.
patients - NSCLC non-sq. 1L
RG7446 PD-L1 MAb + chemo -
NSCLC sq. 1L
RG7446 PD-L1 MAb + chemo -
NSCLC non sq. 1L
RG7446 PD-L1 MAb + chemo
+/- Avastin - NSCLC non sq. 1L
RG7853 alectinib Alk-mut.pos. -
NSCLC 1L
Removed from Phase I Removed from Phase II Removed from Phase III Removed from
Registration
2 NMEs
RG7410 TAAR1 ago - schizophrenia
RG7342 mGlu5 PAM - schizophrenia
2 NMEs
RG7790 setrobuvir – HCV
RG7321 pictilisib – solid tumors
1 AI
RG435 Avastin - NSCLC adj.
1 AI following US approval
RG3645 Lucentis - diabetic
retinopathy
1 AI following EU approval
RG435 Avastin – cervical cancer
Status as of April 22, 2015
Roche Group development pipeline
52
Phase I
(31 NMEs + 12 AIs)
Raf & MEK dual inh solid tumors
ChK1 inh solid tum & lymphoma
Oncology Other disease areas
Status as of April 22, 2015
lumretuzumab (HER3 MAb) solid tumors
idasanutlin (MDM2 ant) s. & 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+Zelboraf+/-cobimetinib melanoma
Steap 1 ADC prostate ca.
PD-L1+Avastin+chemo solid tumors
PD-L1 MAb+Tarceva NSCLC EGFR+
PD-L1 MAb+cobimetinib solid tumors
venetoclax+Gazyva CLL CLL
PD-L1 MAb solid tumors
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
a-synuclein MAb Parkinson's Disease
SMN2 splicer spinal muscular atrophy
TLR7 agonist HBV RG7795
RG3645
RG7203
RG7893
aldosterone synth inh met. diseases RG7641
RG7716
RG7935
RG7800
HIF1 alpha LNA solid tumors
RG7304
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
- inflammatory diseases RG7880
- autoimmune diseases RG7625
- infectious diseases RG7689
DBO β-lactamase inh bact. infections RG6080
TAU MAb Alzheimer’s RG7345
emactuzumab (CSF-1R) + PDL1 s.tumors RG7155
SERD (2) ER+(HER2-neg) mBC RG6047
IDO inh solid tumors RG6078
duligotuzumab (HER3/EGFR)+ cobi s. tum. RG7597
CEA IL2v + PD-L1 MAb solid tumors RG7813
venetoclax heme indications RG7601
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
53
Phase II (22 NMEs + 14 Als) Phase III (9 NMEs + 27 Als) Registration (1 NME + 2 Als)
1 US only : FDA submission decision pending
2 Approved in US, submitted in EU
* FPI imminent
crenezumab Alzheimer’s RG7412 lampalizumab geographic atrophy RG7417
Perjeta HER2+ BC neoadj RG12732
cobimetinib + Zelboraf m. melanoma RG7421
MabThera SC CLL RG105 Avastin glioblastoma 1L RG435
Kadcyla +/- Perjeta HER2+ mBC 1L RG3502
ocrelizumab RMS RG1594
Gazyva DLBCL1L RG7159
ocrelizumab PPMS RG1594
Actemra large-vessel vasculitis CHU
lebrikizumab severe asthma RG3637
Zelboraf melanoma adj RG7204
Perjeta+Herceptin HER2+gastric ca 1L RG1273
Actemra giant cell arteritis RG1569
etrolizumab ulcerative colitis RG7413
Perjeta+Herceptin HER2+ mBC 2L RG1273
alectinib ALK+ NSCLC 1L RG7853
Gazyva iNHL rituximab-ref RG7159
Gazyva follicular lymphoma 1L RG7159
venetoclax+Rituxan CLL rel/ref RG7601
Kadcyla HER2+ gastric cancer 2L RG3502
gantenerumab Alzheimer’s RG1450
PD-L1 MAb NSCLC 2L RG7446
Kadcyla + Perjeta HER2+ BC adj RG3502
Kadcyla + Perjeta HER2+ BC neoadj RG3502
IL-6R MAb neuromyelitis optica CHU
Perjeta+Herceptin HER2+ BC adj RG1273
Kadcyla HER2+ BC adj RG3502
venetoclax+Gazyva CLL 1L RG7601
Avastin ovarian cancer 1L RG4351
Avastin rel. ovarian ca. Pt-sensitive RG4351
PD-L1 MAb bladder cancer 2L RG7446
bitopertin obsessive compulsive dis. RG1678
danoprevir HCV RG7227
basimglurant TRD RG7090
sembragiline (MAO-B inh) Alzheimer’s RG1577
Actemra systemic sclerosis RG1569
polatuzumab vedotin hem tumors RG7596
V1 receptor antag autism RG7314
ipatasertib solid tumors RG7440
lebrikizumab idiopathic pulmonary fibrosis RG3637
LptD antibiotic antibacterial
venetoclax 17p del CLL rel/ref RG7601
PD-L1 MAb +Avastin RCC RG7446
Flu A MAb influenza RG7745
IL-31R MAb atopic dermatitis CHU
FIXa/FX bispecific MAb hemophilia A RG6013
PD-L1 MAb NSCLC 2/3L RG7446
GABRA5 NAM Down Syndrome RG1662
ADC lifastuzumab vedotin Pt-resist. OC RG7599
PD-L1 MAb bladder cancer 1/2L RCC RG7446
emactuzumab (CSF-1R) PVNS/s. tumors RG7155
taselisib NSCLC sq 2L RG7604
venetoclax DLBCL RG7601
vanucizumab (Ang2-VEGF MAb) mCRC RG7221
glypican-3 MAb liver cancer RG7686
GIP/GLP-1 dual ago type 2 diabetes RG7697
Esbriet SSc–interstitial lung disease RG6062
cobimetinib+paclitaxel TNBC RG7421
Avastin+Tarceva EGFR mut+ NSCLC RG435
venetoclax+Rituxan FL rel/ref RG7601
SERD ER+(HER2-neg) mBC RG6046
URAT 1 inh gout CHU
RG7929
Kadcyla HER2+ NSCLC RG3502
lebrikizumab IPF RG3637
alectinib ALK+ NSCLC 2L RG7853
RG7929 olesoxime spinal muscular atrophy RG6083
PD-L1+chemo NSCLC non-sq 1L RG7446
NSC PD-L1+chemo+Avastin NSCLC non-sq 1L RG7446
PD-L1+chemo NSCLC sq 1L RG7446*
PD-L1 MAb Dx+ NSCLC sq 1L RG7446*
PD-L1 MAb Dx+ NSCLC non-sq 1L RG7446*
taselisib ER+(HER2-neg) mBC RG7604
etrolizumab Crohn’s disease RG7413
Status as of April 22, 2015
taselisib ER+(HER2-neg) BC neoadj RG7604
NME submissions and their additional indications
Projects currently in phase 2 and 3
54 * lead market China
Unless stated otherwise, submissions are planned to occur in US and EU
lebrikizumab (RG3637) severe asthma
PD-L1 MAb (RG7446) NSCLC 2/3L
2016
PDL-1 MAb (RG7446) bladder cancer
ocrelizumab (RG1594) PPMS
venetoclax (RG7601) CLL rel/ref
glypican-3 MAb (RG7686) liver cancer
lampalizumab (RG7417)
geographic atrophy
ipatasertib (RG7440) solid tumors
polatuzumab vedotin (RG7596)
heme tumors
taselisib (RG7604) HER2 neg ER+ mBC
lifastuzumab (RG7599)
Pt resistant OC
emactuzumab (RG7155)
PVNS and solid tumors
vanucizumab (RG7221)
colorectal cancer
FIXa/FX bispecific MAb (RG6013) hemophilia A
SERD (RG6046) ER+(HER2-neg) mBC
ocrelizumab (RG1594) RMS
2015
alectinib (RG7853) Alk+ NSCLC 2L
alectinib (RG7853) Alk+ NSCLC 1L
PDL-1 MAb (RG7446) combo Avastin RCC
2017
olesoxime (RG6083) SMA
bitopertin (RG1678)
obsessive compulsive dis.
danoprevir* (RG7227) HCV
basimglurant (RG7090) depression
crenezumab (RG7412) Alzheimer‘s
gantenerumab (RG1450) Alzheimer‘s
V1 receptor antag (RG7314) autism
etrolizumab (RG7413) ulcerative colitis
sembragiline (RG1577) Alzheimer‘s
LptD antibiotic (RG7929) antibacterial
lebrikizumab (RG3637) idiopathic pulmonary fibrosis
Flu A MAb (RG7745) influenza
GABRA5 NAM (RG1662) Down syndrome
etrolizumab (RG7413) Crohn’s disease
2018 and beyond
venetoclax (RG7601)
DLBCL
cobimetinib+paclitaxel TNBC
venetoclax (RG7601) + Gazyva CLL 1L
venetoclax (RG7601) + Rituxan FL rel/ref
taselisib ( RG7604) NSCLC sq 2L
PDL1 MAb (RG7446)+ chemo NSCLC non-sq 1L
PDL1 MAb (RG7446) NSCLC sq 1L (Dx+)
PDL1 MAb (RG7446) NSCLC non-sq 1L (Dx+)
PDL1 MAb (RG7446)+ chemo NSCLC sq 1L
PDL1 MAb (RG7446)+chemo + Avastin NSCLC non-sq 1L
taselisib ( RG7604) ER+(HER2-neg) BC neoadj
New Molecular Entity Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
Status as of April 22, 2015
* approved in EU
Unless stated otherwise, submissions are planned to occur in US and EU
Submissions of additional indications for existing
products
Projects currently in phase 2 and 3
55
Neuroscience
Ophthalmology
Other
NME
Oncology
Immunology
Infectious Diseases
CardioMetabolism
2015
Kadcyla +/- Perjeta
HER2+ mBC 1L
Kadcyla
HER2+ gastric cancer 2L
Avastin (US)
GBM
Gazyva iNHL rituximab refractory
Avastin +Tarceva(EU)
EGFR mut+ NSCLC
*Avastin (US) ovarian cancer 1st L
*Avastin (US) rel. ovarian ca. Pt-sens
2018 and beyond
Actemra systemic sclerosis
Kadcyla
HER2+ BC adj
Kadcyla+Perjeta
HER2+ BC adj
Kadcyla+Perjeta
HER2+ BC neoadj
Kadcyla
HER2+ NSCLC
Perjeta+Herceptin
HER2+ gastric cancer 1L
Gazyva follicular lymphoma 1L
2017
Status as of April 22, 2015
Perjeta + Heceptin HER2+ BC adj
Actemra giant cell arteritis
2016
Gazyva DLBCL 1L
Perjeta + Herceptin
HER2+ mBC 2L
Zelboraf
melanoma adj.
Major granted and pending approvals 2015
56
Neuroscience
Ophthalmology
Other
NME
Oncology
Immunology
Infectious Diseases
CardioMetabolism
EU
US
Approved Pending approvals
Avastin cervical cancer
April 2015
Perjeta HER2+ BC neoadj
Filed September 2014
cobimetinib + Zelboraf
m. melanoma
Filed September 2014
MabThera SC CLL
Filed November 2014
cobimetinib + Zelboraf
m. melanoma
Filed December 2014
Lucentis diabetic retinopathy
February 2015
Status as of April 22, 2015
Japan-Chugai
Xeloda gastric cancer adj
Filed December 2014
Bonviva osteoporosis (oral) Filed February 2015
Cancer immunotherapy pipeline overview
57 Status as of April 22, 2015
Phase II
(1NME + 3 Als)
PD-L1 MAb +Avastin RCC RG7446
PD-L1 MAb NSCLC 2/3L RG7446
PD-L1 MAb bladder cancer 1/2L RCC RG7446
emactuzumab (CSF-1R) PVNS/s. tumors RG7155
Phase III
(1NME + 6AIs)
PD-L1 MAb NSCLC 2L RG7446
PD-L1 MAb bladder cancer 2L RG7446
PD-L1+chemo NSCLC non-sq 1L RG7446
NSC PD-L1+chemo+Avastin NSCLC non-sq 1L RG7446
PD-L1+chemo NSCLC sq 1L RG7446
PD-L1 MAb Dx+ NSCLC sq 1L RG7446
PD-L1 MAb Dx+ NSCLC non-sq 1L RG7446
*external collaborations: INCB- Incyte INCB024360; CDX-1127- Celldex CD27 MAb
Phase I
(7 NMEs + 9 AIs)
PD-L1+Zelboraf+/-cobimetinib melanoma
PD-L1+Avastin+chemo solid tumors
PD-L1 MAb+Tarceva NSCLC EGFR+
PD-L1 MAb+cobimetinib solid tumors
PD-L1 MAb solid tumors
CEA IL2v solid tumors
PD-L1 MAb+ipi/IFN solid tumors
OX40 MAb solid tumors
RG7446
RG7446
RG7446
RG7446
RG7446
RG7813
RG7446
RG7888
CEA CD3 TCB solid tumors RG7802
CD40 iMAb+PD-L1 MAb solid tumors RG7876
PD-L1 MAb+Gazyva lymphoma RG7446
emactuzumab (CSF-1R) + PDL1 s.tumors RG7155
IDO inh solid tumors RG6078
CEA IL2v + PD-L1 MAb solid tumors RG7813
PD-L1 MAb + IDO inh solid tumors *INCB
PD-L1 MAb + varlilumab solid tumors *CDX
Doing now what patients need next