Roche
2014 results
3
This presentation contains certain forward-looking statements. These forward-looking
statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’,
‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among
other things, strategy, goals, plans or intentions. Various factors may cause actual results to
differ materially in the future from those reflected in forward-looking statements contained in
this presentation, among others:
1 pricing and product initiatives of competitors;
2 legislative and regulatory developments and economic conditions;
3 delay or inability in obtaining regulatory approvals or bringing products to market;
4 fluctuations in currency exchange rates and general financial market conditions;
5 uncertainties in the discovery, development or marketing of new products or new uses of existing
products, including without limitation negative results of clinical trials or research projects, unexpected
side-effects of pipeline or marketed products;
6 increased government pricing pressures;
7 interruptions in production;
8 loss of or inability to obtain adequate protection for intellectual property rights;
9 litigation;
10 loss of key executives or other employees; and
11 adverse publicity and news coverage.
Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to
mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily
match or exceed the historical published earnings or earnings per share of Roche.
For marketed products discussed in this presentation, please see full prescribing information on our website
www.roche.com
4
Group
Severin Schwan
2014 performance
Outlook
2014: Targets achieved
6
Targets for 2014
FY 2014
Group sales
Low to mid-single digit growth
1
+5%
Core EPS
Ahead of sales growth
1
+5%
+7%
excl. one-time
US Pharma fee
2
Dividend
Further increase dividend
3
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
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%
1driven by HER2 franchise (+20%
1), Avastin (+6%
1), Actemra (+23%
1) and
Professional Diagnostics (+8%
1)
•
Outperformance in all major regions: +6%
1in US, Japan & International; +3%
1in Europe
M&A
•
InterMune: Acquisition completed
•
Foundation Medicine: Collaboration announced
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
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 %
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
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%
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
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 Rates2014: 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 etrolizumab2anti-PDL1
taselisib
1venetoclax (Bcl2i)
cobimetinib
4pictilisib
1alectinib
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
2014 performance
Outlook
Launch new products
Cobimetinib + Zelboraf: US and EU
Esbriet: 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)
2015 outlook
18
Group sales growth
1
Low to mid-single digit
Core EPS growth
1
Ahead of sales growth
2
Dividend outlook
Further increase dividend in Swiss francs
1 At constant exchange rates
19
Pharmaceuticals Division
Daniel O’Day
2014 results
Innovation
Outlook
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 %
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
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
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%
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
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
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%
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
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
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
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
2014 results
Innovation
Outlook
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 etrolizumab2anti-PDL1
taselisib
1venetoclax (Bcl2i)
cobimetinib
4pictilisib
1alectinib
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
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 2018 2019 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
Hematology franchise
Extensive late stage clinical trial program
34
Compound Combination Indication P 1 P 2 P 3 Gazyva Mono GREEN R/R CLLGazyva 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)
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
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-CD40IMA942 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 therapiesNew in 2014
T cell killing
Anti-PD-L1 Anti-CSF-1R Anti-CEA-IL2v Anti-OX40IDO inhibitor (NewLink Genetics) NME (undisclosed)
IDO inhibitor* (Incyte)
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 2015Roche 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 doubletsRoche 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, 2015Oncology – 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
NON -IN HI B ITO R
Prophylaxis with bypassing agents
Every other day, IV On-demand treatment with
bypassing agents 2-3h intervals, IV IN HI B ITO R
Immune Tolerance Induction 70-80 % success rate
limitation due to very high cost and heavy burden for patients
ACE 910
FVIIIa
2014 results
Innovation
Outlook
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
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
EMEA
1
+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 countries
2
1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey
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 RoWSales
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
2017E
2022E
Other
Asia
RPD reagent volume
x2
50
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
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
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
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
Harmony
TMPrenatal Test
Digital analysis of selected
regions (DANSR
TM) technology
Key launches 2014
56
Area
Product
Market
BA
1Instruments
/
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 LIS
2WW*
EU
EU
WW
RMD
RPD
RPD
RTD
Diabetes
Care
Accu-Chek Insight-
Next generation insulin pump & bGm
3system
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, DPX
4, WNV
5–
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
BA
1Instruments
/
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
59
Finance
Alan Hippe
2014: Highlights
60
Business
•
Solid sales and Core EPS growth: +5%
1; Core EPS +7%
1excluding US Pharma fee*
•
Core operating profit up +3%
1or +5%
1excluding US Pharma fee*
•
Cash generation remains strong with operating FCF of CHF 15.8bn, a decrease of -2%
1due 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%
1due 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
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
2014 performance
Focus on cash
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
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
17,160
15,488
2,187
17,904
16,108
2,177
17,636
16,001
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 %p
1(-1.1 %p)
-0.9 %p
1(-1.3 %p)
-0.2 %p
1(-0.8 %p)
+2 %
1(-4 %)
+4 %
1(-1 %)
+3 %
1(-1 %)
(-0.1%p
2)
(+0.3%p
2)
% of sales
1 CER=Constant Exchange Rates
-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
Interest
All other, net
2014
expense
Net income
from equity
securities
Improvement of 34% in CHF / 32% at CER
CHFm
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
Current
62.2
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
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
2014 performance
Focus on cash
16,135
14,710
1,890
16,381
14,976
1,962
15,778
14,821
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 %p
1(-1.8 %p)
-5.3 %p
1(-5.5 %p)
-1.7 %p
1(-0.9 %p)
-24 %
1(-28 %)
0 %
1(-1 %)
-2 %
1(-4 %)
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
Greece
Dec 2014
Dec 2013
Dec 2012
Dec 2011
-52%
12014: Accounts receivable in Southern Europe
further decreased
71
1 CER=Constant Exchange Rates-6.7
+15.8
-14.0
-10.5
-12.6
Dividends -6.7 Taxes -3.0 Treasury -0.82014: 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
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
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 0.88 0.88 0.89 0.90 0.90 0.91 0.94 0.95 0.96 0.98 0.91 0.89 0.89 0.90 0.93 0.94 0.93 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 1.23 1.23 1.23 1.23 1.21 1.22 1.22 1.22 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
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
2015 outlook
77
Group sales growth
1
Low to mid-single digit
Core EPS growth
1
Ahead of sales growth
2
Dividend outlook
Further increase dividend in Swiss francs
1 At constant exchange rates
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 NMEsRG6047 SERD (2) – ER-pos (HER2-neg) mBC
RG6078 IDO inh - solid tumors RG7802 CEA CD3 TCB - solid tumors RG7876 CD40 iMAb+PDL1 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 SERDER-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 NMEsRG7666 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