Rochec8b3baa6-37c4-47fe-b... · Kawaguchi, et al. ESWI 2017; Portsmouth, et al. IDWeek 2017; a 95%...
Transcript of Rochec8b3baa6-37c4-47fe-b... · Kawaguchi, et al. ESWI 2017; Portsmouth, et al. IDWeek 2017; a 95%...
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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.
Q1 2018: Strong sales growth in both divisions
5CER=Constant Exchange Rates
2018 2017
CHFbn CHFbn CHF CER
Pharmaceuticals Division 10.7 10.2 5 7
Diagnostics Division 2.9 2.8 5 5
Roche Group 13.6 12.9 5 6
Change in %
Q1 2018: Sales growth for the seventh consecutive year
6
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5%
6%
5%
7%
6%
4% 4%
6%
3%3%
4%
6% 6%
5%
6%
0%
2%
4%
6%
8%
10%
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
Q2
15
Q3
15
Q4
15
Q1
16
Q2
16
Q3
16
Q4
16
Q1
17
Q2
17
Q3
17
Q4
17
Q1
18
All growth rates at Constant Exchange Rates (CER)
Q1 2018: Strong sales growth in US and International
7
0
1
2
3
4
5
6
7
Japan International Europe US
Diagnostics
Pharma
CHFbn
+15%
-7%+5%
0%
-1%+9%
-8%
+8%
+14%
-5%
0%
+6%
All growth rates at Constant Exchange Rates (CER)
Roche significantly advancing patient care, BTD’s reflecting
the quality of our research
8
Phase duration (years)
No = 7.5
Fast track = 5.8
Accelerated review = 3.8
Breakthrough therapy = 3.6
2018: New products with annualized sales of >CHF 8bn*
~80% of growth driven by new products
9* Venclexta sales are booked by partner AbbVie.
Replace and extend the business
Through continuously improving standard of care
Replace existing businessesEntering new
franchises
Perjeta: Launched in eBC in US
Gazyva: Launched in FL in US/EU
Hemlibra: Launched in inh. patients in US/EU;
BTD in non-inh.
Tecentriq: IMpower150 with OS benefit
Venclexta: Launched in 17p del; Filed in CLL R/R
baloxavir: Filing initiated in US
entrectinib: Acquisition of Ignyta completed
VA2: Strong Ph II data in DME
10
MabThera
Gazyva,
Venclexta,
polatuzumab vedotin,
Sub Cut
Herceptin
Perjeta,
Kadcyla,
Sub Cut
AvastinTecentriq,
entrectinib
LucentisVA2,
port delivery
Tamiflu baloxavir (Cap Endo)
Achievements Q1 2018
VA2=anti-VEGF/anti-angiopoietin-2 bispecific antibody; MS=multiple sclerosis; SMA=spinal muscular atrophy; eBC=early breast cancer; FL=follicular lymphoma; BTD=Breakthrough
Therapy Designation; CLL R/R=relapsed/refractory (R/R) chronic lymphocytic leukemia; DME=diabetic macular edema
MS:
Ocrevus
Hemophilia:
Hemlibra
CNS:
SMA, Autism,
Huntington’s
11
Record number of NMEs at pivotal stage
Q1 entrants: Anti-VEGF/Ang2 biMAb, entrectinib, baloxavir marboxil
Oncology
Neuroscience
Ophthalmology
Immunology
Infectious Disease
NME=new molecular entities; For details on the indications and line extensions please consult the pipeline appendix. Cap Endonuclease inhibitor (baloxavir marboxil)
2018 outlook raised
From “stable to low single digit” to “low single digit”
12
Group sales growth1 • Low-single digit
Core EPS growth1• Broadly in line with sales, excl. US tax reform benefit
• High-single digit, incl. US tax reform benefit
Dividend outlook • Further increase dividend in Swiss francs
1 Sales growth at Constant Exchange Rates (CER)
Q1 2018: Pharma sales
Accelerated growth in US due to new products
15CER=Constant Exchange Rates
2018 2017
CHFm CHFm CHF CER
Pharmaceuticals Division 10,672 10,177 5 7
United States 5,516 5,070 9 15
Europe 2,287 2,273 1 -7
Japan 851 856 -1 0
International 2,018 1,978 2 5
Change in %
Q1 2018: New products with strong momentum, out growing
biosimilar onset
16Absolute values and growth rates at Constant Exchange Rates (CER)
0 1 2 3
Cotellic +
Zelboraf
Alecensa
Tecentriq
Tarceva
Hematology
Avastin
HER2
Perjeta
Herceptin
Kadcyla
+6%
-2%
-32%
+29%
-7%
Gazyva/Gazyvaro
Cotellic
MabThera/Rituxan
(Oncology)
-6%
+81%
Q1 2018: Oncology sales stable
17Q1 2018 Oncology sales: CHF 6.4bn (CER growth 0%); All growth rates at Constant Exchange Rates (CER); CIT=cancer immunotherapy; FL=follicular lymphoma
YoY CER growth
CHFbn
• Increased competition
• EU: Decline largely due to price cut in France
• US/EU: 1L lung cancer shares stable after CIT entry
• Perjeta: Strong growth in all regions; US momentum due to early APHINITY approval
• Kadcyla: Growth driven by International
• EU: Increasing competition from CIT
• US: 1L new patient market share of >50% achieved following 1L approval in Q4
• EU: Strong 1L launch in key markets
• EU: Launch in lung (2/3L) and bladder (2L and 1L cisplatin ineligible) ongoing
• US: 2L lung cancer and 1L cisplatin ineligible bladder shares stable
• US/EU: Good initial uptake of Gazyva in 1L FL in the early launch countries
Her2 franchise: Growth driven by Perjeta
18
0
500
1,000
1,500
2,000
2,500
3,000
Q1 15 Q1 16 Q1 17 Q1 18
Herceptin Perjeta Kadcyla
+23%
YoY CER growth
+6%+9%
CER=Constant Exchange Rates; eBC=early breast cancer; NCCN=National Comprehensive Cancer Network; AGO=Arbeitsgemeinschaft Gynäkologische Onkologie
CHFm
+6% Her2 franchise Q1 2018
• Perjeta US (+18%): Accelerated growth driven by eBC
following approval in the adjuvant setting (APHINITY)
• Perjeta in eBC on NCCN, St. Gallen, and AGO (Germany)
guidelines
Outlook 2018
• US: Continued Perjeta uptake in eBC
• EU: Approval in adjuvant BC (APHINITY)
• EU: Market entry of Herceptin biosimilars
Hematology: Entering the rejuvenation phase
19
0
500
1,000
1,500
2,000
Q1 15 Q1 16 Q1 17 Q1 18
MabThera/Rituxan (Onc) Gazyva/Gazyvaro
+5%
YoY CER growth
+4%+3%
CHFm
-7%
Hematology Q1 2018
CD20 franchise
• MabThera (onc) US (+2%): Stable volumes in all indications
• MabThera (onc) EU (-43%): Biosimilar roll-out ongoing
• Gazyva (+27%): Growth driven by 1L FL early launches
Venclexta*
• Venclexta sales reached USD 59m (+179%) with ~40%
patient share reached in R/R CLL with 17p deletion
Outlook 2018
• US: first biosimilar entry in H2 expected
• US/EU approval Venclexta + Rituxan in R/R CLL (MURANO)
• Ph II data for Polatuzumab vedotin + BR in R/R DLBCL to be
shared with health authorities
CER=Constant Exchange Rates; FL=follicular lymphoma; CLL=chronic lymphoid leukemia; BR=bendamustine+Rituxan; DLBCL=diffuse large B-cell lymphoma; * Venclexta sales are
booked by partner AbbVie.
Alecensa: US market leadership in 1L ALK+ NSCLC achieved
20
Alecensa Q1 2018
• US: New patient share of >50% in first quarter of launch
• Launch supported by FMI`s NGS-based companion
diagnostic (FoundationOne CDx) and approval of the
Ventana companion diagnostic
• EU: Strong launch in key markets
Outlook 2018
• Continued 1L momentum
• Updated mPFS data from Ph III study (ALEX) comparing
Alecensa vs crizotinib to be presented at ASCO
• Ph III adjuvant study (ALINA) initiated
CER=Constant Exchange Rates; FMI=Foundation Medicine; NGS=next generation sequencing
0
25
50
75
100
125
150
Q1 15 Q1 16 Q1 17 Q1 18
US Europe International Japan
YoY CER growth
+81%
+124%
+161%
CHFm
Immunology: Annualized sales of around CHF 8bn
21CER=Constant Exchange Rates; CIU=chronic idiopathic urticaria
Immunology Q1 2018
Esbriet (+13%)
• Penetration in mild to moderate patient segment increasing
Xolair (+7%)
• Growth driven by pediatric asthma, allergic asthma and CIU
Actemra (+13%)
• Launch in giant cell arteritis ongoing
• Auto-injector approved in the EU and Australia
Outlook 2018
• Strong growth expected with the exception of MabThera
0
400
800
1,200
1,600
2,000
Q1 15 Q1 16 Q1 17 Q1 18
MabThera/Rituxan (RA) Actemra IVActemra SC XolairCellCept PulmozymeEsbriet Other
CHFm YoY CER growth
+20%
+16%
+11%+4%
Ocrevus: Strong EU launch; ~7% US market share after 3 quarters
22
0
100
200
300
400
500
600
Q2 17 Q3 17 Q4 17 Q1 18
US Europe International
CHFm
Ocrevus Q1 2018
• Strong launches in EU and International
• US growing due to increasing number of returning patients
and new patients
• RMS: 30% treatment naive/previously discontinued vs. 70%
switches from all other approved medications
Outlook 2018
• Continued launches in EU and International
• Further increasing US market share with earlier use
RMS=relapsing forms of multiple sclerosis
2018: New products with annualized sales of >CHF 8bn*
~80% of growth driven by new products
23* Venclexta sales are booked by partner AbbVie.
25
IMpower150(Tecentriq+cb/pac+/-Avastin)
PFS/OS (H1 2018)
IMpower130(Tecentriq+cb+nab-pac)
PFS/OS
IMpower132(Tecentriq+cp/cb+pem)
PFS/OS
IMpower131(Tecentriq+cb+pac/nab-pac)
PFS/OS
IMpower1331
(Tecentriq+cb+etoposide)
PFS/OS
March 26: IMpower150 met co-primary OS endpoint at interim analysis
March 20: IMpower131 met co-primary PFS endpoint
= Roche with potential first chemo combo
CIT 1L lung cancer program reading out in H1 2018
Source: Datamonitor; incidence rates 7 major markets (US, Japan, France, Germany, Italy, Spain, UK); Note: Outcome studies are event driven, timelines may change; 1IMpower133 in extensive stage SCLC; CIT=cancer immunotherapy; cb=carboplatin; pac=paclitaxel; nab-pac=nab-paclitaxel (Abraxane); cp=cisplatin; pem=pemetrexed
(PFS)
(OS)
(PFS)
With liver
metastases
PDL-1 status (SP142 and SP263) and Teff signatures
Tecentriq in 1L non-squamous NSCLC
IMpower150: A unique opportunity in key subgroups
26
EGFR/ALK genetic alterations and liver metastases
Kowanetz M, et al., AACR 2018; ITT=intent-to-treat; WT=wild type; mPFS=median progression free survival; TC=tumor cells; IC=immune cells
• Clinically meaningful PFS benefit in ITT and key subgropus (EGFR/ALK+ and patients with liver metastases)
• PD(L)1 monotherapy has not shown significant benefit in 2L EGFR/ALK+ patients
• Tumors in patients with liver metastases are characterized by immune suppressive tumor environments, and
they usually demonstrate poorer outcomes
• The observed efficacy in these key subgroups may be due to the addition of Avastin to Tecentriq
Hemlibra: BTD for non-inhibitor prophylaxis
HAVEN 3 and 4 submitted to WFH
27BTD=breakthrough designation; WFH=world federation of hemophilia; CMS=centers for medicare & medicaid services
HAVEN 3 and 4 submitted to WFH (Glasgow, May 20-24)
Hemlibra designated as Part B drug by CMS
28Kawaguchi, et al. ESWI 2017; Portsmouth, et al. IDWeek 2017; a 95% CI of median time could not be obtained by Brookmeyer and Crowley method (1982); b Not determined;
*Co-development with Shionogi; Roche holds worldwide license excluding Japan and Taiwan
Phase III (CAPSTONE-1) results for acute uncomplicated influenza
Baloxavir marboxil* in Influenza A & B
FDA filing for healthy adults and adolescents planned in 2018
• Small molecule inhibiting viral
RNA replication via a novel and
highly selective mode of action
• One-time dosing due to long half-
life + well tolerated
CAP-dependent
endonuclease inhibitor
• Significant reduction in time to alleviation of symptoms by >24 hrs vs placebo (p<0.0001)
• Time to cessation of viral shedding reduced by 48 hrs vs Tamiflu (p<0.0001) potentially
leading to reduced transmission rates
• Approved in Japan in Feb 2018
• Ongoing Ph III development program in populations at high risk and pediatrics
Strong network in Oncology
• Leading EMR system and analytics solutions used by ~15%
of US oncologists and covering ~15% of active patients
29
Leading real world data base
• Research-quality EMR data base covers 10m patients, over 2m of them active
• 90% of large Pharma companies are working with Flatiron data
While Flatiron will remain independent, acquisition will help to expand our existing partnership and
provide required resources to accelerate key strategic projects in the field of personalized healthcare
Acquisition of Flatiron in Q1
Leading player driving personalized patient care in oncology
30
Lung
• Tecentriq + cb/pac +/- Avastin: Ph III OS (IMpower150) in 1L
non-squamous NSCLC
• Tecentriq + cb + pac/nab-pac: Ph III PFS (IMpower131) in 1L
squamous NSCLC
• Alecensa: Ph III update (ALEX) in 1L ALK+ NSCLC
Hepatocellular carcinoma
• Tecentriq + Avastin: Ph Ib expansion (GO30140) in HCC
Breast
• Ipatasertib: Ph II (LOTUS) in 1L TNBC
Biomarker development
• Tecentriq: Ph II interim analysis (B-F1RST) to support blood TMB
as predictive biomarker
• Tecentriq: Tissue TMB as predictive biomarker in NSCLC, mUC
and melanoma
Hematology
• Venclexta + Rituxan: Ph III (MURANO) MRD analysis in R/R
CLL
• Venclexta + dec/aza: Ph Ib (NCT02203773) in 1L AML
• Venclexta + car + dex: Ph II (NCT02899052) in R/R MM
ASCO 2018: Highlights in various cancer types*
*Planned submissions (to be confirmed); Outcome studies are event driven, timelines may change; cb=carboplatin; pac=paclitaxel; nab-pac=nab-paclitaxel (Abraxane); TMB=
tumor mutational burden; aza=azacitidine; dec=decitabine; car=carfilzomib; dex=dexamethasone; Alecensa in collaboration with Chugai; Venclexta in collaboration with AbbVie
2018: Key late-stage news flow*
32
Compound Indication Milestone
Regulatory
Ocrevus RMS / PPMS EU approval
Perjeta + Herceptin Adjuvant HER2+ eBC EU approval
Tecentriq + cb/pac +/- Avastin 1L non-sq NSCLC US/EU filing
Tecentriq + Avastin 1L RCC US/EU filing
Hemlibra Hemophilia A inhibitors EU approval
Hemlibra Hemophilia A non-inhibitors US/EU filing
Hemlibra Every 4 weeks dosing inhibitors/non-inhibitors US/EU filing
baloxavir marboxil Influenza A and B US filing
Venclexta + Rituxan R/R CLL US/EU approval
Phase III readouts
Tecentriq + chemo 1L lung program Ph III IMpower130/132/133
Tecentriq + chemo 1L lung program Ph III IMpower131
Tecentriq + nab-pac 1L TNBC Ph III IMpassion130
Tecentriq + Cotellic 2/3L CRC Ph III IMblaze370 / COTEZO
Actemra Systemic sclerosis Ph III focuSSced
* Outcome studies are event-driven: timelines may change
Q1 2018: Diagnostics Division sales
Good growth in all business units
34CER=Constant Exchange Rates
Underlying growth of Molecular Diagnostics excluding sequencing business: +7%
2018 2017
CHFm CHFm CHF CER
Diagnostics Division 2,911 2,765 5 5
Centralised and Point of Care Solutions 1,716 1,641 5 4
Diabetes Care 478 447 7 5
Molecular Diagnostics 468 441 6 6
Tissue Diagnostics 249 236 6 7
Change in %
North America
+7%
26% of divisional sales
Latin America
+1%
6% of divisional sales
Japan
-8%
3% of divisional salesEMEA1
+2%
42% of divisional sales
Q1 2018: Diagnostics regional sales
Growth driven by Asia Pacific and North America
35
Asia Pacific
+10%
23% of divisional sales
+9% growth in E7 countries2
1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, TurkeyAll growth rates at Constant Exchange Rates
Q1 2018: Diagnostics Division highlights
Growth driven by Immunodiagnostics
36
• Immunodiagnostics (+5%); clinical
chemistry (+3%)
• US blood glucose measurement business
(+24%)
• Virology (+5%), HIV (+20%); HPV (+5%);
cobas® Liat® (+262%)
• Advanced staining portfolio (+8%); primary
staining (+20%)
0.0 0.5 1.0 1.5 2.0
Tissue
Diagnostics
Molecular
Diagnostics
Diabetes
Care
Centralised
and Point of
Care
Solutions
EMEA
North America
RoW
+7%
+5%
+4%
+6%
CHFbn
1
1 Underlying growth of Molecular Diagnostics excluding sequencing business: +7%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
YoY CER growth
15157
470
969
1,526
2,222
2,945
3,747
4,878
5,188
2009 2010 2011 2012 2013 2014 2015 2016 2017 YTD March
2018
5,000 installations of cobas® 8000 modular analyzer series
Performing 15m tests/day
37
+30%
No of installations
Strong Flu season driving cobas® Liat® System sales
Pediatric and emergency room focus segments
• Easy to use with less than one minute hands on time
• Lab quality performance in 20 minutes or less
Menu of assays available
CE US
cobas® Influenza A/B
cobas® Strep A
cobas® Influenza A/B & RSV
cobas® Cdiff
Growing number of placements worldwide
Suitable for testing in a variety of settings
US ~1500
EU ~220
APAC ~15
Chile ~8
cobas® Liat®
assay tube
cobas® Liat®
Analyzer
38
39
Launch of cobas® Plasma Separation Card
For testing and monitoring of HIV patients in resource limited settings
• No refrigeration needed for patient plasma samples
during transport to the lab
• Only card that meets the WHO sensitivity requirement
for determining HIV treatment
• Compatible with HIV-1 viral load testing on the cobas®
6800/8800 and cobas® AmpliPrep/TaqMan systems
Launch* of VENTANA DP 200 slide scanner for digital pathology
Reliable, high-speed scanning of histology slides, with excellent image quality
VENTANA DP 200 slide scanner
• Unique no-touch slide processing reduces
slide handling errors
• Application of the International Color
Consortium profile matching what is observed
under a microscope
• Digital Imaging and Communications in
Medicine (DICOM) Standard compatible
• Provides a foundation for a future menu of
Roche image analysis algorithms
*CE marked for IVD use; approved in the US for research use only 40
Key launches 2018
41
Area Product Market
Instruments/
Devices
Central Laboratory cobas pro integrated solution – Serum Work Area solution for medium throughput to lower high throughout labs CE
Specialty Testing cobas m 511 – World's first fully digital morphology analyzer and cell counter US
Workflow CCM connectivity to cobas c513 – Connection of cobas c 513 to CCM Automation System for high volume HbA1c testing WW
Tissue Dx BenchMark ULTRA Plus – New and differentiated Advanced Staining System CE
Digital Pathology VENTANA DP200 – Reliable low-volume scanner with superior image quality CE
Diabetes Care Solo Patch Pump – Small and tubeless insulin delivery device operated through a remote control which includes a blood
glucose meterCE
Tests/
Assays
Endocrinology IGFBP3 – Completion of the existing growth hormone menu of hGH and IGF-1 CE
Infectious Diseases Zika IgG – Highly specific immunoassay for the in vitro qualitative detection of IgG antibodies to Zika virus in human serum and
plasmaCE
Microbiologycobas CT/NG – Highest throughput CT/NG test on the market with workflow efficiency benefits US
cobas 6800/8800 MTB/MAI – High volume solution for MTB/MAI testing; efficient approach to disease management (mixed
testing) for infectious diseaseCE
Virology Plasma Separation Card – Card-like sample collection device; separates plasma from whole blood; for use with CAP/CTM HIV-
1 & cobas HIV-1 (6800/8800)CE
Sequencing AVENIO FFPET RUO oncology kits – 3 separate tissue based assay kits for solid tumors WW
Software Decision Support NAVIFY Tumor Board v 1.x – EMR integration WW
• Strong Group sales growth, particularly in the US (+14%) and International (+6%)
• Strong growth in both divisions, Pharmaceuticals (+7%); Diagnostics (+5%)
Q1 2018: Highlights
43
Sales
• Overall slightly negative - negative USD development only partially offset by EUR
Currency impact on sales
All growth rates at Constant Exchange Rates (CER)
• Ignyta deal closed (USD 1.7bn)
• Flatiron Health deal closed (USD 1.9bn)
M&A
Q1 2018: Group sales
Sales increase driven by US, Diagnostics Division and International
44Absolute values and growth rates at Constant Exchange Rates (CER)
¹ average Full Year 2017 to average Q1 2018 Fx
+821
+757-180
+641
-166+97 +4
+129
United States Europe Intl. Japan Diagnostics
Division
Group Fx Group
CHF
Pharma Division
+7%
+15% -7% +5% 0% +5% +6% +5%
1
CER
sales
growth
YTD Mar
2018
vs.
YTD Mar
2017
Exchange rate impact on sales growth
Negative impact from USD, partially offset by EUR
CER = Constant Exchange Rates (avg full year 2017)
+6.4%
+5.0%
+1.6p+0.3p +0.1p 0.0p -0.1p -0.5p -2.8p
CER EUR Other
Europe
As-Pac Other JPY Lat-Am USD CHF
CHF
sales
growth
YTD Mar
2018
vs.
YTD Mar
2017
45
0.96 0.93 0.950.96 0.96 0.96 0.96 0.96 0.96 0.96 0.96 0.96
0.95 0.95 0.95 0.95
1.00 0.99 0.98 0.98
J F M A M J J A S O N D
1.17 1.15 1.17 1.18 1.18 1.18 1.18 1.18 1.18 1.18 1.18 1.18
1.16 1.17 1.17 1.17
1.07 1.081.09
1.11
J F M A M J J A S O N D
Low currency impact expected in 2018
Assuming the 31 March 2018 exchange rates remain stable
until end of 2018,
2018 impact is expected to be (%p):
CHF / USD
CHF / EUR
-6% -4% -3% -3%
+9% +9% +7% +6%
Assumed average YTD 2018
Monthly avg fx rates 2018 Q1 HY Sep YTD FY
Sales -1 0 0 0
Core
operating
profit
0 -1
Core EPS 0 -1
Fx rates at 31 Mar 2018
Average
YTD 2017
46
2018 outlook raised
From “stable to low single digit” to “low single digit”
47
Group sales growth1 • Low-single digit
Core EPS growth1• Broadly in line with sales, excl. US tax reform benefit
• High-single digit, incl. US tax reform benefit
Dividend outlook • Further increase dividend in Swiss francs
1 Sales growth at Constant Exchange Rates (CER)
48
Pipeline summary
Marketed products additional indications
Global Development late-stage trials
pRED (Roche Pharma Research & Early Development)
gRED (Genentech Research & Early Development)
Roche Group Q1 2018 results
Diagnostics
Foreign exchange rate information
New to phase I New to phase II New to phase III New to registration
Changes to the development pipeline
Q1 2018 update
Removed from phase II Removed from phase III Removed from registration
1 NME:
RG7945 NME - glaucoma
2 AIs:
RG7446 Tecentriq + Avastin – 1L HCC
RG7446 Tecentriq – SCCHN adj
1 NME following EU approval:
RG6013 Hemlibra – hemophilia A FVIII inh
1 AI following US approval:
RG3645 Lucentis 0.3mg PFS – DME/DR
1 NME:
RG6268 entrectinib – NSCLC ROS1+
1 AI:
RG6268 entrectinib – NTRK1 pan tumor
49
1 NME:
RG3637 lebrikizumab± Esbriet – IPF
Status as of April 26, 2018
1 AI:
RG105 MabThera/Rituxan – pemphigus
vulgaris
2 NMEs:
RG6148 NME –HER2+ BC
RG6173 NME – asthma
1 NME from Chugai:
CHU NME - endometriosis
3 AIs:
RG7421 Cotellic + Tecentriq – RCC, UC,
H&N cancer
RG7440 ipatasertib + Tecentriq +
taxane - TNBC
RG7601 Venclexta + Cotellic±Tecentriq - MM
Removed from phase I
Roche Group development pipeline
50
RG6264 Perjeta + Herceptin FDC SC HER2+ BC
RG6026 CD20 TCB heme tumors
RG6058 tiragolumab (TIGIT) ± T solid tumors
RG6109 - AML
RG6114 mPI3K alpha inh HR+ BC
RG6146 BET inh combos solid + heme tumors
RG6148 - HER2+ BC
RG6160 - multiple myeloma
RG6171 SERD (3) ER+ (HER2neg) mBC
RG6180 personalized cancer vaccine ± T oncology
RG6185 pan-RAF inh + Cotellic solid tumors
RG7155emactuzumab + T solid tumors
emactuzumab + selicrelumab solid tumors
RG7159 anti-CD20 combos heme tumors
RG7386 FAP-DR5 biMAb solid tumors
RG7421
Cotellic + Zelboraf + T melanoma
Cotellic + T 2L BRAF WT mM
Cotellic + T RCC, UC, H&N ca
RG7440 ipatasertib + taxane + T TNBC
RG7446
Tecentriq solid tumors
Tecentriq NMIBC
T-based Morpheus platform solid tumors
T + Avastin + Cotellic 2/3L CRC
T ± Avastin ± chemo HCC, GC, PaC
RG7446
T + Cotellic solid tumors
T + ipi/IFN solid tumors
T + Tarceva/Alecensa NSCLC
T + anti-CD20 combos heme tumors
T ± lenalidomide ± daratumumab MM
T + K/HP HER2+ BC
T + HMA MDS
T + radium 223 mCRPC
T + guadecitabine AML
T + rucaparib ovarian ca
T + Gazyva/tazemetostat r/r DLBCL + FL
RG7461 FAP IL2v FP combos solid tumors
RG7601
Venclexta + Cotellic/idasanutlin AML
Venclexta ± azacitadine r/r MDS
Venclexta + Cotellic ± T MM
RG7741 ChK1 inh solid tumors
RG7802 CEA TCB ± T solid tumors
RG7813 CEA IL2v FP* + T solid tumors
RG7828 CD20 TDB ± T heme tumors
RG7876selicrelumab (CD40) + T solid tumors
selicrelumab + vanucizumab solid tumors
RG7882 MUC16 ADC ovarian ca
CHURaf/MEK dual inh solid tumors
glypican-3/CD3 biMAb solid tumors
Phase I (45 NMEs + 26 AIs)
RG6069 anti-fibrotic agent fibrosis
RG6107 C5 inh MAb PNH
RG6151 - asthma
RG6173 - asthma
RG6174 - inflammatory diseases
RG7835 IgG-IL2 FP autoimmune diseases
RG7880 IL-22Fc inflammatory diseases
RG7990 - asthma
RG6004 HBV LNA HBV
RG6080 nacubactam bact. infections
RG7854 TLR7 agonist (3) HBV
RG7861 anti-S. aureus TAC infectious diseases
RG7907 HBV Capsid (2) HBV
RG7992 FGFR1/KLB MAb metabolic diseases
RG6000 - ALS
RG6029 Nav1.7 inh (2) pain
RG6042 ASO Huntington’s
RG7816 GABA Aa5 PAM autism
RG7906 - psychiatric disorders
RG6147 - geographic atrophy
CHU
PTH1 recep. ago hypoparathyroidism
- hyperphosphatemia
- endometriosis
New Molecular Entity (NME) CardioMetabolism RG-No Roche/Genentech *INN: cergutuzumab amunaleukin
**out-licensed to Galderma and Maruho AD
*** Ph2 pivotal
Additional Indication (AI) Neuroscience CHU Chugai managed
Oncology Ophthalmology PRO Proximagen managed
Immunology Other NOV Novimmune managed T=Tecentriq
TCB=T cell bispecific
TDB=T cell dependent bispecific
Infectious Diseases RG1569 Branded as RoActemra (EU)
Status as of April 26, 2018
Roche Group development pipeline
51
RG6268entrectinib NSCLC ROS1+
entrectinib NTRK1 pan tumor
RG7388 idasanutlin polycythemia vera
RG7421 Cotellic + T ± taxane TNBC
RG7440 ipatasertib TNBC neoadj
RG7596 polatuzumab vedotin r/r DLBCL + FL
RG7601
Venclexta + Rituxan DLBCL
Venclexta + Rituxan r/r FL
Venclexta + azacitadine 1L MDS
RG7604 taselisib + letrozole (HER2-neg) BC neoadj
RG7686 codrituzumab HCC
RG6125 Cadherin-11 MAb RA
RG6149 ST2 MAb asthma
RG7159 obinutuzumab lupus
RG7625 Cat-S antag autoimmune diseases
RG7845 fenebrutinib (BTK inh) RA, lupus, CSU
CHU nemolizumab** pruritus in dialysis patients
PRO VAP-1 inh inflammatory disease
NOV TLR4 MAb autoimmune diseases
CHU URAT1 inh gout
RG1662 basmisanil CIAS
RG1678 bitopertin beta thalassemia
RG6083 olesoxime SMA
RG6100 Tau MAb Alzheimer’s
RG7314 balovaptan autism
RG7916 SMN2 splicer(2)*** SMA
RG7935 α-synuclein MAb Parkinson's
RG3645 ranibizumab PDS wAMD
RG7716 VEGF-ANG2 biMAb wAMD, DME
Phase II (19 NMEs + 10 AIs)
RG3502Kadcyla HER2+ BC adj
Kadcyla + Perjeta HER2+ BC adj
RG6013Hemlibra hemophilia A w/o FVIII inh
Hemlibra Q4W hemophilia A
RG7388 idasanutlin + chemo AML
RG7440ipatasertib + abiratorone 1L CRPC
ipatasertib + chemo 1L TNBC/HR+ BC
RG7421Cotellic+Zelboraf+T 1L BRAFm melanoma
Cotellic + T 1L BRAF WT melanoma
RG7596 polatuzumab vedotin 1L DLBCL
RG7446
Tecentriq NSCLC adj
Tecentriq MIBC adj
Tecentriq Dx+ 1L sq + non-sq SCLC
Tecentriq RCC adj
T + nab-paclitaxel 1L non-sq NSCLC
T + chemo+ Avastin 1L ovarian cancer
T + chemo + Avastin 1L non-sq NSCLC
T + pemetrexed 1L non-sq NSCLC
T + nab-paclitaxel 1L sq NSCLC
T ± chemo SCCHN adj
T + paclitaxel 1L TNBC
T + nab-paclitaxel 1L TNBC
T + nab-paclitaxel TNBC neoadj
T + Avastin RCC
T + Avastin 1L HCC
T + Cotellic 3L CRC
T ± chemo 1L mUC
T + chemo 1L extensive stage SCLC
T + enzalutamide CRPC
RG7446/RG7853 Tecentriq or Alecensa 1L NSCLC Dx+
RG7601
Venclexta + Gazyva 1L CLL
Venclexta + bortezomib MM
Venclexta + azacitidine 1L AML
Venclexta + LDAC 1L AML
RG7604 taselisib + fulvestrant ER+(HER2-neg) mBC
RG105 MabThera pemphigus vulgaris
RG1569 Actemra systemic sclerosis
RG3648 Xolair nasal polyps
RG7413 etrolizumab ulcerative colitis
etrolizumab Crohn’s
RG6152 baloxavir marboxil influenza
RG1450 gantenerumab Alzheimer’s
RG6168 satralizumab NMO
RG6206 anti-myostatin adnectin DMD
RG7412 crenezumab Alzheimer’s
Phase III (9 NMEs + 36 AIs)
RG435 Avastin1 ovarian FL
RG1273 Perjeta + Herceptin2 HER2+ BC adj
RG7601 Venclexta + Rituxan r/r CLL
RG1569 Actemra auto injector3 RA
RG105 MabThera/Rituxan pemphigus vulgaris
Registration (5 AIs)
1 US only, 2 Approved in US, 3 Approved in EU
See previous page for legend
Status as of April 26, 2018
20192018 2021 and beyond2020
NME submissions and their additional indications
Projects currently in phase II and III
RG6152baloxavir marboxil
Influenza
RG7596polatuzumab vedotin
r/r DLBCL
RG7604
taselisib+fulvestrantPIK3CAmut ER+(HER2-neg) mBC
RG7388idasanutlin
polycythemia vera
RG7440ipatasertib
TNBC neoadj
RG7596polatuzumab vedotin
1L DLBCL
RG7604
taselisib + letrozoleER+ (HER2-neg)
BC neoadj
RG1450gantenerumab
Alzheimer‘s
RG1662basmisanil
CIAS
RG1678bitopertin
beta thalassemia
RG6083olesoxime
SMA
RG6100Tau MAb
Alzheimer’s
RG7314balovaptan
autism
RG7412crenezumabAlzheimer’s
RG7935α-synuclein MAb
Parkinson’s
RG7716VEGF/ANG2 biMAb
wAMD/DME
RG6125Cadherin-11 MAb
RA
RG6149ST2 MAb
asthma
RG7413etrolizumab
ulcerative colitis
RG7413etrolizumab
Crohn’s
RG7625Cat S antag
autoimmune diseases
RG7845fenebrutinib
autoimmune diseases
RG6168satralizumab
(SA237) neuromyelitis optica
RG6268 entrectinib
NSCLC ROS1+
RG6268entrectinib
NTRK1 pantumor
RG7388idasanutlin
AML
RG6206anti-myostatin adnectin
DMD
RG7916SMN2 splicer(2)
SMA
RG7440ipatasertib+abiratorone
1L CRPC
RG7596polatuzumab vedotin
r/r FL
RG7440ipatasertib +chemo
1L TNBC / HR+ BC
Status as of April 26, 2018 52
New Molecular Entity (NME) CardioMetabolism
Additional Indication (AI) Neuroscience
Oncology Ophthalmology
Immunology Other
Infectious Diseases
✓ Indicates submission to health authorities has occurred
Unless stated otherwise submissions are planned to occur in US and EU
RG105MabThera ✓
pemphigus vulgaris
RG1569Actemra
systemic sclerosis
RG1569Actemra auto injector (US)
RA/GCA ✓
RG6013Hemlibra
hemophilia A FVIII non-inh
RG6013Hemlibra
hemophilia A, Q4W
RG7601Venclexta + Rituxan (EU) ✓
r/r CLL
RG7601Venclexta + aza/LDAC
1L AML
RG7446Tecentriq + Cotellic
3L CRC
RG7446Tecentriq+chemo+Avastin
1L non-sq NSCLC
RG7446Tecentriq + nab-paclitaxel
1L sq NSCLC
RG7446Tecentriq + nab-paclitaxel
1L non-sq NSCLC
RG7446Tecentriq + pemetrexed
1L non-sq NSCLC
RG7446Tecentriq + chemo1L extens. stage SCLC
RG7446Tecentriq + Avastin
RCC
RG7446Tecentriq + nab-paclitaxel
TNBC
RG7601Venclexta + Rituxan
r/r FL
RG7601Venclexta + Rituxan
DLBCL
RG7601Venclexta + aza
1L MDS
RG7421Cotellic+Tecentriq±taxane
TNBC
RG3645ranibizumab PDS
wAMD
RG7159obinutuzumab
lupus nephritis
RG7446/
RG7853
Tecentriq or Alecensa1L NSCLC Dx+
RG7446TecentriqNSCLC adj
RG7446TecentriqMIBC adj
RG7446TecentriqRCC adj
RG7446 Tecentriq + Avastin
1L HCC
RG7446 Tecentriq + chemo
SCCHN adj
RG7421Cotellic + Tecentriq
1L BRAF WT melanoma
RG7421
Cotellic + Tecentriq + Zelboraf
1L BRAFmut melanoma
RG7446Tecentriq
1L non-sq + sq NSCLC (Dx+)
RG7446Tecentriq + nab-paclitaxel
TNBC neoadj
RG7446 Tecentriq + paclitaxel
1L TNBC
RG7601Venclexta + Gazyva
1L CLL
RG7601Venclexta + bortezomib
MM
Status as of April 26, 2018 53
2018 2019 2021 and beyond2020
RG3648Xolair
nasal polyps
RG3502Kadcyla
HER2+ BC adj.
RG3502Kadcyla + Perjeta
HER2+ BC adj.
RG7446Tecentriq ± chemo
1L mUC
RG7446Tecentriq + enzalutamide
CRPC
RG7446 Tecentriq+chemo+Avastin
1L ovarian cancer
AI submissions for existing products; currently in phase II and III
New Molecular Entity (NME) CardioMetabolism
Additional Indication (AI) Neuroscience
Oncology Ophthalmology
Immunology Other
Infectious Diseases
✓ Indicates submission to health authorities has occurred
Unless stated otherwise submissions are planned to occur in US and EU
Major granted and pending approvals 2018
EU Japan-ChugaiUS
RG435Avastin
Ovarian FL, Filed Aug 2017
RG7601Venclexta + Rituxanr/r CLL, Filed Dec 2017
RG1569Actemra auto injector RA/GCA, Filed Jan 2018
RG105Rituxan
pemphigus vulgaris, Filed Dec 2017
RG1273Perjeta + Herceptin
HER2+ BC adj, Filed Aug 2017
RG7601Venclexta + Rituxanr/r CLL, Filed Jan 2018
RG105MabThera
pemphigus vulgaris, Filed Feb 2018
Approved
Pending Approval
54
Status as of April 26, 2018
New Molecular Entity (NME) CardioMetabolism
Additional Indication (AI) Neuroscience
Oncology Ophthalmology
Immunology Other
Infectious Diseases
RG3645Lucentis
0.3 mg PFS DME/DR, March 2018 RG1594
Ocrevus
PPMS & RMS, Jan 2018
RG6013
Hemlibra (emicizumab)hemophilia A FVIII inh (ped/adults),
February 2018
RG1569Actemra auto injector
RA, March 2018
RG6013
Hemlibra (emicizumab)hemophilia A FVIII inh (ped +
adults), March 2018
RG7446Tecentriq
2L+ NSCLC, Jan 2018
RG7446
Tecentriq + other anti-tumor drugs
1L NSCLC, March 2018
Cancer immunotherapy pipeline overview
RG7421 Cotellic + T ± taxane TNBC
Gradalis** Tecentriq + Vigil ovarian ca
GTHX** Tecentriq + trilaciclib SCLC
IMDZ** Tecentriq + NY-ESO-1 soft tissue sarcoma
SNDX** Tecentriq + entinostat TNBC
RG6026 CD20 TCB hematopoietic tumors
RG6058 tiragolumab (TIGIT) ± T solid tumors
RG6160 - multiple myeloma
RG6180 personalized cancer vaccine ± T oncology
RG7155emactuzumab + T solid tumors
emactuzumab + selicrezumab solid tumors
RG7421
Cotellic + Zelboraf + T melanoma
Cotellic + T BRAF WT mM 2L
Cotellic + T RCC, UC, H&N ca
RG7440 ipatasertib + taxane + T TNBC
RG7446
Tecentriq solid tumors
Tecentriq NMIBC
T-based Morpheus platform pancreatic ca
T + Cotellic ± Avastin 2/3L CRC
T ± Avastin ± chemo HCC, GC, PaC
T + Cotellic solid tumors
T + ipi/IFN solid tumors
T + Tarceva/Alecensa NSCLC
T + anti-CD20 multiple combos lymphoma
T ± lenalidomide ± daratumumab MM
T + K/HP HER2+ BC
T + HMA MDS
T + radium 223 mCRPC
T + guadecitabine AML
T + rucaparib ovarian ca
T + Gazyva/tazemetostat r/r DLBCL + FL
RG7461 FAP IL2v FP combos solid tumors
RG7601 Venclexta + Cotellic ± T MM
RG7802 CEA TCB ± T solid tumors
RG7813 CEA IL2v FP* + T solid tumors
RG7828 CD20 TDB ± T solid tumors
RG7876selicrelumab (CD40) + T solid tumors
selicrelumab + vanucizumab solid tumors
RG7421Cotellic+Zelboraf+T 1L BRAFm melanoma
Cotellic + T 1L BRAF WT melanoma
RG7446
Tecentriq NSCLC adj
Tecentriq MIBC adj
Tecentriq Dx+ 1L sq + non-sq SCLC
Tecentriq RCC adj
T + nab-paclitaxel 1L non-sq NSCLC
T + chemo + Avastin 1L ovarian cancer
T + chemo + Avastin 1L non-sq NSCLC
T + pemetrexed 1L non-sq NSCLC
T + nab-paclitaxel 1L sq NSCLC
T ± chemo SCCHN adj
T + paclitaxel 1L TNBC
T + nab-paclitaxel 1L TNBC
T + nab-paclitaxel TNBC neoadj
T + Avastin RCC
T + Avastin 1L HCC
T + Cotellic 3L CRC
T ± chemo 1L mUC
T + chemo 1L extensive stage SCLC
T + enzalutamide CRPC
RG7446/RG7853 Tecentriq or Alecensa 1L NSCLC Dx+
New Molecular Entity (NME) RG-No Roche/Genentech
Additional Indication (AI) *INN: cergutuzumab amunaleukin
Oncology T=Tecentriq; TCB=T cell bispecific
TDB=T cell dependent bispecific
RG7446
T-based Morpheus pancreatic cancer
T-based Morpheus gastric cancer
T-based Morpheus HR+ BC
T-based Morpheus NSCLC
T-based Morpheus 2L TNBC
AMGN** Tecentriq + talimogene laherp TNBC, CRCCheckmate** Tecentriq + CMP-001 NSCLC
BLRX** Tecentriq + BL-8040 AML, solid tumorsCRVS** Tecentriq + CPI-444 solid tumors EXEL** Tecentriq + cabozantinib solid tumorsHALO** Tecentriq + PEGPH20 CCC, GBCINO** Tecentriq + INO5401+INO9012 bladder caJNJ** Tecentriq ± daratumumab solid tumorsKITE** Tecentriq + KTE-C19 r/r DLBCL
Phase I (10 NMEs + 32 AIs) Phase III (22 AIs)
Phase II (5 AIs)
MORPHEUS Platform - Phase Ib/II (5 AIs)
55
** External collaborations: AMGN – Amgen oncolytic virus; BLRX - BioLine Rx CXCR4 antag; Checkmate - TLR9 agonist; CRVS – Corvus ADORA2A antag; EXEL – Exelexis’ TKI; Gradalis – EATC therapy; GTHX – G1 Therapeutics CDK4/6; HALO – Halozyme PEGPH20; IMDZ – Immune Design CMB305; INO - Inovio T cell activating immunotherapy (INO-5401), IL-12 activator (INO-9012); JNJ – Janssen CD38 MAb; KITE – Kite KTE-C19; SNDX – Syndax HDAC inh
Status as of April 26, 2018