Rochec8b3baa6-37c4-47fe-b... · Kawaguchi, et al. ESWI 2017; Portsmouth, et al. IDWeek 2017; a 95%...

Roche

Q1 2018 results

Basel, 26 April 2018

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.

Group

Severin SchwanChief Executive Officer

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%


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)

Pharmaceuticals Division

Daniel O’DayCEO Roche Pharmaceuticals

13

Q1 2018 performance

Innovation

Outlook

14

Q1 2018: Pharma sales

Accelerated growth in US due to new products


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.

Q1 2018 performance

Innovation

Outlook

24

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

Q1 2018 performance

Innovation

Outlook

31

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

Diagnostics Division

Roland DiggelmannCEO Roche Diagnostics

33

Q1 2018: Diagnostics Division sales

Good growth in all business units


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%


Japan

-8%

3% of divisional salesEMEA1

+2%


Q1 2018: Diagnostics regional sales

Growth driven by Asia Pacific and North America

35

Asia Pacific

+10%


+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

Finance

Alan HippeChief Financial Officer

42

• 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


• 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)


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


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


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


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


1L non-sq NSCLC

RG7446Tecentriq + pemetrexed

1L non-sq NSCLC

RG7446Tecentriq + chemo1L extens. stage SCLC

RG7446Tecentriq + Avastin

RCC


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+)


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




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





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


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