Karl Mahler Head of Investor Relations, Roche Kepler ...3a080b2a-d991-4f22-aa10-bb62ba417671/... ·...

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Transcript of Karl Mahler Head of Investor Relations, Roche Kepler ...3a080b2a-d991-4f22-aa10-bb62ba417671/... ·...

Karl Mahler Head of Investor Relations, Roche Kepler Healthcare Conference Zurich, March 2015

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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.

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Performance update

Extending leadership in Personalized Healthcare

Building pillars of growth

Summary

2014: Targets achieved

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Targets for 2014 FY 2014

Group sales Low to mid-single digit growth1 +5%

Core EPS Ahead of sales growth1

+5%

+7% excl. one-time

US Pharma fee2

Dividend Further increase dividend3 CHF 8.00

+3%

1 At constant exchange rates 2 One-time double charge of CHF 202m for the US Branded Prescription Drug fee in 2014, following final regulations issued by the US

Internal Revenue Service which advanced the timing of recording the liability 3 2014 dividend as proposed by the Board of Directors

Pipeline in context: 2012-14 leading companies

Roche major contributor to advancing patient care

Rank Company #

1 Roche 5

1 Novartis 5

3 GSK 4

4 Merck 3

4 Boehringer I. 3

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Rank Company #

1 GSK 7

2 Roche 5

2 JnJ 5

2 Pfizer 5

4 Astra Zeneca 4

Source: FDA, Evaluate, and company websites. Data as of December 31, 2014, 12012-2014

5 Breakthrough Therapy Designations 5 Recently-approved

NMEs

2014: Continued sales growth for 4 years

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0% 0% 1%

4%

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

0%

2%

4%

6%

8%

10%

Q1

11

Q2

11

Q3

11

Q4

11

Q1

12

Q2

12

Q3

12

Q4

12

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

All growth rates at Constant Exchange Rates (CER)

17,16015,488

2,187

17,904

16,108

2,177

17,63616,001

2,096

Roche Group Pharma Division Diagnostics Division

2012 2013 2014

37.7% 38.3% 37.2%

44.0% 44.4% 43.6%

21.3% 20.8% 19.5%

2014: Core operating profit and margin

Margin at high levels

8

CHFm

-0.5 %p1

(-1.1 %p)

-0.9 %p1

(-1.3 %p)

-0.2 %p1

(-0.8 %p)

+2 %1

(-4 %)

+4 %1

(-1 %)

+3 %1

(-1 %)

(-0.1%p2)

(+0.3%p2)

% of sales

1 CER=Constant Exchange Rates 2 At CER excluding one-time double charge for the US Branded Prescription Drug fee in 2014

Sales to cash conversion across the industry

2014A FCF1

(CHFm)

2014A FCF / sales2

Roche

Novartis

AZN GSK Sanofi

JnJ

Merck&Co

BMS

0

2.000

4.000

6.000

8.000

10.000

12.000

14.000

10% 15% 20% 25% 30% 35%

1 FCF defined as Total Cash Flows from Operations – Capex. Absolute figures converted to CHF based on average annual FX rates for 2014 2 2014A FCF as % 2014A sales

Average

9

2014: Dividend and payout ratio further increased

10 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

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Performance update

Extending leadership in Personalized Healthcare

Building pillars of growth

Summary

Roche strategy: Focused on medically

differentiated therapies

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Generics

Differentiation

MedTech

OTC

Pre

miu

m f

or

inn

ova

tio

n

Dia Pharma

Focus

Regulators: Optimised benefit / risk ratio

Payors: Optimised benefit / cost ratio

Healthcare IT impacting R&D and patient care

Applications relevant across Pharma value chain

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Summary of R&D collaboration

Enabling personalized healthcare for patients

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

Roche/FMI collaboration

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15

Performance update

Extending leadership in Personalized Healthcare

Building pillars of growth

- Cancer immunotherapy

- Hematology/Hemophilia

- Immunology

Summary

2014 Roche cancer immunotherapy:

Six NMEs moved into the clinic

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Priming & activation

Anti-CEA-IL2v

Anti-OX40

NME (Anti-ctyokine)

Anti-CD27*

Antigen presentation

Anti-CD40

IMA942 vaccine* (Immatics)

Antigen release

T cell infiltration

T cell Trafficking

Cancer T cell recognition

Anti-CEA-CD3

Anti-HER2-TDB

Antigen/T cell bispecific Mabs

ImmTAC* (Immunocore)

Anti VEGF: Avastin

Targeted therapies:

Tarceva, cobimetinib,

Zelboraf, Gazyva

Clinical development Preclinical development

* Partnered projects (external)

Established therapies

New in 2014

T cell killing

Anti-PD-L1

Anti-CSF-1R

Anti-CEA-IL2v

Anti-OX40

IDO inhibitor (NewLink Genetics)

NME (undisclosed)

IDO inhibitor* (Incyte)

Chen and Mellman. Immunity 2013

Roche cancer immunotherapy

Pipeline as of 2014 year end…

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Phase II Phase III

Anti-PDL1

NSCLC (Dx+)

Anti-PDL1

NSCLC 2/3L

Anti-PDL1+Avastin

Renal 1L

Anti-PDL1

Bladder 1/2L

Phase I

Anti-OX40

Solid tumors

CEA CD3

Solid tumors

IDO

Solid tumors

Anti-CSF1R

Solid tumors

Anti-PDL1

Solid tumors

Anti-PDL1+Zelboraf

Melanoma

Anti-PDL1+Tarceva

NSCLC

PDL1+Avastin+FOLFOX

CRC

Anti-PDL1 + Gazyva

Blood cancer

Anti-CEA IL-2v

Solid tumors

Anti-PDL1

TNBC

Anti-PDL1+Avastin

Solid tumors

Anti-PDL1+cobimetinib

Solid tumors

Anti-PDL1+ipilimumab

Solid tumors

Anti-PDL1+ CD40

Solid tumors

Anti-PDL1+IFN-alfa

Solid tumors

Anti-PDL1

NSCLC 2/3 L

Status as at December 2014

Anti-PDL1 trials

NMEs monotherapy

Immune doublets

Roche cancer immunotherapy

…and additional trials already decided upon

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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

PDL1+Avastin+chemo**

1L non sq NSCLC

Anti-PDL1+chemo**

1L non sq NSCLC

Anti-PDL1+chemo**

1L sq NSCLC

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 March 25, 2015

Cancer immunotherapy today

Approved in monotherapy, later line

19 Control

Medical benefit

Immunotherapy Targeted Therapy

Me

dic

al

be

ne

fit

(PFS

/OS

)

Time 1 2

Anti-PDL1 (MPDL 3280A) in bladder cancer

Confirming strength in cancer immunotherapy

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PD-L1 IHC (n)

ORR (95% CI)

Dx+ vs Dx- ORR (95% CI)

Median PFS (range), weeks

IHC 3 (n=10) 60% (27-85) 52% (34-69)

Not reached (5 to 48+)

IHC 2 (n=23) 48% (27-68) 24 (5 to 50+)

IHC 1 (n=24) 17% (6-37) 14% (6-28)

11 (0.1+ to 30+)

IHC 0 (n=12) 8% (0-35) 7 (5 to 24+)

Durability of response PD-L1

IHC

Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov. Diagnostic PD-L1-positive: IHC 2 (≥ 5% but < 10% ICs); IHC 3 (≥ 10%. ), PD-L1

negative: IHC 0 (< 1% of ICs) and IHC 1 (≥ 1% but < 5%).

Bladder cancer: No new therapies since 30 y

UBC

RCC

Prostate cancer

No

. o

f d

rug

s a

pp

rove

d b

y F

DA

Year

Cancer Immunotherapy: Increase eligibility

through combinations

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Lung Bladder Renal Mela-noma

TNBC Head & Neck

Hema-tology

Solid tumours

4L/3L

2L

1L

adjuvant

Bro

ad

er

pa

tie

nt

po

pu

lati

on

More eligible tumour types

Likely monotherapy Likely combinations

Cancer Immunotherapy: Combinability and

tolerability will be decisive

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Eff

ica

cy

present past future

Squamous Non-squamous

PD1 / PD-L1 vs

chemo

PD-L1 + chemo vs chemo

Avastin

Paclitaxel

Abraxane

Carboplatin

chemo

Chemo-backbones

Non Small Cell Lung Cancer

Predictability of treatment outcomes crucial

23 1 Soria et. al. ESMO 2014 Dx+≥5% IC, Brahmer et. al. ASCO 2014 , Dx+≥5% TC, Antonia et. al. ESMO 2014 Dx+ not disclosed

Prevalence PDL+ PDL-

Roche 20% 46% 18%

A 43% 26% 10%

B 65% 15% 14%

0%

17%

33%

50%

0% 20% 40% 60% 80%

Cut-off for prevalence

A

B

Roche

Eff

ica

cy

PD-L1+

15%

26%

46%

Example: Biomarker data for PD-L1/ PD-1 inh. in NSCL1

low High Medium

Higher likelihood of

reimbursement

Lower likelihood of

reimbursement

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Multiple Sclerosis

Looking for the next step in MS therapy

0

10

20

30

40

50

60

70

80

90

ocrelizumab natalizumab cladribine rituximab fingolimod interferon

ß-1a sc

interferon

ß-1b

glatiramer

acetate

%

Relative reduction in Annualized Relapse Rate (ARR)

•Trial durations vary from 6 mos. to 3 yrs; studies included different patient populations, different in/exclusion criteria, different ARR definitions and data were collected over a time span of more than 20 years

interferon

ß-1a sc interferon

ß-1b sc

Pattern indicates phase II

Solid indicates phase III

Biosimilars are not all the same

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G-CSF Bio-Oncology

Live saving / extending no yes

Immediate ‘feedback’ in case

of treatment failures

yes no

Alternative treatment options

(in- class alternative)

yes no

‘In patient’ experience with

biosimilars

yes no

ACE 910 in Hemophilia A

A novel FVIIIa mimetic bispecific antibody

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Mode of action

Novel approach promoting FX activation

and acceleration of coagulation

Kitazawa, Shima, Yoshioka, Hattori . Nature Medicine 2012;18(10):1570,

Sampei, et al. PLoS One 2013;8(2):e57479, Muto, Shima, Hattori . J Thromb

Haemost 2014;12:206

Targeted product profile

• Less frequent dosing

• Subcutaneous

• Avoid induction of inhibiting antibodies

Prophylaxis

3 times/week, IV

On-demand treatment

1-3 times/bleeding event, IV

Inhibiting Factor VIII antibodies in 20-33% of the patients NO

N-I

NH

IBIT

OR

Prophylaxis with bypassing

agents

Every other day, IV

On-demand treatment with

bypassing agents

2-3h intervals, IV

IN

HIB

ITO

R

Immune Tolerance Induction

70-80 % success rate

limitation due to very high cost and heavy burden for

patients

ACE 910

FVIIIa

In collaboration with Chugai

Lampalizumab: Pivotal phase 3 started

• CHROMA & SPECTRI: 2

identical, randomized

studies (c.940 pts each)

Primary endpoint:

Reduction in the rate

of GA1 disease

progression

• Phase 2 (MAHALO):

Showed high efficacy in

subpopulation with

exploratory biomarker

1 Geographic Atrophy 27

Dry AMD

30-50m pts

Initially, visual acuity minimally affected; signs are anatomic (drusen & pigmentary

changes) with symptoms of visual function impairment

CFI

biomarker

profile +ve

CFI

biomarker

profile -ve

other

Phase 3 study population

Geographic

Atrophy

3-5m pts

Wet AMD

neovascularization GA is a progressive, irreversible

disorder severely impacting visual

function and patient quality of life

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Performance update

Foundation Medicine acquisition

Pharma pipeline update

Outlook

2015 ASCO Abstracts planned for presentation

Strong news flow across various cancer types

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Skin • cobimetinib+Zelboraf: Ph3 (coBRIM); PFS &

biomarker update • cobimetinib+Zelboraf: Ph1b (BRIM7); OS

update Lung • Alectinib: Ph2 in 2L ALK+ NSCLC • aPDL1: Ph2 (POPLAR) in 2/3L NSCLC • aPDL1: Ph2 (FIR) in PDL1+ advanced NSCLC • aPDL1: Ph1 update in NSCLC • aPDL1: Ph1 data from chemo combos in

NSCLC • aPDL1: Pooled biomarker analysis in NSCLC

GU • aPDL1: Ph1 update in bladder

Breast/GYN • Kadcyla+Perjeta: Ph3 (MARIANNE); primary

data in 1L HER2+ mBC

Hematology

• GAZYVA: Ph3 (GADOLIN) in R/R iNHL

Rituxan/MabThera RA

Neuroscience

6 NMEs

ocrelizumab

gantenerumab

Roche: A pipeline of differentiated products

Launched

Phase III

Phase II 10 NMEs + 9 AIs

Rituxan/MabThera

Xeloda

Herceptin

Perjeta

Kadcyla

Avastin

Gazyva/Gazyvaro

Tarceva

Zelboraf

Erivedge

Immunology/

Ophthalmology

Actemra/RoActemra

Lucentis

Xolair

Esbriet

Pulmozyme

lebrikizumab

lampalizumab3

etrolizumab2

anti-PDL1

taselisib1

venetoclax (Bcl2i)

cobimetinib4

pictilisib1

alectinib

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Oncology

Neuroscience

Ophthalmology

Immunology

Oncology

3 AIs

1 Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014; 4 Filed in combination with Zelboraf in metastatic melanoma

AI = Additional Indication; NME = New Molecular Entity

2015 outlook

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Group sales growth1 Low to mid-single digit

Core EPS growth1 Ahead of sales growth2

Dividend outlook Further increase dividend in Swiss francs

1 At constant exchange rates 2 Excluding sale of filgrastim rights in 2014

Doing now what patients need next

Hematology franchise

Extensive late stage clinical trial program

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Compound Combination Indication P 1 P 2 P 3

Gazyva +chemo GREEN CLL

Gazyva +chemo GOYA aNHL

Gazyva +chemo GADOLIN iNHL

Gazyva +chemo GALLIUM 1L FL

Gazyva +PDL1 R/R FL

Gazyva +PDL1 aNHL

venetoclax* +Rituxan MURANO R/R CLL

venetoclax +Gazyva CLL14 CLL

venetoclax R/R CLL 17p

venetoclax +Rituxan/+BR R/R FL

venetoclax +Rituxan/Gazyva+chemo 1L aNHL

venetoclax +BR R/R NHL

venetoclax +chemo R/R MM

venetoclax +chemo AML

polatuzumab +Rituxan/Gazyva ROMULUS NHL

polatuzumab +Gazyva/BR R/R FL

polatuzumab +Gazyva/BR aNHL

* venetoclax in collaboration with AbbVie

BR = bendamustine+Rituxan

venetoclax (Bcl2 inhibitor); polatuzumab vedotin (CD79b ADC)

Biosimilars delayed to 2017

MabThera/

Rituxan

Gazyva

MabThera/

Rituxan

venetoclax

CD79b

ADC

Other

molecules Gazyva

venetoclax

CD79b

ADC

Other

molecules

CLL11 study, etc. CLL14 study, etc.

Replace

CD20 backbone

Extend

Replace & Extend

Illustrative

MURANO study, etc.

2014: Both Divisions with sales growth in all

regions

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0

2

4

6

8

10

12

14

16

18

20

Japan International Europe US

Diagnostics

Pharma

CHFbn

+6%

+3% +2%

+7%

+2%

+13%

0%

+4%

+6%

+3%

+6%

+6%

All growth rates at Constant Exchange Rates (CER)

Launch new products Esbriet: US and EU

Cobimetinib + Zelboraf: US and EU

2015 milestones

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Renew CD20 franchise Gazyva (aggressive NHL)*

Entry into Multiple Sclerosis Ocrelizumab: Phase 3 readout

Expand cancer

immunotherapy

PD-L1: Bladder, Lung, Renal, Triple Negative BC

NMEs: OX40, CD40, CEA-IL2, CSF1R, IDO, CEA-CD3

Entry into Hemophilia ACE910: Start of pivotal trials

Diagnostics Rollout of key platforms (cobas 6800 / 8800)

* Event-driven (interim analysis)