Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ......

22
Improving the standard of care Alan Hippe CFO Roche London, November 2015

Transcript of Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ......

Page 1: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Improving the standard of care

Alan Hippe

CFO Roche

London, November 2015

Page 2: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

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 2

Page 3: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Performance update

Growth from existing and new products

Productivity and efficiency

Outlook

3

Page 4: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Q3 2015: Sales growth for fifth consecutive year

4 All growth rates at constant exchange rates (CER)

0% 0% 1%

4%

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

5%

7%

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

Q1

15

Q2

15

Q3

15

Page 5: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

HY 2015: Strong underlying Group core operating

profit & margin

5

% of sales

CHFbn

CER=Constant Exchange Rates

* Excluding sale of filgrastim rights in 2014 at CER

8'3 8'6 9'5 9'4 9'2

38'1% 38'5%

40'7% 41'0%

39'2%

HY 2011 HY 2012 HY 2013 HY 2014 HY 2015

+2% at CER (+7%*)

(+0.4%p

excl. filgrastim*)

Page 6: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

HY 2015: Strong underlying Group core operating

profit & margin

6

% of sales

CHFbn

CER=Constant Exchange Rates

* Excluding sale of filgrastim rights in 2014 at CER

8'3 8'6 9'5 9'4 9'2

38'1% 38'5%

40'7% 41'0%

39'2%

HY 2011 HY 2012 HY 2013 HY 2014 HY 2015

+2% at CER (+7%*)

(+0.4%p

excl. filgrastim*)

Page 7: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

2014: Dividend and payout ratio further increased

7 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); Note: For 1995, a special dividend was paid

out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996

Page 8: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Performance update

Growth from existing and new products

Productivity and efficiency

Outlook

8

Page 9: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Roche strategy: Focused on medically

differentiated therapies

9

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

Page 10: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

HER2 franchise: Significant growth opportunities

in current indications

• Increased patient share

• Longer treatment duration

• Emerging markets

10

96%

84%

63% 58%

93%

<5%

51%

58%

25%

<5%. <5% <5% 0%

100%

Herceptin Perjeta 1L Perjeta 2L Kadcyla

mBC

Patient shares

Sources: Market research tracking studies; Latest quarter Q315 in EU5 and US

US

EU5

EM

Growth

Neoadjuvant Adjuvant

Page 11: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Anti-CD20: Multiple approaches across the

franchise 1L CLL Typical

5%

1L CLL Fit

6%

CLL 17p-del

1%

R/R CLL

5%

1L aNHL

27%

R/R aNHL

6%

iNHL

49%

GAZYVA (GOYA) in aNHL

(improve > SoC)

Gazyva (GALLIUM)

(improve > SoC)

Gazyva (GREEN)- Extend

chemo backbone

Venetoclax –

Extend efficacy

Rapidly and sustainably

convert market to SC

Broad development program for venetoclax as add on and in new tumour types

11

Rapidly and sustainably

convert market to SC

SoC=standard of care; SC=subcutaneous; CLL=chronic lymphocytic leukemia; iNHL=indolent non-hodgkin’s lymphoma; aNHL=aggressive NHL

Page 12: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Franchise strategies for long term growth

New indications and longer duration

12

Growth

opportunity Indication

Global peak

sales potential

HER2

Potential and

new indications

Perjeta adjuvant (APHINITY)

Herceptin SC*

CD20

Potential and

new indications

Gazyva aNHL (GOYA)

Gazyva iNHL (GALLIUM)

MabThera SC*

Venetoclax

Small: up to CHF 0.5 bn medium= CHF 0.5 to CHF 1bn large > CHF1bn

*Sales replacing current IV products; SC=subcutaneous; iNHL=indolent non-hodgkin’s lymphoma; aNHL=aggressive NHL

Page 13: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Multiple major pivotal trials reading out near term

Significant filing and launch activities ahead

13

Year Molecule Indication Market

opportunity

Incremental

infrastructure

2015

Alectinib ALK+ NSCLC Low to medium

Cotellic/Zelboraf Melanoma Low

Venetoclax Hematology (CLL 17p del)* Low

2016

Ocrelizumab Multiple Scelerosis Medium

Atezolizumab NSCLC, bladder (2/3L) Medium

Lebrikizumab Asthma, AD, IPF, COPD Large

APHINITY Adj HER2+ breast cancer Low

GOYA NHL (aggressive) Low

2017

ACE 910 Hemophilia A Low to medium

Lampalizumab Geographic atrophy Low to medium

GALLIUM NHL (indolent) Low

Atezolizumab+chemo NSCLC (1L) Low

2018 Taselisib (PI3Ki) HER2-/HR+ breast cancer Low to medium

Idasanutlin (MDM2) Acute myeloid leukemia Low to medium

Oncology Neuroscience Ophthalmology Immunology

Small: up to CHF 0.5 bn medium= CHF 0.5 to CHF 1bn large > CHF1bn

NSCLC=non-small cell lung cancer; CLL=chronic lymphocytic leukemia; AD=atopic dermatitis; IPF=idiopathic pulmonary fibrosis; COPD=chronic obstructive pulmonary disease; NHL=non-hodgkin’s lymphoma; * first indication

Page 14: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Performance update

Growth from existing and new products

Productivity and efficiency

Outlook

14

Page 15: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Network

efficiencies

Complexity

reduction

Continuous process

improvement

Optimize utilization &

increase reliability

Do the same

with less

Focus resources on

key value driver

Remove >40% of all

presentations by stream-

lining the EP1 portfolio

(<0.1% sales impact2)

Improve capacity planning

across the network & align

to future needs

Implement lean principles,

e.g. to decrease end-to-end

cycle time by up to 50%3

Source: 1. Established Products 2. In 2016 3. For processes in scope

Need

Valu

e

We are also driving operational efficiencies

Select examples Technical Operations

15

Page 16: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

2015E 2014 2013 2012

Resources shifted to new & strategic products…

…while overall spend only increases slightly

Strategic In-market

Recently launched + NME

Mature

Product Marketing and Medical Costs (2012 – 2015)

60% 75%

16

Page 17: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Achievements: Productivity

Doubled number of projects at same costs

2012 2013 2014 2010 2011

+90%

Filing Ph0-2 Ph3 Pharma Development Spend

Late stage development costs & number of projects

Excludes Chugai, pRED and gRED, Medical Affairs and PTD

Source: Roche internal development data 17

Page 18: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Performance update

Growth from existing and new products

Productivity and efficiency

Outlook

18

Page 19: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

2015 outlook: Guidance upgraded

19

Group sales growth1 Mid-single digit

Core EPS growth1 Ahead of sales growth2

Dividend outlook Further increase dividend in Swiss francs

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

Page 20: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Positive outlook

Strong pipeline mitigates biosimilar impact

2014 2015E 2016E 2017E 2018E 2019E 2020E 2021E 2022E 2023E

Marketed

products

Sales

Pipeline

Biosimilars

MabThera, Herceptin, Avastin

NME launches

Venetoclax, Alectinib, Cotellic, Ocrelizumab, Atezolizumab,

Lebrikizumab, ACE910, Lampalizumab

20

Page 21: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Newsflow in H2 2015

21

Vienna, 25 -29 Sep

• atezolizumab (+chemo)

- NSCLC: POPLAR , BIRCH,

P1b chemo combo update

- Bladder: P2 (2L cohort)

• alectinib

- ALK+ NSCLC: P2 update

• CEA-IL2v FP; IDOi

- solid tumors: P1 updates

San Antonio, 8-12 Dec

• Atezolizumab + chemo

- TNBC: P1b abraxane combo

San Antonio, 19-22 Nov

• atezolizumab

- GBM: P1

Barcelona, 7-10 Oct

• ocrelizumab

- RMS: P3 OPERA I/II

- PPMS: P3 ORATORIO

Orlando, 5-8 Dec

• venetoclax

- R/R CLL 17p del: P2

• venetoclax combinations

- AML: P1 + chemo

- NHL: P1 + Rituxan+benda

- CLL: P1 + Gazyva

• Gazyva + chemo

- NHL: P3 GADOLIN update

- CLL: P3 GREEN update

San Francisco, 18-21 Nov

• atezolizumab + Zelboraf

- mM: P1

• Cotellic + Zelboraf

- BRAF+mM: coBRIM OS data

Presentations planned

Page 22: Improving the standard of care - roche.com · PDF fileImproving the standard of care Alan ... 3 delay or inability in obtaining regulatory approvals or bringing products to market;

Doing now what patients need next