33
1 Roche: Committed to innovation and profitable growth Dr. Alan Hippe, CFO Roche May 2012

Roche: Committed to innovation and profitable growth1c368bcd-5327-4908-9573-ab5c37e3374e/...India Turkey Mexico Russia Korea +5%1 1 CER=Constant Exchange Rates; absolute values in

  • Upload
    ngonhu

  • View
    214

  • Download
    1

Embed Size (px)

Citation preview

1

Roche: Committed to innovation and profitable growth

Dr. Alan Hippe, CFO Roche

May 2012

2

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; and11 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

3

A good start into the year

Strong fundamentals

Sustainable strategy

4

Q1 2012: Highlights

5 positive late-stage trials and regulatory filings • Avastin in metastatic colorectal cancer: treatment through multiple lines (TML)• T-DM1 in HER2+ metastatic breast cancer (EMILIA)• Herceptin subcutaneous in HER2+ breast cancer (HANNAH)-filed in EU• Actemra in polyarticular-course juvenile idiopathic arthritis (CHERISH)• Actemra in rheumatoid arthritis (ADACTA)

Sales• Group and Pharma: +2%1 (+3%1 excluding Tamiflu)• Diagnostics: +4%1

• Negative currency impact (-3%p)

1 at Constant Exchange Rates

2 Approvals of New Molecular Entities• Erivedge in advanced basal cell carcinoma – approved in US• Zelboraf in metastatic melanoma – approved in EU

Q1 2012: Group salesOn track to meet full-year guidance

51 CER=Constant Exchange Rates

2012 2011 change in %CHF m CHF m CHF CER

Pharmaceuticals Division 8,624 8,712 -1 2

Diagnostics Division 2,403 2,408 0 4

Roche Group 11,027 11,120 -1 2

Q1 2012: Pharma sales driversOncology and Pegasys main growth drivers

6 6Absolute amounts in CHF m at Constant Exchange Rates (CER) average 2011; all growth rates at CER

-150 -100 -50 0 50 100 150

NeoRecormon/Epogin

Boniva/Bonviva

Tamiflu

CellCept

Zelboraf

Xeloda

Actemra/RoActemra

Herceptin

MabThera/Rituxan

Pegasys

InternationalUSJapanWestern Europe

+32%

+7%

+7%

+46%

NA

-24%

-28%

-19%

+15%

-31%

Pharma quarterly growth (excluding Tamiflu)

7Absolute amounts in CHF m at Constant Exchange Rates (CER) average 2011; all YOY growth rates at CER

-,200

-,100

,0

,100

,200

,300

,400

Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12

USInternationalWEJapan

CHF

m

+1%

+1%0%

+3% +3%

Q1 2012: US back to strong growthDriven by Oncology and Pegasys

81 CHF m at average 2011 exchange rates; 2CER=Constant Exchange Rates

88

52

38

36

26

22

20

Pegasys

Rituxan

Herceptin

Xeloda

Zelboraf

Actemra

Tarceva

US growth contribution1 Growth2

+144%

+8%

+11%

+31%

NA

+87%

+18%

US: +6%2

Q1 2012: Western EuropeSignificant impact of genericized products

91 CER=Constant Exchange Rates

2,117

2,039

-63

-77 +61

Q1 2011Sales

Q1 2012Sales

BonvivaCellCept

Neorecormon

MirceraOther tail productsPricing pressure

MabTheraRoActemraHerceptinZelborafPegasys -4%1

@2011FX

@2011FX

E7 countries: solid growth despite strong baseOne-off effects in Q1 in China and Russia

10

,0,

200,000,

400,000,

600,000,

800,000,

1000,000,

Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12

Brazil

China

India

Turkey

Mexico

RussiaKorea

+5%1

1 CER=Constant Exchange Rates; absolute values in CHF m at average 2011 exchange rates

+15%

+19%

China: Roche outgrowing the market

11

14%

20%24%

32%29%*

19%

16% 16%

17%

0%

5%

10%

15%

20%

25%

30%

35%

Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12

RocheChinese market

Source: IMS Hospital Audits, January 2012; * Roche estimate for Q1 in-market sales in China

Securing growth for HER2 franchiseHannaH and EMILIA advancing the standard of care

12

Adjuvant BC Herceptin + chemo Herceptin subcutaneous + chemo (HannaH)Herceptin & pertuzumab + chemo

1st line mBC Herceptin + chemo

T-DM1 & pertuzumab

Herceptin & pertuzumab + chemo(CLEOPATRA)

2nd line mBC Xeloda + lapatinib T-DM1 (EMILIA)

2010 20162012 2013 2014 20152011

Timelines refer to the expected dates of first filing

Established standard of care Potential new standard of care Future standard of care

• DAUPHINE (phII)treatment-naive chronic HepC

Q2 2012: Clinical data to be presented at upcoming meetings

13

EULARBerlin, June 6-9

ASCOChicago, June 1-5

EASLBarcelona, April 18-22

danoprevir

mericitabine

• EMILIA (submitted) pretreated HER2+ mBC

• PhII safety study in HER2+ eBC

• TMLtreatment through multiple lines in mCRC

• AURELIAplatinum resistant ovarian cancer

• ADACTA (submitted)Head-to-Head vs. Humira

• PROPEL, JUMP-C (phII) treatment-naive and failure chronic HepC G1/4

T-DM1

Avastin

Actemra

Virology Oncology Inflammation

• INFORM-SVR (phII, interferon-free combination)treatment-naive and interferon intolerant chronic HepC G1

danoprevir+mericitabine

14

A good start into the year

Strong fundamentals

Sustainable strategy

Sales 47,473 42,531 -10 +1Core operating profit 16,591 15,149 -9 +6

as % of sales 34.9 35.6

Core net financial income -2,272 -1,581 -30 -19Core tax rate in % 21.9 21.3 -0.6 p

Core net income 11,181 10,685 -4 +11as % of sales 23.6 25.1Attributable to Roche shareholders 10,955 10,470 -4 +11

Core EPS (CHF) 12.78 12.30 -4 +11

Operating free cash flow 14,149 13,733 -3 +14% of sales 29.8 32.3 +2.5 p

Free cash flow 4,699 3,904 -17 +21% of sales 9.9 9.2 -0.7 p

2011: Group performance Core EPS growth +11%1

15

CHF m % Change2010 2011 CHF CER

1 CER = Constant Exchange Rates

16,591

-609

-1,140

+1,764*

TamifluAvastin US/WECellCept US/WEBoniva US/WE

sales Profit growthunderlyingbusiness1

Cost savings OperationalExcellence

Core Operating

Profit2011

@ FY10Fx rates

CoreOperating

Profit2010

@ FY10Fx rates

– US healthcare reform incl. excise tax– EU austerity measures– Japan price cuts 2010 +6%

17,643+1,037

2011: Core operating profit developmentProfit growth driven by productivity improvements

16* corresponds to CHF 1,836 m at exchange rates at the time of Operational Excellence announcement;1 including Genentech integration synergies

CHF m

Group core operating profit (CHF bn) and margin

Continuous growth in operating profit and margin

15.116.3 16.6

15.1

33.0% 33.2%34.9% 35.6%

2008 2009 2010 2011

+6% in CER1

1 CER = constant exchange rates17

Continuous increase in dividends and pay-out ratio

18

2.002.50

3.40

4.605.00

6.006.60 6.80

2004 2005 2006 2007 2008 2009 2010 2011

CHF

Average yearly dividend growth (2004-2011): 19%

1 compound annual growth rate

2011Payout Ratio

of 55.3%

Pay-out ratio calculated as dividend per share divided by core earnings per share (diluted); 2011 as proposed by the Board of Directors

19

Debt maturity profileQ1 2012 Evolution

Nominal values @ actual FX rates; *Original net proceeds in CHF

Of the CHF 48.2bn bonds and notes issued to finance the Genentech transaction, cumulative 23.6bn (49%) have been repaid as of 31 Mar 2012 *

0

1

2

3

4

5

6

2012 2013 2014 2015 2016 2017 2018 2019 2021 2022 2023 2035 2039

USD EUR CHF GBP

Repayments in Q1/2012

Refinancing in Q1/2012

CHF bn

Tender ofEUR 782m

Repaymentof CHF

2.2bn atmaturity

20

A good start into the year

Strong fundamentals

Sustainable strategy

21

Roche: Focused on medically differentiated therapies

Generics

Differentiation

Focus

MedTech

OTC

Prem

ium

for

inno

vatio

n

DiaPharma

P&L structure reflecting innovation based strategyPeer group core operating profit margin 2011

22

33%32%

30%29%29%29%28%

24%23%

Eli LillyNovartis

JNJPfizer

MerckGSK

AstraSanofiRoche

R&D % sales Core operating profit margin% sales

M&D+G&A % sales

21%19%

17%16%

15%14%14%

13%12%

Eli LillyRocheMerck

NovartisAstra

SanofiGSK

PfizerJNJ

43%

39%

36%

34%

34%

31%

27%

27%

27%

Pfizer

Astra

Roche

Sanofi

Merck

GSK

JNJ

Novartis

Eli Lilly

Source: Industry success rates - Linda Martin, KMR, Bernstein R&D conference 2011Roche – publically available data, BCG analysis

• Understanding of disease biology

• Leveraging Personalized Healthcare -stratify patient population early on

• Rigorous decision making –transition only most promising projects

R&D productivityExcellence in science key lever to reduce attrition

Phase 1 Phase 2 Phase 3RegistrationPhase 0Research

4%64% 48% 25% 83%67%Probabilityof success -

Launch

Major decision points

Industry success rate 2005-2009

Industry: 4%Roche: 9%

23

Personalised Healthcare is a reality todaySignificant progress in 2011

24

PertuzumabMetastatic Breast Cancer

HER2 expression level

APPROVED

LebrikizumabSevere uncontrolled asthma

Periostin level

ZelborafMetastatic MelanomaBRAF V600E Mutation

T-DM1Metastatic Breast CancerHER2 expression level

Mericitabine and danoprevir Hepatitis C

HCV viral load, genotype

MetMAbNSCLC

Met Status

FILED TO FILE IN 2012

Ph III Ph III Ph III decision in 2012

Roche Diagnostics commitment to PHCPreferred Partner for Companion Diagnostics (CDx)

25

1025 38

70101

169>200

2005 2006 2007 2008 2009 2010 2011

Internalcollaborations1

Externalcollaborations1

• Personalized Healthcare collaborations with more than 30 pharma and biotech companies

• Tissue Diagnostics signs 4 new partnerships- Pfizer (Crizotinib – ALK IHC)- Syndax (Entinostat- E-cadherin)- Aeterna Zentaris (AEZS 108 – LHRH) - Bayer (antibody-drug conjugate)

1 Including R&D collaborations and CDx projects

Roche strategy for post-patent biologics marketplace Actively pursuing multiple strategies

26

Protect high standardsEnforce efficacy and safety standards, defend intellectual property

Act to expand patient access in emerging markets Change from global pricing to tiered pricing, including 2nd brand

Protect

Re-define the standard of care Mode of administration, combination therapies and new drugs

Innovate

Expand

Filings and launches in 2012

OncologyImmunologyCardioMetabolism

T-DM1 HER2+ advanced mBC

27

Tarceva (US)NSCLC EGFR mutation 1st line

Herceptinsc formulation HER2+

AvastinmCRC TML

ActemraRA DMARD IR H2H (EU)

Actemrasc formulation

AvastinmBC 2nd line (EU)

MabTherasc formulation (EU)

LucentisAMD 0.5 mg PRN (US)*

Erivedge (US) adv. basal cell carcinoma

pertuzumabHER2+ mBC 1st line

Zelborafmet. melanoma

Activaseextend. time window AIS (US)

Avastinrelapsed ovarian cancer (EU)

Lucentisdiabetic macular edema (US)

RituxanNHL faster infusion (US)

ActemraDMARD IR (US)

Launches Filed/awaiting launch Planned filings

New Molecular Entities

Additional indications

Actemrapolyarticular JIA

* New dosing regimen for already approved indication

2011: Three New Molecular Entities filedExpanding into selected therapeutic franchises

28

20152012 2013 20142011

aleg

litaz

ar

Met

MA

b

ocre

lizum

ab

T-D

M1

pert

uzum

ab

Zelb

oraf

Eriv

edge

mer

icita

bine

PotentialFilingYear

GA

101

Gly

T-1

Larger(> 1 bn)

Smaller(up to ~1 bn)

Non risk-adjusted

Metabolism

Oncology

Immunology

Neuroscience

Virology

dano

prev

ir2016

lebr

ikiz

umab

Outlook for 2012

29Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2011: CHF 1.8 bn

Sales growth (CER) Group & Pharma: low to mid-single digitDiagnostics: above market

Core EPS growth target (CER)

High single-digit

Dividend outlook Continue attractive dividend policy

Operational Excellencesavings 2012+ : CHF 2.4 bn*

30

We Innovate Healthcare

16,27214,836

1,742

16,59114,776

2,202

15,14913,406

2,178

Roche Group Pharma Division Diagnostics Division

33.2%34.9% 35.6%

38.0%39.9% 40.9%

17.3%21.1% 22.4%

CHF m

% of sales

+1.8 %p1

(+0.7 %p)

+1.6 %p1

(+1.3 %p)

+2.1 %p1

(+1.0 %p)

+14 %1

(-1 %)

+5 %1

(-9 %)

+6 %1

(-9 %)

2010 20112009

Group core operating profit and margin Strong margin increase over years

311 CER = Constant Exchange Rates

Roche: Staying focused on Prescription and Diagnostics

32= Active Business Unit = Recent Transaction (post 2006)

= Recent Transaction New Business Area (post 2006)

Rx1 OTC Vaccines Animal Health Generics Bio-

similars Dx Others

Novartis 60% Ophthalmology

Merck & Co 90%

Pfizer 87%

GSK 82% Generics/EMs

Sanofi Aventis 79% Generics/EMs

Bayer 31% Crop/Material Science

Abbott 57% Medical devices

J&J 36% Medical devices

Eli Lilly 94% Branded Gx Intention

AstraZeneca 100% Branded Gx Intention

Roche 78%

Amgen 100%

BMS 100%

Div

ersi

fied

Focu

sed

1 As of 2010 salesSource: FCMG; Company Annual Reports

Roche: Focus on selected business/disease areasAim to play in the lead

33

Roche 1 1

Novartis

Abbott

Sanofi

Pfizer

Merck

JNJ

AstraZeneca

Amgen

1

2

1

1*

1 1

4

2

4

5

6

8

10

7

5

2

3

1 4

5

6

8

9

4 2

8

Sources: IMS MIDAS in PADDS; For Diagnostic: Industry Analyst Report; *Lucentis sold by Roche in US, by Novartis in RoW

2*

3

7

3

6