kepler seminar, zurich march 24, 2011 - roche
TRANSCRIPT
Kepler Seminar, Zurich March 24, 2011
Roche Karl Mahler, Head of Investor Relations Nina Mojas, IR officer
Translating excellence in science into
customer benefit
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
4
Solid fundamentals
Challenges to address
Building the future
5
2010: Summary
Financial guidance fully met
Operational Excellence on track
• Most of the concerned employees individually notified
• R&D prioritised
• Divestitures of factories initiated
Pipeline is gaining strength
• 12 New Molecular Entities (NMEs) in late stage
Personalised Healthcare is becoming reality
• 6 late stage assets tailored to specific patient groups
6
Pharmaceuticals Division 38,996 37,058 -5 -2 +5
Diagnostics Division 10,055 10,415 +4 +8 +8
Roche Group 49,051 47,473 -3 0 +5
2009 2010 Excluding
CHF m CHF m CHF local Tamiflu*
change in %
2010: Group sales
Solid underlying growth in line with guidance
* local currency
7
2009 vs. 2008 2010 vs. 2009
Growth rates maintained despite healthcare
reforms and austerity measures
Q1 Q2 Q3 Q4 FY Q1 Q2 Q3 Q4 FY
Pharmaceuticals Division 8 14 15 8 11 10 -2 -5 -8 -2
excl. Tamiflu 7 7 5 -3 4 8 3 4 4 5
Diagnostics Division 8 7 10 10 9 9 9 7 6 8
Roche Group 8 12 14 8 10 9 0 -3 -5 0
excl. Tamiflu 7 7 6 0 5 9 4 5 4 5
8
Key Pharmaceuticals & Diagnostics products
A risk-diversified portfolio of drugs and BUs
Sa
les (
CH
F b
n)
* 2010 sales
0
5
10
15
20
25
30
35
'03 '04 '05 '06 '07 '08 '09 '10
2 with > than CHF 6 bn
1 with > than CHF 5 bn
11 with > than CHF 1 bn
MabThera/Rituxan
Xeloda
NeoRecormon CellCept
Herceptin
Avastin
Pegasys
Clinical Chemistry
Immunochemistry
Tarceva
Lucentis
>C
HF 6
bn
* >
CH
F 1
bn
* >
CH
F 5
bn
*
Diabetes Care
Molecular Dx Boniva
9
Pharma sales in International / emerging markets
0
1
2
3
4
5
6
7
8
9
10
2006 2007 2008 2009 2010
Tarceva
Xeloda
CellCept
Pegasys
Avastin
MabThera / Rituxan
Herceptin
Rest excl. Tamiflu
All figures at 2010 exchange rates
CHF bn
10
Opportunities in emerging markets
Large untapped potential for our innovative products
Opportunities in emerging markets
• strong and long-standing presence
• providing access is key: disease
awareness, local clinical trials and
training for healthcare professionals
Current
penetration
(%) Herceptin
MabThera
oncology
China ~5% 12%
Russia 25% 26%
Emerging markets: by 2012 ~ 80% of US market value,
more than Western Europe (IMS)
11
Continuous profit growth and margin improvement
16.6
16.3
33.2%
34.9%
2009 2010
Group Core operating profit and margin
+7%1
(+2%)
+2.1%p1
(+1.7%p)
CH
F b
n
% of sales
1 at constant exchange rates
12
2.50
3.40
4.60
6.00
6.60
5.00
2.00
55.0%
51.6%
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
2004 2005 2006 2007 2008 2009 2010
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
55%
2010: Continuous increase of pay-out ratio over
three years1
CHF Average yearly dividend growth
(2004-2010): 22%
1 compound annual growth rate
Payout ratio
1 As announced in relation to the financial results for 2007 Pay-out ratio calculated as dividend per share divided 2010 Dividend: Proposed by the Board of Directors by core earnings per share (diluted) Pay-out ratio calculated as dividend per share divided by earnings (before exceptional items) per share (diluted)
13
Solid fundamentals
Challenges to address
Building the future
We need to justify the value of our products
more than ever
German Benefit Prognosis (2011) UK Value Based Pricing (2014)
Narrowing labels indicate initially smaller
market opportunities
• 1980-1990: Pivotal studies considered
reasonably generalizable
• Nowadays:
– More narrow label to start with than
in the past
– Insurance companies moving towards
limiting re-imbursement in this
context
Drug X is indicated in
Metastatic Breast Cancer (MBC)
Drug X + Y is indicated
In MBC
X + Y on schedule
A indicated in MBC
X + Y on sched.
A in ‘substantive
studies’ only
1980s 1990s 2000s 2010
Higher costs even when products are on the market 46% of NMEs were approved with a REMS
Level 1 Med Guide Level 2 Comm Plan Level 3 ETASU
NME
(BLAs) 11 Extavia
Cimzia, Dysport,
Simponi, Stelara,
Kalbitor, Actemra, Xiafelx,
Krystexxa
Nplate, Lumizyme
NMEs
(small molecules) 18
Vimpat, Nucynta, Savella, Banzel,
Votrient, Pradaxa
Effient, Vibativ,
Xenazine, Multaq, Samsca,
Victoza, Zortress, Prolia,
Gilenya
Promacta,
Sabril,
Entereg
Indication Change /
Label Updates 28
Treximet, Aplenzin, Trilipix,
Zolpimist, Edluar, Creon, Actoplus
MET XR, Cambia, Zipsor, Zenpep,
Colcrys, Lyrica Solution, Tyzeka
Solution, Pennsaid, Oleptro,
Silenor, Pancreaze, Suprep, H.P.
Acthar Gel, Axiron
Embeda, Ampyra, Dulera
Onsolis,
Zyprexa Relprevv, Exalgo,
Oxycontin, Suboxone
Typical Promotions Less Effective Launch Trajectory
0
2
4
6
8
10
12
14
16
18
20
1 2 3 4 5 6 7 8 9 10 11 12
2004 2005 2006
2007 2008 2009
Months Since Launch
Ave
rag
e S
ale
s U
S$
M
Source: IMS
18
Solid fundamentals
Challenges to address
Building the future
19
A leading pipeline
12 NMEs in late-stage development
2007 2008 2009 2010
Number of NMEs
2
4
10 Metabolic
Oncology
Inflammation
ocrelizumab
dalcetrapib
pertuzumab
taspoglutide
Actemra
CNS
ocrelizumab
12
Virology
1 LIP decision made, phase III start pending
dalcetrapib
aleglitazar
Glycine
reuptake inh
ocrelizumab MS
lebrikizumab1
HCV pol inh1
pertuzumab
BRAF inhibitor
T-DM1
Hedgehog inh
GA101 (CLL, NHL)
MetMAb1
dalcetrapib
aleglitazar
Glycine
reuptake inh
ocrelizumab
pertuzumab
BRAF inhibitor
T-DM1
Hedgehog inh
GA101 (CLL)
taspoglutide
20
HER2-positive breast cancer
Improving the standard of care
2010 2016
Early
(adjuvant) BC
Herceptin
+ chemotherapy
Herceptin Subcutaneous
+ chemotherapy
Herceptin &
pertuzumab +
chemotherapy
2012 2013 2014 2015 2011
1st line
mBC
Herceptin
+ chemotherapy
T-DM1& pertuzumab
(MARIANNE)
Herceptin & pertuzumab + chemotherapy
(CLEOPATRA)
2nd line
mBC
Xeloda
+ lapatinib
T-DM1
(EMILIA)
Timelines refer to the expected dates of first filing
21
16.8%
24.0%
45.8%
29.0%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Herceptin +
docetaxel
Herceptin &
pertuzumab +
docetaxel
Herceptin &
pertuzumab
pertuzumab +
docetaxel
path
olo
gic
al com
ple
te r
esp
on
se
ITT population summary
p = 0.0141
p = 0.0198
p = 0.003
Herceptin & pertuzumab in neoadjuvant HER2+ BC
An encouraging result from NEOSPHERE trial
SABCS 2010
Phase III (CLEOPATRA) data in 1st line patients and filing in 2011
22
Growth despite biosimilars
HER2 market example
Value decline
EU and RoW
Herceptin value assumption post
biosimilars launch based on the
German EPO market experience
New HER2
targeted products 3
2 Increased penetration
in International
markets
1 Pertuzumab
T-DM1
Herceptin
sub cut.
23
RG7204 for metastatic melanoma meets
overall survival endpoint in Phase III
Patient Population
Second- and Third line
Malignant Melanoma
BRAF mutation positive
First-line Malignant Melanoma
BRAF mutation positive
Phase/Study Phase II BRIM2 Phase III BRIM3
# of Patients N=132 N=675
Design • Single ARM: RG7204 • ARM A: RG7204
• ARM B: dacarbazine
Primary Endpoint • Best overall response rate assessed by IRC
using RECIST criteria • Overall survival
Status • Presented at Int. Melanoma Congress 2010 • FPI Q1 2010; fully recruited in Dec 2010
• Met OS and PFS endpoints in Jan 2011
Expect filing in 2011 in US and EU
24
Hedgehog pathway inhibitor in basal cell carcinoma
Positive pivotal phase II reported
• RG3616 is efficacious in treating advanced basal
cell carcinoma
– 33 BCC patients treated in Phase I*
– >50% had a response (IRF assessed)
• 2 (6.1%) complete response
• 16 (48.5%) partial response
– Median duration of response >8.8 months
– Well-tolerated with reversible, mild adverse
events
* Von Hoff, et al., New England Journal of Medicine, September 2009 In collaboration with Curis
Positive pivotal phase II data – US filing in 2011
Phase I efficacy data
25
Impact on product pipeline
Progressing Personalized Healthcare
T-DM1
Metastatic breast cancer (HER-2 expression level)
Pertuzumab
Metastatic breast cancer (HER-2/3 expression level)
RG 7128
Hepatitis C (HCV viral load, genotype)
1 LIP and phase III decision pending
MetMAb
Non-small cell lung cancer (MET status)
Lebrikizumab1
Asthma (periostin level)
RG7204
Metastatic melanoma (BRAF V600E mutation)
Key clinical trials since October 2010 15 of 15 in 5 months
Breast Cancer: T-DM1 in 1st line
HER2-positive breast cancer
randomised Phase II data – ESMO
(October 8–12, Milano)
Non-Small Cell Lung Cancer:
MetMAb in 2nd/3rd line NSCLC
randomised Phase II – ESMO
(October 8–12, Milano)
Ovarian Cancer: Avastin
in front line ovarian cancer
ICON7 Phase III pivotal trial – ESMO
(October 8–12, Milano)
Multiple Sclerosis:
Ocrelizumab in RRMS
randomised Phase II – ECTRIMS
(October 15, Gothenburg)
Hepatitis C: Nucleoside
Polymerase inh (RG7128)
randomised Phase IIb PROPEL interim data –
AASLD (October 28–Nov 2, Boston)
Metastatic Melanoma:
BRAF inhibitor vemurafenib
Phase II Melanoma Research Congress
(November 4–9, Sydney)
Non-Hodgkin's Lymphoma:
GA101 in aNHL
randomised Phase II data – ASH
(December 4–7, Orlando)
Schizophrenia: GlyT-1 inh
randomised Phase II – ACNP
(December 5–9, Miami)
Breast Cancer: Pertuzumab
randomised Phase II NEOSPHERE – SABCS
(December 8–12, San Antonio)
Asthma: Lebrikizumab
randomised Phase II – data in house
Metastatic Melanoma:
BRAF inhibitor vemurafenib
Phase III interim analysis results
(January 18, 2011)
Advanced Non-Small Cell
Lung Cancer (NSCLC): Tarceva
Phase III EURTAC study interim analysis
results (January 27, 2011)
Ovarian Cancer: Avastin in 2nd line
platinum sensitive ovarian cancer
OCEANS Phase III (February 8, 2011)
Diabetic macular edema (DME):
Lucentis RISE phase III
(February 14, 2011)
Basal Cell Carcinoma (mBCC)
Hedgehog inhibitor vismodegib
Pivotal Phase II
(March 21, 2011)
27 27
2011: Major clinical news for late-stage NMEs 7 Phase III and 9 Phase II studies
Compound Indication Study
BRAF inh 1st line met melanoma Ph III BRIM3
Lucentis diabetic macular edema Ph III RISE Ph III RIDE
Avastin relapsed ovarian cancer Ph III OCEANS
Pertuzumab + Herceptin 1st line HER2+ mBC Ph III CLEOPATRA
Herceptin adj HER2+BC sc Ph III HANNAH
Actemra Early RA Ph III Head-to-head against Humira
Hedgehog Pathway Inh advanced BCC Ph II pivotal study
T-DM1 1st line HER2+ mBC Ph II PFS data
GA101 Relapsed indolent NHL Ph II Head-to-Head against
MabThera/Rituxan
MetMab NSCLC 2nd / 3rd line Ph II final data
Lebrikizumab asthma Ph II MILLY
Nucleoside Pol Inh Hepatitis C Ph IIb PROPEL final data; JUMP-C
Dalcetrapib Atheroclerosis CV risk red. Ph IIb dal-VESSEL; dal-PLAQUE
28
Conclusions
Roche well positioned for the future
• Unchanged innovation-driven strategy
• Optimized operational setup driving current business and increasing
profitability
• Continued significant investments in industry-leading product pipeline
• Personalized Healthcare (PHC) becoming a reality
29
We Innovate Healthcare
30
Outlook for 2011
Barring unforeseen events; LC=Local Currency; * vs. 2010: CHF 0.8 bn
Sales growth (in LC) Group & Pharma (excl. Tamiflu): low single-digit
Diagnostics: significantly above market
Core EPS growth target
(in LC) High single-digit
Genentech synergies 2011+ : CHF 1.0 bn*
Debt Aim to return to net cash position by 2015
Dividend outlook Grow dividend in-line with Core EPS growth
Operational Excellence
savings 2011 : CHF 1.8 bn
2012+ : CHF 2.4 bn
31
Long patent protection
Biosimilars facing high hurdles
Long primary patent protection
of our key biologics
Patents US EU
ROW/EM
Avastin 2019 similar
Lucentis 2019 marketed by
Novartis
Rituxan/
MabThera 2018 earlier
Herceptin 2019 earlier
Pegasys 2018 similar
Biosimilars outlook
US: FDA in the process of
developing guidelines
Long data exclusivity for biologics:
proposed 12 years
ROW/EM: investment in countries
with strong IP regulations (China)
Brand awareness important
EU: legal and regulatory hurdles
likely to remain high for biosimilars
32
Priorities 2011
Improve Efficiency
• Implement ‘Operational Excellence’ as
announced
• Capture remaining synergies from
Genentech integration
Drive Innovation and Growth
• Progress late-stage pipeline
• Prepare launches for potentially three
NMEs (BRAF inhibitor, pertuzumab,
hedgehog inhibitor)
• Launch key diagnostic tests (HPV,
BRAF, KRAS, EGFR)
• Invest in emerging markets
2011: Bring personalised healthcare to patients
33
Change CHF m 2009 2010 CHF m % loc %
2010: Group performance
+10% Core EPS growth1 as guided
Sales 49,051 47,473 -1,578 -3 0
Core operating profit 16,272 16,591 +319 +2 +7
as % of sales 33.2 34.9
Core net income 11,317 11,181 -136 -1
as % of sales 23.1 23.6
Attributable to Roche shareholders 10,636 10,955 +319 +3
Core EPS (CHF) 12.34 12.78 +0.44 +4 +10
1 at constant exchange rates