nina goworek, investor relations officer 10 november 2011 · nina goworek, investor relations...
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Roche: Committed to innovation and profitable growth
Nina Goworek, Investor Relations Officer 10 November 2011
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; 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
More than 115 years of Roche Historical timeline
0
10,000
20,000
30,000
40,000
50,000
1896 1934 1970 1990 2000 2007 2010
Founding International expansion
Fragrances & Flavours
Diagnostics
Genentech
Chugai
Disetronic
Diversification
Strategic Transition - focus on Pharmaceuticals & Diagnostics
Sales in 2010: 47’473 million CHF
Personalised Healthcare
Limited Company
Ventana
Boehringer Mannheim
Spin off Fragrances & Flavours Sale OTC Sale Vitamins & Fine Chemicals
#1 in in-vitro
diagnostics
#1 in biotech
One Company
Today
Pharma Diagnostics
Roche Group Structure
Chugai Genentech Roche Diabetes
Care
Roche Applied Science
Roche Professional Diagnostics
Roche Molecular
Diagnostics
Roche Tissue
Diagnostics
Roche Pharma
5
Pharmaceuticals
Diagnostics
Personalized Healthcare
Financials
Pharma: Strong position in a large market
% Pharma Rx market share (2010)
8%
7%
6%
5% 5% 5%
Source: EvaluatePharma Rx + OTC estimate Other represents Australia and Canada
Source: EvaluatePharma
6
Pharma growth rates have declined in last decade
From double digit to single digit
Source: EvaluatePharma
• Bolus of patent expiries • Price pressures • Utilization controls
Pharma market growth rate (prescription drugs)
7
8 % Sales Lost calculated by subtracting given year sales (‘10, ’11, ‘12, ‘13) from full year sales from year prior to LOE. Data excludes sales lost impact of products with LOE prior to 2010. Source: Evaluate Pharma
Roche: Limited exposure to patent expiries in the short and medium term
40%
35%
30%
25%
0%
20%
10%
15%
5%
2010 2011 2012 2013
Business impact from biosimilars 2014/15 and beyond?
Roche strategy for post-patent biologics marketplace Actively pursuing multiple strategies
9
Protect high standards Enforce 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
A leading pipeline 12 NMEs in late-stage development
1LIP decision made, phase III start pending; 2approved in US, filed in EU
2007 2008 2009 2010
Number of NMEs
2
4
10 Metabolic
Oncology
Inflammation
ocrelizumab
dalcetrapib
pertuzumab
taspoglutide
Actemra
CNS
ocrelizumab
12
Virology
dalcetrapib
aleglitazar
Glycine reuptake inh
ocrelizumab MS
lebrikizumab1
HCV pol inh1
pertuzumab
Zelboraf2
T-DM1
vismodegib
GA101 (CLL, NHL)
MetMAb
dalcetrapib
aleglitazar
Glycine reuptake inh
ocrelizumab
pertuzumab
BRAF inhibitor
T-DM1
Hedgehog inh
GA101 (CLL)
taspoglutide
Expected filing timelines
2014 2014 2013 2015 2013 2015 2014
Approved in US, filed in EU Filed in US
2012 2013 Q4 2011
11
HER2 franchise Building on the strength of Herceptin
T-DM1 • Retains Herceptin’s biologic activity
• Targeted intracellular delivery of a potent cell-killing agent, DM1
Pertuzumab • Disrupts HER2:HER3 receptor dimers and
downstream signaling
• In combination with Herceptin: potential to create new standard of care for women with HER2-positive metastatic BC
T-DM1 vs. Herceptin + docetaxel in breast cancer Ph II: significant improvement in PFS
12
Pro
porti
on p
rogr
essio
n-fre
e
1 . 0
0 . 8
0 . 6
0 . 4
0 . 2
0 . 0
Trastuzumab +docetaxel (n=70)
T-DM1 (n=67)
Median PFS, mos
Hazard ratio
Log-rank P value
T+D T-DM1
9.2 14.2
0.594 0.0353
0 2 16 18 20 Time (months)
4 6 8 10 12 14
Hurvitz SA, et al. Abstract 5.001. ESMO 2011; Hazard ratio and log-rank P value were from stratified analysis
PFS, 1st line HER2+ breast cancer
Trastuzumab + docetaxel (n=66)
T-DM1 (n=69)
Median duration of treatment, months
T-DM1 – 10.0 Trastuzumab 8.1 – Docetaxel 5.5 –
Example
Median OS (month)
Dose escalation 25.2
Extension 13.8
WT or sub-therapeutic. 4.18
Extension cohort in phase I estimated survival: 1 year = 50%, 2 years = 38%
— V600E dose escalation (n=16) — Extension, 960 mg twice daily (n=32) — WT or sub-therapeutic exposure (n=33)
1 year 2 years
0 3 6 9 12 15 18 21 24 27 30 33 36 0
10
20
30
40
50
60
70
80
90
100
Time since first dose (months)
Ove
rall
surv
ival (
%)
Vemurafenib phase I overall survival Updated KM estimates (Aug. 2011)
McArthur, ECCO/ESMO 2011; Flaherty et al, NEJM 2011 13
Example
MEK inhibitor (GDC-0973) in combination with Zelboraf
MEK inh. (GDC-0973) in combination with BRAF inh.
Before initiation of Zelboraf
15 weeks on Zelboraf
after relapse
14 Nature 468,902–903; 16 December 2010
Example
Week 16: no BCC on biopsy
Vismodegib in metastatic and locally advanced Basal Cell Carcinoma Phase II data at EADO and ESMO
Week 20 Baseline Week 8
15 A. Sekulic et al., EADO 2011 In collaboration with Curis
15
Filed in Q3 2011 in US
Example
16
Ocrelizumab in RMS Looking for the next step in MS therapy
Relative reduction in Annualized Relapse Rate vs. placebo in a range of phase 2/3 trials
NOTES: • Pattern: Solid bars represent Phase III studies; pattern = Phase II • 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
0
10
20
30
40
50
60
70
80
90
ocrelizumab natalizumab rituximab fingolimod BG-12 interferon ß-1a sc
interferon ß-1b
glatiramer acetate
%
Example
Portfolio outlook An update on key compounds
17
2011 2016 2013 2014 2015 2012
Ale
glita
zar
Lebr
ikiz
umab
Met
MA
b
Ocr
eliz
umab
T-D
M1
Pert
uzum
ab
Vem
uraf
enib
Vism
odeg
ib
Mer
icita
bine
Launch Year
GA
-101
Gly
t-1
Dal
cetr
apib
pRED gRED
Larger
Smaller
Market potential
Status as of September 30, 2011
NME Additional Indication
Oncology Inflammation/Immunology Virology Metabolic/Cardiovascular CNS Ophthalmology Others
RG-No Roche Genentech managed CHU Chugai managed
CIF/MEK inh solid tumors RG7167
Raf & MEK dual inh solid tumors RG7304
MDM2 ant (2) solid & hem tumors RG7112
PI3 kinase inh solid tumors RG7321
BRaf inh(2) BRAF mut. melanoma RG7256
anti-PLGF MAb solid tumors RG7334
anti-glypican-3 MAb liver cancer RG7686
tumor immunotherapy oncology RG7446
MEK inh solid tumors RG7420
PI3 K/mTOR inh solid & hem tumors RG7422 AKT inhibitor solid tumors RG7440
MEK inh solid tumors RG7421
anti-D22 ADC hem. malignancies RG7593
anti-Her3/EGFR m. epithelial tumors RG7597
anti-angiogenic solid tumors RG7594
IAP ant (2) solid tum & lymphoma RG7459
anti-FGFR3 MAb oncology RG7444
PI3K inh oncology RG7604
- ADC prostate ca. RG7450
- ADC hematologic tumors RG7596
- ADC ovarian ca. RG7458
- solid tumors or NHL RG7603
anti-CD44-MAb solid tumors RG7356
ALK inhibitor NSCLC CHU - solid tumors CHU
Bcl-2 inh CLL RG7601 - ADC oncology RG7599
Chk-1 inh tumors or lymphoma RG7602
Tweak MAb oncology RG7212
- ADC multiple myeloma RG7598
WT-1 vaccine oncology CHU
mGluR2 antag (2) depression RG1578
BACE inh Alzheimer’s RG7129
ABCA1 inducer dyslipidemia RG7273
GABRA5 cogn. disorders RG1662
CRTH2 antag asthma RG7185
nucleoside pol inh HCV RG7432 Cat S antag CV risk in CKD RG7236
GIP/GLP-1 dual ago type 2 diabetes RG7685
anti-IL-17 MAb RA RG4934
V1 receptor antag (2) autism RG7314
- metabolic RG7652
Anti-IL 6 MAb RA CHU
triple reuptake inh depression RG7166
18
Roche development pipeline
vismodegib operable BCC RG3616 MetMAb mNSCLC RG3638
pertuzumab HER2+ EBC RG1273 pertuzumab HER2+ mBC 2nd line RG1273 T-DM1 HER2+ EBC RG3502
Zelboraf papillary thyroid cancer RG7204
mericitabine HCV RG7128
lebrikizumab severe asthma RG3637
MetMAb mBC RG3638 MetMAb mCRC 1L RG3638
anti-oxLDL MAb sec prev CV events RG7418
navitoclax (ABT-263) sol & hem tum RG7433
rontalizumab SLE RG7415
danoprevir HCV RG7227
mGluR5 antag (2) TRD RG7090
anti-LT alpha MAb RA RG7416
gantenerumab Alzheimer‘s RG1450
P selectin MAb ACS/CVD RG1512
anti-M1 prime MAb asthma RG7449
11 beta HSD inh metabolic diseases RG4929
rhu Mab Beta7 ulcerative colitis RG7413
anti-factor D Fab geogr. atrophy RG7417
anti-EGFL7 MAb solid tumors RG7414
anti-Abeta MAb Alzheimer‘s RG7412
MAO-B inh AD RG1577
EGFR Mab solid tumors RG7160
Phase I Phase II
18
MabThera ANCA assoc vascul RG105
Xolair chronic idiopathic urticaria RG3648
Rituxan NHL fast infusion RG105
Avastin HER2+ BC adj RG435 Avastin BC combo Herceptin 1st line RG435 Avastin NSCLC adj RG435
GRI schizophrenia negative sympt. RG1678
Avastin HER2-neg. BC adj RG435
Avastin high risk carcinoid RG435 Avastin glioblastoma 1st line RG435
Avastin triple-neg. BC adj RG435
aleglitazar CV risk reduction in T2D RG1439 dalcetrapib atherosc. CV risk red. RG1658
Lucentis AMD high dose RG3645
pertuzumab HER2+ mBC 1st line RG1273
Herceptin HER2+ BC s.c. form. RG597 Herceptin HER2+ adj BC (2yrs) RG597
GA101 iNHL relapsed RG7159
Tarceva NSCLC adj RG1415
Actemra early RA RG1569
T-DM1 HER2+ mBC 1st l. RG3502 GA101 CLL RG7159
Actemra RA DMARD IR H2H RG1569
Avastin mCRC TML RG435
T-DM1 HER2+ adv. mBC RG3502
Actemra sc formulation RA RG1569
Tarceva NSCLC EGFR mut 1st line RG1415
MabThera NHL s.c. formulation RG105
ocrelizumab RMS RG1594
Avastin mBC 2nd line RG435
GRI schizophrenia subopt control RG1678
GA101 DLBCL RG7159 GA101 iNHL front-line RG7159
tofogliflozin (SGLT2) type 2 diabetes CHU
ocrelizumab PPMS RG1594
T-DM1 HER2+ mBC 3rd l. RG3502
Phase III
19
Pharmaceuticals
Diagnostics
Personalized Healthcare
Financials
2010 2015E
20
• Labs remain willing to invest to address costs and improve efficiency
• Payers support solutions that deliver health economic and medical value
• New drug approvals increasingly linked to Companion Diagnostics
• Emerging markets adopting “western” standards of care
Market Overview: In vitro Diagnostics Large & growing market, increasing in importance
CAGR
44
57
Molecular
Total
Professional
Tissue
3
5
2
3
USD bn
36 29
5%
11% 5%
9%
Diabetes Monitoring
10 9 3%
Market trends
Source: Independent IVD consulting firm, Roche Analysis, Company reports Excludes Life Sciences & insulin pumps
World-wide IVD Sales by Segment
21
Market Overview: Market share Roche is the clear IVD market leader
20%
12% 11%
9%
7%
3%
Roche Abbott Siemens J&J Beckman bioMérieux
• Total solution offering
• Breadth of technologies
• IT and workflow connectivity
• Completeness of menu
• Strong commercial presence
• Operates in >130 countries
Source: Independent IVD consulting firm, Roche Analysis, Company reports Excludes Life Sciences & insulin pumps
Roche's strengths
22
Performance: Diagnostics Division HY 2011 Leading in sales growth and margin
2010 2011 % change CHF m CHF m CHF CER
Professional Diagnostics 2,449 2,347 -4 +9
Diabetes Care 1,489 1,329 -11 +1
Molecular Diagnostics 604 544 -10 +2
Applied Science 449 377 -16 -4
Tissue Diagnostics 259 259 0 +16
Diagnostics Division 5,250 4,856 -8 +5
Sales 4,856 100.0
Royalties & other op inc 50 1.0
Cost of sales -2,052 -42.3
M & D -1,174 -24.1
R & D -431 -8.9
G & A -186 -3.8
Core operating profit 1,063 21.9
2011 % change CHF m % Sales (at CER)
+5
-41
+2
+7
+11
+2
+5
Sales Operating profit
CER=Constant Exchange Rates, (average full year 2010)
23
Pharmaceuticals
Diagnostics
Personalized Healthcare
Financials
in R&D
Diagnostics Pharma
24
Competitive advantage of having Pharma and Diagnostics in the Group
in Commercial
Develop superior Personalized Healthcare solutions, faster and cheaper Drive faster implementation in the market
Personalised Healthcare – a key enabler Fitting the treatment to the patients
Effectiveness of treatment can be improved . . . • 20-75% of patients do not receive effective treatment1
• >100,000 deaths/yr from adverse drug reactions in US2
. . . by tailoring treatments to selected patient groups defined by biomarkers 1 Spears et al., Trends Mol Med, 2001 2 Lazarou et al., JAMA, 1998
Roche Pharma: a leading pipeline 12 NMEs in late-stage development
26 2007 2008 2009
New molecular entities (NMEs)
2
4
10
Metabolic
Oncology
Inflammation
ocrelizumab
dalcetrapib
pertuzumab
taspoglutide
Actemra
CNS
ocrelizumab
Virology
dalcetrapib
aleglitazar
Glycine reuptake inh
ocrelizumab
pertuzumab
BRAF inhibitor
T-DM1
Hedgehog inh
GA101 (CLL)
taspoglutide
2010
12
dalcetrapib
aleglitazar
Glycine reuptake inh
ocrelizumab MS
lebrikizumab1
HCV pol inh1
pertuzumab
Zelboraf2
T-DM1
vismodegib
GA101 (CLL, NHL)
MetMAb
√
√ √
√ √
√
PHC approach
1LIP decision made, phase III start pending; 2approved in US, filed in EU
A big step forward for our PHC strategy Zelboraf is just the start…
T-DM1 Metastatic breast cancer (HER-2 expression level)
Pertuzumab Metastatic breast cancer
(HER-2/3 expression level)
Mericitabine Hepatitis C
(HCV viral load, genotype)
MetMAb Non-small cell lung cancer
(MET status)
Lebrikizumab1 Asthma
(periostin level)
Zelboraf Metastatic melanoma
(BRAF V600E mutation)
1 LIP decision made, phase III start pending
PHC: Roche internal collaborations Significant increase due to focused PHC strategy
2005 2010 2006 2007 2008 2009
= Companion Dx Projects = R&D Collaborations
Genentech Privatization
Ventana Acquisition
10
28
169
29
Personalised Healthcare- benefit for all stake holders, including the industry
Today Future
Reduced Patient pool
Price increase /stability
Faster penetration
Lower development
costs
Increased market share
Time to market
Benefit from patient stratification
30
Pharmaceuticals
Diagnostics
Personalized Healthcare
Financials
Sales 24,636 21,671 -12 0 Core operating profit 9,159 8,251 -10 +5 as % of sales 37.2 38.1
Core net income 6,062 5,821 -4 +11 as % of sales 24.6 26.9 Attributable to Roche shareholders 5,965 5,697 -4
Core EPS (CHF) 6.95 6.68 -4 +10 IFRS net income 5,565 5,259 -5 +10
as % of sales 22.6 24.3
HY 2011: Group performance Core EPS growth +10%1
31
CHF m %Change 2010 2011 CHF CER
1 at Constant Exchange Rates, CER (average full year 2010)
32
Pharmaceuticals Division 28.4 24.4 -14 -1 +1
Diagnostics Division 7.7 7.1 -8 +6
Roche Group 35.3 31.5 -13 0 +2
Excluding CHF bn 2010 2011 CHF CER Tamiflu1
% change
YTD Sept 2011: Group sales Supporting full-year guidance, strong currency impact
1 at Constant Exchange Rates, CER (average full year 2010)
HY 2011: Group operating performance Positive effects of Operational Excellence
33 1 Cost of goods sold & period cost
-10% in CHF
G&A excl. excise tax
COGS/PC1: +1%
Higher milestone income and product disposal income
Lower royalty (e.g. Tamiflu) and manufacturing costs
Primary care sales force reduction & cost management
Project prioritisation and OpEx savings (Pharma -2%)
Increase due to excise tax in the US
Efficiency improvements
Major drivers Sales
Royalties & other op. inc Cost of sales M & D R & D G & A
Core operating profit
2011 vs. 2010 local growth
Underlying sales growth of Herceptin, Lucentis, MabThera/Rituxan and Actemra
HY 2011: Group core operating profit and margin Strong margin increase over years
34
CHF m % of sales
+1.8 % p1 (+0.9 % p)
-0.2 %p1 (-0.4 %p)
+2.7 %p1 (+1.7 %p)
+5 %1 (-9 %)
+5 %1 (-10 %)
+5 %1 (-10 %)
2010 2011 2009
1 at Constant Exchange Rates
P&L structure reflecting innovation based strategy Peer group core operating profit margin 2010
35
R&D % sales Core operating profit margin % sales
M&D+G&A % sales
FY 2010 figures; restated to a core basis based on publicly available information
1. Pfizer: Non-core items in CoS 2. Eli Lilly: 8%p. lower CoS ratio vs. Roche. Not feasible to judge
if definition of Lilly’s CoS same as Roche’s 3. JNJ: No adjustments feasible as no details are disclosed.
Committed to growing operating free cash generation
Ø 28%
Pfizer 16% Astellas 19%
Becton D. 21% Merck 23%
Novartis 28%
BMS 29% J&J 29%
Takeda 30%
Roche 30% Abbott 32%
Lilly 34% AZ 35%
Sanofi 36% Amgen 36%
Biogen 52% Gilead 52%
Operating free cash flow 2010 (% of sales)
GSK Bayer
(27% excl. Biogen and Gilead) 36
Group operating free cash flow (CHF bn) and margin
37
2.50
3.40
4.60
6.006.60
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 20100%5%10%15%20%25%30%35%40%45%50%55%
Attractive dividend payout ratio
CHF Average yearly dividend growth
(2004-2010): 22%
1 compound annual growth rate
Payout ratio
Pay-out ratio calculated as dividend per share divided by core earnings per share (diluted)
Pay-out ratio calculated as dividend per share divided by earnings (before exceptional items) per share (diluted)
38
2010: 24th consecutive annual increase in the dividend
27% increase in the ADR dividend!
Dividend per share Dividend per American Depositary Receipt1
1Currency rate as determined by the depositary bank during the dividend payment and tax reclaim process
+10%
Increasing shareholder value
Increasing cash generation • HY 2011: Operating free cash flow +27%1 (+7% CHF)
39
P&L: increasing profitability • Operating profit margin increase (37.2% to 38.1% HY 2011)
Committed to an attractive dividend policy • Grow in-line with Core EPS; maintain at least last year’s dividend in CHF
Delivering on productivity improvements • Headcount: 3,000 released from work, further 800 notified since start of
Operational Excellence • Sites: closing/divesting of Boulder, Burgdorf, Kulmbach, Graz and Palo Alto
done or ongoing
1 at Constant Exchange Rates
40
Increased outlook for 2011 Good first half due to strong business performance
Barring unforeseen events; CER=constant exchange rates; * vs. 2010: CHF 0.8 bn
Sales growth (at CER) Group & Pharma (excl. Tamiflu): low single-digit Diagnostics: significantly above market
Core EPS growth target (at CER)
Increased to around 10%
Genentech synergies 2011+ : CHF 1.0 bn*
Dividend outlook Grow in-line with Core EPS; maintain at least last year’s dividend in CHF
Operational Excellence savings
2011 : CHF 1.8 bn 2012+ : CHF 2.4 bn
Roche in brief Innovation & productivity
• Focused innovation strategy – Personalized Healthcare through Pharmaceuticals & Diagnostics – Medically-differentiated products & services
• Leading businesses – Biotech-based leadership in Oncology, Virology; emerging Immunology,
Cardio-metabolic and Neuroscience franchises. Limited patent risk – World’s #1 in-vitro Diagnostics company
• Strong financials – Increasing profitability through growth & productivity with constant focus on
cash flow – Attractive dividend
We Innovate Healthcare