sue morris, thomas kudsk larsen, 3 november 201092af6d7a-d920-4cd0-8a45-5a...sue morris, thomas...
TRANSCRIPT
RocheOppenheimer's 21st Annual Healthcare Conference
Sue Morris, Thomas Kudsk Larsen, 3 November 2010
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 protected2
Business update
Pipeline highlights
3
Pharmaceuticals Division 29.0 28.4 -2 +1 +5
Diagnostics Division 7.4 7.7 +5 +8
Roche Group 36.4 36.1 -1 +2 +6
YTD Sept YTD Sept ExcludingCHF bn 2009 2010 CHF local Tamiflu*
change in %
Group: Sales YTD September 2010 Solid sales growth in first nine months
*in local currency4
Diagnostics: Growth driven by Professional Diagnostics and Diabetes Care
CHF bn YTD Sept ‘10 vs. YTD Sept ‘09local growth
0 1 2 3 4
Tissue Dia
AppliedScience
MolecularDia
DiabetesCare
ProfessionalDia
EMEANorth AmericaRoW
+10%
+5%
+4%
+8%
+18%
Robust up-take GS Junior DNA sequencer EU & APAC3; Low H1N1 testing dampening reagent sales
Strong placements of cobas 4800 systems ex-US; TaqScreen DPX Test (parvo B19 & HAV) received CE mark
Strong above-market growth in EMEA1 and LATAM2; Driven by Accu-Chek Performa and Accu-Chek Aviva
Nth America growing 10%; Sept US launch of Clinical chemistry modules for cobas 8000 modular analyzer series
Launched 4 new Abs in US as aid diagnosis various cancers; Acquired BioImagene Inc. to strengthen Digital Pathology
1 Europe, Middle East, Africa 2 Latin America 3 Asia Pacific5
Q1 Q2 Q3 Q4 Q1 Q2 Q3Pharmaceuticals Division 8 14 15 8 10 -2 -5
excl. Tamiflu 7 7 5 -3 8 3 4
2009 2010 ExcludingCHF m CHF m CHF local Tamiflu*
change in %
Pharmaceuticals Division 29,034 28,395 -2 +1 +5
United States 11,157 10,878 -3 +1 +4
Western Europe 8,026 7,295 -9 -3 +3
Japan 3,490 3,137 -10 -12 +2
International 6,361 7,085 +11 +11 +11
Pharma: Sales YTD September 2010
*in local currency
Quarterly growth rates% in LC vs. prior year
6
Pharma: Major growth contributors* Oncology products driving growth
*Absolute amounts in CHF m at 2009 exchange rates; products with contribution above CHF 50 m
528
371
318
250
174
168
79
71
-161
-256
-1206
AVASTIN
MABTHERA / RITUXAN
HERCEPTIN
LUCENTIS
ACTEMRA
XELODA
TARCEVA
MIRCERA
NEORECORMON / EPOGIN
CELLCEPT
TAMIFLU
7
Pharma: Late-stage pipeline progressing wellExtensive clinical data by year-end
2007 2008 2009 2010E
Number of NMEs
2
4
10Metabolic
Oncology
Inflammation
ocrelizumab
dalcetrapib
pertuzumab
dalcetrapib
taspoglutide
Actemra
ocrelizumab
aleglitazar
CNS
taspoglutide
ocrelizumab
pertuzumab
T-DM1
Hedgehog inh
BRAF inhibitor
RG7159 (CLL)
GlyT-1 inh
up to 14Virology
1 LIP decision made, phase III pending; 2 LIP and phase III decision pending
SABCS 8-12 Dec.
SMR / Intl. Melanoma Congress 4-9 Nov.
ECTRIMS
ACNP 5-9 Dec.
ASH 4-7 Dec.
AASLD
dalcetrapib
taspoglutide
aleglitazar
SGLT2 inh2
GlyT-1 inh
ocrelizumab MS1
lebrikizumab2
HCV pol inh1
pertuzumab
BRAF inhibitor
T-DM1
Hedgehog inh
RG7159(CLL, NHL)
MetMAb1 ESMO
ESMO
Phase II data expected in 2010
Recruitment finalized
Recruitment on track
Phase II in house
Data in 2011
8
Group: 0utlook for 2010 - on track to achieve goals
Barring unforeseen events;Total Tamiflu sales of up to CHF 1 bn assumed for 2010; LC=Local Currency* Continuous increase in dividend pay-out ratio over the period 2008-2010
Sales growth (in LC) Group & Pharma (excl. Tamiflu): mid single-digitDiagnostics: significantly above market
Core EPS growth (in LC) Double-digit
Synergies 2010: CHF 800 m2011: CHF 1,000 m
Debt 2010: 33% reduction (revised from 25%)2015: Aim to return to net cash position
3 yr Dividend outlook Maintained (as announced in 2008)*
R&D investment Slightly below 2009 level
9
Business update
Pipeline highlights
10
MetMAb is an anti-Met monovalent antibody that inhibits HGF-mediated activation
• Rationale for targeting Met:
– Met is amplified, mutated, overexpressed or uniquely activated in many tumors
– Met expression is associated with worse prognosis in many cancers including NSCLC
– Met activation is implicated in resistance to erlotinib/gefitinib in pts with activating EGFR mutation
• MetMAb:
– One-armed format designed to prevent HGF-mediated stimulation of pathway
– Preclinical activity across multiple tumor models
11
MetMAb
Met
α α
HGF HGF
Met
Growth, Migration, Survival No Activity
Met High NSCLC patients benefit from MetMAb + Tarceva
12
PFS, HR=0.56 OS, HR=0.55
12/23 patients from the Tarceva+placebo arm who crossed over to MetMAb were Met High.
Analysis of Met High Patients
Spigel et al, ESMO 2010
• Intensity of Met staining on tumor cells scored on 0–3 scale
• Met high’ definition: ≥50% tumor cells with a staining intensity of 2+ or 3+– Estimated that about one-half of NSCLC patients would have Met high tumors– Met by IHC was assessed after randomization and prior to unblinding
– In this study:• Tissue was obtained from 100% of patients.• 95% of patients had adequate tissue for evaluation of Met by IHC.• 54% patients had ‘Met High’ NSCLC.
1+ 2+ 3+
Development of Met IHC as a Diagnostic
13Spigel et al, ESMO 2010
14
T-DM1 vs. Herceptin + docetaxel in Breast Cancer Potential for lower rate of chemo-related side effects
T-DM1(n=67)
Trastuzumab + Docetaxel
(n=70)Patients with an Objective Response 32 (47.8%) 29 (41.4%)
Safety Evaluable Patients (n=67) (n=68)
Any AE, n (%) 63 (94.0) 68 (100.0)
Grade ≥3 AE 25 (37.3) 51 (75.0)
Three most common AEs (any grade) in trastuzumab + docetaxel arm:
Alopecia (hair loss)Neutropenia (reduction white blood cells)Diarrhea
1 (1.5)5 (7.5)
7 (10.4)
45 (66.2)39 (57.4)31 (45.6)
ESMO 2010
Ocrelizumab phase II RRMS 24-week data results
15
Gd-enhancing T1 lesions
Weeks
Lesions on MRI by week (ITT): average imputation
p<0.0001 for both ocrelizumabdoses vs placebo
Ocrelizumab 2000 mg (n=52)
Ocrelizumab 600 mg (n=51)Placebo (n=54)
IFN beta-1a (n=52)
ARR at week 24
Li et al, ECTRIMS
Primary endpoint
0-24 weeks
n=54 n=55 n=55 n=54
80% 73%
P=0.0005
P=0.0014
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Short-term newsflowProgress of New Molecular Entities
Ocrelizumab in Multiple Sclerosisrandomised phase II in RRMSECTRIMS (15 October, Gothenburg)
Nucleoside Polymerase inh. in HCVphase IIb PROPEL interim dataAASLD (October 28-Nov 2, Boston)
BRAF inh. in 2nd /3rd line melanomasingle arm phase II (BRIM-2)Intl. Melanoma Congress (November 4-9, Sydney)
GA101 in Non-Hodgkin’s Lymphomaphase II data in aNHLASH (December 4-7, Orlando)
GlyT-1 inh. in Schizophreniarandomised phase IIACNP (December 5-9, Miami)
Pertuzumab in neoadj. HER2+Breast Cancer randomised phase II NEOSPHERESABCS (December 8-12, San Antonio)
Roche's Late Stage Pipeline UpdateFocus on data presented at ESMO, ECTRIMS, ASH, International Melanoma Congress and ACNP
London, December 9th, 2010
Roche in briefUnique high-tech healthcare investment
• Clear strategy
– Biotech-based; medically-differentiated products; poised to become leader in Personalized Healthcare
• Attractive risk profile
– Limited patent risk; lowest among large-cap biotech & pharma
– Late stage pipeline progressing well with up to 14 new molecular entities
• Assets in place for sustained success
– New Rheumatology & Autoimmune franchise
– Emerging franchise in Metabolism & Diabetes; earlier-stage compounds in CNS (FPI expected to GlyT-I Phase III by year-end)
Unique high-tech healthcare investment17
We Innovate Healthcare
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