committed to innovation and growth - roche to innovation and growth roland diggelmann, coo roche...
TRANSCRIPT
Committed to innovation and growth
Roland Diggelmann,COO Roche Diagnostics
Chicago, 29 July 2014
HY 2014 Group results
DiagnosticsOverview & strategyHY 2014 overview Outlook
2
HY 2014: Highlights
3
Regulatory updates
Innovation
1 CER=Constant Exchange Rates; 2 Breakthrough Therapy Designation; 3 Lipopolysaccharide transporter; 4 Subcutaneous; 5 Platinum resistant
Growth
• EU approval: MabThera SC4
• CHMP positive opinion: Gazyvaro CLL front line, Avastin in ovarian cancer5
• Japan approval: Alectinib in lung cancer
Immunology • EU approval: Actemra SC4
• US approval: Xolair in chronic idiopathic urticaria
Oncology
• Solid sales performance driven by HER2 franchise (+20%1), Avastin (+6%1), Professional Diagnostics (+9%1)
Profit / Cash
Sales
• +7% core EPS growth1, driven largely by strong underlying business • Strong operating free cash flow (+11%1)
• Priority review for Avastin (cervical & ovarian), BTD2 in aPDL1 (bladder), fast track for LptD3 (antibiotic)
• Acquisition of Seragon, IQuum & Genia
HY 2014: Both Divisions growing in all regionsInternational growth increasing in Q2
4
0
2
4
6
8
10
Japan International Europe US
DiagnosticsPharma
+5%
+3%+2%
+7%
+2%
+12%
+4%
+6%
CHFbn
+5%
+3%
+6%
+5%
All growth rates at constant exchange rates (CER)
5
HY 2014: Increase in core operating profit & margin
9.168.25 8.64
9.499.41
37.2% 38.1% 38.5%40.7%
41.0%
HY 2010 HY 2011 HY 2012 HY 2013 HY 2014
+7% at CER
CER=Constant Exchange Rates
CHFbn
6
HY 2014: Continued increase in Core EPS
6.95 6.68 6.887.58
7.57
HY 2010 HY 2011 HY 2012 HY 2013 HY 2014
CHF
+7% at CER
CER=Constant Exchange Rates
2014 Outlook
71At constant exchange rates
Group sales growth1 Low- to mid-single digit
Core EPS growth1 Ahead of sales growth
Dividend outlook Further increase dividend
HY 2014 Group results
DiagnosticsOverview & strategyHY 2014 overview Outlook
8
In-Vitro Diagnostics market overviewLarge and growing market; Roche is market leader
Market share Market size
9
USD 52 bn
Source: Roche Analysis, Company reports for 2013 validated by an independent IVD consultancy
20%
11%
10%
8%7%3%
40%
Roche
Abbott
Siemens
J&J DanaherBiomerieux
Others Molecular Diagnostics
Professional Diagnostics
Tissue Diagnostics
Diabetes Monitoring
Our business modelPlace instruments to generate recurring revenues through reagent usage
10
ClosedSystems
best instrument technology broadest menu
Our strategyDifferentiation through innovation in testing efficiency and medical value
11
2012 2020
MedicalValue
Drivers ofcompetitive differentiation
TestingEfficiency
HY 2014 Group results
DiagnosticsOverview & strategyHY 2014 overview Outlook
12
HY 2014: Diagnostics sales Growth driven by Professional Diagnostics
13
HY 2014 HY 2013 change in %CHFm CHFm CHF CER
Diagnostics Division 5,140 5,133 0 +6Professional Diagnostics 2,904 2,825 +3 +9
Diabetes Care 1,140 1,205 -5 0
Molecular Diagnostics1 762 781 -2 +4
Tissue Diagnostics 334 322 +4 +9
1Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +6% CER=Constant Exchange Rates
North America+6%
25% of divisional sales
Latin America+11%
7% of divisional sales
Japan+4%
4% of divisional salesEMEA1
+2%
47% of divisional sales
HY 2014: Diagnostics regional sales Growth across all geographies
Asia Pacific+15%
17% of divisional sales
14
16% growth in E7 countries2
1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at constant exchange rates
0%
15
HY 2014: DiagnosticsGrowth driven by Professional Diagnostics
FDA approval for cobas HPV test for primary screening in cervical cancer. HPV (+59%), virology (+5%) and blood screening (+7%)
Sales driven by Accu-Chek Aviva/Performa (+2%), Accu-Chek Mobile (+22%) and Insulin Delivery Systems (+6%)
Growth driven by advanced staining portfolio (+8%) and companion diagnostics (+29%)
1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +6% CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
Sales CHFbn
CER growth
1
+9%
+4%
+9%
Continued double digit growth in immunodiagnostics (+12%) Launch of cobas 6500 fully automated urinalysis system
0 1 2 3
Tissue Dia
MolecularDia
DiabetesCare
ProfessionalDia
EMEANorth AmericaRoW
HY 2014: Diagnostics DivisionProfit influenced by unfavorable base effects
16
2014 vs. 2013CHFm % sales CER growth
Sales 5,140 100.0
Royalties & other op inc 64 1.2Cost of sales -2,319 -45.0M & D -1,170 -22.8R & D -492 -9.6
G & A -235 -4.6
Core operating profit 988 19.2
HY 2014
18%
0%
6%
0%
10%
-10%
6%
18%
Excl. one-off item PSI*: +2%
Admin: +4%Excl. PSI: +3%
CER = Constant Exchange Rates (avg full year 2013) * One-off item: impacts from past service income (PSI) in 2013
-9% in CHF
RPD: Growth driven by serum work area solutionsLargest footprint and broadest menu in the industry
23%Roche
Others
Leader in CHF 19bn SWA market
cobas 8100
Integrated SWA1 solution
• 41% of Diagnostics sales in SWA (+11%):– Immunodiagnostics (+12%)– Clinical chemistry (+9%)
*Source: Roche Analysis, Company reports for 2013 validated by an independent IVD consultancy; 1SWA: serum work area (immunodiagnostics & clinical chemistry)
RPD: Launch of cobas 6500 for urinalysisFully automated urine testing solution
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• Target market ~CHF 600m• Combines urine strip testing & digital
microscopy• 23 parameters measured to help
diagnose urinary tract infections, kidney diseases and diabetes
• Competitive advantages: – Fastest and most accurate instrument– Reagent free– Minimizes manual steps– Improves safety
cobas 6500
urine work area
RPD: Launch of Elecsys® Syphilis TestFor infectious disease and blood screening
19STD=Sexually transmitted diseases
Elecsys Syphilis
cobas 6000
• Expands leading immunoassay portfolio• Target market (HIV, Syphilis, Herpes immunoassay):
~CHF 850m• Test can be performed across entire cobas analyzer
platform series• Competitive advantages:
• High sensitivity/specificity• Low blood sample volume• Short time to result
• Offers complete solution for STD and pre-natal infections testing
• Fulfills WHO requirements for blood safety solutions
Molecular Diagnostics: HPV testingApproval for primary screening in US and Canada
20
• HPV market ~CHF 300m (+13%)
• FDA recommends cobas HPV test as primary screening for cervical cancer and expand screening age to 25 - 29
• ATHENA study: Pap smear misses cervical disease in 1 in 7 HPV 16 positive women
• Ongoing pilot studies: Sweden, Netherlands, UK and Italy
Three results in one test• HPV genotype 16• HPV genotype 18• 12 high risk HPV pool
cobas HPV test (+59%) HPV primary screening
RMD: cobas 8800/6800/4800Setting new standards for molecular testing
Blood Screening Virology HPV & CT/NG Microbiology Genomics & Oncology
• Multiplex HIV, HCV, HBV• West Nile Virus• B19 and HAV
• HIV• Hepatitis B, C• HSV• CMV
• Human Papillomavirus
• Chlamydia & Gonorrhea
• MTBMAI• MRSA• C. Difficile
• BRAF • K-RAS• EGFR• PIK3CA
cobas 4800 SystemRMD Platform Strategy
cobas 8800/6800 Systems
RMD Assays
21
• Advanced PCR automation• Highest throughput (3x above closest competitor)• Broadest menu
• Low to middle volume throughput• Broadest menu
IQuum acquisitionEntering Point of Care in molecular diagnostics
22
Target market:• ~CHF 350m, growing ~20%
Liat (laboratory in a tube) technology:• Fast and simple with automated process
performed in a test tube• Brings laboratory PCR to the Point of Care• Short turnaround time
Portfolio:• Analyzer and Influenza A/B assay approved• Strep A and Respiratory Syncytial Virus tests
in clinical studies• Planned expansion into MRSA and C-difficile
Liat™ Analyzer
Point of Care: e.g. physician’s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus
Genia acquisition Strengthening next generation sequencing pipeline
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Target market: CHF 1.1bn (+20% pa until 2018)
Genia technology:• Single DNA molecule sequencing• Biological nanopore electrical detection• Shorter turnaround time, better sensitivity &
accuracy than existing NGS1 platforms• Opportunity to reduce sequencing costs
Genia technology
1NGS = Next Generation Sequencing
2014 Group results
DiagnosticsOverview & strategyHY 2014 overview Outlook
24
*Excluding US;1Business Areas: RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics,RTD: Roche Tissue Diagnostics; 2 hospital information systems; 3 blood glucose monitoring; 4 parvovirus B19 and hepatitis A virus; 5 west nile virus
Key launches 2014
25
Area Product Market BA1
Instruments/
Devices
Labs
cobas 6800/8800 – Next generation molecular (PCR) systemcobas m 511 – Fully integrated and automated hematology systemcobas 6500 – Automated urinalysis work area platformConnect-V – Middleware providing connectivity to LIS2
WW*EUEUWW
RMDRPDRPDRTD
Diabetes Care
Accu-Chek Insight- Next generation insulin pump & bGm3 systemAccu-Chek Connect – bG meter with connectivity to smart phones, mobile App and cloud
EU
EU
RDC
RDC
Tests/
Assays
Infectious Diseases /Blood Screening
MPX 2.0 – Next generation blood screening multiplex testMPX (HIV, HCV, HBV), HEV, DPX4, WNV5 – Full NAT blood screening menu for cobas 6800/8800 HIV, HCV, HBV – Virology tests for cobas 6800/8800HSV- Detection of Herpes Simplex Virus on cobas 4800Syphilis– Immunoassay for the detection of Treponema pallidum
USWW*
WW*EUEU
RMDRMD
RMDRMDRPD
MicrobiologyMRSA/SA – Next generation assay on cobas 4800C-difficile – Diagnosis of infections and associated diarrhea
EUEU
RMDRMD
Women’s Health
PE Prognosis- Claim extension for short-term prediction of Preeclampsia in pregnancyAMH- Assessment of ovarion reserve for fertility
EUEU
RPDRPD
OutlookSustain sales growth and profitability
26
Drivers
• Further expand installed base and test menu• Launch next generation platforms and drive lab efficiency• Continue to strengthen leading presence in emerging markets• Ongoing adjustments in Diabetes Care to adapt to market environment• Grow PHC* and companion diagnostics collaborations
* Personalised healthcare
27
Doing now what patients need next
Roche strategy: Focused on medicallydifferentiated therapies and personalisedhealthcare
28
Generics
Differentiation
MedTech
OTCPrem
ium
for
inno
vatio
n
DiaPharma
Focus
Regulators: Optimised benefit / risk ratio
Payors: Optimised benefit / cost ratio
Roche Diagnostics' commitment to PHC
29
Oncology
Neurosciencelampalizumabgeographic atrophy
Immunology /Ophthalmology
ocrelizumabMS
cobimetinib (MEKi)melanoma
lebrikizumabasthma
gantenerumabAlzheimer’s
1Phase 3 decision pending
Bcl-2i (GDC 0199)hem. cancers
alectinib (ALKi)NSCLC
taselisib (PI3Ki)1
solid tumours
pictilisib (PI3Ki)1
solid tumours
polatuzumab (aCD79b)1
hem. cancers
etrolizumabUC and CD
Oncology
Neuroscience
Ophthalmology
Immunology
anti-PDL1solid tumours
Majority of Roche Pipeline with a PHC approach
External PHC collaborations2 with more than 40 pharma & biotech companies