Committed to innovation and growth
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1 Committed to innovation and growth Roland Diggelmann, COO Roche Diagnostics Bad Ragaz, 16 Jan 2015
2 Business model & strategy Q overview Major products, launches and newsflow Building a leading sequencing solution Outlook 2
3 In-Vitro Diagnostics market overview Large and growing market; Roche is market leader Market size Market share USD 52 bn Professional Diagnostics 20% Roche Molecular Diagnostics Others 40% Tissue Diagnostics 11% Abbott Diabetes Monitoring 3% Biomerieux 7% J&J 10% 8% Siemens Danaher Source: Roche Analysis, Company reports for 2013 validated by an independent IVD consultancy 3
4 Our business model Place instruments to generate recurring revenues through reagent usage Closed Systems best instrument technology broadest menu 4
5 Our strategy Differentiation through innovation in testing efficiency and medical value Drivers of competitive differentiation Medical Value Testing Efficiency
6 Business model & strategy Q overview Major products, launches and newsflow Building a leading sequencing solution Outlook 6
7 YTD Sept 2014: Diagnostics sales Growth driven by Professional Diagnostics Change in % CHFm CHFm CHF CER Diagnostics Division 7,792 7, Professional Diagnostics 4,397 4, Diabetes Care 1,721 1, Molecular Diagnostics 1,165 1, Tissue Diagnostics Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7% CER=Constant Exchange Rates 7
8 YTD Sept 2014: Diagnostics regional sales Growth across all geographies North America +6% 25% of divisional sales EMEA 1 +3% 46% of divisional sales Japan +3% 4% of divisional sales Latin America +12% 7% of divisional sales Asia Pacific +15% 18% of divisional sales 15% growth in E7 countries 1 1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at constant exchange rates 8
9 Business model & strategy Q overview Major products, launches and newsflow Building a leading sequencing solution Outlook 9
10 Roche Diagnostics Test Portfolio Industry Leading Menu 10
11 First fully-automated Anti-Müllerian hormone test for fertility Expands leading immunoassay portfolio Target market (IVF): ~ 25 mchf ; +10% AMH test superior to FSH, estradiol and ultrasound measurements Competitive advantages vs manual AMH testing: - High sensitivity - Improved accuracy - At any day of the menstrual cycle - Short time to result Test is currently also in development as CDx assay Elecsys AMH cobas e411 FSH = follicle-stimulating hormone; rfsh = recombinant follicle-stimulating hormone; IVF = in vitro fertilization; AMH = Anti-Müllerian hormone 11
12 Invest for growth Reagent manufacturing in China 12
13 Molecular Diagnostics: Meet the new family launches of cobas 6800/8800 High Throughput Reference Labs cobas 8800 Advanced PCR automation Highest throughput (3x above closest competitor) CE launch of blood screening and virology assays Large Hospitals cobas 6800 Medium Hospitals cobas 4800 Low to middle volume throughput Broadest menu incl HPV testing Low Throughput 13
14 HPV testing Approval for primary screening in US and Canada cobas HPV test (+59%) Three results in one test HPV genotype 16 HPV genotype high risk HPV pool HPV primary screening HPV market ~CHF 300m (+13%) FDA recommends cobas HPV test as primary screening for cervical cancer and expand screening age to ATHENA study: Pap smear misses cervical disease in 1 in 7 HPV 16 positive women Ongoing pilot studies: Sweden, Netherlands, UK and Italy 14
15 Global access program Landmark partnership in HIV with United Nations The program Special access pricing partnership 40% savings on viral load tests The goals UNAIDS target by 2020: - 90% diagnosed - 90% treated - 90% virally suppressed cobas AmpliPrep/cobas TaqMan HIV-1 Test 15
16 Entering Molecular Point of Care Diagnostics Acquisition of Iquum and launch of cobas Liat analyzer Liat Analyzer Liat tube Target market: ~CHF 350m, growing ~20% Liat (laboratory in a tube) technology: Fastest and easy to use with automated process performed in a test tube Brings laboratory PCR to the Point of Care Offers real-time PCR in 20 min or less CLIA waiver expected in 2015 Portfolio: Influenza A/B and Strep A test are both CE Marked and FDA cleared Respiratory Syncytial Virus tests in clinical studies Planned expansion into MRSA and C-difficile Point of Care: e.g. physician s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus 16
17 Diabetes Care: Personalized management New product launches in 2014 Blood glucose monitoring Wireless transfer of blood glucose results Connect: App with proven bolus advisor Data synchronization with healthcare professional portal via cloud Diabetes therapy system Two-way bluetooth communication between pump and remote control Remote control with proven bolus advisor Discrete and easy handling; intuitive display Accu-Chek Aviva / Performa Connect Accu-Chek Insight 17
18 Business model & strategy Q overview Major products, launches and newsflow Building a leading sequencing solution Outlook 18
19 Roche is market leader in DNA testing Complement offering with leading sequencing solution DNA testing market*: 10-year estimates Next-generation sequencing (NGS) will be the fastest-growing segment DNA testing uses different technologies which are complementary in applications: Molecular (PCR): virology blood screening Oncology Infectious disease In situ hybridization (ISH) oncology Sequencing: Whole genome sequencing and targeted sequencing Mutation detection Oncology Pre-natal, newborn Infectious disease * Includes Lab developed tests; PCR: polymerase chain reaction; Sanger: oldest sequencing technology; ISH: in situ hybridization
20 New Diagnostic Technology: Sequencing Our vision: Complete end to end solution Sample preparation DNA isolation Menu Development Library preparation Target enrichment Sequencing Menu Development: Oncology, Genetic Testing 2 and 3 Analysis Reporting Data / Result Storage? P AvanSci: technology acquisition; Abvitro: technology acquisition; Kapa Biosystems: distribution agreement; Garvan Institute: research collaboration; Nimblegen: acquisition; Ariosa: acquisition; Genia: acquisition; Pacific Biosciences: partnership; Stratos: research collaboration; Bina: acquisition 20
21 Genia Sequencing Technology Next generation sequencing Genia technology 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 NGS 1 platforms Opportunity to reduce sequencing costs 1 NGS = Next Generation Sequencing 21
22 Sequencing menu: Non-invasive prenatal testing Acquisition of Ariosa Harmony TM Prenatal Test Target market $400m sales worldwide in 2013, +32% pa Digital analysis of selected regions (DANSR TM ) technology results in a 10x more efficient approach Technology Analyzes circulating fetal DNA with microarray technology Highly cost effective and accurate Screens for the risk of Down syndrome (trisomy 21), Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13) in a pregnancy Strategy Expand market access through kit distribution model Add test to Roche sequencing platform when available 22
23 Business model & strategy Q overview Major products, launches and newsflow Building a leading sequencing solution Outlook 23
24 Key launches 2014 Area Product Market BA 1 Instruments / Devices Labs Diabetes Care cobas 6800/8800 Next generation molecular (PCR) system cobas m 511 Fully integrated and automated hematology system cobas 6500 Automated urinalysis work area platform Connect-V Middleware providing connectivity to LIS 2 Accu-Chek Insight- Next generation insulin pump & bgm 3 system Accu-Chek Connect bg meter with connectivity to smart phones, mobile App and cloud WW* EU EU WW EU EU RMD RPD RPD RTD RDC RDC Tests / Assays Infectious Diseases / Blood Screening MPX 2.0 Next generation blood screening multiplex test MPX (HIV, HCV, HBV), HEV, DPX 4, WNV 5 Full NAT blood screening menu for cobas 6800/8800 HIV, HCV, HBV Virology tests for cobas 6800/8800 HSV- Detection of Herpes Simplex Virus on cobas 4800 Syphilis Immunoassay for the detection of Treponema pallidum US WW* WW* EU EU RMD RMD RMD RMD RPD Microbiology MRSA/SA Next generation assay on cobas 4800 C-difficile Diagnosis of infections and associated diarrhea EU EU RMD RMD Women s Health PE Prognosis- Claim extension for short-term prediction of Preeclampsia in pregnancy AMH- Assessment of ovarion reserve for fertility EU EU RPD RPD * Excluding US; 1 Business 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 24
25 Outlook Sustain sales growth and profitability 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 25
26 Doing now what patients need next 26
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