Doing Now What Patients Need Next. Teppo Hyytiä 21 May 2015

Transcription

1 Doing Now What Patients Need Next Teppo Hyytiä 21 May 2015 Roche Diagnostics Oy Future Diagnostics Symposium

2 The Roche Group Our Company Strategy Our Innovation Pharmaceuticals Diagnostics

3 Basic facts at a glance Founded 1896 in Basel, Switzerland Founding families still hold majority stake Employing 88,500 people Currently active in 150 countries on all continents 2014 sales of 47.5 billion Swiss francs million patients treated with one of Roche s top 25 selling medicines billion diagnostic tests performed Clear focus on healthcare Leadership in pharmaceuticals (#3)* World s largest biotech company (position #1)* with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS Leadership in in vitro diagnostics (#1) and pioneer in diabetes management Unique innovation model * Source: Decision Resources, Q4/2014

4 Basic facts at a glance Focusing on innovative pharmaceuticals drugs and diagnostic tests Our aim is to discover, develop and market innovative solutions that bring clear medical benefit in disease areas with high unmet medical need Oncology (e.g. breast, cervical, colon cancer) Virology (e.g. hepatitis, HIV) Inflammation and autoimmune disorders (e.g. rheumatoid arthritis, asthma) Cardiovascular and metabolic disorders (e.g. diabetes) Central Nervous System (e.g. Alzheimer's) Our products and services help to prevent, diagnose and treat diseases, thus enhancing people s health and quality of life

5 118 years of Roche Historical timeline Sales 2014: 47,462 million CHF 50 Personalised Medicine Strategic Transition Focus on Pharma & Diagnostics Ventana Diagnostics Boehringer Mannheim Genentech Chugai Disetronic Spin-Off Fragrances & Flavours Sale OTC Sales Vitamins & Fine Chemicals Fragrances Limited & Flavours 10 Company Diversification Founding Intern. expansion / / /

6 Innovative since 1896 Sirup Vitamins CNS Anti-infectives Oncology 1896/98 Vitamin C Vitamin A Vitamin B1, B2, Founding Expansio n Limited Company Valium (anxiety) Madopar (parkinson) Rivotril (epilepsy) Dormicum (anaesthesia) Clinical Diagnostics Invirase (HIV) Pegasys (HCV) Tamiflu (influenza) 1940/ / / /10 Genentec h Diversificatio n Automation MabThera (NHL) Herceptin (breast cancer) Avastin (colon cancer) Boehringe Disetroni Chugai Ventan r Spin off Fragrances c & Flavours a Sale OTC, Vitamins & Fine Chemicals Molecular Diagnostics/ Biomarker PHC 2020/30 Differentiating molecular medicines and diagnostics Enterotube CEA-RIA Cobas Bio Cobas Mira Cobas Core PCR (HIV, HXV) Elecsys ImmunDx Accu-Chek (Diabetes) Histology Sequencing cobas 6000 (SWA)

7 Strengthening Pharma and Diagnostics Building biotech expertise Rich History One Company PCR Genentech * Syntex Syntex #1 in IVD Boehringer M. Ventana Genentech Chugai * Boehringer M. #1 in Biotech Today * majority ownership

8 Diagnostics Pharma Roche Group Our Structure Roche Pharma Genentech Chugai Professional Diagnostics Molecular Diagnostics Tissue Diagnostics Diabetes Care

9 Roche Group Structure with global reach Commercial Reach Direct Roche Presence Distributors

10 Value for patients Roche products in a nutshell

11 The Roche Group Our Company Strategy Our Innovation Pharmaceuticals Diagnostics

12 Premium for innovation Roche Strategy Focused on medically differentiated therapies Pharma Dia Focus MedTech Generics OTC Differentiation

13 Roche Group what makes us distinctive Optimally positioned for the future Combined strengths of Pharmaceuticals and Diagnostics Leader in Pharma Leader in Diagnostic s Synergies in research, development and marketing Unique global network of alliances Pioneering Personalised Healthcare Early detection Preventio n Diagnose Therapy Therapy monitorin g

14 Personalised Healthcare (PHC) - driver of change Key to enabling highly differentiated medicines Healthcare Pressures: Benefit-Risk Ratio Economic Pressures: Benefit-Cost Ratio New Technologies: Expanded Capabilities Need for highly differentiated medicines that positively impact public health

15 PHC - Fitting the treatment to the patients Delivering better, safer and more efficacious treatments Roche Personalised Healthcare means: To better understand disease diversity or subtypes To identify the differences between patients To identify the best drug targets To improve the quality and efficiency of R&D results Optimising patient care Making development of new tests and drugs more efficient To provide biomarkers and diagnostic tests

16 Personalised Healthcare versus standard treatment Patients with same syndrome One-size-fits-all approach

17 Personalised Healthcare versus standard treatment Group of patients with the same syndrome Targeted therapy

18 Roche already offers a range of examples Targeted therapies - approved Oncology Breast- and stomach cancer: Herceptin for patients with HER2-positive cancer Metastatic melanoma (skin cancer): Zelboraf for patients with BRAF-positive metastatic melanoma Lung cancer: Tarceva first-line treatment for patients with EGFR-positive non-small lung cancer Virology Hepatitis B and C infections: Pegasys (HBV) and Pegasys/Copegus (HCV), genotype and viral load testing HIV: Invirase/ Viracept/ Fuzeon, viral load testing Diagnosis Providing biomarkers and diagnostic tests

19 Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component Phase 2 Phase 3/Registration Marketed FIXa/FX bispecific MAb MAO-B inh PD-L1 MAb Tarceva SERD GABRA5 NAM venetoclax (Bcl-2 inh) Zelboraf CSF-1R MAb bitopertin alectinib (ALK inh) Erivedge Ang2-VEGF MAb basimglurant taselisib Rituxan ipatasertib V1 receptor antag cobimetinib Gazyva polatuzumab vedotin crenezumab lebrikizumab Herceptin lifastuzumab vedotin olesoxime etrolizumab Perjeta glypican-3 MAb danoprevir gantenerumab Kadcyla Flu A MAb ocrelizumab Avastin LptD antibiotic lampalizumab Xeloda Esbriet Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Molecular Diagnostics Tissue Diagnostics Professional Diagnostics Pulmozyme Xolair Actemra Lucentis

20 The Roche Group Our Company Strategy Our Innovation Pharmaceuticals Diagnostics

21 R&D innovation springs from diverse sources Wealth of scientific pool Science & engineering Researchers in the world Scientists in Pharma R&D in US & Europe Scientists in Roche Pharma R&D

22 What We Work On Restoring sight Ophthalmolog y Oncology Developing effective cancer therapies Developing medicines for serious brain diseases Neuroscience Infectious Diseases Developing effective treatments for life-threatening infectious diseases Tackling rare genetic disorders Rare Diseases

23 The Roche Group Our Company Strategy Our Innovation Pharmaceuticals Diagnostics

24 Roche Group Structure -- Pharmaceuticals Pharma Diagnostics

25 Pharmaceuticals businesses Driving excellence in innovation in therapeutic areas Oncology Transplantation Virology Metabolism Bone, Anemia Inflammation Autoimmune

26 Roche Group development pipeline Phase II (22 NMEs + 14 Als) Phase III (9 NMEs + 27 Als) Registration (1 NME + 2 RG435 RG3502 RG6013 RG6046 RG7155 RG7221 RG7421 RG7440 RG7446 RG7446 RG7446 RG7596 RG7601 RG1569 RG3637 RG6062 CHU RG7227 RG7745 RG1577 RG1678 danoprevir bitopertin HCV obsessive compulsive dis. RG7929 RG6083 olesoxime spinal muscular atrophy RG7090 basimglurant TRD RG7314 FIXa/FX bispecific MAb ipatasertib PD-L1 MAb +Avastin polatuzumab vedotin venetoclax Actemra sembragiline (MAO-B inh) V1 receptor antag solid tumors hem tumors systemic sclerosis lebrikizumab Esbriet SSc interstitial idiopathic pulmonary lung disease fibrosis IL-31R MAb Flu A MAb LptD antibiotic hemophilia A PD-L1 MAb NSCLC 2/3L RCC ADC RG7599 lifastuzumab vedotin Pt-resist. OC RG7601 RG7601 RG7604 RG7604 RG7686 RG7853 RG3637 RG7929 RG7697 CHU RG1662 Avastin+Tarceva Kadcyla SERD emactuzumab (CSF-1R) PVNS/s. tumors vanucizumab (Ang2-VEGF MAb) cobimetinib+paclitaxel PD-L1 MAb bladder cancer 1/2L RCC venetoclax venetoclax+rituxan taselisib taselisib glypican-3 MAb alectinib lebrikizumab GIP/GLP-1 dual ago URAT 1 inh GABRA5 NAM EGFR mut+ NSCLC HER2+ NSCLC ER+(HER2-neg) mbc mcrc TNBC 17p del CLL rel/ref DLBCL FL rel/ref NSCLC sq 2L ER+(HER2-neg) BC neoadj liver cancer ALK+ NSCLC 2L IPF atopic dermatitis influenza antibacterial type 2 diabetes gout Alzheimer s Down Syndrome autism RG435 RG1273 RG1273 RG1273 RG3502 RG3502 RG3502 RG3502 RG3502 RG7159 RG7159 RG7159 RG7204 RG7446 RG7601 RG7601 RG7853 RG1569 RG3637 RG7413 RG1450 RG1594 RG1594 Avastin Kadcyla +/- Perjeta Gazyva Actemra gantenerumab ocrelizumab ocrelizumab glioblastoma 1L RG435 1 Avastin ovarian cancer 1L RG435 1 Avastin rel. ovarian ca. Pt-sensitive RG7446 NSC RG7446 RG7446* RG7446* RG7446* RG7446 RG7604 RG7413 HER2+ mbc 1L DLBCL1L large-vessel vasculitis Alzheimer s RMS PPMS RG7412 crenezumab Alzheimer s RG7417 lampalizumab geographic atrophy CHU CHU Perjeta+Herceptin Perjeta+Herceptin Perjeta+Herceptin Kadcyla Kadcyla Kadcyla + Perjeta Kadcyla + Perjeta Gazyva Gazyva Zelboraf PD-L1 MAb PD-L1+chemo PD-L1 MAb venetoclax+rituxan venetoclax+gazyva alectinib Actemra lebrikizumab etrolizumab IL-6R MAb HER2+ mbc 2L HER2+ BC adj HER2+gastric ca 1L HER2+ gastric cancer 2L HER2+ BC adj HER2+ BC adj HER2+ BC neoadj inhl rituximab-ref follicular lymphoma 1L melanoma adj NSCLC 2L NSCLC non-sq 1L PD-L1+chemo+Avastin NSCLC non-sq 1L PD-L1+chemo PD-L1 MAb Dx+ PD-L1 MAb Dx+ taselisib etrolizumab NSCLC sq 1L NSCLC sq 1L NSCLC non-sq 1L bladder cancer 2L CLL rel/ref CLL 1L ER+(HER2-neg) mbc ALK+ NSCLC 1L giant cell arteritis severe asthma ulcerative colitis Crohn s disease neuromyelitis optica RG105 Als) MabThera SC RG Perjeta HER2+ BC neoadj RG7421 cobimetinib + Zelboraf m. melanoma 1 US only : FDA submission decision pending 2 Approved in US, submitted in EU * FPI imminent New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other CLL RG-No Roche Genentech managed CHU Chugai managed RG105 MabThera is branded as Rituxan in US and Japan RG1569 Actemra is branded as RoActemra in EU RG7159 Gazyva is branded as Gazyvaro in EU Status as of April 22, 2015

27 The Roche Group Our Company Strategy Our Innovation Pharmaceuticals Diagnostics

28 Roche Group Structure - Diagnostics Pharma Diagnostics

29 The diagnostics value chain An integral part of treatment decision making Roche Diagnostics is offering diagnostic tests along the entire healthcare chain: Roche Diagnostics Screening Diagnosis Prognosis Stratification Monitoring Am I at risk? What disease do I have? Will I get worse? Will I be cured? Which drug should I take? Is the drug working for me? Healthy Asymptomatic / Symptomatic disease Chronic disease

30 Revaluing Diagnostics In vitro diagnostics testing has long been a silent champion of healthcare: IVD accounts for ~2% of worldwide healthcare spending IVD influences >60% of clinical decision-making Source: European Diagnostic Manufacturers Association (EDMA) 2009

31 Roche Diagnostics Division Serving both clinical and life sciences segments Professional Diagnostics Business Area Molecular Diagnostics Business Area Tissue Diagnostics Business Area Diabetes Care Business Unit Serum work area/immunoassays and clinical chemistry Point-of-care testing Coagulation and specialty testing Virology Blood screening Genomics/oncology Microbiology Women s health Primary staining Advanced staining Workflow management Digital pathology Blood glucose monitoring Insulin delivery Diabetes management systems Workflow management Biochemical reagents Custom Biotech Nucleic acid DNA purification and real-time PCR Sequencing Unit offering sequencing solutions for both clinical and life science segments

32 Roche Diagnostics Business strategy Roche Diagnostics differentiates itself in the marketplace through: continuously increasing testing efficiency developing novel tests with high medical value Revaluing diagnostics Medical Value Testing Efficiency Unmet needs Access & create IP Clinical evidence Total lab solutions Modular offering Complete menus Lab IT and workflow

33 Molecular Diagnostics Launch of cobas 6800/8800 & test menu expansion 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 Low Throughput cobas 4800 Low to middle volume throughput Broadest menu incl HPV testing

34 Entering Molecular Point of Care Diagnostics Acquisition of IQuum - testing close to the patient Liat Analyzer Target market: ~CHF 350m, growing ~20% p.a. Laboratory in a tube technology: Fast and easy to use CLIA waiver expected in 2015 Portfolio: Influenza A/B and Strep A test, CE marked and FDA cleared Plans to extend menu in: Respiratory Syncytial Virus tests MRSA and C-difficile Point of Care: e.g. physician s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus

35 Sequencing strategy Building a leading sequencing solution Developing complete innovative sequencing solutions Sample preparation Testing Platform Menue of assays Data analysis Reporting Abvitro: technology acquisition; Ariosa: acquisition; Genia: acquisition; Pacific Biosciences: partnership; Bina: acquisition; Foundation Medicine: partnership

36 I m great because I don t play the game where it is, but where it s going to be! -Wayne Gretsky

37 Doing now what patients need next