Roche Diagnostics

Business Overview 2013

Key launches 2013

Area Instruments/devices Laboratories Diabetes Care Life sciences Tests/assays Oncology Calcitonin proGRP EGFR ER CINtec PLUS Cytology Infectious diseases MPX 2.0 HCV 2.0 Transplantation Sequencing Cyclosporin, Tacrolimus SeqCap EZ Reagent Kits immunoassay, supports medullary thyroid cancer diagnosis and monitoring immunoassay, assists in the diagnosis of small cell lung cancer PCR test, supports therapy selection for non-small cell lung cancer IHC tissue test for breast cancer diagnosis immunocytochemistry test for diagnosis of cervical pre-cancer PCR next-generation blood screening, multiplex test for HIV, HCV and HBV PCR next-generation HCV viral load test immunoassays for monitoring of immunosuppressive drug therapy for sample preparation for targeted next-generation sequencing EU EU US US EU US US EU WW cobas 8100 Accu-Chek Insight Accu-Chek Active GS FL X+ long amplicons next-generation modular pre-analytics next-generation insulin pump and blood glucose meter next-generation blood glucose meter with maltose-independent test strips software for long-read targeted sequencing for DNA variant detection EU EU EU WW Product name Description Market

EU=European Union; US=United States; WW=worldwide.

Table of Contents
Roche Diagnostics Business Strategy Facts and Figures Competitive Advantages Business Areas Business Areas/Unit Roche Professional Diagnostics Roche Molecular Diagnostics Roche Tissue Diagnostics Roche Diabetes Care Roche Applied Science Divisional Structure

2 3 4 5

6 8 10 12 14 16

Business Strategy
Revalue Diagnostics Focus on unmet needs

Roche Diagnostics differentiates itself in the marketplace through innovation in testing efficiency and medical value.

Improving medical value Increasing testing efciency

2020

Access and create IP Deliver clinical evidence

Total lab solutions Modular offering Complete menus Lab IT and workow

Increase testing efciency

Roche develops solutions that continually improve the speed, accuracy and reliability of lab testing through automation, workow integration and information management. We enable labs to better handle expanding testing and data volumes. We further drive lab efciency by providing our lab customers with modular solutions and complete test menus.

Provide true medical value

ds

Ever more of our efforts are concentrated on exploiting advanced scientic knowledge and technological progress to increase the medical value of our offering. Medical value is delivered by tests for screening, diagnosis, prognosis, prediction or monitoring of disease, as well as by companion diagnostic tests used for treatment selection or response prediction to a specic drug. We prioritise those areas with the highest unmet medical need and devote substantial resources to acquiring the necessary intellectual property to develop new tests, and then to demonstrate their clinical utility and health economic benet. With the advent of molecular diagnostics, totally new realms of detection are emerging.

Molecular analysis of human DNA can conrm the presence of disease genes, detect which altered genes and proteins are disturbing normal cell function, and, with a genetic prole of the patient, also predict whether heor she should respond well to Deliver clinical specic drug therapy regimens. These evidence newest diagnostic methods are not only redening clinical testing, but they are also essential in the development of targeted Offer complete enus molecular drugs. Diagnostics are integral to the new paradigm of Personalised Healthcare and as the world market leader, Roche Diagnostics is leading the way forward and revaluing diagnostics.

Offering diagnostic tests along the entire healthcare chain

Healthy Risk assessment Predisposition for developing disease Asymptomatic disease Screening/Diagnosis Early detection Symptomatic disease Diagnosis Identifying disease Prognostic Predict probable disease course Prediction Predict response to a drug Personalised Healthcare Chronic disease/Cured Monitoring Monitor drug efficacy/ disease recurrence

Revalue Diagnostics

IVD accounts for < 2% of total worldwide healthcare spending

Yet it Influences > 60% of critical decision-making

In vitro diagnostic (IVD) testing has long been a silent champion of healthcare, directing over 60% of clinical decision making, although it accounts for only 2% of global healthcare spending.

Facts and Figures

2012 Employees: 28,517 Sales: 10,267 million CHF Growth: 4% (local currency) Position in IVD market
20%

Sales by Business Area/Unit

Tissue Diagnostics 6% Applied Science 7% Molecular Diagnostics 11% Professional Diagnostics 51% Diabetes Care 25%

11%

Sales by region
10% 9% 8% 3% Professional Diagnostics 51% J&J Beckman bioMrieux

Tissue Diagnostics 6% Applied Science 7% Molecular Diagnostics 11%

Roche Abbott Siemens Diabetes Care 25%

North America 26% EMEA (Europe, Middle East and Africa) 46% Latin America 8% Asia-Pacific 15% Japan 6%

Source: Industry analyst report, Roche analysis, company reports, excludes Life Sciences and Insulin Pumps

Roches Diagnostics Division is the worlds leading supplier of in vitro diagnostics (IVDs). Performed in a laboratory or at the Point of Care on blood, tissue or other patient samples, IVDs are a critical source of objective information helping doctors detect and diagnose diseases, select appropriate treatments and monitor patient respon se to care. In addition, scientists use the Divisions research products to gain a better understanding of the causes of disease and to discover new treatments. Roche Diagnostics serves customers spanning the entire healthcare spectrum from

hospitals and commercial medical labs to physicians and patients with conditions requiring them to self-test as well as the medical research institutions. The Division offers a wide range of technologies allowing the detection and analysis of a multitude of sample types on a large base of instruments installed worldwide. Roches IVD test menu is one of the broadest in the industry and is being expanded continually, drawing on the latest scientic advances. In 2012 Roche held approximately 20% of the global IVD market, which is valued at an estimated 48 billion US dollars in annual sales.

Main Diagnostics Sites R&D/Manufacturing Regional hubs 100500 employees * untill end of 2012 Tokyo

Ponce

Singapore

Competitive Advantages
Total solution offering
Breadth of technologies
DNA/RNA-based Protein-based Cell-based

Completeness of menu
Inflammation/Autoimmune
Virology/Microbiology

IT and workow connectivity 

Cardiology

NAM

EMEA Japan

Oncology
Womens health
Metabolic diseases

Hematology

LATAM

APAC

Strong commercial presence

Active in all diagnostic segments Present in over 130 countries Large installed base worldwide

945,000,000
ER/ICU Physicians office Research lab

Elecsys tests sold in 2012 2,589,041 tests per day, 30 per second

NAM

EMEA Japan APAC

15,000,000
Accu-Chek Active meters sold worldwide
Pathology lab Hospital/ Commercial lab

LATAM

90% satised customers

Patient

Leader in Personalised Healthcare

With its leading Pharmaceuticals and Diagnostics businesses under one roof, no other company is better positioned to deliver Personalised Healthcare (PHC) than Roche. An unrestricted exchange of know-how and intellectual property, combined with the companys breadth of diagnostic technologies, allows for fast assay development and technical validation. A robust research diagnostic is essential to identify patient subsets for clinical trials, and once the targeted medicine is in the marketplace, the approved IVD test is used for treatment selection, response prediction and therapeutic monitoring.

Business Areas
Innovation Excellence
Business Areas / Unit are set up according to the fields of activities of our customers and are responsible for research and development, product portfolio management, global strategic direction and marketing, along with business development in their area of expertise.

Business Area Structure 2012

In vitro Diagnostics Professional Diagnostics
Business Area

Life Science Molecular Diagnostics

Business Area

Tissue Diagnostics
Business Area

Diabetes Care
Business Unit

Applied Science
Business Area

Private labs Hospital labs Hospital Point of Care Physicians office

 S erum work area/ immunoassays and clinical chemistry  Point-of-care testing  C oagulation and specialty testing Workflow management

Molecular labs Blood-screening labs

Histopathology labs

People with diabetes Hospitals Healthcare professionals Diabetes nurse educators

 Blood glucose monitoring  Insulin delivery  D iabetes management systems

Academia and Pharma Biotech research

Virology  Blood screening G enomics/oncology Microbiology  Womens health

 Primary staining  Advanced staining  Workflow management  D igital pathology

Nucleic acid DNA purification and gene expression  S equencing solutions  Custom Biotech and bioreagents

Outlook 2013
In April 2013 Roche announced changes to the management and set-up of its life science business and its plans to restructure the infrastructure by placing similar platform technologies and reagents for life science and clinical diagnostics customers under like governance bodies:  P CR technology and Nucleic Acid related product lines will be managed out of the Roche Molecular Diagnostics business area. This includes the real-time PCR and Nucleic Acid Purification platforms and reagents, as well as nucleic acid related Biochemical Reagents  The Custom Biotech portfolio, which includes platforms and reagents that are more closely aligned with our clinical chemistry portfolio, will move to the Professional Diagnostics business area. As a consequence, the Applied Science business area will be integrated into Roche Molecular Diagnostics and Roche Professional Diagnostics as of the end of 2013. This restructuring better enables technology flow-through from life sciences to clinical diagnostics and enhances our responsiveness to scientific and market needs. It also builds synergies and leverages the commercial expertise in our IVD business areas to better address our customers needs.

Roche Professional Diagnostics

2012 Employees: 1,130 Sales:  5,165 million CHF
(51% of divisional sales)

Growth: 8% (local currency) Market share

Professional diagnostics market Siemens 15.2% Abbott 11.8% Danaher 10.5% Roche 16.1% J&J OCD 5.2% Alere 4.2% bioMrieux 4.5% Others 32.5%
Source: Industry analyst report, Roche analysis, company reports

Roche Professional Diagnostics (RPD) is the largest Business Area. It is a leading supplier of solutions, instrument systems, tests, software and services that help laboratories deliver reliable results more efficiently and cost-effectively. It is also strengthening its position as a leader in the growing market for point-of-care testing products to support clinical decision- making close to the patient, in doctors offices, emergency rooms and other primary and specialty care settings. Furthermore, RPD develops laboratory information, workflow and data management solutions as well as connectivity components to maximise laboratory efficiency. In 2012 Roche had over 16% share of a growing global market worth 34.6 billion US dollars.

Sites Rotkreuz, Switzerland: Headquarters, Marketing, Medical Affairs, Business Development Mannheim and Penzberg, Germany, and Indianapolis, IN, USA: R&D, Production, Quality, Clinical Trials, Regulatory Affairs Disease areas Wide variety of indication elds, including oncology, virology, cardiovascular, inammatory and infectious diseases Customers Hospital and commercial labs Lab networks Point of Care including emergency rooms, intensive-care units, patients bedsides, physicians offices, pharmacies, homes, blood banks Best-sellers 2012 Immunoassays Clinical chemistry Coagulation monitoring

2,321 million CHF (+15%) 1,514 million CHF (+5%) 350 million CHF (+8%) RPD portfolio >100 immunoassays and applications >120 clinical chemistry tests >30 instruments with >100 modular combinations

Segments and products Serum work area (SWA): immunoassays and clinical chemistry
With a broad portfolio of modular instruments, software and assays, SWA offers immunology and clinical chemistry systems for use by commercial labs, hospital core labs, medical centres, blood screening centres (in most countries outside US) and laboratory networks. The platforms can be combined in a flexible manner to fit the size of the lab and its required throughput. Platforms*: cobas 4000 analyzer series (low-volume labs), cobas 6000 analyzer series (mid-volume labs), cobas 8000 modular analyzer series (large-volume labs)

cobas 6000 analyzer series

cobas 8000 modular analyzer series

Point-of-care testing
Point-of-care (POC) testing meets the requirements for short turnaround times in critical care situations. Rapid determination of time-critical parameters (e.g. blood glucose, cardiac markers and blood gases) can accelerate decision-making in the emergency room or intensive-care units. Platforms*: CoaguChek systems (coagulation monitoring), Accu-Chek Inform II (blood glucose), cobas b 101 system (HbA1c and lipid testing), cobas h 232 system (point of care cardiac reader)

CoaguChek XS system

cobas b 101 system

Specialty testing
For the urinalysis testing discipline RPD offers analyzers and test strips which enable testing of urine samples reliably and efficiently. Multiplate analyzer is a solution for rapid determination of a patients platelet function enabling to predict patients thrombotic and bleeding risk and to tailor anti-platelet therapies. Platforms*: Multiplate system, cobas u 411 analyzer

Multiplate system

cobas u 411 analyzer

Workflow and IT management

Cobas IT and workflow solutions enable our customers to leverage the maximum performance from their cobas instrument line-up including fully automated pre- and postanalytical workflow management. They benefit from a flexible workflow management across their laboratory organization and a close monitoring of their production for the highest testing efficiency and ultimately medical value. Platforms*: cobas p 312 pre-analytical system, cobas p 501 post-analytical system, cobas 8100 automated workflow series, cobas connection modules (CCM), cobas IT middleware, cobas IT 1000 application

cobas p 312 pre-analytical system

cobas p 501 post-analytical system

Key tests
Test on the market** HE4 (human epididymal protein 4) immunoassay PSA (prostate specific antigen) immunoassay HIV combi PT immunoassay Anti-HCV immunoassay TORCH panel of immunoassays Application ovarian cancer prostate cancer HIV Hepatitis C Toxoplasmosis, other (syphilis), rubella, cytomegalovirus, herpes simplex Acute coronary syndrome sFlt/PIGF immunoassay Vitamin D total test HbA1c (glycated hemoglobin 1A) test Test on the market** IL-6, PCT and Tina-quant CRP immunoassays NT-proBNP test TSH (thyrotropin) test FT4 (free thyroxine) test Application Sepsis management Heart failure Thyroid function testing Hyperthyroidism and hypothyroidism Pre-eclampsia Determination of vitamin D level Diabetes care

Troponin T / Troponin I tests

* Non-exhaustive

** Not available in all markets

Roche Molecular Diagnostics

2012 Employees: 1,100 Sales:  1,168 million CHF
(11% of divisional sales)

Growth: 4% (local currency) Market position

Molecular market Moleculardiagnostics Diagnostics market Roche 32% Novartis 10%

Roche Molecular Diagnostics (RMD) develops and com mercialises advanced diagnostics and blood screening platforms and tests based on Roches proprietary real-time Polyme rase Chain Reaction (PCR) technology. PCRs unique ability to exponentially amplify small amounts of target DNA has resulted in numerous diagnostic techniques which would otherwise be too time-consuming or impossible to perform. Roche is a leader in the highly competitive molecular diagnostics market, valued at 4 billion US dollars and growing 7% annually.

Others 10% bioMrieux 2% Cepheid 8% Siemens 4%

Abbott 7% Qiagen 9% BD 8% Gen-Probe 10%

Source: Industry analyst report, Roche analysis, company reports

Sites Pleasanton, CA, USA: Headquarters, Marketing, R&D Rotkreuz, Switzerland: Development, Production Branchburg, NJ, USA: Production Disease areas Virology, Oncology, Blood screening, Womens health, Microbiology Customers Hospital and commercial labs Blood banks Technologies Polymerase Chain Reaction (PCR) Best-sellers 2012 Virology (HBV, HCV, HIV) Blood screening

562 million CHF (+2%) 323 million CHF (+5%)

RMD portfolio
> >

10 instruments 25 reagents (tests)

Segments and products Virology

Viral infections rank among the biggest causes of death worldwide. Early detection and viral load identication (the quantity of virus in the blood) are crucial for the right treatment decision regarding the drug, the therapy dose and the treatment duration. Moreover, monitoring of viral load during treatment is essential to observe treatment efcacy. Tests: HIV, HCV, HBV, CMV Platforms*: cobas AmpliPrep/cobas TaqMan system, cobas AmpliPrep/cobas TaqMan 48 system, cobas p 630 analyzer

cobas p 630 instrument

cobas AmpliPrep instrument

cobas TaqMan analyzer

Blood screening
Each year, more than 80 million units of donated blood are stored and distributed worldwide. RMD provides blood banks with highly sensitive and automated real-time PCR tests to detect HIV, hepatitis, parvovirus and West Nile Virus, helping to ensure the highest safety for blood supplies. Tests: Multiplex HIV/HCV/HBV, Duplex B19V/HAV, West Nile Virus Platforms*: cobas s 201 system, cobas s 401 system

cobas s 201 system

Genomics and oncology

Cancer is an extremely complex disease, with many subtypes and variations that can inuence disease progression and response to therapy. RMDs gene-based tests help doctors better understand specic biologic factors to select the right therapy, thus enabling personalised healthcare. Tests: BRAF, KRAS, EGFR and PIK3CA mutation tests Platforms*: cobas 4800 system

cobas z 480

Microbiology
Time is critical in the detection and identication of bloodstream infections typically caused by bacteria and fungi. Effective treatment depends on nding the source of infection and making appropriate decisions about antibiotics or antifungals quickly and efciently. Tests: MRSA, Tuberculosis, Sepsis, Herpes Platforms*: LightCycler analyzer, cobas TaqMan

LightCycler analyzer

cobas TaqMan analyzer

Womens health
The Human papillomavirus (HPV) is the most prevalent cause of cervical cancer, one of the most common cancers in women worldwide with more than 25,000 dying each year. Demand for screening tests for both, HPV as well as C.trachomatis/ N . gonorrhoeae (CT/NG), which may cause pelvic inflammatory disease, is growing rapidly. Tests: HPV, CT/NG Platforms*: cobas 4800 system

cobas 4800 system

Key tests
Test on the market** cobas 4800 BRAF V600 Mutation Test cobas KRAS Mutation Test cobas EGFR Mutation Test cobas PIK3CA Mutation Test (RUO)*** cobas AmpliPrep/cobas TaqMan Dual Target HIV-1 Test, v 2.0 LightCycler MRSA Advanced Test cobas TaqScreen DPX Test * Non-exhaustive Application Melanoma Colorectal cancer Non-small cell lung cancer Breast, colorectal and other solid tumors HIV Methicillin-resistant Staphylococcus aureus Parvovirus B19/Hepatitis A *** For research use only Test on the market** cobas TaqScreen MPX Test, v 2.0 cobas TaqScreen West Nile Virus Test cobas AmpliPrep/cobas TaqMan HCV Test, v 2.0 cobas AmpliPrep/cobas TaqMan HBV Test, v 2.0 LightCycler Septi Fast Test cobas 4800 CT/NG Test cobas HPV Test Application HIV-1 (Groups M&O), HIV-2, HCV, HBV West Nile Virus Hepatitis C Hepatitis B Sepsis C. trachomatis and N. gonorrhoeae infection Cervical cancer

** Not available in all markets

Roche Tissue Diagnostics

2012 Employees: 1,500 Sales:  631 million CHF
(6% of divisional sales)

Growth: 12% (local currency) Market position

Advanced staining market
Abbott 11%

Roche Tissue Diagnostics (RTD) (Ventana Medical Systems, Inc. in North America) is a world-leading supplier of tissue-based cancer diagnostics. It develops and manufactures medical diagnostic instruments, digital pathology solutions, image and workow software and reagent systems that provide innovative automation technology for use in slide-based tissue diagnostics to aid in diagnosis of cancer and infectious disease.
Roche 45%

Abbott 14%

Leica 13%
Sources: Industry analyst report, Roche analysis, company reports

Dako 18%

In addition, the company offers premier workow management solutions designed to improve laboratory workow efciency, providing automated safeguards to enhance the quality of patient healthcare. Its instruments and reagent systems are used in histology, cytology and drug discovery laboratories worldwide. In 2012, Roche gained over 1% of market share to own 23% share of the tissue diagnostics market, which is valued at over 2.5 billion US dollars and grew approximately 78%.

Sites Tucson, AZ, USA: Headquarters, R&D, Production Mountain View, CA, USA: R&D, Marketing Disease areas Oncology Customers Hospital-based pathology laboratories Academic pathology laboratories Community pathology laboratories Reference pathology laboratories Drug discovery laboratories (pharma) Medical research centres  Technologies Immunohistochemistry (IHC) In situ hybridisation (ISH) Digital pathology and workow Special staining Best-sellers 2012 Advanced tissue staining Primary tissue staining

RTD portfolio 518 million CHF (+13%) 59 million CHF (+13%)

> 245

IHC antibodies 30 ISH probes 10 instruments + 2 software solutions

10

Segments and products Primary staining

The hematoxylin and eosin (H&E) staining process is the primary test run on tissue samples entering the Antomical Pathology (AP) laboratory. The SYMPHONY platform fully automates the H&E process including coverslipping. The SYMPHONY system is the only H&E stainer that helps mitigate cross-contamination through individual slide staining. The individual application of fresh reagents on each slide produces high quality results, improving visualisation and discrimination of microanatomic detail. Platforms: SYMPHONY system SYmphonY

Special Stains
Special stains are a fundamental aid in diagnosing a variety of illnesses, from infection to cancer. The BenchMark Special Stains system delivers complete baking-through-staining automation for special stains, to enhance stain quality and turnaround time. Eliminating manual processes and temperature batching with automated deparaffinisation and independent slide heating, the BenchMark Special Stains system improves workflow efficiency. This innovative platform also reduces patient and laboratory technician risk with individual slide staining and reduced exposure to harmful chemicals. Platforms: BenchMark Special Stains system BenchMark Special Stains

Advanced staining
About 20% of all slides entering a histology lab must undergo further advanced testing. Immunohistochemistry and in situ hybridisation allow visualisation of molecular targets on tissues, thus revealing the presence and properties of abnormal cells, DNA and RNA sequences. Platforms: BenchMark GX,BenchMark ULTRA and BenchMark XT IHC automated staining instruments, Discovery ULTRA and Discovery XT systems BenchMark ULTRA

Workow management
The VANTAGE workow management system is the rst of its kind in the industry. VANTAGE software and hardware tools and services automate, streamline and integrate lab work and information flow to help provide increased productivity and patient safety gains. Platforms: VANTAGE workflow management system VANTAGE

Digital pathology
RTD provides comprehensive digital pathology solutions including slide scanning image acquisition, image management, advanced algorithms for image analysis, and comprehensive patient reporting. Full integration of digital pathology tools extends the benefits of automation and personalised healthcare solutions by providing even greater efficiencies, productivity, and diagnostic intelligence. Platforms/Software: iScan Coreo scanner, VENTANA iScan HT scanner (RUO), Virtuoso image and workflow management software, and Companion Algorithm image analysis software VENTANA iScan HT scanner

Key tests
Test on the market* HER2neu (4B5) Image Analysis Software PR (1E2) Image Analysis Software Ki-67 (30-9) Image Analysis Software p53 (DO-7) Image Analysis Software Application Breast cancer Breast cancer Breast cancer Breast cancer Test on the market* SISH HER2 Probe** ERG (EPR 3864) Rabbit Monoclonal Primary Antibody for IHC testing Application Breast/gastric cancer Prostate cancer

* Not available in all markets

** Ex-US only

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Roche Diabetes Care

2012 Employees: 5,500 Sales:  2,566 million CHF
(25% of divisional sales)

Growth: -4% (local currency) Market position

Blood glucose monitoring market Blood glucose monitoring market Others 15.2% Roche 29.1% Insulin delivery systems market Insulin delivery systems market Roche 13%

Roche Diabetes Care (RDC) develops and commercia lises blood glucose (bG) monitoring and insulin delivery systems that enable people with diabetes to manage their condition more effectively. The goal of diabetes therapy is to maintain the bG levels in a (near-)normal range and thus avoid diabetes-related complications. RDC not only offers individual product innovations but integrated diabetes management solutions meeting the everyday needs of our customers for an optimised therapy management. Roche is the industry leader with a 29% market share of a global bG monitoring market worth over 8 billion US dollars.

Abbott 14.6%

Animas 11% Smith 0.5% Insulet 9%

Bayer 14.6% Lifescan 26.5% Medtronic 67%

Source: Industry analyst reports, Roche analysis, company reports

Sites Mannheim, Germany: Headquarters, R&D, Production Indianapolis, IN, USA; Yogneam Illit, Israel: R&D, Production Disease areas Metabolic diseases/Diabetes Customers People with diabetes Hospitals Healthcare professionals Diabetes nurse educators Best-sellers 2012 Blood glucose monitoring Insulin delivery systems

2,476 million CHF (-5%) 233 million CHF (+8%)

RDC portfolio 11 bG monitoring systems 5 lancing devices 3 insulin pump systems 4 infusion sets for insulin pumps 5 information management systems

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Segments and products Blood glucose monitoring

BG meters are designed for self-monitoring of blood glucose, helping people with diabetes keep the blood glucose levels in a (near-)normal range by adjusting their medication especially their insulin doses according to their individual needs. Platforms*: Meters: Accu-Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Nano SmartView, Accu-Chek Aviva Expert, Accu-Chek Performa, Accu-Chek Performa Nano, Accu-Chek Active, Accu-Chek Compact Plus, Accu-Chek Mobile Lancing systems: Accu-Chek Softclix, Accu-Chek Multiclix, Accu-Chek Fastclix

Accu-Chek Aviva Expert

Accu-Chek Mobile

Accu-Chek Nano SmartView

Accu-Chek Active

Insulin delivery
Connected to the body via an infusion set, insulin pumps deliver the exact amount of insulin required to cover a bodys physiological needs 24 hours a day. This offers enhanced flexibility and safety to people with diabetes. The newest portfolio additions combine the insulin pump with bG testing, a pump remote control and extensive data management features. Platforms*: Insulin pump systems: Accu-Chek Combo, Accu-Chek Spirit Infusion sets: Accu-Chek FlexLink, Accu-Chek TenderLink, Accu-Chek Rapid-D Link

Accu-Chek Combo

Accu-Chek FlexLink

Diabetes management systems

The Accu-Chek information management systems not only facilitate the visualisation and assessment of individual blood glucose patterns, they also support the users decision-making. The built-in bolus advisor of the Accu-Chek Combo insulin pump system enables quick and easy determination of the right amount of insulin (bolus), which the pump subsequently and discretely delivers into the body at the push of a button. Platforms*: Accu-Chek 360 software, Accu-Chek Smart Pix

Accu-Chek 360 software

Accu-Chek Smart Pix

* Non-exhaustive

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Roche Applied Science

2012 Employees: 400 Sales:  737 million CHF
(7% of divisional sales)

Growth: -3% (local currency) Market position

Life science served market
Roche 8.5% BioRad 2.9% Illumina 7.2% Thermo Fisher 4.6% Sigma Aldrich 5.2% Life Technologies 26.5% Qiagen 7%

Others 38.2%
Source: Industry analyst report, Roche analysis, company reports

Roche Applied Science (RAS) is a worldclass supplier of speciality biochemicals and producer of research reagents and systems for Life Science research. RAS is an established partner for research institutions, universities and pharmaceutical industry worldwide. Its products facilitate medical research in todays most important avenues of exploration and provide tools for researching the cause of and predisposition for a disease. RAS products often represent the rst entry into innovative bioanalytical tools and methods and have potential to one day be de veloped for use as an IVD. The global Life Science research served market, valued at 9.3 billion US dollars, grew approximately 4.5% in 2012. Roche has roughly a 8.5% share of this market.

Sites Penzberg, Germany: Headquarters, R&D, Production, Marketing Branford, CT, USA: 454 Life Sciences Madison, WI, USA: Roche NimbleGen Rotkreuz, Switzerland: Instrument development and production Customers Life Science research in academia, biotech and pharma Technologies Polymerase Chain Reaction (PCR) DNA sequencing Nucleic acid purification Best-sellers 2012 Nucleic acid DNA purication and gene expression Genomics Custom Biotech

233 million CHF (+5%) 126 million CHF (-19%) 217 million CHF (+8%)

RAS portfolio > 2,000 test kits and reagents 20 instruments

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Segments and products Nucleic acid DNA purication and gene expression
Gene expression research evaluates how a gene is used in the synthesis of a functional gene product which is in most cases a protein. Nucleic acid purication technology is used to isolate nucleic acids from manifold sample materials. Platforms*: MagNA Pure Compact, MagNA Pure LC, MagNA Pure 96, LightCycler 2.0, LightCycler 480, LightCycler 1536, LightCycler Nano

LightCycler 480

MagNA Pure 96

LightCycler Nano

Sequencing solutions
DNA sequencing detects the exact order of the nucleotides and is the rst step to understan d ing how genes work together to direct growth, development and maintenance of an entire organism. Platforms*: Genome Sequencer FLX, GS Junior (powered by 454 sequencing technology)

Genome Sequencer FLX

GS Junior

Custom Biotech and bioreagents

With experience and strong customer orientation, Custom Biotech supplies reagents and services customised to the quality and regulatory needs of pharmaceutical, diagnostic, and biotech industries, and bioreagents for research applications. Platforms*: Cedex Bio Bioprocess Analyzer

Cedex Bio Bioprocess Analyzer

* Non-exhaustive

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Divisional Structure
The Diagnostics Division is managed via a matrix organisation of Business Areas/ Unit, Regions and Global Functions.

Business Areas Global Functions Business Unit

Diagnostics Regions

Regional Organisation
The regional organisations are responsible for all aspects of sales and marketing within the region and in the affiliated countries, for implementation of global processes at the regional level and for the company management in line with local regulations and practice.

Regions
Asia-Pacific EMEA (Europe, Middle East, Africa) Japan LATAM (Latin America) North America

Advantages of a Regional Set-up

Tailored market strategies Innovative pricing models Increase access to healthcare Infrastructure Development Customer Satisfaction

Global Functions
To maximise efficiencies, a number of functions have been centralised globally. The four global functions support the Business Areas and Regional Organisations to drive business success within the division.

Global Operations
Global Operations consists of three areas, Manufacturing, Supply Chain and Direct Procurement, and is responsible for the production and supply of Roche Diagnostics reagents, consumables, and many instruments. The global function manages a continuum of processes for all BAs to ensure customers receive the products they purchased on time and in full and is a key driver of excellence in operations in Diagnostics, maintaining a strong focus on process efficiency and profitability.

Global Quality and Regulatory

Global Quality and Regulatory is responsible for provision and maintenance of the resources, systems and processes at all levels of the organization necessary to ensure full compliance with requirements given by authorities and regulatory bodies in order to provide our customers and patients with reliable high-quality products and services. Furthermore, this function drives the submissions and approvals to bring our innovative product to the markets around the globe.

Global Platforms and Support

Global Platforms and Support (GPS) develops solutions instruments, software and systems for laboratory diagnostics according to customer requirements and in close cooperation with the Business Areas. Furthermore, GPS provides global service and support for Roche Diagnostics products.

Global Business Development

Global Business Development concentrates on the development of divisional strategy and global business opportunities by obtaining timely access to external innovation through acquisitions, licensing and partnering. The unit monitors the marketplace for biomarkers and technologies for further development, and initiates divisional projects addressing issues strategically important for the future of the business.

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Doing now what patients need next

We believe its urgent to deliver medical solutions right now even as we develop innovations for the future. We are passionate about transforming patients lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientic rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

We are Roche.

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Published by F. Hoffmann-La Roche Ltd Group Communications 4070 Basel, Switzerland communications.diagnostics@roche.com 2013 All trademarks mentioned enjoy legal protection. www.roche.com 7 000 914