Roche Diagnostics Business Overview 2013

Key launches 2013

Area Product name Description Market

Instruments/devices

Laboratories cobas 8100 next-generation modular pre-analytics EU

Diabetes Accu-Chek Insight next-generation insulin pump and blood glucose meter EU

Care Accu-Chek Active next-generation blood glucose meter with maltose-independent test strips EU

Life sciences GS FL X+ long amplicons software for long-read targeted sequencing for DNA variant detection WW

Tests/assays

Oncology Calcitonin immunoassay, supports medullary thyroid cancer diagnosis and monitoring EU

proGRP immunoassay, assists in the diagnosis of small cell lung cancer EU

EGFR PCR test, supports therapy selection for non-small cell lung cancer US

ER IHC tissue test for breast cancer diagnosis US

CINtec PLUS Cytology immunocytochemistry test for diagnosis of cervical pre-cancer EU

Infectious diseases MPX 2.0 PCR next-generation blood screening, multiplex test for HIV, HCV and HBV US

HCV 2.0 PCR next-generation HCV viral load test US

Transplantation Cyclosporin, Tacrolimus immunoassays for monitoring of immunosuppressive drug therapy EU

Sequencing SeqCap EZ Reagent Kits for sample preparation for targeted next-generation sequencing WW

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

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Table of Contents

Roche DiagnosticsBusiness Strategy 2Facts and Figures 3Competitive Advantages 4Business Areas 5

Business Areas/UnitRoche Professional Diagnostics 6Roche Molecular Diagnostics 8Roche Tissue Diagnostics 10Roche Diabetes Care 12Roche Applied Science 14

Divisional Structure 16

2

Business Strategy

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.

Increase testing efficiency

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

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

Provide true medical value

Ever more of our efforts are concentrated on exploiting advanced scientific 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 specific 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 benefit. With the advent of molecular diagnostics, totally new realms of detection are emerging.

Revalue Diagnostics

Molecular analysis of human DNA can con-firm the presence of disease genes, detect which altered genes and proteins are disturbing normal cell function, and, with a genetic profile of the patient, also predict whether he or she should respond well to specific drug therapy regimens. These newest diagnostic methods are not only redefining clinical testing, but they are also essential in the development of targeted molecular drugs. Diagnostics are integral to the new paradigm of Personalised Health-care and as the world market leader, Roche Diagnostics is leading the way forward and revaluing diagnostics.

2020

ds

•

•

• Deliver clinical evidence

•

• Offer complete enus

Improving medical value

Increasing testing efficiency

– Revalue Diagnostics– Focus on unmet needs– Access and create IP– Deliver clinical evidence

– Total lab solutions– Modular offering– Complete menus– Lab IT and workflow

Offering diagnostic tests along the entire healthcare chain

Healthy Asymptomatic disease Symptomatic disease Chronic disease/Cured

Risk assessmentPredisposition for developing disease

Screening/DiagnosisEarly detection

DiagnosisIdentifyingdisease

PrognosticPredict probable disease course

PredictionPredict response to a drugPersonalised Healthcare

MonitoringMonitor drug efficacy/ disease recurrence

IVD accounts for < 2% of total worldwide healthcare spending

Yet it Influences > 60% of critical decision-making

3

Ponce

Singapore

Tokyo

North America 26%

Professional Diagnostics 51%

Diabetes Care 25%

Molecular Diagnostics 11%

Applied Science 7%Tissue Diagnostics 6%

Latin America 8%

Asia-Pacific 15%

Japan 6%

EMEA (Europe, Middle East and Africa)

46%

North America 26%

Professional Diagnostics 51%

Diabetes Care 25%

Molecular Diagnostics 11%

Applied Science 7%Tissue Diagnostics 6%

Latin America 8%

Asia-Pacific 15%

Japan 6%

EMEA (Europe, Middle East and Africa)

46%Roche Abbott Siemens J&J Beckman bioMérieux

20%

11%10%

9%

8%

3%

Facts and Figures

2012Employees: 28,517Sales: 10,267 million CHFGrowth: 4% (local currency)

Position in IVD market

Sales by Business Area/Unit

Sales by region

Roche’s Diagnostics Division is the world’s 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 Division’s 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 techno-logies allowing the detection and analysis of a multitude of sample types on a large base of instruments installed worldwide. Roche’s IVD test menu is one of the broadest in the industry and is being expanded continually, drawing on the latest scientific 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.

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

Main Diagnostics Sites R&D/Manufacturing Regional hubs

100–500 employees* untill end of 2012

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945,000,000 Elecsys tests sold in 2012

15,000,000 Accu-Chek Active meters sold worldwide

2,589,041 tests per day, 30 per second

90% satisfied customers

Total solution offering

Strong commercial presence

Leader in Personalised Healthcare

Competitive Advantages

DNA/RNA-based Protein-based Cell-based

EMEA

APAC

Japan

LATAM

NAM

EMEA

APAC

Japan

LATAM

NAM

Inflammation/Autoimmune

Metabolic diseases

Virology/MicrobiologyCardiology

OncologyWomen’s health

Hematology

Breadth of technologies

Active in all diagnostic segments

Completeness of menu

Present in over 130 countries

IT and workflow connectivity

Large installed base worldwide

Research labER/ICU

Hospital/Commercial lab

Physician’s office

Pathology lab Patient

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 company’s 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.

5

Innovation Excellence

Outlook 2013

In April 2013 Roche announced changes to the management and set-up of its life science business and its plans to restruc-ture the infrastructure by placing similar platform technologies and reagents for life science and clinical diagnostics customers under like governance bodies:

• PCR 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

Business Areas

Business Area Structure 2012

In vitro Diagnostics Life Science

Professional DiagnosticsBusiness Area

Molecular DiagnosticsBusiness Area

Tissue DiagnosticsBusiness Area

Diabetes Care

Business Unit

Applied Science

Business Area

Private labs Hospital labs Hospital Point of Care Physician’s office

Molecular labs Blood-screening labs

Histopathology labs People with diabetesHospitalsHealthcare professionalsDiabetes nurse educators

Academia and Pharma Biotech research

– Serum work area/ immunoassays and clinical chemistry

– Point-of-care testing– Coagulation and

specialty testing– Workflow management

– 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

– Nucleic acid DNA purification and gene expression

– Sequencing solutions– Custom Biotech and bio-

reagents

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

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 Profes-sional Diagnostics as of the end of 2013. This restructuring better enables technol-ogy flow-through from life sciences to clinical diagnostics and enhances our responsiveness to scientific and market needs. It also builds synergies and lever-ages the commercial expertise in our IVD business areas to better address our customers’ needs.

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Roche Professional Diagnostics

2012Employees: 1,130Sales: 5,165 million CHF

(51% of divisional sales)

Growth: 8% (local currency)

Market share

Professional diagnostics market

Sites Rotkreuz, Switzerland: Headquarters, Marketing, Medical Affairs, Business DevelopmentMannheim and Penzberg, Germany, and Indianapolis, IN, USA: R&D, Production, Quality, Clinical Trials, Regulatory Affairs

Disease areas Wide variety of indication fields, including oncology, virology, cardiovascular, inflammatory and infectious diseases

CustomersHospital and commercial labsLab networksPoint of Care including emergency rooms, intensive-care units, patients bedsides, physician’s offices, pharmacies, homes, blood banks

Best-sellers 2012 Immunoassays 2,321 million CHF (+15%)Clinical chemistry 1,514 million CHF (+5%)Coagulation monitoring 350 million CHF (+8%)

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 manage-ment 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.

Roche 16.1%

Abbott 11.8%

Danaher 10.5%

J&J OCD 5.2%

Alere 4.2%

bioMérieux 4.5%

Siemens 15.2%

Others 32.5%

RPD portfolio

>100 immunoassays and applications>120 clinical chemistry tests>30 instruments with >100 modular combinations

Source: Industry analyst report, Roche analysis, company reports

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cobas 6000 analyzer series

cobas 8000 modular analyzer series

CoaguChek XS system

cobas u 411 analyzer

cobas p 501 post-analytical system

cobas b 101 system

Test on the market** Application

HE4 (human epididymal protein 4) immunoassay

ovarian cancer

PSA (prostate specific antigen) immunoassay

prostate cancer

HIV combi PT immunoassay HIV

Anti-HCV immunoassay Hepatitis C

TORCH panel of immunoassays Toxoplasmosis, other (syphilis), rubella, cytomegalovirus, herpes simplex

Troponin T / Troponin I tests Acute coronary syndrome

Test on the market** Application

IL-6, PCT and Tina-quant CRP immunoassays

Sepsis management

NT-proBNP test Heart failure

TSH (thyrotropin) test Thyroid function testing

FT4 (free thyroxine) test Hyperthyroidism and hypothyroidism

sFlt/PIGF immunoassay Pre-eclampsia

Vitamin D total test Determination of vitamin D level

HbA1c (glycated hemoglobin 1A) test Diabetes care

Multiplate system

cobas p 312 pre-analytical system

Key tests

Segments and products

Serum work area (SWA): immunoassays and clinical chemistryWith 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)

Point-of-care testingPoint-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-mak-ing 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)

Specialty testingFor 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 patient’s platelet function enabling to predict patient’s thrombotic and bleeding risk and to tailor anti-platelet therapies.Platforms*: Multiplate system, cobas u 411 analyzer

Workflow and IT managementCobas 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

* Non-exhaustive ** Not available in all markets

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Roche Molecular Diagnostics

2012Employees: 1,100Sales: 1,168 million CHF

(11% of divisional sales)

Growth: 4% (local currency)

Market position

Molecular diagnostics market

Sites Pleasanton, CA, USA: Headquarters, Marketing, R&DRotkreuz, Switzerland: Development, ProductionBranchburg, NJ, USA: Production

Disease areas Virology, Oncology, Blood screening, Women’s health, Microbiology

CustomersHospital and commercial labsBlood banks

TechnologiesPolymerase Chain Reaction (PCR)

Best-sellers 2012 Virology (HBV, HCV, HIV) 562 million CHF (+2%)Blood screening 323 million CHF (+5%)

Roche Molecular Diagnostics (RMD)develops and com mercialises advanced diagnostics and blood screening platforms and tests based on Roche’s proprietary real-time Polyme rase Chain Reaction (PCR) technology. PCR’s 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.

Molecular Diagnostics market

Roche 32%

Abbott 7%

Qiagen 9%

Gen-Probe 10%BD 8%

Novartis 10%

bioMérieux 2%

Siemens 4%Cepheid 8%

Others 10%

RMD portfolio

> 10 instruments> 25 reagents (tests)

Source: Industry analyst report, Roche analysis, company reports

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Segments and products

VirologyViral infections rank among the biggest causes of death worldwide. Early detection and viral load identification (the quantity of virus in the blood) arecrucial 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 efficacy.Tests: HIV, HCV, HBV, CMVPlatforms*: cobas AmpliPrep/cobas TaqMan system, cobas AmpliPrep/cobas TaqMan 48 system, cobas p 630 analyzer

Blood screeningEach 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

Genomics and oncologyCancer is an extremely complex disease, with many subtypes and variations that can influence disease progression and response to therapy. RMD’s gene-based tests help doctors better understand specific biologic factors to select the right therapy, thus enabling personalised healthcare.Tests: BRAF, KRAS, EGFR and PIK3CA mutation testsPlatforms*: cobas 4800 system

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

Women’s healthThe 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/NGPlatforms*: cobas 4800 system

cobas TaqMananalyzer

cobas s 201 system

cobas z 480

cobas 4800 system

cobas TaqMan analyzer

Test on the market** Application

cobas 4800 BRAF V600 Mutation Test Melanoma

cobas KRAS Mutation Test Colorectal cancer

cobas EGFR Mutation Test Non-small cell lung cancer

cobas PIK3CA Mutation Test (RUO) *** Breast, colorectal and other solid tumors

cobas AmpliPrep/cobas TaqMan Dual Target HIV-1 Test, v 2.0

HIV

LightCycler MRSA Advanced Test Methicillin-resistant Staphylococcus aureus

cobas TaqScreen DPX Test Parvovirus B19/Hepatitis A

Test on the market** Application

cobas TaqScreen MPX Test, v 2.0 HIV-1 (Groups M&O), HIV-2, HCV, HBV

cobas TaqScreen West Nile Virus Test

West Nile Virus

cobas AmpliPrep/cobas TaqMan HCV Test, v 2.0

Hepatitis C

cobas AmpliPrep/cobas TaqMan HBV Test, v 2.0

Hepatitis B

LightCycler SeptiFast Test Sepsis

cobas 4800 CT/NG Test C. trachomatis and N. gonorrhoeae infection

cobas HPV Test Cervical cancer

Key tests

cobas AmpliPrepinstrument

cobas p 630instrument

LightCycler analyzer

* Non-exhaustive ** Not available in all markets *** For research use only

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Roche Tissue Diagnostics

2012Employees: 1,500Sales: 631 million CHF

(6% of divisional sales)

Growth: 12% (local currency)

Market position

Advanced staining market

Roche Tissue Diagnostics (RTD) (Ventana Medical Systems, Inc. in North America) is a world-leading supplier of tissue-based cancer diagnostics. It develops and manu-factures medical diagnostic instruments, digital pathology solutions, image and workflow 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.

In addition, the company offers premier workflow management solutions designed to improve laboratory workflow efficiency, providing automated safeguards to enhance the quality of patient healthcare. Its instru-ments 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 7–8%.

Roche 45%

Abbott 14%

Leica 13%

Dako 18%

Abbott 11%

RTD portfolio

> 245 IHC antibodies 30 ISH probes10 instruments + 2 software solutions

Sources: Industry analyst report, Roche analysis, company reports

Sites Tucson, AZ, USA: Headquarters, R&D, ProductionMountain View, CA, USA: R&D, Marketing

Disease areas Oncology

CustomersHospital-based pathology laboratoriesAcademic pathology laboratoriesCommunity pathology laboratoriesReference pathology laboratoriesDrug discovery laboratories (pharma) Medical research centres

Technologies Immunohistochemistry (IHC)In situ hybridisation (ISH)Digital pathology and workflowSpecial staining

Best-sellers 2012Advanced tissue staining 518 million CHF (+13%)Primary tissue staining 59 million CHF (+13%)

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SyMPHONy

BenchMark ULTRA

VANTAGE

Key tests

VENTANA iScan HT scanner

BenchMark Special Stains

Segments and products

Primary stainingThe 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

Special StainsSpecial 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

Advanced stainingAbout 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

Workflow managementThe VANTAGE workflow management system is the first 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

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

Test on the market* Application

HER2neu (4B5) Image Analysis Software

Breast cancer

PR (1E2) Image Analysis Software Breast cancer

Ki-67 (30-9) Image Analysis Software Breast cancer

p53 (DO-7) Image Analysis Software Breast cancer

Test on the market* Application

SISH HER2 Probe** Breast/gastric cancer

ERG (EPR 3864) Rabbit Monoclonal Primary Antibody for IHC testing

Prostate cancer

* Not available in all markets ** Ex-US only

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Roche Diabetes Care

2012Employees: 5,500Sales: 2,566 million CHF

(25% of divisional sales)

Growth: -4% (local currency)

Sites Mannheim, Germany: Headquarters, R&D, ProductionIndianapolis, IN, USA; Yogneam Illit, Israel: R&D, Production

Disease areas Metabolic diseases/Diabetes

CustomersPeople with diabetesHospitalsHealthcare professionalsDiabetes nurse educators

Best-sellers 2012Blood glucose monitoring 2,476 million CHF (-5%)Insulin delivery systems 233 million CHF (+8%)

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.

Roche 29.1%

Roche 13%

Abbott 14.6%Animas 11%

Smith 0.5%

Insulet 9%

Medtronic 67%

Blood glucose monitoring market Insulin delivery systems market

Lifescan 26.5%Bayer 14.6%

Others 15.2%

Market position

Blood glucose monitoring market Insulin delivery systems market

RDC portfolio

11 bG monitoring systems5 lancing devices3 insulin pump systems4 infusion sets for insulin pumps5 information management systems

Source: Industry analyst reports, Roche analysis, company reports

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Accu-Chek Aviva Expert

Accu-Chek Combo

Accu-Chek Mobile

Accu-Chek Active

Accu-Chek FlexLink

Accu-Chek Smart PixAccu-Chek 360° software

Accu-Chek NanoSmartView

Segments and products

Blood glucose monitoringBG meters are designed for self-monitoring of blood glucose, helping peoplewith 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 MobileLancing systems: Accu-Chek Softclix, Accu-Chek Multiclix, Accu-Chek Fastclix

Insulin deliveryConnected to the body via an infusion set, insulin pumps deliver the exact amount of insulin required to cover a body’s 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

Diabetes management systemsThe Accu-Chek information management systems not only facilitate the visualisation and assessment of individual blood glucose patterns, they also support the user’s 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

* Non-exhaustive

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Roche Applied Science

2012Employees: 400Sales: 737 million CHF

(7% of divisional sales)

Growth: -3% (local currency)

Market position

Life science served market

Sites Penzberg, Germany: Headquarters, R&D, Production, MarketingBranford, CT, USA: 454 Life SciencesMadison, WI, USA: Roche NimbleGenRotkreuz, Switzerland: Instrument development and production

CustomersLife Science research in academia, biotech and pharma

TechnologiesPolymerase Chain Reaction (PCR)DNA sequencingNucleic acid purification

Best-sellers 2012 Nucleic acid DNA purification and gene expression 233 million CHF (+5%)Genomics 126 million CHF (-19%)Custom Biotech 217 million CHF (+8%)

Roche Applied Science (RAS) is a world-class 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 pharmaceut-ical industry worldwide. Its products facilitate medical research in today’s most important avenues of exploration and provide tools for researching the cause of and predisposition for a disease. RAS products often represent the first 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.

RAS portfolio

> 2,000 test kits and reagents20 instruments

Qiagen 7%

Thermo Fisher 4.6%

Illumina 7.2%

BioRad 2.9%Roche 8.5% Life Technologies 26.5%

Sigma Aldrich 5.2%

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

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Segments and products

Nucleic acid DNA purification and gene expressionGene 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 purification 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

Sequencing solutionsDNA sequencing detects the exact order of the nucleotides and is the first step to understan ding 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)

Custom Biotech and bioreagentsWith 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

MagNA Pure 96

Genome Sequencer FLX GS Junior

Cedex Bio Bioprocess Analyzer

LightCycler NanoLightCycler 480

* Non-exhaustive

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Divisional Structure

Business AreasDiagnostics Regions

Global Functions

Business Unit

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

Regional Organisation

Global Functions

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.

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.

Regions Advantages of a Regional Set-up

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

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

Global Operations Global Quality and Regulatory

Global Operations consists of three areas, Manufacturing, Supply Chain and Direct Procurement, and is responsible for the production and supply of Roche Diagnostic’s 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 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 Business Development

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 concentrates on the development of divisional strategy and global business opportunities by obtaining timely access to exter-nal 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 fu-ture of the business.

Doing now what patients need next

We believe it’s 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 scientific 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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Doing now what patients need next

We believe it’s 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 scientific 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.

Published byF. Hoffmann-La Roche Ltd Group Communications4070 Basel, Switzerlandcommunications.diagnostics@roche.com

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