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Company Presentation

2015

What makes DiaSorin a partner of choice

ConstantInnovation

DiaSorin continues to invest constantly

in R&D leveraging its distinctive

expertise in the field of Immuno and

Molecular diagnostics to consistently

deliver high quality assays improving

laboratory efficiency.

Loyal to Customers

Direct and indirect global

distribution with a strong

commitment and network to

serve customers worldwide.

DiaSorin offers the

broadest range of specialty

tests available in the

immunodiagnostics market,

and also soon in Molecular.

Dedicatedto content

2company presentation international - april 15

Out of a ww Immunoassay market of €8bn, DiaSorin main clinical areas of focus are:

5%

%: percentage of WW Immunoassay market

DiaSorin: a pure player in Immunoassay

INFECTIOUS DISEASES

OTHERS

AUTOIMMUNITY

GI STOOL TESTING

BONE AND MINERAL

HEPATITIS AND RETROVIRUSES

ONCOLOGY AND ENDOCRINOLOGY

18%

24%

7%

4,5%

6,5%

26%

14%


Continuous innovation, high-quality products and long-standing commitment to customers needs

1968. DiaSorin’s birth as division of Sorin Biomedica SpA2000. Management Buyout, SpA

The Foundation

Our history >40 years of value

2008• Acquisition of Biotrin, leader in Parvovirus

• Acquisition of Murex, entering blood bank market

• Commercial expansion: new subsidiares in Europe, Australia, South Africa

• DiaSorin buys from Eiken Chemical the license for the use of LAMP technology, dedicated to Molecular Diagnostics

2000 - 2006• Acquisition of Byk Sangtec and rights to liaison® platform

• Products conversion from ELISA to CLIA

• New commercial branches (Mexico, Israel and China)

• CLIA portfolio expansion

2007• July 19, 2007: Stock market debut in the Italian Stock Exchange

2010• Launch of new LIAISON® XL system platform

2013• Agreement with Roche• Commercial expansion: Switzerland

2012• Acquisition of NorDiag, specialized in the extraction of nucleic acids

• Focus on molecular diagnostic: launch of the first product on LIAISON® IXT and LIAISON® IAM systems.

• Joint Venture DiaSorin - Trivitron in India

>900 employees

500 employees

2014• CLIA product expansion: Launch of Stool Diagnostic profile on LIAISON® Systems

• Success and increase of liaison® XL installations

• WW expansion and consolidation of DiaSorin commercial presence

• Entrance in the Molecular Diagnostics market

1620 employees

TODAY


Global presence with deep R&D expertise

DiaSorin worldwide presence

SOUTH AFRICAKyalami

UKDartford

USAStillwater

• HEPATITIS C ELISA

• BONE & MINERAL• STOOL DIAGNOSTIC • HYPERTENSION• FERTILITY (Steroids)

• MUREX ELISA

IRELANDDublin

• MOLECULAR

• TUMOR MARKER• THYROIDS• FERTILITY (Hormones)

GERMANYDietzenbach

SUBSIDIARIES

DISTRIBUTORS

INDUSTRIAL SITES COMPANIES WORLDWIDE

6 27R&D FACILITIES

6EMPLOYEES INDEPENDENT DISTRIBUTORS

1,620 >80COUNTRIES GROUP PRESENCE

>60

• INFECTIOUS DISEASE• AUTOIMMUNITY• ENDOCRINOLOGY

ITALY Saluggia,Gerenzano

* R&D facility

* R&D facility

* R&D facility

* R&D facility

INDUSTRIAL SITES

6COMPANIES WORLDWIDE

27R&D FACILITIES

5EMPLOYEES

1,620INDIPENDENTDISTRIBUTORS

>80

COUNTRIESGROUP PRESENCE

>60


Knowledge is the challenge

We believe in re search to develop innovative solutions to enhance efficiency.DiaSorin is committed to providing the highest quality assays for consistent patient care.

BECAUSE THE MORE YOU KNOw, THE MORE YOU CAN DO.


FACTS

129 researchers worldwide

~6% of revenues

invested

6/8 new immunoassays

every year

2/3 new molecular

assays every year

2/3 products redeveloped

every year

R&D: main competencies & facts

MOLECULAR DIAGNOSTICS

• New Reagents• New Technologies• Assays Optimization• Pre-industrialization

IMMUNODIAGNOSTICS

• New Assay Prototypes• New Technologies• New Reagents• Assays Optimization• Pre-industrialization

MOLECULAR DIAGNOSTICS

• New Reagents• New Technologies

IMMUNODIAGNOSTICS

• Assays Optimization• Pre-industrialization


Our Solutions

DiaSorin laboratory solutions

Technologies to meet your needs

A family of fully automated systems with the wide range of specialties

Microplates automated systems dedicated to Blood Bank & Serology Laboratories

ELISAEnzyme Linked

ImmunoSorbent Assay

CLIAChemiLuminescence

Immuno Assay

A menu of specialties for Diagnostic Molecular Laboratories

Q-LAMPLIAISon® Instant

Amplification Molecular


Commitment to Molecular Diagnostic

BECOME LEADER IN ONCO-HAEMATOLOGY• Leverage on the innovative DiaSorin Q-LAMP technology to change the paradigm of molecular diagnosis of leukemias

• Offer ultra rapid, simple and reliable solutions for a timely diagnosis of haematologic malignancies at the onset, improving management of urgencies

• Enlarge the portfolio, after the successfull launch of the first product Iam BCR-ABL

• Enter the field of therapy monitoring by developing quantitative solutions

CONSOLIDATE THE INFECTION DISEASE PORTFOLIO• 6 products launched, for diagnosis and monitoring of infection diseases

• Consolidate the business in the european countries

• Improve penetration into de-centralized laboratories

EXPAND THE TACTICAL NUCLEIC ACID EXTRACTION BUSINESS• Tactical sales of extraction products via OEM partners and third party distributors


Committed to efficiency

You can count on us

Objectivessharing

1Educational training

2Professional customer support

3World class service at the click of a mouse

4We speak easy, we speak green

5

DiaSorin competence, professionalism and enthusiasm are our commitment to deliver excellence in your laboratory.


Compact design

liaison® reagents quality

Wide range of specialties

High Throughput, up to 180 t/hour

Easy to use & reliable

System checks ensure quality results

Point in space connectivity to LAS

LIaISOn® XL

Innovation to meet your needs


LIAISON® XLine connects multiple LIAISON® XL to Pre-Analytical modules offering the complete automation of the working process and a wide range of Immunoassays.

LIaISOn® XLine

Streamline the process and improve the efficiency of your laboratory

Fully automated sample input and sorter module

Sample decapper module

Centrifuge module

Flexible configuration


LIaISOn® SystemsInstalled base evolution

605 1,075

1,665

2007 2008 2009 2010 2011 2012 2013

LIAISON® LIAISON® XL

2014

5,2724,740

4,206

3,641

2,9752,510

2,070

2,070 2,510

2,975

3,641 4,078 4,135 4,197

128

5,872

4,207


Dedicated to content

and counting...

DiaSorin, more than 100 assays menu


Leading position in Specialty Assays

The LIaISOn® family collection menu

AUTOIMMUNITYANA Screen(2)

dsDNA(2)

tTG IgA(2)

ENA Screen(2)

Cardiolipin IgG(2)

Cardiolipin IgM(2)

BONE & MINERAL25-OH Vitamin D TOTALN-TACT® PTH Gen II1-84 PTHOsteocalcinBAP OSTASE®1,25 dihydroxyvitamin D(1)

FGF 23**Sclerostin**

CARDIAC MARKERSTroponin I(2)

Myoglobin(2)

CK-MB(2)

ENDOCRINOLOgYTHYROIDTSH (3rd Gen.)Free T3Free T4T3T4TgAnti-TgAnti-TPO

REPRODUCTIVEENDOCRINOLOGYLHFSHProlactinProgesteroneTestosterone

EstradiolhCG/ß-hCGDHEA-S

ADRENAL FUNCTIONACTHCortisol

GROWTHhGHIGF-I

DIABETESC-PeptideInsulin

HYPERTENSIONDirect ReninAldosterone

INfECTIOUS DISEASESEPSISSEPSIS BRAHMS PCT®(2)

BRAHMS PCT® II Gen

CHAGASChagas IgG

TREPONEMATreponema Screen

EBVEBV IgMVCA IgGEBNA IgGEA IgG

TORCHToxo IgGToxo IgMToxo IgG AvidityRubella IgGRubella IgMCMV IgGCMV IgM

CMV IgG AvidityHSV-1/2 IgGHSV-1 IgGHSV-2 IgGHSV-1/2 IgMParvovirus B19 IgGParvovirus B19 IgM

BORRELIABorrelia burgdorferi IgGBorrelia burgdorferi IgM

VZVVZV IgGVZV IgM

MYCOPLASMAMycoplasma pneumoniae IgGMycoplasma pneumoniae IgM

MEASLES & MUMPSMeasles IgGMeasles IgMMumps IgGMumps IgM

CHLAMYDIA Chlamydia T. IgGChlamydia T. IgA

BORDETELLABordetella pertussis Toxin IgGBordetella pertussis Toxin IgA

VIRAL HEPATITIS AND RETROVIRUSESHBsAg(2)

HBsAg Quant(1)

HBsAg Confirmatory testAnti- HBs IIAnti- HBs II plusAnti- HBcHBc IgM

HBeAgAnti-HBeAnti-HAVHAV IgMHCV Ab(1)

HIV Ab/Ag(1)

HIV Ab/Ag HT(1) HTLV I/II(1)

ONCOLOgYTUMOUR MARKERSCEAFree PSATotal PSACA 15-3®

CA 125 II™CA 19-9™TPA®-MNSES100AFPhCG/ß-hCGTgß2-MicroglobulinTKCalcitonin

ANAEMIAFerritin

STOOL DIAgNOSTICC. difficile GDHC. difficile Toxin A and BH. pylori SAEHEC (2) RotavirusAdenovirusCalprotectinCampylobacter

* Soon Available** Under Development1 - Available on LIAISON® XL only2 - Available on LIAISON® only


Success Stories

* EDMA DATA**EDMA DATA AND INTERNAL DATA

Leadership in Infectious Disease with market share from 20 to 40% in TORCH, EBV and other ID markers*

EUROPE

First fully automated CLIA panel for the diagnosis of TORCH infections CHINA Parvovirus B19, EBV, HSV market

leadership, in CLIA technology**

Fully automated solution for disease testing and the first, fully automated MMRV CLIA panel

USA

wORLDwIDE

DiaSorin leadership in Infectious Disease and Torch

SEPSISSEPSIS BRAHMS PCT®

BRAHMS PCT® II Gen

CHAGASChagas IgG



TORCHToxo IgGToxo IgMToxo IgG AvidityRubella IgGRubella IgMCMV IgGCMV IgMCMV IgG AvidityHSV-1/2 IgGHSV-1 IgGHSV-2 IgGHSV-1/2 IgMParvovirus B19 IgGParvovirus B19 IgM


VZVVZV IgGVZV IgM


MEASLES & MUMPSMeasles IgGMeasles IgMMumps IgG

Mumps IgM

CHLAMYDIA Chlamydia T. IgGChlamydia T. IgA

BORDETELLABordetella pertussis Toxin IgGBordetella pertussis Toxin IgA


The broadest menu available in full automation

Source: Companies websites

3317

1212

11

766

5

BIOPLEX

IMMULITE 2000-2000 XPI

ARCHITECT

COBAS E

VITROS 3600

AXSYM

UNICEL DXI - ACCESS

ADVIA CENTAUR XP

ADVIA CENTAUR CP 4

TORCHToxo IgGToxo IgMToxo IgG AvidityRubella IgGRubella IgMCMV IgGCMV IgMCMV IgG AvidityHSV-1/2 IgGHSV-1 IgGHSV-2 IgGHSV-1/2 IgMParvovirus B19 IgGParvovirus B19 IgM




VZVVZV IgGVZV IgM


MEASLES & MUMPSMeasles IgGMeasles IgMMumps IgGMumps IgM

CHLAMYDIA Chlamydia t. IgGChlamydia t. IgA

BORDETELLABordetella pertussis toxin IgGBordetella pertussis toxin IgA

DiaSorin leadership in Infectious Disease and TORCh


DIASORIN liaison® Xl

BIOMERIEUX VIDAS

SIEMENS ADVIA CENTAuR XP

IMMuLITE 2000-2000 XPI

ADVIA CENTAuR CP

ABBOTT ARCHITECT 2000

aXsym

ROCHE COBAS E

BIORAD BIOPLEX 2200

BECKMAN uNICEL DXI-ACCESS

ORTHO VITROS ECI/3600

32 14 461221

124

3316

11 7 1813 163

11 16 276 12 1810 14 2415 2 176 9 156

6 12 18

ID HEP/RETR/SYPHILIS/CHAgAS

The broadest consolidated Menu on the market

LIaISOn® XL:serology/virology menu

Source: Companies websites


1982 - 1989HBV assays

1st HIV assay & HCV IP filing

2004HCV Type

2006HCV Ag/Ab

Murex acquires Wellcome

1993

HIV HTLV Syphilis

1995Abbott acquires Murex

1998HCV v 4.0HBsAg, other HBV assays

1999

Anti-HBcHAV TotalHDV

HIV Ag/AbHAV IgM

2000 - 2002

1978-1982

DiaSorin RIA & ELISA HBV (FDA)

1994

DiaSorin ELISA HCV HIV

1995

DiaSorin ELISA HIV tetra

DiaSorin LIAISON® HBV and HAV

20032013

LIAISON® XLCHAGAS

2014

LIAISON® XLHIV HT

2012

LIAISON® XL HTLV I/II

DiaSorin Launches LIAISON® XL HCV, HIV

HBsAg

DiaSorin acquires Murex

Murex and DiaSorin… a history of science and technology

Commitment to hepatitis & Retroviruses (1)


Commitment to hepatitis & Retroviruses (2)

INTEGRAL MUREX

NOT AVAILABLE IN US AND CANADA

Quality of MUREX brand

Synergic technology solution: ELISA & CLIA

Multiple platform

Global presence with more than 700 blood banks

Growing penetration in blood bank laboratories


The first company to fully automate the testing of Aldosterone and Direct Renin worldwide

hypertension

AldosteroneDirect Renin

Hypertension is affecting around 2 billion people worldwide, ~20% of those may suffer from resistant hypertension.

The tests support in the diagnosis of primary and secondary hyperaldosteronism in patients with resistant hypertension.

DiaSorin proudly introduced worldwide the two assays on its LIAISON® systems, providing clinicians and labs with reliable, consistent and fast results.

of the population are hypertensive (htn)

~30%

of hypertensive patients are resistAnt hypertensive (res-htn)

~ 20%

>23%of resistant htn patients have primAry Aldosteronism


25 years of worldwideleadership in Vitamin D

Launch of 1,25 Dihydroxyvitamin D

DiaSorin (INCSTAR) introduced first 3H-based RIA.

DiaSorin’s RIA Vitamin D was the first FDA-cleared.

LIAISON® 25 OH Vitamin D was the first fully automated CLIA assay FDA cleared.

LIAISON® 25 OH Vitamin D TOTAL Assay was FDA cleared.

Modified version of LIAISON® 25 OH Vitamin D TOTAL assay released outside U.S. (FDA Cleared).

> FDA approved

BEST-IN-CLASS Quality, Accuracy, Precision

Assay of choice in top Labs WW (for example LabCorp, Sonic, ARUP, Quest)

DiaSorin methods cited in most Vitamin D publications

Continuous R&D investment to maintain leadership


LIaISOn® XL1,25 Dihydroxyvitamin D

• Firstfullyautomated,extractionfree

• Firstresultinjust65minutes

• Moretestsfromthesamepatienttube (eg25-OHVitaminD,PTH)

Continuing worldwide leadership in Vitamin D testing


Stool TestingMade easy

Performe Stool testing menu in complete automation without quality compromise

TEST MENU STOOL DIAGNOSTIC

• C. difficile GDH

• C. difficile Toxin A and B

• H. pylori SA

• EHEC

• Rotavirus

• Adenovirus

• Calprotectin

• Campylobacter


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