Company presentation



Similar documents
Company Presentation. Product availability mentioned in this presentation are subject to local regulatory approval

Annex to the Accreditation Certificate D-ML according to DIN EN ISO 15189:2014

P R O D U C T S CATALOG

EU Declaration of Conformity

INTERIM REPORT ON OPERATIONS OF THE DIASORIN GROUP AT SEPTEMBER 30, 2012 Third quarter of 2012

Quality Forward. UniCel DxI Access Immunoassay Systems

Microbiology Specimen Collection Instructions. Alphabetical List of Microbiology Tests

Immunoassay. Product Portfolio. Part of the IDS group

Diagnostics Division. Roland Diggelmann COO Roche Diagnostics. Picture

About Our Products. Blood Products. Purified Infectious/Inactivated Agents. Native & Recombinant Viral Proteins. DNA Controls and Primers for PCR

Infectious Disease Markers (IDMs) Data

IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1)

Blood Testing Protocols. Disclaimer

Viral Hepatitis Case Report

Your Partner in Antibody Development. Product and Service Catalog

Meridian Healthcare. medical diagnostics & equipment. Professional Product List 2013

Broad Selection of Antibodies & Antigens. for the Diagnostics Industry in North America

Viral Hepatitis APHL survey report

2.0 Rationale, Purpose and Scope Definitions General Principles... 7

Borrelia burgdorferi IgG, IgM Fully automated chemiluminescence assays for quantitative determination of Borrelia antibodies in serum and CSF

IMMUNOASSAY PREMIUM PLUS LEVEL 3 (IA PREMIUM PLUS 3)

Where Convenience Begins. BEP 2000 Advance System. Answers for life.

Hepatitis and Retrovirus. LIAISON XL Accurate detection of HIV infection. HIV Ab/Ag FOR OUTSIDE THE US AND CANADA ONLY

JIANGSU CARTMAY INDUSTRIAL CO.,LTD mail:

LIAISON XL HBsAg Quant

LIAISON XL HCV Ab Accurate diagnosis of the early stage of HCV infection

2015 Outpatient Chronic Hepatitis B Management

Rapid Screening Tests

LAB 1 - Direct agglutination. Serology-the study of the in vitro reactions between antibody and antigen

Annex to the Accreditation Certificate D-PL according to DIN EN ISO/IEC 17025:2005

LC-MSMS - state of the art in endocrinology

Streptococcus pneumoniae IgG AB (13 Serotypes), MAID... 7

Molecular diagnostics is now used for a wide range of applications, including:


VLLM0421c Medical Microbiology I, practical sessions. Protocol to topic J10

Reconsideration Code Reconsideration Code Description Nuclear Matrix Protein 22 (NMP22), qualitative

Viral Safety of Plasma-Derived Products

Biotest AG. Company Presentation. July Company Presentation EU. Biotest AG

THE CZECH MARKET WITH IN VITRO DIAGNOSTIC MEDICAL DEVICES

Viral Antigens/Virale Antigene. SARS Proteins/SARS Proteine

PROPOSED DOCUMENT. Global Harmonization Task Force. Title: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

AIR FORCE REPORTABLE EVENTS GUIDELINES & CASE DEFINITIONS

Samsung POINT OF CARE Systems - Cardiac/Acute Care Biomarkers LABGEO IB Clinical Chemistry Analytes LABGEO PT

Bio-Rad Laboratories EXTERNAL QUALITY ASSURANCE SERVICES EQAS. External Quality Assurance Services

TRANSLATING VISIONS INTO SOLUTIONS

EPIDEMIOLOGY OF HEPATITIS B IN IRELAND

Appendix B: Provincial Case Definitions for Reportable Diseases

CAP Accreditation Checklists 2015 Edition

Product: Point-of-care immunoassay system yielding rapid labquality quantitative blood test results with unprecedented ease-ofuse.

ST. VINCENT'S. MEDICAL CENTER St. Vincent's Healthcare

Basic Immunologic Procedures. Complex Serological Tests

TRI-LEVEL CARDIAC CONTROL (CRD CONTROL 1, 2, 3)

Coding and Billing for HIV Services in Healthcare Facilities

Specimen Collection Guide

the central lab of choice for investigative sites and sponsors

Background Information

Effective Treatment of Lyme Borreliosis with Pentacyclic Alkaloid Uncaria tomentosa (TOA-free Cat s Claw)

Hepatitis C. Laboratory Tests and Hepatitis C

The EliA System Time for the essentials Cost efficient and flexible A boost in service for your laboratory and your clinicians

INNOVATION TO MEET YOUR NEEDS

PROFICIENCY TESTING. Clinical Laboratory Improvement Amendments (CLIA) DOs and DON Ts. Brochure # 8

Liaquat University of Medical & Health Sciences, Jamshoro

Testing for RA. The Ideal Lab Test. William M. Wason, MD, PhD 9/24/2010. Confusion Abounds

Institut für Klinische Chemie und Laboratoriumsmedizin. In vitro Diagnostics in the Health Care System of Germany. Karl J. Lackner

Molecular Diagnosis of Hepatitis B and Hepatitis D infections

Course Curriculum for Master Degree in Medical Laboratory Sciences/Clinical Biochemistry

HBV DNA < monitoring interferon Rx

THE EDGBASTON PRIVATE MEDICAL PRACTICE THE PATIENT GUIDE

Biokit, S.A. was founded in 1973 with entirely private capital. Its purpose is the research, development, production and distribution of clinical

Background: 1) Does your center have effective ways of collecting data from multiple sources to submit to multiple organizations?

Factors Influencing LC/MS/MS Moving into Clinical and Research Laboratories

Medical Laboratory Technology Program. Student Learning Outcomes & Course Descriptions with Learning Objectives

30% Off Cycle 1. Possible Preliminary Discussions With Contract Negotiations

Professional Product List 2015

Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions

MEDICAL NUTRITION THERAPY (MNT) CLINICAL NUTRITION THERAPY Service Time CPT Code

MHDO CompareMaine Updated: 9/17/2015

CANADIAN RULE BASED CLASSIFICATION SYSTEM (IVDD) Life Sciences British Columbia NRC-Industry Research Assistance Program

IKDT Laboratory. IKDT as Service Lab (CRO) for Molecular Diagnostics

How Does a Doctor Test for AIDS?

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH

Who We Are. Denis Thiery Chairman and Chief Executive Officer

Infectious Disease Antibodies and Antigens. ...Viro Stat. Supplying Researchers and Manufacturers Since

Blood Screening Assays. CTS lab locations where assays are performed are indicated by alpha codes D, P, and T.

ViroGen Catalog. Table of contents

2.1.2 Characterization of antiviral effect of cytokine expression on HBV replication in transduced mouse hepatocytes line

CAREERS IN BIOMEDICAL SCIENCE & THE IBMS. Betty Kyle Scottish Regional Representative IBMS Lead Biomedical Scientist NHS Lanarkshire

QuickTiter FeLV Core Antigen ELISA Kit (FeLV p27)

25-hydroxyvitamin D: from bone and mineral to general health marker

Transcription:

Company Presentation

COMPANY PROFILE Global Leader in IVD for over 40 years Italian multinational company Worldwide Broadest Menu in CLIA immunoassay Listed on the stock market in the FTSE Mid Cap Index Focus on Specialty Products New Player in Molecular Diagnostics 2

HISTORY Extension of the master agreement with Laboratory Corporation of America till 2018 2014 CLIA product expansion (6/8 new products launched every year) Success and increase of Liaison XL installations WW expansion and consolidation of DiaSorin commercial presence Entrance in the Molecular Diagnostics market Today 2013 Agreement with Roche Commercial expansion: Switzerland Launch of new Liaison XL system platform 2010 2012 Acquisition of NorDiag, specialized in the extraction of nucleic acids JV DiaSorin - Trivitron in India July 19, 2007: Stock market debut in the Italian Stock Exchange 2007 2008-2010 Acquisition of Biotrin, leader in Parvovirus Acquisition of Murex, entering blood bank market Commercial expansion (Portugal, Austria, Czech Republic, Canada, Australia, Ireland, South Africa, Netherlands) 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 1986-1999 2000 Management Buyout, backed by Investimenti e Partecipazioni S.p.A. and other investors DiaSorin S.r.l. sold to American Standard Inc. 1970-1985 Development of new products on RIA and ELISA 1968 DiaSorin s birth as division of Sorin Biomedica S.p.A. 3

GLOBAL PRESENCE subsidiaries distributors ireland - dublin* MOLECULAR * R&D facility Norway - Oslo* MOLECULAR * R&D facility Germany - Dietzenbach* TUMOR MARKERS HORMONOLOGY * R&D facility usa - stillwater* BONE & MINERAL ENDOCRINOLOGY * R&D facility uk - dartford MUREX ELISA Italy - saluggia, Gerenzano* INFECTIOUS DISEASE * R&D facilities South Africa - Kyalami HEPATITIS C ELISA Industrial Sites 6 employees 1,615 companies Worldwide 28 6 independent distributors >80 R&D facilities countries Group presence >60 4

SHAREHOLDERS BASIS Carlo Rosa 2.1% 6.5% 2.8% 3.7% 27.9% 44.0% 8.5% 4.5% Even Chen Finde SS Threadneedle Asset Management Holdings Ltd DiaSorin Spa Oppenheimerfunds Inc. Norges bank Market 5

TOP MANAGEMENT Chairman Gustavo Denegri Chief Executive Officer Carlo Rosa Senior Corporate VP Chief Financial Officer Pier Luigi De Angelis Senior Corporate VP Commercial Operations Chen M. Even Senior Corporate VP and Chief Medical Officer Francesco Colotta Senior Corporate VP Human Resources Stefano Ronchi 6

The IVD Market

A 44 BILLION WORLDWIDE MARKET Clinical Chemistry Self-monitoring blood glucose 21.0% 21.0% 6.0% 6.0% 6.0% 9.0% Microbiology Hematology Point of care Others Immunodiagnostics 23.0% 9.0% Molecular Diagnostics Oncology & Endocrinology 25.7% 9.3% Bone & Mineral Cardiac Markers Infectious Diseases 60.0% GI Stool Testing 5.0% 12.9% Hepatitis & Retrovirus Infectious Diseases 20.0% 12.0% 3.0% 6.4% 5.7% Autoimmunity Allergy Drug monitoring & others Other 15.0% 25.0% Onco-hematology 8

Systems & Solutions

SYSTEMS & SOLUTIONS Immunodiagnostics Molecular Diagnostics CLIA ChemiLuminescent Immuno Assay: latest and most used technology by hospitals and private laboratories, with tests run on random access and fully automatized systems, providing results in 30-45 minutes EXTRACTION 1 st phase: Extraction of nucleic acids (DNA or RNA) of a virus or a tumor cell ELISA Enzyme Linked ImmunoSorbent Assay: 2 nd generation technology, mainly used in blood banks, with tests run on semi-automated systems, providing results in ~3-4 hours RIA freedom evolyzer 2-150/ 8 AMPLIFICATION 2 nd phase: Amplification of nucleic acids found in the patient s fluid sample to identify and count the amount of DNA/RNA extracted DETECTION Radio Immuno Assay: oldest technology, still used mainly for research purposes, with tests performed manually 3 rd phase: Detection of the amplified DNA/RNA found in the patient s sample to give the final result 10

FOCUS ON LIAISON XL Fully automated solution Complete sample processing, measurement and evaluation High efficiency High Throughput Flash chemiluminescence technology Samples identified via a bar code reader and reported to user Flexible configuration Perfect compatibility of tests with LIAISON analyzer Quality of all samples monitored Wide range of specialties LIAISON XL VS. COMPETITORS SYSTEMS Menu of Specialties Throughput Level of Automation Total Menu Highest number of clia specialties available in the world Comparable/higher vs. competitors: 180 tests/hour Comparable/higher vs. competitors Broadest CLIA menu in the World: 105 products 11

FOCUS ON LABORATORY AUTOMATION SYSTEM Streamline the process and improve the efficency of your laboratory LIAISON XLine connects multiple LIAISON XL to Pre-Analytical modules offering the complete automation of the working process and a wide range of Immunology assays available. Easy to navigate, user interface to control the workcell Fully automated sample input and sorter module Sample decapper module Centrifuge module Flexible configuration 12

INSTALLED BASE EVOLUTION 2,510 2,975 CAGR +16.86% 3,641 4,206 128 4,740 605 5,272 1,075 2,070 2,070 2,510 2,975 3,641 4,078 4,135 4,197 2007 2008 2009 2010 2011 2012 2013 LIAISON LIAISON XL TOTAL 13

DIASORIN SUPPLY CHAIN 1 2 2 3 raw materials production production distribution Biology & Biochemical Department Biology & Biochemical Department transportation by air, sea or land of reagents to logistic hubs or clients buy External Suppliers general (i.e. magnetic beads, purified water, plastic for cartridges) biological (i.e. antibodies, isoluminol) make R&D Department Biological and chemical production and purification production of internal raw materials, processing of external raw materials, and purification of the material in order to isolate the needed elements storage Manufacturing storage cell banks for conservation of raw materials or semifinished products at the correct temperature for the material from storage to mass production: antibody multiplications together with other raw materials (e.g. water, beats and other control fluids) are inserted in plastic cartridges cartridges with reagents A subsidiaries and sites that distribute locally B distributors Clients (hospitals, labs) subsidiaries distributors 14

Products

THE LIAISON FAMILY COLLECTION 107 Assays Menu and leading position in Specialty Assays BONE & MINERAL 25-OH Vitamin D TOTAL N-TACT PTH Gen II 1-84 PTH Osteocalcin BAP OSTASE 1,25 dihydroxyvitamin D FGF 23** Sclerostin** THYROID TSH (3rd Gen.) Free T3 Free T4 T3 T4 Tg Anti-Tg Anti-TPO REPRODUCTIVE ENDOCRINOLOGY LH FSH Prolactin Progesterone Testosterone Estradiol hcg/ß-hcg AUTOIMMUNITY ANA Screen dsdna ttg IgA ENA Screen Cardiolipin IgG Cardiolipin IgM TUMOUR MARKERS CEA Free PSA Total PSA CA 15-3 CA 125 II CA 19-9 TPA -M NSE S100 AFP hcg/ß-hcg Tg ß2-Microglobulin TK Calcitonin HYPERTENSION Direct Renin Aldosterone DIABETES C-Peptide Insulin SEPSIS BRAHMS PCT BRAHMS PCT II Gen** VIRAL HEPATITIS AND retroviruses HBsAg HBsAg Confirmatory test Anti-HBs II Anti-HBc HBc IgM HBeAg Anti-HBe Anti-HAV HAV IgM HCV Ab HIV Ab/Ag HTLV I/II HIV Ab/Ag HT Chagas Chagas IgG TORCH Toxo IgG Toxo IgM Toxo IgG Avidity Rubella IgG Rubella IgM CMV IgG CMV IgM CMV IgG Avidity HSV-1/2 IgG HSV-1 IgG HSV-2 IgG HSV-1/2 IgM Parvovirus B19 IgG Parvovirus B19 IgM BORRELIA Borrelia burgdorferi IgG Borrelia burgdorferi IgM VZV VZV IgG VZV IgM MYCOPLASMA Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM CHLAMYDIA Chlamydia t. igg Chlamydia t. iga Bordetella Bordetella pertussis Toxin IgG* Bordetella pertussis Toxin IgA* STOOL DIAGNOSTICS C. difficile GDH C. difficile Toxin A and B H. pylori SA EHEC Rotavirus Adenovirus Calprotectin* Campylobacter* ANAEMIA Ferritin CARDIAC MARKERS Troponin I Myoglobin CK-MB ADRENAL FUNCTION ACTH Cortisol DHEA-S GROWTH hgh IGF-I TREPONEMA Treponema Screen EBV EBV IgM VCA IgG VCA IgA** EBNA IgG EA IgG MEASLES & MUMPS Measles IgG Measles IgM Mumps IgG Mumps IgM * Soon Available ** Under Development 16

Strategy

Hepatitis and Retroviruses

HEPATITIS & RETROVIRUSES Diasorin experience and reputation in Infectious Diseases Diasorin full menu availability HIV HIV HT Leverage on HBsAg T. pallidum Chagas HTLV I-II HCV Liaison XL 19

Gastro-intestinal stool testing

NEW AUTOMATED SYSTEM IN STOOL TESTING set up of optimal assay conditions with liaison and liaison xl Gastro-intestinal Infections + companion one-step simple sample preparation device C. Difficile Toxins A&B Enterohemorragic E. Coli C. Difficile GDH Rotavirus H. Pylori Adenovirus Gastro-intestinal inflammatory/ autoimmune diseases Calprotectin LIAISON Stool Clean-up Device In Development develop an innovative immunodiagnostic chemiluminescent system characterized by: biological matrix currently poorly automated wide applicability integrable with molecular diagnostics 21

Endocrinology & Hypertension

ENDOCRINOLOGY & HYPERTENSION Chronic Kidney Disease (CKD) and Bone Metabolism ckd bone mass loss High bone turnover (increased reabsorption) Low bone turnover (reduced formation) Hyperphosphate FGF-23 Hyperphosphate FGF-23 Reduced 1.25 Vit D 1.25 Vit D Reduced 1.25 Vit D 1.25 Vit D In Development High Sclerostin Sclerostin Assay A unique offer for the detection of the key hypertension markers on a fully automated platform Renin and Aldosterone differentially expressed in each specific hypertension-inducing condition To discriminate which clinical condition is inducing hypertension in the patient, both RENIN and ALDOSTERONE must be measured as the only Company in the World to have both products running on CLIA Technology Renin and Aldosterone: CE and FDA approved 23

Molecular Diagnostics

DIASORIN IN THE MOLECULAR DIAGNOSTICS 3 phases to run a molecular diagnostic test STRATEGY Sample preparation phase: Extraction technology Reagent + + kits dna/rna amplification: Amplification technology Amplification + Detection on the same machine: LAMP technology on the LIAISON IAM 7 specialty assays in Infectious Diseases + 5 in Onco-hematology Detection phase: NAT Assays on a dedicated platform 25

Research & Development

R&D: MAIN COMPETENCIES & FACTS Molecular Diagnostics ImmunoDiagnostics New Reagents New Technologies Assays Optimization Pre-industrialization New Assays Prototypes New Technologies New Reagents Assays Optimization Pre-industrialization Molecular Diagnostics New Reagents New Technologies ImmunoDiagnostics Assays Optimization Pre-industrialization 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 27

IMMUNODIAGNOSTICS PIPELINE 2012-2015 Infectious Diseases Specialty ID Serology Blood Banks Automated Stool Testing Mumps IgG, IgM HTLV I II Clostridium difficile Toxin A/B Campylobacter Measles IgG, IgM Chagas Clostridium difficile GDH Calprotectin Chlamydia trachomatis IgG, IgA HIV Combo High Throughput Helicobacter Pylori Antigen Mycoplasma pneumoniae IgG, IgM HBsAg High Throughput E. Coli Shiga Toxin Chlamydia Pneumoniae IgG, IgM, IgA Rotavirus Bordetella pertussis IgG, IgA Adenovirus Hormonology Bone & Mineral Hypertension PTH (Next Generation) Aldosterone 1,25-Dihydroxy Vitamin D FGF-23 Sclerostin Under Development 28

MOLECULAR DIAGNOSTICS PIPELINE 2012-2015 Infectious Diseases Parvovirus (PARVO) Varicella Zoster Virus (VZV) Cytomegalovirus (CMV) BK Virus (BKV) Toxoplasmosis (TOXO) Herpes Simplex Virus (HSV 1&2) Epstein-Barr Virus (EBV) Onco-Hematology Chronic Myeloid Leukemia (CML) Acute Myeloid Leukemia (AML) Myeloproliferative Neoplasms (MYELO NEOPL) Acute Promyelocitic Leukemia (APL) Acute Lymphoblastic Leukemia (ALL) Under Development 29

Financials

REVENUES BY TECHNOLOGY % on TOT Revenues 0.4% 0.7% 10.7% 10.3% 11.6% 9.3% 27.0% 23.0% 9.2% 9.6% 7.7% 5.5% 15.0% 19.5% 10.0% 4.5% 11.8% 12.2% 4.0% 9.9% 12.5% 3.1% 15.4% 50.7% 57.4% 63.6% 69.9% 73.7% 73.5% 68.3% 2007 2008 2009 2010 2011 2012 2013 CLIA ELISA RIA Instruments Molecular 31

REVENUES BY GEOGRAPHY % on TOT Revenues North America Latin America 28.8% 24.1% fy'12 fy'13 10.4% 11.1% fy'12 fy'13 Europe & Africa Asia Pacific 46.4% 48.3% fy'12 fy'13 14.4% 16.5% fy'12 fy'13 32