Company presentation

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1 Company Presentation

2 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

3 HISTORY Extension of the master agreement with Laboratory Corporation of America till 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 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 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) 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 Management Buyout, backed by Investimenti e Partecipazioni S.p.A. and other investors DiaSorin S.r.l. sold to American Standard Inc Development of new products on RIA and ELISA 1968 DiaSorin s birth as division of Sorin Biomedica S.p.A. 3

4 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

5 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

6 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

7 The IVD Market

8 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

9 Systems & Solutions

10 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 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

11 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

12 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

13 INSTALLED BASE EVOLUTION 2,510 2,975 CAGR % 3,641 4, , ,272 1,075 2,070 2,070 2,510 2,975 3,641 4,078 4,135 4, LIAISON LIAISON XL TOTAL 13

14 DIASORIN SUPPLY CHAIN 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

15 Products

16 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

17 Strategy

18 Hepatitis and Retroviruses

19 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

20 Gastro-intestinal stool testing

21 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

22 Endocrinology & Hypertension

23 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

24 Molecular Diagnostics

25 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

26 Research & Development

27 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

28 IMMUNODIAGNOSTICS PIPELINE 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

29 MOLECULAR DIAGNOSTICS PIPELINE 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

30 Financials

31 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% CLIA ELISA RIA Instruments Molecular 31

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

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