Diasorin S.p.a. · MIL:DIA
Diasorin — Investor Day (October 2012)
56 slides from Diasorin's investor day presentation, October 2012
Slide 1: Our new opportunity: Molecular Diagnostics Analyst Day
Our new opportunity: Molecular Diagnostics Analyst Day October 2012 10 Wed Dublin
Slide 2: Q-LAMP the 2nd Generation LAMP, Isothermal Evolution in Molecular Diagnostics
Q-LAMP nd the 2 Generation LAMP, Isothermal Evolution in Molecular Diagnostics Francesco Colotta MD Senior Corporate VP and Chief Medical Officer
Slide 3: Aim of the Presentation
AIM OF THE PRESENTATION A Q-LAMP technology: • HIGHLY PERFORMING • SIMPLE WORKFLOW • FAST TIME TO RESULTS • COST SAVING B Strategic directions for: • NEXT WAVES OF PRODUCTS • INSTRUMENTS • CONSOLIDATED OFFER TO CUSTOMERS
Slide 4: Human Molecular Diagnostics
HUMAN MOLECULAR DIAGNOSTICS DETECTING NUCLEIC ACIDS (NAs) IN THE HUMAN BODY EXOGENOUS NAs ENDOGENOUS NAs VIRUSES CANCER CELLS BACTERIA CONGENITAL DISEASES PARASITES ACQUIRED GENETIC DISEASES
Slide 5: DNA
DNA The Diagnostic Specialist aa
Slide 6: EBV Specific DNA Stretch
EBV SPECIFIC DNA STRETCH GAGAACATTGCAGAAGGTTTAAGACTTCTC
Slide 7: Amplification of EBV-Specific DNA
AMPLIFICATION OF EBV-SPECIFIC DNA MOLECULAR DIAGNOSIS OF EBV = DETECTION OF EBV-SPECIFIC DNA IN HUMAN BODY BLOOD GAGAACATTGCAGAAGGTTTAAGACTTCTC IN VITRO GAGAACATTGCAGAAGGTTTAAGACTTCTC G AGAACATTGCAGAAGGTTTAAGACTTCTC AGAACATTGCAGAAGGTTTAAGACTTCTCT GAGAACATTGCAGAAGGTTTAAGACTTCT GAGAACATTGCAGAAGGTTTAAG
Slide 8: Molecular Diagnosis of EBV
MOLECULAR DIAGNOSIS OF EBV GAGAACATTGCAGAAGGTTTAAGACTTCTC TCCCCTGTGAGGAACTACTGTCTTCACGCA GAGAACATTGCAGAAGGTTTAAGACTTCTC G AG GAACATTGCAGAAGGTTTAAGACTTCTC AACATTGC GCAGAAGG GGTTTAAGACTTCTC GAGAACATTGCAGAAGGTTTAAGACTTCTC G AGAACATTGCAGAAGGTTTAAGACTTCTC GAACATTGCAGAAGGTTTAAGACTTCTC GAGAACATTGCAGAAGGTTT
Slide 9: Extraction and Amplification
EXTRACTION AND AMPLIFICATION EXTRACTION DNA BUFFER DETECTION BLOOD SAMPLE AMPLIFICATION RNA DNA REVERSE TRANSCRIPTION
Slide 10: Amplification with PCR
AMPLIFICATION W/ PCR DNA PCR AMPLIFICATION STEPS ENZYMES TEMPERATURES 70° C REVERSE REVERSE 42° C AMPLIFICATION TRANSCRIPTION TRANSCRIPTASE 99° C 4° C 94 °C, 30 SEC (DENATURATION) DNA 65 °C, 60 SEC AMPLIFICATION TERMOSTABLE (ANNEALING) 35 X POLYMERASE RNA DNA 72 °C, 60 SEC (POLIMERIZATION)
Slide 11: Amplification with PCR and LAMP
AMPLIFICATION W/ PCR AND LAMP DNA PCR LAMP AMPLIFICATION STEPS ENZYMES TEMPERATURES ENZYME TEMPERATURE 70° C REVERSE REVERSE 42° C AMPLIFICATION TRANSCRIPTION TRANSCRIPTASE 99° C 4° C LAMP 94 °C, 30 SEC ≈ 65°C POLYMERASE (DENATURATION) DNA 65 °C, 60 SEC AMPLIFICATION TERMOSTABLE (ANNEALING) POLYMERA
Slide 12: Multiplexing of LAMP
MULTIPLEXING OF LAMP Q-LAMP TUBES / 12 PATIENTS AMPLIFICATION TECHNOLOGY BCR-ABL BCR- -A ABL PML-RARα PCR 124 12 24 4 124 SIMPLER WORKFLOW LAMP 14 4 14 EENZYME NZYME BCR-ABL p210 PCR = 3 ASSAYS BCR-ABL p190 MULTIPLEXING CONTROL OF LAMP BCR-ABL p210, LAMP = 1 ASSAY p190 AND CONTROL IN ONE ASSAY
Slide 13: Amplification with PCR and LAMP
AMPLIFICATION W/ PCR AND LAMP DNA PCR LAMP AMPLIFICATION STEPS ENZYMES TEMPERATURES ENZYME TEMPERATURE 70° C REVERSE REVERSE 42° C AMPLIFICATION TRANSCRIPTION TRANSCRIPTASE 99° C 4° C LAMP 94 °C, 30 SEC ≈ 65°C POLYMERASE (DENATURATION) DNA 65 °C, 60 SEC AMPLIFICATION TERMOSTABLE (ANNEALING) POLYMERA
Slide 14: Rapidity of Time to Diagnosis
RAPIDITY OF TIME TO DIAGNOSIS Q-LAMP TIME TO DIAGNOSIS AMPLIFICATION TECHNOLOGY BCR-ABL PML-RARα SIMPLER WORKFLOW PCR 3.5 – 6.5 h 3.5 – 6.5 h FASTER TIME TO DIAGNOSIS LAMP 50 MIN 30-40 MIN ENZYME
Slide 15: Assay Performance - IDs
ASSAY PERFORMANCE - IDs Q-LAMP AMPLIFICATION ! TECHNOLOGY ! SIMPLER WORKFLOW Parvo: LAMP vs PCR Viral Load 12,00 FASTER TIME 10,00 LAMP PArvo (Log IU/mL) TO DIAGNOSIS 8,00 y = 1,07x - 0,55 R = 0,98 6,00 SENSITIVITY 4,00 2,00 HIGH ASSAY SPECIFICITY 0,00 0,00 2,00 4,00 6,00 8,00 10,00 12,00 PERFORMANC
Slide 16: Robustness to Matrix Inhibitors
ROBUSTENESS TO MATRIX INHIBITORS Q-LAMP 2 PATIENTS REQUIRED PRE-TREATMENT WITH HEPARINASE TO BE AMPLIFICATION DETECTED BY PCR. TECHNOLOGY D FOR THIS PRE-TREATMENT WAS NOT REQUIRED R DETECTION BY LAMP. SIMPLER WORKFLOW HOME BREW PCR (BIOMED) FASTER TIME TO DIAGNOSIS + - SENSITIVITY + 79 0 LAMP HIGH A
Slide 17: Amenable to Qualitative and Quantitative Assays
AMENABLE TO QUALITATIVE AND QUANTITATIVE ASSAYS Q-LAMP CMV AMPLIFICATION TECHNOLOGY EBV QUANT ASSAYS PARVO SIMPLER WORKFLOW W BKV FASTER TIME TO DIAGNOSIS TOXO HIGH ASSAY PERFORMANCE VZV QUALITATIVE AND QUANTITATIVE HSV 1-2 QUAL ASSAYS BCR-ABL p210, p190 PML-RARα BCR 1-3 PML-RARα BCR 2
Slide 18: Wide Applicability
WIDE APPLICABILITY Q-LAMP AMPLIFICATION TECHNOLOGY RNA SIMPLER WORKFLOW VIRUSES, BACTERIA DNA HUMAN CELLS FASTER TIME TO DIAGNOSIS HIGH ASSAY PATHOGEN SPECIFIC SEQUENCES PERFORMANCE POINT MUTATIONS, TRANSLOCATIONS QUALITATIVE AND QUANTITATIVE WHOLE SERUM WIDE BLOOD APPLICABILITY PLASMA BONE MARROW U
Slide 19: Allowing Cost Savings for Labs
ALLOWING COST SAVINGS FOR LABS Q-LAMP AMPLIFICATION TECHNOLOGY SIMPLER WORKFLOW FASTER TIME TO DIAGNOSIS HIGH ASSAY PERFORMANCE QUALITATIVE AND QUANTITATIVE WIDE APPLICABILITY REDUCED LABOUR REDUCED REAGENT COSTS COSTS COST SAVINGS SIMPLE NO PCR ROYALITIES INSTRUMENTATION
Slide 20: Molecular Diagnostics Product Portfolio
MOLECULAR DIAGNOSTICS PRODUCT PORTFOLIO 2012 2013 4Q 1Q 2Q 3Q 4Q H. Influenza B CMV C. Diff. S. VZV Pneumoniae N. BKV Meningitidis IDs PARVO TOXO EBV HSV 1&2 BCR-ABL p210 c-Kit 816 CBFB-A & p190 p PML-RARα BCR1 c-Kit 822 CBFB-D ONCO & BCR3 PML-RARα CBFB-E BCR2 AML-ETO 1 LIAISON IAM LIAISON IXT
Slide 21: Liaison IAM: Getting the Best Out of LAMP
: GETTING THE BEST OUT OF LAMP SMALL BENCH TOP INSTRUMENT VERY ACCURATE TEMPERATURE CONTROL THREE DETECTION CHANNELS (GREEN, YELLOW, ORANGE) TWO ALTERNATIVE DETECTION MODES: MULTIPLEX FLUORESCENCE ANNEALING ANALYSIS SAFE PLASTIC STRIP-TUBES
Slide 22: Liaison IAM: Getting the Best Out of LAMP
: GETTING THE BEST OUT OF LAMP A DEDICATED SOFTWARE EASY TO USE AND LOADED WITH FEATURES AUTOMATED DATA ANALYSIS BARCODE READER TO TRACE REAGENTS AND SAMPLES CONNECTIVITY TO LIS CONNECTIVITY OF UP TO 6 INSTRUMENTS USER FRIENDLY REPORT GENERATION
Slide 23: Extraction and Amplification
EXTRACTION AND AMPLIFICATION EXTRACTION DNA BUFFER DETECTION BLOOD SAMPLE AMPLIFICATION RNA DNA REVERSE TRANSCRIPTION
Slide 24: Liaison IXT: Making Extraction Simple
: MAKING EXTRACTION SIMPLE NOVEL PIPETTING SYSTEM UV STERILIZATION 1-12 SAMPLES PROCESSED WITH PREFILLED REAGENTS COST EFFECTIVE WIDE RANGE OF SAMPLE TYPES EASE OF USE
Slide 25: Liaison IXT – Available Tests
LIAISON IXT – AVAILABLE TESTS DNA FROM TISSUE BUGS’n BEADSTM RNA FROM CELLS VIRAL NA CEL CELL LL DNA FROM STOOL SEPARA SEPARATION ATION AT DNA FROM BLOOD 200 l AND 500 l
Slide 26: Conclusions – Today
CONCLUSIONS – TODAY DiaSorin Q-LAMP technology made: • Simple • Fast • Highly performing • Quantitative • Cost convenient DiaSorin LAMP characteristics adequate to support a business model focused on decentralized Labs 1st wave: • 7 kits in IDs • 3 kits (detecting 5 molecular markers) in Onco-Hemato
Slide 27: Conclusions – Tomorrow
CONCLUSIONS – TOMORROW Growth • 30 molecular products by 2015 • New automated and integrated instrument for NA extraction and amplification • New cell separation kits targeting HLA labs on Liaison IXT
Slide 28: Molecular Diagnostics: A Market Perspective & Opportunity
Molecular Diagnostics A Market Perspective & Opportunity Paul Eros Global VP Marketing Molecular
Slide 29: Molecular Diagnostics Market Overview
MOLECULAR DIAGNOSTICS MARKET OVERVIEW In 2011 the MDx IVD market TOTAL IVD MARKET: $44 BILLION grew 11% to $4.1 billion Continued strong growth expected OTHER NAT 9% MDx is the fastest growing segments in the In Vitro Diagnostics market 17% COAGULATION Health care reforms 4% 23% IA embracing innovat
Slide 30: Where the Growth Comes From
WHERE THE GROWTH COMES FROM INCREMENTAL REVENUE PER SEGMENT 4,100 REVENUE ($ MILLIONS) 95 60 85 FII, FV, Oncology, Stratified 100 Medicine, 3,700 60 Growth in HCAI and alternatives Strong research and academic HPV expected to where rapid interest Major growth grow +20% pa results are from new viral b
Slide 31: Drivers of Overall IVD Market Also Drive MDx
DRIVERS OF OVERALL IVD MARKET ALSO DRIVE MDx Increased patient awareness More patient self testing Global Baby Booming populations SOCIAL Rapid spread of Infectious Disease Ageing population Improving healthcare in developing regions Increasing laboratory test menus Need to improve time to result TE
Slide 32: Molecular Diagnostics and Infectious Disease
MOLECULAR DIAGNOSTICS AND INFECTIOUS DISEASE 60% of the Molecular Diagnostics market is Infectious Disease Testing Qualitative identification and profiling HIV of the Infectious Disease agent HPV HBV/HCV CT/NG Blood Screening Gastro intestinal/Stool Healthcare Acquired Infections Quantification of the
Slide 33: Infectious Disease Market
INFECTIOUS DISEASE MARKET EMERGING 19% VIRAL LOAD MONITORING BLOOD 40% ID VALUED AT $2.5BILLION SCREENING 16% WOMENS HEALTH 25% INFECTIOUS DISEASE ONCOLOGY GENETICS & PRENATAL Source: Report by “Frost and Sullivan” 2010 INFECTIOUS DISEASE GROWTH DRIVEN BY ■ Respiratory parameters ■ Herpes virus pane
Slide 34: Molecular Diagnostics – Growth Trends
MOLECULAR DIAGNOSTICS – GROWTH TRENDS Decentralized “Point of Impact” testing Four areas of future rapid growth for Cancer Diagnostics Molecular Diagnostics testing Prenatal Diagnostics & Genetic Testing Source: Report by “Frost and Sullivan” 2010
Slide 35: Molecular Lab Networks and Centralisation
MOLECULAR LAB NETWORKS AND CENTRALISATION Networked/referral lab approach Referral Sample Flow Centre High cost to referring lab with lab Longer TAT Result Flow Specialist services not catered for Difficult to request new tests Centralised Molecular Service Laboratory. High test volumes. Non-urgent
Slide 36: Centralised, Decentralised and Fragmented Approaches to MDx
CENTRALISED, DECENTRALISED AND FRAGMENTED APPROACHES TO MDx Roche Roche BioMerieux GenProbe BioMerieux Siemens Qiagen Qiagen Roche Novartis Abbott Cepheid Highly Specialist/ Fragmented Centralised Decentralised Blood Banks Specialist Centres R&D focus Central virology labs Non-core lab Homebrew High
Slide 37: Primary Focus
PRIMARY FOCUS Highly Specialist/ Decentralised Fragmented Centralised HIGHLY OPPORTUNISTIC PRIMARY FOCUS OPPORTUNISTIC (ALMOST NEVER) (ALWAYS) (SOMETIMES) Alongside high volume DiaSorin Serology Customers Extraction and cell separation systems for additional content - MDx for confirmatory - MDx to di
Slide 38: DiaSorin Twin Pillar Strategy
DIASORIN TWIN PILLAR STRATEGY Content Extraction Emerging Infectious Life Science Disease Research OncoHematology Diagnostics Pharmaceutical HLA and Cell Separation & Biotechnology Available Market Available Market $746 million $1 billion
Slide 39: DiaSorin Content Pillar: Emerging Infectious Disease
DIASORIN CONTENT PILLAR Content Optimised assays with Emerging Infectious extraction Disease First phase launch 7 assays aligned with DiaSorin $550 million serology portfolio Growth +15% Follow up launch of C.Diff assay (FDA & CE-IVD) OncoHematology Additional assays launched 2013/2014 and 2015 HLA
Slide 40: Decentralised Point of Impact Testing – Liaison IAM
DECENTRALISED “POINT OF IMPACT” TESTING – LIAISON IAM Small footprint Isothermal reaction • No thermal cycling Less complexity Less to go wrong Cost effective Small batches Modular Unique software Linking instruments Grow with workload
Slide 41: DiaSorin Content Pillar: OncoHematology
DIASORIN CONTENT PILLAR Content Emerging Infectious Disease Large unmet need for diagnosis OncoHematology and monitoring of therapy Launch 2013 $136 million BCR-ABL (p190 & p210) Growth +12% PML-RARα (BCR 1, 2 & 3) HLA and Cell Separation Portfolio expansion 2013/2014/2015
Slide 42: DiaSorin Content Pillar: OncoHematology
DIASORIN CONTENT PILLAR Complete solutions to diagnose Content and monitor leukaemia Rapid, Economical, Efficient Emerging Infectious and Approved assays Disease OncoHematology $136 million Growth +12% HLA and Cell Separation
Slide 43: First Wave Launch Infectious Disease & Oncology
FIRST WAVE LAUNCH INFECTIOUS DISEASE & ONCOLOGY Liaison Ixt extraction system & Liaison Iam Q-LAMP system Infectious Diseases assays Onco Haematology assays • Epstein-Barr Virus (EBV) • Chronic Myeloid Leukemia (CML) • Cytomegalovirus (CMV) • BCR-ABL p190 • Parvovirus (PARVO) • BCR-ABL p210 • Toxopl
Slide 44: DiaSorin Content Pillar: HLA and Cell Separation
DIASORIN CONTENT PILLAR Content Emerging Infectious Disease Unique position in cell separation using specially designed reagent kit OncoHematology Lymphocyte Cell prep for Cell separation prep for HLA OncoHematology for research HLA and Cell Separation typing Diagnostics applications and cell cultur
Slide 45: HLA Typing Cell Preparation
DIASORIN CONTENT PILLAR HLA TYPING CELL PREPARATION Content Liaison Ixt/ Arrow HLA cell separation and cross – matching Emerging Infectious Disease Donor HLA antibodies in transplant OncoHematology recipients can lead to hyper acute graft rejection Cross matching carried out to ensure HLA and Cell S
Slide 46: HLA Typing Cell Preparation
DIASORIN CONTENT PILLAR HLA TYPING CELL PREPARATION Content Emerging Infectious Disease OncoHematology Arrow, CellSep kit & Ab bound Mag Beads displaces the use of time consuming techniques like Ficoll / Dextran density HLA and Cell Separation gradients Arrow capable of 12 preps in 45 min Vastly sim
Slide 47: Number of Transplants per Annum in USA
DIASORIN CONTENT PILLAR HLA TYPING CELL PREPARATION Content NUMBER OF TRANSPLANTS PER ANNUM IN USA KIDNEY 16,898 Emerging Infectious LIVER 6,291 Disease PANCREAS 350 KIDNEY/PANCREAS 828 OncoHematology HEART 2,333 LUNG 1,770 HLA and Cell Separation HEART/LUNG 41 INTESTINE 151 $60 million TOTAL 28,662
Slide 48: HLA Typing Cell Preparation Worldwide Estimates
DIASORIN CONTENT PILLAR HLA TYPING CELL PREPARATION Content HLA TYPING CELL PREPARATION WORLDWIDE ESTIMATES NUMBER OF SOLID ORGAN TRANSPLANTS P.A. 55,000 Emerging Infectious Disease NUMBER OF BONE MARROW TRANSPLANTS 40,000 MEAN NUMBER OF CRASS MATCHES / TRANSPLANT 8 OncoHematology TOTAL AVAILABLE MA
Slide 49: DiaSorin Extraction Pillar
DIASORIN EXTRACTION PILLAR BULLET ARROW Extraction Life Science Research Installed Base: Diagnostics 382 instruments Installed Base: 44 instruments OEM supply Pharmaceutical & contracts Biotechnology Specialist extraction kits: Blood, gDNA, RNA, Stool, Viral NA, Bacterial NA Available Market Revenue
Slide 50: Strategy Execution
STRATEGY EXECUTION CONTENT DRIVEN EXTRACTION OPPORTUNITIES INFECTIOUS Extraction DISEASE Amplification & Detection DISTRIBUTORS Extraction in: LSR Pharmaceutical Biotechnology DiaSorin HAEM ONCOLOGY Direct Sales Distribution Team Extraction partners Amplification & Detection Cell Separation Extraction
Slide 51: Growth Strategy
GROWTH STRATEGY STRATEGY LOOKING FORWARD EXPLOITING SYNERGIES INSTRUMENTS AND ASSAYS TO MAKE MOLECULAR TARGETING BETWEEN NA EXTRACTION, DIAGNOSIS SIMPLER, FASTER, COST EFFECTIVE AND DECENTRALIZED LABS CELL SEPARATION AND HIGHLY PERFORMING GENETIC TESTING MICROBIOLOGY HEMATOLOGY HLA TYPING LABS LABS
Slide 52: Molecular Diagnostics drivers
Molecular Diagnostics drivers Riccardo Fava Head of IR and Media 1
Slide 53: Where We Will Be Different
WHERE WE WILL BE DIFFERENT COMPETITORS Strictly linked to our Immunoassay offer: BUSINESS • Confirmatory results (doubtful results on Immunoassay tests) OPPORTUNITY • Differentiation of service (2nd step of the diagnostic process on a patient found infected with the immunoassay technology) Always dri
Slide 54: Where We Will Be Different
WHERE WE WILL BE DIFFERENT COMPETITORS LAMP … …to make molecular diagnosis: Adequate sensitivity equivalent to PCR Adequate specificity AMPLIFICATION Simpler reaction set-up simpler faster PCR TECHNOLOGY Shorter time-to-result Low manufacturing costs cost effective Quantitative complete and accurate
Slide 55: The "3W" Communication Strategy
THE “3W” COMMUNICATION STRATEGY WHEN WHERE * WHAT OCT 17-20 Investor Day Presentation • Market size and the players • The 3 key decisions (Milan, London, New York) • DiaSorin purpose and strategy - Amplification technology: LAMP 2011 • 2015 Revenues potential = € 15-20 mln (Eiken Chemical) - Liaison
Slide 56: Key Points and Drivers
Key points and drivers Revenues Costs € 15-20 mln by 2015 (ref. Investor Day, Oct 2011), Biotrin site fully converted as the only MDx considering: manufacturing site of the Group • Amplification / detection end-user price going R&D and CAPEX to deploy the first-step execution down to a € 10-15 range