Diasorin S.p.a. · MIL:DIA
Diasorin — Investor Day (June 2017)
77 slides from Diasorin's investor day presentation, Jun 26, 2017
Slide 1: Specialty is in our DNA
Investor Day Specialty is in our DNA June 26th, 2017 Investor Day 1
Slide 2: Disclaimer
Disclaimer These statements are related, among others, to the intent, belief or current expectations of the customer base, estimates regarding future growth in the different business lines and the global business, market share, financial results and other aspects of the activities and situation relat
Slide 3: Agenda
Agenda Introduction Immunodiagnostics Strategic Setting Strategic Projects Molecular Diagnostics Strategic Setting Immunodiagnostic execution USA Europe China Molecular Diagnostic execution USA Europe Financials Main takeaways Investor Day 3
Slide 4: Introduction
Introduction Investor Day 4
Slide 5: What we do
What we do 1 2 A patient feels sick Patient goes and refers to the physician. to a diagnostic lab and 3 On the basis of symptoms a blood sample is taken the physician orders a set of diagnostic tests The blood sample is mixed with specifically designed tests in an automated platform 5 4 Patient goes
Slide 6: Three different cycles
Three different cycles 2000-2008 2008-2016 • ELISA/RIA to CLIA conversion • Conversion from LIAISON to LIAISON XL • Menu expansion with unique specialties • Menu expansion with Infectious Disease Specialties 2017-BEYOND • Strategic alliances • Vitamin D leadership • Acquisitions BIOTRIN ONE SEGMENT,
Slide 7: Three different cycles
Three different cycles 2017 - BEYOND Immunoassay Molecular Diagnostics • LIAISON XL and LIAISON XS • Access to new content & opportunity to innovate • Alliances to boost development of differentiating specialties TWO LEGS Investor Day 7
Slide 8: Main targets & achievements from 2015 long-term guidance
Main targets & achievements from 2015 long-term guidance Revenues ~ +8% CAGR (over achieved) Financials Ebitda ~ +9.5% CAGR (over achieved) Net result ~ +10.0% CAGR (over achieved) Management of LIAISON installed base Technology Development LIAISON XL LAS connectivity Development of Product Developm
Slide 9: Strategic Setting: Immunodiagnostics
Strategic Setting: Immunodiagnostics Investor Day 9
Slide 10: Immunoassay innovation: 1970-2016
Immunoassay innovation: 1970-2016 (~ 200 ASSAYS) Area of MENU opportunity GY OLO HN TEC NAL SIG C LIA FULL CONNECTIVITY SA FULLY AUTOMATED ELI SYSTEMS (Immuno+Clinical Chemistry) FIRST AUTOMATED SYSTEMS BENCH-TOP RIA SOLUTIONS RIA AUTOMATION Investor Day 10
Slide 11: DiaSorin «First» : Fully Automated CLIA assays
DiaSorin «First» : Fully Automated CLIA assays > 45 times «First» in the last 10 years ZIKA IGM STOOL DX ASSAYS (8) PARVOVIRUS (2) 1,25 VITAMIN D MUMPS IGM BORDETELLA MEASLES IGM TORCH (11) ALDOSTERON HSV 1 IGG MYCOPLASMA (2) ALDOSTERON FGF 23 DIRECT RENIN HSV 2 IGG DIRECT RENIN BORRELLIA PARVOVIRUS
Slide 12: DiaSorin menu positioning
DiaSorin menu positioning Me too tests High volume specialties Investigational markers Differentiating specialties Investor Day 12
Slide 13: Menu: Me-too tests
Me-too tests ONCOLOGY ß2-Microglobulin GROWTH REPRODUCTIVE ENDO- Main characteristics TUMOUR MARKERS CEA TK Calcitonin hGH IGF-I CRINOLOGY LH Free PSA FSH No Research & Development Total PSA CA 15-3 ENDOCRINOLOGY THYROID ADRENAL FUNCTION ACTH Prolactin Progesterone Testosterone Menu required CA 125
Slide 14: Menu: High volume specialties
High volume specialties INFECTIOUS DISEASE Toxo IgG Avidity Measles IgM HBc IgM Main characteristics EBV EBV IgM Rubella IgG Rubella IgM Mumps IgG Mumps IgM HBeAg Anti-HBe VCA IgG CMV IgG VZV Anti-HAV Limited Research & Development EBNA IgG EA IgG CMV IgM CMV IgG Avidity VZV IgG VZV IgM HAV IgM HCV
Slide 15: Menu: Differentiating specialties
Differentiating specialties STOOL DIAGNOSTICS BORDETELLA CHRONIC KIDNEY Main characteristics C. difficile GDH C. difficile Toxin A and B Bordetella pertussis Toxin IgG DISEASE 1-84 PTH H. pylori SA Bordetella pertussis Osteocalcin Relevant Research & Development EHEC Rotavirus Toxin IgA MYCOPLASMA BAP
Slide 16: Menu: Investigational markers
Investigational markers CHRONIC KIDNEY DISEASES Main characteristics FGF-23 Ratio (Vitamin D 1,25-PTH 1,84) Sclerostin (*) High Research & Development capabilities Vitamin K (*) Menu required Very strong menu differentiation & Patent Protection Very high marketing and clinical costs required * Under
Slide 17: Investigational markers: hormones dysregulated in CKD
Investigational markers: hormones dysregulated in CKD Existing market Future market opportunity in the US and Europe Market value today 100 €/mln Market value tomorrow ~ 200 €/mln DiaSorin market share 25% DiaSorin is investigating the Ratio VitD 1,25 / PTH 1-84 as an early marker to predict 1. eGFR
Slide 18: Where we plan to invest R&D money
Where we plan to invest R&D money 6 4 2016: DiaSorin products available 2017-2019: DiaSorin new tests 2016: # tests of the main competitor within the area 3 62 42 43 29 24 2 2 2 Investigational Markers Differentiating specialties High volume specialties Me too tests Investor Day 18
Slide 19: Immunodiagnostic Strategic Projects
Immunodiagnostic Strategic Projects Investor Day 19
Slide 20: LIAISON XS: the opportunity
LIAISON XS: the opportunity PPM Moderate to High 27.467 complexity POLs COMPLIANCE These POLs use Instruments 11,721 normally found in Hospitals and WAIVER Private Labs 75.964 ACCREDITATION 5,767 PUBLIC TOWNSHIP HOSPITAL 37,763 Professional Medical Service PUBLIC COMMUNITY MEDICAL Institution SERVIC
Slide 21: Development of Differentiating Specialty Tests
Development of Differentiating Specialty Tests Internal Development e.g. ZIKA Test R&D Pipeline Leverage on LIAISON Content & Technology Development of differentiating specialty tests Products creating complementary opportunities that should generate €/mln 25-50 each Access to partners’ specialties
Slide 22: US Opportunity: partnership with Beckman Coulter
US Opportunity: partnership with Beckman Coulter Hepatitis & Retrovirus market HAV HBV HCV HIV (excluding Blood Bank Business) 500 $/mln #2 #7 #1 #1 140 220 HAV HBV 100 HCV 40 Full CLIA Hepatitis & Retrovirus Panel available by 2020 HIV Data in $/mln Source: internal HBV HAV HCV HIV LAS Stand alone
Slide 23: Strategic Setting: Molecular Diagnostics
Strategic Setting: Molecular Diagnostics Investor Day 23
Slide 24: Technologies in the Molecular Diagnostic Market
Technologies in the Molecular Diagnostic Market ON MENU Area of T ECTI N / DE opportunity TIO I FICA PL AM s ray - Ar ncing ue - Seq lex ltip Mu ex Singl PCR Area of AUTOMATION opportunity Investor Day 24
Slide 25: Immunodiagnostic execution
2017-2019 Immunodiagnostic execution Investor Day 25
Slide 26: Strategic markets
Strategic markets North America Europe Apac ~34% of sales ~43% of sales ~17% of sales Source: Company data on Q1 2017 Results Investor Day 26
Slide 27: Investor Day
Investor Day 27
Slide 28: US market
US market US Market Immunoassay: DiaSorin Today Strategy Menu 27% $5.6 bn in 2015, estimated OTHERS LABS $ 7.5 bn in 2020, +6% CAGR* • Reinforce • New Launches: 13% High Penetration collaboration with Calprotectin, Zika selected menu 14% 35% • MDX Menu Offering HOSPITAL OUTREACH 11% POL & OTHERS Lar
Slide 29: US: 2017-2019 Menu
US: 2017-2019 Menu Launches Market Value DiaSorin Positioning Current Mkt ~$5 mln Satisfy labs need for Calprotectin automation to cope with volume growth (+30% year) ~$30 mln Potential Mkt Current Mkt ~$2 mln Zika Unique fully automated assay available Potential ~$60 mln Mkt Current Mkt ~$40 mln Pr
Slide 30: US: Calprotectin
US: Calprotectin Market Size Strategy $30 M potential Large Reference Labs 30% growth/year • Increasing volumes • Need for Automation Current Mkt ~$5 mln Hospitals • Opportunity to enter the GI labs in large hospital centers to address a growing clinical need • Fully automated assays to: • Increase
Slide 31: US: Zika
US: Zika Market Size Strategy Today Limited market due to CDC guidelines Phase 1 Large Reference Labs Capture the current «send out» business Opportunity tomorrow Deal closed with 2 main big laboratory chains To be part of the pre-natal screening panel(*) Expand to second tier reference laboratories
Slide 32: Investor Day
Investor Day 32
Slide 33: EU markets
EU markets Europe is a flat market, undergoing lab consolidation since several years DiaSorin Today Strategy Menu • France: -69% labs in the last 5 years • Italy: -31% labs in the last 5 years > 100 Total Lab Automation (TLA) • Continue reinforce strategic • Broadest fully alliances (Roche) and explo
Slide 34: EUROPE: Total Lab Automation (TLA) with Roche
EUROPE: Total Lab Automation (TLA) with Roche Aim to 50 TLA by 2019 Cobas 8100 – Large Hospitals CCM - Large Private Labs Cooperation Agreement expanded to include Cobas Connection Module (CCM) CCM allow more scalable and flexible Total Lab Automation including analytics Differentiating specialties I
Slide 35: EUROPE: GI stool testing, unique panel and fast growing customer base
EUROPE: GI stool testing, unique panel and fast growing customer base • DiaSorin pioneered the automation of the stool matrix, a very complex and diversified matrix GI Infections • Growing acceptance of the fully automated DiaSorin solution • Focus on data driven best in class Calprotectin: new • C.
Slide 36: Investor Day
DiaSorin Investor Day
Slide 37: CHINA: Healthcare Development
CHINA: Healthcare Development Two Invoice Policy Objective: reduce healthcare costs consolidating current multi-layered distribution Proposed solutions test in 2 provinces: 1)Shaanxi: GPOs (Package Deals) •Limit number of distributors •2 invoices to be presented to the Hospital, Company Consolidatio
Slide 38: CHINESE market
CHINESE market IVD China Market: €2.3 bn in 2016, estimated €4.0 bn in 2020, DiaSorin Today Strategy Menu +12% CAGR* 64% of • Leverage BECKMAN COUL- • Hepatitis & Retroviruses total revenues TER collaboration in TLA • HEV • ELISA to CLIA conversion • ToRCH, Parvovirus, EBV +25% YoY Class III Hospita
Slide 39: CHINA: Private labs
CHINA: Private labs The Private Lab Market • The Private Labs segment was worth $870M in 2015 and it is expected to double in size by 2020, with a >20% growth rate • The top 4 groups, Kingmed, Dian, Adicon and Da An Gene, represented 70% of total Private Segment in 2015 • Number of Private Labs is g
Slide 40: CHINA: Infectious Diseases panel
CHINA: Infectious Diseases panel Infectious Disease Market SIZE: 45 €/MLN • DiaSorin Market Share: 28% • Growth: +18% CLIA • ELISA still 62% of the market (market reimbursement 33% ELISA open for CLIA as well) 62% Strategy • ELISA to CLIA conversion 5% • Leverage installed base with add–on: EBV, Par
Slide 41: CHINA: Heps & Retrovirus (ex Blood Banks)
CHINA: Heps & Retrovirus (ex Blood Banks) Hepatitis & Retrovirus (ex Blood Banks) market SIZE : 400€/MLN ELISA • DiaSorin Market Share: 2% 62% • Growth: +15% • ELISA still 62% of the market CLIA 31% Strategy • ELISA to CLIA Conversion - with Beckman for TLA OTHERS - DiaSorin stand alone 7% • Add new
Slide 42: Molecular Diagnostics: the market
Molecular Diagnostics: the market Investor Day 42
Slide 43: Molecular Market is Growing at a Rapid Pace
Molecular Market is Growing at a Rapid Pace INHERITED Tests used to detect, quantify or characterize DISEASES TRANSPLANT 227M nucleic acid analytes in patient RNA or DNA 325M CANCER 630M GLOBAL KITS HISTOLOGY 780M MOLECULAR DIAGNOSTICS MARKET ~$6BN (2016) BLOOD SCREENING INFECTIOUS 976M INSTRUMENTS
Slide 44: Technologies in the Molecular Diagnostic Market
Technologies in the Molecular Diagnostic Market TECHNOLOGY Mini Panel & Single Assay Sequencing Multiplex Respiratory HPV Gastro-intestinal MENU HCV Oncology Sepsis … …. INSTRUMENT Investor Day 44
Slide 45: Strategic Considerations for US and Europe
Strategic Considerations for US and Europe Multiple types of regulatory Mechanism for Coverage, Decentralization approvals with differing Coding and Payment associated costs Multiple Regulatory Reimbursement Market Dynamics Contributing Considerations Landscape for Testing Factors One Common Directi
Slide 46: Molecular Kits and Reagents
Molecular Kits and Reagents Produced by manufacturer Kits Level of complexity given to rigorously tested for safety and CE or FDA approved test efficacy in clinical trials for “approval cleared Highly complex to Clia Waived or clearance” Sold as separate components instead Reagents Manufactured in co
Slide 47: Strategic Considerations for US and Europe
Strategic Considerations for US and Europe KITS KITS ASRs ASRs Investor Day 47
Slide 48: Laboratory Developed Test Market
Laboratory Developed Test Market LDT’s meet specific patient needs that are not being served by existing tests in the marketplace Rare Diseases Allows for labs to differentiate Reagents themselves ASRs Public Health Emergencies Labs can customize to their needs Novel, Unique & Esoteric testing needs
Slide 49: Laboratory Developed Test Market
Laboratory Developed Test Market Continued existance of LDT if Regulatory burden is too high Analyte Analyte found by Initial testing Analyte established and Regulatory FDA “Approved” LDT Lifecycle Research Academic available as LDT Pathway selected or “Cleared” Kit known in medical Centers communit
Slide 50: Well Positioned for Growth in Molecular Diagnostics Tests and Reagents
Well Positioned for Growth in Molecular Diagnostics Tests and Reagents 11 57 ASRs Real-time PCR assays for quantitative, Analyte Specific Reagents (ASR) qualitative and multi-analyte detection Infectious Disease Transplant Inherited Diseases Respiratory HAI/ Gastro Women’s Monitoring Coagulation Heal
Slide 51: Platforms in the Molecular Diagnostic Market
Platforms in the Molecular Diagnostic Market Point of Care systems Benchtop systems High throughput systems CLIA Limited menu Single Multiplex Total Lab Limited menu (HCV, waived (e.g. FLU) target Automation HIV, HBV, HPV, CT/NG) Direct Amplification Disc (DAD) Multiplex Disc Universal Disc (UD) New
Slide 52: Our technology
Our technology Compact. Powerful. Expandable. Unique technology developed by 3M, with no extraction required Versatile Same platform, multiple discs Direct Amplification Disc Universal Disc (DAD) (UD) PCR Based ASRs & Kits 8 reaction well 96 reaction well Low to Mid Volume High Volume Investor Day 52
Slide 53: In use across multiple lab segments
In use across multiple lab segments Investor Day 53
Slide 54: DiaSorin Molecular Strategy for the US
DiaSorin Molecular Strategy for the US Investor Day 54
Slide 55: Molecular Innovation- Drivers of Growth
Molecular Innovation- Drivers of Growth Molecular Market = ~$3B Specialty Testing Strategy • ASRs • Kits Investor Day 55
Slide 56: US: Market dynamics and trends
US: Market dynamics and trends Molecular testing has decentralized across lab segments KITS ASR’s All labs run kits. The kit selected Utilized in high complexity labs is based on lab complexity and specific needs Reference Labs • National Reference Lab • High complexity • Regional Reference Lab • Mod
Slide 57: Assay Menu Segmentation
Assay Menu Segmentation Core Lab Viral Load Monitoring, Women’s Health, Regional Transplant, STI Hospital Lab Reference Labs Respiratory, Healthcare-associated Run both menus found infections (HAI), Women’s Health, in Core and Hospital Sexually Transmitted Infections (STI), Labs Syndromic Testing PO
Slide 58: US Regulatory Landscape
US Regulatory Landscape Pathway differs for assays based on classification and risk with varying levels of Cost and Time to “clearance” or “approval” Pre Market COSTS Application Prospective Clinical Trial De novo Traditional Clinical Study 510K ASR No regulatory ~1 year to Market ~1.5 years to ~2-3
Slide 59: USA: Options for Infectious Disease Testing
USA: Options for Infectious Disease Testing Viral Load Monitoring Transplant HAI’s HIV CMV/EBV/BKV/HSV/VZV MRSA Hepatitis B Virus HHV6/HHV8/ CRE Hepatitis C Virus Adeno Parvo/JCV VRE Large Systems Entrenched competitor Large Systems High Regulatory Cost Burden Rapidly Eroding Market High Regulatory
Slide 60: Molecular Kits Pipeline Strategy
Molecular Kits Pipeline Strategy Kits Vector CONGENITAL Borne CMV MENINGITIS Level of Differentiation ATYPICAL PNEUMONIA RESISTANCE ASSAYS BORDETELLA M. GENITALIUM HSV - MC/C VZV ENTERIC PANELS VAGINOSIS GROUP B STREP Competitive Intensity 3 years pipeline strategy 3-5 years pipeline strategy Invest
Slide 61: ASRs Pipeline Strategy
ASRs Pipeline Strategy Avg. # 4 new ASRs / Year Reagents ASRs 2017 - 2019 2019 - beyond Infectious Disease Immuno- Genetics compromised Vector-Borne Resistance Gastro- Respiratory intestinal infections Differentiating specialties Investor Day 61
Slide 62: DiaSorin Molecular Strategy for Europe
DiaSorin Molecular Strategy for Europe Investor Day 62
Slide 63: Molecular Innovation- Drivers of Growth
Molecular Innovation- Drivers of Growth Molecular Market = ~$2.5 BN Post Transplant Strategy KITS ONLY Investor Day 63
Slide 64: Europe: Centralization of Pathology Services
Europe: Centralization of Pathology Services Molecular Diagnostics Driven to Centralized Services High Volume Parameters Specialty testing Central Service Labs Not Routinely Decentralized Throughput & Economies of scale Performed in Core Lab Automation Easy to use Batch Processing Rapid results The
Slide 65: Europe: Options in High Throughput testing
Europe: Options in High Throughput testing Viral Load Monitoring Women’s Health Post Transplantation CMV/EBV/BKV HIV CT/NG/TV HSV/VZV Hepatitis B Virus HPV HHV6/HHV8/Adeno Hepatitis C Virus Parvo/JCV Big Players No Clear Leader Established Players Established Systems Big Players Absent Competitive A
Slide 66: Current Post Transplant Landscape - EU
Current Post Transplant Landscape - EU ROCHE COBAS 6800 Beckman Elitech Veris Ingenius Automation Roche Qiagen CAP/CTM Extraction Amplification Easy Mag Magna Pure QiaCube + ABI7500 BioRad Rotogene No/Low Flexibility Flexibility Ability to accept multiple matrices and run size/flexibility Size of circ
Slide 67: Europe Molecular Post Transplant
Europe Molecular Post Transplant Strategy Instrument for 11 transplant assays extraction/PCR set up CMV HSV 1 HHV8 EBV HSV 2 ADENOVIRUS BKV VZV PARVOVIRUS LIAISON MDX for Amplification HHV6 JCV Provide complete transplant menu Investor Day 67
Slide 68: Europe Molecular Post Transplant
Europe Molecular Post Transplant Solution Automation Consolidation- Flexibility- Full Transplant Harmonization One Vendor for Extraction/PCR and Amplification Primary Matrices Menu Standardization Investor Day 68
Slide 69: Europe: IMMUNO - MDX Synergy
Europe: IMMUNO - MDX Synergy Expand cross selling opportunity IMMUNO-MDX with most complete panel Post Transplantation Panel Immuno ID Assays MDX PANEL CMV VZV CMV ADENOVIRUS EBV TOXO EBV PARVOVIRUS HSV 1 PARVOVIRUS HSV 1 HHV6 HSV 2 HSV 2 HHV8 VZV JCV BKV Existing DiaSorin Market Share 37% Investor
Slide 70: WW Molecular Strategy and Post Transplant strategy
WW Molecular Strategy 3 and 3 Post Transplant strategy strategy Expand our position by developing menu content Targeted expansion into central core labs with on three discs in three segments (Reference Labs, automation and full transplant menu Hospital Labs and Community Hospital Labs) Investor Day
Slide 71: 2017-2019 financials
2017-2019 financials Investor Day 71
Slide 72: 2019 Revenues guidance (@ 2016 Exchange rates)
2019 Revenues guidance (@ 2016 Exchange rates) €/mln 2016A 2019E CAGR (*) Impact on top of existing business opportunities Revenues 569 ~ 735 ~ +9% 2017 2018 2019 Beyond 2019 Beckman Agreement in China CLIA tests 396 ~ 500 ~ +8% Roche Agreement US Gastro-Intestinal strategy QIAGEN Partnership LIAISO
Slide 73: EBITDA margin safeguarding initiatives
EBITDA margin safeguarding initiatives Yearly market price pressure & mix EBITDA margin sefeguarding initiatives Industrial processes optimization Services Efficiencies Me too -3% to -6% • Increase efficiency and productivity • Centralization of back-office services • Increase Operational flexibility •
Slide 74: 2019 guidance (@ 2016 Exchange rates)
2019 guidance (@ 2016 Exchange rates) €/mln 2016A 2019E CAGR (*) Revenues 569 ~ 735 ~ +9% CLIA Tests 396 ~ 500 ~ +8% ELISA Tests 77 ~ 70 ~ -3% Molecular Tests 32 ~ 52(**) ~ 87 ~ +40% ~ +18%(**) Instruments & Others 65 ~ 78 ~ +6% Ebitda 217 280-285 ~ +9% Ebitda Margin 38.2% ~ 38.5% Tax Rate 33.0% ~ 3
Slide 75: Main takeaways
Main takeaways Investor Day 75
Slide 76: Main takeaways
Main takeaways 1. Solid growth of the Immunoassay franchise with addition of innovative and differentiating new products 2. Launch of Liaison XS allows penetration of the small labs/POL segment 3. QIAGEN partnership demonstrates that DiaSorin is seen well positioned to serve the Specialty market als
Slide 77: DiaSorin The Diagnostic Specialist
DiaSorin The Diagnostic Specialist