2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed...

44
2018 Roadshow Presentaon

Transcript of 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed...

Page 1: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

2018Roadshow Presentation

Page 2: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 20182

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 relating to the Company.

Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and actual results may differ materially from those expressed in or implied by these forward-looking statements as a result of various factors, many of which are beyond the ability of DiaSorin S.p.A. to control or estimate precisely.The Company does not undertake to update or otherwise revise any forecasts or objectives presented herein, except in compliance with the disclosure obligations applicable to companies whose shares are listed on a stock exchange. 

Piergiorgio Pedron, the Officer Responsible for the preparation of corporate financial reports of DiaSorin S.p.A., in accordance with the second subsection of art. 154-bis, part IV, title III, second paragraph, section V-bis, of Legislative Decree February 24, 1998, no. 58, declares that, to the best of his knowledge, the financial information included in the present document corresponds to book of accounts and book-keeping entries of the Company. 

Disclaimer

Page 3: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 20183

We operate in two IVD segments

26%ONCOLOGY & ENDOCRINOLOGY

3%DRUG MONITORING 6%

ALLERGY

7%AUTOIMMUNITY

7%BONE & MINERAL

15%CARDIAC MARKERS

5%GI STOOL TESTING

13%INFECTIOUS DISEASES

18%HEPATITIS & RETROVIRUS

57%INFECTIOUS DISEASES

3%INHERITED DISEASES

5%TRANSPLANT

9%CANCER

11%HISTOLOGY

15%BLOOD SCREENING

Immunodiagnostics: ~ 18% of IVD market Molecular Diagnostics: ~ 12% of IVD market

Page 4: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 20184

Where we are

Page 5: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 20185

Revenues and EBITDA

434 435 444

499

569

637

775

170 163 160 185

217 238

300

2012 2013 2014 2015 2016 2017 2019*

Revenues EBITDA * 2019 Company Guidance

Data in €/mln

Page 6: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 2018

Immunodiagnostics

Page 7: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 20187

Area ofopportunity

MEN

U

AUTOMATION

SIGNAL TECHNOLOGY

RIA

ELISA

RIA

BENCH-TOPSOLUTIONS

(~ 200 ASSAYS)

FIRST AUTOMATEDSYSTEMS

FULLY AUTOMATEDSYSTEMS

FULL CONNECTIVITY(Immuno+Clinical Chemistry)

CLIA

Immunoassay innovation: 1970-2016

Page 8: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 20188

LIAISON family platforms

Magnetic particles

CalibratorsDiluent

Each test hasits specific cartridge

100 samples for each cartridge

Same raw materialfor routine and specialty tests

New in 2019

LAS

Conjugate

Page 9: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 20189

Installed base evolution

LAS

2009 2010 2011 2012 2013 2014 2015 2016 2017

3,641 4,078 4,135 4,197 4,207 4,044 3,880

128 605 1,075 1,665

2,292 3,518

+682 +437 +57 +62 +10 -163

+128 +477 +470 +590 +627

2,959

3,641

4,206 4,740

5,272 5,872

6,336

7,398

3,999

2,863

6,862

+571

-45 -119

+655

Page 10: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201810

Men

u

ONCOLOGY TUMOUR MARKERS

CEA

Free PSA

Total PSA

CA 15-3

CA 125 II

CA 19-9

TPA-M

NSE

S100

AFP

Tg

Tg Gen II(*)

hCG/ß-hCG

ß2-Microglobulin

TK

Calcitonin

ENDOCRINOLOGYTHYROID

TSH (3rd Gen.)

Free T3

Free T4

T3

T4

Tg

Tg Gen II(*)

Anti-Tg

Anti-TPO

GROWTHhGHIGF-I

ADRENAL FUNCTIONACTHCortisolDHEA-S

ANAEMIAFerritinFolate(*)Vitamin B12(*)

DIABETESC-PeptideInsulin

REPRODUCTIVE

ENDOCRINOLOGY

LH

FSH

Prolactin

Progesterone

Testosterone

Estradiol

hCG/ß-hCG

Androstenedione

SHBG

BONE & MINERAL25-OH Vitamin D TOTAL

N-TACT PTH II

Menu positioning: 118 tests - the broadest CLIA menu

Men

u

INFECTIOUS DISEASE EBV

EBV IgM

VCA IgG

EBNA IgG

EA IgG

H.PYLORI

H. Pylori IgG

TREPONEMA

Treponema Screen

SEPSIS

BRAHMS PCT II Gen

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

BORRELIA

Borrelia burgdorferi IgG

Borrelia burgdorferi IgM

MEASLES & MUMPS

Measles IgG

Measles IgM

Mumps IgG

Mumps IgM

VZV

VZV IgG

VZV IgM

VIRAL HEPATITIS & RETROVIRUSESHBsAg

HBsAg Quant

HBsAg Confirmatory test

Anti- HBs

Anti- HBs plus

Anti- HBc

HBc IgM

HBeAg

Anti-HBe

Anti-HAV

HAV IgM

HCV Ab

HIV Ab/Ag

HT HTLV I/II

CHAGAS

Chagas IgG

Men

u

STOOL DIAGNOSTICSC. difficile GDH

C. difficile Toxin A and B

H. pylori SA

EHEC

Rotavirus

Adenovirus

Calprotectin

Campylobacter

Elastase (*)

INFECTIOUS DISEASEZika IgM

PARVOVIRUS

Parvovirus B19 IgG

Parvovirus B19 IgM

BORDETELLA

Bordetella pertussis

Toxin IgG

Bordetella pertussis

Toxin IgA

MYCOPLASMA

Mycoplasma pneumoniae

IgG

Mycoplasma pneumoniae

IgM

CHLAMYDIA

Chlamydia T. IgG

Chlamydia T. IgA

TUBERCULOSIS

QuantiFERON TB Gold

Plus (*)

CHRONIC KIDNEY DISEASE1-84 PTH

Osteocalcin

BAP OSTASE

1,25 dihydroxy Vitamin D

ENDOCRINOLOGYHYPERTENSION

Direct Renin

Aldosterone

VIRAL HEPATITIS & RETROVIRUSESAnti-HDV

HEV(*)

HIV Ab/Ag

Men

u

CHRONIC KIDNEY DISEASESFGF-23

Ratio (Vitamin D 1,25-PTH 1,84)

Sclerostin (*)

* Under development

Page 11: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201811

Menu positioning: 118 tests - the broadest CLIA menuM

enu

ONCOLOGY TUMOUR MARKERS

CEA

Free PSA

Total PSA

CA 15-3

CA 125 II

CA 19-9

TPA-M

NSE

S100

AFP

Tg

Tg Gen II

hCG/ß-hCG

ß2-Microglobulin

TK

Calcitonin

ENDOCRINOLOGYTHYROID

TSH (3rd Gen.)

Free T3

Free T4

T3

T4

Tg

Tg Gen II

Anti-Tg

Anti-TPO

GROWTH

hGH

IGF-I

ADRENAL FUNCTION

ACTH

Cortisol

DHEA-S

ANAEMIA

Ferritin

DIABETES

C-Peptide

Insulin

REPRODUCTIVE ENDO-

CRINOLOGY

LH

FSH

Prolactin Progesterone

Testosterone

Estradiol

hCG/ß-hCG

Androstenedione

SHBG

BONE & MINERAL25-OH Vitamin D TOTAL

N-TACT PTH II

Men

u

INFECTIOUS DISEASE EBV

EBV IgM

VCA IgG

EBNA IgG

EA IgG

H.PYLORI

H. Pylori IgG

TREPONEMA

Treponema Screen

SEPSIS

BRAHMS PCT II Gen

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

BORRELIA

Borrelia burgdorferi IgG

Borrelia burgdorferi IgM

MEASLES & MUMPS

Measles IgG

Measles IgM

Mumps IgG

Mumps IgM

VZV

VZV IgG

VZV IgM

VIRAL HEPATITIS & RETROVIRUSESHBsAg

HBsAg Quant

HBsAg Confirmatory test

Anti- HBs II

Anti- HBs II plus

Anti- HBc

HBc IgM

HBeAg

Anti-HBe

Anti-HAV

HAV IgM

HCV Ab

HIV Ab/Ag

HT HTLV I/II

CHAGAS

Chagas IgG

Men

u

STOOL DIAGNOSTICSC. difficile GDH

C. difficile Toxin A and B

H. pylori SA

EHEC

Rotavirus

Adenovirus

Calprotectin

Campylobacter

INFECTIOUS DISEASEZika IgM

PARVOVIRUS

Parvovirus B19 IgG

Parvovirus B19 IgM

BORDETELLA

Bordetella pertussis

Toxin IgG

Bordetella pertussis

Toxin IgA

MYCOPLASMA

Mycoplasma pneumoniae

IgG

Mycoplasma pneumoniae

IgM

CHLAMYDIA

Chlamydia T. IgG

Chlamydia T. IgA

CHRONIC KIDNEY DISEASE1-84 PTH

Osteocalcin

BAP OSTASE

1,25 dihydroxy Vitamin D

ENDOCRINOLOGYHYPERTENSION

Direct Renin

Aldosterone

VIRAL HEPATITIS & RETROVIRUSESAnti-HDV

Men

u

CHRONIC KIDNEY DISEASESFGF-23

Ratio (Vitamin D 1,25-PTH 1,84)

Sclerostin (*)

Vitamin K (*)

* Under development

Me too tests#46

Differentiating specialties#28

Investigational markers#2

High volume specialties#42

Page 12: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201812

Where we plan to invest R&D money

Differentiating specialties Me too testsHigh volume specialtiesInvestigational Markers

2

29

62

28

42 46

2

6 2

2017: DiaSorin products available

2018-2019: DiaSorin new tests

# tests of the main competitorwithin the area

22

Page 13: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201813

1998 2006

VITAMIN D

EBV PANEL (4)

DIRECT RENIN

BORRELLIA

HSV 1 IGG

TORCH (11)

PARVOVIRUS (2)

PARVOVIRUS (2)

BORDETELLA

ZIKA IGM

FGF 23

MUMPS IGM

1,25 VITAMIN D

STOOL DX ASSAYS (8)

ALDOSTERON

DIRECT RENIN

CHLAMIDIA T. (2)

MEASLES IGM

ALDOSTERON

MYCOPLASMA (2)

HSV 2 IGG

VZV IGG

TREPONEMA

2007 20082010 2011

20122013

20142015

2016

2017

DiaSorin «First» : Fully Automated CLIA assays

> 45 times «First»in the last 10 years

Page 14: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201814

Development of Differentiating Specialty Tests

R&D Pipeline

Internal Development

Leverage on LIAISONContent & Technology

Products creating complementary opportunities that

should generate €/mln 25-50 each

Development ofdifferentiatingspecialty tests

Access to partner’s specialties

e.g.ZIKA Test

B·R·A·H·M·S

Differentiating specialties

New from 2019

Page 15: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201815

LIAISON XS: the opportunity

Moderate to Highcomplexity POLs

Professional Medical Service Institution

These POLs use Instruments normally found in Hospitals and Private Labs

Basic Medical Service Institution

27,467

COMPLIANCE

PPM

11,721

5,767

18,296

37,763

UNRATED HOSPITAL9,440

8,966

MATERNAL & CHILD HEALTHCARE STATION

3,071

CDC

3,484

75,964 ACCREDITATION

WAIVER

PUBLIC TOWNSHIP

HOSPITAL

CLASS 2 HOSPITALCLASS 1 HOSPITAL

PUBLIC COMMUNITY MEDICALSERVICE CENTER

7,700

2,155CLASS 3 HOSPITAL

Page 16: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 2018

Molecular Diagnostics

Page 17: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201817

MEN

U

AUTOMATION

AMPLIFICATION / DETECTION

PCR Singlex

Multiplex

- Arrays

- Sequencing

Technologies in the Molecular Diagnostic Market

Area ofopportunity

Area ofopportunity

Page 18: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201818

Platforms in the Molecular Diagnostic Market

Point of Care systems

CLIAwaived

Limited menu (e.g. FLU)

Singletarget

Multiplex

Direct AmplificationDisc (DAD)

Multiplex Disc Universal Disc (UD)

Total Lab Automation

New Project

Limited menu(HCV, HIV, HBV, HPV, CT/NG)

High throughput systemsBenchtop systems

DiaSorin positioning

Page 19: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201819

Our technology: Liaison MDX

Direct Amplification Disc(DAD)

8 reaction wellLow to Mid Volume

96 reaction wellHigh Volume

Universal Disc(UD)

Compact. Powerful. Expandable.Technology

Unique technology developed by 3M, with no extraction required

VersatileSame platform, multiple discs

PCR Based

ASRs & Kits

Page 20: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201820

DiaSorin menu positioning

Analyte Specific Reagents(ASRs for US market only)

Real-time PCR assays for quantitative,qualitative and multi-analyte detection

Infectious Disease Transplant Inherited Diseases

Respiratory

Meningitis Vector Borne

Monitoring CoagulationWomen’s

Health/STIHAI/ Gastro

13 61

ASRs

Lab Developed Tests (LDT)

Page 21: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201821

Molecular kits and ASRs

ASRs

ASRs

KitsKits

Kits

Produced by manufacturer rigorously tested for safety and efficacy in clinical trials for “approval or clearance”

Sold as separate components instead of a kit, building blocks or “active ingredients” of LDT

Manufactured in compliance with cGMPs to help ensure quality

Level of complexity given to approved test

Highly complex to Clia Waived

ASRs

Page 22: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201822

Molecular Kits Pipeline Strategy

Competitive Intensity

Leve

l of D

iffer

entia

tion

3 years pipeline strategy

RESISTANCE ASSAYS

ATYPICAL PNEUMONIA

M. GENITALIUM

VZV

ENTERIC PANELS

GROUP B

STREP

CONGENITAL

CMV

BORDETELLA

VectorBorne

MENINGITIS

HSV - MC/C

VAGINOSIS

Differentiating specialties Me too testsHigh volume specialtiesInvestigational Markers 3-5 years pipeline strategy

Kits

Avg. # 2 new Kits / Year

Page 23: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201823

Avg. # 4 new ASRs / YearReagents ASRs

2017 - 2019 2019 - beyond

InfectiousDisease

Immuno-compromised

Respiratory

ResistanceVector-Borne

Gastro-intestinalinfections

Genetics

ASRs Pipeline Strategy

Differentiating specialties

Page 24: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201824

Europe: Options in High Throughput testing

Viral Load Monitoring

HIVHepatitis B VirusHepatitis C Virus

Big PlayersEstablished Systems

Well ServedHighly Competitive

Very Late Entry

Established PlayersCompetitive Arena

Barriers to Entry (HPV)Rapidly Eroding Price

No Clear LeaderBig Players AbsentImprove WorkflowMore Stable Price

DS knows this Market

Post Transplantation offers path to entry

Women’s Health

CT/NG/TVHPV

Post Transplantation

CMV/EBV/BKVHSV/VZV

HHV6/HHV8/AdenoParvo/JCV

Page 25: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201825

Europe Molecular Post Transplant

Instrument forextraction/PCR set up

Provide complete transplant menu

11 transplant assays

CMV

EBV

BKV

HSV 1

HSV 2

VZV

HHV6

HHV8

ADENOVIRUS

PARVOVIRUS

JCVLIAISON MDX forAmplification

Strategy

Page 26: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201826

Post TransplantationPanel

Immuno ID Assays

Existing DiaSorinMarket Share 37%

MDX PANEL

Expand cross selling opportunity IMMUNO-MDXwith most complete panel

CMVEBVHSV 1HSV 2

CMVEBVHSV 1HSV 2VZVBKV

VZVTOXOPARVOVIRUS

ADENOVIRUSPARVOVIRUSHHV6HHV8JCV

Europe: IMMUNO - MDX Synergy

Market size estimates:~100 €/mln

Page 27: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 2018

Mid-term objectives

Page 28: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201828

1

2

3

4

5

6

7

2019 targetsSolid growth of the Immunoassay franchise with addition of innovative and differentiating new products Revenues

~ 775 €/mln

CAGR 16-19: ~ +11%

2019 Company Guidance

EBITDA295-300 €/mln

EBITDA Margin: ~ 38.5%

CAGR 16-19: ~ +11%

NET RESULT160-165 €/mln

On sales: ~ 21.0%

CAGR 16-19: ~ +13%

CUMULATIVE FREE CASH FLOW

465-475 €/mln

Launch of Liaison XS allows penetration of the small labs/POLs segment

QIAGEN partnership demonstrates that DiaSorin is seen well posi-tioned to serve the Specialty market also by other large IVD players

Conversion of SIEMENS’ Elisa customers base to LIAISON XL/XS platforms

Molecular Diagnostics is a second leg and will offer lots of opportunities to develop Specialty ID products

Strong financial performance driven by solid margins in both segments (IA and Molecular)

Committed to targeted bolt on acquisitions to strengthen our product portfolio or allow access to new customers in consolidated markets

Page 29: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201829

2008-2009 2010 2011-2012 2015-20162013-2014 2017

CLIA menuexpansionTechnological

evolution

Geographicexpansion

Partnership

M&A

LIAISON XL

MERIDIANBIOSCIENCE

PortugalAustria

Czech RepublicCanada

AustraliaIreland

South AfricaNetherlands

India

BIOTRINMUREX

(ABBOTT ELISA business)

NORDIAG FOCUSDIAGNOSTICS

SIEMENS ELISAbusiness

Switzerland Poland

ROCHE BECKMANCOULTER

QIAGEN

TECAN

LIAISON IAMLIAISON IXT LIAISON MDX

LIAISON XSproject

(launch in 2019)

Business Development, partnerships and M&A

Page 30: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 2018

Q3 and 9M 2018 Results

Page 31: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201831

Highlights

FREE CASH FLOW

PRODUCT DEVELOPMENT

REVENUES €/mln 162.8 (*) +9.0% +9.5%

EBITDA €/mln 58.9 +5.3% +6.8%

EBITDA MARGIN

-128 bps

36.2%

22.1%

+22.7% €/mln 35.9 NET RESULT

+€/mln 128.8 NET FINANCIAL POSITION (**)

MOLECULAR

HSV (US market) KIT Infectious diseases

9M’18

€/mln 494.0 (*)

€/mln 187.1

€/mln 116.8

€/mln 100.6

+ 5.4% + 9.1%

+ 9.8% + 8.7% CLIA EX VIT D 25 OH + 10.3% + 7.5%

- 3.4% - 3.0% VIT D OH25 - 3.3% - 8.1%

+25.9% + 24.7% ELISA TESTS + 27.3% + 23.0%

- 0.0% + 4.0% M OLECULAR TESTS + 8.5% + 1.6%

+16.5% + 15.0% INSTRUMENTS & OTHER REV. + 6.5% + 3.6%

+2.7% +7.5%

- 99bps

37.9%

23.6%

+22.0%

ASRs Reagents specific to bacterial target carried by ticks

Anaplasma phagocytophilum

Ehrlichia

Babesia

IMMUNO

PCT II GEN (US market) Infectious diseases

-100 bps -60bps

36.5% 38.3%

@ CER @ curr

* Revenues include Siemens’s ELISA business contribution (consolidated as of Sept 2017)

** NFP does not include debts vs. shareholders for special dividends for €/mln 98.4

@ CER @ curr

% ON REVENUES HDV (CE mark) Hepatitis & Retrovirus

~ +9% at CER vs 2017 ( °)

~ +12% at CER vs 2017 ( °)

(°) 2017 €/US$ avg. exchange rate = 1.13

COMPANY GUIDANCE

FY 2018

EBITDA

REVENUES

+3.1%

BUSINESS DEVELOPMENT

VZV (EU market)

Group B Strep (EU market, US market submission)

Launched in the CE market in partnership with QIAGEN, the LIAISON QuantiFERON-TB Gold Plus as an aid to detect latent tuberculosis infection on LIAISON analyzer systems .

LIAISON QuantiFERON TB-GOLD PLUS

Signed on October 9, 2018 in order to sell DiaSorin’s FDA-cleared Helicobacter pylori stool antigen test to detect H. pylori for use on LIAISON platform in the U.S . and U.K.

Strategic collaboration with Meridian

PRODUCT DEVELOPMENT

(°) Eventual postponement to 2019 of certain large tenders to countries served through distributors could negatively affect 2018 financial statements closure.

Q3’18

Page 32: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201832

Q3 and 9M 2018 revenues growthQ3’18 vs. Q3’17

@ CER

@ curr Total Group revenues

• Vitamin D volumes slowdown (mainly US ) • MUREX sales slowdown (mainly in Export, China and

Brazil ) • FOREX : -€/mln 17.5

9M’18 vs. 9M’17

• All CLIA tests, net of Vitamin D • Siemens’s ELISA business ( acquired in

Sept 2017) • Molecular diagnostic kits

CLIA ex Vitamin D tests +8.7%

+9.8%

Vitamin D test (CLIA) -3.0%

-3.4%

CLIA

ELISA tests (*) +24.7%

+25.9%

Instruments & Other Revenues +15.0%

+16.5%

Molecular Diagnostic tests +4.0%

-0.0%

+7.5%

+10.3%

-8.1%

-3.3%

+23.0%

+27.3%

+3.6%

+6.5%

+1.6%

+8.5%

@ CER

@ curr

@ CER

@ curr

@ CER

@ curr

@ CER

@ curr

@ CER

@ curr

* Including the contribution of Siemens’s ELISA business, consolidated as of September 2017

Q3’18 vs. Q3’17 9M’18 vs. 9M’17

EUROPE & AFRICA

Germany +22.6%

+12.5%

+22.7%

+14.3%

Italy +8.2% +9.1%

France +15.9%

NORTH AMERICA

USA -1.8%

-1.0%

+16.3%

-0.7%

+0.0%

ASIA PACIFIC

China

Distributors

Australia

+4.3%

+12.4%

+64.6%

+23.1%

+1.5%

+17.1%

+40.0%

+16.0%

Q3’18 vs. Q3’17 9M’18 vs. 9M’17

Brazil

LATIN AMERICA

Distributors

-10.5%

+1.3%

-0.4%

+1.6%

Mexico +26.2% +10.1%

+6.8% +0.4%

Growth boosted by CLIA ex Vitamin D tests.

Positive contribution from molecular diagnostic kits

Growth in CLIA tests, partially offset by downward trend in Murex ELISA and Instruments sales

Growth driven by Siemens’ ELISA business and instruments sales

Upward trend in CLIA tests and growth from Siemens ’ ELISA business

Positive performance of CLIA tests offset by a negative trend in Murex ELISA (mainly due to a delay in public clients’ payments), Vitamin D and instruments sales

Positive performance

driven

by

CLIA

tests

Managerial outlook on reported data; Change QoQ and 9Mo9M @ CER

+9.0% +5.4%

+9.5% +9.1%

Increase in all CLIA tests (mainly GI stool panel, Vitamin D 1,25, PCT and Hepatitis & Retrovirus panel)

Growth driven by CLIA ex Vitamin D tests and Siemens’ ELISA business acquisition. Negative contribution from Vitamin D (mainly price pressure)

Positive contribution from CLIA ex Vitamin D, offset by lower Vitamin D (mainly volumes)

Growth driven by instruments sales, Siemens’ ELISA business and CLIA tests (mainly endocrinology, autoimmunity, thyroid and Vitamin D 1,25)

Page 33: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201833

9M 2018 revenues breakdownby technology

CLIA tests

67.4%

Instruments & other revenues

12.0%

Molecular

diagnostic tests

8.5%

ELISA tests

12.1%

CLIA tests

65.9% ELISA tests

14.2%

Molecular

diagnostic tests

8.2%

Instruments & other revenues

11.7%

by geography

North America

31.8%

Latin America

7.4%

Asia Pacific

18.1%

Europe & Africa

42.7%

North America

28.2%

Latin America

6.4%

Asia Pacific

19.3%

Europe & Africa

46.1%

(*) Revenues include Siemens’ ELISA business acquired on Sept 29, 2017

5

9M’18 9M’18 (*)(*)

9M’179M’17

9M’18 9M’18 (*)(*)

9M’179M’17

Page 34: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201834

Installed base expansion7,398 7,501 7,623

+116

-13

+123

-1

@ Dec 31, 2017 @ March 31, 2018 @ June 30, 2018

-31

3,880 3,867 3,866

3,518 3,634 3,757

+367

3,849

3,885

7,734

@ Sept 30, 2018

-17

+128

Page 35: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201835

Q3 and 9M 2018 profitability profile

+ 7.5%

9M’18 EBITDA upward compared to 9M’17 notwithstanding:

• some one-off costs related to a legal action with Meridian(*), closed with a strategic agreement announced on Oct. 9, 2018 and the closure

of the Irish manufacturing site

• FOREX negative impact (-€/mln 8.8)

EBITDA (€/MLN)

EBITDA MARGIN

+5.3%

-128 bps

Change %

+2.7%

-99 bps

Change %

38.3%

+6.8%

36.5%

182.2 187.1

38.9% 37.9%

56.0 58.9

37.5% 36.2%

9M’18 Q3’17 Q3’18 9M’17

@ CER

@ CER - 100 bps - 60 bps

(*) Press release available in the Investor Relations section on www.diasorin.com

(*) Press release available in the Investor Relations section on www.diasorin.com

Page 36: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 2018

Business Development

Page 37: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201837

Business and product development

Rationale

Technology

Impact on revenues

in China in the US

Increase penetration in big labs

Immuno (CLIA)

Increase penetration in big labs

Launch Hepatitis & Retroviruses

panel

PARTNERSHIPS

Market share: conversion from ELISA to CLIA

Immuno (ELISA)

New market opportunities leveraging on

QFT technology

Immuno (CLIA)

Immuno (CLIA) Molecular

(Extraction)

Extraction for European post transplantation

strategy

PORTFOLIO ACQUISITION

NEW PRODUCT CO-DEVELOPMENT NEW PLATFORMS DEVELOPMENT

Immuno (CLIA) Immuno (CLIA)

Beyond 2019

2019

2018

2017

Access to new mkt segment:POLs (US)

Class I-II hospitals (China)

Hub and Spoke (EU)

Page 38: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 2018

2017 -2019 guidance

Page 39: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201839

2017-2019 guidance

1 Solid growth of Immunoassay franchise with addition of innovative and differentiating new products

2 Launch of LIAISON XS allows penetration of the small labs/POLs segment

QIAGEN partnership demonstrates that DiaSorin is seen well positioned to serve the Specialty market also by other large IVD players

3

5 Molecular Diagnostics is a second leg and will offer lots of opportunities to develop Specialty ID products

Conversion of SIEMENS’ Elisa customers base to LIAISON XL/XS platforms 4

6 Strong financial performance driven by solid margins in both segments (Immunoassay and Molecular)

2018 2016

637.5

+12.0% reported

+13.1% @ CER

2016

~ +9% @ CER

2017 (**)

2017-2019 STRATEGIC GOALS GUIDANCE DATA IN €/MLN

Committed to targeted bolt on acquisitions to strengthen our product portfolio or allow access to new customers in consolidated markets

7

ACTUAL RESULTS DATA IN €/MLN

2017

569.3

217.3

REVENUES

EBITDA

2019

237.9

+9.5% reported

+11.5% @ CER 2016

EBITDA REPORTED

241.2

+11.0% reported

+13.0% @ CER

2016

EBITDA ADJUSTED (*)

3-years plan guidance confirmed

EBITDA

3-years plan guidance confirmed

~ +12% @ CER

2017 (**)

REVENUES

(*) Managerial outlook on reported data: net of positive contribution from acquisition of Siemens’ ELISA business and non recurring costs related to closing of Irish facility

(**) Eventual postponement to 2019 of certain large tenders to countries served through distributors could negatively affect 2018 financial statements closure.

Page 40: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 2018

Annexes

Page 41: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201841

Income Statement

Net revenues

Gross profitGross Margin

S&M

R&D

G&A

Total operating expenses% on sales

Other operating income (expense)

EBITEBIT margin

Net financial income (expense)

Profit before taxesIncome taxes

Net result

EBITDAEBITDA margin

Data in € million2017 2018 amount %

149.4 162.8 +13.4 +9.0%

100.5 109.2 +8.7 +8.6%67.3% 67.1% -21 bps

(29.7) (32.2) -2.5 +8.4%

(10.7) (11.2) -0.5 +4.2%

(15.0) (17.2) -2.3 +15.2%

(55.4) (60.7) -5.2 +9.4%37.1% 37.3% +15 bps

(1.4) (2.2) -0.8 +58.5%

43.7 46.3 +2.6 +6.0%29.2% 28.4% -79 bps

(1.1) (0.5) +0.6 -56.4%

42.5 45.8 +3.3 +7.7%(13.3) (9.9) +3.4 -25.4%

29.3 35.9 +6.6 +22.7%

56.0 58.9 +3.0 +5.3%37.5% 36.2% -128 bps

Q3 Change

2017 2018 amount %

468.6 494.0 +25.3 +5.4%

319.7 336.0 +16.3 +5.1%68.2% 68.0% -20 bps

(89.8) (97.2) -7.4 +8.2%

(32.3) (33.4) -1.1 +3.4%

(47.9) (49.2) -1.2 +2.6%

(170.1) (179.8) -9.7 +5.7%36.3% 36.4% +11 bps

(4.8) (6.9) -2.1 +43.0%

144.8 149.3 +4.5 +3.1%30.9% 30.2% -67 bps

(4.1) 0.8 +4.9 n.m.

140.7 150.1 +9.4 +6.7%(45.0) (33.4) +11.6 -25.9%

95.7 116.8 +21.1 +22.0%

182.2 187.1 +5.0 +2.7%38.9% 37.9% -99 bps

9M Change

Page 42: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201842

Balance Sheet

Goodwill and intangibles assets 344.4 355.8 +11.4

Property, plant and equipment 92.3 92.9 +0.5

Other non-current assets 23.8 24.8 +1.0

Net working capital 190.7 215.2 +24.5

Assets held for sale 4.0 - -4.0

Other non-current liabilities (62.5) (60.6) +2.0

Net Invested Capital 592.7 628.1 +35.4

Net Financial Position 149.3 128.8 -20.5

Debts vs. shareholders for special dividends - 98.4 +98.4

Total Shareholders' equity 742.0 658.4 -83.5

ChangeData in € million 12/31/17 09/30/18

Page 43: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201843

Cash Flow Statement

Cash and cash equivalents at the beginning of the period

Operating activities

Investing activities

Financing activities

Acquisitions of companies and business operations

Net change in cash and cash equivalents before investments in financial assets

Divestment/ (Investment) in financial assets

Net change in cash and cash equivalents

Cash and cash equivalents at the end of the period

Data in € million2017 2018

107.9 104.6 -3.3

48.9 45.0 -4.0

(13.0) (14.1) -1.1

17.8 (6.7) -24.5

(30.5) (0.6) +29.9

23.3 23.5 +0.3

(13.7) 13.1 +26.8

9.6 36.6 +27.0

117.5 141.2 +23.7

Q3Change

2017 2018

130.5 159.3 +28.9

125.9 133.4 +7.5

(30.1) (35.1) -5.0

(42.4) (125.3) -82.9

(31.5) (5.1) +26.5

21.8 (32.1) -53.9

(34.8) 14.0 +48.8

(13.0) (18.1) -5.2

117.5 141.2 +23.7

9MChange

Page 44: 2018 Roadshow Presentation - DiaSorin...Women’s Health/STI HAI/ Gastro 13 61 ASRs Lab Developed Tests (LDT) 21 Roadshow Presentation - November 2018 Molecular kits and ASRs ASRs

Roadshow Presentation - November 201844