Investor day 2015

Page 1

DiaSorin InvestoR Day Driving our business through innovation

2015-2017


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 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. Luigi De Angelis, 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.Â

investor day

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What we do

1

5

a patient feels sick and refers to the physician. on the basis of symptoms the physician suspects a pathology

Patient goes back to the physician with test results used to diagnose the pathology

2

Patient goes to a diagnostic lab and a blood sample is taken

3

4

the blood sample is mixed with specifically designed tests in an automated platform

Lab technicians give tests back to the patient

investor day

3


From 2011-2015 to 2015-2017 Plan

5 1 0 2 1 1 0 2 7 1 0 2 5 1 0 2 investor day

4


Revenues comparison between 2011-2015 Plan and Actual 2011-2015 PLan

+101 ¤/mln

304

405

450

¤/mln

¤/mln

¤/mln

2009

2010

2011

2011-2015 actuaL

304

¤/mln change in revenues

630680 ¤/mln

2012

2013

2014

2015e

444

480485*

+101 ¤/mln

405

¤/mln vitamin D revenues

440 ¤/mln

434

¤/mln

435

¤/mln

¤/mln

¤/mln

cLia ex vitamin D revenues

* data based on 2015 guidance: revenues growth at Cer +4-5% and on the assumption of exchange rate eUr/Usd = 1.15 investor day

5


Installed base evolution

+~ 550 * +600 +532

+534 +565 +682

128

605

440 5/mln

1,075

1,665

435

444

5/mln

5/mln

2,959

3,641

4,078

4,135

4,197

4,207

2009

2010

2011

2012

2013

2014

* data based on 2015 guidance

480485 5/mln

2015e

totaL instaLLeD base growth investor day

6


Product Development comparison between 2011-2015 Plan and Actual

2011-2015 PLan

GROWTH

INfEcTIOuS dISEASES

STOOL dIAGNOSTIcS

HYPERTENSION

+11 INfEcTIOuS dISEASES

2011-2015 actuaL

BONE & MINERAL

+16

GROWTH

TuMOuR MARKERS

BONE & MINERAL

INfEcTIOuS dISEASES

STOOL dIAGNOSTIcS

HYPERTENSION

+20 +7

INfEcTIOuS dISEASES

TuMOuR MARKERS

investor day

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2015-2017 PLAN:

STRATEGIC SETTING


Technology development

YE

Y A D R STE

Y A D R E T S E

Y

taLLed U s n i n o n f Liais ad CLia me o n o i o LiDat he Br conso veraging t e h Base, L BiLity rowt g d n a a h avaiL Launc , t n e oPm DeveL on xL: andom r d s n i a a t e of Li UghPU t fitting th o r h t - high instrUmen LaBs e s aCCes f mid-Larg e o aiLaBL v a t n needs te U Con n e m L - fUL Cation i f i L P am nt of mP) e m P o deveL Logy (Q-La o iam teChn aison i L f o h Ction d LaUnCh a r t LaUnC x n fe tion o now-how a i s i U q K aC oLogy n h C e t t ison ix of Lia

W O R R O M TO

Base d e L L a n inst o s i a i L n xL nt of o e s i m e a i g n of L mana o i s n a P ous ex u n i t : con base tivity c D e e L n L n insta Las co L x n Liaiso n o D L bui shiPs e r n e o n L t a r gh Pa U o r h on xs -t s i a i L nt of e m P o DeveL ogy L o t a m o-hae c n o iam in n o s i on ixt s i Lia a i L ion of t a d i L Conso ning PLete m o c o with a Positi g n i n ositio ion P n i r diaso Lar soLut u moLec

investor day

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Technological full spectrum solution: from small to mega automation connectivity GA E M IG /B BS LA

stanD aLone soLution

E

Low focus of main competitors market segment with unmet needs (PoLs & emerging markets) obsolete installed base

Las

IZ S ID

S B A L

ease oF use

M

Liaison速 xs

s

L

L A M

E Z I S

S AB

/

L PO

L

S

investor day

10


lIAISON XS: Strategic Positioning SmAll-SIzE lAbS / POls < 200,000 TubES / YEAR

DIASORIN POSITIONING tests/year

~12,000-24,000

system cost

~50% of Liaison xL

reagents & consumables

same of Liaison xL

technical functioning and software

remote connectivity investor day

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lIAISON XS positioning: POls in uSA

total immunoassay market value of PoLs in usa: > 300 $/mln

accessible immunoassay market value: > 260 $/mln

with low volumes, depending

12%

on the specific needs of

Low volumes

analysis with specialty and

moderate volumes Ultra-low volumes

total market: > 115,000 PoLs in usa

provide a reliable and efficient solution for cLia tests in Labs

4%

high volumes

Liaison xs is designed to

59% 25%

routine tests

Liaison xs

accessible market: 18,000 PoLs in usa (cLia certified)

source: Company data investor day

12


Product Development

W O R R O M TO

Y A D R E T S E

d high

ty an L a i c e as sP

Y

e

n routi h g i h and

ciaLty e P s n o ge evera foCUs L : y g e at r tests oo str nd the offe t e m xPa anD and hooK iaLties to e g. hePatitis C . on sPe roUtine (e h arKet to hig irUs) m e h t v on retro menu a i L c est broaD ts) s (114 te tative i L a u Q es and s s a e s i t ious D gy tes inFect aematoLo h oncos n test o i t c a extr

ation D i L y 2017 B o s t : e r K e r con y he ma ne PLa t i t n u o o s r a test i L C 5 3 - 130-1 tion: a v rKers o a n m n i g n n o existi f Focus o e s ative U v o n n s -i arKer m e v i vat - inno ests t y g o matoL e a h onco e v i t a it Quant s n test o i t c extra

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Innovative use of Existing markers & Innovative markers

clinical approach strategy to drive market expansion Prescribers, regulators and Payers demand greater evidence of healthcare value Development of robust and sustained clinical program critical to commercial success

innovative use of existing markers

innovative markers investor day

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Innovative use of existing markers

cLinicaL areas

marKers

stuDies in PiPeLine

• hypertension

• aldosterone, renin,

• broader clinical use

• heart Failure

infectious Diseases,

• chronic Kidney Diseases

1,25 vitamin D,

• Diabetes

FgF-23…

• gastroenterology

• new clinical indications • Pharma-economic benefits

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Practical Example of innovative use of existing markers heart Failure

chronic Kidney Diseases

vit D 1,25 Pth 1,84 identification of heart Failure Phase and Potential outlook on its evolution

Phase

1

2

34

FgF-23 Patients with chronic Kidney Diseases requiring a prognostic test of deterioration of renal activity

stage

1

2

34

680,000 Patients (in Usa)

18 million of Patients in cKD (in Usa)

intellectual Property

intellectual Property investor day

16


Innovative markers

existing markers

innovative markers

clinical utility

accepted

Likely but not yet demonstrated/accepted

market

defined and acknowledged

small/not yet exploited

competition

high

Low / not existing

Development

Linear

Challenging

risk

Limited risk of technical failure

more demanding technical development

iP Protection

Limited / not existing

available

investor day

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Pratical example of innovative markers

sclerostin - a Protein ProdUCed By oUr Body that redUCes the Bone mass - its deteCtion and qUantitation in BLood might have a diagnostiC UtiLity in high PrevaLenCe CLiniCaL Conditions CharaCterized By Bone mass Loss (e.g. PostmenoPaUsaL osteoPorosis and CKd)

sCLerostin Can Bring to:

new CLiniCaL CLaims agreement with Pharma for ComPanion diagnostiC investor day

18


Driving business through innovation

a m

rK

s r e

ma

rK

et

g n i t e s i te · ex vativ o c · n L h i a · in · Li iso no L · Li aiso n x o a s gy · co iso n nne nx ctiv L ity (xL La s)

investor day

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2015-2017 PLAN:

mARKET AND PRODuCTS


IVD market: Immunodiagnostic

in vitro Diagnostic (ivD) market

immunodiagnostic market

value: ~ 造 45 billion POINT OF CARE MICROBIOLOGY HAEMATOLOGY

7%

value: ~ 造 8.1 billion

OTHER MOLECULAR DIAGNOSTIC

9%

ONcOLOGY ANd ENdOcRINOLOGY

26%

12%

6% 6%

dRuG MONITORING

CLINICAL CHEMISTRY

18%

IMMuNOdIAGNOSTIc

ALLERGY

21% AuTOIMMuNITY

21% SELF-MONITORING BLOOD GLUCOSE

18%

HEPATITIS ANd RETROVIRuSES

3% 6% 15%

7%

GI STOOL TESTING

5%

7%

BONE&MINERAL

cARdIAc MARKERS

13% INfEcTIOuS dISEASE

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broadest ClIA menu in the world

114 tests 83 high routine tests 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

31 specialty tests MYCOPLASMA

Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM

MEASLES & MUMPS Measles IgG Measles IgM Mumps IgG Mumps IgM

CHLAMYDIA

Chlamydia t. IgG Chlamydia t. Iga

BORRELIA

Borrelia burgdorferi IgG Borrelia burgdorferi IgM

BOrDEtELLA

Bordetella pertussis toxin IgG Bordetella pertussis toxin Iga

VIRAL HEPATITIS AND RETRoVIRuSES HBsAg(2) HBsAg Quant(1) HBsAg Confirmatory test Anti- HBs II Anti- HBs II plus Anti- HBc HBc IgM HBeAg Anti-HBe Anti-HAV HAV IgM HCV Ab(1) HIV Ab/Ag(1) HIV Ab/Ag HT(1) HTLV I/II(1)

CHAgAS

REPRODUCTIVE ENDOCRINOLOGY

LH FSH Prolactin Progesterone Testosterone Estradiol hCG/ß-hCG

ANAEMIA Ferritin

HYPERTENSION Direct Renin Aldosterone

Chagas IgG(1)

GROWTH hGH IGF-I

ADRENAL FUNCTION ACTH Cortisol DHEA-S

THYROID

TSH (3rd Gen.) Free T3 Free T4 T3 T4 Tg Anti-Tg Anti-TPO

DIABETES VZV

VZV IgG VZV IgM

EBV

EBV IgM VCA IgG VCA IgA** EBNA IgG EA IgG

** Under Development 1 - Available on LIAISON® XL only 2 - Available on LIAISON® only

SEPSIS StOOL DIAGNOStICS C. difficile GDH (2) C. difficile toxin a and B (2) H. pylori Sa EHEC (2) Rotavirus adenovirus Calprotectin Campylobacter*

Treponema Screen

CARDIAC MARKERS Troponin I(2) Myoglobin(2) CK-MB(2)

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

BONE & MINERAL

C-Peptide Insulin

BRAHMS PCT®(2) BRAHMS PCT® II Gen

TREPoNEMA

TUMOUR MARKERS

AUTOIMMUNITY ANA Screen(2) dsDNA(2) tTG IgA(2) ENA Screen(2) Cardiolipin IgG(2) Cardiolipin IgM(2)

25-OH Vitamin D TOTAL N-TACT® PTH Gen II 1-84 PTH Osteocalcin BAP OSTASE® 1,25 dihydroxyvitamin D(1) FGF 23** Sclerostin**

investor day

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Immunodiagnostic Pipeline: 2015-2017 area bone & mineral

2015

2016

2017

6 to 8 tests

6 to 8 tests

sclerostin fgf-23

gi stool testing

infectious Diseases

Campylobacter

Bordetella g* Bordetella a* PCt ii* h. Pylori igg hCv ii

endocrinology

*already available on the market investor day

23


IVD market: molecular Diagnostic

in vitro Diagnostic (ivD) market

molecular Diagnostic market value: ~ 造 5.4 billion

value: ~ 造 45 billion OTHER HAEMATOLOGY

IMMUNODIAGNOSTIC

9%

18%

6%

OTHER

26% 25%

POINT OF CARE

7% MICROBIOLOGY

6% 12%

MOLEcuLAR dIAGNOSTIc

60%

ONCOLOGY

15% CLINICAL CHEMISTRY

21%

21%

INfEcTIOuS dISEASES

SELF-MONITORING BLOOD GLUCOSE

investor day

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Onco-Haematology Diasorin strategy • market Leadership on specialties in onco-haematology • development and launch of qualitative onco-haematology tests (e.g. BCr aBL launched in 2014), followed by quantitative tests • the most complete menu to diagnose and monitor the different types of Leukemia by 2017 • Leverage the existing portfolio of 6 infectious diseases tests

Diasorin tests in this clinical area

Positioning of Liaison iam development of molecular amplification technology (q-LamP)

bcr-abL 190

ChroniC myeLoid LeUKemia aCUte LymPhoBLastiC LeUKemia

PmL-rara

aCUte PromyeLoCytiC LeUKemia

assays differentiating the current methodology (PCr)

bcr-abL 210

ChroniC myeLoid LeUKemia

easier to use

amL1-eto

aCUte myeLoid LeUKemia

rapid diagnostic response

cbFb-myh11

aCUte myeLoid LeUKemia

sensitivity, accuracy and reliability

investor day

25


molecular Diagnostic Pipeline: 2015-2017 area Qualitative onco-haematology

2015

2016

PmL-rar 1-3

amL-eto 1

PmL-rar 2

cbF D-e

2017

cbF a Quantitative onco-haematology

bcr-abL P210

bcr-abL P190 + abL

bcr-abL abL

PmL-rar 1 + abL PmL-rar 2 + abL PmL-rar 3 + abL

investor day

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2015-2017 PLAN:

BUSINESS EXECUTION


Technological full spectrum solution: from small to mega AUTOMATION CONNECTIVITy

500,000 - 1,200,000 TUbES/yEAr

Automation and consolidation: key competitive drivers Price pressure and focus on routine testing

GA E M IG /B BS LA

LAS

STAND ALONE SOLUTION

Main competitors focus

200,000 - 500,000 TUbES/yEAr

E

IZ S ID

EASE OF USE

S B A L

M

LIAISON速 XS

s

/ S B

L PO

A

<200,000 TUbES/yEAr

L AL

L E Z I

S

SM

investor day

28


lIaISON Xl: stand alone MId-SIzE laBS WOrldWIdE 200,000 - 500,000 TUBES / yEar

dIaSOrIN POSITIONING > 1,600 LIAISON XL installed at worldwide level, (ex mega/big labs) > 70% of LIAISON XL future intallations investor day

29


lIaISON Xl: automation and connectivity MEGa-BIG laBS WOrldWIdE 500,000-1,200,000 TUBES / yEar

laBCOrP

QUEST dIaGNOSTICS

rOCHE

SONIC HEalTHCarE

NEW STraTEGIC ParTNEr

dIaSOrIN POSITIONING Alone through LIAISON XL: Specialties In partnership through the connection of the LIAISON XL LAS: Specialties + High routine

investor day

30


rOCHE

MEGa-BIG laBS WOrldWIdE

TyPE OF AGrEEMENT

# TESTS

CLINICAL ArEAS

WorLdWide eX CHina and JaPan CooPeration aGreeMent, WitH Co-eXCLUsivity on MostLy diasorin sPeCiaLty tests

~ 40

endoCrinoLoGy, HyPertension, inFeCtioUs diseases, Bone & MetaBoLisM

AVAILAbLE MArKET

# yEArS

TyPE OF TESTS

>1,000 MeGa LaBs By 2020 PotentiaLLy addressaBLe By CoBas 8100

5

sPeCiaLties / UniQUe

investor day

31


NEW STraTEGIC ParTNEr

MEGa-BIG laBS WOrldWIdE

TyPE OF AGrEEMENT

# TESTS

CLINICAL ArEAS

distriBUtion aGreeMent in CHina

10

HePatitis and retrovirUses

AVAILAbLE MArKET

# yEArS

TyPE OF TESTS

any LaBoratory served By an aUtoMated PLatForM oF tHe strateGiC Partner

10

HiGH roUtine WitH Liaison XL Las ConneCtivity investor day

32


laBCOrP

MEGa-BIG laBS WOrldWIdE

TyPE OF AGrEEMENT

# TESTS

CLINICAL ArEAS

# LIAISON XL

eXCLUsive sUPPLy aGreeMent

16

vitaMin d + inFeCtioUs diseases + endoCrinoLoGy

> 50 at WorLdWide LeveL

AVAILAbLE MArKET

# yEArS

TyPE OF TESTS

WorLdWide LaBoratories oF LaBCorP

5+

sPeCiaLties

investor day

33


QUEST dIaGNOSTICS

MEGa-BIG laBS WOrldWIdE

TyPE OF AGrEEMENT

# TESTS

CLINICAL ArEAS

# LIAISON XL

sUPPLy aGreeMent

startinG WitH 1

Bone & MineraL

> 50 at WorLdWide LeveL

AVAILAbLE MArKET

# yEArS

TyPE OF TESTS

LaBoratories oF QUest

5

vitaMin d

investor day

34


SONIC HEalTHCarE

MEGa-BIG laBS WOrldWIdE

TyPE OF AGrEEMENT

# TESTS

CLINICAL ArEAS

# LIAISON XL

WorLdWide sUPPLy aGreeMent

> 15

Bone & MineraL + inFeCtioUs diseases + endoCrinoLoGy

MULtiPLes For every LaB + ConneCtivity

AVAILAbLE MArKET

# yEArS

TyPE OF TESTS

soniC HeaLtHCare LaBoratories

3+

sPeCiaLties

investor day

35


Geographic development

Y A D r E t S YE US TINUO N O C and Gions e N r O I e S H N t Ut aLL IC EXPA o H P H , CZECh A G A r U D G o A r O n E H t CA 路G S, ATION rAZIL, B D I , rLAnD L A E I O r h S t t S E u n , CON O A, A , MExIC StrALI L u E A A . r S I .G LAnD) , r (e D E n Z A t I L E Sw IC, Ir frICA, A rEPuBL h t u GAL, SO POrtu

w O r r O M tO Hies

soMe n o S CU EGIC FO

路 STrAT

oGraP e G y e k

kets

Mar n i N O I S

XPAN E C I H P and) EOGrA L G o P E . M g e. 路 SO vant ( e L e r inG BeCoM

investor day

36


Europe CaGr 14a-17e: ~ +6% MArKET

DIASOrIN CUrrENT POSITIONING

• Mature, stable and highly competitive

• Full menu Ce marked

• Ever growing consolidation

• Large installed base: >2,200 (~ 50% Liaison XL)

• Opportunities in both high-routine and specialties throughout all clinical areas

• Over 20 different tests used on 50% of the stand-alone installed base

• Mainly driven by Germany, Italy, France, Spain and the Uk

• Direct presence in all major countries

• Growing opportunities in the smaller countries

STrATEGy • Managing the turnover of Liaison customers to Liaison XL with larger and longer commitments • Add-on strategy of newly developed tests on the existing installed base (e.g. Infectious Diseases tests) • Entering new markets segments such as Stool testing • Addressing mega lab connectivity needs with Roche • Working with customers on high value tests and cost-in-use (e.g. Vitamin D 1,25)

investor day

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USa CaGr 14a-17e: ~ +11% MArKET

• Growing in the range of 2-3% by volumes • So far, out of 43 million non-insured people, Obama Care Program enrolled 12 million • Prices under pressure as reimbursement is cut throughout the health system • LabCorp + Quest Diagnostics + Sonic Healthcare > 30% market share • ~ 120 Regional Reference Labs • > 4,000 medium and small size hospitals • ~ 18,000 PoLs

DIASOrIN CUrrENT POSITIONING

STrATEGy

• Strategic relationship and secure business within LabCorp, Quest Diagnostics and Sonic Healthcare with specialty tests

• Managing the turnover of Liaison customers with few tests to Liaison XL with broader tests menu and longer commitments

• Presence in most of the regional reference laboratories

• Add-on strategy of newly Fda approved tests on the existing Vitamin D installed base (e.g. Infectious Diseases tests)

• 70% market share on Vitamin D • ~ 40 Tests Fda approved • Large portion of installed base with <10 tests per instrument

• Addressing the opportunity of mediumsize hospitals and large PoLs with the Liaison XL and the newly expanded menu • Addressing mega lab connectivity needs with Roche • Working with customers on high value tests and cost-in-use (e.g. Vitamin D 1,25) investor day

38


China CaGr 14a-17e: ~ +22% MArKET

DIASOrIN CUrrENT POSITIONING

• ~ 10,000 CLass ii and iii hospitals • International players are mainly targeting the ~ 8,000 CLass iii and iia hospitals • Local players are targeting smaller CLass i and ii hospitals • CLia technology and full lab automation are gaining ground • Market is still growing double digits

STrATEGy

• Strong positioning in pre-natal screening: full menu best-in-class

• Continue market leadership in Pre-Natal screening

• Leadership in blood bank imported testing

• Growth from Hypertension and Hepatitis & Retrovirus recently registered tests

• A wide product menu offer • ~ 650 instruments installed, of which ~ 150 Liaison XL targeting mainly CLass iii and iia hospitals

• Strategic commercial agreement with local manufacturer which will act as a distributor to address CLass ii and i hospitals in relevant areas • Strategic partnership with an international player to target CLass iii and iia hospitals, offering a complementary product menu

investor day

39


Japan: VITaMIN d approved MArKET

DIASOrIN CUrrENT POSITIONING

• Calcium and Vitamin d deficiency more prevalent than in the Us and Europe • Low exposure to sunlight • With a population of ~ 125 million, there are ~ 13 million cases of osteoporosis • Until recently no approval and no reimbursement for Vitamin D testing

• DiaSorin CLia Vitamin D test approved in Japan in April 2015 • Within 6 months, reimbursement will be defined and tests can be prescribed • Liaison XL already installed in the 3 largest private reference laboratories

STrATEGy • Market awareness and education on Vitamin D testing in order to increase prescriptions related to the approved reimbursement claim (co-marketing with the 3 main reference labs and their networks) • Capture the send-out market

• If 2-4% market penetration within 5 years, total available market will be 2.5-5 million tests

investor day

40


2015-2017 PLAN:

FINaNCIalS


2015-2017 Plan Main assumptions

eUr/Usd exchange rate

Group Tax Rate

CLIA ex Vitamin D

1.15

Main foreign currency to which the Group is exposed

~ 34.0% Mainly as a result of recent changes in Italian tax regulation

Molecular investment contribution to eBitda

Price Erosion

~ 2%

Vitamin D

3-5%

Average discounts granted when a relevant contract with existing customers is renegotiated

Slightly below break-even during the period

Long-term strategic asset open to future development

investor day

42


Guidance 2015-2017 造/MLN

2014a

2017

rEVENUES

444

550-570

CLia ex vitamin d vitamin d eLisa / ria Instruments & other Molecular Diagnostics

EbITDA

160

205-215

36.1%

~ 37.5%

84

110-114

18.9%

~ 20.0%

FCF

91

280-300 (*)

EPS

造 1.55

造 2.00-2.08

eBitda Margin

NET rESULT % on revenues

CAGr

~ ~ ~ ~ ~ ~ ~

+8.0%

~

+10.0%

+16.0% +2.0% -8.0% +4.0% +30.0%

+9.5%

(*) Cumulative 2015-2017

investor day

43


M&a: potential targets oPPortUnities in tHe Market siZe oF tHe tarGet

Listed and/or Private CoMPanies dePendinG on tHe oPPortUnity

MArKET EXPANSION

GEOGrAPHICAL EXPANSION

COMPANIES WITH A DEVELOPED CUSTOMEr bASE ACCESSIbLE WITH THE COMbINED MENU (DiaSorin + Target Company)

ACQUISITION OF LOCAL DISTrIbUTOrS WHEN THE MArKET bECOMES rELEVANT (> 5 造/MLN) (e.g. Switzerland in 2014, Poland in 2015)

CONTENT DrIVEN

TECHNOLOGICAL CONVErSION

COMPANIES WITH CLIA MArKErS/rAW MATErIAL PrOTECTED by IP (e.g. Biotrin with Parvovirus test)

COMPANIES rUNNING TESTS ON OLD TECHNOLOGIES WHICH CAN bE CONVErTED TO CLIA (e.g. Murex with Hepatitis and Retrovirus tests on ELISA converted to CLIA) investor day

44


ANNEXES

investor day

45


Hepatitis and Retrovirus MARKET

VOLUMES TREND 500

LATAM

NORTH AMERICA

200

WW: ¤ 1.5 Billion

APAC

350

EUROPE

450

DIASORIN TESTS IN THE CLINICAL AREA

increase in volumes as a result of population growth, patients who access the diagnosis of these tests and urbanization in emerging markets

PRICE TREND Hepatitis C price erosion following the expiry of the patent. the number of HCv tests will increase following the availability of the new treatment

DIASORIN STRATEGY • Leverage on Infectious Diseases menu

VIRAL HEPATITIS AND RETROVIRUSES HBsAg(2) HBsAg Quant(1) HBsAg Confirmatory test Anti- HBs II Anti- HBs II plus Anti- HBc HBc IgM HBeAg Anti-HBe

Anti-HAV HAV IgM HCV Ab(1) HIV Ab/Ag(1) HIV Ab/Ag HT(1) HTLV I/II(1)

• LIAISON XL to get access to mid-size Labs

CHAgAS

• Leverage on the MUREX brand

Chagas IgG(1)

• Full menu on LIAISON XL (HCv, HBv, Hiv, Hiv Ht, HtLv, syPHiLis e CHaGas) • Significant installed base in key markets (> 5,000) in clinical labs • Strategic Partnership in China • registration of tests in key markets (China and Brazil)

** Under Development - 1 . Available on LIAISON® XL only - 2. Available on LIAISON® only investor day

46


Infectious Diseases (ex Hepatitis and Retrovirus) MARKET LATAM

NORTH AMERICA

170

VOLUMES TREND

300

WW: ¤ 1.1 Billion

280 EUROPE

APAC

300

DIASORIN TESTS IN THE CLINICAL AREA 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

EBV

EBV IgM VCA IgG VCA IgA** EBNA IgG EA IgG

MEASLES & MUMPS Measles IgG Measles IgM Mumps IgG Mumps IgM

CHLAMYDIA

BORDETELLA

Bordetella pertussis Toxin IgG Bordetella pertussis Toxin IgA

SEPSIS

MYCOPLASMA

TREPONEMA

Treponema Screen

PRICE TREND Price pressure following increasing competition and reimbursements’ cuts

DIASORIN STRATEGY

Chlamydia T. IgG Chlamydia T. IgA

BRAHMS PCT®(2) BRAHMS PCT® II Gen

infectious diseases increasing in the world as a result of population growth, especially in the Us and LataM (3-5%) as well as in China (>10%)

Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM

• Use of LIAISON XL to: – Get access to Clinical Mid-size Labs – accelerate the conversion from dated technologies to CLia • Consolidate the infectious diseases market with Hepatitis and retrovirus CLia tests • Strategic Partnership with ROCHE • Broad Menu to gain new clients, leveraging on some «key» products (e.g. Parvovirus, Mycoplasma, Bordetella, Chlamydia and MMrv panel in the Us)

** Under Development - 1 . Available on LIAISON® XL only - 2. Available on LIAISON® only investor day

47


GI Stool Testing MARKET 130

EUROPE

VOLUMES TREND

NORTH AMERICA

200

WW: ¤ 380 Million REST OF THE WORLD

60 350

190 450

DIASORIN TESTS IN THE CLINICAL AREA STOOL DIAgNOSTICS C. difficile GDH (2) C. difficile Toxin A and B (2) H. pylori SA EHEC (2) Rotavirus Adenovirus Calprotectin Campylobacter*

volumes growing at 5-10% CaGr H. Pylori and Calprotectin markets growing C. difficile and norovirus tests on PCr are worth ¤ 100 Million Fecal occult Blood test (FoBt) is worth ¤ 50 Million

PRICE TREND Premium Price on “specialty” tests

DIASORIN STRATEGY • supply of an automated «full» panel for gastrointestinal tests on Liaison and Liaison XL • Leverage on infectious diseases business • Agreement with a leading player to co-develop a gastro-intestinal panel to sell worldwide, ex north america and UK • Goal of positioning diasorin in the microbiology segment

** Under Development - 1 . Available on LIAISON® XL only - 2. Available on LIAISON® only investor day

48


Oncology and Endocrinology MARKET VOLUMES TREND

LATAM

170

780

420

NORTH AMERICA

increase of volumes due to higher prevalence of diseases, population ageing and lifestyles in urban areas

WW: ¤ 2.1 Billion

APAC

EUROPE

PRICE TREND routine tests: low and stable prices specialty tests: high prices (e.g. aldosterone and renin)

730

DIASORIN TESTS IN THE CLINICAL AREA REPRODUCTIVE ENDOCRINOLOgY LH FSH Prolactin Progesterone Testosterone Estradiol hCG/ß-hCG

ANAEMIA Ferritin

HYPERTENSION Direct Renin Aldosterone

DIABETES C-Peptide Insulin

gROWTH hGH IGF-I

ADRENAL FUNCTION ACTH Cortisol DHEA-S

THYROID

TSH (3rd Gen.) Free T3 Free T4 T3 T4 Tg Anti-Tg Anti-TPO

DIASORIN STRATEGY • Use of LIAISON XL and XLINE in medium-large size Labs

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

• Endocrinology specialties (e.g. direct renin and aldosterone for hypertension) to reinforce the reputation of «specialist» and place new analyzers • Expansion of the US Menu to consolidate the positioning of the Liaison Family and, at the same time, to strengthen the leadership position on the vitamin d panel (vitamin d 25 oH + 1,25 oH vitamin d) • registration in China of Oncology and Endocrinology tests

** Under Development - 1 . Available on LIAISON® XL only - 2. Available on LIAISON® only investor day

49


Bone & Mineral (ex Vitamin D 25 OH) MARKET 110 REST OF THE WORLD

VOLUMES TREND

NORTH AMERICA

expected growth on average of 6% CaGr mostly due to the penetration of the 1,25 oH vitamin d, following the clinical evidence of its usage and the necessity of follow up for patients

40

WW: ¤ 270 million

EUROPE

120

DIASORIN TESTS IN THE CLINICAL AREA BONE & MINERAL N-TACT PTH Gen II 1-84 PTH Osteocalcin BAP OSTASE® 1,25 dihydroxyvitamin D(1) FGF 23** Sclerostin** ®

PRICE TREND routine tests: stable (e.g. 1-84 PtH, osteocalcin and BaP ostase) specialty tests: Premium Price, overall for 1,25 oH vitamin d

DIASORIN STRATEGY • 1,25 OH Vitamin D mostly driving the strategy on this clinical area • High-level technology from a scientific point of view • Premium Price of the test • ongoing conversion of the customers from RIA to CLIA • Us market targeted after the Food and drug administration approval • development of the WW Market through clinical studies highlighting the necessity of the test at “time zero” and in the consequent follow up of the patient

** Under Development - 1 . Available on LIAISON® XL only - 2. Available on LIAISON® only investor day

50


Bone & Mineral: Focus on Vitamin D 25 OH MARKET 110 REST OF THE WORLD

VOLUMES TREND

NORTH AMERICA

expected growth on average of 3% CaGr mostly due to unpenetrated markets

PRICE TREND

40

WW: ¤ 270 million

Price erosion in the Us and in europe due to the increased competitiveness and to reimbursement cuts in some countries

EUROPE

120

DIASORIN TESTS IN THE CLINICAL AREA BONE & MINERAL 25-OH Vitamin D TOTAL

DIASORIN STRATEGY • Synergy with other tests of the menu: - securing the CLia vitamin d 25 oH market leveraging on the richness/completeness of the menu available on the Liaison and Liaison XL • New geographies: - opportunities for expansion into new markets (e.g. China and Japan)

** Under Development - 1 . Available on LIAISON® XL only - 2. Available on LIAISON® only investor day

51



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