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
2
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
7
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
9
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
11
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
investor day
13
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
14
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
investor day
15
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
17
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
19
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
investor day
21
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
22
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
24
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
26
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
37
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