Cepheid - Jefferies

Jefferies
Healthcare
Conference
John Bishop
Chairman & CEO
June 2, 2014
1 Cepheid
©
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Worldwide Market Growth by Segment
Overall IVD sales are projected to grow at a 5.9% CAGR through 2017. Molecular
Diagnostics will remain the highest growth segment.
Total = $68.6 B
+5.9% CAGR
Total = $51.9 B
Flow Cytometry
Immunohematology
Histology/Cytology
Microbiology
Molecular Diagnostics
Hem/Coag
Clinical Chemistry
Immunoassay
Point of Care
2
Segment
CAGR %
Point of Care (Whole Blood
Glucose)
2.3%
Point of Care (All other)
8.1%
Immunoassays
5.9%
Clinical Chemistry
3.4%
Hematology/Coagulation
3.0%
Molecular Diagnostics
11.9%
Microbiology
5.0%
Histology/Cytology
9.3%
Immunohematology
4.4%
Flow Cytometry
6.9%
Total Market
5.9%
Market
Diagnostics
2
International
Worldwide MDx Market Overview
Two-thirds of 2012 Molecular Diagnostics market revenue was from diagnostic
virology and bacteriology.
2012
($ Billion)
Percent
of Total
Virology
$1.7
37%
Bacteriology
$1.2
26%
Genetics/Genomics
$0.9
20%
Blood Screening
$0.8
17%
Total Market
$4.6
100%
Discipline
3
Total Market: $4.6 Billion
Market
Diagnostics
3
International
US MDx Laboratory Universe by CLIA Complexity
The most significant trend in molecular laboratories during 2012 was the adoption of
moderately complex tests by laboratories that had not performed molecular diagnostics
in the past.
Molecular Laboratories
By Testing Menu
Total = 2,006
Total = 1,830
-3%

The reduction in labs performing LDTs is
attributable to the availability of more FDA-cleared
assays such as the Roche TaqMan CMV and the
BioFire Respiratory Panel

The growth in moderately complex laboratories is
the result of the adoption of Meridian and Cepheid
assays.

Although the BioFire panel is moderately complex
it was adopted by labs that already performed one
or more molecular assays
Highly Complex, with LDT
Highly Complex, no LDT
Moderately Complex
4
+2%
+39%
Market
Diagnostics
International
Q1 2014: A Solid Start to the Year
• GeneXpert System Placements +78%
‒ Commercial Placements +45%
• Clinical Revenue +26%, Commercial Clinical +19%
‒ Commercial Clinical Xpert Test Revenue +24%*
‒ International Commercial Clinical Revenue +47%
• Continued Menu Execution
‒ Xpert HPV, Xpert Norovirus CE-IVD Release in Early April
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* Normalized for Q113 Backorder-Related Revenue
Strategic Drivers
GLOBAL MARKET
EXPANSION
APPLICABLE MARKET
EXPANSION
MAINTAINING
GROWTH
LEADERSHIP
BROAD MENU
EXPANSION
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Broad Menu Expansion
2
1
Systems Expansion
Test Expansion
3
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Remote Connectivity
and Data Management
Development of Disease Portfolio
Other Genetic
Disease
Oncology
Cervical
Breast
Bladder
Infectious Disease
Bacterial
Viral
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Prostate
Lung
Develop The Most Compelling Test Menu Offering….
Available Now
14
Tests
16
Tests
9
MRSA Surveillance
SA Nasal Complete
C. diff & C. diff/Epi
vanA for VRE
MRSA/SA SSTI
MRSA/SA Blood Culture
EV
Flu
MTB/RIF
CT/NG
GBS & GBS Lim Broth
Factor II&V
MRSA Surveillance
SA Nasal Complete
C. diff/Epi
vanA/vanB for VRE
MRSA/SA SSTI
MRSA/SA Blood Culture
Norovirus (NEW!)
EV
Flu
MTB/RIF
CT & CT/NG
GBS
Factor II&V
HPV (Cervical CA) (NEW!)
BCR-ABL Monitor
© Cepheid
2014-2015
19
Tests
24
Tests
2016-17
Norovirus
Carba-R
MRSA Surveillance-Next Gen
Flu/RSV
CW Flu/RSV
Trichomonas
33
Carba-R
Trichomonas
MRSA Surveillance-Next Gen
Flu/RSV
Bladder CA Monitor/Sympt
BCR-ABL Ultra
HIV Quant
HIV Qualitative
HCV Quant
33
Tests
Tests
2018-19
SA Nasal Complete-Next Gen
Pertussis
Gastro Panel
HSV 1/2 Typing
Vaginitis
CW Vaginitis
CW CT/NG
BCR-ABL Ultra
Breast CA Stratifier
Bladder CA Monitor
Bladder CA Symptomatic
HPV (Cervical CA)
HIV Quant
HCV Quant
HBV Quant
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SA Nasal Complete-Next Gen
Group A/C Strep
Meningitis/Encephalitis
Pertussis
Gastro Panel
HSV 1/2 Typing
Vaginitis
GBS Ultra
HBV Quant
Breast CA Stratifier
Breast CA Signature
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Notes: Targeted Test Menu Subject to Revision; CW = CLIA-Waived
Tests in Italics Represent Product Improvements and are Excluded from Total Test Counts
Group A/C Strep
Meningitis/Encephalitis
Tests GBS Ultra
CW GBS Ultra
CW Group A/C Strep
CW HPV (Cervical CA)
Breast CA Signature
Tests
Pancreatic CA Monitor
EBV / NPC Screen
EBV / NPC Monitor
= US Tests
= International Tests
Develop The Most Compelling Test Menu Offering….
Available Now
14
Tests
16
Tests
10
2014-2015
MRSA Surveillance
SA Nasal Complete
C. diff & C. diff/Epi
vanA for VRE
MRSA/SA SSTI
MRSA/SA Blood Culture
EV
Flu
MTB/RIF
CT/NG
GBS & GBS Lim Broth
Factor II&V
Norovirus
Norovirus
19
Carba-R
19
Tests
Carba-R
MRSA
Surveillance-Next Gen
MRSA Surveillance
SA Nasal Complete
C. diff/Epi
vanA/vanB for VRE
MRSA/SA SSTI
MRSA/SA Blood Culture
Norovirus (NEW!)
EV
Flu
MTB/RIF
CT & CT/NG
GBS
Factor II&V
HPV (Cervical CA) (NEW!)
BCR-ABL Monitor
24 Carba-R
Trichomonas
Tests
Carba-R
Surveillance-Next Gen
24 MRSA
© Cepheid
Tests
2016-17
33
Tests
MRSA Surveillance-Next Gen
Flu/RSV
CWFlu/RSV
Flu/RSV
Trichomonas
CW Flu/RSV
Trichomonas
33
Tests
Trichomonas
Tests Flu/RSV
Bladder
CA Surveillance-Next
Monitor/Sympt
MRSA
Gen
BCR-ABL
Ultra
Flu/RSV
HIVBladder
Quant CA Monitor/Sympt
HIV Qualitative
BCR-ABL Ultra
HCV Quant
HIV Quant
HIV Qualitative
HCV Quant
2018-19
SA Nasal Complete-Next Gen
Pertussis
Gastro Panel
HSV 1/2 Typing
Vaginitis
CW Vaginitis
CW CT/NG
BCR-ABL Ultra
Breast CA Stratifier
Bladder CA Monitor
Bladder CA Symptomatic
HPV (Cervical CA)
HIV Quant
HCV Quant
HBV Quant
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SA Nasal Complete-Next Gen
Group A/C Strep
Meningitis/Encephalitis
Pertussis
Gastro Panel
HSV 1/2 Typing
Vaginitis
GBS Ultra
HBV Quant
Breast CA Stratifier
Breast CA Signature
36
Notes: Targeted Test Menu Subject to Revision; CW = CLIA-Waived
Tests in Italics Represent Product Improvements and are Excluded from Total Test Counts
Group A/C Strep
Meningitis/Encephalitis
Tests GBS Ultra
CW GBS Ultra
CW Group A/C Strep
CW HPV (Cervical CA)
Breast CA Signature
Tests
Pancreatic CA Monitor
EBV / NPC Screen
EBV / NPC Monitor
= US Tests
= International Tests
GeneXpert System Enables Broad Range of
Oncology Opportunities
ANY other validated RNA
expression signature
Breast CA
Recurrence
Signature
Measure
many targets
simultaneously
BCR-ABL
Monitor
(CML)
Breast CA
Classifier
Sensitively
detect
translocations
in blood
Decentralized
Path using
FFPE tissue
specimens
Oncology
Oncology
Product
Product
Development
Development
Using
UsingqPCR
qPCR
Prostate CA
Recurrence
Signature
Bladder CA
Screen
At-Risk
Others
Bladder CA
Symptomatic
Bladder CA
Monitor
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Quantitate
RNA targets
in urine
Quantitate
mutations in
ctDNA
KRAS
Pancreatic
CA Monitor
EGFR, ALK,
KRAS Lung
CA Monitor
Establishing A Full Global Market Presence
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Direct
Direct & Emerging Markets
Distributed
Distributed & Emerging Markets
Emerging Markets
Expanding Scope of Applicable Markets
GX-1
Infinity 80
GX-2
Hospitals
Infinity 48s
GX-4
GX-16
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Expanding Scope of Applicable Markets
Infinity 80
Independent
Labs
Infinity 48s
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Industry Leading Throughput and
Operating Efficiency
2:1
Advantage
Infinity-80
Gen Probe
Tigris
CT/NG Testing Over One 8-Hour shift
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3:1 4:1
Advantage
Gen Probe
Panther
Advantage
BD Viper
4:1
Advantage
Roche Cobas
Taqman 96
4:1
Advantage
Abbott m2000
Menu Application on High Throughput Systems
Manufacturer
Test Menu
On Line Test Capability
US:14
Cepheid
Unlimited
EU:17
US: 9
Roche
(6800, 8800)*
EU:17
US: 6
Hologic
(Tigris)
EU: 6
US: 2
Qiagen
(QiaSymphony RCU)
EU: 2
Becton Dickinson
(Viper)
EU: 4
US: 8
Abbott
(m2000)
EU:14
* Roche 6600/8800 not yet released.
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US: 4
3
4
1
1
1
Expanding Scope of Applicable Markets
GX-1
GX-2
Alternate Sites
• POL’s
• Cruise Ships
• Urgent Care
• Home
• Nursing Homes
• Retail Outlets
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GX-4
We are a better way.
Cepheid
NASDAQ: CPHD
Questions? Contact Investor Relations:
[email protected] or tel. (408) 400 8329
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