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Jefferies Global Healthcare Care Conference 3 June 2015 Leading in Molecular Diagnostics © Cepheid

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Page 1: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

1 © Cepheid

Jefferies Global Healthcare Care Conference 3 June 2015

Leading in Molecular Diagnostics

© Cepheid

Page 2: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

2 © Cepheid 2

Forward-Looking Statement

During the course of this presentation, we may make projections or other forward-looking statements regarding future events or the future financial performance of Cepheid. We wish to caution you that such statements are just projections and that actual events or results may differ materially. We refer you to the documents that we have filed from time to time with the SEC, specifically our last filed Forms 10-K and 10-Q. These documents contain and identify important factors that could cause the actual results to differ materially from those contained in these projections and forward looking statements.

Page 3: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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• High Growth Razor/Razor Blade Model ‒ Commercial Clinical Reagent Sales Grew 35% in Q115 ‒ Total Clinical Revenue Grew 25% in Q115

• Large Installed Base of 8,321 Systems ‒ Record Commercial Placements in 2014 ‒ Commercial Installed Base: 4,473 ‒ HBDC Installed Base: 3,848

• Broad and Growing Test Menu ‒ 8 Tests Added in 2014; 3 in 2015 So Far ‒ 22 Test Menu ex-US, 17 in US ‒ Extending into High Value/Volume Markets

CPHD: a High Growth Leader in Molecular Diagnostics Democratizing Molecular Diagnostics

22 47

96 124

174

236 286

360

441

526

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Total Clinical Sales in $ Millions

45% CAGR (2006–2014)

* 2015 Reflects Mid-point of Guidance dated 4/23/15

*

Page 4: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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GeneXpert System Installed Base – Now at 8,321 4,473 in Commercial Applications

More than 30% of All GeneXpert Systems EVER Placed were Delivered in 2014

Page 5: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

5 © Cepheid

More Systems Installed in the US Than Any Other MDx Manufacturer

System Installed Base as % of Total Instruments (Different Colors Represent Different Systems Offered by Same Manufacturer)

0%

5%

10%

15%

20%

25%

Abbott Other Siemens Qiagen Meridian HOLX/GPRO BD Roche Cepheid

Source: Market Diagnostics International, Manufacturer Share of Hospital Placements, 2012. Based on proprietary survey of 1,800 Labs. Note: most labs have more than one instrument.

Page 6: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

6 © Cepheid

A Broad & Rapidly Growing Test Menu…. 22 Test Menu ex-US, 17 Commercially Available in US

Cepheid: Global Leader in Molecular MRSA

Cepheid: Global Leader in Molecular C. difficile

Cepheid: Global Leader in Molecular TB

New Tests: Xpert HPV (CE-IVD), Xpert Norovirus, Xpert HIV-1 (CE-IVD), Xpert HCV VL (CE-IVD)

#1

#1

#1

Source: Cepheid Internal Analysis

Cepheid: US Leader in Molecular Flu #1

?

Page 7: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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• Cepheid Continues to Compete Effectively & Gain Share

Emmes Database Based on 1,000 US Molecular Institutions

CPHD 2014

Account Share

CPHD 2013

Account Share

CPHD 2014

Volume Share

CPHD 2013

Volume Share

Comment

MRSA & SA 86% 84% 73% 73% BD # Accounts ↔, Roche ↓

C. Diff 63% 60% 63% 59% Meridian & BD # Accounts ↓ Meridian & BD Volume ↓

CT/NG 28% 10% 7% 2% Hologic, BD, Roche # Accounts ↓

GBS 64% 61% 29% 19% BD # Accounts ↓, Volume ↑ Meridian # Accounts & Volume ↑

MTB 44% 28% 27% 21% Hologic # Accounts & Volume ↓ Homebrew # Accounts & Volume ↓

Flu 72% 64% 64% 48% Competitors ↔ to ↓

Used with permission.

Page 8: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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BROAD MENU EXPANSION

APPLICABLE MARKET SEGMENT

EXPANSION

GLOBAL MARKET EXPANSION

MAINTAINING GROWTH

LEADERSHIP

Continued Investment Supports 3-Pronged Strategy

Page 9: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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Market Opportunity Continues to Expand with Menu

2012 2013

2014–15 2016–17

Oncology

Virology

Critical Infectious

Sexual Health

HAIs

$900M

$1.7B

$3.4B

$5.2B

Source: Cepheid Internal Analysis. Reflects expansion of CPHD’s addressable market as additional Xpert tests are added to available menu.

Page 10: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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MRSA Surveillance SA Nasal Complete C. diff & C. diff/Epi Norovirus (Q414) vanA for VRE MRSA/SA SSTI MRSA/SA Blood Culture EV Flu & Flu/RSV (Q414) Ebola (EUA, Q115) MTB/RIF CT/NG GBS & GBS Lim Broth Factor II&V

Solid Progress on Test Menu Expansion Eight Tests Added in 2014, Three Added in 2015 So Far

MRSA Surveillance SA Nasal Complete C. diff/Epi vanA/vanB for VRE MRSA/SA SSTI MRSA/SA Blood Culture Norovirus (Q214) Carba-R (Q214) EV Flu & Flu/RSV (Q314) MTB/RIF CT & CT/NG Trichomonas (Q314) GBS HPV (Cervical CA) (Q214) HIV-1 Viral Load (Q414) HIV-1 Qual (Q215) HCV Viral Load (Q215) Factor II&V BCR-ABL Monitor

MRSA Surveillance-Next Gen BCR-ABL Ultra Bladder CA Monitor/Symptom

Carba-R MRSA Surveillance-Next Gen CW Flu/RSV (Submitted Q215) Trichomonas

Notes: Targeted Test Menu Subject to Revision; CW = CLIA-Waived Tests in Italics Represent Product Improvements and are Excluded from Total Test Counts

SA Nasal Complete-Next Gen Group A/C Strep Meningitis/Encephalitis Pertussis GI Panel HSV 1/2 Typing Vaginitis GBS Ultra HBV Quant Breast CA Stratifier Breast CA Signature

Pancreatic CA Monitor EBV / NPC Screen EBV / NPC Monitor

= US Tests

= International Tests

34 Tests

33 Tests

40 Tests

36 Tests

20 Tests

24 Tests

17 Tests

22 Tests

SA Nasal Complete-Next Gen Pertussis GI Panel HSV 1/2 Typing Vaginitis CW Vaginitis CW CT/NG HPV (Cervical CA) HIV Quant HCV Quant HBV Quant BCR-ABL Ultra Breast CA Stratifier Bladder CA Monitor Bladder CA Symptomatic

Available Now 2015 2016-17 2018-19

Group A/C Strep Meningitis/Encephalitis GBS Ultra CW GBS Ultra CW Group A/C Strep CW HPV (Cervical CA) Breast CA Signature

Page 11: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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Xpert HIV-1 Viral Load ‒ 97% Correlation with Abbott Assay

within Quantitative Range ‒ Lower Limit of Detection than Abbott ‒ CE-IVD Achieved December 2014

Xpert HIV-1 Qualitative ‒ 98% Concordance with Roche Assay ‒ Lower Limit of Detection than Roche ‒ CE-IVD Achieved April 2015

Xpert HCV Viral Load ‒ 95% Concordance with Abbott Assay ‒ CE-IVD Achieved April 2015

Cepheid Entering $1 Billion Virology Market $250 Million Addressable Market with Initial CE-IVD Tests

HIV data based on clinical trial activity and was reported by the GWU School of Public Health at AMP in November 2014.

11 © Cepheid

Page 12: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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• Completed Prototype Honeycomb GeneXpert System

‒ Module Runs in Existing GeneXpert Systems

• Functioning Microwell PCR Reactions ‒ Up to 1,000 Targets

‒ Qualitative & Multiplexed Quantitative mRNA Expression

• Completed Prototype Honeycomb GX Tube with Microwells

• Fluidic Feasibility Achieved

• Targeted for Release to R&D in 2015 ‒ First Commercial Product: Xpert Breast Signature

in 2016–17 ex-US

Strong Progress on High-Multiplexing "Honeycomb"

Page 13: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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BROAD MENU EXPANSION

APPLICABLE MARKET SEGMENT

EXPANSION GLOBAL MARKET

EXPANSION

MAINTAINING GROWTH

LEADERSHIP

Continued Investment Supports 3-Pronged Strategy

Page 14: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

14 © Cepheid

Applicable Market Expansion: Early Traction

• POL’s • Urgent Care • Nursing Homes • Retail Outlets • Cruise Ships • Home

14 © Cepheid

Hospitals Independent Labs Alternative Sites

• POLs • Urgent Care • Nursing Homes • Retail Clinics • Cruise Ships • Universities • Public Health • Home

Page 15: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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• Infinity System + Broad Xpert Test Menu Opening New Possibilities

‒ Highest Volume System Available

‒ Unmatched Labor Efficiency

‒ LEAN, 24/7 Operation

‒ Broadest Menu & Most Tests on Board

• LabCorp Added as Customer in Sept 2014 ‒ 10 Infinity Systems Placed (Reagent Rental)

‒ Expected to Run ~400,000 Xpert GBS Tests Per Year (When Ramped)

‒ Xpert C. difficile Also Adopted

• Second National US Ref. Lab in Oct 2014 ‒ ~100,000 Xpert MRSA, C. diff & GBS

‒ GX Systems Placed Q414-Q115 (Reagent Rental)

Independent Reference Labs

15 © Cepheid

Page 16: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

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• Sexual Health Clinic in Central London

• 100,000 Xpert CT/NG Tests in 2014

• Service Evaluation: ‒ Median time from test to informing patient

reduced from 8 days to 1 day ‒ Median time to treatment for positive patients

reduced from 10 days to 2 days

Dean Street: High Volume at Point of Care

Wingrove I, McOwan A, Nwokolo N, et al. Sex Transm Infect 2014:90:474

The introduction of the GeneXpert within sexual health services has the potential to reduce the prevalence of CT and NG in the community by reducing the duration of infectivity.

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Firm Commitment to Targeted 2017 Business Model

* All targets are Non-GAAP and apply to our Commercial Business only (excluding HBDC)

Target* Comment

Gross Margin High 60s GM was 63% in Q414

Highest Volume Tests Already >70% MRSA Cost <$5 (excluding Royalty)

Research & Development 15-16% Heavy Clinical Trial Expenses (HPV, Virology) Step Down in 2017

Sales & Marketing ~18%

General & Administrative ~8%

Operating Margin Mid 20s

Page 18: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

18 © Cepheid

Cepheid Remains Well Ahead of Competition

18 © Cepheid

What Competitors are Aspiring to Deliver Tomorrow

GeneXpert Delivers Today…

Accurate

Rapid Results in as Little as 30 Minutes

Easy-to-use Moderately Complex

Scalable From 1 to 2,000 tests/day

Proven More than 8,300 Systems Placed Globally

Broad test menu 22 Tests Available Now (17 in US)

Flexibility True Random Access, not Random Batch

Multiplexing capability Low-to-High Level

Page 19: Leading in Molecular Diagnostics - Jefferies Group · 2015-06-11 · • High Growth Razor/Razor Blade Model ‒Commercial Clinical Reagent Sales Grew 35% in Q115 ‒Total Clinical

19 © Cepheid

Cepheid NASDAQ: CPHD

Questions? Contact Investor Relations: [email protected] or tel. (408) 400 8329

We are a better way.