Cepheid The MDx Growth Leader. William Blair Growth Stock Conference June 12, 2012

Transcription

1 Cepheid The MDx Growth Leader William Blair Growth Stock Conference June 12, 2012

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 Form 10-K and most recent Form 10-Q filed. 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. 2

3 CPHD: Leadership in Molecular Diagnostics (MDx) Unmatched Growth in Molecular Diagnostics 33% Clinical Diagnostics Growth in Q GeneXpert Systems Placed in Q1 Largest Sequential $ Increase in Reagent Revenue in Company s History Most Innovative Approach to PCR Testing Driving Adoption Years Ahead of Competitive Systems Addresses Platform Consolidation & Test Dissemination Trends Proven Test Menu Execution MDx market: $4B+, Highest Growth IVD Market 3

4 MDx: the #1 Growth Segment in IVD Market USD $B $10 $9 $8 $7 $6 15% CAGR ~$9.5B Infectious Disease and Oncology Key Growth Segments Cepheid a MDx Leader in Infectious Diseases MRSA and C. diff Leader $5 $4 ~$4.7B Positioned to Extend into Women s Health from 2012 $3 $2 Targeting High Growth Oncology Opportunity $1 $ Other Critical Care Infectious Genetic Blood Screening Oncology Established Infectious Source: Scientia analysis 4

5 GeneXpert System Driving MDx Market Growth 3,079 GeneXpert Systems Placed Driving MDx Market Adoption Clinical Revenue Grew 36% in Guidance Targets Clinical Growth of 25 31% 61% CAGR TOTAL CLINICAL REVENUE IN $ MILLIONS * Midpoint of 2012 Full Year Guidance as of 4/19/12 5

6 Molecular Testing Made Easy with Xpert Complex and Time-Consuming Test Process Performed Automatically Within Cartridge Sample Prep, Amplification & Detection Significant Reduction in Hands-on Time Universal Sample Preparation All Sample Types: Blood, Tissue, Fecal Material, Sputum Unique Cartridge Approach Same Cartridge For All GeneXpert Systems Same Cartridge For All Test Locations 6

7 The Ultimate Platform: Market Scalability Unlimited Disease Applicability Cell Chromosome Genes Genes Sequence mrna Transcription Proteins 7

8 Acknowledged MDx Leader in Platform Innovation Accurate : results Fast : answers Easy : to use Delivering a better way to realize the benefits of molecular diagnostics 8

9 Unique Potential to Consolidate Systems & Tests CRITICAL INFECTIOUS DISEASE HEALTHCARE ASSOCIATED INFECTIONS GENETICS ONCOLOGY IMMUNO- COMPROMISED WOMEN s HEALTH 9

10 Typical High Tech Lab Today (Images from single institution) 10

11 One Platform. Any Test, Any Sample, Any Time. 11

12 Providing Hard Dollar Savings PATIENT BENEFIT Patient tested with Xpert Rapid diagnoses delivered Remove from unnecessary isolation Placed on appropriate therapies Patient discharged more quickly INSTITUTION BENEFIT More efficient lab workflow Pharmacy, isolation savings Improved patient management CASE 1: CASE 2: CASE 3: ANNUAL SAVINGS: >$500K ANNUAL SAVINGS: $1M ANNUAL SAVINGS: $5.2M A Southern Hospital is supporting increased MRSA testing demands with no additional labor and the reduction of antimicrobial use by >20%. Annual savings leading to >$500,000. A Northeastern Hospital is reducing unnecessary isolation by 35 hours. This is leading to an annual savings of $1 million. With all admissions testing for MRSA, a Malaysian Hospital improves patient management resulting in LOS reduction in excess of $5.2 million 12

13 Pipeline 13 Cepheid

14 WW Xpert Test Portfolio: End 2013 Healthcare Associated Infections GROUP 1: HOSPITALS & REFERENCE LABS GROUP 2: PRIMARY CARE Critical Infectious Disease Women s Health Virology Oncology & Genetics CLIA-Waived Testing MRSA/ SA BC vana for VRE EV Flu GBS CT/NG FII & FV BCR/ABL Monitor V2 Flu SA Nasal Complete MRSA/S A SSTI MTB/RIF GBS LB CT BCR/ABL Monitor V1 MRSA C. difficile Vaginitis HPV C. diff/epi Norovirus vana/b MDRO Strong Pipeline of Potentially High Volume Tests HPV Targeted for 2013 ex-us; Vaginitis Targeted for 2013 US & Ex-US HIV, HCV and HBV Targeted for ex-us Five New Tests ex-us, Bringing Total to 22 MDRO, Norovirus, HPV, Vaginitis, and BCR-ABL v2 Targeted for 2013 Four New Tests in US, Bringing Total to 16 MTB-RIF, CLIA-Waived Flu, GBS LB, and Vaginitis Targeted for

15 WW Xpert Test Portfolio: End Healthcare Associated Infections GROUP 1: HOSPITALS & REFERENCE LABS GROUP 2: PRIMARY CARE Critical Infectious Disease Women s Health Virology Oncology & Genetics CLIA-Waived Testing MRSA/ SA BC vana for VRE EV Flu GBS CT/NG HIV VL HCV VL FII & FV BCR/ABL Monitor V2 Flu Vaginitis SA Nasal Complete MRSA/S A SSTI Gastro Panel MTB/RIF GBS LB CT HBV VL Monitor Bladder CA Dx Bladder CA MRSA C. difficile Vaginitis HPV BCR/ABL Monitor V1 Monitor Colon CA C. diff/epi Norovirus HSV 1&2 Bladder CA vana/b MDRO Virology, Oncology and CLIA-Waived Portfolios Entry into New High Volume and/or High Value Markets Seven New Tests Targeted ex-us, Bringing Total to 29 HSV1&2, Gastro Panel, Bladder CA, Monitor Colon CA, HIV, HCV and HBV Nine New Tests Targeted in US, Bringing Total to 25 MDRO, Norovirus, Monitor Bladder CA, Dx Bladder CA, HIV, HCV, HBV 15

16 WW Xpert Test Portfolio: End Healthcare Associated Infections GROUP 1: HOSPITALS & REFERENCE LABS GROUP 2: PRIMARY CARE Critical Infectious Disease Women s Health Virology Oncology & Genetics CLIA-Waived Testing MRSA/ SA BC vana for VRE EV Flu GBS CT/NG HIV VL HCV VL FII & FV BCR/ABL Monitor V2 Flu Vaginitis SA Nasal Complete MRSA/S A SSTI Gastro Panel MTB/RIF GBS LB CT HBV VL Monitor Bladder CA Dx Bladder CA CT/NG Group A Strep MRSA C. difficile Respiratory Panel Meningitis Vaginitis HPV BCR/ABL Monitor V1 Monitor Colon CA C. diff/epi Norovirus Group A Strep HSV 1&2 Mol PAP Bladder CA Breast Metastasis vana/b MDRO Breast Stratificatio n VAP By End 2017, Targeting 37 Tests in US, 36 ex-us Extends Critical Infectious Disease, Oncology & Women s Health Portfolios WW Broadens CLIA Waived Portfolio in US Bringing Cumulative Total to 42 Tests WW 16

17 17 Game Changer: CT/NG

18 Xpert CT/NG Initial Market Opportunity US Hospital-Based Testing Represents ~30%+ Total US CT/NG Test Volume 6,000 US Hospitals Non-Molecular Hospitals ~2/3rds Molecular Labs ~1/3rd CT/NG Tests Sent Out Sent Out ~1/3 rd * Tests Performed In- House ~2/3rds* BD, Roche, PACE Aptima Cepheid s Initial Go-To-Market Focus for Xpert CT/NG * Based on Emmes MDx Survey 2011 and Cepheid Estimates 18

19 2012 First Quarter Overview Strong GeneXpert System Placements Included 122 Commercial, 151 HBDC Revenue of $77.3 Million, Clinical Revenue Grew 33% to $66.9 Million Record Clinical Reagent Revenue of $54.4 Million; 30%+ Growth in HAIs Largest Sequential Growth in Clinical Reagents Ever at $5+ Million o Driven by Commercial Business Continued Execution on Product Portfolio Expansion CT/NG Submitted to FDA Week Ending 8 June 2012 o Certification Achieved Mid-June Infinity-80 Cleared by FDA in June Expect to Submit MTB/RIF for US Clearance by Year-end HIV, HCV, HPV, Vaginitis Progressing Well in Active Development Expect Return to Profitability in the Second Quarter 19

20 What to Look for in 2012 Establishment of Direct Commercial Operations in Germany and South Africa Marked Xpert CT/NG & Xpert CT Infinity-80 System FDA Cleared FDA 510(k) Clearance of Xpert CT/NG Clearance of Xpert MTB/RIF in China Submission of Xpert MTB/RIF to FDA Commercial Non-GAAP Gross Margin in Mid-60s in Q412 Completed Targeted 20

21 Fiscal 2012 Guidance Updated as of 4/19/12 Total Revenue $ mn GAAP Earnings Per Share $0.12 to $0.17 Non-GAAP Earnings Per Share $0.50 to $0.55 Note that non-gaap measures are not prepared in accordance with GAAP and a reconciliation of reported non-gaap financial measures to the most directly comparable GAAP measures can be found in our Q112 earnings release available at Non-GAAP earnings per share guidance for 2012 excludes approximately $26 million related to stock compensation expense, approximately $2.8 million related to the amortization of acquired intangibles, and a $1.8 million non-cash tax benefit relating to an intercompany IP transaction. Guidance Suggests: Full Year Revenue Growth of 20-25% Full Year Clinical Revenue Growth of 25-31% 21

22 We are a better way. 22 Cepheid NASDAQ: CPHD Questions? Contact Investor Relations: investor.relations@cepheid.com or tel. (408)