Orasure Technologies, Inc. · NASDAQ:OSUR
Orasure Technologies — Investor Day (November 2007)
78 slides from Orasure Technologies's investor day presentation, Nov 28, 2007
Slide 1: NASDAQ Analyst Day
OraQuick ADVANCE ® Histofreezer ® OraSure ® Intercept ® NASDAQ ANALYST DAY November 28, 2007 OraSure Technologies, Inc. Exhibit 99.1
Slide 2: Forward-Looking Statements
Forward-Looking Statements These slides and the associated presentation contain certain These slides and the associated presentation contain certain forward-looking statements, including statements with respect forward-looking statements, including statements with respect to revenues, earnings, tech
Slide 3: Agenda
AGENDA Analyst Day Analyst Day Wednesday, November 28, 2007 11:30 – 11:35 am Introduction – Doug Michels, President & CEO 11:35 – 12:30 pm Stephen R. Lee, Ph.D. – EVP & Chief Science Officer 12:30 – 12:45 pm Lunch 12:45 – 1:30 pm Sue Sutton-Jones – SVP of Regulatory Affairs & Quality Assurance 1:30
Slide 4: Hepatitis C Virus Infection
Hepatitis C Virus Infection Statistics (United States) New infections per year 30,000 – 40,000 Persons infected (1.6%) 4.1 million Chronic infection 3.2 million More than half of HCV cases are currently undiagnosed Persons with HIV co-infection 225,000 Growing healthcare burden – 50% of chronically
Slide 5: Risk Factors Associated With Acquiring Hepatitis C Virus
Risk Factors Associated With Acquiring Hepatitis C Virus Past or present injection drug use Transfusion, transplant from infectious donor Infected sex partner(s) Birth to an infected mother Occupational blood exposure (needle sticks) Tattooing/body piercing Renal dialysis
Slide 6: A Simple Test Procedure Utilizing All Sample Types
99.6% 100.0% TEST COLLECT Oral Fluid Oral Fluid Venipuncture Venipuncture Whole Blood Whole Blood Plasma & Plasma & Serum Serum Fingerstick Fingerstick Whole Blood Whole Blood A Simple Test Procedure Utilizing All Sample Types MIX
Slide 7: Prototype OraQuick HCV Test - Interpretation
Prototype OraQuick ® HCV Test- Interpretation Non-reactive : Single line appears at the C (control) triangle • A negative result indicates the absence of target antibodies in the sample. Reactive for anti-HCV : Two lines appear • One at the C (control) triangle and the other at the T (test) triangle
Slide 8: Sensitivity of the Prototype OraQuick HCV Test in Known Infected Individuals
1 Plasma Specimens *No. of EIA reactive specimens tested Lee SR et al. AACC, 2007 Sensitivity of the Prototype OraQuick ® HCV Test in Known Infected Individuals 100% Chronic HCV Infection 100% HIV/HCV Coinfected Patients 100% HCV (RIBA) Positive Plasma Donors 100% Intra-venous Drug Users Sensitivity
Slide 9: Comparison of HCV Seroconversion Sensitivity of OraQuick HCV Prototype with EIA
* 95% Confidence Intervals Lee SR et al. AACC, 2007 Comparison of HCV Seroconversion Sensitivity of OraQuick ® HCV Prototype with EIA 3.2 (1.4 to 5.1)* 47.5 50.7 Differential Sensitivity (Avg. Days Detected Earlier by OraQuick ® ) Average Time To Detection by HCV OraQuick ® (Days) Average Time To De
Slide 10: Sensitivity in Known HCV Positive Subjects
Sensitivity in Known HCV Positive Subjects Tested Using Oral Fluid and Whole Blood 92 (100%) 92 (100%) 92 (100%) No. Detected by OraQuick ® HCV (Oral Fluid) No. Detected by OraQuick ® HCV (Whole Blood) No. Detected by HCV EIA No. of HCV Positive Subjects Source: Lee SR et al. AACC,
Slide 11: Preliminary Performance Data: Low Risk Individuals
HCV ELISA + + - - b a Preliminary Performance Data from the OraQuick ® HCV Prototype in Oral Fluid Samples Paired with Blood, Plasma & Serum: Low Risk Individuals (n=419) a: RIBA 3.0 positive b: RIBA 3.0 indeterminate Subjects gave concordant results when tested with all 5 specimen types (serum, pla
Slide 12: HCV Prototype: Additional Study Findings
HCV Prototype: Additional Study Findings • Verified use of multiple anti-coagulants (EDTA, citrate, heparin): No interference noted • Tested with worldwide genotype panel: Detected all major genotypes and subtypes • Tested specimens with potential interfering serology (HAV, HBV, HIV, HTLV, HSV, Syph
Slide 13: OraQuick Rapid HCV Test Timeline
OraQuick ® Rapid HCV Test Timeline Preclinical development completed and prototype design complete Technology transfer complete and prototype produced at scale in manufacturing facility Clinical study protocols complete and study sites selected Planned trials support CLIA waiver and submission for C
Slide 14: Roche-OraSure Collaboration
Roche-OraSure Collaboration Combining Proven Expertise OraSure Value – Oral fluid market leader – Extensive device development expertise – Assay/ Applications experience with oral fluid – Ref. Lab partner network Roche Value – Leadership in DOA testing market – Extensive assay development expertise
Slide 15: The Intended Result for Both Organizations
The Intended Result for Both Organizations Generation of world class oral fluid assays Faster time to market by combining expertise Maintain leadership positions in the WW DOA testing market Maintain differentiation from competition Ongoing collaboration in collection devices and assays – menu expan
Slide 16: High Throughput SAT Assays - Initial Launch Menu
High Throughput SAT Assays- Initial Launch Menu • Cocaine • Opiates • THC (Marijuana) • Amphetamines/Methamphetamines • Phencyclidine (PCP) Required panel of drugs to be tested according to guidelines from National Institute of Drug Abuse
Slide 17: Progress with High-Throughput Oral Fluid Assays
Progress with High-Throughput Oral Fluid Assays Prototype tests for most of the assays designated for the initial launch menu have been developed Initial performance shows good clinical correlation with existing confirmatory algorithms and excellent precision Performance data on these prototypes was
Slide 18: Dose Response Curve and Cutoff for High Throughput Oral Fluid Opiate Assay
Dose Response Curve and Cutoff for High Throughput Oral Fluid Opiate Assay Oral Fluid Cutoff Concentrations Oral Fluid Cutoff Concentrations *Oral fluid cutoff concentrations are for sample diluted by diluent in the Intercept® Oral Specimen Collection Device. LDL, or analytical sensitivity, is defin
Slide 19: Accuracy of the High Throughput Opiate Assay
Accuracy of the High Throughput Opiate Assay + - + - OTI EIA Assay (10 ng/mL) Opiates Assay (10 ng/mL) A total of 200 individual clinical samples from a low risk population that screened negative with the OraSure Technologies, Inc ( OTI ) Micro-Plate assays ere tested in the semi-quantitative mode w
Slide 20: Precision of the High Throughput Opiate Assay
Precision of the High Throughput Opiate Assay Opiate Assay Within Run Precision, n=21 Opiate Assay Within Run Precision, n=21 Levels tested Within Run Mean Precision Recovery (ng/mL) (ng/mL) (% CV) (%) 5.0 5.3 3.4 7.5 7.7 2.6 10.0 10.3 2.3 12.5 12.6 1.5 40.0 41.0 1.5 Source: Hoch D et al. Society of
Slide 21: Oral Fluid Cutoff Concentrations
Oral Fluid Cutoff Concentrations Oral Fluid Cutoff Concentrations *Oral fluid cutoff concentrations are for sample diluted by diluent in the Intercept® Oral Specimen Collection Device. LDL, or analytical sensitivity, is defined as the lowest drug concentration that can be distinguished from zero cal
Slide 22: Precision of Amphetamines and Methamphetamines Assay
Precision of Amphetamines and Methamphetamines Assay Amphetamines Assay Within Run Precision, n=21 Amphetamines Assay Within Run Precision, n=21 Levels tested Within Run Mean Precision Recovery (ng/mL) (ng/mL) (% CV) (%) 12.5 12.9 2.8 30.0 30.1 1.7 40.0 40.9 1.3 50.0 52.2 1.3 Methamphetamines Assay
Slide 23: Specificity of Amphetamines and Methamphetamines Assay
Specificity of Amphetamines and Methamphetamines Assay A total of 200 individual clinical samples from a low risk population that screened negative with the OraSure Technologies, Inc ( OTI ) Micro-Plate assays were tested in the semi-quantitative mode with Amphetamines and Methamphetamines automated
Slide 24: Sensitivity of Amphetamines and Methamphetamines Assay
Sensitivity of Amphetamines and Methamphetamines Assay A total of 49 clinical samples from a drug prevalent population were tested in the semi-quantitative mode with the automated Amphetamine and Methamphetamine/MDMA assays. All samples were also tested for the presence of d-amphetamine, d-methamphe
Slide 25: Dose Response and Cutoff for High Throughput Oral Fluid Cocaine Assay
Dose Response and Cutoff for High Throughput Oral Fluid Cocaine Assay Oral Fluid Cutoff Concentrations Oral Fluid Cutoff Concentrations *Oral fluid cutoff concentrations are for sample diluted by diluent in the Intercept® Oral Specimen Collection Device. LDL, or analytical sensitivity, is defined as
Slide 26: Precision of the Cocaine Assay
Precision of the Cocaine Assay Cocaine Assay Within Run Precision, n=21 Cocaine Assay Within Run Precision, n=21 Levels tested Within Run Mean Precision Recovery (ng/mL) (ng/mL) (% CV) (%) 2.25 2.5 2.6 3.2 2.8 3.75 3.9 2.9 5.0 2.1 6.25 6.2 1.8 30.6 1.0 Source: Zhao J,, et al. Society of Forensic Tox
Slide 27: Accuracy of the Cocaine High Throughput Assay
Accuracy of the Cocaine High Throughput Assay •A total of 560 clinical sample pools from a drug prevalent population were tested in the semi-quantitative mode with the automated cocaine assay. All samples were also tested for the presence of benzoylecgonine with LC/MS/MS. + - + 4* - 2** Sensitivity
Slide 28: High-Throughput Oral Fluid Assays High Level Milestones
High-Throughput Oral Fluid Assays High level Milestones Conduct alpha studies with prototype assays at customer sites Complete feasibility and finalize design Develop calibrators and controls Conduct technology transfer Complete 510K testing Inventory build and launch
Slide 29: OraQuick HIV Shelf Life Improvement - Current Status
OraQuick ® HIV Shelf Life Improvement - Current Status • Product modifications to support longer shelf life have already been implemented and verified • Proposed modifications do not require additional clinical trials • Currently conducting real-time validation/stability studies using GMP material •
Slide 30: Strategy for Shelf Life Extension
Strategy for Shelf Life Extension Shelf life extension will occur in unregulated markets upon successful completion of stability testing and process validation Shelf life in US and EU will be extended after approval of the appropriate regulatory submissions. Additional submissions will be made in ce
Slide 31: Questions and Answers
Questions and Answers
Slide 32: Key Role in Bringing Products to Market
Key Role in Bringing Products to Market RA/CA/QA play a role in the product lifecycle from conception through to obsolesce of the product. • Strategy • Negotiation • Organization • Subject Matter Experts • Archivists • Business Partners • Looked on by many regulators as the “conscience of a Company”
Slide 33: RA/QA/CA Submission Activities
RA/QA/CA Submission Activities QTR 1 QTR 2 QTR 3 QTR 4 IDE FDA Submissions Int'l Submissions Audits Protocols/Amendments Study Conduct Analyses Reports Over 200 submissions and responses so far this year.
Slide 34: Some of Our International Activities
Some of Our International Activities CE Mark Achieved for OraQuick Dossiers/Documentation • Individual EU countries • Argentina • Brazil • Ecuador • Guatemala • Israel • Russia • Vietnam • Thailand • South Korea • China • Mexico • Philippines • Indonesia • UAE • Validations in multiple African Count
Slide 35: Regulatory Update for HIV OTC
Regulatory Update for HIV OTC Panel track submission Premarket approval is required (PMA) The PMA will be reviewed by the Center for Biologic Evaluation and Research (CBER). We expect the PMA will also be presented to an FDA advisory panel for review and comment.
Slide 36: Clinical Study Considerations
Clinical Study Considerations In designing the proposed program, OraSure gave special consideration to a number of topics: • All protocols must be able to demonstrate that the product meets the criteria defined at the March 10, 2006 BPAC meeting; • The population expected to use the OTC product; • C
Slide 37: Label Comprehension
Label Comprehension Label Comprehension Study Status - completed • Performed after refining labeling and instructions through pre-testing • Tests target population understanding of the instruction materials • Subjects do not conduct a test with an actual device
Slide 38: Reading Contrived Devices
Reading Contrived Devices The purpose of the study is to demonstrate that individuals from the target population are able to accurately interpret various test result. In this study, subjects selected from the target population are given contrived devices to read and interpret the results The subject
Slide 39: Referral to Care and Resource Answer Center
Referral to Care and Resource Answer Center For the referral and resource program we will at minimum include the key points of the CDC Guidelines for HIV Counseling. For the observed and unobserved phases, the counseling system will have functional capabilities intended for launch. 1-800# number acc
Slide 40: OTC Milestones
Status Task OTC Milestones FDA Submission Complete Referral to Care and Resource Answer System Protocol written and to be submitted to FDA by end Q1 2008 Study to be executed in 2008 Unobserved User Study Protocol written and to be submitted to FDA by end Q4 2007 Study to be executed in 2008 Observe
Slide 41: OraQuick HCV Test Clinical Study Update
OraQuick ® HCV Test Clinical Study Update
Slide 42: HCV Regulatory Update
HCV Regulatory Update Submission reviewed by Center for Devices and Radiological Health (CDRH) PMA for a rapid test for HCV 180 day review time estimated Clinical trials are straightforward and uncomplicated.
Slide 43: HCV Rapid Test Human Subject Clinical Trial
HCV Rapid Test Human Subject Clinical Trial Population • Thousands of subjects with signs and symptoms of Hepatitis, or at high HCV infection risk • Hundreds of asymptomatic subjects Inclusion / exclusion criteria • Either gender, $ yrs of age, informed consent • No subjects <2 yrs, therapy for HCV
Slide 44: CLIA Waiver Trial
CLIA Waiver Trial Trial to establish appropriate device characteristics for CLIA-waiver Minimum of 3 U.S. centers (consistent with point-of-care testing) Patients consistent with expected use Test via comparator method (FDA approved EIA, RIBA) blinded from operator OraQuick ® testing by operator
Slide 45: Studies Required for FDA Approval of the HCV Rapid Test
Status Task Studies Required for FDA Approval of the HCV Rapid Test FDA, CLIA, CE Mark Submissions Q4 2007 to begin Clinical performance in human subjects Complete Anticoagulants Complete Interfering substances Complete Food and Beverage Complete Genotypes Complete Unrelated medical conditions Compl
Slide 46: Cryosurgical Clinical / Regulatory Efforts
Cryosurgical Clinical / Regulatory Efforts Clinical Study to expand the claims for an over the counter cryosurgical system were begun in Q3. The last subject will exit the study the end of this month. We are targeting to submit the 510k in Q1 2008. This will increase our offerings for an over the co
Slide 47: Questions and Answers
Questions and Answers
Slide 48: Sales & Marketing Overview
Sales & Marketing Overview Joseph E. Zack EVP – Sales & Marketing
Slide 49: U.S. Market Potential: HIV Tests
17 Million Potential Tests for OraQuick ® Hospitals Public Health MD Offices Government Programs Source: Company Estimates based on Industry Reports. * Excludes OTC market and impact of CDC guideline changes and new program announcement. U.S. Market Potential: HIV Tests * Diverse Customer Base Poten
Slide 50: CDC Revised Recommendations
• Advocate Routine Voluntary HIV screening 13-64 yrs • De-stigmatize HIV testing process • Emphasize cost effectiveness of testing in all ranges of prevalence • Promote opt-out testing models • Increase diagnosis of HIV • Decrease time for testing procedure • Known positives reduce unsafe practices
Slide 51: CDC Initiative
CDC Initiative CDC Opportunity – CDC redirected $45 million in funding to expand HIV testing – Program goal is to test 1.0 million persons for HIV – 23 jurisdictions awarded approximately $35 million – Individual grant size: $600K - $6MM – Program will be for 3 years
Slide 52: The Jurisdictions
The 23 Jurisdictions California Chicago Connecticut District of Columbia Florida Georgia Houston LA County Louisiana Maryland Massachusetts Grant Recipients Michigan Missouri New Jersey New York City New York State North Carolina Ohio Pennsylvania Philadelphia South Carolina Tennessee Virginia
Slide 53: CDC Initiative Status
CDC Initiative Status Working with each of the jurisdictions closely Tracking implementation Bulk of Revenues expected in 2008
Slide 54: Prevention initiatives within U.S. Hospitals
Prevention initiatives within U.S. Hospitals • 20% of pregnant women don’t know their status • Vertical transmission accounts for 100% of all pediatric infections – 98% could have been prevented • 1 million needle stick injuries annually; 16,000 result in HIV exposure ² • More than 55% of patients t
Slide 55: Continued Increase in HIV Testing
Continued Increase in HIV Testing FY03 – FY05 Outpatient Only FY06-07 Outpatient, Inpatient and ED 92,123 56,212 53,598 58,785 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 90,000 100,000 FY03 FY04 FY05 FY06 110,000 120,000 130,000 140,000 132,641 FY07 92,123 56,212 53,598 58,785 10,000 20
Slide 56: Number of HIV-Positive Persons Identified More than Doubled
Number of HIV-Positive Persons Identified More than Doubled FY03 – FY04 Outpatient Only FY05 Outpatient and ED Pilot Sites Only FY06-07 Outpatient, Inpatient and ED 1,514 1,000 1,200 1,400 1,600 FY03 FY04 FY05 FY06 1,618 FY07 1,514 1,000 1,200 1,400 1,600 FY03 FY04 FY05 FY06 1,618 FY07 Impact on HIV
Slide 57: OraQuick testing in the ED
• OraQuick testing in the ED (2002) – 62% accept HIV testing – 98% receive test results – 3,802 patients screened – 93 (2.4%) new HIV positive – 80% entered HIV care • Test Performance – Sensitivity 100% – Specificity 99.94% OraQuick ® ADVANCE ™ Impact on HIV Prevention • 42% of patients tested had
Slide 58: What do patients think?
0% 10% 20% 30% 40% 50% Strongly agree Agree No opinion Disagree Strongly disagree No answer “The ER is a good place to perform HIV testing” 42% 30% 13% 3% 5% 6% - Preliminary data, 680 pts - GWU Hospital ED What do patients think? Impact on HIV Prevention CDC, Dr. Bernie Branson PACHA Meeting, Octob
Slide 59: What do patients think?
0% 30% 60% 90% Yes No Would you recommend to a friend to get an HIV test if they went to the ER? 84% 9% - Preliminary data, 680 pts GWU Hospital ED What do patients think? Impact on HIV Prevention CDC, Dr. Bernie Branson PACHA Meeting, October 15-16, 2007
Slide 60: Social Marketing Program
Social Marketing Program City Initiatives Objective Collaborate with local constituencies to ensure residents know their HIV status – Washington DC – Philadelphia ™ COMING TOGETHER TO
Slide 61: DC - Results to Date
DC – Results to Date * – DC Data* – At the end of 2006, HAA (HIV/AIDS Administration) saw a 75% percent increase in overall HIV screening in the District, yielding a 3.5% positivity rate. – As of September 30, 2006, more than 16,700 residents tested with 580 preliminary positive results (approx. 3.4
Slide 62: Philadelphia
Philadelphia City-wide rapid HIV testing initiative State Senator Hughes, PA Secretary Johnson, PHL Commissioner Paris, AACO Director Cella $1.5 million state grant Largest amount awarded to HIV/AIDS program in State history Focus on traditionally underserved populations Support recently released CD
Slide 63: Global Expansion
Europe • OraQuick • Cryo – OTC & Rx • Substance Abuse China • OraQuick • Cryo – Rx Africa • OraQuick Caribbean • OraQuick South America • OraQuick • Cryo – Rx • Cryo – OTC Australia • Cryo – OTC Mexico • OraQuick • Cryo – Rx • Cryo – OTC Canada • Cryo – OTC Global Expansion
Slide 64: Questions and Answers
Questions and Answers
Slide 65: Operations Overview
Operations Overview P. Michael Formica EVP - Operations
Slide 66: Bethlehem Buildings
Total: Total: 117,000 ft Bethlehem Buildings Tech III Headquarters (48,000 ft ² ) North Building (32,000 ft ² ) South Building (37,000 ft ² ) (Acquired in 2006) (Acquired in 1997) (Acquired in 2006)
Slide 67: Space Allocation
Space Allocation Total 117,000 sq ft 117,000 sq ft Manufacturing Manufacturing 50,500 sq ft Clean Rooms Clean Rooms 15,500 sq ft Warehouse Warehouse 11,000 sq ft Office Space Office Space 40,000 sq ft
Slide 68: Facility/Capacity Long Range Plan
Facility/Capacity Long Range Plan Joint Analysis with Facility Planning Consultants Facilities and Infrastructure Analysis Production Line/ Production Process Capacity Analysis Review of Off-Shore Manufacturing Strategy
Slide 69: OraQuick Capacity Plan
OraQuick Capacity Plan Based on Multiple Production Lines Semi-Automated Assembly Lines Automation Assembly Lines Off-Shore Production Capacity
Slide 70: Tech III Building (48,000 sq ft)
Tech III Building (48,000 sq ft) Corporate Headquarters Finance & Accounting Operations Department Oral Fluid Collection Manufacturing Assay Formulations OraQuick Assembly Control Warehouse (Shipping & Receiving)
Slide 71: North Building (32,000 sq ft)
North Building (32,000 sq ft) Assay Formulations Assay Assembly OraQuick Device Assembly QC Laboratory Vial Filling QED Micro-plate Coating/ Pouching
Slide 72: South Building (37,000 sq ft)
South Building (37,000 sq ft) Sales & Marketing Research & Development Laboratory Research & Development Staff Regulatory & Quality Assurance & Clinical Trials IT/ MIS Staff
Slide 73: Aerial View of Tech III Campus
Aerial View of Tech III Campus
Slide 74: OraQuick International Supply Chain
OraQuick International Supply Chain Bethlehem • FDA Product • CE Product • International, Export Market (Non Approved Product) Thailand • International, Non - FDA Product (Supply Raw material To Thailand)
Slide 75: SAP Installation Update
SAP Installation Update Modules Installed: FICO – Finance & Controlling MM – Materials Management PP – Production Planning QM – Quality Management SD – Sales & Distribution WM – Warehouse Management Present Focus Utilize System Capabilities to Improve Processes
Slide 76: Summary
Summary Summary Facility Planning Driven by Strategic Analysis Facilities & Infrastructure in place for growth Facilities Expansion Possible if Needed
Slide 77: Questions and Answers
Questions and Answers
Slide 78: OraSure Technologies, Inc. Thank You
OraSure Technologies, Inc. Thank You OraQuick ADVANCE ® Histofreezer ® OraSure ® Intercept ®