OraSure Technologies Jefferies 2016 Healthcare Conference

Transcription

1 OraSure Technologies Jefferies 2016 Healthcare Conference

2 Forward-Looking Statements These slides and the associated presentation contain certain forwardlooking statements, including statements with respect to revenues, earnings, technology, new products, product performance, markets, clinical development, regulatory filings and approvals, and business plans. Factors affecting these statements include, but are not limited to, the ability to develop new technology, technology changes, ability to fund research and development, required regulatory approvals, product performance and market acceptance of products. Please see the Company s SEC filings, including its registration statements, and the Company s most recent Form 10-K and Form 10-Q, for a more detailed description of specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. The Company undertakes not duty to update these statements. 2

3 Investment Summary Industry leader in rapid point-of-care infectious disease testing and DNA/RNA sample collection, stabilization and preparation products Multiple Growth Drivers: Market leading rapid HCV test High quality all-in-one molecular diagnostic sample collection devices Growth driven by expanding customer base and broader utilization Newer products offer additional growth opportunities Portfolio of multiple new products addressing large global markets Rapid HIV self-test for developing countries Rapid Ebola test approved. Rapid Zika test currently in development. Strong balance sheet with > $100M in cash, no debt Active business development program 3

4 OraQuick HCV Addressing a Significant Unmet Need 170 million people infected globally, 4-5 million people infected in U.S. The majority of HCV infection remains undiagnosed Newly approved drugs, and those in the pipeline, are driving demand for increased diagnoses and increase the number of patients initiating therapy Availability of a rapid, non-instrumented POC test will increase opportunities for diagnosis through increased testing outside of laboratory settings 4

5 Most Americans Living with HCV Were Born During Baby-boomers account for approximately 2.7 M ( m) HCV+ adults Prevalence five fold higher than others (3.29% vs. 0.55%) ¹ ² 44% did not report an HCV risk ¹ Smith, et al. American Association for the Study of Liver Disease Liver Meeting, San Francisco, CA Armstrong, et al. Ann Int Med

6 OraQuick HCV Rapid HCV Antibody Test The first and only FDA-approved, CLIA-waived rapid HCV test CDC issued new screening guidelines to test all baby-boomers (born ), 80 million Americans U.S. HCV testing for baby-boomers is an enormous opportunity Pilot programs underway in high prevalence areas CDC now estimates 30,000 new HCV infections per year in the U.S. Annual deaths from HCV now surpass combined deaths from 60 other infectious diseases including HIV, pneumococcal disease and TB 6

7 AbbVie Co-Promotion Agreement AbbVie and OraSure are co-promoting the OraQuick HCV Rapid Test in the U.S. OraSure has granted AbbVie exclusive promotional rights in certain markets: Physician Office Employers Retail Clinics Three sources of revenue: Product revenues Exclusivity payments Milestone based fees 7

8 DNA Genotek Product Overview DNA Genotek s powerful platforms have been leveraged to create multiple product line extensions Human Genetics Infectious Disease Genetics Microbiome Oragene Dx collection device is the first and only saliva DNA collection and stabilization device to receive 510(k) clearance. 8

9 DNA Genotek: Improving the Method of Sample Collection Expanded use coming from existing customers and increased demand driven by new genetic testing options and studies Oral fluid - anytime, anywhere sample collection All-in-one, easy, reliable and non-invasive Captures high quality DNA and RNA Ambient temperature stability 9

10 Oragene Helping Drive Results 10

11 2015 Sales Mix ROW 8% EU 18% NA 74% Commercial/Academic mix ~ 69%/31% Commercial revenues are predominately in North America 11

12 DNA Genotek New Product Pipeline All in one system for self-collection and stabilization of gut microbiome Will keep sample integrity for 60 days at ambient temperature Ensures microbiota profiles accurately represent the in vivo state Device minimizes microbial growth and DNA degradation Possess CE-IVD mark for microbiome collector Over 150 customers 12

13 DNA Genotek New Product Pipeline Stabilization and sample prep reagents to improve recoverability of Tuberculosis DNA for Molecular Diagnostic testing, being evaluated in TB labs in over 60 countries Omnigene SPUTUM provides for ambient (4 c c) transport of collected samples while preventing sample degradation for up to 8 days prepit Max enhances yield of analyzable TB DNA, improving sensitivity of diagnostics Study published in the Journal of Epidemiology and Global Health. Real world results reduced culture contamination from 12% to 2% and improved TB detection by 9%. 13

14 Ebola Opportunity Received Emergency Use Authorization ( EUA ) from FDA Secured contract for up to $10.4 million from the Biomedical Advanced Research and Development Authority ( BARDA ) to fund clinical development through FDA EUA, 510(k), and CLIA waiver The only rapid point-of-care test approved for testing of both live patients and cadavers designation greatly expands the utility of test Pursuing additional product purchase commitments 14

15 Development of Rapid POC Zika Test Concern over Zika virus transmission is growing Increasing evidence that Zika infection in pregnant women is linked to microcephaly and other serious birth defects. Also implicated in other neurological disorders. Actively engaged in a development program for Zika - currently pursuing external funding to offset program costs. In process of optimizing assay performance on the OraQuick platform. Evaluating scale up of manufacturing capacity. 15

16 Active Business Development Program Our Criteria: Seeking opportunity to in-license, partner or acquire a product or company that complements or leverages our existing business Primarily focused on molecular diagnostics space Preferably a late-stage or approved product(s) Favorable reimbursement and regulatory profile Disciplined buyers 16

17 Summary Approved products address substantial opportunities in molecular diagnostics and point-of-care testing Diversified product portfolio Multiple revenue growth drivers Active business development program Strong capital structure to support growth 17