2018 RW Baird Health Care Conference. September 5 th, 2018

Transcription

1 2018 RW Baird Health Care Conference September 5 th,

2 Forward-looking Statements This presentation and the accompanying oral commentary contain forward -looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to, any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of the plans, strategies, and objectives of management for future operations; any statements of expectation or belief regarding future events, future regulatory clearances or approvals, potential markets or market size, technology developments, or enforceability of our intellectual property rights; and any statements of assumptions underlying any of the items mentioned. These statements are based on estimates and information available to us at the time of this presentation and are not guarantees of future performance. Actual results could differ materially from our current expectations as a result of many factors, including but not limited to: quarterly fluctuations in our business; market acceptance of our products; the effects of competition and technological advances on our ability to successfully commercialize our products; delays or denials of reimbursement for diagnostic products; the regulatory regime for our products; and any adverse changes in our strategic relationships, including with licensors of our technologies and manufacturers and distributors of our products. These and other risks and uncertainties associated with our business are described in our filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation and do not intend to update these forward-looking statements or to conform these statements to actual results or to changes in our expectations. 2

3 Overview Company Snapshot Unique ncounter Platform Technology ncounter a complete biomarker solution Adopted by leading academic, biopharma, & clinical labs ~670 instrument base with $75-80K+ annualized consumables Spanning Research & Diagnostics From discovery to diagnostics on a single system IVD Prosigna Breast Cancer Assay & companion diagnostics Leader in Oncology, expanding into Immunology and Neuroscience Pipeline of Major Product Launches GeoMx : Digital Spatial Profiling Early Access Launch underway Hyb & Seq : Simplest ever NGS launching

4 ncounter ncounter : Well-Differentiated Platform Powerful Chemistry, Simple Workflow Digitally Counts Single Molecules of Up to 800 Unique Targets Rapid Downstream Validation of NGS-Generated Data Translating Signatures for Clinical Applications Leader in Oncology, expanding into Immunology and Neuroscience 4

5 ncounter Rapidly Growing ncounter System Installed Base ncounter Installed Base SPRINT MAX and FLEX ~480 ~ System Trends Installed base increased to ~670 systems as of June 30, 2018, an increase of 20%+ vs. the prior year ~260 ~350 SPRINT accounted for nearly 50% of Q2:18 units sold Nearly 90% of SPRINTs sold to new customers in H1:

6 ncounter ncounter Use in Oncology is Driving Consumable Products Growth Total Consumable Revenue $ millions 2018 Consumable Trends $50.0 $45.0 $40.0 $35.0 $30.0 $25.0 $20.0 $15.0 $10.0 $5.0 $24.5 $33.1 $41.7 $45.0 Prosigna Cancer Panels Non-Cancer Panels Custom CodeSets Sales of consumable panels increased by 30%+ in H1:18 vs H1:17 Record Prosigna revenue: increased by 36% in Q2:18 vs Q2:17 Oncology represents ~65% of panel sales in H1:18 6 $

7 ncounter Generating Double-Digit Growth in Product and Service Revenue Annual Product & Service Revenue YTD Product & Service Revenue $69.1M $72.0M $79-81M $34.1M +13% $38.4M $56.6M b Guidance Consumables H1'17 Instrument and Service H1'18 7

8 Pipeline Transition from Single to Multiple Platforms Hyb & Seq Clinical Sequencer GeoMx Digital Spatial Profiler ncounter Analysis System 8

9 Pipeline Leveraging Barcoding Chemistry into New Platforms & Markets Spatial Genomics Clinical Sequencing CD28 IL2R CD9 CD4 PD-L1 Digital Spatial Profiling 2019 commercial launch Hyb & Seq 2020 commercial launch 9

10 Digital Spatial Profiling Introducing the GeoMx DSP Platform Your GPS for Biology 10

11 Digital Spatial Profiling GeoMx DSP Provides Deep Spatial Profiling 11

12 Digital Spatial Profiling GeoMx Instrument Prepares Samples for Analysis by ncounter or NGS Slide Processing Molecular Barcode Analysis Instrument GeoMx DSP ncounter OR Next Generation Sequencer Protein Reagents RNA 12

13 Digital Spatial Profiling Marching Toward 1H 19 Full Commercial Launch Technology Access Program Centers of Excellence Early Access GeoMx Priority Site Commercial Release Qualify Technology Early exposure to DSP as a service Scientific Excellence Top tier sites pioneer GeoMx applications Product Quality GeoMx instrument feedback from key customer segments Early Adoption Convert early interest into GeoMx evangelists Global Access Satisfy global demand for GeoMx >55 projects completed to date 3 sites announced 5 sites selected Up to 20 slots available 13

14 Digital Spatial Profiling Oversubscribed DSP TAP Validates Demand & Value DSP Technology Access Program Example Customers and Collaborators Cumulative projects as of Q2: Academic BioPharma 0 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 14 Hundreds of DSP TAP samples run as of June 30, 2018

15 Digital Spatial Profiling Three GeoMx DSP Centers of Excellence IO and Imaging Excellence Clinical Biomarker Discovery NGS Driven Applications Sadik Esener PhD Oregon Health Science University Region: PNW Profile: Strong cancer center with expertise in novel imaging technologies Focus: Develop IO applications & integrate DSP with cutting edge imaging capabilities Christian Blank PhD Netherlands Cancer Institute Region: EMEA Profile: Access to high value clinical samples with high impact study in progress Focus: Explore clinical applications with DSP technology Aviv Regev PhD Broad Institute Region: Boston/NE Profile: Sequencing readout experts in high value geography Focus: Develop NGS driven applications 15

16 Digital Spatial Profiling DSP Early Access Launch Fully Subscribed Leading Pathology KOL in Ivy league institution well versed in emerging spatial technologies Pathology KOL Top Tier Cancer Center Regarded as one of the top cancer centers in the country One of the largest CROs with on site biobank Major CRO Leading Large Pharma One of top 3 pharma Investing in technology to drive development of immunotherapy drugs Prominent European academic medical center with access to large clinical samples Clinical Pathology Powerhouse 16

17 Digital Spatial Profiling GeoMx Priority Site (GPS) Initiative Announced Today GPS initiative designed to capture early interest through pre-orders ahead of full commercial launch GPS Offering Details Limited release: 20 pre-sale opportunities Buy-in price: $295K Package includes: First access to commercial instrument Piloting 10 samples through Technology Access Program ahead of instrument release Reagents to kick start first DSP project 17

18 Digital Spatial Profiling Spatial Profiling in Immuno-Oncology May Inform Combination Therapy Exploding number of targets & combination therapies Complex matrix of tumor and immune cells Unmet need to resolve tumor heterogeneity 18 Balkwill et al, J Cell Sci 2012

19 Digital Spatial Profiling GeoMx DSP Has Demonstrated Utility in Immuno-Oncology Research Leading pathologist, Dr. David Rimm (Yale University) discovers 5 biomarkers predictive of response to immunotherapy in a 59 sample patient study DSP helps redefine biomarkers as target + specific compartment 19

20 Digital Spatial Profiling Spatial Profiling in Neurobiology Explores Disease Mechanisms Complex matrix of neural cells Oligodendrocytes Neurons Key application in Neurobiology Quantitate neural cell response to plaque formation Microglia Astrocytes 20

21 Digital Spatial Profiling GeoMx DSP Profiles How Plaques Impact Brains of Alzheimer s Patients Define Regions Around Amyloid Plaque Profile Expression of 70+ Proteins Tau TDP-43 Amyloid β 1-42 Amyloid β 1-40 Cellular Feature Protein Expression Nucleus Amyloid Plaque Astrocytes P- TDP- 43 Microglia P-S404 Tau GFAP GFAP Iba1 Human Precentral Alzheimer s Disease 666 μm x 666 μm 21

22 Digital Spatial Profiling Key Events for GeoMx Commercialization Q Q Q Commercial Launch H Announce Centers of Excellence Publish First DSP Paper Spatial Genomics Data at AGBT Designate Early Access Sites Immuno-Oncology Data at AMP & SITC Launch GPS initiative Ship First Beta Systems 22

23 Pipeline Leveraging Barcoding Chemistry into New Platforms & Markets Spatial Genomics Clinical Sequencing CD28 IL2R CD9 CD4 PD-L1 Digital Spatial Profiling 2019 commercial launch Hyb & Seq 2020 commercial launch 23

24 Hyb & Seq Platform Clinical Sequencing A Large Opportunity with Unmet Needs Large Clinical Sequencing Market Need for Simple Solution Clinical sequencing is a rapidly growing multi-billion dollar market Largest areas are oncology and reproductive health >5,000 hospitals in the United States Our initial focus: oncology and infectious disease Start End Heat Block qpcr King Fisher Plate Centrifuge Qiaqube Thermocycler Bio- Analyzer Ion Chef Traditional NGS workflow has a significant number of steps Bioinformatics is a major bottleneck Poor compatibility with clinical samples 24

25 Hyb & Seq Platform Hyb & Seq: Developing Potentially Transformative Sequencing Technology Incubate Capture Hyb & Seq Workflow Buffer Filter Sample Sequence Simple and fast sequencing method No library prep, enzymes, or amplification Start sequencing from FFPE tumor biopsy in <60 minutes High consensus accuracy at low coverage Simultaneous capture and sequencing of DNA and RNA Long reads No theoretical upper limit 25

26 Summary Multiple Growth Drivers Over Years Ahead Hyb & Seq Clinical Sequencer GeoMx Digital Spatial Profiler ncounter Analysis System 26