Corporate Overview. December Erik Holmlin President & CEO

Transcription

1 Corporate Overview December 2018 Erik Holmlin President & CEO

2 Forward-Looking Statements This presentation contains forward-looking statements. Forward-looking statements describe future expectations, plans, results or strategies and are generally preceded by terms such as may, will, should, could, would, expects, plans, anticipates, believes, estimates, projects, predicts, potential and similar expressions (including the negative thereof). Forward-looking statements in this presentation include, but are not limited to, statements regarding: (i) growth drivers and expected levels of our organic growth; (ii) improvements to our manufacturing cost efficiency; (iii) the impact of our investment in R&D and commercial initiatives; (iv) our ability to stay in front of competitors improvements in technologies; and (v) other statements that are not historical facts. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Forward-looking statements are based only on current information, assumptions and expectations, and involve a number of risks and uncertainties relating to (i) challenges inherent in developing, manufacturing and commercializing products; (ii) the timing and mix of customer orders among our products; (iii) our ability to further deploy new products and applications and expand the markets for our technology platforms; (iv) third parties abilities to manufacture our instruments and consumables; (v) the success of products competitive with our own; (vi) our expectations and beliefs regarding future growth of the business and the markets in which we operate; (vii) the accuracy of our estimates, (viii) our ability to fund our operations and (ix) the application of generally accepted accounting principles which are highly complex and involve many subjective assumptions. More information about these and other statements, risks and uncertainties is contained in our filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this presentation speak only as of the date on which they were made. We disclaim any intention or obligation to update or revise any forwardlooking statements, whether as a result of new information, occurrence of future events or otherwise except as required by applicable law. 2

3 Overview 3

4 Bionano Genomics Sells Saphyr the Only System that Comprehensively & Cost Efficiently Detects Structural Variations 1 Saphyr Addresses the Need for Comprehensive SV Detection SNPs + Small SVs NGS Comprehensive SV Detection Bionano Saphyr 500 bp 2 Structural Variations (SVs) drive disease, yet sequencing cannot reliably detect them Deletion Translocation Insertion 3 Repeat Expansion The market opportunity for Saphyr is large $2.7B - $3.4B Market Opportunity Inversion Complementing Sequencing Replacing existing Methods in Cytogenetics 4

5 Structural Variations Are the Basis of The Majority of Clinical Testing in Cancer and Genetic Diseases STRUCTURAL VARIATIONS ARE PRINCIPAL DRIVERS IN MANY DISEASES MAJOR GUIDELINES IN ONCOLOGY & GENETIC DISEASE RECOMMEND FIRST-LINE SV TESTING Cancer Huntington s Disease Amyotrophic Lateral Sclerosis (ALS) Duchenne Muscular Dystrophy Myotonic Dystrophy Fragile-X Facioscapulohumeral Muscular Dystrophy Etc. Saphyr now provides a systematic approach to the discovery of new drivers of disease and therapeutic targets that sequencers cannot find 5

6 We Believe That Genome Composition is the Biggest Challenge to NGS as it Seeks to Find SVs Cell Nucleus The human genome comprises 6 billion base pairs across 23 pairs of chromosomes =repetitive sequences 2 /3 of the human genome Amount is repetitive ~5 % 74 % of genetic disorders could not be of repeats in human genome spanned by NGS diagnosed with NGS* * JAMA; Dec 2014; 312:

7 Existing Methods are Unreliable or Too Slow and Cumbersome to Address the Need to Detect Structural Variation Sequencing cannot Reliably Detect Structural Variations NGS reads are too short Improving read lengths hurt speed and accuracy Long read sequencing still misses as many as half of the large SVs in samples Cytogenetics is used to Detect SVs but it is Not Efficient or Scalable Microarrays, FISH & Karyotyping are used in Cytogenetics today These methods are: Slow Highly manual Cumbersome Not scalable 7

8 We Estimate a Total Available Market of $2.7B-$3.4B Based on Complementing Sequencing and Industrializing Cytogenetics SEQUENCING COMPLEMENT CYTOGENETICS REPLACEMENT ~6,000 high throughput sequencers worldwide ~2,500 cytogenetics labs worldwide $1.5B Estimated revenues $0.4B-$0.9B Estimated annual recurring revenues $0.6B Estimated revenues $0.2B-$0.4B Estimated annual recurring revenues 8

9 Leaders in Genome Analysis are Using Bionano 9

10 Our Solution 10

11 Our Solution is Based on Imaging Extremely Long Chromosomal Fragments with the Genome Structure Intact NGS Instead of copying the genome from very small fragments with even shorter (100 bp) NGS reads, Bionano Saphyr directly images genome structure in extremely long (average 250,000 bp) chromosomal fragments 11

12 The Key to Analyzing Long Fragments is Our Ability to Linearize them using Nanochannel Arrays Nanochannel arrays are the cornerstone of our IP Portfolio. The nanoscale confinement causes DNA to unravel and eventually linearize across hundreds of thousands of uniform nanochannels. 12

13 Saphyr Uses Proprietary Labeling and Analysis Tools for Complex SV Detection Direct Labeling and Stain (DLS) Reagents Saphyr Instrument and Bionano Data Solutions Chemistry for sequence motif labeling of genomic DNA Labels sequence motif sites every few thousand base pairs in the genome Enables mapping of extremely long molecules (average of 250,000 base pairs each) Detects structural variants >500 bp Single molecule imager for automated DNA analysis Automates chromosomal fragment imaging Allows visualization of complex rearrangements & SV calling Web-based tool for system management and monitoring 13

14 The Saphyr System and Its Performance 14

15 Saphyr is in a Class of its Own for Performance, Cost and Speed of Structural Variation Detection Unparalleled Performance Low Costs Getting Lower High Throughput Increasing Up to 99% Sensitivity <2 % False positive rate Price Per Genome $500 Target 12 $100 6x $ Increase in daily Per genome throughput in 2020 In 2020 $300 $200 $100 Samples Per Day $

16 Saphyr Detects What Next Generation Sequencing Misses in Side-by-Side Studies Source: Study data from the Garvan Institute,

17 Long-Read Sequencing Sees more SVs than NGS, but Saphyr Sees the Most 17

18 We Believe Saphyr and NGS Provide a Comprehensive Solution for Detecting All Genome Variation Saphyr Long-Read Sequencing Next-Generation Sequencing to Chromosome Variant size in base pairs 18

19 Focus Areas 19

20 SAPHYR USER: DR ERIC VILAIN, HEAD MEDICAL GENETICS, CHILDREN S NATIONAL MEDICAL CENTER Rare Diseases Undiagnosed Genetic Disease Duchenne Muscular Dystrophy (DMD) Bionano found all known SVs associated with DMD Bionano ended a diagnostic odyssey by finding SVs standard of care missed We believe that Bionano has the power to replace multiple tests for genetic disorders DR. ERIC VILAIN DIRECTOR OF THE CENTER FOR GENETIC MEDICINE RESEARCH AT CHILDREN S NATIONAL HOSPITAL, WASHINGTON, DC This will change the way we practice medicine. Dr. Eric Vilain *Next-generation mapping: a novel approach for detection of pathogenic structural variants with a potential utility in clinical diagnosis. Barseghyan et al. Genome Medicine (2017) 9:90. 20

21 SAPHYR USER: DR JAMES BROACH PENN STATE COLLEGE OF MEDICINE Oncology Hematologic Malignancies Acute Myeloid Leukemia (AML) Bionano detected all known translocations, and many more, plus many SVs never before identified in cancer. Bionano also detected hundreds of deletions and insertions that could not be seen by these other methodologies PROF. JAMES BROACH CHAIR OF THE DEPARTMENT OF BIOCHEMISTRY AND MOLECULAR BIOLOGY AT PENN STATE HERSHEY DIRECTOR OF THE PENN STATE INSTITUTE FOR PERSONALIZED MEDICINE Given speed, cost, sensitivity and reliability of the Bionano technology, it may supplant classical cytology as the primary method for clinical detection of genomic structural variation. Dr. James Broach 21

22 SAPHYR USER: DR VANESSA HAYES GARVAN INSTITUTE FOR MEDICAL RESEARCH Oncology Prostate Cancer Research Prostate Cancer Bionano identified 85 large SVs in patients cancer tumors not identified in each patient s own blood NGS missed 90% of them Bionano is unique in its ability to identify all major structural variants in a cancer with high sensitivity DR. VANESSA HAYES LAB HEAD, HUMAN COMPARATIVE AND PROSTATE CANCER GENOMICS With Bionano we identified 15 new potential drivers of prostate cancer Dr. Vanessa Hayes *Next-generation mapping reveals novel large genomic rearrangements in prostate cancer. Oncotarget, 2017, 8:

23 Recently Showed a Significant Increase in Publications Involving Our Product Indicating Growing Adoption & Utilization papers published in 2017 Number of Publications Per Year An explosion in non-human and humancentered publications, including cancer, telomeres, rare diseases and reference quality genomes 23

24 Commercial and Financial 24

25 Solid Business Model Multiple Revenue Streams, Razor/Razor Blade Model Saphyr Instrument & Bionano Access Data Solutions Bionano Prep & Labeling Kits Saphyr Chips 25

26 Strong Revenue Growth with Decreasing Cash Burn $12 $10 $8 $6 $4 $2 $0 $12 $10 $8 $6 $4 $2 $0 Strong Annual Revenue Growth ($M) 40% $6.8 $ Strong YTD Revenue Growth ($M) 20% $6.7 $8.0 YTD (9M) 2017 YTD (9M) 2018 Operating Loss* Cash Revenue By Region YTD (9M) 2017 Cash Burn Down 27% YTD (9M) 2017 $17.7M *Excludes one-time inventory write-off charges. Long-Term Debt YTD (9M) 2018 $13.0M Sept. 30, 2018 $20.7M $10.0M YTD (9M) 2018 N. America $2.1M 32% $3.5M 43% EMEIA $1.4M 22% $2.2M 28% Asia Pacific $3.1M 46% $2.3M 29% Cash & Debt Balances 26

27 Our Sales & Distribution Teams Will Grow Significantly Direct Commercialization (Existing) Distributor (Existing) Additional Direct Commercialization Distribution Support 27

28 Management, Board and Investors 28

29 Experienced Management Team and Board Executive Management Team Erik Holmlin, PhD President, CEO & Board Member Mike Ward Chief Financial Officer Mark Borodkin Chief Operating Officer Warren Robinson Chief Commercial Officer Board of Directors (Non-Executive) David Barker, PhD Chairman of Bionano; former CSO of Illumina Christopher Twomey Former CFO of Biosite; Ernst & Young Albert Luderer, PhD CEO Integrated Dx Jafar Wang Legend Capital Quan Zhou Legend Capital Darren Cai, PhD Former CFO of BGI 29

30 Bionano Genomics is Poised to be the Next Great Genomics Company Unmatched SV Detection Complement NGS + Industrialize Cytogenetics Complete Solution Validated in Publications Global Commercialization Multi-Billion Dollar Market Opportunity 30

31 Thank you Contact: Erik Holmlin

32 Appendix 32

33 Case Study Saphyr explained the molecular basis of disease Clinicians at Children s National Medical Center used Saphyr in a research study in undiagnosed disease and detected a 410kbp duplication & insertion in the DMD gene confirming Duchenne s Muscular Dystrophy* Chromosome 15 Patient Tested Negative by First Line and Advanced Methods Chromosomal Microarray PCR and Sanger Sequencing 410 kbp duplication/insertion Destroys normal function of the DMD Chromosome X Multiplexed Ligation Polymorphism Assay (MLPA) Whole Exon & Whole Genome Sequencing Definitive Molecular Diagnosis Patient is a Candidate for Potentially Life Saving Gene Editing Therapy *Results from Dr. Eric Vilain that we expect to be published 33

34 Case Study Saphyr yielded definitive molecular diagnosis with treatment option Clinicians at Pennsylvania State University used Saphyr and detected a 3.1 Mbp inversion in the PTEN gene, a known tumor suppressor.* Chromosome 10 Normal PTEN gene Patient Tested Negative by First Line and Advanced Methods PTEN gene 3.1 Mbp inversion PTEN gene interrupted FISH Karyotyping Chromosomal Microarray Next Generation Sequencing Chromosome 10 Patient Definitive Molecular Diagnosis The Dx makes the patient eligible for PTEN Rx that are currently in clinical trials *Results from Dr. James Broach that we expect to be published 34