Exhibit 99.1
January 2021R. Erik Holmlin, CEOChris Stewart, CFO Corporate Overview
Legal DisclaimerThis 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. We are under no duty to update any of these forward-looking statements after the date of this presentation to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this presentation. 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 forward-looking statements, whether as a result of new information, occurrence of future events or otherwise except as required by applicable law.
Creating a Market Leader in Cytogenomics
The Diagnostic Journey Often Ends in Frustration, Disappointment and Premature Death Because the Current Tools are Insufficient Constitutional Genetic DiseasesNeuro-developmental disorders (NDDs) occur at a rate of 1 in 6A substantial fraction (50 – 70%) of test results are negativeWithout a definitive molecular diagnosis, these patients may not get optimal treatment and their diagnostic odyssey continues Blood Cancers200,000 new cases diagnosed each year in US among approximately 1 million patients testedAgain, most test results are negativeEven with a definitive diagnosis and good prognosis, average survival in leukemia tends to be split between good outcomes (long survival) and poor outcomes (short survival) – current methods are insufficient
Better Tools are Needed Because the Genome Variations that Cause Disease Are Not All the Same! Insertion Deletion Translocation Inversion Repeat Expansion Single NucleotidePolymorphisms(SNPs)1 base pair (bp) StructuralVariations(SVs)100s bp to Millions bp AneuploidyFull Chromosomes
Sequencers Cannot Reliably Detect Structural Variations 1 to 100s base pairs (bp) 100s bp to Millions bp Insertion Deletion Repeats Translocation Inversion Sequencers can detect these Sequencers are BLIND to these ONLY Saphyr detects these large SVs that cause disease* ✓ SNPs to Small Structural Variants Large Structural Variations (SVs) ✘ ✓ 1 to 10,000 bp We believe that Saphyr is the only genome analysis platform capable of comprehensive, cost effective & efficient detection of large SVs (500 bp and larger)
ACMG, AMP, AAN, AAP recommend KT/FISH/CMA/Frag-X as the standard of care for constitutional disordersWHO/NCCN/NCI/NHS recommend KT/FISH/CMA as standard of care for hematologic malignancies. Cytogenetics & Cytogenomics are the Current Paradigm in Testing for SVs Cytogenetics means the detection of chromosomal disorders in the laboratory by karyotyping (examining the chromosomes within a cell). Molecular cytogenetics involves testing of a specific disease locus by fluorescence-in-situ hybridization (FISH) assay. What is CytogeneticAnalysis? What does it test for? Why sequencing cannot address Cytogenetics? Diseases caused by large genomic aberrations also known as structural abnormalities (not sequence abnormalities). Structural abnormalities include translocations, insertions, deletions and other chromosomal rearrangement of genomic information. The human genome is highly repetitive and large structural abnormalities are often hidden among repeats. Reads from NGS and even long-read sequencing are too short to span the repetitive sections and thus are unable to capture the large structural abnormalities/genomic aberrations. What do Medical Guidelines say?
The Cytogenetics Workflow is a Nightmare! Based on the Cyto worklow at NHS Lothian, Edinburgh Scotland,per Dr. Eddy Maher
Saphyr offers an Alternative to Traditional Cyto Methods by Offering a One-Stop-Shop for Detecting all SVs Recommended by Medical Guidelines
We Estimate our Market Opportunity to be $2.6B – $3.8B Based on Selling As Many as 10,000 Saphyr Systems CYTOGENETICS(Digital Cytogenetics) 2,500+ cytogenetics labs worldwide $0.5B-$0.6B Estimated revenues $0.2B-$0.4B Estimated annual recurring revenues DISCOVERY RESEARCH(Complement Sequencing) 7,000+(and quickly growing) high-throughput sequencers worldwide $1.4B-$1.8B Estimated revenues $0.5B-$1.1B Estimated annual recurring revenues
We Believe Bionano is Alone in Addressing SVs and Digital Cytogenetics Comprehensive SVs+ Digital Cyto Single Cell Analysis SNPs Exomes WGS TranscriptomeRNA SEQ Spatial Analysis DNA RNA
Studies Show 100% Concordance with the Standard of Care Methods BIONANO FOUND ALL clinically reported variants detected by Karyotype, FISH and Chromosomal Microarray NO OTHER TECH has been shown, in a single assay, to deliver results of all 3 traditional technologies
Consortium of US Thought Leaders Recommend Saphyr as an Alternative to Karyotyping in AML
Case Study: Saphyr Found the SV that Was Responsible, Helping Solve This Case in Pediatric Genetic Disease Chromosome 15 Chromosome X 410 kbp duplication/insertion Destroys normal function of the DMD Saphyr detected a 410kbp duplication & insertion in the DMD gene which provided a definitive molecular diagnosis of Duchenne’s Muscular Dystrophy ✓ Juvenile male patient suffering from muscular weakness and developmental delayPatient tested negative by standard and advanced molecular methods ✘ Chromosomal Microarray PCR and Sanger Sequencing Multiplexed Ligation Polymorphism Assay (MLPA) Whole Exon & Whole Genome Sequencing ✘ ✘ ✘ ✘
UCSF & Children’s Hospital of Oakland Study – Largest study of Dx Yield - Shows Saphyr can Diagnose Additional 18% of Undiagnosed Patients
Bionano Data are Proving to be Essential in Advancing Discovery Research ALS Resolved mosaic repeat expansions Alzheimer’s DiseaseIdentified deletions in CR1 Leukemia In 12 patients, found dozens of novel genes with recurring structural variants Hepatocellular CarcinomaIdentified Hep B Virus insertion that caused tumor and replication stress Congenital Diaphragmatic HerniaRevealed complex genome structures and new candidate genes Epilepsy and Developmental DelayDetected 90 kbp mosaic deletion in CDKL5 3q29 Microdeletion SyndromeCharacterized large, complex repeats and rearrangements in parents of 3q29 patients Disorder of Sex Development Identified 6 kbp insertion in WDR11 In results expected to be published, based on comparative studies against one or more of NGS, CMAs, FISH & Karyotoping
Saphyr will be used to identify variants in host genomes that influence COVID-19 response, severity, progression and drug response First study in Wuhan with Bionano service provider GrandOmics is underway European study involving University of Hannover genomic epidemiologists launched March 2020 CHINA EUROPE COMPUTE PARTNERS Bionano Saphyr is Prominently Involved in the Search for Risk Markers that Stratify COVID-19 Patients by Risk and May Help Vaccine and Rx Development Rescale, together with Amazon, Google and Microsoft, are donating compute capacity US-BASED CONSORTIUM COVID19HostGenomeSV.com Consortium founded by Dr Ravi Kolhe at Augusta is enrolling 100s to 1000s of patients in a study that has shown preliminary promise
In August 2020, We Acquired the Diagnostics Service Provider, Lineagen, a Leader in Diagnostic Services for Pediatric Neurodevelopmental Disorders FROM ONE BUCCAL SWAB . . . Multiple revenue streamsCLIA-certified LDTs and servicesPersonalized, easy-to-understand results Genetic counseling and clinical educationEnd-to-end support with reimbursementTest menu that matters FSDx Chromosomal Microarray (CMA) designed to detect larger deletions and duplications in the genome FRx Screening and diagnosis of Fragile X syndrome, the most common known genetic cause of ASD/ID that runs in families Ordered with 75% of FirstStepDx PLUS CMA cases. PGx Testing of genes that can impact dosage and choice of drug types, including Anti-Epilepsy and ADHD drugs NSDx Next generation whole exome gene sequencing (WES) to detect single genome letter changes undetectable by CMA WGDx Most comprehensive genetic test that can detect majority of genome mutations (deletions/duplications/single base changes) EPDx A comprehensive and proprietary panel of over 220 curated genes associated with epilepsy-related conditions Fragile X Syndrome Whole Genome Diagnostic Pharmacogenetics Testing
Lineagen Adds Revenue & Accelerates Clinical Adoption of Saphyr ESSENTIAL COMPONENTS FOR BUILDING REIMBURSED DX MENU ON SAPHYR Trained billing specialists lay groundwork for reimbursement of Saphyr LDTs COMBINING PRODUCT-AND SERVICE-BASED BUSINESSES Proprietary database from Toronto Sick Kids Hospital provides basis for differentiated tests, current and future +60,000 tests performed on +30,000 patients, and counting Proprietary Content in Pediatric Neuro Developmental Disorders Patient Samples & Database Provide expertise for improved Saphyr Dx and workflow integration Differentiated service and critical link between physicians, patients and families Leverage existing relationships and contracts with payors Clinical Cytogeneticists & Custom Interpretation Software Genetic Counseling Certified Coders 3rd Party Payor Contracts REVENUE: IMMEDIATE IMPACT Lineagen adds new revenue streams to help support growth of the combined business Provides centralized and decentralized offerings to support the broader market Development of proprietary LDTs helps drive Saphyr adoptionEnhances Bionano offering to pharma customers seeking new therapeutic targets CLIA Certification Accelerates Saphyr entry into the clinic by adding content, skills, expertise and sample archives
2020 Corporate Highlights Q1 Q2 Q3 Q4 Landmark Publication: Concordance with Cyto in Leukemias Initiated COVID-19 Host Genome Studies 5694 19 Increased Throughput/output Presentations Saphyr Shipped83 installed New Go to Market – Bionano Data CentricServices, Reagent Rentals & Capital Purchase Consortium Presentation: Saphyr Concordance with Cytogenomics Standard of Carein Constitutional Disorders NHS Hospital (UK) adopts Saphyr Largest US FSHD testing site BOARD OF DIRECTORS NEW ADDITIONS Yvonne Linney Hannah Mamuszka Landmark Publication: Concordance with Cyto in Constitutional Disorders Consortium Formation: COVID-19 Host Genetics SV Consortium Acquisition of CLIA business w Clinical Sales German accreditation for Saphyr LDTs Addition of Key New Executives Alka Chaubey, PhD, Chief Medical Officier Chris Stewart, Chief Financial Officer COVID Consortium Adds Studies in Comparative Genomics and MIS-C Improved and Simplified Clinical Analysis Tools Landmark Publication: in Acute Myeloid Leukemia;Authors recommend Saphyr as Karyotype replacement UCSF Publication: Saphyr Increases Diagnostic Yield SAPHYR ADOPTION SAPHYR ADOPTION Saphyr Throughput – 96 human genomes per week FCs SoldVS 468 in Q1 2019 61424 Saphyr Shipped87 installed FCs SoldVS 493 in Q2 2019 111785 Saphyr Shipped93 installed FCs SoldVS 1332 in Q3 2019 12*2362* Saphyr Shipped97 installed FCs SoldVS 1332 in Q3 2019 Revenue: $0.9M Revenue: $1.2M Revenue: $2.2M Revenue*: $3.8M to $4.2M 18 Presentations *Preliminary estimates for Q4 2020
Experienced Management Team and Board Albert Luderer, PhDCEO – Integrated Dx David Barker, PhDChairman of Bionano; former CSO of Illumina Yvonne Linney, PhDFounder – Linney BioConsulting Erik Holmlin, PhDPresident, CEO & Board Member Mark OldakowskiChief Operating Officer Christopher TwomeyFormer CFO of Biosite; Ernst & Young Executive Management Team Board of Directors (Non-Executive) Kristiina Vuori, MD, PhDPresident – Sanford Burnham Prebys MDI Christopher StewartChief Financial Officer Alka Chaubey, PhDChief Medical Officer Hannah MamuszkaCEO – Alva10
Thank You Contact:R. Erik HolmlinCEOeholmlin@bionanogenomics.com Chris StewartCFOcstewart@bionanogenomics.com