Delaware
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001-38613
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26-1756290
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(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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9640 Towne Centre Drive, Suite 100
San Diego, California
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92121
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(Address of Principal Executive Offices)
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(Zip Code)
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Bionano Genomics, Inc.
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Date: March 14, 2019
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By:
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/s/ R. Erik Holmlin, Ph.D.
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R. Erik Holmlin, Ph.D.
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President and Chief Executive Officer
(Principal Executive Officer)
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•
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Record quarterly revenue of $4.0 million; 41% increase over 4Q17
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•
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Record annual revenue of $12.0 million; 26% increase over 2017
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Substantial improvement to essentially many aspects of the Saphyr workflow; capability of processing 42 whole human genomes per week; clinical-grade sensitivity at as low as 5% allele fraction; prices below $500 per genome
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Record number of publications; a 70% increase of human-centered publications over 2017; studies validating the use of Saphyr as an alternative to traditional cytogenetics technologies
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Bionano continued its focus on advancing the capabilities of its Saphyr system for whole genome mapping of structural variations. Throughout 2018 and culminating in a series of product launches in February 2019, Bionano has simplified the Saphyr workflow making it easier to run, return faster results, and cost less than $500 per sample. Saphyr is now capable of processing 42 whole human genomes per week with a workflow that can be automated from sample to answer. We believe these improvements are driving Saphyr
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Bionano expanded the capabilities of its data analysis solutions, improving their sensitivity to all types of structural variations, including those that are present at very low abundance. Access to tools for Bionano data analysis was enhanced through the development of a cloud-based implementation of the analysis pipeline. In addition, the suite now includes a novel routine that has been tested in different leukemias and shown to have high sensitivity for structural variation detection even when the variant of interest is present in as low as 5% allele fraction, which is a critical capability for analysis of cancer samples.
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Bionano collaborated with Genoox, a company that manages next-generation sequencing data analysis, to develop and
launch a platform that combines raw sequencing reads with Bionano-based structural calls from a single patient. Children's National Health System in Washington D.C., which is ranked #1 in the U.S. for infant care, became the initial adopter of the Genoox integrated platform. The new technology offers Children’s National a single platform for sensitive, accurate detection of structural variations and genetic mutations for rare disease, not previously practicable, helping to accelerate genetic diagnosis for children and their families.
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Bionano users published a record number of papers detailing the application of Bionano technology. In particular, 70% more human-centric publications were released in 2018 over 2017. One such publication detailed the largest study conducted on Bionano’s platform, which was comprised of 154 humans across 26 distinct ethnic populations. This publication revealed never-before-seen human genomic variations and genome sequence not represented in the human genome
reference, which demonstrated that the widely used method of aligning short sequencing reads to a static reference genome may be inadequate.
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Another key paper showed Saphyr’s ability to provide accurate molecular diagnoses of facioscapulohumeral muscular dystrophy (FSHD) patients. Saphyr was shown to be an alternative to the Southern blot method, a traditional cytogenetics technique, by offering a simplified workflow that yields highly accurate results with the potential to increase clinical
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Adoption of Saphyr in 2018 by top thought leaders in cytogenetics such as Dr. Brynn Levy at Columbia University and Dr. Alex Hoeschin at Radboud University Medical Center in the Netherlands, and others, has enabled Bionano to initiate a number of studies designed to show equivalency of Saphyr to traditional cytogenetic methods in hematologic oncology indications such as Acute lymphocytic leukemia (ALL) and Acute myelocytic leukemia (AML). We expect initial results from these studies to be presented at scientific meetings beginning in the third quarter of this year and throughout the second half of 2019. We believe these studies will lay the groundwork for Saphyr to penetrate labs that may develop assays for cytogenetic applications, making Saphyr the first digital cytogenetics platform.
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Bionano expanded its commercial team with the addition of key senior executives, including the addition of a head of commercial operations and a seasoned sales team in China as well as a new global head of marketing.
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In August 2018, Bionano completed its initial public offering, raising $23.7 million in gross proceeds.
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Three Months Ended December 31,
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Year Ended December 31,
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2018
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2017
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2018
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2017
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Revenue:
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Product revenue
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$
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3,844,766
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$
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2,556,208
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$
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11,463,173
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$
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8,769,704
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Other revenue
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168,771
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288,915
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537,562
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735,339
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Total revenue
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4,013,537
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2,845,123
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12,000,735
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9,505,043
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Cost of revenue:
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Cost of product revenue
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2,853,339
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1,496,172
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8,562,042
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5,958,537
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Cost of other revenue
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134,777
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—
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149,284
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71,975
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Total cost of revenue
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2,988,116
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1,496,172
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8,711,326
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6,030,512
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Operating expense:
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Research and development
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2,521,467
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2,457,483
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9,484,163
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12,009,170
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Selling, general and administrative
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4,602,518
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3,526,310
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14,220,331
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14,079,658
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Impairment of property and equipment
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—
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604,511
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—
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604,511
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Total operating expenses
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7,123,985
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6,588,304
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23,704,494
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26,693,339
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Loss from operations
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(6,098,563
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)
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(5,239,353
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)
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(20,415,085
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)
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(23,218,808
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)
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Other income (expense)
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Interest expense
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(266,971
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)
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(159,524
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)
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(1,381,024
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)
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(590,927
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)
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Change in fair value of preferred stock warrants and expirations
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—
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(356,429
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)
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3,991,081
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751,933
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Other expense
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(36,716
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)
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(163,686
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(675,853
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)
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(289,010
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)
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Total other income (expenses)
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(303,687
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)
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(679,639
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)
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1,934,204
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(128,004
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Loss before income taxes
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(6,402,251
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)
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(5,918,992
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(18,480,881
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(23,346,812
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)
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Benefit (provision) for income taxes
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(9,207
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(932
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(15,511
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(18,552
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Net loss
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$
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(6,411,458
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)
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$
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(5,919,924
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)
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$
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(18,496,392
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)
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$
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(23,365,364
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)
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December 31,
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2018
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2017
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Assets
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Current assets:
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Cash and cash equivalents
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$
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16,522,729
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$
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1,021,897
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Accounts receivable, net
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4,514,333
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3,352,214
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Inventory
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1,068,557
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1,693,742
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Prepaid expenses and other current assets
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919,500
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1,071,512
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Total current assets
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23,025,119
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7,139,365
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Property and equipment, net
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1,777,302
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3,005,788
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Total assets
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$
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24,802,421
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$
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10,145,153
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Liabilities, convertible preferred stock, and stockholders’ equity (deficit)
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Current liabilities:
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Accounts payable
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$
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1,351,736
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$
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2,302,964
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Accrued expenses
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2,900,129
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3,508,894
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Deferred revenue
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270,998
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211,697
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Preferred stock warrant liability
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—
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3,898,944
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Current portion of long-term debt
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—
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6,729,752
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Total current liabilities
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4,522,863
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16,652,251
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Long-term debt, net of current portion
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9,029,374
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—
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Long-term deferred revenue
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304,467
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142,929
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Other non-current liabilities
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808,366
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567,047
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Total liabilities
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14,665,070
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17,362,227
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Total stockholders’ equity (deficit)
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10,137,351
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(50,227,211
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)
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Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)
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$
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24,802,421
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$
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10,145,153
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