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Bionano Genomics, Inc. (NASDAQ: BNGO), a life sciences
instrumentation company that develops and markets Saphyr, a platform for
ultra-sensitive and ultra-specific structural variation detection in
genome analysis, today reported financial results for the fourth quarter
and year ended December 31, 2018.
Accomplishments and Recent Business Highlights
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 adoptions among clinical
and translational research centers as well as cytogenetics labs as a
digital cytogenetics platform.
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.
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.
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.
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 performance by readily adding new clinical markers
without modifying the assay or workflow. The replacement of
traditional cytogenetics workflows with Saphyr represents the
transition to digital cytogenetics where Saphyr modernizes the entire
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.
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
In August 2018, Bionano completed its initial public offering, raising
$23.7 million in gross proceeds.
“We are very pleased with how Saphyr is becoming an essential tool for
genome analysis and digital cytogenetics worldwide,” said Erik Holmlin,
Ph.D., CEO of Bionano. “We are seeing accelerated interest in our Saphyr
system, as our differentiated capabilities, the unique detection of
structural variations, and our new price point below $500 per whole
human genome sample continues to drive demand.”
Dr. Holmlin added, “We continue to focus on expanding and executing on
our commercial plan. We plan to continue building our commercial team,
and look forward to executing on our strategies to make structural
variation analysis as commonplace as next-generation sequencing and to
lead the emergence of digital cytogenetics.”
Fourth Quarter Financial Highlights
Total Revenue. Total revenue for the fourth quarter 2018 was $4.0
million compared to $2.8 million in the fourth quarter 2017, or an
increase of 41%. Growth over the fourth quarter of 2017 was
predominantly due to an increase in product sales.
Product Revenue. Product revenue for the fourth quarter 2018 was
$3.8 million compared to $2.6 million in the fourth quarter 2017, or an
increase of 50%.
Cost of Revenues. Cost of revenues for the fourth quarter 2018
was $3.0 million compared to $1.5 million in the fourth quarter 2017.
The cost of revenue was higher in the fourth quarter of 2018 primarily
due to increased sales.
Operating Expenses. Operating expenses for the fourth quarter
2018 were $7.1 million compared to $6.6 million in the fourth quarter
2017, or an increase of 8%. The increase was primarily due to an
increase in SG&A resulting from the additional costs of being a public
Full-Year 2018 Financial Highlights
Total Revenue. Total revenue for 2018 was $12.0 million compared
to $9.5 million in 2017, or an increase of 26%. The increase was
predominantly due to significant increases in sales of instruments and
Product Revenue. Product revenue for 2018 was $11.5 million
compared to $8.8 million in 2017, an increase of 31%. The majority of
the increase in product revenue was due to a 29% increase in instrument
unit sales and a 63% increase in consumable unit sales.
Cost of Revenues. Cost of revenues for 2018 was $8.7 million
compared to $6.0 million for 2017. The increase in cost was primarily
due to increased sales of instruments and consumables and predecessor
instrument inventory write-offs of $1.3 million in 2018 as compared to
$0.4 million in 2017.
Operating Expenses. Operating expenses for 2018 were $23.7
million compared to $26.7 million in 2017. This represents a decrease of
11% in operating expenses for 2018 compared to 2017. The decrease in
operating expenses was primarily due a $2.5 million decrease in spending
for research & development.
Cash and Cash Equivalents Balance on December 31, 2018
At December 31, 2018, the Company had cash and cash equivalents of $16.5
million, compared to cash and cash equivalents of $1.0 million at
December 31, 2017.
Conference Call & Webcast Details
The Company will host a conference call and live webcast to discuss its
fourth quarter and full year 2018 financial results and provide an
update on business activities. The event will be held today at 4:30 p.m.
Eastern Time. Dial-in details are as follows:
To access the call, participants should dial the applicable telephone
number above at least 5 minutes prior to the start of the call. An
archived version of the webcast will be available for replay in the
Investors section of the Bionano website.
About Bionano Genomics
Bionano is a life sciences instrumentation company in the genome
analysis space. Bionano develops and markets the Saphyr system, a
platform for ultra-sensitive and ultra-specific structural variation
detection that enables researchers and clinicians to accelerate the
search for new diagnostics and therapeutic targets and is designed to
drive the adoption of digital cytogenetics, which is a more systematic,
streamlined and industrialized form of traditional cytogenetics. The
Saphyr system comprises an instrument, chip consumables, reagents and a
suite of data analysis tools.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Words
such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,”
“intend” and similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) convey
uncertainty of future events or outcomes and are intended to identify
these forward-looking statements. Forward-looking statements include
statements regarding our intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things: the
benefits of recent improvements to the Saphyr system, including with
respect to increased demand, sales and adoption of the Saphyr system;
the opportunities presented by increased adoption of the Saphyr system,
including with respect to increased studies; the anticipated benefits of
conducting additional studies using the Saphyr system; our efforts to
execute on our commercial strategy, including plans to expand our
commercial team. Each of these forward-looking statements involves risks
and uncertainties. Actual results or developments may differ materially
from those projected or implied in these forward-looking statements.
Factors that may cause such a difference include the risks that our
sales, revenue, expense and other financial guidance may not be as
expected, as well as risks and uncertainties associated with: general
market conditions; changes in the competitive landscape and the
introduction of competitive products; changes in our strategic and
commercial plans; our ability to obtain sufficient financing to fund our
strategic plans and commercialization efforts; the loss of key members
of management and our commercial team; and the risks and uncertainties
associated with our business and financial condition in general,
including the risks and uncertainties described in our filings with the
Securities and Exchange Commission, including, without limitation, our
Annual Report on Form 10-K for the year ended December 31, 2018 and in
other filings subsequently made by us with the Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were made and are based
on management's assumptions and estimates as of such date. We do not
undertake any obligation to publicly update any forward-looking
statements, whether as a result of the receipt of new information, the
occurrence of future events or otherwise.
Bionano Genomics, Inc.
Consolidated Statements of Operations
Three Months Ended
Cost of revenue:
Cost of product revenue
Cost of other revenue
Total cost of revenue
Research and development
Selling, general and administrative
Impairment of property and equipment
Total operating expenses
Loss from operations
Other income (expense)
Change in fair value of preferred stock warrants and expirations
Total other income (expenses)
Loss before income taxes
Benefit (provision) for income taxes
Bionano Genomics, Inc.
Consolidated Balance Sheets
Cash and cash equivalents
Accounts receivable, net
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Liabilities, convertible preferred stock, and stockholders’
Preferred stock warrant liability
Current portion of long-term debt
Total current liabilities
Long-term debt, net of current portion
Long-term deferred revenue
Other non-current liabilities
Total stockholders’ equity (deficit)
Total liabilities, convertible preferred stock, and stockholders’
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