Accueil / Communiqués / Bionano Genomics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2018

Bionano Genomics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2018

Thursday, March 14th 2019 at 9:18pm UTC

Highlights:

  • Record quarterly revenue of $4.0 million; 41% increase over 4Q17
  • Record annual revenue of $12.0 million; 26% increase over 2017
  • 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
  • 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

SAN DIEGO–(BUSINESS WIRE)– 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
    cytogenetic workflow.
  • 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
    marketing.
  • 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
company.

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
consumables.

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:

 

Thursday, March 14 @ 4:30 p.m. Eastern Time

Domestic:     877-407-0789
International: 201-689-8562
Passcode: 13687797
Webcast:

http://public.viavid.com/index.php?id=133342

 

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.

Forward-Looking Statements

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   Year Ended
December 31, December 31,
2018   2017 2018   2017
Revenue:
Product revenue $ 3,844,766 $ 2,556,208 $ 11,463,173 $ 8,769,704
Other revenue 168,771   288,915   537,562   735,339  
Total revenue 4,013,537 2,845,123 12,000,735 9,505,043
Cost of revenue:
Cost of product revenue 2,853,339 1,496,172 8,562,042 5,958,537
Cost of other revenue 134,777     149,284   71,975  
Total cost of revenue 2,988,116 1,496,172 8,711,327 6,030,512
Operating expense:
Research and development 2,521,467 2,457,483 9,484,163 12,009,170
Selling, general and administrative 4,602,518 3,526,310 14,220,331 14,079,658
Impairment of property and equipment   604,511     604,511  
Total operating expenses 7,123,985   6,588,304   23,704,494   26,693,339  
Loss from operations (6,098,563 ) (5,239,353 ) (20,415,085 ) (23,218,808 )
Other income (expense)
Interest expense (266,971 ) (159,524 ) (1,381,024 ) (590,927 )
Change in fair value of preferred stock warrants and expirations (356,429 ) 3,991,081 751,933
Other expense (36,716 ) (163,686 ) (675,853 ) (289,010 )
Total other income (expenses) (303,687 ) (679,639 ) 1,934,204   (128,004 )
Loss before income taxes (6,402,251 ) (5,918,992 ) (18,480,881 ) (23,346,812 )
Benefit (provision) for income taxes (9,207 ) (932 ) (15,511 ) (18,552 )
Net loss $ (6,411,458 ) $ (5,919,924 ) $ (18,496,392 ) $ (23,365,364 )
 
 
Bionano Genomics, Inc.
Consolidated Balance Sheets
 
  December 31,
2018   2017
 
Assets
Current assets:
Cash and cash equivalents $ 16,522,729 $ 1,021,897
Accounts receivable, net 4,514,333 3,352,214
Inventory 1,068,557 1,693,742
Prepaid expenses and other current assets 919,500   1,071,512  
Total current assets 23,025,119   7,139,365  
Property and equipment, net 1,777,302   3,005,788  
Total assets $ 24,802,421   $ 10,145,153  
Liabilities, convertible preferred stock, and stockholders’
equity (deficit)
Current liabilities:
Accounts payable $ 1,351,736 $ 2,302,964
Accrued expenses 2,900,129 3,508,894
Deferred revenue 270,998 211,697
Preferred stock warrant liability 3,898,944
Current portion of long-term debt   6,729,752  
Total current liabilities 4,522,863   16,652,251  
Long-term debt, net of current portion 9,029,374
Long-term deferred revenue 304,467 142,929
Other non-current liabilities 808,366   567,047  
Total liabilities 14,665,070 17,362,227
Total stockholders’ equity (deficit) 10,137,351   (50,227,211) )
Total liabilities, convertible preferred stock, and stockholders’
equity (deficit)
$ 24,802,421   $ 10,145,153  
 

Contacts

Bionano Contact:
Mike Ward, CFO
Bionano
Genomics, Inc.
+1 (858) 888-7600
mward@bionanogenomics.com

Bionano Investor Relations Contact:
Ashley
R. Robinson
LifeSci Advisors, LLC
+1 (617) 535-7742
arr@lifesciadvisors.com

Bionano Media Contact:
Kirsten
Thomas
The Ruth Group
+1 (508) 280-6592
kthomas@theruthgroup.com

Source: Bionano Genomics, Inc.


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