Bionano Reports Preliminary Fourth Quarter and Full-Year 2023 Results
January 08 2024 - 8:00AM
Bionano Genomics, Inc. (Nasdaq: BNGO) today reported certain
unaudited preliminary financial and commercial highlights for the
fourth quarter and fiscal year ended December 31, 2023. The
Company’s full results for the fourth quarter and the fiscal year
ended December 31, 2023 are not yet available.
“2023 was a year in which we saw consistent progress in our
business, and we ended the year with a lot of momentum across all
facets of our business,” commented Erik Holmlin, PhD,
president and chief executive officer of Bionano. “In addition to
Bionano’s efforts to advance OGM, our user base has independently
organized to advocate for OGM as an alternative to traditional
cytogenetic methods, with user groups convening across the globe
and an international consortium of researchers publishing a
framework for the adoption and implementation of OGM. We believe
the progress of OGM in 2023, combined with our achievement of our
ELEVATE milestones and our cost savings initiatives and financing,
have positioned us for success in 2024.”
Q4 2023 Preliminary Unaudited Financial and Business
Results
- Revenues for the fourth quarter
2023 are expected to be in the range of $10.4
million to $10.7 million, an estimated increase
of 27% to 30% compared to $8.2 million in the fourth quarter of
2022.
- Full year 2023 revenue is
expected to be in the range of $35.8
million and $36.1 million, an estimated increase
of 29% to 30% compared to full year 2022.
- Installed base of OGM systems
totaled 326 at year-end, which represented a 36% increase
over the 240 installed systems reported at the end of 2022.
- Nanochannel array flowcells
sold in the fourth quarter is expected to be 7,980, an
estimated increase of 67% over the 4,781 flowcells sold in the
fourth quarter of 2022.
- Cash, cash
equivalents, and available-for-sale securities as of December 31,
2023 were approximately $102.8 million, of which $36.1 million is
subject to certain restrictions. We raised net proceeds of
$11.0 million from ATM sales during the period of November 14, 2023
through December 31, 2023. An additional $2.9 million has been
raised in net proceeds from ATM sales in 2024 to date.
Achieved All Full-Year 2023 ELEVATE!
Milestones
- Released the high throughput
OGM instrument, called the Stratys™ system, as part of an early
access program in the fourth quarter of 2023; the full commercial
release is expected in early 2024. The Stratys
system is expected to enable a four-fold increase in raw data
generation rate compared to the
Saphyr® system and is designed for maximum
lab flexibility by enabling up to 12 single access chips,
accessible as they complete runs, without the need to batch
multiple samples on a consumable.
- Released VIA™ software, which
replaces
NxClinical™ software with
a simple and integrated workflow for visualization, interpretation,
and reporting for OGM, microarray and next-generation sequencing
(NGS) data types for enhanced contextualization across multiple
variant types and accelerated time to results at a reduced cost. A
workflow focused on hematological malignancies was released in June
2023, and in December 2023, the Company announced upgrades to its
pipeline for OGM data analysis in VIA software for applications in
constitutional genetic diseases.
- Pre-commercial version of the
Ionic Purification System for isolation of DNA for OGM analysis
running in the field with the full commercial launch
planned for 2024.
- Launched an OGM laboratory
developed test (LDT) for constitutional genetic
disease applications through Bionano Laboratories.
- Submitted a dossier to Medicare
seeking a local coverage determination (LCD) for OGM
coverage.
- Conducted a pre-submission
discussion with FDA in connection with the planned
clearance of the Stratys system.
- Met or exceeded all previously
stated 2023 milestones for prenatal, postnatal, and
hematological malignancy clinical trials, including: sample
enrollment and data collection for prenatal study; interim
publication of the prenatal study; interim publication of the
hematological malignancy study; peer-reviewed interim publication
from postnatal study; and IRB approval for solid tumor study.
“In 2023, we secured additional financing and announced a series
of cost savings initiatives that will continue into this year. We
remain focused on financial discipline and implementing actionable
processes that we believe will enable us to improve margins and
further extend our cash runway. I believe in the power of OGM and
that 2024 has the potential to be a tremendous year for Bionano,”
added Gülsen Kama, chief financial officer of Bionano.
Bionano has not completed preparation of its financial
statements for the fourth quarter or full year of 2023. The
financial performance measures presented in this press release for
the fourth quarter of 2023 and for the year ended December 31, 2023
are preliminary and unaudited, based on management’s initial review
of the information presented, and are thus inherently uncertain and
subject to change as Bionano completes its end-of-period reporting
process and related activities for the fourth quarter of and full
year 2023. Bionano is in the process of completing its customary
year-end close and review procedures as of and for the year ended
December 31, 2023, and the final results for this period could
differ from the preliminary estimated results disclosed in this
press release. During the course of the preparation of Bionano's
unaudited consolidated financial statements and related notes as of
and for the year ended December 31, 2023, Bionano’s independent
registered public accountants may identify items that could cause
final reported results to be materially different from the
preliminary estimates presented herein. Additional information and
disclosures would be required for a more complete understanding of
Bionano’s financial position and results of operations as of and
for the fourth quarter and year ended December 31, 2023.
Accordingly, undue reliance should not be placed on this
preliminary information.
About Bionano
Bionano is a provider of genome analysis solutions that can
enable researchers and clinicians to reveal answers to challenging
questions in biology and medicine. The Company’s mission is to
transform the way the world sees the genome through OGM solutions,
diagnostic services and software. The Company offers OGM solutions
for applications across basic, translational and clinical research.
Through its Lineagen, Inc. d/b/a Bionano
Laboratories business, the Company also provides diagnostic
testing for patients with clinical presentations consistent with
autism spectrum disorder and other neurodevelopmental disabilities.
The Company also offers an industry-leading, platform-agnostic
software solution, which integrates next-generation sequencing and
microarray data designed to provide analysis, visualization,
interpretation and reporting of copy number variants,
single-nucleotide variants and absence of heterozygosity across the
genome in one consolidated view. The Company additionally offers
nucleic acid extraction and purification solutions using
proprietary isotachophoresis technology. For more information,
visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com.
Unless specifically noted otherwise, Bionano’s OGM products
are for research use only and not for use in diagnostic
procedures.
Forward-Looking Statements of Bionano
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “anticipate,” “believe,” “could,” “estimate,”
“expect,” “may,” “plan,” “will,” “should” “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:
certain financial measures, such as our preliminary revenue,
installed base and flowcell sales expected for the fourth quarter
2023 and fiscal year 2023; our ability to execute on our strategy
and achieve our objectives; the impact and utility of our cost
savings initiative and our recent financing to position us for
success in 2024; our ability to continue to drive OGM adoption by
potential customers for routine use in genomic analysis to expand
our OGM installed base and planned product launches and regulatory
developments; the timing of the full commercial release of the
Stratys system and Ionic Purification System and their potential
impact; continued research, presentations and publications
involving OGM and its utility compared to traditional cytogenetics
and our technologies; and our ability to drive adoption of OGM and
our technology solutions; and our prospects for 2024. 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 and uncertainties
associated with: adjustments to our preliminary measures of
financial performance resulting from, among other things, the
completion of our end-of-period review and reporting processes; the
timing and amount of revenue we are able to recognize in a given
fiscal period; the impact of adverse geopolitical and macroeconomic
events, such as recent and future bank failures, global pandemics,
inflation, supply chain disruptions and the ongoing conflict
between Ukraine and Russia and Israel and Hamas, on our business
and the global economy; general market conditions; our ability to
meet the funding conditions to gain access to the minimum cash
amount held as restricted cash in an account control agreement
under the financing; changes in the competitive landscape and the
introduction of competitive technologies or improvements to
existing technologies; changes in our strategic and commercial
plans; our need and ability to obtain sufficient additional
financing to fund our strategic plans and commercialization
efforts, our ability to effectively manage our uses of cash, and
our ability to continue as a “going concern”; the ability or
potential to obtain funding to support adoption or continued use of
our technologies; 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, 2022
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.
CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com
Investor Relations:
David Holmes
Gilmartin Group
+1 (858) 888-7625
IR@bionano.com
Bionano Genomics (NASDAQ:BNGO)
Historical Stock Chart
From Apr 2024 to May 2024
Bionano Genomics (NASDAQ:BNGO)
Historical Stock Chart
From May 2023 to May 2024