Bionano Genomics, Inc. (Nasdaq: BNGO), pioneer of optical genome
mapping (OGM) solutions on the Saphyr® system and provider of
NxClinical™ software, a leading solution for visualization,
interpretation and reporting of genomic data, today reported
financial results for the second quarter ended June 30, 2022.
The Company executed its commercialization
strategy, built scientific momentum by presenting data at key
scientific meetings and drove utilization of the Saphyr system at
leading institutions across the globe, with the following
highlights:
Notable Highlights since the End of Q2
2022:
- A paper was
published in Leukemia, from MD Anderson Cancer Center,
demonstrating the utility of OGM for myelodysplastic syndrome (MDS)
prognostication. The authors reported that in up to 28% of MDS
participants in the study, using OGM instead of traditional methods
of analysis would have resulted in a different prognostic risk
score or additional actionable variants. Prognostic risk scores are
used to determine the therapeutic management that oncologists
follow in MDS so different risk scores could mean different
therapies and potentially better outcomes for patients.
Business Highlights in Q2
2022:
- Total revenue for
Q2 2022 was $6.7 million, a record quarter for the
company.
- Grew the installed
base of Saphyr systems from 176 at the end of Q1 2022 by 20 to 196
as of the end of Q2 2022. The installed base grew 62% compared to
Q2 2021. The addition to the installed base of 20 systems in the
second quarter of 2022 is 67% higher than the 12 systems that were
added in the first quarter of 2022.
- Sold 3,394
nanochannel array flowcells during Q2 2022, a 24% growth over Q2
2021.
- Presented the
latest research on OGM for use in a variety of applications at
industry conferences including American Association for Cancer
Research (AACR) Annual Meeting, American Cytogenomics Conference
(ACC), Advances in Genome Biology and Technology (AGBT) General
Meeting, European Society of Human Genetics Conference ESHG), and
European Association for Cancer Research (EACR) Congress.
- As mentioned as a
highlight after the close of Q1, launched version 6.2 of NxClinical
software with an integrated genomic scar analysis for homologous
recombination deficiency (HRD). This feature provides a
comprehensive, consistent, and automated analysis of biomarkers
from next-generation sequencing (NGS) and microarray data that can
help clinical researchers stratify therapeutic response across
multiple tumor types.
- Announced, together
with Hamilton, the collaborative development of the Long String
VANTAGE for the isolation of Ultra High Molecular Weight (UHMW) DNA
for use in OGM. The Long String VANTAGE is the first Assay Ready
Workstation solution in Hamilton’s Long String Genomics product
program and supports extraction of UHMW DNA at increased scale. We
believe this workflow has the potential to double manual output,
with increased confidence in sample yields and DNA quality.
- Q2 publications
include:
- A study from the
University Hospitals Leuven, Belgium using OGM in combination with
multiple other cytogenetic methods and a new single-cell analysis
method as a comprehensive molecular strategy to characterize the
genomic variation in B-cell acute lymphoblastic leukemia
(B-ALL).
- An evaluation of
OGM from The First Affiliated Hospital of Zhengzhou, the largest
hospital in Central China, highlighting the utility of OGM for
structural variant analysis, including in a workflow for
preimplantation genetic testing.
- The first
peer-reviewed research study, from researchers at the University
Hospital Essen, using OGM to analyze genetic aberrations found in
pediatric patients with acute myeloid leukemia (AML).
- The publication of
a multi-platform study from researchers in the Human Genome
Structural Variation Consortium (HGSVC) using OGM in combination
with other cytogenetic technologies as a comprehensive strategy to
investigate inversions that may lead to genetic disorders.
- OGM using the
Saphyr system continues to be adopted at cytogenetics laboratories
and academic medical centers across the globe.
“We believe our Q2 2022 results, which include
record quarterly revenues for Bionano, show that the foundation we
laid in 2021 has carried us into 2022 and that the great progress
demonstrated by this quarter’s growth in Saphyr system installed
base reflects continued gains in market development and proof of
concept. We were also pleased to see a number of presentations
demonstrating OGM’s utility at cancer and cytogenomics conferences
across Europe and the United States,” commented Erik Holmlin, PhD,
president and chief executive officer of Bionano. “We remain on
track to achieve all of our previously outlined ELEVATE! milestones
for the second half of the year. We believe all of these achieved
and planned advancements, together with further validation of OGM
utility supported by recent publications, lay the foundation for
further penetration of our target markets and revenue growth."
Q2 2022 Financial
Highlights
- Total revenue for
Q2 2022 was $6.7 million, up 73% from Q2 2021, and a 17% increase
from Q1 2022.
- Gross margin for Q2
2022 was 22%, compared to 37% from Q2 2021. The decrease was
primarily due to low yields on our chip consumables produced at our
contract manufacturer. Gross margin improved over the first quarter
of 2022 of 15%, primarily due to improvements in chip yield.
- Q2 2022 GAAP
operating expense was $33.6 million, compared to $17.9 million in
Q2 2021. Q2 2022 non-GAAP1 operating expense was $26.4 million,
compared to $16.1 million in Q2 2021. Q2 2022 non-GAAP operating
expense excludes $5.8 million in stock-based compensation, and $1.4
million in amortization of intangibles. The year-over-year increase
was primarily due to increased headcount-related spending,
increased research and development expenses, and increased
marketing expenses.
- At June 30,
2022, the Company had cash, cash equivalents, and
available-for-sale securities of $187.3 million.
Chris Stewart, chief financial officer of
Bionano added, “Q2 2022 was another outstanding quarter for
Bionano. I’m pleased with our 73% year-over-year revenue growth,
which we achieved against a challenging macro-economic backdrop. We
believe this growth reflects the building excitement about Bionano
solutions that we are seeing in the market. Our capitalization
remains strong with a cash, cash equivalents, and
available-for-sale securities balance of $187.3 million as of
June 30, 2022, and we maintain our full-year revenue guidance
range of $24 million to $27 million.”
Conference Call & Webcast Details |
Date: |
Thursday, August 4th, 2022 |
Time: |
4:30 p.m. Eastern Time |
Live Call: |
https://register.vevent.com/register/BI1ae7bca48c2b4886928f5669d4b90c02 |
Live Webcast: |
https://edge.media-server.com/mmc/p/tm6m746p |
Participants may access a live webcast of the
call on the Investors page of the Bionano website. To participate
via telephone, please register here:
https://register.vevent.com/register/BI1ae7bca48c2b4886928f5669d4b90c02.
Upon registration, all telephone participants will receive a
confirmation email detailing how to join the conference call,
including the dial-in number along with a unique passcode and
registrant ID that can be used to access the call. A replay of the
conference call and webcast will be archived on Bionano’s investor
relations website at https://ir.bionanogenomics.com/ for at least
30 days.
About Bionano Genomics
Bionano Genomics 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 business,
the Company also provides diagnostic testing for patients with
clinical presentations consistent with autism spectrum disorder and
other neurodevelopmental disabilities. Through its BioDiscovery
business, 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. For more
information, visit bionanogenomics.com, lineagen.com or
biodiscovery.com.
Non-GAAP Financial Measures
To supplement Bionano’s financial results
reported in accordance with U.S. generally accepted accounting
principles (GAAP), the Company has provided non-GAAP operating
expense in this press release, which is a non-GAAP financial
measure. Non-GAAP operating expense excludes from GAAP reported
operating expense the following components as detailed in the
reconciliation table accompanying this press release: stock-based
compensation and amortization of intangibles.
Bionano believes that non-GAAP operating expense
is useful to investors and analysts as a supplement to its
financial information prepared in accordance with GAAP for
analyzing operating performance and identifying operating trends in
its business. Bionano uses non-GAAP operating expense internally to
facilitate period-to-period comparisons and analysis of its
operating performance in order to understand, manage and evaluate
its business and to make operating decisions. Accordingly, Bionano
believes this measure allows for greater transparency with respect
to key financial metrics it uses in assessing its own operating
performance and making operating decisions.
This non-GAAP financial measure is not meant to
be considered in isolation or as a substitute for comparable GAAP
measures; should be read in conjunction with the Company’s
consolidated financial statements prepared in accordance with GAAP;
has no standardized meaning prescribed by GAAP; and is not prepared
under any comprehensive set of accounting rules or principles. In
addition, from time to time in the future, there may be other items
that the Company may exclude for purposes of its non-GAAP financial
measures; and the Company may in the future cease to exclude items
that it has historically excluded for purposes of its non-GAAP
financial measures. Likewise, the Company may determine to modify
the nature of its adjustments to arrive at its non-GAAP financial
measures. Because of the non-standardized definitions of non-GAAP
financial measures, the non-GAAP financial measure as used by
Bionano in this press release and the accompanying reconciliation
table has limits in its usefulness to investors and may be
calculated differently from, and therefore may not be directly
comparable to, similarly titled measures used by other
companies.
For a reconciliation of non-GAAP operating
expense to operating expense reported in accordance with GAAP,
please refer to the financial tables accompanying this release.
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 “can,” “expect,” “may,” “plan,”
“anticipate,” “should,” “believe,” “would,” “potential,” “outlook,”
“guidance,” "goal", “will,” “estimate” 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: our expectations
regarding product uptake, revenue growth and increased OGM
adoption, including through publications highlighting the utility
and applications of OGM; our growth prospects and future financial
and operating results, including our 2022 revenue guidance and
anticipated achievement of milestones, the growth of our installed
Saphyr system base, the sales of our flowcell consumables and the
other expectations related thereto; our ability to meet our goal to
drive value and penetrate into our target markets; the anticipated
benefits of the NxClinical software; our commercial expectations,
including the potential market opportunity for structural variation
analysis and OGM; the anticipated benefits and success of our
collaboration efforts, including the opportunities offered by our
anticipated collaboration with Hamilton; continued research,
presentations and publications involving OGM, its utility compared
to traditional cytogenetics and our technologies; our ability to
drive adoption of OGM and our technology solutions; expected timing
and results from our clinical studies; and the execution of our
strategy, including the 2022 ELEVATE! strategy and our anticipated
2022 milestones. 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: the impact of the COVID-19
pandemic and geopolitical and macroeconomic events, such as the
ongoing conflict between Ukraine and Russia and related sanctions,
on our business and the global economy; general market conditions;
changes in the competitive landscape, including the introduction of
competitive technologies or improvements in existing technologies;
changes in our strategic and commercial plans; delays in research
or the receipt of supplies to advance our technologies and
products, as well as delays in the anticipated timing for new
product launches; our ability to obtain sufficient financing to
fund our strategic plans and commercialization efforts; whether
medical and research institutions will adopt and/or continue to use
our technologies, including as a result of their funding and the
results of studies evaluating the utility and effectiveness of OGM;
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, 2021 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@bionanogenomics.com |
|
Investor Relations
and |
Media
Contact: |
Amy Conrad |
Juniper Point |
+1 (858) 366-3243 |
amy@juniper-point.com |
BIONANO GENOMICS, INC |
Condensed Consolidated Balance Sheet
(Unaudited) |
|
(Unaudited) |
|
|
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
27,159,000 |
|
|
$ |
24,571,000 |
|
Investments |
|
160,178,000 |
|
|
|
226,041,000 |
|
Accounts receivable, net |
|
4,851,000 |
|
|
|
4,934,000 |
|
Inventory |
|
20,591,000 |
|
|
|
12,387,000 |
|
Prepaid expenses and other current assets |
|
3,509,000 |
|
|
|
4,481,000 |
|
Total current assets |
|
216,288,000 |
|
|
|
272,414,000 |
|
Property and equipment, net |
|
13,923,000 |
|
|
|
10,318,000 |
|
Operating lease right-of-use asset |
|
6,431,000 |
|
|
|
6,691,000 |
|
Financing lease right-of-use asset |
|
3,810,000 |
|
|
|
3,926,000 |
|
Intangible assets, net |
|
24,005,000 |
|
|
|
26,842,000 |
|
Goodwill |
|
56,254,000 |
|
|
|
56,160,000 |
|
Other long-term assets |
|
841,000 |
|
|
|
749,000 |
|
Total assets |
$ |
321,552,000 |
|
|
$ |
377,100,000 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,695,000 |
|
|
$ |
9,696,000 |
|
Accrued expenses |
|
7,760,000 |
|
|
|
9,694,000 |
|
Contract liabilities |
|
1,180,000 |
|
|
|
684,000 |
|
Operating lease liability |
|
1,757,000 |
|
|
|
1,467,000 |
|
Finance lease liability, related party |
|
292,000 |
|
|
|
299,000 |
|
Contingent consideration |
|
9,224,000 |
|
|
|
— |
|
Total current liabilities |
|
27,908,000 |
|
|
|
21,840,000 |
|
Operating lease liability, net of current portion |
|
5,075,000 |
|
|
|
5,288,000 |
|
Finance lease liability, net of current portion |
|
3,632,000 |
|
|
|
3,642,000 |
|
Contingent consideration |
|
— |
|
|
|
9,066,000 |
|
Long-term contract liabilities |
|
203,000 |
|
|
|
146,000 |
|
Total liabilities |
|
36,818,000 |
|
|
|
39,982,000 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
29,000 |
|
|
|
29,000 |
|
Additional paid-in capital |
|
564,852,000 |
|
|
|
553,747,000 |
|
Accumulated deficit |
|
(278,229,000 |
) |
|
|
(216,119,000 |
) |
Accumulated other comprehensive loss |
|
(1,918,000 |
) |
|
|
(539,000 |
) |
Total stockholders’
equity |
|
284,734,000 |
|
|
|
337,118,000 |
|
Total liabilities and
stockholders’ equity |
$ |
321,552,000 |
|
|
$ |
377,100,000 |
|
|
|
|
|
Bionano Genomics, Inc. |
Condensed Consolidated Statement of Operations
(Unaudited) |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue: |
|
|
|
|
|
|
|
Product revenue |
$ |
3,913,000 |
|
|
$ |
2,496,000 |
|
|
$ |
7,029,000 |
|
|
$ |
4,545,000 |
|
Service and other revenue |
|
2,757,000 |
|
|
|
1,360,000 |
|
|
|
5,337,000 |
|
|
|
2,479,000 |
|
Total revenue |
|
6,670,000 |
|
|
|
3,856,000 |
|
|
|
12,366,000 |
|
|
|
7,024,000 |
|
Cost of revenue: |
|
|
|
|
|
|
|
Cost of product revenue |
|
3,973,000 |
|
|
|
1,869,000 |
|
|
|
7,549,000 |
|
|
|
3,383,000 |
|
Cost of service and other revenue |
|
1,226,000 |
|
|
|
548,000 |
|
|
|
2,485,000 |
|
|
|
1,159,000 |
|
Total cost of revenue |
|
5,199,000 |
|
|
|
2,417,000 |
|
|
|
10,034,000 |
|
|
|
4,542,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
11,767,000 |
|
|
|
4,086,000 |
|
|
|
22,296,000 |
|
|
|
6,765,000 |
|
Selling, general and administrative |
|
21,783,000 |
|
|
|
13,829,000 |
|
|
|
42,060,000 |
|
|
|
23,357,000 |
|
Total operating expenses |
|
33,550,000 |
|
|
|
17,915,000 |
|
|
|
64,356,000 |
|
|
|
30,122,000 |
|
Loss from operations |
|
(32,079,000 |
) |
|
|
(16,476,000 |
) |
|
|
(62,024,000 |
) |
|
|
(27,640,000 |
) |
Other income (expenses): |
|
|
|
|
|
|
|
Interest income |
|
192,000 |
|
|
|
58,000 |
|
|
|
301,000 |
|
|
|
123,000 |
|
Interest expense |
|
(74,000 |
) |
|
|
(268,000 |
) |
|
|
(151,000 |
) |
|
|
(871,000 |
) |
Gain on forgiveness of Paycheck Protection Program Loan |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,775,000 |
|
Loss on debt extinguishment |
|
— |
|
|
|
(2,076,000 |
) |
|
|
— |
|
|
|
(2,076,000 |
) |
Other income (expense) |
|
(156,000 |
) |
|
|
(15,000 |
) |
|
|
(188,000 |
) |
|
|
(29,000 |
) |
Total other income (expense) |
|
(38,000 |
) |
|
|
(2,301,000 |
) |
|
|
(38,000 |
) |
|
|
(1,078,000 |
) |
Loss before income taxes |
|
(32,117,000 |
) |
|
|
(18,777,000 |
) |
|
|
(62,062,000 |
) |
|
|
(28,718,000 |
) |
Provision for income
taxes |
|
(41,000 |
) |
|
|
(9,000 |
) |
|
|
(50,000 |
) |
|
|
(15,000 |
) |
Net loss |
$ |
(32,158,000 |
) |
|
$ |
(18,786,000 |
) |
|
$ |
(62,112,000 |
) |
|
$ |
(28,733,000 |
) |
Bionano Genomics, Inc. |
Reconciliation of GAAP Operating Expense to Non-GAAP
Operating Expense (Unaudited) |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
GAAP operating expense |
$ |
33,550,000 |
|
|
$ |
17,915,000 |
|
|
$ |
64,356,000 |
|
|
$ |
30,122,000 |
|
Stock-based compensation expense |
|
(5,777,000 |
) |
|
|
(1,758,000 |
) |
|
|
(10,879,000 |
) |
|
|
(2,129,000 |
) |
Intangible asset amortization |
|
(1,419,000 |
) |
|
|
(79,000 |
) |
|
|
(2,838,000 |
) |
|
|
(158,000 |
) |
Adjusted non-GAAP operating
expense |
$ |
26,354,000 |
|
|
$ |
16,078,000 |
|
|
$ |
50,639,000 |
|
|
$ |
27,835,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1Non-GAAP operating expense is a non-GAAP financial measure. For
a description of this non-GAAP financial measure, please refer to
“Non-GAAP Financial Measures,” and for a reconciliation of non-GAAP
operating expense to operating expense reporting in accordance with
GAAP, please refer to the financial tables accompanying this
release.
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