Bionano Genomics, Inc. (Nasdaq: BNGO), today reported financial
results for the third quarter ended September 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:
Recent Highlights since the End of Q3
2022:
- For the first time, the American Society of Human Genetics
(ASHG) annual meeting featured a dedicated scientific session on
genome mapping technologies, with researchers highlighting OGM as a
technique that has the potential to revolutionize molecular and
cytogenetic research. Additionally, twenty-four scientific and
poster presentations covered OGM’s utility in genetic disease
research and other research areas including schizophrenia, ataxia,
constitutional and neurodevelopmental disorders.
- Bionano recently held the first scientific user meeting in the
company’s history to bring together over 50 researchers curious
about OGM and experienced users from across the globe, for research
case presentations and demonstrations of Bionano’s
Saphyr® system and NxClinical™ software.
- Together with Hamilton, announced the commercialization 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. Initial testing has been performed on cell lines
and blood samples, with bone marrow aspirates (BMA) and other
sample types expected soon. Results confirmed that labs can process
up to 12 UHMW DNA samples per run and 24 UHMW DNA samples with high
consistency and reproducibility in an eight-hour workday. The
automated workflow marks a significant improvement over the manual
method, dramatically reducing the hands-on time and the number of
samples that can be purified to UHMW DNA. The Long String VANTAGE
is expected to be commercially released in early 2023.
Business Highlights in Q3
2022:
- Total revenue for Q3 2022 was $7.2 million, representing
the highest quarterly revenue to date for the company.
- Grew the installed base of Saphyr systems from 196 at the end
of Q2 2022 by 21 to 217 as of the end of Q3 2022, an 11% increase
compared to Q2 2022. The installed base at the end of Q3 2022 grew
54% compared to Q3 2021.
- Sold 3,975 nanochannel array flowcells during Q3 2022, which is
a record for the number of flowcells sold in any quarter in the
company’s history, represents a 17% sequential increase over Q2
2022 and is comparable to the 3,969 flowcells sold during Q3
2021.
- Presented the latest research on OGM for use in a variety of
applications at industry conferences with record numbers of
scientific presentations and posters on OGM, including at Cancer
Genomics Consortium with 18 events covering OGM’s utility for
research areas across the cancer genomics landscape.
- Announced the launch of Bionano Laboratories, a new
organization that combines Bionano’s OGM data services with the
clinical testing services previously offered by Lineagen, and
the launch of Bionano Laboratories’ first OGM-based laboratory
developed test (LDT). Bionano Laboratories recently
received CLIA-certification for its lab in San Diego. This
certification will enable Bionano Laboratories to offer
services to customers seeking to implement OGM into their
diagnostic routines and for research applications with hospitals,
pharmaceutical companies, and other parties that may desire a more
robust regulatory structure for their projects.
- Studies published during the quarter illustrate the value and
continued adoption of OGM in research areas including the
following:
- Cell bioprocessing quality control: One study
used OGM to investigate numerical and structural changes to two
induced pluripotent stem cells (iPSC) lines, WTC-11 and
Tuba1-GFP, during long-term culturing. This research provides
scientific and practical support for the use of OGM workflows in
regenerative medicine due to OGM’s ability to detect hundreds of
structural variants (SVs), many of which had not been seen by other
cytogenetic methods and which may impact the genomic integrity of
iPSCs. A second study evaluated OGM’s utility for regenerative
medicine as part of a workflow to evaluate the quality of
hypoimmunogenic iPSCs. This study validates OGM’s ability to detect
cryptic and balanced SVs in CRISPR-edited cells, some of which were
not detected by karyotyping, and which may impact the genomic
integrity of iPSCs.
- Repeat expansion disorders: A study evaluated
the utility of OGM in the analysis of repeat expansion disorders.
Researchers in this study describe how OGM can be adopted as an
alternative to Southern blot analysis for the identification of
repeat expansions in the RFC1 gene that can lead to
cerebellar ataxia with neuropathy and bilateral vestibular
areflexia syndrome (CANVAS) and adult-onset ataxia in multiple
populations.
- Hematologic malignancies: One study used OGM
to analyze the impact of chromothripsis (cth)
and TP53 abnormalities in chronic lymphocytic leukemia
(CLL) patients with high genomic complexity. The study noted that
detecting cth using some traditional cytogenetic approaches can be
challenging and reported that OGM was able to reveal rearrangements
associated with cth events, including intra-chromosomal and
inter-chromosomal translocations. A second study evaluated the
performance of OGM for detection of cytogenetic abnormalities in
myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)
samples. This work is the second independent study, following a
recent publication from researchers at MD Anderson Cancer
Center, showing that OGM enables better molecular characterization
of MDS. This paper extends that research to AML and the findings
indicate that OGM may have an even greater impact on the
characterization of AML compared to MDS, which led the researchers
to recommend integrating OGM into new prognostic scoring methods
for both myeloid malignancies.
- Recurrent pregnancy loss (RPL): A study
utilized OGM to detect cryptic balanced chromosomal rearrangements
(BCRs) found in subjects who experienced recurrent pregnancy loss
(RPL). Compared to traditional cytogenetic methods, OGM
successfully identified cryptic reciprocal translocation in all
samples, improving the success rate for finding pathogenic variants
of cryptic BCRs and streamlining the process of detection.
Additionally, a recent case study successfully evaluated OGM as a
method for investigating abnormal noninvasive prenatal testing
(NIPT) results because of its ability to accurately identify
complex structural aberrations relevant to recurrent pregnancy loss
and infertility.
“We believe our Q3 2022 results, which include
the highest quarterly revenues ever for Bionano, reflect continued
gains in market development and commercial validation for OGM. We
were pleased to see improved revenues across all of our global
regions,” 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 our achieved and planned advancements,
together with further validation of OGM utility supported by recent
publications, should lay the foundation for revenue growth and
further penetration of our target markets, including cytogenomics,
discovery research and cell bioprocessing."
Q3 2022 Financial
Highlights
- Total revenue for Q3 2022 was $7.2 million, up 55% from Q3
2021, and an 8% increase from Q2 2022.
- Gross margin for Q3 2022 was 25% and represents a 3% sequential
improvement over Q2 2022. This number is consistent with our gross
margin from Q3 2021 and reflects continued improvements in chip
production yields and the favorable product sales mix for the
quarter.
- Q3 2022 GAAP operating expense was $34.0 million, compared to
$21.8 million in Q3 2021. Q3 2022 non-GAAP1 operating expense was
$26.4 million, compared to $18.7 million in Q3 2021. Q3 2022
non-GAAP operating expense excludes $6.1 million in stock-based
compensation, $1.4 million in amortization of intangibles, and $0.1
million in transaction related expenses. The year-over-year
increase was primarily due to increased headcount and related
spending.
At September 30, 2022, the Company had
cash, cash equivalents, and available-for-sale securities of $180.2
million, which includes $22.5 million in net proceeds raised in Q3
2022 under its ATM facility.
Chris Stewart, chief financial officer of
Bionano added, “Q3 2022 was another outstanding quarter for
Bionano. I’m pleased with our 55% year-over-year revenue growth. We
believe this growth reflects the continued 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 $180.2 million at
quarter-end. We expect revenues for the fourth quarter to be in the
range of $7.5 million to $8 million.”
Conference Call &
Webcast Details |
Date: |
Thursday, November 3rd, 2022 |
Time: |
4:30 p.m. Eastern Time |
Live Call: |
Toll Free: 1-877-502-9276
Toll/International: 1-720-543-0302 |
Live Webcast: |
https://edge.media-server.com/mmc/p/cz29oo8z |
|
|
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,
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. 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 www.bionanogenomics.com, www.bionanolaboratories.com or www.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, amortization of intangibles and transaction related
expenses.
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, market development 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 fourth
quarter guidance and ability to exceed our 2022 revenue guidance,
our anticipated achievement of our ELEVATE! 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; 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: geopolitical and
macroeconomic events, such as the ongoing impact of the COVID-19
pandemic, the 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) |
|
|
|
September 30,2022 |
|
December 31,2021 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
28,166,000 |
|
|
$ |
24,571,000 |
|
Investments |
|
152,024,000 |
|
|
|
226,041,000 |
|
Accounts receivable, net |
|
5,829,000 |
|
|
|
4,934,000 |
|
Inventory |
|
25,046,000 |
|
|
|
12,387,000 |
|
Prepaid expenses and other current assets |
|
7,132,000 |
|
|
|
4,481,000 |
|
Total current assets |
|
218,197,000 |
|
|
|
272,414,000 |
|
Property and equipment, net |
|
15,859,000 |
|
|
|
10,318,000 |
|
Operating lease right-of-use asset |
|
6,030,000 |
|
|
|
6,691,000 |
|
Financing lease right-of-use asset |
|
3,759,000 |
|
|
|
3,926,000 |
|
Intangible assets, net |
|
22,585,000 |
|
|
|
26,842,000 |
|
Goodwill |
|
56,466,000 |
|
|
|
56,160,000 |
|
Other long-term assets |
|
802,000 |
|
|
|
749,000 |
|
Total assets |
$ |
323,698,000 |
|
|
$ |
377,100,000 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
9,407,000 |
|
|
$ |
9,696,000 |
|
Accrued expenses |
|
11,742,000 |
|
|
|
9,694,000 |
|
Contract liabilities |
|
976,000 |
|
|
|
684,000 |
|
Operating lease liability |
|
1,784,000 |
|
|
|
1,467,000 |
|
Finance lease liability, related party |
|
288,000 |
|
|
|
299,000 |
|
Contingent consideration |
|
9,303,000 |
|
|
|
— |
|
Total current liabilities |
|
33,500,000 |
|
|
|
21,840,000 |
|
Operating lease liability, net of current portion |
|
4,694,000 |
|
|
|
5,288,000 |
|
Finance lease liability, net of current portion |
|
3,626,000 |
|
|
|
3,642,000 |
|
Contingent consideration |
|
— |
|
|
|
9,066,000 |
|
Long-term contract liabilities |
|
136,000 |
|
|
|
146,000 |
|
Total liabilities |
|
41,956,000 |
|
|
|
39,982,000 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
30,000 |
|
|
|
29,000 |
|
Additional paid-in capital |
|
593,572,000 |
|
|
|
553,747,000 |
|
Accumulated deficit |
|
(310,038,000 |
) |
|
|
(216,119,000 |
) |
Accumulated other comprehensive loss |
|
(1,822,000 |
) |
|
|
(539,000 |
) |
Total stockholders’
equity |
|
281,742,000 |
|
|
|
337,118,000 |
|
Total liabilities and
stockholders’ equity |
$ |
323,698,000 |
|
|
$ |
377,100,000 |
|
|
|
|
|
Bionano Genomics, Inc. |
Condensed Consolidated Statement of Operations
(Unaudited) |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, 2022 |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
Product revenue |
$ |
3,606,000 |
|
|
$ |
3,300,000 |
|
|
$ |
10,635,000 |
|
|
$ |
7,845,000 |
|
Service and other revenue |
|
3,615,000 |
|
|
|
1,355,000 |
|
|
|
8,952,000 |
|
|
|
3,834,000 |
|
Total revenue |
|
7,221,000 |
|
|
|
4,655,000 |
|
|
|
19,587,000 |
|
|
|
11,679,000 |
|
Cost of revenue: |
|
|
|
|
|
|
|
Cost of product revenue |
|
3,708,000 |
|
|
|
2,340,000 |
|
|
|
11,257,000 |
|
|
|
5,723,000 |
|
Cost of service and other revenue |
|
1,704,000 |
|
|
|
1,161,000 |
|
|
|
4,190,000 |
|
|
|
2,321,000 |
|
Total cost of revenue |
|
5,412,000 |
|
|
|
3,501,000 |
|
|
|
15,447,000 |
|
|
|
8,044,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
12,742,000 |
|
|
|
6,505,000 |
|
|
|
35,036,000 |
|
|
|
13,270,000 |
|
Selling, general and administrative |
|
21,216,000 |
|
|
|
15,327,000 |
|
|
|
63,275,000 |
|
|
|
38,683,000 |
|
Total operating expenses |
|
33,958,000 |
|
|
|
21,832,000 |
|
|
|
98,311,000 |
|
|
|
51,953,000 |
|
Loss from operations |
|
(32,149,000 |
) |
|
|
(20,678,000 |
) |
|
|
(94,171,000 |
) |
|
|
(48,318,000 |
) |
Other income (expenses): |
|
|
|
|
|
|
|
Interest income |
|
436,000 |
|
|
|
29,000 |
|
|
|
737,000 |
|
|
|
152,000 |
|
Interest expense |
|
(73,000 |
) |
|
|
(2,000 |
) |
|
|
(223,000 |
) |
|
|
(873,000 |
) |
Gain on forgiveness of Paycheck Protection Program Loan |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,775,000 |
|
Loss on debt extinguishment |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,076,000 |
) |
Other income (expense) |
|
5,000 |
|
|
|
(67,000 |
) |
|
|
(183,000 |
) |
|
|
(96,000 |
) |
Total other income (expense) |
|
368,000 |
|
|
|
(40,000 |
) |
|
|
331,000 |
|
|
|
(1,118,000 |
) |
Loss before income taxes |
|
(31,781,000 |
) |
|
|
(20,718,000 |
) |
|
|
(93,840,000 |
) |
|
|
(49,436,000 |
) |
Provision for income
taxes |
|
(28,000 |
) |
|
|
(35,000 |
) |
|
|
(79,000 |
) |
|
|
(50,000 |
) |
Net loss |
$ |
(31,809,000 |
) |
|
$ |
(20,753,000 |
) |
|
$ |
(93,919,000 |
) |
|
$ |
(49,486,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bionano Genomics, Inc. |
Reconciliation of GAAP Operating Expense to Non-GAAP
Operating Expense (Unaudited) |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, 2022 |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
GAAP selling, general and
administrative expense |
$ |
21,216,000 |
|
|
$ |
15,327,000 |
|
|
$ |
63,275,000 |
|
|
$ |
38,683,000 |
|
Stock-based compensation expense |
|
(2,453,000 |
) |
|
|
(2,043,000 |
) |
|
|
(6,537,000 |
) |
|
|
(3,708,000 |
) |
Intangible asset amortization |
|
(1,419,000 |
) |
|
|
(79,000 |
) |
|
|
(4,257,000 |
) |
|
|
(237,000 |
) |
Transaction related expenses |
|
(87,000 |
) |
|
|
(240,000 |
) |
|
|
(87,000 |
) |
|
|
(240,000 |
) |
Adjusted non-GAAP selling, general and administrative expense |
$ |
17,257,000 |
|
|
$ |
12,965,000 |
|
|
$ |
52,394,000 |
|
|
$ |
34,498,000 |
|
GAAP research and development
expense |
$ |
12,742,000 |
|
|
$ |
6,505,000 |
|
|
$ |
35,036,000 |
|
|
$ |
13,270,000 |
|
Stock-based compensation expense |
|
(3,606,000 |
) |
|
|
(745,000 |
) |
|
|
(10,401,000 |
) |
|
|
(1,209,000 |
) |
Adjusted non-GAAP research and development expense |
|
9,136,000 |
|
|
|
5,760,000 |
|
|
|
24,635,000 |
|
|
|
12,061,000 |
|
Total adjusted non-GAAP
operating expense |
$ |
26,393,000 |
|
|
$ |
18,725,000 |
|
|
$ |
77,029,000 |
|
|
$ |
46,559,000 |
|
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