Bionano Genomics Reports First Quarter 2021 Financial Results and Highlights Recent Business Progress
May 13 2021 - 4:01PM
Bionano Genomics, Inc. (NASDAQ: BNGO) today
reported financial results and business achievements for the first
quarter ended March 31, 2021 and highlighted recent corporate
updates.
“2021 is off to a solid start for Bionano. In the first quarter,
we sold a record number of flow cells, analyzed a record number of
samples in our service lab, drove broad adoption of Saphyr
instruments and ramped up the installation of Saphyr systems that
weren’t yet operational because of 2020’s travel restrictions,”
said Erik Holmlin, PhD, CEO of Bionano. “With the largest number of
Saphyr systems in service analyzing more genomes than ever before,
we are seeing a sharp increase in the quality and scale of studies
that are being published and presented and the awareness they
build. The power of optical genome mapping, or OGM, data was on
display at our own Next-Generation Cytogenomics Symposium, and
through our strong presence at various key conferences in the US,
Europe and China we continued to drive the awareness we believe is
needed to develop the market for structural variation analysis and
OGM. In Q1 2021 we saw a clear expansion into new geographical
areas and into new applications such as prenatal analysis, cancer
research and drug development. Our customers continued development
of Saphyr-based assays for structural variation analysis in our key
growth areas of prenatal and post-natal genetics, hematologic
malignancies and solid tumors in Europe, the US, Canada and new
markets across the world. As our customers grow the number of
laboratory-developed tests (LDTs) in the market, we expect this
will build out the path to reimbursement of Saphyr-based LDTs by
third party payers in the US and around the world.”
Chris Stewart, Chief Financial Officer of Bionano added, “In the
quarter, we solidified our foundation for growth through two
successful financings, contributing to a cash position of $362
million as of the end of the quarter. We anticipate that the
strength of our balance sheet will enable us to clear barriers to
global adoption of OGM with Saphyr, support applications
development to open up additional end-user markets and drive toward
the next wave of big biology and innovation in genomics.”
Key Business Highlights
The Company executed on its commercialization strategy,
continued to build scientific momentum by presenting data at key
scientific meetings, and drove utilization of Saphyr® at key
institutions across the globe, with the following notable
announcements:
- Hosted the Next-Generation Cytogenomics symposium, which
featured distinguished speakers from around the globe describing
how OGM could be applied to clinical research and discovery
research in pre-natal and postnatal genetic diseases, hematologic
malignancies, solid tumors and host genome COVID research.
- Expanded into new geographic markets including South Africa,
Greece, Russia, South Korea, and important clinical sites in the
United Kingdom and Germany
- King’s College Hospital in London and the NHS Regional Genetics
Laboratory in Belfast City Hospital adopted Saphyr systems.
- Gained Saphyr adoption by the University Health Network in
Toronto, which has the largest hospital diagnostic lab in
Canada.
- Dr Jim Broach at Penn State University published a method for
solid tumor analysis by OGM, unlocking the largest oncology market
for Saphyr.
- Dr Yuval Ebenstein at Tel Aviv University published a method to
analyze DNA methylation in cancer genomes, enabling a new field of
cancer research and drug target discovery.
- Praxis Genomics obtained DEX Z-codes from Palmetto MolDX for
billing in connection with the performance of their whole genome
analysis LDT for constitutional genetic disease.
- Increased the speed of our compute on demand cloud computing
solution by 30% and reduced the cost to the end-user by 50%.
- MD Anderson Cancer Center published a study showing how Saphyr
significantly reduced the time to results for myelodysplastic
syndrome from weeks to 4 days.
- Dr Gordana Raca from Children’s Hospital in Los Angeles
presented results showing that Saphyr detects druggable gene
fusions in pediatric acute leukemias that next-generation
sequencing and cytogenetics missed.
- Developed new applications for Saphyr in the field of prenatal
testing with publications, presentations, and the adoption of
Saphyr by the Foundation for Embryonic Competence; and in cancer
research and drug development with several publications on DNA
methylation and DNA replication.
- Bionano customers presented a record number of presentations
across all four of Bionano’s main target growth markets - prenatal,
postnatal/constitutional genetics, blood cancers and solid tumor
analysis – with Optical Genome Mapping (OGM) at the 2021 Annual
Clinical Genetics Meeting of ACMG. We believe these publications
and presentations demonstrate the utility of OGM across our
targeted markets.
- Strengthened the balance sheet by raising approximately $337
million from two underwritten public offerings of shares of its
common stock, the utilization of its $40 million ATM facility, and
the exercise of outstanding warrants, enabling the company to
advance the business without near term capital constraints.
Financial Highlights
- Total revenue was $3.2 million for the three months ended March
31, 2021, up 179% from $1.1 million in the same period of 2020.
Revenue increased in all regions. The increase in product sales was
driven by increased demand of our reagent rental program and
consumables, while the increase in service revenue was primarily
driven by sales from our Lineagen subsidiary.
- Gross margin for the first quarter of 2021 was 33%, up 8% from
25% in the same period in 2020. The increase was primarily due to a
shift in our product mix toward higher margin consumables and
services.
- Operating expense for the first quarter of 2021 was $12.2
million, an increase of approximately $2.2 million compared to
$10.0 million for the same period in 2020. The change is primarily
due to increased headcount and material and supply expense, offset
by a $1M decrease in bad debt expense.
- At March 31, 2021, the Company had cash and cash equivalents of
$362 million compared to cash and cash equivalents of $38.4 million
at December 31, 2020. The increase in cash is due to the equity
raises that were completed in January 2021.
- A gain on debt extinguishment of $1.8 million was recognized
during the three months ended March 31, 2020 due to the forgiveness
in full of our PPP loan, including all accrued interest.
Upcoming Milestones for 2021 – Initiatives to Drive
Global Adoption of Saphyr
2Q21: Accreditation of Saphyr based LDTs for ALL & FSHD in
certain EU markets
3Q21: Commercial release of prenatal assays and expansion of the
menu of pediatric assays
4Q21: Interim publication of results from pediatric clinical
study
4Q21: Validation of LDTs by 3 sites in both our prenatal
clinical study and our pediatric clinical study
4Q21: Initial prototype of next gen high throughput Saphyr
4Q21: Reach installed base of 150 systems to achieve a 50%
increase over year end 2020
Conference Call & Webcast Details
Date: |
Thursday, May 13, 2021 |
Time: |
4:30 p.m. Eastern Time |
Toll Free: |
(833) 397-0959 |
International: |
(614) 999-1719 |
Conference ID: |
7163806 |
Webcast: |
https://edge.media-server.com/mmc/p/5hjudqv7 |
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 GenomicsBionano is a
genome analysis company providing tools and services based on its
Saphyr system to scientists and clinicians conducting genetic
research and patient testing, and providing diagnostic testing for
those with autism spectrum disorder (ASD) and other
neurodevelopmental disabilities through its Lineagen business.
Bionano’s Saphyr system is a research use only 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 to streamline the
study of changes in chromosomes, which is known as cytogenetics.
The Saphyr system is comprised of an instrument, chip consumables,
reagents and a suite of data analysis tools. Bionano provides
genome analysis services to provide access to data generated by the
Saphyr system for researchers who prefer not to adopt the Saphyr
system in their labs. Lineagen has been providing genetic testing
services to families and their healthcare providers for over nine
years and has performed over 65,000 tests for those with
neurodevelopmental concerns. For more information,
visit www.bionanogenomics.com or www.lineagen.com.
Forward-Looking StatementsThis
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 potential
reimbursement of LDTs based on Saphyr; our cash position and its
potential impact on our ability to execute our operational
objectives; our anticipated milestones for the rest of 2021; and
the advancement of our business strategy. 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 on our
business and the global economy; 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 ability of medical and research
institutions to obtain funding to support adoption or continued use
of our technologies; the loss of key members of management and our
commercial team; our inability to achieve the anticipated benefits
from our acquisition of Lineagen; 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) |
|
|
|
March 31, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
362,057,000 |
|
|
$ |
38,449,000 |
|
Accounts receivable, net |
1,992,000 |
|
|
2,775,000 |
|
Inventory |
3,036,000 |
|
|
3,316,000 |
|
Prepaid expenses and other current assets |
3,166,000 |
|
|
2,250,000 |
|
Total current assets |
370,251,000 |
|
|
46,790,000 |
|
Property and equipment, net |
5,806,000 |
|
|
4,910,000 |
|
Intangible Assets |
1,396,000 |
|
|
1,475,000 |
|
Goodwill |
7,173,000 |
|
|
7,173,000 |
|
Other Long Term Assets |
$ |
235,000 |
|
|
$ |
103,000 |
|
Total
assets |
$ |
384,861,000 |
|
|
$ |
60,451,000 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,209,000 |
|
|
$ |
2,930,000 |
|
Accrued expenses |
4,659,000 |
|
|
5,599,000 |
|
Contract liabilities |
301,000 |
|
|
416,000 |
|
Total current liabilities |
7,169,000 |
|
|
8,945,000 |
|
Long-term debt, net of current portion |
14,866,000 |
|
|
16,326,000 |
|
Long-term contract liabilities |
108,000 |
|
|
98,000 |
|
Total liabilities |
22,143,000 |
|
|
25,369,000 |
|
Stockholders’ equity: |
|
|
|
Common stock |
28,000 |
|
|
19,000 |
|
Additional paid-in capital |
516,321,000 |
|
|
178,747,000 |
|
Accumulated deficit |
(153,631,000 |
) |
|
(143,684,000 |
) |
Total stockholders’
equity |
362,718,000 |
|
|
35,082,000 |
|
Total liabilities and
stockholders’ equity |
$ |
384,861,000 |
|
|
$ |
60,451,000 |
|
|
|
|
|
Bionano Genomics, Inc. |
Condensed Consolidated Statement of
Operations |
|
Three Months EndedMarch 31, |
|
2021 |
|
2020 |
Revenue: |
|
|
|
Product revenue |
$ |
2,049,000 |
|
|
$ |
983,000 |
|
Service and other revenue |
1,119,000 |
|
|
153,000 |
|
Total revenue |
3,168,000 |
|
|
1,136,000 |
|
Cost of revenue: |
|
|
|
Cost of product revenue |
1,513,000 |
|
|
774,000 |
|
Cost of service and other revenue |
612,000 |
|
|
82,000 |
|
Total cost of revenue |
2,125,000 |
|
|
856,000 |
|
Operating expenses: |
|
|
|
Research and development |
2,678,000 |
|
|
2,674,000 |
|
Selling, general and administrative |
9,528,000 |
|
|
7,368,000 |
|
Total operating expenses |
12,206,000 |
|
|
10,042,000 |
|
Loss from operations |
(11,163,000 |
) |
|
(9,762,000 |
) |
Other income (expenses): |
|
|
|
Interest expense |
(538,000 |
) |
|
(761,000 |
) |
Gain on debt extinguishment |
1,775,000 |
|
|
— |
|
Other income (expenses) |
(15,000 |
) |
|
18,000 |
|
Total other income (expenses) |
1,222,000 |
|
|
(743,000 |
) |
Loss before income taxes |
(9,941,000 |
) |
|
(10,505,000 |
) |
Provision for income
taxes |
(6,000 |
) |
|
(5,000 |
) |
Net loss |
$ |
(9,947,000 |
) |
|
$ |
(10,510,000 |
) |
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