Bionano Genomics, Inc. (NASDAQ: BNGO) today
reported financial results and business achievements for the
quarter ended September 30, 2021 and highlighted recent
corporate updates.
“We had the strongest quarter in Bionano’s
history with a record number of Saphyr shipments and installations,
including adoptions at several notable sites, including leading
hospitals, cytogenetics labs and academic medical centers around
the world. With the acquisition of BioDiscovery, a leading software
company with best-in-class solutions for analysis, visualization,
interpretation and reporting of genomics data. for microarray and
next-generation sequencing (NGS), we are transitioning Bionano
Genomics from being the structural variation company into a data
solutions provider. We believe this will enable access to an
expanded market opportunity by leveraging the NGS market through
software. We are extremely pleased with the progress we are making
and the fact that outstanding leaders are joining Bionano to join
us in transforming the way the world sees the genome,” commented
Erik Holmlin, PhD, Chief Executive Officer of Bionano Genomics.
Chris Stewart, Chief Financial Officer of
Bionano added: “Q3 was another excellent quarter. We continued to
achieve meaningful year-over-year revenue growth and maintained a
strong balance sheet with $326 million of cash and marketable
securities as of the quarter-end. We also remain on track to
achieve the milestones we laid out in the first quarter of
2021.”
Recent Business Highlight
On October 18, 2021, we closed our acquisition
of BioDiscovery, Inc. The transaction is expected to accelerate and
broaden Bionano’s market leadership in digital cytogenetics and
comprehensive genome analysis. Bionano’s transaction consideration
for the acquisition of BioDiscovery was up to $100 million,
consisting of a combination of cash and equity. A portion of the
equity is subject to vesting based on continued service of key
employees and a portion of the cash is contingent on achieving full
integration of OGM data into BioDiscovery’s software platform.
Key Business Highlights in
Q3
The Company executed on its commercialization
strategy, built scientific momentum by presenting data at key
scientific meetings and drove utilization of Saphyr at key
institutions across the globe, with the following highlights:
– Expanded the installed
base of Saphyr systems from 121 at the end of Q2 to 141 at the end
of Q3. During the quarter ended September 30,2021, we
shipped a total of 24 Saphyr systems to the field, compared to 11
systems shipped in the same quarter in 2020.
– Sold 3,969 nanochannel
array flow cells during the quarter ended September 30,
2021, which is the most flow cells sold in any quarter
ever and represents 122% growth over the same quarter in 2020.
– Commercial release of
solutions for isolation of ultra-high molecular weight DNA for
prenatal applications supporting the use of samples
derived from amniocentesis and CVS. Bionano Prep SP Amnio and CVS
Culture DNA Isolation Protocol supports both fresh cultures and
cryopreserved cells, which expands the markets served for OGM.
– OGM with Saphyr was
adopted at several notable cytogenetics laboratories and academic
medical centers in the United States, including Brigham
& Woman’s Hospital, which is using OGM to identify structural
variations in constitutional and cancer applications. Outside the
US, Saphyr was adopted in Australia, Europe and China.
– The largest clinical
research study to date evaluating OGM was published in
The Journal of Molecular Diagnostics for a rare
muscle disease, facioscapulohumeral muscular dystrophy, or FSHD, in
about 351 patients. The results demonstrated that OGM provided data
more quickly, accurately, and reproducibly than the current gold
standard method of Southern blot analysis. The findings support the
rationale for adopting OGM as an alternative to Southern blot
analysis as OGM had a greater sizing accuracy as well as a greater
than 99% concordance with Southern blot analysis.
– NuProbe Global, a
global molecular diagnostics leader, adopted Saphyr to be
integrated their proprietary tools, Quantitative Amplicon
Sequencing (QASeq) and Blocker Displacement Amplification (BDA),
for research and development efforts in reproductive health and
oncology liquid biopsies.
– Saphyr customers and
Bionano conducted 10 presentations at the Annual Cancer Genomics
Consortium Meeting in mid-August 2021, highlighting the
benefits of OGM for clinical research applications in solid tumor
analysis, hematological malignancies, products of conception,
prenatal and postnatal constitutional genetics. More than 500
participants from around the globe attended virtually, highlighting
the strong interest in OGM for cancer genomics.
– Bionano customers
presented 11 presentations on OGM at the European Society of Human
Genetics (ESHG) meeting in late August 2021, demonstrating
the clinical utility of OGM across many therapeutic application
areas, along with the unique capabilities of Bionano’s Saphyr®
system to detect all classes of structural variants, across the
genome, at a superior resolution relative to traditional
techniques.
– Added exceptional
talent across commercial leadership functions, including
Amanda Lettmann as Vice President of Global Customer Experience,
Alex Helm as Vice President Strategic Product Marketing, Stephanie
Hoyle as Vice President Corporate Marketing, Amanda Hernandez as
Vice President of Global Sales Training and Development, Justin
Leighton as Vice President and General Manager, Lineagen, and Bob
Hertsenberg as North America Sales Director.
Financial Highlights
– Total revenue for the
third quarter of 2021 was $4.7 million, up 21% from $3.9
million in the second quarter and up 112% from $2.2 million in the
same period of 2020. The sequential increase was driven by
increased demand for our Saphyr optical genome mapping solutions,
including increased instrument sales and greater demand for our
reagent rental program and consumables. The year-over-year increase
was driven by both higher product sales and by the addition of
revenue from Lineagen.
– Gross margin for the
third quarter of 2021 was 24.8%, compared to 37.3% in the
prior quarter and 33.4% from the third quarter of 2020. The
decrease was primarily due to an increase in laboratory and
warranty related expense that are expected to be non-recurring.
– Third quarter
operating expense was $21.8 million, compared to
$17.9 million in the prior quarter and $11.0 million in the
third quarter of 2020. The sequential increase was mainly due to a
$1.8 million increase in headcount and related expenses and a $1.5
million increase in Research and Development expenses related to
expanding our supply chain to produce higher volumes. Third quarter
operating expense included $2.8 million of non-cash stock-based
compensation. The year-over-year increase was primarily due to
increased headcount-related spending as we build out all facets of
our organization to support our expected commercial progress and
increased research and development costs.
– At September 30,
2021, the Company had cash, cash equivalents, and short-term
investments of $326.1 million compared to cash and cash
equivalents of $38.4 million at December 31, 2020. The increase in
cash is primarily due to the equity raises that were completed in
the first quarter of 2021.
Remaining Anticipated Milestones for
2021 – Initiatives to Drive Global Adoption of Saphyr
– 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, November 4,
2021 |
Time: |
4:30 p.m. Eastern Time |
Toll Free: |
1-877-407-0784 |
International: |
1-201-689-8560 |
Conference ID: |
13724790 |
Webcast: |
https://edge.media-server.com/mmc/p/emjvhnfb |
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 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 www.bionanogenomics.com, www.biodiscovery.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 expected benefits
of our acquisition of BioDiscovery, including with respect to its
impact on our market leadership; our anticipated milestones for the
remainder of 2021, including that we remain on track to achieve
these milestones; 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 acquisitions of Lineagen
and BioDiscovery; 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) |
|
|
|
September 30, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
140,736,000 |
|
|
|
$ |
38,449,000 |
|
|
Investments |
$ |
185,333,000 |
|
|
|
$ |
— |
|
|
Accounts receivable, net |
2,996,000 |
|
|
|
2,775,000 |
|
|
Inventory |
9,020,000 |
|
|
|
3,316,000 |
|
|
Prepaid expenses and other current assets |
3,962,000 |
|
|
|
2,250,000 |
|
|
Total current assets |
342,047,000 |
|
|
|
46,790,000 |
|
|
Property and equipment, net |
8,554,000 |
|
|
|
4,910,000 |
|
|
Intangible Assets |
1,238,000 |
|
|
|
1,475,000 |
|
|
Goodwill |
7,173,000 |
|
|
|
7,173,000 |
|
|
Other Long Term Assets |
$ |
645,000 |
|
|
|
$ |
103,000 |
|
|
Total
assets |
$ |
359,657,000 |
|
|
|
$ |
60,451,000 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,875,000 |
|
|
|
$ |
2,930,000 |
|
|
Accrued expenses |
9,416,000 |
|
|
|
5,599,000 |
|
|
Contract liabilities |
411,000 |
|
|
|
416,000 |
|
|
Total current liabilities |
17,702,000 |
|
|
|
8,945,000 |
|
|
Long-term debt |
— |
|
|
|
16,326,000 |
|
|
Long-term contract liabilities |
158,000 |
|
|
|
98,000 |
|
|
Other non-current liabilities |
232,000 |
|
|
|
— |
|
|
Total liabilities |
18,092,000 |
|
|
|
25,369,000 |
|
|
Stockholders’ equity: |
|
|
|
Common stock |
28,000 |
|
|
|
19,000 |
|
|
Additional paid-in capital |
534,823,000 |
|
|
|
178,747,000 |
|
|
Accumulated deficit |
(193,170,000 |
) |
|
|
(143,684,000 |
) |
|
Accumulated Other Comprehensive Loss |
(116,000 |
) |
|
|
— |
|
|
Total stockholders’
equity |
341,565,000 |
|
|
|
35,082,000 |
|
|
Total liabilities and
stockholders’ equity |
$ |
359,657,000 |
|
|
|
$ |
60,451,000 |
|
|
|
|
|
|
Bionano Genomics, Inc. |
Condensed Consolidated Statement of Operations
(Unaudited) |
|
Three Months Ended September 30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
Product revenue |
$ |
3,300,000 |
|
|
|
$ |
1,580,000 |
|
|
|
$ |
7,845,000 |
|
|
|
$ |
3,503,000 |
|
|
Service and other revenue |
1,355,000 |
|
|
|
616,000 |
|
|
|
3,834,000 |
|
|
|
1,010,000 |
|
|
Total revenue |
4,655,000 |
|
|
|
2,196,000 |
|
|
|
11,679,000 |
|
|
|
4,513,000 |
|
|
Cost of revenue: |
|
|
|
|
|
|
|
Cost of product revenue |
2,340,000 |
|
|
|
1,136,000 |
|
|
|
5,723,000 |
|
|
|
2,426,000 |
|
|
Cost of service and other revenue |
1,161,000 |
|
|
|
324,000 |
|
|
|
2,321,000 |
|
|
|
493,000 |
|
|
Total cost of revenue |
3,501,000 |
|
|
|
1,460,000 |
|
|
|
8,044,000 |
|
|
|
2,919,000 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
6,505,000 |
|
|
|
2,304,000 |
|
|
|
13,270,000 |
|
|
|
7,379,000 |
|
|
Selling, general and administrative |
15,327,000 |
|
|
|
8,659,000 |
|
|
|
38,683,000 |
|
|
|
21,640,000 |
|
|
Total operating expenses |
21,832,000 |
|
|
|
10,963,000 |
|
|
|
51,953,000 |
|
|
|
29,019,000 |
|
|
Loss from operations |
(20,678,000 |
) |
|
|
(10,227,000 |
) |
|
|
(48,318,000 |
) |
|
|
(27,425,000 |
) |
|
Other income (expenses): |
|
|
|
|
|
|
|
Interest income (expense) |
27,000 |
|
|
|
(589,000 |
) |
|
|
(721,000 |
) |
|
|
(1,911,000 |
) |
|
Gain on forgiveness of PPP Loan |
— |
|
|
|
— |
|
|
|
1,775,000 |
|
|
|
— |
|
|
Loss on debt extinguishment |
— |
|
|
|
— |
|
|
|
(2,076,000 |
) |
|
|
— |
|
|
Other income (expense) |
(67,000 |
) |
|
|
54,000 |
|
|
|
(96,000 |
) |
|
|
— |
|
|
Total other income (expense) |
(40,000 |
) |
|
|
(535,000 |
) |
|
|
(1,118,000 |
) |
|
|
(1,911,000 |
) |
|
Loss before income taxes |
(20,718,000 |
) |
|
|
(10,762,000 |
) |
|
|
(49,436,000 |
) |
|
|
(29,336,000 |
) |
|
Provision for income
taxes |
(35,000 |
) |
|
|
(30,000 |
) |
|
|
(50,000 |
) |
|
|
(40,000 |
) |
|
Net loss |
$ |
(20,753,000 |
) |
|
|
$ |
(10,792,000 |
) |
|
|
$ |
(49,486,000 |
) |
|
|
$ |
(29,376,000 |
) |
|
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