- Revenues of $17.8 million were driven by RT-PCR COVID-19
testing
- Initiated full commercial launch of CNSide™ cerebrospinal fluid
assay for diagnosing and managing patients with metastatic cancer
involving the central nervous system
- Received approximately 390,000 COVID-19 samples since June
2020
- Hosted KOL webinar with leading neuro-oncologists discussing
their use of CNSide and its importance in clinical decisions that
affect patient outcomes
Conference call begins at 4:30 p.m. Eastern
time today
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, reports financial results
for the three months ended March 31, 2021 and provides a business
update.
“We are reporting profitability for the second consecutive
quarter on revenues of $17.8 million, as our dedicated Biocept team
continued to serve our community with COVID-19 RT-PCR testing
featuring exceptional customer service and rapid turnaround times,”
said Michael Nall, Biocept’s President and CEO. “These outstanding
financial results support further advancements with our core
oncology business and more specifically our focus on neuro-oncology
as we build for a strong long-term future.
“The full commercial launch of CNSide, our cerebrospinal fluid
assay detecting tumor cells and molecular biomarkers, is
transformational for Biocept,” he added. “We developed CNSide to
address a high unmet medical need by providing diagnostic testing
that we believe exceeds the capabilities of the current standard of
care, CSF cytology. In early studies, CNSide has shown better
sensitivity than CSF cytology in detecting patients with metastatic
cancer involving the central nervous system. CNSide has the added
advantage of providing quantitative results, which is showing
promise in assessing patient response to therapy and monitoring
patients for minimal residual disease.
“We are pursuing a clinical strategy to support CNSide as the
new standard-of-care diagnostic for cancer that has metastasized to
the central nervous system. We also are expanding our reach to
neuro-oncologists, medical oncologists and other physicians to
build upon the positive reception our assay has received from early
adopters. Following our soft launch in early 2020, we have seen
CNSide orders increase quarterly with many physicians ordering
repeatedly. We recently hosted a highly informative webinar in
which three neuro-oncology leaders using our CNSide assay in their
practices cited multiple case studies with favorable patient
outcomes,” he added. “This is an exciting opportunity for Biocept
to help patients with breast and lung cancers that have
metastasized to the central nervous system—a U.S. market we
estimate at more than $1 billion annually.
“I’m exceptionally proud of the Biocept team for stepping up to
address the pressing public health need for COVID-19 testing,” said
Mr. Nall. “Since we began offering this service in 2020, we have
received approximately 390,000 samples, including about 140,000
samples during the first quarter. We recently announced a
partnership to make our service available to all 116 California
community colleges including their 2.1 million students, as well as
faculty and staff. We expect COVID-19 testing will continue to be
an important component of our business and provide meaningful
revenues throughout 2021, noting our expectations might change as
the pandemic evolves.”
First Quarter 2021 and Recent Highlights
Commercial Launches, Developments and
Agreements
Oncology
- Initiated the full commercial launch of CNSide, Biocept’s
cerebrospinal fluid assay that offers a timely and accurate method
to diagnose patients with lung and breast cancer that has
metastasized to the central nervous system, along with the ability
to identify actionable biomarkers and assess a patient’s response
to therapy. CNSide is based on Biocept’s proprietary quantitative
tumor cell capture and detection method paired with assays to
identify actionable molecular treatment targets.
- Established a collaboration with Protean BioDiagnostics, an
independent pathology laboratory, to evaluate the ability of the
novel Target Selector™ research use only (RUO) kits to determine
EGFR status in patients with non-small cell lung cancer (NSCLC)
comparing circulating tumor DNA (ctDNA) from blood with
formalin-fixed paraformaldehyde embedded (FFPE) tissue samples.
Protean BioDiagnostics also expects to validate the analytical
performance of a laboratory developed test (LDT) based on Biocept’s
EGFR assay test kit in accordance with the requirements of the
College of American Pathologists (CAP) validation process.
COVID-19
- Partnered with the Foundation for California Community Colleges
to make Biocept’s COVID-19 testing available for purchase and use
with more than 2.1 million students, as well as faculty and staff
through the Foundation’s CollegeBuys program. The availability of
COVID-19 testing is expected to provide information needed to help
protect the safety of campus populations and reduce the spread of
the SARS-CoV-2 virus as students return to campus from the current
remote learning environment.
- Received approximately 390,000 samples for COVID-19 RT-PCR
testing at Biocept’s high-complexity, CLIA-certified,
CAP-accredited and BSL-2 safety level laboratory since beginning to
offer this testing in 2020. The lab is using Thermo Fisher
Scientific’s FDA-approved for EUA testing TaqPath™ molecular
diagnostic platform and kit. The vast majority of test results to
date have been reported to healthcare providers within 48 hours of
sample receipt.
- Entered into development and supply agreements with Aegea
Biotechnologies following success under Biocept’s first agreement
with Aegea to develop a new, highly sensitive quantitative
PCR-based COVID-19 assay. The new assay utilizes the patented
Switch-Blocker™ technology, which is also used in Biocept’s Target
Selector assays. Under the supply agreement, Aegea is supplying the
COVID-19 assay kit for validation in Biocept’s lab. Following
validation, Biocept intends to commercialize an LDT. The assay is
designed for quantitative monitoring of viral RNA load to better
assist healthcare providers in screening and managing
patients.
Clinical Study
- Announced plan to initiate a clinical validation study, the 4C
trial, evaluating the performance of the CNSide assay compared with
current standard of care, which includes imaging, CSF cytology and
clinical evaluation of patients with suspected cancer metastasis
involving the central nervous system. This study and our planned
application for FDA breakthrough device designation will support
the Company’s efforts to introduce an FDA-cleared class II IVD
product.
Industry Presentations and
Publication
- Hosted a neuro-oncology webinar discussing CNSide for the
diagnosis of cancer involving the central nervous system. The
webinar featured a technology overview and leading
neuro-oncologists citing case studies using the CNSide assay with
subsequent favorable patient outcomes.
- Presented a poster with colleagues from NeoGenomics
Laboratories (Nasdaq: NEO) at the Molecular Med Tri-Con Virtual
Conference showing Biocept’s Target Selector molecular assay kit
detected mutations in up to 50% of tissue biopsy specimens from
patients diagnosed with NSCLC that were deemed quantity not
sufficient (QNS) due to a lack of tissue to perform testing. The
assay was used to evaluate the presence of several key EGFR and
KRAS mutations in FFPE biopsy samples that had inadequate tumor for
next-generation sequencing (NGS) analysis.
First Quarter Financial Results
Revenues for the first quarter of 2021 were $17.8 million,
compared with $1.4 million for the first quarter of 2020, with the
increase attributable to RT-PCR COVID-19 testing. Revenues for the
first quarter of 2021 included $17.7 million in commercial test
revenue, which is comprised of $16.8 million attributable to RT-PCR
COVID-19 testing, $39,000 in development services test revenue and
$62,000 in revenue from distributed products, Target Selector RUO
kits, CEE-Sure® blood collection tubes and payments from Aegea
Biotechnologies for services associated with the development of a
COVID-19 assay. Revenues for the first quarter of 2020 included
$1.3 million in commercial test revenue, $60,000 in development
services test revenue and $69,000 in revenue for Target Selector
RUO kits and CEE-Sure blood collection tubes.
Biocept accessioned 145,110 total samples during the first
quarter of 2021, compared with 1,306 total samples during the first
quarter of 2020. The Company accessioned 144,932 commercial
billable samples during the first quarter of 2021, compared with
985 commercial billable samples during the first quarter of 2020.
The increase in total and commercial billable samples was primarily
attributable to COVID-19 testing.
Cost of revenues for the first quarter of 2021 was $9.0 million,
compared with $2.9 million for the first quarter of 2020, with the
increase primarily due to COVID-19-related collection kits and
consumable expenses. Research and development (R&D) expenses
for the first quarter of 2021 were $1.0 million, compared with $1.3
million for the first quarter of 2020, with the decrease primarily
attributable to lower facilities costs and cost of revenue
allocations to R&D. General and administrative (G&A)
expenses for the first quarter of 2021 were $3.1 million, compared
with $1.9 million for the first quarter of 2020, with the increase
primarily due to headcount additions and other expenses related to
COVID-19 testing. Sales and marketing expenses for the first
quarter of 2021 were $1.9 million, compared with $1.5 million for
the first quarter of 2020, with the increase resulting from higher
sales commissions due to higher revenues.
Operating income for the first quarter of 2021 was $2.7 million,
versus an operating loss of $6.2 million for the first quarter of
2020.
Other expense, net for the first quarter of 2021 was $65,000,
compared with other expense, net for the first quarter of 2020 of
$2.2 million, with the decrease mainly due to $2.1 million in
warrant inducement expense in the first quarter of 2020.
Net income attributable to common shareholders for the first
quarter of 2021 was $2.6 million, or $0.19 per diluted share on
13.7 million weighted-average shares outstanding. This compares
with a net loss attributable to common shareholders for the first
quarter of 2020 of $8.3 million, or $1.06 per diluted share on 7.9
million weighted-average shares outstanding. The change in
outstanding share count reflects the 1-for-10 reverse split of
common stock effected in September 2020.
Biocept reported cash and cash equivalents as of March 31, 2021
of $14.2 million, compared with $14.4 million as of December 31,
2020.
Conference Call and Webcast
Biocept will hold a conference call today at 4:30 p.m. Eastern
time to discuss these results and answer questions. The conference
call can be accessed by dialing (855) 656-0927 for domestic
callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for
other international callers. A live webcast of the conference call
will be available on the investor relations page of the Company’s
website at http://ir.biocept.com/events.cfm.
A replay of the call will be available for 48 hours following
its conclusion and can be accessed by dialing (877) 344-7529 for
domestic callers, (855) 669-9658 for Canadian callers or (412)
317-0088 for other international callers. Please use event passcode
10155314. A replay of the webcast will be available for 90
days.
About Biocept
Biocept, Inc. develops and commercializes molecular diagnostic
assays that provide physicians with clinically actionable
information for treating and monitoring patients diagnosed with a
variety of cancers. In addition to its broad portfolio of
blood-based liquid biopsy assays, Biocept has developed the CNSide™
cerebrospinal fluid assay that detects cancer that has metastasized
to the central nervous system. Biocept’s patented Target Selector™
technology captures and quantitatively analyzes CSF tumor cells for
tumor-associated molecular markers, using technology first
developed for use in blood. Biocept also is leveraging its
molecular diagnostic capabilities to offer nationwide COVID-19
RT-PCR testing to support public health efforts during this
unprecedented pandemic. For more information, visit
www.biocept.com. Follow Biocept on Facebook, LinkedIn and
Twitter.
Forward-Looking Statements Disclaimer Statement
This news release contains forward-looking statements that are
based upon current expectations or beliefs, as well as a number of
assumptions about future events. Although we believe that the
expectations reflected in the forward-looking statements and the
assumptions upon which they are based are reasonable, we can give
no assurance that such expectations and assumptions will prove to
be correct. Forward-looking statements are generally identifiable
by the use of words like "may," "will," "should," "could,"
"expect," "anticipate," "estimate," "believe," "intend" or
"project," or the negative of these words or other variations on
these words or comparable terminology. To the extent that
statements in this news release are not strictly historical,
including, without limitation, statements as to the ability of our
assays to uniquely address a high unmet clinical need by
identifying metastatic progression of cancer to the central nervous
system and brain, our ability to establish our assays as the
standard of care in diagnosing cancer with central nervous system
involvement, the extent to which COVID-19 testing will continue to
be an important component of our business and provide meaningful
revenues throughout 2021, and our ability to validate and
commercialize the COVID-19 assay kit co-developed with Aegea
Biotechnologies, such statements are forward-looking, and are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. The reader is cautioned not to put
undue reliance on these forward-looking statements, as these
statements are subject to numerous risk factors as set forth in our
Securities and Exchange Commission (SEC) filings. The effects of
such risks and uncertainties could cause actual results to differ
materially from the forward-looking statements contained in this
news release. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law. Readers are advised to review our filings with the SEC at
http://www.sec.gov/.
BIOCEPT, INC.
CONDENSED BALANCE
SHEETS
December 31,
March 31,
2020
2021
(unaudited)
ASSETS Cash $
14,367,942
$
14,197,547
Accounts receivable, net
14,144,911
17,143,572
Inventories, net
1,929,624
3,258,594
Prepaid expenses and other current assets
2,151,527
697,724
TOTAL CURRENT ASSETS
32,594,004
35,297,437
FIXED ASSETS, NET
2,317,616
2,095,704
LEASE RIGHT-OF-USE ASSETS
12,114,058
12,466,926
OTHER NON-CURRENT ASSETS
425,908
438,776
TOTAL ASSETS $
47,451,586
$
50,298,843
LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES,
NET $
12,494,253
$
11,913,007
NON-CURRENT LIABILITIES, NET
11,264,911
11,614,609
TOTAL LIABILITIES
23,759,164
23,527,616
SHAREHOLDERS’ EQUITY
23,692,422
26,771,227
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $
47,451,586
$
50,298,843
BIOCEPT, INC.
CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
For the three months ended
March 31,
2020
2021
(unaudited)
(unaudited)
NET REVENUES $
1,446,549
$
17,756,190
COSTS AND EXPENSES Cost of revenues
$
2,946,858
$
9,005,856
Research and development expenses
1,312,676
1,042,725
General and administrative expenses
1,904,433
3,119,804
Sales and marketing expenses
1,465,115
1,923,272
Total costs and expenses
7,629,082
15,091,657
(LOSS)/INCOME FROM OPERATIONS
(6,182,533
)
2,664,533
INTEREST AND OTHER INCOME/(EXPENSE), NET
(2,158,805
)
(65,241
)
(LOSS)/INCOME BEFORE INCOME TAXES
(8,341,338
)
2,599,292
INCOME TAXES
—
—
NET (LOSS)/INCOME AND COMPREHENSIVE LOSS $
(8,341,338
)
$
2,599,292
Deemed dividend related to warrants down round provision
(2,774
)
—
NET (LOSS)/INCOME ATTRIBUTABLE TO COMMON SHAREHOLDERS
(8,344,112
)
2,599,292
NET (LOSS)/INCOME PER SHARE - Basic $
(1.06
)
$
0.19
- Diluted $
(1.06
)
$
0.19
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING - Basic
7,899,991
13,400,007
- Diluted
7,899,991
13,667,716
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210512005985/en/
Investor Contact: LHA
Investor Relations Jody Cain Jcain@lhai.com, (310) 691-7100
Media Contact: Sampson PR
Group Andrea Sampson asampson@sampsonprgroup.com, (562)
304-0301
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