SAN DIEGO, May 13, 2020 /PRNewswire/ -- Biocept, Inc.
(NASDAQ: BIOC), a leading provider of molecular technologies
designed to provide physicians with clinically actionable
information to improve the outcomes of patients diagnosed with
cancer, reports financial results for the three months ended
March 31, 2020 and provides an update
on its business progress.
"Revenue for the first quarter was $1.4
million, representing a 41% increase over the prior-year
period driven by a 27% increase in revenue per commercial
accession," said Michael Nall,
President and CEO of Biocept. "We increased revenues even
with the headwinds of the COVID-19 pandemic, which we estimate led
to an approximate 15-25% decline in commercial volume from current
customers and also impacted opportunities for us to gain new
customers with the closing of many physician offices and
labs. Operational efficiencies contributed to progress toward
our goal of positive gross margin resulting in a 50 percentage
point improvement versus the prior-year period. These
efficiencies are primarily related to automation of our lab, with
additional actions yet to be taken this year.
"Importantly, we believe we are well positioned to weather the
pandemic, which is impacting testing volume industrywide, and for a
return to growth as shelter-in-place restrictions are lifted and
physician offices and labs reopen," he added. "We are an
established leader in liquid biopsy and our Target Selector™ assays
and products provide critical information to physicians in
treatment decision-making. We expect that when it is safe for
patients diagnosed with cancer to continue to seek treatment, our
commercial volume will return to a more normal level. We are
particularly pleased with our strengthened balance sheet, having
raised approximately $36.3 million in
net proceeds since the beginning of December 2019. While we
believe that based on historical and planned cash usage, our
current funding is expected to support operations through most of
2021; however, with the uncertainty introduced by the impact of
COVID-19 on revenue and collections, our cash runway may be
shorter."
First Quarter 2020 and Recent Highlights
Commercial Launches
- Announced the availability of Target Selector™ assays to
evaluate cerebrospinal fluid (CSF) for the presence of circulating
tumor cells (CTCs) and biomarkers, which may be indicators of brain
metastases. Of patients diagnosed with breast and lung cancer, up
to 30% and 36%, respectively, will develop brain metastases. The
validations study for our CSF assay was conducted in collaboration
with Providence St. Joseph Health, Southern California, and its wholly owned
affiliates Providence St. John's Health Center and John Wayne
Cancer Institute.
- Launched the availability of research-use-only (RUO) kits that
allow molecular laboratories worldwide to detect oncogene mutations
through the analysis of both Formalin-Fixed Paraffin-Embedded
(FFPE) tissue gained from surgical biopsies as well as circulating
tumor DNA (ctDNA) gained from blood-based liquid biopsies. The
first RUO kit with the ability to use tissue and liquid biopsy
samples is designed for the detection of EGFR mutations that are
among the most frequently evaluated biomarkers of lung cancer. RUO
kits for other oncogene mutations are planned for future
launches.
- Awarded CE-IVD Mark for the Target Selector™ molecular assay
EGFR Kit. The CE Mark confirms that Target Selector™ kits meet the
requirements of the European In-Vitro Diagnostic Devices Directive
and allows Biocept to commercialize these kits throughout the
European Union and other CE Mark geographies. Molecular assay kits
detect key oncogene mutations through the analysis of both FFPE
tissue as well as ctDNA. The EGFR pathway can include mutations
that are among the most frequently evaluated biomarkers for lung
cancer.
- Announced the validation for COVID-19 testing. Biocept operates
a high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety
level laboratory in San Diego,
with specialized, licensed molecular lab staff who have been
trained in performing the COVID-19 testing. The lab will be using
ThermoFisher Scientific's FDA-approved for EUA (Emergency Use
Authorization) testing TaqPath™ molecular diagnostic platform and
kit for SARS-CoV-2 (COVID-19). Due to the national shortage,
Biocept's clients have had difficulty gaining specimen collection
kits to send to Biocept for testing and to date, we have not been
able to perform any COVID 19 testing. In order to address this and
provide needed testing, Biocept intends to manufacture its own
collection kits for distribution to clients and expects those kits
to be available in June.
Commercial Agreements
- Signed laboratory services agreements with two large
California-based independent
physician associations (IPAs) to provide Biocept's Target Selector™
liquid biopsy testing services.
Peer-reviewed Journal Publications
- Announced publication of clinical data in the Journal of
Clinical Pathology that further validates Biocept's Target
Selector™ qPCR Assay using Switch Blocker technology to identify
cancer-related mutations in liquid biopsy samples. Study results
showed a very high concordance between Biocept's liquid biopsy
testing and tissue biopsy and best-in-class detection of
alterations down to a single mutant copy in both analytical and
clinical settings.
Intellectual Property
- Awarded U.S. patent covering antibody and microchannel
technology and enhanced detection of cancer cells. This new patent
expands Biocept's intellectual property estate for capturing and
detecting rare cells of interest, including CTCs, to aid in the
management of patients with cancer.
- Granted Australian and Brazilian patents providing intellectual
property protection for its Primer Switch technology that is useful
for ctDNA analysis using reverse-transcription PCR and associated
methods, including next-generation sequencing (NGS).
Corporate Developments
- Promoted Cory J. Dunn to Senior
Vice President of Commercial Operations. Ms. Dunn joined Biocept as
Vice President of Marketing in October
2018.
First Quarter Financial Results
Revenues for the first quarter of 2020 were $1.4 million, a 41% increase from $1.0 million for the first quarter of 2019.
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
distributed products, Target Selector™ RUO kits and CEE-Sure® blood
collection tubes. Revenues for the first quarter of 2019
included $976,000 in commercial test
revenues, $42,000 in development
services test revenues and $5,000
from RUO kits and blood collection tubes.
Biocept accessioned 1,306 total samples during the first quarter
of 2020, compared with 1,325 total samples during the first quarter
of 2019. The Company accessioned 1,141 billable samples
during the first quarter of 2020 compared with 1,155 billable
samples during the first quarter of 2019. We believe that the
decline in total samples and billable samples was due to the impact
of the COVID-19 pandemic.
Cost of revenues for the first quarter of 2020 was $2.9 million, compared with $2.6 million for the first quarter of 2019.
Cost of revenues increased 13% while revenues increased by 41% as
Biocept continued to leverage its fixed costs.
Research and development (R&D) expenses for the first
quarter of 2020 were $1.3 million,
compared with $1.2 million for the
first quarter of 2019, with the increase primarily due to
development and validation costs related to additional offerings,
such as validation of CSF and COVID-19 assays. General and
administrative (G&A) expenses for the first quarter of 2020
were $1.9 million, compared with
$1.7 million for the first quarter of
2019, with the increase due mainly to a reclassification of
certain customer service and related expenses from sales and
marketing to G&A. Sales and marketing expenses for the first
quarter of 2020 were $1.5 million,
compared with $1.4 million for the
first quarter of 2019, with the increase primarily attributed to
commission on higher revenue.
Other expense, net for the first quarter of 2020 was
$2.2 million, compared with
$62,000 for the first quarter of
2019, with the increase mainly due to $2.1
million in warrant inducement expense. In January 2020, Biocept completed a Warrant
Exercise Inducement offering for net proceeds of approximately
$2.3 million.
The net loss attributable to common shareholders for the first
quarter of 2020 was $8.3 million, or
$0.11 per share on 79.0 million
weighted-average shares outstanding and included $2.1 million in non-cash warrant inducement
expense and the impact of the COVID-19 pandemic. The net loss
attributable to common shareholders for the first quarter of 2019
was $6.0 million, or $0.61 per share on 9.8 million weighted-average
shares outstanding.
Biocept reported cash and cash equivalents as of March 31, 2020 of $21.5
million, compared with $9.3
million as of December 31,
2019. The increase included approximately $17.7 million in net proceeds from two registered
direct offerings and the overallotment of warrants from a
December 2019 financing. In
April 2020, the Company raised net
proceeds of approximately $9.6
million from a registered direct offering.
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
10143445. A replay of the webcast will be available for 90
days.
About Biocept
Biocept, Inc. is a molecular diagnostics company with
commercialized assays for lung, breast, gastric, colorectal and
prostate cancers, and melanoma. The Company uses its
proprietary liquid biopsy technology to provide physicians with
information for treating and monitoring patients diagnosed with
cancer. The Company's patented Target Selector™ liquid biopsy
technology platform captures and analyzes tumor-associated
molecular markers in both CTCs and in ctDNA. With thousands
of tests performed, the platform has demonstrated the ability to
identify cancer mutations and alterations to inform physicians
about a patient's disease and therapeutic options. For
additional information, please visit www.biocept.com.
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 our ability to
provide physicians with clinically actionable information to
improve the outcomes of cancer patients, our ability to weather the
COVID-19 pandemic and return commercial volume to normal levels and
grow our business following the lifting of shelter-in-place
restrictions, our ability to launch additional RUO kits for other
oncogene mutations, and our ability to provide COVID-19 testing,
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/.
Investor Contact:
LHA Investor Relations
Jody Cain
Jcain@lhai.com
(310) 691-7100
BIOCEPT,
INC.
|
CONDENSED BALANCE
SHEETS
|
|
|
|
|
|
|
|
December 31,
|
|
March
31,
|
|
2019
|
|
2020
|
|
|
|
|
(unaudited)
|
ASSETS
|
|
|
|
|
|
Cash
|
$
|
9,301,406
|
|
$
|
21,493,192
|
Accounts
receivable, net
|
|
3,527,078
|
|
|
3,418,897
|
Inventories,
net
|
|
767,986
|
|
|
918,698
|
Prepaid expenses
and other current assets
|
|
296,127
|
|
|
429,131
|
TOTAL CURRENT
ASSETS
|
|
13,892,597
|
|
|
26,259,918
|
FIXED ASSETS,
NET
|
|
1,504,330
|
|
|
1,463,128
|
LEASE RIGHT-OF-USE
ASSETS
|
|
2,335,717
|
|
|
2,089,284
|
TOTAL
ASSETS
|
$
|
17,732,644
|
|
$
|
29,812,330
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES, NET
|
$
|
5,558,812
|
|
$
|
6,031,796
|
NON-CURRENT
LIABILITIES, NET
|
|
973,189
|
|
|
1,050,429
|
TOTAL
LIABILITIES
|
|
6,532,001
|
|
|
7,082,225
|
SHAREHOLDERS'
EQUITY
|
|
11,200,643
|
|
|
22,730,105
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
|
17,732,644
|
|
$
|
29,812,330
|
BIOCEPT,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
For the three months ended March
31,
|
|
|
|
|
|
|
2019
|
2020
|
|
|
(unaudited)
|
(unaudited)
|
|
NET
REVENUES
|
$
|
1,024,239
|
$
|
1,446,549
|
|
COSTS AND
EXPENSES
|
|
|
|
|
|
Cost of
revenues
|
$
|
2,599,364
|
$
|
2,946,858
|
|
Research and
development expenses
|
|
1,223,291
|
|
1,312,676
|
|
General and
administrative expenses
|
|
1,681,837
|
|
1,904,433
|
|
Sales and marketing
expenses
|
|
1,374,560
|
|
1,465,115
|
|
Total costs and
expenses
|
|
6,879,052
|
|
7,629,082
|
|
LOSS FROM
OPERATIONS
|
|
(5,854,813)
|
|
(6,182,533)
|
|
INTEREST AND OTHER
INCOME/(EXPENSE), NET
|
|
(61,974)
|
|
(2,158,805)
|
|
LOSS BEFORE INCOME
TAXES
|
|
(5,916,787)
|
|
(8,341,338)
|
|
INCOME
TAXES
|
|
—
|
|
—
|
|
NET LOSS AND
COMPREHENSIVE LOSS
|
$
|
(5,916,787)
|
$
|
(8,341,338)
|
|
Deemed dividend related
to warrants down round provision
|
|
(99,743)
|
|
(2,774)
|
|
NET LOSS
ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
$
|
(6,016,530)
|
$
|
(8,344,112)
|
|
NET LOSS PER
SHARE
|
|
|
|
|
|
-
Basic
|
$
|
(0.61)
|
$
|
(0.11)
|
|
-
Diluted
|
$
|
(0.61)
|
$
|
(0.11)
|
|
WEIGHTED AVG NUMBER
OF SHARES OUTSTANDING
|
|
|
|
|
|
-
Basic
|
|
9,792,093
|
|
78,999,924
|
|
-
Diluted
|
|
9,792,093
|
|
78,999,924
|
|
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SOURCE Biocept, Inc.