- Revenues for the third quarter of $17.5 million, up 165% over
prior-year quarter, driven by increased RT-PCR COVID-19 testing,
resulting in profitability; cash balance of $27.7 million at
quarter-end
- Robust CNSide™ sequential-quarter volume growth; continued
customer base expansion
- Data generated by leading cancer center demonstrates superior
performance of CNSide versus standard of care
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 and nine months ended September 30, 2021 and provides
a business update.
“With CNSide, our paradigm-changing neuro-oncology test that
uses cerebrospinal fluid for diagnosing and monitoring patients
with brain metastases, we are reporting strong sequential quarter
volume growth, primarily driven by data generated with our academic
partners,” said Michael Nall, Biocept’s President and CEO. “Our
customer base for this proprietary service continues to grow, with
the majority as repeat users.
“As an update on our RT-PCR COVID-19 testing services, we have
now received more than 660,000 samples for testing since June 2020.
Testing volume increased during the third quarter due to the
emergence of the Delta variant and our contracted services with the
California community college system,” he added. “Revenue from
COVID-19 testing drove profitability for both the quarter and
year-to-date, which in turn supports continued investment in our
long-term oncology business.”
Third Quarter 2021 and Recent Highlights
Commercial Developments and
Agreements
Oncology
- Expanded the customer base for CNSide to 40 top U.S. academic
institutions. CNSide is 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.
- Received a positive coverage decision from Medicare and
high-value reimbursement of $2,435 for the Target Selector breast
cancer assay to detect the HER2 biomarker from circulating tumor
cells (CTCs) in liquid biopsy.
COVID-19
- Implemented COVID-19 testing services at more than 30 community
college campuses across California, streamlining the testing and
tracking process for administrators, and allowing students and
staff to easily schedule and fulfill COVID-19 testing
requirements.
Scientific Presentations
- Presented new data from a retrospective study conducted by the
University of Utah Huntsman Cancer Center in a poster at the Third
Annual Conference on Brain Metastases hosted by the Society for
Neuro-Oncology. Study data showed CNSide detected tumor cells in
100% of samples from 15 patients with lung cancer and
leptomeningeal carcinomatosis, while standard of care CSF cytology
detected tumor cells in 40% of samples. CNSide also identified
actionable biomarkers for treatment decision-making extending life
and quality of life for some patients.
- Co-sponsored webinar with Cap Today entitled “A new CSF assay
can improve detection and management of brain metastases,”
featuring presentation by Michael Dugan, MD, Senior Vice President,
Chief Medical Officer and Medical Director of Biocept; Seema
Nagpal, MD, Clinical Associate Professor of Neurology, Division of
Neuro-oncology, Stanford University; and Santosh Kesari, MD, PhD,
Professor of Neurosciences, Chair of the Department of
Translational Neurosciences, Director of Neuro-Oncology Saint
John’s Cancer Institute.
- Presented data at the Third Annual RAS-Targeted Drug
Development Summit on Target Selector assay formats for the
ultra-sensitive detection of KRAS mutations using Switch-Blocker™
technology, which provides advantages for the assessment of
therapeutic tumor response and is cost effective for serial
monitoring.
- Study results were published in the November 2021 issue of the
Journal of Molecular Diagnostics showing that the addition of
Switch-Blocker technology to common PCR-based liquid biopsy assays
increased sensitivity in detecting rare cancer mutations by
200-1,000 times.
Corporate Developments
- Named Samuel Riccitelli as Chairman of the Board; Mr.
Riccitelli joined the Biocept Board of Directors in October
2020.
- Expanded Board membership to nine with the appointments of
Linda Rubinstein and Antonino Morales as Directors. Ms. Rubenstein
and Mr. Morales bring extensive financial and leadership experience
to support growth initiatives and advance the company’s oncology
diagnostics franchise.
- Named David Karlander as Senior Vice President of Commercial
Operations with responsibility for all sales, marketing and
reimbursement initiatives. He brings to Biocept more than 25 years
of experience including building and managing major brands in
clinical diagnostics, medical devices and pharmaceuticals through
all stages of commercialization.
Intellectual Property
- Awarded a South Korean patent for the Primer-Switch technology,
which detects rare mutations in circulating tumor DNA (ctDNA) using
RT-PCR and associated analysis methods. Biocept’s core technology
and products are currently protected by 71 patents worldwide.
Third Quarter Financial Results
Net revenues for the third quarter of 2021 were $17.5 million,
an increase of 165% from $6.6 million for the third quarter of
2020, with the increase primarily attributable to higher RT-PCR
COVID-19 testing. Revenues for the third quarter of 2021 included
$16.5 million in RT-PCR COVID-19 test revenue, $826,000 in oncology
test revenue, $34,000 in development services test revenue and
$71,000 in revenue for distributed products, Target Selector RUO
kits, CEE-Sure® blood collection tubes and payments for development
services. Net revenues for the third quarter of 2020 included $5.7
million in RT-PCR COVID-19 test revenue, $713,000 in oncology test
revenue, $47,000 in development services test revenue and $154,000
in revenue for distributed products, Target Selector RUO kits and
CEE-Sure blood collection tubes and payments for development
services.
Biocept accessioned 154,324 total samples and 152,796 commercial
billable samples during the third quarter of 2021, compared with
52,542 total samples and 48,109 commercial billable samples during
the third quarter of 2020. The increases were primarily
attributable to higher COVID-19 testing.
Cost of revenues for the third quarter of 2021 was $10.3
million, compared with $5.9 million for the third quarter of 2020,
with the increase primarily due to higher COVID-19-related
collection kits and consumable expenses.
Research and development (R&D) expenses for the third
quarter of 2021 were $1.3 million, compared with $1.1 million for
the third quarter of 2020, with the increase primarily attributable
to increases in headcount-related expenses and material costs
associated with investment in CNSide clinical development. General
and administrative (G&A) expenses for the third quarter of 2021
were $3.4 million, compared with $3.0 million for the third quarter
of 2020, with the increase primarily due to headcount additions and
other expenses related to COVID-19 volume. Sales and marketing
expenses for the third quarter of 2021 were $1.9 million, compared
with $1.4 million for the third quarter of 2020, with the increase
due to higher COVID-19 revenue and marketing costs related to
CNSide.
Net income attributable to common stockholders for the third
quarter of 2021 was $427,000, or $0.03 per diluted share on 15.6
million weighted-average shares outstanding. This compares with a
net loss attributable to common stockholders for the third quarter
of 2020 of $4.9 million, or $0.37 per share on 13.3 million
weighted-average shares outstanding.
Nine Month Financial Results
Net revenues for the first nine months of 2021 were $47.3
million, including a $1.1 million increase in reserves for aged
accounts receivables recognized in the second quarter of 2021,
compared with $9.0 million for the first nine months of 2020.
Revenue for the first nine months of 2021 included $47.0 million in
commercial test revenue, $107,000 in development services test
revenue and $167,000 in revenue for Target Selector RUO kits and
CEE-Sure blood collection tubes and payments for development
services.
Operating expenses for the first nine months of 2021 were $45.9
million, and included cost of revenues of $26.8 million, R&D
expenses of $3.5 million, G&A expenses of $9.8 million and
sales and marketing expenses of $5.8 million.
Net income for the first nine months of 2021 was $1.2 million,
or $0.08 per diluted share on 14.3 million weighted-average shares
outstanding. This compares with a net loss for the first nine
months of 2020 of $19.7 million, or $1.74 per share on 11.3 million
weighted-average shares outstanding.
Biocept reported cash and cash equivalents as of September 30,
2021 of $27.7 million, compared with $14.4 million as of December
31, 2020. During the third quarter, the Company raised $9.6 million
from the sale of common stock under its at-the-market equity
offering facility.
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
10161580. 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 regarding the
capabilities and performance of our CNSide assay and Target
Selector technology, 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 risks and uncertainties,
including risks and uncertainties associated with the continually
evolving COVID-19 pandemic and the risk that our products and
services may not perform as expected. These and other factors are
described in greater detail under the "Risk Factors" heading of our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2021,
as filed with the Securities and Exchange Commission (SEC) on
August 16, 2021, and under the "Risk Factors" heading of our
Quarterly Report on Form 10-Q for the quarter ended September 30,
2021, being filed with the SEC today. 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,
September 30,
2020
2021
(unaudited)
ASSETS Cash $
14,367,942
$
27,698,334
Accounts receivable, net
14,144,911
15,972,256
Inventories, net
1,929,624
2,898,325
Prepaid expenses and other current assets
2,151,527
686,330
TOTAL CURRENT ASSETS
32,594,004
47,255,245
FIXED ASSETS, NET
2,317,616
2,151,806
LEASE RIGHT-OF-USE ASSETS
12,114,058
12,100,213
OTHER NON-CURRENT ASSETS
425,908
438,776
TOTAL ASSETS $
47,451,586
$
61,946,040
LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES,
NET $
12,494,253
$
10,403,908
NON-CURRENT LIABILITIES, NET
11,264,911
11,486,448
TOTAL LIABILITIES
23,759,164
21,890,356
SHAREHOLDERS’ EQUITY
23,692,422
40,055,684
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $
47,451,586
$
61,946,040
BIOCEPT, INC. CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE (LOSS)/INCOME For the
three months ended September 30, For the nine months ended
September 30,
2020
2021
2020
2021
(unaudited) (unaudited) (unaudited)
(unaudited) NET REVENUES $
6,586,144
$
17,469,502
$
8,950,160
$
47,272,859
COSTS AND EXPENSES Cost of revenues $
5,859,370
$
10,292,299
$
11,323,668
$
26,759,975
Research and development expenses
1,087,741
1,302,893
3,989,133
3,483,232
General and administrative expenses
3,023,337
3,434,349
6,839,467
9,805,012
Sales and marketing expenses
1,434,481
1,938,415
4,232,867
5,806,348
Total costs and expenses
11,404,929
16,967,956
26,385,135
45,854,567
(LOSS)/INCOME FROM OPERATIONS
(4,818,785
)
501,546
(17,434,975
)
1,418,292
WARRANT INDUCEMENT, INTEREST AND OTHER EXPENSE
(59,549
)
(74,499
)
(2,274,000
)
(219,432
)
(LOSS)/INCOME BEFORE INCOME TAXES
(4,878,334
)
427,047
(19,708,975
)
1,198,860
INCOME TAXES
—
—
—
—
NET (LOSS)/INCOME AND COMPREHENSIVE (LOSS)/INCOME $
(4,878,334
)
$
427,047
$
(19,708,975
)
$
1,198,860
Deemed dividend related to warrants down round provision
—
—
(2,774
)
—
NET (LOSS)/INCOME ATTRIBUTABLE TO COMMON SHAREHOLDERS $
(4,878,334
)
$
427,047
$
(19,711,749
)
$
1,198,860
NET (LOSS)/INCOME PER SHARE - Basic $
(0.37
)
$
0.03
$
(1.74
)
$
0.09
- Diluted $
(0.37
)
$
0.03
$
(1.74
)
$
0.08
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - Basic
13,333,427
15,384,469
11,324,289
14,089,537
- Diluted
13,333,427
15,625,409
11,324,289
14,330,477
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211115006243/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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