SAN DIEGO, Aug. 12, 2019 /PRNewswire/ -- Biocept, Inc.
(NASDAQ: BIOC), a leading commercial provider of liquid biopsy
tests designed to provide physicians with clinically actionable
information to improve the outcomes of cancer patients, reports
financial results for the three and six months ended June 30, 2019, and provides an update on its
business progress.
"I'm pleased to report another quarter of strong performance
with revenues increasing 45% over the prior-year quarter, as we
continue to execute on our new commercial strategy," said
Michael Nall, President and CEO of
Biocept. "Growth was driven by a 26% year-over-year increase
in commercial samples, as we focused our commercial efforts on
segments of the liquid biopsy oncology market where Target
Selector™ can help the most patients, namely in prostate, breast,
and lung cancers. Most importantly, we are helping more patients as
our billable samples accessioned per sales day entering the third
quarter increased approximately 50% from the beginning of the
year.
"We have now launched two tumor-specific panels developed in
collaboration with Thermo Fisher Scientific," he added.
"These products, Target Selector™ NGS Lung Panel and Target
Selector™ NGS Breast Panel, combine Thermo Fishers'
state-of-the-art Ion Torrent™ next-generation sequencing (NGS)
platform with our CLIA laboratory and commercial infrastructure, as
well as our expertise in blood sample preservation and DNA/RNA
isolation. Biocept is the only commercial liquid biopsy
company offering both circulating tumor cell (CTC) and circulating
tumor DNA (ctDNA) analysis with both single-gene and multi-gene
offerings.
"I'm also pleased to report that our initiative with Prognos has
advanced to the next phase as we are beginning to supply them with
de-identified information in real time. We believe this
partnership will allow us to commercialize data generated from our
liquid biopsy testing, with Prognos applying its artificial
intelligence technology to its repository of more than 20 billion
laboratory records to help life science and pharmaceutical
companies develop and market targeted therapies. We are
pleased to be the first liquid biopsy company to strike a
partnership with Prognos," he concluded.
Review of Second Quarter and Recent Highlights
Commercial Business
- Launched Target Selector™ NGS Lung Panel and Target Selector™
NGS Breast Panel, the Company's first two multi-gene liquid biopsy
panels, differentiating Biocept as the only commercial liquid
biopsy provider of single-biomarker testing, tumor-specific panels
and CTCs analysis. The NGS Panels run on Thermo Fisher Scientific's
Ion Torrent™ NGS platform and are being marketed to physicians and
researchers for the detection and monitoring of actionable
biomarkers associated with these tumor-specific cancers.
Commercial Agreements
- Announced an agreement with Beacon Laboratory Benefit
Solutions, Inc. designating Biocept as a BeaconLBS® Lab-of-Choice.
Beacon Laboratory is a nationally recognized provider of laboratory
benefit management technology solutions to U.S.-based health and
managed care companies, and the designation increases patient
access to Biocept's liquid biopsy testing platforms.
Intellectual Property
- Awarded a patent in China
covering methods and devices for the capture of rare cells of
interest, including CTCs, that are shed into the bloodstream by
solid tumors in which an antibody or mixture of antibodies and a
microchannel are used for cell capture, detection and analysis.
This patent covers the use of any biological sample type of
interest.
Second Quarter Financial Results
Revenues for the second quarter of 2019 were $1.2 million, a 45% increase from $822,000 for the second quarter of 2018.
Revenues for the second quarter of 2019 included $1.1 million in commercial test revenue,
$45,000 in development services test
revenue, $28,000 in revenue for
Target Selector RUO kits, which were commercially launched in early
2019, and CEE-Sure blood collection tubes. Revenues for
the second quarter of 2018 included $771,000 in commercial test revenue and
$51,000 in development services test
revenue.
Biocept accessioned 1,066 commercial samples during the second
quarter of 2019, a 26% increase compared with 849 commercial
samples accessioned during the second quarter of 2018. The
Company accessioned 1,211 billable samples in the second quarter of
2019, compared to 996 billable samples for the second quarter of
2018.
Cost of revenues for the second quarters of 2019 and 2018 was
unchanged at $2.7 million, as we
continued to leverage the fixed components of our costs.
Research and development (R&D) expenses for the second
quarter of 2019 were $1.1 million
compared with $1.0 million for the
prior-year period, with the increase primarily due to the
development and validation of the recently launched Target
Selector™ NGS Lung and Target Selector™ NGS Breast liquid biopsy
panels, as well as investments in automation. General and
administrative (G&A) expenses for the second quarters of 2019
and 2018 were unchanged at $1.7
million. As a percentage of revenue, G&A expenses
during the quarter were down 67% as compared to the same period
last year as the Company continues with its cost containment
program. Sales and marketing (S&M) expenses for the second
quarter of 2019 were $1.6 million
compared with $1.4 million for the
second quarter of 2018, with the increase primarily attributed to
higher volume and revenue. Despite the increase in costs, S&M
expenses as a percentage of revenue were down 39% compared to the
same period last year.
Other expenses for the second quarter of 2019 were $1.8 million, which were made up entirely of
non-cash warrant inducement expenses associated with recognizing
the fair value of the inducement warrants issued in May
2019.
The net loss for the second quarter of 2019 was $7.8 million, inclusive of the previously
mentioned non-cash warrant inducement expenses of $1.8 million, or $0.38 per share on 20.5 million weighted-average
shares outstanding. This compares with a net loss for the second
quarter of 2018 of $6.2 million, or
$2.70 per share on 2.3 million
weighted-average shares outstanding. The Company conducted a
1-for-30 reverse stock split of its outstanding common stock, which
was effective in July 2018.
Six Month Financial Results
Revenues for the first six months of 2019 were $2.2 million, a 36% increase from $1.6 million for the first six months of 2018,
and included $2.1 million in
commercial test revenues, $87,000 in
development services test revenues and $33,000 in revenues for Target Selector RUO kits,
which were commercially launched in early 2019, and CEE-Sure
blood collection tubes.
Operating expenses for the first six months of 2019 were
$14 million, and included cost of
revenues of $5.3 million, R&D
expenses of $2.4 million, G&A
expenses of $3.4 million and S&M
expenses of $3.0 million.
The net loss for the first six months of 2019 was $13.8 million, inclusive of the previously
mentioned non-cash warrant inducement expenses of $1.8 million, or $0.83 per share on 16.7 million weighted-average
shares outstanding. This compares with a net loss for the
first six months of 2018 of $12.5
million, or $5.97 per share,
on 2.1 million weighted-average shares outstanding.
Biocept reported cash and cash equivalents as of June 30, 2019 of $12.6
million, compared with $3.4
million as of December 31,
2018. The increase was due to $17.0
million in net proceeds from equity capital raises conducted
in the first quarter of 2019, and $4.9
million from the exercise of common stock warrants in the
second quarter of 2019.
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 webcast will be
available for 90 days.
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
10133829.
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 circulating tumor cells (CTCs) and in plasma (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 grow our
business and drive adoption of our products, and the potential
success of our collaboration with Prognos Health, 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,
|
|
June
30,
|
|
2018
|
|
2019
|
|
|
|
|
(unaudited)
|
ASSETS
|
|
|
|
|
|
Cash
|
$
|
3,423,373
|
|
$
|
12,590,597
|
Accounts
receivable, net
|
|
1,574,325
|
|
|
2,208,955
|
Inventories,
net
|
|
587,222
|
|
|
605,472
|
Prepaid expenses
and other current assets
|
|
425,961
|
|
|
586,267
|
TOTAL CURRENT
ASSETS
|
|
6,010,881
|
|
|
15,991,291
|
FIXED ASSETS,
NET
|
|
2,739,422
|
|
|
1,219,103
|
LEASE RIGHT-OF-USE
ASSETS
|
|
—
|
|
|
2,694,446
|
TOTAL
ASSETS
|
$
|
8,750,303
|
|
$
|
19,904,840
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES, NET
|
$
|
4,609,647
|
|
$
|
5,821,870
|
NON-CURRENT
LIABILITIES, NET
|
|
1,098,137
|
|
|
983,419
|
TOTAL
LIABILITIES
|
|
5,707,784
|
|
|
6,805,289
|
SHAREHOLDERS'
EQUITY
|
|
3,042,519
|
|
|
13,099,551
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
|
8,750,303
|
|
$
|
19,904,840
|
BIOCEPT,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June
30,
|
|
For the six months ended June
30,
|
|
2018
|
|
2019
|
|
2018
|
|
2019
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
NET
REVENUES
|
$
|
822,238
|
|
$
|
1,191,323
|
|
$
|
1,629,181
|
|
$
|
2,215,562
|
COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
$
|
2,699,671
|
|
$
|
2,673,323
|
|
$
|
5,134,557
|
|
$
|
5,272,687
|
Research and
development expenses
|
|
1,019,285
|
|
|
1,148,280
|
|
|
2,089,866
|
|
|
2,371,571
|
General and
administrative expenses
|
|
1,708,970
|
|
|
1,676,310
|
|
|
3,647,634
|
|
|
3,358,147
|
Sales and marketing
expenses
|
|
1,433,174
|
|
|
1,614,732
|
|
|
3,069,716
|
|
|
2,989,292
|
Total costs and
expenses
|
|
6,861,100
|
|
|
7,112,645
|
|
|
13,941,773
|
|
|
13,991,697
|
LOSS FROM
OPERATIONS
|
|
(6,038,862)
|
|
|
(5,921,322)
|
|
|
(12,312,592)
|
|
|
(11,776,135)
|
WARRANT
INDUCEMENT, INTEREST AND OTHER EXPENSE
|
|
(114,239)
|
|
|
(1,894,690)
|
|
|
(196,913)
|
|
|
(1,956,664)
|
LOSS BEFORE INCOME
TAXES
|
|
(6,153,101)
|
|
|
(7,816,012)
|
|
|
(12,509,505)
|
|
|
(13,732,799)
|
INCOME
TAXES
|
|
—
|
|
|
—
|
|
|
(739)
|
|
|
—
|
NET LOSS AND
COMPREHENSIVE LOSS
|
$
|
(6,153,101)
|
|
$
|
(7,816,012)
|
|
$
|
(12,510,244)
|
|
$
|
(13,732,799)
|
Deemed dividend
related to warrants down round provision
|
|
—
|
|
|
|
|
|
-
|
|
|
(99,743)
|
NET LOSS
ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
$
|
(6,153,101)
|
|
$
|
(7,816,012)
|
|
$
|
(12,510,244)
|
|
$
|
(13,832,542)
|
NET LOSS PER
SHARE
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
$
|
(2.70)
|
|
$
|
(0.38)
|
|
$
|
(5.97)
|
|
$
|
(0.83)
|
- Diluted
|
$
|
(2.70)
|
|
$
|
(0.38)
|
|
$
|
(5.97)
|
|
$
|
(0.83)
|
WEIGHTED AVG
NUMBER OF SHARES OUTSTANDING
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
|
2,280,115
|
|
|
20,466,224
|
|
|
2,096,717
|
|
|
16,670,184
|
- Diluted
|
|
2,280,115
|
|
|
20,466,224
|
|
|
2,096,717
|
|
|
16,670,184
|
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SOURCE Biocept, Inc.