SAN DIEGO, Nov. 13, 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 nine months ended September 30, 2019, and provides an update on its
business progress.
"We continued to deliver strong growth during the third quarter
of 2019 with revenues reaching a record $1.5
million, up 101% over the same period in the prior year and
up 28% over the second quarter of this year," said Michael Nall, President and CEO of Biocept.
"Our momentum was driven by a 66% year-over-year increase in
the number of commercial samples received, as we focus on segments
of the liquid biopsy market where our Target Selector™ technologies
and testing platform can help the most patients, namely patients
with lung, prostate and breast cancers. In addition, we continue to
work to control expenses, which has moved us closer to gross margin
positive. We are focused on continued growth in commercial
volume and improvement in gross margin percent through operational
efficiencies.
"Testing for lung cancer continued to be among the largest
contributors to commercial volume due to the difficulties in
securing lung tissue samples from this patient population," he
added. "We also continue to gain traction in the uro-oncology
market where our blood-based testing is used by urologists to
monitor patients with rising prostate-specific antigen (PSA) levels
as well as in the post-surgery setting to identify patients at risk
for cancer recurrence. We are seeing increasing reorders from
the physicians and practices who began using our Target Selector™
products earlier this year, while establishing relationships with
additional urologists and urology practice groups during the third
quarter. We expect continued growth in this business
segment.
"Our Target Selector™ testing for breast cancer was also a key
contributor to commercial volume growth during the quarter.
Clinicians treating patients with breast cancer are utilizing
our blood-based assays for initial profiling of biomarkers to
ensure that critical biomarkers are not missed with the original
tissue biopsy as well as to re-profile patients who have cancer
recurrence in order to determine the most appropriate treatment
plan for each patient," Nall said.
Review of Third Quarter and Recent Highlights
Commercial Agreements
- Announced an agreement with Beacon Laboratory Benefit Solutions
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. This designation increases patient
access to Biocept's liquid biopsy testing platforms.
Regulatory Approval
- Obtained CE IVD Marks for the CEE-Sure® Blood Collection Tube
and the CEE-Sure® Sample Collection Shipping Kit in Europe. These CE Marks confirm that
Biocept's CEE-Sure® products, which are specifically designed to
collect and transport blood and other liquid biopsy specimens, meet
the requirements of the European In-Vitro Diagnostic Devices
Directive. This allows Biocept to commercialize its tubes and
collection/shipping kits throughout the European Union and other CE
Mark geographies.
Industry Conferences and Study Results
- Announced the presentation of six posters at the 2019
Association for Molecular Pathology (AMP) Annual Meeting featuring
clinical data highlighting Target Selector™ tests and kits.
The content of these posters is expected to be published in a
future issue of The Journal of Molecular Diagnostics.
- Presented data at the 2019 IASLC World Conference on Lung
Cancer highlighting the ability of Biocept's circulating tumor DNA
(ctDNA) assays to consistently detect actionable biomarkers from
the blood of patients diagnosed with lung cancer at a mutant allele
frequency as low as 0.01%. The poster featured clinical
experience data from more than 1,400 blood samples drawn from
patients diagnosed with non-small cell lung cancer, and collected
and shipped using the Company's CEE-Sure® Blood Collection
Tubes.
Peer-reviewed Journal Publications
- Announced publication of an article in the peer-reviewed
journal PLOS ONE featuring analytical validation results
demonstrating the ultra-sensitive detection of Target Selector™
testing for EGFR, BRAF and KRAS mutations in plasma ctDNA.
These tests can be performed in the Company's CLIA laboratory with
a commercial turnaround time of only three to four days.
Intellectual Property
- Awarded U.S., Canadian and European patents covering antibody
and microchannel technology and enhanced detection of cancer
cells. These new patents further expand 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 a South Korean patent covering the Target Selector™
oncogene mutation enrichment and detection platform for proprietary
Switch-Blocker technology that is core to Target Selector™ assays
for molecular analysis using real-time PCR, Sanger sequencing and next-generation
sequencing.
- Ended the period with 36 issued patents globally for Biocept's
highly sensitive method of detecting cancer biomarkers.
Third Quarter Financial Results
Revenues for the third quarter of 2019 were $1.5 million, a 101% increase from $762,000 for the third quarter of 2018.
Revenues for the third quarter of 2019 included $1.4 million in commercial test revenue,
$40,000 in development services test
revenue and $60,000 in revenue for
Target Selector™ RUO kits, which were commercially launched in
early 2019, and CEE-Sure® blood collection tubes.
Revenues for the third quarter of 2018 included $698,000 in commercial test revenues and
$64,000 in development services test
revenues.
Biocept accessioned 1,189 commercial samples during the third
quarter of 2019, a 66% increase from the 717 commercial samples
accessioned during the third quarter of 2018. The Company
accessioned 1,332 billable samples in the third quarter of 2019, a
52% increase from 878 billable samples for the third quarter of
2018.
Cost of revenues for the third quarter of 2019 was $2.8 million, compared with $2.5 million for the third quarter of 2018.
Cost of revenues for the third quarter of 2019 increased 14% while
volume increased by nearly 50% as the Company continued to leverage
its fixed costs.
Research and development (R&D) expenses for the third
quarter of 2019 were $1.2 million,
compared with $1.1 million for the
third quarter of 2018, with the increase primarily due to an
increase in materials used for developing and validating new
assays. General and administrative (G&A) expenses for the
third quarter of 2019 were $1.7
million, a decrease from $1.8
million during the third quarter of 2018 as the Company
continued its cost-containment program. Sales and marketing
(S&M) expenses for the third quarter of 2019 were $1.5 million, compared with $1.4 million for the third quarter of 2018, with
the increase primarily attributed to commissions paid for higher
volume and revenue.
The third quarter of 2018 included a non-cash deemed dividend of
$0.6 million for the repricing of
adjustable warrants. There was no comparable charge in the
third quarter of 2019.
The net loss attributable to common shareholders for the third
quarter of 2019 was $5.7 million, or
$0.25 per share on 23.0 million
weighted-average shares outstanding. The net loss
attributable to common shareholders for the third quarter of 2018
was $6.7 million, or $2.42 per share on 2.8 million weighted-average
shares outstanding. The Company completed a 1-for-30 reverse
stock split of its common stock in July 2018.
Nine Month Financial Results
Revenues for the first nine months of 2019 were $3.7 million, a 57% increase from $2.4 million for the first nine months of 2018,
and included $3.5 million in
commercial test revenues, $130,000 in
development services test revenues, and $90,000 in revenues for Target Selector RUO
kits and CEE-Sure® blood collection tubes.
Total costs and expenses for the first nine months of 2019 were
$21.2 million, and included cost of
revenues of $8.1 million, R&D
expenses of $3.5 million, G&A
expenses of $5.1 million and S&M
expenses of $4.5 million.
Other expense for the first nine months of 2019 of $2.0 million consisted of non-cash warrant
inducement expenses associated with recognizing the fair value of
the inducement warrants issued in May
2019 of $1.8 million and
$190,000 of interest expense.
This compares with other expense of $240,000 for the first nine months of 2018
related to interest expense. The nine months ended
September 30, 2019 included a
non-cash deemed dividend of $0.1
million for the repricing of adjustable warrants, compared
with a non-cash deemed dividend of $0.6
million for the repricing of adjustable warrants during the
nine months ended September 30,
2018.
The net loss attributable to common shareholders for the first
nine months of 2019 was $19.5
million, or $1.10 per share on
17.8 million weighted-average shares outstanding. This
compares with a net loss attributable to common shareholders for
the first nine months of 2018 of $19.2
million, or $8.26 per share on
2.3 million weighted-average shares outstanding. The Company
completed a 1-for-30 reverse stock split of its common stock in
July 2018.
Biocept reported cash and cash equivalents as of September 30, 2019 of $6.5
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 exercised
year-to-date in 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
10135501.
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 our expectation of
continued growth in the uro-oncology business segment, 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, including our Quarterly Report
on Form 10-Q for the quarter ended September
30, 2019. 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,
|
|
September
30,
|
|
2018
|
|
2019
|
|
|
|
|
|
(unaudited)
|
ASSETS
|
|
|
|
|
|
Cash
|
$
|
3,423,373
|
|
$
|
6,539,444
|
Accounts
receivable, net
|
|
1,574,325
|
|
|
2,861,659
|
Inventories,
net
|
|
587,222
|
|
|
687,186
|
Prepaid expenses
and other current assets
|
|
425,961
|
|
|
497,121
|
TOTAL CURRENT
ASSETS
|
|
6,010,881
|
|
|
10,585,410
|
FIXED ASSETS,
NET
|
|
2,739,422
|
|
|
1,325,255
|
LEASE RIGHT-OF-USE
ASSETS
|
|
—
|
|
|
2,610,249
|
TOTAL
ASSETS
|
$
|
8,750,303
|
|
$
|
14,520,914
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES, NET
|
$
|
4,609,647
|
|
$
|
5,783,213
|
NON-CURRENT
LIABILITIES, NET
|
|
1,098,137
|
|
|
1,032,243
|
TOTAL
LIABILITIES
|
|
5,707,784
|
|
|
6,815,456
|
SHAREHOLDERS'
EQUITY
|
|
3,042,519
|
|
|
7,705,458
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
|
8,750,303
|
|
$
|
14,520,914
|
BIOCEPT,
INC.
|
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended September
30,
|
|
For the nine months ended September
30,
|
|
|
|
2018
(unaudited)
|
|
2019
(unaudited)
|
|
2018
(unaudited)
|
|
2019
(unaudited)
|
|
NET
REVENUES
|
$
|
761,591
|
|
$
|
1,529,262
|
|
$
|
2,390,772
|
|
$
|
3,744,824
|
|
COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
$
|
2,481,916
|
|
$
|
2,832,735
|
|
$
|
7,616,473
|
|
$
|
8,105,422
|
|
Research and
development expenses
|
|
1,089,746
|
|
|
1,163,546
|
|
|
3,179,612
|
|
|
3,535,116
|
|
General and
administrative expenses
|
|
1,793,720
|
|
|
1,700,380
|
|
|
5,441,354
|
|
|
5,058,525
|
|
Sales and marketing
expenses
|
|
1,404,192
|
|
|
1,462,335
|
|
|
4,473,908
|
|
|
4,451,628
|
|
Total costs and
expenses
|
|
6,769,574
|
|
|
7,158,996
|
|
|
20,711,347
|
|
|
21,150,691
|
|
LOSS FROM
OPERATIONS
|
|
(6,007,983)
|
|
|
(5,629,734)
|
|
|
(18,320,575)
|
|
|
(17,405,867)
|
|
WARRANT
INDUCEMENT, INTEREST AND OTHER EXPENSE
|
|
(39,801)
|
|
|
(62,028)
|
|
|
(236,714)
|
|
|
(2,018,691)
|
|
LOSS BEFORE INCOME
TAXES
|
|
(6,047,784)
|
|
|
(5,691,762)
|
|
|
(18,557,289)
|
|
|
(19,424,558)
|
|
INCOME
TAXES
|
|
—
|
|
|
—
|
|
|
(739)
|
|
|
—
|
|
NET LOSS AND
COMPREHENSIVE LOSS
|
$
|
(6,047,784)
|
|
$
|
(5,691,762)
|
|
$
|
(18,558,028)
|
|
$
|
(19,424,558)
|
|
Deemed dividend
related to warrants down round provision
|
|
(636,370)
|
|
|
—
|
|
|
(636,370)
|
|
|
(99,743)
|
|
NET LOSS
ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
$
|
(6,684,154)
|
|
$
|
(5,691,762)
|
|
$
|
(19,194,398)
|
|
$
|
(19,524,301)
|
|
NET LOSS PER
SHARE
|
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
$
|
(2.42)
|
|
$
|
(0.25)
|
|
$
|
(8.26)
|
|
$
|
(1.10)
|
|
- Diluted
|
$
|
(2.42)
|
|
$
|
(0.25)
|
|
$
|
(8.27)
|
|
$
|
(1.10)
|
|
WEIGHTED AVG
NUMBER OF SHARES OUTSTANDING
|
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
|
2,767,440
|
|
|
23,018,235
|
|
|
2,322,749
|
|
|
17,807,298
|
|
- Diluted
|
|
2,759,614
|
|
|
23,018,235
|
|
|
2,320,111
|
|
|
17,807,298
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/biocept-reports-third-quarter-2019-financial-results-300957826.html
SOURCE Biocept, Inc.