SAN DIEGO, Aug. 14, 2018 /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, 2018, and provides an update on its
business progress.
"We strengthened our financial position by completing a
shareholder rights offering yesterday which added over $10 million to the balance sheet and by retiring
our long-term debt in July, which reduces annual cash expenditures
by more than $2 million," said
Michael Nall, President and CEO of
Biocept. "We have also undergone refinements to our sales
strategy and our commercial team is now focused on the benefits of
Target Selector™ for lung cancer profiling and monitoring, where
the need for our liquid biopsy tests is high. Our sales team
are educating physicians by utilizing case reports that were
published in peer-reviewed journals earlier this year, along with
the clinical guidelines issued by four prominent industry
associations supporting the use of liquid biopsy testing in
patients with lung cancer.
"We are making progress with our transition from a reference
laboratory only to expanding into a diagnostic kit manufacturer
with a global brand," he added. "During the quarter we
shipped our first proprietary blood collection tubes to our global
distributor VWR and expanded our intellection property protection
to 28 issued patents globally. These achievements support the
planned international launch of our research-use only (RUO) liquid
biopsy kits in early 2019.
"We expect to complete validation of our liquid biopsy Next
Generation Sequencing gene panel under our Thermo Fisher Scientific
collaboration in the third quarter, at which time we will be the
only company to offer both individual and panel biomarker
tests. This collaboration provides for joint marketing of
molecular diagnostics and opens opportunities to expand our
customer base to pharmaceutical companies," Mr. Nall concluded.
Review of Second Quarter and Recent Accomplishments
Collaborations
- Entered into an agreement with a large managed care
organization to evaluate the clinical utility and cost
effectiveness of Target Selector™ in patients diagnosed with
non-small cell lung cancer (NSCLC). Biocept's liquid biopsy testing
will be used to profile patients who have been diagnosed with NSCLC
and/or whose disease has progressed on EGFR-targeted therapy. Key
objectives are to evaluate improvements in the molecular profiling
rate of advanced NSCLC patients and reduce the overall cost of
patient care.
- Entered into a partnership with Moores Cancer Center at UC San
Diego Health to conduct two clinical studies in patients with a
variety of solid tumors. These studies will use Target Selector™ to
detect circulating tumor cells (CTCs) and circulating tumor DNA
(ctDNA), and compare results with findings from CT or PET
scans.
- Launched CEE-Sure® blood collection tubes (BCTs) for
research-use only under an exclusive international distribution
agreement with VWR, a leading global provider of product and
service solutions to laboratory and production customers.
CEE-Sure® BCTs allow for the transport of liquid biopsy
samples at room temperature from the clinic to central laboratories
conducting molecular and cellular analyses, with the ability to
preserve both CTCs and cfDNA collected from the patient in the same
tube.
- Entered into a provider agreement with Alliance Global FZ,
LLC to market and distribute Target Selector™ liquid biopsy
tests in the United Arab Emirates and select countries in
the Middle East, North and Sub-Saharan Africa
and Southeast Asia. All diagnostic testing services will be
performed in Biocept's CLIA-certified laboratory in
San Diego with Alliance
Global responsible for sales, marketing and distribution.
Clinical Data Presentations and Publications
- Published a case report in the peer-reviewed journal Clinics
in Oncology demonstrating the clinical utility of Target
Selector™ CTC testing in the management of a patient with
metastatic breast cancer. Biocept's CTC-based assay
detected estrogen receptor (ER) expression and HER2 gene
amplification, which enabled the patient to qualify for anti-HER2
therapy that extended her survival and improved her quality of
life. Several prior attempts to gain this molecular information
from tissue using standard image-guided biopsy were
unsuccessful.
- Published a case report in the peer-reviewed journal
Oncology & Hematology Review demonstrating the clinical
utility of Biocept's Target Selector™ ALK gene rearrangement
test. The CTC-based assay detected the ALK gene
translocation in a patient diagnosed with NSCLC who subsequently
received sequential ALK inhibitor therapies and exhibited excellent
clinical response to the treatment.
- Announced the publication of a letter to the editor in the
peer-reviewed Journal of Thoracic Oncology, the official
journal of the International Association for the study of lung
cancer. The letter outlined the ability of Biocept's Target
Selector™ test to identify a ROS1 gene rearrangement in a patient
with lung cancer, confirming the results of a prior tissue
biopsy. Another liquid biopsy method cited in the report
failed to find this important cancer biomarker.
Patents
- Awarded a Canadian patent covering the use of Biocept's
microchannels for the capture and detection of any target of
interest, including proteins and nucleic acids, as well as the
capture of cancer or other cells that can be used for molecular
analysis in blood and other biological fluids.
- Granted patent protection in seven European countries for
Biocept's Target Selector™ assays for ctDNA analysis using
real-time PCR, Sanger sequencing
and next-generation sequencing.
Corporate
- Completed a shareholder rights offering raising gross proceeds
of approximately $11.6 million.
Second Quarter Financial Results
Revenues for the second quarter of 2018 were $822,000, compared with $1.3 million for the second quarter of 2017.
During the first quarter of 2017, the Company converted from
cash-based revenue recognition for its commercial revenues to
accrual-based revenue recognition. Of the $1.3 million of revenues recognized during the
second quarter of 2017, $1.1 million
were related to revenues recognized on an accrual basis, while
$159,000 were related to revenues
recognized upon the receipt of cash, compared to the second quarter
of 2018, when $822,000 of revenues
were recognized on an accrual basis and no revenues were recognized
upon the receipt of cash. For the second quarter of 2018, revenues
included $761,000 in commercial test
revenues, $52,000 in development
services test revenues and $9,000 in
CEE-Sure blood collection tubes.
Biocept accessioned 1,029 total samples in the second quarter of
2018, compared with 1,405 total samples in the second quarter of
2017. Total accessions include billable samples and samples from
research activities, assay validations and other non-billable
sources. The Company accessioned 996 billable samples in the second
quarter of 2018, compared with 1,225 billable samples for the
second quarter of 2017.
Cost of revenues for the second quarter of 2018 was $2.7 million, compared with $2.4 million for the second quarter of 2017, and
increase of $331,000, or 14%, due
primarily to higher software amortization and other information
technology and laboratory equipment costs, as well as direct costs
associated with the automation of our laboratory operations
including laboratory process improvements.
Research and development (R&D) expenses for the second
quarter of 2018 were $1.0 million,
compared with $842,000 for the second
quarter of 2017, an increase of $177,000, or 21%, due primarily to the addition
of personnel for the development of new biomarker assays and a
higher proportion of allocated laboratory costs in support of
increased R&D activities.
General and administrative (G&A) expenses for the second
quarter of 2018 were $1.7 million,
compared with $1.8 million for the
second quarter of 2017, a decrease of $89,000, or 5%, driven primarily by the decrease
in headcount-related expenses.
Sales and marketing expenses for the second quarter of 2018 were
$1.4 million, compared with
$1.7 million for the second quarter
of 2017, a decrease of $314,000, or
18%, primarily driven by lower headcount related expenses and cost
reduction efforts initiated in the second quarter of 2018.
The net loss for the second quarter of 2018 was $6.2 million, or $2.70 per share on 2.3 million weighted-average
shares outstanding. This compares with a net loss for the second
quarter of 2017 of $5.7 million, or
$6.32 per share on 901,000
weighted-average shares outstanding.
Six Month Financial Results
Revenues for the first six months of 2018 were $1.6 million, compared with $3.0 million for the first six months of 2017,
and included $1.5 million in
commercial test revenues, $96,000 in
development services test revenues and $9,000 in CEE-Sure blood collection tubes. Of the
$3.0 million of revenues recognized
during the first six months of 2017, $1.9
million were related to revenues recognized on an accrual
basis, while $1.1 million were
related to revenues recognized upon the receipt of cash. During the
first quarter of 2017, the Company converted from cash-based
revenue recognition for its commercial revenues to accrual-based
revenue recognition. As a result of this change, the
Company recognized total nonrecurring revenue of $1.0 million during the first six months of 2017
for cases delivered on or prior to December
31, 2016, and the incremental revenue as a result of the
change to accrual accounting for commercial cases was $917,000.
Biocept accessioned 2,080 billable samples during the first six
months of 2018, compared with 2,332 billable samples accessioned
during the first six months of 2017. Total accessions, which also
include samples from research activities, assay validations and
other non-billable sources, were 2,199 for the first six months of
2018, compared with 2,651 total samples for the first six months of
2017.
Cost of revenues for the first six months of 2018 was
$5.1 million, compared with
$4.5 million for the first six months
of 2017, an increase of $637,000 or
14%, driven primarily by an increase in facility and office
expenses with respect to computer equipment, software amortization,
depreciation expense, and allocated information technology and
facility charges as we invested in upgrading our laboratory
equipment and information system and maintain our facility.
R&D expenses for the first six months of 2018 were
$2.1 million, compared with
$1.6 million for the prior-year
period, an increase of $500,000 or
31%, with the increase due primarily to higher lab allocation costs
and headcount-related expenses as we focused on the development and
deployment of next generation sequencing, support and
implementation of data-intensive laboratory processes, and new
product validations. The Company continues to believe that focused
investments in R&D are critical to its future growth and
competitive position in the marketplace.
G&A expenses for the first six months of 2018 were
$3.6 million, compared with
$3.7 million for the first six months
of 2017, a decrease of $57,000 or 2%,
with the decrease driven primarily by the decrease in
headcount-related expenses.
Sales and marketing expenses for the first six months of 2018
were $3.1 million, versus
$3.0 million for the first six months
of 2017, an increase of $45,000 or
1%, with the increase driven primarily by the increase in
infrastructure related costs.
The net loss for the first six months of 2018 was $12.5 million, or $5.97 per share on 2.1 million weighted-average
shares outstanding. This compares with a net loss for the first six
months of 2017 of $10.1 million, or
$12.58 per share on 805,000
weighted-average shares outstanding.
Cash and cash equivalents as of June 30,
2018 were $2.6 million,
compared with $2.1 million as of
December 31, 2017. In January 2018, the Company completed the sale of
common stock and warrants raising $13.3
million in net proceeds. In August 2018, the Company completed a shareholder
rights offering raising gross proceeds of approximately
$11.6 million.
Biocept is implementing a cost-reduction program, which is
expected to save an estimated $1.0
million to $1.5 million
annually, in addition to the more than $2
million reduction in annual cash expenditures from retiring
its long-term debt obligation in July of this year.
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
the conclusion of the call 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 10122826.
About Biocept
Biocept, Inc. is a molecular diagnostics
company with commercialized assays for lung, breast, gastric,
colorectal and prostate cancers, and melanoma. The Company
leverages its proprietary liquid biopsy technology to provide
physicians with clinically actionable information for treating and
monitoring patients diagnosed with cancer. Biocept's patented
Target Selector™ liquid biopsy technology platform captures and
analyzes tumor-associated molecular markers in both circulating
tumor cells (CTCs) and in circulating tumor DNA (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 expand our
business as a diagnostic kit manufacturer, the ability of recent
developments to support future growth, the success of our
collaboration with Thermo Fisher Scientific, the benefits of our
cost-reduction program, and our ability to increase physician
adoption of our liquid biopsy platform, 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 www.sec.gov.
BIOCEPT,
INC.
CONDENSED BALANCE
SHEETS
|
|
|
|
|
|
|
|
December 31,
|
|
June
30,
|
|
2017
|
|
2018
|
|
|
|
|
(unaudited)
|
ASSETS
|
|
|
|
|
|
Cash
|
$
|
2,146,611
|
|
$
|
2,569,111
|
Accounts
receivable, net
|
|
1,193,426
|
|
|
1,437,665
|
Inventories,
net
|
|
498,702
|
|
|
537,037
|
Prepaid expenses
and other current assets
|
|
416,600
|
|
|
854,921
|
TOTAL CURRENT
ASSETS
|
|
4,255,339
|
|
|
5,398,734
|
FIXED ASSETS,
NET
|
|
3,123,567
|
|
|
2,892,576
|
TOTAL
ASSETS
|
$
|
7,378,906
|
|
$
|
8,291,310
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES, NET
|
$
|
4,661,345
|
|
$
|
4,505,481
|
NON-CURRENT
LIABILITIES,
NET
|
|
1,421,527
|
|
|
1,258,261
|
TOTAL
LIABILITIES
|
|
6,082,872
|
|
|
5,763,742
|
SHAREHOLDERS'
EQUITY
|
|
1,296,034
|
|
|
2,527,568
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
|
7,378,906
|
|
$
|
8,291,310
|
|
|
|
|
|
|
|
|
|
|
BIOCEPT,
INC.
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
For the three
months ended June 30,
|
|
|
For the six months
ended June 30,
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
Net
revenues
|
$
|
1,278,961
|
|
|
$
|
822,238
|
|
|
$
|
2,962,026
|
|
|
$
|
1,629,181
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
|
2,368,705
|
|
|
|
2,699,671
|
|
|
|
4,498,159
|
|
|
|
5,134,557
|
|
Research and
development expenses
|
|
841,991
|
|
|
|
1,019,285
|
|
|
|
1,599,249
|
|
|
|
2,089,866
|
|
General and
administrative expenses
|
|
1,798,026
|
|
|
|
1,708,970
|
|
|
|
3,704,661
|
|
|
|
3,647,634
|
|
Sales and marketing
expenses
|
|
1,746,867
|
|
|
|
1,433,174
|
|
|
|
3,025,178
|
|
|
|
3,069,716
|
|
Total costs and
expenses
|
|
6,755,589
|
|
|
|
6,861,100
|
|
|
|
12,827,247
|
|
|
|
13,941,773
|
|
Loss from
operations
|
|
(5,476,628)
|
|
|
|
(6,038,862)
|
|
|
|
(9,865,221)
|
|
|
|
(12,312,592)
|
|
Other income/
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(214,377)
|
|
|
|
(84,239)
|
|
|
|
(296,903)
|
|
|
|
(166,913)
|
|
Other
income
|
|
—
|
|
|
|
(30,000)
|
|
|
|
38,412
|
|
|
|
(30,000)
|
|
Total other income/
(expense):
|
|
(214,377)
|
|
|
|
(114,239)
|
|
|
|
(258,491)
|
|
|
|
(196,913)
|
|
Loss before income
taxes
|
|
(5,691,005)
|
|
|
|
(6,153,101)
|
|
|
|
(10,123,712)
|
|
|
|
(12,509,505)
|
|
Income tax
expense
|
|
(2,146)
|
|
|
|
—
|
|
|
|
(2,146)
|
|
|
|
(739)
|
|
Net loss and
comprehensive loss
|
$
|
(5,693,151)
|
|
|
$
|
(6,153,101)
|
|
|
$
|
(10,125,858)
|
|
|
$
|
(12,510,244)
|
|
Weighted-average
shares outstanding
used in computing net loss per share
attributable to common shareholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
901,001
|
|
|
|
2,280,115
|
|
|
|
804,714
|
|
|
|
2,096,717
|
|
Diluted
|
|
901,001
|
|
|
|
2,280,115
|
|
|
|
804,714
|
|
|
|
2,096,717
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
$
|
(6.32)
|
|
|
$
|
(2.70)
|
|
|
$
|
(12.58)
|
|
|
$
|
(5.97)
|
|
Diluted
|
$
|
(6.32)
|
|
|
$
|
(2.70)
|
|
|
$
|
(12.58)
|
|
|
$
|
(5.97)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Biocept, Inc.