SAN DIEGO, Nov. 9, 2017 /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, 2017, and provides an update on its
business progress.
"This has been a productive period in developing new
distribution channels, launching key biomarker tests, and
initiating an important clinical study all aimed at supporting
further physician adoption of our Target Selector™ liquid biopsy
platform," said Michael Nall,
President and CEO of Biocept. "By signing the distribution
agreement with VWR and launching our Pathology Program strategy, we
are executing on key steps towards our strategy to move to the
distribution of our patented technologies while also continuing to
be a leader in the liquid biopsy services space.
"Our Pathology Program initiative is a first-of-its-kind
strategy in liquid biopsy focused on community pathologists, the
physicians who determine patient diagnosis. Pathologists have
strong relationships with medical oncologists and other physicians
who refer specimens to them, and are the first to know when tissue
is limited or inadequate from a traditional surgical biopsy. This
novel program allows us to expand our relationships with hospital
systems across the U.S. while improving continuity of care for
these patients by bringing more stakeholders into the liquid biopsy
value chain," he added. "We also entered a co-marketing
agreement with Miraca Life Sciences, a leading U.S. diagnostics and
services provider, to broaden the distribution of our liquid biopsy
tests to community-based oncologists and hematologists. This
arrangement will give us broader coverage in order to drive
adoption of our industry-leading testing solutions. In
addition, we entered into a research agreement with the
University of Texas Southwestern Medical
Center to study ALK alterations in non-small cell lung
cancer. Patients who have an ALK translocation have been
shown to benefit from targeted therapy."
Review of Third Quarter 2017 and Recent
Accomplishments
Distribution Agreements
- Launched the first and only initiative in liquid biopsy to
enable community pathologists to report molecular biomarker
information using innovative liquid biopsy technology for their
patients diagnosed with cancer.
- Entered into an agreement with leading diagnostics laboratory
and service provider Miraca Life Sciences to market Target
Selector™ liquid biopsy tests and services to community-based
oncologists and hematologists across the U.S.
- Entered into an exclusive global agreement (excluding
China) with global laboratory
product supplier VWR International, LLC to distribute Biocept's
proprietary blood collection tubes that preserve circulating tumor
DNA (ctDNA) for up to 8 days and circulating tumor cells (CTCs) for
up to 4 days at room temperature, thereby enabling worldwide
shipment of liquid biopsy samples.
Clinical Development
- Initiated a clinical study with the University of Texas Southwestern Medical Center to
profile and monitor non-small cell lung cancer patients with
ALK rearrangements using our Target Selector™ liquid biopsy
test.
Commercial Biomarker Launch
- Announced the commercial availability of the Company's assay
for mutations of the NRAS oncogene associated with multiple cancer
types including metastatic melanoma, colorectal and lung cancers,
increasing the number of CLIA-certified liquid biopsy tests to
15.
- Increased the number of commercially available biomarkers for
breast cancer with the launch of a liquid biopsy test for
progesterone receptor (PR), which completes our menu of assays for
all NCCN Guideline®-based biomarkers pertinent to the care of
patients with breast cancer.
Healthcare Payer Agreements
- Executed a preferred provider agreement with Scripps Health
Plan, expanding in-network access to Biocept's liquid biopsy
testing.
Corporate Developments
- Named renowned lung cancer expert Fred
R. Hirsch, MD, PhD, Professor of Medicine and Pathology at
the University of Colorado Cancer
Center, to Biocept's Clinical Advisory Board.
Third Quarter Financial Results
Revenues for the third quarter of 2017 increased 6% to
$1.1 million, from $1.0 million for the third quarter of 2016, and
included $1.0 million in commercial
test revenues and $67,000 in
development services test revenues. These results reflect the
impact on sales and volume from the hurricanes in Texas and Florida, as well as the earthquake in
Mexico City. In addition, there
were 2 fewer sales days in the third quarter of 2017 compared with
the third quarter of 2016. We believe these factors negatively
impacted our reported volume in the third quarter of 2017 by
approximately 15 to 20%. Of the $1.1
million of revenues recognized during the third quarter of
2017, $0.9 million related to
revenues recognized on an accrual basis and $102,000 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. The Company
recognized incremental revenue in the third quarter of $125,000 as a result of the change to accrual
accounting for commercial cases.
Biocept accessioned 1,343 total samples in the third quarter of
2017, up 7% from the 1,251 total samples in the third quarter of
2016. Total accessions include billable samples and samples from
research activities, assay validations and other non-billable
sources. The Company accessioned 1,203 billable samples in the
third quarter of 2017, a 2% increase from the 1,183 billable
samples accessioned during the third quarter of 2016.
Cost of revenues for the third quarter of 2017 was $2.5 million, compared with $1.9 million for the third quarter of 2016, with
the increase primarily attributable to an increase in laboratory
capacity to service anticipated higher sample volume resulting from
the Company's sales force expansion, pathology partnership
initiative, and investments in upgrading its laboratory information
system, equipment, and facility. As test volumes continue to
increase, the Company expects to leverage its fixed and
semi-variable costs, reducing costs per sample and improving gross
margins.
Research and development (R&D) expenses for the third
quarter of 2017 were $857,000
compared with $601,000 for the
prior-year period, with the increase due to higher headcount,
greater consumption of materials and higher costs associated with
research and development activities.
General and administrative (G&A) expenses for the third
quarter of 2017 were $1.8 million
compared with $1.9 million for the
third quarter of 2016, with the decrease primarily due to lower
third-party billing provider costs resulting from bringing the
Company's billing function in-house, lower stock-based compensation
expense and lower patent costs.
Sales and marketing expenses for the third quarter of 2017 were
$1.7 million, versus $1.3 million for the third quarter of 2016, due
to salesforce expansion.
The net loss for the third quarter of 2017 was $5.8 million, or $0.20 per share on 29.6 million weighted-average
shares outstanding. This compares with a net loss for the third
quarter of 2016 of $4.7 million, or
$0.57 per share on 8.4 million
weighted-average shares outstanding.
Nine Month Financial Results
Revenues for the first nine months of 2017 more than doubled to
$4.1 million from $1.9 million for the first nine months of 2016,
and included $3.9 million in
commercial test revenues and $212,000
in development services test revenues. Of the $4.1 million of revenues recognized during the
first nine months of 2017, $2.9
million related to revenues recognized on an accrual basis
and $1.2 million related to revenues
recognized upon the receipt of cash. As a result of the change to
accrual accounting during the first quarter of 2017, the Company
recognized total nonrecurring revenue of $839,000 during the first nine 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 $1.0 million.
Biocept accessioned 3,994 total samples during the first nine
months of 2017, up 19% from the 3,365 total samples for the first
nine months of 2016. Total accessions include billable samples and
samples from research activities, assay validations and other
non-billable sources. The Company accessioned 3,535 billable
samples during the first nine months of 2017, a 14% increase from
the 3,110 billable samples accessioned during the first nine months
of 2016.
Cost of revenues for the first nine months of 2017 was
$7.0 million compared with
$5.0 million for the first nine
months of 2016, with the increase primarily attributable to higher
commercial test volumes and an increase in laboratory capacity to
service anticipated higher sample volume resulting from the
Company's sales force expansion, pathology partnership initiative,
and investments in upgrading its laboratory information system,
equipment, and facility.
R&D expenses for the nine months ended September 30, 2017 were $2.5 million compared with $2.0 million for the prior-year period, with the
increase due to higher headcount and higher costs associated with
research and development activities.
G&A expenses for the first nine months of 2017 were
$5.5 million compared with
$4.9 million for the first nine
months of 2016, primarily due to higher personnel costs associated
with the expansion of the Company's in-house billing function, as
well as higher consulting and outside service provider costs
associated with increased commercial activities and corporate
strategy initiatives.
Sales and marketing expenses for the first nine months of 2017
were $4.7 million, versus
$3.9 million for the first nine
months of 2016, due to salesforce expansion and higher marketing
costs.
The net loss for the first nine months of 2017 was $15.9 million, or $0.62 per share on 25.8 million weighted-average
shares outstanding. This compares with a net loss for the first
nine months of 2016 of $14.2 million,
or $1.88 per share on 7.5 million
weighted-average shares outstanding.
Cash and cash equivalents were $5.9
million as of September 30,
2017, compared with $4.6
million as of December 31,
2016.
Conference Call and Webcast
Biocept will hold a conference call today at 4:30 pm 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 10113804.
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 increase
physician adoption of our liquid biopsy platform, our ability to
move to the distribution of our patented technologies, our ability
to expand relationships with hospital systems across the U.S., our
ability to broaden the distribution of our liquid biopsy tests, and
our ability to leverage our fixed and semi-variable costs to
improve margins, 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,
|
|
September
30,
|
|
2016
|
|
2017
|
|
|
|
|
(unaudited)
|
|
ASSETS
|
|
|
|
|
|
|
Cash
|
$
|
4,609,332
|
|
$
|
5,879,025
|
|
Accounts
receivable, net
|
|
128,969
|
|
|
1,133,372
|
|
Inventories,
net
|
|
549,045
|
|
|
775,106
|
|
Prepaid expenses
and other current assets
|
|
484,649
|
|
|
412,916
|
|
TOTAL CURRENT
ASSETS
|
|
5,771,995
|
|
|
8,200,419
|
|
FIXED ASSETS,
NET
|
|
1,806,331
|
|
|
2,919,796
|
|
TOTAL
ASSETS
|
$
|
7,578,326
|
|
$
|
11,120,215
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
CURRENT
LIABILITIES, NET
|
$
|
4,393,552
|
|
$
|
5,838,197
|
|
NON-CURRENT
LIABILITIES,
NET
|
|
2,526,113
|
|
|
1,255,939
|
|
TOTAL
LIABILITIES
|
|
6,919,665
|
|
|
7,094,136
|
|
SHAREHOLDERS'
EQUITY
|
|
658,661
|
|
|
4,026,079
|
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
|
7,578,326
|
|
$
|
11,120,215
|
|
|
|
|
|
|
|
|
|
|
|
|
Biocept,
Inc.
|
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended September
30,
|
|
For the nine months ended September
30,
|
|
2016
|
|
2017
|
|
2016
|
|
2017
|
NET
REVENUES
|
$
|
1,047,280
|
|
$
|
1,111,411
|
|
$
|
1,931,509
|
|
$
|
4,073,437
|
COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
|
1,876,288
|
|
|
2,487,054
|
|
|
5,020,649
|
|
|
6,985,213
|
Research and
development
|
|
600,613
|
|
|
856,698
|
|
|
2,044,968
|
|
|
2,455,947
|
General and
administrative
|
|
1,918,543
|
|
|
1,834,771
|
|
|
4,923,431
|
|
|
5,539,432
|
Sales and
marketing
|
|
1,278,455
|
|
|
1,675,852
|
|
|
3,875,063
|
|
|
4,701,030
|
Total costs and
expenses
|
|
5,673,899
|
|
|
6,854,375
|
|
|
15,864,111
|
|
|
19,681,622
|
LOSS FROM
OPERATIONS
|
|
(4,626,619)
|
|
|
(5,742,964)
|
|
|
(13,932,602)
|
|
|
(15,608,185)
|
INTEREST AND OTHER
INCOME/(EXPENSE), NET
|
|
(116,457)
|
|
|
(75,465)
|
|
|
(277,793)
|
|
|
(333,956)
|
LOSS BEFORE INCOME
TAXES
|
|
(4,743,076)
|
|
|
(5,818,429)
|
|
|
(14,210,395)
|
|
|
(15,942,141)
|
INCOME
TAXES
|
|
-
|
|
|
(2,877)
|
|
|
(2,053)
|
|
|
(5,023)
|
NET LOSS AND
COMPREHENSIVE LOSS
|
$
|
(4,743,076)
|
|
$
|
(5,821,306)
|
|
$
|
(14,212,448)
|
|
$
|
(15,947,164)
|
NET LOSS PER
SHARE
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
$
|
(0.57)
|
|
$
|
(0.20)
|
|
$
|
(1.88)
|
|
$
|
(0.62)
|
- Diluted
|
$
|
(0.57)
|
|
$
|
(0.20)
|
|
$
|
(1.88)
|
|
$
|
(0.62)
|
WEIGHTED AVG
NUMBER OF SHARES OUTSTANDING
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
|
8,370,691
|
|
|
29,605,953
|
|
|
7,549,663
|
|
|
25,816,181
|
- Diluted
|
|
8,370,691
|
|
|
29,605,953
|
|
|
7,549,663
|
|
|
25,816,181
|
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SOURCE Biocept, Inc.