SAN DIEGO, March 25, 2020 /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 12 months ended December 31, 2019, and provides an update on its
business progress.
"I'm pleased to report our sixth consecutive quarter of growth
with fourth quarter revenues reaching a record $1.8 million, more than double the prior year's
quarterly revenues," said Michael
Nall, President and CEO of Biocept. "Our growth for
the quarter was driven by year-over-year increases of 46% in
commercial test volume and 34% in average reimbursement per
patient, predominantly due to reporting on more tests per accession
ordered by referring doctors. While growing revenues, we also
benefitted from operating efficiencies, including automation
initiatives in our CLIA-certified laboratory. These
efficiencies combined with higher sample volume moved us
significantly closer to positive gross margin. We have more
actions to complete the automation of our lab and we are pleased
with the contribution from these efforts so far.
"Revenue for the full year 2019 increased 70% over the prior
year," said Mr. Nall. "A key growth driver throughout 2019
was our decision to focus on prostate cancer, including committing
more commercial resources to urologists and urology practices and
introducing additional prognostic and predictive biomarker
tests. As the year progressed, we were encouraged that more
urologists were using more biomarkers per test for more of their
patients.
"I'm exceptionally proud of our strong operational performance
throughout 2019 and into 2020. Among notable accomplishments,
we launched the first-and-only liquid biopsy test to evaluate
cerebrospinal fluid as well as NGS test panels for lung and breast
cancer. We also added a new revenue stream from sales of our
Target Selector™ research-use only (RUO) kits, further expanded our
intellectual property portfolio with new U.S. and foreign patents,
and presented compelling data further validating our technology at
multiple scientific conferences and in peer-reviewed journals," he
added. "So far this year, we have raised net proceeds of
$17.5 million from two equity
offerings and warrant exercises, positioning us for continued
execution on our growth strategy."
2019 and Recent Highlights
Commercial Launches
- Announced the availability of Target Selector™ assays to
evaluate cerebrospinal fluid (CSF) for the presence of circulating
tumor cells (CTCs) and biomarkers, which may be indicators of brain
metastases. Of patients diagnosed with breast and lung
cancer, 30% and 36%, respectively, will develop brain metastases.
The validations study for the CSF assay was conducted in
collaboration with Providence St. Joseph Health, Southern California, and its wholly owned
affiliates Providence St. John's Health Center and John Wayne
Cancer Institute.
- 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 CTC 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.
- Launched Target Selector™ pan-TRK assay for the detection of
TRK proteins, which are actionable biomarkers that can be used to
qualify patients for treatment with TRK inhibitor therapies.
The pan-TRK assay, which utilizes Biocept's proprietary CTC
platform to screen for TRK gene alternations, is a unique liquid
biopsy offering.
- Launched expanded pathology partnership service, EmpowerTC™,
with additional prognostic and predictive biomarker tests to enable
urology and uropathology practices to perform liquid biopsy testing
and interpret results generated in Biocept's CLIA-certified
laboratory.
- Announced the availability of RUO kits, which enable molecular
laboratories around the world to utilize Target Selector™
circulating tumor DNA (ctDNA) assays to perform liquid biopsy
testing. Also announced an agreement with Agiomix FZ-LLC, a
provider of genomics sample and bioinformatics services for
research and clinical applications, to validate and purchase
Biocept's Target Selector™ RUO kits for use in its laboratory.
Commercial Agreements
- Announced an agreement with Beacon Laboratory Benefit Solutions
designating Biocept as a BeaconLBS® Lab-of-Choice, increasing
patient access to Biocept' liquid biopsy testing platforms.
Beacon Laboratory is a nationally recognized provider of laboratory
benefit management technology solutions to U.S.-based health and
managed care companies.
- Signed an agreement with a large California-based independent physician
association (IPA) to provide Biocept's Target Selector™ liquid
biopsy testing services to physicians and patients in their
network.
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. These clearances allow Biocept to commercialize
its tubes and collection/shipping kits throughout the European
Union and other CE Mark geographies.
Industry Conference Presentations
- Presented 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
will 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 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.
- Presented a poster at the 2019 American Association for Cancer
Research Annual Meeting demonstrating the ability of the Target
Selector™ assay to detect ESR1 mutations with high sensitivity,
resulting in inclusion of the test in a clinical trial sponsored by
a major pharmaceutical company.
- Presented a poster at the 2019 San Antonio Breast Cancer
Symposium® demonstrating the ability of the Target Selector™
CTC platform to aid in the monitoring and treatment of breast
cancer. Study results demonstrated the platform's ability to
accurately detect, enumerate and interrogate CTCs in a cohort of
more than 1,500 patients, representing various clinical and
treatment stages of breast cancer.
Peer-reviewed Journal Publications
- Announced publication of clinical data in Journal of
Clinical Pathology that further validates Biocept's Target
Selector™ qPCR Assay using "Switch Blocker" technology to identify
cancer-related mutations in liquid biopsy samples. Study results
showed a very high concordance between Biocept's liquid biopsy
testing and tissue biopsy and best-in-class detection of
alterations down to a single mutant copy in both analytical and
clinical settings.
- Announced publication of case studies in Clinics in
Oncology demonstrating the clinical utility of Target
Selector™ testing in the management of patients diagnosed with
advanced non-small cell lung cancer. In each case study,
Biocept's liquid biopsy testing detected activating EGFR
mutations where tissue biopsy was inadequate, and targeted
EGFR-directed therapy was subsequently administered.
- Announced publication of an article in 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.
- 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.
- Obtained a patent in Japan
covering the use of 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 rare cells that can be used
for molecular analysis in blood and other biological
fluids.
- Awarded a patent in the U.S. covering devices for the detection
of cells of interest, including CTCs that are shed into the
bloodstream by solid tumors where an antibody, or mixture of
antibodies, and any solid surface are used for cell capture,
detection and analysis, including any biological sample type, using
single antibodies or cocktails of antibodies.
- Exited 2019 with 37 issued patents globally for Biocept's
highly sensitive method of detecting cancer biomarkers.
Corporate Developments
- Promoted Cory J. Dunn, M.S., M.
Ed. to Senior Vice President of Commercial Operations. Ms.
Dunn joined Biocept as Vice President of Commercial Operations in
October 2018.
Fourth Quarter Financial Results
Revenues for the fourth quarter of 2019 were $1.8 million, a 108% increase from $859,000 for the fourth quarter of 2018.
Revenues for the fourth quarter of 2019 included $1.6 million in commercial test revenue,
$87,000 in development services test
revenue, and $108,000 in revenue for
Target Selector™ RUO kits, which were commercially launched in
early 2019, and CEE-Sure® blood collection tubes. Revenues
for the fourth quarter of 2018 included $820,000 in commercial test revenues and
$39,000 in development services test
revenues.
Biocept accessioned 1,159 commercial samples during the fourth
quarter of 2019, a 46% increase from the 795 commercial samples
accessioned during the fourth quarter of 2018. The Company
accessioned 1,278 billable samples during the fourth quarter of
2019, a 36% increase from 938 billable samples during the fourth
quarter of 2018.
Cost of revenues for the fourth quarter of 2019 was $2.9 million, compared with $2.4 million for the fourth quarter of
2018. Cost of revenues increased 18% while billable accession
volume increased by 36% as the Company continued to leverage its
fixed costs.
Research and development (R&D) expenses for the fourth
quarter of 2019 were $1.2 million,
compared with $1.3 million for the
fourth quarter of 2018, with the decrease primarily due to lower
allocated cost of laboratory associated activities. General
and administrative (G&A) expenses for the fourth quarter of
2019 were $1.9 million, compared with
$1.6 million for the fourth quarter
of 2018, with the increase due mainly to a reclass of customer
service and related expenses from Sales & Marketing to G&A.
Sales and marketing (S&M) expenses for the fourth quarter of
2019 were $1.5 million, compared with
$1.4 million for the fourth quarter
of 2018, with the increase primarily attributed to commissions paid
for higher volume and revenue.
The fourth quarter of 2019 included a non-cash deemed dividend
of $22,000 for the repricing of
adjustable warrants. There was no comparable charge in the
fourth quarter of 2018.
The net loss attributable to common shareholders for the fourth
quarter of 2019 was $5.7 million, or
$0.20 per share on 29.1 million
weighted-average shares outstanding. The net loss
attributable to common shareholders for the fourth quarter of 2018
was $6.0 million, or $1.43 per share on 4.2 million weighted-average
shares outstanding.
Full Year Financial Results
Revenues for 2019 were $5.5
million, a 70% increase from $3.3
million for 2018. Revenues for 2019 included
$5.1 million in commercial test
revenues, $212,000 in development
services test revenues, and $200,000
in revenues for Target Selector™ RUO kits and CEE-Sure® blood
collection tubes. Revenues for 2018 included $3.0 million in commercial test revenues and
$199,000 in development services test
revenues.
Biocept accessioned 4,425 commercial samples during 2019, a 35%
increase from the 3,273 commercial samples accessioned during
2018. The Company accessioned 4,976 billable samples during
2019, a 28% increase from 3,896 billable samples during 2018.
Cost of revenues for 2019 was $11.0
million, compared with $10.1
million for 2018. Cost of revenues for 2019 increased
9% while billable accession volume increased by nearly 28%, both
compared with 2018.
Total costs and expenses for 2019 were $28.6 million, and included cost of revenues of
$11.0 million, R&D expenses of
$4.7 million, G&A expenses of
$7.0 million and S&M expenses of
$5.9 million.
Other expense for 2019 of $2.1
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 $250,000 of interest expense related to equipment
finance leases. This compares with other expense for 2018 of
$311,000 related to interest
expense. Non-cash deemed dividend for the repricing of
adjustable warrants for 2019 was of $0.1
million, compared with $0.6
million for 2018.
The net loss attributable to common shareholders for 2019 was
$25.3 million, or $1.22 per share on 20.7 million weighted-average
shares outstanding. This compares with a net loss
attributable to common shareholders for 2018 of $25.2 million, or $9.01 per share on 2.8 million weighted-average
shares outstanding. The per-share figures reflect a 1-for-30
reverse split of common stock completed in July 2018.
Biocept reported cash and cash equivalents as of December 31, 2019 of $9.3
million, compared with $3.4
million as of December 31,
2018. The increase includes $25.7
million in net proceeds from equity capital raises conducted
in the first and fourth quarters of 2019, and $4.9 million from the exercise of common stock
warrants during 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 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
10140336. A replay of the webcast will be available for 90
days.
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 CTCs and in 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 continue to
see benefits from our automation efforts, 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. 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
Media:
CORE IR
Jules Abraham
julesa@coreir.com
917-885-7378
BIOCEPT,
INC.
|
CONDENSED BALANCE
SHEETS
|
|
|
|
|
|
|
|
December 31,
|
|
December
31,
|
|
2018
|
|
2019
|
|
|
|
|
|
(unaudited)
|
ASSETS
|
|
|
|
|
|
Cash
|
$
|
3,423,373
|
|
$
|
9,301,406
|
Accounts
receivable, net
|
|
1,574,325
|
|
|
3,527,078
|
Inventories,
net
|
|
587,222
|
|
|
767,986
|
Prepaid expenses
and other current assets
|
|
425,961
|
|
|
296,127
|
TOTAL CURRENT
ASSETS
|
|
6,010,881
|
|
|
13,892,597
|
FIXED ASSETS,
NET
|
|
2,739,422
|
|
|
1,504,330
|
LEASE RIGHT-OF-USE
ASSETS
|
|
—
|
|
|
2,335,717
|
TOTAL
ASSETS
|
$
|
8,750,303
|
|
$
|
17,732,644
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES, NET
|
$
|
4,609,647
|
|
$
|
5,558,812
|
NON-CURRENT
LIABILITIES, NET
|
|
1,098,137
|
|
|
973,189
|
TOTAL
LIABILITIES
|
|
5,707,784
|
|
|
6,532,001
|
SHAREHOLDERS'
EQUITY
|
|
3,042,519
|
|
|
11,200,643
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
|
8,750,303
|
|
$
|
17,732,644
|
BIOCEPT,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended December
31,
|
|
For the year ended December
31,
|
|
|
2018
|
|
2019
|
|
2018
|
|
2019
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
NET
REVENUES
|
$
|
859,526
|
|
$
|
1,783,742
|
|
$
|
3,250,298
|
|
$
|
5,528,566
|
COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
$
|
2,435,262
|
|
$
|
2,872,098
|
|
$
|
10,051,735
|
|
$
|
10,977,520
|
Research and
development expenses
|
|
1,288,957
|
|
|
1,161,905
|
|
|
4,468,572
|
|
|
4,697,022
|
General and
administrative expenses
|
|
1,632,670
|
|
|
1,911,593
|
|
|
7,074,024
|
|
|
6,970,120
|
Sales and marketing
expenses
|
|
1,440,798
|
|
|
1,489,216
|
|
|
5,914,706
|
|
|
5,940,843
|
Total costs and
expenses
|
|
6,797,687
|
|
|
7,434,812
|
|
|
27,509,037
|
|
|
28,585,505
|
LOSS FROM
OPERATIONS
|
|
(5,938,161)
|
|
|
(5,651,070)
|
|
|
(24,258,739)
|
|
|
(23,056,939)
|
INTEREST AND OTHER
INCOME/(EXPENSE), NET
|
|
(74,265)
|
|
|
(62,408)
|
|
|
(310,976)
|
|
|
(2,081,100)
|
LOSS BEFORE INCOME
TAXES
|
|
(6,012,426)
|
|
|
(5,713,478)
|
|
|
(24,569,715)
|
|
|
(25,138,039)
|
INCOME
TAXES
|
|
(1,886)
|
|
|
—
|
|
|
(1,886)
|
|
|
—
|
NET LOSS AND
COMPREHENSIVE LOSS
|
$
|
(6,014,312)
|
|
$
|
(5,713,478)
|
|
$
|
(24,571,601)
|
|
$
|
(25,138,039)
|
Deemed dividend
related to warrants down round provision
|
|
—
|
|
|
(21,829)
|
|
|
(636,370)
|
|
|
(121,572)
|
NET LOSS
ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
$
|
(6,014,312)
|
|
$
|
(5,735,307)
|
|
$
|
(25,207,971)
|
|
$
|
(25,259,611)
|
NET LOSS PER
SHARE
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
$
|
(1.43)
|
|
$
|
(0.20)
|
|
$
|
(9.01)
|
|
$
|
(1.22)
|
- Diluted
|
$
|
(1.43)
|
|
$
|
(0.20)
|
|
$
|
(9.01)
|
|
$
|
(1.22)
|
WEIGHTED AVG
NUMBER OF SHARES OUTSTANDING
|
|
|
|
|
|
|
|
|
|
|
|
- Basic
|
|
4,209,221
|
|
|
29,128,632
|
|
|
2,798,243
|
|
|
20,660,894
|
- Diluted
|
|
4,209,221
|
|
|
29,128,632
|
|
|
2,798,243
|
|
|
20,660,894
|
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SOURCE Biocept, Inc.