Q4 features revenues of $18.5 million; 2020
revenues reach $27.5 million driven by COVID-19 testing
Introduces strategy to establish proprietary
CSF assay as the standard of care in detecting cancer that has
metastasized to the brain or central nervous system
Conference call begins at 4:30 p.m. Eastern
time today
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, reports financial results
for the three and 12 months ended December 31, 2020 and provides a
business update.
“I’m exceptionally proud of the Biocept team for their
enthusiasm and dedication in supporting the COVID-19 testing needs
of our community while advancing our oncology business for a strong
post-pandemic future,” said Michael Nall, President and CEO of
Biocept. “Our COVID-19 testing has provided valuable information to
our clients, which has helped contain viral spread. We received
about 140,000 samples for COVID-19 testing during the fourth
quarter and, even with the relocation of our corporate headquarters
and CLIA laboratory, our team provided the vast majority of
COVID-19 test results to health providers within 48 hours of
receiving the sample.
“Our financial results for the fourth quarter reflect our team’s
success with revenues reaching $18.5 million, resulting in our
first-ever profitable quarter,” he added. “Our ability to generate
higher revenues in recent quarters due to COVID-19 testing
significantly reduced our cash burn in 2020, while we continued to
provide excellent service for our oncology and COVID-19
customers.
“The focus of our oncology business going forward is clearly on
our neuro-oncology strategy and cerebrospinal fluid (CSF) assay,”
he added. “This assay uniquely addresses a high unmet clinical need
by identifying metastatic progression of cancer to the central
nervous system and brain. Approximately 10% to 30% of patients
diagnosed with cancer, depending on tumor type, will ultimately
experience spread of their disease to the central nervous system.
Pilot studies have shown our CSF assay to be significantly more
sensitive than conventional CSF cytology, the current standard of
care, in detecting lung and breast cancer that has metastasized to
the brain or central nervous system. Our CSF assay has the added
advantages of identifying actionable molecular targets that provide
physicians with valuable information in making treatment decisions,
as well as providing quantitative information for monitoring
treatment response and disease progression.
“Initial acceptance by neuro-oncology early-adopters has been
highly encouraging as physicians from nearly two dozen leading
academic institutions have ordered our assay with many becoming
repeat users. Given the advantages of this offering, we have
engaged a group of neuro-oncology thought-leaders from leading
institutions to work with us in developing a strategy to establish
our assay as the standard of care in diagnosing cancer with central
nervous system involvement under National Comprehensive Cancer
Network (NCCN) guidelines. Key among these actions is gathering
clinical data in support of our testing. Later this year, we expect
to start our Four C registry trial, which is designed to provide
clinical validation of the performance of our assay against CSF
cytology in predicting clinical outcomes in patients with suspected
brain and central nervous system metastases,” Mr. Nall
concluded.
2020 and Recent Highlights
Corporate Developments
- Named Michael C. Dugan, MD as Chief Medical Officer and Medical
Director with responsibilities for overseeing medical policy
decision-making and the operations of Biocept’s CLIA-certified,
CAP-accredited, high-complexity molecular laboratory. Dr. Dugan is
highly respected in the molecular diagnostics industry and has
served in leading medical positions at Exact Sciences, Quest
Diagnostics Nichols Institute and Roche Molecular Systems.
- Appointed Samuel D. Riccitelli to the Biocept Board of
Directors. Mr. Riccitelli has more than 35 years of experience in
the healthcare industry, including extensive experience in the
molecular diagnostics industry, having served in executive-level
positions and on the Boards of multiple publicly traded
companies.
- Relocated Biocept’s corporate offices and laboratory to a new
39,000 square foot facility in San Diego. The move aligns with the
Company’s strategy of supporting growth while reducing overhead
expense, and was completed with minimal impact to customers and
saves approximately 20% annually in rental expense.
- Raised net proceeds of $27.3 million in 2020 including the
exercise of warrants.
Clinical Study
- Announced plans for the Four C registry study, a
non-interventional trial evaluating the performance of Biocept’s
CSF assay compared with clinical imaging, CSF cytology and clinical
evaluation in patients with suspected leptomeningeal disease (LMD).
The study is expected to enroll 200 patients with the objective of
providing clinical validation for the Company’s assay compared with
CSF cytology in predicting clinical outcomes.
Commercial Launches, Developments and
Agreements
Oncology
- Announced the commercial availability of the Target Selector™
assay to evaluate CSF for the presence of circulating tumor cells
(CTCs) and biomarkers, which may be indicators of brain metastases,
in patients with advanced lung and breast cancer. The validation
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.
- Announced a positive coverage decision by Highmark, America's
fourth-largest Blue Cross Blue Shield affiliate, for Target
Selector™ liquid biopsy assays for use in the diagnosis and
treatment of patients with non-small cell lung cancer (NSCLC). The
coverage determination follows two years of evaluation by the
Allegheny Health Network Cancer Institute of Biocept’s liquid
biopsy assays to more rapidly assess the molecular status of
patients with NSCLC, enabling oncologists to select the most
appropriate therapy while also reducing the overall cost of
care.
- Established a collaboration with Protean BioDiagnostics to
research the ability of the Target Selector™ assay to determine
EGFR status in NSCLC in an independent pathology laboratory
setting. Protean BioDiagnostics also expects to validate the
analytical performance of a laboratory developed test (LDT) based
on Biocept’s EGFR assay test kit in accordance with the
requirements of the College of American Pathologists (CAP)
validation process.
- Entered into an agreement with reference-based pricing network
Medical Cost Containment Professionals, LLC to process
out-of-network claims for Target Selector™ liquid biopsy testing.
Claims will be adjudicated through this network at pre-negotiated
pricing in a timely manner, helping to accelerate collections while
reducing the length of time receivables remain outstanding.
- Signed laboratory services agreements with four
California-based independent physician associations (IPAs) to
provide Target Selector™ liquid biopsy testing services.
- Launched research-use-only (RUO) kits that allow molecular
laboratories worldwide to detect oncogene mutations in tissue and
liquid biopsies through the analysis of Formalin-Fixed
Paraffin-Embedded (FFPE) tissue gained from surgical biopsies, as
well as circulating tumor DNA (ctDNA) gained from blood. The first
RUO kit with the ability to use tissue and liquid biopsy samples is
designed for the detection of EGFR mutations, which are among the
most frequently evaluated biomarkers of lung cancer.
- Expanded the menu of molecular assay kit offerings with the
launch of a Target Selector™ kit to detect BRAF mutations. Similar
to the EGFR kit, the BRAF RUO kit detects key oncogene mutations
through the analysis of both FFPE tissue gained from surgical
biopsies, as well as ctDNA gained from blood. The BRAF mutation is
among the most frequently evaluated biomarkers across many solid
tumors, including lung cancer and melanoma.
COVID-19
- Received more than 300,000 samples for COVID-19 RT-PCR testing
at Biocept’s high-complexity, CLIA-certified, CAP-accredited and
BSL-2 safety level laboratory since beginning testing in 2020. The
lab is using Thermo Fisher Scientific’s FDA-approved for EUA
testing TaqPath™ molecular diagnostic platform and kit. The vast
majority of results to date have been reported to healthcare
providers within 48 hours of sample receipt.
- Expanded the agreement with MultiPlan, a healthcare cost
management company offering payment integrity and network-based and
analytics-based services, to include COVID-19 testing at a
pre-negotiated price per test. More than 1 million healthcare
providers participate in MultiPlan’s networks and 60 million health
plan members have access to its services.
- Signed a semi-exclusive agreement with a skilled nursing
facility network with more than 50 sites in multiple states to
provide COVID-19 testing to its residents and employees.
- Entered into development and supply agreements with Aegea
Biotechnologies. The first agreement covered the development of a
new, highly sensitive quantitative PCR-based COVID-19 assay
utilizing the patented Switch-Blocker™ technology, which is also
used in Biocept’s Target Selector™ assays. After successful
development of the assay, Biocept and Aegea entered into a supply
agreement under which Aegea is supplying the COVID-19 assay kit for
validation in Biocept’s lab. Following validation, Biocept intends
to commercialize an LDT. The test is designed for quantitative
monitoring of RNA viral load in order to better assist healthcare
providers in screening and managing patients.
Industry Conference Presentations and
Publication
- Presented data from a pilot study showing the Target Selector™
molecular assay kit using Biocept’s Switch-Blocker™ technology
detected mutations in up to 50% of tissue biopsy specimens from
patients diagnosed with NSCLC that were deemed quantity not
sufficient for NGS analysis at the Molecular Med Tri-Con Virtual
Conference.
- Presented results from a small, prospective study comparing
Biocept’s CSF testing to conventional CSF cytology in patients with
NSCLC and LMD metastasis at the "Hot Topic: Liquid Biopsy" meeting
of the International Association for the Study of Lung Cancer.
Study results indicate that Biocept’s CSF testing may play an
important role in providing valuable information to
neuro-oncologists in making treatment decisions for patients with
lung cancer metastases to the brain and spinal cord.
- Presented results from a study using the Company’s CSF assay to
analyze CSF samples of patients with primary lung or breast cancer
with either brain metastasis or LMD at the Society for
Neuro-Oncology’s SNO2020 Virtual Conference.
- Presented data affirming the ability of the Target Selector™
platform to identify potentially actionable mutations in the CSF of
patients whose cancer has metastasized to the central nervous
system at the American Society for Clinical Oncology (ASCO) 2020
Virtual Scientific Program. The data were presented in a poster by
the study’s principal investigator Kevin Kalinsky, MD, MS,
associate professor of medicine at Columbia University Vagelos
College of Physicians and Surgeons, and an oncologist at New
York-Presbyterian/Columbia University Irving Medical Center.
- Presented results from a prospective study showing Target
Selector™ was highly accurate in monitoring HER2 alterations in
patients with metastatic breast cancer at the virtual 2020 San
Antonio Breast Cancer Symposium® (SABC®). The results were featured
in a poster presentation by Vered Stearns, MD, professor of
oncology, breast cancer research chair in oncology, and director of
the Women's Malignancies Disease Group at Johns Hopkins University
School of Medicine/Johns Hopkins Sidney Kimmel Cancer Center.
- Clinical data were published in the Journal of Clinical
Pathology that further validate 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 the Company’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.
Intellectual Property
- Awarded patents in the U.S., Japan, Australia and Brazil for
Primer-Switch technology, which is useful for the detection of rare
mutations, including cancer biomarkers, found in tissue, blood and
CSF using ctDNA analysis through RT-PCR and associated analysis
methods, including NGS.
- Awarded patents in the U.S., Canada and Hong Kong covering the
enhanced detection of cancer cells. These patents expand the
Company’s IP estate for capturing and detecting rare cells of
interest, including CTCs, to aid in the management of patients with
cancer.
- Awarded a patent in Japan for the use of binding entities in
combination with any solid surface to capture and detect any target
of interest, including CTCs, from any sample type. This patent
combines well with the Company’s patented microchannel and
cell-staining platforms, and provides opportunities for
out-licensing technology with a focus on any target of interest,
including single-cell analysis and other methodologies.
- Expanded the Company’s global IP portfolio to 70 issued
patents.
Regulatory Approval
- Awarded CE-IVD Mark for the Target Selector™ molecular assay
EGFR Kit. The CE Mark confirms that Target Selector™ kits meet the
requirements of the European In-Vitro Diagnostic Devices Directive,
and allows Biocept to commercialize these kits throughout the
European Union and other geographies that recognize the CE Mark.
Molecular assay kits detect key oncogene mutations through the
analysis of both FFPE tissue and ctDNA.
Fourth Quarter Financial Results
Revenues for the fourth quarter of 2020 were $18.5 million,
compared with $1.8 million for the fourth quarter of 2019, with the
increase attributable to RT-PCR COVID-19 testing. Revenues for the
fourth quarter of 2020 included $18.3 million in commercial test
revenue, inclusive of $17.6 million attributable to RT-PCR COVID-19
testing, and $32,000 in development services test revenue and
$160,000 in revenue from distributed products, Target Selector™ RUO
kits, CEE-Sure® blood collection tubes and payments from Aegea
Biotechnologies for services associated with the development of a
COVID-19 assay. 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.
Biocept accessioned 145,129 total samples during the fourth
quarter of 2020, compared with 1,404 total samples during the
fourth quarter of 2019. The Company accessioned 144,932 commercial
billable samples during the fourth quarter of 2020, compared with
1,159 commercial billable samples during the fourth quarter of
2019. The increase in total and billable samples was primarily
attributable to COVID-19-related collection kits and consumable
expenses.
Cost of revenues for the fourth quarter of 2020 was $10.0
million, compared with $2.9 million for the fourth quarter of 2019.
Research and development (R&D) expenses for the fourth quarters
of 2020 and 2019 were relatively flat at $1.2 million. General and
administrative (G&A) expenses for the fourth quarter of 2020
were $3.1 million, compared with $1.9 million for the fourth
quarter of 2019, with the increase primarily due to headcount
additions to handle COVID-19-related activities as well as
consulting expenses. Sales and marketing expenses for the fourth
quarter of 2020 were $2.2 million, compared with $1.5 million for
the fourth quarter of 2019, with the increase resulting from higher
sales commissions due to higher revenues.
The fourth quarter of 2019 included a non-cash deemed dividend
of $22,000 for the repricing of adjustable warrants. There was no
comparable deemed dividend in the fourth quarter of 2020.
Net income attributable to common shareholders for the fourth
quarter of 2020 was $1.9 million, or $0.14 per diluted share on
13.6 million weighted-average shares outstanding. This compares
with a net loss attributable to common shareholders for the fourth
quarter of 2019 of $5.7 million, or $1.97 per share on 2.9 million
weighted-average shares outstanding. The change in outstanding
share count reflects the 1-for-10 reverse split of common stock
effected in September 2020.
Full Year Financial Results
Revenues for 2020 were $27.5 million, compared with $5.5 million
for 2019. Revenues for 2020 included $26.9 million in commercial
test revenue, inclusive of $23.3 million attributable to RT-PCR
COVID-19 testing, and $177,000 in development services test revenue
and $421,000 in revenue for Target Selector™ RUO kits, CEE-Sure
blood collection tubes and payments from Aegea Biotechnologies for
services associated with the development of a COVID-19 assay.
Operating expenses for 2020 were $42.9 million, and included
cost of revenues of $21.3 million, R&D expenses of $5.2
million, G&A expenses of $10.0 million and sales and marketing
expenses of $6.4 million. Operating 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
sales and marketing expenses of $5.9 million.
The net loss for 2020 was $17.8 million, or $1.50 per share on
11.8 million weighted-average shares outstanding. This compares
with a net loss for 2019 of $25.3 million, or $12.23 per share on
2.1 million weighted-average shares outstanding. The change in
outstanding share count reflects the 1-for-10 reverse split of
common stock effected in September 2020.
Biocept reported cash and cash equivalents as of December 31,
2020 of $14.4 million, compared with $9.3 million as of December
31, 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
10152872. A replay of the webcast will be available for 90
days.
About Biocept
Biocept, Inc. develops and commercializes molecular diagnostic
assays that provide physicians with clinically actionable
information for treating and monitoring patients diagnosed with a
variety of cancers, including metastatic tumors involving lung,
breast and the central nervous system. Biocept’s patented Target
Selector™ technology platform captures and analyzes
tumor-associated molecular markers in both circulating tumor cells
(CTCs) and circulating tumor DNA (ctDNA) with higher sensitivity
and specificity than most commercial assays. Additionally, Biocept
is leveraging its molecular diagnostic capabilities to offer
nationwide COVID-19 PCR testing to support public health efforts
during this unprecedented pandemic. For additional information,
visit www.biocept.com. Follow Biocept on Facebook, LinkedIn and
Twitter.
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 the ability of our
assays to uniquely address a high unmet clinical need by
identifying metastatic progression of cancer to the central nervous
system and brain, our ability to establish our assays as the
standard of care in diagnosing cancer with central nervous system
involvement, the expected timing of our Four C registry trial and
its ability to provide clinical validation of the performance of
our assay against CSF cytology in predicting clinical outcomes in
patients with suspected brain and central nervous system
metastases, our ability to validate and commercialize COVID-19
assay kit co-developed with Aegea Biotechnologies, and our ability
to provide physicians with clinically actionable information to
improve the outcomes of cancer patients, 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/.
BIOCEPT, INC.
CONDENSED BALANCE
SHEETS
December 31, December 31,
2019
2020
(unaudited) ASSETS Cash $
9,301,406
$
14,367,942
Accounts receivable, net
3,527,078
14,144,911
Inventories, net
767,986
1,929,624
Prepaid expenses and other current assets
296,127
2,151,527
TOTAL CURRENT ASSETS
13,892,597
32,594,004
FIXED ASSETS, NET
1,504,330
2,317,616
LEASE RIGHT-OF-USE ASSETS
2,335,717
12,114,058
OTHER NON-CURRENT ASSETS
—
425,908
TOTAL ASSETS $
17,732,644
$
47,451,586
LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES,
NET $
5,558,812
$
12,494,253
NON-CURRENT LIABILITIES, NET
973,189
11,264,911
TOTAL LIABILITIES
6,532,001
23,759,164
SHAREHOLDERS’ EQUITY
11,200,643
23,692,422
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $
17,732,644
$
47,451,586
BIOCEPT, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the three months ended December 31, For the
year ended December 31,
2019
2020
2019
2020
(unaudited)
(unaudited)
(unaudited)
NET REVENUES $
1,783,742
$
18,511,238
$
5,528,566
$
27,461,398
COSTS AND EXPENSES Cost of revenues $
2,872,098
$
10,012,659
$
10,977,520
$
21,336,791
Research and development expenses
1,161,905
1,231,146
4,697,022
5,220,278
General and administrative expenses
1,911,593
3,134,073
6,970,120
9,973,082
Sales and marketing expenses
1,489,216
2,166,635
5,940,843
6,399,502
Total costs and expenses
7,434,812
16,544,513
28,585,505
42,929,653
(LOSS)/INCOME FROM OPERATIONS
(5,651,070)
1,966,725
(23,056,939)
(15,468,255)
INTEREST AND OTHER INCOME/(EXPENSE), NET
(62,408)
(64,650)
(2,081,100)
(2,338,649)
(LOSS)/INCOME BEFORE INCOME TAXES
(5,713,478)
1,902,075
(25,138,039)
(17,806,904)
INCOME TAXES
—
—
—
—
NET (LOSS)/INCOME AND COMPREHENSIVE LOSS $
(5,713,478)
$
1,902,075
$
(25,138,039)
$
(17,806,904)
Deemed dividend related to warrants down round provision
(21,829)
-
(121,572)
(2,774)
NET (LOSS)/INCOME ATTRIBUTABLE TO COMMON SHAREHOLDERS $
(5,735,307)
$
1,902,075
$
(25,259,611)
$
(17,809,678)
NET (LOSS)/INCOME PER SHARE - Basic $
(1.97)
$
0.14
$
(12.23)
$
(1.50)
- Diluted $
(1.97)
$
0.14
$
(12.23)
$
(1.50)
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING - Basic
2,912,859
13,396,824
2,066,086
11,845,255
- Diluted
2,912,859
13,604,025
2,066,086
11,845,255
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210329005710/en/
Investor Contact: LHA
Investor Relations Jody Cain Jcain@lhai.com, (310) 691-7100
Media Contact: Sampson PR
Group Andrea Sampson asampson@sampsonprgroup.com, (562)
304-0301
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