- Net revenues of $19.9 million up 12% over Q1 2021
- CNSide™ assay volume up 219% over Q1 2021 and up 70% over Q4
2021
- Expanded CNSide customer base with additional oncologists from
six leading cancer centers
- Previews re-focused and rationalized strategy following
comprehensive business review
Business update conference call to be held June
7, 2022 at 4:00 p.m. ET
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, reports financial results
for the three months ended March 31, 2022 and provides a business
update.
“Net revenues for the first quarter increased 12% to $19.9
million, driven by RT-PCR COVID-19 testing services,” said Samuel
D. Riccitelli, Biocept’s Chairman, and interim President and CEO.
“We continued to generate strong growth with our proprietary
neuro-oncology assay CNSide™, with volume up 70% sequentially and
up 219% over the prior-year period. We also expanded our customer
base with six of the leading cancer centers with an increasing
number of oncologists placing first-time CNSide orders, and now
have more than 40 ordering physicians across the U.S. We exited the
quarter with a cash position we believe is sufficient to fund
planned operations for at least the next year, including our
planned investments in CNSide.
“Following a comprehensive review of our assets, operations and
commercial opportunities, we are excited to preview our re-focused
and rationalized business strategy to build shareholder value. Our
objective is to lead the emerging category of neurological tumor
diagnostics with CNSide and become the partner of choice for
biopharma companies developing therapies to treat cancer that has
metastasized to the central nervous system. The initial diagnostic
scenarios we are focused on represent a $1.2 billion annual market
opportunity in the U.S. and a $2.0 billion opportunity
worldwide.
“We intend to generate evidence of clinical utility that will
support CNSide reimbursement and adoption into patient care
guidelines through our own and investigator-initiated clinical
trials, while forming collaborations with biopharma companies that
are developing treatments for central nervous system tumors or
looking to expand indications of use for existing targeted
therapies. We also will support our community with RT-PCR COVID-19
testing for as long as necessary, while judiciously exiting our
blood-based oncology diagnostics business in order to focus
resources on the most promising opportunities involving cerebral
spinal fluid,” said Mr. Riccitelli.
Biocept management will hold a conference call to discuss its
re-focused and rationalized business strategy on June 7, 2022.
Management plans to resume holding quarterly conference calls
concurrent with the reporting of financial results beginning with
the second quarter of 2022.
First Quarter Financial Results
Net revenues for the first quarter of 2022 were $19.9 million, a
12% increase from $17.8 million for the first quarter of 2021.
Revenues for the first quarter of 2022 included $18.6 million in
RT-PCR COVID-19 test revenue, $1.3 million in oncology test
revenue, $38,000 in development services test revenue and no
revenue for distributed products, Target Selector™ RUO kits and
CEE-Sure® blood collection tubes. Revenues for the first quarter of
2021 included $16.8 million in RT-PCR COVID-19 test revenue, $2.5
million in oncology test revenue, $39,000 in development services
test revenue and $62,000 in revenue for distributed products,
Target Selector RUO kits and CEE-Sure blood collection tubes and
payments associated with the development of a RT-PCR COVID-19
assay.
Biocept accessioned 153,056 commercial samples during the first
quarter of 2022, compared with 141,340 commercial samples during
the first quarter of 2021.
Cost of revenues for the first quarter of 2022 was $10.3
million, compared with $9.0 million for the prior-year period, with
the increase related primarily to the RT-PCR COVID-19 testing
business.
Research and development expenses for the first quarter of 2022
were $1.9 million, compared with $1.0 million for the first quarter
of 2021, with the increase primarily attributable to additional
costs associated with preparing for the CNSide clinical trial, now
called the FORESEE trial, which is expected to begin enrollment
during the third quarter of 2022. General and administrative
expenses for the first quarter of 2022 were $6.8 million, compared
with $3.1 million for the first quarter of 2021, with the increase
due primarily to severance and stock-based compensation expenses
related to separation agreements with former executive management.
Sales and marketing expenses for the first quarter of 2022 were
$3.7 million, compared with $1.9 million for the first quarter of
2021, with the increase due primarily to on-going mediation
regarding sales commissions.
The net loss attributable to common stockholders for the first
quarter of 2022 was $2.8 million, or $0.16 per share on 16.8
million weighted-average shares outstanding. This compares with net
income attributable to common stockholders for the first quarter of
2021 of $2.6 million, or $0.19 per diluted share on 13.7 million
weighted-average shares outstanding.
Biocept reported cash and cash equivalents as of March 31, 2022
of $27.6 million, compared with $28.9 million as of December 31,
2021.
Conference Call and Webcast
Biocept will hold a conference call on Tuesday, June 7, 2022
beginning at 4:00 p.m. Eastern Time to discuss its re-focused and
rationalized business strategy and to answer questions.
Participants can pre-register for the conference call here. Callers
who pre-register will be given a conference passcode and unique PIN
to gain immediate access to the call and bypass the live operator.
Participants may pre-register at any time, including up to and
after the call start time.
The conference call can be accessed at the time of the live call
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
8040195. 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. In addition to its portfolio of blood-based
liquid biopsy assays, Biocept has developed the CNSide™
cerebrospinal fluid assay that detects cancer that has metastasized
to the central nervous system. Biocept’s patented Target Selector™
technology captures and quantitatively analyzes cerebrospinal fluid
tumor cells for tumor-associated molecular markers, using
technology first developed for use in blood. Biocept also is
leveraging its molecular diagnostic capabilities to offer RT-PCR
COVID-19 testing to support public health efforts during this
unprecedented pandemic. For more 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 "will," "expect," “objective,” "believe"
or "intend" 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 regarding our new
business strategy, our objectives, markets we may focus on and the
size of market opportunities, our ability to lead the emerging
category of neurological tumor diagnostics and become the partner
of choice for biopharma companies developing therapies to treat
cancer that has metastasized to the central nervous system, our
intention to generate evidence of clinical utility that will
support CNSide reimbursement and adoption into patient care
guidelines through our own and investigator-initiated clinical
trials, our intention to form collaborations with biopharma
companies that are developing treatments for central nervous system
tumors or looking to expand indications of use for existing
targeted therapies, our plan to continue providing RT-PCR COVID-19
testing, our plan to exit from our blood-based oncology diagnostics
business, our expected timing for commencing enrollment of the
FORESEE trial, the sufficiency of our cash position to support our
planned operations for at least the next year, and the capabilities
and performance of our CNSide assay and Target Selector™
technology, 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 risks and uncertainties,
including risks and uncertainties associated with the continually
evolving COVID-19 pandemic; we may be unable to increase sales of
our current products, assays and services or successfully develop
and commercialize other products, assays and services; we may be
unable to execute our new business strategy; we may be unable to
compete successfully with our competitors and increase or sustain
our revenues; we may be unable to identify collaborators willing to
work with us to conduct clinical utility studies, or the results of
those or currently planned studies may not demonstrate that an
assay provides clinically meaningful information and value or have
the other benefits that we expect; Medicare and private payors may
not provide coverage and reimbursement or may breach, rescind or
modify their contracts or reimbursement policies or delay payments;
our estimates regarding the sufficiency of our existing resources
may not be accurate as the actual amount of funds that we will need
will be determined by many factors, some of which are beyond our
control; and the risk that our products and services may not
perform as expected. These and other factors are described in
greater detail under the "Risk Factors" heading of our Annual
Report on Form 10-K for the year ended December 31, 2021, filed
with the Securities and Exchange Commission (SEC) on April 5, 2022,
and in our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2022, being filed with the SEC today. 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
(In thousands, except share
and per share data)
December 31,
March 31,
2021
2022
Assets
(unaudited)
Current assets:
Cash
$
28,864
$
27,566
Accounts receivable, net
13,786
16,351
Inventories, net
2,651
3,221
Prepaid expenses and other current
assets
391
446
Total current assets
45,692
47,584
Fixed assets, net
2,401
2,380
Lease right-of-use assets – operating
9,026
8,892
Lease right-of-use assets – finance
2,842
2,617
Other non-current assets
456
471
Total assets
$
60,417
$
61,944
Liabilities and
Stockholders' Equity
Current liabilities:
Accounts payable
$
7,246
8,076
Accrued liabilities
3,018
4,550
Current portion of lease liabilities –
operating
426
449
Current portion of lease liabilities –
finance
1,083
1,021
Total current liabilities
11,773
14,096
Non-current portion of lease liabilities –
operating
9,736
9,598
Non-current portion of lease liabilities –
finance
1,428
1,221
Total liabilities
22,937
24,915
Shareholders’ equity:
Preferred stock, $0.0001 par value,
5,000,000 shares authorized; 2,106 shares and 2,090 shares issued
and outstanding at December 31, 2021 and March 31, 2022,
respectively.
—
—
Common stock, $0.0001 par value,
150,000,000 shares authorized; 16,849,805 shares and 16,850,161
shares issued and outstanding at December 31, 2021 and March 31,
2022, respectively.
2
2
Additional paid-in capital
303,829
306,146
Accumulated deficit
(266,351
)
(269,119
)
Total shareholders’ equity
37,480
37,029
Total liabilities and shareholders’
equity
$
60,417
$
61,944
Biocept, Inc.
Condensed Statements of
Operations and Comprehensive Loss
(In thousands, except shares
and per share data)
(Unaudited)
For the Three Months Ended
March 31,
2021
2022
Net revenues
$
17,756
$
19,945
Costs and expenses:
Cost of revenues
9,006
10,335
Research and development expenses
1,043
1,851
General and administrative expenses
3,120
6,806
Sales and marketing expenses
1,923
3,660
Total costs and expenses
15,092
22,652
(Loss/)Income from operations
2,664
(2,707
)
Other income/(expense):
Interest expense, net
(65
)
(61
)
Total other income/(expense):
(65
)
(61
)
(Loss)/income before income taxes
2,599
(2,768
)
Income tax expense
—
—
Net (loss)/income and comprehensive
(loss)income
2,599
(2,768
)
Net (loss)/income attributable to common
shareholders
$
2,599
$
(2,768
)
Weighted-average shares outstanding used
in computing net (loss)income per share attributable to common
shareholders:
Basic
13,400,007
16,849,964
Diluted
13,667,716
16,849,964
Net (loss)/income per common share:
Basic
$
0.19
$
(0.16
)
Diluted
$
0.19
$
(0.16
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220523005934/en/
Investor & Media
Contact: LHA Investor Relations Jody Cain
Jcain@lhai.com, (310) 691-7100
Biocept (NASDAQ:BIOC)
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