- Included first revenue from biopharma collaborator using
CNSide™ in their therapeutics clinical trial
- First site opened for patient enrollment in the FORESEE trial
to generate evidence of CNSide’s clinical utility
- Expanded the commercial availability of CNSide to metastatic
melanoma
- CNSide™ orders increased 14% over 1Q 2022 and 212% versus 2Q
2021
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, reports financial results
for the three and six months ended June 30, 2022 and provides a
business update.
“Today we are reporting strong progress in positioning Biocept
as a leader in neurological tumor diagnostics,” said Samuel D.
Riccitelli, Biocept’s Chairman, and interim President and CEO.
“During the second quarter, we reported the first revenue of
$58,000 from a biopharma company using CNSide to support their
therapeutics clinical trial. More recently, we opened enrollment in
our FORESEE trial, the goal of which is to generate evidence of
CNSide’s clinical utility in support of higher reimbursement and
faster adoption into patient care guidelines. In October of 2022,
we also expanded the commercial availability of CNSide to include
metastatic melanoma, the third most common tumor type involved in
central nervous system (CNS) metastasis with more than 60% of stage
IV melanoma patients developing CNS metastasis. We look for
diminishing but cash-flow positive revenue from RT-PCR COVID-19
testing services as demand continues to decline and we do not
anticipate COVID-19 testing revenue beyond December 2022,” said Mr.
Riccitelli.
Biocept expects to report financial results for the third
quarter of 2022 in the coming weeks and to hold an investment
community conference call at that time.
Second Quarter Financial Results
Net revenues for the second quarter of 2022 consisted of
commercial test revenue of $10.6 million, which included $9.8
million in RT-PCR COVID-19 test revenue. Excluding a $1.1 million
increase in reserves for aged accounts receivables in the second
quarter of 2021 that reduced net revenues, revenues were $13.1
million and included $12.0 million in RT-PCR COVID-19 test
revenue.
Biocept accessioned 77,779 commercial samples during the second
quarter of 2022, compared with 104,061 commercial samples during
the second quarter of 2021, with the decline due primarily to lower
RT-PCR COVID-19 testing volume. The average value per commercial
accession for the second quarter of 2022 was $135, up 17% from $115
for the second quarter of 2021, with the increase due to payor
mix.
Cost of revenues for the second quarter of 2022 was $8.0
million, compared with $7.5 million for the prior-year period, with
the increase related to off-site staffing resources related to our
RT-PCT-COVID-19 testing business.
Research and development (R&D) expenses for the second
quarter of 2022 were $1.7 million, compared with $1.1 million for
the second quarter of 2021. The increase was primarily attributable
to additional costs associated with preparing for the FORESEE
trial, which opened enrollment during the third quarter of 2022.
General and administrative (G&A) expenses for the second
quarter of 2022 were $4.3 million, compared with $3.3 million for
the second quarter of 2021, with the increase due primarily to
legal fees and other costs associated with the sales commission
settlement, as well as audit and accounting related fees. Sales and
marketing expenses for the second quarter of 2022 were $1.7
million, compared with $1.9 million for the second quarter of 2021,
with the decrease due primarily to a reduction in commissions
expense.
Net loss attributable to common stockholders for the second
quarter of 2022 was $5.3 million, or $0.31 per share on 16.9
million weighted-average shares outstanding. This compares with net
loss attributable to common stockholders for the second quarter of
2021 of $1.8 million, or $0.14 per share on 13.5 million
weighted-average shares outstanding.
Six Month Financial Results
Net revenues for the first six months of 2022 were $30.6
million, which included $28.4 million of RT-PCR COVID-19 test
revenue, compared with net revenues for the first six months of
2021 of $29.8 million, which included $29.0 million of RT-PCR
COVID-19 test revenue. Net revenues for the first six months of
2021 includes a $1.1 million increase in reserves for age accounts
receivables, which reduced net revenues.
Operating expenses for the first six months of 2022 were $38.4
million, and included cost of revenues of $18.4 million, R&D
expenses of $3.6 million, G&A expenses of $11.1 million and
sales and marketing expenses of $5.3 million. Operating expenses
for the first six months of 2021 were $28.9 million, and included
cost of revenues of $16.5 million, R&D expenses of $2.2
million, G&A expenses of $6.4 million and sales and marketing
expenses of $3.9 million.
Net loss attributable to common stockholders for the first six
months of 2022 was $8.0 million, or $0.48 per share on 16.9 million
weighted average shares outstanding. This compares with net income
attributable to common stockholders for the first six months of
2021 of $772,000, or $0.06 per diluted share on 13.6 million
weighted-average shares outstanding.
Biocept reported cash and cash equivalents as of June 30, 2022
of $22.9 million, compared with $28.9 million as of December 31,
2021.
The U.S. Health Resources and Services Administration (HRSA)
informed providers that after March 22, 2022 it would stop
accepting claims for COVID-19 testing and treatment for uninsured
individuals and that claims submitted prior to that date would be
subject to eligibility and availability of funds. HRSA’s procedure
for recouping credits due from service providers had been to net
these amounts against reimbursements for services provided. Given
that no further payments are expected from HRSA, there is no longer
a mechanism for recoupments. The Company has therefore recorded a
$5.7 million liability for outstanding HRSA credits that were
previously netted against accounts receivable.
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. For more information, visit www.biocept.com.
Follow Biocept on Facebook, LinkedIn, Twitter, and Instagram.
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," “goal,” “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 Biocept
becoming a leader in neurological tumor diagnostics, our intention
to generate evidence of CNSide’s clinical utility in support of
higher reimbursement and faster adoption into patient care
guidelines, our expectations regarding the lack of future RT-PCR
COVID-19 testing revenue, and our expected timing for reporting
third quarter financial results, 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 compete successfully with our competitors and increase
or sustain our revenues; the results of clinical utility 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; risks related to our need
for additional capital; 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 Quarterly
Report on Form 10-Q for the quarter ended March 31, 2022, filed
with the Securities and Exchange Commission (SEC) on May 23, 2022,
and in our Quarterly Report on Form 10-Q for the quarter ended June
30, 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,
June 30,
2021
2022
Assets
(unaudited)
Current assets:
Cash
$
28,864
$
22,928
Accounts receivable
13,786
17,376
Inventories, net
2,651
2,249
Prepaid expenses and other current
assets
391
1,225
Total current assets
45,692
43,778
Fixed assets, net
2,401
2,699
Lease right-of-use assets - operating
9,026
8,758
Lease right-of-use assets - finance
2,842
2,411
Other non-current assets
456
496
Total assets
$
60,417
$
58,142
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
7,246
$
4,830
Accrued liabilities
3,018
2,737
Current portion of lease liabilities -
operating
426
469
Current portion of lease liabilities -
finance
1,083
1,053
Supplier financing
-
524
Total current liabilities
11,773
9,613
Non-current portion of lease liabilities -
operating
9,736
9,462
Non-current portion of lease liabilities -
finance
1,428
957
Other non-current liability
-
5,654
Total liabilities
22,937
25,686
Shareholders’ equity:
Preferred stock, $0.0001 par value,
5,000,000 shares authorized; 2,106 shares issued and outstanding at
December 31, 2021 and June 30, 2022, respectively.
—
—
Common stock, $0.0001 par value,
150,000,000 shares authorized; 16,849,805 shares and 16,922,868
shares issued and outstanding at December 31, 2021 and June 30,
2022, respectively.
2
2
Additional paid-in capital
303,829
306,825
Accumulated deficit
(266,351
)
(274,371
)
Total shareholders’ equity
37,480
32,456
Total liabilities and shareholders’
equity
$
60,417
$
58,142
Biocept, Inc.
Condensed Statements of
Operations and Comprehensive Loss
(In thousands, except shares
and per share data)
(Unaudited)
For the Three Months Ended
June 30,
For the Six Months Ended June
30,
2021
2022
2021
2022
Net revenues
$
12,047
$
10,611
$
29,803
$
30,555
Costs and expenses:
Cost of revenues
7,462
8,023
16,468
18,358
Research and development expenses
1,137
1,729
2,179
3,579
General and administrative expenses
3,251
4,300
6,371
11,106
Sales and marketing expenses
1,945
1,656
3,868
5,316
Total costs and expenses
13,795
15,708
28,886
38,359
(Loss) income from operations
(1,748
)
(5,097
)
917
(7,804
)
Other (expense):
Interest expense
(80
)
(155
)
(145
)
(217
)
Total other (expense):
(80
)
(155
)
(145
)
(217
)
(Loss) income before income taxes
(1,828
)
(5,252
)
772
(8,021
)
Income tax expense
—
—
—
—
Net (loss) income and comprehensive (loss)
income
(1,828
)
(5,252
)
772
(8,021
)
Net (loss) income attributable to common
shareholders
$
(1,828
)
$
(5,252
)
$
772
$
(8,021
)
Weighted-average shares outstanding used
in computing net (loss) income per share attributable to common
shareholders:
Basic
13,462,329
16,906,314
13,431,340
16,876,841
Diluted
13,462,329
16,906,314
13,646,789
16,876,841
Net (loss) income per common share:
Basic
$
(0.14
)
$
(0.31
)
$
0.06
$
(0.48
)
Diluted
$
(0.14
)
$
(0.31
)
$
0.06
$
(0.48
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221110005926/en/
Investor & Media
Contact: LHA Investor Relations Jody Cain
Jcain@lhai.com, (310) 691-7100
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