
Biocept Reports Second Quarter 2021 Financial Results
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Second quarter revenues of
$12.0 million driven by RT-PCR COVID-19 testing -
Continued sequential-quarter CNSide™ volume growth with customer base expanding to more than 30 leading
U.S. academic institutions, including multiple repeat users - Issued coverage with high-value payment by Medicare for the Target Selector™ breast cancer assay to detect the HER2 biomarker
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Received nearly 500,000 samples for COVID-19 RT-PCR testing since
June 2020
Conference call begins at
“We are reporting profitability for the first half of 2021 on revenues of nearly
“We are encouraged by the ongoing adoption of our paradigm-changing neuro-oncology CNSide assay, which provides physicians with a valuable tool to diagnose and manage patients with tumors that have metastasized to the central nervous system,” he added. “CNSide volume has grown each consecutive quarter since our beta launch in early 2020. We have now received orders from more than 30 leading
“Finally, we are pleased with Medicare’s decision to provide coverage and high-value payment for our Target Selector breast cancer assay that detects the HER2 biomarker. Testing for the HER2 biomarker is among the most important sources of information when making treatment decisions for patients diagnosed with breast cancer and is among our most frequently ordered assay profiles,” concluded
Second Quarter 2021 and Recent Highlights
Commercial Developments and Agreements
Oncology
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Announced a positive coverage decision from Medicare and high-value reimbursement of
$2,435 for the Target Selector breast cancer assay to detect the HER2 biomarker from circulating tumor cells (CTCs) in liquid biopsy. The coverage decision became effectiveJuly 4, 2021 . -
Expanded the company’s relationship with Quest Diagnostics to provide patients across the
U.S. with access to the Target Selector NGS lung assay.Biocept anticipates that Quest’s specialized oncology salesforce will begin marketing this Target Selector panel in the fourth quarter of 2021. -
Expanded the customer base for CNSide to more than 30 top
U.S. academic institutions with the majority as repeat customers. CNSide is Biocept’s cerebrospinal fluid assay that offers a timely and accurate method to diagnose patients with lung and breast cancer that has metastasized to the central nervous system, along with the ability to identify actionable biomarkers and assess a patient’s response to therapy.
COVID-19
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Signed an agreement to make Biocept’s COVID-19 testing available to the more than 2.1 million students, as well as faculty and staff of the
California community colleges. The availability of COVID-19 testing is expected to provide information to help protect the safety of campus populations and reduce the spread of the SARS-CoV-2 virus as students return to campus. -
Coordinated with CLEARED4 to develop and implement a system to streamline testing protocols and track COVID-19 testing results. The system is intended to help
Biocept customers, includingCalifornia community colleges, ease the administrative burden of complying with complex health requirements. -
Received nearly 500,000 samples for COVID-19 RT-PCR testing at Biocept’s high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory since the company began offering this test in
June 2020 . The lab is using Thermo Fisher Scientific’s FDA-approved for EUA testing TaqPath™ molecular diagnostic platform and kit.
Corporate Developments
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Named
Samuel Riccitelli as Chairman of the Board;Mr. Riccitelli joined the Biocept Board as a Director inOctober 2020 . -
Expanded Board membership to nine with the appointments of
Linda Rubinstein andAntonino Morales as Directors.Ms. Rubenstein andMr. Morales bring extensive financial and leadership experience to support growth initiatives and advance the oncology diagnostics franchise. -
Named
David Karlander as Senior Vice President of Commercial Operations with responsibility for all sales, marketing and reimbursement initiatives. He brings toBiocept more than 25 years of industry experience including building and managing major brands in diagnostics, devices and pharmaceuticals through all stages of commercialization. -
Biocept common stock was added to the Russell Microcap® Index, a broadly used performance benchmark for smaller growth stocks in theU.S. Membership in the Index is for one year with automatic inclusion in the appropriate growth and value style indexes.
Presentations
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Hosted a neuro-oncology webinar discussing CNSide for the diagnosis and management of cancer involving the central nervous system. The webinar featured a technology overview and leading neuro-oncologists from
Northwestern University ,Yale University and theBarrow Neurological Institute who reviewed case studies using the CNSide assay with subsequent favorable patient outcomes.
Intellectual Property
- Awarded a South Korean patent for the Primer-Switch technology, which detects rare mutations in circulating tumor DNA (ctDNA) using RT-PCR and associated analysis methods. Biocept’s core technology and products are currently protected by 71 patents worldwide.
Second Quarter Financial Results
Net revenues for the second quarter of 2021 were
Cost of revenues for the second quarter of 2021 was
Research and development (R&D) expenses for the second quarter of 2021 were
The net loss attributable to common shareholders for the second quarter of 2021 was
Six Month Financial Results
Net revenues for the first six months of 2021 were
Operating expenses for the first six months of 2021 were
Net income for the first six months of 2021 was
Conference Call and Webcast
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 10157985. A replay of the webcast will be available for 90 days.
About
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 regarding the anticipated increases in COVID-19 testing volume, our anticipation that Quest’s specialized oncology salesforce will begin marketing the Target Selector panel in the fourth quarter of 2021, 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 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
CONDENSED BALANCE SHEETS | ||||||
|
|
|
|
|||
2020 |
|
2021 |
||||
|
|
|
(unaudited) |
|||
ASSETS | ||||||
Cash | $ |
14,367,942 |
$ |
19,451,189 |
||
Accounts receivable, net |
14,144,911 |
12,595,694 |
||||
Inventories, net |
1,929,624 |
3,016,342 |
||||
Prepaid expenses and other current assets |
2,151,527 |
897,370 |
||||
TOTAL CURRENT ASSETS |
32,594,004 |
35,960,595 |
||||
FIXED ASSETS, NET |
2,317,616 |
2,078,464 |
||||
LEASE RIGHT-OF-USE ASSETS |
12,114,058 |
12,125,445 |
||||
OTHER NON-CURRENT ASSETS |
425,908 |
438,776 |
||||
TOTAL ASSETS | $ |
47,451,586 |
$ |
50,603,280 |
||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||
CURRENT LIABILITIES, NET | $ |
12,494,253 |
$ |
9,654,472 |
||
NON-CURRENT LIABILITIES, NET |
11,264,911 |
11,596,985 |
||||
TOTAL LIABILITIES |
23,759,164 |
21,251,457 |
||||
SHAREHOLDERS’ EQUITY |
23,692,422 |
29,351,823 |
||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ |
47,451,586 |
$ |
50,603,280 |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
For the three months ended |
For the six months ended |
|||||||||||||||
2020 |
|
2021 |
|
2020 |
|
2021 |
|
|||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
NET REVENUES | $ |
917,471 |
|
$ |
12,047,166 |
|
$ |
2,364,020 |
|
$ |
29,803,356 |
|
||||
COSTS AND EXPENSES | ||||||||||||||||
Cost of revenues | $ |
2,517,902 |
|
$ |
7,461,819 |
|
$ |
5,464,760 |
|
$ |
16,467,675 |
|
||||
Research and development expenses |
1,588,716 |
|
1,137,614 |
|
2,901,392 |
|
2,180,339 |
|
||||||||
General and administrative expenses |
1,911,239 |
|
3,250,859 |
|
3,815,672 |
|
6,370,663 |
|
||||||||
Sales and marketing expenses |
1,333,271 |
|
1,944,661 |
|
2,798,386 |
|
3,867,933 |
|
||||||||
Total costs and expenses |
7,351,128 |
|
13,794,953 |
|
14,980,210 |
|
28,886,610 |
|
||||||||
(LOSS)/INCOME FROM OPERATIONS |
(6,433,657 |
) |
(1,747,787 |
) |
(12,616,190 |
) |
916,746 |
|
||||||||
INTEREST AND OTHER INCOME/(EXPENSE), NET |
(55,646 |
) |
(79,692 |
) |
(2,214,451 |
) |
(144,933 |
) |
||||||||
(LOSS)/INCOME BEFORE INCOME TAXES |
(6,489,303 |
) |
(1,827,479 |
) |
(14,830,641 |
) |
771,813 |
|
||||||||
INCOME TAXES |
— |
|
— |
|
— |
|
— |
|
||||||||
NET (LOSS)/INCOME AND COMPREHENSIVE LOSS | $ |
(6,489,303 |
) |
$ |
(1,827,479 |
) |
$ |
(14,830,641 |
) |
$ |
771,813 |
|
||||
Deemed dividend related to warrants down round provision |
— |
|
— |
|
(2,774 |
) |
— |
|
||||||||
NET (LOSS)/INCOME ATTRIBUTABLE TO COMMON SHAREHOLDERS | $ |
(6,489,303 |
) |
$ |
(1,827,479 |
) |
$ |
(14,833,415 |
) |
$ |
771,813 |
|
||||
NET (LOSS)/INCOME PER SHARE | ||||||||||||||||
- Basic | $ |
(0.51 |
) |
$ |
(0.14 |
) |
$ |
(1.44 |
) |
$ |
0.06 |
|
||||
- Diluted | $ |
(0.51 |
) |
$ |
(0.14 |
) |
$ |
(1.44 |
) |
$ |
0.06 |
|
||||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING | ||||||||||||||||
- Basic |
12,717,372 |
|
13,462,329 |
|
10,308,681 |
|
13,431,340 |
|
||||||||
- Diluted |
12,717,372 |
|
13,462,329 |
|
10,308,681 |
|
13,646,789 |
|
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LHA Investor Relations
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