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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Biocept Inc | NASDAQ:BIOC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.4349 | 0.37 | 0.3799 | 0 | 01:00:00 |
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
Clinical Study
Commercial Launches, Developments and Agreements
Oncology
COVID-19
Industry Conference Presentations and Publication
Intellectual Property
Regulatory Approval
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, net3,527,078
14,144,911
Inventories, net767,986
1,929,624
Prepaid expenses and other current assets296,127
2,151,527
TOTAL CURRENT ASSETS13,892,597
32,594,004
FIXED ASSETS, NET1,504,330
2,317,616
LEASE RIGHT-OF-USE ASSETS2,335,717
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, NET973,189
11,264,911
TOTAL LIABILITIES6,532,001
23,759,164
SHAREHOLDERS’ EQUITY11,200,643
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 expenses1,161,905
1,231,146
4,697,022
5,220,278
General and administrative expenses1,911,593
3,134,073
6,970,120
9,973,082
Sales and marketing expenses1,489,216
2,166,635
5,940,843
6,399,502
Total costs and expenses7,434,812
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 - Basic2,912,859
13,396,824
2,066,086
11,845,255
- Diluted2,912,859
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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