
Biocept Reports Third Quarter 2019 Financial Results
"We continued to deliver strong growth during the third quarter of 2019 with revenues reaching a record
"Testing for lung cancer continued to be among the largest contributors to commercial volume due to the difficulties in securing lung tissue samples from this patient population," he added. "We also continue to gain traction in the uro-oncology market where our blood-based testing is used by urologists to monitor patients with rising prostate-specific antigen (
"Our Target Selector™ testing for breast cancer was also a key contributor to commercial volume growth during the quarter. Clinicians treating patients with breast cancer are utilizing our blood-based assays for initial profiling of biomarkers to ensure that critical biomarkers are not missed with the original tissue biopsy as well as to re-profile patients who have cancer recurrence in order to determine the most appropriate treatment plan for each patient," Nall said.
Review of Third Quarter and Recent Highlights
Commercial Agreements
- Announced an agreement with Beacon Laboratory Benefit Solutions designating
Biocept as a BeaconLBS® Lab-of-Choice.Beacon Laboratory is a nationally recognized provider of laboratory benefit management technology solutions to U.S.-based health and managed care companies. This designation increases patient access toBiocept's liquid biopsy testing platforms.
Regulatory Approval
- Obtained CE IVD Marks for the CEE-Sure® Blood Collection Tube and the CEE-Sure® Sample Collection Shipping Kit in
Europe . These CE Marks confirm thatBiocept's CEE-Sure® products, which are specifically designed to collect and transport blood and other liquid biopsy specimens, meet the requirements of the European In-Vitro Diagnostic Devices Directive. This allowsBiocept to commercialize its tubes and collection/shipping kits throughout theEuropean Union and other CE Mark geographies.
Industry Conferences and Study Results
- Announced the presentation of six posters at the 2019
Association for Molecular Pathology (AMP) Annual Meeting featuring clinical data highlighting Target Selector™ tests and kits. The content of these posters is expected to be published in a future issue ofThe Journal of Molecular Diagnostics . - Presented data at the 2019
IASLC World Conference on Lung Cancer highlighting the ability ofBiocept's circulating tumor DNA (ctDNA) assays to consistently detect actionable biomarkers from the blood of patients diagnosed with lung cancer at a mutant allele frequency as low as 0.01%. The poster featured clinical experience data from more than 1,400 blood samples drawn from patients diagnosed with non-small cell lung cancer, and collected and shipped using the Company's CEE-Sure® Blood Collection Tubes.
- Announced publication of an article in the peer-reviewed journal PLOS ONE featuring analytical validation results demonstrating the ultra-sensitive detection of Target Selector™ testing for EGFR, BRAF and KRAS mutations in plasma ctDNA. These tests can be performed in the Company's CLIA laboratory with a commercial turnaround time of only three to four days.
Intellectual Property
- Awarded U.S., Canadian and European patents covering antibody and microchannel technology and enhanced detection of cancer cells. These new patents further expand
Biocept's intellectual property estate for capturing and detecting rare cells of interest, including CTCs to aid in the management of patients with cancer. - Granted a South Korean patent covering the Target Selector™ oncogene mutation enrichment and detection platform for proprietary Switch-Blocker technology that is core to Target Selector™ assays for molecular analysis using real-time PCR,
Sanger sequencing and next-generation sequencing. - Ended the period with 36 issued patents globally for
Biocept's highly sensitive method of detecting cancer biomarkers.
Third Quarter Financial Results
Revenues for the third quarter of 2019 were
Cost of revenues for the third quarter of 2019 was
Research and development (R&D) expenses for the third quarter of 2019 were
The third quarter of 2018 included a non-cash deemed dividend of
The net loss attributable to common shareholders for the third quarter of 2019 was
Nine Month Financial Results
Revenues for the first nine months of 2019 were
Total costs and expenses for the first nine months of 2019 were
Other expense for the first nine months of 2019 of
The net loss attributable to common shareholders for the first nine months of 2019 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 10135501.
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 as to our ability to provide physicians with clinically actionable information to improve the outcomes of cancer patients, our ability to grow our business and drive adoption of our products, and our expectation of continued growth in the uro-oncology business segment, 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 (
Investor Contact:
LHA Investor Relations
Jcain@lhai.com
(310) 691-7100
BIOCEPT, INC. |
|||||
CONDENSED BALANCE SHEETS |
|||||
December 31, |
September 30, |
||||
2018 |
2019 |
||||
(unaudited) |
|||||
ASSETS |
|||||
Cash |
$ |
3,423,373 |
$ |
6,539,444 |
|
Accounts receivable, net |
1,574,325 |
2,861,659 |
|||
Inventories, net |
587,222 |
687,186 |
|||
Prepaid expenses and other current assets |
425,961 |
497,121 |
|||
TOTAL CURRENT ASSETS |
6,010,881 |
10,585,410 |
|||
FIXED ASSETS, NET |
2,739,422 |
1,325,255 |
|||
LEASE RIGHT-OF-USE ASSETS |
— |
2,610,249 |
|||
TOTAL ASSETS |
$ |
8,750,303 |
$ |
14,520,914 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||||
CURRENT LIABILITIES, NET |
$ |
4,609,647 |
$ |
5,783,213 |
|
NON-CURRENT LIABILITIES, NET |
1,098,137 |
1,032,243 |
|||
TOTAL LIABILITIES |
5,707,784 |
6,815,456 |
|||
SHAREHOLDERS' EQUITY |
3,042,519 |
7,705,458 |
|||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
8,750,303 |
$ |
14,520,914 |
BIOCEPT, INC. |
||||||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
||||||||||||
For the three months ended September 30, |
For the nine months ended September 30, |
|||||||||||
2018 (unaudited) |
2019 (unaudited) |
2018 (unaudited) |
2019 (unaudited) |
|||||||||
NET REVENUES |
$ |
761,591 |
$ |
1,529,262 |
$ |
2,390,772 |
$ |
3,744,824 |
||||
COSTS AND EXPENSES |
||||||||||||
Cost of revenues |
$ |
2,481,916 |
$ |
2,832,735 |
$ |
7,616,473 |
$ |
8,105,422 |
||||
Research and development expenses |
1,089,746 |
1,163,546 |
3,179,612 |
3,535,116 |
||||||||
General and administrative expenses |
1,793,720 |
1,700,380 |
5,441,354 |
5,058,525 |
||||||||
Sales and marketing expenses |
1,404,192 |
1,462,335 |
4,473,908 |
4,451,628 |
||||||||
Total costs and expenses |
6,769,574 |
7,158,996 |
20,711,347 |
21,150,691 |
||||||||
LOSS FROM OPERATIONS |
(6,007,983) |
(5,629,734) |
(18,320,575) |
(17,405,867) |
||||||||
WARRANT INDUCEMENT, INTEREST AND OTHER EXPENSE |
(39,801) |
(62,028) |
(236,714) |
(2,018,691) |
||||||||
LOSS BEFORE INCOME TAXES |
(6,047,784) |
(5,691,762) |
(18,557,289) |
(19,424,558) |
||||||||
INCOME TAXES |
— |
— |
(739) |
— |
||||||||
NET LOSS AND COMPREHENSIVE LOSS |
$ |
(6,047,784) |
$ |
(5,691,762) |
$ |
(18,558,028) |
$ |
(19,424,558) |
||||
Deemed dividend related to warrants down round provision |
(636,370) |
— |
(636,370) |
(99,743) |
||||||||
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS |
$ |
(6,684,154) |
$ |
(5,691,762) |
$ |
(19,194,398) |
$ |
(19,524,301) |
||||
NET LOSS PER SHARE |
||||||||||||
- Basic |
$ |
(2.42) |
$ |
(0.25) |
$ |
(8.26) |
$ |
(1.10) |
||||
- Diluted |
$ |
(2.42) |
$ |
(0.25) |
$ |
(8.27) |
$ |
(1.10) |
||||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
||||||||||||
- Basic |
2,767,440 |
23,018,235 |
2,322,749 |
17,807,298 |
||||||||
- Diluted |
2,759,614 |
23,018,235 |
2,320,111 |
17,807,298 |
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