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PRNewswire 28-Mar-2019 4:05 PM
SAN DIEGO, March 28, 2019 /PRNewswire/ -- Biocept, Inc. (NASDAQ:BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of cancer patients, reports financial results for the three and 12 months ended December 31, 2018, and provides an update on its business progress.
"Revenues and billable samples for the fourth quarter reached their highest levels in 2018, as we benefited from our refocused commercial strategy," said Michael Nall, President and CEO of Biocept. "Our efforts to enhance our growth in test volumes has continued into 2019.
"A key driver of growth is the relaunch of our EmpowerTC™, or pathology partnership, service, which enables local pathologists to access our Target Selector™ circulating tumor cell (CTC) platform and integrate it into their practice," he added. "We recently expanded this offering into the uro-oncology market segment with the addition of new prognostic and predictive biomarker tests to aid physicians in the treatment of prostate cancer. We also are benefitting from physician interest in the use of our CTC platform to evaluate patients with breast cancer, supported by a renewed interest in CTCs as a diagnostic specimen in the past couple of years. In 2017 alone, over 1,500 papers were published on CTC analysis, and the ability of our platform to analyze biomarkers in CTCs, as well as capture and quantify the number of CTCs in a given patient sample, sets Biocept apart from most other liquid biopsy companies.
"We have raised more than $18 million in equity capital since the beginning of 2019, and we now believe that we have the financial resources to implement our business strategy throughout the year. In addition to the expected growth in our U.S. laboratory testing business, we plan to increase additional Biocept testing in non-U.S. territories with our liquid biopsy kit strategy and to launch our molecular oncology multi-gene testing panel in the second quarter of 2019 to address the needs of our clinical, research and pharmaceutical company customers and prospective customers. We made good progress last year, and believe that this year is going to be an exciting and productive year for Biocept," he added.
2018 and Recent Highlights
Commercial Launches
Collaborations
Industry Conferences and Study Results
Intellectual Property
Corporate
Fourth Quarter Financial Results
Revenues for the fourth quarter of 2018 were $860,000, and included approximately $820,000 in commercial test revenues and approximately $39,000 in development services test revenues. This compares with revenue of $1.0 million for the fourth quarter of 2017, which included $935,000 in commercial test revenues and $61,000 in development services test revenues.
Biocept accessioned 1,043 total samples in the fourth quarter of 2018 compared with 1,057 total samples in the fourth quarter of 2017. Total accessions include billable samples and samples from research activities, assay validations and other non-billable sources. The Company accessioned 938 billable samples in the fourth quarter of 2018 compared with 982 billable samples in the fourth quarter of 2017.
Cost of revenues for the fourth quarters of 2018 and 2017 was unchanged at $2.4 million.
Research and development (R&D) expenses for the fourth quarter of 2018 were $1.3 million compared with $0.9 million for the fourth quarter of 2017, with the increase due to a higher proportion of allocated laboratory costs associated with research and evaluation cases, costs associated with the development of new assays and automation of the CLIA laboratory, and costs related to the validation of the Thermo Fisher Scientific molecular oncology assay panel.
General and administrative (G&A) expenses for the fourth quarter of 2018 were $1.6 million versus $1.7 million for the fourth quarter of 2017, and sales and marketing expenses for the fourth quarter of 2018 were $1.4 million versus $1.6 million for the fourth quarter of 2017, with the declines due to the Company's initiatives to contain operating expenses.
The net loss for the fourth quarter of 2018 was $6.0 million, or $1.43 per share on 4.2 million weighted-average shares outstanding. This compares with a net loss for the fourth quarter of 2017 of $5.7 million, or $5.36 per share on 1.1 million weighted-average shares outstanding. In July 2018, we conducted a 1-for-30 reverse stock split of our outstanding common stock.
Full Year Financial Results
Net revenues recognized on an accrual basis were approximately $3.2 million for the year ended December 31, 2018, compared with approximately $3.8 million for the same period in 2017, a decrease of $593,000, or 15%. As reported, net revenues were approximately $3.2 million for the year ended December 31, 2018, compared with approximately $5.1 million for the same period in 2017, a decrease of $1.8 million, or 36%. All $3.2 million of net revenues recognized during the year ended December 31, 2018, were recognized on an accrual basis, as compared to the same period in 2017 when approximately $3.8 million of the $5.1 million in net revenues were recognized on an accrual basis and approximately $1.2 million of the net revenues were recognized upon the receipt of cash.
Biocept accessioned 4,252 total samples during 2018 compared with 5,051 total samples for 2017. The Company accessioned 3,896 billable samples during 2018 compared with 4,517 billable samples accessioned during 2017.
Cost of revenues for 2018 was $10.1 million compared with $9.3 million for 2017, with the increase primarily due to increases in depreciation expense, computer maintenance and equipment, software amortization, and allocated information technology and facility charges related to the implementation of our pathology partnership initiative.
R&D expenses for 2018 were $4.5 million compared with $3.4 million for the prior year, with the increase due to higher laboratory and personnel costs related to bringing new products to market.
G&A expenses for 2018 were $7.1 million versus $7.2 million for 2017, with the decrease due to lower stock-based compensation expenses and a decrease in facilities, depreciation, repairs and maintenance expenses.
Sales and marketing expenses for 2018 were $5.9 million versus $6.3 million for 2017, with the decrease due to lower personnel and travel costs, as well as a decrease in marketing materials, trade show and conference costs.
The net loss to common shareholders for 2018 was $25.2 million, or $9.01 per share on 2.8 million weighted-average shares outstanding. This compares with a net loss for 2017 of $21.6 million, or $23.58 per share on 917,000 weighted-average shares outstanding.
Cash and cash equivalents were $3.4 million as of December 31, 2018, compared with $2.1 million as of December 31, 2017. Since January 1, 2019, the Company has raised gross proceeds of $18.5 million through equity offerings of common stock and warrants.
In the first quarter of this year we announced an initiative to reduce the use of cash. In July, we extinguished our term debt facility with Oxford Financial eliminating approximately $2.1 million and in other categories an additional approximate $1.2 million for a total reduction of approximately $3.3 million in use of cash on an annualized basis. We also anticipate realizing additional reductions in use of cash in the near future from outsourcing our microfluidic channel manufacturing to a contract manufacturer. In addition, our current facility lease will expire in July 2020, and we anticipate that we will be able to realize further expense reductions in the future by obtaining a replacement facility lease with more favorable terms.
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 webcast will be available for 90 days.
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 10128915.
About Biocept
Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient's disease and therapeutic options. For additional information, please visit www.biocept.com.
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, the number of billable samples we will have in the first quarter of 2019, whether our financial resources will allow us to implement our business strategy throughout the year, our ability to drive additional testing in non-U.S. territories, the success of our collaboration with Thermo Fisher Scientific and our ability to validate and commercially launch products as a result thereof, the success of our agreement with Agiomix, and our ability to increase physician adoption of our liquid biopsy platform, 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.
Investor Contact:
LHA Investor Relations
Jody Cain
Jcain@lhai.com
(310) 691-7100
BIOCEPT, INC. |
|||||
CONDENSED BALANCE SHEETS |
|||||
December 31, |
December 31, |
||||
2017 |
2018 |
||||
(unaudited) |
|||||
ASSETS |
|||||
Cash |
$ |
2,146,611 |
$ |
3,423,373 |
|
Accounts receivable, net |
1,193,426 |
1,574,325 |
|||
Inventories, net |
498,702 |
587,222 |
|||
Prepaid expenses and other current assets |
416,600 |
425,961 |
|||
TOTAL CURRENT ASSETS |
4,255,339 |
6,010,881 |
|||
FIXED ASSETS, NET |
3,123,567 |
2,739,422 |
|||
TOTAL ASSETS |
$ |
7,378,906 |
$ |
8,750,303 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||||
CURRENT LIABILITIES, NET |
$ |
4,661,345 |
$ |
4,609,647 |
|
NON-CURRENT LIABILITIES, NET |
1,421,527 |
1,098,137 |
|||
TOTAL LIABILITIES |
6,082,872 |
5,707,784 |
|||
SHAREHOLDERS' EQUITY |
1,296,034 |
3,042,519 |
|||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
7,378,906 |
$ |
8,750,303 |
BIOCEPT, INC. |
|||||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|||||||||||
For the three months ended December 31, |
For the year ended December 31, |
||||||||||
2017 |
2018 |
2017 |
2018 |
||||||||
(unaudited) |
(unaudited) |
(unaudited) |
|||||||||
NET REVENUES |
$ |
995,226 |
$ |
859,526 |
$ |
5,068,663 |
$ |
3,250,298 |
|||
COSTS AND EXPENSES |
|||||||||||
Cost of revenues |
$ |
2,359,909 |
$ |
2,435,262 |
$ |
9,345,122 |
$ |
10,051,735 |
|||
Research and development expenses |
908,800 |
1,288,960 |
3,364,747 |
4,468,572 |
|||||||
General and administrative expenses |
1,650,097 |
1,632,670 |
7,189,529 |
7,074,024 |
|||||||
Sales and marketing expenses |
1,642,941 |
1,440,798 |
6,343,971 |
5,914,706 |
|||||||
Total costs and expenses |
6,561,747 |
6,797,690 |
26,243,369 |
27,509,037 |
|||||||
LOSS FROM OPERATIONS |
(5,566,521) |
(5,938,164) |
(21,174,706) |
(24,258,739) |
|||||||
INTEREST AND OTHER INCOME/(EXPENSE), NET |
(97,451) |
(74,262) |
(431,407) |
(310,976) |
|||||||
LOSS BEFORE INCOME TAXES |
(5,663,972) |
(6,012,426) |
(21,606,113) |
(24,569,715) |
|||||||
INCOME TAXES |
(2,601) |
(1,147) |
(7,624) |
(1,886) |
|||||||
NET LOSS AND COMPREHENSIVE LOSS |
$ |
(5,666,573) |
$ |
(6,013,573) |
$ |
(21,613,737) |
$ |
(24,571,601) |
|||
Deemed dividend related to warrants down round provision |
- |
- |
- |
(636,370) |
|||||||
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS |
$ |
(5,666,573) |
$ |
(6,013,573) |
$ |
(21,613,737) |
$ |
(25,207,971) |
|||
NET LOSS PER SHARE |
|||||||||||
- Basic |
$ |
(5.36) |
$ |
(1.43) |
$ |
(23.58) |
$ |
(9.01) |
|||
- Diluted |
$ |
(5.36) |
$ |
(1.43) |
$ |
(23.58) |
$ |
(9.01) |
|||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
|||||||||||
- Basic |
1,058,055 |
4,209,221 |
916,599 |
2,798,243 |
|||||||
- Diluted |
1,058,055 |
4,209,221 |
916,599 |
2,798,243 |
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SOURCE Biocept, Inc.