Biocept Reports 2017 Fourth Quarter and Full Year Financial Results
"Revenues for 2017 increased 57% over 2016, as we capitalized on relationships with health plans and reaped the rewards of improved billing and collection processes to increase reimbursement for our Target Selector liquid biopsy tests, which contributed to our ability to successfully change to accrual-based revenue recognition," said
"Billable sample volume for 2017 increased 7% over the prior year. Due to a slight decline in year-over-year sample volume for the fourth quarter, we have taken actions to refine our sales strategy that have resulted in a return to sample volume growth so far in the first quarter of 2018. Specifically, we evaluated billable sample volume by geography and are replacing or repositioning our sales professionals in underperforming territories. We also are placing more focus on our Empower TC™ program, which is the only liquid biopsy offering that includes pathologists in the decision chain. Initial acceptance of this program has been strong with several major healthcare institutions agreeing to use our service. We anticipate this program will gain further traction with additional large clients and together with other recent developments will support growth," he added.
"Earlier today, we announced a collaboration with
"We anticipate benefits from new evidence-based treatment guidelines jointly issued by four prominent clinical associations pertaining to the use of liquid biopsy testing in patients with lung cancer. These guidelines call for using liquid biopsy at the time of cancer diagnosis or recurrence when tissue is inadequate or unavailable, as well as for patients who fail first-line targeted therapy and must be reassessed for second-line targeted treatment. The new recommendations further validate the clinical utility of liquid biopsy and its benefits for rapidly obtaining information about a patient's tumor while reducing the risk of invasive tissue biopsies. We are leveraging these guidelines into our commercial programs," Mr. Nall concluded.
Review of 2017 and Recent Accomplishments
Commercial Programs and Distribution Agreements
- Launched Empower TC™, a novel initiative to enable community pathologists to report molecular biomarker information to their patients with cancer using
Biocept's liquid biopsy technology. - Entered into an exclusive global agreement (excluding
China ) withVWR International, LLC to distributeBiocept's proprietary blood collection tubes that preserve circulating tumor DNA (ctDNA) for up to eight days and circulating tumor cells (CTCs) for up to four days at room temperature, thereby enabling worldwide shipment of liquid biopsy samples.
Commercial Biomarker Launches
- Launched an assay for progesterone receptor (PR), completing the menu of assays for all NCCN Guideline®-based biomarkers pertinent to the care of patients with breast cancer.
- Announced the commercial availability of an assay for mutations of the NRAS oncogene associated with multiple cancer types including metastatic melanoma, colorectal and lung cancer.
Collaborations
- Selected by the
Addario Lung Cancer Medical Institute (ALCMI) to participate as a liquid biopsy testing provider in the landmark ALCMI-009 Liquid Biopsy trial, a 400-patient, multicenter, well-controlled, prospective trial to demonstrate the clinical utility of liquid biopsy for use in detecting and assessing clinically actionable biomarkers in patients with lung cancer. - Announced a multiphase agreement granting
Oregon Health Sciences University exclusive rights to offer Target Selector liquid biopsy testing services throughout the state ofOregon and to jointly develop molecular assays. - Entered into a laboratory services agreement with a national cancer treatment center to provide Target Selector liquid biopsy testing services within a nationwide multi-hospital network.
Industry Conferences and Study Results
- Presented study results showing that incorporation of Thermo Fisher's QuantStudio 5 PCR Instrument into our Target Selector platform improves sensitivity and specificity for the detection of lung cancer biomarkers at the fifth
AACR-IASLC International Joint Conference . - Presented study data demonstrating the ability of
Biocept's patented blood collection tubes to successfully collect and preserve patient blood samples for use with single gene tests and a broad liquid biopsy panel in a poster at the 2017American Association for Cancer Research (AACR) Annual Meeting. - Announced three abstracts featuring the Target Selector platform at the 2017
American Society of Clinical Oncology (ASCO ) Annual Meeting.
Healthcare Payer Agreements
- Entered into an in-network provider agreement with
Blue Cross Blue Shield of Texas and a group purchasing organization agreement with a large national health plan association. - Executed preferred provider agreements with Scripps Health Plan and with MediNcrease, expanding in-network access to
Biocept's liquid biopsy testing. - Signed an in-network provider agreement with
Wellmark, Inc. , the largest health insurer inIowa andSouth Dakota , andBiocept's thirdBlue Cross Blue Shield contract.
Patents
- Granted a U.S. patent for the Target Selector "switch-blocker" technology, a method of enriching patient specimens for oncogene mutations of interest, allowing for ultra-high sensitivity and specificity for the detection of cancer-associated mutations.
- Granted a patent in the U.S. with broad claims for antibody capture of targets of interest on any solid surface including circulating tumor cells (CTCs) and other materials shed by solid tumors into blood.
- Awarded a patent in
Japan for the use of antibodies to capture any target of interest from any sample type on a device surface. These targets include CTCs, sub-cellular vesicles and exosomes shed by solid tumors into the bloodstream. - Awarded a patent in
Australia for the use of antibodies in microchannels for the capture of cancer cells, including uses for CTCs and other rare cells. - Granted patents in the U.S. and
Australia for the company's Target Selector ctDNA assay platform, which enriches for mutations of interest associated with cancer.
Corporate
- Raised more than
$35 million in gross proceeds from the sale of common stock and warrants, and from the exercise of warrants since the beginning of 2017, inclusive of our equity financing in January 2018.
Fourth Quarter Financial Results
Revenues for the fourth quarter of 2017 were
Cost of revenues for the fourth quarter of 2017 was
Research and development (R&D) expenses for the fourth quarter of 2017 were
General and administrative (G&A) expenses for the fourth quarter of 2017 were
Sales and marketing expenses for the fourth quarter of 2017 were
The net loss for the fourth quarter of 2017 was
Full Year Financial Results
Revenues for 2017 were
Cost of revenues for the year ended
Research and development (R&D) expenses for the year ended
General and administrative (G&A) expenses for the year ended
Sales and marketing expenses for the year ended
The net loss for 2017 was
Cash and cash equivalents were
Conference Call and Webcast
A replay of the call will be available for 48 hours following the conclusion of the call 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 10117300.
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, the success of our Empower TC™ program, the ability of recent developments to support future growth, our ability to maintain sample volume growth, the success of our collaboration with
BIOCEPT, INC. |
||||||||||
CONDENSED BALANCE SHEETS |
||||||||||
December 31, |
December 31, |
|||||||||
2016 |
2017 |
|||||||||
(unaudited) |
||||||||||
ASSETS |
||||||||||
Cash |
$ |
4,609,332 |
$ |
2,146,611 |
||||||
Accounts receivable, net |
128,969 |
1,193,426 |
||||||||
Inventories, net |
549,045 |
498,702 |
||||||||
Prepaid expenses and other current assets |
484,649 |
416,600 |
||||||||
TOTAL CURRENT ASSETS |
5,771,995 |
4,255,339 |
||||||||
FIXED ASSETS, NET |
1,806,331 |
3,123,567 |
||||||||
TOTAL ASSETS |
$ |
7,578,326 |
$ |
7,378,906 |
||||||
LIABILITIES AND SHAREHOLDERS' EQUITY |
||||||||||
CURRENT LIABILITIES, NET |
$ |
4,393,552 |
$ |
4,661,345 |
||||||
NON-CURRENT LIABILITIES, NET |
2,526,113 |
1,421,527 |
||||||||
TOTAL LIABILITIES |
6,919,665 |
6,082,872 |
||||||||
SHAREHOLDERS' EQUITY |
658,661 |
1,296,034 |
||||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
7,578,326 |
$ |
7,378,906 |
||||||
BIOCEPT, INC. |
|||||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|||||||||||
For the three months ended December 31, |
For the year ended December 31, |
||||||||||
2016 |
2017 |
2016 |
2017 |
||||||||
(unaudited) |
(unaudited) |
(unaudited) |
|||||||||
NET REVENUES |
$ |
1,291,587 |
$ |
995,226 |
$ |
3,223,096 |
$ |
5,068,663 |
|||
COSTS AND EXPENSES |
|||||||||||
Cost of revenues |
1,899,462 |
2,359,909 |
6,920,111 |
9,345,122 |
|||||||
Research and development expenses |
668,399 |
908,800 |
2,713,367 |
3,364,747 |
|||||||
General and administrative expenses |
1,636,994 |
1,650,097 |
6,560,425 |
7,189,529 |
|||||||
Sales and marketing expenses |
1,179,167 |
1,642,941 |
5,054,230 |
6,343,971 |
|||||||
Total costs and expenses |
5,384,022 |
6,561,747 |
21,248,133 |
26,243,369 |
|||||||
LOSS FROM OPERATIONS |
(4,092,435) |
(5,566,521) |
(18,025,037) |
(21,174,706) |
|||||||
INTEREST AND OTHER INCOME/(EXPENSE), NET |
(94,439) |
(97,451) |
(372,232) |
(431,407) |
|||||||
LOSS BEFORE INCOME TAXES |
(4,186,874) |
(5,663,972) |
(18,397,269) |
(21,606,113) |
|||||||
INCOME TAXES |
— |
(2,601) |
(2,053) |
(7,624) |
|||||||
NET LOSS AND COMPREHENSIVE LOSS |
$ |
(4,186,874) |
$ |
(5,666,573) |
$ |
(18,399,322) |
$ |
(21,613,737) |
|||
NET LOSS PER SHARE |
|||||||||||
- Basic |
$ |
(0.27) |
$ |
(0.18) |
$ |
(1.92) |
$ |
(0.79) |
|||
- Diluted |
$ |
(0.27) |
$ |
(0.18) |
$ |
(1.92) |
$ |
(0.79) |
|||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
|||||||||||
- Basic |
15,620,049 |
31,489,993 |
9,578,285 |
27,246,292 |
|||||||
- Diluted |
15,620,049 |
31,489,993 |
9,578,285 |
27,246,292 |
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SOURCE
Investor Contact: LHA Investor Relations, Jody Cain, Jcain@lhai.com, (310) 691-7100, Media Contact: Trevelino/Keller, Colleen Murphy, cmurphy@trevelinokeller.com, (404) 214-0722, Ext. 109