Biocept Reports Fourth Quarter and Full Year 2016 Financial Results
"We made great progress in 2016 and ended the year on a high note, with revenues and new account start-ups reaching the highest levels of any quarter in 2016," said
"We plan to further build on our position as a leader in liquid biopsy during 2017 by continuing to execute on our key initiatives aimed at increasing physician adoption of our Target Selector™ liquid biopsy platform," concluded
Review of 2016 and Recent Accomplishments
Corporate
- Completed two equity offerings in 2016 raising an aggregate of approximately
$15 million in gross proceeds. - Increased our cash position since
December 31, 2016 by approximately$4.6 million as a result of the exercise of warrants from ourOctober 2016 financing. - Named
Timothy Kennedy as Chief Financial Officer and Senior Vice President of Finance and Operations, and appointedDavid Moskowitz as Vice President,Strategy and Corporate Communications .
Commercial Biomarker Launches
- Expanded into immuno-oncology with the launch of our PD-L1 protein expression test to be among the first to commercialize a CLIA-validated, blood-based test for detection of this protein marker.
- Launched an androgen receptor (AR) test marking our expansion into prostate cancer and increasing our breast cancer offering into a subgroup of patients with triple negative breast cancer.
- Launched our RET oncogene fusion test to provide important information for therapeutic options for a subgroup of patients with non-small cell lung cancer.
Healthcare Payer Agreements
- Expanded managed care contracts with six new agreements, including
Blue Cross Blue Shield of Texas and a group-purchasing agreement with a large, national health plan association.
Collaborations
- Announced a
Columbia University Medical Center -sponsored clinical study for our Target Selector™ platform using cerebrospinal fluid to rapidly and accurately diagnose brain metastases in breast cancer patients. The study is aimed at demonstrating the versatility of our platform in biofluids other than blood in order to address a true unmet clinical need. - Announced a collaboration with
MedStar Georgetown University Hospital to evaluate resistance biomarkers in patients diagnosed with non-small cell lung cancer being treated with EGFR inhibitors or chemotherapy. - Signed a master services agreement with a major biopharmaceutical company to develop targeted liquid biopsy tests for multiple tumor types and molecular targets.
- Entered into a collaboration with renowned clinical investigator
Shilpa Gupta , M.D., atMasonic Cancer Center ,University of Minnesota , to study the clinical utility of liquid biopsy testing in bladder, testicular, and prostate cancers. - Formed a
Clinical Advisory Board of renowned oncologists to provide guidance on expanding our physician customer base and supporting usage of our liquid biopsy tests.
Industry Conferences and Study Results
- Presented study results providing robust analytical validation for our PD-L1 liquid biopsy test at the
IASLC World Conference on Lung Cancer in collaboration with Dr.David Rimm ofYale University School of Medicine , a renowned PD-L1 diagnostics thought leader. - Announced the presentation of study results demonstrating that our Target Selector™ platform delivered 90% concordance and the capability to rapidly detect EGFR, ALK, BRAF and ROS1 alterations in non-small cell lung cancer patients at the
European Society for Medical Oncology (ESMO) Congress . Study collaborators were AstraZeneca and theNational Cancer Institute inMexico City . - Announced the presentation of two abstracts supporting the use of our Target Selector™ platform for highly sensitive real-time monitoring and potential early identification of biomarkers at the
American Society of Clinical Oncology (ASCO) conference. - Reported results from a collaborative study with the
Sarah Cannon Research Institute demonstrating high concordance of our Target-Selector™ platform versus tissue biopsy, and the ability to monitor key biomarkers in metastatic breast cancer in real time, at the San Antonio Breast Cancer Symposium.
Patents
- Awarded a
U.S. patent covering the use of a novel stain in the detection of rare cells such as CTCs from blood and other biological fluids. - Granted Japanese patent covering microchannel and antibody capture.
- Expanded patent protection in
China to cover the use of a novel staining method in the detection of rare cells such as CTCs from blood and other biological fluids. - Awarded patent in
Australia for the use of antibodies in capturing cells in microchannels, including uses for CTCs and other rare cells.
International Marketing Agreements
- Entered into distribution agreements to market our portfolio of liquid biopsy tests in
Canada with Teneovita Medical, inIsrael with Progenetics, and inthe Philippines with theHarle Group . - Signed agreement with Quest Diagnostics Mexico to market proprietary liquid biopsy tests to detect EGFR mutations associated with lung cancer.
Fourth Quarter Financial Results
We accessioned 1,101 billable samples in the fourth quarter of 2016, a 78% increase from 618 billable samples accessioned during the fourth quarter of 2015. When samples from research, assay validations, and other non-billable sources are included, total samples were 1,175 during the fourth quarter of 2016, up 77% from 663 total samples for the fourth quarter of 2015.
Revenues for the fourth quarter of 2016 increased to
Cost of revenues of
Research and development expenses of
General and administrative expenses for the fourth quarter of 2016 increased to
Sales and marketing expenses of approximately
Net loss for the fourth quarter of 2016 was
Full Year 2016 Financial Results
We accessioned 4,211 billable assays in 2016, an increase of 131% from 1,824 during 2015. Revenues in 2016 increased to
Total costs and expenses were
Net loss for 2016 was
We reported cash and cash equivalents of
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 10101325.
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 improve the outcomes of cancer patients, our ability to reduce our operating
expenses and improve margins, our ability to become contribution margin-positive during 2017, our plans to begin reporting sales on an accrual basis later this year, our ability to grow our commercial test volume and adoption, our ability to pursue value-creating initiatives, and our ability to build on our commercial leadership position in the liquid biopsy field, 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
| ||||||||||
CONDENSED BALANCE SHEETS | ||||||||||
|
| |||||||||
2015 |
2016 | |||||||||
(Unaudited) |
||||||||||
ASSETS |
||||||||||
Cash and cash equivalents |
$ |
8,821,329 |
$ |
4,609,332 |
||||||
Accounts receivable |
34,200 |
128,969 |
||||||||
Inventories, net |
349,271 |
549,045 |
||||||||
Prepaid expenses and other current assets |
435,938 |
484,649 |
||||||||
TOTAL CURRENT ASSETS |
9,640,738 |
5,771,995 |
||||||||
FIXED ASSETS, NET |
946,180 |
1,806,331 |
||||||||
TOTAL ASSETS |
$ |
10,586,918 |
$ |
7,578,326 |
||||||
LIABILITIES AND SHAREHOLDERS' EQUITY |
||||||||||
CURRENT LIABILITIES |
$ |
3,340,788 |
$ |
4,393,552 |
||||||
NON-CURRENT LIABILITIES, NET |
3,553,395 |
2,526,113 |
||||||||
TOTAL LIABILITIES |
6,894,183 |
6,919,665 |
||||||||
SHAREHOLDERS' EQUITY |
3,692,735 |
658,661 |
||||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
10,586,918 |
$ |
7,578,326 |
| |||||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||
For the three months ended December 31, |
For the year ended | ||||||||||
2015 |
2016 |
2015 |
2016 | ||||||||
(Unaudited) |
(Unaudited) |
(Unaudited) | |||||||||
REVENUES |
$ |
218,283 |
$ |
1,291,587 |
$ |
609,909 |
$ |
3,223,096 | |||
COSTS AND EXPENSES |
|||||||||||
Cost of revenues |
1,275,691 |
1,899,462 |
4,596,158 |
6,920,111 | |||||||
Research and development |
784,379 |
668,399 |
2,857,770 |
2,713,367 | |||||||
General and administrative |
1,404,515 |
1,636,994 |
5,686,398 |
6,560,425 | |||||||
Sales and marketing |
1,264,168 |
1,179,167 |
3,880,386 |
5,054,230 | |||||||
Total costs and expenses |
4,728,753 |
5,384,022 |
17,020,712 |
21,248,133 | |||||||
LOSS FROM OPERATIONS |
(4,510,470) |
(4,092,435) |
(16,410,803) |
(18,025,037) | |||||||
INTEREST AND OTHER INCOME/(EXPENSE), NET |
(106,900) |
(94,439) |
(537,115) |
(372,232) | |||||||
LOSS BEFORE INCOME TAXES |
(4,617,370) |
(4,186,874) |
(16,947,918) |
(18,397,269) | |||||||
INCOME TAXES |
(130) |
— |
(1,608) |
(2,053) | |||||||
NET LOSS & COMPREHENSIVE LOSS |
$ |
(4,617,500) |
$ |
(4,186,874) |
$ |
(16,949,526) |
$ |
(18,399,322) | |||
NET LOSS PER SHARE |
|||||||||||
- Basic |
$ |
(0.73) |
$ |
(0.27) |
$ |
(3.07) |
$ |
(1.92) | |||
- Diluted |
$ |
(0.73) |
$ |
(0.27) |
$ |
(3.07) |
$ |
(1.92) | |||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
|||||||||||
- Basic |
6,307,316 |
15,620,049 |
5,512,989 |
9,578,285 | |||||||
- Diluted |
6,307,316 |
15,620,049 |
5,512,989 |
9,578,285 |
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