
Biocept Reports 2018 Fourth Quarter and Full Year Financial Results
"Revenues and billable samples for the fourth quarter reached their highest levels in 2018, as we benefited from our refocused commercial strategy," said
"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
"We have raised more than
2018 and Recent Highlights
Commercial Launches
- Announced the availability of research-use-only (RUO) kits, which enable molecular laboratories around the world to utilize Target Selector™ circulating tumor DNA (ctDNA) assays to perform liquid biopsy testing.
- Launched CEE-Sure® blood collection tubes (BCTs) for RUO under an exclusive global distribution agreement with VWR, a leading provider of products and services to laboratory and production customers. CEE-Sure® BCTs allow for the transport and preservation of CTCs and circulating free DNA (cfDNA) at room temperature from the clinic to central laboratories in the same tube.
- Launched expanded pathology partnership service, EmpowerTC, with additional prognostic and predictive biomarker tests. The expanded service provides the capability to perform tests that can aid physicians and pathologists in the management of patients diagnosed with prostate cancer.
Collaborations
- Entered into an agreement with
Prognos, Inc. to utilize its proprietary de-identification software to collect and transmit data to assist pharmaceutical and life science clients in ensuring patients receive the correct therapies. - Announced a partnership with
Thermo Fisher Scientific to validate its Oncomine™ next-generation sequencing panel inBiocept's CLIA laboratory. Following validation,Biocept has the opportunity to become a Thermo Fisher Liquid Biopsy Center of Excellence with the potential to jointly market services to the pharmaceutical industry. - Entered into a commercial agreement with
Highmark Health and the Allegheny Health Network, to evaluate the clinical utility and cost effectiveness of Target Selector™ in patients diagnosed with non-small cell lung cancer (NSCLC). - Announced a collaboration with
Providence St. Joseph Health ,Southern California , and its wholly owned affiliates Providence Saint John's Health Center and theJohn Wayne Cancer Institute , to conduct a study to validate the use of cerebrospinal fluid with the Target Selector™ platform. - Entered into a partnership with the
Moores Cancer Center atUC San Diego Health to conduct two studies in patients with a variety of solid tumors to compare results from Target Selector™ with findings from computed tomography (CT) or positron emission tomography (PET) scans. - Entered into an agreement with
Agiomix FZ-LLC , a provider of genomics sample and bioinformatics services for research and clinical applications, to validate Target Selector™ technology. Subject to validation, Agiomix will purchaseBiocept's RUO kits for use in its laboratory.
Industry Conferences and Study Results
- Announced the publication of case studies in the peer-reviewed journals Clinics in Oncology and Oncology & Hematology Review demonstrating the clinical utility of Target Selector™ in managing advanced NSCLC and metastatic breast cancer.
- Presented a poster at the 2019
American Association for Cancer Research Annual Meeting demonstrating the ability of the Target Selector™ liquid biopsy test to detect ESR1 mutations with high sensitivity. - Presented two posters at the
International Association for the Study of Lung Cancer's 19thWorld Conference on Lung Cancer featuring the ability of Target Selector™ technology platforms to detect and monitor actionable biomarkers in patients diagnosed with NSCLC. - Presented two posters at the
Fifth AACR-IASLC International Joint Conference , one featuring clinical data generated in collaboration with theUniversity of Minnesota demonstrating the clinical utility of monitoring metastatic testicular cancer usingBiocept's CTC assay technology, and the other highlighting data showing that incorporatingThermo Fisher Scientific's QuantStudio 5 PCR Instrument into the Target Selector™ platform improves sensitivity and specificity for the detection of lung cancer biomarkers. - Announced the publication of a letter to the editor in the peer-reviewed
Journal of Thoracic Oncology outlining the ability of the Target Selector™ test to identify a ROS1 gene rearrangement in a patient with lung cancer, confirming the results of a prior tissue biopsy.
Intellectual Property
- Issued patents in the U.S.,
Australia , seven European countries,China andJapan for assays to perform ctDNA analysis using real-time PCR,Sanger sequencing and next-generation sequencing encompassingBiocept's proprietary "switch-blocker" technology that enriches patient specimens, resulting in ultra-high sensitivity and specificity for the detection of cancer-associated mutations found in blood, tissue and other biological sources. - Awarded patents in
Australia ,Canada andJapan covering the use of microchannels for the capture and detection of any target of interest, including proteins and nucleic acids, as well as the capture of cancer or other cells that can be used for molecular analysis in blood and other biological fluids.
Corporate
- Appointed
Edwin C. Hendrick as Senior Vice President, Chief Commercial Officer. Hendrick brings more than 25 years of healthcare sales and commercial leadership experience including senior-level commercial and operational positions in clinical diagnostics. - Retired our term debt facility with Oxford Finance eliminating approximately
$2.1 million in annualized cash expenditures.
Fourth Quarter Financial Results
Revenues for the fourth quarter of 2018 were
Cost of revenues for the fourth quarters of 2018 and 2017 was unchanged at
Research and development (R&D) expenses for the fourth quarter of 2018 were
General and administrative (G&A) expenses for the fourth quarter of 2018 were
The net loss for the fourth quarter of 2018 was
Full Year Financial Results
Net revenues recognized on an accrual basis were approximately
Cost of revenues for 2018 was
R&D expenses for 2018 were
G&A expenses for 2018 were
Sales and marketing expenses for 2018 were
The net loss to common shareholders for 2018 was
Cash and cash equivalents were
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
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 10128915.
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, 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 (
Investor Contact:
LHA Investor Relations
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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