NEW YORK (GenomeWeb) – Biocept reported after the close of the market Thursday that its fourth quarter 2018 revenues dropped 14 percent year over year as both total test volumes and billable tests fell short of the prior-year period.
The liquid biopsy assay company reported total revenues of $859,526 for the three months ended Dec. 31, 2018 compared to $995,226 in the same period last year.
Overall revenue for Q4 2018 included $39,000 from development services and $820,000 in commercial test revenues from the accession of 1,043 total samples, 938 of which were billable samples. In the same quarter of 2017, the firm saw $61,000 from development and $935,000 from commercial tests representing 1,057 samples, 982 of which were billable.
CEO Michael Nall said in a statement that despite the year-over-year reduction, revenues and billable samples for the fourth quarter were up sequentially and reached their highest level of the year in Q4.
"Our efforts to enhance our growth in test volumes has continued into 2019," he added.
Biocept's Q4 net loss widened to $6.0 million from $5.7 million in Q4 2017. Its net loss per share for 2018 was $1.43 per share on 4.2 million weighted-average shares outstanding, compared to $5.36 per share on 1.1 million weighted-average shares outstanding. In July 2018, the firm conducted a 1-for-30 reverse stock split of its outstanding common stock.
The company's R&D expenses for Q4 2018 rose 43 percent to $1.3 million from $908,800 a year ago due to changes in the allocation of laboratory costs, money spent in the development of new assays, lab automation, and costs related to the validation of the Thermo Fisher Scientific molecular oncology assay panel, Biocept said. SG&A costs shrank 6 percent to $3.1 million from $3.3 million in the year-ago period.
For full-year 2018, Biocept's revenues dropped 35 percent to $3.3 million from $5.1 million in 2017. The firm noted that revenues in 2018 were recognized on an accrual basis, while those in 2017 were recognized on receipt of cash. With 2017 numbers adjusted to reflect accrual, the firm's 2018 revenues were down 15 percent compared to $3.8 million the prior year, the company said.
Biocept accessioned 4,252 total samples, including 3,896 billable samples during 2018 compared with 5,051 total samples and 4,517 billable samples in 2017.
Biocept's net loss for full-year 2018 widened to $25.2 million from $21.6 million in 2017. Its net loss per share shrank to $9.01 per share on 2.8 million weighted-average shares outstanding from $23.58 per share on 917,000 weighted-average shares outstanding.
Its R&D costs in 2018 rose 32 percent to $4.5 million from $3.4 million in 2017. The firm said this increase was due to higher laboratory and personnel costs supporting the launch of new products. Its SG&A expenses for the year dropped to $13 million from $13.5 million, reflecting a decrease in personnel and travel costs, as well as lower marketing, trade show, and conference spending.
Milestones for the firm during 2018 and following months include its launch of research-use-only (RUO) kits to enable molecular laboratories around the world to use its Target Selector circulating tumor DNA assays.
The company also launched its CEE-Sure blood collection tubes for RUO under an exclusive global distribution agreement with VWR, and it began expanded its pathology partnership service, EmpowerTC.
On a call with investors discussing the firm's financial results, Nall also said that the company is making good progress in its study with Highmark Health to evaluate the clinical impact of the test in advanced lung cancer.
Nall said that Highmark had calculated that significant numbers of lung cancer patients in its Allegheny affiliate fail to receive testing for biomarkers like EGFR, ALK, and ROS1. In the study Biocept is recruiting 100 patients who will be tested with its liquid biopsy assays with the hope that it can identify actionable biomarkers in patients who can't or don't have tissue samples available.
"With our technology we believe that testing 100 percent of advanced lung cancer patients is achievable due to the convenience and reliability of using a simple blood sample," Nall said during the call. "Oncologists in the Allegheny network are very interested in this approach and I am happy to provide an update that the study now has accrued 25 of the 100 planned patients," he added.
"So far, the early results indicate that our liquid biopsy testing has identified actionable biomarkers in some of the patients tested, and, importantly, several patients have responded to treatment driven by the information that our testing provided," he said.
Biocept's Chief Commercial Officer Edwin Hendrick highlighted three other areas that the firm's sales force is going to be focusing on in the coming year. The first is breast cancer, where the company sees a renewed interest in the use of circulating tumor cells. The second is urology and urologic oncology, where he argued that pathologists will be especially interested in the firm's EmpowerTC program, which allows them to conduct the reporting aspect of a Biocept test in house and collect revenue for that performed portion.
Finally, the company also plans to target naturopathic doctors. According to Hendrick, when he joined Biocept "a good percent of [company] test volumes" were already coming from the naturopathic community, something the firm has not previously discussed publicly.
As part of its strategy moving forward, Hendrick said that the company is going to actively dedicate resources toward developing this market and driving test volume.
"Importantly, NDs are early adopters when it comes to monitoring a patient's disease using CTCs and ctDNA. And we and many experts believe that patient monitoring is where the real promise lies for liquid biopsy," he said.
Finally, Nall said that Biocept also expects to increase its reach further with the launch of multigene testing in the second quarter of this year.
The company finished the year with cash and cash equivalents totaling $3.4 million. In subsequent months, it has raised additional gross proceeds of $18.5 million through equity offerings of common stock and warrants.
"We now believe that we have the financial resources to implement our business strategy throughout the year," Nall added.
In late morning trading on the Nasdaq on Friday, Biocept's shares were down a fraction of 1 percent at $1.17.