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Trovagene Q4 Revenues up 41 Percent as Net Loss Widens

This story has been updated to provide comments from Trovagene's management made during a conference call with investors.

NEW YORK (GenomeWeb) – Trovagene reported after the close of the market on Thursday that its fourth quarter revenues rose 41 percent year over year.

The liquid biopsy MDx developer said its revenues rose to $79,000 for the three months ended Dec. 31, 2015, up from $56,000 in Q4 2014. However, the revenues significantly missed analysts' estimates of $100,000 for the quarter.

Meanwhile, Trovagene reported a net loss $7.4 million, or $0.26 per share, in Q4 2015, compared to a net loss of $4.7 million, or $.25 per share, in the year-ago quarter. Analysts had been expecting a loss of $.25 for the quarter. The company attributed the increased loss primarily to greater operating expenses in the quarter, as well as over the full year.

The company's R&D spending in Q4 rose 78 percent year over year to $3.2 million from $1.8 million, while its SG&A costs were up about 52 percent to $4.1 million from $2.7 million.

For full-year 2015, Trovagene reported revenues rose 12 percent to $313,000 from $280,000 in 2014, again missing the analyst estimates of $340,000.

Its net loss for the year widened to $27.5 million, or $1.21 per share, compared to $14.3 million, or $.88 per share in 2014. Analysts had estimated a loss of $1.05 per share for the year. According to the company, the increase was due to higher total operating expenses compared to the previous year.

"2015 was our coming out year, as the introduction of our liquid biopsy solution for cancer monitoring was met with great response by physicians," Trovagene CEO Antonius Schuh said in a statement.

The firm currently has ongoing clinical collaborations testing its assays in lung, colon, pancreatic, and skin cancer, data from which was presented during the year at various medical and scientific conferences.

The company also launched a clinical experience program to enable trial use of its technology and a pilot marketing and sales program for its platform during 2015, which it said generated "strong interest and ordering" by practicing oncologists.

Trovagene's lab processed a total of 412 commercial samples in 2015, 180 of which were billable, Trovagene CFO Steve Zaniboni said during a call discussing the company's earnings Thursday.

In 2016, the company will focus on moving more customers out of the no-charge sample evaluation of the CEP, and increasing the number of active ordering physicians and submission of billable samples. "We are already encouraged to see the ratio of billable samples to no-charge samples increase from one-to-three in Q4 of 2015 to a ratio of three-to-one through February of this year," Zaniboni said.

Trovagene's full-year R&D spending increased 58 percent to $10.6 million from $6.7 million the previous year, and its SG&A costs rose 68 percent to $14.3 million from $8.5 million in 2014.

Having raised aggregate gross proceeds of approximately $63 million in two public offerings during the year, the company exited 2015 with $67.5 million in cash and cash equivalents.

Other goals for Trovagene in 2016 include increasing the number of oncologists using its assays in clinical practice and solidifying favorable health insurance reimbursement for its testing. The company also hopes to publish additional clinical utility results, and to finalize a plan for a comprehensive health-economic study in 2016.

"After demonstrating technological feasibility in 2014 and clinical and commercial feasibility 2015, we anticipate that 2016 will be the year where we assume a leadership role in building the market for cancer monitoring using circulating tumor DNA with our proprietary, highly sensitive, non-invasive and quantitative … technology," Zaniboni said during the call.

The company expects to release clinical study results at several oncology conferences this year including AACR and ASCO, and is also investing in two health economic studies to support favorable health insurance coverage.

Trovagene's shares were down nearly 14 percent to $5.22 in morning trading on the Nasdaq.