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Trovagene Q3 Revenues Climb 56 Percent

NEW YORK (GenomeWeb) – Trovagene reported after the close of the market Wednesday a 56 percent increase in its third quarter revenues on increased demand for its diagnostic services, falling short of analysts' consensus estimate.

For the three-month period ended Sept. 30, Trovagene's revenues climbed to $89,000 from $57,000 in Q3 last year, widely missing the Wall Street estimate of $320,000. Contributing to the increase was a sharp rise in diagnostic service revenues to $38,000 from $6,000. Meanwhile, a dip in royalty revenues to $47,000 from $51,000 was offset by $4,000 in clinical research service revenues, which the company did not record in the year-ago period.

Trovagene CEO Bill Welch said during a conference call to discuss the financial results that the company made significant progress during the quarter in promoting the technology underlying its Trovera line of blood- and urine-based assays for the detection of cancer-associated mutations in EGFR, KRAS, and BRAF through the announcement of collaborations with research institutes, including the University of Michigan Comprehensive Cancer Center and the University of Southern California Norris Comprehensive Cancer Center, as well as the Pancreatic Cancer Action Network.

"In addition, we're pleased that data demonstrating the clinical utility of our Trovera liquid biopsy tests in lung cancer was published in peer-reviewed oncology journals," he added. "We also saw expanded access to our Trovera test by existing and new physicians while we gained our first Tier 1 payor contract" through a deal with BCBS Illinois.

Welch also noted that Trovagene has been focusing its marketing efforts on "oncology centers where there is a need for a highly sensitive, non-invasive detection of the EGFR T790M mutation for patients with late-stage non-small cell lung cancer," and that about two-thirds of the top 30 prescribing institutions for third-generation EGFR tyrosine kinase inhibitors — which are used to treat the disease — have clinical experience with the company's EGFR test.

"We also increased the total number of ordering physicians by 40 percent and new ordering physicians by 20 percent in the third quarter over the second quarter," he said. "We believe that market continues to show strong interest in highly sensitive, clinically actionable diagnostics."

Trovagene's Q3 net loss surged to $10.2 million, or $.34 per share, from $2.7 million, or $.23 per share, the year before. Analysts had, on average, been expecting a loss per share of $.33.

The San Diego-based company's R&D spending in the quarter rose to $3.9 million from $2.5 million. Trovagene Vice President of Finance and Administration Elizabeth Anderson attributed this to the ongoing development of a universal urine collection and DNA preservation kit, and work on a new multi-gene panel of clinically actionable mutations for melanoma, and lung, colorectal, and pancreatic cancers.

Meanwhile, SG&A expenses jumped to $5.6 million from $3.7 million the year before due to the deployment of a commercial team to promote Trovagene's technology and testing platform.

At the end of the third quarter, Trovagene had cash, cash equivalents, and short-term investments totaling $46.9 million.

Looking ahead, Trovagene expects to launch the new urine collection and DNA preservation kit for research use in early 2017, CSO Mark Erlander said during the call. The multi-gene panel — which will encompass more than 200 insertions, deletions, and mutation variants across EGFR, KRAS, NRAS, BRAF, PIK3CA, and C-kit — will likely complete initial validation testing in the fourth quarter, with clinical validation occurring in the Q1 2017.

During early morning trading on the Nasdaq Thursday, shares of Trovagene were down about 1 percent at $3.50.