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Trovagene Q1 Revenues Fall 6 Percent as Net Loss Swells

NEW YORK (GenomeWeb) – Trovagene reported after the close of the market on Tuesday that its first quarter revenues fell nearly 6 percent year over year as its net loss increased 43 percent.

For the three months ended March 31, the liquid biopsy MDx developer reported revenues of $120,000 compared to $127,000 in Q1 2015, falling short of analysts' estimate of $260,000.

Trovagene reported $113,000 in royalty revenues compared to $125,000 in Q1 2015, and $7,000 in diagnostic service revenues, up from $2,000 in the year-ago quarter.

The company reported a net loss of $10.3 million, or $0.36 per share, for Q1 2016, compared to a net loss of $7.2 million, or $.33 per share, in the year-ago quarter. Analysts had been expecting a loss of $.29 per share. The company attributed the increasing net loss to growing operating expenses.

Trovagene's Q1 R&D spending rose about 45 percent year over year to $3.2 million from $2.2 million, while its SG&A costs almost quadrupled to $7 million from $1.9 million.

"Our strong balance sheet positions us to execute on our business plan and create significant stockholder value," Bill Welch, who became Trovagene's new CEO in April, said in a statement. "Our key goals for 2016 include increasing the number of oncologists using our assays in clinical practice, gaining traction with health insurance companies, and presenting and publishing additional clinical results from large prospective data sets supporting the utility of our assay platform."

Highlights for Trovagene during the first months of the year included a patient case report published in Cancer Discovery in which researcher were able to confirm BRAF V600E mutational status and quantitatively monitor changes in urinary circulating tumor DNA to assess response to novel combination drug therapy.

The firm also presented clinical study results at several medical and scientific conferences, including the Molecular Medicine Tri-Conference and American Association for Cancer Research annual meeting.

Trovagene also entered into several agreements with preferred provider networks representing approximately 160 million covered lives, the company said.

During a call discussing the firm's Q1 earnings Trovagene Vice President of Marketing Rob Kelley said that current commercial efforts have been met with "increasing physician interest" and usage of the company's test, particularly in the detection of resistance mutations associated with first- and second-generation tyrosine kinase inhibitors for non-small cell lung cancer.

"While still early in our commercial launch, lung cancer currently accounts for approximately 58 percent of our total test volume. We are also beginning to see clinical interest in monitoring driver mutations for other cancers using our platform. Pancreatic cancer and colorectal cancer for example, now constitute 24 percent of tests ordered," he said during the call.

Kelley also said that strategies to increase the proportion of tests Trovagene can actually bill for is also progressing. In Q1 of 2016 the company saw an increase of 13 percent in overall test volume compared to the three months ended Dec. 31, 2015. More importantly, Kelley said, the percentage of billable samples grew approximately 50 percent quarter over quarter "demonstrating that physicians are seeing increasing value in our products."

Some analysts had expected significantly higher Dx revenues associated with a much faster ramp up in test volume than Trovagene appears to be achieving. Leerink, for example, said in a statement that it had forecasted $100,000 in test revenue for the quarter.

Trovagene exited the quarter with $60 million in cash and cash equivalents.

In Wednesday morning trading on the Nasdaq its shares were down about 7 percent at $3.33.