Skip to main content
Premium Trial:

Request an Annual Quote

Exact Sciences Q1 Revenues Tumble as it Awaits FDA Decision

NEW YORK (GenomeWeb) – Exact Sciences today announced a year-over-year tumble in its first quarter revenues as it awaits a decision by the US Food and Drug Administration on the company's colorectal cancer screening test.

The Madison, Wis.-based molecular diagnostics firm reported $294,000 in revenues for the three months ended March 31, down 71 percent from $1.0 million for the first quarter in 2013. The figure fell short of the consensus analyst revenue estimate of $600,000.

Revenues in the quarter were derived completely from non-cash amortization of upfront licensing fees from Genzyme, which were amortized during a five-year collaboration period that ended in January, Exact Sciences said.

The firm is currently awaiting word from the FDA on its premarket approval submission for Cologuard, which analyzes hemogloblin, multiple DNA methylation markers, mutations in the KRAS gene, and the total amount of DNA in the stool sample. In late March, an FDA panel unanimously recommended approval of the test. While the FDA is not beholden to the panel's recommendation, the agency often has followed its panels' recommendations.

Also in March, the company published in the New England Journal of Medicine results from its pivotal clinical study demonstrating superior results with Cologuard versus fecal immunochemical testing.

"The publication of our DeeP-C clinical trial data in the New England Journal of Medicine and the subsequent endorsement of Cologuard by an FDA panel are two key strategic milestones as we work to commercialize the product," Exact Sciences Chairman and CEO Kevin Conroy said in a statement. "We continue to be pleased with our launch-readiness efforts and look forward to working with physicians and patients, pending FDA approval, to improve colon cancer screening."

Exact Sciences' net loss for the first quarter increased to $16.1 million, or $.23 per share, from a net loss of $10.9 million, or $.17 per share, a year ago. On average, analysts had anticipated a loss of $.19 per share.

The company shaved its R&D spending by 1 percent year over year to $7.4 million from $7.5 million, but more than doubled its SG&A costs to $9.0 million from $4.4 million.

Exact Sciences exited the quarter with $17.8 million in cash and cash equivalents. Subsequent to the end of the first quarter, the company raised $137.7 million in net proceeds in a public offering of 11.5 million shares of its common stock.

Shares of Exact Sciences were down 4 percent at $11.52 in morning trading on the Nasdaq on Thursday.