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Exact Sciences Q2 Revenues Flat

The story has been updated to include comments from Exact Sciences' conference call this morning.

NEW YORK (GenomeWeb News) – Exact Sciences today reported flat revenues year over year for its second quarter.

Revenues, comprised completely of licensing fees, totaled $1.0 million for the quarter ended June 30, matching revenues from a year ago, as well as the average Wall Street estimate.

The firm — which is awaiting a decision from the US Food and Drug Administration on the company's premarket approval submission for its Cologuard colorectal cancer screening test — posted a loss of $12.3 million, or $.19 per share, for the second quarter, just missing the consensus Wall Street estimate of a loss of $.18 per share. A year ago, Exact Sciences' loss was $14.8 million, or $.26 per share.

R&D spending was down 47 percent to $6.5 million, compared to $12.2 million a year ago. SG&A costs increased 86 percent to $6.9 million from $3.7 in the second quarter of 2012.

Exact Sciences finished the quarter with $21.5 million in cash and cash equivalents. Last month, it reported $73.4 million in net proceeds from a public offering of its stock.

"With the completion of Exact's submission to the FDA for Cologuard … the company's top priorities are commercial readiness and operational excellence," company President and CEO Kevin Conroy said in a statement. "The entire team at Exact is focused on building a strong foundation from which we can launch Cologuard, pending FDA approval. All of us understand the potential impact of Cologuard and we look forward to bringing it to patients."

In addition to its PMA submission to FDA, the company is in parallel pursuit of Medicare coverage for Cologuard and in a conference call today after the release of its earnings results, Conroy said that the company continues "to engage very positively" with the Centers for Medicare and Medicaid Services on coverage and reimbursement for the test.

"We further believe that CMS' recently updated approach to reimbursing molecular diagnostic tests will appropriately and fairly value Cologuard from a reimbursement perspective," he said.

He also said that Exact Sciences has decided to build its own CLIA laboratory and expects to have the facility operational by the end of this year. The 40,000 square-foot lab, which will be located within a few miles from the company's headquarters in Madison, Wis., will have the ability to perform 1 million tests each year.

Additionally, the company plans to partner with an outside laboratory to provide testing services, though the majority of the testing will be performed at Exact Sciences' CLIA lab, Conroy said.

Exact Sciences' shares were down 3 percent to $13.89 in afternoon trading on the Nasdaq.

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