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Exact Sciences Posts Flat Q1 Revenues; Loss More than Doubles as Clinical Trial Costs Spike

NEW YORK (GenomeWeb News) – Exact Sciences today reported revenues for the first quarter were flat year over year, while its net loss more than doubled.

For the period ended March 31, the Madison, Wis.-based molecular diagnostics firm brought in revenues of $1.0 million, the same as a year ago, matching Wall Street estimates. All revenues for the quarter were derived from license fees. It had no product royalty fees in the quarter compared to $4,000 a year ago.

Exact Sciences remains on track in the development of its Cologuard test for colorectal cancer and the DeeP-C clinical trial for the test, President and CEO Kevin Conroy said in a statement.

"In addition to completing the DeeP-C trial, we remain focused on the successful execution of our other 2012 priorities: making our FDA submission and continuing our manufacturing and marketing preparation," he said.

The trial targets 1,000 patients, and Conroy said on a conference call following the earnings release that full enrollment is expected to be achieved sometime in the third quarter.

He also said that the company has begun a pharmacoeconomic study for Cologuard but has delayed a possible publication of it as the firm has decided to focus on reimbursements from payors.

"[A]nd as part of that we've actually de-focused that paper until next year," he said. Company officials declined to provide details about any progress on reimbursements, however.

Beyond Cologuard, Conroy said that other potential tests in Exact Sciences' pipeline include tests for ulcerative colitis and Crohn's disease.

The firm's R&D costs rose three-fold year over year to $9.0 million, from $3.0 million a year ago, while its SG&A costs increased 13 percent to $2.7 million from $2.4 a year ago. The spike in operating costs, Exact Sciences said, resulted primarily from costs associated with the Cologuard clinical trial.

Exact Sciences' net loss for the quarter was $10.6 million, or $.19 per share, compared to $4.4 million, or $.08 per share, a year ago, and missed Wall Street estimates of a net loss of $.18 per share.

The firm ended the quarter with $12.3 million in cash and cash equivalents and $71.2 million in short-term marketable securities.

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