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UPDATE: Exact Sciences Reports Flat Q1 Revenues

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

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

The Madison, Wis.-based company reported revenues of $1.0 million for the three months ended March 31, even with the year-ago period and matching the average Wall Street estimate.

All revenues came from licensing fees. The firm is in the process of filing its premarket approval submission with the US Food and Drug Administration for its Cologuard colorectal cancer screening test. Exact Sciences filed the first two modules and anticipates filing the third and final module, which will contain data from its DeeP-C clinical trial, in May or early June, company President and CEO Kevin Conroy said on a conference call following the release of the firm's earnings results.

In April, the company announced top-line data from the trial.

In parallel with its FDA submission, the company will complete and submit its Medicare national coverage application to the Centers for Medicare and Medicaid Services, Conroy said. The company also plans to analyze Deep-C's full data set to submit to a medical journal for publication.

Exact Sciences will pursue a two-pronged early adoption strategy for Cologuard, Conroy said. The company will target large healthcare systems and groups, which "employ a high percentage of the physicians in the" US, he said, and typically have strong screening programs. Together that "presents a great opportunity for Exact Sciences to drive significant adoption of Cologuard."

A second step in its strategy will focus on about 2,000 physicians that Conroy said are "the highest prescribing physicians." These doctors account for about 2 million fecal occult blood tests and fecal immunochemical tests, or 20 percent, "of the non-invasive market" each year.

Exact Sciences also plans to implement a service program in conjunction with Cologuard that will facilitate organized screening programs with healthcare systems, physicians, and patients, he added.

The firm's net loss for the quarter was $10.9 million, or $.17 per share, compared to a net loss of $10.6 million, or $.19 per share, a year ago, beating the average analyst estimate of a loss of $.20 per share.

The firm's R&D spending was down 17 percent to $7.5 million from $9.0 million a year ago, while SG&A spending rose 63 percent to $4.4 million from $2.7 million.

Exact Sciences exited the quarter with $8.1 million in cash and cash equivalents and $87.4 million in marketable securities.

The company also said that Thomas Carey has joined its board of directors. He is a member of Spencer Stuart, a global executive search firm.

In Wednesday afternoon trade on the Nasdaq, shares of Exact Sciences were down 2 percent at $9.14.

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