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UPDATE: Exact Sciences' Q3 Revenues Flat

The story has been updated to include comments from a conference call.

NEW YORK (GenomeWeb News) – Exact Sciences said today that revenues in the third quarter came in flat year over year as the firm matched consensus Wall Street estimates on the top and bottom line.

For the three months ended Sept. 30, revenues of $1.0 million were even with the year-ago figure and matched the average analyst estimate of $1.0 million. All revenues came from licensing fees both in the most recently concluded quarter and the year-ago period.

The firm's R&D costs spiked 72 percent year over year to $10.5 million from $6.1 million, while SG&A costs increased 25 percent to $3.5 million from $2.8 million.

Exact Sciences is currently conducting the DeeP-C clinical trial, as well as a pharmacoeconomic study, for its Cologuard colorectal cancer screening test. On a conference call following the release of the firm's earnings results, CFO Maneesh Arora said that DeeP-C will close on Nov. 15 and the company remains on track on both its plans to submit Cologuard for approval by the US Food and Drug Administration and for commercialization of the test upon approval.

Exact Sciences President and CEO Kevin Conroy added on the call that the company has to date more than 12,000 patients from 87 sites enrolled in the clinical trial.

The company has submitted a pre-PMA submission to FDA for Cologuard and subsequently had a joint meeting with FDA and the Centers for Medicare and Medicaid Services, he said. Comments from the agencies have been incorporated into the submission plan and Exact Sciences plans on pursuing a modular submission for Cologuard.

The first module, the manufacturing module, is anticipated in December. The second module, the analytical module, will follow in February. In March top-line results from the trial are expected, and a clinical module will then be submitted to FDA.

Conroy also said that the company expects an expedited review of its submission, and it expects CMS to issue a national coverage decision in parallel with the FDA submission, which would result in a coverage, coding, and payment decision by CMS within three months of FDA's decision.

"This parallel review, we believe, differentiates us from other diagnostic tests and many other medical devices in that we expect to have FDA approval" and broad CMS reimbursement efforts "shortly after FDA approval and at the time of launch," Conroy said. "This is important because nearly 50 percent of our intended patient population are covered by Medicare."

The company has also identified as a new market opportunity the detection of colon cancer and precancer in the inflammatory bowel disease cancer population, Conroy said. The test that Exact Sciences plans for this market uses the current biomarkers and system used for Cologuard, and a recent Mayo Clinic study on a small sample population found 100 percent cancer sensitivity, 80 percent precancer sensitivity, and 89 percent specificity.

"We believe that this is a significant market opportunity because today [only] about half of patients with IBD get screened," Conroy said. The company plans to get IRB approval by the end of this year and to begin enrolling patients in the first quarter of 2013.

The Madison, Wis.-based molecular diagnostics firm said that its net loss in the third quarter increased to $13 million, or $.21 per share, from a net loss of $7.8 million, or $.15 per share, a year ago. The average analyst net-loss-per share estimate was $.21.

Exact Sciences had $12.7 million in cash and cash equivalents at the end of the quarter. It also had $105.9 million in marketable securities. In August the company raised $57.8 million in a public offering.

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