The story has been updated to include comments from the company's earnings conference call.
NEW YORK (GenomeWeb News) – Exact Sciences today reported that revenues for the second quarter dropped 23 percent year over year.
For the three months ended June 30, the company posted receipts of $1.0 million, down from $1.3 million a year ago, but in line with Wall Street estimates. Almost all of the drop-off came from its licensing-related revenues, which make up the vast majority of the company's revenues, while product royalty revenues retreated 14 percent to $6,000 from $7,000.
R&D spending more than doubled to $5.2 million from $2.1 million in the second quarter of 2010. SG&A spending spiked 47 percent to 2.5 million from $1.7 million a year ago.
Last month, the company initiated the clinical trial for its Cologuard colorectal cancer screening test. In a statement today, Kevin Conroy, president and CEO of Exact Sciences, said, "We are now focused on the trial's successful completion and delivering to market a patient-friendly screening test that enables the early detection of the disease," he said.
On a conference call following the release of the firm's earnings, Conroy reiterated that about 10,000 patients, and possibly more, will be enrolled in the clinical trial, which is expected to take between 12 and 15 months to complete.
Preparation for a submission to the US Food and Drug Administration is expected to take another three months, and will include analytical studies, which would put Exact Sciences' pre-market approval application to the agency for Cologuard in the fourth quarter of 2012, Conroy said.
He also said that the final biomarker panel for the test has been set. They include NDRG4 for the detection of hypermethylation, which along with BMP3, also for hypermethylation detection, form the "bedrock" for the test, Conroy said.
The other biomarkers include seven point mutations in the KRAS gene; quantitative beta-actin; and quantitative hemoglobin FIT.
The company is ahead of its internal schedule in developing an automation solution, which will perform DNA extraction and plate setup for incubation and detection.
"Our goal is to make the processing of the patient samples as simple and lab-friendly as possible and as robust as possible," Conroy said.
Net loss for the quarter shot up 164 percent to $6.6 million, or $.013 a share, from $2.5 million, or $.06 a share, from a year ago, and missed analyst estimates of a loss of $.10 a share.
Exact Sciences ended the quarter with $38.3 million in cash and cash equivalents.
In late afternoon trading on Nasdaq, shares of Exact Sciences were down nearly 7 percent to $8.09.