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BG Medicine Q2 Revenues Spike; Company Withdraws FDA Submission for CardioScore Test

NEW YORK (GenomeWeb News) – BG Medicine said today that revenues for the second quarter increased 181 percent year over year, surpassing the consensus Wall Street estimates on the top and bottom line.

For the three months ended June 30, the Waltham, Mass.-based company recorded $622,000 in revenues, up from $221,000 a year ago, beating the average analyst estimate of $520,000. Product revenues spiked to $566,000 from $46,000 a year ago, "reflecting increasing demand for the BGM Galectin-3 test," BG Medicine said, while service revenues dropped to $56,000 from $175,000.

The company lowered its R&D spending 13 percent to $2.1 million from $2.4 million, but increased SG&A spending 72 percent to $4.3 million from $2.5 million, due to commercialization efforts associated with the BGM Galectin-3 test, as well as personnel-related costs and expenses from being a public company, BG Medicine said.

The company went public in February 2011.

Its net loss for the period increased to $6.4 million, or $.32 per share, from a net loss of $4.8 million, or $.25 per share, a year ago. On average, analysts had estimated a loss of $.35 per share.

In late 2011 BG Medicine applied for US Food and Drug Administration clearance of its CardioScore, a test for identifying individuals at high risk for near-term cardiovascular events such as a heart attack or stroke. Eric Bouvier, president and CEO of the company, said today that BG Medicine withdrew its 510(k) submission on August 8 after determining it would not be able to respond in full to a request from FDA to confirm certain data from BG Medicine's BioImage validation study for the test.

"The data were originally obtained through medical insurance claims, a method previously validated in numerous peer-reviewed studies," Bouvier said in a statement. "Due to the time involved in the adjudication process, we determined that we would not be able to submit a complete response by the August 15, 2012 deadline.

"We intend to submit a new 510(k) as soon as we are satisfied that the information requested by the FDA is addressed in the new submission," he continued. "We remain very confident about the performance of the CardioScore test, and the submission of a thorough and responsive 510(k) is one of our highest priorities."

BG Medicine finished the quarter with $23.3 million in cash, cash equivalents, and restricted cash.

In Thursday morning trading on the Nasdaq shares of BG were down 6 percent at $6.50.