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Nanosphere's Q2 Loss Rises on Expenses

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Nanosphere reported after the close of the market Thursday that its second-quarter revenues increased around 28 percent, but its net loss jumped 64 percent on higher spending.

The Northbrook, Ill.-based molecular diagnostics firm brought in total revenues of $516,803 for the three-month period ended June 30, up from $402,237 for the second quarter of 2009. It fell short of analysts' consensus estimate for revenues of $880,000.

"We continue to make progress against our milestones for expanding the test menu for the Verigene System," Nanosphere President and CEO William Moffitt said in a statement. "The tests in development address critical market needs, ranging from faster, more accurate infectious disease assays to pharmacogenetic assays, where testing at the point-of-care that enables timely and accurate therapy is becoming increasingly important."

Nanosphere's net loss climbed to $13.8 million, or $.50 per share, from $8.4 million, or $.38 per share, on increased costs.

The firm's R&D expenses rose slightly to $4.6 million from $4.4 million, while its SG&A spending jumped to $9.1 million from $3.7 million.

Nanosphere said the increase was primarily due to a $3.5 million contingency reserve and $1.5 million in litigation expenses related to a patent dispute with Eppendorf. It also noted that it is engaged in settlement talks with Eppendorf and has recorded a contingency reserve associated with the potential settlement of the litigation.

Eppendorf filed the suit last year, alleging that Nanosphere has willfully infringed on a patent covering its Silverquant microarray technology. Moffitt said during a conference call following the release of the results that if a settlement is not reached, Nanosphere is prepared to continue to defend against the litigation.

Nanosphere finished the quarter with $57.7 million in cash and cash equivalents.

During the call, Moffitt provided an update on the firm's pipeline of molecular diagnostic tests.

"We are about to file a PMA with the FDA for our 2C19 assay used to guide anti-platelet therapy using clopidogrel, more commonly known by the brand name Plavix," Moffitt said. He said that the firm intends to file for clearance this month.

In addition, Moffitt said that Nanosphere has started clinical trials on an expanded respiratory viruses panel. The new panel will contain influenza A and B, respiratory syncytial virus A and B, and subtyping for seasonal H1, seasonal H3, and the 2009 novel H1N1, as well as viral mutations leading to Tamiflu (oseltamivir) resistance. It expects to file for 510(k) clearance of the panel in the fourth quarter, said Moffitt.

Nanosphere recently withdrew a 510(k) application for its cardiac troponin assay, but it plans to submit a new 510(k) using a different predicate device, said Moffitt. He noted that the original application was based on the Beckman Coulter AccuTnI assay, which earlier this year ran into problems with a positive bias when run on Beckman's UniCel DxI Immunoassay Systems.

Moffitt said that the firm is taking the time to migrate the assay to its newest platform, the Verigene SP, which will enable customers to co-locate cardiac troponin testing and the CYP2C19 assay using one common instrument platform.

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