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Nanosphere's FY 2010 Revenues Drop 9 Percent

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Nanosphere reported after the close of the market Wednesday that its full-year 2010 revenues declined 9 percent to $2 million from $2.2 million.

The Northbrook, Ill.-based molecular diagnostics developer fell short of analysts' consensus estimate of $2.4 million in revenues for the year.

Its product sales increased to $1.4 million from $1.1 million year over year, while its grant and contract revenue fell to $610,000 from $1.1 million.

Nanosphere's net loss for the year was $40.6 million, or $1.46 per share, compared to a net loss of $33.9 million, or $1.46 per share, for FY 2009.

Its R&D spending inched up 1 percent to $18.8 million from $18.6 million, and its SG&A expenses increased 52 percent to $22 million from $14.5 million.

The firm said its increased costs year over year were driven entirely by a patent dispute with Eppendorf. It settled that dispute for $4 million in August, and as a result acquired certain patents and the patent rights on a global basis.

"The investments we made in 2010 and continue to make in new product development, menu expansion and preparations for launch in international markets will begin to pay dividends in 2011," Nanosphere President and CEO William Moffitt said in a statement. "We are very pleased to be turning the corner from development to commercialization and growth in 2011."

The firm recently received 510(k) clearance from the US Food and Drug Administration for its Verigene Respiratory Virus Plus Nucleic Acid Test, which runs on the Verigene molecular diagnostics system.

"The drivers of new customer placements and revenue this year include the newly released respiratory virus assay with subtyping, the 2C19 assay for Plavix metabolism, and launch of our product line in Europe and Asia throughout the course of the year," Moffitt said during a conference call following the release of the financial results.

He cited numerous catalysts for revenue growth and market expansion in 2012 and beyond, including a bloodstream infection assay that it intends to file for FDA clearance around the middle of 2011, which is expected to generate incremental revenue at the beginning of 2012. In addition, Moffitt said the firm would seek a CE Mark for the product this year.

"There is significant demand for this product both here in the US and in Europe," he said.

Nanosphere also is developing a C. difficile assay and an enteric assay that it aims to bring to market in 2012.

The firm also expects to file for FDA clearance of its troponin assay this summer, and it expects a product launch in the first part of 2012. "We've seen a lot of change in the troponin market over the last couple of years, and the need for more sensitive assays has never been better understand," said Moffitt.

He said published articles have pointed to the need for troponin testing not only for triage of chest pain patients but identification of the earliest stages of cardiovascular disease. Moffitt also said that some publications have cited the potential of an ultra-sensitive troponin assay in managing patients with chronic heart failure, which would be "an entirely new application for this assay."

Nanosphere did not provide revenue figures for its fourth quarter, but based on the numbers provided for its previous quarters this year, its revenues would be around $310,000 for the three months ended Dec. 31. For Q4 2009, it had reported revenues of $828,000.

It noted that its Q4 2010 net loss was $7.4 million, down from $9.1 million in Q4 2009.

The firm finished the year with $39.6 million in cash and cash equivalents.

in early Thursday trade on the Nasdaq, shares of Nanosphere were unchanged at $3.50.

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