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Snippets: Apr 1, 2009

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Epigenomics' 2008 Revenues Flat Year over Year; Net Loss Declines

German molecular diagnostics firm Epigenomics this week reported fiscal-year 2008 revenues of €2.6 million (US$3.4 million), flat with revenues of €2.6 million for 2007.

The company's FY 2008 net loss dropped 7 percent to €12.3 million, or €.47 per share, from €13.2 million, or €.74 per share.

The firm noted that its R&D costs declined 5 percent to €10 million from €10.5 million year over year.

Epigenomics said that it and Abbott are in the final stages of development and clinical validation of the firm's mSEPT9 assay for colorectal cancer. The test is on track for a fourth-quarter 2009 launch in Europe followed by a filing for US approval that is planned for 2010, said Epigenomics.

The Berlin-based firm also has a partnership with clinical lab giant Quest Diagnostics to develop and launch a laboratory-developed test version of the mSEPT9 assay.

Epigenomics finished the year with €12.1 million in liquid assets.


Response Genetics Cites Delay in Test Samples for Q4 Revenue Decline

Response Genetics reported last week that its fourth-quarter revenues fell 41 percent due primarily to a delay in receiving clinical samples from pharmaceutical customers.

The Los Angeles-based molecular diagnostics test developer and lab operator reported revenues of $1.4 million for the three-month period ended Dec. 31, compared to revenues of $2.4 million for the fourth quarter of 2007. The company said that it anticipates receiving those delayed clinical samples in 2009 through 2010.

Response Genetics posted a net loss of $3.4 million, or $.33 per share, versus a loss of $911,555, or $.09 per share, for the fourth quarter of 2007.

The company's R&D expenses dropped to $436,736 from $566,293, while its general and administrative spending climbed to $2.3 million from $1.3 million year over year.

Response Genetics also recognized an impairment charge of $893,826 related to its UK facility, which it closed in order to consolidate operations at its CLIA-certified lab in Los Angeles.

For full-year 2008, Response Genetics brought in revenues of $7.1 million, down 9 percent from revenues of $7.8 million for 2007. Its net loss for the year rose 86 percent to $9.5 million, or $.93 per share, from $5.1 million, or $.78 per share.

The firm's R&D expenses for 2008 fell to $2.2 million from $2.5 million, and its general and administrative spending jumped to $7.9 million from $5.2 million.

"Sales of our ResponseDX diagnostic tests are off to a promising start in 2009 with approximately 500 tests processed in the first quarter compared to approximately 300 tests processed in the fourth quarter of 2008 — a 60 percent increase in tests processed," Kathleen Danenberg, president and CEO of Response Genetics, said in a statement.

Response Genetics finished the year with $9.5 million in cash and cash equivalents.


Exact Sciences Cuts Q4 Loss on Reduce Costs

Exact Sciences reported this week that its fourth-quarter net loss shrunk by nearly half on reduced spending.

The Marlborough, Mass.-based molecular diagnostics developer brought in license fees of $338,000 for the quarter compared to $337,000 in license fees for the fourth quarter of 2007. The fourth quarter of 2007 also included product sales of $6,000 compared to none for Q4 2008.

During the quarter, Exact made a roughly $450,000 payment to Laboratory Corporation of America under a royalty obligation compared to a comparable payment of nearly $1 million in Q4 2007.

Exact's net loss for the fourth quarter of 2008 was $2.1 million, or $.08 per share, compared to a net loss of $4 million, or $.15 per share, for Q4 2007. The reduction in its net loss was due primarily to lower spending.

Exact's R&D spending dropped to $70,000 in the quarter from $1.3 million for the fourth quarter of 2007, while its SG&A spending dropped slightly to $1.9 million from $2 million.

For full-year 2008, Exact had revenues of $1.4 million compared to $2.9 million for 2007. The firm said that the revenue decline was due to a $1.5 million reduction in non-cash license fee amortization revenues in 2008 compared to the prior year.

The company recorded a charge of $2.2 million in 2008 related to its third-party royalty obligation to LabCorp compared to a similar charge of $1.1 million in 2007.

Exact's 2008 net loss was $9.7 million, or $.36 per share, compared to a 2007 net loss of $12 million, or $.44 per share.

The firm finished the year with $4.9 million in unrestricted cash and cash equivalents.

In January, Exact sold to Genzyme certain intellectual property assets related to the fields of prenatal and reproductive health in a deal that is expected to provide the firm with a cash infusion of $24.5 million. The deal helped the firm fend off a hostile takeover attempt by Sequenom.

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Gain of Oversight

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