GenMark Diagnostics Reports Preliminary Fourth Quarter And Fiscal Year 2011 Results

GenMark Diagnostics, Inc. (Nasdaq:GNMK) today reported preliminary financial results for the fourth quarter and fiscal year ended December 31, 2011. The Company will release its full financial statements and related disclosures along with its Form 10-K filing for the period ending December 31, 2011 upon completion of its independent audit, which includes the Company’s first Sarbanes-Oxley audit of internal controls, by March 15, 2012.

Revenues for the quarter ending December 31, 2011 were $2.0 million compared with $805,000 during the fourth quarter of 2010. The 148% year-over-year increase in total revenue reflects an increase in the number of systems in the field, growth in test menu and a significant increase in the number of tests sold. Reagent revenues for the fourth quarter grew 159% year over year to $1.8 million from $695,000. Instrument and other revenues increased by 104% year over year to $224,000 from $110,000 due mainly to capital sales of instruments. The Company placed 26 net analyzers during the quarter, bringing the installed base to 167, all in end-user laboratories within the U.S. market.

Gross profit for the quarter ending December 31, 2011 is expected to be between 17% and 20% of sales, compared with a gross loss of $0.8 million and negative 100% for the same period in 2010. The improvement to positive gross profit was largely driven by three factors. First, the significant increase in volume allowed for the absorption of fixed manufacturing overhead costs. Second, a number of previously disclosed manufacturing inefficiencies were resolved and this resulted in significantly better and sustainable yields. Third, capital sales of several depreciated instruments improved the gross margin mix. Excluding the favorable gross margin mix, the gross profit during the fourth quarter would have been 12% to 15% of revenue.

For the fiscal year ending December 31, 2011, revenues increased 92%, from $2.6 million in 2010 to $5.0 million in 2011, and gross margin turned from negative to positive during the latter half of the year. Two new assays were introduced during the year: a Hepatitis C Virus genotyping RUO test and a multiplexed Respiratory Viral Panel, the latter of which has been submitted to the FDA for 510(k) clearance. The Company placed 85 net analyzers during the year, bringing the total installed base to 167, and reagent annuity per analyzer increased from $30,000 to $50,000.

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