GenMark Diagnostics fourth quarter revenues increase to $2.0M

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.

The Company ended 2011 with $30.3 million in cash and short-term investments, reflecting the cash proceeds from the follow-on offering completed during the year. The Company intends to continue utilizing its cash balances to invest in new product and menu development, including the development of its NexGen platform, and for infrastructure improvements and general corporate purposes.

"With a continued focus on execution in the fourth quarter of 2011, we achieved strong revenue growth and made significant progress across all operational areas," commented Hany Massarany, GenMark's President and CEO. "During the quarter we significantly improved our manufacturing operations and achieved a positive gross margin on sharply higher revenue. We also submitted our Respiratory Viral Panel to the FDA, with an expectation of 510(k) clearance in 2012. We continued to work diligently on developing our NexGen platform, while at the same time growing our installed XT-8 base to 167 analyzers and our annuity per analyzer to more than $50,000. In 2012 we will maintain our focus on execution across new product development, commercial operations and infrastructure development," Mr. Massarany further stated.

For 2012, the Company expects revenue to grow by more than 100% over 2011 levels to greater than $10 million, with a disproportionate amount of the revenue occurring in the back end of the year due to the seasonality of the flu season. In addition, the Company expects to significantly grow the installed base in 2012 by placing in excess of 100 analyzers in customer laboratories. Gross margin is expected to remain positive throughout 2012 with improvements commensurate with anticipated volume growth. Lastly, the Company plans to introduce two to three new assays in 2012 and will continue to invest heavily in its NexGen platform development.