GenMark Diagnostics Reports Third Quarter 2012 Results

Tools

CARLSBAD, CALIF. — GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today reported financial results for the third quarter ended September 30, 2012.

Revenues for the quarter ending September 30, 2012 were $5.3 million compared with $1.3 million during the third quarter of 2011. The 299% year-over-year increase in total revenue reflects an increase in the number of systems placed at customer sites and a significant increase in the number of tests sold, including as a result of test menu expansion. Reagent revenues for the third quarter grew 339% year-over-year to $5.1 million from $1.1 million. Instrument and other revenues increased by 1% year-over-year to $157,000 from $156,000 due mainly to capital sales of instruments.

The Company placed a net 35 analyzers during the quarter, bringing the total installed base to 255. All of the Company's 255 analyzers have been placed with end-user laboratories within the U.S. market.

Gross profit for the quarter ending September 30, 2012 was $2.2 million, or 42% of revenue, compared with a gross loss of $469,000, or (36%) of revenue for the same period in 2011. The continued improvement in gross profit is the result of significant sales volume increases and manufacturing efficiencies.

Operating expenses increased $2.8 million to $8.5 million during the third quarter of 2012 compared with the third quarter of 2011. Selling, General and Administrative expenses increased $262,000 year-over-year due to the increase in revenue, headcount growth and other corporate expenses. Research and Development expenses increased $2.6 million due to an expansion of the R&D team, menu development for the XT-8 and initial development work on the NexGen platform.

Loss per share was $0.20 for the third quarter of 2012, compared with a loss per share of $0.31 in the third quarter of 2011.

"Our Commercial team delivered another strong quarter. We expanded our installed base to 255 by placing 35 new analyzers in the field. We also significantly grew our reagents business in the third quarter by adding new customers, as well as expanding menu utilization and revenue with existing customers," stated GenMark's President & CEO Hany Massarany. "Furthermore, we accomplished several key product development goals in the quarter, including launching our FDA cleared RVP Test, as well as successfully showing a prototype of our NexGen sample-to-answer system at the Association for Molecular Pathology (AMP) meeting at the end of October."

The Company ended the third quarter of 2012 with $57.0 million in cash, cash equivalents and restricted cash. 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.

YEAR-TO-DATE 2012

Revenue for the first nine months of 2012 was $11.0 million, compared to $3.0 million for the prior year period, an increase of 271%. Reagent revenue for the first nine months of 2012 was $10.4 million, compared to $2.6 million for the prior year period, and instrument and other revenue for the first nine months of 2012 was $538,000 compared to $382,000 for the prior year period. Based on YTD results, the company has raised FY 2012 revenue guidance to in excess of $18 million.

Net loss for the first nine months of 2012 was $17.4 million, or $0.71 loss per share, compared to net loss of $18.5 million, or $1.20 loss per share, for the prior year period.

INVESTOR CONFERENCE CALL

GenMark will hold a conference call to discuss third quarter 2012 results and the outlook for 2012 at 9:00 AM EST tomorrow, Thursday, November 8. The conference call and webcast can be accessed live through the Company's website under the Investor Relations section and will be archived for future reference. To listen to the conference call, please dial (877) 312-5847 (US/Canada) or (253) 237-1154 (International) and use the conference ID number 47091443 approximately five minutes prior to the start time.

ABOUT GENMARK

GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark's proprietary eSensor® detection technology, GenMark's eSensor® XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets four tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Respiratory Virus Panel, Thrombophilia Risk Test, and Warfarin Sensitivity Test. A number of other tests, including HCV Genotyping and 2C19 are in development. For more information, visit www.genmarkdx.com.

SAFE HARBOR STATEMENT

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our growth strategy, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially from those expressed or implied by such statements. Some of these risks and uncertainties include, but are not limited to, our research and development plans and timelines, including with respect to our NexGen platform, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection of our intellectual property rights, and regulatory uncertainties regarding approval or clearance for our products, as well as other risks and uncertainties described under the "Risk Factors" in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.