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,
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
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
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
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.
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.
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.
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