Third Quarter Revenue of $8.5 Million, Up
34% Versus Prior YearXT-8 Installed Base Expanded by 25 to
616European ePlex™ Launch Now Expected in the First Quarter
of 2016External ePlex Studies Recently Commenced at the
First Customer Site
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading
provider of automated, multiplex molecular diagnostic testing
systems, today reported third quarter 2015 financial results.
Revenue for the third quarter of 2015 was $8.5 million, an
increase of 34% over the prior year period. During the quarter, 25
additional XT-8 analyzers were placed in end-user laboratories,
resulting in a total installed base of 616 analyzers within the
U.S. market.
Gross profit for the third quarter was $5.1 million, or 60% of
revenue, compared with $3.7 million, or 59% of revenue in the same
period of 2014.
“We are pleased with the continued strong performance of our
XT-8 business and the progress we are making towards the European
launch of our ePlex sample-to-answer system in the first quarter of
2016,” said Hany Massarany, President and Chief Executive Officer
of GenMark. “We recently commenced external ePlex Alpha studies at
the first customer site. We also tested numerous clinical samples
on the ePlex system at GenMark and will be presenting results from
these studies at The Association of Molecular Pathology Conference
in Texas next week,” added Massarany.
Operating expenses for the third quarter of 2015 were $16.2
million compared to $14.0 million in the same period of 2014. The
16% increase was mainly driven by personnel related expenses across
the organization as the Company prepares for the upcoming launch of
the ePlex system.
Loss per share was $0.27 per share for the third quarter of 2015
compared to a loss of $0.23 per share in the same period of
2014.
The Company ended the quarter with $54.2 million in cash and
cash equivalents and intends to continue utilizing its cash
balances to invest in the global commercialization of the ePlex
system.
Business Outlook
For full year 2015, the Company continues to expect revenue in
the range of $38 to $40 million and gross margin of 57% to 59%. The
Company now expects to place more than 90 XT-8 analyzers for the
full year.
The Company will be hosting a conference call to discuss third
quarter 2015 results in further detail on Tuesday, October 27, 2015
starting at 4:30 p.m. Eastern Time. The conference call will be
concurrently webcast. The link to the webcast will be available on
the GenMark Diagnostics, Inc. website at www.genmarkdx.com 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 62237999
approximately five minutes prior to the start time.
ABOUT GENMARK DIAGNOSTICS
GenMark Diagnostics (NASDAQ: GNMK) 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-8TM 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. The eSensor detection technology is
also incorporated into GenMark’s sample-to-answer system, ePlexTM.
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 the timely
commercialization of our ePlex system and our future financial
performance, are all subject to risks and uncertainties that could
cause our actual results and financial position to differ
materially. Some of these risks and uncertainties include, but are
not limited to, our ability to successfully commercialize our ePlex
system and its related test menu in a timely manner, constraints or
inefficiencies caused by unanticipated acceleration and
deceleration of customer demand, our ability to successfully expand
sales of our product offerings outside the United States, and
third-party payor reimbursement to our customers, 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.
GENMARK DIAGNOSTICS, INC. UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except
par value) September 30, 2015 December
31, 2014 Current assets Cash and cash equivalents
$ 34,212 $ 36,855 Marketable securities 19,966 33,651 Accounts
receivable, net of allowances of $2,702 and $2,702, respectively
4,332 4,889 Inventories 2,714 2,137 Prepaid expenses and other
current assets 874 575
Total current assets 62,098 78,107
Property and equipment, net 11,557 11,052 Intangible assets, net
2,470 1,870 Restricted cash 758 758 Other long-term assets 184 183
Total assets $ 77,067 $ 91,970
Current liabilities
Accounts payable $ 4,893 $ 5,126 Accrued compensation 4,885 5,172
Other current liabilities 1,695 1,995
Total current
liabilities 11,473 12,293
Long-term liabilities Deferred
rent 1,308 1,445 Long-term debt 9,794 — Other non-current
liabilities 249 208
Total liabilities 22,824 13,946
Stockholders’ equity Preferred stock, $0.0001 par value;
5,000 authorized, none issued — — Common stock, $0.0001 par value;
100,000 authorized; 42,445 and 41,859 shares issued and outstanding
as of September 30, 2015 and December 31, 2014, respectively 4 4
Additional paid-in capital 350,124 340,502 Accumulated deficit
(295,887) (262,472) Accumulated other comprehensive income 2 (10)
Total stockholders’ equity 54,243 78,024
Total
liabilities and stockholders’ equity $ 77,067 $ 91,970
GENMARK DIAGNOSTICS, INC. UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (In
thousands, except per share data) Three Months
Ended Nine Months Ended September 30,
September 30, 2015 2014
2015 2014 Revenue Product
revenue $ 8,382 $ 6,233 $ 25,944 $ 20,593 License and other revenue
90 67 281 175
Total revenue 8,472 6,300 26,225 20,768 Cost
of revenue 3,352 2,609 10,630 9,300
Gross profit 5,120 3,691
15,595 11,468
Operating expenses Sales and marketing 3,587
3,159 10,984 9,516 General and administrative 3,061 2,900 10,393
9,051 Research and development 9,589 7,904 27,292 23,297
Total
operating expenses 16,237 13,963 48,669 41,864
Loss from
operations (11,117) (10,272) (33,074) (30,396)
Other income
(expense) Interest income 30 45 99 206 Interest expense (289)
(14) (607) (18) Other income (expense) (14) (33) 193 (34)
Total
other income (expense) (273) (2) (315) 154
Loss before
provision for income taxes (11,390) (10,274) (33,389) (30,242)
Income tax expense (benefit) 4 (616) 26 (591)
Net loss $
(11,394) $ (9,658) $ (33,415) $ (29,651) Net loss per share, basic
and diluted $ (0.27) $ (0.23) $ (0.79) $ (0.72) Weighted average
number of shares outstanding, basic and diluted 42,312 41,446
42,061 41,273
Other comprehensive loss Net loss $ (11,394) $
(9,658) $ (33,415) $ (29,651) Foreign currency translation
adjustments (1) — 8 — Net unrealized gains (losses) on marketable
securities, net of tax (4) (3) (20) 6
Comprehensive loss $
(11,399) $ (9,661) $ (33,427) $ (29,645)
GENMARK
DIAGNOSTICS, INC. UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS (In thousands) Nine
Months Ended September 30, 2015 2014
Operating activities Net loss $ (33,415) $ (29,651)
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation and amortization 2,500 1,870 Amortization
of premiums on investments 157 577 Amortization of deferred debt
issuance costs 199 — Gain on sale of investment in preferred stock
(223) — Stock-based compensation 7,347 4,478 Non-cash inventory
adjustments 567 517 Other non-cash adjustments 9 — Changes in
operating assets and liabilities: Accounts receivable 557 151
Inventories (980) 209 Prepaid expenses and other assets (320) (691)
Accounts payable (358) (318) Accrued compensation 575 1,757 Other
liabilities (295) (1,131)
Net cash used in operating
activities (23,680) (22,232)
Investing activities
Payments for intellectual property licenses (550) (350) Purchases
of property and equipment (2,868) (3,699) Purchases of marketable
securities (14,797) (28,054) Proceeds from sales of marketable
securities 223 7,497 Maturities of marketable securities 28,350
36,250
Net cash provided by investing activities 10,358
11,644
Financing activities Proceeds from issuance of common
stock 427 373 Principal repayment of borrowings (15) (51) Proceeds
from borrowings 10,000 — Costs associated with debt issuance (718)
— Proceeds from stock option exercises 986 201
Net cash provided
by financing activities 10,680 523
Effect of exchange rate
changes on cash (1) —
Net decrease in cash and cash
equivalents (2,643) (10,065) Cash and cash equivalents at
beginning of period 36,855 35,723 Cash and cash equivalents at end
of period $ 34,212 $ 25,658
Non-cash investing and financing
activities Transfer of instruments from property and equipment
to inventory $ 165 $ 156 Property and equipment costs included in
accounts payable $ 248 $ 364 Intellectual property acquisitions
included in other current liabilities $ 800 $ 550
Supplemental
cash flow disclosures Cash paid for income taxes, net $ 9 $ 27
Cash received for interest $ 256 $ 783 Cash paid for interest $ 607
$ 18
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version on businesswire.com: http://www.businesswire.com/news/home/20151027006742/en/
GenMark Diagnostics, Inc.Hany MassaranyPresident/Chief Executive
Officer760-448-4325
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