Second Quarter Revenue of $7.6 Million, Up
17% Versus Prior Year
XT-8 Installed Base Expanded by 29 to
591
European ePlex™ Launch Expected by the End
of Fourth Quarter 2015
Full Year Revenue Guidance Maintained at
$38-40 Million; Gross Margin Increased to 57-59%
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading
provider of automated, multiplex molecular diagnostic testing
systems, today reported second quarter 2015 financial results.
Revenue for the second quarter of 2015 was $7.6 million, an
increase of 17% over the prior year period. During the quarter, 29
additional XT-8 analyzers were placed in end-user laboratories,
resulting in a total installed base of 591 analyzers within the
U.S. market.
Gross profit for the second quarter was $4.4 million, or 57% of
revenue, compared with $3.5 million, or 53% of revenue in the same
period of 2014.
“We are pleased with the continued robust performance of our
XT-8 business. Revenue, gross margin and new analyzer placements
were all strong in the second quarter,” said Hany Massarany,
President and Chief Executive Officer of GenMark. “Concurrently, we
remain focused on the transfer of the ePlex cartridge to
manufacturing. We are committed to bringing to market the highest
quality system we can, and establishing the high volume
manufacturing processes necessary to support the clinical studies
and European launch. We have made solid progress in the quarter and
expect the European launch of ePlex by the end of the fourth
quarter,” added Massarany.
Operating expenses for the second quarter of 2015 were $16.3
million compared to $14.7 million in the same period of 2014. The
11% 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 $0.29 per share for the second quarter of
2015 compared to a loss of $0.27 per share in the same period of
2014.
The Company ended the quarter with $62.6 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. Gross margin expectations for the
full year are being increased to 57% to 59%. The Company expects to
place approximately 25-35 additional XT-8 analyzers in the second
half of the year.
The Company will be hosting a conference call to discuss second
quarter 2015 results in further detail on Thursday, August 6, 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 87665468
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-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. The eSensor detection technology is
also incorporated into GenMark’s sample-to-answer system, ePlex™.
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) June 30, December 31,
2015 2014 Current assets Cash and cash
equivalents 32,075 36,855 Marketable securities 30,487 33,651
Accounts receivable, net of allowances of $2,702 and $2,702,
respectively 3,559 4,889 Inventories 1,966 2,137 Prepaid expenses
and other current assets 1,028 575
Total current
assets 69,115 78,107 Property and equipment, net 11,821 11,052
Intangible assets, net 1,741 1,870 Restricted cash 758 758 Other
long-term assets 182 183
Total assets 83,617
91,970
Current liabilities Accounts payable
4,094 5,126 Accrued compensation 4,081 5,172 Other current
liabilities 1,111 1,995
Total current
liabilities 9,286 12,293
Long-term liabilities Deferred
rent 1,359 1,445 Long-term debt 9,700 — Other non-current
liabilities 255 208
Total liabilities 20,600
13,946
Stockholders’ equity Preferred stock,
$0.0001 par value; 5,000 authorized, none issued — — Common stock,
$0.0001 par value; 100,000 authorized; 42,375 and 41,859 shares
issued and outstanding as of June 30, 2015 and December 31, 2014,
respectively 4 4 Additional paid-in capital 347,509 340,502
Accumulated deficit (284,493 ) (262,472 ) Accumulated other
comprehensive income (3 ) (10 )
Total stockholders’ equity
63,017 78,024
Total liabilities and stockholders’
equity 83,617 91,970
GENMARK
DIAGNOSTICS, INC. UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS (In thousands, except per
share data) Three Months Ended
Six Months Ended June 30, June 30,
2015 2014
2015 2014 Revenue
Product revenue $ 7,550 $ 6,494 $ 17,562 $ 14,360 License and other
revenue 96 61 191
108
Total revenue 7,646 6,555 17,753 14,468 Cost of
revenue 3,286 3,100 7,278
6,691
Gross profit 4,360 3,455 10,475 7,777
Operating expenses Sales and marketing 3,704 3,379 7,397
6,357 General and administrative 3,662 3,218 7,332 6,151 Research
and development 8,924 8,123
17,703 15,393
Total operating expenses
16,290 14,720 32,432
27,901
Loss from operations (11,930 )
(11,265 ) (21,957 ) (20,124 )
Other income
(expense) Interest income 33 74 69 161 Interest expense (245 )
(2 ) (317 ) (4 ) Other income (expense) (11 ) 2
206 —
Total other income
(expense) (223 ) 74 (42 )
157
Loss before provision for income taxes (12,153 )
(11,191 ) (21,999 ) (19,967 ) Income tax expense (benefit)
(1 ) 19 22 26
Net
loss $ (12,152 ) $ (11,210 ) $ (22,021 ) $ (19,993 ) Net loss
per share, basic and diluted $ (0.29 ) $ (0.27 ) $ (0.53 ) $ (0.49
) Weighted average number of shares outstanding, basic and diluted
42,091 41,293 41,934
41,186
Other comprehensive loss Net loss $
(12,152 ) $ (11,210 ) $ (22,021 ) $ (19,993 ) Foreign currency
translation adjustments — — 9 — Net unrealized gains (losses) on
marketable securities, net of tax 1 26
(16 ) 9
Comprehensive loss $ (12,151 )
$ (11,184 ) $ (22,028 ) $ (19,984 )
GENMARK DIAGNOSTICS,
INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS (In thousands) Six Months Ended
June 30, 2015 2014
Operating activities Net loss $ (22,021 ) $ (19,993 )
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation and amortization 1,632 1,167 Amortization
of premiums on investments 126 394 Amortization of deferred debt
issuance costs 116 — Gain on sale of investment in preferred stock
(223 ) — Stock-based compensation 4,823 2,949 Non-cash inventory
adjustments 543 457 Other non-cash adjustments 15 — Changes in
operating assets and liabilities: Accounts receivable 1,331 731
Inventories (246 ) 608 Prepaid expenses and other assets (472 )
(447 ) Accounts payable (1,212 ) (501 ) Accrued compensation (231 )
1,375 Other liabilities (39 ) (259 )
Net cash used
in operating activities (15,858 ) (13,519 )
Investing
activities Payments for intellectual property licenses (550 ) —
Purchases of property and equipment (2,243 ) (2,626 ) Purchases of
marketable securities (14,797 ) (28,200 ) Proceeds from sales of
marketable securities 223 7,497 Maturities of marketable securities
17,850 27,450
Net cash provided by
investing activities 483 4,121
Financing activities
Proceeds from issuance of common stock 427 373 Principal repayment
of borrowings (10 ) (46 ) Proceeds from borrowings 10,000 — Costs
associated with debt issuance (718 ) — Proceeds from stock option
exercises 894 180
Net cash provided
by financing activities 10,593 507
Effect of exchange rate changes on cash 2 —
Net decrease
in cash and cash equivalents (4,780 ) (8,891 ) Cash and cash
equivalents at beginning of period 36,855
35,723 Cash and cash equivalents at end of period $ 32,075
$ 26,832
Non-cash investing and financing
activities Transfer of instruments from property and equipment
to inventory $ 127 $ 113 Property and equipment costs included in
accounts payable $ 303 $ 513 Intellectual property acquisitions
included in other current liabilities $ — $ 900
Supplemental
cash flow disclosures Cash paid for income taxes, net $ 15 $ 26
Cash received for interest $ 196 $ 555 Cash paid for interest $ 317
$ 4
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version on businesswire.com: http://www.businesswire.com/news/home/20150806006324/en/
GenMark Diagnostics, Inc.Hany MassaranyPresident/Chief Executive
Officer760-448-4325
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