Second Quarter Revenue Increased 64% Versus
Prior Year to $12.5 millionePlex® Systems
Installed at Twelve European CustomersePlex FDA Submission
Expected in Fourth Quarter
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading
provider of automated, multiplex molecular diagnostic testing
systems, today announced financial results for the second quarter
ended June 30, 2016.
Revenue for the second quarter of 2016 was $12.5 million, an
increase of 64% over the prior year period.
Gross profit for the second quarter of 2016 was $7.8 million, or
62% of revenue, compared with $4.4 million, or 57% of revenue in
the same period of 2015.
“XT-8 continues to deliver strong results. Our second quarter
revenues were once again mainly driven by our infectious disease
menu and reflected the unusually late 2015/16 flu season,” said
Hany Massarany, President and Chief Executive Officer of GenMark.
“Over the past few weeks, we installed ePlex systems in several
European customer sites. Initial feedback has been very positive,
confirming the ease of use of the ePlex platform, its intuitive
user interface and comprehensive reporting capabilities.
Furthermore, we have installed ePlex systems at all of our U.S.
clinical trial sites. These sites are on track to initiate clinical
studies for our ePlex respiratory pathogen (RP) panel this quarter,
and we expect to submit our ePlex instrument and RP panel for FDA
510(k) clearance during fourth quarter,” added Massarany.
Operating expenses for the second quarter of 2016 were $20.4
million compared to $16.3 million in the same period for 2015. The
increase was mainly driven by research and development expenses as
efforts continued towards the launch of ePlex.
Loss per share was $0.30 per share for the second quarter of
2016 compared to a loss of $0.29 per share in the same period of
2015.
The Company ended the quarter with $37.5 million in cash and
cash equivalents and intends to continue utilizing its cash
balances to invest in the global commercialization of the ePlex
system. The Company’s existing debt facility can provide up to an
additional $20 million to support the launch of ePlex
internationally as well as domestically.
Business Outlook
For full year 2016, the Company continues to expect revenue in
the range of $47 to $51 million while gross margin expectations
have increased to 57% to 59%.
The Company will host a conference call to discuss second
quarter results in further detail on Thursday, July 28, 2016
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 47375589
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 FDA
clearance and 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, 2016 2015
Current assets Cash and cash equivalents $ 29,561 $ 35,385
Marketable securities 7,939 10,080 Accounts receivable, net of
allowances of $2,751 and $2,727, respectively 5,417 6,847
Inventories 2,614 3,054 Prepaid expenses and other current assets
1,315 591
Total current assets
46,846 55,957 Property and equipment, net 12,654 11,396 Intangible
assets, net 2,188 2,376 Restricted cash 758 758 Other long-term
assets 177 180
Total assets $
62,623 $ 70,667
Current liabilities Accounts
payable $ 6,106 $ 4,376 Accrued compensation 4,616 3,861 Current
portion of long-term debt 2,920 (373 ) Other current liabilities
2,238 2,725
Total current
liabilities 15,880 10,589
Long-term liabilities Deferred
rent 1,378 1,257 Long-term debt 16,737 9,890 Other non-current
liabilities 183 334
Total
liabilities 34,178 22,070
Stockholders’ equity Preferred stock, $0.0001 par value;
5,000 authorized, none issued — — Common stock, $0.0001 par value;
100,000 authorized; 42,994 and 42,551 shares issued and outstanding
as of June 30, 2016 and December 31, 2015, respectively 4 4
Additional paid-in capital 358,938 353,233 Accumulated deficit
(330,535 ) (304,669 ) Accumulated other comprehensive income
38 29
Total stockholders’ equity
28,445 48,597
Total liabilities and
stockholders’ equity $ 62,623 $ 70,667
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, 2016
2015 2016 2015
Revenue Product revenue $ 12,425 $ 7,550 $ 23,384 $ 17,562
License and other revenue 87 96
192 191
Total revenue 12,512 7,646
23,576 17,753 Cost of revenue 4,720 3,286
9,095 7,278
Gross profit
7,792 4,360 14,481 10,475
Operating expenses Sales and
marketing 3,300 3,704 7,009 7,397 General and administrative 3,876
3,662 7,296 7,332 Research and development 13,204
8,924 25,472 17,703
Total operating expenses 20,380 16,290
39,777 32,432
Loss from
operations (12,588 ) (11,930 ) (25,296 )
(21,957 )
Other income (expense) Interest income 26
33 55 69 Interest expense (308 ) (245 ) (585 ) (317 ) Other income
(42 ) (11 ) (9 ) 206
Total
other income (expense) (324 ) (223 ) (539
) (42 )
Loss before provision for income taxes
(12,912 ) (12,153 ) (25,835 ) (21,999 ) Income tax (benefit)
expense (5 ) (1 ) 31 22
Net loss $ (12,907 ) $ (12,152 ) $ (25,866 ) $ (22,021 ) Net
loss per share, basic and diluted $ (0.30 ) $ (0.29 ) $ (0.60 ) $
(0.53 ) Weighted average number of shares outstanding, basic and
diluted 42,864 42,091 42,768
41,934
Other comprehensive loss Net
loss $ (12,907 ) $ (12,152 ) $ (25,866 ) $ (22,021 ) Foreign
currency translation adjustments (34 ) — 13 9 Net unrealized losses
on marketable securities, net of tax (5 ) 1
(21 ) (16 )
Comprehensive loss $ (12,946 ) $
(12,151 ) $ (25,874 ) $ (22,028 )
GENMARK DIAGNOSTICS, INC. UNAUDITED CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands)
Six Months Ended June 30,
2016 2015 Operating
activities Net loss $ (25,866 ) $ (22,021 ) Adjustments to
reconcile net loss to net cash used in operating activities:
Depreciation and amortization 1,791 1,632 Amortization of premiums
on investments 35 126 Amortization of deferred debt issuance costs
169 116 Gain on sale of investment in preferred stock — (223 )
Stock-based compensation 4,540 4,823 Provision for bad debt 23 —
Non-cash inventory adjustments 92 543 Other non-cash adjustments 19
15 Changes in operating assets and liabilities: Accounts receivable
1,406 1,331 Inventories 306 (246 ) Prepaid expenses and other
assets (721 ) (472 ) Accounts payable 1,289 (1,212 ) Accrued
compensation 1,119 (231 ) Other liabilities 303
(39 )
Net cash used in operating
activities
(15,495 ) (15,858 )
Investing activities
Payments for intellectual property licenses (800 ) (550 ) Purchases
of property and equipment (2,404 ) (2,243 ) Purchases of marketable
securities (2,532 ) (14,797 ) Proceeds from sales of marketable
securities — 223 Maturities of marketable securities 4,650
17,850
Net cash provided by (used in)
investing activities
(1,086 ) 483
Financing activities
Proceeds from issuance of common stock 449 427 Principal repayment
of borrowings (17 ) (10 ) Proceeds from borrowings 10,000 10,000
Costs associated with debt issuance (30 ) (718 ) Proceeds from
stock option exercises 352 894
Net
cash provided by financing activities 10,754
10,593
Effect of exchange rate changes on cash
3 2
Net decrease in cash and cash equivalents (5,824 )
(4,780 ) Cash and cash equivalents at beginning of period
35,385 36,855 Cash and cash equivalents at end
of period $ 29,561 $ 32,075
Non-cash investing and
financing activities Transfer of instruments from property and
equipment to inventory $ 42 $ 127 Property and equipment costs
included in accounts payable $ 588 $ 303
Supplemental cash flow
disclosures Cash paid for income taxes, net $ 13 $ 15 Cash
received for interest $ 51 $ 196 Cash paid for interest $ 408 $ 317
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version on businesswire.com: http://www.businesswire.com/news/home/20160728006545/en/
GenMark Diagnostics, Inc.Hany Massarany,
760-448-4325President/Chief Executive Officer
GenMark Diagnostics (NASDAQ:GNMK)
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