Third Quarter Revenue of $8.5 Million, Up 34% Versus Prior Year
XT-8
Installed Base Expanded by 25 to 616
European ePlex™
Launch Now Expected in the First Quarter of 2016
External
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
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20151027006742/en/
Copyright Business Wire 2015