First Quarter Revenue Increased 13% Versus
Prior Year to $12.5 million
Over 70 ePlex® Customer
Agreements in Place Totaling More than 100 Analyzers
ePlex Blood Culture Identification Fungal
Pathogen Panel CE Mark Achieved
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of
automated, multiplex molecular diagnostic testing systems, today
announced financial results for the first quarter ended March 31,
2017.
Revenue for the first quarter of 2017 was $12.5 million, an
increase of 13% over the prior year period. Annuity per XT-8
analyzer was $72 thousand in the first quarter and in the mid-$70
thousand range over the last 4 quarters.
Gross profit for the first quarter was $6.2 million, or 49% of
revenue, compared with $6.7 million, or 60% of revenue in the same
period of 2016.
“Customer experience with ePlex has confirmed its superior ease
of use and workflow efficiency, compared with other systems on the
market. We designed ePlex to seamlessly integrate the entire
diagnostic process from test order entry to reporting patient
results,” said Hany Massarany, President and Chief Executive
Officer of GenMark. “Customers are also very positive about our
efforts to expand the ePlex menu, including our three panel
approach to sepsis testing. We recently achieved CE Mark for the
Blood Culture ID Fungal Pathogen Panel and expect the Gram Positive
and Gram Negative Pathogen Panels to follow suit this quarter.
Additionally, our Regulatory and Clinical Affairs teams have been
working very closely with the FDA on our 510(k) submissions for the
ePlex instrument and RP Panel. We have closed out all the questions
raised by the agency during its review process and expect FDA
clearance soon,” added Massarany.
Operating expenses for the first quarter of 2017 were $19.7
million compared to $19.4 million in the same period for 2016. The
increase was mainly driven by Marketing and Sales expenses as the
Company continues to expand its commercial organization in support
of the global ePlex product launch.
Loss per share was $0.30 per share for the first quarter of
2017, which was equal to the loss per share in the first quarter of
2016.
The Company ended the quarter with $24.2 million in cash and
cash equivalents. 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 2017, the Company continues to expect revenue in
the range of $65 to $70 million and gross margin in the range of
48-52%.
The Company will be hosting a conference call to discuss first
quarter results in further detail on Tuesday, May 2, 2017 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 51141106
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 our future financial
performance, the timely commercialization and regulatory clearance
of our ePlex system, and the availability of future financing, 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. CONSOLIDATED
BALANCE SHEETS (In thousands, except par value)
March 31, 2017 December 31, 2016
Current assets Cash and cash equivalents $ 13,178 $ 15,959
Marketable securities 11,007 25,607 Accounts receivable, net of
allowances of $2,749 and $2,740, respectively 7,487 9,048
Inventories 9,019 6,633 Prepaid expenses and other current assets
1,419 1,202
Total current assets 42,110 58,449
Non-current assets Property and equipment, net 18,482 18,268
Intangible assets, net 2,546 2,670 Restricted cash 758 758 Other
long-term assets 179 179
Total assets $ 64,075
$ 80,324
Current liabilities Accounts payable
$ 5,696 $ 8,703 Accrued compensation 4,510 5,650 Loan payable 7,685
7,935 Other current liabilities 3,159 4,133
Total
current liabilities 21,050 26,421
Long-term liabilities
Deferred rent 3,524 3,652 Long-term debt 12,261 11,880 Other
non-current liabilities 186 220
Total
liabilities 37,021 42,173
Stockholders’
equity Preferred stock, $0.0001 par value; 5,000 authorized,
none issued — — Common stock, $0.0001 par value; 100,000
authorized; 47,084 and 46,554 shares issued and outstanding at
March 31, 2017 and December 31, 2016, respectively 5 4 Additional
paid-in capital 396,217 393,322 Accumulated deficit (369,188 )
(355,270 ) Accumulated other comprehensive income 20 95
Total stockholders’ equity 27,054 38,151
Total liabilities and stockholders’ equity $ 64,075
$ 80,324
GENMARK DIAGNOSTICS,
INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands, except per share data) Three Months
Ended March 31, 2017 2016
Revenue Product revenue $ 12,470 $ 10,959 License and other
revenue 65 105
Total revenue 12,535 11,064 Cost of revenue
6,352 4,375
Gross profit 6,183 6,689
Operating expenses Sales and marketing 4,693 3,709 General
and administrative 4,011 3,419 Research and development 11,035
12,269
Total operating expenses 19,739
19,397
Loss from operations (13,556 ) (12,708 )
Other income (expense) Interest income 52 29 Interest
expense (507 ) (277 ) Other income 95 33
Total
other expense (360 ) (215 )
Loss before provision for income
taxes (13,916 ) (12,923 ) Income tax expense 1 35
Net loss $ (13,917 ) $ (12,958 ) Net loss per share, basic
and diluted $ (0.30 ) $ (0.30 ) Weighted average number of shares
outstanding, basic and diluted 46,846 42,672
Other comprehensive
loss Net loss $ (13,917 ) $ (12,958 ) Foreign currency
translation adjustments 91 47 Net unrealized losses on marketable
securities, net of tax (16 ) (17 )
Comprehensive loss $
(13,842 ) $ (12,928 )
GENMARK DIAGNOSTICS,
INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In
thousands) Three Months Ended March 31,
2017 2016 Operating activities Net loss
$ (13,917 ) $ (12,958 ) Adjustments to reconcile net loss to net
cash used in operating activities: Depreciation and amortization
1,217 900 Amortization of premiums on investments 19 16
Amortization of deferred debt issuance costs 151 92 Stock-based
compensation 2,808 2,402 Provision for bad debt 9 29 Non-cash
inventory adjustments 317 75 Other non-cash adjustments (85 ) (49 )
Changes in operating assets and liabilities: Accounts receivable
1,558 1,385 Inventories (3,118 ) 501 Prepaid expenses and other
assets (216 ) — Accounts payable (2,821 ) 617 Accrued compensation
(1,144 ) 989 Other liabilities (343 ) (42 )
Net cash used in
operating activities (15,565 ) (6,043 )
Investing
activities Payments for intellectual property licenses — (800 )
Purchases of property and equipment (1,888 ) (966 ) Purchases of
marketable securities 13,896 — Maturities of marketable securities
12,708 (1,766 )
Net cash provided by (used in) investing
activities 13,896 (966 )
Financing activities Principal
repayment of borrowings (6 ) (5 ) Proceeds from borrowings — —
Costs associated with debt issuance (20 ) (10 ) Proceeds from stock
option exercises 88 345
Net cash provided by
financing activities 62 330
Effect of exchange
rate changes on cash 14 7
Net decrease in cash and cash
equivalents (2,781 ) (7,472 ) Cash and cash equivalents at
beginning of period 15,959 35,385 Cash and cash
equivalents at end of period $ 13,178 $ 27,913
Non-cash investing and financing activities Transfer of
instruments from (to) property and equipment into inventory $ (415
) $ 38 Property and equipment costs included in accounts payable $
183 $ 285
Supplemental cash flow disclosures Cash paid for
income taxes, net $ 5 $ 13 Cash received for interest $ 108 $ 21
Cash paid for interest $ 347 $ 184
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170502006701/en/
GenMark Diagnostics, Inc.Hany Massarany, President/Chief
Executive Officer760-448-4325
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From Mar 2024 to Apr 2024
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From Apr 2023 to Apr 2024