SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 9, 2018
GENMARK DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 001-34753
(State or other jurisdiction
5964 La Place Court
Carlsbad, California 92008
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
Emerging Growth Company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Selection 13(a) of the Exchange Act. o
Item 2.02. Results of Operations and Financial Condition.
On January 9, 2018, GenMark Diagnostics, Inc. (the "Company") issued a press release announcing its preliminary financial results for the fourth quarter and fiscal year ended December 31, 2017. A copy of the press release is attached hereto as Exhibit 99.1.
The information contained under this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 9.01. Financial Statements and Exhibits.
The following exhibit is furnished with this Current Report:
Press release dated January 9, 2018
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
GENMARK DIAGNOSTICS, INC.
January 9, 2018
/s/ Scott Mendel
Chief Financial Officer
January 9, 2018
GenMark Diagnostics Provides Preliminary Operational and Financial Results for 2017
CARLSBAD, Calif - GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today provided preliminary operational and financial results for the year ended December 31, 2017.
Total revenue for 2017 expected to be approximately $52.5 million, representing an increase of 7% over 2016
Total revenue for the fourth quarter of 2017 expected to be approximately $16.0 million, representing an increase of 8% over the fourth quarter of 2016
Placed 49 ePlex® analyzers in the fourth quarter of 2017
Finished the quarter with an installed base of 196 ePlex analyzers in U.S. and European labs
Launched ePlex NP targeting customers with lower testing volumes, contributing to fourth quarter placements
Initiated the first of three clinical trials for the ePlex BCID family of panels
“Our commercial teams
delivered another quarter of strong ePlex placements. With a growing portion of this installed base now in routine clinical use, ePlex is beginning to make a meaningful contribution to our revenues. We expect this trend to continue in 2018, based on the strength of our sales funnel and the changes we are making to optimize our approach in Europe," said Hany Massarany, President and Chief Executive Officer. "We are also delighted with the recent launch of ePlex NP – a new configuration of the ePlex system designed to improve patient access to multiplex molecular diagnostics and drive ePlex adoption in lower volume testing sites,” added Massarany.
These preliminary results are based on management's initial analysis of operations for the quarter and year ended December 31, 2017 and are subject to further internal review and audit by the company's external auditors. The company expects to issue full 2017 financial results and 2018 guidance in late February.
About GenMark Diagnostics
GenMark Diagnostics (NASDAQ: GNMK) is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. Utilizing GenMark's proprietary eSensor® detection technology, GenMark's eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream, and gastrointestinal infections. 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 preliminary, unaudited 2017 financial performance, regulatory submissions and approvals, and the timely and effective commercialization and clinical impact of our ePlex system, 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, our preliminary 2017 financial results are unaudited results based on management’s current expectations and are subject to closing and year-end audit adjustments, 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.
Investor Relations Contact
Lynn Pieper Lewis or Leigh Salvo