UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 17, 2013
GENMARK DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 001-34753
Delaware | 27-2053069 | |
(State or other jurisdiction of incorporation) |
(I.R.S. Employer Identification No.) |
5964 La Place Court, Suite 100
Carlsbad, California
(Address of principal executive offices, including zip code)
760-448-4300
(Registrants 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):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
On June 17, 2013, GenMark Diagnostics, Inc. (the Company) issued a press release announcing updated guidance for the Companys 2013 fiscal year. A copy of the press release is attached hereto as Exhibit 99.1.
The information furnished pursuant to this Current Report on Form 8-K, including Exhibit 99.1, 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.
(d) | The following exhibit is furnished with this Current Report: |
99.1 | Press release dated June 17, 2013. |
SIGNATURES
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. | ||||||
Date: June 17, 2013 | /s/ Eric Stier | |||||
Eric Stier | ||||||
Senior Vice President, General Counsel and Secretary |
EXHIBITS
Exhibit Number |
Description | |
99.1 | Press release dated June 17, 2013 |
Exhibit 99.1
June 17, 2013
GenMark Diagnostics Updates Annual Revenue Guidance
GenMark expects to grow 50% year over year despite revenue uncertainties from largest customer
CARLSBAD, Calif.(BUSINESS WIRE) GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today updated its annual revenue guidance for the year ending December 31, 2013. As a result of additional uncertainties relating to the future revenue contribution from its largest customer, together with persisting reimbursement and other challenges affecting the emerging pharmacogenomics market sector, the Company is updating its annual revenue guidance to approximately $ 30 million from its original estimate of approximately $ 35 million.
Our core business continues to exceed our expectations, with new customers, increasing placements of new analyzers and expanded menu utilization, stated GenMarks President & CEO Hany Massarany. As previously communicated, we remained prudently cautious regarding the future revenue contribution from the pharmacogenomics sector, including our single largest customer. In light of the recent developments which introduced additional uncertainty regarding this customer, we have taken a more conservative outlook and reduced our revenue expectations for the remainder of the year, Massarany further stated. Nevertheless, we believe the significant growth rates we are experiencing in our core business strengthen our position and support year-over-year growth of about 50%, resulting in approximately $ 30 million of annual revenue. Furthermore, we continue to make excellent progress toward the development of our NexGen sample-to-answer system, which we believe will fuel significant growth and our future success as a global leader in molecular diagnostics.
INVESTOR CONFERENCE CALL
GenMark will hold a conference call to discuss todays announcement at 4:45PM EDT today. The conference call and webcast can be accessed live through the Companys website 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 97857118 approximately five minutes prior to the start time.
ABOUT GENMARK
GenMark Diagnostics 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 GenMarks proprietary eSensor® detection technology, GenMarks 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. GenMark currently markets four tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Respiratory Virus Panel, Thrombophilia Risk Test, and Warfarin Sensitivity Test. A number of other tests, including HCV Genotyping, 2C19 Genotyping, and 3A4/3A5 Genotyping are available for research use only. 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 expected 2013 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, third-party payor reimbursement to our customers, the loss of a significant customer, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, 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.
Contacts
GenMark Diagnostics, Inc.
Hany Massarany
President & Chief Executive Officer
(760) 448-4358
Source: GenMark Diagnostics, Inc.