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): October 8, 2020
|GENMARK DIAGNOSTICS, INC.|
|(Exact name of registrant as specified in its Charter)|
|(State or other jurisdiction of incorporation)||(Commission File Number)||(IRS Employer Identification No.)|
|5964 La Place Court|
|(Address of principal executive office)||(Zip Code)|
Registrant’s telephone number, including area code: (760) 448-4300
|(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))
|Securities registered pursuant to Section 12(b) of the Act:|
|Title of each class||Trading|
|Name of each exchange on which registered|
|Common Stock, par value $0.0001 per share||GNMK||The NASDAQ Stock Market LLC|
|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 ||☐|
|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.||☐|
Item 2.02. Results of Operations and Financial Condition.
On October 8, 2020, GenMark Diagnostics, Inc. (the “Company”) issued a press release announcing its preliminary financial results for the fiscal quarter ended September 30, 2020. 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.
(d) Exhibits. The exhibits shall be deemed to be filed or furnished, depending on the relevant item requiring such exhibit, in accordance with the provisions of Item 601 of Regulation S-K (17 CFR 229.601) and Instruction B.2 to this form.
Press release dated October 8, 2020
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
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:||October 8, 2020||/s/ Eric Stier|
|Senior Vice President, General Counsel and Secretary|
October 8, 2020
GenMark Diagnostics Provides Preliminary Financial Results for Third Quarter 2020
Third Quarter 2020 Revenue Expected to Represent Approximately 104% Year-Over-Year Growth
CARLSBAD, Calif. - GenMark Diagnostics, Inc. (NASDAQ:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today provided preliminary financial results for the quarter ended September 30, 2020.
Third Quarter 2020 Highlights
•Placed net 70 ePlex® analyzers, finishing the quarter with a global installed base of more than 720 ePlex analyzers, an increase of 47% versus the third quarter of 2019
•Total revenue expected to be approximately $42.6 million, representing an increase of 104% over the third quarter of 2019
–ePlex revenue expected to be approximately $38.0 million, an increase of 187% compared to the third quarter of 2019
–Average annuity per analyzer of approximately $193,000, up 82% over the third quarter of 2019
–Exited the quarter with ePlex Respiratory Pathogen Panel 2 (RP2) revenue representing approximately 63% of ePlex consumable revenue, driven by the growing number of customer conversions from ePlex SARS-CoV-2 to RP2 ahead of respiratory season
•Gross margin expected to be in the range of 38% to 39%, compared to 34% in the third quarter of 2019
“I am extremely proud of the hard work and meaningful progress our team has made during these unprecedented times,” said Scott Mendel, President and Chief Executive Officer. “We continued to see strong demand for both ePlex systems and consumables, including a significant portion of our customers adopting sample-to-answer syndromic testing for the first time. In addition to our commercial successes in the quarter, our manufacturing expansion effort remains on track to meet our capacity goal of 150,000 to 175,000 tests per month by the end of 2020 and 200,000 per month by the end of first quarter of 2021,” concluded Mendel.
These preliminary results are based on management's initial analysis of operations for the quarter ended September 30, 2020 and are subject to further internal review. The company expects to issue full third quarter 2020 financial results in late October.
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 financial and operational performance, our ability to secure enduring revenue streams extending beyond the COVID-19 pandemic, regulatory submissions and approvals, and plans and objectives of management, 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, disruptions to our supply chain, audit adjustments to our preliminary results, our ability to successfully obtain 510(k) market clearance for our EUA products, constraints or inefficiencies caused by unanticipated acceleration and deceleration of customer demand, our ability to retain customers beyond the COVID-19 pandemic, 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.
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