GNMK GenMark Diagnostics Inc

First Quarter Revenue of $10.1 Million, Up 28% Versus Prior Year

XT-8 Installed Base Expanded by 22 to 562

European ePlex™ Launch on Track for Fourth Quarter 2015

Full Year Revenue Guidance Maintained at $38-40 Million

GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today reported first quarter 2015 financial results.

As previously reported, revenue for the first quarter of 2015 was $10.1 million, an increase of 28% over the prior year period. During the quarter, 22 additional XT-8 analyzers were placed in end-user laboratories, resulting in a total installed base of 562 analyzers within the U.S. market.

Gross profit for the first quarter was $6.1 million, or 61% of revenue, compared with $4.2 million, or 58% of revenue in the same period of 2014.

“Our XT-8 products continue to drive excellent revenue growth and gross margin,” said Hany Massarany, President and Chief Executive Officer of GenMark. “Last week we showcased our ePlex sample-to-answer system at major industry exhibitions in the U.S. and Europe. Customers were very enthusiastic about the functionality of ePlex, as well as the assay designs and initial data presented at these meetings. We remain on track for the European launch of ePlex in the fourth quarter of this year,” added Massarany.

Operating expenses for the first quarter of 2015 were $16.1 million compared to $13.1 million in the same period of 2014. The 24% 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 $0.24 per share for the first quarter of 2015 compared to a loss of $0.21 per share in the same period of 2014.

The Company ended the quarter with $71.0 million in cash and cash equivalents and intends to continue utilizing its cash balances to invest in the global commercialization of the ePlex platform.

Business Outlook

For full year 2015, the Company continues to expect revenue in the range of $38 to $40 million and gross margin in the range of 53-55%. The Company expects to place approximately 50 XT-8 analyzers in the first half of 2015, and 25-35 additional XT-8 analyzers in the second half of the year.

The Company will be hosting a conference call to discuss first quarter 2015 results in further detail on Tuesday, May 5, 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 21561248 approximately five minutes prior to the start time.

ABOUT GENMARK DIAGNOSTICS

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 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 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)     March 31, 2015 December 31, 2014 Current Assets Cash and cash equivalents $ 36,913 $ 36,855 Marketable Securities 34,041 33,651 Accounts receivable - net of allowances of $2,702 and $2,702, respectively 4,444 4,889 Inventories 2,148 2,137 Prepaid expenses and other current assets 770   575   Total current assets 78,316 78,107 Property and equipment, net 11,354 11,052 Intangible assets, net 1,806 1,870 Restricted cash 758 758 Other long-term assets 115   183   Total assets $ 92,349   $ 91,970   Current liabilities Accounts payable $ 3,390 $ 3,468 Accrued compensation 3,388 5,172 Loan payable — — Other current liabilities 2,832   3,653   Total current liabilities 9,610 12,293 Long-term liabilities Deferred rent 1,402 1,445 Long term debt 9,502 — Other non-current liabilities 249   208   Total liabilities 20,763   13,946   Stockholders’ equity Preferred stock, $0.0001 par value; 5,000 authorized, none issued — — Common stock, $0.0001 par value; 100,000 authorized; 42,128 and 41,859 shares issued and outstanding as of March 31, 2015 and December 31, 2014, respectively 4 4 Additional paid-in capital 343,925 340,502 Accumulated deficit (272,341 ) (262,472 ) Accumulated other comprehensive loss (2 ) (10 ) Total stockholders’ equity 71,586   78,024   Total liabilities and stockholders’ equity $ 92,349   $ 91,970       GENMARK DIAGNOSTICS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (In thousands, except per share data)   Three Months Ended March 31, 2015     2014   Revenue Product revenue $ 10,012 $ 7,866 License and other revenue 95   47   Total revenue 10,107 7,913 Cost of revenue 3,991   3,591   Gross profit 6,116 4,322 Operating expenses Sales and marketing 3,693 2,979 General and administrative 3,671 2,933 Research and development 8,779   7,270   Total operating expenses 16,143   13,182   Loss from operations (10,027 ) (8,860 ) Other income (expense) Interest income 36 86 Interest expense (73 ) (1 ) Other income (expense) 217   (2 )   Total other income (expense) 180   83   Loss before provision for income taxes (9,847 ) (8,777 ) Provision for income taxes 22   6   Net loss $ (9,869 )   $ (8,783 )   Net loss per share, basic and diluted $ (0.24 )   $ (0.21 )   Weighted average number of shares outstanding, basic and diluted 41,774   41,079   Other comprehensive loss Net loss $ (9,869 ) $ (8,783 ) Foreign currency translation adjustments 9   —   Net unrealized gains (losses) on available-for-sale investments, net of tax (17 ) 12   Comprehensive loss $ (9,877 )   $ (8,771 )       GENMARK DIAGNOSTICS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands)   Three Months Ended March 31, 2015   2014 Operating activities Net loss $ (9,869 ) $ (8,783 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 797 574 Amortization of premiums on investments 73 198 Amortization of deferred debt issuance costs 49 — Gain on sale of investment in preferred stock (223 ) — Stock-based compensation 2,339 1,389 Non-cash inventory adjustments 402 219 Other non-cash adjustments 20 — Changes in operating assets and liabilities: Accounts receivable 445 283 Inventories (366 ) 169 Prepaid expenses and other assets (216 ) 107 Accounts payable (775 ) (449 ) Accrued compensation (919 ) 10 Other liabilities (22 ) (101 ) Net cash used in operating activities (8,265 ) (6,384 ) Investing activities Change in restricted cash — — Purchase of available-for-sale securities (14,797 ) (13,039 ) Payments for intellectual property licenses (550 ) — Purchases of property and equipment (411 ) (1,149 ) Proceeds from sales of marketable securities and preferred stock 223 5,499 Maturities of short-term investments 14,350   7,250   Net cash used in investing activities (1,185 ) (1,439 ) Financing activities Principal repayment of borrowings (5 ) (42 ) Proceeds from borrowings 10,000 — Costs associated with debt issuance (700 ) — Proceeds from stock option exercises 222   25   Net cash provided by (used in) financing activities 9,517   (17 ) Effect of exchange rate changes on cash (9 ) —   Net decrease in cash and cash equivalents 58 (7,840 ) Cash and cash equivalents at beginning of period 36,855   35,723   Cash and cash equivalents at end of period $ 36,913   $ 27,883   Non-cash investing and financing activities Transfer of systems from property and equipment into inventory $ 48 $ 54 Property and equipment costs incurred but not paid included in accounts payable $ 818 $ 1,022 Supplemental cash flow disclosures Cash paid for income taxes, net $ 17 $ 8 Cash received for interest $ 109 $ 284 Cash paid for interest $ 73 $ 1  

GenMark Diagnostics, Inc.Hany MassaranyPresident/Chief Executive Officer760-448-4358